Aneel Bhangu

Surgical research collaboratives in the UK

www.thelancet.com Vol 382 September 28, 2013 1091 Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/ To our knowledge, these UK traineeled models are a world-first, and we welcome international collaboration to facilitate develop ment in other countries. A global surgical proof of principle study is planned for early 2014, with dissemination via social media (such as GlobalSurg). We hope that this will make possible development of traineeled collaboratives on a truly global scale.

Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy

PurposeIncisional hernia is a common long-term complication after laparotomy. This study investigated whether prophylactic mesh reinforcement of laparotomy reduced the rate of incisional hernia, with emphasis on trial design and quality.MethodsA systematic review of published literature was performed for studies comparing incisional hernia presence following conventional closure or prophylactic mesh reinforcement. Studies were assessed using the Cochrane Risk of Bias Tool, the Jadad score and the Newcastle Ottawa Scale (NOS). The primary endpoint was incisional hernia, assessed by meta-analysis.ResultsSeven studies [four randomised controlled trials (RCTs) and three prospective trials] included 588 patients; 262 received mesh reinforcement. All studies included elective patients at high risk of incisional hernia. Six incorporated a polypropylene mesh and one a biologic mesh. Four studies were judged high quality by NOS and two of four RCTs were at low risk of bias, although overall outcome assessment from all studies was either poor or mediocre. Mesh significantly reduced the rate of incisional hernia [odds ratio (OR) 0.15, pxa0<xa00.001]; the same effect was seen in RCTs only (OR 0.17, pxa0<xa00.001). A borderline increase of seroma seen with a fixed effect model (OR 1.82, pxa0=xa00.050) was not seen with a random effect model (OR 1.86, pxa0=xa00.210, I2xa0=xa045xa0%).ConclusionMesh reinforcement of laparotomy significantly reduced the rate of incisional hernia in high-risk patients. However, poor assessment of secondary outcomes limits applicability; routine placement in all patients cannot yet be recommended. More evidence regarding the rates of adverse events, cost-benefits and quality of life are needed.

A detailed analysis of outcome reporting from randomised controlled trials and meta-analyses of inguinal hernia repair

IntroductionEvidence is needed to justify whether investment in an internationally agreed core outcome set for inguinal hernia surgery is needed. This study aimed to assess outcome reporting from randomised controlled trials (RCTs) and meta-analyses in inguinal hernia surgery.MethodsRCTs and meta-analyses comparing surgical technique or mesh type for primary inguinal hernia repair were systematically identified. Verbatim details, type, frequency and definition of clinician-observed and -assessed outcomes were summarised. Patient-reported outcome measures (PROMs) were analysed for instrument validity and frequency of domain reporting.Results40 RCTs (10,810 patients) and 7 meta-analyses (17,280 patients) were identified. No single PROM was reported by all studies. There were 58 different clinician-observed outcomes, with recurrence (nxa0=xa047, 100xa0%), wound infection (nxa0=xa033, 70.2xa0%), haematoma (nxa0=xa031, 77.5xa0%) and seroma formation (nxa0=xa022, 46.8xa0%) being most frequently reported. All studies measured patients’ views, although only 12 (30.0xa0%) used validated instruments. The SF36 was the most commonly used multi-dimensional valid PROM (nxa0=xa07), and a visual analogue scale assessing pain (nxa0=xa032) was the most frequently used unidimensional scale. Non-validated questionnaires assessed 25 other aspects of patients’ health. Two meta-analyses defined recurrence and three chronic pain although neither ensured that included RCTs adhered to the definitions.ConclusionsOutcome reporting from RCTs concerning inguinal hernia repair is inconsistent and poorly defined, limiting meta-analyses, which themselves do not control for the differing definitions of assessed outcomes. This study justifies investment in a standardised core outcome set for inguinal hernia surgery, to improve outcome reporting and evidence synthesis.

A multicentre cohort study assessing day of week effect and outcome from emergency appendicectomy

Background There is evidence to suggest that patients undergoing treatment at weekends may be subject to different care processes and outcomes compared with weekdays. This study aimed to determine whether clinical outcomes from weekend appendicectomy are different from those performed on weekdays. Method Multicentre cohort study during May–June 2012 from 95 centres (89 within the UK). The primary outcome was the 30-day adverse event rate. Multilevel modelling was used to account for clustering within hospitals while adjusting for case mix to produce adjusted ORs and 95% CIs. Results When compared with Monday, there were no significant differences for other days of the week considering 30-day adverse events in adjusted models. On Sunday, rates of simple appendicitis were highest, and rates of normal (OR 0.62, 95% CI 0.42 to 0.90) and complex appendicitis (OR 0.65, 95% CI 0.46 to 0.93) lowest. This was accompanied by a 43% lower likelihood in use of laparoscopy on Sunday (OR 0.47, 95% CI 0.32 to 0.69), accompanied by the lowest level of consultant presence for the week. When pooling weekends and weekdays, laparoscopy use remained less likely at the weekend (OR 0.68, 95% CI 0.55 to 0.83), with no significant difference for 30-day adverse event rate (OR 1.01, 95% CI 0.80 to 1.29). Conclusions This study found that weekend appendicectomy was not associated with increased 30-day adverse events. It cannot rule out smaller increases that may be shown by larger studies. It further illustrated that patients operated on at weekends were subject to different care processes, which may expose them to risk.

