Developing outcome measures assessing wound management and patient experience: a mixed methods study.

OBJECTIVES: To develop outcome measures to assess practical management of primary surgical wounds and patient experience.

DESIGN: Mixed methods, including qualitative interviews and data extraction from published randomised controlled trials (RCTs).

SETTING: Two university-teaching NHS hospitals and three district NHS hospitals in the South West and Midlands regions of England.

PARTICIPANTS: Sixty-four patients and 15 healthcare professionals from abdominal general surgical specialities and obstetrics (caesarean section).

METHODS: Measures were developed according to standard guidelines to identify issues relevant to patients' experiences of surgical wounds and dressings, including analysis of existing RCT outcomes and semi-structured interviews. These were written into provisional questionnaire items for a single outcome measure. Cognitive interviews with patients and healthcare professionals assessed face validity, acceptability and relevance. Findings from interviews were regularly shared with the study team who suggested amendments to modify and reword items to improve understanding before further iterative testing with patients and healthcare professionals.

RESULTS: Analyses of existing RCT outcomes and interviews produced a total of 69 issues. Pretesting and iterative revision established the need for two separate measures. One measure addresses healthcare professionals' experience of wound management in two key areas: exudate and its impact, and allergic reactions to the dressing. The other measure addresses patients' experience of wounds in seven key areas: wound comfort, dressing removal, dressings to protect the wound, impact on daily activities, ease of movement, anxiety about the wound and satisfaction with dressing. Each measure took less than five min to complete and both were understood and acceptable to patients and healthcare professionals.

CONCLUSION: This in-depth study has developed two measures to assess practical management of primary surgical wounds and patient experience. Further work to test their validity, reliability and application to other settings is now required.

TRIAL REGISTRATION NUMBER: HTA - 12/200/04; Pre-results.