Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

lfranki@frontlinemedcom.com

Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

lfranki@frontlinemedcom.com

Enhanced recovery approaches were safe and effective at promoting earlier restoration of gut function in acute pancreatitis patients, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Patients recruited for the trial were admitted directly from an emergency department and received either enhanced care consisting of patient-directed oral intake, early ambulation, and nonopioid analgesia or received normal care consisting of opioid analgesia, physician-directed diet, and nursing parameters, Elizabeth Dong, MD, of the Kaiser Permanente Los Angeles Medical Center and her associates said.

Among the 46 patients included in the study, 61% had an etiology of gallstones, 15% had an etiology of alcohol, 13% had hyperglyceridemia, and 11% had a different etiology. Median age was 53.1 years, Dr. Dong and her associates noted.

Time to successful oral refeeding, the primary study endpoint, was significantly reduced in the enhanced treatment group, with a median time of 13.8 hours, compared with the normal treatment group, in which median time to oral refeeding was 124.8 hours. In addition, patients in the enhanced care group had a mean pancreatitis activity score of 43.5 after 48-72 hours, while patients in the control group had a mean score of 72.1.

Length of stay and frequency of 30-day readmission did not differ significantly between study groups.

The study was not funded by industry grants, and no disclosures were reported.

lfranki@frontlinemedcom.com

The presence of serrated polyps on index colonoscopies without low-risk adenomas was not associated with metachronous high-risk adenomas on surveillance exams, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Data for the study were collected from 4,616 adults who had two colonoscopies on record with the New Hampshire Colonoscopy Registry. Patients with high-risk adenomas at the index colonoscopy were excluded from the study. The median time between index and surveillance exams was 4.9 years, and median age was 61 years, according to Joseph Anderson, MD, of Geisel School of Medicine at Dartmouth, Hanover, N.H., and his associates.

lfranki@frontlinemedcom.com

The presence of serrated polyps on index colonoscopies without low-risk adenomas was not associated with metachronous high-risk adenomas on surveillance exams, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Data for the study were collected from 4,616 adults who had two colonoscopies on record with the New Hampshire Colonoscopy Registry. Patients with high-risk adenomas at the index colonoscopy were excluded from the study. The median time between index and surveillance exams was 4.9 years, and median age was 61 years, according to Joseph Anderson, MD, of Geisel School of Medicine at Dartmouth, Hanover, N.H., and his associates.

lfranki@frontlinemedcom.com

The presence of serrated polyps on index colonoscopies without low-risk adenomas was not associated with metachronous high-risk adenomas on surveillance exams, according to a study presented at the World Congress of Gastroenterology at ACG 2017.

Data for the study were collected from 4,616 adults who had two colonoscopies on record with the New Hampshire Colonoscopy Registry. Patients with high-risk adenomas at the index colonoscopy were excluded from the study. The median time between index and surveillance exams was 4.9 years, and median age was 61 years, according to Joseph Anderson, MD, of Geisel School of Medicine at Dartmouth, Hanover, N.H., and his associates.

lfranki@frontlinemedcom.com

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #47: Care Plan

This measure is aimed at capturing the percentage of patients aged 65 years and older who have a documented advance care plan in their medical records.

What you need to do: Discuss with the patient the creation of an advance care plan or the naming of a surrogate decision maker and then document that in the medical record. If the patient does not wish to make a plan or is unable to name a decision maker, document that along with the fact that the issue of advance care planning was discussed.

Eligible cases include patients aged 65 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 99201, 99202, 99203, 99204, 99205,99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a Quality Data Code that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1123F indicates that advance care planning was discussed and documented, and an advance care plan or surrogate decision maker was documented in the medical record. On the other hand, CPT II 1124F should be used if advance care planning was discussed and documented in the medical record, but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B–allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #47: Care Plan

This measure is aimed at capturing the percentage of patients aged 65 years and older who have a documented advance care plan in their medical records.

What you need to do: Discuss with the patient the creation of an advance care plan or the naming of a surrogate decision maker and then document that in the medical record. If the patient does not wish to make a plan or is unable to name a decision maker, document that along with the fact that the issue of advance care planning was discussed.

Eligible cases include patients aged 65 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 99201, 99202, 99203, 99204, 99205,99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a Quality Data Code that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1123F indicates that advance care planning was discussed and documented, and an advance care plan or surrogate decision maker was documented in the medical record. On the other hand, CPT II 1124F should be used if advance care planning was discussed and documented in the medical record, but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B–allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

If you haven’t started reporting quality data for the Merit-Based Incentive Payment System (MIPS), there’s still time to avoid a 4% cut to your Medicare payments.

Under the Pick Your Pace approach being offered this year, the Centers for Medicare & Medicaid Services allows clinicians to test the system by reporting on one quality measure for one patient through paper-based claims. Be sure to append a Quality Data Code (QDC) to the claim form for care provided up to Dec. 31, 2017, in order to avoid a penalty in payment year 2019.

Consider this measure:
 

Measure #47: Care Plan

This measure is aimed at capturing the percentage of patients aged 65 years and older who have a documented advance care plan in their medical records.

What you need to do: Discuss with the patient the creation of an advance care plan or the naming of a surrogate decision maker and then document that in the medical record. If the patient does not wish to make a plan or is unable to name a decision maker, document that along with the fact that the issue of advance care planning was discussed.

Eligible cases include patients aged 65 years or older on the date of the encounter and a patient encounter during the performance period. Applicable codes include (CPT or HCPCS): 99201, 99202, 99203, 99204, 99205,99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99291, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0402, G0438, G0439.

To get credit under MIPS, be sure to include a Quality Data Code that shows that you successfully performed the measure or had a good reason for not doing so. For instance, CPT II 1123F indicates that advance care planning was discussed and documented, and an advance care plan or surrogate decision maker was documented in the medical record. On the other hand, CPT II 1124F should be used if advance care planning was discussed and documented in the medical record, but the patient did not wish or was not able to name a surrogate decision maker or provide an advance care plan.

CMS has a full list of measures available for claims-based reporting at qpp.cms.gov. The American Medical Association has also created a step-by-step guide for reporting on one quality measure.

Certain clinicians are exempt from reporting and do not face a penalty under MIPS:

• Those who enrolled in Medicare for the first time during a performance period.
• Those who have Medicare Part B–allowed charges of $30,000 or less.
• Those who have 100 or fewer Medicare Part B patients.
• Those who are significantly participating in an Advanced Alternative Payment Model (APM).

PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.

When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.

ands456/ThinkStock

koakes@frontlinemedcom.com
On Twitter @karioakes

PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.

When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.

ands456/ThinkStock

koakes@frontlinemedcom.com
On Twitter @karioakes

PHILADELPHIA – Cognitive-behavioral therapy tailored to perimenopausal and postmenopausal women who were experiencing both insomnia and vasomotor symptoms effectively improved both sleep and mood, according to a small controlled study.

When 40 women were randomized to receive either cognitive-behavioral therapy for menopausal insomnia (CBTMI) or education about menopause and sleep, those who received CBTMI had significantly reduced scores on both objective and subjective scales of depression, and their sleep also improved.

ands456/ThinkStock

koakes@frontlinemedcom.com
On Twitter @karioakes

The headline in the Oct. 13, 2017, Portland (Maine) Press Herald hinted that I was about to read a sad story: “New Hampshire doctor, 85, may lose practice because she doesn’t use computer.” Anna Konopka, MD, who has a 300-patient practice in New London, doesn’t use a computer in her office, and as a consequence can’t participate in her state’s mandated prescription drug monitoring program. She has appealed to the governor, but if her appeal is denied she will be forced to close her office.

The closure will present a hardship for the residents of this small New Hampshire town, who will have to replace their obviously committed physician who has served them for more than 30 years. And I am sure that Dr. Konopka would have preferred to end her professional career on her own terms. It isn’t going to be easy to give up that positive feedback from her patients that every primary care physician enjoys even on her worst day.

copyright monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.

The headline in the Oct. 13, 2017, Portland (Maine) Press Herald hinted that I was about to read a sad story: “New Hampshire doctor, 85, may lose practice because she doesn’t use computer.” Anna Konopka, MD, who has a 300-patient practice in New London, doesn’t use a computer in her office, and as a consequence can’t participate in her state’s mandated prescription drug monitoring program. She has appealed to the governor, but if her appeal is denied she will be forced to close her office.

The closure will present a hardship for the residents of this small New Hampshire town, who will have to replace their obviously committed physician who has served them for more than 30 years. And I am sure that Dr. Konopka would have preferred to end her professional career on her own terms. It isn’t going to be easy to give up that positive feedback from her patients that every primary care physician enjoys even on her worst day.

copyright monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.

The headline in the Oct. 13, 2017, Portland (Maine) Press Herald hinted that I was about to read a sad story: “New Hampshire doctor, 85, may lose practice because she doesn’t use computer.” Anna Konopka, MD, who has a 300-patient practice in New London, doesn’t use a computer in her office, and as a consequence can’t participate in her state’s mandated prescription drug monitoring program. She has appealed to the governor, but if her appeal is denied she will be forced to close her office.

The closure will present a hardship for the residents of this small New Hampshire town, who will have to replace their obviously committed physician who has served them for more than 30 years. And I am sure that Dr. Konopka would have preferred to end her professional career on her own terms. It isn’t going to be easy to give up that positive feedback from her patients that every primary care physician enjoys even on her worst day.

copyright monkeybusinessimages/Thinkstock

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@frontlinemedcom.com.

According to the International Association for the Study of Pain (IASP), pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”¹ Chronic pain (pain lasting more than 3 months) has a high prevalence in the U.S. veteran population. In a recently published article by Richard Nahin, PhD, of the National Institutes of Health, 65.5% of U.S. veterans reported pain in the previous 3 months with 9.1% classified as having severe pain (defined as “which occurs most days or every day and bothers the individual a lot”) compared with 6.4% among nonveterans.² In addition, male veterans were more likely to report severe pain, 9%, compared with male nonveterans, 4.7%.² Veterans make up about 6.2% of the U.S. population; therefore, the number of veterans negatively impacted by pain is substantial.^3,4 Compared with individuals with other chronic diseases, such as heart disease, chronic obstructive pulmonary disease, or diabetes mellitus, a recent population-based, matched cohort study reported that only patients with Alzheimer disease have a poorer quality of life (QOL) than do those with chronic pain.⁵

Background

When comparing veterans to nonveterans, Nahin also reported that younger veterans aged 18 to 39 years had significantly higher rates for severe pain, compared with similarly aged nonveterans, 7.8% vs 3.2%, respectively. The prevalence of severe pain was significantly higher among veterans than it was for nonveterans experiencing the following: back pain, 21.6% vs 16.7% among nonveterans; jaw pain, 37.5% vs 22.9%, respectively; severe migraine and headaches, 26.4% vs 15.9%, respectively; and neck pain, 27.7% vs 21.9%, respectively. The veterans also were more likely than were nonveterans to have joint pain, 43.6% vs 31.5% , respectively.²

A study by Kerns and colleagues noted that almost 50% of older veterans (mean age 65.6 years) experience chronic pain regularly.⁶ Based on responses of 685 veterans to the Health-Risk Behavior Screening Questionnaire (HRBSQ), this study also found that the presence of pain was strongly associated with patient reports of worsening health and emotional distress. Rollin Gallagher, MD, of the Philadelphia VAMC, reported that veterans who experienced pain tended to have more personal problems due to higher rates of psychiatric and social comorbidities, such as substance abuse, depression, posttraumatic stress syndrome, and early work disabilities.⁷ Gallagher also has noted that the number of veterans seeking pain treatment has grown steadily over the past 2 decades due to the aging veteran population retiring and seeking VA care for chronic illness management.

In January 2017, the VA released an analysis of health care use among recent Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), and Operation New Dawn (OND) veterans from October 2001 through June 2015.⁸ The VA noted that 1,965,534 veterans have become eligible for VA health care since fiscal year 2002. Of the 1,218,857 OIF/OEF/OND veterans treated during this period, 62.3% (759,850) were treated for diseases of the musculoskeletal system and connective tissue, 58.1% (708,062) were treated for mental disorders, and 58.7% (715,263) were treated for “symptoms, signs and ill-defined conditions.”

According to the VA, “the ICD-9-CM diagnostic category ‘Symptoms, Signs and Ill-Defined Conditions’ is a diverse, catch-all category that consists of 160 sub-categories and includes primarily symptoms that do not yet have an identified cause and clinical findings that are not coded elsewhere.” The most frequently reported codes in this category, in order of magnitude are General Symptoms (ICD-9-CM 780), Symptoms Involving Respiratory System and Other Chest Symptoms (ICD-9-CM 786), and Symptoms Involving Head and Neck (ICD-9-CM 784).

Musculoskeletal ailments (ie, joint and back disorders), mental health disorders and symptoms, signs, and ill-defined conditions are the 3 most frequently coded diagnoses related to medical treatment in OEF/OIF/OND veterans. This demonstrates the high rate of pain-related conditions with comorbid mental health diagnoses.

Public Health Challenge

Recognizing that pain is a public health challenge, the National Academy of Sciences published the landmark study Relieving Pain in America.⁹ The study reported that pain affects at least 100 million Americans, greatly reducing quality of life. In addition, annual financial costs to society are estimated at $560 to $635 billion, with federal and state costs almost $100 billion annually. Given the challenges of addressing chronic pain, especially in the U.S. veteran population, the VHA has likewise outlined 6 recommendations for transforming VA pain care:

1. Educate veterans/families to promote self-efficacy and shared decision making, provide access to all relevant sources;
2. Educate/train all team members to their discipline-specific competencies, including team-based care;
3. Develop and integrate nonpharmacologic modalities into care plans;
4. Institute evidence-based medication prescribing, use of pain procedures, and safe opioid use (universal precautions);
5. Implement approaches for bringing the veteran’s whole team together, such as virtual pain consulting (SCAN-ECHO, e-consults, telehealth, clinical video teleconsultation and education) and for maintaining ongoing communication between team members; and
6. Establish metrics to monitor pain care and outcomes at both the individual level and population level.¹⁰

The American Pain Society (APS) differentiates multidisciplinary care vs interdisciplinary pain care.¹¹ Multidisciplinary pain care is provided by several disciplines that may not be coordinated. Treatment may occur with different goals and in parallel rather than with an integrated approach. The APS suggests that professional identities are clearly defined, team membership is a secondary consideration in multidisciplinary care, and the leadership is typically hierarchical with a physician in charge. In this model of care, each team member has a “clearly defined place in the overall care of the patient, contributing their expertise in relative isolation from one another.”¹¹

In contrast, according to APS, interdisciplinary teams have complementary roles that enhance patient care. Each discipline has valuable knowledge and a set of skills that complement other team members who are collaborative partners. The interdisciplinary approach encourages complementary roles and responsibilities, conjoint problem solving, and shared accountability. Treatment decisions are consensus based.

Pain Programs

In a review of 4 interdisciplinary pain programs (Mayo Clinic Pain Rehabilitation Center, the Brooks Rehabilitation Pain Rehabilitation Program, the Rehabilitation Institute of Chicago Center for Pain Management, and the Cleveland Clinic Foundation Chronic Pain Rehabilitation Program), Stanos found that the compositions of the staff were similar.¹² In general, staff consisted of pain management physicians, pain psychologists, physical and occupational therapists, and nurse coordinators. The Mayo Clinic had more personnel, including a clinical pharmacist, the Brooks program had an additional biofeedback specialist, and the Cleveland Clinic had a tai chi instructor. The programs ranged from 3 to 5 weeks of daily programming. The duration of services provided were dependent on the payers. Stanos concluded that functional status, as measured by the Pain Disability Index, improved on discharge, 6 months, and 1 year after treatment at the Cleveland Clinic.

Cosio and Lin described their experience in a multidisciplinary outpatient pain clinic at Jesse Brown VAMC in Chicago.¹³ Their study noted that the number of veterans in their multidisciplinary pain clinic on chronic opioids significantly decreased, the degree of pain relief increased, and veterans reported improvements in mobility and ability to complete activities of daily living (ADLs). Overall veteran satisfaction with this pain program was reportedly high.

Cosio and Lin also published a study of the effect of complementary alternative medicine (CAM) utilization at a VAMC, which included a 12-week pain education school that was offered to all veterans and families.¹⁴ They noted that veterans began using at least 1 more CAM modality before the completion of the pain education program. However, it is unclear from the 2 studies whether the pain education program was incorporated into their multidisciplinary pain clinic.

Outpatient Functional Restoration Program

Given the challenges of addressing chronic pain and at the same time fostering an interdisciplinary approach to management, the VA Puget Sound Health Care System (VAPSHCS) team initiated a program development and quality improvement process for addressing pain and restoring function for veteran patients.

The VA Northwest Health Network (VISN 20) offers health care services for veterans located in the states of Alaska, Idaho, Oregon, Washington, and parts of California and Montana. VISN 20 has 8 parent facilities, which include the Seattle and American Lake divisions of the VAPSHCS. The VAPSHCS has established a comprehensive, interdisciplinary functional restoration pain program that integrates medical, psychosocial, and complementary alternative medicine.

The Outpatient Functional Restoration Program (OFRPP) pain team consists of a chief who is board certified in pain medicine and addiction medicine; a board-certified pain medicine physician; 2 physician assistants, one of whom has formal training in acupuncture and another who is trained in tai chi, qigong, hypnosis, and mindfulness; nurse care coordinators; a pain psychologist with training in acceptance and commitment therapy, cognitive behavioral therapy, yoga nidra, and hypnosis; a second pain psychologist who has a background in rehabilitation psychology; a physical therapist; and a pain clinical pharmacy specialist.

Prior to participation in OFRPP, veterans were required to attend 4 weekly pain education classes for 4 consecutive weeks. The classes educate veterans and their families on the complexity of managing chronic pain. Topics cover medical, pharmacologic and nonpharmacologic approaches to pain, including CAM and psychological modalities (Table 1). The pain orientation classes introduce veterans to available treatment options, and in some cases, veterans decide committing to a more intensive pain rehabilitation program is a good fit.

The program is based on the biopsychosocial model of pain care and Commission on Accreditation for Rehabilitation Facilities (CARF) interdisciplinary pain rehabilitation program standards. The length of the program was determined after reviewing data from existing VA outpatient pain rehabilitation programs; Pain Clinic staff availability, training and experience; and survey responses from veterans completing the 4-week education. This survey asked veterans whether they would be interested in an outpatient pain rehabilitation program and their preference for length of the program and treatment modalities.

Since its inception, OFRPP has earned a 3-year CARF accreditation. Veterans participate in VAPSHCS American Lake division OFRPP education twice weekly for 4 hours for a total of 8 weeks (Table 2). Each week of programming includes 2 hours of physical therapy didactics, 2 hours of physical therapy (eg, paced cardio exercise, stretching, and core strength and conditioning), 2 hours of mind-body medicine (eg, mantram repetition and neuroplasticity education), and 2 hours of psychology education (behavioral interventions and psychological strategies for pain self-management of pain).

There is also 1 hour of pharmacotherapy education regarding commonly prescribed pain medications and how to take medications safely to avoid common adverse events. The nurse is responsible for care coordination and analysis of outcome measures, data collection, and quality improvement.

Program Effectiveness

Program effectiveness is measured using the POQ-VA (Pain Outcomes Questionnaire-VA). The POQ results and participant feedback are used to ensure ongoing program evaluation and improvement. This outcome measure was selected as the POQ-VA evaluates intervention effectiveness of all the major pain outcomes domains. This questionnaire was developed and validated by the VA.

The sample size was 957 veterans.¹⁵ The POQ-VA is reverse scored, meaning lower scores indicate improvement. Eighty-seven veterans have completed the program with 20 participants completing the 3-month outcome measures, 31 participants completing 6-month outcome measures, and 17 participants completing 12-month outcome measures.

The pain score decreased close to 1 point at 12 months. The mobility gains were maintained at 12 months. The ADL did not improve much after 1 year (Figure 1).

In the other POQ-VA subscales, vitality improved somewhat.

Limitations

Only a small sample size of veterans with chronic pain participated in the functional restoration pain program. Long-term follow-up of participants who successfully completed the program also is desired.

Conclusion

Veterans experiencing complex chronic noncancer pain present a challenge for the VA health care system. Successful management of this requires cooperation among different disciplines and fostering a multimodal and interdisciplinary approach. Functional restoration pain programs have existed for a while and have shown clear evidence of their superiority over monotherapies for patients with chronic noncancer pain.

