Implementation of a stepped-wedge cluster randomized design in routine public health practice: design and application for a tuberculosis (TB) household contact study in a high burden area of Lima, Peru.

Lena Shah,Larissa Otero,Oscar Mori,Marlene Rojas,Carlos Seas,Carlos Zamudio,Timothy F Brewer,Eduardo Gotuzzo,Jay S Kaufman

doi:10.1186/s12889-015-1883-2

Abstract

BackgroundWe designed a pragmatic stepped-wedge cluster randomized controlled trial in order to evaluate provider-initiated evaluation of household contacts (HCs) of smear positive tuberculosis (TB) cases within a routine TB program in Lima, Peru.Methods/DesignNational TB program (NTP) officers of San Juan de Lurigancho District (Lima, Peru) and university-based researchers jointly designed a pragmatic stepped-wedge cluster randomized trial design in order to evaluate a planned active case finding (ACF) program for all HCs of smear-positive TB cases in 34 district healthcare centres. Randomization of time to intervention initiation was stratified by health centre TB case rate. The ACF intervention included provider-initiated home visits of all new sputum smear positive TB patients in order to evaluate household contacts for active TB. Active TB was diagnosed using symptom screening, sputum screening, chest x-ray and clinical evaluation. Once initiated, ACF was provided by NTP staff and integrated into the routine DOTS TB program activities.DiscussionThis study protocol describes the pragmatic stepped-wedge cluster randomized trial of active household contact evaluations within an NTP. The stepped-wedge design met overlapping needs of local TB programmers and researchers to adequately evaluate the large-scale roll out of a new control program in a TB endemic setting. Multiple planning meetings were required to develop the necessary networks and in order to understand the operations, needs and goals of the NTP staff and researchers collaborating on this project. The advantages and challenges of using this study design in practice and within existing routine TB programs in a middle-income country context are discussed.Trial registrationClinicalTrials.gov NCT02174380. Registered 24 Jun 2014

Highlights

GRADE evidence profiles and summary of findings tables
Data cleaning and analysis are pending. This pragmatic stepped-wedge cluster randomized controlled trial (CRCT) protocol is among the very few undertaken in an operational public health program in a lowand middle-income countries (LMICs) [38]
Planning and development of the pragmatic stepped-wedge CRCT protocol This protocol is a joint endeavor between local National TB program (NTP) partners including the operational managers of the Ministry of Health TB program in San Juan de Lurigancho (SJL) and researchers

Summary

Introduction

GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383–94. doi:10.1016/j.jclinepi.2010.04.026. 2. Design and analysis of stepped wedge cluster randomized trials. Systematic review of stepped wedge cluster randomized trials shows that design is used to evaluate interventions during routine implementation. We designed a pragmatic stepped-wedge cluster randomized controlled trial in order to evaluate provider-initiated evaluation of household contacts (HCs) of smear positive tuberculosis (TB) cases within a routine TB program in Lima, Peru. Randomized controlled trials (RCTs) are considered the ‘gold standard’ study design to determine the efficacy of health care interventions [1]. Public health interventions should be evaluated as they are implemented and embedded into local health infrastructure in order to examine the contextual effectiveness and to appropriately support evidence-based public health decision-making [3, 6]

Methods

Findings

Discussion

Conclusion