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Raising the Bar: The Use of Standardized Reporting Guidelines
EDITORIAL
Raising the Bar: The Use of Standardized Reporting Guidelines What makes a study believable? Is Level I evidence “the best”? These are sometimes difficult questions to answer directly, but there are clearly some trials or studies reported that are better than others. For example, a study in which the patient is blinded to the study protocol but the outcome observer is not blinded may lead to its own form of bias in reporting results. In the effort to standardize the reporting of clinical trials, meta-analyses, and other studies, and to publish ethical, responsible, and transparent research, the Journal of Hand Surgery is committing to the following guidelines for authors in both planning and submitting research studies: The CONSORT statement (CONsolidated Standards Of Reporting Trials),
a 22-item checklist designed for use in reporting randomized clinical trials.1 The PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)—to be used in designing and reporting comprehensive reviews.2 The STROBE guidelines (Strengthening the Reporting of Observational Studies in Epidemiology) used for case reports, cohort studies, and patient series.3 The STARD initiative (Standards for Reporting of Diagnostic Accuracy) for diagnostic measure research.4 In addition, the Journal is defining additional criteria for systematic reviews and meta-analyses as follows: A worthy meta-analysis will follow the PRISMA guidelines, be hypothesis-
driven to address a specific aspect of a topic, include sufficient (ideally at least 10) Level I and II evidence studies that can be supplemented with comparative Level III studies, and not include Level IV studies. The result should clarify the issue addressed and be submitted as a full-length scientific article. A repeat meta-analysis should follow the original study by at least 5 years, analyze at least 50% more data, and follow the above guidelines. An appropriate systematic review will similarly follow the PRISMA guidelines, be hypothesis-driven, and focus on a specific aspect of a topic, and it may include low-level evidence. The results should clarify the issue addressed. As a resource for authors, reviewers, and editors, the EQUATOR network (Enhancing the QUAlity and Transparency Of health Research) is an international initiative that serves as a repository for the basis literature, checklists, and other information for these and other guidelines (http://www.equator-network.org), including access to Spanish and other translations.5 Recent evidence has shown that adherence to the use of these guidelines improves both the quality6 and standardization for meta-analyses.7 These data form the basis for evidence-based medicine or the use of existing
Ó 2014 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1905
1906
EDITORIAL
literature to inform decisions about clinical care. It makes sense that the better the quality and organization of the literature, the better we can compare results across studies. This gives us as hand surgeons the tools to choose best practices, supported by rigorous research, for our patients. Jennifer Moriatis Wolf, MD Department of Orthopaedic Surgery University of Connecticut Health Center Farmington, CT http://dx.doi.org/10.1016/j.jhsa.2014.08.001 REFERENCES 1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191e1194. 2. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. 3. Knottnerus A, Tugwell P. STROBE—a checklist to Strengthen the Reporting of Observational Studies in Epidemiology. J Clin Epidemiol. 2008;61(4):323. 4. Bossuyt PM, Reitsma JB; Standards for Reporting of Diagnostic Accuracy. The STARD initiative. Lancet. 2003;361(9351):71. 5. Simera I. EQUATOR Network collates resources for good research. BMJ. 2008;337:a2471. 6. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030. 7. Manchikanti L, Datta S, Smith HS, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 6. Systematic reviews and meta-analyses of observational studies. Pain Physician. 2009;12(5):819e850.
J Hand Surg Am.
r
Vol. 39, October 2014
Raising the Bar: The Use of Standardized Reporting Guidelines What makes a study believable? Is Level I evidence “the best”? These are sometimes difficult questions to answer directly, but there are clearly some trials or studies reported that are better than others. For example, a study in which the patient is blinded to the study protocol but the outcome observer is not blinded may lead to its own form of bias in reporting results. In the effort to standardize the reporting of clinical trials, meta-analyses, and other studies, and to publish ethical, responsible, and transparent research, the Journal of Hand Surgery is committing to the following guidelines for authors in both planning and submitting research studies: The CONSORT statement (CONsolidated Standards Of Reporting Trials),
a 22-item checklist designed for use in reporting randomized clinical trials.1 The PRISMA checklist (Preferred Reporting Items for Systematic Reviews and Meta-Analyses)—to be used in designing and reporting comprehensive reviews.2 The STROBE guidelines (Strengthening the Reporting of Observational Studies in Epidemiology) used for case reports, cohort studies, and patient series.3 The STARD initiative (Standards for Reporting of Diagnostic Accuracy) for diagnostic measure research.4 In addition, the Journal is defining additional criteria for systematic reviews and meta-analyses as follows: A worthy meta-analysis will follow the PRISMA guidelines, be hypothesis-
driven to address a specific aspect of a topic, include sufficient (ideally at least 10) Level I and II evidence studies that can be supplemented with comparative Level III studies, and not include Level IV studies. The result should clarify the issue addressed and be submitted as a full-length scientific article. A repeat meta-analysis should follow the original study by at least 5 years, analyze at least 50% more data, and follow the above guidelines. An appropriate systematic review will similarly follow the PRISMA guidelines, be hypothesis-driven, and focus on a specific aspect of a topic, and it may include low-level evidence. The results should clarify the issue addressed. As a resource for authors, reviewers, and editors, the EQUATOR network (Enhancing the QUAlity and Transparency Of health Research) is an international initiative that serves as a repository for the basis literature, checklists, and other information for these and other guidelines (http://www.equator-network.org), including access to Spanish and other translations.5 Recent evidence has shown that adherence to the use of these guidelines improves both the quality6 and standardization for meta-analyses.7 These data form the basis for evidence-based medicine or the use of existing
Ó 2014 ASSH
r
Published by Elsevier, Inc. All rights reserved.
r
1905
1906
EDITORIAL
literature to inform decisions about clinical care. It makes sense that the better the quality and organization of the literature, the better we can compare results across studies. This gives us as hand surgeons the tools to choose best practices, supported by rigorous research, for our patients. Jennifer Moriatis Wolf, MD Department of Orthopaedic Surgery University of Connecticut Health Center Farmington, CT http://dx.doi.org/10.1016/j.jhsa.2014.08.001 REFERENCES 1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191e1194. 2. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. 3. Knottnerus A, Tugwell P. STROBE—a checklist to Strengthen the Reporting of Observational Studies in Epidemiology. J Clin Epidemiol. 2008;61(4):323. 4. Bossuyt PM, Reitsma JB; Standards for Reporting of Diagnostic Accuracy. The STARD initiative. Lancet. 2003;361(9351):71. 5. Simera I. EQUATOR Network collates resources for good research. BMJ. 2008;337:a2471. 6. Turner L, Shamseer L, Altman DG, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030. 7. Manchikanti L, Datta S, Smith HS, Hirsch JA. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: part 6. Systematic reviews and meta-analyses of observational studies. Pain Physician. 2009;12(5):819e850.
J Hand Surg Am.
r
Vol. 39, October 2014