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N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique.
Shaffer, Jonathan A; Kronish, Ian M; Falzon, Louise; Cheung, Ying Kuen; Davidson, Karina W.
Afiliação
  • Shaffer JA; Department of Psychology, University of Colorado Denver, Denver, CO.
  • Kronish IM; Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, New York, NY.
  • Falzon L; Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, New York, NY.
  • Cheung YK; Department of Biostatistics, Columbia University Mailman School of Public Health, Columbia University, New York, NY.
  • Davidson KW; Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, New York, NY.
Ann Behav Med ; 52(9): 731-742, 2018 08 16.
Article em En | MEDLINE | ID: mdl-30124759
Background: Single-patient, multiple cross-over designs (N-of-1 or single-case randomized clinical trials) with systematic data collection on treatment effects may be useful for increasing the precision of treatments in health psychology. Purposes: To assess the quality of the methods and statistics, describe interventions and outcomes, and explore the heterogeneity of treatment effect of health psychology N-of-1 trials. Methods: We conducted a systematic review of N-of-1 trials from electronic database inception through June 1, 2015. Potentially relevant articles were identified by searching the biomedical electronic databases Ovid, MEDLINE, EMBASE, all six databases in the Cochrane Library, CINAHL, and PsycINFO, and conference proceedings, dissertations, ongoing studies, Open Grey, and the New York Academy's Grey Literature Report. Studies were included if they had health behavior or psychological outcomes and the order of interventions was randomized. We abstracted study characteristics and analytic methods and used the Consolidated Standards of Reporting Trials extension for reporting N-of-1 trials as a quality checklist. Results: Fifty-four N-of-1 trial publications composed of 1,193 participants were included. Less than half of these (36%) reported adequate information to calculate the heterogeneity of treatment effect. Nearly all (90%) provided some quantitative information to determine the superior treatment; 79% used an a priori statistical cutoff, 12% used a graph, and 10% used a combination. Conclusions: N-of-1 randomized trials could be the next major advance in health psychology for precision therapeutics. However, they must be conducted with more methodologic and statistical rigor and must be transparently and fully reported.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicina do Comportamento / Ensaios Clínicos Controlados Aleatórios como Assunto / Estudos Cross-Over Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: Ann Behav Med Assunto da revista: CIENCIAS DO COMPORTAMENTO Ano de publicação: 2018 Tipo de documento: Article País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicina do Comportamento / Ensaios Clínicos Controlados Aleatórios como Assunto / Estudos Cross-Over Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies / Systematic_reviews Limite: Humans Idioma: En Revista: Ann Behav Med Assunto da revista: CIENCIAS DO COMPORTAMENTO Ano de publicação: 2018 Tipo de documento: Article País de publicação: Reino Unido