Federal Practitioner

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a large cohort of insured working adults with severe obesity and nonalcoholic fatty liver disease (NAFLD), the rate of incident cancer was lower during a 10-month median follow-up period among those who underwent bariatric surgery. The rate was especially lower with regard to obesity-related cancers. The risk reduction was greater among patients with cirrhosis.

Among almost 100,000 patients with severe obesity (body mass index >40 kg/m²) and NAFLD, those who underwent bariatric surgery had an 18% and 35% lower risk of developing any cancer or obesity-related cancer, respectively.

Bariatric surgery was associated with a significantly lower risk of being diagnosed with colorectal, pancreatic, endometrial, and thyroid cancer, as well as hepatocellular carcinoma and multiple myeloma (all obesity-related cancers). The findings are from an observational study by Vinod K. Rustgi, MD, MBA, and colleagues, which was published online March 17, 2021, in Gastroenterology.

It was not surprising that bariatric surgery is effective in reducing the malignancy rate among patients with cirrhosis, the researchers wrote, because the surgery results in long-term weight loss, resolution of nonalcoholic steatohepatitis (NASH), and regression of fibrosis.

“Cirrhosis can happen from fatty liver disease or NASH,” Dr. Rustgi, a hepatologist at Robert Wood Johnson Medical School, New Brunswick, N.J., explained to this news organization. “It’s becoming the fastest growing indication for liver transplant, but also the reason for increased rates of hepatocellular carcinoma.”

Current treatment for patients with obesity and fatty liver disease begins with lifestyle changes to lose weight, he continued. “As people lose 10% of their weight, they actually start to see regression of fibrosis in the liver that is correlated with [lower rates of] malignancy outcomes and other deleterious outcomes.” But long-lasting weight loss is extremely difficult to achieve.

Future studies “may identify new targets and treatments, such as antidiabetic-, satiety-, or GLP-1-based medications, for chemoprevention in NAFLD/NASH,” the investigators suggested. However, pharmaceutical agents will likely be very expensive when they eventually get marketed, Dr. Rustgi observed.

Although “bariatric surgery is a more aggressive approach than lifestyle modifications, surgery may provide additional benefits, such as improved quality of life and decreased long-term health care costs,” he and his coauthors concluded.
 

Rising rates of fatty liver disease, obesity

An estimated 30% of the population of the United States has NAFLD, the most common chronic liver disease, the researchers noted in their article. The prevalence of NAFLD increased 2.8-fold in the United States between 2003 and 2011, in parallel with increasing obesity.

NAFLD is more common among male patients with obesity and diabetes and Hispanic patients; “70% of [patients with diabetes] may have fatty liver disease, according to certain surveys,” Dr. Rustgi noted.

Cancer is the second greatest cause of mortality among patients with obesity and NAFLD, he continued, after cardiovascular disease. Cancer mortality is higher than mortality from liver disease.

Obesity-related cancers include adenocarcinoma of the esophagus, cancers of the breast (in postmenopausal women), colon, rectum, endometrium (corpus uterus), gallbladder, gastric cardia, kidney (renal cell), liver, ovary, pancreas, and thyroid, as well as meningioma and multiple myeloma, according to a 2016 report from the International Agency for Research on Cancer working group.

Obesity-related cancer accounted for 40% of all cancer in the United States in 2014 – 55% of cancers in women, and 24% of cancers in men, according to a study published in Morbidity and Mortality Weekly Report in 2017, as previously reported by this news organization.

Several studies, including one presented at Obesity Week in 2019 and later published, have shown that bariatric surgery is linked with a lower risk for cancer in general populations.

One meta-analysis reported that NAFLD is an independent risk factor for cholangiocarcinoma and colorectal, breast, gastric, pancreatic, prostate, and esophageal cancers. In another study, NAFLD was associated with a twofold increased risk for hepatocellular carcinoma and uterine, stomach, pancreatic, and colon cancers, Dr. Rustgi and colleagues noted.

Until now, the impact of bariatric surgery on the risk for cancer among patients with obesity and NAFLD was unknown.
 

Does bariatric surgery curb cancer risk in liver disease?

The researchers examined insurance claims data from the national MarketScan database from Jan. 1, 2007, to Dec. 31, 2017, for patients aged 18-64 years who had health insurance from 350 employers and 100 insurers. They identified 98,090 patients with severe obesity who were newly diagnosed with NAFLD during 2008-2017.

Roughly a third of the cohort (33,435 patients) underwent bariatric surgery. From 2008 to 2017, laparoscopic sleeve gastrectomies increased from 4% of bariatric procedures to 68% of all surgeries. Laparoscopic adjustable gastric band and laparoscopic Roux-en-Y gastric bypass procedures fell from 35% to less than 1% and from 49% to 28%, respectively.

Patients who underwent bariatric surgery were younger (mean age, 44 vs. 46 years), were more likely to be women (74% vs. 62%), and were less likely to have a history of smoking (6% vs. 10%).

During a mean follow-up of 22 months (and a median follow-up of 10 months), there were 911 incident cases of obesity-related cancers. These included cancer of the colon (116 cases), rectum (15), breast (in postmenopausal women; 131), kidney (120), esophagus (16), gastric cardia (8), gallbladder (4), pancreas (44), ovaries (74), endometrium (135), and thyroid (143), as well as hepatocellular carcinoma (49), multiple myeloma (50), and meningioma (6). There were 1,912 incident cases of other cancers, such as brain and lung cancers and leukemia.

A total of 258 patients who underwent bariatric surgery developed an obesity-related cancer (an incidence of 3.83 per 1,000 person-years), compared with 653 patients who did not have bariatric surgery (an incidence of 5.63 per 1,000 person-years).

The researchers noted that study limitations include the fact that it was restricted to privately insured individuals aged 18-64 years with severe obesity. In addition, “the short median follow-up may underestimate the full effect of bariatric surgery on cancer risk,” they wrote.

The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

Over the past decade, natural disasters and health care emergencies have increased 74%, averaging 400 documented events per year.¹ These unpredictable and sometimes devastating events negatively impact the physical and mental health of communities, taxing already stretched health care system resources and the economy.^2,3 During many of these events, patients inappropriately use hospitals, emergency departments (EDs), and critical care resources for chronic disease and elective health care management, resulting in medication shortages, health care access concerns, and treatment delays.⁴

Most available emergency preparedness programs rely solely on volunteers and/or public health providers to address the resultant coverage gap; however, instability in state and federal funding can make it difficult to maintain and sustain focused preparedness and response efforts. Alaska’s vast geography, low population density (1.2 people per square mile), and access limitations (about 200 villages only reachable by air or boat) make it especially challenging to provide reliable and sustained emergency preparedness and response support. Therefore, all eligible health care providers (HCPs) in Alaska must be involved in preparedness and response efforts.

Despite being the most accessible HCPs, pharmacists and student pharmacists, have not been actively involved in statewide emergency preparedness planning and disaster management efforts in Alaska. In preparation for and during disasters, for example, pharmacists may administer vaccinations, conduct point of care testing, dispense emergency medications, provide emergency medication refills, help mitigate medication shortages, and provide reliable health information to other health care professionals, patients, and their families as they prepare for and manage care during the event.⁴

The goal of this paper is to share the experience at the University of Alaska Anchorage/Idaho State University College of Pharmacy (UAA/ISU) in the development and implementation of a sustainable emergency preparedness and response support network (EPRSN) model; leveraging an established university student leadership structure and Doctor of Pharmacy (PharmD) students to support sharing of information among community pharmacies, state emergency response teams, and community members. 

2018 Alaska Earthquake

On November 30, 2018, southcentral Alaska experienced a magnitude 7.1 earthquake, affecting nearly 295,000 people (approximately 40% of Alaska’s population) damaging roads, buildings, homes, and health care facilities. Emergency response efforts were quickly overwhelmed and hospital EDs became overburdened with patients seeking not only emergent, but also chronic care along with requests for prescription refills.

During disasters, disruptions in medication access and adherence are common. Disruptions can lead to disease exacerbation or progression, hospitalization, and/or death; all of which further contribute to the health care system and economic health burden. For example, after Hurricane Katrina, 46% of patients on hypertension medications had less than perfect adherence due to a variety of reasons (eg, not bringing any or enough medications during evacuation, lack of access to refills).⁵ Nonadherence to prescription hypertension medication specifically can lead to stroke, heart attack, and more rapidly progressing kidney dysfunction. Patients with diabetes mellitus (DM) also experience negative consequences due to disruptions in medication adherence.⁶ Lack of access to medications and supplies for DM can likewise lead to significant health sequelae, including acute hyperglycemic events, which can be life-threatening; ongoing hyperglycemia can lead to higher rates of cardiovascular disease, kidney disease, nerve damage, and diabetic retinopathy.⁷ However, the long-term effects of a natural disaster on health in terms of morbidity and mortality often go unreported, and their impact on chronic health conditions may be underestimated and last for years after the event.

As future health care professionals, student pharmacists continually seek opportunities to engage with and support communities; including preparing for, responding to, mitigating against, and recovering from disasters that affect the health care system and access to needed drug therapies. After the earthquake, student pharmacists reached out to state and local emergency response programs detailed within The State of Alaska Emergency Operations Plan to find opportunities to volunteer.

Agencies contacted included the Office of Emergency Management (OEM) for the Municipality of Anchorage. OEM partners with local health, fire, and police departments, the Alaska Department of Health and Social Services and Emergency Management, the Federal Emergency Management Agency, Centers for Disease Control and Prevention, American Red Cross, and the Salvation Army. It is important to note, due to lack of funding, Alaska no longer has a Medical Reserve Corps, which significantly impacts community emergency response and resilience efforts. After the earthquake, the emergency program manager extended an invitation to student pharmacists to join the joint medical emergency conference call, where local HCPs discuss emergency protocols, identify gaps, and work together to identify solutions.

During this call there was a consensus among HCPs that many patients were inappropriately seeking to fill and refill prescription medications in the ED, and staff were ill-prepared to guide patients to the appropriate services, unaware of which pharmacies were impacted by the earthquake; therefore unable to direct patients to still-operational pharmacies in the area. Together faculty and students discussed how student pharmacists could be involved in filling these identified information gaps and enhance communication among HCPs and entities. It was determined that if student pharmacists established and maintained open lines of communication with community pharmacists, they could efficiently determine which pharmacies were open and operational after disasters and disseminate that information to EDs and health care facilities in order to better direct patients to appropriate health care services.

