TY - JOUR
T1 - Risk Factors for Loss to Follow-up in 3202 Patients at 2 Years After Anterior Cruciate Ligament Reconstruction
T2 - Implications for Identifying Health Disparities in the MOON Prospective Cohort Study
AU - MOON Knee Group
AU - Ramkumar, Prem N.
AU - Tariq, Muhammad B.
AU - Amendola, Annunziato
AU - Andrish, Jack T.
AU - Brophy, Robert H.
AU - Dunn, Warren R.
AU - Flanigan, David C.
AU - Huston, Laura J.
AU - Jones, Morgan H.
AU - Kaeding, Christopher C.
AU - Kattan, Michael W.
AU - Marx, Robert G.
AU - Matava, Matthew J.
AU - McCarty, Eric C.
AU - Parker, Richard D.
AU - Vidal, Armando F.
AU - Wolcott, Michelle L.
AU - Wolf, Brian R.
AU - Wright, Rick W.
AU - Spindler, Kurt P.
N1 - Funding Information:
The authors thank the research coordinators, analysts, and support staff from the MOON sites, whose efforts related to regulatory tasks, data collection, participant follow-up, data quality control, analyses, and article preparation have made this consortium successful. The authors also thank all the patients who generously enrolled and participated in this study. Thank you to Brittany Stojsavljevic, Cleveland Clinic Foundation, for editorial management, and thank you to Kevin Chagin for statistical support.
Funding Information:
NCT00478894 (ClinicalTrials.gov identifier). follow-up ACL health disparities risk factors national institute of arthritis and musculoskeletal and skin diseases https://doi.org/10.13039/100000069 No. R01AR053684 Vanderbilt Sports Medicine Research Fund edited-state corrected-proof The authors thank the research coordinators, analysts, and support staff from the MOON sites, whose efforts related to regulatory tasks, data collection, participant follow-up, data quality control, analyses, and article preparation have made this consortium successful. The authors also thank all the patients who generously enrolled and participated in this study. Thank you to Brittany Stojsavljevic, Cleveland Clinic Foundation, for editorial management, and thank you to Kevin Chagin for statistical support. The contents of this work are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. One or more of the authors has declared the following potential conflict of interest or source of funding: Research reported in this publication was partially supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR053684; K.P.S.). The project was also supported by the Vanderbilt Sports Medicine Research Fund, which received unrestricted educational gifts from Smith & Nephew Endoscopy and DonJoy Orthopaedics. K.P.S. has received research funding from DJO, Smith & Nephew Endoscopy, and DonJoy Orthopaedics; consulting fees from the National Football League, Cytori, Flexion Therapeutics, Mitek, and Samumed; hospitality payments from DePuy and Biosense Webster; and royalty from nPhase. A.A. has received compensation for services other than consulting (including serving as a faculty or as a speaker at a venue other than a continuing education program), royalty or license, consulting fees, and hospitality payments from Arthrex; hospitality and education payments from Southtech Orthopedics; and royalties from Smith & Nephew and Arthrosurface. R.H.B. has received speaker fees, hospitality payments, compensation for services other than consulting (including serving as faculty or as a speaker at a venue other than a continuing education program), and education payments from Arthrex and Smith & Nephew; consultant fees from Magellan, Sanofi-Aventix, and Isto Technology; education payments from Elite Orthopedics; and a grant from Zimmer Holding. W.R.D. has received hospitality payments, compensation for serving as faculty or as a speaker for a nonaccredited and noncertified continuing education program, and consulting fees from Linvatec Corporation and hospitality payments from Wright Medical Technology. D.C.F. has received consulting fees, hospitality payments, and compensation for services other than consulting (including serving as faculty or as a speaker at a venue other than a continuing education program) from Smith & Nephew, Vericel, and Linvatec Corporation; consulting fees from Mitek, Conmed, DePuy Synthes, Ceterix Orthopaedics, Medical Device Business, Zimmer Biomet, and Aastrom Biosciences; education payments from CDC Medical; and compensation for services other than consulting (including serving as faculty or as a speaker at a venue other than a continuing education program) and hospitality payments from Sanofi US Services. L.J.H. received a grant from the National Institutes of Health / National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR060846; R.W.W., principal investigator). R.G.M. holds equity compensation for a seat on the scientific advisory board for Mend, received royalties from books published by Springer and Demos Health, and has received education payments from Arthrex. M.J.M. has received education payments from Arthrex, Breg, Smith & Nephew, Elite Orthopedics, and Apollo and consulting fees from Arthrex, Schwartz Biomedical, Heron Therapeutics, and Pacira. E.C.M. has received consulting fees from Zimmer Biomet, Biomet Orthopedics, and DePuy Orthopaedics; royalties from Zimmer Biomet and Biomet Sports Medicine; and fellowship grants from Smith & Nephew, Arthrex, Mitek, Ossur, and Breg. R.D.P. has received royalties from Zimmer Biomet and hospitality payments from Zimmer Biomet, Smith & Nephew, and the Musculoskeletal Transplant Foundation. A.F.V. has received consulting fees from Smith & Nephew and Stryker; speaker fees, education payments, and hospitality payments from Arthrex; and hospitality payments from Steris Corporation. B.R.W. has received consulting fees from ConMed; is a founder/owner of SportsMed Innovate; has received hospitality payments, consulting fees, and compensation for serving as faculty or as a speaker for a nonaccredited and noncertified continuing education program from Linvatec Corporation; and has received education payments from Wardlow Enterprises. R.W.W. has received a grant from the National Institutes of Health / National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR060846; principal investigator). C.C.K. has received hospitality payments from DJO and Arthrex, consulting fees from Zimmer Biomet, and a grant from DJO. M.L.W. has received education payments from Gemini Mountain Medical. M.H.J. serves on the Scientific Advisory Board for Samumed and has received salary support for research from the National Institutes of Health. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Background: Understanding the risk factors for loss to follow-up in prospective clinical studies may allow for a targeted approach to minimizing follow-up bias and improving the generalizability of conclusions in anterior cruciate ligament reconstruction (ACLR) and other sports-related interventions. Purpose: To identify independent risk factors associated with failure to complete (ie, loss to follow-up) patient-reported outcome measures (PROMs) at 2 years after ACLR within a well-funded prospective longitudinal cohort. Study Design: Cohort study (prognosis); Level of evidence, 2. Methods: All patients undergoing primary or revision ACLR enrolled in the prospectively collected database of the multicenter consortium between 2002 and 2008 were included. Multivariate regression analyses were conducted to determine which baseline risk factors were significantly associated with loss to follow-up at a minimum of 2 years after surgery. Predictors assessed for loss to follow-up were as follows: consortium site, sex, race, marital status, smoking status, phone number provided (home or cell), email address provided (primary or secondary), years of school completed, average hours worked per week, working status (full-time, part-time, homemaker, retired, student, or disabled), number of people living at home, and preoperative PROMs (Knee injury and Osteoarthritis Outcome Score, Marx Activity Rating Scale, and International Knee Documentation Committee). Results: A total of 3202 patients who underwent ACLR were enrolled. The 2-year PROM follow-up rate for this cohort was 88% (2821 of 3202). Multivariate analyses showed that patient sex (male: odds ratio [OR], 1.80) and race (black: OR, 3.64; other nonwhite: OR, 1.81) were independent predictors of 2-year loss to follow-up of PROMs. Education level was a nonconfounder. Conclusion: While education level did not predict loss to follow-up, patients who are male and nonwhite are at increased risk of loss to follow-up of PROM at 2 years. Capturing patient outcomes with minimal loss depends on equitable, not equal, opportunity to maximize generalizability and mitigate potential population-level health disparities. Registration: NCT00478894 (ClinicalTrials.gov identifier).
AB - Background: Understanding the risk factors for loss to follow-up in prospective clinical studies may allow for a targeted approach to minimizing follow-up bias and improving the generalizability of conclusions in anterior cruciate ligament reconstruction (ACLR) and other sports-related interventions. Purpose: To identify independent risk factors associated with failure to complete (ie, loss to follow-up) patient-reported outcome measures (PROMs) at 2 years after ACLR within a well-funded prospective longitudinal cohort. Study Design: Cohort study (prognosis); Level of evidence, 2. Methods: All patients undergoing primary or revision ACLR enrolled in the prospectively collected database of the multicenter consortium between 2002 and 2008 were included. Multivariate regression analyses were conducted to determine which baseline risk factors were significantly associated with loss to follow-up at a minimum of 2 years after surgery. Predictors assessed for loss to follow-up were as follows: consortium site, sex, race, marital status, smoking status, phone number provided (home or cell), email address provided (primary or secondary), years of school completed, average hours worked per week, working status (full-time, part-time, homemaker, retired, student, or disabled), number of people living at home, and preoperative PROMs (Knee injury and Osteoarthritis Outcome Score, Marx Activity Rating Scale, and International Knee Documentation Committee). Results: A total of 3202 patients who underwent ACLR were enrolled. The 2-year PROM follow-up rate for this cohort was 88% (2821 of 3202). Multivariate analyses showed that patient sex (male: odds ratio [OR], 1.80) and race (black: OR, 3.64; other nonwhite: OR, 1.81) were independent predictors of 2-year loss to follow-up of PROMs. Education level was a nonconfounder. Conclusion: While education level did not predict loss to follow-up, patients who are male and nonwhite are at increased risk of loss to follow-up of PROM at 2 years. Capturing patient outcomes with minimal loss depends on equitable, not equal, opportunity to maximize generalizability and mitigate potential population-level health disparities. Registration: NCT00478894 (ClinicalTrials.gov identifier).
KW - ACL
KW - follow-up
KW - health disparities
KW - risk factors
UR - http://www.scopus.com/inward/record.url?scp=85074039945&partnerID=8YFLogxK
U2 - 10.1177/0363546519876925
DO - 10.1177/0363546519876925
M3 - Article
C2 - 31589465
AN - SCOPUS:85074039945
SN - 0363-5465
VL - 47
SP - 3173
EP - 3180
JO - American Journal of Sports Medicine
JF - American Journal of Sports Medicine
IS - 13
ER -