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Loss to follow-up in orthopaedic clinical trials: a systematic review

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Abstract

Purpose

The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs).

Methods

We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorded for each trial. Orthopaedic subspecialty, country of origin, number of enrolled patients, patient age, follow-up strategy, and funding type were also recorded.

Results

Loss to follow-up was not reported in 111 of these studies (20 %). Mean loss to follow-up was 10.4 %. No orthopaedic subspecialty demonstrated significantly different follow-up rates. Remote follow-up strategies did not reduce the loss to follow-up rate. Studies with a minimum follow-up length of three years showed significantly higher loss to follow-up rates compared with studies with shorter minimum follow-up time (14.8 % versus 9.8 %, p = 0.01). Studies performed in the United States had a significantly higher rate of loss to follow-up compared with non-United States studies (13.8 % versus 9.4 %; p = 0.01).

Conclusions

Loss to follow-up rates in published orthopaedic randomized controlled trials is overall relatively low. A substantial portion of publications does not adequately report follow-up data. Studies performed in the United States and studies with longer follow-up periods seem to be at higher risk for loss to follow-up.

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Authors and Affiliations

  1. Department of Orthopaedic Surgery, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr, MC-7774, San Antonio, TX, 78229, USA

    Jeremy S. Somerson, Katherine C. Bartush, Jeffrey B. Shroff & Boris A. Zelle

  2. McMaster University, Hamilton, ON, Canada

    Mohit Bhandari

Authors
  1. Jeremy S. Somerson
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  2. Katherine C. Bartush
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  3. Jeffrey B. Shroff
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  4. Mohit Bhandari
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  5. Boris A. Zelle
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Corresponding author

Correspondence to Boris A. Zelle.

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Funding

No funding was received for this study.

Conflicts of interest

Boris A. Zelle has received research grants from DePuySynthes and the Orthopaedic Trauma Association. Boris A. Zelle has received a speaker honorarium from AO Trauma North America. None of which is related to this study.

M. Bhandari reports funding received from Smith & Nephew, Stryker, Amgen, Zimmer, Moximed, Bioventus, Merck, Eli Lilly, Sanofi, Ferring, Conmed, DePuy and Bioventus. None of which is related to this article.

Jeremy S. Somerson, Katherine C. Bartush, and Jeffrey Shroff declare that they have no conflicts of interest.

Appendix

Appendix

Classification of studies to orthopaedic subspecialty categories was performed by consensus to the following groups: orthopaedic trauma, sports medicine, pediatric orthopaedic surgery, foot and ankle surgery, adult hip and knee reconstruction, shoulder and elbow surgery, hand surgery and orthopedic oncology. Studies evaluating fracture prevention and medical management were categorized as orthopaedic trauma. Pediatric foot conditions (e.g. clubfoot) were categorized as pediatric orthopaedics. Shoulder and elbow conditions were categorized to sports medicine if they related to instability, while reconstructive and arthroplasty procedures were categorized to shoulder and elbow surgery.

The following orthopaedic and general medical journals were included in the hand search: Acta Orthopaedica Scandinavica, American Journal of Sports Medicine, Arthroscopy, BMC Musculoskeletal Disorders, British Medical Journal, Canadian Medical Association Journal, Clinical Orthopaedics and Related Research, European Spine Journal, Foot Ankle International, Hip International, Indian Journal of Orthopaedics, Injury, International Orthopaedics, Journal of the American Medical Association, Journal of Arthroplasty, Journal of Bone and Joint Surgery, Journal of Bone and Joint Surgery British, Journal of Hand Surgery American, Journal of Neurosurgery: Spine, Journal of Orthopaedic Research, Journal of Orthopaedic Trauma, Journal of Pediatric Orthopaedics, Journal of Pediatric Orthopaedics B, Journal of Shoulder and Elbow Surgery, Journal of Trauma, The Knee, Lancet, New England Journal of Medicine, Osteoarthritis and Cartilage, Physical Therapy, Spine, and The Spine Journal.

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Somerson, J.S., Bartush, K.C., Shroff, J.B. et al. Loss to follow-up in orthopaedic clinical trials: a systematic review. International Orthopaedics (SICOT) 40, 2213–2219 (2016). https://doi.org/10.1007/s00264-016-3212-5

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  • DOI: https://doi.org/10.1007/s00264-016-3212-5

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