Observations 

A question/answer format and time line approach was used to review the steps leading to EPRSN program development and establishment of project/model deliverables.

Identified gaps

Chronic disease management. According to interviews conducted by the National Center for Disaster Preparedness, people often inappropriately use EDs during disasters.⁸ EDs do not stock enough medications to refill prescriptions for patients outside of their emergent care needs and are typically ill-suited for patients’ chronic disease management. At the time of the earthquake in Alaska no specific place/organization had been established to collect, store, or disseminate information regarding available pharmacy resources in an emergency. Had such a system been in place to actively inform HCPs and community members which pharmacies were open and operational, it is likely that many negative consequences related to health care utilization could have been reduced or avoided, including the number of people inappropriately using EDs for chronic prescription medication refills. This would not only reduce the burden on the health care system but allow for patients with both emergency and chronic needs to be seen quickly and prevent unnecessary health care costs.

Pharmacists play a vital role in managing chronic diseases.⁹ Due to extensive education and training, they are considered medication experts, ideally suited to manage chronic medication therapy, help prevent or minimize disease exacerbation and/or progression, reduce preventable health care costs, improve patient quality of life, and reduce morbidity and mortality.⁹ Pharmacists are accessible and strategically located throughout communities and provide patients with continuity of care other HCPs may be unable to provide. For example, during the COVID-19 pandemic, pharmacies remained open when other primary care providers (PCPs) were not. In addition, during times of natural disasters pharmacies tend to remain open unless there are extenuating circumstances (eg, unsafe building infrastructure, unsafe drug supply).

Emergency Response. To determine the role pharmacists play in emergency preparedness efforts we looked initially to the peer-reviewed literature (search terms: emergency preparedness, natural disasters, pharmacy/pharmacies) then turned to materials and research produced by organizations outside of the traditional commercial and academic publishing channels; however, most emergency preparedness protocols and standard operating procedures (SOPs) did not pertain to pharmacies or acknowledge the contribution of pharmacists. Researchers urge both state and federal governments to foster relationships with and use community pharmacist’s expertise and expanded roles in order to improve the nation’s public health.¹⁰

Historically, pharmacists within the US Public Health Service (PHS) have responded alongside local HCPs to meet the needs of communities during public health emergencies. Pharmacists were pivotal in the 2009 response to H1N1 influenza and the 2015 Ebola response, both abroad and within the United States.⁶ Pharmacists screened and triaged patients, provided life-saving vaccinations, and supported community and health care system education initiatives. However, as the COVID-19 pandemic has demonstrated, responding to a public health crisis takes more than the 1,000 pharmacists serving in the PHS.¹¹ The American Society of Health-System Pharmacists argues that all pharmacists should be involved in working with public health planners.¹²

Community and health-systems pharmacists are vital to current and future public health responses and represent a largely untapped resource. Pharmacists across the country, especially in rural and underserved communities, have the potential to significantly impact emergency preparedness and response efforts. The > 319,000 US pharmacists comprise a sizable portion of the population and can play vital roles during emergency situations or disasters.¹³ Often after catastrophic events, community pharmacists provide first-aid, emergency refills, medication counseling, point of care testing, triage patients and serve on emergency response teams.¹⁴ However, pharmacists alone cannot address all medication-related patient needs and student pharmacists likewise have a role in emergency preparedness and response efforts. By participating in these efforts and learning these roles as students, they are better prepared to engage in emergency efforts as pharmacists.

Student pharmacist support. There are more than 140 accredited pharmacy schools across the United States, employing > 6,500 pharmacy faculty, and teaching > 63,000 student pharmacists.¹⁵ The majority of schools provide free and volunteer-based health care services and collaborate with local, regional, and national entities such as state boards of pharmacy, professional pharmacy organizations, and the American Pharmacist Association (APhA). Through the APhA Academy of Student Pharmacists (ASP), in 2018 and 2019 Operation Heart Campaign, 4,239 patients were referred to a PCP for follow-up care, 117,251 patients received health and wellness services, and 2,772,179 patients were educated regarding cardiovascular disease, the most common noncommunicable disease in the United States.^16,17 Also, in 2018 and 2019, APhA-ASPs Operation Diabetes Campaign referred 3,785 patients to their PCP, provided health and wellness services to 36,334 patients, and educated 1,114,281 patients regarding DM.¹⁸

Student pharmacists are positioned across the country with reach to rural and underserved communities and have student organizational structures in place to manage student volunteers and support health care service opportunities. These structures could readily be used to augment and provide emergency pharmacy services and the coordination of chronic care services during times of emergency or disaster. Student leaders are well situated to coordinate communication and cooperation across health care disciplines and to facilitate local community pharmacy resource information collection and distribution.

Emergency Preparation Program

To address gaps in emergency preparedness and response, student pharmacists at UAA/ISU took the following steps to develop the EPRSN. Planning involved a multistep process. Step 1 identified important uncaptured data (eg, operational status, staffing, hours of operation, continuity and safety of drug supply chain, building/parking lot damage) required to direct patients to the appropriate medication-related care during an emergency. For step 2, student pharmacists obtained a list of the 138 pharmacies in Alaska from the state board of pharmacy. Pharmacies were contacted by student pharmacists using an established telephone script and updated contact information collected was stored on a secure, online drive accessible to UAA/ISU College of Pharmacy faculty and students using their UAA/ISU email address. In step 3, the APhA-ASP president elect and 3 leaders in each of the 16 APhA-ASP operation in charge of the EPRSN Alaska initiative, surveyed student leaders to determine student willingness to participate. Step 4 was to develop an organizational structure using established leadership structure to collect, capture, update, and share pharmacy data with state emergency response teams. Sustainability from year to year will be ensured through incorporation into the APhA-ASP student engagement framework (eg, annual training led by the president elect, contact information updated biyearly by student leaders, and oversight provided by College of Pharmacy faculty). Step 5 was to create SOPs, flowcharts, telephone scripts, talking points, and student training materials. And in the final preparatory step, plan documents and deliverables were provided to faculty administration and advisors within the College of Pharmacy for initial approval and presented to the student leadership for final approval.

EPRSN will be activated in the case of a natural disaster or state of emergency. Pharmacy students will contact all pharmacies within the designated area to collect up-to-date vital information (eg, operational status, staffing, hours of operation, safe drug supply, building/parking lot damage). Collected information will be disseminated to appropriate community members, HCPs, health care facilities, and emergency preparedness officials, under the direction of the Emergency Program Manager. 

Discussion

In order to make informed and timely decisions during emergency situations, patients, HCPs, and health care systems must have appropriate situational awareness. The ability of decision makers to respond is directly dependent on timeliness and relevance of the information collected and shared and greatly contributes to this awareness. Accurate, effective, and consistent information collection has historically been one of the greatest challenges to situational awareness. This is particularly important in times of disaster when necessary emergency situation data may not exist, tools to collect data are inefficient and/or ineffective, and/or current data are inaccessible to relevant parties.¹⁹ This was the case in the Alaska earthquake of 2018 and more recently the COVID-19 pandemic of 2020 where information sharing deficits and structural barriers became even more evident.  

Transfer of knowledge and information is especially critical during an emergency situation. Ineffective communication and information sharing results in transfer gaps. Gaps that result from inadequate transfers of care between HCPs are referred to as hand-off gaps. Training gaps result from inadequate preparation on the part of HCPs and civic leaders as well as in public health policies and procedures and in understanding of needs in emergent situations. Organization gaps occur when an individual changes positions or leaves a given institution and the acquired knowledge is not shared with others before departure or the replacement individual does not receive necessary training. 

In both the Alaska earthquake and the COVID-19 pandemic, gaps in hand-offs, training, and organization were identified. Pharmacists were involved in the solution, providing care, addressing unmet health needs, and supporting the health care system. Many patients and HCPs remain unaware of the services pharmacists are capable and willing to provide, but at even a more basic level they are unsure of what services may be needed in emergency situations. Pharmacists are often used and considered vital HCPs after natural disasters or emergency situations, providing services that extend beyond their normal duties, yet remain within their SOP and expertise and address the medication management needs of their patients, ensuring safe, effective, and continuous access to needed pharmaceuticals.

It is vital that pharmacists and student pharmacists take an active role in emergency preparedness, that students get involved early in outreach and engagement initiatives for which they are ideally suited to coordinate in their communities, and that College of Pharmacy faculty support student pharmacist efforts to continue to highlight the professional roles of pharmacists, in routine health care as well as during times of crisis or disaster. It is important to note that an indirect but important cause of patient mortality related to an emergency event is the inability to access routine health care. If pharmacists and student pharmacists were more involved in emergency preparedness and response efforts, they could play an even greater role in providing much needed health care to patients during times when the health care system is overtaxed (facilitating medication refills and providing administrative and health care support).

Conclusions

Emergency and disaster preparedness are vital to promote the appropriate use of health care resources and prevent health-related complications. Student pharmacists represent a sustainable resource, uniquely positioned to identify community needs, support emergency efforts, coordinate with local pharmacies, and work with pharmacists and others to ensure patients receive the care they need. This work has the potential to improve utilization of health care resources and service delivery during natural disasters and emergencies, on a local, state, and regional level, with the overall goal of maintaining patient health and well-being.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

The United States continues to confront an opioid crisis that also affects older adults. According to the Substance Abuse and Mental Health Services Administration from 1999 to 2010, there has been a 4-fold increase in opioid overdose deaths.¹ Between 2010 and 2015, the rate of opioid-related inpatient stays and emergency department (ED) visits for people aged ≥ 65 years increased by 34% and 74%, respectively, and opioid-related overdose deaths continue to increase among older patients.^1,2

Background

Chronic pain is estimated to affect 50 million US adults.³ Individuals receiving long-term opioid therapy may not have experienced relief with other medications or cannot take them for medical safety reasons. Losing access to opioid prescriptions can contribute to misuse of illicit opioids. Implementing best practices for prescription opioid management in older adults is challenging. Older adults have a high prevalence of chronic pain, which is linked to disability and loss of function, reduced mobility, falls, depression, anxiety, sleep disorders, social isolation, and suicide or suicidal ideation.⁴ Until recently, chronic pain in older adults was often treated primarily with long-term opioid prescriptions, despite little evidence for the effectiveness of that treatment for chronic conditions. The prevalence of long-term opioid use in adults has increased from 1.8% (1999-2000) to 5.4% (2013-2014), and 25% of adult long-term opioid users are aged ≥ 65 years.⁵

Older adults are especially vulnerable to developing adverse events (AEs) from opioid use, including constipation, confusion, nausea, falls, and overdose. These factors make safe prescribing more challenging even when opioids are an appropriate therapeutic choice. Older adults often have multiple chronic conditions and take multiple medications that increase risk of AEs due to drug-disease and drug-drug interactions. Finding appropriate alternatives for pain management can be challenging in the presence of dementia if other pharmacologic options are contraindicated or mobility issues limit access to other therapeutic options.

