Outcomes & Clinical Trials
Welcome to the APSA Outcomes and Clinical Trials (OCT) page.
The OTC 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?
•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.
SYSTEMATIC
REVIEWS
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.
–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.
Note: Systematic reviews aid, but do not replace, sound clinical
reasoning.
Systematic Reviews currently available
•Gastroschisis/Omphalocele
•Antibiotic
for Appendicitis
REFERENCES
1. http://www.ahrq.gov/clinic/outfact.htm
2. http://www.nlm.nih.gov/mesh
3. Lee SJ, Earle CC, Weeks JC. J Natl Cancer Inst. 2000;92:195-204
4. http://www.nichd.nih.gov/health/clinicalresearch/
5. http://grants.nih.gov/grants/policy/hs/glossary.htm
6. Cook DJ, Mulrow CD, Haynes RB. Ann Int Med 1997;126:376-380
CURRENT
CLINICAL TRIALS AND STUDIES / POST A TRIAL OR
STUDY
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.
HELPFUL LINKS
http://clinicaltrials.gov/
RELATED SURVEY
RESULTS
The results of a 2009 online survey of APSA
members' Research
Interest and Funding is available.
