ealth care providers, researchers, and policy
makers are inundated with unmanageable amounts of information on a daily
basis. There are too many trials, approximately 8000 articles get
published every day, and there are about 25000 biomedical journals in
print [1]. All published studies are not equally well designed or
interpreted. Systematic Reviews (SRs) identify, appraise and synthesize
research-based evidence and present it in accessible format for
clinicians and healthcare practitioners. SRs integrate existing
information and provide data for rational decision-making by providing
systematically generated scientific evidence for policy briefs.
Knowledge and training in evidence-based medicine (EBM) is essential for
informed clinical decision-making and treatment choices. It helps the
clinicians to critically appraise the promotional literature about new
drugs. In addition, it also equips them with skills to undertake and
publish systematic reviews in journal publications. For the policy
makers, the knowledge of EBM helps in prioritization of health issues
leading to judicious use of limited resources.
Conduct of systematic reviews is based on an EBM
approach that distinguishes it from the traditional reviews: an explicit
and systematic process of search; criteria-based selection of studies
and critical appraisal and synthesis of scientific evidence that is
without personal bias inherent in traditional reviews and expert
opinions. Systematic reviews top the ’evidence pyramid’ [2] by
generating level 1 evidence due to rigorous methodology (adopted and
a priori outlined in the protocol), and relatively large sample size
achieved by pooling data from a set of studies. Results of meta-analyses
(not always a part of systematic review) provide a comprehensive but
concise view of research evidence on specific issues for the policy
makers.
History of Evidence-Based Medicine
The term evidence-based medicine was coined by a
group of epidemiologists led by David Sackett and Gordon Guyatt from
McMaster university. EBM is defined as "the conscientious, explicit and
judicious use of current best evidence in making decisions about the
care of individual patients". The practice of EBM means integrating
individual clinical experience with the best available external clinical
evidence from systematic research [3].
Deeply inspired by the works of Archie Cochrane and
his comments about systematic analysis of randomized controlled trials
(RCTs), Prof. Iain Chalmers during the years 1978-82 started work for
establishing the National Perinatal Epidemiology Unit in Oxford by hand
searching of 15 journals upto 1948, to find 3500 RCTs and preparing
their critical summaries. Thus the Oxford Database of Perinatal Trials
and later Database of Pregnancy and Childbirth were established. These
efforts led to the establishment of the Cochrane Collaboration in 1992,
known for its systematic reviews. The James Lind Initiative, formed in
2003, is another organization that promotes/lobbies for better and
relevant RCTs, because these studies can provide the most important
information needed to improve healthcare [4].
The Role of Evidence in Guiding Health Research
The Indian Council of Medical Research (ICMR), New
Delhi, is the apex body in India for the formulation, coordination and
promotion of biomedical research. It contributes significantly to the
formulation of policy at the national level through the translational
component of research output of its constituent institutions. However,
due to incoherent and duplicating efforts of various agencies involved
in research and lack of coordination among them, a gap between research,
decision-making and clinical practice still remains [5]. The shared
conceptual clarity among researchers and policy makers about the scope
and nature of health research to be conducted is insufficient. During
the past, in absence of evidence from systematic reviews, the national
disease control programs have been guided by the outputs of operational
research carried out in the country [6]. At present, there is a scope of
knowledge brokering – a strategy to close the ’know–do gap’ to promote
evidence [7-9]. Systematic reviews can fill this gap efficiently.
ICMR Initiatives in EBM
The science of evidence-based medicine is still in
its infancy in the country. ICMR has promoted EBM in India by funding an
Advanced Center for EBM (2007-2011) that hosted the South Asian Cochrane
Network & Centre (SACNC) at the Christian Medical College, Vellore.
In 2007, ICMR procured a national subscription to The
Cochrane Library making it accessible to all Indian scientists. This was
a major achievement that opened the doors of EBM in India. Accessibility
of the Cochrane library through a national subscription led to an
increase in the number of contributors to the Cochrane Library from
India.
In another initiative, ICMR established an Advance
Center for Evidence-Based Child Health (CAR EBCH) at the Post Graduate
Institute, Chandigarh since 2011. Through its capacity building
component, CAR EBCH is training students and young faculty of medical
colleges in various parts of India.
Outcomes of Ongoing Initiatives: A Situational
Analysis
SACNC is taking lead and is steadily increasing the
pool of personnel trained in EBM around the network sites. The Cochrane
contributors from India are concentrated in institutions that hosted the
network sites. Further efforts are needed to engage more and more Indian
scientists in the conduct of systematic reviews. Capacity building
beyond the SACNC network sites is needed [10].
National subscription to The Cochrane Library over a
period of 7 years has led to an increase in Cochrane Reviews by Indian
authors. Protocols and full reviews with Indian authors have increased
marginally from 11 (in 2005) to 272 (in February 2014).
The number of journal publications listed as
systematic reviews by Indian authors still remains limited. Systematic
reviews published in the PubMed indexed journals by Indian authors are
limited to 1437 (till March 2014). Indian medical journals, indexed at
IndMed, published 62 systematic reviews upto 2014 [11].
