Dataset Information

Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation.

ABSTRACT:

Background

Early in the pandemic, there were no evidence-based treatments for SARS-CoV-2, creating an urgent need to identify effective therapeutics. However, public participation in medical research is low; trial enrollment in the US is typically 10-20%. Thus, the aim of this study was to identify common themes underpinning patient reasons to decline participation and evaluate the impact of specific contextual factors.

Methods

This sub-study was conducted in five VISN-1 Clinical Trials Network participating facilities from 4/10/2020-2/3/2021. The trial evaluated the addition of the IL-6-inhibitor, Sarilumab, to the current standard of care for inpatients with moderate-to-severe SARS-CoV-2. Consent procedures varied by site and included fully in-person and fully remote processes. Reasons for declining enrollment were collected among eligible patients who declined to participate but agreed to answer a short follow-up question. Qualitative data were analyzed using directed content analysis. Enrollment rates were assessed using simple, descriptive statistics.

Results

N = 417 COVID-19 positive inpatients were screened and 53/162 eligible patients enrolled. Enrollment varied across study sites and by study period. Prior to identification of effective treatment, the enrollment rate was 10/11 (91%) versus 43/144 (30%) during the later period of the study. N = 85/102 patients who did not enroll answered the follow-up question. The most commonly reported responses were: concerns about the study drug and participation in clinical research in general, comorbidity concerns, competing priorities, external factors, and external advice and influence from family members and clinicians.

Conclusions

Identifying reasons behind declining to enroll may help investigators develop strategies to increase research participation.

SUBMITTER: Dassum SR

PROVIDER: S-EPMC9827740 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation.

Dassum Samira Reyes SR Ferguson Ryan R Woods Patricia P Flynn Maura M Visnaw Karen K Holmberg Erika E Schiller Sara S Shannon Colleen C Brophy Mary M Monach Paul P Leatherman Sarah S Branch-Elliman Westyn W

Contemporary clinical trials 20230109

<h4>Background</h4>Early in the pandemic, there were no evidence-based treatments for SARS-CoV-2, creating an urgent need to identify effective therapeutics. However, public participation in medical research is low; trial enrollment in the US is typically 10-20%. Thus, the aim of this study was to identify common themes underpinning patient reasons to decline participation and evaluate the impact of specific contextual factors.<h4>Methods</h4>This sub-study was conducted in five VISN-1 Clinical ...[more]

PMID: 36632925

Similar Datasets

Project description:Having an unhealthy lifestyle is associated with a higher risk of developing lifestyle-related diseases. Current evidence suggests that interventions targeting health-risk behaviors can help people improve their lifestyles and prevent lifestyle-related diseases. However, preventive programs are often challenged by low participation rates. Reasons for non-participation include lack of time and/or interest, and/or no perceived need for lifestyle intervention. This study explores causes for non-participation in a sample of people who chose not to take up a targeted preventive program (TOF pilot2 study). Patient-reported reasons as well as sociodemographic characteristics and lifestyle factors are in focus. A total of 4633 patients from four Danish GP clinics received an invitation to take part in the TOF pilot2 study. Patients who chose not to participate in the TOF pilot2 study were asked to fill in a questionnaire concerning reasons for non-participation, lifestyle, BMI and self-rated health. Descriptive analyses were used to summarize the results. A total of 2462 patients (53.1%) chose not to participate in the TOF pilot2 study. Among these, 84 (3.4%) answered the full questionnaire on reasons for not participating, lifestyle, BMI and self-rated health. The most common reasons for non-participation were lack of time, having an already healthy lifestyle, and feeling healthy. Based on their self-reported lifestyle 45 (53.6%) of the non-participants had one or more health-risk behaviors including smoking, unhealthy diet, BMI ≥ 35 and/or sedentary lifestyle and were therefore eligible to receive the targeted intervention at the GP or the MHC in the original TOF pilot2 study. When planning future preventive programs it is important to know the main reasons for patients to not participate. This study provides rare insight into why people opt out of health interventions and advances the evidence base in this area. Our results may inform efforts to better involve these patients in preventive health programs. Trial registration number: NCT02797392 .

Project description:To explore reasons for non-participation in a primary care-based physical activity trial and understand how these may contribute to recruitment of non-representative research samples. We also aimed to elicit non-participants' own recommendations for enhancing trial uptake in primary care.Semistructured telephone interviews with non-participants to a randomised controlled trial of a very brief intervention for promoting physical activity conducted in primary care (the Very Brief Interventions trial), with thematic analysis of interview transcripts.5 general practice (GP) surgeries in the East of England, UK.Interviews were completed with 10 female and 6 male non-participants of white ethnicity and aged between 40 and 71 years. 13 of the 16 interviewees were either active or moderately active according to the GP Physical Activity Questionnaire (GPPAQ).Interviewees discussed a range of reasons for non-participation. These included beliefs surrounding the personal relevance of the trial based on preconceptions of intervention content. Many interviewees considered themselves either sufficiently active or too functionally limited to increase activity levels further, so rendering participation pointless in their view. Other identified barriers included a lack of free time, for trial participation and for increasing physical activity, and dissatisfaction with appointment scheduling systems in place at GP surgeries. Interviewees questioned the appropriateness of primary care as a context for delivering interventions to promote physical activity. In general, interviewees were positively disposed towards the idea of trial participation, especially if personal benefits are made salient, but suggested that interventions could be delivered in a different setting such as the internet.To increase participation in physical activity promotion trials conducted in primary care, the content of invitation materials and procedures for contacting potential participants require reconsideration. Specific recommendations include streamlining intervention materials and enhancing their relevance to the health concerns of invitees.ISRCTN72691150; Pre-results.

Dataset Information

Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation.

Background

Methods

Results

Conclusions

Publications

Patient- reported reasons for non-participation in a COVID-19 therapeutics clinical trial: Findings from a multi-center investigation.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets