title: Assessing treatment-as-usual provided to control groups in adherence trials: Exploring the use of an open-ended questionnaire for identifying behaviour change techniques.
abstract: OBJECTIVE
  Reporting guidelines call for descriptions of control group support in equal detail as for interventions. However, how to assess the active content (behaviour change techniques (BCTs)) of treatment-as-usual (TAU) delivered to control groups in trials remains unclear. The objective of this study is to pre-test a method of assessing TAU in a multicentre cost-effectiveness trial of an HIV-treatment adherence intervention.
  
  
  METHODS
  HIV-nurses (N = 21) completed a semi-structured open-ended questionnaire enquiring about TAU adherence counselling. Two coders independently coded BCTs.
  
  
  METHODS
  Completeness and clarity of nurse responses, inter-coder reliabilities and the type of BCTs reported were examined.
  
  
  RESULTS
  The clarity and completeness of nurse responses were adequate. Twenty-three of the 26 identified BCTs could be reliably coded (mean κ = .79; mean agreement rate = 96%) and three BCTs scored below κ = .60. Total number of BCTs reported per nurse ranged between 7 and 19 (M = 13.86, SD = 3.35).
  
  
  CONCLUSIONS
  This study suggests that the TAU open-ended questionnaire is a feasible and reliable tool to capture active content of support provided to control participants in a multicentre adherence intervention trial. Considerable variability in the number of BCTs provided to control patients was observed, illustrating the importance of reliably collecting and accurately reporting control group support.
authors.affiliation: a Department of Communication, Amsterdam School of Communication Research ASCoR , University of Amsterdam , Amsterdam , The Netherlands.
authors.forename: Edwin J M
authors.initials: EJ
authors.lastname: Oberjé
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: Dima
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Pijnappel
authors.forename: Jan M
authors.initials: JM
authors.lastname: Prins
authors.forename: Marijn
authors.initials: M
authors.lastname: de Bruin
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000706:statistics & numerical data*; D035061:Control Groups; D003376:Counseling; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
keywords: behaviour change techniques; control group; randomised controlled trial; treatment-as-usual