Peer Review and the Randomized Controlled Trial: Helping Sports Medicine Realize the Level I Hype
This 40-minute presentation is a recorded capture from Reviewer Workshop on July 14, 2022 in Colorado Springs, CO at the AOSSM Annual Meeting.
David C. Landy, MD, PhD
Learning objectives:
1. Assess balancing after randomization in clinical trials and how to evaluate the impact of imbalance.
2. Describe the importance of primary hypothesis testing in clinical trials and what is being done to protect this testing.
3. Explain the importance of distinguishing within and between group comparisons in clinical trials and avoiding spin.
ACCREDITATION STATEMENT The American Orthopaedic Society for Sports Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
AMA CREDIT DESIGNATION STATEMENT The American Orthopaedic Society for Sports Medicine designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CLAIMING CREDIT In order to obtain AMA PRA Category 1 Credits™ participants must complete the activity and evaluation. Please note that this is an online-only activity. Participants must complete the activity and evaluation online. No hard copy submissions will be accepted.
DISCLOSURE STATEMENT In accordance with the guidelines of the ACCME, it is the policy of the AOSSM that faculty and planners disclose to the learners all financial relationships during the past twelve months with any commercial interest (any entity producing, marketing, re-selling, or distributing health care goods and services consumed by, or used on, patients). In accordance with AOSSM policy, faculty participation is predicated upon timely submission and review of AOSSM disclosures. Non-compliance results in faculty being stricken from the program.
Additional resources for further study:
1. Altman DG. Comparability of randomized groups. The Statistician. 1985;34:125-36.
2. Pijls BG. The table I fallacy: P values in baseline tables of randomized controlled trials. J Bone Joint Surg Am. 2022;Epub ahead of print.
3. Cowles M, Davis C. On the origins of the .05 level of statistical significance. Am Psychol. 1982;37:553-558.
4. Landy DC, Utset-Ward TJ, Lee MJ. What Are the implications of alternative alpha thresholds for hypothesis testing in orthopaedics? Clin Orthop Relat Res. 2019;477:2358-2363.
5. Chahal J, Tomescu SS, Ravi B, Bach BR Jr, Ogilvie-Harris D, Mohamed NN, Gandhi R. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov. Am J Sports Med. 2012;40:1970-7.
6. Reider B. Keeping track of trials. Am J Sports Med. 2012;40:1967-9.
7. Arthur W, Zaaza Z, Checketts JX, Johnson AL, Middlemist K, Basener C, Jellison S, Wayant C, Vassar M. Analyzing spin in abstracts of orthopaedic randomized controlled trials with statistically insignificant primary endpoints. Arthroscopy. 2020:1443-1450.e1.