|Year : 2015 | Volume
| Issue : 2 | Page : 122-128
Reporting guidelines in health research: A review
Arun K Simon, Ashwini Rao, Gururaghavendran Rajesh, Ramya Shenoy, Mithun B Pai
Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal University, Mangalore, Karnataka, India
|Date of Web Publication||25-May-2015|
Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal University, Light House Hill Road, Mangalore - 575 001, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Contemporary health research has come under close scrutiny, exposing alarming flaws in the reporting of research. The reporting guidelines can aid in identification of poorly reported studies and can bring transparency to health research. The guidelines also help journal editors, peer reviewers, funding agencies, and readers to better discern health research. Reporting guidelines encourage accurate and thorough reporting of fundamental aspects of health research so that the results of studies can be replicated by others. Reporting guidelines are potent tools to improve the practice of research and in reducing reporting bias. For the present review, both electronic and manual literature search was carried out. Electronic databases like PubMed, MEDLINE, EBSCO host, and Science Direct were searched for extracting relevant articles. Various key words and their combinations were used for literature search like reporting guidelines, checklist, research, publishing standards, study design, medicine, and dentistry. The search results were scrutinized for relevance to the topic and only full text articles in English were incorporated. Various reporting guidelines were identified and grouped under headings based on study design. This review article attempts to highlight the various reporting guidelines in literature relating to health research, its potential applications, and its limitations.
Keywords: Checklist, health care research, reporting guidelines, research report
|How to cite this article:|
Simon AK, Rao A, Rajesh G, Shenoy R, Pai MB. Reporting guidelines in health research: A review. Indian J Public Health 2015;59:122-8
|How to cite this URL:|
Simon AK, Rao A, Rajesh G, Shenoy R, Pai MB. Reporting guidelines in health research: A review. Indian J Public Health [serial online] 2015 [cited 2020 Sep 29];59:122-8. Available from: http://www.ijph.in/text.asp?2015/59/2/122/157532
| Introduction|| |
Research may be defined as "the systematic and objective analysis and recording of controlled observations that may lead to the development of generalizations, principles, or theories, resulting in prediction and possible control of events."  In healthcare, there are large gaps in knowledge and theories. Research should address these issues since healthcare professionals cannot afford to take risks. Meticulously organized and controlled research helps researchers to test and compare different approaches, theories, and explore different methods.
The development of quality systematic reviews is crippled by the deficiencies in health research, which acts as a barrier for establishing treatment recommendations and ultimately patients care is compromised. A careful investigation of published studies has thrown light on the inadequacies in reporting of health research. Reporting guidelines are potent tools to improve the practice of research and in reducing bias and errors. It helps to minutely assess methodological quality of studies, detect possible biases, and compare findings.  There is a pressing need for reporting guidelines with the application of rigorous methodology in all forms of research.
Reporting guidelines attempt to modulate and standardize various hypotheses, interpretations, and methods which make them handy to use. The reporting guidelines ensure consistency in the methods used to report health research. Although variations in health research may exist, by utilizing reporting guidelines we can make reasonably confident conclusions when comparing various studies. Without the reporting guidelines, comparisons between various studies would be challenging. The aim of this article was to review the literature regarding the various published reporting guidelines in health research and explore their strengths and weakness.
| Literature Search|| |
Both electronic and manual literature search was carried out for the present article. Electronic databases like PubMed, MEDLINE, EBSCO host, and Science Direct were searched for extracting relevant articles. Exploration of Google Scholar and different web-based search engines were also done to retrieve articles. Various key words and their combinations were used for literature search like reporting guidelines, checklist, research, publishing standards, study design, medicine, and dentistry. Medical and dental literature was reviewed for articles which documented reporting guidelines in health research. Evaluation of the titles and abstracts retrieved was done before taking into account full text articles. Only full text articles in English were included. Independent and duplicate assessment for the quality of the included articles was undertaken by two members of the review team (Rao and Simon). In case of disagreements, consensus was reached through discussion between other members of the review team. Both online and manual search were carried out for the references from the retrieved articles. A total of 55,236 studies were retrieved after literature search [Figure 1] and 40,512 articles remained after duplicate removal. After the review of titles and abstracts, 253 studies remained for full text reading, out of which 177 relevant studies were selected.
