Gastric outlet obstruction: A red flag, potentially manageable

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Gastric outlet obstruction: A red flag, potentially manageable

A 72-year-old woman presents to the emergency department with progressive nausea and vomiting. One week earlier, she developed early satiety and nausea with vomiting after eating solid food. Three days later her symptoms progressed, and she became unable to take anything by mouth. The patient also experienced a 40-lb weight loss in the previous 3 months. She denies symptoms of abdominal pain, hematemesis, or melena. Her medical history includes cholecystectomy and type 2 diabetes mellitus, diagnosed 1 year ago. She has no family history of gastrointestinal malignancy. She says she smoked 1 pack a day in her 20s. She does not consume alcohol.

On physical examination, she is normotensive with a heart rate of 105 beats per minute. The oral mucosa is dry, and the abdomen is mildly distended and tender to palpation in the epigastrium. Laboratory evaluation reveals hypokalemia and metabolic alkalosis.

Computed tomography (CT) reveals a mass 3 cm by 4 cm in the pancreatic head. The mass has invaded the medial wall of the duodenum, with obstruction of the pancreatic and common bile ducts and extension into and occlusion of the superior mesenteric vein, with soft-tissue expansion around the superior mesenteric artery. CT also reveals retained stomach contents and an air-fluid level consistent with gastric outlet obstruction.

INTRINSIC OR EXTRINSIC BLOCKAGE

Gastric outlet obstruction, also called pyloric obstruction, is caused by intrinsic or extrinsic mechanical blockage of gastric emptying, generally in the distal stomach, pyloric channel, or duodenum, with associated symptoms of nausea, vomiting, abdominal pain, and early satiety. It is encountered in both the clinic and the hospital.

Here, we review the causes, diagnosis, and management of this disorder.

BENIGN AND MALIGNANT CAUSES

Causes of obstruction are classified as either benign or malignant (Table 1). However, all cases of gastric outlet obstruction should be assumed to be due to underlying malignancy unless proven otherwise.1

In a retrospective study of 76 patients hospitalized with gastric outlet obstruction between 2006 and 2015 at our institution,2 29 cases (38%) were due to malignancy and 47 (62%) were due to benign causes. Pancreatic adenocarcinoma accounted for 13 cases (17%), while gastric adenocarcinoma accounted for 5 cases (7%); less common malignant causes were cholangiocarcinoma, cancer of the ampulla of Vater, duodenal adenocarcinoma, hepatocellular carcinoma, and metastatic disease. Of the benign causes, the most common were peptic ulcer disease (13 cases, 17%) and postoperative strictures or adhesions (11 cases, 14%).

These numbers reflect general trends around the world.

Less gastric cancer, more pancreatic cancer

The last several decades have seen a trend toward more cases due to cancer and fewer due to benign causes.3–14

In earlier studies in both developed and developing countries, gastric adenocarcinoma was the most common malignant cause of gastric outlet obstruction. Since then, it has become less common in Western countries, although it remains more common in Asia and Africa.7–14 This trend likely reflects environmental factors, including decreased prevalence of Helicobacter pylori infection, a major risk factor for gastric cancer, in Western countries.15–17

At the same time, pancreatic cancer is on the rise,16 and up to 20% of patients with pancreatic cancer develop gastric outlet obstruction.18 In a prospective observational study of 108 patients with malignant gastric outlet obstruction undergoing endoscopic stenting, pancreatic cancer was by far the most common malignancy, occurring in 54% of patients, followed by gastric cancer in 13%.19

Less peptic ulcer disease, but still common

Peptic ulcer disease used to account for up to 90% of cases of gastric outlet obstruction, and it is still the most common benign cause.

In 1990, gastric outlet obstruction was estimated to occur in 5% to 10% of all hospital admissions for ulcer-related complications, accounting for 2,000 operations annually.20,21 Gastric outlet obstruction now occurs in fewer than 5% of patients with duodenal ulcer disease and fewer than 2% of patients with gastric ulcer disease.22

Peptic ulcer disease remains an important cause of obstruction in countries with poor access to acid-suppressing drugs.23

Gastric outlet obstruction occurs in both acute and chronic peptic ulcer disease. In acute peptic ulcer disease, tissue inflammation and edema result in mechanical obstruction. Chronic peptic ulcer disease results in tissue scarring and fibrosis with strictures.20

Environmental factors, including improved diet, hygiene, physical activity, and the decreased prevalence of H pylori infection, also contribute to the decreased prevalence of peptic ulcer disease and its complications, including gastric outlet obstruction.3 The continued occurrence of peptic ulcer disease is associated with widespread use of low-dose aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), the most common causes of peptic ulcer disease in Western countries.24,25

Other nonmalignant causes of gastric outlet obstruction are diverse and less common. They include caustic ingestion, postsurgical strictures, benign tumors of the gastrointestinal tract, Crohn disease, and pancreatic disorders including acute pancreatitis, pancreatic pseudocyst, chronic pancreatitis, and annular pancreas. Intramural duodenal hematoma may cause obstruction after blunt abdominal trauma, endoscopic biopsy, or gastrostomy tube migration, especially in the setting of a bleeding disorder or anticoagulation.26

Tuberculosis should be suspected in countries in which it is common.7 In a prospective study of 64 patients with benign gastric outlet obstruction in India,27 16 (25%) had corrosive injury, 16 (25%) had tuberculosis, and 15 (23%) had peptic ulcer disease. Compared with patients with corrosive injury and peptic ulcer disease, patients with gastroduodenal tuberculosis had the best outcomes with appropriate treatment.

Other reported causes include Bouveret syndrome (an impacted gallstone in the proximal duodenum), phytobezoar, diaphragmatic hernia, gastric volvulus, and Ladd bands (peritoneal bands associated with intestinal malrotation).7,28,29

 

 

PRESENTING SYMPTOMS

Symptoms of gastric outlet obstruction include nausea, nonbilious vomiting, epigastric pain, early satiety, abdominal distention, and weight loss.

In our patients, the most common presenting symptoms were nausea and vomiting (80%), followed by abdominal pain (72%); weight loss (15%), abdominal distention (15%), and early satiety (9%) were less common.2

Patients with gastric outlet obstruction secondary to malignancy generally present with a shorter duration of symptoms than those with peptic ulcer disease and are more likely to be older.8,13 Other conditions with an acute onset of symptoms include gastric polyp prolapse, percutaneous endoscopic gastrostomy tube migration, gastric volvulus, and gallstone impaction.

Patients with gastric outlet obstruction associated with peptic ulcer disease generally have a long-standing history of symptoms, including dyspepsia and weight loss over several years.4

SIGNS ON EXAMINATION

On examination, look for signs of chronic gastric obstruction and its consequences, such as malnutrition, cachexia, volume depletion, and dental erosions.

A succussion splash may suggest gastric outlet obstruction. This is elicited by rocking the patient back and forth by the hips or abdomen while listening over the stomach for a splash, which may be heard without a stethoscope. The test is considered positive if present 3 or more hours after drinking fluids and suggests retention of gastric materials.30,31

In thin individuals, chronic gastric outlet obstruction makes the stomach dilate and hypertrophy, which may be evident by a palpably thickened stomach with visible gastric peristalsis.4

Other notable findings on physical examination may include a palpable abdominal mass, epigastric pain, or an abnormality suggestive of metastatic gastric cancer, such as an enlarged left supraclavicular lymph node (Virchow node) or periumbilical lymph node (Sister Mary Joseph nodule). The Virchow node is at the junction of the thoracic duct and the left subclavian vein where the lymphatic circulation from the body drains into the systemic circulation, and it may be the first sign of gastric cancer.32 Sister Mary Joseph nodule (named after a surgical assistant to Dr. William James Mayo) refers to a palpable mass at the umbilicus, generally resulting from metastasis of an abdominal malignancy.33

SIGNS ON FURTHER STUDIES

Laboratory evaluation may show signs of poor oral intake and electrolyte abnormalities secondary to chronic nausea, vomiting, and dehydration, including hypochloremic metabolic alkalosis and hypokalemia.

The underlying cause of gastric outlet obstruction has major implications for treatment and prognosis and cannot be differentiated by clinical presentation alone.1,9 Diagnosis is based on clinical features and radiologic or endoscopic evaluation consistent with gastric outlet obstruction.

Plain radiography may reveal an enlarged gastric bubble, and contrast studies may be useful to determine whether the obstruction is partial or complete, depending on whether the contrast passes into the small bowel.

Figure 1. Computed tomography of the abdomen in the axial plane shows gastric distention (A, arrow) and a 3.9-cm mass at the pancreatic head, with compression of the descending duodenum (B, arrow), resulting in gastric outlet obstruction. The patient, a 72-year-old woman, presented with 1 week of nausea and vomiting and was found to have pancreatic cancer. She was treated with endoscopic stenting.
CT or magnetic resonance imaging may show gastric distention with retained stomach contents, suggesting a gastric, pyloric, duodenal, or pancreatic mass (Figure 1).

Upper endoscopy is often needed to establish the diagnosis and cause. Emptying the stomach with a nasogastric tube is recommended before endoscopy to minimize the risk of aspiration during the procedure, and endotracheal intubation should be considered for airway protection.34 Findings of gastric outlet obstruction on upper endoscopy include retained food and liquid. Endoscopic biopsy is important to differentiate between benign and malignant causes. For patients with malignancy, endoscopic ultrasonography is useful for diagnosis via tissue sampling with fine-needle aspiration and locoregional staging.35

A strategy. Most patients whose clinical presentation suggests gastric outlet obstruction require cross-sectional radiologic imaging, upper endoscopy, or both.36 CT is the preferred imaging study to evaluate for intestinal obstruction.36,37 Patients with suspected complete obstruction or perforation should undergo CT before upper endoscopy. Oral contrast may interfere with endoscopy and should be avoided if endoscopy is planned. Additionally, giving oral contrast may worsen patient discomfort and increase the risk of nausea, vomiting, and aspiration.36,37

Following radiographic evaluation, upper endoscopy can be performed after gastric decompression to identify the location and extent of the obstruction and to potentially provide a definitive diagnosis with biopsy.36

DIFFERENTIATE FROM GASTROPARESIS

Gastroparesis is a chronic neuromuscular disorder characterized by delayed gastric emptying without mechanical obstruction.38 The most common causes are diabetes, surgery, and idiopathy. Other causes include viral infection, connective tissue diseases, ischemia, infiltrative disorders, radiation, neurologic disorders, and paraneoplastic syndromes.39,40

Gastric outlet obstruction and gastroparesis share clinical symptoms including nausea, vomiting, abdominal pain, early satiety, and weight loss and are important to differentiate.36,38 Although abdominal pain may be present in both gastric outlet obstruction and gastroparesis, in gastroparesis it tends not to be the dominant symptom.40

Gastric scintigraphy is most commonly used to objectively quantify delayed gastric emptying.39 Upper endoscopy is imperative to exclude mechanical obstruction.39

 

 

MANAGEMENT

Initially, patients with signs and symptoms of gastric outlet obstruction should be given:

  • Nothing by mouth (NPO)
  • Intravenous fluids to correct volume depletion and electrolyte abnormalities
  • A nasogastric tube for gastric decompression and symptom relief if symptoms persist despite being NPO
  • A parenteral proton pump inhibitor, regardless of the cause of obstruction, to decrease gastric secretions41
  • Medications for pain and nausea, if needed.

Definitive treatment of gastric outlet obstruction depends on the underlying cause, whether benign or malignant.

Management of benign gastric outlet obstruction

Symptoms of gastric outlet obstruction resolve spontaneously in about half of cases caused by acute peptic ulcer disease, as acute inflammation resolves.9,22

Endoscopic dilation is an important option in patients with benign gastric outlet obstruction, including peptic ulcer disease. Peptic ulcer disease-induced gastric outlet obstruction can be safely treated with endoscopic balloon dilation. This treatment almost always relieves symptoms immediately; however, the long-term response has varied from 16% to 100%, and patients may require more than 1 dilation procedure.25,42,43 The need for 2 or more dilation procedures may predict need for surgery.44 Gastric outlet obstruction after caustic ingestion or endoscopic submucosal dissection may also respond to endoscopic balloon dilation.36

Eradication of H pylori may be effective and lead to complete resolution of symptoms in patients with gastric outlet obstruction due to this infection.45–47

NSAIDs should be discontinued in patients with peptic ulcer disease and gastric outlet obstruction. These drugs damage the gastrointestinal mucosa by inhibiting cyclo-oxygenase (COX) enzymes and decreasing synthesis of prostaglandins, which are important for mucosal defense.48 Patients may be unaware of NSAIDs contained in over-the-counter medications and may have difficulty discontinuing NSAIDs taken for pain.49

These drugs are an important cause of refractory peptic ulcer disease and can be detected by platelet COX activity testing, although this test is not widely available. In a study of patients with peptic ulcer disease without definite NSAID use or H pylori infection, up to one-third had evidence of surreptitious NSAID use as detected by platelet COX activity testing.50 In another study,51 platelet COX activity testing discovered over 20% more aspirin users than clinical history alone.

Surgery for patients with benign gastric outlet obstruction is used only when medical management and endoscopic dilation fail. Ideally, surgery should relieve the obstruction and target the underlying cause, such as peptic ulcer disease. Laparoscopic surgery is generally preferred to open surgery because patients can resume oral intake sooner, have a shorter hospital stay, and have less intraoperative blood loss.52 The simplest surgical procedure to relieve obstruction is laparoscopic gastrojejunostomy.

Patients with gastric outlet obstruction and peptic ulcer disease warrant laparoscopic vagotomy and antrectomy or distal gastrectomy. This removes the obstruction and the stimulus for gastric secretion.53 An alternative is vagotomy with a drainage procedure (pyloroplasty or gastrojejunostomy), which has a similar postoperative course and reduction in gastric acid secretion compared with antrectomy or distal gastrectomy.53,54

Daily proton pump inhibitors can be used for patients with benign gastric outlet obstruction not associated with peptic ulcer disease or risk factors; for such cases, vagotomy is not required.

Management of malignant gastric outlet obstruction

Patients with malignant gastric outlet obstruction may have intractable nausea and abdominal pain secondary to retention of gastric contents. The major goal of therapy is to improve symptoms and restore tolerance of an oral diet. The short-term prognosis of malignant gastric outlet obstruction is poor, with a median survival of 3 to 4 months, as these patients often have unresectable disease.55

Surgical bypass used to be the standard of care for palliation of malignant gastric obstruction, but that was before endoscopic stenting was developed.

Endoscopic stenting allows patients to resume oral intake and get out of the hospital sooner with fewer complications than with open surgical bypass. It may be a more appropriate option for palliation of symptoms in patients with malignant obstruction who have a poor prognosis and prefer a less invasive intervention.55,56

Figure 2. Esophagogastroduodenoscopy (A) shows a large submucosal mass in the duodenal bulb (upper arrow), with localized erosions (lower arrow). The mass was 40 × 41 mm in cross-sectional diameter on endoscopic ultrasonography. Fine-needle aspiration and pathology study revealed pancreatic adenocarcinoma. The obstruction was successfully opened (B) with a 22-mm × 12-cm WallFlex stent (Boston Scientific). The patient tolerated a liquid diet after the procedure.

Endoscopic duodenal stenting of malignant gastric outlet obstruction has a success rate of greater than 90%, and most patients can tolerate a mechanical soft diet afterward.34 The procedure is usually performed with a 9-cm or 12-cm self-expanding duodenal stent, 22 mm in diameter, placed over a guide wire under endoscopic and fluoroscopic guidance (Figure 2). The stent is placed by removing the outer catheter, with distal-to-proximal stent deployment.

Patients who also have biliary obstruction may require biliary stent placement, which is generally performed before duodenal stenting. For patients with an endoscopic stent who develop biliary obstruction, endoscopic retrograde cholangiopancreatography can be attempted with placement of a biliary stent; however, these patients may require biliary drain placement by percutaneous transhepatic cholangiography or by endoscopic ultrasonographically guided transduodenal or transgastric biliary drainage.

From 20% to 30% of patients require repeated endoscopic stent placement, although most patients die within several months after stenting.34 Surgical options for patients who do not respond to endoscopic stenting include open or laparoscopic gastrojejunostomy.55

Laparoscopic gastrojejunostomy may provide better long-term outcomes than duodenal stenting for patients with malignant gastric outlet obstruction and a life expectancy longer than a few months.

A 2017 retrospective study of 155 patients with gastric outlet obstruction secondary to unresectable gastric cancer suggested that those who underwent laparoscopic gastrojejunostomy had better oral intake, better tolerance of chemotherapy, and longer overall survival than those who underwent duodenal stenting. Postsurgical complications were more common in the laparoscopic gastrojejunostomy group (16%) than in the duodenal stenting group (0%).57

In most of the studies comparing endoscopic stenting with surgery, the surgery was open gastrojejunostomy; there are limited data directly comparing stenting with laparoscopic gastrojejunostomy.55 Endoscopic stenting is estimated to be significantly less costly than surgery, with a median cost of $12,000 less than gastrojejunostomy.58 As an alternative to enteral stenting and surgical gastrojejunostomy, ultrasonography-guided endoscopic gastrojejunostomy or gastroenterostomy with placement of a lumen-apposing metal stent is emerging as a third treatment option and is under active investigation.59

Patients with malignancy that is potentially curable by resection should undergo surgical evaluation before consideration of endoscopic stenting. For patients who are not candidates for surgery or endoscopic stenting, a percutaneous gastrostomy tube can be considered for gastric decompression and symptom relief.

CASE CONCLUDED

The patient underwent esophagogastroduodenoscopy with endoscopic ultrasonography for evaluation of her pancreatic mass. Before the procedure, she was intubated to minimize the risk of aspiration due to persistent nausea and retained gastric contents. A large submucosal mass was found in the duodenal bulb. Endoscopic ultrasonography showed a mass within the pancreatic head with pancreatic duct obstruction. Fine-needle aspiration biopsy was performed, and pathology study revealed pancreatic adenocarcinoma. The patient underwent stenting with a 22-mm by 12-cm WallFlex stent (Boston Scientific), which led to resolution of nausea and advancement to a mechanical soft diet on hospital discharge.

She was scheduled for follow-up in the outpatient clinic for treatment of pancreatic cancer.

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Andree H. Koop, MD
Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

William C. Palmer, MD
Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL

Fernando F. Stancampiano, MD
Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

Address: Fernando F. Stancampiano, MD, Division of Community Internal Medicine, Mayo Clinic, 4500 San Pablo Road S, Jacksonville, FL 32224; [email protected]

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Cleveland Clinic Journal of Medicine - 86(5)
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Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

William C. Palmer, MD
Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL

Fernando F. Stancampiano, MD
Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

Address: Fernando F. Stancampiano, MD, Division of Community Internal Medicine, Mayo Clinic, 4500 San Pablo Road S, Jacksonville, FL 32224; [email protected]

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Andree H. Koop, MD
Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

William C. Palmer, MD
Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL

Fernando F. Stancampiano, MD
Division of Community Internal Medicine, Mayo Clinic, Jacksonville, FL

Address: Fernando F. Stancampiano, MD, Division of Community Internal Medicine, Mayo Clinic, 4500 San Pablo Road S, Jacksonville, FL 32224; [email protected]

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A 72-year-old woman presents to the emergency department with progressive nausea and vomiting. One week earlier, she developed early satiety and nausea with vomiting after eating solid food. Three days later her symptoms progressed, and she became unable to take anything by mouth. The patient also experienced a 40-lb weight loss in the previous 3 months. She denies symptoms of abdominal pain, hematemesis, or melena. Her medical history includes cholecystectomy and type 2 diabetes mellitus, diagnosed 1 year ago. She has no family history of gastrointestinal malignancy. She says she smoked 1 pack a day in her 20s. She does not consume alcohol.

On physical examination, she is normotensive with a heart rate of 105 beats per minute. The oral mucosa is dry, and the abdomen is mildly distended and tender to palpation in the epigastrium. Laboratory evaluation reveals hypokalemia and metabolic alkalosis.

Computed tomography (CT) reveals a mass 3 cm by 4 cm in the pancreatic head. The mass has invaded the medial wall of the duodenum, with obstruction of the pancreatic and common bile ducts and extension into and occlusion of the superior mesenteric vein, with soft-tissue expansion around the superior mesenteric artery. CT also reveals retained stomach contents and an air-fluid level consistent with gastric outlet obstruction.

INTRINSIC OR EXTRINSIC BLOCKAGE

Gastric outlet obstruction, also called pyloric obstruction, is caused by intrinsic or extrinsic mechanical blockage of gastric emptying, generally in the distal stomach, pyloric channel, or duodenum, with associated symptoms of nausea, vomiting, abdominal pain, and early satiety. It is encountered in both the clinic and the hospital.

Here, we review the causes, diagnosis, and management of this disorder.

BENIGN AND MALIGNANT CAUSES

Causes of obstruction are classified as either benign or malignant (Table 1). However, all cases of gastric outlet obstruction should be assumed to be due to underlying malignancy unless proven otherwise.1

In a retrospective study of 76 patients hospitalized with gastric outlet obstruction between 2006 and 2015 at our institution,2 29 cases (38%) were due to malignancy and 47 (62%) were due to benign causes. Pancreatic adenocarcinoma accounted for 13 cases (17%), while gastric adenocarcinoma accounted for 5 cases (7%); less common malignant causes were cholangiocarcinoma, cancer of the ampulla of Vater, duodenal adenocarcinoma, hepatocellular carcinoma, and metastatic disease. Of the benign causes, the most common were peptic ulcer disease (13 cases, 17%) and postoperative strictures or adhesions (11 cases, 14%).

These numbers reflect general trends around the world.

Less gastric cancer, more pancreatic cancer

The last several decades have seen a trend toward more cases due to cancer and fewer due to benign causes.3–14

In earlier studies in both developed and developing countries, gastric adenocarcinoma was the most common malignant cause of gastric outlet obstruction. Since then, it has become less common in Western countries, although it remains more common in Asia and Africa.7–14 This trend likely reflects environmental factors, including decreased prevalence of Helicobacter pylori infection, a major risk factor for gastric cancer, in Western countries.15–17

At the same time, pancreatic cancer is on the rise,16 and up to 20% of patients with pancreatic cancer develop gastric outlet obstruction.18 In a prospective observational study of 108 patients with malignant gastric outlet obstruction undergoing endoscopic stenting, pancreatic cancer was by far the most common malignancy, occurring in 54% of patients, followed by gastric cancer in 13%.19

Less peptic ulcer disease, but still common

Peptic ulcer disease used to account for up to 90% of cases of gastric outlet obstruction, and it is still the most common benign cause.

In 1990, gastric outlet obstruction was estimated to occur in 5% to 10% of all hospital admissions for ulcer-related complications, accounting for 2,000 operations annually.20,21 Gastric outlet obstruction now occurs in fewer than 5% of patients with duodenal ulcer disease and fewer than 2% of patients with gastric ulcer disease.22

Peptic ulcer disease remains an important cause of obstruction in countries with poor access to acid-suppressing drugs.23

Gastric outlet obstruction occurs in both acute and chronic peptic ulcer disease. In acute peptic ulcer disease, tissue inflammation and edema result in mechanical obstruction. Chronic peptic ulcer disease results in tissue scarring and fibrosis with strictures.20

Environmental factors, including improved diet, hygiene, physical activity, and the decreased prevalence of H pylori infection, also contribute to the decreased prevalence of peptic ulcer disease and its complications, including gastric outlet obstruction.3 The continued occurrence of peptic ulcer disease is associated with widespread use of low-dose aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), the most common causes of peptic ulcer disease in Western countries.24,25

Other nonmalignant causes of gastric outlet obstruction are diverse and less common. They include caustic ingestion, postsurgical strictures, benign tumors of the gastrointestinal tract, Crohn disease, and pancreatic disorders including acute pancreatitis, pancreatic pseudocyst, chronic pancreatitis, and annular pancreas. Intramural duodenal hematoma may cause obstruction after blunt abdominal trauma, endoscopic biopsy, or gastrostomy tube migration, especially in the setting of a bleeding disorder or anticoagulation.26

Tuberculosis should be suspected in countries in which it is common.7 In a prospective study of 64 patients with benign gastric outlet obstruction in India,27 16 (25%) had corrosive injury, 16 (25%) had tuberculosis, and 15 (23%) had peptic ulcer disease. Compared with patients with corrosive injury and peptic ulcer disease, patients with gastroduodenal tuberculosis had the best outcomes with appropriate treatment.

Other reported causes include Bouveret syndrome (an impacted gallstone in the proximal duodenum), phytobezoar, diaphragmatic hernia, gastric volvulus, and Ladd bands (peritoneal bands associated with intestinal malrotation).7,28,29

 

 

PRESENTING SYMPTOMS

Symptoms of gastric outlet obstruction include nausea, nonbilious vomiting, epigastric pain, early satiety, abdominal distention, and weight loss.

In our patients, the most common presenting symptoms were nausea and vomiting (80%), followed by abdominal pain (72%); weight loss (15%), abdominal distention (15%), and early satiety (9%) were less common.2

Patients with gastric outlet obstruction secondary to malignancy generally present with a shorter duration of symptoms than those with peptic ulcer disease and are more likely to be older.8,13 Other conditions with an acute onset of symptoms include gastric polyp prolapse, percutaneous endoscopic gastrostomy tube migration, gastric volvulus, and gallstone impaction.

Patients with gastric outlet obstruction associated with peptic ulcer disease generally have a long-standing history of symptoms, including dyspepsia and weight loss over several years.4

SIGNS ON EXAMINATION

On examination, look for signs of chronic gastric obstruction and its consequences, such as malnutrition, cachexia, volume depletion, and dental erosions.

A succussion splash may suggest gastric outlet obstruction. This is elicited by rocking the patient back and forth by the hips or abdomen while listening over the stomach for a splash, which may be heard without a stethoscope. The test is considered positive if present 3 or more hours after drinking fluids and suggests retention of gastric materials.30,31

In thin individuals, chronic gastric outlet obstruction makes the stomach dilate and hypertrophy, which may be evident by a palpably thickened stomach with visible gastric peristalsis.4

Other notable findings on physical examination may include a palpable abdominal mass, epigastric pain, or an abnormality suggestive of metastatic gastric cancer, such as an enlarged left supraclavicular lymph node (Virchow node) or periumbilical lymph node (Sister Mary Joseph nodule). The Virchow node is at the junction of the thoracic duct and the left subclavian vein where the lymphatic circulation from the body drains into the systemic circulation, and it may be the first sign of gastric cancer.32 Sister Mary Joseph nodule (named after a surgical assistant to Dr. William James Mayo) refers to a palpable mass at the umbilicus, generally resulting from metastasis of an abdominal malignancy.33

SIGNS ON FURTHER STUDIES

Laboratory evaluation may show signs of poor oral intake and electrolyte abnormalities secondary to chronic nausea, vomiting, and dehydration, including hypochloremic metabolic alkalosis and hypokalemia.

The underlying cause of gastric outlet obstruction has major implications for treatment and prognosis and cannot be differentiated by clinical presentation alone.1,9 Diagnosis is based on clinical features and radiologic or endoscopic evaluation consistent with gastric outlet obstruction.

Plain radiography may reveal an enlarged gastric bubble, and contrast studies may be useful to determine whether the obstruction is partial or complete, depending on whether the contrast passes into the small bowel.

Figure 1. Computed tomography of the abdomen in the axial plane shows gastric distention (A, arrow) and a 3.9-cm mass at the pancreatic head, with compression of the descending duodenum (B, arrow), resulting in gastric outlet obstruction. The patient, a 72-year-old woman, presented with 1 week of nausea and vomiting and was found to have pancreatic cancer. She was treated with endoscopic stenting.
CT or magnetic resonance imaging may show gastric distention with retained stomach contents, suggesting a gastric, pyloric, duodenal, or pancreatic mass (Figure 1).

Upper endoscopy is often needed to establish the diagnosis and cause. Emptying the stomach with a nasogastric tube is recommended before endoscopy to minimize the risk of aspiration during the procedure, and endotracheal intubation should be considered for airway protection.34 Findings of gastric outlet obstruction on upper endoscopy include retained food and liquid. Endoscopic biopsy is important to differentiate between benign and malignant causes. For patients with malignancy, endoscopic ultrasonography is useful for diagnosis via tissue sampling with fine-needle aspiration and locoregional staging.35

A strategy. Most patients whose clinical presentation suggests gastric outlet obstruction require cross-sectional radiologic imaging, upper endoscopy, or both.36 CT is the preferred imaging study to evaluate for intestinal obstruction.36,37 Patients with suspected complete obstruction or perforation should undergo CT before upper endoscopy. Oral contrast may interfere with endoscopy and should be avoided if endoscopy is planned. Additionally, giving oral contrast may worsen patient discomfort and increase the risk of nausea, vomiting, and aspiration.36,37

Following radiographic evaluation, upper endoscopy can be performed after gastric decompression to identify the location and extent of the obstruction and to potentially provide a definitive diagnosis with biopsy.36

DIFFERENTIATE FROM GASTROPARESIS

Gastroparesis is a chronic neuromuscular disorder characterized by delayed gastric emptying without mechanical obstruction.38 The most common causes are diabetes, surgery, and idiopathy. Other causes include viral infection, connective tissue diseases, ischemia, infiltrative disorders, radiation, neurologic disorders, and paraneoplastic syndromes.39,40

Gastric outlet obstruction and gastroparesis share clinical symptoms including nausea, vomiting, abdominal pain, early satiety, and weight loss and are important to differentiate.36,38 Although abdominal pain may be present in both gastric outlet obstruction and gastroparesis, in gastroparesis it tends not to be the dominant symptom.40

Gastric scintigraphy is most commonly used to objectively quantify delayed gastric emptying.39 Upper endoscopy is imperative to exclude mechanical obstruction.39

 

 

MANAGEMENT

Initially, patients with signs and symptoms of gastric outlet obstruction should be given:

  • Nothing by mouth (NPO)
  • Intravenous fluids to correct volume depletion and electrolyte abnormalities
  • A nasogastric tube for gastric decompression and symptom relief if symptoms persist despite being NPO
  • A parenteral proton pump inhibitor, regardless of the cause of obstruction, to decrease gastric secretions41
  • Medications for pain and nausea, if needed.

Definitive treatment of gastric outlet obstruction depends on the underlying cause, whether benign or malignant.

Management of benign gastric outlet obstruction

Symptoms of gastric outlet obstruction resolve spontaneously in about half of cases caused by acute peptic ulcer disease, as acute inflammation resolves.9,22

Endoscopic dilation is an important option in patients with benign gastric outlet obstruction, including peptic ulcer disease. Peptic ulcer disease-induced gastric outlet obstruction can be safely treated with endoscopic balloon dilation. This treatment almost always relieves symptoms immediately; however, the long-term response has varied from 16% to 100%, and patients may require more than 1 dilation procedure.25,42,43 The need for 2 or more dilation procedures may predict need for surgery.44 Gastric outlet obstruction after caustic ingestion or endoscopic submucosal dissection may also respond to endoscopic balloon dilation.36

Eradication of H pylori may be effective and lead to complete resolution of symptoms in patients with gastric outlet obstruction due to this infection.45–47

NSAIDs should be discontinued in patients with peptic ulcer disease and gastric outlet obstruction. These drugs damage the gastrointestinal mucosa by inhibiting cyclo-oxygenase (COX) enzymes and decreasing synthesis of prostaglandins, which are important for mucosal defense.48 Patients may be unaware of NSAIDs contained in over-the-counter medications and may have difficulty discontinuing NSAIDs taken for pain.49

These drugs are an important cause of refractory peptic ulcer disease and can be detected by platelet COX activity testing, although this test is not widely available. In a study of patients with peptic ulcer disease without definite NSAID use or H pylori infection, up to one-third had evidence of surreptitious NSAID use as detected by platelet COX activity testing.50 In another study,51 platelet COX activity testing discovered over 20% more aspirin users than clinical history alone.

Surgery for patients with benign gastric outlet obstruction is used only when medical management and endoscopic dilation fail. Ideally, surgery should relieve the obstruction and target the underlying cause, such as peptic ulcer disease. Laparoscopic surgery is generally preferred to open surgery because patients can resume oral intake sooner, have a shorter hospital stay, and have less intraoperative blood loss.52 The simplest surgical procedure to relieve obstruction is laparoscopic gastrojejunostomy.

Patients with gastric outlet obstruction and peptic ulcer disease warrant laparoscopic vagotomy and antrectomy or distal gastrectomy. This removes the obstruction and the stimulus for gastric secretion.53 An alternative is vagotomy with a drainage procedure (pyloroplasty or gastrojejunostomy), which has a similar postoperative course and reduction in gastric acid secretion compared with antrectomy or distal gastrectomy.53,54

Daily proton pump inhibitors can be used for patients with benign gastric outlet obstruction not associated with peptic ulcer disease or risk factors; for such cases, vagotomy is not required.

Management of malignant gastric outlet obstruction

Patients with malignant gastric outlet obstruction may have intractable nausea and abdominal pain secondary to retention of gastric contents. The major goal of therapy is to improve symptoms and restore tolerance of an oral diet. The short-term prognosis of malignant gastric outlet obstruction is poor, with a median survival of 3 to 4 months, as these patients often have unresectable disease.55

Surgical bypass used to be the standard of care for palliation of malignant gastric obstruction, but that was before endoscopic stenting was developed.

Endoscopic stenting allows patients to resume oral intake and get out of the hospital sooner with fewer complications than with open surgical bypass. It may be a more appropriate option for palliation of symptoms in patients with malignant obstruction who have a poor prognosis and prefer a less invasive intervention.55,56

Figure 2. Esophagogastroduodenoscopy (A) shows a large submucosal mass in the duodenal bulb (upper arrow), with localized erosions (lower arrow). The mass was 40 × 41 mm in cross-sectional diameter on endoscopic ultrasonography. Fine-needle aspiration and pathology study revealed pancreatic adenocarcinoma. The obstruction was successfully opened (B) with a 22-mm × 12-cm WallFlex stent (Boston Scientific). The patient tolerated a liquid diet after the procedure.

Endoscopic duodenal stenting of malignant gastric outlet obstruction has a success rate of greater than 90%, and most patients can tolerate a mechanical soft diet afterward.34 The procedure is usually performed with a 9-cm or 12-cm self-expanding duodenal stent, 22 mm in diameter, placed over a guide wire under endoscopic and fluoroscopic guidance (Figure 2). The stent is placed by removing the outer catheter, with distal-to-proximal stent deployment.

Patients who also have biliary obstruction may require biliary stent placement, which is generally performed before duodenal stenting. For patients with an endoscopic stent who develop biliary obstruction, endoscopic retrograde cholangiopancreatography can be attempted with placement of a biliary stent; however, these patients may require biliary drain placement by percutaneous transhepatic cholangiography or by endoscopic ultrasonographically guided transduodenal or transgastric biliary drainage.

From 20% to 30% of patients require repeated endoscopic stent placement, although most patients die within several months after stenting.34 Surgical options for patients who do not respond to endoscopic stenting include open or laparoscopic gastrojejunostomy.55

Laparoscopic gastrojejunostomy may provide better long-term outcomes than duodenal stenting for patients with malignant gastric outlet obstruction and a life expectancy longer than a few months.

