Werden unerwünschte Interventionseffekte in Herzinsuffizienzstudien ausreichend berücksichtigt?

DOI: 10.3238/zfa.2020.0406-0413

german translation / full article

Carolin Patschkowski, Ana I. González, Jeanet W. Blom, Liam G. Glynn, Mieke L. van Driel, Christiane Muth

Keywords: adverse drug reactions adverse effects heart failure multimorbidity patient safety

BackgroundPatients with chronic heart failure (CHF) are generally treated by family physicians. Since the majority of those patients are multimorbid, it is particularly important to consider the potential harms of interventions. To systematically review harms reporting in randomized controlled trials (RCTs) of interventions involving patients with CHF.MethodsWe reviewed the systematic study sample used by Blom JW et al. 2015 to investigate the effectiveness of heart failure interventions (systematic searches in MEDLINE for phase 3/4 RCTs in adult patients with CHF, published between January 2011 and June 2012). Based on the extended CONSORT recommendations on harms reporting (the original 22 criteria encompassed by Consolidated Standards of Reporting Trials have been extended to include ten specific new recommendations on harms reporting in title, abstract and main text), we examined the included articles in full, extracted data on harms reporting, and conducted a descriptive evidence synthesis. If authors did not provide a balanced discussion of benefits and harms and did not report results on harms, we considered the study not to have reported on them.ResultsOf 106 RCTs overall, 52 trials (49 %) did not provide any assessment of harms, 34 (32 %) adhered to half the CONSORT harms recommendations, and none met all ten of them. Harms were addressed in title and abstract in 21 trials (20 %) and defined in 15 trials (14 %). In methods sections, data collection on harms was reported in 25 (24 %) and planned analyses in 18 trials (17 %). In results sections, 34 trials (32 %) described harms-related withdrawals and 50 (47 %) presented absolute risks of adverse events. Fifty-four trials (51 %) provided a balanced discussion of benefits and harms. ConclusionsHarms reporting in CHF trials needs to improve, as clinicians and patients cannot make balanced evidence-based decisions on the future course of treatment without information on both benefits and harms. Keywordsheart failure; patient safety; adverse effects; adverse drug reactions; multimorbidity

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