Pain treatment plans should be based on realistic functional goals using a shared decision-making approach accounting for patient and provider expectations. All reasonable nondrug and nonopioid treatments should be considered before opioids are initiated. A comprehensive, person-centered, approach to pain management in older adults that includes opioids, other medications, and complementary and integrative care could improve both pain control and function,and reduce the harms of unnecessary opioid exposure.⁶ A validated risk review should be performed and documented on all patients starting opioids except patients enrolled in hospice care.

In 2018, the US Department of Veterans Affairs (VA) required all facilities to complete case reviews for veterans identified in the Stratification Tool for Opioid Risk Mitigation (STORM) dashboard as being at particularly high risk for AEs among patients prescribed opioids.⁷ We present our experience with a 1-year management of 48 high-risk older patients receiving chronic prescription opioid therapy. These patients obtained all their care at the VA with complete record documentation.

Methods

The Tennessee Valley Healthcare System (TVHS) is an integrated VA health care system with > 100,000 veteran patients in middle Tennessee with 2 medical centers 40 miles apart, and 12 community-based outpatient clinics. In 2011, TVHS developed a geriatric patient-centered medical home model for geriatric primary care—the geriatric patient aligned care team (GeriPACT).⁸ GeriPACT consists of a GeriPACT primary care provider (geriatrician or geriatric nurse practitioner with a panel of about 800 outpatients), social worker, clinical pharmacist, registered nurse care manager, licensed vocational nurse, and clerical staff. GeriPACT is a special population PACT within primary care for complex geriatric and other high-risk vulnerable veterans providing integrated, interdisciplinary assessment and longitudinal management, and coordination of both VA and non-VA-funded (eg, Medicare and Medicaid) services for patients and caregivers. GeriPACT at the Nashville TVHS campus has an enrollment of 745 patients of whom 48 receive chronic prescription opioid therapy. The practice is supported by the VA Computerized Patients Record System (CPRS), including the electronic patient portal, My healtheVet, with telemedicine capabilities. Data were collected by chart review with operations data extracted from the Veterans Health Information System and Technology Architecture.

Best practices for prescription opioids for chronic pain follow the US Department of Health and Human Services Interagency Task Force pain management recommendations.⁴ These include: (1) Effective pain evaluation and management, including diagnostic evaluation and indicated referrals; (2) appropriately prescribed opioids when indicated; and (3) active management of opioid users to prevent AEs and misuse. Strategies used in GeriPACT were adopted from the pain management task force and designed to address needs and challenges associated with responsible chronic opioid prescribing (Table 1).

Results

Chronic opioid patients comprised 6.4% of the GeriPACT population. These patients had many comorbidities, including diabetes mellitus (35%), pulmonary disease (25%), congestive heart failure (18.8%), and dementia (8%). There were 54% with estimated glomerular filtration rates (eGFR) < 60 mL/min, indicating at least stage 3 chronic kidney disease (Table 2). Patients had an average RIOSORD Score of 21 and a 14% risk of opioid induced respiratory depression, and 20% received mental health services.

The mean CAN score was 83.1, suggesting a 1-year risk of 20% for a major AE and 5% mortality risk. Many patients with chronic opioid use were transferred to GeriPACT from primary care due to presence of complex medical issues in addition to need for chronic pain management. In this population, 8% were coprescribed benzodiazepines and opioids. Consults were obtained from interventional pain for 37.5% of patients and palliative care for 27% of patients, the majority for goals of care related to chronic illness and advance directive discussions, and in 1 patient for pain and symptom management. The majority of patients (81%) had advance care planning documents or discussions documented in the electronic health record, and 87.5% of patients received home and community-based support in addition to GeriPACT care.

Medication Reduction

Pharmacists routinely counseled patients regarding the appropriate timing of refills and made monthly calls to request refills of controlled drugs. Three patients agreed to opioid dose reduction due to improved clinical status. Two patients had 25% and 30% dose reductions, respectively, and 1 patient was able to be discontinue opioids. This was achieved through reduction of therapy and or substitution of alternative nonopioid pain medications. One patient was initiated on a slow benzodiazepine taper schedule after decades of benzodiazepine use in addition to engagement with a whole health coach and primary care mental health integration provider. Another patient was disenrolled from the clinic because of repeated nonadherence and positive UDSs for polysubstance use disorder.

Accidental Overdoses

There were 2 patients with accidental overdoses who survived, both on high morphine equivalent daily doses (MEDDs). One patient was admitted to the intensive care unit for increasing confusion after taking more than the prescribed opioids (120 mg MEDD) due to uncontrolled pain for 2 months following surgery. The second patient was taking 66 mg MEDD with multiple risk factors for respiratory depression (severe chronic obstructive pulmonary disease requiring oxygen, obstructive sleep apnea, and concomitant benzodiazepine use) who repeatedly refused tapering of opioids and benzodiazepines. He was found unresponsive in respiratory depression by home health staff. Both patients had naloxone kits in their home that were not administered.

Urine Drug Screening

There was an occasional negative opioid UDS attributed to patients on a low-dose opioid administered more than 24 hours before. Five patients (10.4%) had positive UDSs. Two patients were positive for cocaine, and because of chronic persistent pain and complex medical problems cared for in the clinic, counseled and continued on therapy with no repeat infractions. Two patients were positive for cannabinoids attributed to CBD oil products, which are legal in Tennessee. One patient had repeated positive UDSs for polysubstance abuse and was terminated from the clinic, preferring to use cannabinoids and other substances illegally. Meperidine, fentanyl, tramadol, and other synthetic opioids are not detected on a routine UDS.

Discussion

Primary care is critical in optimizing the prescribing and use of opioids in older adults. The patient-centered medical home can give health care providers the tools and support to provide evidence—based pain management for their older adult patients and to facilitate prescription and monitoring of appropriate opioid use to minimizing AEs and OUD risk. This includes a reliable health information technology monitoring system as part of a collaborative, person-centered care practice capable of managing frail older patients with multiple chronic conditions as well as social risk factors. GeriPACT was able to implement guideline—based evaluation and treatment of chronic pain patients through optimal management of opioids, risk reduction, and monitoring and management of AEs, misuse, and dose tapering using shared decision-making strategies when appropriate.

Complex older patients on chronic opioid treatment can do well and are best managed by an interdisciplinary team. Our panel had a high prevalence of chronic opioid patients and a high expected mortality based on the severity of comorbidities. Patients had frequent access to care with utilization of many support services. Patients received care for many chronic illnesses at the same time they received opioid therapy and generally were satisfied and adherent to their treatment plan. Published reports of the prevalence of coprescribing of benzodiazepines and opioids of 1.1 to 2.7% in the general population, may be lower than our veteran population.¹⁴ Despite the fact that nearly 20% of the population had a history of opioid misuse, only 1 patient was terminated from the clinic because of repeated episodes of polysubstance use disorder.

GeriPACT has the capability to be responsive to the changing needs of older chronic pain patients as a learning health system using continuous process improvement with frequent team meetings and interdisciplinary care.¹⁵ Our experience with chronic pain management demonstrates the feasibility and quality of guideline-based management and enhances our understanding of the intersection of care, chronic pain management, and opioid use disorder in older adults.

Limitations

Our experience with this population of older veterans may not be applicable to other geriatric populations. While all patients received their primary care at VA and patients were seen regularly, our data may not account for possible use of some community services, including hospitalization and long-term care.

Conclusions

Guideline-based patient-centered medical home management of patients with chronic pain treated with opioids can be an effective model to maintain and improve measures of health and well-being in older patients. Primary care management is critical in optimizing the prescribing and use of opioids in older adults. These complex older patients are best managed by an interdisciplinary team.

Acknowledgments

This work was supported in part by the Geriatric Workforce Enhancement Program, HRSA Grant: 1-U1Q-HP 033085-01-00.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.

Parkinson disease (PD) is the second most common neurodegenerative disorder after Alzheimer disease.¹ Age-standardized incidence rates of PD in population-based studies in Europe and the United States range from 8.6 to 19.0 per 100,000 individuals, using a strict diagnostic criterion for PD.² The negative impact of PD on health-related quality of life imposes a heavy burden on veterans. According to the US Department of Veterans Affairs (VA) National Parkinson’s Disease Consortium, the VA has as many as 50,000 patients with PD under its care. Because of this demand, the VA has strived to revolutionize available services for veterans with PD and related movement disorders.³

The classic motor symptoms of resting tremors, bradykinesia, postural instability, and rigidity of this progressive neurodegenerative disorder is a significant cause of functional limitations that lead to increased falls and inability to perform activities of daily living that challenges the individual and caregiver. ⁴ Rehabilitation has been considered as an adjuvant to surgical and medical treatments for PD to maximize function and minimize complications. High-intensity multimodal exercise boot camps and therapy that focuses on intensely exercising high-amplitude movements, have been shown to improve motor performance in PD.^5,6 Available evidence has shown that exercise-dependent plasticity is the main mechanism underlying the effects of physiotherapy because it increases synaptic strength and affects neurotransmission.⁷ Although there is no consensus on the optimal approach for rehabilitation, innovative techniques have been proposed and studied. One such approach involves virtual reality (VR), which has begun to attract attention for its potential use during rehabilitation.⁸

VR is a simulated experience created by computer-based technology that grants users access to a virtual environment. There are 2 categories of VR: immersive and nonimmersive. Immersive VR is the most direct experience of virtual environments and usually is implemented through a head-mounted display. These displays have monitors in front of each eye, which can provide monocular or biocular imaging with the most common display being small liquid crystal display (LCD) panels.