A 2017 retrospective study of 155 patients with gastric outlet obstruction secondary to unresectable gastric cancer suggested that those who underwent laparoscopic gastrojejunostomy had better oral intake, better tolerance of chemotherapy, and longer overall survival than those who underwent duodenal stenting. Postsurgical complications were more common in the laparoscopic gastrojejunostomy group (16%) than in the duodenal stenting group (0%).57

In most of the studies comparing endoscopic stenting with surgery, the surgery was open gastrojejunostomy; there are limited data directly comparing stenting with laparoscopic gastrojejunostomy.55 Endoscopic stenting is estimated to be significantly less costly than surgery, with a median cost of $12,000 less than gastrojejunostomy.58 As an alternative to enteral stenting and surgical gastrojejunostomy, ultrasonography-guided endoscopic gastrojejunostomy or gastroenterostomy with placement of a lumen-apposing metal stent is emerging as a third treatment option and is under active investigation.59

Patients with malignancy that is potentially curable by resection should undergo surgical evaluation before consideration of endoscopic stenting. For patients who are not candidates for surgery or endoscopic stenting, a percutaneous gastrostomy tube can be considered for gastric decompression and symptom relief.

CASE CONCLUDED

The patient underwent esophagogastroduodenoscopy with endoscopic ultrasonography for evaluation of her pancreatic mass. Before the procedure, she was intubated to minimize the risk of aspiration due to persistent nausea and retained gastric contents. A large submucosal mass was found in the duodenal bulb. Endoscopic ultrasonography showed a mass within the pancreatic head with pancreatic duct obstruction. Fine-needle aspiration biopsy was performed, and pathology study revealed pancreatic adenocarcinoma. The patient underwent stenting with a 22-mm by 12-cm WallFlex stent (Boston Scientific), which led to resolution of nausea and advancement to a mechanical soft diet on hospital discharge.

She was scheduled for follow-up in the outpatient clinic for treatment of pancreatic cancer.

A 72-year-old woman presents to the emergency department with progressive nausea and vomiting. One week earlier, she developed early satiety and nausea with vomiting after eating solid food. Three days later her symptoms progressed, and she became unable to take anything by mouth. The patient also experienced a 40-lb weight loss in the previous 3 months. She denies symptoms of abdominal pain, hematemesis, or melena. Her medical history includes cholecystectomy and type 2 diabetes mellitus, diagnosed 1 year ago. She has no family history of gastrointestinal malignancy. She says she smoked 1 pack a day in her 20s. She does not consume alcohol.

On physical examination, she is normotensive with a heart rate of 105 beats per minute. The oral mucosa is dry, and the abdomen is mildly distended and tender to palpation in the epigastrium. Laboratory evaluation reveals hypokalemia and metabolic alkalosis.

Computed tomography (CT) reveals a mass 3 cm by 4 cm in the pancreatic head. The mass has invaded the medial wall of the duodenum, with obstruction of the pancreatic and common bile ducts and extension into and occlusion of the superior mesenteric vein, with soft-tissue expansion around the superior mesenteric artery. CT also reveals retained stomach contents and an air-fluid level consistent with gastric outlet obstruction.

INTRINSIC OR EXTRINSIC BLOCKAGE

Gastric outlet obstruction, also called pyloric obstruction, is caused by intrinsic or extrinsic mechanical blockage of gastric emptying, generally in the distal stomach, pyloric channel, or duodenum, with associated symptoms of nausea, vomiting, abdominal pain, and early satiety. It is encountered in both the clinic and the hospital.

Here, we review the causes, diagnosis, and management of this disorder.

BENIGN AND MALIGNANT CAUSES

Causes of obstruction are classified as either benign or malignant (Table 1). However, all cases of gastric outlet obstruction should be assumed to be due to underlying malignancy unless proven otherwise.1

In a retrospective study of 76 patients hospitalized with gastric outlet obstruction between 2006 and 2015 at our institution,2 29 cases (38%) were due to malignancy and 47 (62%) were due to benign causes. Pancreatic adenocarcinoma accounted for 13 cases (17%), while gastric adenocarcinoma accounted for 5 cases (7%); less common malignant causes were cholangiocarcinoma, cancer of the ampulla of Vater, duodenal adenocarcinoma, hepatocellular carcinoma, and metastatic disease. Of the benign causes, the most common were peptic ulcer disease (13 cases, 17%) and postoperative strictures or adhesions (11 cases, 14%).

These numbers reflect general trends around the world.

Less gastric cancer, more pancreatic cancer

The last several decades have seen a trend toward more cases due to cancer and fewer due to benign causes.3–14

In earlier studies in both developed and developing countries, gastric adenocarcinoma was the most common malignant cause of gastric outlet obstruction. Since then, it has become less common in Western countries, although it remains more common in Asia and Africa.7–14 This trend likely reflects environmental factors, including decreased prevalence of Helicobacter pylori infection, a major risk factor for gastric cancer, in Western countries.15–17

At the same time, pancreatic cancer is on the rise,16 and up to 20% of patients with pancreatic cancer develop gastric outlet obstruction.18 In a prospective observational study of 108 patients with malignant gastric outlet obstruction undergoing endoscopic stenting, pancreatic cancer was by far the most common malignancy, occurring in 54% of patients, followed by gastric cancer in 13%.19

Less peptic ulcer disease, but still common

Peptic ulcer disease used to account for up to 90% of cases of gastric outlet obstruction, and it is still the most common benign cause.

In 1990, gastric outlet obstruction was estimated to occur in 5% to 10% of all hospital admissions for ulcer-related complications, accounting for 2,000 operations annually.20,21 Gastric outlet obstruction now occurs in fewer than 5% of patients with duodenal ulcer disease and fewer than 2% of patients with gastric ulcer disease.22

Peptic ulcer disease remains an important cause of obstruction in countries with poor access to acid-suppressing drugs.23

Gastric outlet obstruction occurs in both acute and chronic peptic ulcer disease. In acute peptic ulcer disease, tissue inflammation and edema result in mechanical obstruction. Chronic peptic ulcer disease results in tissue scarring and fibrosis with strictures.20

Environmental factors, including improved diet, hygiene, physical activity, and the decreased prevalence of H pylori infection, also contribute to the decreased prevalence of peptic ulcer disease and its complications, including gastric outlet obstruction.3 The continued occurrence of peptic ulcer disease is associated with widespread use of low-dose aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), the most common causes of peptic ulcer disease in Western countries.24,25

Other nonmalignant causes of gastric outlet obstruction are diverse and less common. They include caustic ingestion, postsurgical strictures, benign tumors of the gastrointestinal tract, Crohn disease, and pancreatic disorders including acute pancreatitis, pancreatic pseudocyst, chronic pancreatitis, and annular pancreas. Intramural duodenal hematoma may cause obstruction after blunt abdominal trauma, endoscopic biopsy, or gastrostomy tube migration, especially in the setting of a bleeding disorder or anticoagulation.26

Tuberculosis should be suspected in countries in which it is common.7 In a prospective study of 64 patients with benign gastric outlet obstruction in India,27 16 (25%) had corrosive injury, 16 (25%) had tuberculosis, and 15 (23%) had peptic ulcer disease. Compared with patients with corrosive injury and peptic ulcer disease, patients with gastroduodenal tuberculosis had the best outcomes with appropriate treatment.

Other reported causes include Bouveret syndrome (an impacted gallstone in the proximal duodenum), phytobezoar, diaphragmatic hernia, gastric volvulus, and Ladd bands (peritoneal bands associated with intestinal malrotation).7,28,29

 

 

PRESENTING SYMPTOMS

Symptoms of gastric outlet obstruction include nausea, nonbilious vomiting, epigastric pain, early satiety, abdominal distention, and weight loss.

In our patients, the most common presenting symptoms were nausea and vomiting (80%), followed by abdominal pain (72%); weight loss (15%), abdominal distention (15%), and early satiety (9%) were less common.2

Patients with gastric outlet obstruction secondary to malignancy generally present with a shorter duration of symptoms than those with peptic ulcer disease and are more likely to be older.8,13 Other conditions with an acute onset of symptoms include gastric polyp prolapse, percutaneous endoscopic gastrostomy tube migration, gastric volvulus, and gallstone impaction.

Patients with gastric outlet obstruction associated with peptic ulcer disease generally have a long-standing history of symptoms, including dyspepsia and weight loss over several years.4

SIGNS ON EXAMINATION

On examination, look for signs of chronic gastric obstruction and its consequences, such as malnutrition, cachexia, volume depletion, and dental erosions.

A succussion splash may suggest gastric outlet obstruction. This is elicited by rocking the patient back and forth by the hips or abdomen while listening over the stomach for a splash, which may be heard without a stethoscope. The test is considered positive if present 3 or more hours after drinking fluids and suggests retention of gastric materials.30,31

In thin individuals, chronic gastric outlet obstruction makes the stomach dilate and hypertrophy, which may be evident by a palpably thickened stomach with visible gastric peristalsis.4

Other notable findings on physical examination may include a palpable abdominal mass, epigastric pain, or an abnormality suggestive of metastatic gastric cancer, such as an enlarged left supraclavicular lymph node (Virchow node) or periumbilical lymph node (Sister Mary Joseph nodule). The Virchow node is at the junction of the thoracic duct and the left subclavian vein where the lymphatic circulation from the body drains into the systemic circulation, and it may be the first sign of gastric cancer.32 Sister Mary Joseph nodule (named after a surgical assistant to Dr. William James Mayo) refers to a palpable mass at the umbilicus, generally resulting from metastasis of an abdominal malignancy.33

SIGNS ON FURTHER STUDIES

Laboratory evaluation may show signs of poor oral intake and electrolyte abnormalities secondary to chronic nausea, vomiting, and dehydration, including hypochloremic metabolic alkalosis and hypokalemia.

The underlying cause of gastric outlet obstruction has major implications for treatment and prognosis and cannot be differentiated by clinical presentation alone.1,9 Diagnosis is based on clinical features and radiologic or endoscopic evaluation consistent with gastric outlet obstruction.

Plain radiography may reveal an enlarged gastric bubble, and contrast studies may be useful to determine whether the obstruction is partial or complete, depending on whether the contrast passes into the small bowel.

Figure 1. Computed tomography of the abdomen in the axial plane shows gastric distention (A, arrow) and a 3.9-cm mass at the pancreatic head, with compression of the descending duodenum (B, arrow), resulting in gastric outlet obstruction. The patient, a 72-year-old woman, presented with 1 week of nausea and vomiting and was found to have pancreatic cancer. She was treated with endoscopic stenting.
CT or magnetic resonance imaging may show gastric distention with retained stomach contents, suggesting a gastric, pyloric, duodenal, or pancreatic mass (Figure 1).

Upper endoscopy is often needed to establish the diagnosis and cause. Emptying the stomach with a nasogastric tube is recommended before endoscopy to minimize the risk of aspiration during the procedure, and endotracheal intubation should be considered for airway protection.34 Findings of gastric outlet obstruction on upper endoscopy include retained food and liquid. Endoscopic biopsy is important to differentiate between benign and malignant causes. For patients with malignancy, endoscopic ultrasonography is useful for diagnosis via tissue sampling with fine-needle aspiration and locoregional staging.35

A strategy. Most patients whose clinical presentation suggests gastric outlet obstruction require cross-sectional radiologic imaging, upper endoscopy, or both.36 CT is the preferred imaging study to evaluate for intestinal obstruction.36,37 Patients with suspected complete obstruction or perforation should undergo CT before upper endoscopy. Oral contrast may interfere with endoscopy and should be avoided if endoscopy is planned. Additionally, giving oral contrast may worsen patient discomfort and increase the risk of nausea, vomiting, and aspiration.36,37

Following radiographic evaluation, upper endoscopy can be performed after gastric decompression to identify the location and extent of the obstruction and to potentially provide a definitive diagnosis with biopsy.36

DIFFERENTIATE FROM GASTROPARESIS

Gastroparesis is a chronic neuromuscular disorder characterized by delayed gastric emptying without mechanical obstruction.38 The most common causes are diabetes, surgery, and idiopathy. Other causes include viral infection, connective tissue diseases, ischemia, infiltrative disorders, radiation, neurologic disorders, and paraneoplastic syndromes.39,40

Gastric outlet obstruction and gastroparesis share clinical symptoms including nausea, vomiting, abdominal pain, early satiety, and weight loss and are important to differentiate.36,38 Although abdominal pain may be present in both gastric outlet obstruction and gastroparesis, in gastroparesis it tends not to be the dominant symptom.40

Gastric scintigraphy is most commonly used to objectively quantify delayed gastric emptying.39 Upper endoscopy is imperative to exclude mechanical obstruction.39

 

 

MANAGEMENT

Initially, patients with signs and symptoms of gastric outlet obstruction should be given:

  • Nothing by mouth (NPO)
  • Intravenous fluids to correct volume depletion and electrolyte abnormalities
  • A nasogastric tube for gastric decompression and symptom relief if symptoms persist despite being NPO
  • A parenteral proton pump inhibitor, regardless of the cause of obstruction, to decrease gastric secretions41
  • Medications for pain and nausea, if needed.

Definitive treatment of gastric outlet obstruction depends on the underlying cause, whether benign or malignant.

Management of benign gastric outlet obstruction

Symptoms of gastric outlet obstruction resolve spontaneously in about half of cases caused by acute peptic ulcer disease, as acute inflammation resolves.9,22

Endoscopic dilation is an important option in patients with benign gastric outlet obstruction, including peptic ulcer disease. Peptic ulcer disease-induced gastric outlet obstruction can be safely treated with endoscopic balloon dilation. This treatment almost always relieves symptoms immediately; however, the long-term response has varied from 16% to 100%, and patients may require more than 1 dilation procedure.25,42,43 The need for 2 or more dilation procedures may predict need for surgery.44 Gastric outlet obstruction after caustic ingestion or endoscopic submucosal dissection may also respond to endoscopic balloon dilation.36

Eradication of H pylori may be effective and lead to complete resolution of symptoms in patients with gastric outlet obstruction due to this infection.45–47

NSAIDs should be discontinued in patients with peptic ulcer disease and gastric outlet obstruction. These drugs damage the gastrointestinal mucosa by inhibiting cyclo-oxygenase (COX) enzymes and decreasing synthesis of prostaglandins, which are important for mucosal defense.48 Patients may be unaware of NSAIDs contained in over-the-counter medications and may have difficulty discontinuing NSAIDs taken for pain.49

These drugs are an important cause of refractory peptic ulcer disease and can be detected by platelet COX activity testing, although this test is not widely available. In a study of patients with peptic ulcer disease without definite NSAID use or H pylori infection, up to one-third had evidence of surreptitious NSAID use as detected by platelet COX activity testing.50 In another study,51 platelet COX activity testing discovered over 20% more aspirin users than clinical history alone.

Surgery for patients with benign gastric outlet obstruction is used only when medical management and endoscopic dilation fail. Ideally, surgery should relieve the obstruction and target the underlying cause, such as peptic ulcer disease. Laparoscopic surgery is generally preferred to open surgery because patients can resume oral intake sooner, have a shorter hospital stay, and have less intraoperative blood loss.52 The simplest surgical procedure to relieve obstruction is laparoscopic gastrojejunostomy.

Patients with gastric outlet obstruction and peptic ulcer disease warrant laparoscopic vagotomy and antrectomy or distal gastrectomy. This removes the obstruction and the stimulus for gastric secretion.53 An alternative is vagotomy with a drainage procedure (pyloroplasty or gastrojejunostomy), which has a similar postoperative course and reduction in gastric acid secretion compared with antrectomy or distal gastrectomy.53,54

Daily proton pump inhibitors can be used for patients with benign gastric outlet obstruction not associated with peptic ulcer disease or risk factors; for such cases, vagotomy is not required.

Management of malignant gastric outlet obstruction

Patients with malignant gastric outlet obstruction may have intractable nausea and abdominal pain secondary to retention of gastric contents. The major goal of therapy is to improve symptoms and restore tolerance of an oral diet. The short-term prognosis of malignant gastric outlet obstruction is poor, with a median survival of 3 to 4 months, as these patients often have unresectable disease.55

Surgical bypass used to be the standard of care for palliation of malignant gastric obstruction, but that was before endoscopic stenting was developed.

Endoscopic stenting allows patients to resume oral intake and get out of the hospital sooner with fewer complications than with open surgical bypass. It may be a more appropriate option for palliation of symptoms in patients with malignant obstruction who have a poor prognosis and prefer a less invasive intervention.55,56

Figure 2. Esophagogastroduodenoscopy (A) shows a large submucosal mass in the duodenal bulb (upper arrow), with localized erosions (lower arrow). The mass was 40 × 41 mm in cross-sectional diameter on endoscopic ultrasonography. Fine-needle aspiration and pathology study revealed pancreatic adenocarcinoma. The obstruction was successfully opened (B) with a 22-mm × 12-cm WallFlex stent (Boston Scientific). The patient tolerated a liquid diet after the procedure.

Endoscopic duodenal stenting of malignant gastric outlet obstruction has a success rate of greater than 90%, and most patients can tolerate a mechanical soft diet afterward.34 The procedure is usually performed with a 9-cm or 12-cm self-expanding duodenal stent, 22 mm in diameter, placed over a guide wire under endoscopic and fluoroscopic guidance (Figure 2). The stent is placed by removing the outer catheter, with distal-to-proximal stent deployment.

Patients who also have biliary obstruction may require biliary stent placement, which is generally performed before duodenal stenting. For patients with an endoscopic stent who develop biliary obstruction, endoscopic retrograde cholangiopancreatography can be attempted with placement of a biliary stent; however, these patients may require biliary drain placement by percutaneous transhepatic cholangiography or by endoscopic ultrasonographically guided transduodenal or transgastric biliary drainage.

From 20% to 30% of patients require repeated endoscopic stent placement, although most patients die within several months after stenting.34 Surgical options for patients who do not respond to endoscopic stenting include open or laparoscopic gastrojejunostomy.55

Laparoscopic gastrojejunostomy may provide better long-term outcomes than duodenal stenting for patients with malignant gastric outlet obstruction and a life expectancy longer than a few months.

A 2017 retrospective study of 155 patients with gastric outlet obstruction secondary to unresectable gastric cancer suggested that those who underwent laparoscopic gastrojejunostomy had better oral intake, better tolerance of chemotherapy, and longer overall survival than those who underwent duodenal stenting. Postsurgical complications were more common in the laparoscopic gastrojejunostomy group (16%) than in the duodenal stenting group (0%).57

In most of the studies comparing endoscopic stenting with surgery, the surgery was open gastrojejunostomy; there are limited data directly comparing stenting with laparoscopic gastrojejunostomy.55 Endoscopic stenting is estimated to be significantly less costly than surgery, with a median cost of $12,000 less than gastrojejunostomy.58 As an alternative to enteral stenting and surgical gastrojejunostomy, ultrasonography-guided endoscopic gastrojejunostomy or gastroenterostomy with placement of a lumen-apposing metal stent is emerging as a third treatment option and is under active investigation.59

Patients with malignancy that is potentially curable by resection should undergo surgical evaluation before consideration of endoscopic stenting. For patients who are not candidates for surgery or endoscopic stenting, a percutaneous gastrostomy tube can be considered for gastric decompression and symptom relief.

CASE CONCLUDED

The patient underwent esophagogastroduodenoscopy with endoscopic ultrasonography for evaluation of her pancreatic mass. Before the procedure, she was intubated to minimize the risk of aspiration due to persistent nausea and retained gastric contents. A large submucosal mass was found in the duodenal bulb. Endoscopic ultrasonography showed a mass within the pancreatic head with pancreatic duct obstruction. Fine-needle aspiration biopsy was performed, and pathology study revealed pancreatic adenocarcinoma. The patient underwent stenting with a 22-mm by 12-cm WallFlex stent (Boston Scientific), which led to resolution of nausea and advancement to a mechanical soft diet on hospital discharge.

She was scheduled for follow-up in the outpatient clinic for treatment of pancreatic cancer.

References
  1. Johnson CD. Gastric outlet obstruction malignant until proved otherwise. Am J Gastroenterol 1995; 90(10):1740. pmid:7572886
  2. Koop AH, Palmer WC, Mareth K, Burton MC, Bowman A, Stancampiano F. Tu1335 - Pancreatic cancer most common cause of malignant gastric outlet obstruction at a tertiary referral center: a 10 year retrospective study [abstract]. Gastroenterology 2018; 154(6, suppl 1):S-1343.
  3. Hall R, Royston C, Bardhan KD. The scars of time: the disappearance of peptic ulcer-related pyloric stenosis through the 20th century. J R Coll Physicians Edinb 2014; 44(3):201–208. doi:10.4997/JRCPE.2014.303
  4. Kreel L, Ellis H. Pyloric stenosis in adults: a clinical and radiological study of 100 consecutive patients. Gut 1965; 6(3):253–261. pmid:18668780
  5. Shone DN, Nikoomanesh P, Smith-Meek MM, Bender JS. Malignancy is the most common cause of gastric outlet obstruction in the era of H2 blockers. Am J Gastroenterol 1995; 90(10):1769–1770. pmid:7572891
  6. Ellis H. The diagnosis of benign and malignant pyloric obstruction. Clin Oncol 1976; 2(1):11–15. pmid:1277618
  7. Samad A, Khanzada TW, Shoukat I. Gastric outlet obstruction: change in etiology. Pak J Surg 2007; 23(1):29–32.
  8. Chowdhury A, Dhali GK, Banerjee PK. Etiology of gastric outlet obstruction. Am J Gastroenterol 1996; 91(8):1679. pmid:8759707
  9. Johnson CD, Ellis H. Gastric outlet obstruction now predicts malignancy. Br J Surg 1990; 77(9):1023–1024. pmid:2207566
  10. Misra SP, Dwivedi M, Misra V. Malignancy is the most common cause of gastric outlet obstruction even in a developing country. Endoscopy 1998; 30(5):484–486. doi:10.1055/s-2007-1001313
  11. Essoun SD, Dakubo JCB. Update of aetiological patterns of adult gastric outlet obstruction in Accra, Ghana. Int J Clin Med 2014; 5(17):1059–1064. doi:10.4236/ijcm.2014.517136
  12. Jaka H, Mchembe MD, Rambau PF, Chalya PL. Gastric outlet obstruction at Bugando Medical Centre in Northwestern Tanzania: a prospective review of 184 cases. BMC Surg 2013; 13:41. doi:10.1186/1471-2482-13-41
  13. Sukumar V, Ravindran C, Prasad RV. Demographic and etiological patterns of gastric outlet obstruction in Kerala, South India. N Am J Med Sci 2015; 7(9):403–406. doi:10.4103/1947-2714.166220
  14. Yoursef M, Mirza MR, Khan S. Gastric outlet obstruction. Pak J Surg 2005; 10(4):48–50.
  15. Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015; 136(5):E359–E386. doi:10.1002/ijc.29210
  16. Parkin DM, Stjernsward J, Muir CS. Estimates of the worldwide frequency of twelve major cancers. Bull World Health Organ 1984; 62(2):163–182. pmid:6610488
  17. Karimi P, Islami F, Anandasabapathy S, Freedman ND, Kamangar F. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol Biomarkers Prev 2014; 23(5):700–713. doi:10.1158/1055-9965.EPI-13-1057
  18. Jeurnink SM, Steyerberg EW, van Hooft JE, et al; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT) study): a multicenter randomized trial. Gastrointest Endosc 2010; 71(3):490–499. doi:10.1016/j.gie.2009.09.042
  19. Tringali A, Didden P, Repici A, et al. Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study. Gastrointest Endosc 2014; 79(1):66–75. doi:10.1016/j.gie.2013.06.032
  20. Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet 2009; 374(9699):1449–1461. doi:10.1016/S0140-6736(09)60938-7
  21. Gibson JB, Behrman SW, Fabian TC, Britt LG. Gastric outlet obstruction resulting from peptic ulcer disease requiring surgical intervention is infrequently associated with Helicobacter pylori infection. J Am Coll Surg 2000; 191(1):32–37. pmid:10898181
  22. Kochhar R, Kochhar S. Endoscopic balloon dilation for benign gastric outlet obstruction in adults. World J Gastrointest Endosc 2010; 2(1):29–35. doi:10.4253/wjge.v2.i1.29
  23. Kotisso R. Gastric outlet obstruction in Northwestern Ethiopia. East Cent Afr J Surg 2000; 5(2):25-29.
  24. Hamzaoui L, Bouassida M, Ben Mansour I, et al. Balloon dilatation in patients with gastric outlet obstruction related to peptic ulcer disease. Arab J Gastroenterol 2015; 16(3–4):121–124. doi:10.1016/j.ajg.2015.07.004
  25. Najm WI. Peptic ulcer disease. Prim Care 2011; 38(3):383–394. doi:10.1016/j.pop.2011.05.001
  26. Veloso N, Amaro P, Ferreira M, Romaozinho JM, Sofia C. Acute pancreatitis associated with a nontraumatic, intramural duodenal hematoma. Endoscopy 2013; 45(suppl 2):E51–E52. doi:10.1055/s-0032-1325969
  27. Maharshi S, Puri AS, Sachdeva S, Kumar A, Dalal A, Gupta M. Aetiological spectrum of benign gastric outlet obstruction in India: new trends. Trop Doct 2016; 46(4):186–191. doi:10.1177/0049475515626032
  28. Sala MA, Ligabo AN, de Arruda MC, Indiani JM, Nacif MS. Intestinal malrotation associated with duodenal obstruction secondary to Ladd’s bands. Radiol Bras 2016; 49(4):271–272. doi:10.1590/0100-3984.2015.0106
  29. Alibegovic E, Kurtcehajic A, Hujdurovic A, Mujagic S, Alibegovic J, Kurtcehajic D. Bouveret syndrome or gallstone ileus. Am J Med 2018; 131(4):e175. doi:10.1016/j.amjmed.2017.10.044
  30. Lau JY, Chung SC, Sung JJ, et al. Through-the-scope balloon dilation for pyloric stenosis: long-term results. Gastrointest Endosc 1996; 43(2 Pt 1):98–101. pmid:8635729
  31. Ray K, Snowden C, Khatri K, McFall M. Gastric outlet obstruction from a caecal volvulus, herniated through epiploic foramen: a case report. BMJ Case Rep 2009; pii:bcr05.2009.1880. doi:10.1136/bcr.05.2009.1880
  32. Baumgart DC, Fischer A. Virchow’s node. Lancet 2007; 370(9598):1568. doi:10.1016/S0140-6736(07)61661-4
  33. Dar IH, Kamili MA, Dar SH, Kuchaai FA. Sister Mary Joseph nodule—a case report with review of literature. J Res Med Sci 2009; 14(6):385–387. pmid:21772912
  34. Tang SJ. Endoscopic stent placement for gastric outlet obstruction. Video Journal and Encyclopedia of GI Endoscopy 2013; 1(1):133–136.
  35. Valero M, Robles-Medranda C. Endoscopic ultrasound in oncology: an update of clinical applications in the gastrointestinal tract. World J Gastrointest Endosc 2017; 9(6):243–254.
  36. ASGE Standards of Practice Committee; Fukami N, Anderson MA, Khan K, et al. The role of endoscopy in gastroduodenal obstruction and gastroparesis. Gastrointest Endosc 2011; 74(1):13–21. doi:10.1016/j.gie.2010.12.003
  37. Ros PR, Huprich JE. ACR appropriateness criteria on suspected small-bowel obstruction. J Am Coll Radiol 2006; 3(11):838–841. doi:10.1016/j.jacr.2006.09.018
  38. Pasricha PJ, Parkman HP. Gastroparesis: definitions and diagnosis. Gastroenterol Clin North Am 2015; 44(1):1–7. doi:10.1016/j.gtc.2014.11.001
  39. Stein B, Everhart KK, Lacy BE. Gastroparesis: a review of current diagnosis and treatment options. J Clin Gastroenterol 2015; 49(7):550–558. doi:10.1097/MCG.0000000000000320
  40. Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol 2013; 108(1):18–37.
  41. Gursoy O, Memis D, Sut N. Effect of proton pump inhibitors on gastric juice volume, gastric pH and gastric intramucosal pH in critically ill patients: a randomized, double-blind, placebo-controlled study. Clin Drug Investig 2008; 28(12):777–782. doi:10.2165/0044011-200828120-00005
  42. Kuwada SK, Alexander GL. Long-term outcome of endoscopic dilation of nonmalignant pyloric stenosis. Gastrointest Endosc 1995; 41(1):15–17. pmid:7698619
  43. Kochhar R, Sethy PK, Nagi B, Wig JD. Endoscopic balloon dilatation of benign gastric outlet obstruction. J Gastroenterol Hepatol 2004; 19(4):418–422. pmid:15012779
  44. Perng CL, Lin HJ, Lo WC, Lai CR, Guo WS, Lee SD. Characteristics of patients with benign gastric outlet obstruction requiring surgery after endoscopic balloon dilation. Am J Gastroenterol 1996; 91(5):987–990. pmid:8633593
  45. Taskin V, Gurer I, Ozyilkan E, Sare M, Hilmioglu F. Effect of Helicobacter pylori eradication on peptic ulcer disease complicated with outlet obstruction. Helicobacter 2000; 5(1):38–40. pmid:10672050
  46. de Boer WA, Driessen WM. Resolution of gastric outlet obstruction after eradication of Helicobacter pylori. J Clin Gastroenterol 1995; 21(4):329–330. pmid:8583113
  47. Tursi A, Cammarota G, Papa A, Montalto M, Fedeli G, Gasbarrini G. Helicobacter pylori eradication helps resolve pyloric and duodenal stenosis. J Clin Gastroenterol 1996; 23(2):157–158. pmid:8877648
  48. Schmassmann A. Mechanisms of ulcer healing and effects of nonsteroidal anti-inflammatory drugs. Am J Med 1998; 104(3A):43S–51S; discussion 79S–80S. pmid:9572320
  49. Kim HU. Diagnostic and treatment approaches for refractory peptic ulcers. Clin Endosc 2015; 48(4):285–290. doi:10.5946/ce.2015.48.4.285
  50. Ong TZ, Hawkey CJ, Ho KY. Nonsteroidal anti-inflammatory drug use is a significant cause of peptic ulcer disease in a tertiary hospital in Singapore: a prospective study. J Clin Gastroenterol 2006; 40(9):795–800. doi:10.1097/01.mcg.0000225610.41105.7f
  51. Lanas A, Sekar MC, Hirschowitz BI. Objective evidence of aspirin use in both ulcer and nonulcer upper and lower gastrointestinal bleeding. Gastroenterology 1992; 103(3):862–869. pmid:1499936
  52. Zhang LP, Tabrizian P, Nguyen S, Telem D, Divino C. Laparoscopic gastrojejunostomy for the treatment of gastric outlet obstruction. JSLS 2011; 15(2):169–173. doi:10.4293/108680811X13022985132074
  53. Lagoo J, Pappas TN, Perez A. A relic or still relevant: the narrowing role for vagotomy in the treatment of peptic ulcer disease. Am J Surg 2014; 207(1):120–126. doi:10.1016/j.amjsurg.2013.02.012
  54. Csendes A, Maluenda F, Braghetto I, Schutte H, Burdiles P, Diaz JC. Prospective randomized study comparing three surgical techniques for the treatment of gastric outlet obstruction secondary to duodenal ulcer. Am J Surg 1993; 166(1):45–49. pmid:8101050
  55. Ly J, O’Grady G, Mittal A, Plank L, Windsor JA. A systematic review of methods to palliate malignant gastric outlet obstruction. Surg Endosc 2010; 24(2):290–297. doi:10.1007/s00464-009-0577-1
  56. Goldberg EM. Palliative treatment of gastric outlet obstruction in terminal patients: SEMS. Stent every malignant stricture! Gastrointest Endosc 2014; 79(1):76–78. doi:10.1016/j.gie.2013.07.056
  57. Min SH, Son SY, Jung DH, et al. Laparoscopic gastrojejunostomy versus duodenal stenting in unresectable gastric cancer with gastric outlet obstruction. Ann Surg Treat Res 2017; 93(3):130–136. doi:10.4174/astr.2017.93.3.130
  58. Roy A, Kim M, Christein J, Varadarajulu S. Stenting versus gastrojejunostomy for management of malignant gastric outlet obstruction: comparison of clinical outcomes and costs. Surg Endosc 2012; 26(11):3114–119. doi:10.1007/s00464-012-2301-9
  59. Amin S, Sethi A. Endoscopic ultrasound-guided gastrojejunostomy. Gastrointest Endosc Clin N Am 2017; 27(4):707–713. doi:10.1016/j.giec.2017.06.009
References
  1. Johnson CD. Gastric outlet obstruction malignant until proved otherwise. Am J Gastroenterol 1995; 90(10):1740. pmid:7572886
  2. Koop AH, Palmer WC, Mareth K, Burton MC, Bowman A, Stancampiano F. Tu1335 - Pancreatic cancer most common cause of malignant gastric outlet obstruction at a tertiary referral center: a 10 year retrospective study [abstract]. Gastroenterology 2018; 154(6, suppl 1):S-1343.
  3. Hall R, Royston C, Bardhan KD. The scars of time: the disappearance of peptic ulcer-related pyloric stenosis through the 20th century. J R Coll Physicians Edinb 2014; 44(3):201–208. doi:10.4997/JRCPE.2014.303
  4. Kreel L, Ellis H. Pyloric stenosis in adults: a clinical and radiological study of 100 consecutive patients. Gut 1965; 6(3):253–261. pmid:18668780
  5. Shone DN, Nikoomanesh P, Smith-Meek MM, Bender JS. Malignancy is the most common cause of gastric outlet obstruction in the era of H2 blockers. Am J Gastroenterol 1995; 90(10):1769–1770. pmid:7572891
  6. Ellis H. The diagnosis of benign and malignant pyloric obstruction. Clin Oncol 1976; 2(1):11–15. pmid:1277618
  7. Samad A, Khanzada TW, Shoukat I. Gastric outlet obstruction: change in etiology. Pak J Surg 2007; 23(1):29–32.
  8. Chowdhury A, Dhali GK, Banerjee PK. Etiology of gastric outlet obstruction. Am J Gastroenterol 1996; 91(8):1679. pmid:8759707
  9. Johnson CD, Ellis H. Gastric outlet obstruction now predicts malignancy. Br J Surg 1990; 77(9):1023–1024. pmid:2207566
  10. Misra SP, Dwivedi M, Misra V. Malignancy is the most common cause of gastric outlet obstruction even in a developing country. Endoscopy 1998; 30(5):484–486. doi:10.1055/s-2007-1001313
  11. Essoun SD, Dakubo JCB. Update of aetiological patterns of adult gastric outlet obstruction in Accra, Ghana. Int J Clin Med 2014; 5(17):1059–1064. doi:10.4236/ijcm.2014.517136
  12. Jaka H, Mchembe MD, Rambau PF, Chalya PL. Gastric outlet obstruction at Bugando Medical Centre in Northwestern Tanzania: a prospective review of 184 cases. BMC Surg 2013; 13:41. doi:10.1186/1471-2482-13-41
  13. Sukumar V, Ravindran C, Prasad RV. Demographic and etiological patterns of gastric outlet obstruction in Kerala, South India. N Am J Med Sci 2015; 7(9):403–406. doi:10.4103/1947-2714.166220
  14. Yoursef M, Mirza MR, Khan S. Gastric outlet obstruction. Pak J Surg 2005; 10(4):48–50.
  15. Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015; 136(5):E359–E386. doi:10.1002/ijc.29210
  16. Parkin DM, Stjernsward J, Muir CS. Estimates of the worldwide frequency of twelve major cancers. Bull World Health Organ 1984; 62(2):163–182. pmid:6610488
  17. Karimi P, Islami F, Anandasabapathy S, Freedman ND, Kamangar F. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol Biomarkers Prev 2014; 23(5):700–713. doi:10.1158/1055-9965.EPI-13-1057
  18. Jeurnink SM, Steyerberg EW, van Hooft JE, et al; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT) study): a multicenter randomized trial. Gastrointest Endosc 2010; 71(3):490–499. doi:10.1016/j.gie.2009.09.042
  19. Tringali A, Didden P, Repici A, et al. Endoscopic treatment of malignant gastric and duodenal strictures: a prospective, multicenter study. Gastrointest Endosc 2014; 79(1):66–75. doi:10.1016/j.gie.2013.06.032
  20. Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet 2009; 374(9699):1449–1461. doi:10.1016/S0140-6736(09)60938-7
  21. Gibson JB, Behrman SW, Fabian TC, Britt LG. Gastric outlet obstruction resulting from peptic ulcer disease requiring surgical intervention is infrequently associated with Helicobacter pylori infection. J Am Coll Surg 2000; 191(1):32–37. pmid:10898181
  22. Kochhar R, Kochhar S. Endoscopic balloon dilation for benign gastric outlet obstruction in adults. World J Gastrointest Endosc 2010; 2(1):29–35. doi:10.4253/wjge.v2.i1.29
  23. Kotisso R. Gastric outlet obstruction in Northwestern Ethiopia. East Cent Afr J Surg 2000; 5(2):25-29.
  24. Hamzaoui L, Bouassida M, Ben Mansour I, et al. Balloon dilatation in patients with gastric outlet obstruction related to peptic ulcer disease. Arab J Gastroenterol 2015; 16(3–4):121–124. doi:10.1016/j.ajg.2015.07.004
  25. Najm WI. Peptic ulcer disease. Prim Care 2011; 38(3):383–394. doi:10.1016/j.pop.2011.05.001
  26. Veloso N, Amaro P, Ferreira M, Romaozinho JM, Sofia C. Acute pancreatitis associated with a nontraumatic, intramural duodenal hematoma. Endoscopy 2013; 45(suppl 2):E51–E52. doi:10.1055/s-0032-1325969
  27. Maharshi S, Puri AS, Sachdeva S, Kumar A, Dalal A, Gupta M. Aetiological spectrum of benign gastric outlet obstruction in India: new trends. Trop Doct 2016; 46(4):186–191. doi:10.1177/0049475515626032
  28. Sala MA, Ligabo AN, de Arruda MC, Indiani JM, Nacif MS. Intestinal malrotation associated with duodenal obstruction secondary to Ladd’s bands. Radiol Bras 2016; 49(4):271–272. doi:10.1590/0100-3984.2015.0106
  29. Alibegovic E, Kurtcehajic A, Hujdurovic A, Mujagic S, Alibegovic J, Kurtcehajic D. Bouveret syndrome or gallstone ileus. Am J Med 2018; 131(4):e175. doi:10.1016/j.amjmed.2017.10.044
  30. Lau JY, Chung SC, Sung JJ, et al. Through-the-scope balloon dilation for pyloric stenosis: long-term results. Gastrointest Endosc 1996; 43(2 Pt 1):98–101. pmid:8635729
  31. Ray K, Snowden C, Khatri K, McFall M. Gastric outlet obstruction from a caecal volvulus, herniated through epiploic foramen: a case report. BMJ Case Rep 2009; pii:bcr05.2009.1880. doi:10.1136/bcr.05.2009.1880
  32. Baumgart DC, Fischer A. Virchow’s node. Lancet 2007; 370(9598):1568. doi:10.1016/S0140-6736(07)61661-4
  33. Dar IH, Kamili MA, Dar SH, Kuchaai FA. Sister Mary Joseph nodule—a case report with review of literature. J Res Med Sci 2009; 14(6):385–387. pmid:21772912
  34. Tang SJ. Endoscopic stent placement for gastric outlet obstruction. Video Journal and Encyclopedia of GI Endoscopy 2013; 1(1):133–136.
  35. Valero M, Robles-Medranda C. Endoscopic ultrasound in oncology: an update of clinical applications in the gastrointestinal tract. World J Gastrointest Endosc 2017; 9(6):243–254.
  36. ASGE Standards of Practice Committee; Fukami N, Anderson MA, Khan K, et al. The role of endoscopy in gastroduodenal obstruction and gastroparesis. Gastrointest Endosc 2011; 74(1):13–21. doi:10.1016/j.gie.2010.12.003
  37. Ros PR, Huprich JE. ACR appropriateness criteria on suspected small-bowel obstruction. J Am Coll Radiol 2006; 3(11):838–841. doi:10.1016/j.jacr.2006.09.018
  38. Pasricha PJ, Parkman HP. Gastroparesis: definitions and diagnosis. Gastroenterol Clin North Am 2015; 44(1):1–7. doi:10.1016/j.gtc.2014.11.001
  39. Stein B, Everhart KK, Lacy BE. Gastroparesis: a review of current diagnosis and treatment options. J Clin Gastroenterol 2015; 49(7):550–558. doi:10.1097/MCG.0000000000000320
  40. Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol 2013; 108(1):18–37.
  41. Gursoy O, Memis D, Sut N. Effect of proton pump inhibitors on gastric juice volume, gastric pH and gastric intramucosal pH in critically ill patients: a randomized, double-blind, placebo-controlled study. Clin Drug Investig 2008; 28(12):777–782. doi:10.2165/0044011-200828120-00005
  42. Kuwada SK, Alexander GL. Long-term outcome of endoscopic dilation of nonmalignant pyloric stenosis. Gastrointest Endosc 1995; 41(1):15–17. pmid:7698619
  43. Kochhar R, Sethy PK, Nagi B, Wig JD. Endoscopic balloon dilatation of benign gastric outlet obstruction. J Gastroenterol Hepatol 2004; 19(4):418–422. pmid:15012779
  44. Perng CL, Lin HJ, Lo WC, Lai CR, Guo WS, Lee SD. Characteristics of patients with benign gastric outlet obstruction requiring surgery after endoscopic balloon dilation. Am J Gastroenterol 1996; 91(5):987–990. pmid:8633593
  45. Taskin V, Gurer I, Ozyilkan E, Sare M, Hilmioglu F. Effect of Helicobacter pylori eradication on peptic ulcer disease complicated with outlet obstruction. Helicobacter 2000; 5(1):38–40. pmid:10672050
  46. de Boer WA, Driessen WM. Resolution of gastric outlet obstruction after eradication of Helicobacter pylori. J Clin Gastroenterol 1995; 21(4):329–330. pmid:8583113
  47. Tursi A, Cammarota G, Papa A, Montalto M, Fedeli G, Gasbarrini G. Helicobacter pylori eradication helps resolve pyloric and duodenal stenosis. J Clin Gastroenterol 1996; 23(2):157–158. pmid:8877648
  48. Schmassmann A. Mechanisms of ulcer healing and effects of nonsteroidal anti-inflammatory drugs. Am J Med 1998; 104(3A):43S–51S; discussion 79S–80S. pmid:9572320
  49. Kim HU. Diagnostic and treatment approaches for refractory peptic ulcers. Clin Endosc 2015; 48(4):285–290. doi:10.5946/ce.2015.48.4.285
  50. Ong TZ, Hawkey CJ, Ho KY. Nonsteroidal anti-inflammatory drug use is a significant cause of peptic ulcer disease in a tertiary hospital in Singapore: a prospective study. J Clin Gastroenterol 2006; 40(9):795–800. doi:10.1097/01.mcg.0000225610.41105.7f
  51. Lanas A, Sekar MC, Hirschowitz BI. Objective evidence of aspirin use in both ulcer and nonulcer upper and lower gastrointestinal bleeding. Gastroenterology 1992; 103(3):862–869. pmid:1499936
  52. Zhang LP, Tabrizian P, Nguyen S, Telem D, Divino C. Laparoscopic gastrojejunostomy for the treatment of gastric outlet obstruction. JSLS 2011; 15(2):169–173. doi:10.4293/108680811X13022985132074
  53. Lagoo J, Pappas TN, Perez A. A relic or still relevant: the narrowing role for vagotomy in the treatment of peptic ulcer disease. Am J Surg 2014; 207(1):120–126. doi:10.1016/j.amjsurg.2013.02.012
  54. Csendes A, Maluenda F, Braghetto I, Schutte H, Burdiles P, Diaz JC. Prospective randomized study comparing three surgical techniques for the treatment of gastric outlet obstruction secondary to duodenal ulcer. Am J Surg 1993; 166(1):45–49. pmid:8101050
  55. Ly J, O’Grady G, Mittal A, Plank L, Windsor JA. A systematic review of methods to palliate malignant gastric outlet obstruction. Surg Endosc 2010; 24(2):290–297. doi:10.1007/s00464-009-0577-1
  56. Goldberg EM. Palliative treatment of gastric outlet obstruction in terminal patients: SEMS. Stent every malignant stricture! Gastrointest Endosc 2014; 79(1):76–78. doi:10.1016/j.gie.2013.07.056
  57. Min SH, Son SY, Jung DH, et al. Laparoscopic gastrojejunostomy versus duodenal stenting in unresectable gastric cancer with gastric outlet obstruction. Ann Surg Treat Res 2017; 93(3):130–136. doi:10.4174/astr.2017.93.3.130
  58. Roy A, Kim M, Christein J, Varadarajulu S. Stenting versus gastrojejunostomy for management of malignant gastric outlet obstruction: comparison of clinical outcomes and costs. Surg Endosc 2012; 26(11):3114–119. doi:10.1007/s00464-012-2301-9
  59. Amin S, Sethi A. Endoscopic ultrasound-guided gastrojejunostomy. Gastrointest Endosc Clin N Am 2017; 27(4):707–713. doi:10.1016/j.giec.2017.06.009
Issue
Cleveland Clinic Journal of Medicine - 86(5)
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Cleveland Clinic Journal of Medicine - 86(5)
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345-353
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345-353
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Gastric outlet obstruction: A red flag, potentially manageable
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Gastric outlet obstruction: A red flag, potentially manageable
Legacy Keywords
gastric outlet obstruction, GOO, gastric cancer, pancreatic cancer, endoscopic stenting, peptic ulcer disease, Andree Koop, William Palmer, Fernando Stancampiano
Legacy Keywords
gastric outlet obstruction, GOO, gastric cancer, pancreatic cancer, endoscopic stenting, peptic ulcer disease, Andree Koop, William Palmer, Fernando Stancampiano
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KEY POINTS

