345 research outputs found

    Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration

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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 generalisability 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

    Mejorar la comunicación de estudios observacionales en epidemiología (STROBE): explicación y elaboración

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    Gran parte de la investigación biomédica es de tipo observacional. Los informes de los estudios observacionales a menudo poseen una calidad insuficiente, lo que dificulta la evaluación de sus fortalezas y debilidades para generalizar los resultados. Teniendo en cuenta la evidencia empírica y consideraciones teóricas, un grupo de expertos en metodología, investigadores y editores de revistas científicas, desarrollaron una lista de recomendaciones para aumentar la calidad de las publicaciones de los estudios observacionales: (STROBE). La Declaración STROBE consiste en una lista de verificación de 22 puntos que guardan relación con las diferentes secciones de un artículo: título, resumen, introducción, metodología, resultados y discusión. De ellos, 18 puntos son comunes a los tres diseños de estudio: cohorte, casos y controles, y transversales; los otros cuatro son específicos para cada una de estas tres modalidades. La Declaración STROBE proporciona a los autores información sobre cómo mejorar la calidad de los artículos sobre estudios observacionales y facilita a los revisores, editores de revistas y lectores su apreciación crítica y su interpretación. Este documento explicativo tiene el propósito de impulsar el uso, la comprensión y la difusión de la Declaración STROBE. Se presentan el significado y el análisis razonado para cada punto de la lista de verificación, proporcionando uno o varios ejemplos publicados en la literatura y, en lo posible, referencias de estudios empíricos relevantes y literatura metodológica. También se incluyen ejemplos de diagramas de flujo. La Declaración STROBE, el presente documento y la página Web asociada () son recursos útiles para mejorar la divulgación de la investigación observacional.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 generalisability 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 () should be helpful resources to improve reporting of observational research

    Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration.

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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 generalisability 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. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine R.T. Saygitov.Present translation was first published in Digital Diagnostics. doi: 10.17816/DD70821. It is published with minor changes related to the literary editing of the translation itself

    Повышение качества отчётов о наблюдательных исследованиях в эпидемиологии (STROBE): разъяснения и уточнения

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    Большинство медицинских исследований являются наблюдательными (observational). Сообщения о таких ис-следованиях часто невысокого качества, что затрудняет оценку сильных и слабых сторон работы, а также обоб-щаемости (generalizability) её результатов. Принимая во внимание эмпирические свидетельства и теоретические соображения, группа методологов, исследователей и научных редакторов разработала рекомендации «Повышение качества отчётов о наблюдательных исследованиях в эпидемиологии (STROBE): разъяснения и уточнения». Реко-мендации STROBE содержат 22 пункта, связанных с оформлением следующих разделов научных статей: название, аннотация, введение, методы, результаты и их обсуждение, при этом 18 пунктов являются общими для когортных исследований (cohort studies), исследований «случай–контроль» (case-control studies) и одномоментных исследова-ний (cross-sectional studies); 4 пункта специфичны для каждого из указанных дизайнов исследований (study designs). STROBE ― руководство для авторов, необходимое для повышения качества отчётов о наблюдательных исследова-ниях, облегчающее критическую оценку исследования и его интерпретацию рецензентами, редакторами журналов и читателями. Цель этой разъясняющей и уточняющей статьи ― способствовать более широкому применению, пониманию и распространению стандартов STROBE. В ней даётся разъяснение смысла и обоснование применения каждого пункта руководства (checklist). По каждому пункту приводятся один или несколько опубликованных при-меров правильного представления исследований и, при возможности, библиографические ссылки на подходящие эмпирические исследования и методологическую литературу. Представлены примеры потоковых диаграмм (flow diagrams) для описания последовательности исследования. Рекомендации STROBE, настоящая статья и соответ-ствующий веб-сайт (http://www.strobe-statement.org/) должны стать полезным источником для повышения качества отчётов о результатах наблюдательных исследований. This article is the reprint with Russian translation of the original that can be observed here: Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med. 2007;4(10):e297. doi: 10.1371/journal.pmed.0040297

    The relationship of the factor V Leiden mutation or the deletion-deletion polymorphism of the angiotensin converting enzyme to postoperative thromboembolic events following total joint arthroplasty

