Preparing for pragmatic trials in dementia care: Health equity considerations for nonpharmacological interventions.
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SUBMITTER: Aranda MP
PROVIDER: S-EPMC10841288 | biostudies-literature | 2023 Dec
REPOSITORIES: biostudies-literature
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Preparing for pragmatic trials in dementia care: Health equity considerations for nonpharmacological interventions.
Aranda María P MP Baier Rosa R Hinton Ladson L Peak Katherine D KD Jackson Jonathan D JD Dilworth-Anderson Peggye P Gitlin Laura N LN Jutkowitz Eric E Quiñones Ana R AR
Journal of the American Geriatrics Society 20230901 12
Inequities with regard to brain health, economic costs, and the evidence base for dementia care continue. Achieving health equity in dementia care requires rigorous efforts that ensure disproportionately affected populations participate fully in-and benefit from-clinical research. Embedding-proven interventions under real-world conditions and within existing healthcare systems have the potential to examine the effectiveness of an intervention, improve dementia care, and leverage the use of exist ...[more]
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Project description:IntroductionTo improve dementia care delivery for persons across all backgrounds, it is imperative that health equity is integrated into pragmatic trials.MethodsWe reviewed 62 pragmatic trials of people with dementia published 2014 to 2019. We assessed health equity in the objectives; design, conduct, analysis; and reporting using PROGRESS-Plus which stands for Place of residence, Race/ethnicity, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, and other factors such as age and disability.ResultsTwo (3.2%) trials incorporated equity considerations into their objectives; nine (14.5%) engaged with communities; 4 (6.5%) described steps to increase enrollment from equity-relevant groups. Almost all trials (59, 95.2%) assessed baseline balance for at least one PROGRESS-Plus characteristic, but only 10 (16.1%) presented subgroup analyses across such characteristics. Differential recruitment, attrition, implementation, adherence, and applicability across PROGRESS-Plus were seldom discussed.DiscussionOngoing and future pragmatic trials should more rigorously integrate equity considerations in their design, conduct, and reporting.HighlightsFew pragmatic trials are explicitly designed to inform equity-relevant objectives.Few pragmatic trials take steps to increase enrollment from equity-relevant groups.Disaggregated results across equity-relevant groups are seldom reported.Adherence to existing tools (e.g., IMPACT Best Practices, CONSORT-Equity) is key.
| S-EPMC9899766 | biostudies-literature
Project description:BackgroundThe randomized controlled trial (RCT) is considered the gold standard study design to inform decisions about the effectiveness of interventions. However, a common limitation is inadequate reporting of the applicability of the intervention and trial results for people who are "socially disadvantaged" and this can affect policy-makers' decisions. We previously developed a framework for identifying health-equity-relevant trials, along with a reporting guideline for transparent reporting. In this study, we provide a descriptive assessment of health-equity considerations in 200 randomly sampled equity-relevant trials.MethodsWe developed a search strategy to identify health-equity-relevant trials published between 2013 and 2015. We randomly sorted the 4316 records identified by the search and screened studies until 100 individually randomized (RCTs) and 100 cluster randomized controlled trials (CRTs) were identified. We developed and pilot-tested a data extraction form based on our initial work, to inform the development of our reporting guideline for equity-relevant randomized trials.ResultsIn total, 39 trials (20%) were conducted in a low- and middle-income country and 157 trials (79%) in a high-income country focused on socially disadvantaged populations (78% CRTs, 79% RCTs). Seventy-four trials (37%) reported a subgroup analysis across a population characteristic associated with disadvantage (25% CRT, 49% RCTs), with 19% of included studies reporting subgroup analyses across sex, 9% across race/ethnicity/culture, and 4% across socioeconomic status. No subgroup analyses were reported for place of residence, occupation, religion, education, or social capital. One hundred and forty-one trials (71%) discussed the applicability of their results to one or more socially disadvantaged populations (68% of CRT, 73% of RCT).DiscussionIn this set of trials, selected for their relevance to health equity, data that were disaggregated for socially disadvantaged populations were rarely reported. We found that even when the data are available, opportunities to analyze health-equity considerations are frequently missed. The recently published equity extension of the Consolidated Reporting Standards for Randomized Trials (CONSORT-Equity) may help improve delineation of hypotheses related to socially disadvantaged populations, and transparency and completeness of reporting of health-equity considerations in RCTs. This study can serve as a baseline assessment of the reporting of equity considerations.
