The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff.

BACKGROUND: Sharing trial results with participants is a moral imperative, but too often does not happen in appropriate ways. METHODS: We carried out semi-structured interviews with patients (n = 13) and site staff (n = 11), and surveyed 180 patients and 68 site staff who were part of the Show RESPECT study, which tested approaches to sharing results with participants in the context of the ICON8 ovarian cancer trial (ISRCTN10356387). Qualitative and free-text data were analysed thematically, and findings used to develop the SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants. This paper presents the framework, with illustrations drawn from the Show RESPECT study. RESULTS: Our adaptable 'SHOW RESPECT' framework covers (1) Supporting and preparing trial participants to receive results, (2) HOw will the results reach participants?, (3) Who are the trial participants?, (4) REsults-what do they show?, (5) Special considerations, (6) Provider-who will share results with participants?, (7) Expertise and resources, (8) Communication tools and (9) Timing of sharing results. While the data upon which the framework is based come from a single trial, many of our findings are corroborated by findings from other studies in this area, supporting the transferability of our framework to trials beyond the UK ovarian cancer setting in which our work took place. CONCLUSIONS: This adaptable 'SHOW RESPECT' framework can guide researchers as they plan how to share aggregate trial results with participants. While our data are drawn from a single trial context, the findings from Show RESPECT illustrate how approaches to communication in a specific trial can influence patient and staff experiences of feedback of trial results. The framework generated from these findings can be adapted to fit different trial contexts and used by other researchers to plan the sharing of results with their own participants. TRIAL REGISTRATION: ISRCTN96189403. Registered on February 26, 2019. Show RESPECT was supported by the Medical Research Council (MC_UU_12023/24 and MC_UU_00004/08) and the NIHR CRN.

Trial participants' self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck.

BACKGROUND: Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback. METHODS: We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase. RESULTS: Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases. CONCLUSIONS: Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.

Using the GRADE evidence to decision framework to reach recommendations together with ethnic minority community organizations: the example of COVID-19 vaccine uptake in the United Kingdom.

OBJECTIVES: To make recommendations regarding factors that affect COVID-19 vaccine uptake by ethnic minority individuals in the United Kingdom, together with strategies that could be used to increase uptake. STUDY DESIGN AND SETTING: The results of two rapid systematic reviews-one identifying factors that affect respiratory vaccine uptake in ethnic minority adults and the other identifying experimental evaluations of strategies to increase vaccine uptake in ethnic minority adults-were put into Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Evidence to Decision frameworks to support discussion with a panel of ethnic minority community organizations, community-focused small companies, and academics of the relevance of the review findings to the UK COVID context. Aided by the frameworks, the panel made recommendations for factors that need to be addressed to increase vaccine uptake, and for which strategies might be used to increase uptake. RESULTS: Our two reviews contained 31 relevant research studies published in English between 2016 and 2021, all of which were from the United Kingdom (8/31), the United States (20), and Australia (3). We identified six factors-two linked to trust, three linked to information, and one on accessibility-that affected uptake. Strategies that had been evaluated fell into three categories: using trusted messengers, tailoring the message, and increasing convenience. These were put into GRADE Evidence to Decision frameworks and discussed over a series of meetings with individuals from nine ethnic minority community organizations and two community-focused small companies and academics. Community partners provided insight into why ethnic minority individuals in the United Kingdom had lower vaccine uptake, particularly with regard to the impact of nonhealth-related UK Government policy on individuals' heath decision-making. Recommendations included recognizing that trust will be low among some ethnic groups, thinking more broadly as to who messengers should be in a low-trust environment, ensuring that information is tailored to the information needs of specific ethnic groups and working to increase convenience. Our results are at https://www.collaborationforchange.co.uk. CONCLUSION: GRADE Evidence to Decision frameworks could be used more widely to structure discussions of research evidence between researchers, community organizations, and other nonresearch partners.

Clinician-Spoken Plain Language in Health Care Encounters: A Qualitative Analysis to Assess Measurable Elements.

PURPOSE: Good communication and use of plain language in health care encounters improve outcomes, including emotional health, symptom resolution, and functional status. Yet there is limited research on how to measure and report spoken plain language, which is the use of familiar, clear language. The authors aimed to describe key, measurable elements of spoken plain language that can be assessed and reported back to clinicians for self-reflection. METHOD: The authors conducted secondary analysis of transcripts from recorded encounters between breast cancer surgeons and patients with early-stage breast cancer. Two coders used a hybrid qualitative analysis with a framework based on U.S. Federal Plain Language Guidelines. To develop major themes, they examined (1) alignment with the Guidelines and (2) code frequencies within and across transcripts. They also noted minor themes. RESULTS: From 74 transcripts featuring 13 surgeons, the authors identified 2 major themes representing measurable elements of spoken plain language: (1) clinicians had a propensity to use both explained and unexplained medical terms, and (2) clinicians delivered information using either short turns (one unit of someone speaking) with 1 topic or long turns with multiple topics. There were 3 minor themes that were not indicative of whether or not clinicians used spoken plain language. First, clinicians regularly used absolute risk communication techniques. Second, question-asking techniques varied and included open-ended, close-ended, and comprehension checks. Third, some clinicians used imagery to describe complex topics. CONCLUSIONS: Clinicians' propensity to use medical terms with and without explanation and parse encounters into shorter or longer turns are measurable elements of spoken plain language. These findings will support further research on the development of a tool that can be used in medical education and other settings. This tool could provide direct and specific feedback to improve the plain language practices of clinicians in training and beyond.

Most UK cardiovascular disease trial protocols feature criteria that exclude ethnic minority participants: a systematic review.

OBJECTIVES: We systematically reviewed UK cardiovascular disease (CVD) randomized controlled trial (RCT) protocols to identify the proportion featuring eligibility criteria that may disproportionately exclude ethnic minority (EM) participants. METHODS: We searched MEDLINE, Embase, and Cochrane Library databases, January 2014-June 2022, to identify UK CVD RCT protocols. We extracted nonclinical eligibility criteria from trial protocols and inductively categorized the trials by their language, consent, and broad (ambiguous) criteria. Findings are narratively reported. RESULTS: Of the seventy included RCT protocols, most (87.1%; 61/70) mentioned consent within the eligibility criteria, with more than two-thirds (68.9%; 42/61) indicating a requirement for 'written' consent. Alternative consent pathways that can aid EM participation were absent. English language requirement was present in 22.9% (16/70) of the studies and 37.1% (26/70) featured broad criteria that are open to interpretation and subject to recruiter bias. Only 4.3% (3/70) protocols mentioned the provision of translation services. CONCLUSION: Most UK CVD trial protocols feature eligibility criteria that potentially exclude EM groups. Trial eligibility criteria must be situated within a larger inclusive recruitment framework, where ethnicity is considered alongside other intersecting and disadvantaging identities.