This functional restoration pain program incorporated various evidence-based medical, rehabilitative, psychological interventions with mind body medicine, mindfulness and integrative pain modalities. The authors continually meet and assess the success of the program. Although the initial outcome measures are encouraging, increased veteran participation in answering their post program completion surveys is desired. The goal is to improve veterans’ self-management of their chronic pain, leading to reductions in pain symptoms, medication, and health care provider use, as well as improve veterans’ function and overall QOL.

According to the International Association for the Study of Pain (IASP), pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”¹ Chronic pain (pain lasting more than 3 months) has a high prevalence in the U.S. veteran population. In a recently published article by Richard Nahin, PhD, of the National Institutes of Health, 65.5% of U.S. veterans reported pain in the previous 3 months with 9.1% classified as having severe pain (defined as “which occurs most days or every day and bothers the individual a lot”) compared with 6.4% among nonveterans.² In addition, male veterans were more likely to report severe pain, 9%, compared with male nonveterans, 4.7%.² Veterans make up about 6.2% of the U.S. population; therefore, the number of veterans negatively impacted by pain is substantial.^3,4 Compared with individuals with other chronic diseases, such as heart disease, chronic obstructive pulmonary disease, or diabetes mellitus, a recent population-based, matched cohort study reported that only patients with Alzheimer disease have a poorer quality of life (QOL) than do those with chronic pain.⁵

Background

When comparing veterans to nonveterans, Nahin also reported that younger veterans aged 18 to 39 years had significantly higher rates for severe pain, compared with similarly aged nonveterans, 7.8% vs 3.2%, respectively. The prevalence of severe pain was significantly higher among veterans than it was for nonveterans experiencing the following: back pain, 21.6% vs 16.7% among nonveterans; jaw pain, 37.5% vs 22.9%, respectively; severe migraine and headaches, 26.4% vs 15.9%, respectively; and neck pain, 27.7% vs 21.9%, respectively. The veterans also were more likely than were nonveterans to have joint pain, 43.6% vs 31.5% , respectively.²

A study by Kerns and colleagues noted that almost 50% of older veterans (mean age 65.6 years) experience chronic pain regularly.⁶ Based on responses of 685 veterans to the Health-Risk Behavior Screening Questionnaire (HRBSQ), this study also found that the presence of pain was strongly associated with patient reports of worsening health and emotional distress. Rollin Gallagher, MD, of the Philadelphia VAMC, reported that veterans who experienced pain tended to have more personal problems due to higher rates of psychiatric and social comorbidities, such as substance abuse, depression, posttraumatic stress syndrome, and early work disabilities.⁷ Gallagher also has noted that the number of veterans seeking pain treatment has grown steadily over the past 2 decades due to the aging veteran population retiring and seeking VA care for chronic illness management.

In January 2017, the VA released an analysis of health care use among recent Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), and Operation New Dawn (OND) veterans from October 2001 through June 2015.⁸ The VA noted that 1,965,534 veterans have become eligible for VA health care since fiscal year 2002. Of the 1,218,857 OIF/OEF/OND veterans treated during this period, 62.3% (759,850) were treated for diseases of the musculoskeletal system and connective tissue, 58.1% (708,062) were treated for mental disorders, and 58.7% (715,263) were treated for “symptoms, signs and ill-defined conditions.”

According to the VA, “the ICD-9-CM diagnostic category ‘Symptoms, Signs and Ill-Defined Conditions’ is a diverse, catch-all category that consists of 160 sub-categories and includes primarily symptoms that do not yet have an identified cause and clinical findings that are not coded elsewhere.” The most frequently reported codes in this category, in order of magnitude are General Symptoms (ICD-9-CM 780), Symptoms Involving Respiratory System and Other Chest Symptoms (ICD-9-CM 786), and Symptoms Involving Head and Neck (ICD-9-CM 784).

Musculoskeletal ailments (ie, joint and back disorders), mental health disorders and symptoms, signs, and ill-defined conditions are the 3 most frequently coded diagnoses related to medical treatment in OEF/OIF/OND veterans. This demonstrates the high rate of pain-related conditions with comorbid mental health diagnoses.

Public Health Challenge

Recognizing that pain is a public health challenge, the National Academy of Sciences published the landmark study Relieving Pain in America.⁹ The study reported that pain affects at least 100 million Americans, greatly reducing quality of life. In addition, annual financial costs to society are estimated at $560 to $635 billion, with federal and state costs almost $100 billion annually. Given the challenges of addressing chronic pain, especially in the U.S. veteran population, the VHA has likewise outlined 6 recommendations for transforming VA pain care:

1. Educate veterans/families to promote self-efficacy and shared decision making, provide access to all relevant sources;
2. Educate/train all team members to their discipline-specific competencies, including team-based care;
3. Develop and integrate nonpharmacologic modalities into care plans;
4. Institute evidence-based medication prescribing, use of pain procedures, and safe opioid use (universal precautions);
5. Implement approaches for bringing the veteran’s whole team together, such as virtual pain consulting (SCAN-ECHO, e-consults, telehealth, clinical video teleconsultation and education) and for maintaining ongoing communication between team members; and
6. Establish metrics to monitor pain care and outcomes at both the individual level and population level.¹⁰

The American Pain Society (APS) differentiates multidisciplinary care vs interdisciplinary pain care.¹¹ Multidisciplinary pain care is provided by several disciplines that may not be coordinated. Treatment may occur with different goals and in parallel rather than with an integrated approach. The APS suggests that professional identities are clearly defined, team membership is a secondary consideration in multidisciplinary care, and the leadership is typically hierarchical with a physician in charge. In this model of care, each team member has a “clearly defined place in the overall care of the patient, contributing their expertise in relative isolation from one another.”¹¹

In contrast, according to APS, interdisciplinary teams have complementary roles that enhance patient care. Each discipline has valuable knowledge and a set of skills that complement other team members who are collaborative partners. The interdisciplinary approach encourages complementary roles and responsibilities, conjoint problem solving, and shared accountability. Treatment decisions are consensus based.

Pain Programs

In a review of 4 interdisciplinary pain programs (Mayo Clinic Pain Rehabilitation Center, the Brooks Rehabilitation Pain Rehabilitation Program, the Rehabilitation Institute of Chicago Center for Pain Management, and the Cleveland Clinic Foundation Chronic Pain Rehabilitation Program), Stanos found that the compositions of the staff were similar.¹² In general, staff consisted of pain management physicians, pain psychologists, physical and occupational therapists, and nurse coordinators. The Mayo Clinic had more personnel, including a clinical pharmacist, the Brooks program had an additional biofeedback specialist, and the Cleveland Clinic had a tai chi instructor. The programs ranged from 3 to 5 weeks of daily programming. The duration of services provided were dependent on the payers. Stanos concluded that functional status, as measured by the Pain Disability Index, improved on discharge, 6 months, and 1 year after treatment at the Cleveland Clinic.

Cosio and Lin described their experience in a multidisciplinary outpatient pain clinic at Jesse Brown VAMC in Chicago.¹³ Their study noted that the number of veterans in their multidisciplinary pain clinic on chronic opioids significantly decreased, the degree of pain relief increased, and veterans reported improvements in mobility and ability to complete activities of daily living (ADLs). Overall veteran satisfaction with this pain program was reportedly high.

Cosio and Lin also published a study of the effect of complementary alternative medicine (CAM) utilization at a VAMC, which included a 12-week pain education school that was offered to all veterans and families.¹⁴ They noted that veterans began using at least 1 more CAM modality before the completion of the pain education program. However, it is unclear from the 2 studies whether the pain education program was incorporated into their multidisciplinary pain clinic.

Outpatient Functional Restoration Program

Given the challenges of addressing chronic pain and at the same time fostering an interdisciplinary approach to management, the VA Puget Sound Health Care System (VAPSHCS) team initiated a program development and quality improvement process for addressing pain and restoring function for veteran patients.

The VA Northwest Health Network (VISN 20) offers health care services for veterans located in the states of Alaska, Idaho, Oregon, Washington, and parts of California and Montana. VISN 20 has 8 parent facilities, which include the Seattle and American Lake divisions of the VAPSHCS. The VAPSHCS has established a comprehensive, interdisciplinary functional restoration pain program that integrates medical, psychosocial, and complementary alternative medicine.

The Outpatient Functional Restoration Program (OFRPP) pain team consists of a chief who is board certified in pain medicine and addiction medicine; a board-certified pain medicine physician; 2 physician assistants, one of whom has formal training in acupuncture and another who is trained in tai chi, qigong, hypnosis, and mindfulness; nurse care coordinators; a pain psychologist with training in acceptance and commitment therapy, cognitive behavioral therapy, yoga nidra, and hypnosis; a second pain psychologist who has a background in rehabilitation psychology; a physical therapist; and a pain clinical pharmacy specialist.

Prior to participation in OFRPP, veterans were required to attend 4 weekly pain education classes for 4 consecutive weeks. The classes educate veterans and their families on the complexity of managing chronic pain. Topics cover medical, pharmacologic and nonpharmacologic approaches to pain, including CAM and psychological modalities (Table 1). The pain orientation classes introduce veterans to available treatment options, and in some cases, veterans decide committing to a more intensive pain rehabilitation program is a good fit.

The program is based on the biopsychosocial model of pain care and Commission on Accreditation for Rehabilitation Facilities (CARF) interdisciplinary pain rehabilitation program standards. The length of the program was determined after reviewing data from existing VA outpatient pain rehabilitation programs; Pain Clinic staff availability, training and experience; and survey responses from veterans completing the 4-week education. This survey asked veterans whether they would be interested in an outpatient pain rehabilitation program and their preference for length of the program and treatment modalities.

Since its inception, OFRPP has earned a 3-year CARF accreditation. Veterans participate in VAPSHCS American Lake division OFRPP education twice weekly for 4 hours for a total of 8 weeks (Table 2). Each week of programming includes 2 hours of physical therapy didactics, 2 hours of physical therapy (eg, paced cardio exercise, stretching, and core strength and conditioning), 2 hours of mind-body medicine (eg, mantram repetition and neuroplasticity education), and 2 hours of psychology education (behavioral interventions and psychological strategies for pain self-management of pain).

There is also 1 hour of pharmacotherapy education regarding commonly prescribed pain medications and how to take medications safely to avoid common adverse events. The nurse is responsible for care coordination and analysis of outcome measures, data collection, and quality improvement.

