BackgroundComparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition.MethodsWe used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis.ResultsWe identified support for the trial’s methodology and vision, and elicited themes illustrating parents’ emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views.ConclusionsThe early involvement of parents and former patients identified the centrality of parents’ emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.

Background: Growing evidence for coronary stents in patients with stable coronary artery disease (CAD) suggests that the benefits of stents are uncertain. The goal of this study was to assess patients' informational needs and how patients react to information about the uncertain benefit of stents to CAD patients. Methods: Semi-structured qualitative interviews (N=20) were conducted with patients with stable CAD who received a recent stent. Data were coded and analyzed using a mixed inductive-deductive approach. Results: Some patients mistakenly believed that the purpose of their stent was to prevent a future heart attack, and few were previously aware of the uncertain benefit. Nearly all patients perceived positive outcomes from their procedure, even if their symptoms persisted. Some patients had difficulty accepting evidence that stents may not reduce the risk of heart attack or reliably improve symptoms. Nonetheless, patients still expressed a desire to receive new information about the uncertain benefits of stents and wanted to have received this information early in their care. Conclusion:Many patients with stable CAD do not understand the intended benefit of coronary stents and want to be informed of the evidence of uncertain benefit of coronary stents, even if this would not change their decision. Improved communication and patient education tools are needed to better inform patients. An intervention providing patients with this information early has the potential to solve these problems.

Objectives We involved public and professional stakeholders to assess a novel data interrogation tool, the Neonatal Health Intelligence Tool, for a National Data Asset, the National Neonatal Research Database. Methods We recruited parents, preterm adults, data managers, clinicians, network managers and researchers (trialists and epidemiologists) for consultations demonstrating a prototype tool and semi-structured discussion. A thematic analysis of consultations is reported by stakeholder group. Results We held nine on-line consultations (March–December 2021), with 24 stakeholders: parents (n=8), preterm adults (n=2), data managers (n=3), clinicians (n=3), network managers (n=2), triallists (n=3) and epidemiologists (n=3). We identified four themes from parents/preterm adults: struggling to consume information, Dads and data, bring data to life and yearning for predictions; five themes from data managers/clinicians/network managers: benchmarking, clinical outcomes, transfers and activity, the impact of socioeconomic background and ethnicity, and timeliness of updates and widening availability; and one theme from researchers: interrogating the data. Discussion Other patient and public involvement (PPI) studies have reported that data tools generate concerns; our stakeholders had none. They were unanimously supportive and enthusiastic, citing visualisation as the tool’s greatest strength. Stakeholders had no criticisms; instead, they recognised the tool’s potential and wanted more features. Parents saw the tool as an opportunity to inform themselves without burdening clinicians, while clinicians welcomed an aid to explaining potential outcomes to parents. Conclusion All stakeholder groups recognised the need for the tool, praising its content and format. PPI consultations with all key groups, and their synthesis, illustrated desire for additional uses from it.

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