Development and pilot testing of a patient-reported outcome measure to assess symptoms of parastomal hernia.

AIM: The aim was to develop and pilot a patient-reported outcome measure (PROM) to assess symptoms of parastomal hernia (PSH). METHODS: Standard questionnaire development was undertaken (phases 1-3). An initial list of questionnaire domains was identified from validated colorectal cancer PROMs and from semi-structured interviews with patients with a PSH and health professionals (phase 1). Domains were operationalized into items in a provisional questionnaire, and 'think-aloud' patient interviews explored face validity and acceptability (phase 2). The updated questionnaire was piloted in patients with a stoma who had undergone colorectal surgery and had a computed tomography scan available for review. Patient-reported symptoms were examined in relation to PSH (phase 3). Three sources determined PSH presence: (i) data about PSH presence recorded in hospital notes, (ii) independent expert review of the computed tomography scan and (iii) patient report of being informed of a PSH by a health professional. RESULTS: For phase 1, 169 and 127 domains were identified from 70 PROMs and 29 interviews respectively. In phase 2, 14 domains specific to PSH were identified and operationalized into questionnaire items. Think-aloud interviews led to three minor modifications. In phase 3, 44 completed questionnaires were obtained. Missing data were few: 5/660 items. PSH symptom scores associated with PSH presence varied between different data sources. The scale with the most consistent differences between PSH presence and absence and all data sources was the stoma appearance scale. CONCLUSION: A PROM to examine the symptoms of PSH has been developed from the literature and views of key informants. Although preliminary testing shows it to be understandable and acceptable it is uncertain if it is sensitive to PSH-specific symptoms and further psychometric testing is needed.

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention.

OBJECTIVES: To describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma formation. DESIGN: (1) Literature reviews, to identify reported variations in surgical components of stoma formation, were supplemented by (2) intraoperative qualitative research (observations, videos and interviews), to identify unreported variations used in practice to generate (3) a 'long list' of items, which were rationalised using (4) consensus methods, providing a pragmatic list of CRF items to be captured in the Cohort study to Investigate the Prevention of parastomal HERnias (CIPHER) study. SETTING: Two secondary care surgical centres in England. PARTICIPANTS: Patients undergoing stoma formation, surgeons undertaking stoma formation and stoma nurses. OUTCOME MEASURES: Successful identification of key CRF items to be captured in the CIPHER study. RESULTS: 59 data items relating to stoma formation were identified and categorised within six themes: (1) surgical approach to stoma formation; (2) trephine formation; (3) reinforcing the stoma trephine with mesh; (4) use of the stoma as a specimen extraction site; (5) closure of other wounds during the procedure; and (6) spouting the stoma. CONCLUSIONS: This study used multimodal data collection to understand and capture the technical variations in stoma formation and design bespoke CRFs for a multicentre cohort study. The CIPHER study will use the CRFs to examine associations between the technical variations in stoma formation and risks of developing a parastomal hernia. TRIAL REGISTRATION NUMBER: ISRCTN17573805.

The changing face of paediatric airway endoscopic surgery: An 8-year single surgeon review.

INTRODUCTION: As a recently established division, we sought to reflect on the development of our paediatric airway surgery service, and prospectively examine the diagnoses that underwent microlaryngobronchoscopy (MLB) to help quantify the evolving population demographics of paediatric airway disorders. MATERIAL AND METHODS: This was a prospective longitudinal study conducted of all paediatric MLBs performed by a single surgeon in a tertiary paediatric ENT centre between 2012 and 2019. RESULTS: A total of 1040 MLBs were performed in 498 patients at the paediatric ENT centre of the Royal London Hospital. Median age at first procedure was 19 months. Median follow-up was 48 months. Primary diagnoses were laryngomalacia (21%), subglottic stenosis (SGS - 18%), laryngeal cleft (13%), and normal anatomy (28.3%). Repeat procedures were needed in 39.1% patients, who underwent a median of 2 repeat procedures. SGS (57.7%) constituted majority of the repeat category, followed by laryngeal cleft (12.36%), laryngomalacia (10.15%), unilateral/bilateral vocal cord palsy(4.24%) and laryngeal papilloma(4.24%). Laryngeal papilloma constituted largest number of procedures per patient (Median = 4, IQR = 5.75), followed by subglottic web and SGS. Mean length of stay(LOS) was 0.67 ± 0.96 days(d), with laryngeal cleft cases recording longest mean LOS. There was a steady increase in proportion of day-surgeries across study period [6.9% (2012) vs 59%(2019)]. CONCLUSION: SGS constitutes the major bulk of paediatric airway surgery, reflective of increasing number of premature births and prolonged intubation among neonates. Day-case MLB is a safe and feasible option in selected patients. This long-term data provides useful information to accurately prognosticate patients regarding potential number of repeat procedures for each diagnosis.

Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study).

AIM: Abdominal surgery sometimes necessitates the creation of a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia adjacent to and related to the stoma. PSH affects approximately 40% of patients within 2 years of stoma formation. Complications of PSH reduce a patient's quality of life and can be severe (e.g. bowel obstruction). PSHs are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The aim of the CIPHER study is to investigate the influence of different surgical techniques on the development of PSH. METHOD: The UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study) aims to recruit 4000 patients undergoing elective or expedited surgery with the intention of forming an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons will describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as a specimen extraction site and wound closure. The primary outcome will be incident PSH during follow-up, defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes will include surgical site infection, the Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. RESULTS: Results of the study will be submitted for publication in peer-reviewed journals. All publications relating to the results of CIPHER will use a corporate authorship, 'The CIPHER Study Investigators' with named writing committee members. CONCLUSION: The CIPHER study will be the first to investigate detailed surgical methods of stoma formation in a large, representative cohort of patients with a range of primary indications, both cancer and noncancer.

The role of antibiotics in the surgical management of paediatric obstructive sleep apnoea (OSA): a cohort study.

PURPOSE: Obstructive sleep apnoea (OSA) describes an irregular night-time breathing pattern that is present in approximately 1.8% of children and can have a negative impact on quality of life. The use of antibiotics postoperatively is controversial. They are commonly prescribed; however, they can also be associated with side effects and resistance. This study explores the role of antibiotics in the post-operative management of children with OSA in a cohort of children. METHODS: We conducted a retrospective cohort study of children undergoing surgery for OSA or sleep disordered breathing (SDB) at a tertiary paediatric ENT referral centre from November 2018 to November 2019. RESULTS: This study identified 382 children who had undergone surgical treatment for OSA or sleep disordered breathing (SDB); 319 underwent adenotonsillectomy, 53 adenoidectomy and 10 tonsillectomies. Antibiotics were given post-operatively to 158 (41%) patients and 18 (11%) of these patients presented to hospital with post-operative complications. A higher number of patients re-presented to hospital from the group who did not receive antibiotics (p = 0.982). Bleeding (p = 0.886) and infection (p = 0.823) were also more common in those children who did not receive antibiotics. CONCLUSION: Antibiotics led to fewer complications and re-presentations to hospital in children undergoing operative management of OSA; however, this trend was not found to be statistically significant.

Squamous cell cancer of the temporal bone: a review of the literature.

BACKGROUND AND AIMS: Squamous cell carcinoma (SCC) of the temporal bone is a rare malignancy accounting for only 0.2% of head and neck cancers. There is currently no clear consensus on staging or common approach to management. It is the aim of this work to provide the readers with a review of the current literature on this malignancy. METHODS: A literature review was performed identifying 16 case series with patient numbers ranging from 12 to 124. A total of 708 patients were included in this review, 67% presented with advanced disease. 578 cases were managed operatively with lateral temporal bone resection, some underwent local resection alone in early stage disease. In all studies radiation therapy was used as an adjunct to some degree. RESULTS: More than half of studies reported 100% either 2-, 3- or 5-year survival for T1 and T2 disease with no nodal involvement. Survival correlated with disease stage and in five studies SCC differentiation was found to be a significant prognostic factor. Post-operative radiotherapy was found to improve survival in only one study. CONCLUSIONS: Temporal bone SCC is a readily treatable malignancy in early stage disease, however late stage disease has a poor prognosis. Differentiation of the SCC and stage of disease at presentation appear to have the greatest influence on 5-year survival rates. Further work is required in both the identification of early stage disease and in the treatment of later T3 and T4 lesions.

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

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).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.