Reporting of randomized factorial trials was frequently inadequate.
J Clin Epidemiol
; 117: 52-59, 2020 01.
Article
en En
| MEDLINE
| ID: mdl-31585174
ABSTRACT
OBJECTIVES:
Factorial designs can allow efficient evaluation of multiple treatments within a single trial. We evaluated the design, analysis, and reporting in a sample of factorial trials. STUDY DESIGN ANDSETTING:
Review of 2 × 2 factorial trials evaluating health-related interventions and outcomes in humans. Using Medline, we identified articles published between January 2015 and March 2018. We randomly selected 100 articles for inclusion.RESULTS:
Most trials (78%) did not provide a rationale for using a factorial design. Only 63 trials (63%) assessed the interaction for the primary outcome, and 39/63 (62%) made a further assessment for at least one secondary outcome. 12/63 trials (19%) identified a significant interaction for the primary outcome and 16/39 trials (41%) for at least one secondary outcome. Inappropriate methods of analysis to protect against potential negative effects from interactions were common, with 18 trials (18%) choosing the analysis method based on a preliminary test for interaction, and 13% (n = 10/75) of those conducting a factorial analysis including an interaction term in the model.CONCLUSION:
Reporting of factorial trials was often suboptimal, and assessment of interactions was poor. Investigators often used inappropriate methods of analysis to try to protect against adverse effects of interactions.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Ensayos Clínicos como Asunto
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Límite:
Humans
Idioma:
En
Revista:
J Clin Epidemiol
Asunto de la revista:
EPIDEMIOLOGIA
Año:
2020
Tipo del documento:
Article