Arthroplasty studies with greater than 1000 participants: analysis of follow-up methods

Abstract

Background The use of patient-reported outcome measures (PROMs) has become a mainstay of orthopedic joint arthroplasty research. Large studies with >1000 participants are vital to orthopedic research, as they allow for comprehensive multivariable analysis. Achieving high follow-up rates minimizes potential response bias. Maintaining adequate follow-up rates becomes more challenging as sample size increases. We aimed to systematically review the present literature to determine the follow-up rates of large cohorts/registries of total joint arthroplasty patients and to identify factors associated with successful collection of PROMs. Methods A comprehensive literature search of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Inclusion criteria were: ≥1000 participants, ≥6 months of postoperative follow-up, and use of validated PROMs postoperatively. Results Of 720 abstracts screened, 21 studies met inclusion criteria. Only 2 studies reported achieving a PROM follow-up rate ≥80%, but neither collected PROMs preoperatively. The median rate of follow-up was 70%, and the median number of patients was 2970. Only 38% (8 of 21) of studies collected baseline PROMs prior to surgery. Conclusions Very few studies in the present literature have collected validated PROMs on ≥1000 patients with ≥80% follow-up; these parameters are conducive to comprehensive multivariable analysis, while maintaining study validity and avoiding follow-up bias. Federal funding and a central coordinating site may be helpful in achieving follow-up in studies of this magnitude. Level of Evidence Level III, systematic review of studies with Level of Evidence I-III.

Standardizing Muscle Strength Measurement in Femoroacetabular Impingement Syndrome: Response

“…4,5 As previously acknowledged, it is difficult to achieve a follow-up of more than 80% of study participants in large orthopaedic surgery cohorts and registries. 6 The authors of the current study agree that it is never possible to eliminate all bias with respect to loss to follow-up and that it is impossible to achieve 100% follow-up in longitudinal studies; however, we respectfully disagree with the statement that 20% dropout rate is considered significant.…”

What is the minimum response rate on patient-reported outcome measures needed to adequately evaluate total hip arthroplasties?

“…Although practice shows difficulties in achieving high response rates, response rates of > 80% are achievable in orthopaedic patients [7,[26][27][28][29]. It is even shown to be feasible to achieve > 90% response rate in busy orthopaedic hospitals, urban and rural, using a digital collection system without any major disruption to the clinical work flow [29].…”

“…However, achieving high response rates depends more on the method in PROs collection chosen. Making PROs collection a part of routine care, using a PROMs digital administration station in the hospital and collecting via multiple sources (for example mail and email) are the keys to high response rates [7,[27][28][29]. In arthroplasty patients, a critical factor is making sure PROs are collected preoperatively as it results in a 3 times more chance of collecting the PROs 3 months after surgery and even a 15 times more chance at 12 months [30].…”

“…In arthroplasty patients, a critical factor is making sure PROs are collected preoperatively as it results in a 3 times more chance of collecting the PROs 3 months after surgery and even a 15 times more chance at 12 months [ 30 ]. Maintaining high postoperative response rates is crucial as non-responding patients can introduce bias which results in incomparable PROs if the non-responders are different than the responders [ 28 , 31 ] and missing data are not at random [ 32 ]. Therefore, it is advised that hospitals should take the winners in effort and costs in this method to at least reach the lower limit of 60% response rate.…”

Are responders to patient health surveys representative of those invited to participate? An analysis of the Patient-Reported Outcome Measures Pilot from the Australian Orthopaedic Association National Joint Replacement Registry

“…However, unlike registries that commonly have near-complete coverage of all procedures, PROMs collection is rarely complete, being limited by resources and patient responsiveness. Registry-based PROMs collection in joint replacement surgery has coverage rates rarely higher than 80%, and often less than 50% [ 1 , 2 ]. A 60% threshold has been suggested for completeness in PROMs collection [ 3 ], but with any threshold, it is important to know the representativeness of the sample so that conclusions based on the sample can be applied to the population.…”