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Type of headwear worn during surgery had no impact on SSI rates
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
SAN DIEGO – Surgeon preference for bouffant versus skull caps does not significantly impact superficial surgical site infection rates after accounting for surgical procedure type, results from a an analysis of a previously randomized, prospective trial showed.
“We are all aware of the current battle that is taking place over operating room attire based on the differences between the AORN [Association of periOperative Nurses] recommendations and ACS guidelines,” lead study author Shanu N. Kothari, MD, FACS, said at the annual clinical congress of the American College of Surgeons.
In 2016, Dr. Kothari, director of minimally invasive bariatric surgery at Gundersen Health System, La Crosse, Wisc., and his associates published results from a prospective, randomized non-inferiority trial on the impact of hair removal on surgical site infection rates (J Am Coll Surg 2016;223[5]:704-11). Patients were grouped by the attending surgeons’ preferred cap choice into either bouffant or skull cap groups. Their analysis concluded that hair left on the abdomen had no impact on surgical site infection rates. “What is unique about this study is that two independent certified research nurses independently assessed every wound in that trial,” he said.
For the current study, the researchers re-examined the data by conducting a multivariate analysis to determine the influence of surgical cap choice on SSIs. Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps and skull caps in 39% and 61% of cases, respectively. Bouffant caps were used in 71% of colon/intestine, 42% of hernia/other, 40% of biliary cases and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases in which attending surgeons wore a bouffant and skull cap, respectively (P = .016), with 6% vs. 4% classified as superficial (P = .041), 0.8% vs. 0.2% deep (P = .120), and 1% vs. 0.9% organ space (P = .790). However, when the researchers adjusted for the type of surgery and surgical approach (laparoscopic vs. open), they observed no difference in SSI rates for skull cap, compared with bouffant cap.
“Surgeon preference should dictate the choice of headwear in the operating room,” Dr. Kothari commented. “What I would encourage is perhaps a summit between thought leaders in the ACS and the AORN, [to conduct] a true review of evidence and come up with a universal guideline. There are many other issues we need to be focusing on in surgery, and this probably doesn’t have to be one of them.”
“In general, there is a complete and utter absence of any scientific evidence whatsoever for most of the things we are told to do in terms of wearing what we do in the OR,” said invited discussant E. Patchen Dellinger, MD, FACS, FIDSA, professor of surgery at the University of Washington, Seattle. “In fact, there are prospective randomized trials showing that wearing a [face] mask does not reduce surgical site infection, although I’ve been wearing a mask in the OR for approximately 48 years.”
Dr. Kothari reported having no relevant financial disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Surgeon preference should dictate choice of headwear in the OR.
Major finding: There was no significant difference in the rate of SSI, regardless of whether a skull cap or a bouffant cap was used during surgery.
Study details: Re-examination of a prospective, randomized non-inferiority trial of 1,543 patients, on the impact of hair removal on surgical site infection rates.
Disclosures: Dr. Kothari reporting having no relevant disclosures.
Female surgeons are responsible for more work at home
Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.
As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.
The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.
Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.
Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.
Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).
“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.
Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.
As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.
The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.
Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.
Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.
Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).
“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.
Female surgeons and trainees are more likely to be responsible for household activities such a childcare planning, grocery shopping, and meal planning, according to a pilot survey.
As the rates of women in the medical profession has increased so have the level of dual-professional/dual-physician relationships which presents unique challenges for working professionals including work-home conflicts which are frequently related to surgeon burnout and depression.
The survey found that female surgeons are significantly more likely to be responsible for household responsibilities such as childcare planning, grocery shopping, meal planning, and vacation planning. Conversely, the men surveyed were more likely to pass these responsibilities on to their spouses.
Women were significantly more likely than men to be married to a professional (90% versus 37%, for faculty; 82%versus 41% for trainees; they were also significantly more likely to be married to a spouse who was working full time.
Female surgeons also reported significantly lower personal (mean 3.1 vs. 3.7) and work life (mean 2.7 vs. 3.5) satisfaction compared to men, Dr. Baptiste and her colleagues reported. Although female surgeons are burdened with household responsibilities, they are still managing to produce a similar number of publications to their male colleagues. Despite having a similar number of publications, women were less likely to be on track for tenure (adjusted P less than.01) and be at a lower rank despite equivalent years of practice (interaction P less than.001) than their male colleagues.Due to the increased demands on female surgeons many are more likely to delay child-bearing until completion of medical school or residency. This leads to women surgeons having fewer children (P = .04) and younger children (P less than.001).Medical trainees appear to equally divide responsibilities. Childcare planning was a shared responsibility among female trainees as well as financial planning, although financial planning was often the primary responsibility of male surgical trainees (P = .004). Although female trainees were significantly more likely not to have children (82% vs. 33% and delay childbearing until after medical school (100% vs. 46%) or residency (77% vs. 19%) compared to men. Household chores were equally shared for female trainees, but were still seen by men trainees as a spousal responsibility (P less than.001). Vacation planning was seen as entirely sex neutral among trainees.
Similar to their surgeon counterparts, female trainees reported lower work satisfaction (mean 2.9 vs. 3.4, P = .009). But, there were no differences between male and female trainees for reported personal life or work-life balance.As the number of female surgeons rises, strategies must be implemented regarding recruitment of female faculty, according to the authors. Universities such as Stanford have implemented strategies to recruit and retain female surgeons which resulted in a 74% increase in female faculty and a 66% increase in promotion of female faculty members (Acad Med. 2014 Jun;89[6]:904-11).
“Implementation of research-driven changes in policies that facilitate successful career development and promotion will aid in equalizing [sex] disparities, lead to improvement in recruitment, and result in retention of the current and subsequent generations of surgeons” wrote Dr. Baptiste and her colleagues.All the authors of this study reported no financial conflicts of interest.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point:
Major finding: Childcare planning, grocery shopping, and meal planning were all significantly more likely to be managed by women.
Data source: Pilot survey of 127 faculty surgeons and 116 trainees in the Department of Surgery at a single, large academic medical center.
Disclosures: All the authors of this study reported no financial conflicts of interest.
Perioperative blood transfusion linked to worse outcomes in renal cell carcinoma
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
Perioperative blood transfusion (PBT) is associated with poorer outcomes among patients who underwent nephrectomy for renal cell carcinoma (RCC), according to a retrospective review of 1,159 patients.
