Correspondence to: Catherine Arundel (email: catherine.arundel@york.ac.uk)
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BJS, https://doi.org/10.1093/bjs/znaf077, published 06 May 2025
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Dear Editor
We thank Yan Shao and Jinshan Liu for their comments.
It is satisfying to know that our work was considered rigorous and inspiring. The issues raised seem to relate to patient adherence and practitioner skill level variability
Patient adherence - we agree that “patient adherence” may be an important factor to consider but it is complex and multi-faceted. Some of the difficulties around “patient adherence” include
Definitions: What is considered “non adherent” in patients on NPWT. The lack of a core outcome set for research involving SWHSI is a real problem which we are addressing1. Researchers have considered < 16 hours / day of NPWT as “non adherent”2, whilst others might consider early cessation as “non adherent”3. Due to this lack of precise definition, it is difficult to estimate the precise incidence of “nonadherence”.
Factors contributing to “nonadherence”: Factors contributing “nonadherence” are multiple and highly variable but may include; confidence with the healthcare team, consistency in therapy advice, coping with pain, former negative experiences with NPWT, a normal activity pattern, social support from family or friends, and support from the healthcare team3. However, these are likely to vary from patient to patient and would require individual appraisal and modifiability assessment.
Monitoring of “nonadherence”: Whilst remote therapy monitoring (RTM) is possible4, it is associated with added time and expense.
Interventions to improve “nonadherence”:Due to its multifaceted nature it is not clear which interventions are effective at improving nonadherence. There is some evidence that targeted engagement (telephone calls) may improve short term adherence (the next day) the impact on more prolonged adherence has not been evaluated5.
Does improved “nonadherence” result in accelerated healing; Whilst low levels of evidence (510 patient cohort study) suggest improvements in non-adherence may be associated with improved healing (surrogate markers – percentage reduction in wound size) it is not clear whether this reached statistical significance2. Our RCT demonstrated that in 349 patients randomised to NPWT there was no evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47). Most of these patients were adherent and had NPWT for a median of 46.6 (SE 4.1) days. If a treatment is not clinically effective, non-adherence is irrelevant6.
Skill level of practitioners.
The Nursing and Midwifery Code of practice sets out clear standards for practice including accountability for practice7. In addition, clinical governance in all NHS trusts, ensures nursing practice is safe, effective, and patient-focused continuously improving care and safeguarding high standards8. Finally, each site participating in SWHSI-2 could resource specific training if required from individual manufacturers – this was sign posted by the SWHSI-2 TMG. The use of NPWT has become routine in the NHS and we believe some of the themes regarding concerns regarding knowledge and training highlighted almost a decade ago9 may now be obsolete. There has also been advancement in NPWT such that the devices themselves identify problem with device use / treatment efficacy (e.g. lack of seal). Many of the sites in SWHSI-2 were high volume units with a huge experience of NPWT therefore variation in nursing practice we feel is unlikely to be significant, supported by the low device related adverse events. Finally, NPWT application in SWHSI-2 was as per manufacturer guidelines, inclusive of current (we believe minimal) diversity of practice i.e. the data in the trial reflects high-quality real-world practice – no modelling required.
References
SWHSI-3 - Surgical Wounds Healing by Secondary Intention: Development of a Core Outcome Set, and Psychometric Evaluation and Mapping of the WoundQoL Wound-specific Quality of Life Questionnaire. Career Development Award, NIHR303688, Dr Misha Sidapra, University of Hull. Start Date: April 2024 (Active) https://fundingawards.nihr.ac.uk/award/NIHR303688
Griffin L, Leyva Casillas LM. A Patient-centered Remote Therapy Monitoring Program Focusing on Increased Adherence to Wound Therapy: A Large Cohort Study. Wounds. 2018 Aug;30(8):E81-E83. PMID: 30212369.
Janssen AHJ, Wegdam JA, de Vries Reilingh TS, Vermeulen H, Eskes AM. Which determinants are considered to be important for adherence to Negative Pressure Wound Therapy: A multimethods study. J Tissue Viability. 2021 May;30(2):250-255. doi: 10.1016/j.jtv.2021.01.009. Epub 2021 Feb 6. PMID: 33581961.
Lumpkins A, Stanton T. Benefits of a Patient-centered Remote Therapy Monitoring Program Focusing on Increased Adherence to Wound Therapy. Wounds. 2019 Aug;31(8):E49-E53. PMID: 31483754.
Griffin L, Casillas LL. Evaluating the Impact of a Patient-centered Remote Monitoring Program on Adherence to Negative Pressure Wound Therapy. Wounds. 2018 Mar;30(3):E29-E31. PMID: 29584605.
Arundel C, Mandefield L, Fairhurst C, Baird K, Gkekas A, Saramago P, Chetter I, on behalf of the SWHSI-2 Trial Investigators. Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial. The Lancet, Volume 405, Issue 10490, 1689 – 1699
https://www.england.nhs.uk/mat-transformation/matrons-handbook/governance-patient-safety-and-quality
McCaughan D., Sheard L., Cullum N., Dumville JC., Chetter IC. Nurses’ and surgeons’ views and experiences of surgical wounds healing by secondary intention: A qualitative study. Journal of Clinical Nursing 2020; 29(13-14):2557-2571.
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