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Abstract Background Clinical trials routinely have patients lost to follow up. We propose a methodology to understand their possible effect on the results of statistical tests by altering the concept of the fragility index to treat the outcomes of observed patients as fixed but incorporate the potential outcomes of patients lost to follow up as random and subject to modification. Methods We reanalyse the statistical results of three clinical trials on coronary artery bypass grafting (CABG) to study the possible effect of patients lost to follow up on the treatment effect statistical significance. To do so, we introduce the LTFU-aware fragility indices as a measure of the robustness of a clinical trial’s statistical results with respect to patients lost to follow up. Results The analyses illustrate that clinical trials can either be completely robust to the outcomes of patients lost to follow up, extremely sensitive to the outcomes of patients lost to follow up, or in an intermediate state. When a clinical trial is in an intermediate state, the LTFU-aware fragility indices provide an interpretable measure to quantify the degree of fragility or robustness. Conclusions The LTFU-aware fragility indices allow researchers to rigorously explore the outcomes of patients who are lost to follow up, when their data is the appropriate kind. The LTFU-aware fragility indices are sensitivity measures in a way that the original fragility index is not.

Abstract Background The objective of this study was to assess the overall quality of study-level meta-analyses in high-ranking journals using commonly employed guidelines and standards for systematic reviews and meta-analyses. Methods 100 randomly selected study-level meta-analyses published in ten highest-ranking clinical journals in 2016–2017 were evaluated by medical librarians against 4 assessments using a scale of 0–100: the Peer Review of Electronic Search Strategies (PRESS), Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), Institute of Medicine’s (IOM) Standards for Systematic Reviews, and quality items from the Cochrane Handbook. Multiple regression was performed to assess meta-analyses characteristics’ associated with quality scores. Results The overall median (interquartile range) scores were: PRESS 62.5(45.8–75.0), PRISMA 92.6(88.9–96.3), IOM 81.3(76.6–85.9), and Cochrane 66.7(50.0–83.3). Involvement of librarians was associated with higher PRESS and IOM scores on multiple regression. Compliance with journal guidelines was associated with higher PRISMA and IOM scores. Conclusion This study raises concerns regarding the reporting and methodological quality of published MAs in high impact journals Early involvement of information specialists, stipulation of detailed author guidelines, and strict adherence to them may improve quality of published meta-analyses.

Abstract Background Single centre studies support No Touch (NT) saphenous vein graft (SVG) harvesting technique. The primary objective of the SUPERIOR SVG study was to determine whether NT versus conventional (CON) SVG harvesting was associated with improved SVG patency 1 year after coronary artery bypass grafting surgery (CABG). Methods Adults undergoing isolated CABG with at least 1 SVG were eligible. CT angiography was performed 1-year post CABG. Leg adverse events were assessed with a questionnaire. A systematic review was performed for published NT graft patency studies and results aggregated including the SUPERIOR study results. Results Two hundred and-fifty patients were randomized across 12-centres (NT 127 versus CON 123 patients). The primary outcome (study SVG occlusion or cardiovascular (CV) death) was not significantly different in NT versus CON (NT: 7/127 (5.5%), CON 13/123 (10.6%), p = 0.15). Similarly, the proportion of study SVGs with significant stenosis or total occlusion was not significantly different between groups (NT: 8/102 (7.8%), CON: 16/107 (15.0%), p = 0.11). Vein harvest site infection was more common in the NT patients 1 month postoperatively (23.3% vs 9.5%, p

Abstract Background Studies have shown that patients who undergo trans-catheter aortic valve replacement (TAVR) have high rates of hospital readmission. Our objectives were to identify the causes of readmission after TAVR, determine whether transitional care factors were associated with a reduction in readmission and to identify other predictors that could be used to target quality improvement efforts. Methods We conducted a chart abstraction study that included all patients who underwent TAVR in Ontario, Canada between 2007 and 2013 and survived to hospital discharge. These data were linked to provincial administrative databases. The association between transitional care factors (home care, rehabilitation, family physician and cardiologist follow-up) and 1-year hospital readmission was examined using a time-to-event analysis. Cause-specific hazards models were used to account for the competing risk of death. Results There were 937 patients in the cohort and the rate of readmission at 1-year was 49%. The most common causes of readmission were heart failure and bleeding. Rehabilitation (HR 1.34, 95% CI 1.11–1.62; p = 0.002) and cardiologist follow-up (HR 1.41, 95% CI 1.14–1.75; p = 0.002) were both associated with higher readmission rates. While, home care (HR 1.18, 95% CI 0.96–1.44; p = 0.12) and family physician follow-up (HR 1.04, 95% CI 0.85–1.28; p = 0.71) were not associated with readmission. Conclusion Readmission post TAVR is common; however, we did not identify any transitional care factors associated with reductions in hospital readmission. This suggests ongoing research is required to identify targets for improvement in post-procedural care.

Abstract Background Most patients undergoing Transcatheter aortic valve implantation (TAVR) are elderly with significant co-morbidities and there is limited information available regarding factors that influence length of stay (LOS) post-procedure. The aim of this study was to identify the patient, and procedural factors that affect post-TAVR LOS using a contemporary multinational registry. Methods We conducted a retrospective cohort study, with patients recruited from three high volume tertiary institutions. The primary outcome was the LOS post-TAVR procedure. We examined patient and procedural factors in a cause-specific Cox multivariable regression model to elucidate their effect on LOS, accounting for the competing risk of post-procedural death. Hazard ratios (HR) greater than 1 indicate a shorter LOS, while HRs less than 1 indicate a longer LOS. Results The cohort consisted of 809 patients. Patient factors associated with longer LOS were older age, prior atrial fibrillation, and greater patient urgency. Patient factors associated with shorter LOS were lower NYHA class, higher ejection fraction and higher mean aortic valve gradients. Procedural characteristics associated with shorter LOS were conscious sedation (HR = 1.19, 95% CI 1.06–1.35, p = 0.004). Transapical access was associated with prolonged LOS (HR = 0.49, 95% CI 0.41–0.58, p