Program Effectiveness

Program effectiveness is measured using the POQ-VA (Pain Outcomes Questionnaire-VA). The POQ results and participant feedback are used to ensure ongoing program evaluation and improvement. This outcome measure was selected as the POQ-VA evaluates intervention effectiveness of all the major pain outcomes domains. This questionnaire was developed and validated by the VA.

The sample size was 957 veterans.¹⁵ The POQ-VA is reverse scored, meaning lower scores indicate improvement. Eighty-seven veterans have completed the program with 20 participants completing the 3-month outcome measures, 31 participants completing 6-month outcome measures, and 17 participants completing 12-month outcome measures.

The pain score decreased close to 1 point at 12 months. The mobility gains were maintained at 12 months. The ADL did not improve much after 1 year (Figure 1).

In the other POQ-VA subscales, vitality improved somewhat.

Limitations

Only a small sample size of veterans with chronic pain participated in the functional restoration pain program. Long-term follow-up of participants who successfully completed the program also is desired.

Conclusion

Veterans experiencing complex chronic noncancer pain present a challenge for the VA health care system. Successful management of this requires cooperation among different disciplines and fostering a multimodal and interdisciplinary approach. Functional restoration pain programs have existed for a while and have shown clear evidence of their superiority over monotherapies for patients with chronic noncancer pain.

This functional restoration pain program incorporated various evidence-based medical, rehabilitative, psychological interventions with mind body medicine, mindfulness and integrative pain modalities. The authors continually meet and assess the success of the program. Although the initial outcome measures are encouraging, increased veteran participation in answering their post program completion surveys is desired. The goal is to improve veterans’ self-management of their chronic pain, leading to reductions in pain symptoms, medication, and health care provider use, as well as improve veterans’ function and overall QOL.

According to the International Association for the Study of Pain (IASP), pain is “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”¹ Chronic pain (pain lasting more than 3 months) has a high prevalence in the U.S. veteran population. In a recently published article by Richard Nahin, PhD, of the National Institutes of Health, 65.5% of U.S. veterans reported pain in the previous 3 months with 9.1% classified as having severe pain (defined as “which occurs most days or every day and bothers the individual a lot”) compared with 6.4% among nonveterans.² In addition, male veterans were more likely to report severe pain, 9%, compared with male nonveterans, 4.7%.² Veterans make up about 6.2% of the U.S. population; therefore, the number of veterans negatively impacted by pain is substantial.^3,4 Compared with individuals with other chronic diseases, such as heart disease, chronic obstructive pulmonary disease, or diabetes mellitus, a recent population-based, matched cohort study reported that only patients with Alzheimer disease have a poorer quality of life (QOL) than do those with chronic pain.⁵

Background

When comparing veterans to nonveterans, Nahin also reported that younger veterans aged 18 to 39 years had significantly higher rates for severe pain, compared with similarly aged nonveterans, 7.8% vs 3.2%, respectively. The prevalence of severe pain was significantly higher among veterans than it was for nonveterans experiencing the following: back pain, 21.6% vs 16.7% among nonveterans; jaw pain, 37.5% vs 22.9%, respectively; severe migraine and headaches, 26.4% vs 15.9%, respectively; and neck pain, 27.7% vs 21.9%, respectively. The veterans also were more likely than were nonveterans to have joint pain, 43.6% vs 31.5% , respectively.²

A study by Kerns and colleagues noted that almost 50% of older veterans (mean age 65.6 years) experience chronic pain regularly.⁶ Based on responses of 685 veterans to the Health-Risk Behavior Screening Questionnaire (HRBSQ), this study also found that the presence of pain was strongly associated with patient reports of worsening health and emotional distress. Rollin Gallagher, MD, of the Philadelphia VAMC, reported that veterans who experienced pain tended to have more personal problems due to higher rates of psychiatric and social comorbidities, such as substance abuse, depression, posttraumatic stress syndrome, and early work disabilities.⁷ Gallagher also has noted that the number of veterans seeking pain treatment has grown steadily over the past 2 decades due to the aging veteran population retiring and seeking VA care for chronic illness management.

In January 2017, the VA released an analysis of health care use among recent Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), and Operation New Dawn (OND) veterans from October 2001 through June 2015.⁸ The VA noted that 1,965,534 veterans have become eligible for VA health care since fiscal year 2002. Of the 1,218,857 OIF/OEF/OND veterans treated during this period, 62.3% (759,850) were treated for diseases of the musculoskeletal system and connective tissue, 58.1% (708,062) were treated for mental disorders, and 58.7% (715,263) were treated for “symptoms, signs and ill-defined conditions.”

According to the VA, “the ICD-9-CM diagnostic category ‘Symptoms, Signs and Ill-Defined Conditions’ is a diverse, catch-all category that consists of 160 sub-categories and includes primarily symptoms that do not yet have an identified cause and clinical findings that are not coded elsewhere.” The most frequently reported codes in this category, in order of magnitude are General Symptoms (ICD-9-CM 780), Symptoms Involving Respiratory System and Other Chest Symptoms (ICD-9-CM 786), and Symptoms Involving Head and Neck (ICD-9-CM 784).

Musculoskeletal ailments (ie, joint and back disorders), mental health disorders and symptoms, signs, and ill-defined conditions are the 3 most frequently coded diagnoses related to medical treatment in OEF/OIF/OND veterans. This demonstrates the high rate of pain-related conditions with comorbid mental health diagnoses.

Public Health Challenge

Recognizing that pain is a public health challenge, the National Academy of Sciences published the landmark study Relieving Pain in America.⁹ The study reported that pain affects at least 100 million Americans, greatly reducing quality of life. In addition, annual financial costs to society are estimated at $560 to $635 billion, with federal and state costs almost $100 billion annually. Given the challenges of addressing chronic pain, especially in the U.S. veteran population, the VHA has likewise outlined 6 recommendations for transforming VA pain care:

1. Educate veterans/families to promote self-efficacy and shared decision making, provide access to all relevant sources;
2. Educate/train all team members to their discipline-specific competencies, including team-based care;
3. Develop and integrate nonpharmacologic modalities into care plans;
4. Institute evidence-based medication prescribing, use of pain procedures, and safe opioid use (universal precautions);
5. Implement approaches for bringing the veteran’s whole team together, such as virtual pain consulting (SCAN-ECHO, e-consults, telehealth, clinical video teleconsultation and education) and for maintaining ongoing communication between team members; and
6. Establish metrics to monitor pain care and outcomes at both the individual level and population level.¹⁰

The American Pain Society (APS) differentiates multidisciplinary care vs interdisciplinary pain care.¹¹ Multidisciplinary pain care is provided by several disciplines that may not be coordinated. Treatment may occur with different goals and in parallel rather than with an integrated approach. The APS suggests that professional identities are clearly defined, team membership is a secondary consideration in multidisciplinary care, and the leadership is typically hierarchical with a physician in charge. In this model of care, each team member has a “clearly defined place in the overall care of the patient, contributing their expertise in relative isolation from one another.”¹¹

In contrast, according to APS, interdisciplinary teams have complementary roles that enhance patient care. Each discipline has valuable knowledge and a set of skills that complement other team members who are collaborative partners. The interdisciplinary approach encourages complementary roles and responsibilities, conjoint problem solving, and shared accountability. Treatment decisions are consensus based.

Pain Programs

In a review of 4 interdisciplinary pain programs (Mayo Clinic Pain Rehabilitation Center, the Brooks Rehabilitation Pain Rehabilitation Program, the Rehabilitation Institute of Chicago Center for Pain Management, and the Cleveland Clinic Foundation Chronic Pain Rehabilitation Program), Stanos found that the compositions of the staff were similar.¹² In general, staff consisted of pain management physicians, pain psychologists, physical and occupational therapists, and nurse coordinators. The Mayo Clinic had more personnel, including a clinical pharmacist, the Brooks program had an additional biofeedback specialist, and the Cleveland Clinic had a tai chi instructor. The programs ranged from 3 to 5 weeks of daily programming. The duration of services provided were dependent on the payers. Stanos concluded that functional status, as measured by the Pain Disability Index, improved on discharge, 6 months, and 1 year after treatment at the Cleveland Clinic.

Cosio and Lin described their experience in a multidisciplinary outpatient pain clinic at Jesse Brown VAMC in Chicago.¹³ Their study noted that the number of veterans in their multidisciplinary pain clinic on chronic opioids significantly decreased, the degree of pain relief increased, and veterans reported improvements in mobility and ability to complete activities of daily living (ADLs). Overall veteran satisfaction with this pain program was reportedly high.

Cosio and Lin also published a study of the effect of complementary alternative medicine (CAM) utilization at a VAMC, which included a 12-week pain education school that was offered to all veterans and families.¹⁴ They noted that veterans began using at least 1 more CAM modality before the completion of the pain education program. However, it is unclear from the 2 studies whether the pain education program was incorporated into their multidisciplinary pain clinic.

Outpatient Functional Restoration Program

Given the challenges of addressing chronic pain and at the same time fostering an interdisciplinary approach to management, the VA Puget Sound Health Care System (VAPSHCS) team initiated a program development and quality improvement process for addressing pain and restoring function for veteran patients.

The VA Northwest Health Network (VISN 20) offers health care services for veterans located in the states of Alaska, Idaho, Oregon, Washington, and parts of California and Montana. VISN 20 has 8 parent facilities, which include the Seattle and American Lake divisions of the VAPSHCS. The VAPSHCS has established a comprehensive, interdisciplinary functional restoration pain program that integrates medical, psychosocial, and complementary alternative medicine.

The Outpatient Functional Restoration Program (OFRPP) pain team consists of a chief who is board certified in pain medicine and addiction medicine; a board-certified pain medicine physician; 2 physician assistants, one of whom has formal training in acupuncture and another who is trained in tai chi, qigong, hypnosis, and mindfulness; nurse care coordinators; a pain psychologist with training in acceptance and commitment therapy, cognitive behavioral therapy, yoga nidra, and hypnosis; a second pain psychologist who has a background in rehabilitation psychology; a physical therapist; and a pain clinical pharmacy specialist.

Prior to participation in OFRPP, veterans were required to attend 4 weekly pain education classes for 4 consecutive weeks. The classes educate veterans and their families on the complexity of managing chronic pain. Topics cover medical, pharmacologic and nonpharmacologic approaches to pain, including CAM and psychological modalities (Table 1). The pain orientation classes introduce veterans to available treatment options, and in some cases, veterans decide committing to a more intensive pain rehabilitation program is a good fit.

