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

Abstract

ObjectivesTo develop outcome measures to assess practical management of primary surgical wounds and patient experience.DesignMixed methods, including qualitative interviews and data extraction from published randomised controlled trials (RCTs).SettingTwo university-teaching NHS hospitals and three district NHS hospitals in the South West and Midlands regions of England.ParticipantsSixty-four patients and 15 healthcare professionals from abdominal general surgical specialities and obstetrics (caesarean section).MethodsMeasures 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.ResultsAnalyses 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.ConclusionThis 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 numberHTA - 12/200/04; Pre-results.

Patient‐reported experience measures are essential to improving quality of care for chronic wounds: An international qualitative study

“…Despite multi‐stakeholder pressure to improve quality of care in the chronic wound population, and international evidence supporting PREMs as a tool for quality improvement, there is a paucity of research evaluating patient experiences and processes of care among patients diagnosed with chronic wounds 31‐40 . Many of the currently used quality measures for chronic wounds consist of objective outcome variables, patient‐reported quality of life outcomes, or process indicators derived from clinical or administrative data without patient input 31‐33 .…”

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

“…In 2014, the UK National Institute of Health Research, therefore, called for research proposals to address these issues with feasibility and pilot work to establish if a major RCT was possible. The Bluebelle study, a programme of research including non-randomised feasibility projects (phase A) and a pilot RCT (phase B), was designed to inform the design of a main trial 12–16. Phase A included interviews with key stakeholders to explore their views of dressings and a trial design,12 a survey of surgical wounds to examine current dressing practice13 and developmental work to design questionnaires to assess SSI15 and other aspects of wound management 14.…”

A randomized controlled trial on the effect of a silver carboxymethylcellulose dressing on surgical site infections after breast cancer surgery

“…Our findings are highly relevant for healthcare providers, with significant differences in favour of the Aquacel group on two of the recently proposed outcome measures to assess wound management by Elliot[ 32 ]: patient satisfaction with the dressing and dressing removal. Based on our exploratory subgroup analysis, the treatment effect of silver-containing dressings on SSI rates might be different between breast conserving surgery and mastectomy.…”

“…Generalisation of our findings should be done with caution, as we acknowledge the fact that there is a lack of clear evidence about the value of dressings in surgical practice, and some surgeons use glue or no dressings[ 32 ], as opposed to the simple dressing which we have used as control intervention.…”