Using multivariate analysis and controlling for potential confounders such as clinical and pathologic features, receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Previous research suggests that PBT may be associated with worse oncological outcomes following cancer surgery, although the data have been inconsistent. In this study, Dr. Abu-Ghanem and colleagues conducted a retrospective study that examined effect of PBT on the prognosis of 1,159 patients who underwent radical nephrectomy or partial nephrectomy for RCC, between 1987 to 2013.
Within this cohort, 198 patients (17.1%) received a PBT, and the median follow-up was 63.2 months. Receipt of PBT was associated with a symptomatic presentation (P less than .001) and a higher rate of adverse pathological features that included larger tumors (P less than .001), high nuclear grade (P less than .001), presence of tumor necrosis (P less than .001), and capsular invasion (P less than .001). Patients who received PBT were also more likely to have undergone an open surgical procedure (P less than .05).
The authors found that receipt of a PBT was associated with significantly worse 5-year relapse free survival (81% vs. 92%, P less than .01) as well as metastatic free survival (79% vs. 93%, P less than .001). Receiving a PBT was also associated with a worse 5-year CSS (85% vs. 95%, P less than .001) and OS (73% vs. 81%, P less than .001) versus those who were not transfused.
A subgroup analysis showed that patients who underwent a partial nephrectomy also had worse outcomes if they received a PBT as compared to those who didn’t; 5-year relapse free survival was 81% vs. 90% (P = .014), CSS was 89% vs. 97% (P = .019) and OS was 82% vs. 92%, (P = .016).
There were no funding sources or author disclosures listed in the article.
FROM UROLOGIC ONCOLOGY
Key clinical point: Major finding: Receipt of PBT was associated with significantly increased risk of tumor recurrence (HR = 2, P = .02, metastatic progression (HR = 2.5, P = .007), and death from RCC (HR = 2.5, P = .02).
Data source: Retrospective study that included 1,159 patients with RCC who underwent nephrectomy and evaluated outcomes in those who received a PBT versus those who did not.
Disclosures: There are no funding sources or author disclosures listed.
Eliminating patient-controlled analgesia accelerates discharge after bariatric surgery
NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.
“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.
The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.
At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.
In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).
The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.
Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.
“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”
Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.
“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”
Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.
“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.
The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.
At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.
In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).
The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.
Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.
“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”
Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.
“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”
Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
NATIONAL HARBOR, MD – Hospital discharge after bariatric surgery can be significantly and meaningful accelerated by using multimodality pain control techniques that do not include patient-controlled analgesia (PCA), according to data from a two-hospital study presented at Obesity Week 2017.
“It was our impression that PCA was delaying milestones of recovery, so we prospectively evaluated this hypothesis. The result was a meaningful reduction in the length of stay without any meaningful adverse consequences,” reported Aline Van, RN, a weight loss surgery nurse navigator at Doctors Hospital, Manteca, Calif.
The study was conducted because of concern that nausea and vomiting related to PCA was a common cause of discharge delay at both Doctors Hospital in Manteca (DHM) and the affiliated Doctors Medical Center (DMC) in Modesto. Led by Maria Marple, PA-C, the two-part prospective study consisted of an initial six-month evaluation of average length of stay (LOS) and a formal evaluation of the causes of delayed discharge. In the second phase, the same analyses were performed over a six-month period when PCA was halted.
At 1.83 days in one center and 1.84 days in the other, the average LOS was nearly identical during the initial six-month baseline evaluation. In the 75 patients evaluated in this period at DHC, inadequate fluid intake due to nausea and vomiting was involved in 61.7% of the cases in which discharge was delayed. At DMC, where 46 patients were evaluated in the baseline period, 47.6% of delays were due to inadequate fluid intake attributed to nausea and vomiting. In both cases, this was the most common reason for delay.
In the study period after PCA was discontinued, inadequate fluid intake remained the major cause of delayed discharges, but there were fewer discharge delays overall due to less nausea and vomiting. The average length of stay among the 104 patients treated in the study period at DHM fell to 1.64 days, while the average LOS fell to 1.66 days in the 83 patients treated at DMC. This was largely driven by a reduction in the proportion of patients with >2 days LOS, which fell from 52% to 41% at DHC (P = .04) and from 45% to 32% at DMC (P = .008).
The surgical procedures at both centers (all performed laparoscopically) included sleeve gastrectomy, gastric bypass, and duodenal switch. Although a multimodality approach is employed for postoperative pain control at both institutions, the protocols differ modestly. At DHC, acetaminophen by mouth is the primary postoperative analgesic with hydromorphone permitted if needed. At DMC, intravenous acetaminophen is used in the first 24 hours in all patients with acetaminophen/hydrocodone offered if needed.
Since the trial was completed and results analyzed, PCA has been discontinued completely at both institutions. In follow-up to date there has been a slight additional reduction in average LOS at both institutions, reaching 1.5 days at DHC and 1.61 days at DMC.
“The four to five hour average reduction in LOS following discontinuation of PCA is significant because it frees up beds at our hospital, which is run at capacity,” Ms. Van said. “When considered cumulatively, the average reduction in LOS is very meaningful.”
Although the benefits are generally attributed to reduced nausea and vomiting, which has implications for a better patient experience, Ms. Van also believes patients are having faster cognitive and physical recovery since PCA was eliminated, producing faster time to ambulation and discharge readiness.
“There really have been no negatives,” Dr. Coates confirmed. “In our experience, eliminating PCA has been better for the patients and has important implications for costs.”
Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
AT OBESITY WEEK 2017
Key clinical point: When patient-controlled analgesia (PCA) after bariatric surgery is eliminated, time to discharge is accelerated with no adverse consequences.
Major finding: The average 0.2 day (4.8 hour) reduction (P < .05) was characterized as clinically meaningful.
Data source: Prospective, non-randomized study.
Disclosures: Ms. Van and Dr. Coates reported no financial relationships relevant to this topic.
Heart surgery halves in-hospital mortality in trisomy 13 and 18
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
The article by Kosiv and colleagues provides “compelling evidence that congenital heart surgery can be considered” in infants with trisomy 13 or 18, according Kathy J. Jenkins, MD, MPH, and Amy E. Roberts, MD in their accompanying editorial. The decision, however, should be made as part of a comprehensive treatment plan, they said.
“In our view, this should only occur when parents are fully informed of the still significant residual infant mortality risk with cardiac surgery … and unavoidable, severe neurocognitive delays,” they wrote in their editorial.
