Methodologic Issues in Health Informatics Trials: The Complexities of Complex Interventions
- Ivan Shcherbatykha,b,
- Anne Holbrooka,b,c,
- Lehana Thabanea,b,
- Lisa Dolovicha,d COMPETE III investigators
- aCentre for Evaluation of Medicines, St Joseph's Healthcare Hamilton Hamilton, ON, Canada
- bDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada
- cDivision of Clinical Pharmacology and Therapeutics, Department of Medicine, McMaster University, Hamilton, ON, Canada
- dDepartment of Family Medicine, McMaster University, Hamilton, ON, Canada
- Correspondence: Ivan Shcherbatykh, Centre for Evaluation of Medicines, 105 Main Street East, Level P1, Hamilton, Ontario L8N1G6 Canada Email: <shcheriy{at}mcmaster.ca>
- Received 22 May 2007
- Accepted 27 April 2008
Abstract
Objective All electronic health (e-health) interventions require validation as health information technologies, ideally in randomized controlled trial settings. However, as with other types of complex interventions involving various active components and multiple targets, health informatics trials often experience problems of design, methodology, or analysis that can influence the results and acceptance of the research. Our objective was to review selected key methodologic issues in conducting and reporting randomized controlled trials in health informatics, provide examples from a recent study, and present practical recommendations.
Design For illustration, we use the COMPETE III study, a large randomized controlled clinical trial investigating the impact of a shared decision-support system on the quality of vascular disease management in Ontario, Canada.
Results We describe a set of methodologic, logistic, and statistical issues that should be considered when planning and implementing trials of complex e-health interventions, and provide practical recommendations for health informatics trialists.
Conclusions Our recommendations emphasize validity and pragmatic considerations and would be useful for health informaticians conducting or evaluating e-health studies.
Footnotes
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The COMPETE III study was funded by the Ontario Ministry of Health and Long-Term Care Primary Health Care Transition Fund #G03-02820. Dr. Ivan Shcherbatykh is supported in part by the Canadian Institutes for Health Research (CIHR) Health Informatics PhD/Postdoc Strategic Training Program and by the Father Sean O'Sullivan Research Centre, St. Joseph's Healthcare Hamilton, Canada. Dr. Anne Holbrook was supported in part by a CIHR Investigator award.
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This paper was presented in part at the Critical Issues in eHealth Research Conference: Toward Quality Patient Centered Care, September 11–12, 2006, Bethesda, MD US, and the International Conference addressing Information Technology and Communications in Health 2007, February 16–18, 2007, Victoria, BC Canada.
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No conflicts of interest.