The program is based on the biopsychosocial model of pain care and Commission on Accreditation for Rehabilitation Facilities (CARF) interdisciplinary pain rehabilitation program standards. The length of the program was determined after reviewing data from existing VA outpatient pain rehabilitation programs; Pain Clinic staff availability, training and experience; and survey responses from veterans completing the 4-week education. This survey asked veterans whether they would be interested in an outpatient pain rehabilitation program and their preference for length of the program and treatment modalities.

Since its inception, OFRPP has earned a 3-year CARF accreditation. Veterans participate in VAPSHCS American Lake division OFRPP education twice weekly for 4 hours for a total of 8 weeks (Table 2). Each week of programming includes 2 hours of physical therapy didactics, 2 hours of physical therapy (eg, paced cardio exercise, stretching, and core strength and conditioning), 2 hours of mind-body medicine (eg, mantram repetition and neuroplasticity education), and 2 hours of psychology education (behavioral interventions and psychological strategies for pain self-management of pain).

There is also 1 hour of pharmacotherapy education regarding commonly prescribed pain medications and how to take medications safely to avoid common adverse events. The nurse is responsible for care coordination and analysis of outcome measures, data collection, and quality improvement.

Program Effectiveness

Program effectiveness is measured using the POQ-VA (Pain Outcomes Questionnaire-VA). The POQ results and participant feedback are used to ensure ongoing program evaluation and improvement. This outcome measure was selected as the POQ-VA evaluates intervention effectiveness of all the major pain outcomes domains. This questionnaire was developed and validated by the VA.

The sample size was 957 veterans.¹⁵ The POQ-VA is reverse scored, meaning lower scores indicate improvement. Eighty-seven veterans have completed the program with 20 participants completing the 3-month outcome measures, 31 participants completing 6-month outcome measures, and 17 participants completing 12-month outcome measures.

The pain score decreased close to 1 point at 12 months. The mobility gains were maintained at 12 months. The ADL did not improve much after 1 year (Figure 1).

In the other POQ-VA subscales, vitality improved somewhat.

Limitations

Only a small sample size of veterans with chronic pain participated in the functional restoration pain program. Long-term follow-up of participants who successfully completed the program also is desired.

Conclusion

Veterans experiencing complex chronic noncancer pain present a challenge for the VA health care system. Successful management of this requires cooperation among different disciplines and fostering a multimodal and interdisciplinary approach. Functional restoration pain programs have existed for a while and have shown clear evidence of their superiority over monotherapies for patients with chronic noncancer pain.

This functional restoration pain program incorporated various evidence-based medical, rehabilitative, psychological interventions with mind body medicine, mindfulness and integrative pain modalities. The authors continually meet and assess the success of the program. Although the initial outcome measures are encouraging, increased veteran participation in answering their post program completion surveys is desired. The goal is to improve veterans’ self-management of their chronic pain, leading to reductions in pain symptoms, medication, and health care provider use, as well as improve veterans’ function and overall QOL.

Image by Lance Liotta

Researchers say they have discovered a compound that can overcome resistance to apoptosis in acute myeloid leukemia (AML).

The compound, BTSA1, works by activating the BCL-2 family protein BAX.

BTSA1 prompted apoptosis in leukemia cells while sparing healthy cells. It also suppressed AML in mice without producing side effects.

Evripidis Gavathiotis, PhD, of Albert Einstein College of Medicine in Bronx, New York, and his colleagues described these results in Cancer Cell.

The team knew that apoptosis occurs when BAX is activated by pro-apoptotic proteins. However, cancer cells can avoid apoptosis by producing anti-apoptotic proteins that suppress BAX and the proteins that activate it.

“Our novel compound revives suppressed BAX molecules in cancer cells by binding with high affinity to BAX’s activation site,” Dr Gavathiotis said. “BAX can then swing into action, killing cancer cells while leaving healthy cells unscathed.”

Dr Gavathiotis was the lead author of a paper published in Nature in 2008 that first described the structure and shape of BAX’s activation site. He has since looked for small molecules that can activate BAX strongly enough to overcome cancer cells’ resistance to apoptosis.

His team initially screened more than 1 million compounds to reveal those with BAX-binding potential. The most promising 500 compounds were then evaluated in the lab.

“A compound dubbed BTSA1 (short for BAX Trigger Site Activator 1) proved to be the most potent BAX activator, causing rapid and extensive apoptosis when added to several different human AML cell lines,” said Denis Reyna, a doctoral student in Dr Gavathiotis’s lab.

The researchers also tested BTSA1 in blood samples from patients with high-risk AML. BTSA1 induced apoptosis in the patients’ AML cells but did not affect healthy hematopoietic stem cells.

Finally, the researchers generated mouse models of AML. BTSA1 was given to half the mice, while the other half served as controls.

On average, the BTSA1-treated mice survived significantly longer than the control mice—55 days and 40 days, respectively (P=0.0009). In fact, 43% of BTSA1-treated mice were still alive after 60 days and showing no signs of AML.

In addition, the mice treated with BTSA1 showed no evidence of toxicity.

“BTSA1 activates BAX and causes apoptosis in AML cells while sparing healthy cells and tissues, probably because the cancer cells are primed for apoptosis,” Dr Gavathiotis said.

He and his colleagues found that AML cells contained significantly higher BAX levels than normal blood cells from healthy subjects.

“With more BAX available in AML cells, even low BTSA1 doses will trigger enough BAX activation to cause apoptotic death, while sparing healthy cells that contain low levels of BAX or none at all,” Dr Gavathiotis said.

He and his team plan to determine if BTSA1 will elicit similar results in other cancer types.

Image by Lance Liotta

Researchers say they have discovered a compound that can overcome resistance to apoptosis in acute myeloid leukemia (AML).

The compound, BTSA1, works by activating the BCL-2 family protein BAX.

BTSA1 prompted apoptosis in leukemia cells while sparing healthy cells. It also suppressed AML in mice without producing side effects.

Evripidis Gavathiotis, PhD, of Albert Einstein College of Medicine in Bronx, New York, and his colleagues described these results in Cancer Cell.

The team knew that apoptosis occurs when BAX is activated by pro-apoptotic proteins. However, cancer cells can avoid apoptosis by producing anti-apoptotic proteins that suppress BAX and the proteins that activate it.

“Our novel compound revives suppressed BAX molecules in cancer cells by binding with high affinity to BAX’s activation site,” Dr Gavathiotis said. “BAX can then swing into action, killing cancer cells while leaving healthy cells unscathed.”

Dr Gavathiotis was the lead author of a paper published in Nature in 2008 that first described the structure and shape of BAX’s activation site. He has since looked for small molecules that can activate BAX strongly enough to overcome cancer cells’ resistance to apoptosis.

His team initially screened more than 1 million compounds to reveal those with BAX-binding potential. The most promising 500 compounds were then evaluated in the lab.

“A compound dubbed BTSA1 (short for BAX Trigger Site Activator 1) proved to be the most potent BAX activator, causing rapid and extensive apoptosis when added to several different human AML cell lines,” said Denis Reyna, a doctoral student in Dr Gavathiotis’s lab.

The researchers also tested BTSA1 in blood samples from patients with high-risk AML. BTSA1 induced apoptosis in the patients’ AML cells but did not affect healthy hematopoietic stem cells.

Finally, the researchers generated mouse models of AML. BTSA1 was given to half the mice, while the other half served as controls.

On average, the BTSA1-treated mice survived significantly longer than the control mice—55 days and 40 days, respectively (P=0.0009). In fact, 43% of BTSA1-treated mice were still alive after 60 days and showing no signs of AML.

In addition, the mice treated with BTSA1 showed no evidence of toxicity.

“BTSA1 activates BAX and causes apoptosis in AML cells while sparing healthy cells and tissues, probably because the cancer cells are primed for apoptosis,” Dr Gavathiotis said.

He and his colleagues found that AML cells contained significantly higher BAX levels than normal blood cells from healthy subjects.

“With more BAX available in AML cells, even low BTSA1 doses will trigger enough BAX activation to cause apoptotic death, while sparing healthy cells that contain low levels of BAX or none at all,” Dr Gavathiotis said.

He and his team plan to determine if BTSA1 will elicit similar results in other cancer types.

Image by Lance Liotta

Researchers say they have discovered a compound that can overcome resistance to apoptosis in acute myeloid leukemia (AML).

The compound, BTSA1, works by activating the BCL-2 family protein BAX.

BTSA1 prompted apoptosis in leukemia cells while sparing healthy cells. It also suppressed AML in mice without producing side effects.

Evripidis Gavathiotis, PhD, of Albert Einstein College of Medicine in Bronx, New York, and his colleagues described these results in Cancer Cell.

The team knew that apoptosis occurs when BAX is activated by pro-apoptotic proteins. However, cancer cells can avoid apoptosis by producing anti-apoptotic proteins that suppress BAX and the proteins that activate it.

“Our novel compound revives suppressed BAX molecules in cancer cells by binding with high affinity to BAX’s activation site,” Dr Gavathiotis said. “BAX can then swing into action, killing cancer cells while leaving healthy cells unscathed.”

Dr Gavathiotis was the lead author of a paper published in Nature in 2008 that first described the structure and shape of BAX’s activation site. He has since looked for small molecules that can activate BAX strongly enough to overcome cancer cells’ resistance to apoptosis.

His team initially screened more than 1 million compounds to reveal those with BAX-binding potential. The most promising 500 compounds were then evaluated in the lab.

“A compound dubbed BTSA1 (short for BAX Trigger Site Activator 1) proved to be the most potent BAX activator, causing rapid and extensive apoptosis when added to several different human AML cell lines,” said Denis Reyna, a doctoral student in Dr Gavathiotis’s lab.

The researchers also tested BTSA1 in blood samples from patients with high-risk AML. BTSA1 induced apoptosis in the patients’ AML cells but did not affect healthy hematopoietic stem cells.

Finally, the researchers generated mouse models of AML. BTSA1 was given to half the mice, while the other half served as controls.

On average, the BTSA1-treated mice survived significantly longer than the control mice—55 days and 40 days, respectively (P=0.0009). In fact, 43% of BTSA1-treated mice were still alive after 60 days and showing no signs of AML.

In addition, the mice treated with BTSA1 showed no evidence of toxicity.

