Evidence-based perinatal and paediatric health care: The contribution of the Cochrane Collaboration and the Canadian Cochrane Network and Centre

As health care professionals and consumers of health care, paediatricians are overwhelmed by an exponentially increasing amount of information (1,2). We are faced with challenges on how to assess critically and implement the best available evidence in our efforts to improve clinical outcomes, reduce costs and increase satisfaction with care for our clients and/or ourselves in a timely fashion (3,4). In 1987, Cindy Mulrow (5) reported that medical reviews did not routinely use scientific methods to identify, assess and synthesize information, and she proposed the systematic assessment of reviews to improve their quality in the future. Later, she provided the rationale for systematic reviews (2). Systematic reviews establish whether scientific findings are consistent and can be generalised across populations, settings and treatment variations, or whether findings vary significantly by particular subsets. Meta-analyses in particular can increase power and precision of estimates of treatment effects and exposure risks. Finally explicit methods used in systematic reviews limit bias and, hopefully, will improve reliability and accuracy of conclusions. Archie Cochrane noted several decades ago that there was a need for ongoing critical appraisal and synthesis of research findings on the effectiveness of health care interventions (6). He challenged the obstetric profession for not having used the randomized controlled trial design to ascertain whether interventions related to pregnancy and childbirth were effective. In 1979, he awarded the “wooden spoon” to obstetrics and the “silver spoon” to phtisiology (the study of tuberculosis) because of Sir Austin Bradford Hill's landmark trials on the use of streptomycin in patients with tuberculosis (7). Archie Cochrane's challenge led Iain Chalmers, an obstetrician, and his co-workers to create the Oxford Database of Perinatal Trials (8). Based on this database of controlled clinical trials, Iain Chalmers, Murry Enkin and Mark Keirse published the first textbook in health care that was based on systematic reviews of randomized controlled trials, Effective Care in Pregnancy and Child Birth, in 1989 (9). This landmark publication was followed in 1992 by Effective Care of the Newborn, which was edited by John Sinclair and Michael Bracken (10). The editors, contributors and users of these textbooks quickly realized that, to keep up with the rapid developments in the fields of perinatology and neonatology, the published reviews required timely updates that would only be possible using electronic publication techniques. This realization formed the basis for the Cochrane Collaboration, which was established in the early 1990s with the aim to help people make well-informed decisions about (all forms of) health care by preparing, maintaining and promoting the accessibility of systematic reviews of the effects of health care interventions (4,11). Its work is based on 10 principles: fostering collaboration, building on the enthusiasm of individuals, avoiding duplication, minimizing bias, keeping up-to-date, striving for relevance, promoting access, ensuring quality, maintaining continuity and enabling participation (12). The main product of the Cochrane Collaboration is The Cochrane Library (12), which is published quarterly on CD-ROM and on the Internet, and is distributed on a subscription basis. The Cochrane Library (Issue 1, 2002) includes the Cochrane Database of Systematic Reviews (1297 complete reviews and 1013 protocols [systematic reviews in progress]), the Database of Abstracts of Reviews of Effectiveness (3299 abstracts of reviews that have been critically appraised by reviewers at the National Health Service [NHS] Centre for Reviews and Dissemination at the University of York, England), the Cochrane Controlled Trials Register (336,094 references to controlled trials), the NHS Economic Evaluation Database (8922 structured abstracts of economic evaluations of health care interventions), the Health Technology Assessment Database (containing 2318 abstracts produced by the International Network of Agencies for Health Technology Assessment and other health care technology agencies), the Cochrane Database of Methodology Reviews (nine reviews), and the Cochrane Methodology Register (3595 references to information on the science of reviewing research and evidence-based health care) (12). There are 50 review groups within the Cochrane Collaboration and, of these, the Pregnancy and Child Birth and the Neonatal review groups have been the most active, with 198 and 118 full reviews, respectively, in The Cochrane Library (12) (about 25% of all complete reviews). These reviews form a solid foundation for evidence-based perinatal and neonatal health care and provide directions for future research (4). There are many reviews of interventions in children that are published by other review groups. In February 2000, the Cochrane Child Health Field was established under the leadership of Dr Terry Klassen, Edmonton, Alberta, to ensure the presence of a child health focus within the Cochrane Collaboration (12). The Cochrane Child Health Field does not have a primary responsibility for producing reviews; however, it does ensure that there are Cochrane review groups that can conduct reviews on aspects of child health for which the need has been identified. The goals of the Child Health Field include support for the production of child-focused, clinically relevant, methodologically rigorous systematic reviews and support for the dissemination and utilization of evidence within these reviews in decision-making that affects the health and well-being of children around the world (12). Each review in The Cochrane Library (12) includes recommendations for practice and future research. The majority of the reviews advise that further research be conducted before a recommendation for clinical practice can be made. However, a number of Cochrane neonatal reviews have been incorporated into recent statements published jointly by the Canadian Paediatric Society and the American Academy of Pediatrics (13–16). These statements address pain management in the neonate and the use of postnatal corticosteroids to treat or prevent chronic lung disease in preterm infants (13–16). Several Cochrane reviews have formed the basis for recently completed or ongoing perinatal and neonatal randomized controlled trials funded by the Canadian Institutes for Health Research (CIHR), Medical Research Council (United Kingdom) and National Institutes of Health (United States). In a