Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts

Gabel, Matthew; Bollinger, Rebecca M.; Knox, Melissa; Coble, Dean W.; Grill, Joshua D.; Edwards, Dorothy Farrar; Stark, Susan; Lingler, Jennifer H.

doi:10.1097/wad.0000000000000514

Cited by 9 publications

(12 citation statements)

References 22 publications

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“…Previous qualitative and quantitative evidence has suggested that potential trial participants may perceive high time commitments and demanding follow-up schedules as too burdensome, leading to increased screening failure and dropouts . Quantifying participant burden and incorporating it into the study protocol to evaluate feasibility has been suggested …”

Section: Discussionmentioning

confidence: 99%

Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials

Ying,

Ehrhardt

2023

JAMA Netw Open

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ImportancePilot trials often lead to study design changes in subsequent full-scale trials. Yet, it remains unclear whether these modifications improve the feasibility of the larger trial.ObjectiveTo compare feasibility estimates between pilot and full-scale trials and identify pilot trial characteristics and modifications associated with equivalent or improved feasibility in the full-scale trial.Design, Setting, and ParticipantsThis cohort study used pilot trials published between January 2005 and December 2018 and their corresponding full-scale trials. PubMed was searched for trials on February 19, 2022.ExposuresPilot trial characteristics and postpilot trial design modifications.Main Outcomes and MeasuresThe outcome of interest was difference in 3 feasibility parameters: successful screening probability, enrollment rate, and retention probability. These metrics were defined as equivalent or improved if the full-scale trial’s estimate was within or exceeding 10% of the pilot trial’s estimate.ResultsA total of 249 pairs of pilot and full-scale trials were analyzed, with 43%, 77%, and 82% of full-scale trials having equivalent or improved successful screening probabilities, enrollment rates, and retention probabilities, respectively. When pilot trials used feasibility progression criteria (relative risk [RR], 1.94; 95% CI, 1.02-5.97) and maintained masking for participants (RR, 1.82; 95% CI, 1.04-4.33) or health care practitioners (RR, 1.81; 95% CI, 1.03-3.97) consistent with the full-scale trial, the likelihood of achieving equivalent or improved screening success in full-scale trials increased. Increasing study sites after the pilot was associated with higher likelihood of equivalent or improved enrollment rates (RR, 1.03; 95% CI, 1.01-1.08). Adding extra content to the intervention (RR, 0.82; 95% CI, 0.66-0.98), changing to active control (RR, 0.74; 95% CI, 0.48-0.99), administrating the control treatment more frequently (RR, 0.60; 95% CI, 0.29-0.93), different follow-up lengths (RR, 0.85; 95% CI, 0.73-0.97), and more follow-up visits (RR, 0.86; 95% CI, 0.75-0.98) were associated with lower likelihood of equivalent or improved retention probability in the full-scale trial.Conclusions and relevanceIn this cohort study of pilot and full-scale trial pairs, pilot trial characteristics and postpilot modifications had varying associations with full-scale trial’s feasibility. If full-scale trials planned for masking, it was desirable to use it in the pilot. Modifications increasing participant burden might decrease full-scale trial feasibility. Trialists and funders should consider both pilot trial data and proposed design changes when assessing full-scale trials.

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Section: Discussionmentioning

confidence: 99%

Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials

Ying,

Ehrhardt

2023

JAMA Netw Open

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“…PeRBA and demographic data were collected as part of a larger, multicenter study of participants in longitudinal studies of AD. 5,7 A standardized protocol was used across all 4 Alzheimer Disease Research Centers (ADRCs) involved: Washington University in St. Louis (Knight ADRC); University of Pittsburgh (PITT ADRC); University of Wisconsin (Wisconsin ADRC); and the University of California-Irvine (UCI ADRC). PeRBA was administered as part of a 20-minute survey about participation in longitudinal AD studies from 2018 to 2019.…”