Caregivers helping families make the decision, they added, should be aware that delays in decision-making might make operations impossible or even more risky than they already are.
“The revolution in congenital heart surgery … has now changed the equation for infants with trisomy 18 and 13 just as it did for trisomy 21 in the past,” the authors wrote. “However, numerous factors must be taken into account to optimize decision-making for each infant and family.”
Dr. Jenkins, MD, MPH, and Dr. Roberts, MD are with the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts. These comments are based on their editorial (Pediatrics 2017. doi: https://doi.org/10.1542/peds.2017-2809). The authors reported no potential conflicts of interest.
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
For infants with trisomy 13 or trisomy 18, congenital heart surgery is associated with a significant decrease in in-hospital mortality, according to results of a large, retrospective, multicenter cohort study.
In-hospital mortality was 45% lower in trisomy 13 patients (P = .003) and 64% lower in trisomy 18 patients (P less than.001) who underwent surgery, data show (Pediatrics 140(5); 2017. doi: https://doi.org/10.1542/peds.2017-0772).
The study, based on records from the 44 participating children’s hospitals represented in the Pediatric Health Information System (PHIS) database, included 1,668 newborns with trisomy 13 or 18 who were admitted within 14 days of birth. Median age at admission was less than 1 day for both groups.
Congenital heart disease was present in 925 out of 1,020 infants with trisomy 18 (91%) and 555 out of 648 with trisomy 13 (86%), the report stated.
For those infants with congenital heart disease, overall mortality was highest during the first hospital admission (63%), investigators wrote. However, for those undergoing congenital heart surgery, multivariate analysis showed decreased in-hospital mortality vs. those who had no surgery for both the trisomy 13 (30% vs. 55%, respectively, P = .003) and the trisomy 18 groups (16% vs. 44%, P less than .001).
This is not only the largest-ever study of trisomy 13 and 18 ever reported, according to the investigators, but also the first to show that higher weight, female sex, and older age at admission are associated with improved survival following congenital heart surgery among these patients. Multiple logistic regression analysis showed significant effects of these risk factors on mortality for both the trisomy 13 and 18 infant subsets, according to Dr. Kosiv and her colleagues.
These findings come at a time when many centers elect not to perform congenital heart surgery in trisomy 13 and 18 patients, the investigators wrote, noting that management is typically limited to medical strategies due to the “markedly short life expectancy” and grave prognosis associated with the condition.
Mortality was markedly decreased, but still considerably higher than what would be expected for congenital heart surgery in the general population, which is an important consideration for families and practitioners who are considering the procedure, investigators said in their report.
Nevertheless, the present findings suggest that “CHS may not be futile, at least not in the short-term, in patients with T13 and T18,” Dr. Kosiv and colleagues wrote. “Additionally, these results suggest that CHS may allow families to be able to take their children home and avoid [them] dying in the hospital.”
FROM PEDIATRICS
Key clinical point: Despite many centers choosing not to perform congenital heart surgery in infants with trisomy 13 and trisomy 18, doing so cuts in-hospital mortality by more than half.
Major finding: In-hospital mortality was 45% lower in trisomy 13 patients (P = 0.003) and 64% lower in trisomy 18 patients (P < 0.001) who underwent surgery.
Data source: A large, retrospective, multicenter cohort study of 1,668 newborns with trisomy 13 or 18 admitted within 14 days of birth.
Disclosures: The authors reported no potential conflicts of interest.
White House opioid panel calls for more addiction specialists
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
Docs to receive slightly better Medicare pay bump than originally proposed
Physicians will see a 0.41% increase to their payments under the Medicare physician fee schedule in 2018, a slight increase from the proposed 0.31% uptick but still short of the 0.5% increase promised under the Medicare Access and CHIP Reauthorization Act (MACRA).
Officials at the Centers for Medicare & Medicaid Services were unable to find adequate funding in so-called misvalued codes to back the larger increase, as required by law, according to the final version of the 2018 physician fee schedule, released Nov. 2 and scheduled for publication in the Federal Register on Nov. 15.
“We finalized these changes based on stakeholder feedback and to better align with the MIPS data submission requirements for the quality performance category,” CMS said in a fact sheet detailing the provisions of the final rule.
CMS also is delaying the start of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted appropriate use criteria. The program will begin with an educational and operational testing year in 2020. Physicians will be required to start using AUCs and reporting this information on claims, but CMS will pay claims regardless of whether they correctly contain the required AUC data.
“This allows both clinicians and the agency to prepare for this new program,” the agency said in the fact sheet, CMS had proposed 2019 be the educational and operational testing year.
In response to comments submitted to the agency, CMS is changing its policy on billing codes for biosimilars administered under Medicare Part B.
“Effective January 1, 2018, newly approved biosimilar products with a common reference product will no longer be grouped in the same billing code,” the agency said in the fact sheet. “By encouraging innovation and greater manufacturer participation in the marketplace, we believe that this policy change will result in the licensing of more biosimilar products, thus creating a stable and robust market, driving market competition, and decreasing uncertainty about access and payment.”
The final rule implements proposed expansion of the Medicare Diabetes Prevention Program from a demonstration project to a nationwide program in 2018, however the implementation will be delayed for three months until April 1, 2018, rather than at the beginning of the year. The program provides payments to physicians based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program and achieving specific weight loss goals.
CMS also finalized a number of new telemedicine payment codes.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Mike Nelson, MD, FCCP, comments: One need not “google” too long to find that the United States performs quite poorly in overall health care when compared with other nations, despite spending more than any of the comparators…we’re 37th this year. This information from Avalere Health portends a further drop in our ranking next year. The privilege of good health is a responsibility of the individual, but the right to affordable health care is a responsibility of the government. It is time for our legislators to stop playing partisan politics and start communicating to propose a workable and affordable solution.
Physicians will see a 0.41% increase to their payments under the Medicare physician fee schedule in 2018, a slight increase from the proposed 0.31% uptick but still short of the 0.5% increase promised under the Medicare Access and CHIP Reauthorization Act (MACRA).
Officials at the Centers for Medicare & Medicaid Services were unable to find adequate funding in so-called misvalued codes to back the larger increase, as required by law, according to the final version of the 2018 physician fee schedule, released Nov. 2 and scheduled for publication in the Federal Register on Nov. 15.
“We finalized these changes based on stakeholder feedback and to better align with the MIPS data submission requirements for the quality performance category,” CMS said in a fact sheet detailing the provisions of the final rule.
