Reporting of Safety Results in Published Reports of Randomized Controlled Trials

Abstract

Background: Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant. Poor safety reporting can lead to misinterpretation andinadequateconclusionsabouttheinterventionsassessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs). Methods:We searched the MEDLINE database for reports of RCTs published from in 6 general medical journals with a high impact factor. Data were extracted by use of a standardized form to appraise the presentation of safety results in text and tables.Results: Adverse events were mentioned in 88.7% of the 133 reports. No information on severe adverse events and For editorial comment see page 1737

PRISMA harms checklist: improving harms reporting in systematic reviews

“…[1][2][3][4][5][6][7][8][9][10] A misconception may be perpetuated that a given intervention is safe, when its safety (that is, absence of harm) is actually uncertain. [4][5][6][7][8][9][10] Systematic reviews often compound poor reporting of harms in primary studies by failing to report harms or doing so inadequately.…”

“…[1][2][3][4][5][6][7][8][9][10] A misconception may be perpetuated that a given intervention is safe, when its safety (that is, absence of harm) is actually uncertain. [4][5][6][7][8][9][10] Systematic reviews often compound poor reporting of harms in primary studies by failing to report harms or doing so inadequately. [11][12][13][14][15][16][17][18][19][20] There are guidelines for reporting systematic reviews 1 21 22 but they focus on how best to report treatment benefits.…”

Antiplatelet Therapy for Every Diabetic Person?

“…The safety profile of aspirin in individuals with diabetes also needs to be evaluated with greater attention to the real world setting. Randomized clinical trials are often inadequate to provide reliable information on safety (36,37), and observation of very large populations is needed to better estimate the risk profile in different patient subgroups.…”

The predictive value of cumulative toxicity for quality of life in patients with metastatic colorectal cancer during first-line palliative chemotherapy

“…Limited information is available on the burden represented by all (including low-grade) AEs experienced in RCTs 6–8. Several methods to improve toxicity reporting have been proposed.…”