Measuring Quality of Life in Deprescribing Trials: A Scoping Review.

BACKGROUND: Quality of life (QoL) is an important outcome to capture in clinical trials evaluating deprescribing interventions. OBJECTIVE: We aimed to conduct a scoping review to examine how QoL has been measured in deprescribing trials among older people and identify potentially relevant QoL scales, to better inform QoL measurement in future deprescribing trials. METHODS: We searched MEDLINE, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials, Google Scholar, Epistemonikos, ClinicalTrials.gov, and reference lists of eligible studies (from inception to October 2023). We included randomized and non-randomized comparative studies with a control group that evaluated deprescribing and polypharmacy reduction interventions in people ≥ 65 years of age and measured QoL as an outcome. We also included studies describing the development and validation of QoL scales related to deprescribing, polypharmacy, or medication burden in adults ≥ 18 years of age. Two independent reviewers screened titles and abstracts, then full texts. Two independent reviewers extracted data from 25% of eligible studies in order to verify agreement, then a single reviewer extracted data from the remaining studies, which a second reviewer cross-checked. We critically appraised scales based on the COSMIN checklist. RESULTS: We retrieved 7290 articles, of which 52 were eligible for inclusion, including 44 deprescribing trials and eight scale development studies. From these studies, we found 21 scales that have been used in the context of deprescribing/polypharmacy (12 generic scales used in clinical trials and nine medication-specific scales). Variations of the generic EQ-5D were the most used scales. The measurement properties of scales for capturing changes in QoL from deprescribing were uncertain. Medication-specific QoL scales have not been employed in deprescribing clinical trials and thus, their performance in this context is also not clear. CONCLUSIONS: Several existing QoL scales have been applied to the context of deprescribing/polypharmacy clinical trials, and new scales specific to the problem have been proposed. If deprescribing does impact QoL, our findings suggest it is uncertain whether existing QoL scales can practically and reliably capture such a change or whether any scale is best. However, this review compares various aspects of the scales that researchers and clinicians can consider in decisions about measuring QoL in deprescribing trials, and in planning future research. PROTOCOL REGISTRATION: Open Science Framework: osf.io/aez6w.

Development and validation of a performance-based palliative care assessment tool for student pharmacists.

INTRODUCTION: Integration of hospice and palliative care principles within pharmacy curricula is essential to fill the need of pharmacist training in this growing specialty. A formalized assessment tool to evaluate skill development does not exist for student pharmacists specific to palliative care. The objective of this study was to develop a valid and reliable, palliative care-focused, performance-based assessment tool for student pharmacists. METHODS: Eight academic palliative care (PC) pharmacists were recruited for the workgroup to perform domain development, validation, tool creation, and reliability testing for this performance-based assessment tool. Hospice and palliative care clinical pharmacist entrustable professional activities (EPAs) served as the framework. Content validity testing utilized content validity index and scale universal agreement (S-CVI/UA) to determine level of agreement for activities included in the tool. Student volunteers completed a standardized patient case and workgroup members served as raters during the reliability testing phase. Interrater reliability was measured through calculation of Fleiss Kappa scores for each activity. RESULTS: Out of 14 EPAs, nine were deemed "essential" to include in the tool. Thirty-four supporting activities for the nine essential EPAs were drafted. Two rounds of content validity testing were necessary to achieve S-CVI/UA of 0.9593. Consensus was reached from workgroup members for activities deemed necessary to include in the tool after questionnaire distribution utilizing a Fleiss Kappa cutoff >0.6. CONCLUSIONS: This validated tool will afford colleges and schools of pharmacy with PC curricula an opportunity to assess student achievement of PC-specific skills and evaluate curricular effectiveness.

A virtual breakthrough series collaborative to support deprescribing interventions across Veterans Affairs healthcare settings.

BACKGROUND: Virtual collaborative models are a practical way to implement a supportive environment for multi-team learning. In this project, we aimed to describe the processes and outcomes of a virtual deprescribing collaborative that facilitated implementation of deprescribing interventions around the country. METHODS: Two successive cohorts comprised of multidisciplinary teams from geographically diverse veterans affairs (VA) sites were selected via an application process to participate in a virtual deprescribing collaborative. Each site developed its own deprescribing protocol and took part in regular meetings, mentoring groups, monthly data reporting, and other learning activities over an approximate 9 month period, per cohort. Standard measures were number of veterans served and medications deprescribed. Descriptive and qualitative analyses were utilized. RESULTS: Twenty-one total VA sites were selected to participate in the deprescribing collaborative in two cohorts (Cohort 1, n = 12 sites; Cohort 2, n = 9 sites). The majority of sites' practice areas directly served the older adult population, and the majority of site leads were pharmacists. The most utilized tool used by the collaborative sites was the VA VIONE decision support tool (n = 14) and the most common strategy was individualized medication review. Combining outcomes from both Cohorts 1 and 2, a total of n = 4770 veterans were served, with 8332 medications deprescribed. Eighty-two percent of Cohort 1 sites surveyed reported their deprescribing program was still being utilized after 1 year follow up. CONCLUSIONS: This virtual deprescribing collaborative aided in the successful implementation of both established and novel deprescribing practices across a variety of VA practice sites that care for older adults. The shared learning experience enhanced problem solving and allowed for interdisciplinary teamwork. Overall the collaborative was successful in improving polypharmacy for several thousand older adults.

