Development of a 'universal-reporter' outcome measure (UROM) for patient and healthcare professional completion: a mixed methods study demonstrating a novel concept for optimal questionnaire design.

Objectives To 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. Design A 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. Setting A case study in surgical wound assessment undertaken in two UK hospital trusts and one university setting. Participants Patients who had recently undergone general abdominal surgery and healthcare professionals involved in post-surgical wound care. Results Phase 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. Conclusion UROMs 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.