Unbalanced reporting of benefits and harms in abstracts on rofecoxib

Jørgensen, Arne Lund; Jørgensen, Karsten Juhl; Gøtzsche, Peter C

doi:10.1007/s00228-010-0791-8

Cited by 4 publications

(1 citation statement)

References 46 publications

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“…For example, biases favouring the reporting of only benefits and the use of vague general statements (eg, “safe” or “well tolerated”) are common. This is true for both abstracts of published papers and abstracts presented at conferences 3132…”

Section: Consort Harms 2022: Checklist Items Explanation and Elaborationmentioning

confidence: 91%

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Junqueira

Zorzela

Golder

et al. 2023

BMJ

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Randomised controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (ie, all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist, and elaborate on each item relevant to complete reporting of harms in randomised controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomised controlled trials should use the integrated checklist presented in this paper.

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Section: Consort Harms 2022: Checklist Items Explanation and Elaborationmentioning

confidence: 91%

CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomised trials

Junqueira

Zorzela

Golder

et al. 2023

BMJ

View full text Add to dashboard Cite

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Current awareness: Pharmacoepidemiology and drug safety

2010

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 23 sections: 1 Reviews; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Antidiabetic Agents; 21 Contrast Agents; 22 Bone Conservation Agents; 23 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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