Additional Criteria Considered When Evaluating Studies
Studies
of diagnosis must meet these additional criteria:
- Inclusion
of a spectrum of participants, some, but not all of whom have the disorder
or derangement of interest.
- Diagnostic
(gold) standard (e.g., diagnosis according to DSM IV or ICD-10 criteria
after assessment by clinically qualified reviewer) preferably with documentation
of reproducible criteria for subjectively interpreted diagnostic standard
(e.g., report of statistically significant measure of agreement among
observers)
- Each
participant must receive both the new test and some form of the diagnostic
standard
- Interpretation
of diagnostic standard without knowledge of test result
- Interpretation
of test without knowledge of diagnostic standard result
- Analysis
consistent with study design.
Review
articles must meet these additional criteria:
- Statement
of the clinical topic
- An
identifiable description of the methods indicating the sources
- Explicit
statement of the inclusion and exclusion criteria applied for selecting
articles for detailed review.
- At
least one article included in the review must meet the above noted criteria
for treatment, diagnosis, prognosis, causation, quality improvement,
or the economics of healthcare programmes.
Studies
of prognosis must meet these additional criteria
- Inception
cohort (first onset or assembled at a uniform point in the development
of the disease) of individuals, all initially free of the outcome of
interest
- Follow
up of at leat 80% of patients until the occurrence of a major study
end point or to the end of the study
- Analysis
consistent with study design.
Studies
of causation must meet these additional criteria:
- Observations
concerning the relationship between modifiable exposures and putative
clinical outcomes
- Prospective
data collection with clearly identified comparison group(s) for those
at risk of the outcome of interest (in descending order of preference,
from randomized controlled trials, cohort studies with case by case
matching or statistical adjustment to create comparable groups, or nested
case control studies)
- Masking
of observers of outcome to exposure (this criterion is assumed to be
met if the outcome is objective)
- Analysis
consistent with design.
Articles meeting the criteria set out above are abstracted according to the procedure for more informative abstracts with the following modification: abstracts can be up to 440 words in length; and each is reviewed by an expert in the content area covered by the article and a commentary is added to provide the context of the article in the research that has preceded it; to provide any important methodological problems that affect interpretation; and to provide recommendations for clinical application. The author of the article is given the opportunity to review the abstract and commentary before publication.