Nonimmersive VR typically allows a participant to view a virtual environment by using standard high-resolution monitors rather than a headset or an immersive screen room. Many systems are readily available to the general public as electronic interactive entertainment (ie, video games). Interaction with the virtual world happens through interfaces such as keyboards and controllers while viewing a television or computer monitor. These systems often are more accessible and affordable when compared with immersive VR, although this is changing rapidly.

VR therapy is a noninvasive therapeutic alternative modality for PD. This review aims to study the use of VR to treat PD from a rehabilitative standpoint. Although not the only review on the topic, this systematic review is the first to examine the differences between immersive and nonimmersive VR rehabilitation for PD. VR technology is evolving rapidly and the research behind its clinical applications is steadily growing, especially as accessibility improves. This review also is an updated summary of the current literature on the effectiveness of VR therapy during PD rehabilitation.

Methods

Starting in July 2019, the authors searched several databases (PubMed, Google Scholar, Cochrane, and the Physiotherapy Evidence Database [PEDro]) for articles by using the keyword “Parkinson’s disease” combined with either “virtual reality” or “video games.” To find studies specific to rehabilitation, searches included the additional keyword: “rehabilitation.” After compiling an initial set of 89 articles, titles were reviewed to eliminate duplicates. The authors then read the abstracts to exclude study protocols, systematic reviews, and studies that used VR but did not focus on PD or any therapeutic outcome.

Articles were sorted into immersive or nonimmersive virtual reality categories. To be included as immersive VR, studies had to use any type of VR headset or full-scale VR room. Anything less immersive or similar to a traditional video game was included in the nonimmersive VR category. Articles that met inclusion criteria were selected for the systematic review. Criteria for inclusion in this review were: (1) English language; (2) included a study population focused on PD; (3) used some form of VR therapy; and (4) assessed potential rehabilitation by quantitative outcome measures. Only articles published in peer-reviewed journals were included.

Data were extracted into 2 tables specifically modified for this review: immersive and nonimmersive VR. Extracted data included study author name and publication date, study design, methodologic quality, sample size and group allocation, symptom progression via the Hoehn and Yahr Scale (1 to 5), VR modality, presence of control groups, primary outcomes, and primary findings.

Results

This review is reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA).¹⁰ After screening and assessment, 28 articles met inclusion criteria for this review: 7 using immersive VR and 21 using nonimmersive VR (Figure). The immersive studies included 2 RCTs (both with PEDro scores of 5), 1 controlled study with a PEDro score of 5, 1 pre-post pilot study, and 3 cohort studies (Table 2). The nonimmersive studies included 13 RCTs with an average PEDro score of 5.8; 2 pre-post pilot studies, 1 repeated measures study with a historic control, 1 non-RCT, 2 pre-post prospective studies, and 2 cohort studies (1 retrospective and 1 prospective) (Table 3).

Several outcome and assessment tools were used; the most common measures were related to gait, balance, kinematics, and VR feasibility. Studies varied in VR modalities and protocol, ranging from 21 sessions of Nintendo Wii Fit gaming for 7 weeks to 1 session of VR headset use.

Immersive VR

There were fewer immersive VR studies and these studies had lower mean PEDro scores when compared with nonimmersive VR studies. The VR modalities in the immersive studies used a VR headset or a multisensory immersive system that included polarized glasses. All the studies showed positive improvement in primary outcomes with the exception of Ma and colleagues,which showed no difference in success rates or kinematics with moving balls, and only showed improvement in reaching for stationary balls.¹¹ The mean number of participants in the studies was 18.4.

All 7 studies had each participant complete tasks without VR then with the VR therapy. None of the studies compared immersive VR therapy with more conventional therapies. Robles-Garcia and colleagues compared 2 VR groups where the experimental group imitated an avatar’s finger tapping in the VR system while the control group lacked this imitation.¹² The authors found that adding that imitation to the VR group lead to an increase in movement amplitude.

Among the immersive VR studies, only Janeh and colleagues commented on possible adverse effects (AEs) and found that VR was a safe method without AEs of discomfort or simulator sickness.¹³ The other 6 studies did not make any mention or discussion of AEs related to the training.

Nonimmersive VR

VR modalities used in nonimmersive studies included consumer video gaming systems. Nintendo Wii and Microsoft Xbox Kinect were most commonly used. Among the 21 studies, 14 compared VR therapy with a type of traditional exercise (eg, treadmill training, stretching exercises, balance training). The mean number of participants of the studies was 28.3.

Five studies showed a difference between the VR and traditional training groups.^14-18 However, 9 studies showed positive improvement in both groups and found no between-group differences.^19-25 Among the remaining 7 studies, all showed improvement in primary outcomes after adding VR interventional therapy. In 1 RCT, 3 groups were compared (no intervention, Nintendo Wii, and Xbox Kinect) for gait tests, anxiety levels, memory, and attention.²⁶ The authors found that only the Nintendo Wii group showed improvement in outcomes. A prospective cohort study was the only one to compare different doses of VR therapy (10 sessions vs 15 sessions of Nintendo Wii Fit).²⁷ The authors found that both groups demonstrated the same amount of improvement on balance performances with no group effect.

Ten studiesreported no AEs during the training, but also did not define what was considered an AE.^{15,16,19,22-25,27-29} Eight studies did not make any mention of AEs.^{14,17,21,26,27,30-32} Yen and colleagues reported no AEs during training except for the patients’ tendency to fall.²⁰ However, therapists supervised the patients to avoid falls and no falls occurred. Nuic and colleaguesreported 3 serious AEs, unrelated to the training: severe pneumonia (n = 1) and deep-brain stimulation generator replacement (n = 2).³³ During the video game training sessions no specific AEs occurred. Only Pompeu and colleagues defined an AE as any untoward medical occurrence such as convulsion, syncope, dizziness, vertigo, falls, or any medical condition that required hospitalization or disability.³⁴ One researcher registered the occurrence of any AE; however, none occurred during the study period.

Discussion

This systematic review demonstrates that VR therapy is a promising addition to rehabilitation for PD. Evidence supporting VR therapy is limited, but is continually expanding, and current evidence has shown improvement in assessments and rehabilitative outcomes involving PD. Most nonimmersive studies have shown that VR therapy does not lead to better outcomes when compared with traditional therapy but also is not harmful and does provide similar improvement. Immersive VR studies, on the other hand, have not compared therapy with conventional training extensively, and tend to focus more on time for task completion or movement.

There were fewer immersive VR studies than nonimmersive VR studies. This could be because of the increased technological difficulty and demand to correctly execute immersive VR modalities, as well as the—until recently—substantial expense. This might be another reason why the mean PEDro scores for immersive VR RCTs were lower than the mean scores found in nonimmersive RCTs.

Limitations

This review was limited by several factors related to the included studies. A variety of rating scales were used in the immersive and nonimmersive VR studies. Although there was some general overlap with common measurements such as gait, balance, kinematics, and VR feasibility, no studies had the same primary and secondary outcomes. Such heterogeneity in protocols and outcomes limited our ability to draw conclusions from these differing studies. Additionally, the average number of participants of both immersive and nonimmersive studies were small and the statistical significance of findings should be interpreted with caution. Finally, VR devices and systems differed between studies, further limiting comparisons. Although these factors limit this systematic review, we can still identify treatment and research implications. Adequately powered future studies with standardized protocols would further improve the available evidence and support for VR as an intervention.

Conclusions

VR therapy is a promising rehabilitation modality for PD. Additional investigations of VR therapy and PD should include direct comparisons between immersive and nonimmersive VR therapies. It could be hypothesized that the greater immersion and engagement potential of immersive VR would demonstrate greater functional improvement compared with nonimmersive VR, but there is no data to support this for PD. VR therapy for PD appears to be a relatively safe alternative or adjunct to traditional therapy with a potentially positive impact on a variety of symptoms and is growing as an innovative therapeutic approach for PD patients.

Surgical treatment of degenerative lumbar spine disease has been rising steadily in the United States, and an increasing fraction of surgery involves lumbar fusion.^1,2 Various techniques are used to accomplish a lumbar fusion, including noninstrumented fusion, anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (XLIF, OLIF), posterior pedicle screw fusion, posterior cortical screw fusion, posterior interbody fusion (TLIF, PLIF), and interspinous process fusion. Rigid, metallic fusion hardware provides high stability and fusion rates, but it likely leads to stress shielding and adjacent segment disease.³ There is interest in less rigid and dynamic stabilization techniques to reduce the risk of adjacent segment disease, such as polyetheretherketone (PEEK) rods, which have been available since 2007. However, literature regarding PEEK rod utility is sparse and of mixed outcomes.^3,4 Additional patient reported outcome (PRO) information would be useful to both surgeons and patients. Using institutional data, this review was designed to examine our experience with PEEK rod lumbar fusion and to document PROs.

Methods

The study was approved by the institutional review board at the US Department of Veterans Affairs (VA) Portland Health Care System (VAPHCS) in Oregon with a waiver of authorization. In this retrospective, single center study, data were queried from the senior author’s (DAR) case logs from VA Computerized Patient Record System (CPRS). Electronic medical records, imaging, and PROs of all consecutive patients undergoing lumbar fusion at 1 or 2 levels with PEEK rods for degenerative disease were retrospectively reviewed. Cases of trauma, malignancy, or infection were excluded. From March 2011 through October 2019, 108 patients underwent lumbar fusion with PEEK rods.

