The use of community advisory boards in pragmatic clinical trials: The case of the adult day services plus project

IntroductionCommunity advisory boards (CABs) continue to gain wide use and acceptance in global health research including in HIV clinical trials. They provide means through which community concerns regarding the trial can be considered by the research team, and provide an important platform of communication between the researchers and the community about study goals. Therefore, this systematic review protocol will guide the review of qualitative evidence on the ethical roles of CABs in HIV clinical trials based on the three fundamental ethical principles: respect for the person, beneficence and justice.Methods and analysisThis systematic review of qualitative evidence will involve searching four medical databases: PubMed, ScienceDirect, CINAHL and Cochrane Library. Additionally, other relevant evidence will be obtained through hand searching and grey literature. Searches will be limited to studies published in the English language from 1989 (the year that CABs were first established in HIV clinical trials) to 2019. Articles searched will be screened by two independent authors based on inclusion and exclusion criteria. Included articles will be appraised for quality using the Critical Appraisal Skills Programme checklist and followed by qualitative data extraction. Findings will be analysed based on the meta-aggregative approach with the aid of EPPI-Reviewer 4 web-based software.Ethics and disseminationEthical approval does not apply to this review. Data will be disseminated through scientific conferences and peer-reviewed journals to inform policies and stake-holders about the ethical role of CABs.PROSPERO registration numberCRD42019133787.

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TRANSLATIONAL ADVISORY BOARDS IN RESEARCH: EXPERIENCES FROM A PRAGMATIC RESEARCH TRIAL

Innovation in Aging ◽

10.1093/geroni/igz038.505 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S139-S140

Author(s):

Keith A Anderson ◽

Holly Dabelko-Schoeny ◽

Laura N Gitlin ◽

Joseph E Gaugler ◽

Sokha Koeuth ◽

...

Keyword(s):

Large Scale ◽

Drop Out ◽

Research Experiences ◽

Adult Day Services ◽

Advisory Boards ◽

Pragmatic Research ◽

Points Of View ◽

Day Services ◽

And Control ◽

Industry Professionals

Abstract Translational Advisory Boards (TABs) are select groups of researchers, practitioners, and, in some cases, service recipients (e.g., patients, caregivers) that convene regularly to advise researchers on ongoing studies. TABs provide direction and support, knowledge and insight, alternative points of view, and suggestions for overcoming obstacles and improving research functions. TABs are especially valuable in applied research in which “real world” conditions create challenges ranging from the anticipated (e.g., participant drop out) to the unanticipated (e.g., government shutdown). In this presentation, the researchers evaluate one TAB involved with an ongoing pragmatic research trial of Adult Day Services Plus (ADS Plus), an intervention for family caregivers to persons with dementia. Including individuals with diverse points of view was critical in the composition of the TAB. The TAB consisted of four seasoned researchers, four ADS industry professionals, and six program directors from the ADS Plus treatment and control groups. Creating meetings that were productive was imperative. TAB sessions were held bi-annually and had highly structured agendas soliciting guidance on specific issues. Qualitative analysis of the TAB sessions revealed three themes: assistance with recruitment; fidelity of the intervention; and sustainability of the intervention. This guidance helped the researchers to shift directions in recruitment and to consider further refinement of the intervention to increase sustainability. In looking at costs, the annual research personnel, TAB personnel, and overhead expenses were estimated at $2,500-$3,000 and $4,000-$5,500, respectively. In conclusion, TABs can be an effective tool to support research and should be considered for use in large-scale projects.

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The role of community advisory boards in community-based HIV clinical trials: a qualitative study from Tanzania

BMC Medical Ethics ◽

10.1186/s12910-021-00737-w ◽

2022 ◽

Vol 23 (1) ◽

Author(s):

Godwin Pancras ◽

Bruno F. Sunguya ◽

Nathanael Sirili ◽

Emmanuel Balandya ◽

Eligius Lyamuya ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Phenomenological Approach ◽

Community Based ◽

Middle Income ◽

Advisory Boards ◽

Institutional Review ◽

Hiv Clinical Trials ◽

Community Advisory Boards

Abstract Background Community Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania. Methodology We adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1. Results The findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. Conclusion The study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants.

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Forming and implementing community advisory boards in low- and middle-income countries: a scoping review

BMC Medical Ethics ◽

10.1186/s12910-019-0409-3 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 4

Author(s):

Yang Zhao ◽

Thomas Fitzpatrick ◽

Bin Wan ◽

Suzanne Day ◽

Allison Mathews ◽

...

