CoChat
Sign Up
Cited by 9Tuberculosis Research and EpidemiologyStatistical Methods in Clinical TrialsHealth Policy Implementation Science

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

Open access
Shah, Lena, Rojas, Marlene, Mori, Oscar, Zamudio, Carlos, Kaufman, Jay S., Otero, Larissa, Gotuzzo, Eduardo, Seas, Carlos +1 more·2015·BMC Public Health
DOI 10.1186/s12889-015-1883-2PMC PMC4481074
Open this paper in CoChat — free accountOpen PDF

Abstract

BACKGROUND: 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. METHODS/DESIGN: National 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 REGISTRATION: ClinicalTrials.gov NCT02174380. Registered 24 Jun 2014.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/s12889-015-1883-2

Cites

4 of 4 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The sizeable body of work in maternal and child health and tuberculosis reflects urgent regional priorities and supports SWD's applicability for evaluating high-burden conditions in resource-limited settings.

    “The sizeable body of work in maternal and child health and tuberculosis similarly reflects urgent regional priorities and supports SWD's applicability for evaluating high-burden conditions in resource-limited settings (16, 114).”

    From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [114]

    The Discussion (page not available in our copy) says the stepped-wedge design was useful for evaluating a TB intervention in an endemic area of Peru, supporting the claim's TB example. This single study does not establish a sizeable body of work in maternal and child health or tuberculosis, or a broader regional pattern of research priorities. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Research works printed but not linked: 34

