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Contemporary Challenges to Population Studies of Cardiovascular Disease - Dr. Robert Goldberg

Disease Surveillance Questions - In designing surveillance systems suitable for global, national, or regional application:

  • What information is essential or indispensable?
  • What are the most valid, cost-efficient, and practical means for obtaining this information?
  • How can relevant data be obtained for potentially generalizable populations?
  • How can the system of surveillance become sustained?
  • How can this information continue to be made useful and of interest for different audiences?

Population-Based Approach to Surveillance

  • Broad-based perspective enhances generalizability and interpretation of findings
  • Ability to calculate incidence rates of disease and other pertinent health outcomes
  • Reflects more "real world" patients with disease, and their likely management practices, as compared to individuals studied in RCT's of more select patient samples with potentially narrow inclusion criteria

Non-Population Based Approach to Surveillance

  • Hospitals or clinics included for study may not be representative of centers from defined area
  • Patients hospitalized at select medical centers may have different characteristics from those seen in usual care settings
  • Management practices may not reflect those utilized in a community setting
  • Incidence rates of disease cannot be calculated with a "catch-can" ascertainment approach

"Cold" Pursuit Surveillance

  • Advantages
    • Complete case ascertainment
    • Cost efficiencies and minimal logistical complexities
  • Disadvantages
    • Cannot obtain supplemental data not available from medical or other records for research purposes
    • Need systematic lists and sampling frames for case selection

"Warm" Pursuit Surveillance

  • Advantages
    • Supplemental data not included in medical records can be obtained through direct patient or surrogate interviews
    • Can identify potential etiologic or prognostic factors in a more systematic and standardized manner
  • Disadvantages
    • High potential for incomplete case ascertainment
    • Greater logistical difficulties involved in identifying patients and ascertaining information
    • Increased personnel costs

Endpoints to be examined in CHD Surveillance Systems

  • New hospitalized events of AMI
  • Out-of-hospital deaths due to CHD
  • CFR's (hospital, 28 day, 1 year, longer)
  • Prehospital delay times
  • Use of EMS
  • Medical care (medications and procedures)

Obstacles to accessing and reviewing hospital and ambulatory care records

  • Ability to construct an appropriate sampling frame for sample selection
  • Reliability of ICD codes for case ascertainment
  • Selection of 1º or 2º discharge dx's of CHD for purposes of case ascertainment
  • Jumping into the "long and winding que" for accessing medical records (and importance of developing personal relationships)
  • Missing records
  • Incomplete records
  • Quality of information and lack of standardized questioning and recording
  • Quiet space for data abstractors

Data Abstraction Issues

  • Case definitions to be utilized
    • Standardized criteria
    • No upper age cap
    • Decision on transferred cases
  • Hospital data elements
  • Post discharge data elements
    • Mortality
    • Morbidity
    • QOL
    • Medication adherence

HIPAA, Consent, and Confidentiality Issues

  • Type of study to be conducted (mailed questionnaire, medical record review, phone survey)
  • Initial IRB approvals and dealing with medical care centers either without an IRB or who meet infrequently
  • Patient identifiers and matching criteria for follow-up information
  • Assuring patient confidentiality

Event Adjudication

  • Determination of which events that need continual review (e.g., UA, HF) and those which may not need further review and adjudication (e.g., receipt of CABG)
  • Need for standardized definitions
  • Need for experienced clinicians
  • Adequate "case" information to validate or rule out from further consideration
  • Maintaining group interest in review process and emphasizing importance of reviewers task

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