Development of a single, practical measure of surgical site infection (SSI) for patient report or observer completion

Macefield, Rhiannon; Reeves, Barnaby C; Milne, Thomas Kg; Nicholson, Alex; Blencowe, Natalie S; Calvert, Melanie; Avery, Kerry; Messenger, David E.; Bamford, Richard; Pinkney, Thomas; Blazeby, Jane M

doi:10.1177/1757177416689724

Cited by 27 publications

(32 citation statements)

References 21 publications

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“…Prior examples of remote follow up are already being reported in clinical trials, and in routine clinical practice . Specific work aimed at identifying SSIs using remote technology is already underway . Combining this growing area of interest with established methods of improving follow up, such as offering incentives, may improve study recruitment and retention.…”

Section: Discussionmentioning

confidence: 99%

“…However, the ASEPSIS score remains only one of a number of definitions of SSI, and our study combined the use of ASEPSIS and CDC definitions of SSI . To achieve data that accurately reflect true SSI rates, a combination of assessment methods, involving searching existing computerised data for GP attendances or antibiotic prescriptions, telephone consultations, validated questionnaire use, and targeted clinical review, should be used . Several study groups are currently designing, or validating, novel methods for the follow up of patients post‐discharge, which aim to increase the capture rate of data on SSI in both research trials and clinical practice, and incorporating one or more of these tools may benefit any RCT arising as a result of this pilot study.…”

Section: Discussionmentioning

confidence: 99%

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A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection

Totty

Hitchman

Cai

et al. 2019

International Wound Journal

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A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection

Totty

Hitchman

Cai

et al. 2019

International Wound Journal

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“…The WHQ was developed as part of the Bluebelle study, a feasibility study that included a pilot RCT to examine whether an RCT of different wound dressing strategies for reducing SSI was possible. Initial development of the WHQ has been reported previously. The WHQ was designed as a single questionnaire for patient and/or observer completion.…”

Section: Methodsmentioning

confidence: 99%

Validation of the Bluebelle Wound Healing Questionnaire for assessment of surgical-site infection in closed primary wounds after hospital discharge

Macefield¹,

Blazeby²,

Reeves³

et al. 2019

Journal of British Surgery

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Background Accurate assessment of surgical‐site infection (SSI) is crucial for surveillance and research. Self‐reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self‐assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face‐to‐face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self‐ versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face‐to‐face reference diagnosis (using Centers for Disease Control and Prevention criteria) were examined. Results Some 561 of 792 self‐assessments (70·8 per cent) and 597 of 791 observer assessments (75·5 per cent) were completed, with few missing data or problems reported. Data supported a single‐scale structure with strong internal consistency (α greater than 0·8). Reliability between test–retest and self‐ versus observer assessments was good (κ 0·6 or above for the majority of items). Sensitivity and specificity for SSI discrimination was high (area under the receiver operating characteristic (ROC) curve 0·91). Conclusion The Bluebelle WHQ is acceptable, reliable and valid with a single‐scale structure for postdischarge patient or observer assessment of SSI in closed primary wounds.

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“…Interviews were conducted with nine patients and 10 HCPs. 72 Identified themes reflected the findings from the analysis of existing tools. In addition, one new domain (smell) emerged from both patient and HCP interviews.…”

Section: In-depth Interviewsmentioning

confidence: 99%

“…During pre-testing, interviews highlighted that the initial plain language description for some items required modification to ensure a more accurate interpretation of the intended sign/symptom or intervention. 72 Throughout the cyclical pre-testing phase of interviews and revisions, a total of eight versions of the WHQ were tested. Modifications included changes to the wording and structure of items, layout, instructions and response categories.…”

Section: In-depth Interviewsmentioning

confidence: 99%

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT

Reeves

Rooshenas

Macefield

et al. 2019

Health Technol Assess

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Background Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. Objective To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. Design Phase A – semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B – pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. Setting Usual NHS care. Participants Patients undergoing elective/non-elective abdominal surgery, including caesarean section. Interventions Phase A – none. Phase B – simple dressing, glue-as-a-dressing (tissue adhesive) or ‘no dressing’. Main outcome measures Phase A – pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B – participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. Data sources Phase A – interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B – participants and HCPs in five hospitals. Results Phase A – we interviewed 102 participants. HCPs interpreted ‘dressing’ variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a ‘no dressing’ group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B – from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients’ understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test–retest and Cronbach’s alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. Limitations Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. Conclusions A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4–8 weeks. Trial registration Phase A – Current Controlled Trials ISRCTN06792113; Phase B – Current Controlled Trials ISRCTN49328913. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

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Development of a single, practical measure of surgical site infection (SSI) for patient report or observer completion

Cited by 27 publications

References 21 publications

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection

A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride‐coated dressings versus standard care for the primary prevention of surgical site infection

Validation of the Bluebelle Wound Healing Questionnaire for assessment of surgical-site infection in closed primary wounds after hospital discharge

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT

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