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ObjectivesTo describe the novel concept of, and methods for developing, a ‘universal-reporter’ outcome measure (UROM); a single questionnaire for completion by patients and/or healthcare professionals (HCPs) when views on the same subject are required.DesignA mixed methods study with three phases—phase I: identification of relevant content domains from existing clinical tools, patient questionnaires and in-depth interviews with multistakeholders; phase II: item development using a novel approach that considered plain language in conjunction with medical terminology; and phase III: pretesting with multistakeholders using cognitive interviews.SettingA case study in surgical wound assessment undertaken in two UK hospital trusts and one university setting.ParticipantsPatients who had recently undergone general abdominal surgery and healthcare professionals involved in post-surgical wound care.ResultsPhase I: In the example case study, 19 relevant content domains were identified from two clinical tools, two patient questionnaires and 19 multistakeholder interviews (nine patients, 10 HCPs). Phase II: Domains were operationalised into items and subitems (secondary components to collect further information, if relevant). The version after pretesting had 16 items, five of which included further subitems. Plain language in conjunction with medical terminology was applicable in nine (27%) items/subitems. Phase III: Pretesting with 28 patients and 14 HCPs found that the UROM was acceptable to both respondent groups. An unanticipated secondary finding of the study was that the combined use of plain language and medical terminology during questionnaire development may be a useful, novel technique for evaluating item interpretation and thereby identifying items with inadequate content validity.ConclusionUROMs are a novel approach to outcome assessment that are acceptable to both patients and HCPs. Combining plain language and medical terminology during item development is a recommended technique to improve accuracy of item interpretation and content validity during questionnaire design. More work is needed to further validate this novel approach and explore the application of UROMs to other settings.

Objective To evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements “QRI actions” to address these as recruitment proceeds. Study Design and Setting A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators. Results Five UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.