Randomised comparative effectiveness trial of Pulmonary Embolism Prevention after hiP and kneE Replacement (PEPPER): the PEPPER trial protocol.

INTRODUCTION: More than 1 million elective total hip and knee replacements are performed annually in the USA with 2% risk of clinical pulmonary embolism (PE), 0.1%-0.5% fatal PE, and over 1000 deaths. Antithrombotic prophylaxis is standard of care but evidence is limited and conflicting. We will compare effectiveness of three commonly used chemoprophylaxis agents to prevent all-cause mortality (ACM) and clinical venous thromboembolism (VTE) while avoiding bleeding complications. METHODS AND ANALYSIS: Pulmonary Embolism Prevention after HiP and KneE Replacement is a large randomised pragmatic comparative effectiveness trial with non-inferiority design and target enrolment of 20 000 patients comparing aspirin (81 mg two times a day), low-intensity warfarin (INR (International Normalized Ratio) target 1.7-2.2) and rivaroxaban (10 mg/day). The primary effectiveness outcome is aggregate of VTE and ACM, primary safety outcome is clinical bleeding complications, and patient-reported outcomes are determined at 1, 3 and 6 months. Primary data analysis is per protocol, as preferred for non-inferiority trials, with secondary analyses adherent to intention-to-treat principles. All non-fatal outcomes are captured from patient and clinical reports with independent blinded adjudication. Study design and oversight are by a multidisciplinary stakeholder team including a 10-patient advisory board. ETHICS AND DISSEMINATION: The Institutional Review Board of the Medical University of South Carolina provides central regulatory oversight. Patients aged 21 or older undergoing primary or revision hip or knee replacement are block randomised by site and procedure; those on chronic anticoagulation are excluded. Recruitment commenced at 30 North American centres in December 2016. Enrolment currently exceeds 13 500 patients, representing 33% of those eligible at participating sites, and is projected to conclude in July 2024; COVID-19 may force an extension. Results will inform antithrombotic choice by patients and other stakeholders for various risk cohorts, and will be disseminated through academic publications, meeting presentations and communications to advocacy groups and patient participants. TRIAL REGISTRATION: NCT02810704.

Governance of Academic Health Centers and Systems: A Conceptual Framework for Analysis.

Health care has evolved from a cottage industry to a very complex one constituting nearly one-fifth of the U.S. economy. Large aggregated health care systems have evolved primarily for the purpose of optimizing financial performance by capturing greater market share and taking advantage of economies of scale in care delivery. With the noble intent of providing a broader base of support for the academic mission, academic health centers (AHCs) have followed suit by partnering with community hospitals and organizations with variable prior experience in the education and research arenas. Such a strategy makes good business sense, but it creates challenges for the academic mission. Singular emphasis on physicians' clinical productivity enhances financial margin but often reduces faculty time and effort dedicated to the academic mission. While individual AHC governance is varied, the leadership structure of large aggregated health systems built around an AHC is even more complex and heterogeneous. Yet, to ensure the prosperity of the academic mission, the governance structure of such health care systems is of critical importance. Preservation of academic oversight of the faculty practice plan, a unifying central focal point of organizational decision making, and genuine physician leadership are three overarching governance characteristics that strengthen the prosperity of the academic mission within large aggregated health systems. Despite the heterogeneous nature of academic health system governance, these critical components of organizational leadership structure facilitate support of a robust academic mission. Understanding these principles and objectives of governance is essential for critical faculty engagement in AHC leadership activities.

The Mark Coventry Award: Prevention of readmission for venous thromboembolism after total knee arthroplasty.

Venous thromboembolism is the most common reason for readmission after total knee arthroplasty. Prospective contrast venography was conducted from 1984 to 2003 in 1321 patients undergoing total knee arthroplasty. Patients with deep venous thrombosis or pulmonary embolism were treated with warfarin; those with negative venograms received no further anticoagulation. From 1984 to 1992, patients not completing venography were discharged without warfarin; since 1993 patients without venography received warfarin for 6 weeks. Readmission for deep venous thrombosis, pulmonary embolism, or bleeding was tracked for 6 months. Venography was completed in 810 patients; 343 (42.3%) had deep venous thrombosis. Readmission for venous thromboembolism occurred in 0.6% of patients after total knee compared with 1.62% after total hip arthroplasty. Following total knee arthroplasty, patients discharged on warfarin (target INR 2.0) had a 0.21% readmission rate compared with 1.05% for patients with negative venograms discharged without further anticoagulation. One patient suffered a fatal pulmonary embolism after negative venography and no outpatient prophylaxis. Secondary prophylaxis with extended warfarin therapy reduced venous thromboembolism-related readmission. Surveillance venograms were a poor predictor of ultimate thromboembolism risk and need for extended anticoagulation therapy. We therefore recommend extended warfarin prophylaxis for all patients after hospital discharge following total knee arthroplasty.

Resident selection: a key to the future of orthopaedics.

Recognizing the challenges presented in the process of resident selection, in 1981 the American Orthopaedic Association formed a Steering Committee on Resident Selection. This Committee was charged with studying the processes involved in the selection of orthopaedic residents and developing guidelines and making suggestions to program directors. The activities of the Committee focused on five areas: (1) the mechanics of resident selection; (2) the assessment of cognitive skills; (3) the assessment of motor ability; (4) the assessment of noncognitive factors (the affective domain); (5) the assessment of "dropouts." The Committee made the following recommendations to help program directors in the selection of residents: (1) use of a standardized application form; (2) full disclosure to applicants; (3) careful selection of candidates to be interviewed; (4) careful planning and implementation of the interview and visit; (5) broad faculty representation and discussion at time of selection; (6) due diligence when necessary. We still believe these criteria important in resident selection.

The John Charnley Award: prevention of readmission for venous thromboembolic disease after total hip arthroplasty.

UNLABELLED: Venous thromboembolic disease remains the most common reason for readmission after total hip arthroplasty. Prospective analysis of screening contrast venography was done from 1984 to 2003 in 1972 patients having elective total hip arthroplasty. Patients with deep venous thrombosis or pulmonary embolism received warfarin therapy; those with negative venograms received no further anticoagulation. From 1984 to 1992, patients not completing venography were discharged without warfarin; since 1993, patients without venography received warfarin for 6 weeks. Readmission for deep venous thrombosis, pulmonary embolism, or bleeding was tracked for 6 months. Venograms were completed in 1032 patients; 175 (16.9%) had deep venous thrombosis. Deep venous thrombosis was reduced by a clinical pathway that included continuous epidural anesthesia (14.2% versus 22.5%). The overall readmission rate for venous thromboembolic disease was 1.62%, including 14 pulmonary emboli (three fatal) and 18 femoral deep venous thrombosis. Readmission occurred in 0.27% (1 of 360) patients on continued warfarin, compared with 2.2% (19 of 880) with negative venograms discharged without further anticoagulation. Three patients (0.15%) suffered fatal pulmonary emboli; all had negative venograms and received no outpatient prophylaxis. Extended outpatient warfarin therapy provided effective protection against venous thromboembolic disease readmission. Surveillance venography was a poor predictor of need for continued prophylaxis; all patients should have extended anticoagulation after total hip arthroplasty. LEVEL OF EVIDENCE: Therapeutic study, Level I-1 (high-quality randomized trial with statistically significant difference or no statistically significant difference but narrow confidence intervals). See the Guidelines for Authors for a complete description of levels of evidence.