Patterns and Trends in Receipt of Opioids Among Patients Receiving Treatment for Cancer in a Large Health System.

BACKGROUND: Given limited evidence on opioid prescribing among patients receiving treatment for cancer during the ongoing opioid epidemic, our objective was to assess predictors of and trends in opioid receipt during cancer treatment, including how patterns differ by type of cancer. METHODS: Using cancer registry data, we identified patients with a first lifetime primary diagnosis of breast, colorectal, or lung cancer from 2013 to 2017 who underwent treatment within a large cancer center network. Cancer registry data were linked to electronic health record information on opioid prescriptions. We examined predictors of and trends in receipt of any opioid prescription within 12 months of cancer diagnosis. RESULTS: The percentage of patients receiving opioids varied by cancer type: breast cancer, 35% (1,996/5,649); colorectal, 37% (776/2,083); lung, 47% (1,259/2,654). In multivariable analysis, opioid use in the year before cancer diagnosis was the factor most strongly associated with receipt of opioids after cancer diagnosis, with 4.90 (95% CI, 4.10-5.86), 5.09 (95% CI, 3.88-6.69), and 3.31 (95% CI, 2.68-4.10) higher odds for breast, colorectal, and lung cancers, respectively. We did not observe a consistent decline in opioid prescribing over time, and trends differed by cancer type. CONCLUSIONS: Our findings suggest that prescription of opioids to patients with cancer varies by cancer type and other factors. In particular, patients are more likely to receive opioids after cancer diagnosis if they were previously exposed before diagnosis, suggesting that pain among patients with cancer may commonly include non-cancer-related pain. Heterogeneity and complexity among patients with cancer must be accounted for in developing policies and guidelines aimed at addressing pain management while minimizing the risk of opioid misuse.

Modified Application of Cardiac Rehabilitation in Older Adults (MACRO) Trial: Protocol changes in a pragmatic multi-site randomized controlled trial in response to the COVID-19 pandemic.

BACKGROUND: Older adults are at higher risk for cardiovascular disease and functional decline, often leading to deterioration and dependency. Cardiac rehabilitation (CR) provides opportunity to improve clinical and functional recovery, yet participation in CR decreases with age. Modified Application of CR in Older Adults (MACRO) is a National Institute on Aging (NIA)-funded pragmatic trial that responds to this gap by aiming to increase enrollment of older adults into CR and improving functional outcomes. This article describes the methodology and novel features of the MACRO trial. METHODS: Randomized, controlled trial of a coaching intervention (MACRO-I) vs. usual care for older adults (age ≥ 70 years) eligible for CR after an incident cardiac hospitalization. MACRO-I incorporates innovations including holistic risk assessments, flexible CR format (i.e., helping patients to select a CR design that aligns with their personal risks and preferences), motivational prompts, nutritional emphasis, facilitated deprescription, enhanced education, and home visits. Key modifications were necessitated by the COVID-19 pandemic, including switching from a performance-based primary endpoint (Short Physical Performance Battery) to a patient-reported measure (Activity Measure for Post-Acute Care Computerized Adaptive Testing). Changes prompted by COVID-19 maintain the original intent of the trial and provide key methodologic advantages. CONCLUSIONS: MACRO is exploring a novel individualized coaching intervention to better enable older patients to participate in CR. Due to COVID-19 many aspects of the MACRO protocol required modification, but the primary objective of the trial is maintained and the updated protocol will more effectively achieve the original goals of the study.

Introduction of the BNT162b2 vaccine during a COVID-19 nursing home outbreak.

BACKGROUND: Coronavirus disease 2019 (COVID-19) outbreaks often occur in nursing homes and prompt frequent surveillance testing for SARS-CoV-2. A single dose of the BNT162b2 vaccine reduces viral load and transmission. In this study, we describe the real-world efficacy of BNT162b2 single-dose vaccination during a COVID-19 outbreak at a Veterans Affairs Community Living Center (CLC). METHODS: From 12/2/20 to 5/14/21, twice weekly antigen testing was used to detect COVID-19 among 146 residents at the CLC. Residents without a prior history of COVID-19 who agreed to immunization were vaccinated with the BNT162b2 vaccine on 12/16/20 and 1/6/21. Single-dose vaccine efficacy was determined for days 1-21 and days 14-21 after the first vaccine dose. RESULTS: The outbreak occurred from 12/2/20 to 1/7/21 with an attack rate of 30.8% (45/146); 46.7% (21/45) of the cases were due to asymptomatic COVID-19. One unit accounted for 77.8% (35/45) of the cases. In the vaccine analysis, 116 residents were a median age of 74.5 years and 93.1% (108/116) had ≥ 1 comorbid condition. Between the first and second dose, 15.5% (15/97) of vaccinated residents, and 21.2% (4/19) of unvaccinated residents developed COVID-19 (P = .81). One week after the second dose, no cases of COVID-19 occurred. CONCLUSIONS: Albeit limited by the small numbers, a single dose of the BNT162b2 vaccine was not efficacious at preventing COVID-19 during this nursing home outbreak.

A Systematic Review of Palliative Care Content in the Doctor of Pharmacy Curriculum.

Objective. To describe the methods of teaching and evaluating palliative care experiences for pharmacy students.Findings. A literature search retrieved 971 reports, from which 26 studies met all of study criteria. Educational interventions concerning palliative care included didactic courses, flipped classrooms, advanced pharmacy practice experiences (APPEs), workshops, and seminars. Total direct hours of education in palliative care ranged from 1-200. Seven (27%) focused experiences were reported as required, while nine (35%) were reported as elective. The majority (n=14, 54%) of studies measured pharmacy students' confidence, attitudes, or perceptions as the main outcome, and of those most studies reported an improvement. Five (19%) studies reported on interprofessional experiences in palliative care conducted in the United States, and four (15%) studies reported on similar experiences conducted outside the United States. When reported, most experiences were developed for students to complete prior to beginning their APPE year. All of the included studies used a non-randomized design.Summary. This review suggests a palliative care experience for pharmacy students should be interprofessional, occur during the year prior to APPEs, and measure skills-based outcomes.

Association between opioid dose escalation and time to death in a comfort measures only population.

PURPOSE: Opioids are crucial to the relief of pain and dyspnea experienced by patients dying in the hospital setting; however, there are concerns about the association of opioid dosage with hastened death via opioid-induced respiratory depression, and there is little published evidence regarding the association between opioid dose escalation and time to death in the inpatient comfort measures only (CMO) population. METHODS: The medical records of adult patients admitted to 2 hospitals who had an active CMO order at the time of death and received opioid dose escalations after CMO pronouncement were assessed in a retrospective cohort study. Patients were categorized into higher and lower opioid dose escalation groups according to an institutional palliative care symptom guide. A Cox proportional hazards model was constructed to test the associations between dose escalation group, patient sex, opioid naivety, palliative care consultation, and opioid dosage after CMO pronouncement (independent variables) and time to death (dependent variable). RESULTS: In the 71-patient cohort, 39 patients (54.9%) were male and 32 (45.1%) were female. The mean (SD) age of patients was 67.2 (16.6) years. Higher dose escalation (n = 46, 64.8%) was associated with a nonsignificant decrease in survival time compared to lower dose escalation (n = 25, 35.2%), with a mean difference in time to death of 19.8 hours (hazard ratio [HR], 1.67; 95% confidence interval [CI], 0.94-2.97). Receipt of a palliative care consult (n = 56, 78.9%) during the final hospital visit was associated with increased survival time (mean difference, 20.1 hours; HR, 0.32; 95% CI, 0.16-0.63). CONCLUSION: Time to death in an inpatient CMO population was not significantly associated with the degree of opioid dose escalation.

Does Deprescribing Improve Quality of Life? A Systematic Review of the Literature.