How good are surgeons at identifying appendicitis? Results from a multi-centre cohort study

BACKGROUNDnConvincing arguments for either removing or leaving in-situ a macroscopically normal appendix have been made, but rely on surgeons accurate intra-operative assessment of the appendix. This study aimed to determine the inter-rater reliability between surgeons and pathologists from a large, multicentre cohort of patients undergoing appendicectomy.nnnMATERIALS AND METHODSnThe Multicentre Appendicectomy Audit recruited consecutive patients undergoing emergency appendicectomy during April and May 2012 from 95 centres. The primary endpoint was agreement between surgeon and pathologist and secondary endpoints were predictors of this disagreement.nnnRESULTSnThe final study included 3138 patients with a documented pathological specimen. When surgeons assessed an appendix as normal (n = 496), histopathological assessment revealed pathology in a substantial proportion (n = 138, 27.8%). Where surgeons assessed the appendix as being inflamed (n = 2642), subsequent pathological assessment revealed a normal appendix in 254 (9.6%). There was overall disagreement in 392 cases (12.5%), leading to only moderate reliability (Kappa 0.571). The grade of surgeon had no significant impact on disagreement following clinically normal appendicectomy. Females were at the highest risk of false positives and false negatives and pre-operative computed tomography was associated with increased false positives.nnnCONCLUSIONSnThis multi-centre study suggests that surgeons judgements of the intra-operative macroscopic appearance of the appendix is inaccurate and does not improve with seniority and therefore supports removal at the time of surgery.

Collaboration is key to strengthening surgical research capacity in sub-Saharan Africa.

The paucity of research in areas of greatest clinical need must be addressed urgently. We propose a model of collaboration in an era of information systems and emerging mobile health technology that has had significant success across the UK and has shown early encouraging results in South Africa (SA). We foresee that recent examples of surgical research collaboratives in SA will continue to promote regional, national and international hub-and-spoke models and ultimately increase the South-South collaboration that is urgently needed to diffuse the skills and knowledge required to address the unmet surgical need in sub-Saharan Africa.

Global health trials methodological research agenda: results from a priority setting exercise.

BackgroundMethodological research into the design, conduct, analysis and reporting of trials is essential to optimise the process. UK specialists in the field have established a set of top priorities in aid of this research. These priorities, however, may not be reflected in the needs of similar research in low- to middle-income countries (LMICs) with different healthcare provision, resources and research infrastructure. The aim of the study was to identify the top priorities for methodological research in LMICs to inform further research and ultimately to improve clinical trials in these regions.MethodsAn online, two-round survey was conducted from December 2016 to April 2017 amongst researchers and methodologists working on trials in LMICs. The first round required participants to suggest between three and six topics which they felt were priorities for trial methodological research in LMICs. The second round invited participants to grade the importance of a compulsory list of topics suggested by four or more individuals, and an optional list of the remaining topics.FindingsRounds 1 and 2 were completed by 412 and 314 participants, respectively. A wide spread of years of experience, discipline, current country of residence, origin of trials training and area of involvement in trials was reported. The topics deemed most important for methodological research were: choosing appropriate outcomes to measure and training of research staff.ConclusionBy presenting these top priorities we have the foundations of a global health trials methodological research agenda which we hope will foster future research in specific areas in order to increase and improve trials in LMICs.

Ban on publishing industry funded research could harm surgical innovation.

A blanket ban on publishing drug industry funded research has implications for surgical research.1 Industry collaborations in surgery involve drugs and devices, with the latter driving technological advancement. Recent efforts—encouraged by the Royal College of Surgeons of England (RCSEng)—have focused on strengthening these collaborations to promote and …

Recognising contributions to work in research collaboratives: Guidelines for standardising reporting of authorship in collaborative research

BACKGROUNDnTrainee research collaboratives (TRCs) have been revolutionary changes to the delivery of high-quality, multicentre research. The aim of this study was to define common roles in the conduct of collaborative research, and map these to academic competencies as set out by General Medical Council (GMC) in the United Kingdom. This will support trainers and assessors when judging academic achievements of those involved in TRC projects, and supports trainees by providing guidance on how to fulfil their role in these studies.nnnMETHODSnA modified Delphi process was followed. Electronic discussion with key stakeholders was undertaken to identify and describe common roles. These were refined and mapped to GMC educational domains and International Committee of Medical Journal Editors authorship (ICJME) guidelines. The resulting roles and descriptions were presented to a face-to-face consensus meeting for voting. The agreed roles were then presented back to the electronic discussion group for approval.nnnRESULTSnElectronic discussion generated six common roles. All of these were agreed in face-to-face meetings, where two further roles identified and described. All eight roles required skills that map to part of the academic requirements for surgical training in the UK.nnnDISCUSSIONnThis paper presents a standardised framework for reporting authorship in collaborative group authored research publications. Linkage of collaborator roles to the ICMJE guidelines and GMC academic competency guidelines will facilitate incorporation into relevant training curricular and journal publication policies.