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Assessing treatment-as-usual provided to control groups in adherence trials: Exploring the use of an open-ended
Edwin J M Oberjé1, Alexandra L Dima, Frank J Pijnappel
1a Department of Communication, Amsterdam School of Communication Research ASCoR , University of Amsterdam , Amsterdam , The Netherlands.
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.
Design:
HIV-nurses (N = 21) completed a semi-structured open-ended questionnaire enquiring about TAU adherence counselling. Two coders independently coded BCTs.
Main Outcome Measures:
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.
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