Why clinical trial outcomes fail to translate into benefits for patients

Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with...

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Veröffentlicht in:Current controlled trials in cardiovascular medicine Jg. 18; H. 1; S. 122
Hauptverfasser: Heneghan, Carl, Goldacre, Ben, Mahtani, Kamal R.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: London BioMed Central 14.03.2017
BioMed Central Ltd
Springer Nature B.V
Schlagworte:
Analysis
Bias
Biomedicine
Cardiovascular disease
Clinical decision making
Clinical outcomes
Clinical significance
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - statistics & numerical data
Commentary
Data Interpretation, Statistical
Endpoint Determination - statistics & numerical data
Health Sciences
Humans
Management
Medical care
Medicine
Medicine & Public Health
Patient care
Patient Participation
Patients
Publication Bias
Quality of life
Research Design - statistics & numerical data
Rheumatoid arthritis
Statistics for Life Sciences
Ten years of Trials
Treatment Outcome
Core outcome sets
Publication bias
Reporting bias
Composite outcomes
Clinical outcomes
Surrogate outcomes
ISSN:1745-6215, 1745-6215
Online-Zugang:Volltext
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Zusammenfassung:Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy. These complex issues include the use of surrogate, composite and subjective endpoints; a failure to take account of patients’ perspectives when designing research outcomes; publication and other outcome reporting biases, including the under-reporting of adverse events; the reporting of relative measures at the expense of more informative absolute outcomes; misleading reporting; multiplicity of outcomes; and a lack of core outcome sets. Trial outcomes can be developed with patients in mind, however, and can be reported completely, transparently and competently. Clinicians, patients, researchers and those who pay for health services are entitled to demand reliable evidence demonstrating whether interventions improve patient-relevant clinical outcomes.
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ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-017-1870-2