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Measurement reactivity in randomized clinical trials (RCTs) increased self-monitoring among participants. Frequent interviews and data collection tools heightened awareness of catheter issues, impacting study validity.

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Area of Science:

  • Clinical Research Methodology
  • Health Services Research

Background:

  • Measurement reactivity is a threat to internal validity in randomized clinical trials (RCTs).
  • Self-monitoring can be influenced by data collection methods within a study.

Purpose of the Study:

  • To describe how self-monitoring contributed to measurement reactivity in a randomized clinical trial (RCT).
  • To discuss the implications of measurement reactivity on self-monitoring and suggest methods to minimize its effects.

Main Methods:

  • Secondary data analysis of responses from 145 participants in a 12-month RCT.
  • Iterative coding and consensus among three researchers on participant responses regarding perceived study participation value.

Main Results:

  • Both calendar use and bimonthly interviews increased participants' self-monitoring of urinary catheter problems.
  • The control group also showed increased attention to catheter issues due to interview questions.

Conclusions:

  • Measurement reactivity, driven by data collection methods like interviews and calendars, can enhance self-monitoring in RCTs.
  • Strategies are needed to mitigate the impact of measurement reactivity on study outcomes and validity.