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Development of a research participants' perception survey to improve clinical research.

ABSTRACT: Clinical research participants' perceptions regarding their experiences during research protocols provide outcome-based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants' clinical research experiences. Use of validated surveys measuring patient-centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes.We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion-related validity, and item usefulness. Responses were tested for fit into existing patient-centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient.Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient-centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69-0.85).The validated survey offers a new method for assessing and improving outcomes of clinical research processes.

SUBMITTER: Yessis JL

PROVIDER: S-EPMC3605037 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Development of a research participants' perception survey to improve clinical research.

Yessis Jennifer L JL Kost Rhonda G RG Lee Laura M LM Coller Barry S BS Henderson David K DK

Clinical and translational science 20121015 6

<h4>Introduction</h4>Clinical research participants' perceptions regarding their experiences during research protocols provide outcome-based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants' clinical research experiences. Use of validated surveys measuring patient-centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes.<h4>Methods</h4>We derived survey questions from d ...[more]

PMID: 23253666

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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:OBJECTIVE:Researchers 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 DESIGN:We 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. RESULTS:Discrepant 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. CONCLUSIONS:Women 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 STATEMENT:Among 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.

Project description:BackgroundThe adoption of health technologies is key to empower research participants and collect quality data. However, the acceptance of health technologies is usually evaluated in patients or healthcare practitioners, but not in clinical research participants.MethodsA 27-item online questionnaire was provided to the 11,695 members of a nutrition clinical research participant database from the Nantes area (France), to assess (1) participants' social and demography parameters, (2) equipment and usage of health apps and devices, (3) expectations in research setting and (4) opinion about the future of clinical research. Each item was described using frequency and percentage overall and by age classes. A global proportion comparison was performed using chi-square or Fisher-exact tests.ResultsA total of 1529 respondents (81.0% women, 19.0% men) completed the survey. Main uses of health apps included physical activity tracking (54.7%, age-related group difference, p < 0.001) and food quality assessment (45.7%, unrelated to age groups). Overall, 20.4% of respondents declared owning a connected wristband or watch. Most participants (93.8%) expected the use of connected devices in research. However, protection of personal data (37.5%), reliability (35.5%) and skilled use of devices (28.5%) were perceived as the main barriers. Most participants (93.3%) would agree to track their food intake using a mobile app, and 80.5% would complete it for at least a week while taking part in a clinical study. Only 13.2% would devote more than 10 min per meal to such record. A majority (60.4%) of respondents would accept to share their social media posts in an anonymous way and most (82.2%) of them would accept to interact with a chatbot for research purposes.ConclusionsOur cross-sectional study suggests that clinical study participants are enthusiastic about all forms of digital health technologies and participant-centered studies but remain concerned about the use of personal data. Repeated assessments are suggested to evaluate the research participant's interest in technologies following the increase in use and demand for innovative health services during the pandemic of COVID-19.

Project description:ObjectiveTo determine continuing medical education (CME) course participants' use of social media (SM) and their attitudes about the value of SM for enhancing CME education and to examine associations between participants' characteristics and attitudes toward SM.Participants and methodsWe conducted a cross-sectional survey and validation study of 539 participants at a Mayo Clinic Internal Medicine CME course in November 2011. The Social Media Use and Perception Instrument (SMUPI) consisted of 10 items (5-point Likert scales) and categorical response options. The main outcome measures were psychometric characteristics of the SMUPI scale, course participants' use of SM, and their attitudes regarding the importance of SM for enhancing CME.ResultsOf 539 CME course participants, 327 (61%) responded to the SMUPI survey. Most respondents (291 [89%]) reported using SM, with the most common types being YouTube (189 of the 327 participants [58%]) and Facebook (163 of 327 [50%]). Factor analysis revealed a 2-dimensional assessment of course participants' attitudes. Internal consistency reliability (Cronbach α) was excellent for factor 1 (0.94), factor 2 (0.89), and overall (0.94). The CME course participants' favorable attitudes toward SM were associated with younger age (20-29 years, mean score 3.13; 30-39 years, 3.40; 40-49 years, 3.39; 50-59 years, 3.18; 60-69 years, 2.93; and ≥70 years, 2.92; P=.02), using SM frequently (never, mean score 2.49; less than once monthly, 2.75; once monthly, 3.21; weekly, 3.31; and daily, 3.81; P<.0001), and professional degree (PhD, mean score 3.00; MD, 3.05; DO, 3.35; PA, 3.42; and NP, 3.50; P=.01).ConclusionWe describe the first validated measure of CME course participants' use of and attitudes toward SM. Our results suggest that CME course directors should guide SM strategies toward more youthful, technology-savvy CME participants and that SM will become increasingly worthwhile in CME as younger learners continue to enter the profession.

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Development of a research participants' perception survey to improve clinical research.

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Development of a research participants' perception survey to improve clinical research.

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