CMS also is delaying the start of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted appropriate use criteria. The program will begin with an educational and operational testing year in 2020. Physicians will be required to start using AUCs and reporting this information on claims, but CMS will pay claims regardless of whether they correctly contain the required AUC data.
“This allows both clinicians and the agency to prepare for this new program,” the agency said in the fact sheet, CMS had proposed 2019 be the educational and operational testing year.
In response to comments submitted to the agency, CMS is changing its policy on billing codes for biosimilars administered under Medicare Part B.
“Effective January 1, 2018, newly approved biosimilar products with a common reference product will no longer be grouped in the same billing code,” the agency said in the fact sheet. “By encouraging innovation and greater manufacturer participation in the marketplace, we believe that this policy change will result in the licensing of more biosimilar products, thus creating a stable and robust market, driving market competition, and decreasing uncertainty about access and payment.”
The final rule implements proposed expansion of the Medicare Diabetes Prevention Program from a demonstration project to a nationwide program in 2018, however the implementation will be delayed for three months until April 1, 2018, rather than at the beginning of the year. The program provides payments to physicians based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program and achieving specific weight loss goals.
CMS also finalized a number of new telemedicine payment codes.
Physicians will see a 0.41% increase to their payments under the Medicare physician fee schedule in 2018, a slight increase from the proposed 0.31% uptick but still short of the 0.5% increase promised under the Medicare Access and CHIP Reauthorization Act (MACRA).
Officials at the Centers for Medicare & Medicaid Services were unable to find adequate funding in so-called misvalued codes to back the larger increase, as required by law, according to the final version of the 2018 physician fee schedule, released Nov. 2 and scheduled for publication in the Federal Register on Nov. 15.
“We finalized these changes based on stakeholder feedback and to better align with the MIPS data submission requirements for the quality performance category,” CMS said in a fact sheet detailing the provisions of the final rule.
CMS also is delaying the start of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted appropriate use criteria. The program will begin with an educational and operational testing year in 2020. Physicians will be required to start using AUCs and reporting this information on claims, but CMS will pay claims regardless of whether they correctly contain the required AUC data.
“This allows both clinicians and the agency to prepare for this new program,” the agency said in the fact sheet, CMS had proposed 2019 be the educational and operational testing year.
In response to comments submitted to the agency, CMS is changing its policy on billing codes for biosimilars administered under Medicare Part B.
“Effective January 1, 2018, newly approved biosimilar products with a common reference product will no longer be grouped in the same billing code,” the agency said in the fact sheet. “By encouraging innovation and greater manufacturer participation in the marketplace, we believe that this policy change will result in the licensing of more biosimilar products, thus creating a stable and robust market, driving market competition, and decreasing uncertainty about access and payment.”
The final rule implements proposed expansion of the Medicare Diabetes Prevention Program from a demonstration project to a nationwide program in 2018, however the implementation will be delayed for three months until April 1, 2018, rather than at the beginning of the year. The program provides payments to physicians based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program and achieving specific weight loss goals.
CMS also finalized a number of new telemedicine payment codes.
No benefit found in pre-bariatric surgery weight loss programs
NATIONAL HARBOR, MD – Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.
“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.
No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.
A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.
No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.
“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.
Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”
In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.
Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.
While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.
“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.
Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.
NATIONAL HARBOR, MD – Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.
“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.
No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.
A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.
No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.
“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.
Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”
In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.
Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.
While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.
“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.
Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.
NATIONAL HARBOR, MD – Many third-party payers require candidates for bariatric surgery to complete weight loss programs in order to qualify for reimbursement, but two new studies presented at Obesity Week 2017 have found no identifiable justification for the delay in treatment.
“When comparing those who did or did not participate in a weight management program, there was no significant benefit in regard to surgery complications, patient rate of followup, or percent excess weight loss at 12 months,” reported Andrew Schneider, MD, who is completing his residency in general surgery in the Greenville Health Systems, Greenville, South Carolina.
No significant differences were observed in a long list of procedural and outcome variables including operating time, length of hospital stay, and excess weight loss (EWL) at 3, 6, and 12 months, according to Dr. Schneider, who emphasized that no differences even approached significance.
A second study, evaluating the effect of presurgical weight management programs from a different perspective, drew the same conclusion. In this study, the goal was to correlate the number of preoperative weight loss sessions with change in multiple outcomes including EWL, according Genna Hymowitz, PhD, a psychologist at the Stony Brook Medicine Bariatric and Metabolic Weight Loss Center, Stony Brook, New York.
No correlation was observed between number of presurgical weight management program visits and any outcome evaluated in followup out to 12 months, according to Dr. Hymowitz. There was one exception.
“The number of visits attended and weight loss 3 weeks after surgery was a negative correlation, suggesting that the number of sessions attended was associated with lower excess weight loss,” Dr. Hymowitz reported.
Insurance company requirements for presurgical weight management programs vary widely, but the American Society for Metabolic and Bariatric Surgery (ASMBS) concluded in a position statement issued in 2011 that they are unsupported by controlled evidence. According to this statement, which referenced several clinical studies, “there is no evidence of any kind that insurance mandated preoperative weight loss…has any clear impact on postoperative outcomes or weight loss.”
In the ASBMS statement, the objection is directed at specific requirements for medically supervised weight loss program. These can demand six or more months of participation before reimbursement for surgery will be granted. In the ASBMS statement, mandated treatment required by insurance companies is distinguished from Medicare policy. Medicare reimbursement requires patients to fail medical treatment prior to bariatric surgery but providers are allowed to define failure. In contrast, specified periods of medical management required by insurance companies can have the effect of delaying treatment with proven efficacy in appropriate candidates.
Asked to speculate why insurance companies mandate supervised weight loss program for bariatric surgery eligibility, Dr. Schneider suggested that it might be considered a method to evaluate patient motivation and compliance. However, he also acknowledged that the requirement is likely to provide a barrier for some individuals thereby reducing surgical costs for the third-party payers.
While there are now several studies, including those cited in the ASBMS position statement, arguing that these mandates should be eliminated, longer followup is needed, according to Maher El Chaar, MD, Co-Medical Director, Bariatric surgery, St. Luke’s University Hospital, Allentown, Pennsylvania. One of the moderators for the Obesity Week session in which the two latest studies were presented, Dr. El Chaar said that insurance company representatives with whom he has spoken insist that longer-term studies are needed.