|Figure 1: Flowchart depicting inclusion of studies after literature search|
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| Reporting Guidelines In Health Research|| |
With a view to categorize the core concepts of reporting guidelines in health research, the review was divided into the following sections based on various study designs:
Care (Case Report)
"Case reports can be conceptualized as a formulized description of a particular individual's history with a disease presentation and progress."  They have proved helpful in the identification of adverse and beneficial effects, the recognition of new diseases, unusual forms of common diseases, and the presentation of rare diseases. For completeness, transparency, and data analysis in case reports, the CARE guidelines were given in a consensus meeting of the CARE group at the University of Michigan in Ann Arbor in October 2012. It is a 13-item checklist in the English language translated into Chinese, Spanish, and German. ,
In the absence of reporting guidelines, case reports often are found to be unsatisfactory to be aggregated for data analysis, convey research design, or pilot clinical practice. The CARE checklist guides authors to fulfil the requirements of completeness in case reports. It strikes a fine balance between requisite detail and the concise writing required to make case reports more attractive. Some of the requirements of medical journals like conflict of interests, de-identification of patient-related data, and ethics committee approval do not find mention in CARE guidelines. 
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology)
An observational study draws conclusions on the probable effect of a treatment on subjects, where one characteristic is studied in relation to variations in others, where the investigator plays no role in assigning exposure to the study subjects. 
The STROBE initiative was established after considering the fact that observational studies are often not detailed and clear enough to estimate their strengths and weaknesses. At a 2-day workshop in Bristol, United Kingdom, in September 2004, three working groups identified items to include in checklists for each type of study.  The version 4 of the STROBE statement given in 2007 replaces the previous version given in 2004/05. It is a 22-item checklist in the English language and has been translated into Chinese, German, Greek, Japanese, Persian, Portuguese, Spanish, and Italian. ,
Versatility of STROBE
STROBE-ME:  Strengthening the Reporting of Observational studies in Epidemiology - Molecular Epidemiology.
STROME-ID:  Strengthening the Reporting of Molecular Epidemiology for Infectious Diseases.
STREGA:  Strengthening the Reporting of Genetic Association Studies.
STROBE guidelines address the three main types of observational studies: Cohort, case-control, and cross-sectional studies. It helps in giving a clear presentation of what was planned, done, and found in an observational study.  Overzealous reporting of findings in the scientific community is minimized by improving the methodology of studies. Authors can make informed decisions about the requirement and focus of new studies. The STROBE checklist is not a recipe for setting up or conducting studies. It is also not an instrument to evaluate the quality of observational research.  Some designs like case-crossover studies or ecological studies are not suitable for application of STROBE guidelines.
Parallel group randomized trials
CONSORT (Consolidated Standards of Reporting Trials)
A randomized controlled trial is an epidemiological experiment in which subjects are randomly allocated into groups, usually called study and control groups, to receive or not to receive an experimental preventive or therapeutic procedure, maneuver, or intervention. 
The CONSORT 2010 Group met in Montebello, Quebec, Canada, in January 2007 to give the CONSORT 2010 statement. This update improves the wording and clarity of the previous checklist given in 2001.  It is a 25-item checklist in the English language translated into Chinese, French, Greek, Japanese, Persian, Brazilian Portuguese, and Spanish. ,
The CONSORT checklist was developed to guide peer reviewers and editors in their evaluation of manuscripts. Evaluation of healthcare interventions can be misleading unless unbiased comparisons can be assured. Utilizing CONSORT checklist makes trial reports clear, complete, and transparent. It is to be noted that the CONSORT checklist was not meant to be used as a quality assessment instrument. Many items are not explicitly mentioned in CONSORT, such as ethics committee approval and obtaining informed consent from participants. 
CONSORT in different settings
CONSORT cluster:  Consort 2010 statement: Extension to cluster randomised trials
CONSORT harms:  Better reporting of harms in randomized trials: An extension of the CONSORT statement.
CONSORT pragmatic trials:  Improving the reporting of pragmatic trials: An extension of the CONSORT statement.
