Re-infection outcomes following one- and two-stage surgical revision of infected hip prosthesis in unselected patients: protocol for a systematic review and an individual participant data meta-analysis.

Setor K Kunutsor,Stephen Jones,Matthew Wilson,Ashley W Blom,Ben Burston,Jason Webb,Ian Stockley,Tim Board,John-Paul Whittaker,Adrian Taylor,Andrew Toms,Andrew D Beswick,Michael R Whitehouse

doi:10.1186/s13643-015-0044-0

Abstract

BackgroundSeveral aggregate published reviews have compared the effectiveness of one- and two-stage surgical revision to prevent re-infection following prosthetic hip infection and have reported inconsistent results. In addition, there were several features of these previous reviews which limited the validity of the findings. In the absence of a well-designed clinical trial, we propose the Global Infection Orthopaedic Management (INFORM) collaboration, a worldwide collaborative systematic review and meta-analysis of individual participant data (IPD) to address the existing uncertainties.MethodsCohort studies (prospective or retrospective) and randomised controlled trials conducted in unselected patients with infection treated exclusively by one- or two-stage revision and reporting re-infection outcomes within 2 years of revision will be retrieved by searching the following databases: MEDLINE, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials and the WHO International Clinical Trials Registry Platform. Reference lists of relevant studies will be manually scanned and there will be email contact with investigators of grey literature and conference abstracts. Investigators will be invited to join the Global INFORM collaboration and share their individual level data. The primary outcome of the analyses will be incidence of re-infection within 2 years of commencement of revision surgery. Primary analyses will be conducted comparing the one-stage to the two-stage surgical revision. IPD analyses will be based on Cox proportional hazard (PH) models estimated for each study separately. Study-specific log hazard ratios will be combined using random-effects meta-analysis with fixed-effects meta-analysis in subsidiary analyses. Hazard ratios for re-infection according to different individual level characteristics such as sex, age groups, body mass index and comorbidities will also be assessed.DiscussionThe analyses will enable a consistent approach to the definition of re-infection outcomes, more detailed analyses under a broader range of circumstances and exploration of potential sources of heterogeneity and produce much more valid and precise estimates of re-infection outcomes.Systematic review registrationPROSPERO 2015: CRD42015016664Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0044-0) contains supplementary material, which is available to authorized users.

Highlights

Several aggregate published reviews have compared the effectiveness of one- and two-stage surgical revision to prevent re-infection following prosthetic hip infection and have reported inconsistent results
There is an increasing interest in the use of the single-stage revision as it may be associated with significantly less morbidity and disability; may eliminate the requirement for prolonged stay in the hospital; and overall healthcare costs of this procedure may be less than the two-stage procedure
In the absence of such a clinical trial, we propose the Global Infection Orthopaedic Management (INFORM) collaboration, a worldwide collaborative systematic review and metaanalysis of individual participant data (IPD) to address the existing uncertainties in the previous reviews

Summary

Methods

We will conduct this systematic review and IPD metaanalysis using a predefined protocol and in accordance with methods recommended by the IPD Meta-analysis Methods Group of the Cochrane Collaboration [14] and other published guidelines [15]. Primary analyses will be repeated to calculate HRs for reinfection according to different individual and study level characteristics such as sex, age groups, body mass index, comorbidities, major geographical regions (that is, Europe/ North America/Australia/NZ, South Asia and East Asia) and study quality (low versus high quality studies). We anticipate that this will take the form of a teleconference but will explore the feasibility of holding a workshop locally or at an appropriate international conference

Discussion

Background

Findings