| S-EPMC7118943 | biostudies-literature
Project description:ObjectiveTo use evidence on addressing racism in social care intervention research to create a framework for advancing health equity for all populations with marginalized social identities (e.g., race, gender, and sexual orientation). Such groups have disproportionate social needs (e.g., food insecurity) and negative social determinants of health (SDOH; e.g., poverty). We recommend how the Agency for Healthcare Research and Quality (AHRQ) could advance health equity for marginalized populations through social care research and care delivery.Data sources and study settingThis commentary is informed by a literature review of social care interventions that were affiliated with healthcare systems; input from health equity researchers, policymakers, and community leaders attending the AHRQ Health Equity Summit; and consensus of the authors.Principal findingsWe recommend that AHRQ: (1) create an ecosystem that values research on SDOH and the effectiveness and implementation of social care interventions in the healthcare sector; (2) work with other federal agencies to (a) develop position statements with actionable recommendations about racism and other systems that perpetuate marginalization based on social identity and (b) develop aligned, complementary approaches to research and care delivery that address social marginalization; (3) advance both inclusive care delivery and inclusive research teams; (4) advance understanding of racism as a social determinant of health and effective strategies to mitigate its adverse impact on health; (5) advance the creation and scaling of effective strategies for addressing SDOH in healthcare systems, particularly in co-creation with community partners; and (6) require social care intervention researchers to use methods that advance our understanding of social health equity.ConclusionsAHRQ, as a federal agency, could help advance health equity using a range of strategies, including using the agency's levers to ensure AHRQ stakeholders examine and address the unique experiences of socially marginalized populations in SDOH and social care intervention research.
| S-EPMC10684037 | biostudies-literature
Project description:IntroductionThis review aims to describe the landscape of pragmatic randomized controlled trials (RCTs) in the context of Alzheimer's disease (AD) and related dementias with respect to ethical considerations.MethodsSearches of MEDLINE were performed from January 2014 until April 2019. Extracted information included: trial setting, interventions, data collection, study population, and ethical protections (including ethics approvals, capacity assessment, and informed consent).ResultsWe identified 62 eligible reports. More than two-thirds (69%) included caregivers or health-care professionals as research participants. Fifty-eight (94%) explicitly identified at least one vulnerable group. Two studies did not report ethics approval. Of 57 studies in which patients were participants, 55 (96%) reported that consent was obtained but in 37 studies (67%) no mention was made regarding assessment of the patients' capacity to consent to research participation.DiscussionFew studies reported protections implemented when vulnerable participants were included. Shortcomings remain when reporting consent approaches and capacity assessment.
| S-EPMC9060321 | biostudies-literature
Project description:ObjectivePain is one of the most significant causes of morbidity and disability worldwide. The efficacy of several nonpharmacological approaches for pain management has been established, but significant gaps exist between this evidence and their limited availability and use in routine clinical practice. Questions remain about their effectiveness and how best to integrate them in usual care to optimize patient-centered outcomes. Pragmatic clinical trials (PCTs) may help address this gap. Informed by the Pragmatic Explanatory Continuum Indicator Summary (PRECIS-2), we sought to describe the key features of optimized PCTs of nonpharmacological approaches for the management of pain and common co-occurring conditions.MethodsTo accomplish this objective, we searched the published literature on PCTs of nonpharmacological pain management approaches from 2010-2019 and applied the PRECIS-2 criteria. We discuss key PRECIS-2 domains of interest for designing and performing PCTs and cite specific examples from the published literature as potential models for future PCTs.ResultsWe found 13 nonpharmacological PCTs. They were heterogeneous in size, recruitment, follow-up time, and location. The lessons learned from these studies led us to explicate key features of trials on the explanatory-pragmatic continuum across the PRECIS-2 domains that can be used by future investigators when designing their clinical trials of nonpharmacological approaches to pain management.ConclusionsWe encourage the increased application of PCTs to produce timely and valuable results and products that will inform the development of safe and effective integrated pain care plans that optimize important patient-centered outcomes.
| S-EPMC7825099 | biostudies-literature
Project description:BackgroundPragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision.MethodsMEDLINE, Embase, CINAHL and PsycINFO were searched from inception to January 2022. Articles and book chapters that discussed how to identify or develop usual care comparators were included. Experts in the field were also contacted. Reference lists and forward citation searches of included articles were screened. Data were analysed using a narrative synthesis approach.ResultsOne thousand nine hundred thirty records were identified, 1611 titles and abstracts screened, 112 full texts screened, and 16 articles included in the review. Results indicated that the content of a usual care comparator should be informed by the aims of the trial, existing care practices, clinical guidelines, and characteristics of the target population. Its content should also be driven by the trial's requirements to protect participants, inform practice, and be methodologically robust, efficient, feasible and acceptable to stakeholders. When deciding the content of usual care, researchers will need to gather information about these drivers, balance tensions that might occur when responding to different trial objectives, and decide how usual care will be described and monitored in the trial.DiscussionWhen deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial's design phase.Trial registrationPROSPERO CRD42022307324.
| S-EPMC10860249 | biostudies-literature
Project description:IntroductionRacial inequities in birth outcomes persist in the United States. Doula care may help to decrease inequities and improve some perinatal health indicators, but access remains a challenge. Recent doula-related state legislative action seeks to improve access, but the prioritization of equity is unknown. We reviewed recent trends in doula-related legislation and evaluated the extent to which new legislation addresses racial health equity.MethodsWe conducted a landscape analysis of the LegiScan database to systematically evaluate state legislation mentioning the word "doula" between 2015 and 2020. We identified and applied nine criteria to assess the equity focus of the identified doula-related legislative proposals. Our final sample consisted of 73 bills across 24 states.ResultsWe observed a three-fold increase in doula-related state legislation introduced over the study period, with 15 bills proposed before 2019 and 58 proposed in 2019-2020. Proposed policies varied widely in content and scope, with 53.4% focusing on Medicaid reimbursement for doula care. In total, 12 bills in 7 states became law. Seven of these laws (58.3%) contained measures for Medicaid reimbursement for doula services, but none guaranteed a living wage based on the cost of living or through consultation with doulas. Only two states (28.6%; Virginia and Oregon) that passed Medicaid reimbursement for doulas also addressed other racial equity components.ConclusionsThere has been an increase in proposed doula-related legislation between 2015 and 2020, but racial health equity is not a focus among the laws that passed. States should consider using racial equity assessments to evaluate proposed doula-related legislation.
