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Balancing methodological purity and social relevance: monitoring participant compliance in a behavioural RCT

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Abstract

The adoption of the randomised controlled trial within public health research to test behavioural and lifestyle interventions means that trial researchers are increasingly expected to balance ambitions of methodological rigour and social relevance in the performance of a trial. Striking this balance is particularly important when it comes to the issue of participant compliance. This article draws from fieldwork among researchers in an exercise trial in Denmark to explore the work entailed in achieving and measuring participant compliance from a distance. By drawing on perspectives from surveillance studies, we focus on the practices, technologies and forms of knowing involved in aligning participant’s bodies and practices with specific data production ambitions. The analysis highlights the work and challenges entailed in retaining participants within the scope of the researchers’ monitoring. In conclusion, we suggest that the firm commitment to produce quantitative data on compliance elides the work, challenges and collaborative practices entailed in achieving compliance and highlighting the challenges of ensuring compliance. The article describes the randomised controlled trial, not as a powerful governmental socio-technical apparatus, but as a fragile, situated, and fundamentally challenged surveillance system. This has important implications for ambitions to consider the complexity of behavioural interventions.

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Notes

  1. The authors have translated all quotes from Danish to English.

  2. Studies from the field of intervention research suggest that high study demands may prevent participants from complying with trial protocols. Participants’ concerns about or resistance to interventions, in addition to issues of feasibility and acceptability, may also influence their compliance with a trial protocol. Furthermore, factors such as health conditions, socioeconomic status, trust, education level, lack of social support, and minority status may constitute barriers to retaining participants (Atwood et al. 1992; Moser et al. 2000; Zweben et al. 2009; Brueton et al. 2017).

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Acknowledgements

This article is based on ethnographic fieldwork that was made possible by grants from the University of Copenhagen’s Excellence Programme for Interdisciplinary Research. We are grateful for the support. We also want to thank the researchers, research assistants, and trial participants for sharing their experiences of engaging in the trial. Finally, we would like to thank the anonymous reviewers for critically engaging with our work, and Amy Clotworthy and Nicolai Paulsen for carefully editing the manuscript.

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  1. Copenhagen Centre for Health Research in the Humanities, The Saxo Institute, University of Copenhagen, Copenhagen, Denmark

    Jonas Winther

  2. Department of Anthropology, University of Copenhagen, Copenhagen, Denmark

    Line Hillersdal

  3. Karen Blixens Plads 8, building 12, 2nd floor, 2300, Copenhagen, Denmark

    Jonas Winther

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Correspondence to Jonas Winther.

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The trial in focus of the article was approved by the ethical committee of The Capital Region of Denmark (H-4-2013-108), registered at the Danish Data Protection Agency and at clinicaltrials.gov (identifier: NCT01962259 & NCT01973686) and adhered to the principles of the Helsinki declaration.

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Winther, J., Hillersdal, L. Balancing methodological purity and social relevance: monitoring participant compliance in a behavioural RCT. BioSocieties 15, 555–579 (2020). https://doi.org/10.1057/s41292-019-00163-7

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