“When I point out that there is no data supporting mandated weight management programs, they tell me that there is very little data beyond 12 months,” Dr. El Chaar explained. He suggested data beyond 12 months could be helpful in the effort to get these requirements waived.
Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.
AT OBESITY WEEK 2017
Key clinical point: Two studies concluded mandated weight loss programs prior to bariatric surgery offer no clinical value.
Major finding: When compared for weight loss at 3, 6, or 12 months after surgery, there was no difference in weight change for participants versus non-participants.
Data source: Retrospective and prospective analyses.
Disclosures: Dr. Schneider and Dr. Hymowitz reported no relevant financial relationships.
Seven years after bariatric surgery, more than 40% still off insulin
NATIONAL HARBOR, MD – Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.
“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.
Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.
Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.
Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.
When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).
However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).
In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.
Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).
“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.
Dr. Aminian reported having no relevant financial relationships.
As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.
“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
NATIONAL HARBOR, MD – Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.
“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.
Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.
Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.
Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.
When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).
However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).
In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.
Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).
“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.
Dr. Aminian reported having no relevant financial relationships.
As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.
“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
NATIONAL HARBOR, MD – Forty-four percent of insulin-dependent patients with type 2 diabetes mellitus (DM2) were at their glycemic target without insulin a median of seven years after surgery. The data from the largest study to evaluate long-term outcomes in this population were presented at Obesity Week 2017.
“These data confirm that the impressive metabolic effects of bariatric surgery in patients with type 2 diabetes are sustained beyond five years,” reported Ali Aminian, MD, a surgeon who specializes in bariatric procedures at the Cleveland Clinic, Cleveland, Ohio. He said that long-term efficacy has not been well characterized previously.
Reaching the glycemic target, defined as less than 7% HbA1c, without insulin was only one of the primary endpoints. The other was diabetes remission, which was defined as HbA1c less than 6.5%, fasting blood glucose less than 126 mg/dL, and being off all diabetes medications. This was observed in 15% of the patients after a median of 7 years followup.
Contrasting short-term results, defined as outcomes one to two years after bariatric surgery with the long-term followup, Dr. Aminian was able to show that declines were relatively modest over time. For example, 51% were at the glycemic target off insulin at the short-term mark, which translates into an absolute decline of only 7% relative to the 44% observed at the long-term followup assessment.
Similarly, 70% had achieved the American Diabetes Association (ADA) goal of less than 7% within the first two years of surgery, while 59% remained at this goal at the most recent followup. The proportion taking insulin at the short-term mark was 36% rising only to 40% long-term.
When data were stratified by procedure, results favored RYGB over sleeve gastrectomy. For example, 47% of the RYGB patients versus 33% of the sleeve gastrectomy patients were able to reach the ADA goal without insulin at the end of the study. The proportions in diabetes remission were 17% and 10%, respectively. RYGB was also associated with greater improvement in BMI (median -12 vs. - 8 kg/m2) and reduced late weight gain (median 20% vs. 31%).
However, Dr. Aminian, who did not provide statistical calculations for these differences, cautioned that higher risk patients might have been preferentially selected for sleeve gastrectomy. He noted that difference in median HbA1c levels was significantly lower in the RYGB group two years after surgery (P less than .001) but the numerical advantage had lost significance at the last followup (P = .32).
In an evaluation of predictors for glycemic control, a shorter duration of diabetes (less than 10 years) and good glycemic control prior to surgery were both predictors of achieving the primary outcomes on the basis of a multivariate analysis, according to Dr. Aminian. Younger age was a marginal predictor, but Dr. Aminian said that neither type of procedure nor presurgical BMI predicted outcomes from the multivariate analysis.
Relative to baseline, there were significant improvements in median LDL (P = .001). In addition, HDL, triglyceride levels, systolic, and diastolic blood pressure measurements were all significantly improved, both short-term and long-term after bariatric surgery (all P values less than .001), according to Dr. Aminian. When expressed as ADA goals, 82% of participants had blood pressure less than 140/90 mm Hg 7 years after surgery relative to 44% at baseline (P less than .001). The proportion with LDL less 100 mg/dL approached, but did not reach clinical significance (61% vs. 70%; P=0.06).
“When you consider all three parameters [ADA targets for glycemic control, blood pressure control, and lipid control], only 3% of patients met all three targets at baseline but 32% [P< less than .001] were at these targets at long-term followup,” Dr. Aminian reported.
Dr. Aminian reported having no relevant financial relationships.
As the invited discussant on these data, Raul Rosenthal, MD, Director, Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, Florida, reiterated that time with diabetes prior to bariatric surgery may be an important predictor of postsurgical control of metabolic parameters.
“I published a paper about 10 years ago on outcomes in patients with diabetes, and in our experience 5 years was the limit. If you have a history of 5 years or less with diabetes, the chance of going into remission were 80%, and if it was more than 5 years, the likelihood dropped dramatically,” Dr. Rosenthal noted. He indicated duration of diabetes deserves further evaluation for its potential relevance to the optimal timing of bariatric surgery.
AT OBESITY WEEK 2017
Key clinical point: In the largest study to follow insulin-dependent patients after bariatric surgery, substantial benefits persist after median 7 years of followup.
Major finding: Among 252 insulin-dependent patients followed for a minimum of 5 years, 44% remain off insulin and 15% are off all anti-diabetic medications.
Data source: Retrospective single-center analysis.
Disclosures: Dr. Aminian reported having no relevant financial relationships.
Failure to diagnose is a continuing challenge
Question: A middle-aged woman developed cellulitis after sustaining multiple mosquito bites in her lower left leg. The area of infection did not appear to reach the knee, which housed a prosthesis implanted there 3 years earlier. Over the next few days, she had significant knee pain, which was attributed to the surrounding cellulitis. Her pulse rate reached 105 beats per min, and her temperature was 101° F, but she was continued on oral antibiotics as an outpatient. Later that evening, she collapsed at home.
Which of the following is best?
A. Fever and tachycardia alone are enough to make the diagnosis of systemic inflammatory response syndrome (SIRS) and should have raised sepsis as a cause.
B. In septic patients, even a short delay in antibiotic administration can significantly affect morbidity and mortality.
C. Failure to diagnose is the most common basis for a medical malpractice claim.
D. The doctor may have anchored his diagnosis on the mosquito-bite incident, and should have considered a septic joint and/or sepsis in the differential.
