Study Design Definitions
Appropriateness category: Defined as content pertaining directly to determining whether individuals who are provided with a health care service had the appropriate clinical indications to receive that service. Methodologic criteria for this category: Explicit criteria for appropriateness of care applied; data source was independent of the study investigators or there was an assessment of the reliability of the application of the criteria and the auditors were blind to practitioner identity and, if more than one institution was involved, institution identity.
Process Assessment category: Defined as content pertaining directly to assessing the process of care for people with a given health problem. These observational studies addressed who did what, to whom, why, where, when and how well. Methodologic criteria for this category: Explicit criteria for process of care applied; the data source is independent of the study investigators, or there was an assessment of the reliability of the application of the criteria and the auditors were blind to practitioner identity and, if more than one institution was involved, institution identity.
Outcomes Assessment category: Defined as content pertaining directly to the appraisal of various clinical decisions/management paths and their effects on patient well-being (outcomes). Studies were observational in nature. Methodologic criteria for this category: At least one of the outcomes is objective or derived from a data source that is independent of the study.
Costs category: Defined as content pertaining directly to the costs or financing of a health care issue. No methodologic criteria applied.
Economics category: Defined as content pertaining directly to a comparison of the cost and effects of at least two different forms of service provision. Methodologic criteria for this category: Question is a comparison of alternatives; alternative services or activities are compared on outcomes produced (effectiveness) and resources consumed (costs); effectiveness and cost estimated are based on individual patient data; results are presented in terms of the incremental or additional costs and outcomes of one intervention over another; sensitivity analysis is performed if there is uncertainty. Evidence of effectiveness must be from a methodologically rigorous study of diagnosis, treatment, quality improvement, or a systematic review article that involved real patients. NOTE: Economics is a subset of the Costs category.
Qualitative Research Studies category: Defined as content that relates to how people feel or experience certain situations, and data collection methods and analyses are appropriate for qualitative data. No methodologic criteria applied.
Quality Improvement Studies category: Defined as content pertaining directly to interventions intended to improve the quality of healthcare, including studies of continuing education for the purpose of improving the quality of care. The focus is on the providers and processes of care. Methodologic criteria for this category: Primary articles - Random allocation of participants to comparison groups, outcome assessment of at least 80% of those entering the investigation accounted for in one major analysis at any given follow-up assessment, and analysis consistent with the study design. Review articles - A clear statement of the clinical topic of the review, a methods section indicating how the evidence was retrieved and from what sources, an explicit statement of the inclusion and exclusion criteria, and inclusion of at least one study that passed on the methodological criteria for a primary study of quality improvement.
Last Reviewed: February 23, 2024