Dataset Information

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

ABSTRACT: Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including 'acknowledgement of individual contribution', 'contributing for a collective benefit' and 'receiving accessible and easy to understand results'. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients' final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

SUBMITTER: Racine E

PROVIDER: S-EPMC6973522 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Racine Emmy E Hurley Caroline C Cheung Aoife A Sinnott Carol C Matvienko-Sikar Karen K Baumgartner Christine C Rodondi Nicolas N Smithson William H WH Kearney Patricia M PM

HRB open research 20180411

<b>Background:</b> While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). <b>Methods:</b> This is a mixed methods study with three consecutiv ...[more]

PMID: 32002507

Similar Datasets

Project description:IntroductionUnderstanding clinical trial experiences can illuminate opportunities to optimize trial design and management, with potential benefits for recruitment and retention. This study sought to better understand clinical trial participant experiences and attitudes within spinal muscular atrophy (SMA), and how the evolving treatment landscape and participant characteristics may predict attitudes.MethodsA survey was developed following a review of published literature and discussions with caregivers of SMA trial participants. This was distributed via email to known trial participants in Cure SMA's database, announcements in Cure SMA's newsletter, and emails to SMA clinical trial principal investigators.ResultsSeventy complete surveys reflecting unique clinical trial experiences were included in analysis. Responses revealed positive attitudes about clinical trial management overall. Top motivators for trial participation included clinical benefit, investigational drug access, and the opportunity to help others. Top concerns were safety, whether benefits would justify risks, and concerns about pain accompanying tests. The greatest stressors were fear of pain, adverse event concerns, and challenges managing medical complications of SMA. Top benefits of trial participation were hope for a better future, helping others, and relationships with the study team. In regression analysis, participant gender, age, and race all emerged as significant predictors (p < 0.05) of motivators, concerns, stressors, and benefits, as did respondent type, knowledge about SMA, distance to the trial site, and treatment era. Top recommendations for improving study management all related to receiving more information.ConclusionThis research provides new perspective on patient experiences in SMA clinical trials. It underscores the importance of information and efforts to anticipate and accommodate participant needs. These findings may inform study design and interactions with research participants. They may become especially important in supporting recruitment and retention as more treatment options become available.

Project description:ImportancePatients are increasingly being given access to their test results, but little is known about how preferences vary with the test under consideration or the results of the test (normal or abnormal).ObjectiveThis study was conducted to examine preferences for test result communication.Design, setting, and participantsWe surveyed adults to explore their preferences for test result notification for three common diagnostic tests of varying "emotional impact" (dual-energy x-ray absorptiometry [DXA], genital herpes, and cancer biopsy) when test results were 1) normal and 2) abnormal. We conducted our survey between June and August 2012 on the campus of an academic medical center. For each scenario, subjects were asked to rank seven methods that might be used to communicate test results (letter, unsecured email, secured email, text message, telephone call, secure Web portal, office visit) in order of acceptability.Main outcome measuresThe main measures were the percentage of respondents who ranked a particular test result notification method favorably and the percentage who ranked it as unacceptable.ResultsWhen test results were normal, subjects' notification preferences were generally similar for DXA, herpes and cancer biopsy, with telephone and letter ranked most favorably for all three tests. Conversely, text message and unsecured email were viewed as unacceptable notification methods for normal results by 45.0-55.0 % of subjects across all three tests. When test results were abnormal, office visits became more popular. A higher proportion of subjects ranked office visits as their most preferred notification method for our test with high "emotional impact" (cancer biopsy) (38.4 %) as compared to DXA (28.2 %) and herpes (27.9 %) (P = 0.02). For most test scenarios, younger subjects appeared to rank electronic communication modalities (secure email or Web portal) higher than older subjects, though this difference did not reach statistical significance (P = 0.29).ConclusionsPreferences for test result notification can differ substantially depending upon the test under consideration and results of the test. Providers and health care systems should consider these factors when deciding how to communicate results to patients.

Project description:Backgroundand purpose Participant recruitment is central to all clinical trials. Any delay in recruitment affects the completion and ultimate success of the trial. We report our experience with patient screening and randomization in CombiRx, which may inform the design of other trials. CombiRx was a multicenter, phase III, double-blind, randomized clinical trial comparing the combined use of interferon beta-1a and glatiramer acetate to either agent alone in patients with relapsing-remitting multiple sclerosis (RRMS). This trial was launched in January 2005 in 69 centers in the United States and Canada under a co-operative agreement with the National Institute of Neurological Disorders and Stroke (NINDS). The goal was to recruit 1000 patients over 1.5 years after a 6-month start-up period. Instead, the investigators required 4.25 years to enroll 1008 patients.MethodsDuring this trial, we assessed the effectiveness of various recruitment strategies, utility of rescreening prior screen failures, and potential factors and strategies used in study conduct, research, and infrastructure, all of which affected recruitment of participants and ultimately time to completion of CombiRx. We particularly were interested in the variability in time to site initiation between academic centers and private practice sites.ResultsPhysicians who were directly involved in the medical care of patients with RRMS were the primary source of patients recruited to CombiRx. A flexible study design that allowed for rescreening of the initial screen failures after a period of time was useful due to the relapsing/remitting course of the disease. Academic centers took longer to implement the trial than the private practice centers, but once sites were approved for enrollment, there was no important difference in the number of participants enrolled.LimitationsThe CombiRx trial was conducted during a period when multiple new medications were being tested, thus affecting the pace of recruitment and limiting ability to generalize our experiences. However, the lessons we learned about process are relevant.ConclusionParticipants can be enrolled successfully in a clinical trial for RRMS, but factors affecting the time to achieve the requirements needed to start screening can be unpredictable and problematic. Prospective planning by the sponsors and investigators, use of central institutional review boards (IRBs), master trial agreements and secure remote desktop access to the trial database may expedite trial implementation and participant recruitment. A good scientific research question with flexible study design and active involvement of the clinicians are important factors driving recruitment. Clinical trials can be implemented successfully both in private practices and at academic centers, a consideration when selecting sites.

Dataset Information

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Publications

Participants' perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets