Justification and reporting of subgroup analyses were lacking or inadequate in randomized controlled trials.
J Clin Epidemiol
; 108: 17-25, 2019 04.
Article
de En
| MEDLINE
| ID: mdl-30557676
ABSTRACT
OBJECTIVES:
The aim of the article was to assess the appropriateness and rationales of subgroup analyses planned in protocols of randomized controlled trials and reported in subsequent corresponding trial publications. STUDY DESIGN ANDSETTING:
We searched PubMed to identify trial protocols published in journals during 2006-2017. From a total of 3,774 initially identified records, we included a random sample of 479 protocols and identified 280 trial publications corresponding to the included protocols.RESULTS:
Subgroup analyses were specified in 19% of the protocols and reported in 21% of the trial publications. Of the 94 protocols with planned subgroup analyses, 32% mentioned testing for interaction, and only three considered statistical power. Subgroup analyses were not prespecified in 56% of the 59 trial publications with subgroup analyses. Subgroup analyses were stated as prespecified in nine trial publications, without support evidence from the corresponding protocols. Subgroup analyses were often reported insufficiently for assessing the consistency of subgroup effects across studies. Justifications for subgroup analyses were provided in only four trial protocols and seven trial publications.CONCLUSION:
Inappropriate specification and reporting of subgroup analyses remain problematic in protocols and reports of randomized controlled trials. Justifications or rationales for subgroup analyses were only rarely provided in trial protocols and reports.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Essais contrôlés randomisés comme sujet
/
Interprétation statistique de données
Type d'étude:
Clinical_trials
/
Systematic_reviews
Limites:
Humans
Langue:
En
Journal:
J Clin Epidemiol
Sujet du journal:
EPIDEMIOLOGIA
Année:
2019
Type de document:
Article
Pays d'affiliation:
Royaume-Uni