systematic review, bias is reduced by the systematic identification, appraisal, synthesis and, if relevant, statistical aggregation of all relevant studies on a specific topic according to a predetermined and explicit method (17). Meta-analysis is a term used when research findings from several studies are quantitatively integrated using statistical methods (18). Specific trials are included in, or excluded from, reviews based on explicit quality criteria to minimize bias. Statistical effect measures used in meta-analysis of randomized control trials include risk difference (the difference in the incidence of an outcome between the experimental and control group), odds ratio (the ratio of the odds of having or not having the disease in the exposed and nonexposed group) and relative risk (the ratio of the incidence of the outcome in the exposed and nonexposed group). Number needed to treat is calculated by dividing one by the risk difference. In a meta-analysis, the contribution of an individual trial to the summary estimate of effectiveness is weighted by its size (number of patients enrolled) and the event rate (4). The 95% confidence interval (CI) around the point estimate provides information about the accuracy (confidence) of the finding (19). A large CI indicates imprecision; a narrow CI implies precision. An example of a finding from a systematic review is the use of intravenous immunoglobulin to prevent nosocomial (hospital acquired) infections in preterm infants (20). This intervention, based on a large number of infants studied, results in a statistically significant 4% reduction in the nosocomial infection rate. The 95% confidence around that effect estimate is 2% to 6%. This translates into a number needed to treat to avoid one nosocomial infection of 25, with a 95% CI of 17 to 50. This information, in addition to the point estimates for other important outcomes such as mortality (which was not statistically significantly reduced), needs to be applied in the local setting of a specific neonatal intensive care unit. In most units, such a large number needed to treat (with a blood product) to avoid an adverse outcome (nosocomial infection with no reduction in mortality) would not be considered to be beneficial. On the other hand, antenatal treatment with corticosteroids in mothers who are in danger of giving birth preterm will reduce the mortality among neonates by 4.3% (95% CI; 2.4% to 6.3%) (21). This translates into a number needed to treat of 23 pregnant women, with a 95% CI of 16 to 42 women. Because this is a low cost intervention associated with few known side effects, current clinical guidelines recommend the use of antenatal corticosteroids in most instances in which pregnant women are likely to give birth preterm (22,23). The Canadian Cochrane Network and Centre (CCN/C) is one of 14 national centres contributing to the Cochrane Collaboration (12). The mission of the CCN/C is to foster evidence-based health care decision making by identifying and supporting individuals in Canada who wish to become involved with the Cochrane Collaboration, and by promoting the awareness, appreciation, distribution, and use of Cochrane systematic reviews for health care interventions. The CCN/C is a partnership of the centre staff, site representatives from all 16 Canadian academic health sciences centres, six collaborative review groups (Hypertension, Inflammatory Bowel Disease, Neonatal, Back, Musculoskeletal, Effective Practice and Organization of Care), the Child Health Field, the Cochrane Reporting Bias Methods Group and 18 consumer and health professional affiliate organizations. The CCN/C is responsible for communications, and updates stakeholders through CC Info and Cochrane News (http://cochrane.mcmaster.ca). The CCN/C encourages the creation of multidisciplinary site groups involving health care professionals, policy makers, health system managers, cultural leaders, librarians and consumers at each of the Canadian academic health sciences centres. The CCN/C conducts training and education workshops on the development of protocols, completing reviews, statistical methods and meta-analysis, and has also held collaborative seminars and workshops with colleagues in the United States. Abstracts of systematic reviews, and plain-language synopses for consumers are posted on the Web site (http://cochrane.mcmaster.ca). The Web site has links to other organizations that synthesize research findings, and a link to the Canadian Health Network. The CCN/C produces an annual report and an abbreviated version is made available in both of Canada's official languages. The international Cochrane Collaboration organizes an annual colloquium and the CCN/C is planning for the 12th Cochrane Colloquium to take place in Ottawa, Ontario in October 2004. The research synthesis conducted in the systematic reviews in The Cochrane Library to evidence-based decision-making can be seen as an important contribution to knowledge management and translation. Knowledge management is a well-established business concept that has recently been introduced to other areas, including health care (24). Knowledge management is the process of bridging the gap between the overwhelming amount of research data, information and evidence, its synthesis and dissemination, and its absorption and resulting action by influential role models, and it includes ongoing surveillance of the results of such actions. The idea of knowledge translation has been adopted by the CIHR as one of its “cross-cutting processes” in the conceptual framework of health research. The CIHR defines knowledge translation as, “the exchange, synthesis and ethically-sound application of knowledge...” a definition that corresponds closely to the missions of the Cochrane Collaboration and the CCN/C (25). The translation of results of Cochrane reviews have the potential of improving the outcomes of health care, increasing consumer and health care provider satisfaction, decreasing costs, and directing future research in the paediatric population. Currently, the CIHR and the Conference of the Deputy Ministers of Health fund the CCN/C. Funding for the review and methods groups and the Child Health Field includes the National Institutes of Health (United States), the National Health Services (United Kingdom), CIHR, private donors, the Children's Health Foundation of Northern Alberta, the Children's and Women's Health Centre of British Columbia, the Alberta Heritage Fund for Medical Research, the Arthritis Society, the Institute for Work and Health, McMaster University, Mount Sinai Hospital and the 16 health sciences centres across Canada.

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