  • Causes of gastric outlet obstruction fall into 2 categories: benign and malignant. The cause should be presumed to be malignant until proven otherwise.
  • Peptic ulcer disease, a benign cause, used to account for most cases of gastric outlet obstruction. It is still common but has declined in frequency with the development of acid-suppressing drugs.
  • Gastric cancer used to be the most common malignant cause but has declined in frequency in Western countries with treatment for Helicobacter pylori infection. Now, pancreatic cancer predominates.
  • Endoscopic stenting is an effective, minimally invasive treatment for patients with malignant gastric outlet obstruction and poor prognosis, allowing resumption of oral intake and improving quality of life.
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More Medicare beneficiaries receiving hospice care services than in previous years

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Background: Studies abound on the accelerated cost and health care activities of patients toward the end of life. Previous analyses of Medicare trends of medical care at the time of death have been compiled in 2000, 2005, 2009, and 2011; this study reexamines recent trends.

Study design: Retrospective cohort of a random sample of Medicare Fee-for-Service and Medicare Advantage decedents during 2000-2015.

Setting: Medicare patients in acute care hospitals, home/community, hospice inpatient care units, or nursing homes.

Dr. Willie H. Smith Jr.

Synopsis: Approximately 1.4 million Medicare Fee-for-Service decedents and 870,000 Medicare Advantage decedents were studied in a random sample that included 20% of Medicare Fee-for-Service recipients in the years 2000, 2005, 2009, 2011, and 2015 and 100% of Medicare Advantage patients in the years 2011 and 2015. Deaths of Medicare Fee-for-Service recipients occurring in acute care hospitals and nursing homes decreased from 32.6% (95% confidence interval, 32.4%-32.8%) in 2000 to 19.8% (95% CI, 19.6%-20.0%) in 2015. Patients who died while receiving hospice services increased from 21.6% (95% CI, 21.5%-21.8%) in 2000 to 50.4% (95% CI, 50.2%-50.6%) in 2015. Review of Medicare Advantage data demonstrated similar shifts.

Although there are concerns about the accuracy of reported location of community deaths and these results may not be generalizable to other, non-Medicare populations, the study overall adds statistical data on death trends and suggests an improvement in the use of palliative and hospice care services.

Bottom line: Compared with previous years, fewer Medicare beneficiaries are dying in acute care settings, and more beneficiaries are receiving hospice care in other settings.

Citation: Teno J et al. Site of death, place of care, and health care transitions among U. S. Medicare beneficiaries between 2000-2015. JAMA. 2018;320(3):264-71.

Dr. Smith is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

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Background: Studies abound on the accelerated cost and health care activities of patients toward the end of life. Previous analyses of Medicare trends of medical care at the time of death have been compiled in 2000, 2005, 2009, and 2011; this study reexamines recent trends.

Study design: Retrospective cohort of a random sample of Medicare Fee-for-Service and Medicare Advantage decedents during 2000-2015.

Setting: Medicare patients in acute care hospitals, home/community, hospice inpatient care units, or nursing homes.

Dr. Willie H. Smith Jr.

Synopsis: Approximately 1.4 million Medicare Fee-for-Service decedents and 870,000 Medicare Advantage decedents were studied in a random sample that included 20% of Medicare Fee-for-Service recipients in the years 2000, 2005, 2009, 2011, and 2015 and 100% of Medicare Advantage patients in the years 2011 and 2015. Deaths of Medicare Fee-for-Service recipients occurring in acute care hospitals and nursing homes decreased from 32.6% (95% confidence interval, 32.4%-32.8%) in 2000 to 19.8% (95% CI, 19.6%-20.0%) in 2015. Patients who died while receiving hospice services increased from 21.6% (95% CI, 21.5%-21.8%) in 2000 to 50.4% (95% CI, 50.2%-50.6%) in 2015. Review of Medicare Advantage data demonstrated similar shifts.

Although there are concerns about the accuracy of reported location of community deaths and these results may not be generalizable to other, non-Medicare populations, the study overall adds statistical data on death trends and suggests an improvement in the use of palliative and hospice care services.

Bottom line: Compared with previous years, fewer Medicare beneficiaries are dying in acute care settings, and more beneficiaries are receiving hospice care in other settings.

Citation: Teno J et al. Site of death, place of care, and health care transitions among U. S. Medicare beneficiaries between 2000-2015. JAMA. 2018;320(3):264-71.

Dr. Smith is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

Background: Studies abound on the accelerated cost and health care activities of patients toward the end of life. Previous analyses of Medicare trends of medical care at the time of death have been compiled in 2000, 2005, 2009, and 2011; this study reexamines recent trends.

Study design: Retrospective cohort of a random sample of Medicare Fee-for-Service and Medicare Advantage decedents during 2000-2015.

Setting: Medicare patients in acute care hospitals, home/community, hospice inpatient care units, or nursing homes.

Dr. Willie H. Smith Jr.

Synopsis: Approximately 1.4 million Medicare Fee-for-Service decedents and 870,000 Medicare Advantage decedents were studied in a random sample that included 20% of Medicare Fee-for-Service recipients in the years 2000, 2005, 2009, 2011, and 2015 and 100% of Medicare Advantage patients in the years 2011 and 2015. Deaths of Medicare Fee-for-Service recipients occurring in acute care hospitals and nursing homes decreased from 32.6% (95% confidence interval, 32.4%-32.8%) in 2000 to 19.8% (95% CI, 19.6%-20.0%) in 2015. Patients who died while receiving hospice services increased from 21.6% (95% CI, 21.5%-21.8%) in 2000 to 50.4% (95% CI, 50.2%-50.6%) in 2015. Review of Medicare Advantage data demonstrated similar shifts.

Although there are concerns about the accuracy of reported location of community deaths and these results may not be generalizable to other, non-Medicare populations, the study overall adds statistical data on death trends and suggests an improvement in the use of palliative and hospice care services.

Bottom line: Compared with previous years, fewer Medicare beneficiaries are dying in acute care settings, and more beneficiaries are receiving hospice care in other settings.

Citation: Teno J et al. Site of death, place of care, and health care transitions among U. S. Medicare beneficiaries between 2000-2015. JAMA. 2018;320(3):264-71.

Dr. Smith is an assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.

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Don’t delay palliative care for IPF patients

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Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

 

 


About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.

The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.

The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).

Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.

The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.

The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.

But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”

The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

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Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

 

 


About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.

The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.

The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).

Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.

The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.

The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.

But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”

The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

Rapid deterioration of life quality of patients with idiopathic pulmonary fibrosis (IPF) begins years before death and indicates that early, integrated palliative care should be a priority, according to the finding of a survey study.

IPFeditor/Wikimedia Commons

“Patients with IPF suffer from exceptionally low [health-related quality of life] together with severe breathlessness and fatigue already two years before death. In addition, physical and emotional well-being further deteriorates near death concurrently with escalating overall symptom burden,” wrote Kaisa Rajala, MD, and her colleagues at Helsinki University Hospital.

They conducted a substudy of patients in the larger FinnishIPF study to assess health-related quality of life (HRQOL) and symptom burden in the period before death. Among 300 patients invited to participate, 247 agreed. Patient disease and sociodemographic data were collected from the FinnishIPF records and the study group completed questionnaires five times at 6 month intervals. The study began in April 2015 and continued until August 2017, by which time 92 (37%) of the patients had died (BMC Pulmonary Medicine 2018;18:172; doi: 0.1186/s12890-018-0738-x).

The investigators used self-reporting tools to look at HRQOL and symptom burden: RAND 36-item Health Survey (RAND-36), the Modified Medical Research and Council Dyspnea Scale (MMRC), the Modified Edmonton Symptom Assessment Scale (ESAS), and the Numeric Rating Scale (NRS).

 

 


About 35% of these patients were being treated with antifibrotic medication. Most of the patients had comorbidities, with cardiovascular disease being the most common.

The dimensions of HRQOL studied were physical function, general health, vitality, mental health, social function, and bodily pain. These patients experienced a gradual impairment in HRQOL similar to that of patients with chronic obstructive pulmonary disease, but with a pronounced, rapid deterioration beginning in the last 2 years of life.

The symptom burden also intensified in the last 2 years of life and ramped up significantly in the last 6 months before death. NRS scores are on a scale of 0-10, from no symptoms to worst symptoms. In most clinical situations, NRS scores equal to greater than 4 trigger more comprehensive symptom assessment. The scores for symptoms for these patients during the last 6 months were dyspnea, 7.1 (standard deviation 2.8); tiredness, 6.0 (SD 2.5), cough, 5.0 (SD 3.5), pain with movement, 3.9 (SD 3.1), insomnia, 3.9 (SD 2.9), anxiety, 3.9 (SD 2.9), and depression, 3.6 (SD 3.1).

Investigators noted the steep change in the proportion of patients with MMRC scores greater than or equal to 3 (needing to stop walking after approximately 100 m or a few minutes because of breathlessness) beginning in the last 2 years of life.

The study limitations are its relatively small size, the self-reported data, and the lack of lung function measurements in most patients in the last 6 months of life.

The findings point to the urgent need for early palliative care in IPF patients, the investigators concluded. They noted that the sharp decline in HRQOL is similar to that seen in lung cancer patients, in contrast to the more gradual trend seen in COPD patients.

But there are common benefits of an early palliative program for all of these patients, they stressed. “Early integrated palliative care for patients with lung cancer has shown substantial benefits, such as lower depression scores, higher HRQOL, better communication of end-of-life care preferences, less aggressive care at the end of life, and longer overall survival. Similarly, a randomized trial demonstrated better control of dyspnea and a survival benefit with integrated palliative care in patients with COPD and interstitial lung disease. In addition to cancer patients, early integrated palliative care may reduce end-of-life acute care utilization, and allow patients with IPF to die in their preferred locations. Integrated palliative care in IPF patients seems to lower respiratory-related emergency room visits and hospitalizations and may allow more patients to die at home.”

The study was funded by The Academy of Finland and various Finnish nonprofit organizations funded the study.

SOURCE: Rajala K et al. BMC Pulm Med. 2018;18:172. doi: 0.1186/s12890-018-0738-x.

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Advance care planning codes not being used

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Doctors are not taking advantage of Medicare codes designed to compensate them for time spent with discussing end-of-life plans with their Medicare patients.

Starting in 2016, the Centers for Medicare & Medicaid Services began paying physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30 minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

In 2016, health care professionals in New England (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) billed Medicare 26,522 times for the advance care planning (ACP) codes for a total of 24,536 patients, which represented less than 1% of Medicare beneficiaries in New England at the time, according to Kimberly Pelland, MPH, of Healthcentric Advisors, Providence, R.I., and her colleagues. Most claims were billed in the office, followed by in nursing homes, and in hospitals; 40% of conversations occurred during an annual wellness visit (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8107).

Internists billed Medicare the most for ACP claims (65%), followed by family physicians (22%) gerontologists (5%), and oncologist/hematologists (0.3%), according to the analysis based on 2016 Medicare claims data and Census Bureau data. A greater proportion of patients with ACP claims were female, aged 85 years or older, enrolled in hospice, and died in the study year. Patients had higher odds of having an ACP claim if they were older and had lower income, and if they had cancer, heart failure, stroke, chronic kidney disease, or dementia. Male patients who were Asian, black, and Hispanic had lower chances of having an ACP claim.

In a related study, Emmanuelle Belanger, PhD, of Brown University, Providence, R.I., and her colleagues examined national Medicare data from 2016 to the third quarter of 2017. Across the United States, 2% of Medicare patients aged 65 years and older received advance care planning services that were billed under the ACP codes (JAMA Intern Med. 2019 March 11. doi: 10.1001/jamainternmed.2018.8615). Visits billed under the ACP codes increased from 538,275 to 633,214 during the same time period. Claim rates were higher among patients who died within the study period, reaching 3% in 2016 and 6% in 2017. The percentage of decedents with an ACP billed visit varied strongly across states, with states such as North Dakota, South Dakota, and Wyoming having the fewest ACP visits billed and states such as California and Nevada having the most. ACP billed visits increased in all settings in 2017, but primarily in hospitals and nursing homes. Nationally, internists billed the codes most (48%), followed by family physicians (28%).

Dr. Mary M. Newman

While the two studies indicate low usage of the ACP codes, many physicians are discussing advance care planning with their patients, said Mary M. Newman, MD, an internist based in Lutherville, Md., and former American College of Physicians adviser to the American Medical Association Relative Scale Value Update Committee (RUC).

“What cannot be captured by tracking under Medicare claims data are those shorter conversations that we have frequently,” Dr. Newman said in an interview. “If we have a short conversation about advance care planning, it gets folded into our evaluation and management visit. It’s not going to be separately billed.”

At the same time, some patients are not ready to discuss end-of-life options and decline the discussions when asked, Dr. Newman said. Particularly for healthier patients, end of life care is not a primary focus, she noted.

“Not everybody’s ready to have an advance care planning [discussion] that lasts 16-45 minutes,” she said. “Many people over age 65 are not ready to deal with advance care planning in their day-to-day lives, and it may not be what they wish to discuss. I offer the option to patients and some say, ‘Yes, I’d love to,’ and others decline or postpone.”



Low usage of the ACP codes may be associated with lack of awareness, uncertainty about appropriate code use, or associated billing that is not part of the standard workflow, Ankita Mehta, MD, of Mount Sinai in New York wrote an editorial accompanying the studies (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8105).

“Regardless, the low rates of utilization of ACP codes is alarming and highlights the need to create strategies to integrate ACP discussions into standard practice and build ACP documentation and billing in clinical workflow,” Dr. Mehta said.

Dr. Newman agreed that more education among physicians is needed.

“The amount of education clinicians have received varies tremendously across the geography of the country,” she said. “I think the codes are going to be slowly adopted. The challenge to us is to make sure we’re all better educated on palliative care as people age and get sick and that we are sensitive to our patients explicit and implicit needs for these discussions.”

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Doctors are not taking advantage of Medicare codes designed to compensate them for time spent with discussing end-of-life plans with their Medicare patients.

Starting in 2016, the Centers for Medicare & Medicaid Services began paying physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30 minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

In 2016, health care professionals in New England (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) billed Medicare 26,522 times for the advance care planning (ACP) codes for a total of 24,536 patients, which represented less than 1% of Medicare beneficiaries in New England at the time, according to Kimberly Pelland, MPH, of Healthcentric Advisors, Providence, R.I., and her colleagues. Most claims were billed in the office, followed by in nursing homes, and in hospitals; 40% of conversations occurred during an annual wellness visit (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8107).

Internists billed Medicare the most for ACP claims (65%), followed by family physicians (22%) gerontologists (5%), and oncologist/hematologists (0.3%), according to the analysis based on 2016 Medicare claims data and Census Bureau data. A greater proportion of patients with ACP claims were female, aged 85 years or older, enrolled in hospice, and died in the study year. Patients had higher odds of having an ACP claim if they were older and had lower income, and if they had cancer, heart failure, stroke, chronic kidney disease, or dementia. Male patients who were Asian, black, and Hispanic had lower chances of having an ACP claim.

In a related study, Emmanuelle Belanger, PhD, of Brown University, Providence, R.I., and her colleagues examined national Medicare data from 2016 to the third quarter of 2017. Across the United States, 2% of Medicare patients aged 65 years and older received advance care planning services that were billed under the ACP codes (JAMA Intern Med. 2019 March 11. doi: 10.1001/jamainternmed.2018.8615). Visits billed under the ACP codes increased from 538,275 to 633,214 during the same time period. Claim rates were higher among patients who died within the study period, reaching 3% in 2016 and 6% in 2017. The percentage of decedents with an ACP billed visit varied strongly across states, with states such as North Dakota, South Dakota, and Wyoming having the fewest ACP visits billed and states such as California and Nevada having the most. ACP billed visits increased in all settings in 2017, but primarily in hospitals and nursing homes. Nationally, internists billed the codes most (48%), followed by family physicians (28%).

Dr. Mary M. Newman

While the two studies indicate low usage of the ACP codes, many physicians are discussing advance care planning with their patients, said Mary M. Newman, MD, an internist based in Lutherville, Md., and former American College of Physicians adviser to the American Medical Association Relative Scale Value Update Committee (RUC).

“What cannot be captured by tracking under Medicare claims data are those shorter conversations that we have frequently,” Dr. Newman said in an interview. “If we have a short conversation about advance care planning, it gets folded into our evaluation and management visit. It’s not going to be separately billed.”

At the same time, some patients are not ready to discuss end-of-life options and decline the discussions when asked, Dr. Newman said. Particularly for healthier patients, end of life care is not a primary focus, she noted.

“Not everybody’s ready to have an advance care planning [discussion] that lasts 16-45 minutes,” she said. “Many people over age 65 are not ready to deal with advance care planning in their day-to-day lives, and it may not be what they wish to discuss. I offer the option to patients and some say, ‘Yes, I’d love to,’ and others decline or postpone.”



Low usage of the ACP codes may be associated with lack of awareness, uncertainty about appropriate code use, or associated billing that is not part of the standard workflow, Ankita Mehta, MD, of Mount Sinai in New York wrote an editorial accompanying the studies (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8105).

“Regardless, the low rates of utilization of ACP codes is alarming and highlights the need to create strategies to integrate ACP discussions into standard practice and build ACP documentation and billing in clinical workflow,” Dr. Mehta said.

Dr. Newman agreed that more education among physicians is needed.

“The amount of education clinicians have received varies tremendously across the geography of the country,” she said. “I think the codes are going to be slowly adopted. The challenge to us is to make sure we’re all better educated on palliative care as people age and get sick and that we are sensitive to our patients explicit and implicit needs for these discussions.”

 

Doctors are not taking advantage of Medicare codes designed to compensate them for time spent with discussing end-of-life plans with their Medicare patients.

Starting in 2016, the Centers for Medicare & Medicaid Services began paying physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30 minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

In 2016, health care professionals in New England (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) billed Medicare 26,522 times for the advance care planning (ACP) codes for a total of 24,536 patients, which represented less than 1% of Medicare beneficiaries in New England at the time, according to Kimberly Pelland, MPH, of Healthcentric Advisors, Providence, R.I., and her colleagues. Most claims were billed in the office, followed by in nursing homes, and in hospitals; 40% of conversations occurred during an annual wellness visit (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8107).

Internists billed Medicare the most for ACP claims (65%), followed by family physicians (22%) gerontologists (5%), and oncologist/hematologists (0.3%), according to the analysis based on 2016 Medicare claims data and Census Bureau data. A greater proportion of patients with ACP claims were female, aged 85 years or older, enrolled in hospice, and died in the study year. Patients had higher odds of having an ACP claim if they were older and had lower income, and if they had cancer, heart failure, stroke, chronic kidney disease, or dementia. Male patients who were Asian, black, and Hispanic had lower chances of having an ACP claim.

In a related study, Emmanuelle Belanger, PhD, of Brown University, Providence, R.I., and her colleagues examined national Medicare data from 2016 to the third quarter of 2017. Across the United States, 2% of Medicare patients aged 65 years and older received advance care planning services that were billed under the ACP codes (JAMA Intern Med. 2019 March 11. doi: 10.1001/jamainternmed.2018.8615). Visits billed under the ACP codes increased from 538,275 to 633,214 during the same time period. Claim rates were higher among patients who died within the study period, reaching 3% in 2016 and 6% in 2017. The percentage of decedents with an ACP billed visit varied strongly across states, with states such as North Dakota, South Dakota, and Wyoming having the fewest ACP visits billed and states such as California and Nevada having the most. ACP billed visits increased in all settings in 2017, but primarily in hospitals and nursing homes. Nationally, internists billed the codes most (48%), followed by family physicians (28%).

Dr. Mary M. Newman

While the two studies indicate low usage of the ACP codes, many physicians are discussing advance care planning with their patients, said Mary M. Newman, MD, an internist based in Lutherville, Md., and former American College of Physicians adviser to the American Medical Association Relative Scale Value Update Committee (RUC).

“What cannot be captured by tracking under Medicare claims data are those shorter conversations that we have frequently,” Dr. Newman said in an interview. “If we have a short conversation about advance care planning, it gets folded into our evaluation and management visit. It’s not going to be separately billed.”

At the same time, some patients are not ready to discuss end-of-life options and decline the discussions when asked, Dr. Newman said. Particularly for healthier patients, end of life care is not a primary focus, she noted.

“Not everybody’s ready to have an advance care planning [discussion] that lasts 16-45 minutes,” she said. “Many people over age 65 are not ready to deal with advance care planning in their day-to-day lives, and it may not be what they wish to discuss. I offer the option to patients and some say, ‘Yes, I’d love to,’ and others decline or postpone.”



Low usage of the ACP codes may be associated with lack of awareness, uncertainty about appropriate code use, or associated billing that is not part of the standard workflow, Ankita Mehta, MD, of Mount Sinai in New York wrote an editorial accompanying the studies (JAMA Intern Med. 2019 March 11. doi:10.1001/jamainternmed.2018.8105).

“Regardless, the low rates of utilization of ACP codes is alarming and highlights the need to create strategies to integrate ACP discussions into standard practice and build ACP documentation and billing in clinical workflow,” Dr. Mehta said.

Dr. Newman agreed that more education among physicians is needed.

“The amount of education clinicians have received varies tremendously across the geography of the country,” she said. “I think the codes are going to be slowly adopted. The challenge to us is to make sure we’re all better educated on palliative care as people age and get sick and that we are sensitive to our patients explicit and implicit needs for these discussions.”

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The ever-evolving scope of hospitalists’ clinical services

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More care ‘beyond the walls’ of the hospital

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

Dr. Linda M. Kurian

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.

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More care ‘beyond the walls’ of the hospital

More care ‘beyond the walls’ of the hospital

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

Dr. Linda M. Kurian

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.

 

The 2018 State of Hospital Medicine (SoHM) Report provides indispensable data about the scope of clinical services routinely provided by adult and pediatric hospitalists. This year’s SoHM report reveals that a growing number of Hospital Medicine Groups (HMGs) serving adults are involved in roles beyond the inpatient medical wards, including various surgical comanagement programs, outpatient care, and post-acute care services.

Dr. Linda M. Kurian

The survey also compares services provided by academic and nonacademic HMGs, which remain markedly different in some areas. As the landscape of health care continues to evolve, hospitalists transform their scope of services to meet the needs of the institutions and communities they serve.

In the previous three SoHM reports, it was well established that more than 87% of adult hospital medicine groups play some role in comanaging surgical patients. In this year’s SoHM report, that role was further stratified to capture the various subspecialties represented, and to identify whether the hospitalists generally served as admitting/attending physician or consultant.

Hospitalists’ roles in comanagement are most prominent for care of orthopedic and general surgery patients, but more than 50% of surveyed HMGs reported being involved in comanagement in some capacity with neurosurgery, obstetrics, and cardiovascular surgery. Additionally, almost 95% of surveyed adult HMGs reported that they provided comanagement services for at least one other surgical specialty that was not listed in the survey.

The report also displays comanagement services provided to various medical subspecialties, including neurology, GI/liver, oncology, and more. Of the medical subspecialties represented, adult HMGs comanaged GI/liver (98.2%) and oncology (97.7%) services more often than others.

Interestingly, more HMGs are providing care for patients beyond the walls of the hospital. In the 2018 SoHM report, over 17% of surveyed HMG respondents reported providing care in an outpatient setting, representing an increase of 6.5 percentage points over 2016. Most strikingly, from 2016 to 2018, there was a 12 percentage point increase in adult HMGs reporting services provided to post-acute care facilities (from 13.1% to 24.8%).

These trends were most notable in the Midwest region where nearly 28% of HMGs provide patient care in an outpatient setting and up to 34% in post-acute care facilities. In part, this trend may result from the increased emphasis on improving transitions of care, by providing prehospital preoperative services, postdischarge follow-up encounters, or offering posthospitalization extensivist care.

Within the hospital itself, there remain striking differences in certain services provided by academic and nonacademic HMGs serving adults. Nonacademic HMGs are far more likely to cover patients in an ICU than their academic counterparts (72.0% vs. 34.3%). In contrast, academic hospitalist groups were significantly more inclined to perform procedures. However, the report also showed that there was an overall downtrend of percentage of HMGs that cover patients in an ICU or perform procedures.

As the scope of hospitalist services continues to change over time, should there be concern for scope creep? It depends on how one might view the change. As health care becomes ever more complex, high-functioning HMGs are needed to navigate it, both within and beyond the hospital. Some might consider scope evolution to be a reflection of hospitalists being recognized for their ability to provide high-quality, efficient, and comprehensive care. Hospital medicine groups will likely continue to evolve to meet the needs of an ever-changing health care environment.

Dr. Kurian is chief of the academic division of hospital medicine at Northwell Health in New York. She is a member of the SHM Practice Analysis Committee.

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Palliative care has improved for critically ill children, but challenges remain

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Palliative care among critically ill pediatric patients in the intensive care unit is highly variable across institutions, and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.

Jim Kling/MDedge News
Dr. Siobhan O'Keefe

The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.

“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.

Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.

 

 

The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.

Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).

Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).

Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.

SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.

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Palliative care among critically ill pediatric patients in the intensive care unit is highly variable across institutions, and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.

Jim Kling/MDedge News
Dr. Siobhan O'Keefe

The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.

“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.

Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.

 

 

The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.

Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).

Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).

Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.

SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.

Palliative care among critically ill pediatric patients in the intensive care unit is highly variable across institutions, and is more common among older children, female children, and those with government insurance or at a high risk of mortality. The findings come from a retrospective analysis of data from 52 hospitals, which included ICU admissions (except neonatal ICU) during 2007-2018.

