Title: Surgical interventions to treat severe pressure sores (SIPS)
Funder: Department of Health and Social Care

Abstract: Being immobile for too long can lead to discomfort, for example pins and needles or pain. These sensations prompt us to move and this avoids poor blood flow which can lead to pressure ulcers (sometimes called bed sores). Pressure ulcers mainly affect older people confined to a bed or chair. However, younger or seriously ill patients with limited movement, for example due to a spinal injury, can be affected._x000D_ _x000D_ Pressure ulcers are a serious problem for patients and their carers. They range in severity from red skin (Stage 1) to deep wounds through muscle to bone (Stage 4). Pressure ulcers have a major impact on quality of life; they may heal slowly and become infected and increase the risk of dying in older people. They are also a costly problem for the NHS. People with pressure ulcers are usually treated in the community but may need hospital care. _x000D_ _x000D_ Common treatments for pressure ulcers include pressure relief, dressings and encouraging movement and change of position. Surgery can be used to try and close deep pressure ulcers but in the UK this treatment is not common. When we talked to people affected by pressure ulcers, finding out whether surgery works as a treatment was very important to them. We want to answer this question but at the moment it is not clear which patients with pressure ulcers may benefit from an operation and which of the different ways of doing the surgery seems best. _x000D_ _x000D_ We propose to find out more about how best to conduct research in this area in three ways: _x000D_ _x000D_ Firstly, we will ask for the opinions and experiences of doctors, nurses and patients about the range of ways in which people with deep pressure ulcers are treated. We will then formally survey a larger group of health professionals who treat severe pressure ulcers to find out whether they use surgery and, if so, on which patients and what other treatments they use._x000D_ _x000D_ Secondly, we will analyse data collected routinely in the NHS over the last 5-8 years. We will describe the care that has been provided in England to patients with severe pressure ulcers, the kinds of patients who have been treated in different ways and examine how care is different in different places. To inform whether surgical treatments should be more widely available, we will identify patients who were similar when admitted to hospital with a severe pressure ulcer and compare health outcomes (such as going back to hospital and death) among those who did and did not have surgery. _x000D_ _x000D_ Thirdly, we will hold meetings with experienced health care professionals and patients to review the survey findings and the data analyses. We will use an established method to reach agreement about which treatments are appropriate for whom. These steps are vital to ensure relevant future research. _x000D_ _x000D_ The opinions and experiences of people affected by pressure ulcers are very important in ensuring the value of our results to the NHS. As well as including people affected by ulcers in agreeing which treatments are appropriate for whom, we will also work with the Wounds Research PPI Forum in Manchester during this work. We have invited a patient to be a co-applicant and will invite others to join the independent committee overseeing the study. _x000D_ _x000D_ We will ensure that the findings of this work reach all the relevant people who can benefit from them in a suitable format. This includes plain English summaries for the public and relevant material for other people such as health professionals or NHS Trusts.

Lay abstract: Design: _x000D_ The SIPS study has three workstreams (WS). _x000D_ WS1: literature reviews; survey of surgeons and nurses managing patients with severe pressure ulcers in secondary care or community settings._x000D_ WS2: retrospective cohort studies using routinely collected data (HES, CPRD Gold and CPRD Aurum). The HES cohort will include admitted patient care (APC) and outpatient care datasets. ICD-10 diagnoses and OPCS procedures are coded in the APC dataset. CPRD Gold and CPRD Aurum contain data about consultations, diagnoses, interventions, test results, prescriptions and referrals, coded by Read and SNOMED codes. _x000D_ WS3: formal consensus process, among (a) health professionals and (b) patients and carers, to make recommendations about which treatments are appropriate for whom and when._x000D_ _x000D_ Setting: Pressure ulcer management in primary and secondary NHS care._x000D_ _x000D_ Target population: WS1: health professionals with expertise relevant to the management of pressure ulcers. WS2: patients >=18 years in England (a) admitted to hospital, with an ICD-10 diagnosis code for a severe pressure ulcer, or (b) registered with a general practice contributing data to CPRD, with a Read or SNOMED code indicating a pressure ulcer. WS3: health professionals and patients with expertise/experience relevant to the management of pressure ulcers._x000D_ _x000D_ Health technologies being assessed: Reconstructive surgery operations coded with OPCS-4 codes S17-S26. Surgical debridement (OPCS code S57.1) will also be described. _x000D_ _x000D_ Outcomes:_x000D_ WS1: respondents’ answers to survey questions._x000D_ WS2: duration of index admission; subsequent admission (Y/N) and frequency; diagnoses at subsequent admission; repeat procedures; mortality; types and frequency of usual care._x000D_ WS3: responses of panel members to consensus statements. _x000D_ _x000D_ Sample size: We expect the HES cohort to comprise about 140,000 index admissions, of which about 300 will include surgical reconstruction. Descriptive estimates of outcomes will be uncertain, e.g. a 20% risk of readmission will have a 95% CI of 16% to 24%. Usual care in patients will be characterised estimated precisely. For illustration, a matched cohort (1 surgery: 2 usual care) will have about 90% power to detect a relative risk of 0.6 for frequent dichotomous outcomes (e.g. a decrease in readmission from 20% to 12%, total n=1,056). We expect the CPRD cohort to comprise about 75,000 incident pressure ulcers. Management of these ulcers will be summarised descriptively, including referrals to community nursing teams, tissue viability services and to hospital. We expect to be able to follow very few incident ulcers through to surgical reconstruction._x000D_ _x000D_ Study timetable: The total duration will be 24 months. WS1 and WS2 will run in parallel up to month 15. WS3 will start (recruiting consensus panel members) in month 13, with consensus panel meetings between months 19-22. Parts of the final report describing WS1 and WS2 will be drafted in parallel with WS3 consensus activities._x000D_ _x000D_ Expertise in team: Reeves and Dumville are experienced methodologists with expertise in analysing routine data and will lead the team. Co-applicants/collaborators comprise: a patient with a severe pressure ulcer, nurses with wounds/tissue viability/community nursing expertise, plastic and orthopaedic surgeons managing patients having reconstructive surgery, a GP with expertise in CPRD and Read codes, a PPI lead, a statistician, and a methodologist with routine data and consensus expertise.

Research activity codes: 6.4 SURGERY
Health categories: SKIN