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Introduction It has been proposed that the majority of modern published medical research is of poor quality, particularly in surgery with Richard Horton’s famous 1996 editorial in The Lancet describing surgical research as a “comic opera” [1]. Less than a decade later, a prominent editorial claimed that it can be proven that most research findings are false [2] and more recent work has highlighted the extent of data fabrication in randomised controlled trials (RCTs) published in anaesthetic and general medical journals.[3]. Despite exhortations over two decades ago for less but better research,[4] surgical research has arguably continued to be of largely poor quality. Although RCTs theoretically represent the reference standard in generating research evidence, many are conducted without the input of clinical trials units (CTUs), methodologists, statisticians, public and patient involvement etc and are of overall poor methodological quality and insufficiently robust design [5]. RCTs may sit anywhere along the pragmatic (real world) - explanatory (idealistic) continuum,[6] but trials of interventions intended for widespread use should be pragmatic in nature to confirm or refute the effectiveness of the intervention under investigation. These methodological weaknesses lead to bias and spurious statistical outcomes, in particular the issue of “fragility”. The fragility index is a measure of the minimum number of participants who would need to have had a different outcome for the RCT to lose statistical significance. It serves as a means of quantifying the robustness of an RCT.[7] For those RCTs with statistically nonsignificant primary end points, the reverse frailty index (the minimum number of events that must be changed to move the result from nonsignificant to statistically significant) similarly highlights robustness. [8] Many clinical guidelines in everyday practice internationally are based on surgical RCTs, however if they themselves are flawed, then the guidelines may be vulnerable despite the use of robust methodologies, such as GRADE [9] and AGREE II.[10] We shall herein explore the influence of fragility in hernia surgery RCTs.[5] Aim We aim to investigate the fragility and/or reverse fragility (robustness) of statistical findings in surgical RCTs of interventions for hernia prevention and treatment. Hypotheses We hypothesise that: 1. Most surgical RCTs on hernia prevention and treatment that form the basis of modern clinical guidelines are fragile. 2. Fragility is associated with RCT design (along pragmatic / explanatory continuum). 3. Fragility is negatively associated with clinical trials unit involvement / competitive funding / patient and public involvement (PPI). 4. Unpublished RCTs represent the most under-reported (due to negative findings) and fragile group. Registered but incomplete trials with a published protocol are less fragile. 5. Fragility has not altered with time, due to factors including career pressures. Methods 1. Utilise the following search strategy: ((hernia) NOT (spine OR disc OR lumbar OR cervical OR brain OR hiat*)) AND (inguinal OR groin OR femoral OR ventral OR incisional OR parastomal OR umbilical OR epigastric) Search Pubmed & Embase. Search Clinical trials databases (ISRCTN / clinicaltrials.gov). Inclusion criteria: RCTs, adult humans (>18 years), 1st Jan 2000 - 31st Dec 2022. In print or online, on repair or prophylaxis of hernia. Any surgical technique, including sutures or mesh. Exclusion criteria: non-English language studies. 2. SRMA as per Cochrane – search trials registries (ISRCTN, clinical trials.gov) for unpublished RCTs and published protocols. 3. Dual search / screen, dual data extraction into Excel spreadsheet. 4. Create PRISMA flow diagram (2020). 5. For each RCT to be included, calculate / apply: a. Fragility index or reverse fragility index. b. PRECIS-2 score. c. Evidence of Clinical Trials Unit involvement (methodologist / statistician). d. Evidence of patient and public involvement. Data extraction Excel table columns for each search: • Study / RCT name • Pubmed citation • Include or exclude (complete rest if including, give reason why excluding) • Year protocol registered • Site registered with • Published protocol? • Year study published (order studies chronologically by this column) • Journal published in • Authors • Full citation • RCT design • Total number of patients • Intervention • Control • Positive or negative study • FI / RFI (calculation) • PRECIS-2 score • CTU involvement (methodologist / statistician) • External competitive funding? • Industry funding? • Evidence of PPI References 1. Horton R. Surgical research or comic opera: questions, but few answers. Lancet 1996 Apr 13;347(9007):984-5. 2. Ioannidis JPA. Why Most Published Research Findings Are False. PLoS Med 2005. 2(8): e124. https://doi.org/10.1371/journal.pmed.0020124 3. Carlisle JB. Data fabrication and other reasons for non-random sampling in 5087 randomised, controlled trials in anaesthetic and general medical journals. Anaesthesia 2017. 72(8):944-52. 4. Altman DG. The scandal of poor medical research. BMJ 1994;308:283. doi:10.1136/bmj.308.6924.283 5. Gohel MS, Chetter I. Are clinical trials units essential for a successful trial? BMJ 2015;350:h2823 doi:10.1136/bmj.h2823. 6. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe K E, Zwarenstein M et al. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015; 350:h2147. doi:10.1136/bmj.h2147. 7. Tignanelli CJ, Napolitano LM. The Fragility Index in Randomized Clinical Trials as a Means of Optimizing Patient Care. JAMA Surg. 2019;154(1):74-79. doi:10.1001/jamasurg.2018.4318 8. Khan MS, Fonarow GC, Friede T, et al. Application of the Reverse Fragility Index to Statistically Nonsignificant Randomized Clinical Trial Results. JAMA Netw Open. 2020;3(8):e2012469. doi:10.1001/jamanetworkopen.2020.12469 9. Schünemann H, Brożek J, Guyatt G, Oxman A. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. Available from: https://gdt.gradepro.org/app/handbook/handbook.html. 10. Brouwers MC, Kho ME, Browman GP et al. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ 2010. 182(18): E839-42. doi: 10.1503/cmaj.090449.

Cervical fractures are highly prevalent in older adults, commonly occurring following a fall from a standing height. Atlanto-axial segment (C2 segment) is the most commonly affected, followed by sub-axial cervical spine (C5, 6 and 7). The management of such injuries is complex and often limited by systemic factor including delirium, cognitive impairments and intolerance to immobilization. Most fractures of the cervical spine are considered stable and are treated with a rigid collar. In fact, most trauma guidelines recommend the use of cervical collars following a fracture. However, there are significant adverse events to the long-term use of cervical collars including the development of pressure ulcers, impaired respiratory function and dysphasia. In the frail elderly, immobilization has been associated with aspiration and respiratory failure. Given the high incidence of adverse events it is imperative that we identify the best immobilization protocols that may lead to better overall outcomes. Thus, the objectives of this scoping review will be to collect and summarize information from original studies on available cervical immobilization protocols following a cervical fracture, and when possible collect information on the effectiveness and harms of different protocols.