Jim Kling/MDedge News
Dr. Siobhan O'Keefe

The good news is that palliative care consultations have increased, with consultations in less than 1% of cases at the start of the study and rising quickly to more than 7% in 2018.

“In the adult world, palliative care has expanded in recent decades, and I think now that it’s coming to the pediatric world, it’ll just continue to go up,” said Siobhan O’Keefe, MD, in an interview. Dr. O’Keefe is with Children’s Hospital Colorado, Aurora. She presented the study at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

More work needs to be done, she said. “We are not uniformly using palliative care for critically ill children in the U.S., and it varies across institutions. That’s probably not the ideal situation,” said Dr. O’Keefe. The study did not track palliative care versus the presence of board-certified palliative care physicians or palliative care fellowships, but she suspects they would correlate.

Dr. O’Keefe called for physicians to think beyond the patient, to family members and caregivers. “We need to focus on family outcomes, how they are taking care of children with moderate disability, and incorporate that into our outcomes,” she said. Previous research has shown family members to be at risk of anxiety, depression, unemployment, and financial distress.

 

 

The researchers analyzed data from 740,890 patients with 1,024,666 hospitalizations (82% had one hospitalization). They divided subjects into three cohorts, one of which was a category of patients with criteria for palliative care based on previous research (PC-ICU). The PC-ICU cohort included patients with an expected length of stay more than 2 weeks, patients receiving extracorporeal membrane oxygenation (ECMO), severe brain injuries, acute respiratory failure with serious comorbidity, hematologic or oncologic disease, metabolic disease, renal failure that required continuous renal replacement therapy, hepatic failure, or serious chromosomal abnormality. A second cohort included chronic complex conditions not found in the PC-ICU cohort (additional criteria), and a third cohort had no criteria for palliative care.

Thirty percent of hospitalizations met the PC-ICU cohort criteria, 40% met the additional cohort criteria, and 30% fell in the no criteria cohort. The PC-ICU group had the highest mortality, at 8.03%, compared with 1.08% in the additional criteria group and 0.34% in the no criteria group (P less than .00001).

Palliative care consultations occurred more frequently in 5-12 year olds (odds ratio 1.06; 95% confidence interval, 1.01-1.13) and in those aged 13 years or older (OR, 1.38; 95% CI, 1.3-1.46), in females (OR, 1.13; 95% CI, 1.06-1.15), and in patients with government insurance (OR, 1.23; 95% CI, 1.17-1.29). Compared with those in the no criteria cohort, PC-ICU patients were more likely to receive a palliative care consult (OR, 75.5; 95% CI, 60.4-94.3), as were those in the additional criteria group (OR, 19.1; 95% CI, 15.3-23.9).

Cross-institutional palliative care frequency varied widely among patients in the PC-ICU group, ranging from 0% to 44%. The frequency ranged from 0% to 12% across institutions for patients in the additional criteria group.

SOURCE: O’Keefe S et al. Critical Care Congress 2019, Abstract 418.

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A National WestlawNext Database Analysis of Malpractice Litigation in Radiation Oncology (FULL)

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A National WestlawNext Database Analysis of Malpractice Litigation in Radiation Oncology
Although litigation involving radiation oncologists was infrequent and most verdicts were in favor of defendants, many cases resulted from claims of excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests.

A rise in medical malpractice insurance premiums and malpractice claims has brought the issue of medical malpractice to the forefront of medicine over the past few decades.1 The VA has more than tripled the number of legal settlements it has made over the past 5 years, and it has paid more than $871 million in medical malpractice settlements over the past decade.2,3 Legislation by the federal and state governments in the U.S., collectively referred to as tort reform, has been passed to curb the rate at which malpractice claims are filed; to set caps on noneconomic damages, such as pain and suffering; to control the effect of these claims on insurance premiums; and to prevent the delivery of negligent and harmful medical care.1

An observed high prevalence of medical malpractice claims has significant consequences within the clinical setting and has given rise to the practice of defensive medicine.4-8 Even the perceived threat of possible tort action may lead to aberrant practice behaviors. These defensive medical practices may include excessive testing, unnecessary referrals to other physicians or health facilities, or even refusal to treat particular patients.4,9-11 Furthermore, physicians devote valuable time and energy engaging in lawsuits rather than in delivering quality care to their patients.12

The increasingly litigious environment has discouraged physicians from practicing medicine, leading to earlier retirement, geographic relocation, and restriction of scope of services, all limiting patients’ access to health care.13 One such figure reported in 2008 found that in the U.S., defensive medicine costs can total nearly $56 billion.14 Radiation oncology is generally considered a medium-to-low risk specialty for litigation.15,16 Its average annual indemnity payment in 2006 was $276,792 and has increased at a rate of $1,500 per year, ranking it fifth among 22 specialty groups.16 Studies revealed that the practice of defensive medicine is not strictly limited to the U.S. and has been reported in other countries.6,17-20,21

A recent study by Jena and colleagues found that nearly 10% of oncologists face a malpractice claim annually, the 10th highest among the specialties surveyed.22 Malpractice within the field of radiation oncology has been previously discussed in the literature.16,23,24 There are limited data that examine the basis for these claims, the resulting jury verdicts, and the subsequent indemnity payments associated with claims.24,25

In this study, the authors sought to describe radiation oncology malpractice claims over the past 30 years. It is hoped that this study will not only help traditional oncologists in particular, but also all other practitioners who might be included as co-defendants to be more aware of the common causes of action that plaintiffs have been using to sue.

Methods

This public and online study did not involve human subjects research and accordingly did not require institutional review board approval. The WestlawNext (Thomson Reuters, New York) online legal database was used to search retrospectively for state and federal jury verdicts and settlements related to radiation oncology and medical malpractice. The database is a collection of several thousand search engines that can locate court dockets, jury verdicts, and settlements compiled by attorney-editors. Local cases and claims that were dismissed prior to proceeding to trial or that were settled out of court were not available. All cases in the database were considered and provided this study’s sample size, spanning from January 1, 1985, to December 31, 2015.

Given the boolean search functionality integrated into the Westlaw database, search parameters included “radiation oncology” and “medical malpractice” to yield the greatest number of cases (n = 223). All derived cases were manually reviewed, and files that were duplicates or associated with litigation unrelated to radiation oncology were excluded from analysis (n = 191).

Analysis

Factors that were collected and considered included the state and county in which the claim was filed, the age and sex of the litigant at the time of malpractice, the year the case was settled, co-defendant specialties, jury verdicts, award payouts, death status of the litigant and the alleged basis for the medical malpractice claim. A lack of informed consent, a failure to treat in a timely manner, a failure to order appropriate tests or to make a timely referral, misinterpretation of a test, excessive radiation, unnecessary radiation, unnecessary surgery, and procedural error all were included as alleged bases for the malpractice claim. Descriptive statistics were then compiled.

Results

A total of 32 cases were included for analysis (Tables 1, 2, and 3). Anonymized summaries of all 32 cases are provided in the Appendix. The average age of the patient was 54.6 years (range 34-83) and included 17 (54.8%) female and 14 (45.2%) male patients. 

The cases were distributed across 12 states, with 9 cases (28.1%) in Florida, 4 (12.5%) in New York, and 3 (9.4%) in California. Of 31 cases with available data, 19 suits (61.3%) were brought against 1 or 2 defendants, and 12 (38.7%) had ≥ 3 defendants. Radiation oncologists were defendants in all the cases. Otolaryngologists and orthopedic surgeons were the 2 most commonly named co-defendants, each named in 9.4% of cases.

 

 

Excessive radiation (n = 11, 34.4%), unnecessary radiation (n = 8, 25%), and a failure to refer and/or order appropriate tests (n = 9, 28.1%) were the 3 most commonly alleged causes of malpractice. A lack of informed consent was implicated in less than one-seventh of cases (4; 12.5%). In 7 (21.9%) cases, the patient passed away.

Between 1985 and 2015, decisions were made in radiation oncologists’ favor in more than half of the cases. The jury ruled for the plaintiff in 11 (34.4%) cases and for the defendant in 17 (53.1%) cases. Settlements were reached in 4 (12.5%) cases, with a mean payout of $1,476,775. 

Cases that proceeded to trial had a mean payout of $4,744,219. Payouts ranged from $25,000 to $16,000,000.

Discussion

A physician’s duty is to provide medical care within the standard of care. In the courtroom, a radiation oncologist is judged on what a “reasonably prudent” radiation oncologist would do in similar circumstances.26 The plaintiff must establish the standard of care for the patient’s specific diagnosis with evidence, which is often accomplished through expert testimony. A physician is deemed negligent when deviating from this standard of care. The plaintiff must establish 4 factors to be awarded compensation for medical negligence: (1) the physician owed a professional duty to the patient such as the doctor-patient relationship; (2) the physician breeched this duty or failed to meet the standard of care; (3) proximate cause—the breach of duty by the physician directly caused the patient’s injury; and (4) the patient experienced emotional and/or physical damage while in the care of the physician.27

Reasons for Malpractice Claims

The WestlawNext search revealed 3 top theories of breach of standard of care: excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests. As a result, these theories can be interpreted as medical malpractice law in evolution. In other words, the courts still may be laying groundwork to clarify these theories.

However, a more cynical interpretation of why these 3 top theories of breech of standard of care were seen would note the practice of using expert witness testimony as “hired guns” in the U.S. legal system. Plaintiff attorneys know that use of expert witnesses can increase the attorney’s billable hours during the discovery phase and can decrease the likelihood that the case would be thrown out as lacking merit. Nevertheless, when the claim eventually does go to trial, it may lack merit, but not before plaintiff and defense attorneys complete many hours of work. This use of the legal system for financial gains can potentially confound the true reasons why the search resulted in these 3 top theories of breach of standard of care.

A lack of informed consent was not a major issue and was cited only in 4 (12.5%) cases as the cause of alleged malpractice. This finding was reassuring, as informed consent is an important issue that reinforces the physician-patient relationship and enhances patient trust. Previous studies found a perceived lack of informed consent as a basis for a malpractice claim in more than 34% of otolaryngology cases,25% of cranial nerve surgery cases,and 39% of facial plastic surgery cases.28-30 Perhaps the physician patient discussion in radiation oncology may be different compared with that of surgery, as treatments in radiation oncology are guided by large clinical trials, and patients are often referred after discussions with other specialty providers, such as surgeons and medical oncologists. Improving patients’ understanding of their radiation treatment plans is important in reducing malpractice claims relating to informed consent, and recent studies have identified areas where patient education can be improved.31,32

Settlements

Although settlements were reached in a minority of cases, the monetary value of jury verdicts favoring the plaintiff were 3-fold higher than those of out-of-court settlements. Specifically, cases that were settled had a mean payout of $1,476,775, which sharply contrasts with cases that proceeded to trial and a mean payout of $4,744,219. The highest jury award to the plaintiff was $16,000,000, involving a case where it was determined that a double dose of radiation was delivered to a patient’s shoulder. In a simple risk-reward analysis, this suggests that radiation oncologists should consider settling out of court if a malpractice guilty verdict seems possible. However, given the retrospective nature of the analysis, only limited conclusions can be drawn regarding the effectiveness of such a strategy.

Regardless, cases that were settled or judged on the plaintiff’s behalf were for a much higher value in radiation oncology compared with indemnity payment claims data in other high-risk specialties (emergency medicine, general surgery, obstetrics and gynecologic surgery, and radiology).33 It is important to highlight the magnitude of real and perceived harm that can be associated with radiation oncology. Regarding perceived harm, the public may lack an understanding of how radiation works. Interestingly, even though the perceived harm may be misplaced, the real harm is still there. Unlike other specialties where some errors can be reversed (ie, if heparin is mistakenly administered, its effects can be reversed by protamine sulfate), once radiation is delivered, it is not reversible. The harm is permanent and can cause disability.

Settlements are often lower in legal cases due to insurance policy limitations, the time line of award payout (settlement funds are paid more rapidly, as verdict awards are dependent on the conclusion of the case), and the inherent risk that an appeals court may overturn a verdict or reduce the amount of the award.34 For all the radiation oncology cases that proceeded to trial, more than half (53.1%) of the cases were in favor of the physician (Table 3). While this is positive news for radiation oncologists, it is still lower than the national average of 75% of malpractice verdicts in favor of the physician.34,35 In contrast, 65% of colorectal surgery cases resulted in a verdict in favor of the physician.36

 

 

Geographic Locations

The concentration of cases in a few states in this analysis is likely due to a combination of factors, including the distinct legal climates in individual states and the geographic unequal distribution of radiation oncologists across the country. For instance, California’s Medical Injury Compensation Reform Act of 1975 caps limited pain, suffering, inconvenience, physical impairment, disfigurement, and other noneconomic and nonmedical damages in malpractice to $250,000.37-39 Because of this cap, plaintiffs and their attorneys may be more hesitant to file a suit.

Radiation oncologists also remain concentrated in highly populated metropolitan health service areas, likely due to the attractiveness of academic centers, the large patient base required to sustain a practice, and the large capital investment needed to obtain the radiation equipment and staff resources to establish practices.40-42

Evolving Malpractice Theories

Zaorsky and colleagues used a similar methodology to this study.24 However, the distinction between this study and the Zaorsky study is that the latter attempted to use medical malpractice cases to draw conclusions on the validity and utility of quality assurance programs, specifically the Accreditation Program for Excellence (APEx) and the Radiation Oncology Incident Learning System (RO-ILS).43-45 The APEx/RO-ILS systems report only errors and faults, and medical malpractice is based on different sets of variables, such as legal theories, litigation procedures, plaintiff/defense zealousness, and the judicial system of inclusion and exclusion of cases in the docket. It is not possible to control for these confounding variables. This study, in contrast to the Zaorsky study, distills the essence of medical malpractice in radiation oncology and draws conclusions to advance the theories of recovery of monetary damage.

Limitations

The WestlawNext database is a comprehensive source for outcomes and details in malpractice litigation and draws from multiple legal sources, but there are limitations to acknowledge. This study is a retrospective analysis and is limited by the inherent bias associated with its design. As noted in previous studies,28,46 some jurisdictions may include only cases reported by attorneys on a voluntary basis with the purpose of predicting future outcomes and awards.47 Settlements may be underrepresented in this study. Out-of-court settlements often are not filed with state or federal courts and thus do not become part of the public record. The level of detail in jury verdicts in this database also is heterogeneous, and each case has different details and varying depths emphasized.

A better source of settlements and plaintiff verdict awards may be the National Practitioner Data Bank (NPDB), an electronic repository created by the U.S. Congress. It contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers. However, the reports are confidential and not available to the public.

This study had a low number of cases (n = 32), but the information provided is impactful given there is a lack of access to a better source. For instance, insurance companies provide claims data, but the data have been criticized because insurers may be biased in determining which data to release. As discussed previously, the NPDB is not available for public review. Therefore, it is uncertain how many of the medical malpractice cases the WestlawNext database captures.

Based on the discussion with multiple medical malpractice lawyers practicing in various jurisdictions across the country and law school reference librarians, there is a concurrence that about 70% to 90% of claims are not taken on by plaintiff attorneys because of lack of merit or for procedural legal reasons, such as when there is no standing or when the statute of limitations has expired. Of the 10% to 30% claims that proceed to trial, about 90% result in a confidential settlement. Moreover, the court can render an order or an opinion. If it is an order, the case is never recorded. If it is an opinion, the case still may not be included in the WestlawNext database. Only cases that are on appeal, with controversy, proceed through the state and federal appellate system; judges still can decide whether to publish the results from these cases. Depending on jurisdiction, these factors result in 20% to 92% of opinions not being published for any given year. However, opinions that are marked for publishing should be included in the WestlawNext database with negligible omissions and errors. The percentage of published cases in WestlawNext database of all claims could very well be only 1% to 5%.

Nevertheless, the WestlawNext database covers a large geographic area and is a comprehensive source of litigation information. The authors selected WestlawNext over other online legal databases (ie, Bloomberg Law, LexisNexis, VerdictSearch) due to its reputation, quality of case entries, and ease of navigation. WestlawNext is well known among lawyers and legal professions, and it has been validated through previous studies in other medical fields such as general surgery and its subspecialties,36,48 otolaryngology,28,46,47,49 ophthalmology,50 urology,51 dermatology,52 and plastic surgery.53

 

 

Conclusion

Litigation involving radiation oncologists were infrequent, and most verdicts were in favor of defendant radiation oncologists. Excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests were noted in most cases. Settlements were reached in the minority of cases, although mean payouts were more than 3 times less in these cases compared with jury verdicts. An increased awareness of radiation oncology malpractice litigation has the potential to improve physician-patient relationships and provide insight into the situations and conditions that commonly lead to litigation within the radiation oncology field.

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References

1. Mello MM, Studdert DM, Brennan TA. The new medical malpractice crisis. N Engl J Med. 2003;348(23):2281-2284.

2. Howard C, Blau R. Exclusive: legal settlements at Veterans Affairs more than tripled since 2011, many due to medical malpractices. http://www.nydailynews.com/amp /news/national/legal-settlements-veterans-affairs-triple -article-1.2654179. Published May 30, 2016. Accessed January 10, 2018.

3. Rosiak L. VA paid $871M in medical malpractice deals in past decade. http://amp.dailycaller.com/2015/12/17/va-has-paid-230m-in-medical-malpractice-settlements. Published December 17, 2015. Accessed January 11, 2018.

4. Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005;293(21):2609-2617.

5. Bishop TF, Federman AD, Keyhani S. Physicians’ views on defensive medicine: a national survey. Arch Intern Med. 2010;170(12):1081-1083.

6. Carrier ER, Reschovsky JD, Mello MM, Mayrell RC, Katz D. Physicians’ fears of malpractice lawsuits are not assuaged by tort reforms. Health Aff (Millwood). 2010;29(9):1585-1592.

7. Hermer LD, Brody H. Defensive medicine, cost containment, and reform. J Gen Intern Med. 2010;25(5):470-473.

8. Rothberg MB, Class J, Bishop TF, Friderici J, Kleppel R, Lindenauer PK. The cost of defensive medicine on 3 hospital medicine services. JAMA Intern Med. 2014;174(11):1867-1868.

9. Martello J. Basic medical legal principles. Clin Plast Surg. 1999;26(1):9-14, v.

10. Kessler DP. Evaluating the medical malpractice system and options for reform. J Econ Perspect. 2011;25(2):93-110.

11. Rosenblatt RA, Detering B. Changing patterns of obstetric practice in Washington State: the impact of tort reform. Fam Med. 1988;20(2):101-107.

12. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Health Aff (Millwood). 2013;32(1):111-119.

13. Mello MM, Williams CH. Medical malpractice: impact of the crisis and effect of state tort reforms. Research Synthesis Report No. 10. Princeton, NJ: The Robert Wood Johnson Foundation; 2006.

14. Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff (Millwood). 2010;29(9):1569-1577.

15. Ramella S, Mandoliti G, Trodella L, D’Angelillo RM. The first survey on defensive medicine in radiation oncology. Radiol Med. 2015;120(5):421-429.

16. Marshall DC, Punglia RS, Fox D, Recht A, Hattangadi-Gluth JA. Medical malpractice claims in radiation oncology: a population-based study 1985-2012. Int J Radiat Oncol Biol Phys. 2015;93(2):241-250.

17. Baicker K, Fisher ES, Chandra A. Malpractice liability costs and the practice of medicine in the medicare program. Health Aff (Millwood). 2007;26(3):841-852.

18. Kessler DP, McClellan MB. How liability law affects medical productivity. J Health Econ. 2002;21(6):931-955.

19. Dubay L, Kaestner R, Waidmann T. The impact of malpractice fears on cesarean section rates. J Health Econ. 1999;18(4):491-522.

20. Lakdawalla DN, Seabury SA. The welfare effects of medical malpractice liability. Int Rev Law Econ. 2012;32(4):356-369.

21. Ortashi O, Virdee J, Hassan R, Mutrynowski T, Abu-Zidan F. The practice of defensive medicine among hospital doctors in the United Kingdom. BMC Med Ethics. 2013;14(1):42.

22. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.

23. Marshall D, Tringale K, Connor M, Punglia R, Recht A, Hattangadi-Gluth J. Nature of medical malpractice claims against radiation oncologists. Int J Radiat Oncol Biol Phys. 2017;98(1):21-30.

24. Zaorsky NG, Ricco AG, Churilla TM, Horwitz EM, Den RB. ASTRO APEx® and RO-ILS™ are applicable to medical malpractice in radiation oncology. Future Oncol. 2016;12(22):2643-2657.

25. Hattangadi J, Murphy J, Sanghvi P, Recht A, Punglia RS. A 25-year epidemiologic study of medical malpractice claims in radiation oncology. Int J Radiat Oncol Biol Phys. 2014;90(1)(suppl 9):S749.

26. Necessary elements of proof that injury resulted from failure to follow accepted standard of care. Washington State Legislature. Revised Code of Washington 7.70.040. 2011.

27. Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12(1):109-112.

28. Svider PF, Husain Q, Kovalerchik O, et al. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Am J Otolaryngol. 2013;34(6):699-705.

29. Svider PF, Sunaryo PL, Keeley BR, Kovalerchik O, Mauro AC, Eloy JA. Characterizing liability for cranial nerve injuries: a detailed analysis of 209 malpractice trials. Laryngoscope. 2013;123(5):1156-1162.

30. Svider PF, Keeley BR, Zumba O, Mauro AC, Setzen M, Eloy JA. From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures. Laryngoscope. 2013;123(8):1849-1853.

31. Prabhu AV, Crihalmeanu T, Hansberry DR, et al. Online palliative care and oncology patient education resources through Google: do they meet national health literacy recommendations? Pract Radiat Oncol. 2017;7(5):306-310.

32. Prabhu AV, Hansberry DR, Agarwal N, Clump DA, Heron DE. Radiation oncology and online patient education materials: deviating from NIH and AMA recommendations. Int J Radiat Oncol Biol Phys. 2016;96(3):521-528.

33. Carroll AE, Buddenbaum JL. High and low-risk specialties experience with the U.S. medical malpractice system. BMC Health Serv Res. 2013;13:465.

34. Vidmar N. Juries and medical malpractice claims: empirical facts versus myths. Clin Orthop Relat Res. 2009;467(2):367-375.

35. Danzon PM. Medical Malpractice: Theory, Evidence, and Public Policy. Cambridge, MA: Harvard University Press; 1985.

36. Gordhan CG, Anandalwar SP, Son J, Ninan GK, Chokshi RJ. Malpractice in colorectal surgery: a review of 122 medicolegal cases. J Surg Res. 2015;199(2):351-356.

37. Code CC. Civil Code Section 3333.2. In: California So, ed1975.

38. Waters TM, Budetti PP, Claxton G, Lundy JP. Impact of state tort reforms on physician malpractice payments. Health Aff (Millwood). 2007;26(2):500-509.

39. Studdert DM, Yang YT, Mello MM. Are damages caps regressive? A study of malpractice jury verdicts in California. Health Aff (Millwood). 2004;23(4):54-67.

40. Aneja S, Smith BD, Gross CP, et al. Geographic analysis of the radiation oncology workforce. Int J Radiat Oncol Biol Phys. 2012;82(5):1723-1729.

41. ASTRO Workforce Committee. 2002 Radiation Oncology Workforce Study: American Society for Therapeutic Radiology and Oncology. Int J Radiat Oncol Biol Phys. 2003;56(2):309-318.

42. Fears D. Renewed effort to lure doctors to rural areas faces obstacles. Washington Post. http://www.was hingtonpost.com/wp-dyn/content/article/2010/08/08/AR2010080802832.html. Published August 9, 2010. Accessed January 11, 2018.

43. American Society for Radiation Oncology. RO-ILS. https://www.astro.org/RO-ILS.aspx. Accessed January 12, 2018.

44. Hoopes DJ, Dicker AP, Eads NL, et al. RO-ILS: Radiation Oncology Incident Learning System: a report from the first year of experience. Pract Radiat Oncol. 2015;5(5):312-318.

45. American Society for Radiation Oncology. APEx® Program Standards. Version 1.4. https://www.astro.org/uploaded Files/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Updated February 1, 2016. Accessed January 12, 2018.

46. Svider PF, Kovalerchik O, Mauro AC, Baredes S, Eloy JA. Legal liability in iatrogenic orbital injury. Laryngoscope. 2013;123(9):2099-2103.

47. Nash JJ, Nash AG, Leach ME, Poetker DM. Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011;144(1):10-15.

48. Choudhry AJ, Haddad NN, Rivera M, et al. Medical malpractice in the management of small bowel obstruction: a 33-year review of case law. Surgery. 2016;160(4):1017-1027.

49. Ta JH, Liu YF, Krishna P. Medicolegal aspects of iatrogenic dysphonia and recurrent laryngeal nerve injury. Otolaryngol Head Neck Surg. 2016;154(1):80-86.

50. Engelhard SB, Collins M, Shah C, Sim AJ, Reddy AK. Malpractice litigation in pediatric ophthalmology. JAMA Ophthalmol. 2016;134(11):1230-1235.

51. Sunaryo PL, Svider PF, Jackson-Rosario I, Eloy JA. Expert witness testimony in urology malpractice litigation. Urology. 2014;83(4):704-708.

52. Rayess HM, Gupta A, Svider PF, et al. A critical analysis of melanoma malpractice litigation: should we biopsy everything? Laryngoscope. 2017;127(1):134-139.

53. Paik AM, Mady LJ, Sood A, Eloy JA, Lee ES. A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases. Aesthet Surg J. 2014;34(1):79-86.

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Mr. Prabhu and Mr. Funahashi are medical students and Dr. Agarwal is a resident, all at the University of Pittsburgh School of Medicine in Pennsylvania. Dr. Quang is an Associate Professor, Department of Radiation Oncology, Veterans Affairs Puget Sound Health Care System, University of Washington School of Medicine, and University of Washington School of Law, Seattle, Washington. Mr. Gupta and Mr. Badeti are medical students at Rutgers New Jersey and Otolaryngology 2, Newark, New Jersey. Dr. Adeeb is a resident, Department of Neurosurgery, Louisiana State University, Shreveport, Louisiana. Dr. Moore is a Clinical Instructor, Department of Neurological Surgery, Stanford University School of Medicine, Palo Alto, California. Dr. Heron is Professor and Vice Chairman of Clinical Affairs, Department of Radiation Oncology and Otolaryngology; and Dr. Beriwal is a Professor, Department of Radiation Oncology, both at UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine.

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Mr. Prabhu and Mr. Funahashi are medical students and Dr. Agarwal is a resident, all at the University of Pittsburgh School of Medicine in Pennsylvania. Dr. Quang is an Associate Professor, Department of Radiation Oncology, Veterans Affairs Puget Sound Health Care System, University of Washington School of Medicine, and University of Washington School of Law, Seattle, Washington. Mr. Gupta and Mr. Badeti are medical students at Rutgers New Jersey and Otolaryngology 2, Newark, New Jersey. Dr. Adeeb is a resident, Department of Neurosurgery, Louisiana State University, Shreveport, Louisiana. Dr. Moore is a Clinical Instructor, Department of Neurological Surgery, Stanford University School of Medicine, Palo Alto, California. Dr. Heron is Professor and Vice Chairman of Clinical Affairs, Department of Radiation Oncology and Otolaryngology; and Dr. Beriwal is a Professor, Department of Radiation Oncology, both at UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine.

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Mr. Prabhu and Mr. Funahashi are medical students and Dr. Agarwal is a resident, all at the University of Pittsburgh School of Medicine in Pennsylvania. Dr. Quang is an Associate Professor, Department of Radiation Oncology, Veterans Affairs Puget Sound Health Care System, University of Washington School of Medicine, and University of Washington School of Law, Seattle, Washington. Mr. Gupta and Mr. Badeti are medical students at Rutgers New Jersey and Otolaryngology 2, Newark, New Jersey. Dr. Adeeb is a resident, Department of Neurosurgery, Louisiana State University, Shreveport, Louisiana. Dr. Moore is a Clinical Instructor, Department of Neurological Surgery, Stanford University School of Medicine, Palo Alto, California. Dr. Heron is Professor and Vice Chairman of Clinical Affairs, Department of Radiation Oncology and Otolaryngology; and Dr. Beriwal is a Professor, Department of Radiation Oncology, both at UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine.

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Although litigation involving radiation oncologists was infrequent and most verdicts were in favor of defendants, many cases resulted from claims of excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests.
Although litigation involving radiation oncologists was infrequent and most verdicts were in favor of defendants, many cases resulted from claims of excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests.

A rise in medical malpractice insurance premiums and malpractice claims has brought the issue of medical malpractice to the forefront of medicine over the past few decades.1 The VA has more than tripled the number of legal settlements it has made over the past 5 years, and it has paid more than $871 million in medical malpractice settlements over the past decade.2,3 Legislation by the federal and state governments in the U.S., collectively referred to as tort reform, has been passed to curb the rate at which malpractice claims are filed; to set caps on noneconomic damages, such as pain and suffering; to control the effect of these claims on insurance premiums; and to prevent the delivery of negligent and harmful medical care.1

An observed high prevalence of medical malpractice claims has significant consequences within the clinical setting and has given rise to the practice of defensive medicine.4-8 Even the perceived threat of possible tort action may lead to aberrant practice behaviors. These defensive medical practices may include excessive testing, unnecessary referrals to other physicians or health facilities, or even refusal to treat particular patients.4,9-11 Furthermore, physicians devote valuable time and energy engaging in lawsuits rather than in delivering quality care to their patients.12

The increasingly litigious environment has discouraged physicians from practicing medicine, leading to earlier retirement, geographic relocation, and restriction of scope of services, all limiting patients’ access to health care.13 One such figure reported in 2008 found that in the U.S., defensive medicine costs can total nearly $56 billion.14 Radiation oncology is generally considered a medium-to-low risk specialty for litigation.15,16 Its average annual indemnity payment in 2006 was $276,792 and has increased at a rate of $1,500 per year, ranking it fifth among 22 specialty groups.16 Studies revealed that the practice of defensive medicine is not strictly limited to the U.S. and has been reported in other countries.6,17-20,21

A recent study by Jena and colleagues found that nearly 10% of oncologists face a malpractice claim annually, the 10th highest among the specialties surveyed.22 Malpractice within the field of radiation oncology has been previously discussed in the literature.16,23,24 There are limited data that examine the basis for these claims, the resulting jury verdicts, and the subsequent indemnity payments associated with claims.24,25

In this study, the authors sought to describe radiation oncology malpractice claims over the past 30 years. It is hoped that this study will not only help traditional oncologists in particular, but also all other practitioners who might be included as co-defendants to be more aware of the common causes of action that plaintiffs have been using to sue.

Methods

This public and online study did not involve human subjects research and accordingly did not require institutional review board approval. The WestlawNext (Thomson Reuters, New York) online legal database was used to search retrospectively for state and federal jury verdicts and settlements related to radiation oncology and medical malpractice. The database is a collection of several thousand search engines that can locate court dockets, jury verdicts, and settlements compiled by attorney-editors. Local cases and claims that were dismissed prior to proceeding to trial or that were settled out of court were not available. All cases in the database were considered and provided this study’s sample size, spanning from January 1, 1985, to December 31, 2015.

Given the boolean search functionality integrated into the Westlaw database, search parameters included “radiation oncology” and “medical malpractice” to yield the greatest number of cases (n = 223). All derived cases were manually reviewed, and files that were duplicates or associated with litigation unrelated to radiation oncology were excluded from analysis (n = 191).

Analysis

Factors that were collected and considered included the state and county in which the claim was filed, the age and sex of the litigant at the time of malpractice, the year the case was settled, co-defendant specialties, jury verdicts, award payouts, death status of the litigant and the alleged basis for the medical malpractice claim. A lack of informed consent, a failure to treat in a timely manner, a failure to order appropriate tests or to make a timely referral, misinterpretation of a test, excessive radiation, unnecessary radiation, unnecessary surgery, and procedural error all were included as alleged bases for the malpractice claim. Descriptive statistics were then compiled.

Results

A total of 32 cases were included for analysis (Tables 1, 2, and 3). Anonymized summaries of all 32 cases are provided in the Appendix. The average age of the patient was 54.6 years (range 34-83) and included 17 (54.8%) female and 14 (45.2%) male patients. 

The cases were distributed across 12 states, with 9 cases (28.1%) in Florida, 4 (12.5%) in New York, and 3 (9.4%) in California. Of 31 cases with available data, 19 suits (61.3%) were brought against 1 or 2 defendants, and 12 (38.7%) had ≥ 3 defendants. Radiation oncologists were defendants in all the cases. Otolaryngologists and orthopedic surgeons were the 2 most commonly named co-defendants, each named in 9.4% of cases.

 

 

Excessive radiation (n = 11, 34.4%), unnecessary radiation (n = 8, 25%), and a failure to refer and/or order appropriate tests (n = 9, 28.1%) were the 3 most commonly alleged causes of malpractice. A lack of informed consent was implicated in less than one-seventh of cases (4; 12.5%). In 7 (21.9%) cases, the patient passed away.

Between 1985 and 2015, decisions were made in radiation oncologists’ favor in more than half of the cases. The jury ruled for the plaintiff in 11 (34.4%) cases and for the defendant in 17 (53.1%) cases. Settlements were reached in 4 (12.5%) cases, with a mean payout of $1,476,775. 

Cases that proceeded to trial had a mean payout of $4,744,219. Payouts ranged from $25,000 to $16,000,000.

Discussion

A physician’s duty is to provide medical care within the standard of care. In the courtroom, a radiation oncologist is judged on what a “reasonably prudent” radiation oncologist would do in similar circumstances.26 The plaintiff must establish the standard of care for the patient’s specific diagnosis with evidence, which is often accomplished through expert testimony. A physician is deemed negligent when deviating from this standard of care. The plaintiff must establish 4 factors to be awarded compensation for medical negligence: (1) the physician owed a professional duty to the patient such as the doctor-patient relationship; (2) the physician breeched this duty or failed to meet the standard of care; (3) proximate cause—the breach of duty by the physician directly caused the patient’s injury; and (4) the patient experienced emotional and/or physical damage while in the care of the physician.27

Reasons for Malpractice Claims

The WestlawNext search revealed 3 top theories of breach of standard of care: excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests. As a result, these theories can be interpreted as medical malpractice law in evolution. In other words, the courts still may be laying groundwork to clarify these theories.

However, a more cynical interpretation of why these 3 top theories of breech of standard of care were seen would note the practice of using expert witness testimony as “hired guns” in the U.S. legal system. Plaintiff attorneys know that use of expert witnesses can increase the attorney’s billable hours during the discovery phase and can decrease the likelihood that the case would be thrown out as lacking merit. Nevertheless, when the claim eventually does go to trial, it may lack merit, but not before plaintiff and defense attorneys complete many hours of work. This use of the legal system for financial gains can potentially confound the true reasons why the search resulted in these 3 top theories of breach of standard of care.

A lack of informed consent was not a major issue and was cited only in 4 (12.5%) cases as the cause of alleged malpractice. This finding was reassuring, as informed consent is an important issue that reinforces the physician-patient relationship and enhances patient trust. Previous studies found a perceived lack of informed consent as a basis for a malpractice claim in more than 34% of otolaryngology cases,25% of cranial nerve surgery cases,and 39% of facial plastic surgery cases.28-30 Perhaps the physician patient discussion in radiation oncology may be different compared with that of surgery, as treatments in radiation oncology are guided by large clinical trials, and patients are often referred after discussions with other specialty providers, such as surgeons and medical oncologists. Improving patients’ understanding of their radiation treatment plans is important in reducing malpractice claims relating to informed consent, and recent studies have identified areas where patient education can be improved.31,32

Settlements

Although settlements were reached in a minority of cases, the monetary value of jury verdicts favoring the plaintiff were 3-fold higher than those of out-of-court settlements. Specifically, cases that were settled had a mean payout of $1,476,775, which sharply contrasts with cases that proceeded to trial and a mean payout of $4,744,219. The highest jury award to the plaintiff was $16,000,000, involving a case where it was determined that a double dose of radiation was delivered to a patient’s shoulder. In a simple risk-reward analysis, this suggests that radiation oncologists should consider settling out of court if a malpractice guilty verdict seems possible. However, given the retrospective nature of the analysis, only limited conclusions can be drawn regarding the effectiveness of such a strategy.