E. All are correct.
Answer: E. “Failure to diagnose” is a legal term, whereas in medical usage we tend to use terms such “missed diagnosis,” “overlooked condition,” or “diagnostic error.” If such failure is shown to be a breach of the standard of care and is proven to be a proximate cause of the patient’s injury, then a case for medical negligence is made out. Even if the situation is atypical or complex, there still is the duty to refer, if customarily required, to an appropriate specialist, and failure to do so may also constitute negligence.
Diagnostic errors tend to cause the most severe injuries, especially in hospitalized patients. Roughly 5% of autopsies uncover a diagnostic error that was amenable to appropriate treatment, and some 50,000 annual hospital deaths may be the result of a delayed, incorrect, or overlooked diagnosis.
Failure to diagnose occurs in both outpatient and in-hospital settings, recurring examples being myocardial infarction, dissecting aneurysm, pulmonary embolism, appendicitis, ectopic pregnancy, meningitis, cancers, and fractures.
In a records-review study covering a large urban Veterans Affairs facility and an integrated private health care system in a primary care setting, the authors reported that pneumonia, heart failure, acute renal failure, cancer, and urinary tract infections (UTIs) were frequently missed diagnoses.2 They identified 190 diagnostic errors over a 12-month period in 2006-2007, and they attributed them to “process breakdowns” involving the practitioner-patient clinical encounter, referrals, patient factors, follow-up and tracking of diagnostic information, and interpretation of test results. Deficiencies in bedside history taking, physical exam, and test ordering were common; significantly, there was no documentation of an initial differential diagnosis in 80% of misdiagnosed cases.
Malpractice carriers regularly compile data regarding the nature of their covered losses, and their reports on diagnostic errors, although not subject to the usual scientific peer review, have generally corroborated the published literature.
For example, data from 2009 to 2013 collected by MIEC, a large malpractice mutual insurance company on the West Coast, impute almost half of all general medicine claims to diagnostic errors.3 The cases, frequently involving cancer and heart disease, resulted in high-severity injuries and death. Lapses in clinical judgment, communication, and patient-related behavior issues were the primary contributing factors that affected the diagnosis-related claims. Pitfalls included errors in patient assessment, diagnostic processing, provider follow-up, and referral to specialists.
Recent reports have drawn attention to sepsis, an example of SIRS, as an important missed diagnosis, often with deadly consequences. It has been pointed out that if a sepsis case goes to trial, jurors will immediately learn that mortality rates are increased if antibiotics are delayed, even for a short period. In one study, each hour’s delay increased mortality by 7.6%, mortality being 21.1% if antibiotics were given in the first hour, compared with 58% if delayed by more than 6 hours.4
To avoid suits, physicians should be alert to seemingly minor vital sign changes, such as new tachypnea or tachycardia. Notably, patients can have severe sepsis and septic shock without fever or hypothermia. Uncomplicated sepsis is common and can quickly progress to severe sepsis, with organ failure and septic shock. The Surviving Sepsis Campaign has estimated that more than 750,000 individuals develop severe sepsis in North America each year, with mortality around 50%.
The Sullivan Group,which comprises a team of professionals dedicated to perfecting a system solution that reduces medical error and improves patient safety, recently published a wrongful-death narrative from undiagnosed sepsis.5 The decedent gave birth to her first child after 24 hours of labor, sustaining severe vaginal and rectal tearing. Three days later, she began experiencing chills, nausea, worsening vaginal pain, and fever. Her temperature reached 101.9° F (38.8° C). The following day, 4 days after delivery, she was seen by a nurse practitioner in the emergency department with symptoms of nausea, abdominal and back pain, and fever. She was tachycardic at 115 per minute.
The presence of fever plus tachycardia should have raised the diagnosis of SIRS, especially in view of her abdominal pain and a recent complicated delivery. Instead, the practitioner diagnosed a UTI and discharged her on antibiotics. That same afternoon, she collapsed and was admitted for sepsis. Despite an emergency hysterectomy, her condition worsened, she developed multiple organ failure and septic shock, and died the next day. The source of her sepsis was endometritis, and the jury returned a $20 million verdict for the plaintiff.
Observers of medical errors point to our recurring failure to continue to consider alternatives after forming an initial tentative diagnosis, and warn us about the various cognitive biases familiar to behavioral economists but ignored by many doctors.6 These include anchoring bias, in which one is locked into an aspect of the case; framing bias, in which there is misdirection because of the way the problem was posed; availability bias, in which things are judged by what comes readily to mind, such as a recent experience; and confirmation bias, in which one looks for confirmatory evidence of one’s preferred diagnosis while ignoring evidence to the contrary.
In the case outlined earlier, the Sullivan Group noted that the practitioner did not consider sepsis because of cognitive bias, anchoring, and premature closure. The trial documents indicated that the urinalysis did not show bacteria, but the practitioner may have settled – prematurely – on the UTI diagnosis, based on the presence of WBCs in the urine and her obstetrics history. Having anchored on that thought process and prematurely closed her decision making, the practitioner then ignored the elevated white blood cell count with a left shift, and a depressed platelet count of 50,000. Perhaps UTI was a reasonable consideration in the differential, but the working diagnosis of sepsis should have been first and foremost.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials may have been published in earlier columns in Internal Medicine News, and can be accessed at www.mdedge.com/taxonomy/term/83/path_term/21/latest. For additional information, readers may contact the author at [email protected].
References
1. BMJ Qual Saf. 2013 Aug;22(8):672-80.
2. JAMA Intern Med. 2013 Mar 25;173(6):418-25.
3. MIEC, the Exchange, Issue 8, March 2017.
4. Crit Care Med. 2006 Jun;34(6):1589-96.
5. The Sullivan Group. Case: Avoiding cognitive bias in diagnosing sepsis.
6. Acad Med. 2003 Aug;78(8):775-80.
Question: A middle-aged woman developed cellulitis after sustaining multiple mosquito bites in her lower left leg. The area of infection did not appear to reach the knee, which housed a prosthesis implanted there 3 years earlier. Over the next few days, she had significant knee pain, which was attributed to the surrounding cellulitis. Her pulse rate reached 105 beats per min, and her temperature was 101° F, but she was continued on oral antibiotics as an outpatient. Later that evening, she collapsed at home.
Which of the following is best?
A. Fever and tachycardia alone are enough to make the diagnosis of systemic inflammatory response syndrome (SIRS) and should have raised sepsis as a cause.
