title: N-of-1 randomized trials for psychological and health behavior outcomes: a systematic review protocol.
abstract: BACKGROUND
  Randomized controlled trials are the sine qua non of causal inference; however, heterogeneity of treatment effects for many chronic conditions and for many symptoms often limits their utility. Single-patient studies in which patients select a treatment after trying a randomized sequence of treatments (i.e., multiple crossover trials) offer an alternative to traditional randomized controlled trials by providing scientifically valid results in a practical manner that can be used by patients and their providers to decide upon their personally optimal treatment. Although N-of-1 trials have been used in the medical literature, their use for interventions that consist of psychological or health behavior outcomes is unknown. This systematic review thus aims to describe the interventions and outcomes and assess the quality of N-of-1 trials for psychological or health behavior outcomes.
  
  
  METHODS
  Electronic databases (Ovid MEDLINE, EMBASE, CINAHL, PsycINFO, and the six databases in the Cochrane Library) will be searched using all relevant subject headings and free-text terms to represent N-of-1 trials and psychological or behavioral interventions. Full text review and bibliography searching will be conducted. Unpublished studies will be sought by searching trial registries and contacting authors of included studies. Eligibility criteria are the following: population, all human participants for whom N-of-1 trials with psychological or health behavior outcomes have been conducted; interventions, all interventions for which N-of-1 trials have been conducted; comparison, placebo or active treatment control; and outcome, psychological and health behavior outcomes including self-perceived disease severity and psychological phenomena such as mood and affect. Studies that do not contain sufficient trial detail, describe only design or statistical analytic issues in N-of-1 trials without presentation of an N-of-1 trial itself, and/or are not written in the English language are ineligible. Screening, data extraction, and quality assessment will be conducted by two independent reviewers with disagreements resolved through discussion.
  
  
  CONCLUSIONS
  This systematic review will describe the interventions and outcomes and assess the quality of N-of-1 trials for psychological or health behavior outcomes. The results will clarify the use of this research methodology in the health psychology and behavioral medicine literature and may pave the way for additional N-of-1 trials to be conducted.
  
  
  BACKGROUND
  PROSPERO CRD42015017853.
authors.affiliation: Department of Medicine, Columbia University Medical Center, 622 West 168th Street, PH9 West, Room 318, New York, NY, 10032, USA. js3742@cumc.columbia.edu.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Shaffer
authors.affiliation: Department of Medicine, Columbia University Medical Center, 622 West 168th Street, PH9 West, Room 318, New York, NY, 10032, USA. af2215@cumc.columbia.edu.
authors.forename: Louis
authors.initials: L
authors.lastname: Falzon
authors.affiliation: Department of Biostatistics, Columbia Mailman School of Public Health, New York, NY, USA. cheung@biostat.columbia.edu.
authors.forename: Ken
authors.initials: K
authors.lastname: Cheung
authors.affiliation: Department of Medicine, Columbia University Medical Center, 622 West 168th Street, PH9 West, Room 318, New York, NY, 10032, USA. kwd2124@cumc.columbia.edu.
authors.forename: Karina W
authors.initials: KW
authors.lastname: Davidson
mesh_terms: D001521:Behavior Therapy; D002908:Chronic Disease; D002985:Clinical Protocols; D015438:Health Behavior; D006801:Humans; D001523:Mental Disorders / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D000078202:Systematic Reviews as Topic