Regardless, cases that were settled or judged on the plaintiff’s behalf were for a much higher value in radiation oncology compared with indemnity payment claims data in other high-risk specialties (emergency medicine, general surgery, obstetrics and gynecologic surgery, and radiology).33 It is important to highlight the magnitude of real and perceived harm that can be associated with radiation oncology. Regarding perceived harm, the public may lack an understanding of how radiation works. Interestingly, even though the perceived harm may be misplaced, the real harm is still there. Unlike other specialties where some errors can be reversed (ie, if heparin is mistakenly administered, its effects can be reversed by protamine sulfate), once radiation is delivered, it is not reversible. The harm is permanent and can cause disability.

Settlements are often lower in legal cases due to insurance policy limitations, the time line of award payout (settlement funds are paid more rapidly, as verdict awards are dependent on the conclusion of the case), and the inherent risk that an appeals court may overturn a verdict or reduce the amount of the award.34 For all the radiation oncology cases that proceeded to trial, more than half (53.1%) of the cases were in favor of the physician (Table 3). While this is positive news for radiation oncologists, it is still lower than the national average of 75% of malpractice verdicts in favor of the physician.34,35 In contrast, 65% of colorectal surgery cases resulted in a verdict in favor of the physician.36

 

 

Geographic Locations

The concentration of cases in a few states in this analysis is likely due to a combination of factors, including the distinct legal climates in individual states and the geographic unequal distribution of radiation oncologists across the country. For instance, California’s Medical Injury Compensation Reform Act of 1975 caps limited pain, suffering, inconvenience, physical impairment, disfigurement, and other noneconomic and nonmedical damages in malpractice to $250,000.37-39 Because of this cap, plaintiffs and their attorneys may be more hesitant to file a suit.

Radiation oncologists also remain concentrated in highly populated metropolitan health service areas, likely due to the attractiveness of academic centers, the large patient base required to sustain a practice, and the large capital investment needed to obtain the radiation equipment and staff resources to establish practices.40-42

Evolving Malpractice Theories

Zaorsky and colleagues used a similar methodology to this study.24 However, the distinction between this study and the Zaorsky study is that the latter attempted to use medical malpractice cases to draw conclusions on the validity and utility of quality assurance programs, specifically the Accreditation Program for Excellence (APEx) and the Radiation Oncology Incident Learning System (RO-ILS).43-45 The APEx/RO-ILS systems report only errors and faults, and medical malpractice is based on different sets of variables, such as legal theories, litigation procedures, plaintiff/defense zealousness, and the judicial system of inclusion and exclusion of cases in the docket. It is not possible to control for these confounding variables. This study, in contrast to the Zaorsky study, distills the essence of medical malpractice in radiation oncology and draws conclusions to advance the theories of recovery of monetary damage.

Limitations

The WestlawNext database is a comprehensive source for outcomes and details in malpractice litigation and draws from multiple legal sources, but there are limitations to acknowledge. This study is a retrospective analysis and is limited by the inherent bias associated with its design. As noted in previous studies,28,46 some jurisdictions may include only cases reported by attorneys on a voluntary basis with the purpose of predicting future outcomes and awards.47 Settlements may be underrepresented in this study. Out-of-court settlements often are not filed with state or federal courts and thus do not become part of the public record. The level of detail in jury verdicts in this database also is heterogeneous, and each case has different details and varying depths emphasized.

A better source of settlements and plaintiff verdict awards may be the National Practitioner Data Bank (NPDB), an electronic repository created by the U.S. Congress. It contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers. However, the reports are confidential and not available to the public.

This study had a low number of cases (n = 32), but the information provided is impactful given there is a lack of access to a better source. For instance, insurance companies provide claims data, but the data have been criticized because insurers may be biased in determining which data to release. As discussed previously, the NPDB is not available for public review. Therefore, it is uncertain how many of the medical malpractice cases the WestlawNext database captures.

Based on the discussion with multiple medical malpractice lawyers practicing in various jurisdictions across the country and law school reference librarians, there is a concurrence that about 70% to 90% of claims are not taken on by plaintiff attorneys because of lack of merit or for procedural legal reasons, such as when there is no standing or when the statute of limitations has expired. Of the 10% to 30% claims that proceed to trial, about 90% result in a confidential settlement. Moreover, the court can render an order or an opinion. If it is an order, the case is never recorded. If it is an opinion, the case still may not be included in the WestlawNext database. Only cases that are on appeal, with controversy, proceed through the state and federal appellate system; judges still can decide whether to publish the results from these cases. Depending on jurisdiction, these factors result in 20% to 92% of opinions not being published for any given year. However, opinions that are marked for publishing should be included in the WestlawNext database with negligible omissions and errors. The percentage of published cases in WestlawNext database of all claims could very well be only 1% to 5%.

Nevertheless, the WestlawNext database covers a large geographic area and is a comprehensive source of litigation information. The authors selected WestlawNext over other online legal databases (ie, Bloomberg Law, LexisNexis, VerdictSearch) due to its reputation, quality of case entries, and ease of navigation. WestlawNext is well known among lawyers and legal professions, and it has been validated through previous studies in other medical fields such as general surgery and its subspecialties,36,48 otolaryngology,28,46,47,49 ophthalmology,50 urology,51 dermatology,52 and plastic surgery.53

 

 

Conclusion

Litigation involving radiation oncologists were infrequent, and most verdicts were in favor of defendant radiation oncologists. Excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests were noted in most cases. Settlements were reached in the minority of cases, although mean payouts were more than 3 times less in these cases compared with jury verdicts. An increased awareness of radiation oncology malpractice litigation has the potential to improve physician-patient relationships and provide insight into the situations and conditions that commonly lead to litigation within the radiation oncology field.

Click here to read the digital edition.

A rise in medical malpractice insurance premiums and malpractice claims has brought the issue of medical malpractice to the forefront of medicine over the past few decades.1 The VA has more than tripled the number of legal settlements it has made over the past 5 years, and it has paid more than $871 million in medical malpractice settlements over the past decade.2,3 Legislation by the federal and state governments in the U.S., collectively referred to as tort reform, has been passed to curb the rate at which malpractice claims are filed; to set caps on noneconomic damages, such as pain and suffering; to control the effect of these claims on insurance premiums; and to prevent the delivery of negligent and harmful medical care.1

An observed high prevalence of medical malpractice claims has significant consequences within the clinical setting and has given rise to the practice of defensive medicine.4-8 Even the perceived threat of possible tort action may lead to aberrant practice behaviors. These defensive medical practices may include excessive testing, unnecessary referrals to other physicians or health facilities, or even refusal to treat particular patients.4,9-11 Furthermore, physicians devote valuable time and energy engaging in lawsuits rather than in delivering quality care to their patients.12

The increasingly litigious environment has discouraged physicians from practicing medicine, leading to earlier retirement, geographic relocation, and restriction of scope of services, all limiting patients’ access to health care.13 One such figure reported in 2008 found that in the U.S., defensive medicine costs can total nearly $56 billion.14 Radiation oncology is generally considered a medium-to-low risk specialty for litigation.15,16 Its average annual indemnity payment in 2006 was $276,792 and has increased at a rate of $1,500 per year, ranking it fifth among 22 specialty groups.16 Studies revealed that the practice of defensive medicine is not strictly limited to the U.S. and has been reported in other countries.6,17-20,21

A recent study by Jena and colleagues found that nearly 10% of oncologists face a malpractice claim annually, the 10th highest among the specialties surveyed.22 Malpractice within the field of radiation oncology has been previously discussed in the literature.16,23,24 There are limited data that examine the basis for these claims, the resulting jury verdicts, and the subsequent indemnity payments associated with claims.24,25

In this study, the authors sought to describe radiation oncology malpractice claims over the past 30 years. It is hoped that this study will not only help traditional oncologists in particular, but also all other practitioners who might be included as co-defendants to be more aware of the common causes of action that plaintiffs have been using to sue.

Methods

This public and online study did not involve human subjects research and accordingly did not require institutional review board approval. The WestlawNext (Thomson Reuters, New York) online legal database was used to search retrospectively for state and federal jury verdicts and settlements related to radiation oncology and medical malpractice. The database is a collection of several thousand search engines that can locate court dockets, jury verdicts, and settlements compiled by attorney-editors. Local cases and claims that were dismissed prior to proceeding to trial or that were settled out of court were not available. All cases in the database were considered and provided this study’s sample size, spanning from January 1, 1985, to December 31, 2015.

Given the boolean search functionality integrated into the Westlaw database, search parameters included “radiation oncology” and “medical malpractice” to yield the greatest number of cases (n = 223). All derived cases were manually reviewed, and files that were duplicates or associated with litigation unrelated to radiation oncology were excluded from analysis (n = 191).

Analysis

Factors that were collected and considered included the state and county in which the claim was filed, the age and sex of the litigant at the time of malpractice, the year the case was settled, co-defendant specialties, jury verdicts, award payouts, death status of the litigant and the alleged basis for the medical malpractice claim. A lack of informed consent, a failure to treat in a timely manner, a failure to order appropriate tests or to make a timely referral, misinterpretation of a test, excessive radiation, unnecessary radiation, unnecessary surgery, and procedural error all were included as alleged bases for the malpractice claim. Descriptive statistics were then compiled.

Results

A total of 32 cases were included for analysis (Tables 1, 2, and 3). Anonymized summaries of all 32 cases are provided in the Appendix. The average age of the patient was 54.6 years (range 34-83) and included 17 (54.8%) female and 14 (45.2%) male patients. 

The cases were distributed across 12 states, with 9 cases (28.1%) in Florida, 4 (12.5%) in New York, and 3 (9.4%) in California. Of 31 cases with available data, 19 suits (61.3%) were brought against 1 or 2 defendants, and 12 (38.7%) had ≥ 3 defendants. Radiation oncologists were defendants in all the cases. Otolaryngologists and orthopedic surgeons were the 2 most commonly named co-defendants, each named in 9.4% of cases.

 

 

Excessive radiation (n = 11, 34.4%), unnecessary radiation (n = 8, 25%), and a failure to refer and/or order appropriate tests (n = 9, 28.1%) were the 3 most commonly alleged causes of malpractice. A lack of informed consent was implicated in less than one-seventh of cases (4; 12.5%). In 7 (21.9%) cases, the patient passed away.

Between 1985 and 2015, decisions were made in radiation oncologists’ favor in more than half of the cases. The jury ruled for the plaintiff in 11 (34.4%) cases and for the defendant in 17 (53.1%) cases. Settlements were reached in 4 (12.5%) cases, with a mean payout of $1,476,775. 

Cases that proceeded to trial had a mean payout of $4,744,219. Payouts ranged from $25,000 to $16,000,000.

Discussion

A physician’s duty is to provide medical care within the standard of care. In the courtroom, a radiation oncologist is judged on what a “reasonably prudent” radiation oncologist would do in similar circumstances.26 The plaintiff must establish the standard of care for the patient’s specific diagnosis with evidence, which is often accomplished through expert testimony. A physician is deemed negligent when deviating from this standard of care. The plaintiff must establish 4 factors to be awarded compensation for medical negligence: (1) the physician owed a professional duty to the patient such as the doctor-patient relationship; (2) the physician breeched this duty or failed to meet the standard of care; (3) proximate cause—the breach of duty by the physician directly caused the patient’s injury; and (4) the patient experienced emotional and/or physical damage while in the care of the physician.27

Reasons for Malpractice Claims

The WestlawNext search revealed 3 top theories of breach of standard of care: excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests. As a result, these theories can be interpreted as medical malpractice law in evolution. In other words, the courts still may be laying groundwork to clarify these theories.

However, a more cynical interpretation of why these 3 top theories of breech of standard of care were seen would note the practice of using expert witness testimony as “hired guns” in the U.S. legal system. Plaintiff attorneys know that use of expert witnesses can increase the attorney’s billable hours during the discovery phase and can decrease the likelihood that the case would be thrown out as lacking merit. Nevertheless, when the claim eventually does go to trial, it may lack merit, but not before plaintiff and defense attorneys complete many hours of work. This use of the legal system for financial gains can potentially confound the true reasons why the search resulted in these 3 top theories of breach of standard of care.

A lack of informed consent was not a major issue and was cited only in 4 (12.5%) cases as the cause of alleged malpractice. This finding was reassuring, as informed consent is an important issue that reinforces the physician-patient relationship and enhances patient trust. Previous studies found a perceived lack of informed consent as a basis for a malpractice claim in more than 34% of otolaryngology cases,25% of cranial nerve surgery cases,and 39% of facial plastic surgery cases.28-30 Perhaps the physician patient discussion in radiation oncology may be different compared with that of surgery, as treatments in radiation oncology are guided by large clinical trials, and patients are often referred after discussions with other specialty providers, such as surgeons and medical oncologists. Improving patients’ understanding of their radiation treatment plans is important in reducing malpractice claims relating to informed consent, and recent studies have identified areas where patient education can be improved.31,32

Settlements

Although settlements were reached in a minority of cases, the monetary value of jury verdicts favoring the plaintiff were 3-fold higher than those of out-of-court settlements. Specifically, cases that were settled had a mean payout of $1,476,775, which sharply contrasts with cases that proceeded to trial and a mean payout of $4,744,219. The highest jury award to the plaintiff was $16,000,000, involving a case where it was determined that a double dose of radiation was delivered to a patient’s shoulder. In a simple risk-reward analysis, this suggests that radiation oncologists should consider settling out of court if a malpractice guilty verdict seems possible. However, given the retrospective nature of the analysis, only limited conclusions can be drawn regarding the effectiveness of such a strategy.

Regardless, cases that were settled or judged on the plaintiff’s behalf were for a much higher value in radiation oncology compared with indemnity payment claims data in other high-risk specialties (emergency medicine, general surgery, obstetrics and gynecologic surgery, and radiology).33 It is important to highlight the magnitude of real and perceived harm that can be associated with radiation oncology. Regarding perceived harm, the public may lack an understanding of how radiation works. Interestingly, even though the perceived harm may be misplaced, the real harm is still there. Unlike other specialties where some errors can be reversed (ie, if heparin is mistakenly administered, its effects can be reversed by protamine sulfate), once radiation is delivered, it is not reversible. The harm is permanent and can cause disability.

Settlements are often lower in legal cases due to insurance policy limitations, the time line of award payout (settlement funds are paid more rapidly, as verdict awards are dependent on the conclusion of the case), and the inherent risk that an appeals court may overturn a verdict or reduce the amount of the award.34 For all the radiation oncology cases that proceeded to trial, more than half (53.1%) of the cases were in favor of the physician (Table 3). While this is positive news for radiation oncologists, it is still lower than the national average of 75% of malpractice verdicts in favor of the physician.34,35 In contrast, 65% of colorectal surgery cases resulted in a verdict in favor of the physician.36

 

 

Geographic Locations

The concentration of cases in a few states in this analysis is likely due to a combination of factors, including the distinct legal climates in individual states and the geographic unequal distribution of radiation oncologists across the country. For instance, California’s Medical Injury Compensation Reform Act of 1975 caps limited pain, suffering, inconvenience, physical impairment, disfigurement, and other noneconomic and nonmedical damages in malpractice to $250,000.37-39 Because of this cap, plaintiffs and their attorneys may be more hesitant to file a suit.

Radiation oncologists also remain concentrated in highly populated metropolitan health service areas, likely due to the attractiveness of academic centers, the large patient base required to sustain a practice, and the large capital investment needed to obtain the radiation equipment and staff resources to establish practices.40-42

Evolving Malpractice Theories

Zaorsky and colleagues used a similar methodology to this study.24 However, the distinction between this study and the Zaorsky study is that the latter attempted to use medical malpractice cases to draw conclusions on the validity and utility of quality assurance programs, specifically the Accreditation Program for Excellence (APEx) and the Radiation Oncology Incident Learning System (RO-ILS).43-45 The APEx/RO-ILS systems report only errors and faults, and medical malpractice is based on different sets of variables, such as legal theories, litigation procedures, plaintiff/defense zealousness, and the judicial system of inclusion and exclusion of cases in the docket. It is not possible to control for these confounding variables. This study, in contrast to the Zaorsky study, distills the essence of medical malpractice in radiation oncology and draws conclusions to advance the theories of recovery of monetary damage.

Limitations

The WestlawNext database is a comprehensive source for outcomes and details in malpractice litigation and draws from multiple legal sources, but there are limitations to acknowledge. This study is a retrospective analysis and is limited by the inherent bias associated with its design. As noted in previous studies,28,46 some jurisdictions may include only cases reported by attorneys on a voluntary basis with the purpose of predicting future outcomes and awards.47 Settlements may be underrepresented in this study. Out-of-court settlements often are not filed with state or federal courts and thus do not become part of the public record. The level of detail in jury verdicts in this database also is heterogeneous, and each case has different details and varying depths emphasized.

A better source of settlements and plaintiff verdict awards may be the National Practitioner Data Bank (NPDB), an electronic repository created by the U.S. Congress. It contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers. However, the reports are confidential and not available to the public.

This study had a low number of cases (n = 32), but the information provided is impactful given there is a lack of access to a better source. For instance, insurance companies provide claims data, but the data have been criticized because insurers may be biased in determining which data to release. As discussed previously, the NPDB is not available for public review. Therefore, it is uncertain how many of the medical malpractice cases the WestlawNext database captures.

Based on the discussion with multiple medical malpractice lawyers practicing in various jurisdictions across the country and law school reference librarians, there is a concurrence that about 70% to 90% of claims are not taken on by plaintiff attorneys because of lack of merit or for procedural legal reasons, such as when there is no standing or when the statute of limitations has expired. Of the 10% to 30% claims that proceed to trial, about 90% result in a confidential settlement. Moreover, the court can render an order or an opinion. If it is an order, the case is never recorded. If it is an opinion, the case still may not be included in the WestlawNext database. Only cases that are on appeal, with controversy, proceed through the state and federal appellate system; judges still can decide whether to publish the results from these cases. Depending on jurisdiction, these factors result in 20% to 92% of opinions not being published for any given year. However, opinions that are marked for publishing should be included in the WestlawNext database with negligible omissions and errors. The percentage of published cases in WestlawNext database of all claims could very well be only 1% to 5%.

Nevertheless, the WestlawNext database covers a large geographic area and is a comprehensive source of litigation information. The authors selected WestlawNext over other online legal databases (ie, Bloomberg Law, LexisNexis, VerdictSearch) due to its reputation, quality of case entries, and ease of navigation. WestlawNext is well known among lawyers and legal professions, and it has been validated through previous studies in other medical fields such as general surgery and its subspecialties,36,48 otolaryngology,28,46,47,49 ophthalmology,50 urology,51 dermatology,52 and plastic surgery.53

 

 

Conclusion

Litigation involving radiation oncologists were infrequent, and most verdicts were in favor of defendant radiation oncologists. Excessive radiation, unnecessary radiation, and a failure to refer and/or order appropriate tests were noted in most cases. Settlements were reached in the minority of cases, although mean payouts were more than 3 times less in these cases compared with jury verdicts. An increased awareness of radiation oncology malpractice litigation has the potential to improve physician-patient relationships and provide insight into the situations and conditions that commonly lead to litigation within the radiation oncology field.

Click here to read the digital edition.

References

1. Mello MM, Studdert DM, Brennan TA. The new medical malpractice crisis. N Engl J Med. 2003;348(23):2281-2284.

2. Howard C, Blau R. Exclusive: legal settlements at Veterans Affairs more than tripled since 2011, many due to medical malpractices. http://www.nydailynews.com/amp /news/national/legal-settlements-veterans-affairs-triple -article-1.2654179. Published May 30, 2016. Accessed January 10, 2018.

3. Rosiak L. VA paid $871M in medical malpractice deals in past decade. http://amp.dailycaller.com/2015/12/17/va-has-paid-230m-in-medical-malpractice-settlements. Published December 17, 2015. Accessed January 11, 2018.

4. Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005;293(21):2609-2617.

5. Bishop TF, Federman AD, Keyhani S. Physicians’ views on defensive medicine: a national survey. Arch Intern Med. 2010;170(12):1081-1083.

6. Carrier ER, Reschovsky JD, Mello MM, Mayrell RC, Katz D. Physicians’ fears of malpractice lawsuits are not assuaged by tort reforms. Health Aff (Millwood). 2010;29(9):1585-1592.

7. Hermer LD, Brody H. Defensive medicine, cost containment, and reform. J Gen Intern Med. 2010;25(5):470-473.

8. Rothberg MB, Class J, Bishop TF, Friderici J, Kleppel R, Lindenauer PK. The cost of defensive medicine on 3 hospital medicine services. JAMA Intern Med. 2014;174(11):1867-1868.

9. Martello J. Basic medical legal principles. Clin Plast Surg. 1999;26(1):9-14, v.

10. Kessler DP. Evaluating the medical malpractice system and options for reform. J Econ Perspect. 2011;25(2):93-110.

11. Rosenblatt RA, Detering B. Changing patterns of obstetric practice in Washington State: the impact of tort reform. Fam Med. 1988;20(2):101-107.

12. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Health Aff (Millwood). 2013;32(1):111-119.

13. Mello MM, Williams CH. Medical malpractice: impact of the crisis and effect of state tort reforms. Research Synthesis Report No. 10. Princeton, NJ: The Robert Wood Johnson Foundation; 2006.

14. Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff (Millwood). 2010;29(9):1569-1577.

15. Ramella S, Mandoliti G, Trodella L, D’Angelillo RM. The first survey on defensive medicine in radiation oncology. Radiol Med. 2015;120(5):421-429.

16. Marshall DC, Punglia RS, Fox D, Recht A, Hattangadi-Gluth JA. Medical malpractice claims in radiation oncology: a population-based study 1985-2012. Int J Radiat Oncol Biol Phys. 2015;93(2):241-250.

17. Baicker K, Fisher ES, Chandra A. Malpractice liability costs and the practice of medicine in the medicare program. Health Aff (Millwood). 2007;26(3):841-852.

18. Kessler DP, McClellan MB. How liability law affects medical productivity. J Health Econ. 2002;21(6):931-955.

19. Dubay L, Kaestner R, Waidmann T. The impact of malpractice fears on cesarean section rates. J Health Econ. 1999;18(4):491-522.

20. Lakdawalla DN, Seabury SA. The welfare effects of medical malpractice liability. Int Rev Law Econ. 2012;32(4):356-369.

21. Ortashi O, Virdee J, Hassan R, Mutrynowski T, Abu-Zidan F. The practice of defensive medicine among hospital doctors in the United Kingdom. BMC Med Ethics. 2013;14(1):42.

22. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.

23. Marshall D, Tringale K, Connor M, Punglia R, Recht A, Hattangadi-Gluth J. Nature of medical malpractice claims against radiation oncologists. Int J Radiat Oncol Biol Phys. 2017;98(1):21-30.

24. Zaorsky NG, Ricco AG, Churilla TM, Horwitz EM, Den RB. ASTRO APEx® and RO-ILS™ are applicable to medical malpractice in radiation oncology. Future Oncol. 2016;12(22):2643-2657.

25. Hattangadi J, Murphy J, Sanghvi P, Recht A, Punglia RS. A 25-year epidemiologic study of medical malpractice claims in radiation oncology. Int J Radiat Oncol Biol Phys. 2014;90(1)(suppl 9):S749.

26. Necessary elements of proof that injury resulted from failure to follow accepted standard of care. Washington State Legislature. Revised Code of Washington 7.70.040. 2011.

27. Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12(1):109-112.

28. Svider PF, Husain Q, Kovalerchik O, et al. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Am J Otolaryngol. 2013;34(6):699-705.

29. Svider PF, Sunaryo PL, Keeley BR, Kovalerchik O, Mauro AC, Eloy JA. Characterizing liability for cranial nerve injuries: a detailed analysis of 209 malpractice trials. Laryngoscope. 2013;123(5):1156-1162.

30. Svider PF, Keeley BR, Zumba O, Mauro AC, Setzen M, Eloy JA. From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures. Laryngoscope. 2013;123(8):1849-1853.

31. Prabhu AV, Crihalmeanu T, Hansberry DR, et al. Online palliative care and oncology patient education resources through Google: do they meet national health literacy recommendations? Pract Radiat Oncol. 2017;7(5):306-310.

32. Prabhu AV, Hansberry DR, Agarwal N, Clump DA, Heron DE. Radiation oncology and online patient education materials: deviating from NIH and AMA recommendations. Int J Radiat Oncol Biol Phys. 2016;96(3):521-528.

33. Carroll AE, Buddenbaum JL. High and low-risk specialties experience with the U.S. medical malpractice system. BMC Health Serv Res. 2013;13:465.

34. Vidmar N. Juries and medical malpractice claims: empirical facts versus myths. Clin Orthop Relat Res. 2009;467(2):367-375.

35. Danzon PM. Medical Malpractice: Theory, Evidence, and Public Policy. Cambridge, MA: Harvard University Press; 1985.

36. Gordhan CG, Anandalwar SP, Son J, Ninan GK, Chokshi RJ. Malpractice in colorectal surgery: a review of 122 medicolegal cases. J Surg Res. 2015;199(2):351-356.

37. Code CC. Civil Code Section 3333.2. In: California So, ed1975.

38. Waters TM, Budetti PP, Claxton G, Lundy JP. Impact of state tort reforms on physician malpractice payments. Health Aff (Millwood). 2007;26(2):500-509.

39. Studdert DM, Yang YT, Mello MM. Are damages caps regressive? A study of malpractice jury verdicts in California. Health Aff (Millwood). 2004;23(4):54-67.

40. Aneja S, Smith BD, Gross CP, et al. Geographic analysis of the radiation oncology workforce. Int J Radiat Oncol Biol Phys. 2012;82(5):1723-1729.

41. ASTRO Workforce Committee. 2002 Radiation Oncology Workforce Study: American Society for Therapeutic Radiology and Oncology. Int J Radiat Oncol Biol Phys. 2003;56(2):309-318.

42. Fears D. Renewed effort to lure doctors to rural areas faces obstacles. Washington Post. http://www.was hingtonpost.com/wp-dyn/content/article/2010/08/08/AR2010080802832.html. Published August 9, 2010. Accessed January 11, 2018.

43. American Society for Radiation Oncology. RO-ILS. https://www.astro.org/RO-ILS.aspx. Accessed January 12, 2018.

44. Hoopes DJ, Dicker AP, Eads NL, et al. RO-ILS: Radiation Oncology Incident Learning System: a report from the first year of experience. Pract Radiat Oncol. 2015;5(5):312-318.

45. American Society for Radiation Oncology. APEx® Program Standards. Version 1.4. https://www.astro.org/uploaded Files/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Updated February 1, 2016. Accessed January 12, 2018.

46. Svider PF, Kovalerchik O, Mauro AC, Baredes S, Eloy JA. Legal liability in iatrogenic orbital injury. Laryngoscope. 2013;123(9):2099-2103.

47. Nash JJ, Nash AG, Leach ME, Poetker DM. Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011;144(1):10-15.

48. Choudhry AJ, Haddad NN, Rivera M, et al. Medical malpractice in the management of small bowel obstruction: a 33-year review of case law. Surgery. 2016;160(4):1017-1027.

49. Ta JH, Liu YF, Krishna P. Medicolegal aspects of iatrogenic dysphonia and recurrent laryngeal nerve injury. Otolaryngol Head Neck Surg. 2016;154(1):80-86.

50. Engelhard SB, Collins M, Shah C, Sim AJ, Reddy AK. Malpractice litigation in pediatric ophthalmology. JAMA Ophthalmol. 2016;134(11):1230-1235.

51. Sunaryo PL, Svider PF, Jackson-Rosario I, Eloy JA. Expert witness testimony in urology malpractice litigation. Urology. 2014;83(4):704-708.

52. Rayess HM, Gupta A, Svider PF, et al. A critical analysis of melanoma malpractice litigation: should we biopsy everything? Laryngoscope. 2017;127(1):134-139.

53. Paik AM, Mady LJ, Sood A, Eloy JA, Lee ES. A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases. Aesthet Surg J. 2014;34(1):79-86.

References

1. Mello MM, Studdert DM, Brennan TA. The new medical malpractice crisis. N Engl J Med. 2003;348(23):2281-2284.

2. Howard C, Blau R. Exclusive: legal settlements at Veterans Affairs more than tripled since 2011, many due to medical malpractices. http://www.nydailynews.com/amp /news/national/legal-settlements-veterans-affairs-triple -article-1.2654179. Published May 30, 2016. Accessed January 10, 2018.

3. Rosiak L. VA paid $871M in medical malpractice deals in past decade. http://amp.dailycaller.com/2015/12/17/va-has-paid-230m-in-medical-malpractice-settlements. Published December 17, 2015. Accessed January 11, 2018.

4. Studdert DM, Mello MM, Sage WM, et al. Defensive medicine among high-risk specialist physicians in a volatile malpractice environment. JAMA. 2005;293(21):2609-2617.

5. Bishop TF, Federman AD, Keyhani S. Physicians’ views on defensive medicine: a national survey. Arch Intern Med. 2010;170(12):1081-1083.

6. Carrier ER, Reschovsky JD, Mello MM, Mayrell RC, Katz D. Physicians’ fears of malpractice lawsuits are not assuaged by tort reforms. Health Aff (Millwood). 2010;29(9):1585-1592.

7. Hermer LD, Brody H. Defensive medicine, cost containment, and reform. J Gen Intern Med. 2010;25(5):470-473.

8. Rothberg MB, Class J, Bishop TF, Friderici J, Kleppel R, Lindenauer PK. The cost of defensive medicine on 3 hospital medicine services. JAMA Intern Med. 2014;174(11):1867-1868.

9. Martello J. Basic medical legal principles. Clin Plast Surg. 1999;26(1):9-14, v.

10. Kessler DP. Evaluating the medical malpractice system and options for reform. J Econ Perspect. 2011;25(2):93-110.

11. Rosenblatt RA, Detering B. Changing patterns of obstetric practice in Washington State: the impact of tort reform. Fam Med. 1988;20(2):101-107.

12. Seabury SA, Chandra A, Lakdawalla DN, Jena AB. On average, physicians spend nearly 11 percent of their 40-year careers with an open, unresolved malpractice claim. Health Aff (Millwood). 2013;32(1):111-119.

13. Mello MM, Williams CH. Medical malpractice: impact of the crisis and effect of state tort reforms. Research Synthesis Report No. 10. Princeton, NJ: The Robert Wood Johnson Foundation; 2006.

14. Mello MM, Chandra A, Gawande AA, Studdert DM. National costs of the medical liability system. Health Aff (Millwood). 2010;29(9):1569-1577.

15. Ramella S, Mandoliti G, Trodella L, D’Angelillo RM. The first survey on defensive medicine in radiation oncology. Radiol Med. 2015;120(5):421-429.

16. Marshall DC, Punglia RS, Fox D, Recht A, Hattangadi-Gluth JA. Medical malpractice claims in radiation oncology: a population-based study 1985-2012. Int J Radiat Oncol Biol Phys. 2015;93(2):241-250.

17. Baicker K, Fisher ES, Chandra A. Malpractice liability costs and the practice of medicine in the medicare program. Health Aff (Millwood). 2007;26(3):841-852.

18. Kessler DP, McClellan MB. How liability law affects medical productivity. J Health Econ. 2002;21(6):931-955.

19. Dubay L, Kaestner R, Waidmann T. The impact of malpractice fears on cesarean section rates. J Health Econ. 1999;18(4):491-522.

20. Lakdawalla DN, Seabury SA. The welfare effects of medical malpractice liability. Int Rev Law Econ. 2012;32(4):356-369.

21. Ortashi O, Virdee J, Hassan R, Mutrynowski T, Abu-Zidan F. The practice of defensive medicine among hospital doctors in the United Kingdom. BMC Med Ethics. 2013;14(1):42.

22. Jena AB, Seabury S, Lakdawalla D, Chandra A. Malpractice risk according to physician specialty. N Engl J Med. 2011;365(7):629-636.

23. Marshall D, Tringale K, Connor M, Punglia R, Recht A, Hattangadi-Gluth J. Nature of medical malpractice claims against radiation oncologists. Int J Radiat Oncol Biol Phys. 2017;98(1):21-30.

24. Zaorsky NG, Ricco AG, Churilla TM, Horwitz EM, Den RB. ASTRO APEx® and RO-ILS™ are applicable to medical malpractice in radiation oncology. Future Oncol. 2016;12(22):2643-2657.

25. Hattangadi J, Murphy J, Sanghvi P, Recht A, Punglia RS. A 25-year epidemiologic study of medical malpractice claims in radiation oncology. Int J Radiat Oncol Biol Phys. 2014;90(1)(suppl 9):S749.

26. Necessary elements of proof that injury resulted from failure to follow accepted standard of care. Washington State Legislature. Revised Code of Washington 7.70.040. 2011.

27. Moffett P, Moore G. The standard of care: legal history and definitions: the bad and good news. West J Emerg Med. 2011;12(1):109-112.

28. Svider PF, Husain Q, Kovalerchik O, et al. Determining legal responsibility in otolaryngology: a review of 44 trials since 2008. Am J Otolaryngol. 2013;34(6):699-705.

29. Svider PF, Sunaryo PL, Keeley BR, Kovalerchik O, Mauro AC, Eloy JA. Characterizing liability for cranial nerve injuries: a detailed analysis of 209 malpractice trials. Laryngoscope. 2013;123(5):1156-1162.

30. Svider PF, Keeley BR, Zumba O, Mauro AC, Setzen M, Eloy JA. From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures. Laryngoscope. 2013;123(8):1849-1853.

31. Prabhu AV, Crihalmeanu T, Hansberry DR, et al. Online palliative care and oncology patient education resources through Google: do they meet national health literacy recommendations? Pract Radiat Oncol. 2017;7(5):306-310.

32. Prabhu AV, Hansberry DR, Agarwal N, Clump DA, Heron DE. Radiation oncology and online patient education materials: deviating from NIH and AMA recommendations. Int J Radiat Oncol Biol Phys. 2016;96(3):521-528.

33. Carroll AE, Buddenbaum JL. High and low-risk specialties experience with the U.S. medical malpractice system. BMC Health Serv Res. 2013;13:465.

34. Vidmar N. Juries and medical malpractice claims: empirical facts versus myths. Clin Orthop Relat Res. 2009;467(2):367-375.

35. Danzon PM. Medical Malpractice: Theory, Evidence, and Public Policy. Cambridge, MA: Harvard University Press; 1985.

36. Gordhan CG, Anandalwar SP, Son J, Ninan GK, Chokshi RJ. Malpractice in colorectal surgery: a review of 122 medicolegal cases. J Surg Res. 2015;199(2):351-356.

37. Code CC. Civil Code Section 3333.2. In: California So, ed1975.

38. Waters TM, Budetti PP, Claxton G, Lundy JP. Impact of state tort reforms on physician malpractice payments. Health Aff (Millwood). 2007;26(2):500-509.

