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 1) identification of relevant content domains from existing clinical tools, patient questionnaires and in-depth interviews with multi-stakeholders; Phase 2) item development using a novel approach: plain language in conjunction with medical terminology; and Phase 3) pre-testing with multi-stakeholders 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 1) In the example case study, 19 relevant content domains were identified from two clinical tools, two patient questionnaires and 19 multi-stakeholder interviews (9 patients, 10 HCPs). Phase 2) Domains were operationalised into 16 initial items. Plain language in conjunction with medical terminology was applicable in nine (27%) items. Phase 3) Pre-testing 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.

Keywords
Outcome measurement, questionnaire development, content validity, item construction, patient-reported outcome.