Systematic reviews and meta-analyses
PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)
"A systematic review attempts to collate all empirical evidence that fits pre-specified eligibility criteria to answer a specific research question and meta-analysis uses statistical techniques to integrate and summarize the results of included studies."  The PRISMA checklist published in 2009 was the result of a 3-day meeting held in Ottawa, Canada in June 2005.The PRISMA checklist given for systematic reviews and meta-analyses is a 27-item checklist in the English language and has been translated into Spanish, Russian, and Korean replacing the previous version QUOROM [Quality of Reporting of Meta-analyses guidelines]. ,
PRISMA-Abstracts:  Reporting Systematic Reviews in Journal and Conference Abstracts. PRISMA-Equity:  Reporting Guidelines for Systematic Reviews with a Focus on Health Equity. Key information is often poorly reported in systematic reviews, thus questioning their potential usefulness. The reporting of systematic reviews should be complete and transparent to facilitate readers to gauge the strengths and weaknesses. PRISMA guidelines help authors to ensure the transparent and complete reporting of systematic reviews and meta-analyses that are also relevant when reporting systematic reviews of non-randomized studies. 
MOOSE (Meta-analysis Of Observational Studies in Epidemiology)
In many conditions, randomized controlled designs are not practical and only data from observational studies maybe available. The inherent biases and differences in study designs makes Meta-analyses of observational studies challenging. To provide a systematic way of performing research synthesis, the MOOSE checklist was given during a workshop held in Atlanta, GA. in April 1997. The checklist was given in the English language and consists of 6 domains. 
Potential biases in the original studies, make the calculation of the estimate of effect of exposure misleading. The interpretation of summaries becomes problematic due to the diversity of study designs and populations. Publication bias may influence outcomes when combining results of several observational studies. The MOOSE guidelines can be used to identify sources of variability in results across studies. 
TREND (Transparent Reporting of Evaluations with Nonrandomized Designs)
Drawing inferences from nonrandomized designs may be necessary, as RCTs are often not practical or not ethical for evaluating many public health interventions. The TREND checklist was given for nonrandomized evaluations during the Centers for Disease Control and Prevention (CDC's) Journal editors meeting in Atlanta, GA. in July 2003. It is a 22-item checklist in the English language. TREND checklist encourages standardized and transparent reporting for nonrandomized intervention research evaluations in public health related fields. The strength of the TREND checklist is its consistency with the CONSORT checklist. The authors of the TREND checklist have proposed it for intervention evaluation studies using nonrandomized designs, and not for all research using nonrandomized designs. 
Economic evaluations of health interventions
CHEERS (Consolidated Health Economic Evaluation Reporting Standards)
Economic evaluation has been deﬁned as "the comparative analysis of alternative courses of action in terms of both their costs and their consequences."  The CHEERS checklist, developed by a task force supported by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), was published in 2013. The guidelines were developed considering the fact that economic evaluations require more reporting space for items, such as resource use, costs, preference related information, and cost effectiveness results.  It is a 24-item checklist given in the English language. 
Transparency in reporting economic evaluations is of paramount importance due to the risk of making costly decisions due to poor reporting in addition to the lack of mechanisms that promote accountability. The CHEERS statement is an effective consolidation providing a starting point for standard reporting. Although the guidelines allow analysts the freedom to choose different methods, some less common approaches and contexts for conducting health economic evaluation are not well represented. 
Studies of diagnostic accuracy
STARD (Standards for reporting of diagnostic accuracy)
In studies of diagnostic accuracy, one or more tests are evaluated with the purpose of detecting or predicting a target condition. Exaggerated and biased results from poorly designed and reported diagnostic studies can trigger their premature dissemination and can lead physicians into making incorrect treatment decisions. To limit healthcare costs by preventing unnecessary testing and to improve the quality of reporting of studies of diagnostic accuracy, the STARD guidelines were published by the STARD steering committee in 2003.  It is a 25-item checklist given in the English language, which has been translated into Chinese, Dutch, French, German, Italian, Spanish, and Japanese.  It is useful to detect the potential bias and to assess the generalizability and applicability of the results. 
The methodology for designing and conducting studies of diagnostic accuracy is still maturing and the understanding of the sources of variability and the potential for bias is growing. The STARD guidelines support the author to describe essential elements of the design and conduct of the study, the execution of tests, and the results and to appraise the applicability of the findings. Since studies of diagnostic accuracy are not the only type of studies to evaluate diagnostic tests, STARD guidelines may not be applicable in certain situations. 
