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Feasibility of effectiveness trials in pediatric anesthesia
1Akershus University Hospital, Lørenskog, Norway.
Insights
Pediatric anesthesia research needs to expand beyond efficacy studies to include effectiveness and cost-effectiveness. This shift is crucial for understanding how interventions perform in real-world clinical settings for children.
Area of Science:
- Pediatric Anesthesia Research
- Health Services Research
Background:
- Pediatric anesthesia research has historically prioritized efficacy studies, limiting generalizability to routine clinical practice.
- Effectiveness and cost-effectiveness research in pediatric anesthesia face systematic and cultural barriers.
- Understanding the interplay between efficacy, effectiveness, and cost-effectiveness is key to advancing pediatric anesthesia research.
Purpose of the Study:
- To highlight the importance of expanding research in pediatric anesthesia beyond efficacy studies.
- To examine the challenges and necessity of effectiveness and cost-effectiveness research in pediatric anesthesia.
- To propose a framework for understanding effectiveness research using Cochrane's hierarchy and the disease, illness, and sickness model.
Main Methods:
- Conceptual analysis integrating Cochrane's hierarchy of investigation.
- Application of the disease, illness, and sickness model from the philosophy of science.
- Discussion of challenges in measuring patient-centered outcomes in pediatric populations.
Main Results:
- Effectiveness studies, focusing on the illness perspective, are central to understanding intervention applicability in routine practice.
- Patient-centered outcomes are vital for generalizability but present unique measurement challenges in children.
- Cost-effectiveness research (sickness perspective) is underdeveloped in pediatric anesthesia.
Conclusions:
- Pediatric anesthesia research must evolve to incorporate effectiveness and cost-effectiveness studies.
- Addressing challenges in measuring patient-centered outcomes is essential for effective pediatric anesthesia research.
- Expanding research scope will improve the applicability and value of interventions in pediatric clinical practice.
Background:
Effectiveness studies aim to investigate whether an intervention does more good than harm in normal clinical practice.
Discussion:
Historically, research in pediatric anesthesia has appropriately concentrated on efficacy studies which even if of excellent design, tell us little about how generalizable or applicable the findings are to routine clinical practice. Simultaneously effectiveness and cost-effectiveness research has been limited due to systematic and cultural factors. To understand the challenges of effectiveness research in children, it is necessary to examine the overlapping relationship between efficacy, effectiveness, and cost-effectiveness studies. This can be illuminated with Cochrane´s hierarchy of investigation and the disease, illness, and sickness modelfrom the philosophy of science. Effectiveness (illness perspective) studies form the middle rung of Cochrane´s research hierarchy, between efficacy (disease perspective) and cost-effectiveness (sickness perspective) research. Effectiveness studies aim to be generalizable and determine whether interventions work in routine clinical practice. Since outcomes that reflect patient priorities offer the most generalizability these are encouraged in effectiveness studies. Due to developing consciousness and communication in young children, identifying and measuring patient-centered outcomes has challenges. These challenges are not insurmountable and with appropriate communication and research techniques the subjective nature of the experience of illness in the young may be elucidated and should direct research goals where possible. Sickness perspective research, in terms of cost-effectiveness, remains underdeveloped in pediatric anesthesia.
Summary:
Pediatric anesthesia has a strong base in efficacy research, but the need to expand research to include effectiveness and eventually cost-effectiveness studies should not be ignored.
