Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications

Melander, Hans; Ahlqvist-Rastad, Jane; Meijer, Gertie; Beermann, B

doi:10.1136/bmj.326.7400.1171

Cited by 556 publications

(353 citation statements)

References 30 publications

(5 reference statements)

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“…Authors or funders may have conflicts of interest that influence any of the following: the design of the study 228 ; choice of exposures, 228,229 outcomes, 230 statistical methods, 231 and selective publication of outcomes 230 and studies. 232 Consequently, the role of the funders should be described in detail: in what part of the study they took direct responsibility (eg, design, data collection, analysis, drafting of the manuscript, decision to publish).…”

Section: Other Information 22 Funding: Give the Source Of Funding Andmentioning

confidence: 99%

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

et al. 2007

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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...

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Section: Other Information 22 Funding: Give the Source Of Funding Andmentioning

confidence: 99%

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

et al. 2007

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“…In human health, there is evidence that authors or funders might have conflicts of interest that influence any of the following: the design of the study,125 choice of exposures,125, 126 outcomes,127 statistical methods,128 and selective publication of outcomes and studies 127, 129. Potential conflicts of interest include financial arrangements outside of research funding that could influence authors.…”

Section: (B) Conflicts Of Interest Describe Any Conflicts Of Intermentioning

confidence: 99%

Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary Extension

O’Connor

Sargeant

Dohoo

et al. 2016

Veterinary Internal Medicne

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The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement was first published in 2007 and again in 2014. The purpose of the original STROBE was to provide guidance for authors, reviewers, and editors to improve the comprehensiveness of reporting; however, STROBE has a unique focus on observational studies. Although much of the guidance provided by the original STROBE document is directly applicable, it was deemed useful to map those statements to veterinary concepts, provide veterinary examples, and highlight unique aspects of reporting in veterinary observational studies. Here, we present the examples and explanations for the checklist items included in the STROBE‐Vet statement. Thus, this is a companion document to the STROBE‐Vet statement methods and process document (JVIM_14575 “Methods and Processes of Developing the Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary (STROBE‐Vet) Statement” undergoing proofing), which describes the checklist and how it was developed.

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“…To illustrate this, consider decisions on whether or not to publish certain results. In biomedical science, such decisions are sometimes biased; findings that are unfavorable to a certain drug (e.g., the drug is ineffective or not safe) are not published, while favorable findings are published more than once (Melander 2003;Schott et al 2010, pp. 296-298).…”

Section: Fruitfulnessmentioning

confidence: 99%

The Epistemic Integrity of Scientific Research

Winter

Kosolosky

2012

Sci Eng Ethics

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We live in a world in which scientific expertise, and its epistemic authority and autonomy, become more and more important. On the other hand, the financial interests in research, which could potentially corrupt science, are increasing. Due to these two tendencies, a concern for the integrity of scientific research becomes increasingly vital. This concern is, however, hollow if we do not have a clear account of research integrity. Therefore, it is important that we explicate this concept. Following Rudolf Carnap"s characterization of the task of explication, this means that we should develop a concept that is (1) similar to our common sense notion of research integrity, (2) exact, (3) fruitful, and (4) as simple as possible. Since existing concepts do not meet these four requirements, we develop a new concept in this article. We describe a concept of epistemic integrity that is based on the property of deceptiveness, and argue that this concept does meet Carnap"s four requirements of explication. To illustrate and support our claims we use several examples from scientific practice, mainly from biomedical research.

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Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications

Cited by 556 publications

References 30 publications

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

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

Explanation and Elaboration Document for the STROBE‐Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology—Veterinary Extension

The Epistemic Integrity of Scientific Research

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