Outcomes & Clinical Trials
Welcome to the APSA Outcomes and Clinical Trials (OCT) page.
The OCT Committee aims to facilitate the efforts of APSA members, either
individually or as an organization, to develop clinical outcomes data
and evidence-based recommendations relevant to the practice of pediatric
surgery. What you'll find on this page:
- What is Outcomes Research?
- Systematic Reviews
- Evidence-Based Medicine in Pediatric Surgery
- Clinical Trials and Studies: SUBMIT A TRIAL/STUDY, VIEW EXISTING PROJECTS
- Surveys & Results
- Helpful Link
- Outcomes Research
Outcomes research seeks to understand the end results of particular health care practices and interventions. For clinicians and patients, outcomes research provides evidence about benefits, risks, and results of treatments so they can make more informed decisions1. Outcomes research is aimed at assessing the quality and effectiveness of health care as measured by the attainment of a specified end result or outcome, improved health, lowered morbidity or mortality, and improvement of abnormal states2. Classically, the key feature of outcomes research was the emphasis on effectiveness (the effect of an intervention as applied to broad populations in real practice). The umbrella term "outcomes research" now loosely covers a broad range of study questions (quality of care, access, decision making, prediction rules, and effectiveness), methods (analysis of administrative databases and decision analysis), and end points (health-related quality of life and costs)3.
- Health Services Research
The terms "outcomes research" and "health services research" are increasingly synonymous. Those who make a distinction between these terms regard outcomes research as measuring and addressing clinical issues and health services research as responding to policy questions3. Outcomes and health services research seek to identify the most effective and most efficient interventions, treatments, and services4. Health services research is usually concerned with relationships between need, demand, supply, use, and outcome of health services2.
- Clinical Trial
The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)5. The key feature of a clinical trial is to measure the effect of the intervention under controlled circumstances.
- Lee SJ, Earle CC, Weeks JC. J Natl Cancer Inst. 2000;92:195-204
- Cook DJ, Mulrow CD, Haynes RB. Ann Int Med 1997;126:376-380
The APSA Outcomes and Clinical Trials Committee is writing a series of systematic reviews on topics in pediatric general surgery. Timely, useful evidence from the biomedical literature should be an integral component of clinical decision making6. A properly conducted systematic review faithfully summarizes the evidence from all relevant studies on the topic of interest, and it does so concisely and transparently. Systematic reviews are summaries of the medical literature that are performed using a thorough literature search. Each review addresses a clearly formulated question. Note: Systematic reviews aid, but do not replace, sound clinical reasoning.
- When the results of primary studies are summarized but not statistically combined, the review may be called a qualitative systematic review.
- A quantitative systematic review, or meta-analysis, is a systematic review that uses statistical methods to combine the results of two or more studies.
Systematic Reviews currently available:
The 97th Clinical Congress of the American College of Surgeons held in San Francisco, CA in October, 2011 included a session entitled, "Evidence-Based Medicine in Pediatric Surgery: Don't Confuse Me with Facts, My Mind is Made Up". The session was moderated by Marjorie Arca and Daniel Ostlie. View the four PowerPoint sessions below, which are made available through the APSA Website at the request of the membership (The slides are the property of R. Moss, S. St. Peter, F. Abdullah and K. Oldham. They may not be altered or reproduced in any form.)
(1) Darwin to Cochrane: Evolution and Evidence-Based
Medicine by R. Lawrence Moss
(2) Applying Results of Randomized Trials to Clinical Practice by Shawn St. Peter
(3) Outcomes Studies and Clinical Practice by Fizan Abdullah
(4) American College of Surgeons National Surgical Quality Improvement Program--Pediatric by Keith T. Oldham.
In this section, APSA members can view and post their current
clinical trials and studies. We hope that through this
section, we can disseminate information to other members and
facilitate collaborative research efforts.
|VIEW ONGOING PROJECTS|
|POST A CLINICAL TRIAL/STUDY|