Domains | Information collected within each domain |
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Study design | Study design; investigational interventions; study endpoints; inclusion criteria; exclusion criteria |
Patient characteristics | Number of participants at baseline; main intervention; diagnosis; surgery |
Treatment | Main intervention; dosage of medications; frequency of taking medications; treatment duration |
Outcomes | Cushing QoL; Tuebingen CD-25; other HRQL measures utilized in the study; HRQOL factors; HRQL results; survival (number of patients who died during the study), response (how patients responded to treatment); healthcare utilization (length of hospital stays, visits to emergency room, unplanned medical visits) |
PRO measures | PRO purpose; PRO administration (how it was used to collect patient data); PRO scoring; PRO factors (clinical areas assessed by the measure); PRO primary citation (original authors of the measure); reliability/validity of the PRO measure; number of items in the measure; limitations of the PRO measure; HRQL change (improvements or declines in functioning that was assessed using the measure); HRQL response change (external or environmental factors that impacts the patient’s HRQL); recommendations (comments on the usefulness of the measure) |