Abstract

High-quality research in hand surgery is increasingly important. A vital component is national and international multicenter collaborative research because of better generalizability and larger sample sizes. However, sharing patient data between centers can be hampered by regulations and privacy issues or reluctance to share patient data. Therefore, in this paper, we illustrate an approach for collaborative clinical research without sharing patient data while obtaining similar outcomes. To illustrate that this collaborative clinical research approach without sharing patient data leads to similar outcomes compared to aggregating all individual patient data in one database, we simulate an approach of performing meta-analyses on summary statistics of individual-center data. In the simulation, we compare the results to conventional analyses in an existing multicenter database of patients treated for Dupuytren's disease at three different centers with either limited fasciectomy (LF) or needle aponeurotomy (PNF). We share example data and all analysis code in a public GitHub Library. We found similar results for the meta-analysis approach without sharing individual patient data as in the conventional approach for 1) the proportion of patients treated for recurrences, 2) the Total MHQ score after both treatments, 3) the comparison of Total MHQ score after both treatments, and 4) the comparison of both treatments when correcting for confounders with regression analysis. CLINICAL SIGNIFICANCE: We illustrate how collaborative studies can be performed without sharing individual patient data while obtaining similar results as with conventional analyses. This approach can help speed up collaborative research without losing precision in outcome analysis.

Highlights

  • Collaborative observational studies and collaborative randomized controlled trials are increasingly important and commonly-performed.[1]

  • 112 of the trials were single-center and from the remaining multicenter trials, only two recruited patients internationally. This is problematic since Bellemo et al showed that many findings from single-center trials are contradicted when reproduced in a multicenter design.[5]. This is confirmed in a meta-analysis, depicting that the treatment effect reported in single-center trials is significantly different from multicenter trials

  • We present this for four frequently-performed analyses in collaborative research: 1) calculating incidence rates, 2) calculating mean outcomes of treatments, 3) differences in mean outcomes between treatments, and 4) treatment effects, corrected for confounders with regression analysis

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Summary

Introduction

Collaborative observational studies and collaborative randomized controlled trials are increasingly important and commonly-performed.[1]. A systematic review on the quality of surgical randomized controlled trials (RCT) in hand surgery showed that between 1981 and 2015, only 125 RCT’s were conducted and concluded that the overall quality of these trials was low.[4]. 112 of the trials were single-center and from the remaining multicenter trials, only two recruited patients internationally. This is problematic since Bellemo et al showed that many findings from single-center trials are contradicted when reproduced in a multicenter design.[5]. This is confirmed in a meta-analysis, depicting that the treatment effect reported in single-center trials is significantly different from multicenter trials. The results of single-center trials should be cautiously used for decision making because of the risk bias.[6]

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