Exploring the landscape of oesophageal discontinuity procedures and creation of cervical oesophagostomy in the modern era: a scoping review protocol.

INTRODUCTION: Oesophageal discontinuity remains a challenge for thoracic and foregut surgeons globally. Whether arising emergently after catastrophic oesophageal or gastric disruption or arising in the elective setting in the case of staged reconstruction for esophagectomy or long gap atresia in the paediatric population, comprehensive review of this patient population remains unexplored within the surgical literature.The goal of this scoping review is to map the landscape of literature exploring the creation and takedown of cervical oesophagostomy with the intent to answer four questions (1) What are the primary indications for oesophageal discontinuity procedures? (2) What are the disease-specific and healthcare utilisation outcomes for oesophageal discontinuity procedures? (3) What is the primary indication for reversal procedures? (4) What are the disease-specific and healthcare utilisation outcomes for reversal procedures? METHODS: This review will follow the Arksey and O'Malley (2005) framework for scoping reviews. Paediatric (<18 years old) and adult (>18 years old) patients, who have received a cervical oesophagostomy in the context of a gastrointestinal discontinuity procedure or those who have had reversal of a cervical oesophagostomy, will be included for analysis. We will search MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) databases for papers from 1990 until 2023. Interventional trials, prospective and retrospective observational studies, reviews, case series and qualitative study designs will be included. Two authors will independently review all titles, abstracts and full texts to determine which studies meet the inclusion criteria. ETHICS AND DISSEMINATION: No ethics approval is required for this review. Results will be disseminated through scientific presentations and relevant conferences targeted for researchers examining upper gastrointestinal/foregut surgery. REGISTRATION DETAILS: This protocol is registered with Open Science Framework (osf.io/s3b4g).

Assessing the robustness of positive vascular surgery randomized controlled trials using their fragility index.

OBJECTIVE: The fragility index (FI) measures the robustness of statistically significant findings in randomized controlled trials (RCTs) by quantifying the minimum number of event conversions required to reverse a dichotomous outcome's statistical significance. In vascular surgery, many clinical guidelines and critical decision-making points are informed by a handful of key RCTs, especially regarding open surgical versus endovascular treatment. The objective of this study is to evaluate the FI of RCTs with statistically significant primary outcomes that compared open vs endovascular surgery in vascular surgery. METHODS: In this meta-epidemiological study and systematic review, MEDLINE, Embase, and CENTRAL were searched for RCTs comparing open versus endovascular treatments for abdominal aortic aneurysms, carotid artery stenosis, and peripheral arterial disease to December 2022. RCTs with statistically significant primary outcomes were included. Data screening and extraction were conducted in duplicate. The FI was calculated by adding an event to the group with the smaller number of events while subtracting a nonevent to the same group until Fisher's exact test produced a nonstatistically significant result. The primary outcome was the FI and proportion of outcomes where the loss to follow-up was greater than the FI. The secondary outcomes assessed the relationship of the FI to disease state, presence of commercial funding, and study design. RESULTS: Overall, 5133 articles were captured in the initial search with 21 RCTs reporting 23 different primary outcomes being included in the final analysis. The median FI (first quartile, third quartile) was 3 (3, 20) with 16 outcomes (70%) reporting a loss to follow-up greater than its FI. Mann-Whitney U test revealed that commercially funded RCTs and composite outcomes had greater FIs (median, 20.0 [5.5, 24.5] vs median, 3.0 [2.0, 5.5], P = .035; median, 21 [8, 38] vs median, 3.0 [2.0, 8.5], P = .01, respectively). The FI did not vary between disease states (P = .285) or between index and follow-up trials (P = .147). There were significant correlations between the FI and P values (Pearson r = 0.90; 95% confidence interval, 0.77-0.96), and the number of events (r = 0.82; 95% confidence interval, 0.48-0.97). CONCLUSIONS: A small number of event conversions (median, 3) are needed to alter the statistical significance of primary outcomes in vascular surgery RCTs evaluating open surgical and endovascular treatments. Most studies had loss to follow-up greater than its FI, which can call into question trial results, and commercially funded studies had a greater FI. The FI and these findings should be considered in future trial design in vascular surgery.

Integration of the social determinants of health into quality indicators for colorectal cancer surgery: a scoping review protocol.

INTRODUCTION: Quality monitoring is a critical component of high-performing cancer care systems. Quality indicators (QIs) are standardised, evidence-based measures of healthcare quality that allow healthcare systems to track performance, identify gaps in healthcare delivery and inform areas of priority for strategic planning. Social structures and economic systems that allow for unequal access to power and resources that shape health and health inequities can be described through the social determinants of health (SDoH) framework. Therefore, granular analysis of healthcare quality through SDoH frameworks is required to identify patient subgroups who may experience health inequity. Given the high burden of disease of colorectal cancer (CRC) and well-defined cancer care pathways, CRC is often the first disease site targeted by health systems for quality improvement. The objective of this review is to examine how SDoH have been integrated into QIs for CRC surgery. This review aims to address three primary questions: (1) Have SDoH been integrated into the development, reporting and assessment of CRC surgery QIs? (2) When integrated, what measures and statistical methods have been applied? (3) In which direction do individual SDoH influence QIs outputs? METHODS: This review will follow Arksey and O'Malley frameworks for scoping reviews. We will search MEDLINE, EMBASE, HealthSTAR databases for papers that examine QIs for CRC surgery applicable to healthcare systems from database inception until January 2023. Interventional trials, prospective and retrospective observational studies, reviews, case series and qualitative study designs will be included. Two authors will independently review all titles, abstracts and full texts to determine which studies meet the inclusion criteria. ETHICS & DISSEMINATION: No ethics approval is required for this review. Results will be disseminated through scientific presentation and relevant conferences targeted for researchers examining healthcare quality and equity in cancer care. REGISTRATION DETAILS: osf.io/vfzd3-Open Science Framework.

Derivation and validation of predictors of oral anticoagulant-related adverse events in seniors transitioning from hospital to home.

INTRODUCTION: Oral anticoagulant (OAC)-related adverse events are high post-hospitalization. We planned to develop and validate a prediction model for OAC-related harm within 30 days of hospitalization. METHODS: We undertook a population-based study of adults aged ≥66 years who were discharged from hospital on an OAC from September 2010 to March 2015 in Ontario, Canada. The primary outcome was a composite of time to first hospitalization or emergency department visit for a hemorrhagic or thromboembolic event, or mortality within 30 days of hospital discharge. Cox proportional hazards regression was used to build the model. RESULTS: We included 120,721 patients of which 5423 experienced the outcome. Most patients were aged ≥75 years (59.5%) and were female (55.6%). Sixty percent of the cohort had a follow-up visit with a healthcare provider within 7 days of discharge. Patients discharged on a direct acting OAC versus warfarin (apixaban: Hazard Ratio [HR] 0.82, 95% confidence interval [CI] 0.71-0.94; dabigatran: HR 0.73, 95% CI 0.63-0.84; rivaroxaban: HR 0.79, 95% CI 0.71-0.88), were prevalent users of the dispensed OAC versus incident users (HR 0.82, 95% CI 0.69-0.96), had a joint replacement in the past 35 days (HR 0.40, 95% CI 0.33-0.50) or major surgery during index hospital stay (HR 0.69, 95% CI 0.60-0.80) had a lower risk for the outcome. The Cox model was stable with acceptable discrimination but poor goodness-of-fit. CONCLUSIONS: A model for OAC-related harm in the early post-discharge period was developed. External validation studies are required to understand the model's poor calibration.