title: Examining the influence of treatment preferences on attrition, adherence and outcomes: a protocol for a two-stage partially randomized trial.
abstract: BACKGROUND
  Empirical evidence pertaining to the influence of treatment preferences on attrition, adherence and outcomes in intervention evaluation trials is inconsistent. The inconsistency can be explained by the method used for allocating treatment and measuring preferences. The current methodological study is designed to address these factors by implementing the two-stage partially randomized or preference trial design, and administering a validated measure to assess participants' preferences for the treatments under evaluation. It aims to compare attrition, adherence and outcomes for participants allocated randomly or by preference to treatment. The study is in its final stages of data collection; its protocol is presented in this paper.
  
  
  METHODS
  A partially randomized clinical or preference trial is used. Eligible participants are randomized to two trial arms. First is the random arm involving random assignment to treatments, and second is the preference arm involving allocation to the chosen treatment. Participants with chronic insomnia are targeted. Two behavioral treatments are offered, stimulus control therapy and sleep restriction therapy, in the same format (small group) and dose (two sessions given over a 4-week period). A participant log is used to collect data on attrition. Adherence is evaluated in terms of exposure and enactment of treatment. Sleep-related outcomes (sleep parameters and perceived insomnia severity) are measured at pretest, posttest, 6 and 12 month follow-up. Treatment preferences, adherence and outcomes are assessed with reliable and valid measures.
  
  
  CONCLUSIONS
  The advantages and limitations of the preference trial design are highlighted. The challenges in implementing the trial are discussed relative to the distribution of participants in the groups defined by treatment received and method of treatment allocation.
  
  
  BACKGROUND
  ClinicalTrials.gov Registry NCT02513017.
authors.affiliation: School of Nursing, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2 K3 Canada.
authors.forename: Souraya
authors.initials: S
authors.lastname: Sidani
authors.affiliation: School of Nursing, York University, Toronto, ON Canada.
authors.forename: Mary
authors.initials: M
authors.lastname: Fox
authors.affiliation: Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON Canada.
authors.forename: David L
authors.initials: DL
authors.lastname: Streiner
authors.affiliation: School of Nursing, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2 K3 Canada.
authors.forename: Joyal
authors.initials: J
authors.lastname: Miranda
authors.affiliation: School of Nursing, Ryerson University, 350 Victoria Street, Toronto, ON M5B 2 K3 Canada.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Fredericks
authors.affiliation: Nursing Research and Evidence-Based Practice, Phoenix Veterans Affairs Health Care System, Phoenix, AZ USA.
authors.forename: Dana R
authors.initials: DR
authors.lastname: Epstein
keywords: Adherence to treatment; Attrition; Behavioral therapy; Insomnia; Outcomes; Treatment preference; Two-stage randomized clinical trial