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‣ Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

Cummings, Jorden A.; Zagrodney, Jessica M.; Day, T. Eugene
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 20/05/2015 Português
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Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.

‣ Needs Assessment for Research Use of High-Throughput Sequencing at a Large Academic Medical Center

Geskin, Albert; Legowski, Elizabeth; Chakka, Anish; Chandran, Uma R; Barmada, M. Michael; LaFramboise, William A.; Berg, Jeremy; Jacobson, Rebecca S.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 26/06/2015 Português
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Next Generation Sequencing (NGS) methods are driving profound changes in biomedical research, with a growing impact on patient care. Many academic medical centers are evaluating potential models to prepare for the rapid increase in NGS information needs. This study sought to investigate (1) how and where sequencing data is generated and analyzed, (2) research objectives and goals for NGS, (3) workforce capacity and unmet needs, (4) storage capacity and unmet needs, (5) available and anticipated funding resources, and (6) future challenges. As a precursor to informed decision making at our institution, we undertook a systematic needs assessment of investigators using survey methods. We recruited 331 investigators from over 60 departments and divisions at the University of Pittsburgh Schools of Health Sciences and had 140 respondents, or a 42% response rate. Results suggest that both sequencing and analysis bottlenecks currently exist. Significant educational needs were identified, including both investigator-focused needs, such as selection of NGS methods suitable for specific research objectives, and program-focused needs, such as support for training an analytic workforce. The absence of centralized infrastructure was identified as an important institutional gap. Key principles for organizations managing this change were formulated based on the survey responses. This needs assessment provides an in-depth case study which may be useful to other academic medical centers as they identify and plan for future needs.

‣ Information Management in Cancer Registries: Evaluating the Needs for Cancer Data Collection and Cancer Research

Zachary, Iris; Boren, Suzanne A; Simoes, Eduardo; Jackson-Thompson, Jeannette; Davis, J Wade; Hicks, Lanis
Fonte: University of Illinois at Chicago Library Publicador: University of Illinois at Chicago Library
Tipo: Artigo de Revista Científica
Publicado em 01/07/2015 Português
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Cancer registry data collection involves, at a minimum, collecting data on demographics, tumor characteristics, and treatment. A common, identified, and standardized set of data elements is needed to share data quickly and efficiently with consumers of this data. This project highlights the fact that, there is a need to develop common data elements; Surveys were developed for central cancer registries (CCRs) and cancer researchers (CRs) at NCI-designated Cancer Centers, in order to understand data needs. Survey questions were developed based on the project focus, an evaluation of the research registries and database responses, and systematic review of the literature. Questions covered the following topics: 1) Research, 2) Data collection, 3) Database/ repository, 4) Use of data, 5) Additional data items, 6) Data requests, 7) New data fields, and 8) Cancer registry data set. A review of the surveys indicates that all cancer registries’ data are used for public health surveillance, and 96% of the registries indicate the data are also used for research. Data are available online in interactive tables from over 50% of CRs and 87% of CCRs. Some other survey responses indicate that CCR treatment data are not complete for example treatment data...

‣ The focus group technique in library research: an introduction.

Glitz, B
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /10/1997 Português
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The focus group technique is one example of a qualitative research methodology used to explore the opinions, knowledge, perceptions, and concerns of individuals in regard to a particular topic. The focus group typically involves six to ten individuals who have some knowledge of or experience with the topic. The group discussion is led by a moderator who guides participants through a series of open-ended questions. The information gathered can provide important clues to human attitudes and values as they relate to the topic. Such information can be extremely useful to libraries that are trying to gain a better understanding of their patrons' needs and thus make better management decisions to help satisfy those needs. The technique can also be used successfully in conjunction with other research tools, such as surveys, either to help develop a questionnaire or to explain specific survey results. This paper introduces the use of focus groups in library research, the skills needed to conduct groups, and their strengths and weaknesses. Examples of the use of focus groups in health sciences libraries are presented, including the results of a survey from these libraries.

‣ Understanding Public Opinion in Debates over Biomedical Research: Looking beyond Political Partisanship to Focus on Beliefs about Science and Society

Nisbet, Matthew; Markowitz, Ezra M.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 18/02/2014 Português
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As social scientists have investigated the political and social factors influencing public opinion in science-related policy debates, there has been growing interest in the implications of this research for public communication and outreach. Given the level of political polarization in the United States, much of the focus has been on partisan differences in public opinion, the strategies employed by political leaders and advocates that promote those differences, and the counter-strategies for overcoming them. Yet this focus on partisan differences tends to overlook the processes by which core beliefs about science and society impact public opinion and how these schema are often activated by specific frames of reference embedded in media coverage and popular discourse. In this study, analyzing cross-sectional, nationally representative survey data collected between 2002 and 2010, we investigate the relative influence of political partisanship and science-related schema on Americans' support for embryonic stem cell research. In comparison to the influence of partisan identity, our findings suggest that generalized beliefs about science and society were more chronically accessible, less volatile in relation to media attention and focusing events...

