Random allocation of participants to comparison groups

Follow up (end point assessment) of ≥80% of those entering the investigation

Outcome measure of known or probable clinical importance.

Inclusion of a spectrum of participants, some, but not all of whom, have the condition of interest

Objective diagnostic (“gold”) standard (eg, central venous pressure) or current clinical standard for diagnosis (eg, sphygmomanometer reading for hypertension), preferably with documentation of reproducible criteria for subjectively interpreted diagnostic standard (ie, report of statistically significant measure of agreement beyond chance 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.

Inception cohort (first onset or assembled at a uniform point in the development of a condition or disease) of individuals, all initially free of the outcome of interest

Follow up of ≥80% of participants until the occurrence of a major study endpoint or to the end of the study.

Observations concerning the relation between modifiable exposures and putative clinical outcomes

Prospective data collection with clearly identified comparison group(s) for those at risk of, or having, the outcome of interest (in descending order of preference, from randomised controlled trials, quasi-randomised controlled trials, non-randomised controlled trials, cohort study with case by case matching or statistical adjustment to create comparable groups, or nested case control studies)

Blinding (masking) of observers of outcome to exposure (criterion assumed to be met if outcome is objective, eg, all cause mortality or self administered psychometric test)

Random allocation of participants or units to comparison groups

Follow up of ≥80% of participants

Outcome measure of known or probable clinical importance.

The economic question must compare alternative courses of action

Alternative diagnostic or therapeutic services or quality assurance activities must be compared on the basis of both the outcomes produced (effectiveness) and resources consumed (costs)

Evidence of effectiveness must be from a study (or studies) of real (not hypothetical) patients, which meets the criteria for treatment, assessment, quality assurance, or a review article

Results should be presented in terms of the incremental or additional costs and outcomes of one intervention over another

Where there is uncertainty in the estimates or imprecision in the measurement, a sensitivity analysis should be done.

The guide must be generated in ≥1 set of real (not hypothetical) patients (training set)

The guide must be validated in an independent set of real patients (test set)

The guide must pertain to treatment, assessment, prognosis, or causation.

A clear statement of the clinical topic being reviewed

A clear description of the sources and methods for identifying articles

Specification of the inclusion and exclusion criteria for selecting articles for detailed review

≥ 1 article in the review must meet the above noted criteria for treatment, assessment, prognosis, causation, quality assurance, or economics of healthcare programmes.