B. In septic patients, even a short delay in antibiotic administration can significantly affect morbidity and mortality.
C. Failure to diagnose is the most common basis for a medical malpractice claim.
D. The doctor may have anchored his diagnosis on the mosquito-bite incident, and should have considered a septic joint and/or sepsis in the differential.
E. All are correct.
Answer: E. “Failure to diagnose” is a legal term, whereas in medical usage we tend to use terms such “missed diagnosis,” “overlooked condition,” or “diagnostic error.” If such failure is shown to be a breach of the standard of care and is proven to be a proximate cause of the patient’s injury, then a case for medical negligence is made out. Even if the situation is atypical or complex, there still is the duty to refer, if customarily required, to an appropriate specialist, and failure to do so may also constitute negligence.
Diagnostic errors tend to cause the most severe injuries, especially in hospitalized patients. Roughly 5% of autopsies uncover a diagnostic error that was amenable to appropriate treatment, and some 50,000 annual hospital deaths may be the result of a delayed, incorrect, or overlooked diagnosis.
Failure to diagnose occurs in both outpatient and in-hospital settings, recurring examples being myocardial infarction, dissecting aneurysm, pulmonary embolism, appendicitis, ectopic pregnancy, meningitis, cancers, and fractures.
In a records-review study covering a large urban Veterans Affairs facility and an integrated private health care system in a primary care setting, the authors reported that pneumonia, heart failure, acute renal failure, cancer, and urinary tract infections (UTIs) were frequently missed diagnoses.2 They identified 190 diagnostic errors over a 12-month period in 2006-2007, and they attributed them to “process breakdowns” involving the practitioner-patient clinical encounter, referrals, patient factors, follow-up and tracking of diagnostic information, and interpretation of test results. Deficiencies in bedside history taking, physical exam, and test ordering were common; significantly, there was no documentation of an initial differential diagnosis in 80% of misdiagnosed cases.
Malpractice carriers regularly compile data regarding the nature of their covered losses, and their reports on diagnostic errors, although not subject to the usual scientific peer review, have generally corroborated the published literature.
For example, data from 2009 to 2013 collected by MIEC, a large malpractice mutual insurance company on the West Coast, impute almost half of all general medicine claims to diagnostic errors.3 The cases, frequently involving cancer and heart disease, resulted in high-severity injuries and death. Lapses in clinical judgment, communication, and patient-related behavior issues were the primary contributing factors that affected the diagnosis-related claims. Pitfalls included errors in patient assessment, diagnostic processing, provider follow-up, and referral to specialists.
Recent reports have drawn attention to sepsis, an example of SIRS, as an important missed diagnosis, often with deadly consequences. It has been pointed out that if a sepsis case goes to trial, jurors will immediately learn that mortality rates are increased if antibiotics are delayed, even for a short period. In one study, each hour’s delay increased mortality by 7.6%, mortality being 21.1% if antibiotics were given in the first hour, compared with 58% if delayed by more than 6 hours.4
To avoid suits, physicians should be alert to seemingly minor vital sign changes, such as new tachypnea or tachycardia. Notably, patients can have severe sepsis and septic shock without fever or hypothermia. Uncomplicated sepsis is common and can quickly progress to severe sepsis, with organ failure and septic shock. The Surviving Sepsis Campaign has estimated that more than 750,000 individuals develop severe sepsis in North America each year, with mortality around 50%.
The Sullivan Group,which comprises a team of professionals dedicated to perfecting a system solution that reduces medical error and improves patient safety, recently published a wrongful-death narrative from undiagnosed sepsis.5 The decedent gave birth to her first child after 24 hours of labor, sustaining severe vaginal and rectal tearing. Three days later, she began experiencing chills, nausea, worsening vaginal pain, and fever. Her temperature reached 101.9° F (38.8° C). The following day, 4 days after delivery, she was seen by a nurse practitioner in the emergency department with symptoms of nausea, abdominal and back pain, and fever. She was tachycardic at 115 per minute.
The presence of fever plus tachycardia should have raised the diagnosis of SIRS, especially in view of her abdominal pain and a recent complicated delivery. Instead, the practitioner diagnosed a UTI and discharged her on antibiotics. That same afternoon, she collapsed and was admitted for sepsis. Despite an emergency hysterectomy, her condition worsened, she developed multiple organ failure and septic shock, and died the next day. The source of her sepsis was endometritis, and the jury returned a $20 million verdict for the plaintiff.
Observers of medical errors point to our recurring failure to continue to consider alternatives after forming an initial tentative diagnosis, and warn us about the various cognitive biases familiar to behavioral economists but ignored by many doctors.6 These include anchoring bias, in which one is locked into an aspect of the case; framing bias, in which there is misdirection because of the way the problem was posed; availability bias, in which things are judged by what comes readily to mind, such as a recent experience; and confirmation bias, in which one looks for confirmatory evidence of one’s preferred diagnosis while ignoring evidence to the contrary.
In the case outlined earlier, the Sullivan Group noted that the practitioner did not consider sepsis because of cognitive bias, anchoring, and premature closure. The trial documents indicated that the urinalysis did not show bacteria, but the practitioner may have settled – prematurely – on the UTI diagnosis, based on the presence of WBCs in the urine and her obstetrics history. Having anchored on that thought process and prematurely closed her decision making, the practitioner then ignored the elevated white blood cell count with a left shift, and a depressed platelet count of 50,000. Perhaps UTI was a reasonable consideration in the differential, but the working diagnosis of sepsis should have been first and foremost.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials may have been published in earlier columns in Internal Medicine News, and can be accessed at www.mdedge.com/taxonomy/term/83/path_term/21/latest. For additional information, readers may contact the author at [email protected].
References
1. BMJ Qual Saf. 2013 Aug;22(8):672-80.
2. JAMA Intern Med. 2013 Mar 25;173(6):418-25.
3. MIEC, the Exchange, Issue 8, March 2017.
4. Crit Care Med. 2006 Jun;34(6):1589-96.
5. The Sullivan Group. Case: Avoiding cognitive bias in diagnosing sepsis.
6. Acad Med. 2003 Aug;78(8):775-80.
Question: A middle-aged woman developed cellulitis after sustaining multiple mosquito bites in her lower left leg. The area of infection did not appear to reach the knee, which housed a prosthesis implanted there 3 years earlier. Over the next few days, she had significant knee pain, which was attributed to the surrounding cellulitis. Her pulse rate reached 105 beats per min, and her temperature was 101° F, but she was continued on oral antibiotics as an outpatient. Later that evening, she collapsed at home.