“BTSA1 activates BAX and causes apoptosis in AML cells while sparing healthy cells and tissues, probably because the cancer cells are primed for apoptosis,” Dr Gavathiotis said.

He and his colleagues found that AML cells contained significantly higher BAX levels than normal blood cells from healthy subjects.

“With more BAX available in AML cells, even low BTSA1 doses will trigger enough BAX activation to cause apoptotic death, while sparing healthy cells that contain low levels of BAX or none at all,” Dr Gavathiotis said.

He and his team plan to determine if BTSA1 will elicit similar results in other cancer types.

A 60-year-old man presents for a follow-up visit to talk about his congestive heart failure. He has New York Heart Association class 3 heart failure with a left ventricular ejection fraction of 30%. You notice that he is downcast, and based on his self-administered 9-item Patient Health Questionnaire (PHQ-9) score of 17, you determine that he is having a concomitant major depressive episode. Should you start him on an SSRI?

Depression is widely recognized as an independent risk factor for cardiovascular disease (CVD), as well as adverse outcomes in patients with known CVD.^2-5 Previous studies have identified poor health behaviors as the primary underlying link between depression and CVD risk.^2,6 Conversely, a recent systematic review found that positive constructs, mediated primarily through lifestyle behaviors, may have a protective effect on outcomes.⁷

Recently, researchers have focused on treating depression to simultaneously improve CVD outcomes. While some studies have shown SSRIs to be a safe and effective treatment for depression in patients with coronary disease, they have not demonstrated improvement in CVD outcomes.^8,9 However, a post hoc analysis of the ENRICHD trial did suggest that SSRI treatment may improve mortality and morbidity post-MI.¹⁰

The prevalence of depression among patients with heart failure ranges from 10% to 40%, depending on disease severity.¹¹ Depression is associated with lower quality of life (QoL), poorer treatment adherence, and higher rates of rehospitalization among patients with heart failure; it is an independent predictor of mortality in this patient population.¹ Until recently, only one RCT (the SADHART-CHF study) looked at SSRI treatment in patients with heart failure and depression.¹² In that 12-week trial, sertraline did not improve depression or CVD outcomes when compared with placebo—but the study period may have been too short to capture long-term outcomes.

STUDY SUMMARY

SADHART-CHF, but better

In the MOOD-HF study, investigators sought to determine whether SSRI treatment for depression in patients with heart failure could improve CVD outcomes over a longer study period (up to 24 mo).¹ Specifically, this RCT assessed whether treatment with escitalopram could reduce morbidity and mortality risk in patients with comorbid chronic systolic heart failure and depression.

This double-blind, placebo-controlled trial was conducted at 16 tertiary medical centers in Germany between 2009 and 2014. Adult patients with New York Heart Association class 2 to 4 heart failure and left ventricular ejection fractions < 45% were screened for depression using the PHQ-9. Patients with PHQ-9 scores ≥ 12 underwent a structured psychiatric interview with a psychiatrist or psychosomatic specialist, and those diagnosed with major depression were invited to participate in the trial. Patients with recent SSRI use and/or psychotherapy were excluded.

Eligible participants were randomized to receive either escitalopram (10-20 mg/d) or placebo for up to 24 months, in addition to standard heart failure care. The starting dose of 5 mg was increased to 10 to 20 mg as tolerated until week 12 of the study; the dose at 12 weeks was considered the maintenance dose. Psychiatric and medical assessments were performed every six months during the study period. Depression severity was assessed using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS).

Outcomes. The study used a composite endpoint of all-cause death or hospitalization; the primary outcome was time to first event of this composite. Secondary outcomes included MADRS score at 12 weeks, anxiety as assessed by the Generalized Anxiety Disorder 7-item scale, and health-related QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The sample size was calculated to achieve 80% power for the primary outcome. Baseline characteristics between the intervention and placebo groups were balanced after randomization, and the modified intention-to-treat study population included participants who took at least one dose of the study medication.¹

Results. Ultimately, 372 participants were included in the analysis (185 escitalopram, 187 placebo). A primary endpoint event occurred in 116 participants (63%) in the escitalopram group and in 119 participants (64%) in the placebo group (hazard ratio [HR], 0.99).¹ No differences were found between treatment groups for the primary endpoints in either adjusted or unadjusted analyses.

The mean MADRS score changed from 20.2 at baseline to 11.2 at 12 weeks with escitalopram, and from 21.4 to 12.5 in the placebo group (between-group difference, –0.9).¹⁰ Overall, the two treatment groups had comparable daily medication doses and mean treatment duration (18 mo), and both groups demonstrated partial remission of depression symptoms, improved health status, and improved QoL over the study period.

Interestingly, the placebo group experienced significantly improved QoL at 12 months.¹ There were no between-group differences in adverse events or safety measures.¹ The trial was discontinued prematurely based on futility after a recommendation from the data and safety monitoring committee.

WHAT’S NEW

Longer study period/different SSRI

The MOOD-HF trial directly addresses the major criticism of the SADHART-CHF trial by conducting the study over a much longer duration (up to 24 mo vs 12 wk). Also, in contrast to SADHART-CHF, this trial studied escitalopram rather than sertraline, because some evidence indicates that escitalopram is superior at treating primary depression.¹³ Despite these differences, the results of MOOD-HF are consistent with the findings of SADHART-CHF: SSRI treatment for patients with heart failure and depression did not reduce the elevated morbidity and mortality risk seen with these comorbid conditions.

Also consistent with SADHART-CHF findings, participants in both groups in the MOOD-HF trial had partial remission of depressive symptoms over the study period, with no significant difference between those treated with escitalopram versus placebo. Given that this high-quality trial replicated the findings of SADHART-CHF with a longer treatment period and a potentially more effective SSRI, the results of MOOD-HF should put to rest the practice of initiating SSRI treatment in depressed patients with heart failure in an attempt to affect CVD outcomes.

CAVEATS

There are other SSRI fish in the sea

There are other SSRIs, besides escitalopram and sertraline, available for use. However, it is likely that this is a class effect.

Additionally, none of the patients in this trial had severe depression, as their PHQ-9 scores were all below 19. Therefore, it remains to be determined if treating severe depression has an impact on cardiovascular outcomes.

Lastly, and most importantly, this study only looked at initiating SSRIs for depression in the setting of heart failure. The trial did not include patients already taking SSRIs for pre-existing depression. Thus, the results do not imply evidence for discontinuing SSRIs in patients with heart failure.

Treating comorbid depression and CVD to mitigate the elevated risk for adverse clinical outcomes remains nuanced and elusive. The same can be said of non-CVD chronic conditions (eg, diabetes) based on recent systematic reviews.¹³ In sum, these studies suggest that a traditional screen-and-treat approach using SSRIs for depression treatment to affect chronic disease outcomes (that are likely lifestyle-related) may not be cost-effective or patient-centered.

A recent study showing that cognitive behavioral therapy did improve depression—but not heart failure—among patients with both conditions reaffirms that teasing out the impact of depression on lifestyle behaviors and chronic disease outcomes among multimorbid patients is more complex than previously thought.¹⁴ Nevertheless, this area of research should continue to be explored, given the worsened chronic disease outcomes in the presence of depression.

CHALLENGES TO IMPLEMENTATION

Changing the tide can be difficult

As with any behavior change, we expect that it will be a challenge to convince providers to stop initiating SSRI treatment to affect cardiovascular outcomes in patients with depression and heart failure—especially given the body of evidence denoting depression as a risk factor for increased morbidity and mortality in this population.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquires Network and The Journal of Family Practice (2017;66[9]:564-567).

A 60-year-old man presents for a follow-up visit to talk about his congestive heart failure. He has New York Heart Association class 3 heart failure with a left ventricular ejection fraction of 30%. You notice that he is downcast, and based on his self-administered 9-item Patient Health Questionnaire (PHQ-9) score of 17, you determine that he is having a concomitant major depressive episode. Should you start him on an SSRI?

Depression is widely recognized as an independent risk factor for cardiovascular disease (CVD), as well as adverse outcomes in patients with known CVD.^2-5 Previous studies have identified poor health behaviors as the primary underlying link between depression and CVD risk.^2,6 Conversely, a recent systematic review found that positive constructs, mediated primarily through lifestyle behaviors, may have a protective effect on outcomes.⁷

Recently, researchers have focused on treating depression to simultaneously improve CVD outcomes. While some studies have shown SSRIs to be a safe and effective treatment for depression in patients with coronary disease, they have not demonstrated improvement in CVD outcomes.^8,9 However, a post hoc analysis of the ENRICHD trial did suggest that SSRI treatment may improve mortality and morbidity post-MI.¹⁰

The prevalence of depression among patients with heart failure ranges from 10% to 40%, depending on disease severity.¹¹ Depression is associated with lower quality of life (QoL), poorer treatment adherence, and higher rates of rehospitalization among patients with heart failure; it is an independent predictor of mortality in this patient population.¹ Until recently, only one RCT (the SADHART-CHF study) looked at SSRI treatment in patients with heart failure and depression.¹² In that 12-week trial, sertraline did not improve depression or CVD outcomes when compared with placebo—but the study period may have been too short to capture long-term outcomes.

STUDY SUMMARY

SADHART-CHF, but better

In the MOOD-HF study, investigators sought to determine whether SSRI treatment for depression in patients with heart failure could improve CVD outcomes over a longer study period (up to 24 mo).¹ Specifically, this RCT assessed whether treatment with escitalopram could reduce morbidity and mortality risk in patients with comorbid chronic systolic heart failure and depression.

This double-blind, placebo-controlled trial was conducted at 16 tertiary medical centers in Germany between 2009 and 2014. Adult patients with New York Heart Association class 2 to 4 heart failure and left ventricular ejection fractions < 45% were screened for depression using the PHQ-9. Patients with PHQ-9 scores ≥ 12 underwent a structured psychiatric interview with a psychiatrist or psychosomatic specialist, and those diagnosed with major depression were invited to participate in the trial. Patients with recent SSRI use and/or psychotherapy were excluded.

Eligible participants were randomized to receive either escitalopram (10-20 mg/d) or placebo for up to 24 months, in addition to standard heart failure care. The starting dose of 5 mg was increased to 10 to 20 mg as tolerated until week 12 of the study; the dose at 12 weeks was considered the maintenance dose. Psychiatric and medical assessments were performed every six months during the study period. Depression severity was assessed using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS).