Surgeries were conducted on a Mizuho OSI Jackson Table via bilateral 3 to 4 cm Wiltse incisions using the Medtronic Quadrant retractor system. Medtronic O-Arm images were acquired and delivered to a Medtronic Stealth Station for navigation of the screws. Monopolar coagulation was not used. PEEK pedicle screws were placed and verified with a second O-Arm spin before placing lordotic PEEK rods in the screw heads. No attempt was made to reduce any spondylolisthesis, but distraction was used to open the foramina and indirectly decompress the canal. An interbody device was placed only in treatment of multiply recurrent disc protrusion. After decortication of the transverse processes and facets, intertransverse fusion constructs consisting of calcium hydroxyapatite soaked in autologous bone marrow blood and wrapped in 6-mg bone morphogenetic protein-soaked sponges were placed on the bone. If canal decompression was indicated, a Medtronic Metrx retractor tube was then placed through one of the incisions and decompression carried out. Wounds were closed with absorbable suture. No bracing was used postoperatively. Figure 1 shows a typical single level PEEK rod fusion construct.

Statistical Analysis

Pre- and postoperative pairwise t tests were completed for patients with a complete data, using SAS 9.2 statistical package. Data are presented as standard deviation (SD) of the mean.

Results

Following application of the inclusion/exclusion criteria, 108 patients had undergone lumbar fusion with PEEK rods. Mean (SD) patient age was 60.2 (10.3) years and 88 patients were male (Table 1). Most surgeries were at L5-S1 and L4-5. There were 97 single-level fusions and 11 bilevel fusions. Seventy-four procedures were for spondylolisthesis, 23 for foraminal stenosis, 5 for degenerative disc disease, 3 for coronal imbalance with foraminal stenosis, 2 for pseudarthrosis after surgery elsewhere, and 1 for multiple recurrent disc herniation (Table 2). Twenty-five patients (23.1%) were current tobacco users and 28 (25.9%) were former smokers, 26 (24.1%) had diabetes mellitus (DM), 16 (14.8%) had low bone density by dual energy X-ray absorptiometry (DEXA) imaging, 35 (32.4%) had depression, and 7 (6.5%) were taking an immunosuppressive agent (chronic steroids, biological response modifiers, or methotrexate). Mean body mass index was 30.1.

Surgical Procedure

Of the 108 patients, the first 18 underwent a procedure with fluoroscopic guidance and the Medtronic FluoroNav and Stealth Systems. The next 90 patients underwent a procedure with O-Arm intraoperative CT scanning and Stealth frameless stereotactic navigation. The mean (SD) length of stay was 1.7 (1.3) days. There were no wound infections and no new neurologic deficits. Mean (SD) follow up time was 30.3 (21.8) months.

Imaging

Final imaging was by radiograph in 73 patients, CT in 31, and magnetic resonance imaging (MRI) in 3 (1 patient had no imaging). Sixty-seven patients (62.0%) had a bilateral arthrodesis, and 15 (13.9%) had at least a unilateral arthrodesis. MRI was not used to assess arthrodesis. Eight patients (7.4%) had no definite arthrodesis. Seventeen patients had inadequate or early imaging from which a fusion determination could not be made. Of 81 patients with > 11 months of follow up, 58 (71.6%) had a bilateral arthrodesis, 12 (14.8%) had a unilateral arthrodesis, 8 (9.9%) had no arthrodesis, and 3 (3.7%) were indeterminate.

No patient had any revision fusion surgery at the index level during follow up. Two patients had adjacent level fusions at 27 and 60 months after the index procedure. One patient had a laminectomy at an adjacent segment at 18 months postfusion, and 1 had a foraminotomy at an adjacent segment 89 months post fusion (Figure 3). Overall, there were 4 (3.7%) adjacent segment surgeries at a mean of 48.5 months after surgery. One patient had a sacro-iliac joint fusion below an L5-S1 fusion 17 months prior for persisting pain after the fusion procedure.

Patient Reported Outcomes

Preoperative SF-36 PF and ODI scores were available for 81 patients (Table 3). Postoperative SF-36 PF scores were obtained at 3 months for 65 of these patients, and at 1 year for 63 patients. Postoperative ODI scores were obtained at 3 months for 65 patients, and at 1 year for 55 patients. Among the 65 patients with completed SF-36 scores at 3 months, a mean increase of 22.4 (95% CI, 17-27; P < .001) was noted, and for the 63 patients at 1 year a mean increase of 30.3 (95% CI, 25-35; P < .001) was noted. Among the 65 patients with completed ODI scores at 3 months, a mean decrease of 6.8 (95% CI, 4.9-8.6; P < .001) was noted, and for the 55 patients with completed ODI scores at 1 year a mean decrease of 10.3 (n = 55; 95% CI, 8.4-12.2; P < .001) was noted.

Cost

We compared the hardware cost of a single level construct consisting of 4 pedicle screws, 4 locking caps, and 2 rods using a PEEK system with that of 2 other titanium construct systems. At VAPHCS, the PEEK system cost was about 71% of the cost of 2 other titanium construct systems and 62% of the cost when compared with Medtronic titanium rods.

Discussion

PEEK is useful for spine and cranial implants. It is inert and fully biocompatible with a modulus of elasticity between that of cortical and cancellous bone, and much lower than that of titanium, and is therefore considered to be semirigid.^3,4,6 PEEK rods are intermediate in stiffness between titanium rods (110 Gigapascals) and dynamic devices such as the Zimmer Biomet DYNESYS dynamic stabilization system or the Premia Spine TOPS system.³ Carbon fiber rods and carbon fiber reinforced PEEK implants are other semirigid rod alternatives.^7,8 PEEK rods for posterior lumbar fusion surgery were introduced in 2007. Li and colleagues provide a thorough review of the biomechanical properties of PEEK rods.³

PEEK is thought to have several advantages when compared with titanium. These advantages include more physiologic load sharing and reduction in stress shielding, improved durability, reduced risk of failure in osteoporotic bone, less wear debris, no change in bone forming environment, and imaging radiolucency.^4,9 Spinal PEEK cages have been reported to allow more uniform radiation dose distribution compared with metal constructs, an advantage that also may pertain to PEEK rods.¹⁰ Disadvantages of PEEK rods include an inability to detect rod breakage easily, lack of data on the use in more than minimally unstable clinical situations, and greater expense, although this was not the authors’ observation.^3,4,11

Importantly, it has been reported that PEEK rods permit a greater range of motion in all planes when compared with titanium rods.⁹ Polyetheretherketone rods unload the bone screw interface and increased the anterior column load to a more physiologic 75% when compared with titanium rods.^6,9 However, in another biomechanical study that compared titanium rods, PEEK rods, and a dynamic stabilization device, it was reported that anterior load sharing was 55%, 59%, and 75%, respectively.¹² This indicated that PEEK rods are closer to metal rods than truly dynamic devices for anterior load sharing. The endurance limit of a PEEK rod construct was similar to that of clinically useful metal systems.⁹ PEEK rods resulted in no increase in postfatigue motion compared with titanium rods in a biomechanical model.¹³ Intradiscal pressures at PEEK instrumented segments were similar to uninstrumented segments and greater than those with titanium rod constructs.¹⁴ Intradiscal pressures at adjacent segments were highest with dynamic devices, intermediate with semirigid rods, and lowest with rigid constructs; however, stress values at adjacent segments were lower in PEEK than titanium constructs in any direction of motion.^15,16

Fusion Rates

The use of PEEK rods in lumbar fusion has been reported previously.^3,4,17,18 However, these studies featured small sample sizes, short follow up times, and contradictory results.⁴ Of 8 outcome reports found in a systematic review, 2 studies reported on procedures designed to create nonfusion outcomes (a third similar trial from 2013 was not included in the systematic review), and 1 study reported only on the condition of PEEK rods removed at subsequent surgery.^3,19-21 Reported fusion rates varied from 86 to 100%.

In 42 patients with PEEK rod fusions who were followed for a mean of 31.4 months, 5 patients required adjacent segment surgery and 3 patients were treated for interbody cage migration and nonunion.¹⁷ Radiographic fusion rate was 86%. These authors concluded that PEEK rod fusion results were similar to those of other constructs, but not better, or perhaps worse than, metal rods.

Other studies have reported better results with PEEK.^{11,18,19,22-24} Highsmith and colleagues reported on 3 successful example cases of the use of PEEK rods.¹¹ De Iure and colleagues reported on 30 cases up to 5 levels (mean, 2.9) using autograft bone, with a mean follow up of 18 months.²³ Results were reported as satisfactory. Three patients had radiographic nonunions, 1 of which required revision for asymptomatic screw loosening at the cranial end of the construct. Qi and colleagues, reported on 20 patients with PEEK rods compared to 21 patients with titanium alloy rods.²⁴ Both groups had similar clinical outcomes, structural parameters, and 100% fusion rates. Athanasakopoulos and colleagues reported on 52 patients with up to 3 level fusions followed for a mean of 3 years.²² There were significant improvements in PROs: at 1 year 96% had radiographic union. Two patients had screw breakage, 1 of whom required revision to a metal rod construct. Colangeli and colleagues reported on 12 patients treated with PEEK rods compared with 12 who were treated with a dynamic system.¹⁸ They reported significant improvements, no complications, and 100% fusion at 6 months. Huang and colleagues reported on 38 patients intended to undergo a nonfusion procedure with 2 years of follow up.¹⁹ They reported good outcomes and 1 case of screw loosening. As no fusion was intended, no fusion outcomes were reported. All these studies suggested that longer follow up and more patients would be needed to assess the role of PEEK rods in lumbar fusion.³

Our results show a radiographic fusion rate of 86.4% and a radiographic nonunion rate of 9.9% in patients followed for at least 12 months. There was no clinical need for revision fusion at the index level. In our retrospective review, patients had high levels of smoking, DM, depression, immunosuppression, and obesity, which may negatively influence radiographic fusion rates when compared with other studies with 100% reported fusion rates. There was no instance of construct breakage or screw breakout, indicating that PEEK rods may allow enough flexibility to avoid construct failure under stress as in a fall.