  1. [1]Guyatt G Oxman AD Akl EA Kunz R Vist G Brozek J GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables J Clin Epidemiol 2011 64 383 94 10.1016/j.jclinepi.2010.04.026 21195583 · DOI · Paper page
  2. [2]Maclure M Explaining pragmatic trials to pragmatic policy-makers CMAJ 2009 180 1001 3 10.1503/cmaj.090076 19372437 PMC2679825 · DOI
  3. [3]Allotey P Reidpath DD Ghalib H Pagnoni F Skelly WC Efficacious, effective, and embedded interventions: implementation research in infectious disease control BMC Public Health 2008 8 343 10.1186/1471-2458-8-343 18826655 PMC2567977 · DOI
  4. [4]Volmink J Garner P Directly observed therapy for treating tuberculosis Cochrane Database Syst Rev 2007 4 1 32 17943789
  5. [5]Sanson-Fisher RW D’Este CA Carey ML Noble N Paul CL Evaluation of Systems-Oriented Public Health Interventions: Alternative Research Designs Annu Rev Public Health 2014 35 9 27 10.1146/annurev-publhealth-032013-182445 24387088 · DOI
  6. [7]Hussey MA Hughes JP Design and analysis of stepped wedge cluster randomized trials Contemp Clin Trials 2007 28 182 91 10.1016/j.cct.2006.05.007 16829207 · DOI
  7. [10]Palmay L Elligsen M Walker SSAN Pinto R Einarson T Simor A Hospital-wide Roll-out of Antimicrobial Stewardship: A Stepped-Wedge Randomized Trial Clin Infect Dis 2014 59 867 74 10.1093/cid/ciu445 24928294 · DOI
  8. [11]Zhan Z Van Den Heuvel ER Doornbos PM Burger H Verberne CJ Wiggers T Strengths and weaknesses of a stepped wedge cluster randomized design: its application in a colorectal cancer follow-up study J Clin Epidemiol 2014 67 454 61 10.1016/j.jclinepi.2013.10.018 24491793 · DOI
  9. [12]Haddow J Adwan H Clark S Tayeh S Antonowicz S Jayia P Use of the surgical Apgar score to guide postoperative care Ann R Coll Surg Engl 2014 96 352 8 10.1308/003588414X13946184900840 24992418 PMC4473931 · DOI
  10. [13]Brown BB Young J Smith DP Kneebone AB Brooks AJ Xhilaga M Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol Implement Sci 2014 9 64 10.1186/1748-5908-9-64 24884877 PMC4048539 · DOI
  11. [14]Van de Steeg L IJkema R Langelaan M Wagner C Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial BMC Geriatr 2014 14 69 76 10.1186/1471-2318-14-69 24884739 PMC4046094 · DOI
  12. [15]Bouwsma EV Anema JR Vonk Noordegraaf A Knol DL Bosmans JE Schraffordt Koops SE The cost effectiveness of a tailored, web-based care program to enhance postoperative recovery in gynecologic patients in comparison with usual care: protocol of a stepped wedge cluster randomized controlled trial JMIR Res Protoc 2014 3 e30 10.2196/resprot.3236 24943277 PMC4090379 · DOI
  13. [16]Badenbroek IF Stol DM Nielen MMJ Hollander M Kraaijenhagen RA de Wit GA Design of the INTEGRATE study: effectiveness and cost-effectiveness of a cardiometabolic risk assessment and treatment program integrated in primary care BMC Fam Pract 2014 15 90 10.1186/1471-2296-15-90 24884779 PMC4022539 · DOI
  14. [17]Chavane L Merialdi M Betrán AP Requejo-Harris J Bergel E Aleman A Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol BMC Health Serv Res 2014 14 228 10.1186/1472-6963-14-228 24886392 PMC4057585 · DOI
  15. [18]Kenyon S Dann S Clarke P Hogan A Jenkinson D Hemming K PD.01 Stepped wedge cluster trial to evaluate training to community midwives to improve membrane sweeping to reduce induction of labour Arch Dis Child Fetal Neonatal Ed 2014 99 Suppl 1 A80 2 10.1136/archdischild-2014-306576.230 · DOI
  16. [19]Franklin BD Reynolds M Sadler S Hibberd R Avery AJ Armstrong SJ The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: a naturalistic stepped wedge study BMJ Qual Saf 2014 23 629 38 10.1136/bmjqs-2013-002776 24742778 PMC4112418 · DOI
  17. [20]Handley MA, Schillinger D, Shiboski S. Quasi-Experimental Designs in Practice-based Research Settings: Design and Implementation Considerations. J Am Board Fam Med 2011:589–96. doi:10.3122/jabfm.2011.05.110067. 21900443 · DOI
  18. [21]Rhoda DA Murray DM Andridge RR Pennell ML Hade EM Studies With Staggered Starts: Multiple Baseline Designs and Group-Randomized Trials Am J Public Health 2011 101 2164 9 10.2105/AJPH.2011.300264 21940928 PMC3222403 · DOI · Paper page
  19. [23]Maclure M Carleton B Schneeweiss S Designed Delays Versus Rigorous Pragmatic Trials Med Care 2009 45 44 9 10.1097/MLR.0b013e318068932a 17909382 · DOI
  20. [24]Moulton LH Golub JE Durovni B Cavalcante SC Pacheco AG Saraceni V Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention Clin Trials 2007 4 190 9 10.1177/1740774507076937 17456522 · DOI
  21. [25]World Health Organization Recommendations for investigating contacts of persons with infectious tuberculosis in low-and middle-income countries 2012 24404639
  22. [26]Grzybowski S Barnett GD Styblo K Contacts of cases of active pulmonary tuberculosis Bull Int Union Tuberc Lung Dis 1975 50 90 106 1218291
  23. [27]Veen J Microepidemics of tuberculosis: the stone-in-the-pond principle Tuber Lung Dis 1992 73 73 6 10.1016/0962-8479(92)90058-R 1643300 · DOI
  24. [28]Corbett EL Watt CJ Walker N Maher D Williams BG Raviglione MC The growing burden of tuberculosis: global trends and interactions with the HIV epidemic Arch Intern Med 2003 163 1009 21 10.1001/archinte.163.9.1009 12742798 · DOI · Paper page
  25. [32]Kiefer EM Shao T Carrasquillo O Nabeta P Seas C Knowledge and attitudes of tuberculosis management in San Juan de Lurigancho district of Lima, Peru J Infect Dev Ctries 2009 3 783 8 20009280
  26. [33]Hill PC Ota MOC Tuberculosis case-contact research in endemic tropical settings: design, conduct, and relevance to other infectious diseases Lancet Infect Dis 2010 10 723 32 10.1016/S1473-3099(10)70164-X 20883968 · DOI
  27. [35]Zwarenstein M Treweek S Gagnier JJ Altman DG Tunis S Haynes B Improving the reporting of pragmatic trials: an extension of the CONSORT statement BMJ 2008 337 a2390 10.1136/bmj.a2390 19001484 PMC3266844 · DOI · Paper page
  28. [36]Moulton LH Golub JE Durovni B Cavalcante SC Pacheco AG Saraceni V Statistical design of THRio: a phased implementation clinic-randomized study of a tuberculosis preventive therapy intervention Clin Trials 2007 4 190 9 10.1177/1740774507076937 17456522 · DOI
  29. [37]Becerra MC Appleton SC Franke MF Chalco K Arteaga F Bayona J Tuberculosis burden in households of patients with multidrug-resistant and extensively drug-resistant tuberculosis: A retrospective cohort study Lancet 2011 377 147 52 10.1016/S0140-6736(10)61972-1 21145581 PMC13508782 · DOI
  30. [38]Morrison J Pai M Hopewell PC Tuberculosis and latent tuberculosis infection in close contacts of people with pulmonary tuberculosis in low-income and middle-income countries: a systematic review and meta-analysis Lancet Infect Dis 2008 8 359 68 10.1016/S1473-3099(08)70071-9 18450516 · DOI
  31. [39]Frieden TR Six Components Necessary for Effective Public Health Program Implementation Am J Public Health 2013 104 17 22 10.2105/AJPH.2013.301608 24228653 PMC3910052 · DOI
  32. [40]Marais BJ Gie RP Hesseling AC Schaaf HS Lombard C Enarson DA A refined symptom-based approach to diagnose pulmonary tuberculosis in children Pediatrics 2006 118 e1350 9 10.1542/peds.2006-0519 17079536 · DOI
  33. [41]Jackson-Sillah D Hill PC Fox A Brookes RH Donkor SA Lugos MD Screening for tuberculosis among 2381 household contacts of sputum-smear-positive cases in The Gambia Trans R Soc Trop Med Hyg 2007 101 594 601 10.1016/j.trstmh.2007.02.001 17368495 · DOI
  34. [42]Golub JE Mohan CI Comstock GW Chaisson RE Active case finding of tuberculosis: historical perspective and future prospects Int J Tuberc Lung Dis 2005 9 1183 203 16333924 PMC4472641