Outcomes. The study used a composite endpoint of all-cause death or hospitalization; the primary outcome was time to first event of this composite. Secondary outcomes included MADRS score at 12 weeks, anxiety as assessed by the Generalized Anxiety Disorder 7-item scale, and health-related QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The sample size was calculated to achieve 80% power for the primary outcome. Baseline characteristics between the intervention and placebo groups were balanced after randomization, and the modified intention-to-treat study population included participants who took at least one dose of the study medication.¹

Results. Ultimately, 372 participants were included in the analysis (185 escitalopram, 187 placebo). A primary endpoint event occurred in 116 participants (63%) in the escitalopram group and in 119 participants (64%) in the placebo group (hazard ratio [HR], 0.99).¹ No differences were found between treatment groups for the primary endpoints in either adjusted or unadjusted analyses.

The mean MADRS score changed from 20.2 at baseline to 11.2 at 12 weeks with escitalopram, and from 21.4 to 12.5 in the placebo group (between-group difference, –0.9).¹⁰ Overall, the two treatment groups had comparable daily medication doses and mean treatment duration (18 mo), and both groups demonstrated partial remission of depression symptoms, improved health status, and improved QoL over the study period.

Interestingly, the placebo group experienced significantly improved QoL at 12 months.¹ There were no between-group differences in adverse events or safety measures.¹ The trial was discontinued prematurely based on futility after a recommendation from the data and safety monitoring committee.

WHAT’S NEW

Longer study period/different SSRI

The MOOD-HF trial directly addresses the major criticism of the SADHART-CHF trial by conducting the study over a much longer duration (up to 24 mo vs 12 wk). Also, in contrast to SADHART-CHF, this trial studied escitalopram rather than sertraline, because some evidence indicates that escitalopram is superior at treating primary depression.¹³ Despite these differences, the results of MOOD-HF are consistent with the findings of SADHART-CHF: SSRI treatment for patients with heart failure and depression did not reduce the elevated morbidity and mortality risk seen with these comorbid conditions.

Also consistent with SADHART-CHF findings, participants in both groups in the MOOD-HF trial had partial remission of depressive symptoms over the study period, with no significant difference between those treated with escitalopram versus placebo. Given that this high-quality trial replicated the findings of SADHART-CHF with a longer treatment period and a potentially more effective SSRI, the results of MOOD-HF should put to rest the practice of initiating SSRI treatment in depressed patients with heart failure in an attempt to affect CVD outcomes.

CAVEATS

There are other SSRI fish in the sea

There are other SSRIs, besides escitalopram and sertraline, available for use. However, it is likely that this is a class effect.

Additionally, none of the patients in this trial had severe depression, as their PHQ-9 scores were all below 19. Therefore, it remains to be determined if treating severe depression has an impact on cardiovascular outcomes.

Lastly, and most importantly, this study only looked at initiating SSRIs for depression in the setting of heart failure. The trial did not include patients already taking SSRIs for pre-existing depression. Thus, the results do not imply evidence for discontinuing SSRIs in patients with heart failure.

Treating comorbid depression and CVD to mitigate the elevated risk for adverse clinical outcomes remains nuanced and elusive. The same can be said of non-CVD chronic conditions (eg, diabetes) based on recent systematic reviews.¹³ In sum, these studies suggest that a traditional screen-and-treat approach using SSRIs for depression treatment to affect chronic disease outcomes (that are likely lifestyle-related) may not be cost-effective or patient-centered.

A recent study showing that cognitive behavioral therapy did improve depression—but not heart failure—among patients with both conditions reaffirms that teasing out the impact of depression on lifestyle behaviors and chronic disease outcomes among multimorbid patients is more complex than previously thought.¹⁴ Nevertheless, this area of research should continue to be explored, given the worsened chronic disease outcomes in the presence of depression.

CHALLENGES TO IMPLEMENTATION

Changing the tide can be difficult

As with any behavior change, we expect that it will be a challenge to convince providers to stop initiating SSRI treatment to affect cardiovascular outcomes in patients with depression and heart failure—especially given the body of evidence denoting depression as a risk factor for increased morbidity and mortality in this population.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquires Network and The Journal of Family Practice (2017;66[9]:564-567).

A 60-year-old man presents for a follow-up visit to talk about his congestive heart failure. He has New York Heart Association class 3 heart failure with a left ventricular ejection fraction of 30%. You notice that he is downcast, and based on his self-administered 9-item Patient Health Questionnaire (PHQ-9) score of 17, you determine that he is having a concomitant major depressive episode. Should you start him on an SSRI?

Depression is widely recognized as an independent risk factor for cardiovascular disease (CVD), as well as adverse outcomes in patients with known CVD.^2-5 Previous studies have identified poor health behaviors as the primary underlying link between depression and CVD risk.^2,6 Conversely, a recent systematic review found that positive constructs, mediated primarily through lifestyle behaviors, may have a protective effect on outcomes.⁷

Recently, researchers have focused on treating depression to simultaneously improve CVD outcomes. While some studies have shown SSRIs to be a safe and effective treatment for depression in patients with coronary disease, they have not demonstrated improvement in CVD outcomes.^8,9 However, a post hoc analysis of the ENRICHD trial did suggest that SSRI treatment may improve mortality and morbidity post-MI.¹⁰

The prevalence of depression among patients with heart failure ranges from 10% to 40%, depending on disease severity.¹¹ Depression is associated with lower quality of life (QoL), poorer treatment adherence, and higher rates of rehospitalization among patients with heart failure; it is an independent predictor of mortality in this patient population.¹ Until recently, only one RCT (the SADHART-CHF study) looked at SSRI treatment in patients with heart failure and depression.¹² In that 12-week trial, sertraline did not improve depression or CVD outcomes when compared with placebo—but the study period may have been too short to capture long-term outcomes.

STUDY SUMMARY

SADHART-CHF, but better

In the MOOD-HF study, investigators sought to determine whether SSRI treatment for depression in patients with heart failure could improve CVD outcomes over a longer study period (up to 24 mo).¹ Specifically, this RCT assessed whether treatment with escitalopram could reduce morbidity and mortality risk in patients with comorbid chronic systolic heart failure and depression.

This double-blind, placebo-controlled trial was conducted at 16 tertiary medical centers in Germany between 2009 and 2014. Adult patients with New York Heart Association class 2 to 4 heart failure and left ventricular ejection fractions < 45% were screened for depression using the PHQ-9. Patients with PHQ-9 scores ≥ 12 underwent a structured psychiatric interview with a psychiatrist or psychosomatic specialist, and those diagnosed with major depression were invited to participate in the trial. Patients with recent SSRI use and/or psychotherapy were excluded.

Eligible participants were randomized to receive either escitalopram (10-20 mg/d) or placebo for up to 24 months, in addition to standard heart failure care. The starting dose of 5 mg was increased to 10 to 20 mg as tolerated until week 12 of the study; the dose at 12 weeks was considered the maintenance dose. Psychiatric and medical assessments were performed every six months during the study period. Depression severity was assessed using the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS).

Outcomes. The study used a composite endpoint of all-cause death or hospitalization; the primary outcome was time to first event of this composite. Secondary outcomes included MADRS score at 12 weeks, anxiety as assessed by the Generalized Anxiety Disorder 7-item scale, and health-related QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The sample size was calculated to achieve 80% power for the primary outcome. Baseline characteristics between the intervention and placebo groups were balanced after randomization, and the modified intention-to-treat study population included participants who took at least one dose of the study medication.¹

Results. Ultimately, 372 participants were included in the analysis (185 escitalopram, 187 placebo). A primary endpoint event occurred in 116 participants (63%) in the escitalopram group and in 119 participants (64%) in the placebo group (hazard ratio [HR], 0.99).¹ No differences were found between treatment groups for the primary endpoints in either adjusted or unadjusted analyses.

The mean MADRS score changed from 20.2 at baseline to 11.2 at 12 weeks with escitalopram, and from 21.4 to 12.5 in the placebo group (between-group difference, –0.9).¹⁰ Overall, the two treatment groups had comparable daily medication doses and mean treatment duration (18 mo), and both groups demonstrated partial remission of depression symptoms, improved health status, and improved QoL over the study period.

Interestingly, the placebo group experienced significantly improved QoL at 12 months.¹ There were no between-group differences in adverse events or safety measures.¹ The trial was discontinued prematurely based on futility after a recommendation from the data and safety monitoring committee.

WHAT’S NEW

Longer study period/different SSRI

The MOOD-HF trial directly addresses the major criticism of the SADHART-CHF trial by conducting the study over a much longer duration (up to 24 mo vs 12 wk). Also, in contrast to SADHART-CHF, this trial studied escitalopram rather than sertraline, because some evidence indicates that escitalopram is superior at treating primary depression.¹³ Despite these differences, the results of MOOD-HF are consistent with the findings of SADHART-CHF: SSRI treatment for patients with heart failure and depression did not reduce the elevated morbidity and mortality risk seen with these comorbid conditions.

Also consistent with SADHART-CHF findings, participants in both groups in the MOOD-HF trial had partial remission of depressive symptoms over the study period, with no significant difference between those treated with escitalopram versus placebo. Given that this high-quality trial replicated the findings of SADHART-CHF with a longer treatment period and a potentially more effective SSRI, the results of MOOD-HF should put to rest the practice of initiating SSRI treatment in depressed patients with heart failure in an attempt to affect CVD outcomes.

CAVEATS

There are other SSRI fish in the sea

There are other SSRIs, besides escitalopram and sertraline, available for use. However, it is likely that this is a class effect.

Additionally, none of the patients in this trial had severe depression, as their PHQ-9 scores were all below 19. Therefore, it remains to be determined if treating severe depression has an impact on cardiovascular outcomes.

Lastly, and most importantly, this study only looked at initiating SSRIs for depression in the setting of heart failure. The trial did not include patients already taking SSRIs for pre-existing depression. Thus, the results do not imply evidence for discontinuing SSRIs in patients with heart failure.

Treating comorbid depression and CVD to mitigate the elevated risk for adverse clinical outcomes remains nuanced and elusive. The same can be said of non-CVD chronic conditions (eg, diabetes) based on recent systematic reviews.¹³ In sum, these studies suggest that a traditional screen-and-treat approach using SSRIs for depression treatment to affect chronic disease outcomes (that are likely lifestyle-related) may not be cost-effective or patient-centered.

