Dataset Information

Exploring treatment preferences facilitated recruitment to randomized controlled trials.

ABSTRACT:

Objective

To explore how patients' treatment preferences were expressed and justified during recruitment to a randomized controlled trial (RCT) and how they influenced participation and treatment decisions.

Study design and setting

Qualitative analysis of audio recordings of recruitment appointments with 93 participants aged 51-70 years in a UK multicenter RCT of localized prostate cancer treatments.

Results

Treatment preferences at recruitment were more complex and dynamic than previously assumed. Most participants expressed views about treatments early in appointments, ranging on a continuum from hesitant to well-formed opinions. As recruiters elicited men's views and provided detailed evidence-based treatment and study information, some opted for their preference, but many became uncertain and open to RCT recruitment, often accepting a different treatment from their original "preference." Discussion of treatment preferences did not act as the expected barrier to recruitment but actively enabled many to express their concerns and reach an informed decision that often included RCT participation.

Conclusion

Exploring treatment preferences and providing evidence-based information can improve levels of informed decision making and facilitate RCT participation. Treatment preferences should be reconceptualized from a barrier to recruitment to an integral part of the information exchange necessary for informed decision making about treatments and RCT participation.

SUBMITTER: Mills N

PROVIDER: S-EPMC3167372 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Exploring treatment preferences facilitated recruitment to randomized controlled trials.

Mills Nicola N Donovan Jenny L JL Wade Julia J Hamdy Freddie C FC Neal David E DE Lane J Athene JA

Journal of clinical epidemiology 20110407 10

<h4>Objective</h4>To explore how patients' treatment preferences were expressed and justified during recruitment to a randomized controlled trial (RCT) and how they influenced participation and treatment decisions.<h4>Study design and setting</h4>Qualitative analysis of audio recordings of recruitment appointments with 93 participants aged 51-70 years in a UK multicenter RCT of localized prostate cancer treatments.<h4>Results</h4>Treatment preferences at recruitment were more complex and dynamic ...[more]

PMID: 21477994

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Project description:BackgroundRecruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire.MethodsA literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i) trial, (ii) site, (iii) patient, (iv) clinical team, (v) information and consent and (vi) study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment.ResultsA web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes.ConclusionsWe have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using this tool with appropriate trial-specific adaptations to monitor and improve recruitment performance in an ongoing trial or conduct the survey at trial completion to gather information on facilitators and barriers to recruitment that can form the basis of interventions and strategies to improve recruitment to future clinical trials.

Project description:BackgroundAlthough recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists.MethodsUsing qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis.ResultsPharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients' questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research.ConclusionsWe noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial.Trial registrationTrial Registration Number: NCT02579655 - initially registered Oct 19, 2015.

Project description:BackgroundIdentifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing.Primary objectiveOur primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed BRCA1/2 mutation randomized to a facilitated cascade testing strategy versus standard of care, proband-mediated, information sharing.Study hypothesisWe hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care.Trial designThe FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known BRCA1/2 mutation (probands) cared for at participating sites will be randomized. Probands randomized to the standard of care group will be instructed to share a family letter with their first-degree relatives and encourage them to complete genetic testing. First-degree relatives of probands randomized to the intervention arm will receive engagement strategies with a patient navigator, an educational video, and accessible genetic testing services.Major inclusion/exclusion criteriaAdult participants who are first-degree relatives of a patient with a BRCA1/2 mutation and have not had prior genetic testing will be included.Primary endpointAnalyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm.Sample sizeOne hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants.Estimated dates for completing accrual and presenting resultsJanuary 2024.Trial registrationNCT04613440.

Dataset Information

Exploring treatment preferences facilitated recruitment to randomized controlled trials.

Objective

Study design and setting

Results

Conclusion

Publications

Exploring treatment preferences facilitated recruitment to randomized controlled trials.

Similar Datasets

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