BACKGROUND: Deprescribing has been shown to reduce potentially inappropriate or unnecessary medications; however, whether these benefits translate into improved quality of life (QOL) is uncertain. OBJECTIVE: The objective of this study was to isolate the impact of deprescribing on patient or designated representative reported QOL; satisfaction with care (SWC) and emergency department (ED) visits and hospitalizations were also investigated to further explore this question. METHODS: This systematic review searched the Cochrane Library, Cumulative Index to Nursing and Allied Health (CINAHL), MEDLINE, and EMBASE from database inception until November 2017. Randomized controlled trials and non-randomized prospective studies of older adults (> 65 years or older) and older persons with life-limiting conditions were included. Two reviewers independently assessed the search results and performed risk of bias assessments. Data on QOL, SWC, and ED visits and hospitalizations were extracted from all identified studies. Risk of bias of individual studies was assessed using measures recommended by the Cochrane Collaboration. RESULTS: Screening of 6543 eligible records identified 12 studies within 13 articles. In ten studies investigating the reduction of at least one medication deprescribed, compared with usual care, all but two found no difference in QOL. To date there has only been one study examining the impact of deprescribing on SWC, which was found to be not statistically significant. Four studies exploring the impact of deprescribing on ED visits and hospitalizations also found no significant difference. However, many studies were found to have a higher performance, detection, or other bias. We found considerable heterogeneity in patient populations, targeted medications for deprescribing, and QOL measurements used in these studies. CONCLUSION: Based on a limited number of studies with varying methodological rigor, deprescribing may not significantly improve QOL or SWC; however, it may not contribute to additional ED visits and hospitalizations. Future controlled studies are needed.

Development of a required longitudinal residency experience focused on deprescribing.

PURPOSE: In this article we describe a novel required longitudinal experience focused on deprescribing designed for postgraduate year 2 (PGY2) geriatric pharmacy residents. This experience was embedded within a clinical pharmacist-driven deprescribing service. Insights on challenges faced and benefits gained during the first offering are also highlighted. SUMMARY: Through collaboration with the University of Pittsburgh School of Pharmacy (UPMC) Palliative and Supportive Institute and the UPMC St. Margaret PGY2 geriatric pharmacy residency program, a year-long required deprescribing-focused experience was developed and executed. The experience was aligned with the American Society of Health-System Pharmacists' standard goals and objectives and was designed to focus and evaluate 3 skills necessary for all pharmacy practitioners: empathy, critical thinking, and communication. There is a need for proactive deprescribing initiatives to reduce the unnecessary burden and cost associated with potentially inappropriate medications for older patients. Focused deprescribing experiences can better equip pharmacist learners with the ability to lead these initiatives. CONCLUSION: A required longitudinal deprescribing-focused experience can provide PGY2 geriatric pharmacy residents with opportunities to practice empathy, critical thinking, and communication beyond those typically offered in a residency program.

The Need for Palliative Care in Pharmacy Education.

There is a growing need for palliative care pharmacists in the United States. There is also a gap in the education of palliative care for pharmacy students. To address both, pharmacy schools must develop and disseminate palliative care-focused experiences, including traditional didactic lectures, problem-based learning, interactive skills, laboratory- and web-based experiences. This commentary presents the need for palliative care-focused experiences in the Doctor of Pharmacy (PharmD) degree program, and how schools can take smaller steps to tackle this issue.

Associations Between Polypharmacy, Symptom Burden, and Quality of Life in Patients with Advanced, Life-Limiting Illness.

BACKGROUND: Polypharmacy may be particularly burdensome near the end of life, as patients "accumulate" medications to treat and prevent multiple diseases. OBJECTIVE: To evaluate associations between polypharmacy, symptom burden, and quality of life (QOL) in patients with advanced, life-limiting illness (clinician-estimated, 1 month-1 year). DESIGN: Secondary analysis of baseline data from a trial of statin discontinuation. PARTICIPANTS: Adults with advanced, life-limiting illness. MAIN MEASURES: Polypharmacy was assessed by summing the number of non-statin medications taken regularly or as needed. Symptom burden was assessed using the Edmonton Symptom Assessment Scale (range 0-90; higher scores indicating greater symptom burden) and QOL was assessed using the McGill QOL Questionnaire (range 0-10; higher scores indicating better QOL). Linear regression models assessed associations between polypharmacy, symptom burden, and QOL. KEY RESULTS: Among 372 participants, 47% were age 75 or older and 35% were enrolled in hospice. The mean symptom score was 27.0 (standard deviation (SD) 16.1) and the mean QOL score was 7.0 (SD 1.3). The average number of non-statin medications was 11.6 (SD 5.0); one-third of participants took ≥ 14 medications. In adjusted models, higher polypharmacy was associated with higher symptom burden (coefficient 0.81; p < .001) and lower QOL (coefficient - .06; p = .001). Adjusting for symptom burden weakened the association between polypharmacy and QOL (coefficient - .03; p = .045) without a significant interaction, suggesting that worse quality of life associated with polypharmacy may be related to medication-associated symptoms. CONCLUSIONS: Among adults with advanced illness, taking more medications is associated with higher symptom burden and lower QOL. Attention to medication-related symptoms and shared decision-making regarding deprescribing are warranted in this setting. NIH TRIAL REGISTRY NUMBER: ClinicalTrials.gov Identifier for Parent Study - NCT01415934.