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How much does pre-trial testing influence complex intervention trials and would more testing make any difference? An

Shaun Treweek1, Frank Sullivan

  • 1Tayside Centre for General Practice, Community Health Sciences Division, University of Dundee, Kirsty Semple Way, Dundee DD2 4BF, UK. s.treweek@chs.dundee.ac.uk

BMC Medical Research Methodology
|June 24, 2006
PubMed
Summary

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Most complex interventions undergo preliminary testing before full trials, but this testing is often not reported. Further research could refine interventions, though funding limitations exist.

Area of Science:

  • Medical Research
  • Clinical Trials
  • Intervention Studies

Background:

  • UK Medical Research Council recommends exploratory trials for complex interventions.
  • Pre-trial testing defines interventions and assesses feasibility (e.g., recruitment).
  • Extent of pre-trial testing for complex interventions is unclear.

Purpose of the Study:

  • Determine the extent of pre-trial testing for complex interventions.
  • Assess if additional testing would have improved intervention selection for full trials.

Main Methods:

  • Email survey of authors publishing complex intervention trials in 2004.
  • Analysis of responses regarding pre-trial testing practices.

Main Results:

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  • 72% of eligible authors responded; 34/42 reported testing their complex interventions.
  • Testing was often extensive but infrequently reported in publications (17/34).
  • 31% believed further testing would have improved intervention effectiveness; 23% cited funding issues.

Conclusions:

  • Complex interventions are typically tested pre-trial, with varying levels of rigor.
  • Lack of reporting on intervention testing hinders evaluation of trial results and future research needs.
  • Further investigation into intervention development and reporting standards is warranted.