2024-28830. Supplemental Evidence and Data Request on Medical Care for Adults With Down Syndrome

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting)

PICOTS	KQ1	KQ2
Population	Adults 18+ years of age with Down syndrome. Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic status.	Adults 18+ years of age with Down syndrome Subgroups: demographics (age, race, ethnicity, gender), geography (rural and urban), socioeconomic status.
Intervention	Screening/diagnostic tests for co-occurring medical conditions in adults with Down syndrome.	Treatment interventions for co-occurring medical conditions in adults with Down syndrome.
Comparator	Alternative test for screening/diagnosis or no screening.	For all conditions, compared with usual care or alternative intervention for treatment.
Outcome	Benefits: accurate diagnosis, time to diagnosis or intervention/treatment. Health and quality of life outcomes. Harms: adverse events related to screening/diagnosis (mortality, medical trauma, unnecessary testing, etc.).	Intermediate outcomes: Treatment adherence. Lab values. Healthcare utilization. Final outcomes: Change in standardized symptom measures. Morbidity/mortality. Quality of life.
		Functional outcomes ( e.g., activities of daily living, assisted living/nursing home status). Caregiver or family outcomes (including caregiver health and quality of life). Harm outcomes: Adverse treatment effects.
Timing	All duration and follow up.	All duration and follow up.
Setting	US and non-US settings. All healthcare settings ( e.g., primary care, specialty care, specialized clinics, etc.)	US and non-US settings. All healthcare settings ( e.g., primary care, specialty care, specialized clinics, etc.).
Abbreviations: KQ = key question.