Comparative Effectiveness Research and Sources for Data

Define Comparative Effectiveness Research.

a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. such a study may compare similar treatment, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy

What is drug efficacy?

investigates whether a drug has the ability to bring about the intended effect

What is drug effectiveness?

investigates whether in the real world a drug in fact achieves its desired effect

What data can we use for non-experiential studies?

large cohort studies, healthcare and clinical databases, disease registries, drug registries, publicly available survey data, health maintenance organizations/health plans, commercial insurance databases, US government claims database, medical record database, in-hospital databases

What are desired qualities of a database?

representative, large, timely, up to date, continuity, linkage on unique identifier, accessible without delay

What databases are maintained by HMOs?

administrative and clinical databases used for clinical care, payment, and operational purposes; used for many epidemiological studies

What are HMOs and health plans a principal source of information for?

demographic data and membership status, outpatient drug exposure, diagnosis, procedures/special examinations, electronic medical records

What are the strengths of HMO databases?

large, diverse, defined populations; automated claims, EMR data, access to providers; varied delivery models and practice patterns; research centers’ ability to contact health plan enrollee for participation in clinical research

What are the weaknesses of HMO databases?

absence of populations groups that are uninsured (less diverse), smaller fraction of the elderly; prescription medications filled out-of-plan, nonprescription medications, and inpatient drug dispending not routinely captured

What are US government claims databases?

Medicaid and Medicare

What is medicaid?

established in 1965; low income pregnant women and members of low income families with children; chronically disabled; low income seniors

What is medicare?

established in 1965; nearly all US resident age 65 and above; permanently disabled adults younger than 65; part D is outpatient Rx drug coverage

True or False: more people are enrolled in Medicaid than Medicare

true

What % of Medicare enrollees are enrolled in Medicare part D?

60%

True or False: there are more men enrolled in Medicaid and Medicare

false

What are the strengths of using Medicare/Medicaid databases?

population size and length of follow-up, accuracy of pharmacy claims, validity of procedure claims, over-representation of underserved populations, ability to validate outcomes, ability to link to external data

What are the weaknesses of using Medicare/Medicaid databases?

non-representativeness, unavailable information, limitations in prescription coverage, eligibility, data validity/access to medical records, out of plan care

What are the purpose of in-hospital databases?

non-experimental studies are important approach to assess comparative effectiveness and safety of medication in hospitalized patients

Over past two decades development of databases with more detailed daily information regarding inpatient care examples

pediatric health information system database (PHIS)

Premier Perspective Database (PPD)

University Health System Consortium (UHC)

Health Facts Database (Cerner Corporation)

What is the PHIS Database?

comparative pediatric database containing clinical and financial data elements; encounters from 43 not- for-profit tertiary children’s hospitals in the US; all hospitals submit inpatient cases, most submit emergency department, ambulatory surgery, and/or observation patients

What is the premier database?

consortium of US not-for-profit hospitals and health systems; contains information on more than 130 million patient discharges; fewer than 1% of patient records are missing with some key elements

What are important data elements?

patient abstract, diagnosis, pharmacy, procedures, laboratory, clinical

What information does the patient abstract provide?

date of birth, race, gender, admission date, discharge date, APR-DRG classification

What information is provided by the diagnosis element?

discharge diagnosis based on ICD-9-CM codes

What information is provided by the pharmacy element?

medications ordered, route of administration, day of administration, pharmacy charge

What information is provided by the procedures element?

procuedures performed based on ICD-9-CM codes, date of procedures

What information is provided by the laboratory element?

lab ordered, day lab delivered, lab charge (does not included actual lab results), microbiology information

What information is provided by the clinical element?

clinical service provided, day service was provided, and charge associated with service

What are the strengths of the Premier Database?

sample size, versatile data source, data quality, efficient, data longevity

What are the weaknesses of the Premier Database?

generalizability of study findings can be questioned, possible misclassification (disease status, exposure status, outcome status), ascertainment bias (hospitalized patients have different lengths of stay, vary across hospitals