39. Studdert DM, Yang YT, Mello MM. Are damages caps regressive? A study of malpractice jury verdicts in California. Health Aff (Millwood). 2004;23(4):54-67.

40. Aneja S, Smith BD, Gross CP, et al. Geographic analysis of the radiation oncology workforce. Int J Radiat Oncol Biol Phys. 2012;82(5):1723-1729.

41. ASTRO Workforce Committee. 2002 Radiation Oncology Workforce Study: American Society for Therapeutic Radiology and Oncology. Int J Radiat Oncol Biol Phys. 2003;56(2):309-318.

42. Fears D. Renewed effort to lure doctors to rural areas faces obstacles. Washington Post. http://www.was hingtonpost.com/wp-dyn/content/article/2010/08/08/AR2010080802832.html. Published August 9, 2010. Accessed January 11, 2018.

43. American Society for Radiation Oncology. RO-ILS. https://www.astro.org/RO-ILS.aspx. Accessed January 12, 2018.

44. Hoopes DJ, Dicker AP, Eads NL, et al. RO-ILS: Radiation Oncology Incident Learning System: a report from the first year of experience. Pract Radiat Oncol. 2015;5(5):312-318.

45. American Society for Radiation Oncology. APEx® Program Standards. Version 1.4. https://www.astro.org/uploaded Files/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Updated February 1, 2016. Accessed January 12, 2018.

46. Svider PF, Kovalerchik O, Mauro AC, Baredes S, Eloy JA. Legal liability in iatrogenic orbital injury. Laryngoscope. 2013;123(9):2099-2103.

47. Nash JJ, Nash AG, Leach ME, Poetker DM. Medical malpractice and corticosteroid use. Otolaryngol Head Neck Surg. 2011;144(1):10-15.

48. Choudhry AJ, Haddad NN, Rivera M, et al. Medical malpractice in the management of small bowel obstruction: a 33-year review of case law. Surgery. 2016;160(4):1017-1027.

49. Ta JH, Liu YF, Krishna P. Medicolegal aspects of iatrogenic dysphonia and recurrent laryngeal nerve injury. Otolaryngol Head Neck Surg. 2016;154(1):80-86.

50. Engelhard SB, Collins M, Shah C, Sim AJ, Reddy AK. Malpractice litigation in pediatric ophthalmology. JAMA Ophthalmol. 2016;134(11):1230-1235.

51. Sunaryo PL, Svider PF, Jackson-Rosario I, Eloy JA. Expert witness testimony in urology malpractice litigation. Urology. 2014;83(4):704-708.

52. Rayess HM, Gupta A, Svider PF, et al. A critical analysis of melanoma malpractice litigation: should we biopsy everything? Laryngoscope. 2017;127(1):134-139.

53. Paik AM, Mady LJ, Sood A, Eloy JA, Lee ES. A look inside the courtroom: an analysis of 292 cosmetic breast surgery medical malpractice cases. Aesthet Surg J. 2014;34(1):79-86.

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Managing malignant pleural effusion

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Managing malignant pleural effusion

Managing patients with malignant pleural effusion can be challenging. Symptoms are often distressing, and its presence signifies advanced disease. Median survival after diagnosis is 4 to 9 months,1–3 although prognosis varies considerably depending on the type and stage of the malignancy.

How patients are best managed depends on clinical circumstances. Physicians should consider the risks and benefits of each option while keeping in mind realistic goals of care.

This article uses brief case presentations to review management strategies for malignant pleural effusion.

CANCER IS A COMMON CAUSE OF PLEURAL EFFUSION

Physicians and surgeons, especially in tertiary care hospitals, must often manage malignant pleural effusion.4 Malignancy is the third leading cause of pleural effusion after heart failure and pneumonia, accounting for 44% to 77% of exudates.5 Although pleural effusion can arise secondary to many different malignancies, the most common causes are lung cancer in men and breast cancer in women; these cancers account for about 75% of all cases of malignant pleural effusion.6,7

A WOMAN ON CHEMOTHERAPY WITH ASYMPTOMATIC PLEURAL EFFUSION

An 18-year-old woman with non-Hodgkin lymphoma has received her first cycle of chemotherapy and is now admitted to the hospital for diarrhea. A routine chest radiograph reveals a left-sided pleural effusion covering one-third of the thoracic cavity. She is asymptomatic and reports no shortness of breath at rest or with exertion. Her oxygen saturation level is above 92% on room air without supplemental oxygen.

Thoracentesis reveals an exudative effusion, and cytologic study shows malignant lymphoid cells, consistent with a malignant pleural effusion. Cultures are negative.

What is the appropriate next step to manage this patient’s effusion?

Observation is reasonable

This patient is experiencing no symptoms and has just begun chemotherapy for her lymphoma. Malignant pleural effusion associated with lymphoma, small-cell lung cancer, and breast cancer is most sensitive to chemotherapy.5 For patients who do not have symptoms from the pleural effusion and who are scheduled to receive further chemotherapy, a watch-and-wait approach is reasonable.

It is important to follow the patient for developing symptoms and obtain serial imaging to evaluate for an increase in the effusion size. We recommend repeat imaging at 2- to 4-week intervals, and sooner if symptoms develop.

If progression is evident or if the patient’s oncologist indicates that the cancer is unresponsive to systemic therapy, further intervention may be necessary with one of the options discussed below.

A MAN WITH LUNG CANCER WITH PLEURAL EFFUSION, LUNG COLLAPSE

Figure 1. Coronal computed tomography shows left-sided pleural effusion (red arrow) and collapsed lung (blue arrow), along with midline shift.

A 42-year-old man with a history of lung cancer is admitted for worsening shortness of breath. Chest radiography reveals a large left-sided pleural effusion with complete collapse of the left lung and contralateral shift of midline structures (Figure 1). Large-volume thoracentesis improves his symptoms. Pleural fluid cytology is positive for malignant cells. A repeat chest radiograph shows incomplete expansion of the left lung, thick pleura, and pneumothorax, indicating a trapped lung (ie, one unable to expand fully). Two weeks later, his symptoms recur, and chest radiography reveals a recurrent effusion.

How should this effusion be managed?

Indwelling pleural catheter placement

In a retrospective cohort study,8 malignant pleural effusion recurred in 97% of patients within 1 month (mean, 4.2 days) of therapeutic aspiration, highlighting the need for definitive treatment.

In the absence of lung expansion, pleuro­desis is rarely successful, and placing an indwelling pleural catheter in symptomatic patients is the preferred strategy. The US Food and Drug Administration approved this use in 1997.9

Indwelling pleural catheters are narrow (15.5 French, or about 5 mm in diameter) and soft (made of silicone), with distal fenestrations. The distal end remains positioned in the pleural cavity to enable drainage of pleural fluid. The middle portion passes through subcutaneous tissue, where a polyester cuff prevents dislodgement and infection. The proximal end of the catheter remains outside the patient’s skin and is connected to a 1-way valve that prevents air or fluid flow into the pleural cavity.

Pleural fluid is typically drained every 2 or 3 days for palliation. Patients must be educated about home drainage and proper catheter care.

 

 

Indwelling pleural catheters are now initial therapy for many

Although indwelling pleural catheters were first used for patients who were not candidates for pleurodesis, they are now increasingly used as first-line therapy.

Since these devices were introduced, several clinical series including more than 800 patients have found that their use for malignant pleural infusion led to symptomatic improvement in 89% to 100% of cases, with 90% of patients needing no subsequent pleural procedures after catheter insertion.10–13

Davies et al14 randomized 106 patients with malignant pleural effusion to either receive an indwelling pleural catheter or undergo pleurodesis. In the first 6 weeks, the 2 groups had about the same incidence of dyspnea, but the catheter group had less dyspnea at 6 months, shorter index hospitalization (0 vs 4 days), fewer hospital days in the first year for treatment-related complications (1 vs 4.5 days), and fewer patients needing follow-up pleural procedures (6% vs 22%). On the other hand, adverse events were more frequent in the indwelling pleural catheter group (40% vs 13%). The most frequent events were pleural infection, cellulitis, and catheter blockage.

Fysh et al15 also compared indwelling pleural catheter insertion and pleurodesis (based on patient choice) in patients with malignant pleural effusion. As in the previous trial, those who received a catheter required significantly fewer days in the hospital and fewer additional pleural procedures than those who received pleurodesis. Safety profiles and symptom control were comparable.

Indwelling pleural catheters have several other advantages. They have been found to be more cost-effective than talc pleurodesis in patients not expected to live long (survival < 14 weeks).16 Patients with an indwelling pleural catheter can receive chemotherapy, and concurrent treatment does not increase risk of infection.17 And a systematic review18 found a 46% rate of autopleurodesis at a median of 52 days after insertion of an indwelling pleural catheter.

Drainage rate may need to be moderated

Chest pain has been reported with the use of indwelling pleural catheters, related to rapid drainage of the effusion in the setting of failed reexpansion of the trapped lung due to thickened pleura. Drainage schedules may need to be adjusted, with more frequent draining of smaller volumes, to control dyspnea without causing significant pain.

A WOMAN WITH RECURRENT PLEURAL EFFUSION, GOOD PROGNOSIS

A 55-year-old woman with a history of breast cancer presents with shortness of breath. Chest radiography reveals a right-sided effusion, which on thoracentesis is found to be malignant. After fluid removal, repeat chest radiography shows complete lung expansion.

One month later, she returns with symptoms and recurrence of the effusion. Ultrasonography does not reveal any adhesions in the pleural space. Her oncologist informs you that her expected survival is in years.

What is the next step?

Chemical pleurodesis

Chemical pleurodesis involves introducing a sclerosant into the pleural space to provoke an intense inflammatory response, creating adhesions and fibrosis that will obliterate the space. The sclerosing agent (typically talc) can be delivered by tube thoracostomy, video-assisted thoracic surgery (VATS), or medical pleuroscopy. Although the latter 2 methods allow direct visualization of the pleural space and, in theory, a more even distribution of the sclerosing agent, current evidence does not favor 1 option over the other,19 and practice patterns vary between institutions.

Tube thoracostomy. Typically, the sclerosing agent is administered once a chest radiograph shows lung reexpansion, and tube output of pleural fluid is less than 150 mL/day.19 However, some studies indicate that if pleural apposition can be confirmed using ultrasonography, then sclerosant administration at that time leads to optimal pleurodesis efficacy and shorter hospitalization.20,21

VATS is usually done in the operating room with the patient under general anesthesia. A double-lumen endotracheal tube allows for single-lung ventilation; a camera is then inserted into the pleural space of the collapsed lung. Multiple ports of entry are usually employed, and the entire pleural space can be visualized and the sclerosing agent instilled uniformly. The surgeon may alternatively choose to perform mechanical pleurodesis, which entails abrading the visceral and parietal pleura with dry gauze to provoke diffuse petechial hemorrhage and an inflammatory reaction. VATS can also be used to perform biopsy, lobectomy, and pneumonectomy.

Medical pleuroscopy. Medical pleuroscopy is usually done using local anesthesia with the patient awake, moderately sedated, and not intubated. Because no double-lumen endotracheal tube is used, lung collapse may not be complete, making it difficult to completely visualize the entire pleural surfaces.

Although no randomized study of VATS vs medical pleuroscopy exists, a retrospective case-matched study22 comparing VATS (under general anesthesia) to single-port VATS (under local anesthesia) noted equivalent rates of pleurodesis. However, the local anesthesia group had a lower perioperative mortality rate (0% vs 2.3%), a lower postoperative major morbidity rate (5.2% vs 9%), earlier improvement in quality of life, and shorter hospitalization (3 vs 5 days).22 In general, the diagnostic sensitivity of pleuroscopy for pleural malignancy is similar to that of VATS (93% vs 97%).23,24

A MAN WITH PLEURAL EFFUSION AND A POOR PROGNOSIS

A 60-year-old man with metastatic pancreatic cancer is brought to the clinic for worsening shortness of breath over the past 2 months. During that time, he has lost 6 kg and has become bedridden.

On examination, he has severe cachexia and is significantly short of breath at rest with associated hypoxia. His oncologist expects him to survive less than 3 months.

His laboratory investigations reveal hypoalbuminemia and leukocytosis. A chest radiograph shows a large left-sided pleural effusion that was not present 2 months ago.

What should be done for him?

Thoracentesis, repeat as needed

Malignant pleural effusion causing dyspnea is not uncommon in certain advanced malignancies and may contribute to significant suffering at the end of life. A study of 298 patients with malignant pleural effusion noted that the presence of leukocytosis, hypoalbuminemia, and hypoxemia was associated with a poorer prognosis. Patients having all 3 factors had a median survival of 42 days.25

Thoracentesis, the least invasive option that may improve dyspnea, can be done in the clinic setting and is a reasonable strategy for patients with advanced cancer and an expected survival of less than 3 months.26 Although recurrence is expected, it may take up to a few weeks, and repeat thoracentesis can be performed as needed.

References
  1. Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society pleural disease guideline 2010. Thorax 2010; 65(suppl 2):ii32–ii40. doi:10.1136/thx.2010.136994
  2. Ruckdeschel JC. Management of malignant pleural effusions. Semin Oncol 1995; 22(2 suppl 3):58–63. pmid:7740322
  3. Bielsa S, Martín-Juan J, Porcel JM, Rodríguez-Panadero F. Diagnostic and prognostic implications of pleural adhesions in malignant effusions. J Thorac Oncol 2008; 3(11):1251–1256. doi:10.1097/JTO.0b013e318189f53d
  4. 35th Annual meeting of the European Association for the Study of Diabetes. Brussels, Belgium, 28 September–2 October, 1999. Abstracts. Diabetologia 1999;42(suppl 1):A1–A354. pmid:10505080
  5. Antony VB, Loddenkemper R, Astoul P, et al. Management of malignant pleural effusions. Eur Respir J 2001; 18(2):402–419. pmid:11529302
  6. Sahn SA. Malignancy metastatic to the pleura. Clin Chest Med 1998; 19(2):351–361. pmid:9646986
  7. Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J 1997; 10(8):1907–1913. pmid:9272937
  8. Anderson CB, Philpott GW, Ferguson TB. The treatment of malignant pleural effusions. Cancer 1974; 33(4):916–922. pmid:4362107
  9. Uzbeck MH, Almeida FA, Sarkiss MG, et al. Management of malignant pleural effusions. Adv Ther 2010; 27(6):334–347. doi:10.1007/S12325-010-0031-8
  10. Suzuki K, Servais EL, Rizk NP, et al. Palliation and pleurodesis in malignant pleural effusion: the role for tunneled pleural catheters. J Thorac Oncol 2011; 6(4):762–767. doi:10.1097/JTO.0b013e31820d614f
  11. Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest 2006; 129(2):362–368. doi:10.1378/chest.129.2.362
  12. Warren WH, Kalimi R, Khodadadian LM, Kim AW. Management of malignant pleural effusions using the Pleur(x) catheter. Ann Thorac Surg 2008; 85(3):1049–1055 doi:10.1016/j.athoracsur.2007.11.039
  13. Murthy SC, Okereke I, Mason DP, Rice TW. A simple solution for complicated pleural effusions. J Thorac Oncol 2006; 1(7):697–700. pmid:17409939
  14. Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA 2012; 307(22):2383–2389. doi:10.1001/jama.2012.5535
  15. Fysh ETH, Waterer GW, Kendall PA, et al. Indwelling pleural catheters reduce inpatient days over pleurodesis for malignant pleural effusion. Chest 2012; 142(2):394–400. doi:10.1378/chest.11-2657
  16. Olfert JA, Penz ED, Manns BJ, et al. Cost-effectiveness of indwelling pleural catheter compared with talc in malignant pleural effusion. Respirology 2017; 22(4):764–770. doi:10.1111/resp.12962
  17. Morel A, Mishra E, Medley L, et al. Chemotherapy should not be withheld from patients with an indwelling pleural catheter for malignant pleural effusion. Thorax 2011; 66(5):448–449. doi:10.1136/thx.2009.133504
  18. Van Meter MEM, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med 2011; 26(1):70–76. doi:10.1007/s11606-010-1472-0
  19. Lee YCG, Baumann MH, Maskell NA, et al. Pleurodesis practice for malignant pleural effusions in five English-speaking countries. Chest 2003; 124(6):2229–2238. pmid:14665505
  20. Villanueva AG, Gray AW Jr, Shahian DM, Williamson WA, Beamis JF Jr. Efficacy of short term versus long term tube thoracostomy drainage before tetracycline pleurodesis in the treatment of malignant pleural effusions. Thorax 1994; 49(1):23–25. pmid:7512285
  21. Sartori S, Tombesi P, Tassinari D, et al. Sonographically guided small-bore chest tubes and sonographic monitoring for rapid sclerotherapy of recurrent malignant pleural effusions. J Ultrasound Med 2004; 23(9):1171–1176. pmid:15328431
  22. Mineo TC, Sellitri F, Tacconi F, Ambrogi V. Quality of life and outcomes after nonintubated versus intubated video-thoracoscopic pleurodesis for malignant pleural effusion: comparison by a case-matched study. J Palliat Med 2014; 17(7):761–768. doi:10.1089/jpm.2013.0617
  23. Michaud G, Berkowitz DM, Ernst A. Pleuroscopy for diagnosis and therapy for pleural effusions. Chest 2010; 138(5):1242–1246. doi:10.1378/chest.10-1259
  24. Bhatnagar R, Maskell NA. Medical pleuroscopy. Clin Chest Med 2013; 34(3):487–500. doi:10.1016/j.ccm.2013.04.001
  25. Pilling JE, Dusmet ME, Ladas G, Goldstraw P. Prognostic factors for survival after surgical palliation of malignant pleural effusion. J Thorac Oncol 2010; 5(10):1544–1550. doi:10.1097/JTO.0b013e3181e95cb8
  26. Beyea A, Winzelberg G, Stafford RE. To drain or not to drain: an evidence-based approach to palliative procedures for the management of malignant pleural effusions. J Pain Symptom Manage 2012; 44(2):301–306. doi:10.1016/j.jpainsymman.2012.05.002
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Yaser Abu El Sameed, MBBS
Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Zaid Zoumot, MBBS, MRCP, MSc, PhD
Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Address: Ali Saeed Wahla, MBBS, Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE; [email protected]

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Yaser Abu El Sameed, MBBS
Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Zaid Zoumot, MBBS, MRCP, MSc, PhD
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Yaser Abu El Sameed, MBBS
Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Zaid Zoumot, MBBS, MRCP, MSc, PhD
Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE

Address: Ali Saeed Wahla, MBBS, Respiratory and Critical Care Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE; [email protected]

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Related Articles

Managing patients with malignant pleural effusion can be challenging. Symptoms are often distressing, and its presence signifies advanced disease. Median survival after diagnosis is 4 to 9 months,1–3 although prognosis varies considerably depending on the type and stage of the malignancy.

How patients are best managed depends on clinical circumstances. Physicians should consider the risks and benefits of each option while keeping in mind realistic goals of care.

This article uses brief case presentations to review management strategies for malignant pleural effusion.

CANCER IS A COMMON CAUSE OF PLEURAL EFFUSION

Physicians and surgeons, especially in tertiary care hospitals, must often manage malignant pleural effusion.4 Malignancy is the third leading cause of pleural effusion after heart failure and pneumonia, accounting for 44% to 77% of exudates.5 Although pleural effusion can arise secondary to many different malignancies, the most common causes are lung cancer in men and breast cancer in women; these cancers account for about 75% of all cases of malignant pleural effusion.6,7

A WOMAN ON CHEMOTHERAPY WITH ASYMPTOMATIC PLEURAL EFFUSION

An 18-year-old woman with non-Hodgkin lymphoma has received her first cycle of chemotherapy and is now admitted to the hospital for diarrhea. A routine chest radiograph reveals a left-sided pleural effusion covering one-third of the thoracic cavity. She is asymptomatic and reports no shortness of breath at rest or with exertion. Her oxygen saturation level is above 92% on room air without supplemental oxygen.

Thoracentesis reveals an exudative effusion, and cytologic study shows malignant lymphoid cells, consistent with a malignant pleural effusion. Cultures are negative.

What is the appropriate next step to manage this patient’s effusion?

Observation is reasonable

This patient is experiencing no symptoms and has just begun chemotherapy for her lymphoma. Malignant pleural effusion associated with lymphoma, small-cell lung cancer, and breast cancer is most sensitive to chemotherapy.5 For patients who do not have symptoms from the pleural effusion and who are scheduled to receive further chemotherapy, a watch-and-wait approach is reasonable.

It is important to follow the patient for developing symptoms and obtain serial imaging to evaluate for an increase in the effusion size. We recommend repeat imaging at 2- to 4-week intervals, and sooner if symptoms develop.

If progression is evident or if the patient’s oncologist indicates that the cancer is unresponsive to systemic therapy, further intervention may be necessary with one of the options discussed below.

A MAN WITH LUNG CANCER WITH PLEURAL EFFUSION, LUNG COLLAPSE

Figure 1. Coronal computed tomography shows left-sided pleural effusion (red arrow) and collapsed lung (blue arrow), along with midline shift.

A 42-year-old man with a history of lung cancer is admitted for worsening shortness of breath. Chest radiography reveals a large left-sided pleural effusion with complete collapse of the left lung and contralateral shift of midline structures (Figure 1). Large-volume thoracentesis improves his symptoms. Pleural fluid cytology is positive for malignant cells. A repeat chest radiograph shows incomplete expansion of the left lung, thick pleura, and pneumothorax, indicating a trapped lung (ie, one unable to expand fully). Two weeks later, his symptoms recur, and chest radiography reveals a recurrent effusion.

How should this effusion be managed?

Indwelling pleural catheter placement

In a retrospective cohort study,8 malignant pleural effusion recurred in 97% of patients within 1 month (mean, 4.2 days) of therapeutic aspiration, highlighting the need for definitive treatment.

In the absence of lung expansion, pleuro­desis is rarely successful, and placing an indwelling pleural catheter in symptomatic patients is the preferred strategy. The US Food and Drug Administration approved this use in 1997.9

Indwelling pleural catheters are narrow (15.5 French, or about 5 mm in diameter) and soft (made of silicone), with distal fenestrations. The distal end remains positioned in the pleural cavity to enable drainage of pleural fluid. The middle portion passes through subcutaneous tissue, where a polyester cuff prevents dislodgement and infection. The proximal end of the catheter remains outside the patient’s skin and is connected to a 1-way valve that prevents air or fluid flow into the pleural cavity.

Pleural fluid is typically drained every 2 or 3 days for palliation. Patients must be educated about home drainage and proper catheter care.

 

 

Indwelling pleural catheters are now initial therapy for many

Although indwelling pleural catheters were first used for patients who were not candidates for pleurodesis, they are now increasingly used as first-line therapy.

Since these devices were introduced, several clinical series including more than 800 patients have found that their use for malignant pleural infusion led to symptomatic improvement in 89% to 100% of cases, with 90% of patients needing no subsequent pleural procedures after catheter insertion.10–13

Davies et al14 randomized 106 patients with malignant pleural effusion to either receive an indwelling pleural catheter or undergo pleurodesis. In the first 6 weeks, the 2 groups had about the same incidence of dyspnea, but the catheter group had less dyspnea at 6 months, shorter index hospitalization (0 vs 4 days), fewer hospital days in the first year for treatment-related complications (1 vs 4.5 days), and fewer patients needing follow-up pleural procedures (6% vs 22%). On the other hand, adverse events were more frequent in the indwelling pleural catheter group (40% vs 13%). The most frequent events were pleural infection, cellulitis, and catheter blockage.

Fysh et al15 also compared indwelling pleural catheter insertion and pleurodesis (based on patient choice) in patients with malignant pleural effusion. As in the previous trial, those who received a catheter required significantly fewer days in the hospital and fewer additional pleural procedures than those who received pleurodesis. Safety profiles and symptom control were comparable.

Indwelling pleural catheters have several other advantages. They have been found to be more cost-effective than talc pleurodesis in patients not expected to live long (survival < 14 weeks).16 Patients with an indwelling pleural catheter can receive chemotherapy, and concurrent treatment does not increase risk of infection.17 And a systematic review18 found a 46% rate of autopleurodesis at a median of 52 days after insertion of an indwelling pleural catheter.

Drainage rate may need to be moderated

Chest pain has been reported with the use of indwelling pleural catheters, related to rapid drainage of the effusion in the setting of failed reexpansion of the trapped lung due to thickened pleura. Drainage schedules may need to be adjusted, with more frequent draining of smaller volumes, to control dyspnea without causing significant pain.

A WOMAN WITH RECURRENT PLEURAL EFFUSION, GOOD PROGNOSIS

A 55-year-old woman with a history of breast cancer presents with shortness of breath. Chest radiography reveals a right-sided effusion, which on thoracentesis is found to be malignant. After fluid removal, repeat chest radiography shows complete lung expansion.

One month later, she returns with symptoms and recurrence of the effusion. Ultrasonography does not reveal any adhesions in the pleural space. Her oncologist informs you that her expected survival is in years.

What is the next step?

Chemical pleurodesis

Chemical pleurodesis involves introducing a sclerosant into the pleural space to provoke an intense inflammatory response, creating adhesions and fibrosis that will obliterate the space. The sclerosing agent (typically talc) can be delivered by tube thoracostomy, video-assisted thoracic surgery (VATS), or medical pleuroscopy. Although the latter 2 methods allow direct visualization of the pleural space and, in theory, a more even distribution of the sclerosing agent, current evidence does not favor 1 option over the other,19 and practice patterns vary between institutions.

Tube thoracostomy. Typically, the sclerosing agent is administered once a chest radiograph shows lung reexpansion, and tube output of pleural fluid is less than 150 mL/day.19 However, some studies indicate that if pleural apposition can be confirmed using ultrasonography, then sclerosant administration at that time leads to optimal pleurodesis efficacy and shorter hospitalization.20,21

VATS is usually done in the operating room with the patient under general anesthesia. A double-lumen endotracheal tube allows for single-lung ventilation; a camera is then inserted into the pleural space of the collapsed lung. Multiple ports of entry are usually employed, and the entire pleural space can be visualized and the sclerosing agent instilled uniformly. The surgeon may alternatively choose to perform mechanical pleurodesis, which entails abrading the visceral and parietal pleura with dry gauze to provoke diffuse petechial hemorrhage and an inflammatory reaction. VATS can also be used to perform biopsy, lobectomy, and pneumonectomy.

Medical pleuroscopy. Medical pleuroscopy is usually done using local anesthesia with the patient awake, moderately sedated, and not intubated. Because no double-lumen endotracheal tube is used, lung collapse may not be complete, making it difficult to completely visualize the entire pleural surfaces.

Although no randomized study of VATS vs medical pleuroscopy exists, a retrospective case-matched study22 comparing VATS (under general anesthesia) to single-port VATS (under local anesthesia) noted equivalent rates of pleurodesis. However, the local anesthesia group had a lower perioperative mortality rate (0% vs 2.3%), a lower postoperative major morbidity rate (5.2% vs 9%), earlier improvement in quality of life, and shorter hospitalization (3 vs 5 days).22 In general, the diagnostic sensitivity of pleuroscopy for pleural malignancy is similar to that of VATS (93% vs 97%).23,24

A MAN WITH PLEURAL EFFUSION AND A POOR PROGNOSIS

A 60-year-old man with metastatic pancreatic cancer is brought to the clinic for worsening shortness of breath over the past 2 months. During that time, he has lost 6 kg and has become bedridden.

On examination, he has severe cachexia and is significantly short of breath at rest with associated hypoxia. His oncologist expects him to survive less than 3 months.

His laboratory investigations reveal hypoalbuminemia and leukocytosis. A chest radiograph shows a large left-sided pleural effusion that was not present 2 months ago.

What should be done for him?

Thoracentesis, repeat as needed

Malignant pleural effusion causing dyspnea is not uncommon in certain advanced malignancies and may contribute to significant suffering at the end of life. A study of 298 patients with malignant pleural effusion noted that the presence of leukocytosis, hypoalbuminemia, and hypoxemia was associated with a poorer prognosis. Patients having all 3 factors had a median survival of 42 days.25

Thoracentesis, the least invasive option that may improve dyspnea, can be done in the clinic setting and is a reasonable strategy for patients with advanced cancer and an expected survival of less than 3 months.26 Although recurrence is expected, it may take up to a few weeks, and repeat thoracentesis can be performed as needed.

Managing patients with malignant pleural effusion can be challenging. Symptoms are often distressing, and its presence signifies advanced disease. Median survival after diagnosis is 4 to 9 months,1–3 although prognosis varies considerably depending on the type and stage of the malignancy.

How patients are best managed depends on clinical circumstances. Physicians should consider the risks and benefits of each option while keeping in mind realistic goals of care.

This article uses brief case presentations to review management strategies for malignant pleural effusion.

CANCER IS A COMMON CAUSE OF PLEURAL EFFUSION

Physicians and surgeons, especially in tertiary care hospitals, must often manage malignant pleural effusion.4 Malignancy is the third leading cause of pleural effusion after heart failure and pneumonia, accounting for 44% to 77% of exudates.5 Although pleural effusion can arise secondary to many different malignancies, the most common causes are lung cancer in men and breast cancer in women; these cancers account for about 75% of all cases of malignant pleural effusion.6,7

A WOMAN ON CHEMOTHERAPY WITH ASYMPTOMATIC PLEURAL EFFUSION

An 18-year-old woman with non-Hodgkin lymphoma has received her first cycle of chemotherapy and is now admitted to the hospital for diarrhea. A routine chest radiograph reveals a left-sided pleural effusion covering one-third of the thoracic cavity. She is asymptomatic and reports no shortness of breath at rest or with exertion. Her oxygen saturation level is above 92% on room air without supplemental oxygen.

Thoracentesis reveals an exudative effusion, and cytologic study shows malignant lymphoid cells, consistent with a malignant pleural effusion. Cultures are negative.

What is the appropriate next step to manage this patient’s effusion?

Observation is reasonable

This patient is experiencing no symptoms and has just begun chemotherapy for her lymphoma. Malignant pleural effusion associated with lymphoma, small-cell lung cancer, and breast cancer is most sensitive to chemotherapy.5 For patients who do not have symptoms from the pleural effusion and who are scheduled to receive further chemotherapy, a watch-and-wait approach is reasonable.

It is important to follow the patient for developing symptoms and obtain serial imaging to evaluate for an increase in the effusion size. We recommend repeat imaging at 2- to 4-week intervals, and sooner if symptoms develop.

If progression is evident or if the patient’s oncologist indicates that the cancer is unresponsive to systemic therapy, further intervention may be necessary with one of the options discussed below.

A MAN WITH LUNG CANCER WITH PLEURAL EFFUSION, LUNG COLLAPSE

Figure 1. Coronal computed tomography shows left-sided pleural effusion (red arrow) and collapsed lung (blue arrow), along with midline shift.

A 42-year-old man with a history of lung cancer is admitted for worsening shortness of breath. Chest radiography reveals a large left-sided pleural effusion with complete collapse of the left lung and contralateral shift of midline structures (Figure 1). Large-volume thoracentesis improves his symptoms. Pleural fluid cytology is positive for malignant cells. A repeat chest radiograph shows incomplete expansion of the left lung, thick pleura, and pneumothorax, indicating a trapped lung (ie, one unable to expand fully). Two weeks later, his symptoms recur, and chest radiography reveals a recurrent effusion.

How should this effusion be managed?

Indwelling pleural catheter placement

In a retrospective cohort study,8 malignant pleural effusion recurred in 97% of patients within 1 month (mean, 4.2 days) of therapeutic aspiration, highlighting the need for definitive treatment.

In the absence of lung expansion, pleuro­desis is rarely successful, and placing an indwelling pleural catheter in symptomatic patients is the preferred strategy. The US Food and Drug Administration approved this use in 1997.9

Indwelling pleural catheters are narrow (15.5 French, or about 5 mm in diameter) and soft (made of silicone), with distal fenestrations. The distal end remains positioned in the pleural cavity to enable drainage of pleural fluid. The middle portion passes through subcutaneous tissue, where a polyester cuff prevents dislodgement and infection. The proximal end of the catheter remains outside the patient’s skin and is connected to a 1-way valve that prevents air or fluid flow into the pleural cavity.

Pleural fluid is typically drained every 2 or 3 days for palliation. Patients must be educated about home drainage and proper catheter care.

 

 

Indwelling pleural catheters are now initial therapy for many

Although indwelling pleural catheters were first used for patients who were not candidates for pleurodesis, they are now increasingly used as first-line therapy.

Since these devices were introduced, several clinical series including more than 800 patients have found that their use for malignant pleural infusion led to symptomatic improvement in 89% to 100% of cases, with 90% of patients needing no subsequent pleural procedures after catheter insertion.10–13

Davies et al14 randomized 106 patients with malignant pleural effusion to either receive an indwelling pleural catheter or undergo pleurodesis. In the first 6 weeks, the 2 groups had about the same incidence of dyspnea, but the catheter group had less dyspnea at 6 months, shorter index hospitalization (0 vs 4 days), fewer hospital days in the first year for treatment-related complications (1 vs 4.5 days), and fewer patients needing follow-up pleural procedures (6% vs 22%). On the other hand, adverse events were more frequent in the indwelling pleural catheter group (40% vs 13%). The most frequent events were pleural infection, cellulitis, and catheter blockage.

Fysh et al15 also compared indwelling pleural catheter insertion and pleurodesis (based on patient choice) in patients with malignant pleural effusion. As in the previous trial, those who received a catheter required significantly fewer days in the hospital and fewer additional pleural procedures than those who received pleurodesis. Safety profiles and symptom control were comparable.

Indwelling pleural catheters have several other advantages. They have been found to be more cost-effective than talc pleurodesis in patients not expected to live long (survival < 14 weeks).16 Patients with an indwelling pleural catheter can receive chemotherapy, and concurrent treatment does not increase risk of infection.17 And a systematic review18 found a 46% rate of autopleurodesis at a median of 52 days after insertion of an indwelling pleural catheter.

Drainage rate may need to be moderated

Chest pain has been reported with the use of indwelling pleural catheters, related to rapid drainage of the effusion in the setting of failed reexpansion of the trapped lung due to thickened pleura. Drainage schedules may need to be adjusted, with more frequent draining of smaller volumes, to control dyspnea without causing significant pain.

A WOMAN WITH RECURRENT PLEURAL EFFUSION, GOOD PROGNOSIS

A 55-year-old woman with a history of breast cancer presents with shortness of breath. Chest radiography reveals a right-sided effusion, which on thoracentesis is found to be malignant. After fluid removal, repeat chest radiography shows complete lung expansion.

One month later, she returns with symptoms and recurrence of the effusion. Ultrasonography does not reveal any adhesions in the pleural space. Her oncologist informs you that her expected survival is in years.

What is the next step?

Chemical pleurodesis

Chemical pleurodesis involves introducing a sclerosant into the pleural space to provoke an intense inflammatory response, creating adhesions and fibrosis that will obliterate the space. The sclerosing agent (typically talc) can be delivered by tube thoracostomy, video-assisted thoracic surgery (VATS), or medical pleuroscopy. Although the latter 2 methods allow direct visualization of the pleural space and, in theory, a more even distribution of the sclerosing agent, current evidence does not favor 1 option over the other,19 and practice patterns vary between institutions.

