Fitting a routine health-care activity into a randomized trial: an experiment possible without informed consent?

Area of Science:

• Health Services Research
• Clinical Trial Design
• Medical Education

Background:

• Randomized controlled trials (RCTs) are challenging to implement for healthcare procedures integrated into routine practice.
• Traditional RCTs may face methodological and practical hurdles, deterring their use in evaluating established healthcare interventions.
• Blinding procedures in healthcare RCTs can be difficult, potentially compromising study validity.

Purpose of the Study:

• To assess the feasibility of conducting a randomized controlled trial (RCT) on the impact of routine individual feedback on family physicians' test ordering behavior.
• To explore alternative informed consent procedures for healthcare research where study-specific consent may conflict with design validity.
• To determine if a modified RCT approach can effectively evaluate interventions within routine healthcare settings without compromising scientific rigor.

Main Methods:

• A randomized controlled trial was conducted to evaluate the effect of routine individual feedback on family physicians' test ordering behavior.
• The trial involved adaptations to the standard RCT design to accommodate the evaluation of an embedded healthcare procedure.
• The study explored the implications of forgoing study-specific informed consent, opting for a general informed consent approach.

Main Results:

• A randomized trial design proved feasible for evaluating a routine healthcare procedure, even with adaptations.
• Refraining from study-specific informed consent, by using general informed consent, successfully avoided potential biases such as the Hawthorne effect and contamination.
• The study demonstrated that general informed consent is an acceptable alternative in healthcare research involving physician performance and quality of care interventions.

Conclusions:

• Randomized controlled trials can be successfully adapted for evaluating interventions already part of routine healthcare.
• Utilizing general informed consent in specific healthcare research contexts, particularly those involving physician behavior, is a valid alternative to study-specific consent.
• This approach enhances the feasibility of conducting rigorous research on quality of care interventions while mitigating design validity threats.