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Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies.The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers.This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated web site (http://www.strobe-statement.org) should be helpful resources to improve reporting of observational research. (Epidemiology 2007;18: 805-835) R ational health care practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis and treatment of diseases. Randomized trials provide valuable evidence about treatments and other interventions. However, much of clinical or public health knowledge comes from observational research. 1 About nine of ten research papers published in clinical speciality journals describe observational research. 2,3 The STROBE StatementReporting of observational research is often not detailed and clear enough to assess the strengths and weaknesses of the investigation. 4,5 To improve the reporting of observational research, we developed a checklist of items that should be addressed: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement (Table 1). Items relate to title, abstract, introduction, methods, results and discussion sections of articles. The STROBE Statement has recently been published in several journals. 6 Our aim is to ensure clear presentation of what was planned, done, and found in an observational study. We stress that the recommendations are not prescriptions for setting up or conducting studies, nor do they dictate methodology or mandate a uniform presentation.STROBE provides general reporting recommendations for descriptive observational studies and studies that investigate 805associations between expos...
Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalizability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies.The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers.This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated web site (http://www.strobe-statement.org) should be helpful resources to improve reporting of observational research. (Epidemiology 2007;18: 805-835) R ational health care practices require knowledge about the etiology and pathogenesis, diagnosis, prognosis and treatment of diseases. Randomized trials provide valuable evidence about treatments and other interventions. However, much of clinical or public health knowledge comes from observational research. 1 About nine of ten research papers published in clinical speciality journals describe observational research. 2,3 The STROBE StatementReporting of observational research is often not detailed and clear enough to assess the strengths and weaknesses of the investigation. 4,5 To improve the reporting of observational research, we developed a checklist of items that should be addressed: the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement (Table 1). Items relate to title, abstract, introduction, methods, results and discussion sections of articles. The STROBE Statement has recently been published in several journals. 6 Our aim is to ensure clear presentation of what was planned, done, and found in an observational study. We stress that the recommendations are not prescriptions for setting up or conducting studies, nor do they dictate methodology or mandate a uniform presentation.STROBE provides general reporting recommendations for descriptive observational studies and studies that investigate 805associations between expos...
Study Selection: Cohort, case-control, and crosssectional studies published as original articles during the period January 2005 through December 2007. Studies were identified with a literature search of PubMed combining the journal title and the term epidemiological studies (free text) and by hand searching all of the issues of each journal to identify relevant articles.Data Extraction: All articles were extracted by 2 reviewers independently using standardized checklists based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations. Data Synthesis:The number and proportion of reported STROBE items were analyzed for each article. The proportion of studies with good reporting for each item was also assessed.Results: A total of 138 articles were included and analyzed. Reporting quality was very mixed. Key areas that were infrequently reported included sample size calculations (n=10 [7%]), missing data (n=8 [6%]), losses to follow-up (n=17 [12%]), and statistical methods (n=19 [14%]). Only 13 studies (9%) explained the role of funders in the research. The quality of reporting was similar across study designs for "critical" questions with the exception of reporting of participant details, which was better reported in cohort studies (96%) compared with cross-sectional (80%) and case-control (70%) studies.Conclusions: It is difficult to judge the quality of dermatological research unless it is reported well. This study has identified a clear need to improve the quality of reporting of observational studies in dermatology. We recommend that dermatology journals adopt the STROBE criteria.
it is not uncommon for highly cited studies of clinical interventions and their outcomes to be contradicted by subsequent research. The author noted several possible factors for this finding, including study-to-study variability and publication bias.An additional contributor to the observed discrepancy among study results concerns the meaning of the typical marker of research significance, the P value. The P value is the probability of a finding, assuming that there is in truth no effect; it is not simply the probability that there is no effect. As noted by Browner and Newman, 2 research studies are analogous to diagnostic tests and P values are like falsepositive rates when what we really seek is akin to a positive predictive value.A diagnostic test with high sensitivity and specificity may still be ineffective if disease prevalence is low. Similarly, a small P value can be misleading if the prior probability of an effect is low. For example, application of Bayes' theorem shows that if the prior probability of an effect is 10%, a P value of .05 from a study with 80% power results in a "falsepositive report probability" 3 of 36%: this leads to a far different interpretation of the study findings than the P value alone would suggest.Because much high-profile research is notable for its surprise factor, the prior probabilities of true effect may often be relatively low. We should not then be surprised when subsequent studies provide contradictory results. As noted by Davidoff, 4 one solution to this quandary is to better understand Bayesian approaches to study analysis and interpretation. Until such approaches are rendered comprehensible to the average researcher, 5,6 however, we should at least understand the limitations of the P value. Financial Disclosures: None reported. 1. Ioannidis JPA. Contradicted and initially stronger effects in highly cited clinical research. JAMA. 2005;294:218-228. 2. Browner WS, Newman TB. Are all significant P values created equal? the analogy between diagnostic tests and clinical research. JAMA. 1987;257:2459-2463. 3. Wacholder S, Chanock S, Garcia-Closas M, et al. Assessing the probability that a positive report is false: an approach for molecular epidemiology studies.
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