Keyword(s):

Clinical Trials ◽

Research Ethics ◽

Scoping Review ◽

Financial Support ◽

Local Communities ◽

Middle Income ◽

Middle Income Countries ◽

Advisory Boards ◽

Community Advisory Boards ◽

Low And Middle Income

Abstract Background Community advisory boards (CABs) have expanded beyond high-income countries (HICs) and play an increasing role in low- and middle-income country (LMIC) research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases (PubMed, Embase, Global Health, Scopus, and Google Scholar) for publications describing or evaluating CABs in LMICs. Two researchers independently reviewed articles for inclusion. Data related to the following aspects of CABs were extracted from included publications: time, country, financial support, research focus, responsibilities, and challenges. Thematic analyses were used to summarize textual data describing challenges. Results Our search yielded 2005 citations, 83 of which were deemed eligible for inclusion. Most studies (65) were published between 2010 and 2017. Upper-middle-income countries were more likely to have studies describing CABs, with South Africa (17), China (8), and Thailand (7) having the greatest numbers. The United States National Institutes of Health was the main source of financial support for CABs. Many CABs (53/88, 60%) focused on HIV research. Thirty-four studies reported how CABs influenced the informed consent process for clinical trials or other aspects of research ethics. CAB responsibilities were related to clinical trials, including reviewing study protocols, educating local communities about research activities, and promoting the ethical conduct of research. Challenges faced by CABs included the following: incomplete ethical regulations and guidance; limited knowledge of science among members of communities and CABs; unstable and unbalanced power relationships between researchers and local communities; poor CAB management, including lack of formal participation structures and absence of CAB leadership; competing demands for time that limited participation in CAB activities; and language barriers between research staff and community members. Several challenges reflected shortcomings within the research team. Conclusions Our findings examine the formation and implementation of CABs in LMICs and identify several ethical challenges. These findings suggest the need for further ethics training among CAB members and researchers in LMICs.

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Community Advisory Boards: Their Role in AIDS Clinical Trials

Health & Social Work ◽

10.1093/hsw/23.4.290 ◽

1998 ◽

Vol 23 (4) ◽

pp. 290-297 ◽

Cited By ~ 47

Author(s):

L. E. Cox ◽

J. R. Rouff ◽

K. H. Svendsen ◽

M. Markowitz ◽

D. I. Abrams ◽

...

Keyword(s):

Clinical Trials ◽

Advisory Boards ◽

Aids Clinical Trials ◽

Community Advisory Boards

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P15-12. Community advisory boards' successes and challenges in AIDS vaccine clinical trials: a Southern Africa experience

Retrovirology ◽

10.1186/1742-4690-6-s3-p213 ◽

2009 ◽

Vol 6 (S3) ◽

Author(s):

T Mokhele

Keyword(s):

Clinical Trials ◽

Southern Africa ◽

Aids Vaccine ◽

Advisory Boards ◽

Successes And Challenges ◽

Community Advisory Boards

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A Caregiver's Guide to Selecting an Adult Day Services Center

PsycEXTRA Dataset ◽

10.1037/e562042010-001 ◽

2013 ◽

Keyword(s):

Adult Day Services ◽

Day Services

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Improving pragmatic clinical trial design using real-world data

Clinical Trials ◽

10.1177/1740774519833679 ◽

2019 ◽

Vol 16 (3) ◽

pp. 273-282 ◽

Cited By ~ 4

Author(s):

Susan M Shortreed ◽

Carolyn M Rutter ◽

Andrea J Cook ◽

Gregory E Simon

Keyword(s):

Clinical Trials ◽

Trial Design ◽

Suicide Attempts ◽

Real World Data ◽

Electronic Health Record Data ◽

Pragmatic Clinical Trial ◽

Pragmatic Clinical Trials ◽

Sample Size Calculations ◽

Record Data ◽

Electronic Health

Background Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Methods Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations. Results Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05. Conclusions Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.

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Adult Day Service Use Decreases Likelihood of Depressive Symptoms Among Black Dementia Caregivers

Innovation in Aging ◽

10.1093/geroni/igaa057.2102 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 618-618

Author(s):

Lauren Parker ◽

Laura Gitlin

Keyword(s):

Depressive Symptoms ◽

Service Use ◽

Demographic Variables ◽

Caregiver Training ◽

Dementia Caregivers ◽

Adult Day Services ◽

Black Caregivers ◽

Health Promoting ◽

Day Services ◽

Intervention Trials

Abstract Black Americans are more likely than others to age with Alzheimer’s Disease (AD) in the community and rely on family members for support. Despite reported positive aspects of caregiving, Black caregivers report greater need for daytime respite and caregiving support. Little is known regarding the health-promoting benefits of daytime respite, like adult day services (ADS), among Black caregivers. Using a sample of 190 Philadelphia-area Black caregivers for community-living persons with dementia, pooled from two behavioral intervention trials: Advancing Caregiver Training and Care of Persons with Dementia in their Environments, the study examined the association between ADS use and depressive symptoms. About 36% of the caregivers used adult day services for their family member with AD. Controlling for demographic variables, social support, self-rated health, religious coping, caregiver burden, and number of years caregiving Black caregivers who utilized ADS had lower depressive symptoms (β= -1.60, p<.05) relative not using ADS.

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