Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry

Dietrich, Julie; Alivojvodic, Jeannine; Seliverstov, Irene; Metcalf, Marilyn; Jakee, Kelsey

doi:10.1177/2168479017725109

Cited by 3 publications

(5 citation statements)

References 4 publications

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“… Semi-structured interviews Aggregate Not specified Elzinga 2016 [ 36 ] Adult patient perspectives on clinical trial result reporting: a survey of cancer patients Current or previous trial participants 189 37% male Median age 60 years Secondary care Canada To assess adult cancer patient preferences surrounding aggregate result disclosure to study participants. 46-item questionnaire N/A N/A Dietrich 2017 [ 37 ] Improving information exchange with clinical trial participants: a proposal for industry Patients, and health care professionals 3045; 462 Not specified Not specified Not specified Various To capture the current status of information exchange and identify possible future practices between the major stakeholders within the clinical research ecosystem. Patients, sponsors, sites, and HCPs were engaged through surveys, interviews, and/or advisory boards N/A N/A Racine 2017 [ 38 ] Participants’ perspectives and preferences on clinical trial results dissemination: the TRUST Thyroid Trial experience Trial participants 123 48 female; 75 male 65–74 years 69; 75+ years 54 Secondary care Ireland 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).…”

Section: Resultsmentioning

confidence: 99%

“…Where can I find the scientific papers? Postal Not specified Not reported Not specified N/A Elzinga 2016 [ 36 ] N/A N/A N/A Not specified Not reported N/A N/A Dietrich 2017 [ 37 ] N/A N/A N/A TransCelerate interviewed sponsors, conducted surveys with patients and HCPs, and conducted advisory boards with patients and sites to capture the current status and identify possible future practices related to information exchange Not reported N/A N/A Racine 2018 Aggregate Headings: What was the TRUST Thyroid Trial? Who was in charge of the trial?…”

Section: Resultsmentioning

confidence: 99%

“…One key implication of our study is the need for researchers to recognise that there will always be the potential for the return of results to cause distress or doubt. Elzinga, 2016 [ 36 ] N/A N/A May provide information to inform participant QoL Raise public awareness of importance of research Provide information to prevent future harm to participant Emphasise importance of participant to the research project Emphasise importance of participant to research in general Reduce secrecy surrounding research studies Decrease chance participant feels used by researcher Distress caused by discovering participant was harmed by the research Distress for family/caregiver where the participant is deceased Distress caused by discovering participant was not helped by the research Distress caused by worries surrounding employability/insurability Distress caused by bringing up old memories and emotions Distress caused by guilt surrounding selection to better arm of the study Dietrich, 2017 [ 37 ] N/A N/A Not specified A general lack of awareness of the true patient preferences in this area and their corresponding value was evident. Racine, 2018 Patient preferred results letter or TRUST results press release Patient understanding No difference between the groups Participants wanted to receive results that are accessible and easy to understand.…”

Section: Resultsmentioning

confidence: 99%

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Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Bruhn

Cowan

Campbell

et al. 2021

Trials

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Background There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. Methods A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Results Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. Conclusions This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Bruhn

Cowan

Campbell

et al. 2021

Trials

View full text Add to dashboard Cite

show abstract

“…Obtaining feedback from clinical trial participants can identify aspects of trial design that could be improved, which may help to increase participant compliance and retention. However, few sponsors of clinical studies have consistent, company-wide processes for collecting feedback from study participants [21]. Developed in accordance with best practices for the validation of PRO instruments [3,13], the SPFQ was designed as a measure of participant satisfaction and understanding of clinical trial procedures for use in a range of indications and trial designs [11,12].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)

Greene

Elmer

Ludlam

et al. 2020

Ther Innov Regul Sci

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Objectives The Study Participant Feedback Questionnaire (SPFQ) is a patient-completed tool designed to assess patient experiences and satisfaction with aspects associated with being involved in a clinical trial. Originally developed in oncology and among English-speaking participants, the aim of the current study was to evaluate the content and cross-cultural validity of the SPFQ in other indications and non-English-speaking countries. Methods Semi-structured qualitative telephone interviews were conducted with 80 participants across eight non-Englishspeaking countries (in Europe, South America and Asia) who had received an investigational medicinal product as part of a clinical trial in the past three years. Interviews comprised concept elicitation to identify concepts of importance to participants' trial experiences, and cognitive debriefing to assess understanding and perceived importance of SPFQ instructions, items and response options. Results Concept elicitation findings supported the content validity of the SPFQ. During cognitive debriefing, SPFQ instructions and the majority of items were well understood by participants. Participants generally considered the SPFQ items important to their clinical trial experience, albeit a handful of items assessed concepts that had not been experienced by trial participants or were redundant with other SPFQ items. The instructions, response options and recall period of the SPFQ were generally well understood. No country-level differences in understanding or importance were apparent. Conclusion Study findings provide evidence for the content and cross-cultural validity of the SPFQ and support implementation of the SPFQ as a means of obtaining participant feedback across global development programmes in a variety of indications.

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“…Patients and their caregivers want to know what the research activity may mean for them and the conditions they are living with. [1][2][3] Plain language summaries (PLS) are summaries of scientific articles written in easy-to-read, nontechnical language. They have the potential to increase the understanding of scientific data by making complex information more accessible to wider audiences.…”

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confidence: 99%

Generating Plain Language Summaries of Scientific Publications with Ethical Foundations: A Practical “How-To” Guide Cocreated with Patients

Schindler

2022

AMWA

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Peer-reviewed scientific publications are written by scientists with peers in mind. However, there is a growing demand of patients and other nonspecialists to understand the potential implications of clinical and medical research. Research summaries of scientific articles in easy-to-read language—called plain language summaries (PLS)—are currently being developed to broaden the reach of scientific articles beyond expert audiences. While PLS can help nonexperts to understand and be informed about scientific articles, there is a risk that PLS contribute to publication bias and hence misinformation of patients and the public and thus achieve the opposite of their intention. Potential issues are an unbalanced selection of the scientific source articles for which a PLS is initiated, lack of alignment of the data presented in the PLS and in the source article, unbalanced reporting of efficacy and safety data, absence of reporting the primary endpoint, or over- or underreporting of secondary endpoint results. To objectively inform patients and to become a trustworthy source of information, the writing of PLS needs to be firmly embedded in a set of ethical principles. To safeguard balanced and fair PLS writing, the cocreated “How To” Guide on PLS writing developed by the Patient Focused Medicines Development initiative comprises a set of 15 ethical considerations. These include the necessity for objective reporting, the need for balanced presentation, the importance of audience focus, the need to apply health literacy principles, and the importance of using inclusive and respectful language. The “How-To” Guide was developed in a stepwise process with several rounds of cocreation, public consultation (two rounds), internal review, and a final external review. The iterative development process ensured input from a wide variety of stakeholders (patient representatives, industry members, publishers, researchers, medical communications agencies, and public officials involved in research bodies). The final “How-To” Guide is a standalone, practical, ready-to-use tool to support multistakeholder cocreation of PLS.

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Improving Information Exchange with Clinical Trial Participants: A Proposal for Industry

Cited by 3 publications

References 4 publications

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)

Generating Plain Language Summaries of Scientific Publications with Ethical Foundations: A Practical “How-To” Guide Cocreated with Patients

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