Chronic pain trials often exclude people with comorbid depressive symptoms: A secondary analysis of 346 randomized controlled trials.

BACKGROUND: Chronic pain and depression are common comorbid conditions, but there is limited evidence-based guidance for management of the two conditions together. In recent years, there has been an increase in the number of chronic pain randomized controlled trials that collect depression outcomes, but it is unknown how often these trials include people with depression or significant depressive symptoms. If trials do not include participants representative of real-world populations, evidence and guidance generated from these trials risk being inapplicable for large proportions of the target population, or worse, risk harm. Thus, in order to identify pathways to improve the conduct of clinical trials, the aims of this study were to (1) estimate the proportion of randomized controlled trials evaluating chronic pain interventions and reporting depression outcomes that include participants with significant depressive symptoms; and (2) assess the variability of inclusion proportions by pain type, intervention type, gender, country of origin, and publication year. METHODS: Studies were extracted from an umbrella review of interventions for chronic pain that reported depression outcomes. Screening and data extraction were completed in duplicate and conflicts were resolved by a third author. Randomized controlled trials with at least 50% adult participants and validated depression scales were included, and randomized controlled trials with populations whose mean scores were at or above depression thresholds at baseline were considered to have included participants with depression. RESULTS: Of the 346 randomized controlled trials analyzed, 142 (41%) included participants with depression. Eight pain-type groups and nine intervention types were identified. Randomized controlled trials investigating fibromyalgia and mixed chronic pain had the highest proportion of participants with depression, whereas studies of arthritis and axial pain had among the lowest. Randomized controlled trials from the United States had a significantly lower inclusion proportion compared with non-US studies, especially for studies on arthritis. The increase in inclusion proportion by publication year was driven by the increase in fibromyalgia studies. DISCUSSION AND CONCLUSION: This study highlights opportunities to improve the conduct of chronic pain clinical trials. The majority of randomized controlled trials s analyzed evaluated participants without significant depressive symptoms at baseline, thus the findings synthesized in systematic reviews and subsequent guidelines are most applicable to the subset of real-world populations that do not have significant depressive symptoms. As well, systemic biases around psychological conditions and gender may be important contributors to differences in the study of depression in fibromyalgia compared with common conditions such as arthritis and axial pain. In order to better inform clinical practice, future research must intentionally include individuals with comorbid depression in trials of common chronic pain conditions, and consider methods to mitigate biases that may distort study design.

Interventions for Depressive Symptoms in People Living with Chronic Pain: A Systematic Review of Meta-Analyses.

OBJECTIVE: This review investigated the effectiveness of clinical interventions on depressive symptoms in people with all types of chronic pain. METHODS: We searched seven electronic databases and reference lists on September 15, 2020, and included English-language, systematic reviews and meta-analyses of trials that examined the effects of clinical interventions on depressive outcomes in chronic pain. Two independent reviewers screened, extracted, and assessed the risk of bias. PROSPERO registration: CRD42019131871. RESULTS: Eighty-three reviews were selected and included 182 meta-analyses. Data were summarized visually and narratively using standardized mean differences with 95% confidence intervals as the primary outcome of interest. A large proportion of meta-analyses investigated fibromyalgia or mixed chronic pain, and psychological interventions were most commonly evaluated. Acceptance and commitment therapy for general chronic pain, and fluoxetine and web-based psychotherapy for fibromyalgia showed the most robust effects and can be prioritized for implementation in clinical practice. Exercise for arthritis, pharmacotherapy for neuropathic pain, self-regulatory psychotherapy for axial pain, and music therapy for general chronic pain showed large, significant effects, but estimates were derived from low- or critically low-quality reviews. CONCLUSIONS: No single intervention type demonstrated substantial superiority across multiple pain populations. Other dimensions beyond efficacy, such as accessibility, safety, cost, patient preference, and efficacy for non-depressive outcomes should also be weighed when considering treatment options. Further effectiveness research is required for common pain types such as arthritis and axial pain, and common interventions such as opioids, anti-inflammatories and acupuncture.

Mal/adaptations: A qualitative evidence synthesis of opioid agonist therapy during major disruptions.

BACKGROUND: Opioid agonist therapy (OAT) has been severely disrupted by the COVID-19 pandemic. The risks of opioid withdrawal, overdose, and diversion have increased, so there is an urgent need to adapt OAT to best support people who use drugs (PWUD). This review examines the views and experiences of PWUD, health care providers, and health system administrators on OAT during major disruptions to medical care to inform appropriate health system responses during the current pandemic and beyond. METHODS: We conducted a systematic review and qualitative evidence synthesis. We searched three comprehensive datasets for qualitative and mixed-methods studies that examined OAT in the context of major disruptions such as natural disasters, and analyzed included studies using thematic analysis and the constant comparative method. We used conceptual frameworks of health systems resilience and adaptive systems to interpret our findings. RESULTS: We included 10 studies published between 2002 and 2020 that examined OAT in the context of hurricanes, earthquakes, and terrorist attacks. We organized our results into three themes: uncertainty, inconsistency, and vulnerability; regulatory inflexibility; and lack of coordination. The highly regulated but poorly coordinated systems of OAT provision lacked flexibility to adapt to major disruptions, thereby manufacturing vulnerability for both PWUD and health workers. CONCLUSIONS: OAT programs must be resilient and adaptable to face major disruptions while maintaining quality care. Our findings provide guidance to develop and implement innovative strategies that increase the adaptive potential of OAT programs while focusing on the needs of PWUD.

Time series-based bibliometric analysis of a systematic review of multidisciplinary care for opioid dose reduction: exploring the origins of the North American opioid crisis.

