[Critical reading of cardiovascular trials with neutral or negative findings].

Approccio critico all’interpretazione dei trial cardiovascolari con risultati neutri o negativi.

Journal

Giornale italiano di cardiologia (2006)
ISSN: 1972-6481
Titre abrégé: G Ital Cardiol (Rome)
Pays: Italy
ID NLM: 101263411

Informations de publication

Date de publication:
Oct 2023
Historique:
medline: 29 9 2023
pubmed: 28 9 2023
entrez: 28 9 2023
Statut: ppublish

Résumé

Randomized controlled trials showing a significant benefit are met with enthusiasm because they may change the standard of care for patients who share the clinical and pathophysiologic characteristics of trial participants. Nonetheless, a well-designed and fully executed trial with neutral or negative findings also represents a critically important investigation deserving careful scientific scrutiny. In this paper we propose a 10-step approach to the interpretation of neutral or negative trials to exclude important methodological issues before concluding that the treatment really does not work. We will discuss this approach using the most classic trials of the past and some notable examples among superiority trials (mostly phase 3 trials) published over the last years.

Identifiants

pubmed: 37767834
doi: 10.1714/4100.40982
doi:

Types de publication

English Abstract Journal Article

Langues

ita

Sous-ensembles de citation

IM

Pagination

818-826

Auteurs

Alberto Aimo (A)

Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna, Pisa - UOC Cardiologia e Medicina Cardiovascolare, Fondazione Toscana Gabriele Monasterio, Pisa.

Vincenzo Castiglione (V)

Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna, Pisa - UOC Cardiologia e Medicina Cardiovascolare, Fondazione Toscana Gabriele Monasterio, Pisa.

Iacopo Fabiani (I)

UOC Cardiologia e Medicina Cardiovascolare, Fondazione Toscana Gabriele Monasterio, Pisa.

Paolo Morfino (P)

Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna, Pisa.

Michele Emdin (M)

Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna, Pisa - UOC Cardiologia e Medicina Cardiovascolare, Fondazione Toscana Gabriele Monasterio, Pisa.

Roberto Ferrari (R)

U.O. Cardiologia, Ospedale Universitario di Ferrara, Ferrara.

Luigi Tavazzi (L)

Maria Cecilia Hospital, GVM Care & Research, Cotignola (RA).

Aldo Pietro Maggioni (AP)

Centro Studi ANMCO, Heart Care Foundation - Fondazione per il Tuo cuore, Firenze.

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Classifications MeSH