Derek Jason Roberts

Background: We sought to determine the effectiveness of discrete strategies and implementation bundles for improving clinical practice guideline (CPG) strongly recommended medication prescription to adults with atherosclerotic occlusive disease. Methods: We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature (inception to December 9, 2025) for randomized controlled trials evaluating discrete strategies or implementation bundles for improving CPG strongly recommended medication prescription to adults with atherosclerotic occlusive disease. Two investigators screened titles/abstracts and full texts, extracted data, assessed risk of bias, and classified discrete strategies and implementation bundles. Random‐effects models were used for meta‐analysis. Grading of Recommendations Assessment, Development and Evaluation was used to assess certainty. Results: We included 31 randomized controlled trials studying 29 unique discrete strategies and implementation bundles. The implementation bundle with the largest effect size for improving CPG strongly recommended medication prescription combined case management, team changes, continuous quality improvement, audit/feedback, and clinician and patient education (relative risk, 2.62 [95% CI, 2.08–3.29]; moderate certainty). Meta‐regression analyses suggested that discrete strategies and implementation bundles using patient education were more effective at improving statin ( P =0.037) and all CPG strongly recommended medication ( P =0.006) prescription. Combining case management, team changes, facilitated relay of information, and audit/feedback reduced all‐cause death and new vascular event risk. Team changes improved prescription of all CPG strongly recommended medications (relative risk, 1.23 [95% CI, 1.11–1.36]; moderate certainty) and reduced major adverse cardiac event risk. Conclusions: Combining case management, team changes, continuous quality improvement, audit/feedback, and clinician and patient education had the largest effect size for improving CPG strongly recommended medication prescription and improved patient outcomes. Team changes improved CPG strongly recommended medication prescription and reduced major adverse cardiac event risk.

Background: Reproducible study findings are those that are shown to be identical or nearly identical when an original study is repeated using similar methods. Findings from many randomized controlled trials (RCTs) in cardiovascular surgery have not been reproduced or are small, statistically fragile, and potentially influenced by funding source. They also demonstrate variable end point selection and protocol adherence, all of which may influence reproducibility of their reported results. Objective: This study aims to assess the reproducibility of RCTs conducted in the most commonly studied disease states in cardiovascular surgery that compared at least one open surgical procedure to an alternative open, interventional catheter-based, or sham procedure or medical therapy. Methods: We will conduct a meta-epidemiological study of the reproducibility of RCTs using umbrella review methodology. We designed the study protocol using the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) statement and published recommendations on conducting umbrella reviews. We will search MEDLINE, Embase, and the CENTRAL from their inception for systematic reviews published in the English language that included data from phase 3 RCTs or those with a clinically important primary outcome and compared an open cardiovascular surgery (performed in the most commonly studied disease states across these specialties) to either an alternative open, catheter-based, or sham procedure or medical therapy. Two investigators will independently review the individual RCTs from these systematic reviews and extract data and assess risk of bias (using the Cochrane Risk of Bias-2 tool), the fragility or reverse fragility indices (which provide a measurement of the statistical robustness of the trials), and the authors’ interpretation of the results (also referred to as spin). RCTs will be classified as the original study if it was the first chronological study (based on participant enrollment date) to evaluate the compared interventions and as reproduction attempts if they reevaluate the compared interventions in a different set of participants. The interpretation of a study’s results will be based on the findings of its primary end point and be used to assess reproducibility. We will also create multivariable regression models to determine whether the adjusted odds of reproducibility are independently predicted by 12 different variables. Results: We registered the study protocol but have not yet conducted the search. We aim to complete the study by the end of 2026 and submit for peer review by the summer of 2027. Conclusions: This study protocol may be used as a framework for future reproducibility research. The results will help guide which cardiovascular surgery practices warrant careful interpretation and which are in need of reproduction studies. They will also identify characteristics of an original RCT in this field that predicts future study reproducibility before reproducibility studies are published.

