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Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants.

ABSTRACT: Amid the growth of addiction medicine randomized controlled trials (RCTs), scholars have begun examining participants' study experiences, highlighting facilitators and barriers to enrollment. However, this work can overlook the interplay between trial participation and social-structural dimensions among people with substance use disorders linked to the social nature of use, socioeconomic marginalization, and time demands of substance procurement and use. To effectively conduct RCTs with this unique population, it is necessary to examine the broader social context of study participation. We conducted nested qualitative interviews with 22 participants involved in an RCT testing a treatment for alcohol and opioid use disorders in HIV clinics. Thematic analyses revealed social-structural circumstances shaping RCT participation as well as how participation constitutes a turning point, prompting individuals to reconfigure social networks, reorient to spatial environments, and reorganize day-to-day life-with implications for how substance use disorder RCTs should be approached by researchers.

SUBMITTER: Jaffe K

PROVIDER: S-EPMC8825438 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants.

Jaffe Kaitlyn K Korthuis P Todd PT Richardson Lindsey L

Qualitative health research 20210602 8

Amid the growth of addiction medicine randomized controlled trials (RCTs), scholars have begun examining participants' study experiences, highlighting facilitators and barriers to enrollment. However, this work can overlook the interplay between trial participation and social-structural dimensions among people with substance use disorders linked to the social nature of use, socioeconomic marginalization, and time demands of substance procurement and use. To effectively conduct RCTs with this uni ...[more]

PMID: 34078194

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Project description:ObjectiveInformation on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent.Methods21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire.ResultsInformation related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68).ConclusionsA booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

Project description:ObjectiveResearchers traditionally rely on participant self-report for contraceptive use. We hypothesized that self-reported contraceptive use by clinical research participants may disagree with objectively measured hormonal status.Study designWe enrolled women in Harare, Zimbabwe, aged 18-34, who by self-report had not used hormonal or intrauterine contraception for >30 days, or depot medroxyprogesterone acetate for >10 months, into a study designed to assess biologic changes with contraceptive initiation and use. Blood samples obtained at enrollment and each follow-up visit (N=1630 from 447 participants) were evaluated by mass spectrometry for exogenous hormones. We individually interviewed a subset of participants (n=20) with discrepant self-reported and measured serum hormones to better understand nondisclosure of contraceptive use.ResultsDiscrepant with self-reported nonuse of hormonal contraception, synthetic progestogens were detectable in 120/447 (27%, 95% confidence interval 23%-31%) enrolled women. Measured exogenous hormones consistent with use of contraceptive pills (n=102), injectables (n=20) and implants (n=3) were detected at enrollment, with 7 women likely using >1 contraceptive. In-depth interviews revealed that participants understood the requirement to be hormone free at enrollment (100%). Most (85%) cited partner noncooperation with condoms/withdrawal and/or pregnancy concerns as major reasons for nondisclosed contraceptive use. All interviewed women (100%) cited access to health care as a primary motivation for study participation. Of participants who accurately reported nonuse of hormonal contraception at enrollment, 41/327 (12.5%) had objective evidence of nonstudy progestin use at follow-up that disagreed with self-reported nonuse.ConclusionsWomen joining contraceptive research studies may misrepresent their use of nonstudy contraceptive hormones at baseline and follow-up. Objective measures of hormone use are needed to ensure that study population exposures are accurately categorized.Implications statementAmong Zimbabwean women participating in a contraceptive research study, 27% had objective evidence of use of nonstudy contraceptives at enrollment that disagreed with self-report. Studies that rely on self-report to identify contraceptive hormone exposure could suffer from significant misclassification.

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Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants.

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Experimental (Re)structuring: The Clinical Trial as Turning Point Among Medical Research Participants.

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