Post on 05-Feb-2016
description
Quality Assurance in Epidemiologic Studies
Manya DeLeon MillerEPID 712
22 March 2000
Topics to be Discussed
• Brief history of quality assurance (QA)
• Applied aspects of QA for use in clinical trials and observational studies
• Some “how to” steps to establish/maintain QA systems
History and Background
• Quality Assurance (QA) is not a new idea: cunieform instructions for quality in work may be found from 2000 b.c.
• Japan and industry initiated “modern” QA efforts/philosophy
History and Background
• Biggest efforts from pharmaceutical industry—clinical trials, FDA changes to require randomized controlled trials in 1960’s
• Alphabet soup: QA, QC, TQI, QM, TQM, etc., etc… What does it all mean?
An Applied Approach to QA
• Data as a skeleton: A person and his realityinterviewer/MD/nurse/etc. case report forms (CRFs)data entrynumbers
An Applied Approach to QA
• The person who used to look like this:
• now looks like this: 1019988563222009
An Applied Approach to QA
• QA necessary to ensure that data are abstracted– HONESTLY– ACCURATELY
So that the subject is adequately reflected by the data.(fraud vs. error…)
An Applied Approach to QA
• REMEMBER:
the data should conform the person; the person doesn’t need to conform to the data codes, etc.!
An Applied Approach to QA
• Always consider the conclusions that will come from your study, and how inaccurate data will affect your conclusions.
An Applied Approach to QA
• Standardization is CRUCIAL• All techniques designed to ensure
that data are collected in a fashion that is:– Standardized– Systematic– Reliable– Valid
An Applied Approach to QA
• Consider system and QA issues BEFORE setting up study… Not during or after!
Steps in QA
• Study set up/study design/protocol• Regulatory• Forms/source documents• QA• QC• Data entry• Monitors/audits
Steps in QA
• Study set up/study design/protocol– Starting with a solid protocol is essential.– Should articulate IN DETAIL all aspects of
the study so that techniques (lab, data abstraction, evaluations, etc.) are the same irrespective of who/where study is done
– NO AMBIGUITY!– See real protocols, book, appendix D, web
Steps in QA
• Regulatory– Regulatory aspects should be well
maintained; part of assuring not only quality, but safety of subjects (and staff)
– IRB– Simple files fine, just be sure that they
are consistent and adherent with regulatory guidelines of institution, city, state, federal
Steps in QA
• Forms/source documents– Forms (often called Case Report Forms or
CRFs) should be well considered and piloted before implementation
– Want to standardize how questions are asked and be sure that answers address the study questions of interest
– Often, bad formsbad study, even if all else is great
– Training is essential!
Steps in QA
• QA– Define (second set of eyes…)– Check all data before submission for
• Logical consistency• Adherence to protocol/study• Correct representation of subject experience
– How to? • Specific training• Red pen sticky note or more elaborate
systems
Steps in QA
• QA– Team spirit essential with QA
Steps in QA
• QC– If possible, great to have a third set of
eyes for QC… obvious logical issues. May work together with data entry or be same person
Steps in QA
• Data entry– Again, training is key– Validity checks in data entry screens– Real time logical checks
(later=harder)– Double data entry (pros/cons)– Random sample double data entry
Steps in QA
• Monitors/audits– In clinical trials, very common – Should also do for cohort/case-
control/cross-sectional studies
Examples
• Pediatric AIDS Clinical Trials Unit
• Partner Notification Study
• Ever heard the saying,– GARBAGE IN, GARBAGE OUT??
• Think about the effort you are giving your study, the conclusions you want to be able to make. Data need to be valid; QA techniques allow valid data to emerge from your study
• Questions??