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    BACKGROUND: Although all patients undergoing total joint arthroplasty are subjected to similar risk factors that predispose to thromboembolism, only a subset of patients develop this complication. The objective of this study was to determine whether a specific genetic profile is associated with a higher risk of developing a postoperative thromboembolic complication. Specifically, we examined if the Factor V Leiden (FVL) mutation or the deletion polymorphism of the angiotensin-converting enzyme (ACE) gene increased a patient's risk for postoperative thromboembolic events. The FVL mutation has been associated with an increased risk of idiopathic thromboembolism and the deletion polymorphism of the ACE gene has been associated with increased vascular tone, attenuated fibrinolysis and increased platelet aggregation. METHODS: The presence of these genetic profiles was determined for 38 patients who had a postoperative symptomatic pulmonary embolus or proximal deep venous thrombosis and 241 control patients without thrombosis using molecular biological techniques. RESULTS: The Factor V Leiden mutation was present in none of the 38 experimental patients and in 3% or 8 of the 241 controls (p = 0.26). Similarly there was no difference detected in the distribution of polymorphisms for the ACE gene with the deletion-deletion genotype present in 36% or 13 of the 38 experimental patients and in 31% or 74 of the 241 controls (p = 0.32). CONCLUSIONS: Our results suggest that neither of these potentially hypercoaguable states are associated with an increased risk of symptomatic thromboembolic events following total hip or knee arthroplasty in patients receiving pharmacological thromboprophylaxis

    Residual confounding after adjustment for age: a minor issue in breast cancer screening effectiveness

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    Residual confounding, after adjustment for age, is the major criticism of observational studies on breast cancer screening effectiveness. We developed realistic scenarios for the prevalence and strength of risk factors on screened and not screened groups, and explored the impact of residual confounding bias. Our results demonstrate that residual confounding bias is a minor issue in screening programme evaluations

    Methods for the analysis of ordinal response data in medical image quality assessment.

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    The assessment of image quality in medical imaging often requires observers to rate images for some metric or detectability task. These subjective results are used in optimisation, radiation dose reduction or system comparison studies and may be compared to objective measures from a computer vision algorithm performing the same task. One popular scoring approach is to use a Likert scale, then assign consecutive numbers to the categories. The mean of these response values is then taken and used for comparison with the objective or second subjective response. Agreement is often assessed using correlation coefficients. We highlight a number of weaknesses in this common approach, including inappropriate analyses of ordinal data, and the inability to properly account for correlations caused by repeated images or observers. We suggest alternative data collection and analysis techniques such as amendments to the scale and multilevel proportional odds models. We detail the suitability of each approach depending upon the data structure and demonstrate each method using a medical imaging example. Whilst others have raised some of these issues, we evaluated the entire study from data collection to analysis, suggested sources for software and further reading, and provided a checklist plus flowchart, for use with any ordinal data. We hope that raised awareness of the limitations of the current approaches will encourage greater method consideration and the utilisation of a more appropriate analysis. More accurate comparisons between measures in medical imaging will lead to a more robust contribution to the imaging literature and ultimately improved patient care

    Reduction in the risk of human breast cancer by selective cyclooxygenase-2 (COX-2) inhibitors

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    BACKGROUND: Epidemiologic and laboratory investigations suggest that nonsteroidal anti-inflammatory drugs (NSAIDs) have chemopreventive effects against breast cancer due to their activity against cyclooxygenase-2 (COX-2), the rate-limiting enzyme of the prostaglandin cascade. METHODS: We conducted a case control study of breast cancer designed to compare effects of selective and non-selective COX-2 inhibitors. A total of 323 incident breast cancer patients were ascertained from the James Cancer Hospital, Columbus, Ohio, during 2003–2004 and compared with 649 cancer free controls matched to the cases at a 2:1 ratio on age, race, and county of residence. Data on the past and current use of prescription and over the counter medications and breast cancer risk factors were ascertained using a standardized risk factor questionnaire. Effects of COX-2 inhibiting agents were quantified by calculating odds ratios (OR) and 95% confidence intervals. RESULTS: Results showed significant risk reductions for selective COX-2 inhibitors as a group (OR = 0.29, 95% CI = 0.14–0.59), regular aspirin (OR = 0.49, 95% CI = 0.26–0.94), and ibuprofen or naproxen (0.36, 95% CI = 0.18–0.72). Acetaminophen, a compound with negligible COX-2 activity and low dose aspirin (81 mg) produced no significant change in the risk of breast cancer. CONCLUSION: Selective COX-2 inhibitors (celecoxib and rofecoxib) were only recently approved for use in 1999, and rofecoxib (Vioxx) was withdrawn from the marketplace in 2004. Nevertheless, even in the short window of exposure to these compounds, the selective COX-2 inhibitors produced a significant (71%) reduction in the risk of breast cancer, underscoring their strong potential for breast cancer chemoprevention
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