The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.

Does Mode of Survey Administration Matter? Using Measurement Invariance to Validate the Mail and Telephone Versions of the Bereaved Family Survey.

CONTEXT: The Veterans Health Administration evaluates outcomes of end-of-life (EOL) care using the Bereaved Family Survey (BFS). Originally, the BFS was administered as a telephone survey but was transitioned to a mail survey beginning October 2012. The transition necessitated an evaluation of the tool's validity using this new mode of administration. OBJECTIVES: The objective of this study was to validate the mail version and to test for measurement invariance (MI) across the two administration modes. METHODS: Telephone and mail versions of the BFS were validated separately between October 2009 and September 2013. MI was evaluated using a series of confirmatory factor analyses (CFAs). Construct validity was evaluated by calculating Cronbach alpha coefficients and examining differences between BFS factor scores for groups with and without quality care indicators (e.g., receipt of a palliative care consult). RESULTS: Our sample consisted of 35,682 decedent BFS scores (27,109 telephone surveys; 8573 mail surveys). BFS item scores were slightly skewed, with a predominance of higher scores for both the telephone and mail version. The average missing rate for each BFS item was minimal, just 2% for each version. The CFA models demonstrated dimensional, configural, metric, and factor mean invariance across administration modes. BFS factor scores were consistently higher when a patient received EOL quality care indicators regardless of mode of administration. CONCLUSION: These findings demonstrate the MI and robust psychometric properties for the BFS across administration modes.

Exploring Nonresponse Bias in the Department of Veterans Affairs' Bereaved Family Survey.

BACKGROUND: Patients' and families' evaluations of health care, including palliative care, are widely used as performance measures. Survey scores may be affected by nonresponse bias, resulting in inaccurate performance evaluation. OBJECTIVES: Our aim was to examine nonresponse bias for the mailed version of the Department of Veterans Affairs (VA) Bereaved Family Survey Performance Measure (BFS-PM) and evaluate the effect of nonresponse bias on facilities' BFS-PM scores. METHODS: A cross-sectional analysis of a national sample was conducted. The sample consisted of 20,540 veterans who died in one of 146 VA Medical Centers (VAMCs) between October 2012 and September 2013. Next of kin (NOK) were asked to complete and return the survey. The BFS-PM is defined as the proportion of NOK who rated overall care for the veteran during the last month of life as "excellent." After creating a model to predict the likelihood of response based on patient and clinical characteristics, we applied inverse probability weights to examine their effect on facilities' scores. We also evaluated facility performance before and after weighting for nonresponse vis-à-vis varying benchmarks. RESULTS: We received 8912 surveys (45% response rate). The mean change in facility BFS-PM scores after weighting was -2%, (range: -10% to+11%). The scores of 31% of facilities changed more than±2%. The number of facilities meeting hypothetical benchmarks of 60%, 70%, and 80% also changed as a result of weighting for nonresponse. CONCLUSION: Our results underscore the importance of appropriately addressing nonresponse in the use of quality-of-care metrics based on Bereaved Family Survey (BFS) data.

A bupropion smoking cessation clinical trial for cancer patients.

OBJECTIVE: Many cancer patients continue to smoke post diagnosis, yet there have been few smoking cessation trials for this population. Depression, which is prevalent among cancer patients, may be a barrier to cessation. METHODS: This double-blind placebo-controlled trial randomized 246 cancer patients to 9 weeks of placebo or bupropion, stratifying by pre-treatment depression symptoms. In addition, all patients received transdermal nicotine and behavioral counseling. Primary outcomes were 7-day point-prevalence abstinence, biochemically confirmed, at the end of treatment (Week 12), and at 6 months post quit day (Week 27). Additional outcomes included: withdrawal, affect, quality of life, compliance, and side effects. RESULTS: There was no main effect of bupropion vs. placebo on abstinence (Odds Ratio [OR] = 1.36, 95% CI: 0.38-4.81, p = .64). Patients with depression symptoms reported significantly lower abstinence rates vs. patients without depression symptoms (OR = .14, 95% CI: 0.02-0.80, p = .03). Bupropion increased abstinence rates, vs. placebo, more for participants with depression vs. those without depression symptoms. For patients with depression symptoms, bupropion reduced withdrawal symptoms and improved quality of life vs. placebo. CONCLUSIONS: For patients with depression symptoms, bupropion increases abstinence rates, lowers withdrawal, and increases quality of life. However, abstinence rates among patients with depression symptoms were low vs. patients without depression symptoms, who exhibited similar abstinence rates when treated with bupropion or transdermal nicotine and counseling alone. These results can guide future smoking cessation intervention studies with cancer patients.

Issues related to implementing a smoking cessation clinical trial for cancer patients.

Given high rates of smoking among cancer patients, smoking cessation treatment is crucial; yet limited data exist to guide integration of such trials into the oncologic context. In order to determine the feasibility of conducting smoking cessation clinical trials with cancer patients, screening and baseline data from a large randomized placebo-controlled pharmacotherapy trial were analyzed. Descriptive statistics and regression analyses were used to compare enrollees to decliners, describe program enrollees, and assess correlates of confidence in quitting smoking. Out of 14,514 screened patients, 263 (<2%) were eligible; 43 (16%) refused enrollment. Among the eligible patients, 220 (84%) enrolled. Enrollment barriers included smoking rate, medical history/contraindicated medication, lack of interest, and language. Compared to enrollees, decliners were more likely to have advanced cancer. The trial enrolled a sample of 67 (>30%) African Americans; participants had extensive smoking histories; many were highly nicotine dependent; and participants consumed about seven alcoholic beverages/week on average. Head and neck and breast cancer were the most common tumors. About 52 (25%) reported depressive symptoms. A higher level of confidence to quit smoking was related to lower depression and lower tumor stage. Integrating a smoking cessation clinical trial into the oncologic setting is challenging, yet feasible. Recruitment strategies are needed for patients with advanced disease and specific cancers. Once enrolled, addressing participant's depressive symptoms is critical for promoting cessation.