Characteristics of Randomized Trials Published in Latin America and the Caribbean According to Funding Source

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Abstract

Introduction

Few studies have assessed the nature and quality of randomized controlled trials (RCTs) in Latin America and the Caribbean (LAC).

Methods and Findings

The aims of this systematic review are to evaluate the characteristics (including the risk of bias assessment) of RCT conducted in LAC according to funding source. A review of RCTs published in 2010 in which the author's affiliation was from LAC was performed in PubMed and LILACS. Two reviewers independently extracted data and assessed the risk of bias. The primary outcomes were risk of bias assessment and funding source. A total of 1,695 references were found in PubMed and LILACS databases, of which 526 were RCTs (N = 73.513 participants). English was the dominant publication language (93%) and most of the RCTs were published in non-LAC journals (84.2%). Only five of the 19 identified countries accounted for nearly 95% of all RCTs conducted in the region (Brazil 70.9%, Mexico 10.1%, Argentina 5.9%, Colombia 3.8%, and Chile 3.4%). Few RCTs covered priority areas related with Millennium Development Goals like maternal health (6.7%) or high priority infectious diseases (3.8%). Regarding children, 3.6% and 0.4% RCT evaluated nutrition and diarrhea interventions respectively but none pneumonia. As a comparison, aesthetic and sport related interventions account for 4.6% of all trials. A random sample of RCTs (n = 358) was assessed for funding source: exclusively public (33.8%); private (e.g. pharmaceutical company) (15.3%); other (e.g. mixed, NGO) (15.1%); no funding (35.8%). Overall assessments for risk of bias showed no statistically significant differences between RCTs and type of funding source. Statistically significant differences favoring private and others type of funding was found when assessing trial registration and conflict of interest reporting.

Conclusion

Findings of this study could be used to provide more direction for future research to facilitate innovation, improve health outcomes or address priority health problems.

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Most cited references 22

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A checklist for health research priority setting: nine common themes of good practice

Roderik F. Viergever, Sylvie Olifson, Abdul Ghaffar … (2010)

Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.

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Productivity costs of cancer mortality in the United States: 2000-2020.

K Robin Yabroff, Angela Mariotto, Bassam Dahman … (2008)

A model that predicts the economic benefit of reduced cancer mortality provides critical information for allocating scarce resources to the interventions with the greatest benefits. We developed models using the human capital approach, which relies on earnings as a measure of productivity, to estimate the value of productivity lost as a result of cancer mortality. The base model aggregated age- and sex-specific data from four primary sources: 1) the US Bureau of the Census, 2) US death certificate data for 1999-2003, 3) cohort life tables from the Berkeley Mortality Database for 1900-2000, and 4) the Bureau of Labor Statistics Current Population Survey. In a model that included costs of caregiving and household work, data from the National Human Activity Pattern Survey and the Caregiving in the U.S. study were used. Sensitivity analyses were performed using six types of cancer assuming a 1% decline in cancer mortality rates. The values of forgone earnings for employed individuals and imputed forgone earnings for informal caregiving were then estimated for the years 2000-2020. The annual productivity cost from cancer mortality in the base model was approximately $115.8 billion in 2000; the projected value was $147.6 billion for 2020. Death from lung cancer accounted for more than 27% of productivity costs. A 1% annual reduction in lung, colorectal, breast, leukemia, pancreatic, and brain cancer mortality lowered productivity costs by $814 million per year. Including imputed earnings lost due to caregiving and household activity increased the base model total productivity cost to $232.4 billion in 2000 and to $308 billion in 2020. Investments in programs that target the cancers with high incidence and/or cancers that occur in younger, working-age individuals are likely to yield the greatest reductions in productivity losses to society.

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Evaluation of cluster randomized controlled trials in sub-Saharan Africa.

Petros Isaakidis, John Ioannidis (2003)

Cluster randomized controlled trials (CRCTs) are attractive in settings in which individual randomization is difficult or impossible. This issue is common when studying several health problems in developing countries. The authors aimed to assess empirically the extent to which the prerequisite design and analysis aspects of cluster randomization were taken into account and reported properly in CRCTs conducted in sub-Saharan Africa. CRCTs published in the last three decades were evaluated by using a checklist based on the Consolidated Standards of Reporting Trials (CONSORT) statement. The authors identified 51 eligible CRCTs; 40 of them (78%) had been published after 1990. Only 10 (20%) studies took clustering into account in sample size or power calculations, and only 19 (37%) took clustering into account in the analysis. Intracluster correlation coefficients and design effects were reported in only one (2%) and three (6%) trials, respectively. An increasing number of CRCTs are conducted in sub-Saharan Africa, but many are not analyzed and reported properly. The special features stemming from cluster randomization need to be addressed in the design, analysis, and reporting of these studies.

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Author and article information

Contributors

D. William Cameron: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, USA )

ISSN (Electronic): 1932-6203

Publication date Collection: 2013

Publication date (Electronic): 13 February 2013

Volume: 8

Issue: 2

Electronic Location Identifier: e56410

Affiliations

[1 ]Health Systems Based on Primary Health Care, Pan American Health Organization (PAHO), Washington D.C., United States of America

[2 ]Argentine Cochrane Centre - Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina

[3 ]Instituto de Investigaciones, Fundación Universitaria Sanitas, Bogotá, Colombia

[4 ]Centro Rehabilitación Oral Avanzada e Implantología (CRAI) Universidad de Concepción (Centro Adherido Chileno de la Red Cochrane Iberoamericana), Santiago, Chile

[5 ]Chilean Branch of the Iberoamerican Cochrane Network, Universidad Católica de la Santísima Concepción, Santiago, Chile

[6 ]Facultad de Medicina, Fundación Universitaria Sanitas, Bogotá, Colombia

[7 ]Iberoamerican Cochrane Centre. Sant Pau Biomedical Research Institute (IIB-Sant Pau), The Biomedical Research Centre Network for Epidemiology and Public Health (CIBERESP) - Universitat Autònoma de Barcelona, Barcelona, Spain

University of Ottawa, Canada

Author notes

* E-mail: reveizl@ 123456paho.org

Competing Interests: The authors declare that they do not have any conflict of interest. The views expressed by authors reflect their personal expert views and do not necessarily reflect the official position or policy of their employers. Ludovic Reveiz is a PhD candidate at the Universitat Autonoma de Barcelona. Stephanie Sangalang contributed to the project during her internship at the Pan-American Health Organization.

Conceived and designed the experiments: LR. Performed the experiments: LR SS DG CEP CAL M.Cortes M.Cañón AB XB. Analyzed the data: LR SS DG CEP CAL M.Cortes M.Cañón AB XB. Wrote the paper: LR SS DG CEP CAL M.Cortes M.Cañón AB XB.

Article

Publisher ID: PONE-D-12-26472

DOI: 10.1371/journal.pone.0056410

PMC ID: 3572054

SO-VID: 2fd8d342-ddad-4404-84e4-606acb3b57cd

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 30 August 2012

Date accepted : 9 January 2013

Page count

Pages: 8

Funding

No current external funding sources were received for this project.

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Characteristics of Randomized Trials Published in Latin America and the Caribbean According to Funding Source

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Abstract

Introduction

Methods and Findings

Conclusion

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PLOS Global Public Health

Most cited references 22

A checklist for health research priority setting: nine common themes of good practice

Productivity costs of cancer mortality in the United States: 2000-2020.

Evaluation of cluster randomized controlled trials in sub-Saharan Africa.

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