‣ Conducting research on the Medicare market: the need for better data and methods.

Wong, H S; Hellinger, F J
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /04/2001 Português
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OBJECTIVE: To highlight data limitations, the need to improve data collection, the need to develop better analytic methods, and the need to use alternative data sources to conduct research related to the Medicare program. Objectives were achieved by reviewing existing studies on risk selection in Medicare HMOs, examining their data limitations, and introducing a new approach that circumvents many of these shortcomings. DATA SOURCES: Data for years 1995-97 for five states (Arizona, Florida, Massachusetts, New York, and Pennsylvania) from the Healthcare Cost and Utilization Project (HCUP) State Inpatient Databases (SIDs), maintained by the Agency for Healthcare Research and Quality; and the Health Care Financing Administration's Medicare Managed Care Market Penetration Data Files and Medicare Provider Analysis and Review Files. STUDY DESIGN: Analysis of hospital utilization rates for Medicare beneficiaries in the traditional fee-for-service (FFS) Medicare and Medicare HMO sectors and examination of the relationship between these rates and the Medicare HMO penetration rates. PRINCIPAL FINDINGS: Medicare HMOs have lower hospital utilization rates than their FFS counterparts, differences in utilization rates vary across states, and HMO penetration rates are inversely related to our rough measure of favorable selection. CONCLUSIONS: Substantial growth in Medicare HMO enrollment and the implementation of a new risk-adjusted payment system have led to an increasing need for research on the Medicare program. Improved data collection...

‣ Current status of the institutional review boards in Korea: constitution, operation, and policy for protection of human research participants.

Kim, Ock-Joo; Park, Byung-Joo; Sohn, Dong-Ryul; Lee, Seung-Mi; Shin, Sang-Goo
Fonte: Korean Academy of Medical Sciences Publicador: Korean Academy of Medical Sciences
Tipo: Artigo de Revista Científica
Publicado em /02/2003 Português
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The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.

‣ Is participation in research as an investigator an effective form of continuing medical education?

Huas, D; Wallace, P
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /12/2000 Português
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Continuing medical education and research are a daily necessity for general practitioners (GPs). This study investigated the possibility that participation in research is an effective form of continuing medical education. Although there was an indication that some modification of GPs' knowledge and skills had occurred, it was not possible to conclude that this was entirely due to participation in research.

‣ The A3 Problem Solving Report: A 10-Step Scientific Method to Execute Performance Improvements in an Academic Research Vivarium

Bassuk, James A.; Washington, Ida M.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 29/10/2013 Português
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The purpose of this study was to illustrate the application of A3 Problem Solving Reports of the Toyota Production System to our research vivarium through the methodology of Continuous Performance Improvement, a lean approach to healthcare management at Seattle Children's (Hospital, Research Institute, Foundation). The Report format is described within the perspective of a 10-step scientific method designed to realize measurable improvements of Issues identified by the Report's Author, Sponsor and Coach. The 10-step method (Issue, Background, Current Condition, Goal, Root Cause, Target Condition, Countermeasures, Implementation Plan, Test, and Follow-up) was shown to align with Shewhart's Plan-Do-Check-Act process improvement cycle in a manner that allowed for quantitative analysis of the Countermeasure's outcomes and of Testing results. During fiscal year 2012, 9 A3 Problem Solving Reports were completed in the vivarium under the teaching and coaching system implemented by the Research Institute. Two of the 9 reports are described herein. Report #1 addressed the issue of the vivarium's veterinarian not being able to provide input into sick animal cases during the work day, while report #7 tackled the lack of a standard in keeping track of weekend/holiday animal health inspections. In each Report...

‣ Randomised comparison of oestrogen versus oestrogen plus progestogen hormone replacement therapy in women with hysterectomy. Medical Research Council's General Practice Research Framework.

Fonte: BMJ Group Publicador: BMJ Group
Tipo: Artigo de Revista Científica
Publicado em 24/02/1996 Português
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OBJECTIVE: To compare the acceptability and symptomatic and metabolic effects of two regimens of hormone replacement therapy in women with hysterectomy. DESIGN: Randomised, double blind comparison. SETTING: Seven group practices in the Medical Research Council's general practice research framework. SUBJECTS: 321 women with hysterectomy aged 35-59. INTERVENTIONS: Hormone replacement therapy with (a) conjugated equine oestrogen 625 micrograms daily alone or (b) conjugated equine oestrogen 625 micrograms daily plus the progestogen norgestrel 150 micrograms daily for the last 12 days of the 'cycle.' MAIN OUTCOME MEASURES: Changes in blood pressure, weight, symptoms, and haemostatic and lipid values. RESULTS: After two years 36% (57/158) of women randomly allocated to take oestrogen alone had discontinued treatment as compared with 30% (49/163) of women allocated to take oestrogen plus progestogen. Smokers were more likely to withdraw than non-smokers. There were no clear differences between the two groups in symptoms often attributed to hormone replacement therapy or in blood pressure or weight. At one year low density lipoprotein cholesterol concentrations had fallen substantially in both groups. High density lipoprotein cholesterol concentrations rose to significantly higher values in women taking oestrogen alone compared with those taking oestrogen plus progestogen...