Section: Participants and Proceduresmentioning

confidence: 99%

“…PeRBA items belong to 1 of 3 domains: (1) logistical burden, including accessibility, time, and finance-related burdens; (2) psychological burden, presenting in emotional challenges; or (3) physical burden, such as physical symptoms of pain or fatigue. The PeRBA-Participant has been psychometrically tested using classic test theory techniques, and has good internal consistency (Cronbach alpha =0.87-0.96) and initial evidence of both convergent and discriminant validity for the pre-enrollment version,6 and cross-validation of the psychometric stability of the postenrollment version of PeRBA 7. Factor analysis revealed PeRBA to measure a unidimensional latent construct of participant burden 6,7…”

mentioning

confidence: 99%

Psychometric Evaluation of the Perceived Research Burden Assessment (PeRBA) in Longitudinal Studies of Alzheimer Disease Using Rasch Analysis

Keleman¹,

Chang

Bollinger³

et al. 2022

Alzheimer Disease &Amp; Associated Disorders

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Introduction: The Perceived Research Burden Assessment (PeRBA) was developed to measure participant perceptions of burden in research studies. This study aimed to examine the psychometric properties of this assessment using Rasch analysis in participants in the longitudinal studies of the Alzheimer disease (AD) and their family members. Methods: PeRBA was administered to 443 participants in studies of AD and 212 family members across 4 Alzheimer Disease Research Centers. We used Rasch analysis to examine PeRBA’s psychometric properties, and data-model fit both at item and scale levels. Results: PeRBA demonstrated good reliability and item and person fit for participants and family members. A few items did not fit the model for participants or family members. Areas of content redundancy were found in items assessing similar amounts of perceived research burden. Areas of content gaps were also found, with no items assessing certain levels of perceived research burden. Conclusion: Analysis results support the good overall psychometric properties of PeRBA among research participants in studies of AD and their family members. Recommendations have been provided to improve the assessment, including rewording items and adding items that could account for a broader range of perceived research burden.

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“…The resulting perceived burden has deleterious effects on recruitment and on study participation in terms of missed study visits and the risk of dropout. 9,10 Consequently, remuneration could be valuable for the recruitment and retention of study participants if it lowers participants' expectations and perceptions about the study burden. [11][12][13] In theory, remuneration may be particularly important for increasing the recruitment of minoritized participants and those with low socio-economic status.…”

mentioning

confidence: 99%

“…Study participation can involve considerable demands on participants’ time, logistical inconveniences, and diagnostic testing that may prove mentally and emotionally exhausting. The resulting perceived burden has deleterious effects on recruitment and on study participation in terms of missed study visits and the risk of dropout 9,10. Consequently, remuneration could be valuable for the recruitment and retention of study participants if it lowers participants’ expectations and perceptions about the study burden 11–13…”

mentioning

confidence: 99%

Remuneration and Recruitment of Study Participants for AD Cohort Studies From the General Public and From Minority Communities

Gabel

Denny

Llibre‐Guerra

et al. 2023

Alzheimer Disease &Amp; Associated Disorders

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Introduction: Offering remuneration for participation in studies of aging and Alzheimer Disease (AD) may improve recruitment, particularly among minoritized and low-income groups. But remuneration may also raise ethical problems and reduce altruistic motivations for participation.Methods: A nationally representative sample of Americans (N = 2030) with large (N = 500) Black and Hispanic oversamples was asked about willingness to participate in a longitudinal AD cohort study after random assignment of remuneration ($0, $50/ visit, $100/visit). Respondents were then asked about their perceived burden, risks, and societal contribution from participation.Results: An offer of remuneration increased willingness to participate, with no difference between $50 and $100. The increase was similar across racial, ethnic, and income groups. Remuneration did not affect perceived risks or altruistic benefits. Compensation caused Whites and Hispanics, but not Blacks, to lower the perceived burden.Discussion: Modest levels of remuneration are likely to improve recruitment to AD research studies without causing collateral ethical or motivation problems. Remuneration does not differentially enhance minority recruitment.

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Perceptions of Research Burden and Retention Among Participants in ADRC Cohorts

Cited by 9 publications

References 22 publications

Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials

Pilot Trial Characteristics, Postpilot Design Modifications, and Feasibility of Full-Scale Trials

Psychometric Evaluation of the Perceived Research Burden Assessment (PeRBA) in Longitudinal Studies of Alzheimer Disease Using Rasch Analysis

Remuneration and Recruitment of Study Participants for AD Cohort Studies From the General Public and From Minority Communities

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