| S-EPMC10224765 | biostudies-literature
Project description:BackgroundEquity in health has become an important policy agenda around the world, prompting health economists to advance methods to enable the inclusion of equity in economic evaluations. Among the methods that have been proposed to explicitly include equity are the weighting analysis, equity impact analysis, and equity trade-off analysis. This is a new development and a comprehensive overview of trends and concepts of health equity in economic evaluations is lacking. Thus, our objective is to map the current state of the literature with respect to how health equity is considered in economic evaluations of health interventions reported in the academic and gray literature.MethodsWe will conduct a scoping review to identify and map evidence on how health equity is considered in economic evaluations of health interventions. We will search relevant electronic, gray literature and key journals. We developed a search strategy using text words and Medical Subject Headings terms related to health equity and economic evaluations of health interventions. Articles retrieved will be uploaded to reference manager software for screening and data extraction. Two reviewers will independently screen the articles based on their titles and abstracts for inclusion, and then will independently screen a full text to ascertain final inclusion. A simple numerical count will be used to quantify the data and a content analysis will be conducted to present the narrative; that is, a thematic summary of the data collected.DiscussionThe results of this scoping review will provide a comprehensive overview of the current evidence on how health equity is considered in economic evaluations of health interventions and its research gaps. It will also provide key information to decision-makers and policy-makers to understand ways to include health equity into the prioritization of health interventions when aiming for a more equitable distribution of health resources.Systematic review registrationThis protocol was registered with Open Science Framework (OSF) Registry on August 14, 2019 (https://osf.io/9my2z/registrations).
| S-EPMC6950907 | biostudies-literature
Project description:Background and objectivesMany investigators of Alzheimer's disease and related dementias (AD/ADRD) are unfamiliar with the embedded pragmatic clinical trials (ePCTs) and the indispensable pilot phase preceding ePCTs. This paper provides a much-needed example for such a pilot phase and discusses implementation barriers and additional infrastructure and implementation strategies developed in preparation for a nationwide AD/ADRD ePCT.Research design and methodsTwo pilot trials were conducted in 2 hospices sequentially to refine and test Aliviado Dementia Care-Hospice Edition, a complex quality improvement intervention for advanced dementia symptom management. Readiness for the subsequent full-scale ePCT was assessed by three milestones: ≥80% training completion rate ("feasibility"), ≥80% posttraining survey respondents indicating intention for practice changes ("applicability"), and at least 1 Aliviado care plan/assessment instrument administered in ≥75% of dementia patients admitted to home hospice within 1-month posttraining ("fidelity").ResultsParticipants included 72 interdisciplinary team members and 11 patients with AD/ADRD across the pilots. Feasibility, applicability, and fidelity outcomes (92%, 93%, and 100%, respectively) all surpassed the preestablished milestones (80%, 80%, and 75%). Main implementation challenges were related to hospice staff turnover, integration of the Aliviado toolbox materials within the electronic health records, and hospices' limited research experience and infrastructure.Discussion and implicationsThis pilot phase demonstrated feasibility, applicability, and fidelity required to proceed to the full-scale ePCT. Our study findings and discussions of additional infrastructure and implementation strategies developed following the pilot phase can inform researchers and clinicians interested in conducting AD/ADRD-related pilot studies for ePTCs or quality improvement initiatives.Clinical trials registration numberNCT03681119.
| S-EPMC8827334 | biostudies-literature
Project description:Funders of research have an opportunity to advance health equity and social justice by incorporating principles of diversity, equity, inclusion, and justice (DEIJ) in their approach to grantmaking. We conducted a pragmatic review to identify opportunities for grantmakers in the health care sector to integrate DEIJ in their funding activities. The resulting framework discusses recommendations within three phases as follows: (1) Organizational Context (i.e., initiate DEIJ efforts within the grantmaking organization, invest in community partnerships, and establish DEIJ goals), (2) Grantmaking Process (i.e., DEIJ-specific practices related to grant design, application, proposal review processes, and support for grantees), and (3) Assessment of Process and Outcomes (i.e., measurement, evaluation, and dissemination to maximize impact of DEIJ efforts). Throughout all grantmaking phases, it is critical to partner with and engage individuals and communities that have been historically marginalized in health care and research. In this article, we describe how adoption of framework practices can leverage grantmaking to advance DEIJ for communities, researchers, and projects.
| S-EPMC11250833 | biostudies-literature