Bibliometric analyses of systematic reviews offer unique opportunities to explore the character of specific scientific fields. In this time series-based analysis, dynamics of multidisciplinary care for chronic pain and opioid prescribing are analyzed over a forty-four year time span. Three distinct periods are identified, each defined by distinct research areas, as well as priorities regarding the use of opioids and the appropriate management of chronic pain. These scientometrically defined periods align with timelines identified previously by narrative historical accounts. Through cross-correlation with a mortality time series, a significant two-year lag between opioid overdose mortality and citation dynamics is identified between 2004 and 2019. This analysis demonstrates a bidirectional relationship between the scientific literature and the North American opioid overdose crisis, suggesting that the scientific literature is both reflective and generative of an important health and social phenomenon. A scientometric phenomenon of memory lapse, namely an overt and prolonged failure to cite older relevant literature, is identified using a metric of mean time to citation. It is proposed that this metric can be used to analyze changes in emerging literature and thus predict the nature of clinical and policy responses to the opioid crisis, and thus potentially to other health and social phenomena.

Validation of stroke-specific protocols for the 10-meter walk test and 6-minute walk test conducted using 15-meter and 30-meter walkways.

Background: Stroke-specific protocols for the 10-meter and 6-minute walk tests that include instructions for people with aphasia, accessible walkway lengths, and allow provision of assistance to walk are needed to facilitate uptake in hospital settings.Objectives: To estimate the test-retest reliability, measurement error, and construct validity of stroke-specific protocols for the 10-meter walk test (10mWT), and 6-minute walk test conducted using a 15-meter walkway (6MWT15m) and 30-meter walkway (6MWT30m), in people post-stroke.Methods: A quantitative, cross-sectional study involving ambulatory people post-stroke was conducted.Results: Data were collected from 21 and 20 participants at baseline and retest, respectively, 1-3 days apart. Mean age was 61 years, median time post-stroke was 134 days, and 90% had experienced an ischemic stroke. Performance on the 10mWT, 6MWT15m, and 6MWT30m across sessions yielded intraclass correlation coefficient (ICC2, 1) estimates of test-retest reliability of 0.83, 0.97, 0.95, respectively, and minimal detectable change values at the 95% confidence level of 0.40m/s, 44.0m, and 67.5m, respectively. Pearson correlation coefficients were 0.80-0.95 (p < .001) between results on all three walk tests and 0.27-0.48 (p < .25) between walk test results and strength subscale scores on the Stroke Impact Scale.Conclusions: Findings showed excellent test-retest reliability; measurement error values similar to current literature; and support for construct validity of the 10mWT, 6MWT15m, and 6MWT30m. Due to the shorter walkway, the 6MWT15m may be more feasible to implement than the 6MWT30m in hospital settings. A larger sample with more severe deficits is required to improve generalizability.

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation.

BACKGROUND: Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health intervention, little is known about how to implement meditation programs within or alongside the health care system. METHODS: We will conduct a hybrid type 1 effectiveness-implementation evaluation. To measure effectiveness, we will conduct a randomized controlled trial comparing Sahaj Samadhi Meditation and the Health Enhancement Program in 160 people living with chronic pain, clinically significant depressive symptoms, and on long-term opioid therapy. Changes in depressive symptoms will be our primary outcome; pain severity, pain-related function, opioid use, and quality of life will be the secondary outcomes. The primary end point will be at 12 weeks with a secondary end point at 24 weeks to measure the sustainability of acute effects. Patients will be recruited from a community-based chronic pain clinic in a large urban center in Mississauga, Canada. The meditation program will be delivered in the clinical environment where patients normally receive their chronic pain care by certified meditation teachers who are not regulated health care providers. We will use a mixed-methods design using the multi-level framework to understand the implementation of this particular co-location model. DISCUSSION: Results of this hybrid evaluation will add important knowledge about the effectiveness of meditation for managing depressive symptoms in people with chronic pain. The implementation evaluation will inform both effectiveness outcomes and future program development, scalability, and sustainability. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04039568. Registered on 31 July 2019.

Frailty in the context of rehabilitation interventions for adults: protocol for a scoping review.

INTRODUCTION: Although a growing number of frail adults can benefit from rehabilitation services, few are included in rehabilitation services, and reasons for their exclusion are not well understood. To inform research directions in rehabilitation for all adults (aged 18 years and older), we will conduct a scoping review to describe (1) the characteristics of frail adult individuals included in rehabilitation interventions (eg, age range, inclusion and exclusion criteria that are applied), (2) the type of rehabilitation interventions that are used for individuals who are considered frail and (3) the commonly reported outcome measures used for these rehabilitation interventions. METHODS: This scoping review will be guided by Arksey and O'Malley's methodological framework. Ageline, Cochrane CINAHL, Embase, MEDLINE, Pubmed, OTSeeker, PeDRO, PsycINFO and Scopus databases will be systematically searched for articles relevant to rehabilitation interventions and health services. To be eligible for inclusion, studies must report on the outcomes from an intervention that involves all individuals (aged 18 and older) who are considered frail. Only English-language, peer-reviewed publications between 1990 and 2018 will be included. A two-step screening process will consist of (1) a title and abstract review and (2) full-text review. In both levels of screening, a minimum of two investigators will independently screen the title and abstract of all retrieved citations for inclusion against a set of minimum inclusion criteria. ANALYSIS: Results will be presented as a narrative synthesis to facilitate the integration of diverse evidence. ETHICS AND DISSEMINATION: This study does not require ethics approval. By examining the current state of rehabilitation interventions for frail adults, this scoping review can offer insight into rehabilitation needs and models of care. It can also guide future rehabilitation research for frail adults. We will share our results with frail adults during a consultation meeting and publish a manuscript in a peer-reviewed rehabilitation journal.