COREQ (Consolidated criteria for Reporting Qualitative research)
Qualitative studies use non-quantitative methods to contribute new knowledge and to provide new perspectives in health care. The COREQ guidelines published in 2007 is a 32-item checklist in the English language for qualitative research interviews and focus groups. , It is useful for eliciting patient priorities and needs to improve the quality of healthcare. Guidelines like COREQ are designed to encourage improvement in the quality of reporting of qualitative studies, which in turn leads to improved conduct. It promotes complete and transparent reporting among researchers and indirectly improves the comprehensiveness and credibility of interview and focus group studies. The checklist consists of items specific to reporting qualitative studies and precludes generic criteria that are applicable to all types of research reports. 
Synthesis of qualitative research
ENTREQ (Enhancing Transparency in Reporting the synthesis of Qualitative research)
"Syntheses of qualitative research can pool data across different contexts, generate new theoretical or conceptual models, identify research gaps, inform the development of primary studies, and provide evidence for the development, implementation and evaluation of health interventions."  ENTREQ guidelines was published as a 21 item checklist in English language in 2012 for reporting synthesis of qualitative studies.  The synthesis of findings from numerous qualitative studies can provide excellent understanding of participants across healthcare contexts. The guidelines assist researchers to enhance the conduct and reporting of qualitative syntheses. It is a useful guide for beginners and readers of syntheses of qualitative health research. 
Quality improvement studies
SQUIRE (Standards for Quality Improvement Reporting Excellence)
"Improvement efforts focus primarily on making care better at unique local sites, rather than on generating new, generalizable scientific knowledge."  Since published reports of improvement work in healthcare differ in both content and quality, the SQUIRE guidelines were developed. It involved the initial publication of guidelines in 2005, a period of open, public feedback, and a consensus conference in April 2007. It is a 19-item checklist in the English language that has been translated into Japanese, Norwegian, and Spanish. 
Quality improvement studies may not be familiar with many journal editors, peer reviewers, funding agencies, and other stakeholders. The SQUIRE guidelines present a comprehensive list which will be useful for large and complex improvement studies. It helps authors write comprehensive, usable articles about quality improvement in healthcare so that findings may be easily discovered and widely disseminated. 
Reporting in vitro studies of dental materials
For evaluating potential new materials or techniques, in vitro research is vital. Although in vitro research cannot reproduce a dynamic environment, it can provide important information about the properties and characteristics of a new material or technique. This checklist was published in 2012 and is a pilot proposal suited for reporting of experiments with extracted human teeth. It is essentially the CONSORT 2010 guidelines adapted to dental in vitro studies consisting of 14 items given in the English language. The checklist acts as a template for reporting in vitro studies in dentistry. 
Basic statistical reporting for articles published in biomedical journals
SAMPL (Statistical Analyses and Methods in the Published Literature)
Large proportions of articles contain errors in the application, analysis, interpretation, or reporting of statistics or in the design or conduct of research. These errors are serious enough to cast doubts on authors' conclusions.  The SAMPL guidelines were developed to overcome poor statistical reporting. The guidelines are given in the English language.  In many journals, guidelines for reporting statistical methods are limited to a paragraph or two in the instructions to the authors. Although the SAMPL guidelines are limited to the most common statistical analyses, they are sufficient to prevent most of the reporting deficiencies routinely found in scientific articles. These guidelines do not address the issues related to the design and conduct of research. The SAMPL guidelines are more specific and they complement the statistical guidelines given by reporting guidelines like CONSORT and STROBE. 
Guidance for developers of health research reporting guidelines
There is often a lack of information on how individual guidelines were developed and there is also dearth of frame works to guide researchers to construct reporting guidelines in health research. Moher et al. in 2010 proposed 18 steps in five phases to help guide authors in developing reporting guidelines.  The SPIRIT 2013 statement provides guidance for developing protocols for clinical trials. 
Additional reporting guidelines in health research
In health research, there are numerous reporting guidelines in published literature and many more in the anvil for specific diseases or conditions. The reporting guidelines in health research discussed in this study are with their acronyms in [Table 1].
| Conclusions|| |
The potential benefits of good reporting are largely untapped. Reporting guidelines assist researchers to not only improve the transparency and completeness of their research reports but also helps to identify poorly reported studies. Peer reviewers and editors can utilize reporting guidelines to strengthen manuscript review. These guidelines are not constant since they evolve with time requiring continual monitoring and updating. Editors have a major responsibility to promote the use of well-developed guidelines for the reporting of research studies published by their journal. A clear and complete reporting of research by the use of reporting guidelines results in more efficient use of the new findings which improves clinical practice and patient care.
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