Loss to Follow-up in Orthopaedic Clinical Trials: a Systematic Review

Overview

Journal Int Orthop

Specialty Orthopedics

Date 2016 May 5

PMID 27142421

Citations 22

Authors

Jeremy S Somerson

Katherine C Bartush

Jeffrey B Shroff

Mohit Bhandari

Boris A Zelle

Affiliations

Soon will be listed here.

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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