Search

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 4 are specific to each of the 3 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, 1 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 (www.strobe-statement.org) should be helpful resources to improve reporting of observational research. [ABSTRACT FROM AUTHOR]

Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover 3 main study designs: cohort, case—control, and cross sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors, to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all 3 study designs and 4 are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available at www.annals.org and on the Web sites of PLoS Medicine and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies. [ABSTRACT FROM AUTHOR]

Presents the viewpoint of the author on the use of observational studies. Belief that they are essential for knowledge about causes and pathogenesis of diseases; How medical practice relies on observational studies of prognosis and diagnosis; Thoughts on the current debate over the value of observational versus randomised research; Example of two cases including the adverse effects of drugs and genetic causes of disease to show under what circumstances evidence from observational research is as good as that from randomised trials: Belief that this description can be generalised to other areas of clinical and epidemiological research; Suggestion for a three-pronged approach to research,.

The article discusses the roles of case reports and case series in evidence-based medicine. The two categories of case reports and case series are the progress of medical science and education and quality assurance. A case-report teaches what is unknown or unrecognized. Case reports have taken a rough treatment concerning patient privacy and autonomy. The greatest challenge of a case-report is that it should bring a general truth.

Presents a study to assess the quality of medical research and the evidence hierarchies that are prone to confuse practitioners and researchers. Use of hierarchies to determine the effects of interventions in clinical decision making; Use of randomized trials to give estimations of treatment effects; Analysis of systemic reviews of research; Suggestion that balanced assessments should make use of a variety of types of research; Investigation of control studies that have found adverse effects.

The author discusses the issue on the protocols preregistration of the epidemiologic studies. Topics discussed include the advantages and disadvantages of preregistration in the randomized controlled trial (RCT), the systematic review of RCT, and the issue of possible failure and fraud on the observational research registration.

A letter to the editor is presented in response to the editorial "Should Protocols for Observational Research Registered?" in the January 30, 2010 issue.

Background: There are no analyses of citations to books on epidemiological and statistical methods in the biomedical literature. Such analyses may shed light on how concepts and methods changed while biomedical research evolved. Our aim was to analyze the number and time trends of citations received from biomedical articles by books on epidemiological and statistical methods, and related disciplines. Methods and Findings: The data source was the Web of Science. The study books were published between 1957 and 2010. The first year of publication of the citing articles was 1945. We identified 125 books that received at least 25 citations. Books first published in 1980–1989 had the highest total and median number of citations per year. Nine of the 10 most cited texts focused on statistical methods. Hosmer & Lemeshow's Applied logistic regression received the highest number of citations and highest average annual rate. It was followed by books by Fleiss, Armitage, et al., Rothman, et al., and Kalbfleisch and Prentice. Fifth in citations per year was Sackett, et al., Evidence-based medicine. The rise of multivariate methods, clinical epidemiology, or nutritional epidemiology was reflected in the citation trends. Educational textbooks, practice-oriented books, books on epidemiological substantive knowledge, and on theory and health policies were much less cited. None of the 25 top-cited books had the theoretical or sociopolitical scope of works by Cochrane, McKeown, Rose, or Morris. Conclusions: Books were mainly cited to reference methods. Books first published in the 1980s continue to be most influential. Older books on theory and policies were rooted in societal and general medical concerns, while the most modern books are almost purely on methods. [ABSTRACT FROM AUTHOR]

Objectives: Instrumental variable (IV) analysis is promising for estimation of therapeutic effects from observational data as it can circumvent unmeasured confounding. However, even if IV assumptions hold, IV analyses will not necessarily provide an estimate closer to the true effect than conventional analyses as this depends on the estimates' bias and variance. We investigated how estimates from standard regression (ordinary least squares [OLS]) and IV (two-stage least squares) regression compare on mean squared error (MSE). Study Design: We derived an equation for approximation of the threshold sample size, above which IV estimates have a smaller MSE than OLS estimates. Next, we performed simulations, varying sample size, instrument strength, and level of unmeasured confounding. IV assumptions were fulfilled by design. Results: Although biased, OLS estimates were closer on average to the true effect than IV estimates at small sample sizes because of their smaller variance. The threshold sample size above which IV analysis outperforms OLS regression depends on instrument strength and strength of unmeasured confounding but will usually be large given the typical moderate instrument strength in medical research. Conclusion: IV methods are of most value in large studies if considerable unmeasured confounding is likely and a strong and plausible instrument is available. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To examine the registration of noninferiority trials, with a focus on the reporting of study design and noninferiority margins. Study Design and Setting: Cross-sectional study of registry records of noninferiority trials published from 2005 to 2009 and records of noninferiority trials in the International Standard Randomized Controlled Trial Number (ISRCTN) or ClinicalTrials.gov trial registries. The main outcome was the proportion of records that reported the noninferiority design and margin. Results: We analyzed 87 registry records of published noninferiority trials and 149 registry records describing noninferiority trials. Thirty-five (40%) of 87 records from published trials described the trial as a noninferiority trial; only two (2%) reported the noninferiority margin. Reporting of the noninferiority design was more frequent in the ISRCTN registry (13 of 18 records, 72%) compared with ClinicalTrials.gov (22 of 69 records, 32%; P =0.002). Among the 149 records identified in the registries, 13 (9%) reported the noninferiority margin. Only one of the industry-sponsored trial compared with 11 of the publicly funded trials reported the margin (P =0.001). Conclusion: Most registry records of noninferiority trials do not mention the noninferiority design and do not include the noninferiority margin. The registration of noninferiority trials is unsatisfactory and must be improved. [Copyright &y& Elsevier]

Abstract: Much of biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study''s generalizability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case–control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. Eighteen items are common to all three study designs and four are specific for cohort, case–control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies. [Copyright &y& Elsevier]