Dataset Information

Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study.

ABSTRACT:

Background

High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.

Methods

We submitted by mail two vignettes that described clinical research studies - a drug trial and a diagnostic study - to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to randomly allocate three study attributes per vignette: in the drug trial, presumed superiority of new drug versus equipoise, public versus industry funding, and random versus non-random treatment allocation; in the diagnostic study, common versus rare disease, genetic versus protein analysis, and automatic reporting of results versus reporting on request.

Results

Of 2600 patients contacted, 1140 (44%) participated. Globally, willingness to participate in a drug trial was lower than in a diagnostic study (44.8% vs. 76.2%; P?ConclusionsPatients were more likely to participate in a hypothetical observational diagnostic study than in a hypothetical drug trial. Participation in the trial was lower when clinical equipoise was expressed and when the trial was funded by industry. These results suggest that some features of study design can influence participation.

SUBMITTER: Gayet-Ageron A

PROVIDER: S-EPMC7183682 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study.

Gayet-Ageron Angèle A Rudaz Sandrine S Perneger Thomas T

BMC medical research methodology 20200426 1

<h4>Background</h4>High patient participation in clinical research reduces selection bias and ensures the generalizability of study findings. We explored study-related factors that may influence patients' willingness to participate in research.<h4>Methods</h4>We submitted by mail two vignettes that described clinical research studies - a drug trial and a diagnostic study - to patients recently discharged from hospital and assessed their willingness to participate. We used a factorial design to r ...[more]

PMID: 32336266

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Project description:BackgroundFrench community pharmacists are facing an increasing demand to provide a wider range of services to meet the needs of the population. These new missions must be evaluated by primary care research studies. This study aims to explore the factors that influence French community pharmacists' willingness to participate in research projects.MethodsA mixed-method design was adopted for this study, comprising an initial quantitative online survey followed by semi-directed interviews. The investigation was conducted at two French faculties of pharmacy, Angers and Nantes, involving students in their 6th and final year of pharmacy education, and their community pharmacist tutors. The survey items were based on a study by Saini et al. and participants responded using five-point Likert scales. The semi-directed interviews were conducted after the quantitative analysis, only with volunteer and already graduated community pharmacists.ResultsA total of 131 people participated in the quantitative analysis, comprising 75 students and 56 pharmacists. Pharmacists and students agreed on the significance of two key aspects: the research must possess a clear and meaningful purpose, and researchers must keep the pharmacists informed about the study's results. Among the 27 proposed items, only three showed significantly different results between students and pharmacists. Moreover, 11 semi-structured interviews were conducted. Research in the community pharmacy domain is relatively new for many pharmacists. Despite limited training, their willingness to participate is contingent on being actively involved from the outset, receiving appropriate support and training. However, the research should be seamlessly integrated into their daily practice, without being too time-consuming and administratively burdensome. Time constraints emerged as the main obstacle, along with concerns about the availability of human resources. Pharmacists expressed strong motivation driven by the research topic's relevance, and its potential impact on patients or the profession. While financial compensation is desirable, it did not appear to be the main criterion for participation in a study.ConclusionsFrench pharmacists are willing to participate in research projects to improve patient care and develop the profession. Research teams must guide and involve from the project's inception.

Project description:BackgroundClinical trials are essential to improve knowledge of anesthesia and perioperative medicine. Unfortunately, many studies face participant-recruitment issues and fail to include the planned number of participants. There is limited published data about how information delivered about the study or how the experiences and attitudes of prospective participants influence willingness to participate. The purpose of this study was to identify such factors in the domain of anesthesia care.MethodsWe performed a cross-sectional study at the Geneva University Hospitals (Switzerland) using a newly developed paper-based questionnaire on a sample of outpatients with a recent hospital stay and that were aged over 18 years, confident speaking French and free of any disease that could hinder participation. We explored patient personal factors, such as current health, past exposure to clinical research and anesthesia, as well as study-related factors. Six different scenarios for clinical studies were assessed. Linear regression modeling was used to assess the specific association between personal and study-related factors and willingness to participate in the studies described in the scenarios.ResultsOn the 1318 eligible patients, 398 fully completed the questionnaire. Multivariable adjustment revealed that factors related to altruistic values (β, 9.6, 95% CI 3.4 to 15.7, P = 0.002), to the feeling of benefiting from a more effective treatment (β, 4.7, 95% CI 0.2 to 9.2, P = 0.041) and to the absence of fear about double blinding (β, 5.7, 95% CI 1.3 to 10.2, P = 0.012) were positively associated with willingness to participate. Conversely, concerns about drug-related adverse effects (β, - 11.7, 95% CI - 16.9 to - 6.5, P < 0.001) and anxiety about surgery (β, - 5.2, 95% CI - 10.0 to - 0.5, P = 0.031) were negatively associated with willingness to participate.ConclusionOur study was based on vignettes illustrating typical scenarios of clinical trials performed in anesthesia. However, their similarities with real studies still remains hypothetical and our results should be interpreted as such. Nevertheless, the study contributes to improve understanding of factors that may act as incentives or barriers to participation in clinical trials. It highlights the importance of providing appropriate information and reassurance to patients.