A recent study showing that cognitive behavioral therapy did improve depression—but not heart failure—among patients with both conditions reaffirms that teasing out the impact of depression on lifestyle behaviors and chronic disease outcomes among multimorbid patients is more complex than previously thought.¹⁴ Nevertheless, this area of research should continue to be explored, given the worsened chronic disease outcomes in the presence of depression.

CHALLENGES TO IMPLEMENTATION

Changing the tide can be difficult

As with any behavior change, we expect that it will be a challenge to convince providers to stop initiating SSRI treatment to affect cardiovascular outcomes in patients with depression and heart failure—especially given the body of evidence denoting depression as a risk factor for increased morbidity and mortality in this population.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquires Network and The Journal of Family Practice (2017;66[9]:564-567).

SAN DIEGO – Thirty-day mortality associated with Staphylococcus aureus bacteremia is reduced if there is guidance from either an antimicrobial stewardship team (AST) or an infectious disease consultant (IDC), according to a multivariate experience at Yale New Haven Hospital presented at an annual scientific meeting on infectious diseases.

“This has been a hot area, because there have been a lot of recent studies suggesting that expert infectious disease advice improves care, but not every study has associated expert advice with a mortality benefit,” said Jacqueline Sherbuk, MD, a fellow in the division of infectious diseases and international health at the University of Virginia, Charlottesville. She was a resident at Yale University when this study was conducted.

In this study, the impact of an IDC on outcome in patients with S. aureus bacteremia was evaluated relative to no expert advice. By itself, an IDC was associated with improved adherence to standards of care for S. aureus bacteremia management, but the reduction in mortality was not statistically significant for those who received IDC guidance relative to those who did not.

“Given that patient care may be guided by consultations from the AST independent of IDC, we looked at the overall impact of expert opinion versus no expert involvement, and this achieved significance on multivariate analysis,” Dr. Sherbuk reported.

For adherence to guidelines, IDC guidance was better than no expert advice on multiple measures, including proportion obtaining an echocardiogram (89% vs. 67%; P less than .001), appropriate definitive antibiotics (98% vs. 80%; P less than .001), and appropriate treatment duration (92% vs. 35%; P less than .001). However, the advantage for 30-day mortality rates was only a trend (11% vs. 21%, P = .07). It was only when patients who received IDC guidance or a consultation from the AST were combined that the difference climbed to significance (11% vs. 23%; P = .04).

“On multivariate analysis, the OR [odds ratio] was substantial, predicting a 60% reduction [OR 0.40; P = .03) in 30-day mortality for expert advice vs. no expert advice,” Dr. Sherbuk reported.

In this retrospective observational study, 261 unique cases of S. aureus bacteremia cases in adult patients established with positive blood cultures were evaluated. The cases were collected over a 1-year period at Yale New Haven Hospital. After exclusion of those who died within 3 days of the initial positive culture or who were transferred to other facilities, 236 were included in this analysis.

IDC guidance, which is not required for S. aureus bacteremia at Yale New Haven Hospital, was provided for 74.5% of the patients. Another 4% of patients received guidance from the AST, which is an independent service often provided prior to IDC guidance, according to Dr. Sherbuk.

copyright Thomas Northcut/Thinkstock

SAN DIEGO – Thirty-day mortality associated with Staphylococcus aureus bacteremia is reduced if there is guidance from either an antimicrobial stewardship team (AST) or an infectious disease consultant (IDC), according to a multivariate experience at Yale New Haven Hospital presented at an annual scientific meeting on infectious diseases.

“This has been a hot area, because there have been a lot of recent studies suggesting that expert infectious disease advice improves care, but not every study has associated expert advice with a mortality benefit,” said Jacqueline Sherbuk, MD, a fellow in the division of infectious diseases and international health at the University of Virginia, Charlottesville. She was a resident at Yale University when this study was conducted.

In this study, the impact of an IDC on outcome in patients with S. aureus bacteremia was evaluated relative to no expert advice. By itself, an IDC was associated with improved adherence to standards of care for S. aureus bacteremia management, but the reduction in mortality was not statistically significant for those who received IDC guidance relative to those who did not.

“Given that patient care may be guided by consultations from the AST independent of IDC, we looked at the overall impact of expert opinion versus no expert involvement, and this achieved significance on multivariate analysis,” Dr. Sherbuk reported.

For adherence to guidelines, IDC guidance was better than no expert advice on multiple measures, including proportion obtaining an echocardiogram (89% vs. 67%; P less than .001), appropriate definitive antibiotics (98% vs. 80%; P less than .001), and appropriate treatment duration (92% vs. 35%; P less than .001). However, the advantage for 30-day mortality rates was only a trend (11% vs. 21%, P = .07). It was only when patients who received IDC guidance or a consultation from the AST were combined that the difference climbed to significance (11% vs. 23%; P = .04).

“On multivariate analysis, the OR [odds ratio] was substantial, predicting a 60% reduction [OR 0.40; P = .03) in 30-day mortality for expert advice vs. no expert advice,” Dr. Sherbuk reported.

In this retrospective observational study, 261 unique cases of S. aureus bacteremia cases in adult patients established with positive blood cultures were evaluated. The cases were collected over a 1-year period at Yale New Haven Hospital. After exclusion of those who died within 3 days of the initial positive culture or who were transferred to other facilities, 236 were included in this analysis.

IDC guidance, which is not required for S. aureus bacteremia at Yale New Haven Hospital, was provided for 74.5% of the patients. Another 4% of patients received guidance from the AST, which is an independent service often provided prior to IDC guidance, according to Dr. Sherbuk.

copyright Thomas Northcut/Thinkstock

SAN DIEGO – Thirty-day mortality associated with Staphylococcus aureus bacteremia is reduced if there is guidance from either an antimicrobial stewardship team (AST) or an infectious disease consultant (IDC), according to a multivariate experience at Yale New Haven Hospital presented at an annual scientific meeting on infectious diseases.

“This has been a hot area, because there have been a lot of recent studies suggesting that expert infectious disease advice improves care, but not every study has associated expert advice with a mortality benefit,” said Jacqueline Sherbuk, MD, a fellow in the division of infectious diseases and international health at the University of Virginia, Charlottesville. She was a resident at Yale University when this study was conducted.

In this study, the impact of an IDC on outcome in patients with S. aureus bacteremia was evaluated relative to no expert advice. By itself, an IDC was associated with improved adherence to standards of care for S. aureus bacteremia management, but the reduction in mortality was not statistically significant for those who received IDC guidance relative to those who did not.

“Given that patient care may be guided by consultations from the AST independent of IDC, we looked at the overall impact of expert opinion versus no expert involvement, and this achieved significance on multivariate analysis,” Dr. Sherbuk reported.

For adherence to guidelines, IDC guidance was better than no expert advice on multiple measures, including proportion obtaining an echocardiogram (89% vs. 67%; P less than .001), appropriate definitive antibiotics (98% vs. 80%; P less than .001), and appropriate treatment duration (92% vs. 35%; P less than .001). However, the advantage for 30-day mortality rates was only a trend (11% vs. 21%, P = .07). It was only when patients who received IDC guidance or a consultation from the AST were combined that the difference climbed to significance (11% vs. 23%; P = .04).

“On multivariate analysis, the OR [odds ratio] was substantial, predicting a 60% reduction [OR 0.40; P = .03) in 30-day mortality for expert advice vs. no expert advice,” Dr. Sherbuk reported.

In this retrospective observational study, 261 unique cases of S. aureus bacteremia cases in adult patients established with positive blood cultures were evaluated. The cases were collected over a 1-year period at Yale New Haven Hospital. After exclusion of those who died within 3 days of the initial positive culture or who were transferred to other facilities, 236 were included in this analysis.

IDC guidance, which is not required for S. aureus bacteremia at Yale New Haven Hospital, was provided for 74.5% of the patients. Another 4% of patients received guidance from the AST, which is an independent service often provided prior to IDC guidance, according to Dr. Sherbuk.

copyright Thomas Northcut/Thinkstock

SAN DIEGO – Rates of reported Legionnaires’ disease nearly quadrupled in the United States between 2000 and 2015, and it is likely underdiagnosed.

“Improved testing and surveillance are needed to improve understanding of disease and outbreak burden,” Laura A. Cooley, MD, said at an annual scientific meeting on infectious diseases. “There is more to learn about environmental sources of Legionella for cases not associated with known outbreaks and about the distribution of Legionella in the environment.”

Cases are higher in the warmer months, and the rates are highest among the elderly, men, and those of black race. Currently, L. pneumophila accounts for about 90% of cases in the United States. “Once it’s transmitted, it has to hit a susceptible population to cause disease, generally older individuals and people with underlying conditions,” Dr. Cooley said.

copyright claudiobaba/iStockPhoto.com

dbrunk@frontlinemedcom.com

SAN DIEGO – Rates of reported Legionnaires’ disease nearly quadrupled in the United States between 2000 and 2015, and it is likely underdiagnosed.

“Improved testing and surveillance are needed to improve understanding of disease and outbreak burden,” Laura A. Cooley, MD, said at an annual scientific meeting on infectious diseases. “There is more to learn about environmental sources of Legionella for cases not associated with known outbreaks and about the distribution of Legionella in the environment.”

Cases are higher in the warmer months, and the rates are highest among the elderly, men, and those of black race. Currently, L. pneumophila accounts for about 90% of cases in the United States. “Once it’s transmitted, it has to hit a susceptible population to cause disease, generally older individuals and people with underlying conditions,” Dr. Cooley said.

copyright claudiobaba/iStockPhoto.com

dbrunk@frontlinemedcom.com

SAN DIEGO – Rates of reported Legionnaires’ disease nearly quadrupled in the United States between 2000 and 2015, and it is likely underdiagnosed.

“Improved testing and surveillance are needed to improve understanding of disease and outbreak burden,” Laura A. Cooley, MD, said at an annual scientific meeting on infectious diseases. “There is more to learn about environmental sources of Legionella for cases not associated with known outbreaks and about the distribution of Legionella in the environment.”

Cases are higher in the warmer months, and the rates are highest among the elderly, men, and those of black race. Currently, L. pneumophila accounts for about 90% of cases in the United States. “Once it’s transmitted, it has to hit a susceptible population to cause disease, generally older individuals and people with underlying conditions,” Dr. Cooley said.

copyright claudiobaba/iStockPhoto.com

dbrunk@frontlinemedcom.com