Background: While current evidence suggests that the clinical outcomes of ST-elevation myocardial infarction (STEMI) are worse among patients with cancer, it is unknown what role the quality of care received during admission plays. We aimed to evaluate the association between care quality and patient survival after discharge. Methods and results: A nationally-linked cohort of STEMI patients (January 2005–March 2019) were obtained from the UK Myocardial Infarction National Audit Project and UK national Hospital Episode Statistics Admitted Patient Care registries. We used the composite opportunity-based quality indicator to measure overall care quality. Survival outcomes were assessed using Cox proportional hazard models and Kaplan–Meier and cumulative survival curves. In total, 6787 STEMI indexed admissions with cancer were identified. Of those, 4340 (63.9%) patients received optimum care, 1320 (19.5%) intermediate care, and 1127(25.2%) low care quality. Patients with low care quality were older [optimum quality median (IQR) = 72.8 (65.1, 79.6), intermediate quality 75.5 (67.9, 82.1), low quality 78.2 (69.2, 84.7)] and more frequently women (optimum quality 21.6%, intermediate quality 27.3%, low quality 35.5%). Compared to patients with optimum care, patients with low care quality had a higher risk of death at 30 days [hazard ratio (HR) 7.0, 95% confidence interval (CI) 5.7–8.7], 1 year (HR 4.0, 95% CI 3.6–4.4), and 5 years (HR 2.6, 95% CI 2.4–2.8). Relative survival analysis revealed that the number of patients who would survive nationally if they received optimal care is 84 (95% CI 67–102), 508 (95% CI 468–548), and 1096 (95% CI 1034–1158) at 30 days, 1 year, and 5 years, respectively. The association between care quality and survival was more profound in the Northwest and Northeast regions. Conclusion: Quality of care is closely associated with short- and long-term survival among STEMI patients with cancer. Improving quality of care may save hundreds to thousands of lives in the shorter and longer term.

Background: In patients with atherosclerotic occlusive diseases, systematic reviews and meta-analyses of randomized controlled trials (RCTs) report that antiplatelets, statins, and antihypertensives reduce the risk of major adverse cardiac events, need for revascularization procedures, mortality, and health care resource use. However, evidence suggests that these patients are not prescribed these medications adequately or do not adhere to them once prescribed. Objective: We aim to systematically review and meta-analyze RCTs examining the effectiveness of implementation or adherence-supporting strategies for improving health care provider prescription of, or patient adherence to, guideline-recommended cardiovascular medications in patients with atherosclerotic occlusive disease. Methods: We designed and reported the protocol according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis-Protocols) statement. We will search MEDLINE, Embase, The Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL from their inception. RCTs examining implementation or adherence-supporting strategies for improving prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with cerebrovascular disease, coronary artery disease, peripheral artery disease, or polyvascular disease (>1 of these diseases) will be included. Two investigators will independently review identified titles/abstracts and full-text studies, extract data, assess the risk of bias (using the Cochrane tool), and classify implementation or adherence-supporting strategies using the refined Cochrane Effective Practice and Organization of Care (EPOC) taxonomy (for strategies aimed at improving prescription) and Behavior Change Wheel (BCW; for adherence-supporting strategies). We will narratively synthesize data describing which implementation or adherence-supporting strategies have been evaluated across RCTs, and their reported effectiveness at improving prescription of, or adherence to, guideline-recommended cardiovascular medications (primary outcomes) and patient-important outcomes and health care resource use (secondary outcomes) within refined EPOC taxonomy levels and BCW interventions and policies. Where limited clinical heterogeneity exists between RCTs, estimates describing the effectiveness of implementation or adherence-supporting strategies within different refined EPOC taxonomy levels and BCW interventions and policies will be pooled using random-effects models. Stratified meta-analyses and meta-regressions will assess if strategy effectiveness varies by recruited patient populations, prescriber types, clinical practice settings, and study design characteristics. GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) will be used to communicate evidence certainty. Results: The search was completed on June 6, 2023. Database searches and the PubMed “related articles” feature identified 4319 unique citations for title/abstract screening. We are currently screening titles/abstracts. Conclusions: These studies will identify which implementation and adherence-supporting strategies are being used (and in which combinations) across RCTs for improving the prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with atherosclerotic occlusive diseases. They will also determine the effectiveness of currently trialed implementation and adherence-supporting strategies, and whether effectiveness varies by patient, prescriber, or clinical practice setting traits. Trial Registration: PROSPERO CRD42023461317; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461317; PROSPERO CRD42023461299; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461299