Project description:BackgroundParticipation rate is one of the main challenges medical researchers face. We examined how demographic background and trust in medical research affect the willingness of people to participate in medical research in Taiwan.MethodsData from the 2011 Taiwan Genomic Survey (a nationwide representative face-to-face survey) were analyzed. The survey included a vignette of a researcher conducting a clinical trial of an investigative medicinal product, and questions for interviewees regarding their willingness to participate in research after they were informed of the scenario description. A total of 3,159 people, aged 18 to 70 years, were sampled, and 1,538 of them completed the survey. With missing data excluded, a total of 1,389 respondents were included in the final analysis.ResultsAbout 12 percent of the respondents answered that they would be willing to participate in medical research. Respondents who had college degrees or above and were married or lived with significant others were less likely to participate in medical research. By contrast, male respondents, and respondents whose household family members had biomedicine-related degrees or had one themselves were more likely to participate in medical research. After adjustment for demographic factors, respondents were more likely to participate in medical research if: (1) they expressed trust in doctors conducting medical research; (2) they agreed that doctors would never ask them to join medical research studies that might harm them; (3) they thought that participating in a medical research study would be safe; and (4) they agreed that researchers had no selfish reasons for doing the medical research.DiscussionSome of our findings, such as the effects of education level and marital status on participation in medical research, are different from most findings of previous studies conducted in other countries. This study is useful for developing strategies to improve participant recruitment. Relevant discussions on research ethics and policies, such as the importance of public trust in medical researchers, could also be based on this study.

Project description:ObjectiveIntensive ambulatory assessment, such as ecological momentary assessment (EMA), is increasingly used to capture naturalistic patient-reported outcomes. EMA design features (eg, study duration, prompt frequency) vary widely between studies, but it is not known if such design decisions influence potential subjects' willingness to participate in a study. We hypothesise that intentions to participate will be higher in studies that are less burdensome and have higher reward (eg, compensation).DesignThis experimental study examined if four EMA study design features (study duration, prompt frequency, prompt length, compensation) affected intentions to participate in a hypothetical EMA study and participation appraisals (eg, participation effort). Participants were randomly assigned to conditions (reflecting a fully crossed design of the four features, each with two levels). Each condition presented a vignette describing a study (each a unique combination of design features) and asked them to report on likelihood of participating and study appraisals.ParticipantsA convenience sample of participants (n=600; 46% female, Mage=40.39) were recruited using an online service.Primary and secondary outcome measuresPrimary outcomes were willingness to participate (No/Yes) and reported participation likelihood (0-100 scale). Secondary outcomes included appraisals of interest, enjoyment, effort, and if the study makes a valuable contribution to science.ResultsWe examined main effects, and two-way interactions for participation likelihood, across study design features. Overall, reported willingness to participate and participation likelihood were high (89%, M=83.90, respectively). Shorter study duration, fewer prompts, shorter prompts and higher compensation increased willingness to participate and elicited higher participation likelihood (each associated with ~6%-8% increases). Findings suggested that more intensive studies were judged as somewhat less interesting and enjoyable, and requiring more effort.ConclusionHypotheses were generally supported. Design features influence behavioural intentions to participate in, and appraisals of, EMA studies. Implications for participant recruitment and generalisability, and remaining research questions, are discussed.