‣ Addressing the credibility gap in general practice research: better theory; more feeling; less strategy.

Howie, J G
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /08/1996 Português
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A substantial international network of general practice researchers has grown up over the past 30 years, and the literature of the discipline is now extensive and diverse. Nevertheless, there is considerable ambivalence within the profession about what research can offer, where its weight should be being put and how best the opportunities its insights create can be taken advantage of. The sometimes disappointingly low credibility of research and researchers needs to be addressed. The issues of the adequacy of underlying 'theory' and of ownership of research agendas may contain the basis of a way forward.

‣ Maximizing the usefulness of food microbiology research.

Roberts, T. A.
Fonte: Centers for Disease Control Publicador: Centers for Disease Control
Tipo: Artigo de Revista Científica
Publicado em //1997 Português
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Funding for food microbiology research often follows disease outbreaks: botulism from vacuum-packed white-fish chubs, listeriosis from soft cheeses, or illness due to Salmonella Enteritidis or Escherichia coli. As a consequence of research, detection, identification, and subtyping methods improve, and more is learned about pathogenicity and virulence. Research also explores the organisms' capacity to multiply or survive in food and to be killed by established or novel processes. However, rarely is there a critical overview of progress or trustworthy statements of generally agreed-on facts. That information is not maintained in a form that can readily be used by regulatory departments and the food industry to ensure a safe food supply. A centralized system is urgently needed that is accessible electronically and carries information in a standardized format on the essential properties of the organisms, including pathogenicity, methods of detection, enumeration and identification, alternative prevention and control methods, and growth and survival characteristics.

‣ Linking research and policy to ensure children's environmental health.

Goldman, L R
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /06/1998 Português
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The U.S. Environmental Protection Agency (U.S. EPA) has made protecting children's environmental health its highest priority. Data on how and when children may be at risk are vital for accomplishing this goal. Recent examples of the link between research and policy include U.S. EPA actions to carry out the recommendations of the National Academy of Sciences on pesticides in children's food, reduce and prevent childhood lead poisoning, and revise national ambient air quality standards for ozone and particulate matter. Today, the Food Quality Protection Act (FQPA), which makes protecting children from pesticide residues in food a national priority, is contributing to the growing need for data for decision making. Further impetus comes from provisions in the FQPA and 1996 Safe Drinking Water Act Amendments for establishing a screening and testing program for potential risks from endocrine disruptors. Another factor is the analysis that will be required under President William J. Clinton's executive order directing all federal agencies, for the first time, to reduce environmental health and safety risks to children. Success of the U.S. international commitment to protect children is directly tied to the strength and availability of environmental data. To meet such challenges...

‣ Mapping Interdisciplinary Fields: Efficiencies, Gaps and Redundancies in HIV/AIDS Research

Adams, Jimi; Light, Ryan
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 15/12/2014 Português
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While interdisciplinarity continues to increase in popularity among funders and other scientific organizations, its potential to promote scientific advances remains under-examined. For HIV/AIDS research, we examine the dynamics of disciplinary integration (or lack thereof) providing insight into a field's knowledge base and those questions that remain unresolved. Drawing on the complete histories of two interdisciplinary journals, we construct bibliographic coupling networks based on overlapping citations to identify segregation into research clusters and estimate topic models of research content. We then compare how readily those bibliographic coupling clusters account for the structuring of topics covered within the field as it evolves over two decades. These comparisons challenge one-dimensional and/or cross-sectional approaches to interdisciplinarity. Some topics are increasingly coordinated across disciplinary boundaries (e.g., vaccine development); others remain relatively segmented into disconnected disciplinary domains for the full period (e.g., drug resistance). This divergence indicates heterogeneity in interdisciplinarity and emphasizes the need for critical approaches to studying the organization of science.