Objectives: Although surgical site infection (SSI) is a commonly used quality metric after lower-limb revascularization surgery, outcomes associated with development of this complication are poorly characterized. We conducted a systematic review and meta-analysis of studies reporting associations between development of an SSI after these procedures and clinical outcomes and healthcare resource use. Methods: We searched MEDLINE, Embase, CENTRAL, and Evidence-Based Medicine Reviews (inception to April 4th, 2023) for studies examining adjusted associations between development of an SSI after lower-limb revascularization surgery and clinical outcomes and healthcare resource use. Two investigators independently screened abstracts and full-text citations, extracted data, and assessed risk of bias. Data were pooled using random-effects models. Heterogeneity was assessed using I ² statistics. GRADE was used to assess estimate certainty. Results: Among 6671 citations identified, we included 11 studies (n = 61,628 total patients) that reported adjusted-associations between development of an SSI and 13 different outcomes. Developing an SSI was associated with an increased adjusted-risk of hospital readmission (pooled adjusted-risk ratio (aRR) = 3.55; 95% CI (confidence interval) = 1.40–8.97; n = 4 studies; n = 13,532 patients; I ² = 99.0%; moderate certainty), bypass graft thrombosis within 30-days (pooled aRR = 2.09; 95% CI = 1.41–3.09; n = 2 studies; n = 23,240 patients; I ² = 51.1%; low certainty), reoperation (pooled aRR = 2.69; 95% CI = 2.67–2.72; n = 2 studies; n = 23,240 patients; I ² = 0.0%; moderate certainty), bleeding requiring a transfusion or secondary procedure (aRR = 1.40; 95% CI = 1.26–1.55; n = 1 study; n = 10,910 patients; low certainty), myocardial infarction or stroke (aRR = 1.21; 95% CI = 1.02–1.43; n = 1 study; n = 10,910 patients; low certainty), and major (i.e., above-ankle) amputation (pooled aRR = 1.93; 95% CI = 1.26–2.95; n = 4 studies; n = 32,859 patients; I ² = 83.0; low certainty). Development of an SSI >30-days after the index operation (aRR = 2.20; 95% CI = 1.16–4.17; n = 3 studies; n = 21,949 patients; low certainty) and prosthetic graft infection (aRR = 6.72; 95% CI = 3.21–12.70; n = 1 study; n = 272 patients; low certainty) were both associated with an increased adjusted-risk of major amputation. Prosthetic graft infection was also associated with an increased adjusted-risk of mortality >30-days after the index procedure (aRR = 6.40; 95% CI = 3.32–12.36; n = 1 study; n = 272 patients; low certainty). Conclusions: This systematic review and meta-analysis suggests that development of an SSI after lower-limb revascularization surgery significantly increases patient morbidity and healthcare resource use. SSI is therefore a valuable quality metric after these surgeries. However, current estimates are based on heterogenous, low-to-moderate certainty evidence and should be confirmed by large, multicenter, cohort studies.

BACKGROUND In patients with atherosclerotic occlusive diseases, systematic reviews and meta-analyses of randomized controlled trials (RCTs) report that antiplatelets, statins, and antihypertensives reduce the risk of major adverse cardiac events, need for revascularization procedures, mortality, and health care resource use. However, evidence suggests that these patients are not prescribed these medications adequately or do not adhere to them once prescribed. OBJECTIVE We aim to systematically review and meta-analyze RCTs examining the effectiveness of implementation or adherence-supporting strategies for improving health care provider prescription of, or patient adherence to, guideline-recommended cardiovascular medications in patients with atherosclerotic occlusive disease. METHODS We designed and reported the protocol according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis-Protocols) statement. We will search MEDLINE, Embase, The Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL from their inception. RCTs examining implementation or adherence-supporting strategies for improving prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with cerebrovascular disease, coronary artery disease, peripheral artery disease, or polyvascular disease (>1 of these diseases) will be included. Two investigators will independently review identified titles/abstracts and full-text studies, extract data, assess the risk of bias (using the Cochrane tool), and classify implementation or adherence-supporting strategies using the refined Cochrane Effective Practice and Organization of Care (EPOC) taxonomy (for strategies aimed at improving prescription) and Behavior Change Wheel (BCW; for adherence-supporting strategies). We will narratively synthesize data describing which implementation or adherence-supporting strategies have been evaluated across RCTs, and their reported effectiveness at improving prescription of, or adherence to, guideline-recommended cardiovascular medications (primary outcomes) and patient-important outcomes and health care resource use (secondary outcomes) within refined EPOC taxonomy levels and BCW interventions and policies. Where limited clinical heterogeneity exists between RCTs, estimates describing the effectiveness of implementation or adherence-supporting strategies within different refined EPOC taxonomy levels and BCW interventions and policies will be pooled using random-effects models. Stratified meta-analyses and meta-regressions will assess if strategy effectiveness varies by recruited patient populations, prescriber types, clinical practice settings, and study design characteristics. GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) will be used to communicate evidence certainty. RESULTS The search was completed on June 6, 2023. Database searches and the PubMed “related articles” feature identified 4319 unique citations for title/abstract screening. We are currently screening titles/abstracts. CONCLUSIONS These studies will identify which implementation and adherence-supporting strategies are being used (and in which combinations) across RCTs for improving the prescription of, or adherence to, guideline-recommended cardiovascular medications in adults with atherosclerotic occlusive diseases. They will also determine the effectiveness of currently trialed implementation and adherence-supporting strategies, and whether effectiveness varies by patient, prescriber, or clinical practice setting traits. CLINICALTRIAL PROSPERO CRD42023461317; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461317; PROSPERO CRD42023461299; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=461299

Introduction International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes. Methods and analysis We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty. Ethics and dissemination Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications. PROSPERO registration number CRD42022362801.