Project description:BackgroundResearch about the decision to participate in a clinical study has tended to be limited to single indications and has focused on narrow sets of study and participant characteristics. This study applied stated preference methods to understand the clinical trial design attributes that most influence willingness to participate and how this varied with participant characteristics.MethodsAdults residing in the US, China, or Poland with a self-reported diagnosis of cancer, heart disease, migraine, rheumatoid arthritis, or multiple sclerosis completed an online survey. Participants were asked whether they would participate in clinical studies defined by seventeen attributes within five categories (payment/support, administration/procedures, treatment-related, study location/time commitment, and data collection/feedback). Participants saw six different hypothetical clinical study profiles. Depending on their participation decision to an initial clinical study profile, the subsequent five questions had one design attribute (randomly selected per question) consecutively improved or deteriorated to elicit preferences. A logistic regression was used to determine which participant characteristics influenced participation decisions. A latent class logit model was used to identify how the influence of study design features varied between participants and whether groups of participants with similar preferences could be identified.ResultsThe survey was completed by 487 participants (32% China, 35% Poland, 33% US; 8%-19% per indication). Willingness to participate was found to be a function of participant age, certain elements of quality of life, and previous treatment experience, in particular number of lines of treatment received and experience of adverse events. Willingness to participate was influenced by study design features such as payment, study duration, and time commitment - both the overall time and whether the time was at home or away from home, with the latter being particularly relevant to participants experiencing fatigue due to their disease.ConclusionsThis study quantifies how study designs influence willingness to participate and how this varies with participant types. These findings suggest that it is how an indication influences quality of life and treatment experience, rather than the indication alone, that impacts participation rates, opening the way for insights that are transferrable across indications, which may be particularly useful when considering rare diseases.

Project description:ImportanceUsing social media to recruit participants is a common and cost-effective practice. Willingness to participate (WTP) in biomedical research is a function of trust in the scientific team, which is closely tied to the source of funding and institutional connections.ObjectiveTo determine whether WTP and willingness to share social media data are associated with the type of research team and online recruitment platform.Design, setting, and participantsThis mixed-methods longitudinal survey and qualitative study was conducted over 2 points (T1 and T2) using Amazon's Mechanical Turk (MTurk) platform. Participants were US adults aged 18 years or older who use at least 1 social media platform. Recruitment was stratified to match race/ethnicity proportions of the 2010 US Census. The volunteer sample consisted of 914 participants at T1, and 655 participants completed the follow-up survey 5 months later (T2).Main outcomes and measuresOutcomes were (1) past experience with online research and sharing social media data for research; (2) WTP in research advertised online; (3) WTP in a study sponsored by a pharmaceutical company, a university, or a federal agency; and (4) willingness to share social media data. Opinions were solicited regarding the European Union's General Data Protection Regulation statute, which came into effect between T1 and T2.ResultsOf 914 participants completing the first survey (T1), 604 (66.1%) were aged 18 to 39 years and 494 (54.0%) were female. Of these, 655 participants (71.7%) responded at T2. While 680 participants (74.4%) indicated WTP in biomedical research, only 454 (49.3%) were willing to share their social media data. Participants were significantly less likely to participate in federally sponsored (odds ratio [OR], 0.58; 95% CI, 0.51-0.64; P < .001) or pharmaceutical company (OR, 0.59; 95% CI, 0.53-0.66; P < .001) research than university-led studies. They were also less likely to share their social medial data for federal (OR, 0.65; 95% CI, 0.58-0.72; P < .001) or pharmaceutical company (OR, 0.50; 95% CI, 0.44-0.56; P < .001) research compared with academic studies. Willingness to participate in pharmaceutical company-led research decreased 11.89% from T1 to T2 (OR for T2, 0.62; 95% CI, 0.54-0.77; P < .001). Reasons for WTP were interest in furthering science, financial incentives, trust in the organization, and data security. While 63.0% of respondents reported seeing new privacy policy emails related to the General Data Protection Regulation law, only 27.1% indicated this positively influenced their WTP. Thematic analysis of responses indicated that WTP may improve with stronger data security measures.Conclusions and relevanceThis study suggests that researchers may see reduced online research participation and data sharing, particularly for research conducted outside academia.

Dataset Information

Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study.

Background

Methods

Results

Publications

Study design factors influencing patients' willingness to participate in clinical research: a randomised vignette-based study.

Similar Datasets

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