Tube thoracostomy. Typically, the sclerosing agent is administered once a chest radiograph shows lung reexpansion, and tube output of pleural fluid is less than 150 mL/day.19 However, some studies indicate that if pleural apposition can be confirmed using ultrasonography, then sclerosant administration at that time leads to optimal pleurodesis efficacy and shorter hospitalization.20,21

VATS is usually done in the operating room with the patient under general anesthesia. A double-lumen endotracheal tube allows for single-lung ventilation; a camera is then inserted into the pleural space of the collapsed lung. Multiple ports of entry are usually employed, and the entire pleural space can be visualized and the sclerosing agent instilled uniformly. The surgeon may alternatively choose to perform mechanical pleurodesis, which entails abrading the visceral and parietal pleura with dry gauze to provoke diffuse petechial hemorrhage and an inflammatory reaction. VATS can also be used to perform biopsy, lobectomy, and pneumonectomy.

Medical pleuroscopy. Medical pleuroscopy is usually done using local anesthesia with the patient awake, moderately sedated, and not intubated. Because no double-lumen endotracheal tube is used, lung collapse may not be complete, making it difficult to completely visualize the entire pleural surfaces.

Although no randomized study of VATS vs medical pleuroscopy exists, a retrospective case-matched study22 comparing VATS (under general anesthesia) to single-port VATS (under local anesthesia) noted equivalent rates of pleurodesis. However, the local anesthesia group had a lower perioperative mortality rate (0% vs 2.3%), a lower postoperative major morbidity rate (5.2% vs 9%), earlier improvement in quality of life, and shorter hospitalization (3 vs 5 days).22 In general, the diagnostic sensitivity of pleuroscopy for pleural malignancy is similar to that of VATS (93% vs 97%).23,24

A MAN WITH PLEURAL EFFUSION AND A POOR PROGNOSIS

A 60-year-old man with metastatic pancreatic cancer is brought to the clinic for worsening shortness of breath over the past 2 months. During that time, he has lost 6 kg and has become bedridden.

On examination, he has severe cachexia and is significantly short of breath at rest with associated hypoxia. His oncologist expects him to survive less than 3 months.

His laboratory investigations reveal hypoalbuminemia and leukocytosis. A chest radiograph shows a large left-sided pleural effusion that was not present 2 months ago.

What should be done for him?

Thoracentesis, repeat as needed

Malignant pleural effusion causing dyspnea is not uncommon in certain advanced malignancies and may contribute to significant suffering at the end of life. A study of 298 patients with malignant pleural effusion noted that the presence of leukocytosis, hypoalbuminemia, and hypoxemia was associated with a poorer prognosis. Patients having all 3 factors had a median survival of 42 days.25

Thoracentesis, the least invasive option that may improve dyspnea, can be done in the clinic setting and is a reasonable strategy for patients with advanced cancer and an expected survival of less than 3 months.26 Although recurrence is expected, it may take up to a few weeks, and repeat thoracentesis can be performed as needed.

References
  1. Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society pleural disease guideline 2010. Thorax 2010; 65(suppl 2):ii32–ii40. doi:10.1136/thx.2010.136994
  2. Ruckdeschel JC. Management of malignant pleural effusions. Semin Oncol 1995; 22(2 suppl 3):58–63. pmid:7740322
  3. Bielsa S, Martín-Juan J, Porcel JM, Rodríguez-Panadero F. Diagnostic and prognostic implications of pleural adhesions in malignant effusions. J Thorac Oncol 2008; 3(11):1251–1256. doi:10.1097/JTO.0b013e318189f53d
  4. 35th Annual meeting of the European Association for the Study of Diabetes. Brussels, Belgium, 28 September–2 October, 1999. Abstracts. Diabetologia 1999;42(suppl 1):A1–A354. pmid:10505080
  5. Antony VB, Loddenkemper R, Astoul P, et al. Management of malignant pleural effusions. Eur Respir J 2001; 18(2):402–419. pmid:11529302
  6. Sahn SA. Malignancy metastatic to the pleura. Clin Chest Med 1998; 19(2):351–361. pmid:9646986
  7. Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J 1997; 10(8):1907–1913. pmid:9272937
  8. Anderson CB, Philpott GW, Ferguson TB. The treatment of malignant pleural effusions. Cancer 1974; 33(4):916–922. pmid:4362107
  9. Uzbeck MH, Almeida FA, Sarkiss MG, et al. Management of malignant pleural effusions. Adv Ther 2010; 27(6):334–347. doi:10.1007/S12325-010-0031-8
  10. Suzuki K, Servais EL, Rizk NP, et al. Palliation and pleurodesis in malignant pleural effusion: the role for tunneled pleural catheters. J Thorac Oncol 2011; 6(4):762–767. doi:10.1097/JTO.0b013e31820d614f
  11. Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest 2006; 129(2):362–368. doi:10.1378/chest.129.2.362
  12. Warren WH, Kalimi R, Khodadadian LM, Kim AW. Management of malignant pleural effusions using the Pleur(x) catheter. Ann Thorac Surg 2008; 85(3):1049–1055 doi:10.1016/j.athoracsur.2007.11.039
  13. Murthy SC, Okereke I, Mason DP, Rice TW. A simple solution for complicated pleural effusions. J Thorac Oncol 2006; 1(7):697–700. pmid:17409939
  14. Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA 2012; 307(22):2383–2389. doi:10.1001/jama.2012.5535
  15. Fysh ETH, Waterer GW, Kendall PA, et al. Indwelling pleural catheters reduce inpatient days over pleurodesis for malignant pleural effusion. Chest 2012; 142(2):394–400. doi:10.1378/chest.11-2657
  16. Olfert JA, Penz ED, Manns BJ, et al. Cost-effectiveness of indwelling pleural catheter compared with talc in malignant pleural effusion. Respirology 2017; 22(4):764–770. doi:10.1111/resp.12962
  17. Morel A, Mishra E, Medley L, et al. Chemotherapy should not be withheld from patients with an indwelling pleural catheter for malignant pleural effusion. Thorax 2011; 66(5):448–449. doi:10.1136/thx.2009.133504
  18. Van Meter MEM, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med 2011; 26(1):70–76. doi:10.1007/s11606-010-1472-0
  19. Lee YCG, Baumann MH, Maskell NA, et al. Pleurodesis practice for malignant pleural effusions in five English-speaking countries. Chest 2003; 124(6):2229–2238. pmid:14665505
  20. Villanueva AG, Gray AW Jr, Shahian DM, Williamson WA, Beamis JF Jr. Efficacy of short term versus long term tube thoracostomy drainage before tetracycline pleurodesis in the treatment of malignant pleural effusions. Thorax 1994; 49(1):23–25. pmid:7512285
  21. Sartori S, Tombesi P, Tassinari D, et al. Sonographically guided small-bore chest tubes and sonographic monitoring for rapid sclerotherapy of recurrent malignant pleural effusions. J Ultrasound Med 2004; 23(9):1171–1176. pmid:15328431
  22. Mineo TC, Sellitri F, Tacconi F, Ambrogi V. Quality of life and outcomes after nonintubated versus intubated video-thoracoscopic pleurodesis for malignant pleural effusion: comparison by a case-matched study. J Palliat Med 2014; 17(7):761–768. doi:10.1089/jpm.2013.0617
  23. Michaud G, Berkowitz DM, Ernst A. Pleuroscopy for diagnosis and therapy for pleural effusions. Chest 2010; 138(5):1242–1246. doi:10.1378/chest.10-1259
  24. Bhatnagar R, Maskell NA. Medical pleuroscopy. Clin Chest Med 2013; 34(3):487–500. doi:10.1016/j.ccm.2013.04.001
  25. Pilling JE, Dusmet ME, Ladas G, Goldstraw P. Prognostic factors for survival after surgical palliation of malignant pleural effusion. J Thorac Oncol 2010; 5(10):1544–1550. doi:10.1097/JTO.0b013e3181e95cb8
  26. Beyea A, Winzelberg G, Stafford RE. To drain or not to drain: an evidence-based approach to palliative procedures for the management of malignant pleural effusions. J Pain Symptom Manage 2012; 44(2):301–306. doi:10.1016/j.jpainsymman.2012.05.002
References
  1. Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society pleural disease guideline 2010. Thorax 2010; 65(suppl 2):ii32–ii40. doi:10.1136/thx.2010.136994
  2. Ruckdeschel JC. Management of malignant pleural effusions. Semin Oncol 1995; 22(2 suppl 3):58–63. pmid:7740322
  3. Bielsa S, Martín-Juan J, Porcel JM, Rodríguez-Panadero F. Diagnostic and prognostic implications of pleural adhesions in malignant effusions. J Thorac Oncol 2008; 3(11):1251–1256. doi:10.1097/JTO.0b013e318189f53d
  4. 35th Annual meeting of the European Association for the Study of Diabetes. Brussels, Belgium, 28 September–2 October, 1999. Abstracts. Diabetologia 1999;42(suppl 1):A1–A354. pmid:10505080
  5. Antony VB, Loddenkemper R, Astoul P, et al. Management of malignant pleural effusions. Eur Respir J 2001; 18(2):402–419. pmid:11529302
  6. Sahn SA. Malignancy metastatic to the pleura. Clin Chest Med 1998; 19(2):351–361. pmid:9646986
  7. Sahn SA. Pleural diseases related to metastatic malignancies. Eur Respir J 1997; 10(8):1907–1913. pmid:9272937
  8. Anderson CB, Philpott GW, Ferguson TB. The treatment of malignant pleural effusions. Cancer 1974; 33(4):916–922. pmid:4362107
  9. Uzbeck MH, Almeida FA, Sarkiss MG, et al. Management of malignant pleural effusions. Adv Ther 2010; 27(6):334–347. doi:10.1007/S12325-010-0031-8
  10. Suzuki K, Servais EL, Rizk NP, et al. Palliation and pleurodesis in malignant pleural effusion: the role for tunneled pleural catheters. J Thorac Oncol 2011; 6(4):762–767. doi:10.1097/JTO.0b013e31820d614f
  11. Tremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest 2006; 129(2):362–368. doi:10.1378/chest.129.2.362
  12. Warren WH, Kalimi R, Khodadadian LM, Kim AW. Management of malignant pleural effusions using the Pleur(x) catheter. Ann Thorac Surg 2008; 85(3):1049–1055 doi:10.1016/j.athoracsur.2007.11.039
  13. Murthy SC, Okereke I, Mason DP, Rice TW. A simple solution for complicated pleural effusions. J Thorac Oncol 2006; 1(7):697–700. pmid:17409939
  14. Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA 2012; 307(22):2383–2389. doi:10.1001/jama.2012.5535
  15. Fysh ETH, Waterer GW, Kendall PA, et al. Indwelling pleural catheters reduce inpatient days over pleurodesis for malignant pleural effusion. Chest 2012; 142(2):394–400. doi:10.1378/chest.11-2657
  16. Olfert JA, Penz ED, Manns BJ, et al. Cost-effectiveness of indwelling pleural catheter compared with talc in malignant pleural effusion. Respirology 2017; 22(4):764–770. doi:10.1111/resp.12962
  17. Morel A, Mishra E, Medley L, et al. Chemotherapy should not be withheld from patients with an indwelling pleural catheter for malignant pleural effusion. Thorax 2011; 66(5):448–449. doi:10.1136/thx.2009.133504
  18. Van Meter MEM, McKee KY, Kohlwes RJ. Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: a systematic review. J Gen Intern Med 2011; 26(1):70–76. doi:10.1007/s11606-010-1472-0
  19. Lee YCG, Baumann MH, Maskell NA, et al. Pleurodesis practice for malignant pleural effusions in five English-speaking countries. Chest 2003; 124(6):2229–2238. pmid:14665505
  20. Villanueva AG, Gray AW Jr, Shahian DM, Williamson WA, Beamis JF Jr. Efficacy of short term versus long term tube thoracostomy drainage before tetracycline pleurodesis in the treatment of malignant pleural effusions. Thorax 1994; 49(1):23–25. pmid:7512285
  21. Sartori S, Tombesi P, Tassinari D, et al. Sonographically guided small-bore chest tubes and sonographic monitoring for rapid sclerotherapy of recurrent malignant pleural effusions. J Ultrasound Med 2004; 23(9):1171–1176. pmid:15328431
  22. Mineo TC, Sellitri F, Tacconi F, Ambrogi V. Quality of life and outcomes after nonintubated versus intubated video-thoracoscopic pleurodesis for malignant pleural effusion: comparison by a case-matched study. J Palliat Med 2014; 17(7):761–768. doi:10.1089/jpm.2013.0617
  23. Michaud G, Berkowitz DM, Ernst A. Pleuroscopy for diagnosis and therapy for pleural effusions. Chest 2010; 138(5):1242–1246. doi:10.1378/chest.10-1259
  24. Bhatnagar R, Maskell NA. Medical pleuroscopy. Clin Chest Med 2013; 34(3):487–500. doi:10.1016/j.ccm.2013.04.001
  25. Pilling JE, Dusmet ME, Ladas G, Goldstraw P. Prognostic factors for survival after surgical palliation of malignant pleural effusion. J Thorac Oncol 2010; 5(10):1544–1550. doi:10.1097/JTO.0b013e3181e95cb8
  26. Beyea A, Winzelberg G, Stafford RE. To drain or not to drain: an evidence-based approach to palliative procedures for the management of malignant pleural effusions. J Pain Symptom Manage 2012; 44(2):301–306. doi:10.1016/j.jpainsymman.2012.05.002
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Cleveland Clinic Journal of Medicine - 86(2)
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Managing malignant pleural effusion
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Managing malignant pleural effusion
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malignant pleural effusion, cancer, indwelling pleural catheter, pleurodesis, thoracentesis, lung collapse, lung cancer, Ali Saeed Wahla, Mateen Uzbeck, Yaser Abu El Sameed, Zaid Zoumot
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  • Asymptomatic pleural effusion in patients currently on chemotherapy does not require treatment but should be monitored for progression.
  • Indwelling pleural catheters are best used to treat effusion with lung collapse and are increasingly used as first-line therapy in other settings.
  • Chemical or mechanical pleurodesis results in filling the pleural space to prevent further fluid accumulation and can be accomplished by one of several methods.
  • For patients near the end of life, simple thoracentesis, repeated as needed, is a reasonable strategy.
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Mohs Micrographic Surgery in the VHA (FULL)

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Mohs Micrographic Surgery in the VHA
Veterans with skin cancer have seen improved access to Mohs micrographic surgery over the past 10 years, yet the challenges of travel distance and care coordination remain.

Skin cancer is one of the most prevalent conditions among VHA patients.1 One of the largest U.S. health care systems, the VHA serves more than 9 million veterans.2 In 2012, 4% of VHA patients had a diagnosis of keratinocyte carcinoma or actinic keratosis; 49,229 cases of basal cell carcinoma and 26,310 cases of squamous cell carcinoma were diagnosed.1 With an aging veteran population and the incidence of skin cancers expected to increase, the development of cost-effective ways to provide easily accessible skin cancer treatments has become a priority for the VHA.

National Comprehensive Cancer Network (NCCN) guidelines recommend 3 types of surgical treatment for localized keratinocyte carcinoma: local destruction, wide local excision (WLE), and Mohs micrographic surgery (MMS). Tumors at low risk for recurrence may be treated with local destruction or WLE, and tumors at high risk may be treated with WLE or MMS.3

Mohs micrographic surgery involves staged narrow-margin excision with intraoperative tumor mapping and complete circumferential peripheral and deep margin assessment (CCPDMA). With the Mohs surgeon acting as both surgeon and dermatopathologist, it is possible to provide intraoperative correlation with the tissue bed and immediate additional margin resection precisely where needed. Relative to WLE, MMS yields improved histopathologic clearance rates and lower 5-year recurrence rates. It also provides improved preservation of normal tissue, optimized aesthetic outcomes, and high patient satisfaction.4-7 All this is achieved in an outpatient setting with the patient under local anesthesia; therefore the cost of ambulatory surgical centers or hospital operating rooms are avoided.5,8,9

The NCCN recommends WLE for high-risk tumors only if CCPDMA can be achieved. However, CCPDMA requires specialized surgical technique, tissue orientation, and pathology and is not equivalent to standard WLE with routine surgical pathology. Even with intraoperative bread-loafed frozen section analysis, WLE does not achieve the 100% margin assessment obtained with MMS.

In 2012, the American Academy of Dermatology in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery developed the Mohs Appropriate Use Criteria,which are now widely used as part of the standard of care to determine which cases of skin cancer should be treated with MMS over other modalities.10 These criteria, which are based on both evidence and expert consensus, take into account tumor size, histology, location, and patient factors, such as immunosuppression.

Despite its established benefits, MMS has not been uniformly accessible to veterans seeking VHA care. In 2007, Karen and colleagues surveyed dermatology chiefs and staff dermatologists from 101 VHA hospitals to characterize veterans’ access to MMS and found MMS available at only 11 VHA sites in 9 states.11 Further, access within the VHA was not evenly distributed across the U.S.

The VHA often makes payments, under “non-VA medical care” or “fee-basis care,” to providers in the community for services that the VHA is otherwise unable to provide. In 2014, Congress passed the Veterans Access, Choice, and Accountability Act and established the Veterans Choice program.2,12 This program allows veterans to obtain medical services from providers outside the VHA, based on veteran wait time and place of residence.12 The goal is to improve access. The present authors distinguish between 2 types of care: there are fee-based referrals managed and tracked by the VHA physician and the Veterans Choice for care without the diagnosing physician involvement or knowledge. In addition to expanding treatment options, the act called for reform within the VHA to improve resources and infrastructure needed to provide the best care for the veteran patient population.2

The authors conducted a study to identify current availability of MMS within the VHA and to provide a 10-year update to the survey findings of Karen and colleagues.11 VHA facilities that offer MMS were surveyed to determine available resources and what is needed to provide MMS within the VHA. Also surveyed were VHA facilities that do not offer MMS to determine how VHA patients with skin cancer receive surgical care from non-VA providers or from other surgical specialties.

Related: Nivolumab Linked to Nephritis in Melanoma

Methods

This study, deemed exempt from review by the University of California San Francisco Institutional Review Board, was a survey of dermatology section and service chiefs across the VHA. Subjects were identified through conference calls with VHA dermatologists, searches of individual VHA websites, and requests on dermatology e-mail listservs and were invited by email to participate in the survey.

The Research Electronic Data Capture platform (REDCap; Vanderbilt University Medical Center) was used for survey creation, implementation, dissemination, and data storage. The survey had 6 sections: site information; MMS availability; Mohs surgeon, Mohs laboratory, and support staff; MMS care; patient referral; and Mohs surgeon recruitment.

Data were collected between June 20 and August 1, 2016. Collected VHA site information included name, location, description, and MMS availability. If MMS was available, data were collected on surgeon training and background, number of MMS cases in 2015, and facility and support staff. In addition, subjects rated statements about various aspects of care provided (eg, patient wait time, patient distance traveled) on a 6-point Likert scale: strongly disagree, moderately disagree, slightly disagree, slightly agree, moderately agree, or strongly agree. This section included both positive and negative statements.

If MMS was not available at the VHA site, data were collected on patient referrals, including location within or outside the VHA and patient use of the Veterans Choice program. Subjects also rated positive and negative statements about referral experiences on a Likert scale (eg, patient wait time, patient distance traveled).

Categorical data were summarized, means and standard deviations were calculated for nominal data, and data analysis was performed with Microsoft Excel (Redmond, WA).

 

 

Results

The authors identified and surveyed 74 dermatology service and section chiefs across the VHA. Of these chiefs, 52 (70.3%) completed the survey. Completed surveys represented 49 hospital sites and 3 community-based outpatient clinics (CBOCs), including an integrated community-based clinic-hospital.

Sites That Provided MMS

Of the 52 sites with a completed survey, 19 provided MMS. These 19 sites were in 13 states and the District of Columbia, and the majority were in major cities along the coasts. All 19 sites were hospital medical centers, not community-based outpatient clinics, and all provided MMS through the dermatology department. In 2015, an estimated 6,686 MMS cases were performed, or an average of 371 per site (range, 40-1,000 cases/site) or 4.9 MMS cases per day (range, 3-8). These 19 sites were divided by yearly volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y).

Physical Space. On average, each site used 2.89 patient rooms (SD, 1.1; range, 1-6) for MMS. The Table lists numbers of patient rooms based on case volume.

The MMS laboratory was adjacent to the surgical suite at 18 of the MMS sites and in the same building as the surgical suite, but not next to it, at 1 site. For their samples, 11 sites used an automated staining method, 7 used hand staining, and 2 used other methods (1 site used both automated and hand staining). Fourteen sites used hematoxlyin-eosin only, 1 used toluidine blue only, 3 used both hematoxlyin-eosin and toluidine blue, and 1 used MART-1 (melanoma antigen recognized by T cells 1) with hematoxlyin-eosin.

Related: Systemic Therapy in Metastatic Melanoma

Mohs Micrographic Surgeons. Sites with higher case volumes had more Mohs surgeons and more Mohs surgeons with VA appointments (captured as “eighths” or fraction of 8/8 full-time equivalent [FTE]). Information on fellowships and professional memberships was available for 30 Mohs surgeons: Ten (33.3%) were trained in fellowships accredited by both the American College of Mohs Surgery (ACMS) and the Accreditation Council for Graduate Medical Education (ACGME), 8 (26.7%) were trained in ACMS-recognized fellowships only, 7 (23.3%) were trained at ACGME-accredited fellowships only, 2 (6.7%) were trained elsewhere, and 3 (10.0%) had training listed as “uncertain.”

The majority of Mohs surgeons were members of professional societies, and many were members of more than one. Of the 30 Mohs surgeons, 24 (80.0%) were ACMS members, 5 (16.7%) were members of the American Society of Mohs Surgery, and 22 (73.3%) were members of the American Society of Dermatologic Surgery. Twenty-five (89.3%) were affiliated with an academic program.

Of the 30 surgeons, 19 (63.3%) were VHA employees hired by eighths, with an average eighths of 3.9 (SD, 2.7), or 49% of a FTE. Data on these surgeons’ pay tables and tiers were insufficient (only 3 provided the information). Of the other 11 surgeons, 10 (33.3%) were contracted, and 1 (3.3%) volunteered without compensation.

Support Staff. Of the 19 MMS sites, 17 (89.5%) used 1 histotechnician, and 2 (10.5%) used more than 1. Ten sites (52.6%) hired histotechnicians as contractors, 8 (42.1%) as employees, and 1 (5.3%) on a fee basis. In general, sites with higher case volumes had more nursing and support staff. Thirteen sites (68.4%) participated in the training of dermatology residents, and 5 sites (26.3%) trained Mohs fellows.

Wait Time Estimate. The survey also asked for estimates of the average amount of time patients waited for MMS. Of the 19 sites, 8 (42.1%) reported a wait time of less than 1 month, 10 (52.6%) reported 2 to 6 months, and 1 (5.3%) reported 7 months to 1 year. Seventeen (89.5%) of the 19 sites had a grading or triage system for expediting certain cancer types. At 7 sites, cases were prioritized on the basis of physician assessment; at 3 sites, aggressive or invasive squamous cell carcinoma received priority; other sites gave priority to patients with melanoma, patients with carcinoma near the nose or eye, organ transplant recipients, and other immunosuppressed patients.

Sites That Did Not Provide MMS

Of the 52 sites with a completed survey, 33 (63.5%) did not provide on-site MMS. Of these 33 sites, 28 (84.8%) used purchased care to refer patients to fee-basis non-VA dermatologists. In addition, 30 sites (90.9%) had patients activate Veterans Choice. Three sites referred patients to VA sites in another VISN.

Surgeon Recruitment

Five sites (9.6%) had an unfilled Mohs micrographic surgeon position. The average FTE of these unfilled positions was 0.6. One position had been open for less than 6 months, and the other 4 for more than 1 year. All 5 respondents with unfilled positions strongly agreed with the statement, “The position is unfilled because the salary is not competitive with the local market.”

 

 

Assessment of Care Provided

Respondents at sites that provided MMS rated various aspects of care (Figure 1). 

Sixteen (84%) reported that MMS was received in a reasonable amount of time, 15 (79%) that facilities and resources for MMS were adequate, 13 (68%) that they themselves were capable of meeting the demands of MMS, 11 (58%) that their sites did not have enough Mohs surgeons, 11 (58%) that the number of support staff for MMS was sufficient, and 14 (74%) that patients had to travel a long distance to access MMS.

Respondents from sites that purchased MMS care from non-VA medical care rated surgery availability and ease of patient follow-up (Figure 2). 

Eighteen (66.7%) reported that referred patients received MMS in a reasonable amount of time, 7 (25.9%) that patients had to travel a long distance to the fee-basis/non-VA care facility, 12 (44.4%) that follow-up after fee-basis/non-VA care for MMS was difficult, and 25 (83.3%) that follow-up after activation of Veterans Choice was difficult.

Related: Getting a Better Picture of Skin Cancer

Discussion

Skin cancer is highly prevalent in the veteran patient population, and each year treatment by the VHA requires considerable spending.1 The results of this cross-sectional survey characterize veterans’ access to MMS within the VHA and provide a 10-year update to the survey findings of Karen and colleagues.11 Compared with their study, this survey offers a more granular description of practices and facilities as well as comparisons of VHA care with care purchased from outside sources. In outlining the state of MMS care within the VHA, this study highlights progress made and provides the updated data needed for continued efforts to optimize care and resource allocation for patients who require MMS within the VHA.

Although the number of VHA sites that provide MMS has increased over the past 10 years—from 11 sites in 9 states in 2007 to 19 sites in 13 states now—it is important to note that access to MMS care highly depends on geographic location.11 The VHA sites that provide MMS are clustered in major cities along the coasts. Four states (California, Florida, New York, and Texas) had > 1 MMS site, whereas most other states did not have any. In addition, only 1 MMS site served all of the northwest U.S. To ensure the anonymity of survey respondents, the authors did not further characterize the regional distribution of MMS sites.

Despite the increase in MMS sites, the number of MMS cases performed within the VHA seemed to have decreased. An estimated 8,310 cases were performed within the VHA in 2006,which decreased to 6,686 in 2015.11 Although these are estimates, the number of VHA cases likely decreased because of a rise in purchased care. Reviewing VHA electronic health records, Yoon and colleagues found that 19,681 MMS cases were performed either within the VHA or at non-VA medical care sites in 2012.1 Although the proportions of MMS cases performed within and outside the VHA were not reported, clearly many veterans had MMS performed through the VHA in recent years, and a high percentage of these cases were external referrals. More study is needed to further characterize MMS care within the VHA and MMS care purchased.

The 19 sites that provided MMS were evenly divided by volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y). Case volume correlated with the numbers of surgeons, nurses, and support staff at each site. Number of patient rooms dedicated to MMS at each site was not correlated with case volume; however, not ascertaining the number of days per week MMS was performed may have contributed to the lack of observed correlation.The majority of Mohs surgeons (25; 89.3%) within the VHA were affiliated with academic programs, which may partly explain the uneven geographic distribution of VHA sites that provide MMS (dermatology residency programs typically are in larger cities). The majority of Mohs surgeons were fellowship-trained through the ACMS or the ACGME. As the ACGME first began accrediting fellowship programs in 2003, younger surgeons were more likely to have completed this fellowship. According to respondents from sites that did not provide MMS, noncompetitive VHA salaries might be a barrier to Mohs surgeon recruitment. If a shift to providing more MMS care within the VHA were desired, an effective strategy could be to raise surgeon salaries. Higher salaries would bring in more Mohs surgeons and thereby yield higher MMS case volumes at VHA sites.

However, whether MMS is best provided for veterans within the VHA or at outside sites through referrals warrants further study. More than 60% of sites provided access to MMS through purchased care, either by fee-basis/non-VA medical care referrals or by the patient-elected Veterans Choice program. According to 84.2% of respondents at MMS sites and 66.7% of respondents at non-MMS sites, patients received care within a reasonable amount of time. In addition, respondents at MMS sites estimated longer patient travel distance for surgery. Respondents reported being concerned about coordination of care and follow-up for patients who received MMS outside the VHA. Other than referrals to outside sites for MMS, current triage practices include referral to other surgical specialties within the VHA, predominantly ear, nose, and throat and plastic surgery, for WLE. Given that access to on-site MMS varies significantly by geographic location, on-site MMS may be preferable in some locations, and external referrals in others. Based on this study's findings, on-site MMS seems superior to external referrals in all respects except patient travel distance. More research is needed to determine the most cost-effective triage practices. One option would be to have each VISN develop a skin cancer care center of excellence that would assist providers in appropriate triage and management.

 

 

Limitations

A decade has passed since Karen and colleagues conducted their study on MMS within the VHA.11 Data from this study suggest some progress has been made in improving veterans’ access to MMS. However, VHA sites that provide MMS are still predominantly located in large cities. In cases in which VHA providers refer patients to outside facilities, care coordination and follow-up are challenging. The present findings provide a basis for continuing VHA efforts to optimize resource allocation and improve longitudinal care for veterans who require MMS for skin cancer. Another area of interest is the comparative cost-effectiveness of MMS care provided within the VHA rather than at outside sites through purchased care. The answer may depend on geographic location, as MMS demand may be higher in some regions than that of others. For patients who receive MMS care outside the VHA, efforts should be made to improve communication and follow-up between VHA and external providers.

This study was limited in that it surveyed only those VHA sites with dermatology services or sections. It is possible, though unlikely, that MMS also was provided through nondermatology services. This study’s 70.3% response rate (52/74 dermatology chiefs) matched that of Karen and colleagues.11 Nevertheless, given that 30% of the surveyed chiefs did not respond and that analysis was performed separately for 2 small subgroups, (19 VHA sites that provided on-site MMS and 33 VHA sites that did not), the present findings may not be representative of the VHA as a whole.

Another limitation was that the survey captured respondent estimates of surgical caseloads and resources. Confirmation of these estimates would require a review of internal medical records and workforce analyses, which was beyond the scope of this study.

Conclusion

Although some progress has been made over the past 10 years, access to MMS within the VHA remains limited. About one-third of VHA sites provide on-site MMS; the other two-thirds refer patients with skin cancer to MMS sites outside the VHA. According to their dermatology chiefs, VHA sites that provide MMS have adequate resources and staffing and acceptable wait times for surgery; the challenge is in patients’ long travel distances. At sites that do not provide MMS, patients have access to MMS as well, and acceptable wait times and travel distances; the challenge is in follow-up, especially with activation of the Veterans Choice program. Studies should focus on standardizing veterans’ care and improving their access to MMS.

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References

1. Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis treatment in the Veterans Health Administration. Dermatol Surg. 2016;42(9):1041-1047.

2. Giroir BP, Wilensky GR. Reforming the Veterans Health Administration—beyond palliation of symptoms. N Engl J Med. 2015;373(18):1693-1695.

3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Basal Cell Skin Cancer 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Updated September 18, 2017. Accessed January 31, 2018.

4. Chren MM, Sahay AP, Bertenthal DS, Sen S, Landefeld CS. Quality-of-life outcomes of treatments for cutaneous basal cell carcinoma and squamous cell carcinoma. J Invest Dermatol. 2007;127(6):1351-1357.

5. Cook J, Zitelli JA. Mohs micrographic surgery: a cost analysis. J Am Acad Dermatol. 1998;39(5, pt 1):698-703.

6. Kauvar AN, Arpey CJ, Hruza G, Olbricht SM, Bennett R, Mahmoud BH. Consensus for nonmelanoma skin cancer treatment, part ii: squamous cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(11):1214-1240.

7. Kauvar AN, Cronin T Jr, Roenigk R, Hruza G, Bennett R; American Society for Dermatologic Surgery. Consensus for nonmelanoma skin cancer treatment: basal cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(5):550-571.

8. Chen JT, Kempton SJ, Rao VK. The economics of skin cancer: an analysis of Medicare payment data. Plast Reconstr Surg Glob Open. 2016;4(9):e868.

9. Tierney EP, Hanke CW. Cost effectiveness of Mohs micrographic surgery: review of the literature. J Drugs Dermatol. 2009;8(10):914-922.

10. Ad Hoc Task Force, Connolly SM, Baker DR, Coldiron BM, et al. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012;67(4):531-550.

11. Karen JK, Hale EK, Nehal KS, Levine VJ. Use of Mohs surgery by the Veterans Affairs Health Care System. J Am Acad Dermatol. 2009;60(6):1069-1070.

12. U.S. Department of Veterans Affairs. Expanded access to non-VA care through the Veterans Choice program. Interim final rule. Fed Regist. 2015;80(230):74991-74996.

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Mr. Tam is a medical student at the University of California, San Francisco School of Medicine. Dr. Yuan is a Clinical Research Fellow, Dr. Mauro is a Professor, and Dr. Arron is an Associate Professor, all in the Department of Dermatology at the University of California San Francisco. Dr. Arron also is the Chief of Mohs Micrographic Surgery and Dr. Mauro is the Interim Deputy Chief of Staff, both at San Francisco Veterans Affairs Health System. Dr. Dellavalle is a Professor in the Department of Dermatology at the University of Colorado Denver and the Chief of the Dermatology Service at the Denver Veteran Affairs Medical Center.

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Mr. Tam is a medical student at the University of California, San Francisco School of Medicine. Dr. Yuan is a Clinical Research Fellow, Dr. Mauro is a Professor, and Dr. Arron is an Associate Professor, all in the Department of Dermatology at the University of California San Francisco. Dr. Arron also is the Chief of Mohs Micrographic Surgery and Dr. Mauro is the Interim Deputy Chief of Staff, both at San Francisco Veterans Affairs Health System. Dr. Dellavalle is a Professor in the Department of Dermatology at the University of Colorado Denver and the Chief of the Dermatology Service at the Denver Veteran Affairs Medical Center.

Author Disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

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Mr. Tam is a medical student at the University of California, San Francisco School of Medicine. Dr. Yuan is a Clinical Research Fellow, Dr. Mauro is a Professor, and Dr. Arron is an Associate Professor, all in the Department of Dermatology at the University of California San Francisco. Dr. Arron also is the Chief of Mohs Micrographic Surgery and Dr. Mauro is the Interim Deputy Chief of Staff, both at San Francisco Veterans Affairs Health System. Dr. Dellavalle is a Professor in the Department of Dermatology at the University of Colorado Denver and the Chief of the Dermatology Service at the Denver Veteran Affairs Medical Center.

Author Disclosures
The authors report no actual or potential conflicts of interest with regard to this article.

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The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.

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Veterans with skin cancer have seen improved access to Mohs micrographic surgery over the past 10 years, yet the challenges of travel distance and care coordination remain.
Veterans with skin cancer have seen improved access to Mohs micrographic surgery over the past 10 years, yet the challenges of travel distance and care coordination remain.

Skin cancer is one of the most prevalent conditions among VHA patients.1 One of the largest U.S. health care systems, the VHA serves more than 9 million veterans.2 In 2012, 4% of VHA patients had a diagnosis of keratinocyte carcinoma or actinic keratosis; 49,229 cases of basal cell carcinoma and 26,310 cases of squamous cell carcinoma were diagnosed.1 With an aging veteran population and the incidence of skin cancers expected to increase, the development of cost-effective ways to provide easily accessible skin cancer treatments has become a priority for the VHA.

National Comprehensive Cancer Network (NCCN) guidelines recommend 3 types of surgical treatment for localized keratinocyte carcinoma: local destruction, wide local excision (WLE), and Mohs micrographic surgery (MMS). Tumors at low risk for recurrence may be treated with local destruction or WLE, and tumors at high risk may be treated with WLE or MMS.3

Mohs micrographic surgery involves staged narrow-margin excision with intraoperative tumor mapping and complete circumferential peripheral and deep margin assessment (CCPDMA). With the Mohs surgeon acting as both surgeon and dermatopathologist, it is possible to provide intraoperative correlation with the tissue bed and immediate additional margin resection precisely where needed. Relative to WLE, MMS yields improved histopathologic clearance rates and lower 5-year recurrence rates. It also provides improved preservation of normal tissue, optimized aesthetic outcomes, and high patient satisfaction.4-7 All this is achieved in an outpatient setting with the patient under local anesthesia; therefore the cost of ambulatory surgical centers or hospital operating rooms are avoided.5,8,9

The NCCN recommends WLE for high-risk tumors only if CCPDMA can be achieved. However, CCPDMA requires specialized surgical technique, tissue orientation, and pathology and is not equivalent to standard WLE with routine surgical pathology. Even with intraoperative bread-loafed frozen section analysis, WLE does not achieve the 100% margin assessment obtained with MMS.

