title: Methodologic issues in health informatics trials: the complexities of complex interventions.
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.
authors.affiliation: Centre for Evaluation of Medicines, St Joseph's Healthcare Hamilton, Hamilton, Ontario L8N1G6, Canada. shcheriy@mcmaster.ca
authors.forename: Ivan
authors.initials: I
authors.lastname: Shcherbatykh
authors.forename: Anne
authors.initials: A
authors.lastname: Holbrook
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.forename: Lisa
authors.initials: L
authors.lastname: Dolovich
mesh_terms: D003362:Cost-Benefit Analysis; D003627:Data Interpretation, Statistical; D020000:Decision Support Systems, Clinical; D057286:Electronic Health Records; D006801:Humans; D009864:Ontario; D017063:Outcome Assessment, Health Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D014652:Vascular Diseases / Q000628:therapy