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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., (© 2024. The Author(s).)

Background: Hope has therapeutic value because it enables people to cope with uncertainty about their future health. Indeed, hope, or therapeutic optimism (TO), is seen as an essential aspect of the provision and experience of medical care. The role of TO in clinical research has been briefly discussed, but the concept, and whether it can be transferred from care to research and from patients to clinicians, has not been fully investigated. The role played by TO in research emerged during interviews with staff involved in a peripartum trial. This paper unpacks the concept of TO in this setting and considers the role it may play in the wider delivery of clinical trials.Methods: The Got-it trial is a UK-based, randomised placebo-controlled trial that investigates the use of sublingual glyceryl trinitrate (GTN) spray to treat retained placenta. Qualitative data were collected in open-ended interviews with obstetricians, research and clinical midwives (n =27) involved in trial recruitment. Data were analysed using the method of constant comparison.Results: TO influenced staff engagement with Got-it at different points in the trial and in different ways. Prior knowledge of, and familiarity with, GTN meant that from the outset staff perceived the trial as low risk. TO facilitated staff involvement in the trial; staff who already understood GTN's effects were optimistic that it would work, and staff collaborated because they hoped that the trial would address what they identified as an important clinical need. TO could fluctuate over the course of the trial, and was sustained or undermined by unofficial observation of clinical outcomes and speculations about treatment allocation. Thus, TO appeared to be influenced by key situational factors: prior knowledge and experience, clinical need and observed participant outcomes.Conclusions: Situational TO plays a role in facilitating staff engagement with clinical research. TO may affect trial recruitment by enabling staff to sustain the levels of uncertainty, or individual equipoise, necessary to collaborate with research while also responding to patients' clinical needs. Staff may benefit from training to deal with fluctuations in TO.Trial Registration: ISCRTN88609453 . Registered on 26 March 2014. [ABSTRACT FROM AUTHOR]

Background: Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations.Methods: In-depth interviews were undertaken with staff (n = 27) and participating women (n = 22). Interviews were analysed thematically. The accounts of women and staff were compared to identify differences and similarities in their views about recruitment and consent procedures.Results: Women and staff regarded recruitment as having been straightforward and facilitated by the use of simplified (verbal and written) summaries of trial information. Both parties, however, conveyed discordant views about whether fully informed consent had been obtained. These differences in perspectives appeared to arise from the different factors and considerations impinging on women and staff at the time of recruitment. While staff placed emphasis on promoting understanding in the emergency situation of RP by imparting information in clear and succinct ways, women highlighted the experiential realities of their pre- and post-birthing situations, and how these had led to quick decisions being made without full engagement with the potential risks of trial participation. To facilitate informed consent, women suggested that trial information should be given during the antenatal period, and, in doing so, articulated a rights-based discourse. Staff, however, voiced opposition to this approach by emphasising a duty of care to all pregnant women, and raising concerns about causing undue distress to the majority of individuals who would not subsequently develop a RP.Conclusions: By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials.Trial Registration: ISCRTN 88609453 . [ABSTRACT FROM AUTHOR]

Background: Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet relatively little qualitative work has explored clinicians' perceptions and understandings of trials. This study interviewed surgeons shortly after the multi-centre, pragmatic RCT in which they had participated had been completed. Methods: We used in-depth interviews with surgeons who participated in the Spine Stabilisation Trial (a pragmatic RCT) to explore their understanding of the trial purpose and how this understanding had influenced their recruitment procedures and interpretation of the results. A purposive sample of eleven participating surgeons was chosen from 8 of the 15 UK trial centres. Results: Although the surgeons thought that the trial was addressing an important question there was little agreement about what this question was: although it was a trial of 'equivalent' treatments, some thought that it was a trial of surgery, others a trial of rehabilitation and others that it was exploring what to do with patients in whom all other treatment options had been unsuccessful. The surgeons we interviewed were not aware of the rationale for the pragmatic inclusion criteria and nearly all were completely baffled about the meaning of 'equipoise'. Misunderstandings about the entry criteria were an important source of confusion about the results and led to reluctance to apply the results to their own practice. Conclusion: The study suggests several lessons for the conduct of future multi-centre trials. Recruiting surgeons (and other clinicians) may not be familiar with the rationale for pragmatic designs and may need to be regularly reminded about the purpose during the study. Reassurance may be necessary that a pragmatic design is not considered a design fault. We conclude that it does matter if clinicians do not understand the rationale for the trial if, as we have shown here, their perception of the trial aims and methods adversely affects who they recruit; if their views affect what the patients are told; and if they mistakenly view the results as unscientific, unreliable and ultimately irrelevant to their practice. [ABSTRACT FROM AUTHOR]