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.

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.

Keywords:

• treatment-as-usual
• randomised controlled trial
• control group
• behaviour change techniques

Acknowledgements

This study was funded by ZonMw (the Netherlands), program Doelmatigheidsonderzoek (grant number 171002208). This funding source had no role in study design, data collection, analysis, interpretation, or writing of the report. We want to thank the HIV-nurses from the seven HIV-clinics which are involved in the AIMS-study for their input and collaboration (Academic Medical Center, Amsterdam; Slotervaart hospital, Amsterdam; St. Lucas-Andreas hospital, Amsterdam; the Leiden University Medical Center, Leiden; HAGA hospital, Den Haag; Erasmus Medical Center, Rotterdam; Isala clinics, Zwolle).

Additional information

Funding

This study was funded by ZonMw (the Netherlands), program Doelmatigheidsonderzoek [grant number 171002208].