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Three years of experience with prospective randomized effectiveness studies
A Hillis1, M H Rajab, C E Baisden
1Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation, Temple, Texas, USA.
Controlled Clinical Trials
|September 19, 1998
Summary
Developing prospective randomized effectiveness studies is feasible in multi-practice settings. This methodology allows for reliable treatment outcome assessment with long-term follow-up of comparison groups.
Area of Science:
- Health Services Research
- Clinical Trials Methodology
- Comparative Effectiveness Research
Background:
- Establishing effective methodologies for prospective randomized effectiveness studies is crucial for advancing evidence-based healthcare.
- Existing observational studies often lack long-term follow-up and direct comparison groups, limiting their reliability.
Purpose of the Study:
- To develop and evaluate a methodology for conducting prospective randomized effectiveness studies within a multi-practice academic medical center setting.
- To establish an operational framework, the effectiveness registry, for designing and supporting comparative practice improvement studies.
Main Methods:
- A demonstration project was implemented across a multispecialty practice, health maintenance organization, and hospital.
- An effectiveness registry was created to manage study design and data collection, modeled after tumor registry procedures.
- Studies involved long-term follow-up of randomized comparison groups, with limited physician data collection and no additional tests beyond clinical care.
Main Results:
- Fourteen trials were approved by the institutional review board (IRB) between October 1993 and April 1997.
- Patient randomization acceptance rate was 74% (596/804), with over 800 patients enrolled in 10 studies.
- Initial findings from two studies have been accepted for publication in major peer-reviewed journals.
Conclusions:
- Prospective randomized effectiveness studies are feasible in multi-practice settings, offering reliable assessment of treatment outcomes.
- The developed methodology, utilizing an effectiveness registry, supports long-term follow-up and comparison of care improvements.
- Collaborative multi-institutional arrangements are recommended to enhance sample sizes for greater statistical power.
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