Patient Reported Outcomes

Recent large studies were reviewed to assess the pre- and postoperative patient PROs reported in comparison with our study population (Table 4). In the Swedish Spine Registry analysis of 765 patients with 3 different types of lumbar fusion, the mean preoperative ODI score was 37 and mean SF-36 physical component score (PCS) was 35 for the most similar approach (posterolateral fusion with instrumentation).²⁵ At 1 year postoperation, the mean ODI was 26 and mean SF-36 PCS was 43. In the Spine Patient Outcomes Research Trial (SPORT) spondylolisthesis trial of 3 fusion types, the mean preoperative ODI was 41.2 and mean SF-36 PF score was 31.2 for the most similar approach (posterolateral instrumented fusion with pedicle screws).²⁶ Postoperative ODI scores at 1 year decreased by a mean 20.9 points and mean SF-36 PF scores increased by 29.9.

We report a mean preoperative SF-36 PF score of 28.9, which is lower than the SPORT study score for posterolateral fusion with instrumentation and the Swedish Study score for posterolateral instrumented fusion with pedicle screws. Similarly, our mean ODI score of 24.8 was better than the scores reported in the Swedish and SPORT studies. Our mean SF-36 PF score at 1 year postoperation was 59.3, compared with 58.5 for the SPORT study group and 46.0 in the Swedish study group. Mean ODI score at 1 year postoperatively was 14.5, which is better than the scores reported in the Swedish and SPORT studies.

Minimally clinically important difference (MCID) is a parameter used to gauge the efficacy of spine surgery. The utility of the MCID based upon PROs has been questioned in lumbar fusion surgery, as it has been thought to measure if the patient is “feeling” rather than “doing” better, the latter of which can be better measured by functional performance measures and objective, external socioeconomic anchors such as return to work and health care costs.²⁷ Nevertheless, validated PROs are reported widely in the spine surgery literature. The MCID in the SF-36 is not well established and can depend upon whether the scores are at the extremes or more in the central range and whether there is large variability in the scores.²⁸ Rheumatoid arthritis was estimated to be 7.1 points on the PF scale and 7.2 on the physical component summary (PCS).²⁹ For total knee replacement, it has been estimated to be 10 points on the SF-36 PCS.³⁰ Lumbar surgery was estimated to be 4.9 points for the SF-36 PCS and 12.8 points for the ODI.³¹ And the SPORT trial it has been estimated that a 30% change in the possible gain (or loss) may be an appropriate criterion.²⁸

With a preoperative mean SF-36 PF of 28.9, a 30% improvement in the available range (70.1) would be 21 points, making our data mean improvement of 30 points above the MCID. With a mean preoperative ODI of 24.6, a 30% improvement in the available range (25.4) would be 7.6 points, making our data mean improvement of 10.3 points better than the MCID. Therefore, our outcome results are comparable with other lumbar fusion outcome studies in terms of degree of disability prior to surgery and amount of improvement from surgery.

Adjacent Segment Disease

The precise factors resulting in adjacent segment disease are not fully defined.^3,32 In reviews of lumbar adjacent segment disease, reported rates ranged from 2.5% at 1 year up to 80 to 100% at 10 years, with lower rates with noninstrumented fusions.^4,32-34 Annual incidence of symptomatic adjacent segment disease following lumbar fusion ranges from 0.6 to 3.9% per year.^32,35,36 Mismatch between lumbar lordosis and pelvic incidence after fusion is thought to lead to higher rates of adjacent segment disease, as can a laminectomy at an adjacent segment.^32,36 Percutaneous fusion techniques or use of the Wiltse approach may lower the risk of adjacent segment disease due to avoidance of facet capsule disruption.^37,38

Dynamic stabilization techniques do not appear be clearly protective against adjacent segment disease, although biomechanical models suggest that they may do so.^33,39,40 A review by Wang and colleagues pooled studies to assess the risk of lumbar adjacent segment disease in spinal fusion to compare to disc arthroplasty and concluded that fusion carried a higher risk of adjacent segment disease.⁴¹ Definitive data on other types of motion preservation devices is lacking.³We show 3 adjacent segment fusions and 1 laminectomy have been needed in 108 patients and at a mean of 46 months after the index procedure and over 2.5 years of mean overall follow up. This is a low adjacent segment surgery rate compared to the historical data cited above, and may suggest some advantage for PEEK rods over more rigid constructs.

Strengths and Limitations

Strengths of this study include larger numbers than prior series of PEEK rod use and use in a population with high comorbidities linked to poor results without reduction in good outcomes. PEEK rods as used at the VAPHCS do not result in higher instrumentation costs than all metal constructs.

Study limitations include the retrospective nature with loss of follow up on some patients and incomplete radiographic and PROs in some patients. The use of 100% stereotactic guidance, the avoidance of interbody devices, and the off-label use of bone morphogenetic protein as part of the fusion construct introduce additional variables that may influence comparison to other studies. To avoid unnecessary radiation exposure, flexion extension films or CT scans were not routinely obtained if patients were doing well.⁴² Additionally, the degree of motion on dynamic views that would differentiate pseudarthrosis from arthrodesis has not been defined.⁵

Conclusions

The results presented show that lumbar fusion with PEEK rods can be undertaken with short hospitalization times and low complication rates, produce satisfactory clinical improvements, and result in radiographic fusion rates similar to metal constructs. Low rates of hardware failure or need for revision surgery were found. Preliminarily results of low rates of adjacent segment surgery are comparable with previously published metal construct rates. Longer follow up is needed to confirm these findings and to investigate whether semirigid constructs truly offer some protection from adjacent segment disease when compared to all metal constructs.

Acknowledgments
The authors thank Shirley McCartney, PhD, for editorial assistance.

Surgical treatment of degenerative lumbar spine disease has been rising steadily in the United States, and an increasing fraction of surgery involves lumbar fusion.^1,2 Various techniques are used to accomplish a lumbar fusion, including noninstrumented fusion, anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (XLIF, OLIF), posterior pedicle screw fusion, posterior cortical screw fusion, posterior interbody fusion (TLIF, PLIF), and interspinous process fusion. Rigid, metallic fusion hardware provides high stability and fusion rates, but it likely leads to stress shielding and adjacent segment disease.³ There is interest in less rigid and dynamic stabilization techniques to reduce the risk of adjacent segment disease, such as polyetheretherketone (PEEK) rods, which have been available since 2007. However, literature regarding PEEK rod utility is sparse and of mixed outcomes.^3,4 Additional patient reported outcome (PRO) information would be useful to both surgeons and patients. Using institutional data, this review was designed to examine our experience with PEEK rod lumbar fusion and to document PROs.

Methods

The study was approved by the institutional review board at the US Department of Veterans Affairs (VA) Portland Health Care System (VAPHCS) in Oregon with a waiver of authorization. In this retrospective, single center study, data were queried from the senior author’s (DAR) case logs from VA Computerized Patient Record System (CPRS). Electronic medical records, imaging, and PROs of all consecutive patients undergoing lumbar fusion at 1 or 2 levels with PEEK rods for degenerative disease were retrospectively reviewed. Cases of trauma, malignancy, or infection were excluded. From March 2011 through October 2019, 108 patients underwent lumbar fusion with PEEK rods.

Surgeries were conducted on a Mizuho OSI Jackson Table via bilateral 3 to 4 cm Wiltse incisions using the Medtronic Quadrant retractor system. Medtronic O-Arm images were acquired and delivered to a Medtronic Stealth Station for navigation of the screws. Monopolar coagulation was not used. PEEK pedicle screws were placed and verified with a second O-Arm spin before placing lordotic PEEK rods in the screw heads. No attempt was made to reduce any spondylolisthesis, but distraction was used to open the foramina and indirectly decompress the canal. An interbody device was placed only in treatment of multiply recurrent disc protrusion. After decortication of the transverse processes and facets, intertransverse fusion constructs consisting of calcium hydroxyapatite soaked in autologous bone marrow blood and wrapped in 6-mg bone morphogenetic protein-soaked sponges were placed on the bone. If canal decompression was indicated, a Medtronic Metrx retractor tube was then placed through one of the incisions and decompression carried out. Wounds were closed with absorbable suture. No bracing was used postoperatively. Figure 1 shows a typical single level PEEK rod fusion construct.

Statistical Analysis

Pre- and postoperative pairwise t tests were completed for patients with a complete data, using SAS 9.2 statistical package. Data are presented as standard deviation (SD) of the mean.

Results

Following application of the inclusion/exclusion criteria, 108 patients had undergone lumbar fusion with PEEK rods. Mean (SD) patient age was 60.2 (10.3) years and 88 patients were male (Table 1). Most surgeries were at L5-S1 and L4-5. There were 97 single-level fusions and 11 bilevel fusions. Seventy-four procedures were for spondylolisthesis, 23 for foraminal stenosis, 5 for degenerative disc disease, 3 for coronal imbalance with foraminal stenosis, 2 for pseudarthrosis after surgery elsewhere, and 1 for multiple recurrent disc herniation (Table 2). Twenty-five patients (23.1%) were current tobacco users and 28 (25.9%) were former smokers, 26 (24.1%) had diabetes mellitus (DM), 16 (14.8%) had low bone density by dual energy X-ray absorptiometry (DEXA) imaging, 35 (32.4%) had depression, and 7 (6.5%) were taking an immunosuppressive agent (chronic steroids, biological response modifiers, or methotrexate). Mean body mass index was 30.1.

Surgical Procedure

Of the 108 patients, the first 18 underwent a procedure with fluoroscopic guidance and the Medtronic FluoroNav and Stealth Systems. The next 90 patients underwent a procedure with O-Arm intraoperative CT scanning and Stealth frameless stereotactic navigation. The mean (SD) length of stay was 1.7 (1.3) days. There were no wound infections and no new neurologic deficits. Mean (SD) follow up time was 30.3 (21.8) months.

Imaging

Final imaging was by radiograph in 73 patients, CT in 31, and magnetic resonance imaging (MRI) in 3 (1 patient had no imaging). Sixty-seven patients (62.0%) had a bilateral arthrodesis, and 15 (13.9%) had at least a unilateral arthrodesis. MRI was not used to assess arthrodesis. Eight patients (7.4%) had no definite arthrodesis. Seventeen patients had inadequate or early imaging from which a fusion determination could not be made. Of 81 patients with > 11 months of follow up, 58 (71.6%) had a bilateral arthrodesis, 12 (14.8%) had a unilateral arthrodesis, 8 (9.9%) had no arthrodesis, and 3 (3.7%) were indeterminate.

