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BioSocieties

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

  • Jonas WintherEmail author
  • Line Hillersdal
Original Article

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.

Keywords

Randomized controlled trial Compliance Surveillance Data Intervention research 

Notes

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.

Compliance with ethical standards

Conflict of interest

We have no competing interests—intellectual or financial—in the research presented in the manuscript.

Ethical approval

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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© Springer Nature Limited 2019

Authors and Affiliations

  1. 1.Copenhagen Centre for Health Research in the Humanities, The Saxo InstituteUniversity of CopenhagenCopenhagenDenmark
  2. 2.Department of AnthropologyUniversity of CopenhagenCopenhagenDenmark
  3. 3.CopenhagenDenmark

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