Which of the following is best?
A. Fever and tachycardia alone are enough to make the diagnosis of systemic inflammatory response syndrome (SIRS) and should have raised sepsis as a cause.
B. In septic patients, even a short delay in antibiotic administration can significantly affect morbidity and mortality.
C. Failure to diagnose is the most common basis for a medical malpractice claim.
D. The doctor may have anchored his diagnosis on the mosquito-bite incident, and should have considered a septic joint and/or sepsis in the differential.
E. All are correct.
Answer: E. “Failure to diagnose” is a legal term, whereas in medical usage we tend to use terms such “missed diagnosis,” “overlooked condition,” or “diagnostic error.” If such failure is shown to be a breach of the standard of care and is proven to be a proximate cause of the patient’s injury, then a case for medical negligence is made out. Even if the situation is atypical or complex, there still is the duty to refer, if customarily required, to an appropriate specialist, and failure to do so may also constitute negligence.
Diagnostic errors tend to cause the most severe injuries, especially in hospitalized patients. Roughly 5% of autopsies uncover a diagnostic error that was amenable to appropriate treatment, and some 50,000 annual hospital deaths may be the result of a delayed, incorrect, or overlooked diagnosis.
Failure to diagnose occurs in both outpatient and in-hospital settings, recurring examples being myocardial infarction, dissecting aneurysm, pulmonary embolism, appendicitis, ectopic pregnancy, meningitis, cancers, and fractures.
In a records-review study covering a large urban Veterans Affairs facility and an integrated private health care system in a primary care setting, the authors reported that pneumonia, heart failure, acute renal failure, cancer, and urinary tract infections (UTIs) were frequently missed diagnoses.2 They identified 190 diagnostic errors over a 12-month period in 2006-2007, and they attributed them to “process breakdowns” involving the practitioner-patient clinical encounter, referrals, patient factors, follow-up and tracking of diagnostic information, and interpretation of test results. Deficiencies in bedside history taking, physical exam, and test ordering were common; significantly, there was no documentation of an initial differential diagnosis in 80% of misdiagnosed cases.
Malpractice carriers regularly compile data regarding the nature of their covered losses, and their reports on diagnostic errors, although not subject to the usual scientific peer review, have generally corroborated the published literature.
For example, data from 2009 to 2013 collected by MIEC, a large malpractice mutual insurance company on the West Coast, impute almost half of all general medicine claims to diagnostic errors.3 The cases, frequently involving cancer and heart disease, resulted in high-severity injuries and death. Lapses in clinical judgment, communication, and patient-related behavior issues were the primary contributing factors that affected the diagnosis-related claims. Pitfalls included errors in patient assessment, diagnostic processing, provider follow-up, and referral to specialists.
Recent reports have drawn attention to sepsis, an example of SIRS, as an important missed diagnosis, often with deadly consequences. It has been pointed out that if a sepsis case goes to trial, jurors will immediately learn that mortality rates are increased if antibiotics are delayed, even for a short period. In one study, each hour’s delay increased mortality by 7.6%, mortality being 21.1% if antibiotics were given in the first hour, compared with 58% if delayed by more than 6 hours.4
To avoid suits, physicians should be alert to seemingly minor vital sign changes, such as new tachypnea or tachycardia. Notably, patients can have severe sepsis and septic shock without fever or hypothermia. Uncomplicated sepsis is common and can quickly progress to severe sepsis, with organ failure and septic shock. The Surviving Sepsis Campaign has estimated that more than 750,000 individuals develop severe sepsis in North America each year, with mortality around 50%.
The Sullivan Group,which comprises a team of professionals dedicated to perfecting a system solution that reduces medical error and improves patient safety, recently published a wrongful-death narrative from undiagnosed sepsis.5 The decedent gave birth to her first child after 24 hours of labor, sustaining severe vaginal and rectal tearing. Three days later, she began experiencing chills, nausea, worsening vaginal pain, and fever. Her temperature reached 101.9° F (38.8° C). The following day, 4 days after delivery, she was seen by a nurse practitioner in the emergency department with symptoms of nausea, abdominal and back pain, and fever. She was tachycardic at 115 per minute.
The presence of fever plus tachycardia should have raised the diagnosis of SIRS, especially in view of her abdominal pain and a recent complicated delivery. Instead, the practitioner diagnosed a UTI and discharged her on antibiotics. That same afternoon, she collapsed and was admitted for sepsis. Despite an emergency hysterectomy, her condition worsened, she developed multiple organ failure and septic shock, and died the next day. The source of her sepsis was endometritis, and the jury returned a $20 million verdict for the plaintiff.
Observers of medical errors point to our recurring failure to continue to consider alternatives after forming an initial tentative diagnosis, and warn us about the various cognitive biases familiar to behavioral economists but ignored by many doctors.6 These include anchoring bias, in which one is locked into an aspect of the case; framing bias, in which there is misdirection because of the way the problem was posed; availability bias, in which things are judged by what comes readily to mind, such as a recent experience; and confirmation bias, in which one looks for confirmatory evidence of one’s preferred diagnosis while ignoring evidence to the contrary.
In the case outlined earlier, the Sullivan Group noted that the practitioner did not consider sepsis because of cognitive bias, anchoring, and premature closure. The trial documents indicated that the urinalysis did not show bacteria, but the practitioner may have settled – prematurely – on the UTI diagnosis, based on the presence of WBCs in the urine and her obstetrics history. Having anchored on that thought process and prematurely closed her decision making, the practitioner then ignored the elevated white blood cell count with a left shift, and a depressed platelet count of 50,000. Perhaps UTI was a reasonable consideration in the differential, but the working diagnosis of sepsis should have been first and foremost.
Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials may have been published in earlier columns in Internal Medicine News, and can be accessed at www.mdedge.com/taxonomy/term/83/path_term/21/latest. For additional information, readers may contact the author at [email protected].
References
1. BMJ Qual Saf. 2013 Aug;22(8):672-80.
2. JAMA Intern Med. 2013 Mar 25;173(6):418-25.
3. MIEC, the Exchange, Issue 8, March 2017.
4. Crit Care Med. 2006 Jun;34(6):1589-96.
5. The Sullivan Group. Case: Avoiding cognitive bias in diagnosing sepsis.
6. Acad Med. 2003 Aug;78(8):775-80.