‣ To Crowdfund Research, Scientists Must Build an Audience for Their Work

Byrnes, Jarrett E. K.; Ranganathan, Jai; Walker, Barbara L. E.; Faulkes, Zen
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Publicado em 10/12/2014 Português
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As rates of traditional sources of scientific funding decline, scientists have become increasingly interested in crowdfunding as a means of bringing in new money for research. In fields where crowdfunding has become a major venue for fundraising such as the arts and technology, building an audience for one's work is key for successful crowdfunding. For science, to what extent does audience building, via engagement and outreach, increase a scientist's abilities to bring in money via crowdfunding? Here we report on an analysis of the #SciFund Challenge, a crowdfunding experiment in which 159 scientists attempted to crowdfund their research. Using data gathered from a survey of participants, internet metrics, and logs of project donations, we find that public engagement is the key to crowdfunding success. Building an audience or “fanbase” and actively engaging with that audience as well as seeking to broaden the reach of one's audience indirectly increases levels of funding. Audience size and effort interact to bring in more people to view a scientist's project proposal, leading to funding. We discuss how projects capable of raising levels of funds commensurate with traditional funding agencies will need to incorporate direct involvement of the public with science. We suggest that if scientists and research institutions wish to tap this new source of funds...

‣ Practical application of air-quality research incorporated in CMHC's research house.

Rafuse, J
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 15/04/1995 Português
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The Canada Mortgage and Housing Corporation has been looking at ways to improve indoor air quality since 1984 and now hopes to interest house designers and manufacturers in the results of its research. Its flagship project has been the construction of a proto-type research house for environmentally hypersensitive people.

‣ Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

Dal-Ré, R; Espada, J; Ortega, R
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em /06/1999 Português
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OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval...

‣ Sociodemographic and motivational characteristics of parents who volunteer their children for clinical research: a controlled study.

Harth, S C; Thong, Y H
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 26/05/1990 Português
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OBJECTIVE--To determine the sociodemographic and motivational characteristics of parents who volunteer their children for clinical research. DESIGN--A questionnaire was administered to parents who volunteered their children for a randomised, double blind, placebo controlled trial of a drug to treat asthma and to a control group of parents whose children were eligible for the trial but had refused the invitation. SETTING--A children's hospital in Australia. SUBJECTS--68 Parents who had volunteered their children and 42 who had not; a response rate of 94% and 70%, respectively. MAIN OUTCOME MEASURES--Responses of parents to questionnaire designed to assess their perceptions, attitudes, and health seeking behaviour as well as sociodemographic data. RESULTS--Volunteering parents were less well educated with only 15% (10/68) of mothers and 16% (11/68) and of fathers having had a tertiary or university education compared with 26% (11/42) of mothers and 45% (19/42) in the non-volunteering group. Fewer volunteering parents had professional or administrative jobs than did non-volunteering parents (mothers 6% (4/68); fathers 9% (6/68) v mothers 14% (6/42); fathers 31% (13/42)). Volunteering parents had less social support, and they displayed greater health seeking behaviour and consumed more habit forming substances. They were motivated by a desire to help others and to contribute to medical research...

‣ A question of rhythm: recent advances in growth hormone research.

Hamilton, J
Fonte: PubMed Publicador: PubMed
Tipo: Artigo de Revista Científica
Publicado em 01/09/1995 Português
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Research by Dr. Gloria Shaffer Tannenbaum at the McGill University-Montreal Children's Hospital Research Institute has led to the development of a new test to differentiate children who are deficient in growth hormone from those who are short but growing normally. This clinical application is the fruit of Tannenbaum's discovery that growth hormone secretion occurs in a rhythmic pattern regulated by intricate interactions between two neurohormones: growth hormone-releasing hormone (GHRH) and somatotropin release-inhibiting factor (SRIF). In the test an analogue of SRIF is used to allow stores of growth hormone to build up. A subsequent challenge with GHRH is then used to identify children with a genuine deficiency. Tannenbaum's research also indicates that there are sexual differences in the pattern of growth hormone release and that growth hormone regulates its own secretion by means of a negative feedback system.

‣ Research synthesis and dissemination as a bridge to knowledge management: the Cochrane Collaboration.

Volmink, Jimmy; Siegfried, Nandi; Robertson, Katharine; Gülmezoglu, A. Metin
Fonte: World Health Organization Publicador: World Health Organization
Tipo: Artigo de Revista Científica
Publicado em /10/2004 Português
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In the current information age, research synthesis is a particularly useful tool for keeping track of scientific research and making sense of the large volumes of frequently conflicting data derived from primary studies. The Cochrane Collaboration is a global initiative "to help people make well-informed decisions about health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of healthcare interventions". In this paper we set the work of the Cochrane Collaboration in historical perspective, explain what a Cochrane review is, and describe initiatives for promoting worldwide dissemination of synthesized information. We also consider emerging evidence of the Cochrane Collaboration's impact on health-care practice, policy, research and education. Finally, we highlight the need for increased investment in the preparation and maintenance of Cochrane reviews, particularly those that address health issues that are relevant to people living in low- and middle-income countries.