No patient had any revision fusion surgery at the index level during follow up. Two patients had adjacent level fusions at 27 and 60 months after the index procedure. One patient had a laminectomy at an adjacent segment at 18 months postfusion, and 1 had a foraminotomy at an adjacent segment 89 months post fusion (Figure 3). Overall, there were 4 (3.7%) adjacent segment surgeries at a mean of 48.5 months after surgery. One patient had a sacro-iliac joint fusion below an L5-S1 fusion 17 months prior for persisting pain after the fusion procedure.

Patient Reported Outcomes

Preoperative SF-36 PF and ODI scores were available for 81 patients (Table 3). Postoperative SF-36 PF scores were obtained at 3 months for 65 of these patients, and at 1 year for 63 patients. Postoperative ODI scores were obtained at 3 months for 65 patients, and at 1 year for 55 patients. Among the 65 patients with completed SF-36 scores at 3 months, a mean increase of 22.4 (95% CI, 17-27; P < .001) was noted, and for the 63 patients at 1 year a mean increase of 30.3 (95% CI, 25-35; P < .001) was noted. Among the 65 patients with completed ODI scores at 3 months, a mean decrease of 6.8 (95% CI, 4.9-8.6; P < .001) was noted, and for the 55 patients with completed ODI scores at 1 year a mean decrease of 10.3 (n = 55; 95% CI, 8.4-12.2; P < .001) was noted.

Cost

We compared the hardware cost of a single level construct consisting of 4 pedicle screws, 4 locking caps, and 2 rods using a PEEK system with that of 2 other titanium construct systems. At VAPHCS, the PEEK system cost was about 71% of the cost of 2 other titanium construct systems and 62% of the cost when compared with Medtronic titanium rods.

Discussion

PEEK is useful for spine and cranial implants. It is inert and fully biocompatible with a modulus of elasticity between that of cortical and cancellous bone, and much lower than that of titanium, and is therefore considered to be semirigid.^3,4,6 PEEK rods are intermediate in stiffness between titanium rods (110 Gigapascals) and dynamic devices such as the Zimmer Biomet DYNESYS dynamic stabilization system or the Premia Spine TOPS system.³ Carbon fiber rods and carbon fiber reinforced PEEK implants are other semirigid rod alternatives.^7,8 PEEK rods for posterior lumbar fusion surgery were introduced in 2007. Li and colleagues provide a thorough review of the biomechanical properties of PEEK rods.³

PEEK is thought to have several advantages when compared with titanium. These advantages include more physiologic load sharing and reduction in stress shielding, improved durability, reduced risk of failure in osteoporotic bone, less wear debris, no change in bone forming environment, and imaging radiolucency.^4,9 Spinal PEEK cages have been reported to allow more uniform radiation dose distribution compared with metal constructs, an advantage that also may pertain to PEEK rods.¹⁰ Disadvantages of PEEK rods include an inability to detect rod breakage easily, lack of data on the use in more than minimally unstable clinical situations, and greater expense, although this was not the authors’ observation.^3,4,11

Importantly, it has been reported that PEEK rods permit a greater range of motion in all planes when compared with titanium rods.⁹ Polyetheretherketone rods unload the bone screw interface and increased the anterior column load to a more physiologic 75% when compared with titanium rods.^6,9 However, in another biomechanical study that compared titanium rods, PEEK rods, and a dynamic stabilization device, it was reported that anterior load sharing was 55%, 59%, and 75%, respectively.¹² This indicated that PEEK rods are closer to metal rods than truly dynamic devices for anterior load sharing. The endurance limit of a PEEK rod construct was similar to that of clinically useful metal systems.⁹ PEEK rods resulted in no increase in postfatigue motion compared with titanium rods in a biomechanical model.¹³ Intradiscal pressures at PEEK instrumented segments were similar to uninstrumented segments and greater than those with titanium rod constructs.¹⁴ Intradiscal pressures at adjacent segments were highest with dynamic devices, intermediate with semirigid rods, and lowest with rigid constructs; however, stress values at adjacent segments were lower in PEEK than titanium constructs in any direction of motion.^15,16

Fusion Rates

The use of PEEK rods in lumbar fusion has been reported previously.^3,4,17,18 However, these studies featured small sample sizes, short follow up times, and contradictory results.⁴ Of 8 outcome reports found in a systematic review, 2 studies reported on procedures designed to create nonfusion outcomes (a third similar trial from 2013 was not included in the systematic review), and 1 study reported only on the condition of PEEK rods removed at subsequent surgery.^3,19-21 Reported fusion rates varied from 86 to 100%.

In 42 patients with PEEK rod fusions who were followed for a mean of 31.4 months, 5 patients required adjacent segment surgery and 3 patients were treated for interbody cage migration and nonunion.¹⁷ Radiographic fusion rate was 86%. These authors concluded that PEEK rod fusion results were similar to those of other constructs, but not better, or perhaps worse than, metal rods.

Other studies have reported better results with PEEK.^{11,18,19,22-24} Highsmith and colleagues reported on 3 successful example cases of the use of PEEK rods.¹¹ De Iure and colleagues reported on 30 cases up to 5 levels (mean, 2.9) using autograft bone, with a mean follow up of 18 months.²³ Results were reported as satisfactory. Three patients had radiographic nonunions, 1 of which required revision for asymptomatic screw loosening at the cranial end of the construct. Qi and colleagues, reported on 20 patients with PEEK rods compared to 21 patients with titanium alloy rods.²⁴ Both groups had similar clinical outcomes, structural parameters, and 100% fusion rates. Athanasakopoulos and colleagues reported on 52 patients with up to 3 level fusions followed for a mean of 3 years.²² There were significant improvements in PROs: at 1 year 96% had radiographic union. Two patients had screw breakage, 1 of whom required revision to a metal rod construct. Colangeli and colleagues reported on 12 patients treated with PEEK rods compared with 12 who were treated with a dynamic system.¹⁸ They reported significant improvements, no complications, and 100% fusion at 6 months. Huang and colleagues reported on 38 patients intended to undergo a nonfusion procedure with 2 years of follow up.¹⁹ They reported good outcomes and 1 case of screw loosening. As no fusion was intended, no fusion outcomes were reported. All these studies suggested that longer follow up and more patients would be needed to assess the role of PEEK rods in lumbar fusion.³

Our results show a radiographic fusion rate of 86.4% and a radiographic nonunion rate of 9.9% in patients followed for at least 12 months. There was no clinical need for revision fusion at the index level. In our retrospective review, patients had high levels of smoking, DM, depression, immunosuppression, and obesity, which may negatively influence radiographic fusion rates when compared with other studies with 100% reported fusion rates. There was no instance of construct breakage or screw breakout, indicating that PEEK rods may allow enough flexibility to avoid construct failure under stress as in a fall.

Patient Reported Outcomes

Recent large studies were reviewed to assess the pre- and postoperative patient PROs reported in comparison with our study population (Table 4). In the Swedish Spine Registry analysis of 765 patients with 3 different types of lumbar fusion, the mean preoperative ODI score was 37 and mean SF-36 physical component score (PCS) was 35 for the most similar approach (posterolateral fusion with instrumentation).²⁵ At 1 year postoperation, the mean ODI was 26 and mean SF-36 PCS was 43. In the Spine Patient Outcomes Research Trial (SPORT) spondylolisthesis trial of 3 fusion types, the mean preoperative ODI was 41.2 and mean SF-36 PF score was 31.2 for the most similar approach (posterolateral instrumented fusion with pedicle screws).²⁶ Postoperative ODI scores at 1 year decreased by a mean 20.9 points and mean SF-36 PF scores increased by 29.9.

We report a mean preoperative SF-36 PF score of 28.9, which is lower than the SPORT study score for posterolateral fusion with instrumentation and the Swedish Study score for posterolateral instrumented fusion with pedicle screws. Similarly, our mean ODI score of 24.8 was better than the scores reported in the Swedish and SPORT studies. Our mean SF-36 PF score at 1 year postoperation was 59.3, compared with 58.5 for the SPORT study group and 46.0 in the Swedish study group. Mean ODI score at 1 year postoperatively was 14.5, which is better than the scores reported in the Swedish and SPORT studies.

Minimally clinically important difference (MCID) is a parameter used to gauge the efficacy of spine surgery. The utility of the MCID based upon PROs has been questioned in lumbar fusion surgery, as it has been thought to measure if the patient is “feeling” rather than “doing” better, the latter of which can be better measured by functional performance measures and objective, external socioeconomic anchors such as return to work and health care costs.²⁷ Nevertheless, validated PROs are reported widely in the spine surgery literature. The MCID in the SF-36 is not well established and can depend upon whether the scores are at the extremes or more in the central range and whether there is large variability in the scores.²⁸ Rheumatoid arthritis was estimated to be 7.1 points on the PF scale and 7.2 on the physical component summary (PCS).²⁹ For total knee replacement, it has been estimated to be 10 points on the SF-36 PCS.³⁰ Lumbar surgery was estimated to be 4.9 points for the SF-36 PCS and 12.8 points for the ODI.³¹ And the SPORT trial it has been estimated that a 30% change in the possible gain (or loss) may be an appropriate criterion.²⁸

With a preoperative mean SF-36 PF of 28.9, a 30% improvement in the available range (70.1) would be 21 points, making our data mean improvement of 30 points above the MCID. With a mean preoperative ODI of 24.6, a 30% improvement in the available range (25.4) would be 7.6 points, making our data mean improvement of 10.3 points better than the MCID. Therefore, our outcome results are comparable with other lumbar fusion outcome studies in terms of degree of disability prior to surgery and amount of improvement from surgery.