Cited by

Sorted by citations

Authors
Shah, L., Rojas, M., Mori, O., Zamudio, C., Kaufman, J. S., Otero, L., Gotuzzo, E., Seas, C., & Brewer, T. F.
Affiliations
  • McGill University (CA)
  • Ministry of Health (PE)
  • Universidad Peruana Cayetano Heredia (PE)
  • University of California, Los Angeles (US)
Corresponding author
Shah, Lena
ORCID
Venue
BMC Public Health
Publisher
Springer Science and Business Media LLC
Published
2015-06-26
Volume
15
Issue
1
Pages
587-587
ISSN
1471-2458 (ISSN-L)
DOI
10.1186/s12889-015-1883-2
PMC
PMC4481074
OpenAlex
W2099321242
Cited by
9
References
4
Citations by year
2026: 2 · 2024: 1 · 2021: 1 · 2020: 2 · 2017: 1 · 2016: 2
FWCI
0.78
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Public Health (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • eScholarship@McGill (McGill) (submittedVersion, other-oa)
  • eScholarship@McGill (McGill) (submittedVersion, cc-by)
  • eScholarship (California Digital Library) (submittedVersion)
  • Greater South Information System
Funders
  • International Development Research Centre
  • Canadian Institutes of Health Research (123370_1)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords
tuberculosis, household contacts, active case finding, stepped-wedge cluster randomized trial, smear-positive tuberculosis, DOTS program, National Tuberculosis Control Program, tuberculosis control, Lima
MeSH terms
Family, Humans, Peru, Research Design, Sputum, Tuberculosis, Public Health Practice, Contact Tracing

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review