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Abstract
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.
- qualitative research
- questionnaire development
- wounds
- dressings
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Footnotes
Contributors All members of the Bluebelle Study Group read and commented on the final version of the paper. Other roles are described below. Lazaros Andronis co-applicant in the Bluebelle study grant (Health Economics); Jane Blazeby Chief investigator of the Bluebelle study grant (NIHR Bluebelle grant HTA - 12/200/04), led the whole study including chairing of management and executive meetings, supervised development of the questionnaires; Natalie Blencowe co-applicant in the Bluebelle study grant, provided feedback on earlier versions of the questionnaires and recruited patients/health care professionals for interviews; Melanie Calvert co-applicant in the Bluebelle study grant (patient-reported outcomes expertise); Joanna Coast co-applicant in the Bluebelle study grant (Health Economics lead); Jenny L Donovan co-applicant in the Bluebelle study grant (Qualitative research co-lead), co-designed and supervised the qualitative research; Tim Draycott co-applicant in the Bluebelle study grant (Obstetric surgical expertise and leadership) principal investigator and lead advisor for obstetric surgery; Jo Dumville provided feedback on earlier versions of the questionnaires; Daisy Elliott wrote the first draft of the manuscript and edited/finalised the paper, contributed to all aspects of qualitative data collection and qualitative data analysis and led development of the questionnaires; Louise Flintoff recruited patients/health care professionals for interviews; Rachel Gooberman-Hill co-applicant in the Bluebelle study grant (patient and public involvement lead); Robert Longman co-applicant in the Bluebelle study grant (Surgical expertise and leadership); Rhiannon Macefield conducted literature reviews and provided feedback on earlier versions of the questionnaires; Laura Magill co-applicant in the Bluebelle study grant, trial manager in Birmingham; Jonathan Mathers co-applicant in the Bluebelle study grant (Qualitative research co-lead); Christel McMullan contributed to all aspects of qualitative data collection and qualitative data analysis, provided feedback on earlier versions of the questionnaires; David Messenger recruited patients/health care professionals for interviews; Charlotte Murkin conducted pre-testing interviews; Helen van der Nelson recruited patients/health care professionals for interviews; Tom Pinkney co-applicant in the Bluebelle study grant (Surgical expertise and leadership); Barnaby C Reeves co-applicant in the Bluebelle study grant (Methodological lead), contributed to overall study design, and provided feedback on earlier versions of the questionnaires; Chris A Rogers co-applicant in the Bluebelle study grant (Statistical lead); Leila Rooshenas contributed to all aspects of qualitative data collection and qualitative data analysis in Phase I and provided feedback on earlier versions of the questionnaires; Andrew Torrance co-applicant in the Bluebelle study grant; Nicky J Welton co-applicant in the Bluebelle study extension grant; Mark Woodward co-applicant in the Bluebelle study grant (Paediatric surgical expertise and leadership) and advisor on paediatric surgery; Trudie Young co-applicant in the Bluebelle study grant (Wound nursing specialist) and advisor on wound care.
Funding The Bluebelle study (Phase A) is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (HTA - 12/200/04) and the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures - MR/K025643/1). JLD and JMB are NIHR Senior Investigators. JLD is also supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) West at University Hospitals Bristol NHS Foundation Trust.
Disclaimer The views expressed are those of the authors and not necessarily those of the MRC, NHS, NIHR or the Department of Health.
Competing interests None declared.
Ethics approval Ethical approval for this work was granted by the Camden and King’s Cross Research Ethics Committee (14/LR/0640) on the 10th April 2014.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The Bluebelle Study Group consists of the following sub-groups: Bluebelle grant co-applicants: Lazaros Andronis (Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK), Jane Blazeby (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK; University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Natalie Blencowe (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK; University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Melanie Calvert (Institute of Applied Health Research, University of Birmingham, Birmingham, UK), Joanna Coast (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK; NIHR Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Trust, Bristol, UK), Tim Draycott (North Bristol NHS Trust, Bristol, UK), Jenny L Donovan (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK; NIHR Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Trust, Bristol, UK), Rachael Gooberman-Hill (Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, UK), Robert Longman (University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Laura Magill (Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, UK), Thomas Pinkney (Centre for Patient Reported Outcomes Research, University of Birmingham; Academic Department of Surgery, Queen Elizabeth Hospital, University of Birmingham, UK), Jonathan Mathers (Institute of Applied Health Research, University of Birmingham, Birmingham, UK), Barnaby C Reeves (Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK), Chris A Rogers (Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK), Leila Rooshenas (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK), Andrew Torrance (Institute of Applied Health Research, University of Birmingham, Birmingham, UK), Nicky J Welton (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK), Mark Woodward (University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Trudie Young (Welsh Wound Innovation Centre, Rhodfa Marics, Ynysmaerdy, Pontyclun, Rhondda Cynon Taf, Wales, UK). Other members of the Bluebelle Study Group: Jo Dumville (School of Nursing, Midwifery & Social Work, University of Manchester, Manchester, UK), Daisy Elliott (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK), Louise Flintoff (University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Rhiannon Macefield (Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK), David Messenger (University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Christel McMullan (Institute of Applied Health Research, University of Birmingham, Birmingham, UK), Charlotte Murkin (School of Social and Community Medicine, University of Bristol, Bristol, UK; University Hospitals Bristol NHS Foundation Trust, Bristol, UK), Helen van der Nelson (Centre for Patient Reported Outcomes Research, University of Birmingham, UK).