In 2012, the American Academy of Dermatology in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery developed the Mohs Appropriate Use Criteria,which are now widely used as part of the standard of care to determine which cases of skin cancer should be treated with MMS over other modalities.10 These criteria, which are based on both evidence and expert consensus, take into account tumor size, histology, location, and patient factors, such as immunosuppression.

Despite its established benefits, MMS has not been uniformly accessible to veterans seeking VHA care. In 2007, Karen and colleagues surveyed dermatology chiefs and staff dermatologists from 101 VHA hospitals to characterize veterans’ access to MMS and found MMS available at only 11 VHA sites in 9 states.11 Further, access within the VHA was not evenly distributed across the U.S.

The VHA often makes payments, under “non-VA medical care” or “fee-basis care,” to providers in the community for services that the VHA is otherwise unable to provide. In 2014, Congress passed the Veterans Access, Choice, and Accountability Act and established the Veterans Choice program.2,12 This program allows veterans to obtain medical services from providers outside the VHA, based on veteran wait time and place of residence.12 The goal is to improve access. The present authors distinguish between 2 types of care: there are fee-based referrals managed and tracked by the VHA physician and the Veterans Choice for care without the diagnosing physician involvement or knowledge. In addition to expanding treatment options, the act called for reform within the VHA to improve resources and infrastructure needed to provide the best care for the veteran patient population.2

The authors conducted a study to identify current availability of MMS within the VHA and to provide a 10-year update to the survey findings of Karen and colleagues.11 VHA facilities that offer MMS were surveyed to determine available resources and what is needed to provide MMS within the VHA. Also surveyed were VHA facilities that do not offer MMS to determine how VHA patients with skin cancer receive surgical care from non-VA providers or from other surgical specialties.

Related: Nivolumab Linked to Nephritis in Melanoma

Methods

This study, deemed exempt from review by the University of California San Francisco Institutional Review Board, was a survey of dermatology section and service chiefs across the VHA. Subjects were identified through conference calls with VHA dermatologists, searches of individual VHA websites, and requests on dermatology e-mail listservs and were invited by email to participate in the survey.

The Research Electronic Data Capture platform (REDCap; Vanderbilt University Medical Center) was used for survey creation, implementation, dissemination, and data storage. The survey had 6 sections: site information; MMS availability; Mohs surgeon, Mohs laboratory, and support staff; MMS care; patient referral; and Mohs surgeon recruitment.

Data were collected between June 20 and August 1, 2016. Collected VHA site information included name, location, description, and MMS availability. If MMS was available, data were collected on surgeon training and background, number of MMS cases in 2015, and facility and support staff. In addition, subjects rated statements about various aspects of care provided (eg, patient wait time, patient distance traveled) on a 6-point Likert scale: strongly disagree, moderately disagree, slightly disagree, slightly agree, moderately agree, or strongly agree. This section included both positive and negative statements.

If MMS was not available at the VHA site, data were collected on patient referrals, including location within or outside the VHA and patient use of the Veterans Choice program. Subjects also rated positive and negative statements about referral experiences on a Likert scale (eg, patient wait time, patient distance traveled).

Categorical data were summarized, means and standard deviations were calculated for nominal data, and data analysis was performed with Microsoft Excel (Redmond, WA).

 

 

Results

The authors identified and surveyed 74 dermatology service and section chiefs across the VHA. Of these chiefs, 52 (70.3%) completed the survey. Completed surveys represented 49 hospital sites and 3 community-based outpatient clinics (CBOCs), including an integrated community-based clinic-hospital.

Sites That Provided MMS

Of the 52 sites with a completed survey, 19 provided MMS. These 19 sites were in 13 states and the District of Columbia, and the majority were in major cities along the coasts. All 19 sites were hospital medical centers, not community-based outpatient clinics, and all provided MMS through the dermatology department. In 2015, an estimated 6,686 MMS cases were performed, or an average of 371 per site (range, 40-1,000 cases/site) or 4.9 MMS cases per day (range, 3-8). These 19 sites were divided by yearly volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y).

Physical Space. On average, each site used 2.89 patient rooms (SD, 1.1; range, 1-6) for MMS. The Table lists numbers of patient rooms based on case volume.

The MMS laboratory was adjacent to the surgical suite at 18 of the MMS sites and in the same building as the surgical suite, but not next to it, at 1 site. For their samples, 11 sites used an automated staining method, 7 used hand staining, and 2 used other methods (1 site used both automated and hand staining). Fourteen sites used hematoxlyin-eosin only, 1 used toluidine blue only, 3 used both hematoxlyin-eosin and toluidine blue, and 1 used MART-1 (melanoma antigen recognized by T cells 1) with hematoxlyin-eosin.

Related: Systemic Therapy in Metastatic Melanoma

Mohs Micrographic Surgeons. Sites with higher case volumes had more Mohs surgeons and more Mohs surgeons with VA appointments (captured as “eighths” or fraction of 8/8 full-time equivalent [FTE]). Information on fellowships and professional memberships was available for 30 Mohs surgeons: Ten (33.3%) were trained in fellowships accredited by both the American College of Mohs Surgery (ACMS) and the Accreditation Council for Graduate Medical Education (ACGME), 8 (26.7%) were trained in ACMS-recognized fellowships only, 7 (23.3%) were trained at ACGME-accredited fellowships only, 2 (6.7%) were trained elsewhere, and 3 (10.0%) had training listed as “uncertain.”

The majority of Mohs surgeons were members of professional societies, and many were members of more than one. Of the 30 Mohs surgeons, 24 (80.0%) were ACMS members, 5 (16.7%) were members of the American Society of Mohs Surgery, and 22 (73.3%) were members of the American Society of Dermatologic Surgery. Twenty-five (89.3%) were affiliated with an academic program.

Of the 30 surgeons, 19 (63.3%) were VHA employees hired by eighths, with an average eighths of 3.9 (SD, 2.7), or 49% of a FTE. Data on these surgeons’ pay tables and tiers were insufficient (only 3 provided the information). Of the other 11 surgeons, 10 (33.3%) were contracted, and 1 (3.3%) volunteered without compensation.

Support Staff. Of the 19 MMS sites, 17 (89.5%) used 1 histotechnician, and 2 (10.5%) used more than 1. Ten sites (52.6%) hired histotechnicians as contractors, 8 (42.1%) as employees, and 1 (5.3%) on a fee basis. In general, sites with higher case volumes had more nursing and support staff. Thirteen sites (68.4%) participated in the training of dermatology residents, and 5 sites (26.3%) trained Mohs fellows.

Wait Time Estimate. The survey also asked for estimates of the average amount of time patients waited for MMS. Of the 19 sites, 8 (42.1%) reported a wait time of less than 1 month, 10 (52.6%) reported 2 to 6 months, and 1 (5.3%) reported 7 months to 1 year. Seventeen (89.5%) of the 19 sites had a grading or triage system for expediting certain cancer types. At 7 sites, cases were prioritized on the basis of physician assessment; at 3 sites, aggressive or invasive squamous cell carcinoma received priority; other sites gave priority to patients with melanoma, patients with carcinoma near the nose or eye, organ transplant recipients, and other immunosuppressed patients.

Sites That Did Not Provide MMS

Of the 52 sites with a completed survey, 33 (63.5%) did not provide on-site MMS. Of these 33 sites, 28 (84.8%) used purchased care to refer patients to fee-basis non-VA dermatologists. In addition, 30 sites (90.9%) had patients activate Veterans Choice. Three sites referred patients to VA sites in another VISN.

Surgeon Recruitment

Five sites (9.6%) had an unfilled Mohs micrographic surgeon position. The average FTE of these unfilled positions was 0.6. One position had been open for less than 6 months, and the other 4 for more than 1 year. All 5 respondents with unfilled positions strongly agreed with the statement, “The position is unfilled because the salary is not competitive with the local market.”

 

 

Assessment of Care Provided

Respondents at sites that provided MMS rated various aspects of care (Figure 1). 

Sixteen (84%) reported that MMS was received in a reasonable amount of time, 15 (79%) that facilities and resources for MMS were adequate, 13 (68%) that they themselves were capable of meeting the demands of MMS, 11 (58%) that their sites did not have enough Mohs surgeons, 11 (58%) that the number of support staff for MMS was sufficient, and 14 (74%) that patients had to travel a long distance to access MMS.

Respondents from sites that purchased MMS care from non-VA medical care rated surgery availability and ease of patient follow-up (Figure 2). 

Eighteen (66.7%) reported that referred patients received MMS in a reasonable amount of time, 7 (25.9%) that patients had to travel a long distance to the fee-basis/non-VA care facility, 12 (44.4%) that follow-up after fee-basis/non-VA care for MMS was difficult, and 25 (83.3%) that follow-up after activation of Veterans Choice was difficult.

Related: Getting a Better Picture of Skin Cancer

Discussion

Skin cancer is highly prevalent in the veteran patient population, and each year treatment by the VHA requires considerable spending.1 The results of this cross-sectional survey characterize veterans’ access to MMS within the VHA and provide a 10-year update to the survey findings of Karen and colleagues.11 Compared with their study, this survey offers a more granular description of practices and facilities as well as comparisons of VHA care with care purchased from outside sources. In outlining the state of MMS care within the VHA, this study highlights progress made and provides the updated data needed for continued efforts to optimize care and resource allocation for patients who require MMS within the VHA.

Although the number of VHA sites that provide MMS has increased over the past 10 years—from 11 sites in 9 states in 2007 to 19 sites in 13 states now—it is important to note that access to MMS care highly depends on geographic location.11 The VHA sites that provide MMS are clustered in major cities along the coasts. Four states (California, Florida, New York, and Texas) had > 1 MMS site, whereas most other states did not have any. In addition, only 1 MMS site served all of the northwest U.S. To ensure the anonymity of survey respondents, the authors did not further characterize the regional distribution of MMS sites.

Despite the increase in MMS sites, the number of MMS cases performed within the VHA seemed to have decreased. An estimated 8,310 cases were performed within the VHA in 2006,which decreased to 6,686 in 2015.11 Although these are estimates, the number of VHA cases likely decreased because of a rise in purchased care. Reviewing VHA electronic health records, Yoon and colleagues found that 19,681 MMS cases were performed either within the VHA or at non-VA medical care sites in 2012.1 Although the proportions of MMS cases performed within and outside the VHA were not reported, clearly many veterans had MMS performed through the VHA in recent years, and a high percentage of these cases were external referrals. More study is needed to further characterize MMS care within the VHA and MMS care purchased.

The 19 sites that provided MMS were evenly divided by volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y). Case volume correlated with the numbers of surgeons, nurses, and support staff at each site. Number of patient rooms dedicated to MMS at each site was not correlated with case volume; however, not ascertaining the number of days per week MMS was performed may have contributed to the lack of observed correlation.The majority of Mohs surgeons (25; 89.3%) within the VHA were affiliated with academic programs, which may partly explain the uneven geographic distribution of VHA sites that provide MMS (dermatology residency programs typically are in larger cities). The majority of Mohs surgeons were fellowship-trained through the ACMS or the ACGME. As the ACGME first began accrediting fellowship programs in 2003, younger surgeons were more likely to have completed this fellowship. According to respondents from sites that did not provide MMS, noncompetitive VHA salaries might be a barrier to Mohs surgeon recruitment. If a shift to providing more MMS care within the VHA were desired, an effective strategy could be to raise surgeon salaries. Higher salaries would bring in more Mohs surgeons and thereby yield higher MMS case volumes at VHA sites.

However, whether MMS is best provided for veterans within the VHA or at outside sites through referrals warrants further study. More than 60% of sites provided access to MMS through purchased care, either by fee-basis/non-VA medical care referrals or by the patient-elected Veterans Choice program. According to 84.2% of respondents at MMS sites and 66.7% of respondents at non-MMS sites, patients received care within a reasonable amount of time. In addition, respondents at MMS sites estimated longer patient travel distance for surgery. Respondents reported being concerned about coordination of care and follow-up for patients who received MMS outside the VHA. Other than referrals to outside sites for MMS, current triage practices include referral to other surgical specialties within the VHA, predominantly ear, nose, and throat and plastic surgery, for WLE. Given that access to on-site MMS varies significantly by geographic location, on-site MMS may be preferable in some locations, and external referrals in others. Based on this study's findings, on-site MMS seems superior to external referrals in all respects except patient travel distance. More research is needed to determine the most cost-effective triage practices. One option would be to have each VISN develop a skin cancer care center of excellence that would assist providers in appropriate triage and management.

 

 

Limitations

A decade has passed since Karen and colleagues conducted their study on MMS within the VHA.11 Data from this study suggest some progress has been made in improving veterans’ access to MMS. However, VHA sites that provide MMS are still predominantly located in large cities. In cases in which VHA providers refer patients to outside facilities, care coordination and follow-up are challenging. The present findings provide a basis for continuing VHA efforts to optimize resource allocation and improve longitudinal care for veterans who require MMS for skin cancer. Another area of interest is the comparative cost-effectiveness of MMS care provided within the VHA rather than at outside sites through purchased care. The answer may depend on geographic location, as MMS demand may be higher in some regions than that of others. For patients who receive MMS care outside the VHA, efforts should be made to improve communication and follow-up between VHA and external providers.

This study was limited in that it surveyed only those VHA sites with dermatology services or sections. It is possible, though unlikely, that MMS also was provided through nondermatology services. This study’s 70.3% response rate (52/74 dermatology chiefs) matched that of Karen and colleagues.11 Nevertheless, given that 30% of the surveyed chiefs did not respond and that analysis was performed separately for 2 small subgroups, (19 VHA sites that provided on-site MMS and 33 VHA sites that did not), the present findings may not be representative of the VHA as a whole.

Another limitation was that the survey captured respondent estimates of surgical caseloads and resources. Confirmation of these estimates would require a review of internal medical records and workforce analyses, which was beyond the scope of this study.

Conclusion

Although some progress has been made over the past 10 years, access to MMS within the VHA remains limited. About one-third of VHA sites provide on-site MMS; the other two-thirds refer patients with skin cancer to MMS sites outside the VHA. According to their dermatology chiefs, VHA sites that provide MMS have adequate resources and staffing and acceptable wait times for surgery; the challenge is in patients’ long travel distances. At sites that do not provide MMS, patients have access to MMS as well, and acceptable wait times and travel distances; the challenge is in follow-up, especially with activation of the Veterans Choice program. Studies should focus on standardizing veterans’ care and improving their access to MMS.

Click here to read the digital edition.

Skin cancer is one of the most prevalent conditions among VHA patients.1 One of the largest U.S. health care systems, the VHA serves more than 9 million veterans.2 In 2012, 4% of VHA patients had a diagnosis of keratinocyte carcinoma or actinic keratosis; 49,229 cases of basal cell carcinoma and 26,310 cases of squamous cell carcinoma were diagnosed.1 With an aging veteran population and the incidence of skin cancers expected to increase, the development of cost-effective ways to provide easily accessible skin cancer treatments has become a priority for the VHA.

National Comprehensive Cancer Network (NCCN) guidelines recommend 3 types of surgical treatment for localized keratinocyte carcinoma: local destruction, wide local excision (WLE), and Mohs micrographic surgery (MMS). Tumors at low risk for recurrence may be treated with local destruction or WLE, and tumors at high risk may be treated with WLE or MMS.3

Mohs micrographic surgery involves staged narrow-margin excision with intraoperative tumor mapping and complete circumferential peripheral and deep margin assessment (CCPDMA). With the Mohs surgeon acting as both surgeon and dermatopathologist, it is possible to provide intraoperative correlation with the tissue bed and immediate additional margin resection precisely where needed. Relative to WLE, MMS yields improved histopathologic clearance rates and lower 5-year recurrence rates. It also provides improved preservation of normal tissue, optimized aesthetic outcomes, and high patient satisfaction.4-7 All this is achieved in an outpatient setting with the patient under local anesthesia; therefore the cost of ambulatory surgical centers or hospital operating rooms are avoided.5,8,9

The NCCN recommends WLE for high-risk tumors only if CCPDMA can be achieved. However, CCPDMA requires specialized surgical technique, tissue orientation, and pathology and is not equivalent to standard WLE with routine surgical pathology. Even with intraoperative bread-loafed frozen section analysis, WLE does not achieve the 100% margin assessment obtained with MMS.

In 2012, the American Academy of Dermatology in collaboration with the American College of Mohs Surgery, the American Society for Dermatologic Surgery, and the American Society for Mohs Surgery developed the Mohs Appropriate Use Criteria,which are now widely used as part of the standard of care to determine which cases of skin cancer should be treated with MMS over other modalities.10 These criteria, which are based on both evidence and expert consensus, take into account tumor size, histology, location, and patient factors, such as immunosuppression.

Despite its established benefits, MMS has not been uniformly accessible to veterans seeking VHA care. In 2007, Karen and colleagues surveyed dermatology chiefs and staff dermatologists from 101 VHA hospitals to characterize veterans’ access to MMS and found MMS available at only 11 VHA sites in 9 states.11 Further, access within the VHA was not evenly distributed across the U.S.

The VHA often makes payments, under “non-VA medical care” or “fee-basis care,” to providers in the community for services that the VHA is otherwise unable to provide. In 2014, Congress passed the Veterans Access, Choice, and Accountability Act and established the Veterans Choice program.2,12 This program allows veterans to obtain medical services from providers outside the VHA, based on veteran wait time and place of residence.12 The goal is to improve access. The present authors distinguish between 2 types of care: there are fee-based referrals managed and tracked by the VHA physician and the Veterans Choice for care without the diagnosing physician involvement or knowledge. In addition to expanding treatment options, the act called for reform within the VHA to improve resources and infrastructure needed to provide the best care for the veteran patient population.2

The authors conducted a study to identify current availability of MMS within the VHA and to provide a 10-year update to the survey findings of Karen and colleagues.11 VHA facilities that offer MMS were surveyed to determine available resources and what is needed to provide MMS within the VHA. Also surveyed were VHA facilities that do not offer MMS to determine how VHA patients with skin cancer receive surgical care from non-VA providers or from other surgical specialties.

Related: Nivolumab Linked to Nephritis in Melanoma

Methods

This study, deemed exempt from review by the University of California San Francisco Institutional Review Board, was a survey of dermatology section and service chiefs across the VHA. Subjects were identified through conference calls with VHA dermatologists, searches of individual VHA websites, and requests on dermatology e-mail listservs and were invited by email to participate in the survey.

The Research Electronic Data Capture platform (REDCap; Vanderbilt University Medical Center) was used for survey creation, implementation, dissemination, and data storage. The survey had 6 sections: site information; MMS availability; Mohs surgeon, Mohs laboratory, and support staff; MMS care; patient referral; and Mohs surgeon recruitment.

Data were collected between June 20 and August 1, 2016. Collected VHA site information included name, location, description, and MMS availability. If MMS was available, data were collected on surgeon training and background, number of MMS cases in 2015, and facility and support staff. In addition, subjects rated statements about various aspects of care provided (eg, patient wait time, patient distance traveled) on a 6-point Likert scale: strongly disagree, moderately disagree, slightly disagree, slightly agree, moderately agree, or strongly agree. This section included both positive and negative statements.

If MMS was not available at the VHA site, data were collected on patient referrals, including location within or outside the VHA and patient use of the Veterans Choice program. Subjects also rated positive and negative statements about referral experiences on a Likert scale (eg, patient wait time, patient distance traveled).

Categorical data were summarized, means and standard deviations were calculated for nominal data, and data analysis was performed with Microsoft Excel (Redmond, WA).

 

 

Results

The authors identified and surveyed 74 dermatology service and section chiefs across the VHA. Of these chiefs, 52 (70.3%) completed the survey. Completed surveys represented 49 hospital sites and 3 community-based outpatient clinics (CBOCs), including an integrated community-based clinic-hospital.

Sites That Provided MMS

Of the 52 sites with a completed survey, 19 provided MMS. These 19 sites were in 13 states and the District of Columbia, and the majority were in major cities along the coasts. All 19 sites were hospital medical centers, not community-based outpatient clinics, and all provided MMS through the dermatology department. In 2015, an estimated 6,686 MMS cases were performed, or an average of 371 per site (range, 40-1,000 cases/site) or 4.9 MMS cases per day (range, 3-8). These 19 sites were divided by yearly volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y).

Physical Space. On average, each site used 2.89 patient rooms (SD, 1.1; range, 1-6) for MMS. The Table lists numbers of patient rooms based on case volume.

The MMS laboratory was adjacent to the surgical suite at 18 of the MMS sites and in the same building as the surgical suite, but not next to it, at 1 site. For their samples, 11 sites used an automated staining method, 7 used hand staining, and 2 used other methods (1 site used both automated and hand staining). Fourteen sites used hematoxlyin-eosin only, 1 used toluidine blue only, 3 used both hematoxlyin-eosin and toluidine blue, and 1 used MART-1 (melanoma antigen recognized by T cells 1) with hematoxlyin-eosin.

Related: Systemic Therapy in Metastatic Melanoma

Mohs Micrographic Surgeons. Sites with higher case volumes had more Mohs surgeons and more Mohs surgeons with VA appointments (captured as “eighths” or fraction of 8/8 full-time equivalent [FTE]). Information on fellowships and professional memberships was available for 30 Mohs surgeons: Ten (33.3%) were trained in fellowships accredited by both the American College of Mohs Surgery (ACMS) and the Accreditation Council for Graduate Medical Education (ACGME), 8 (26.7%) were trained in ACMS-recognized fellowships only, 7 (23.3%) were trained at ACGME-accredited fellowships only, 2 (6.7%) were trained elsewhere, and 3 (10.0%) had training listed as “uncertain.”

The majority of Mohs surgeons were members of professional societies, and many were members of more than one. Of the 30 Mohs surgeons, 24 (80.0%) were ACMS members, 5 (16.7%) were members of the American Society of Mohs Surgery, and 22 (73.3%) were members of the American Society of Dermatologic Surgery. Twenty-five (89.3%) were affiliated with an academic program.

Of the 30 surgeons, 19 (63.3%) were VHA employees hired by eighths, with an average eighths of 3.9 (SD, 2.7), or 49% of a FTE. Data on these surgeons’ pay tables and tiers were insufficient (only 3 provided the information). Of the other 11 surgeons, 10 (33.3%) were contracted, and 1 (3.3%) volunteered without compensation.

Support Staff. Of the 19 MMS sites, 17 (89.5%) used 1 histotechnician, and 2 (10.5%) used more than 1. Ten sites (52.6%) hired histotechnicians as contractors, 8 (42.1%) as employees, and 1 (5.3%) on a fee basis. In general, sites with higher case volumes had more nursing and support staff. Thirteen sites (68.4%) participated in the training of dermatology residents, and 5 sites (26.3%) trained Mohs fellows.

Wait Time Estimate. The survey also asked for estimates of the average amount of time patients waited for MMS. Of the 19 sites, 8 (42.1%) reported a wait time of less than 1 month, 10 (52.6%) reported 2 to 6 months, and 1 (5.3%) reported 7 months to 1 year. Seventeen (89.5%) of the 19 sites had a grading or triage system for expediting certain cancer types. At 7 sites, cases were prioritized on the basis of physician assessment; at 3 sites, aggressive or invasive squamous cell carcinoma received priority; other sites gave priority to patients with melanoma, patients with carcinoma near the nose or eye, organ transplant recipients, and other immunosuppressed patients.

Sites That Did Not Provide MMS

Of the 52 sites with a completed survey, 33 (63.5%) did not provide on-site MMS. Of these 33 sites, 28 (84.8%) used purchased care to refer patients to fee-basis non-VA dermatologists. In addition, 30 sites (90.9%) had patients activate Veterans Choice. Three sites referred patients to VA sites in another VISN.

Surgeon Recruitment

Five sites (9.6%) had an unfilled Mohs micrographic surgeon position. The average FTE of these unfilled positions was 0.6. One position had been open for less than 6 months, and the other 4 for more than 1 year. All 5 respondents with unfilled positions strongly agreed with the statement, “The position is unfilled because the salary is not competitive with the local market.”

 

 

Assessment of Care Provided

Respondents at sites that provided MMS rated various aspects of care (Figure 1). 

Sixteen (84%) reported that MMS was received in a reasonable amount of time, 15 (79%) that facilities and resources for MMS were adequate, 13 (68%) that they themselves were capable of meeting the demands of MMS, 11 (58%) that their sites did not have enough Mohs surgeons, 11 (58%) that the number of support staff for MMS was sufficient, and 14 (74%) that patients had to travel a long distance to access MMS.

Respondents from sites that purchased MMS care from non-VA medical care rated surgery availability and ease of patient follow-up (Figure 2). 

Eighteen (66.7%) reported that referred patients received MMS in a reasonable amount of time, 7 (25.9%) that patients had to travel a long distance to the fee-basis/non-VA care facility, 12 (44.4%) that follow-up after fee-basis/non-VA care for MMS was difficult, and 25 (83.3%) that follow-up after activation of Veterans Choice was difficult.

Related: Getting a Better Picture of Skin Cancer

Discussion

Skin cancer is highly prevalent in the veteran patient population, and each year treatment by the VHA requires considerable spending.1 The results of this cross-sectional survey characterize veterans’ access to MMS within the VHA and provide a 10-year update to the survey findings of Karen and colleagues.11 Compared with their study, this survey offers a more granular description of practices and facilities as well as comparisons of VHA care with care purchased from outside sources. In outlining the state of MMS care within the VHA, this study highlights progress made and provides the updated data needed for continued efforts to optimize care and resource allocation for patients who require MMS within the VHA.

Although the number of VHA sites that provide MMS has increased over the past 10 years—from 11 sites in 9 states in 2007 to 19 sites in 13 states now—it is important to note that access to MMS care highly depends on geographic location.11 The VHA sites that provide MMS are clustered in major cities along the coasts. Four states (California, Florida, New York, and Texas) had > 1 MMS site, whereas most other states did not have any. In addition, only 1 MMS site served all of the northwest U.S. To ensure the anonymity of survey respondents, the authors did not further characterize the regional distribution of MMS sites.

Despite the increase in MMS sites, the number of MMS cases performed within the VHA seemed to have decreased. An estimated 8,310 cases were performed within the VHA in 2006,which decreased to 6,686 in 2015.11 Although these are estimates, the number of VHA cases likely decreased because of a rise in purchased care. Reviewing VHA electronic health records, Yoon and colleagues found that 19,681 MMS cases were performed either within the VHA or at non-VA medical care sites in 2012.1 Although the proportions of MMS cases performed within and outside the VHA were not reported, clearly many veterans had MMS performed through the VHA in recent years, and a high percentage of these cases were external referrals. More study is needed to further characterize MMS care within the VHA and MMS care purchased.

The 19 sites that provided MMS were evenly divided by volume: high (> 500 cases/y), medium (200-500 cases/y), and low (< 200 cases/y). Case volume correlated with the numbers of surgeons, nurses, and support staff at each site. Number of patient rooms dedicated to MMS at each site was not correlated with case volume; however, not ascertaining the number of days per week MMS was performed may have contributed to the lack of observed correlation.The majority of Mohs surgeons (25; 89.3%) within the VHA were affiliated with academic programs, which may partly explain the uneven geographic distribution of VHA sites that provide MMS (dermatology residency programs typically are in larger cities). The majority of Mohs surgeons were fellowship-trained through the ACMS or the ACGME. As the ACGME first began accrediting fellowship programs in 2003, younger surgeons were more likely to have completed this fellowship. According to respondents from sites that did not provide MMS, noncompetitive VHA salaries might be a barrier to Mohs surgeon recruitment. If a shift to providing more MMS care within the VHA were desired, an effective strategy could be to raise surgeon salaries. Higher salaries would bring in more Mohs surgeons and thereby yield higher MMS case volumes at VHA sites.

However, whether MMS is best provided for veterans within the VHA or at outside sites through referrals warrants further study. More than 60% of sites provided access to MMS through purchased care, either by fee-basis/non-VA medical care referrals or by the patient-elected Veterans Choice program. According to 84.2% of respondents at MMS sites and 66.7% of respondents at non-MMS sites, patients received care within a reasonable amount of time. In addition, respondents at MMS sites estimated longer patient travel distance for surgery. Respondents reported being concerned about coordination of care and follow-up for patients who received MMS outside the VHA. Other than referrals to outside sites for MMS, current triage practices include referral to other surgical specialties within the VHA, predominantly ear, nose, and throat and plastic surgery, for WLE. Given that access to on-site MMS varies significantly by geographic location, on-site MMS may be preferable in some locations, and external referrals in others. Based on this study's findings, on-site MMS seems superior to external referrals in all respects except patient travel distance. More research is needed to determine the most cost-effective triage practices. One option would be to have each VISN develop a skin cancer care center of excellence that would assist providers in appropriate triage and management.

 

 

Limitations

A decade has passed since Karen and colleagues conducted their study on MMS within the VHA.11 Data from this study suggest some progress has been made in improving veterans’ access to MMS. However, VHA sites that provide MMS are still predominantly located in large cities. In cases in which VHA providers refer patients to outside facilities, care coordination and follow-up are challenging. The present findings provide a basis for continuing VHA efforts to optimize resource allocation and improve longitudinal care for veterans who require MMS for skin cancer. Another area of interest is the comparative cost-effectiveness of MMS care provided within the VHA rather than at outside sites through purchased care. The answer may depend on geographic location, as MMS demand may be higher in some regions than that of others. For patients who receive MMS care outside the VHA, efforts should be made to improve communication and follow-up between VHA and external providers.

This study was limited in that it surveyed only those VHA sites with dermatology services or sections. It is possible, though unlikely, that MMS also was provided through nondermatology services. This study’s 70.3% response rate (52/74 dermatology chiefs) matched that of Karen and colleagues.11 Nevertheless, given that 30% of the surveyed chiefs did not respond and that analysis was performed separately for 2 small subgroups, (19 VHA sites that provided on-site MMS and 33 VHA sites that did not), the present findings may not be representative of the VHA as a whole.

Another limitation was that the survey captured respondent estimates of surgical caseloads and resources. Confirmation of these estimates would require a review of internal medical records and workforce analyses, which was beyond the scope of this study.

Conclusion

Although some progress has been made over the past 10 years, access to MMS within the VHA remains limited. About one-third of VHA sites provide on-site MMS; the other two-thirds refer patients with skin cancer to MMS sites outside the VHA. According to their dermatology chiefs, VHA sites that provide MMS have adequate resources and staffing and acceptable wait times for surgery; the challenge is in patients’ long travel distances. At sites that do not provide MMS, patients have access to MMS as well, and acceptable wait times and travel distances; the challenge is in follow-up, especially with activation of the Veterans Choice program. Studies should focus on standardizing veterans’ care and improving their access to MMS.

Click here to read the digital edition.

References

1. Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis treatment in the Veterans Health Administration. Dermatol Surg. 2016;42(9):1041-1047.

2. Giroir BP, Wilensky GR. Reforming the Veterans Health Administration—beyond palliation of symptoms. N Engl J Med. 2015;373(18):1693-1695.

3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Basal Cell Skin Cancer 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Updated September 18, 2017. Accessed January 31, 2018.

4. Chren MM, Sahay AP, Bertenthal DS, Sen S, Landefeld CS. Quality-of-life outcomes of treatments for cutaneous basal cell carcinoma and squamous cell carcinoma. J Invest Dermatol. 2007;127(6):1351-1357.

5. Cook J, Zitelli JA. Mohs micrographic surgery: a cost analysis. J Am Acad Dermatol. 1998;39(5, pt 1):698-703.

6. Kauvar AN, Arpey CJ, Hruza G, Olbricht SM, Bennett R, Mahmoud BH. Consensus for nonmelanoma skin cancer treatment, part ii: squamous cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(11):1214-1240.

7. Kauvar AN, Cronin T Jr, Roenigk R, Hruza G, Bennett R; American Society for Dermatologic Surgery. Consensus for nonmelanoma skin cancer treatment: basal cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(5):550-571.

8. Chen JT, Kempton SJ, Rao VK. The economics of skin cancer: an analysis of Medicare payment data. Plast Reconstr Surg Glob Open. 2016;4(9):e868.

9. Tierney EP, Hanke CW. Cost effectiveness of Mohs micrographic surgery: review of the literature. J Drugs Dermatol. 2009;8(10):914-922.

10. Ad Hoc Task Force, Connolly SM, Baker DR, Coldiron BM, et al. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012;67(4):531-550.

11. Karen JK, Hale EK, Nehal KS, Levine VJ. Use of Mohs surgery by the Veterans Affairs Health Care System. J Am Acad Dermatol. 2009;60(6):1069-1070.

12. U.S. Department of Veterans Affairs. Expanded access to non-VA care through the Veterans Choice program. Interim final rule. Fed Regist. 2015;80(230):74991-74996.

References

1. Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis treatment in the Veterans Health Administration. Dermatol Surg. 2016;42(9):1041-1047.

2. Giroir BP, Wilensky GR. Reforming the Veterans Health Administration—beyond palliation of symptoms. N Engl J Med. 2015;373(18):1693-1695.

3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Basal Cell Skin Cancer 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf. Updated September 18, 2017. Accessed January 31, 2018.

4. Chren MM, Sahay AP, Bertenthal DS, Sen S, Landefeld CS. Quality-of-life outcomes of treatments for cutaneous basal cell carcinoma and squamous cell carcinoma. J Invest Dermatol. 2007;127(6):1351-1357.

5. Cook J, Zitelli JA. Mohs micrographic surgery: a cost analysis. J Am Acad Dermatol. 1998;39(5, pt 1):698-703.

6. Kauvar AN, Arpey CJ, Hruza G, Olbricht SM, Bennett R, Mahmoud BH. Consensus for nonmelanoma skin cancer treatment, part ii: squamous cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(11):1214-1240.

7. Kauvar AN, Cronin T Jr, Roenigk R, Hruza G, Bennett R; American Society for Dermatologic Surgery. Consensus for nonmelanoma skin cancer treatment: basal cell carcinoma, including a cost analysis of treatment methods. Dermatol Surg. 2015;41(5):550-571.

8. Chen JT, Kempton SJ, Rao VK. The economics of skin cancer: an analysis of Medicare payment data. Plast Reconstr Surg Glob Open. 2016;4(9):e868.

9. Tierney EP, Hanke CW. Cost effectiveness of Mohs micrographic surgery: review of the literature. J Drugs Dermatol. 2009;8(10):914-922.

10. Ad Hoc Task Force, Connolly SM, Baker DR, Coldiron BM, et al. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012;67(4):531-550.

11. Karen JK, Hale EK, Nehal KS, Levine VJ. Use of Mohs surgery by the Veterans Affairs Health Care System. J Am Acad Dermatol. 2009;60(6):1069-1070.

12. U.S. Department of Veterans Affairs. Expanded access to non-VA care through the Veterans Choice program. Interim final rule. Fed Regist. 2015;80(230):74991-74996.

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Children in military families face unique challenges that other children do not face. Knee pathologies predict accelerated knee osteoarthritis, patients with a poor-prognosis cancer have a higher risk of suicide in the first year, and Nuedexta is mainly being prescribed for dementia and Parkinson’s.

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