The New Initiative
Realizing the limited reach and output from the
already ongoing initiatives, ICMR has initiated a central program at the
national level to complement them, and increase the pool of scientists
trained in the conduct of systematic reviews in India. This program
would directly facilitate the conduct and publication of systematic
reviews by Indian scientists. This National level program is unique in
that it proposes to provide funding to the prospective authors, for
conducting secondary research, in the same way as it does for primary
extramural research. Objectives of this program are to harness the
translational potential of secondary research, by funding systematic
reviews aligned to national health priorities, selected through a
national competitive process; and to provide training, mentoring, and
quality assurance, in order to ensure the timely completion of
high-quality reviews.
ICMR advertised for letters of intent (LOIs) from
Indian scientists interested in carrying out systematic reviews in
maternal, perinatal, newborn, child, and adolescent health. A project
review committee (PRC), consisting of clinicians with expertise in the
area of EBM, critically evaluated the 36 LOIs received for their
suitability and relevance to current national priorities; potential to
identify evidence-gaps for initiation of primary research; compliance
with current best methods in research synthesis; and the expertise of
the review team and their training needs. The 36 LOIs were individually
scored by the lead discussants. In the end there were 9 LOIs accepted by
the committee for submission of full protocol within a period of three
months. A format for preparing the protocol was provided by ICMR to the
selected review authors. Out of the LOIs that were not recommended for
funding in the present form, the committee recognized the potential of
five investigators to become systematic reviewers in future, and
suggested their inclusion in capacity building workshops on EBM
sponsored by ICMR. A total of twenty-three prospective authors were
nominated by the PRC for training in Systematic reviews.
Training, Mentoring and Quality Assurance
A two day protocol development workshop was organized
by ICMR. The facilitators were faculty of SACNC and JHSPH. In order to
ensure uniformity in the methods and standards in the reviews, the
authors were advised to follow the Cochrane Handbook for intervention
reviews to prepare protocols. They could use RevMan, STATA or other
program; however, use of the Cochrane format for the protocols and the
full reviews was recommended. It was advised to grade the overall
quality of the evidence using GRADE profiler,
http://ims.cochrane.org/revman/gradepro Authors were advised to
detail which outcomes (maximum seven) will be considered for inclusion
in the Summary of Findings Tables created using GRADE Pro.
Authors of selected reviews topics related to social
sciences were advised to consult the methods recommended by the EPPI
centre or use the software provided by the EPPI Centre
http://eppi.ioe.ac.uk/cms/. Participants came with their topics for
systematic review that were discussed during the workshop. Handson
training in using Review Manager (RevMan) and GRADE Profiler software
was held. All participants provided feedback via emails and reported
that their training goals were fulfilled.
At the end of the workshop, nine review titles were
shortlisted for development of full protocols, with appropriate funding
assured, contingent on the submission of the protocol. All nine
author-teams submitted protocols using RevMan, within three months.
The selected topics included important knowledge gaps
and research questions of priority in the area of Child Health: exposure
to electronic media and adolescent health outcomes, antihypertensive
drugs for primary or secondary hypertension in children, estimating
equations for glomerular filtration rate for chronic kidney disease in
children, impact of supplemental nutrition component of Integrated Child
Development Scheme (ICDS) program on nutrition of children aged 6-72
months in India, Impact of water, sanitation and hygiene Interventions
on growth, non-diarrheal morbidity and mortality in children, effect of
home visitation by paramedical professional in pregnancy for reducing
low birth weight incidence in developing countries, Impact of Integrated
Management of Childhood Illness (IMCI) strategy of training health care
providers for reduction of childhood mortality in low and middle income
countries, Impact of interventions to increase agricultural production
on children’s nutritional status, and effect of zinc supplementation on
growth in children under 5 years of age in low and middle income
countries.
In April 2014, ICMR invited the authors for a
protocol-refinement workshop. Objectives and methodologies were
discussed and inputs for improve-ment were provided by the PRC members.
Full reviews are expected from authors shortly
It is expected that conclusions drawn from these
systematic reviews in priority areas would provide input for the policy
briefs, and bridge the knowledge gap leading to new primary research.
Scope of The New Initiative
Adequate funding by ICMR, careful pre-selection of
review topics and author teams by the PRC, exposure of potential authors
in Cochrane methodology through provision of suitable training, repeated
quality assurance measures taken up such as protocol refining workshop
and assistance extended by the secretariat, can result in short review
production timelines. This ICMR initiative will help expand the pool of
trained systematic reviews authors in India.
Outcomes of this initial call for letters of intent
for systematic reviews would lead to a continuing scheme of funding for
the benefit of Indian scientists providing condensed, balanced and
verifiable information through conduct of systematic reviews on priority
areas and policy related issues.
References
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by Jan Glover, David Izzo, Karen Odato and Lei Wang. Available from:
http://libguides.indstate.edu/ebp. Accessed October 7, 2014.
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4. Excerpts from the Plenary Lecture delivered by Sir
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