Adjacent Segment Disease

The precise factors resulting in adjacent segment disease are not fully defined.^3,32 In reviews of lumbar adjacent segment disease, reported rates ranged from 2.5% at 1 year up to 80 to 100% at 10 years, with lower rates with noninstrumented fusions.^4,32-34 Annual incidence of symptomatic adjacent segment disease following lumbar fusion ranges from 0.6 to 3.9% per year.^32,35,36 Mismatch between lumbar lordosis and pelvic incidence after fusion is thought to lead to higher rates of adjacent segment disease, as can a laminectomy at an adjacent segment.^32,36 Percutaneous fusion techniques or use of the Wiltse approach may lower the risk of adjacent segment disease due to avoidance of facet capsule disruption.^37,38

Dynamic stabilization techniques do not appear be clearly protective against adjacent segment disease, although biomechanical models suggest that they may do so.^33,39,40 A review by Wang and colleagues pooled studies to assess the risk of lumbar adjacent segment disease in spinal fusion to compare to disc arthroplasty and concluded that fusion carried a higher risk of adjacent segment disease.⁴¹ Definitive data on other types of motion preservation devices is lacking.³We show 3 adjacent segment fusions and 1 laminectomy have been needed in 108 patients and at a mean of 46 months after the index procedure and over 2.5 years of mean overall follow up. This is a low adjacent segment surgery rate compared to the historical data cited above, and may suggest some advantage for PEEK rods over more rigid constructs.

Strengths and Limitations

Strengths of this study include larger numbers than prior series of PEEK rod use and use in a population with high comorbidities linked to poor results without reduction in good outcomes. PEEK rods as used at the VAPHCS do not result in higher instrumentation costs than all metal constructs.

Study limitations include the retrospective nature with loss of follow up on some patients and incomplete radiographic and PROs in some patients. The use of 100% stereotactic guidance, the avoidance of interbody devices, and the off-label use of bone morphogenetic protein as part of the fusion construct introduce additional variables that may influence comparison to other studies. To avoid unnecessary radiation exposure, flexion extension films or CT scans were not routinely obtained if patients were doing well.⁴² Additionally, the degree of motion on dynamic views that would differentiate pseudarthrosis from arthrodesis has not been defined.⁵

Conclusions

The results presented show that lumbar fusion with PEEK rods can be undertaken with short hospitalization times and low complication rates, produce satisfactory clinical improvements, and result in radiographic fusion rates similar to metal constructs. Low rates of hardware failure or need for revision surgery were found. Preliminarily results of low rates of adjacent segment surgery are comparable with previously published metal construct rates. Longer follow up is needed to confirm these findings and to investigate whether semirigid constructs truly offer some protection from adjacent segment disease when compared to all metal constructs.

Acknowledgments
The authors thank Shirley McCartney, PhD, for editorial assistance.

Surgical treatment of degenerative lumbar spine disease has been rising steadily in the United States, and an increasing fraction of surgery involves lumbar fusion.^1,2 Various techniques are used to accomplish a lumbar fusion, including noninstrumented fusion, anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (XLIF, OLIF), posterior pedicle screw fusion, posterior cortical screw fusion, posterior interbody fusion (TLIF, PLIF), and interspinous process fusion. Rigid, metallic fusion hardware provides high stability and fusion rates, but it likely leads to stress shielding and adjacent segment disease.³ There is interest in less rigid and dynamic stabilization techniques to reduce the risk of adjacent segment disease, such as polyetheretherketone (PEEK) rods, which have been available since 2007. However, literature regarding PEEK rod utility is sparse and of mixed outcomes.^3,4 Additional patient reported outcome (PRO) information would be useful to both surgeons and patients. Using institutional data, this review was designed to examine our experience with PEEK rod lumbar fusion and to document PROs.

Methods

The study was approved by the institutional review board at the US Department of Veterans Affairs (VA) Portland Health Care System (VAPHCS) in Oregon with a waiver of authorization. In this retrospective, single center study, data were queried from the senior author’s (DAR) case logs from VA Computerized Patient Record System (CPRS). Electronic medical records, imaging, and PROs of all consecutive patients undergoing lumbar fusion at 1 or 2 levels with PEEK rods for degenerative disease were retrospectively reviewed. Cases of trauma, malignancy, or infection were excluded. From March 2011 through October 2019, 108 patients underwent lumbar fusion with PEEK rods.

Surgeries were conducted on a Mizuho OSI Jackson Table via bilateral 3 to 4 cm Wiltse incisions using the Medtronic Quadrant retractor system. Medtronic O-Arm images were acquired and delivered to a Medtronic Stealth Station for navigation of the screws. Monopolar coagulation was not used. PEEK pedicle screws were placed and verified with a second O-Arm spin before placing lordotic PEEK rods in the screw heads. No attempt was made to reduce any spondylolisthesis, but distraction was used to open the foramina and indirectly decompress the canal. An interbody device was placed only in treatment of multiply recurrent disc protrusion. After decortication of the transverse processes and facets, intertransverse fusion constructs consisting of calcium hydroxyapatite soaked in autologous bone marrow blood and wrapped in 6-mg bone morphogenetic protein-soaked sponges were placed on the bone. If canal decompression was indicated, a Medtronic Metrx retractor tube was then placed through one of the incisions and decompression carried out. Wounds were closed with absorbable suture. No bracing was used postoperatively. Figure 1 shows a typical single level PEEK rod fusion construct.

Statistical Analysis

Pre- and postoperative pairwise t tests were completed for patients with a complete data, using SAS 9.2 statistical package. Data are presented as standard deviation (SD) of the mean.

Results

Following application of the inclusion/exclusion criteria, 108 patients had undergone lumbar fusion with PEEK rods. Mean (SD) patient age was 60.2 (10.3) years and 88 patients were male (Table 1). Most surgeries were at L5-S1 and L4-5. There were 97 single-level fusions and 11 bilevel fusions. Seventy-four procedures were for spondylolisthesis, 23 for foraminal stenosis, 5 for degenerative disc disease, 3 for coronal imbalance with foraminal stenosis, 2 for pseudarthrosis after surgery elsewhere, and 1 for multiple recurrent disc herniation (Table 2). Twenty-five patients (23.1%) were current tobacco users and 28 (25.9%) were former smokers, 26 (24.1%) had diabetes mellitus (DM), 16 (14.8%) had low bone density by dual energy X-ray absorptiometry (DEXA) imaging, 35 (32.4%) had depression, and 7 (6.5%) were taking an immunosuppressive agent (chronic steroids, biological response modifiers, or methotrexate). Mean body mass index was 30.1.

Surgical Procedure

Of the 108 patients, the first 18 underwent a procedure with fluoroscopic guidance and the Medtronic FluoroNav and Stealth Systems. The next 90 patients underwent a procedure with O-Arm intraoperative CT scanning and Stealth frameless stereotactic navigation. The mean (SD) length of stay was 1.7 (1.3) days. There were no wound infections and no new neurologic deficits. Mean (SD) follow up time was 30.3 (21.8) months.

Imaging

Final imaging was by radiograph in 73 patients, CT in 31, and magnetic resonance imaging (MRI) in 3 (1 patient had no imaging). Sixty-seven patients (62.0%) had a bilateral arthrodesis, and 15 (13.9%) had at least a unilateral arthrodesis. MRI was not used to assess arthrodesis. Eight patients (7.4%) had no definite arthrodesis. Seventeen patients had inadequate or early imaging from which a fusion determination could not be made. Of 81 patients with > 11 months of follow up, 58 (71.6%) had a bilateral arthrodesis, 12 (14.8%) had a unilateral arthrodesis, 8 (9.9%) had no arthrodesis, and 3 (3.7%) were indeterminate.

No patient had any revision fusion surgery at the index level during follow up. Two patients had adjacent level fusions at 27 and 60 months after the index procedure. One patient had a laminectomy at an adjacent segment at 18 months postfusion, and 1 had a foraminotomy at an adjacent segment 89 months post fusion (Figure 3). Overall, there were 4 (3.7%) adjacent segment surgeries at a mean of 48.5 months after surgery. One patient had a sacro-iliac joint fusion below an L5-S1 fusion 17 months prior for persisting pain after the fusion procedure.

Patient Reported Outcomes

Preoperative SF-36 PF and ODI scores were available for 81 patients (Table 3). Postoperative SF-36 PF scores were obtained at 3 months for 65 of these patients, and at 1 year for 63 patients. Postoperative ODI scores were obtained at 3 months for 65 patients, and at 1 year for 55 patients. Among the 65 patients with completed SF-36 scores at 3 months, a mean increase of 22.4 (95% CI, 17-27; P < .001) was noted, and for the 63 patients at 1 year a mean increase of 30.3 (95% CI, 25-35; P < .001) was noted. Among the 65 patients with completed ODI scores at 3 months, a mean decrease of 6.8 (95% CI, 4.9-8.6; P < .001) was noted, and for the 55 patients with completed ODI scores at 1 year a mean decrease of 10.3 (n = 55; 95% CI, 8.4-12.2; P < .001) was noted.

Cost

We compared the hardware cost of a single level construct consisting of 4 pedicle screws, 4 locking caps, and 2 rods using a PEEK system with that of 2 other titanium construct systems. At VAPHCS, the PEEK system cost was about 71% of the cost of 2 other titanium construct systems and 62% of the cost when compared with Medtronic titanium rods.

Discussion

PEEK is useful for spine and cranial implants. It is inert and fully biocompatible with a modulus of elasticity between that of cortical and cancellous bone, and much lower than that of titanium, and is therefore considered to be semirigid.^3,4,6 PEEK rods are intermediate in stiffness between titanium rods (110 Gigapascals) and dynamic devices such as the Zimmer Biomet DYNESYS dynamic stabilization system or the Premia Spine TOPS system.³ Carbon fiber rods and carbon fiber reinforced PEEK implants are other semirigid rod alternatives.^7,8 PEEK rods for posterior lumbar fusion surgery were introduced in 2007. Li and colleagues provide a thorough review of the biomechanical properties of PEEK rods.³

PEEK is thought to have several advantages when compared with titanium. These advantages include more physiologic load sharing and reduction in stress shielding, improved durability, reduced risk of failure in osteoporotic bone, less wear debris, no change in bone forming environment, and imaging radiolucency.^4,9 Spinal PEEK cages have been reported to allow more uniform radiation dose distribution compared with metal constructs, an advantage that also may pertain to PEEK rods.¹⁰ Disadvantages of PEEK rods include an inability to detect rod breakage easily, lack of data on the use in more than minimally unstable clinical situations, and greater expense, although this was not the authors’ observation.^3,4,11