Evidence map›Paper›PMID 26109173›Full record

Trial reportBMC public health2015

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

Registry-linked trialAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in BMC public health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02174380 (Cost-effectiveness of a Population-based Active TB Control Program for Tuberculosis, Lima, Peru), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02174380 naunknown statusnot on this map

Cost-effectiveness of a Population-based Active TB Control Program for Tuberculosis, Lima, Peru

TypeinterventionalSponsorLena ShahRan2012 to 2015Enrolled1,900ConditionsTuberculosisArmsActive Household Contact Evaluation
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Screening strategies for active tuberculosis: focus on cost-effectiveness.ClinicoEconomics and outcomes research : CEOR · 2016
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Lena ShahDepartment of Epidemiology, Biostatistics & Occupational Health, McGill University, Purvis Hall, 1020 Pine Ave. West, Montreal, QC, Canada. lena.shah@mail.mcgill.ca.
Marlene RojasRed de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru. eumarle@hotmail.com.
Oscar MoriRed de Salud de San Juan de Lurigancho, Dirección de Salud Lima IV Este, Ministerio de Salud, Lima, Peru. omori77@gmail.com.
Carlos ZamudioInstituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. carlos.zamudio@upch.pe.
Jay S KaufmanDepartment of Epidemiology, Biostatistics & Occupational Health, McGill University, Purvis Hall, 1020 Pine Ave. West, Montreal, QC, Canada. jay.kaufman@mcgill.ca.
Larissa OteroInstituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. larissa.otero@upch.pe.
Eduardo GotuzzoInstituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. eduardo.gotuzzo@upch.pe.
Carlos SeasInstituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru. carlos.seas@upch.pe.
Timothy F BrewerDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA. tbrewer@conet.ucla.edu.

Funding

Canadian Institutes of Health Research MOP 123370
6 · The paper itself

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. DISCUSSION: This 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.

Indexed as

FamilyPublic Health PracticeContact TracingHumansPeruResearch DesignSputumTuberculosis

Identifiers

PMID26109173
PMCPMC4481074

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.