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Alyssa Speier, MS, CIP
Blurred Lines: QA/QI vs. Research
Tel: 617-432-2140E-mail: [email protected]
URL: www.hsph.harvard.edu/ohra/qip
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Overview
• A hotly debated topic• Definitions• OHRP FAQs• Why is it confusing?• Summary of Research elements vs. QA/QI• QA/QI or research scenarios• Research can be QA/QI• Where to look• Example Aims• Logistics to Consider• Cases• Questions?
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A hotly debated topic…
http://www.nytimes.com/2007/12/30/opinion/30gawande.html?_r=2&oref=slogin&
-Atul Gawande, New York Times
Scientific research regulations had previously exempted efforts to improve medical quality and public health-because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to.
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A hotly debated topic…(cont.)
• “Collaborative cohort study” in 103 ICUs in Michigan, conducted by Johns Hopkins, to reduce incidence of catheter-related bloodstream infections
• Study intervention was implementation of a checklist used to ensure adherence to best practices: hand washing, full barrier precautions during insertion of central venous catheters, cleaning skin with chlorhexidine, avoiding femoral site if possible, removing unnecessary catheters
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A hotly debated topic…(cont.)
• Primary hypothesis: rate of infection would be reduced during first three months as compared to baseline
• Secondary hypothesis: reductions would be sustained in subsequent periods
• No randomization in study design because “all ICU teams wanted to implement the intervention”
• Result: overall median rate of catheter-related bloodstream infections decreased from 2.7 infections per 1000 catheter days at baseline, to 0 infections for first quarter and all subsequent quarters during 18 months of follow-up
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A hotly debated topic…(cont.)
• Anonymous complaint to OHRP that this was not treated as non-exempt Human Subjects Research (HSR)
• Hopkins IRB had deemed the study exempt under 46.101(b)(4), but OHRP said that this was a prospective intervention that changed care, not a study of existing standard of care data
• OHRP searched study documents to find that investigators had termed these techniques “study interventions” to test “hypotheses”
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A hotly debated topic…(cont.)
• Hopkins defended that this was only a QA activity
• OHRP: QA can also be HSR
• OHRP found that study activities were non-exempt HSR that needed full IRB review and CR, as well as informed consent
• OHRP: the staff in 103 ICUs were also study subjects
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Definitions
Research (HHS)– A systematic investigation, including
research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
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Definitions (cont.)
Human Subjects (HHS)
– A living individual about whom an investigator
(whether professional or student) conducting
research obtains
(1) data through Intervention or Interaction with the individual, or
(2) information that is both Private and Identifiable
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Definitions (cont.)
Quality Assurance Activities:– The purpose of a QA study is to assure known
quality– Examples: evaluation of direct patient care
processes (typically involved in creating clinical practice guidelines), evaluation of billing practices, accumulation of statistical data for monitoring and clinical performance assessment purposes, and assessment of community-based outreach programs for delivery of health care
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Definitions (cont.)
Quality Improvement (Institute of Medicine):– A systematic pattern of actions that is consistently
optimizing productivity, communication and value within an organization in order to achieve the aim of measuring the attributes, properties, and characteristics of a product/service in the context of the expectation and needs of customers and users of that product
– Intent is key The activity is specifically initiated with a goal of
improving the performance of institutional practice in relationship to an established standard
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OHRP FAQs
HHS regulations for the protection of human subjects do not apply to activities whose purposes are limited to– Implementing a practice to improve the quality of
patient care and collecting patient or provider data regarding the implementation of the practice for clinical practical or administrative purposes
– Delivering healthcare and measuring and reporting provider performance data for clinical, practical, or administrative uses
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Why is it confusing?
Similar Characteristics between Research and QA/QI– Ask clinically important questions– Use patient data– Download data from hospital or billing databases– Apply complex statistical analysis to data– Retrieve patient information from individual patients/participants– Goal of improving patient care
Differences between QI and Research:– QI is designed to bring about immediate improvements in healthcare delivery– QI is designed to have it’s findings applicable only to the local institution– QI is designed to sustain the improvements– QI does not require rigid, fixed protocol and may adapt the project over time– “Research is trying to understand what is the best treatment, while QI is trying to
implement what is known to be the best treatment”1
1McCarthy D, Case Study: Is It Quality Improvement or Research? The Experiences of Intermountain Healthcare and Children’s Hospital Boston, Quality Matters
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Elements Research QA/QI
Purpose Test a formal hypothesisDevelop new scientific knowledge
Assess a process, program, or system
Starting Point A prospectively designed, formal, written research hypothesis
An established set of standards
Benefits Knowledge sought may not benefit subjects involved in study but add to the greater good
Knowledge sought directly benefits the process/program/system
Risks/Burdens May put subjects at risk At least as safe as routine careBreach of confidentiality is the main risk
Data Collection Systematic Systematic
End Point Answer research question Improve the program/process/system
Testing/Analysis Determine validity of hypothesis Compare the program/process/system to established set of standards
Intended Result Share findings with individuals associated with and not associated with the investigation
Share findings only with those individuals associated with the process/program/system
If findings are shared with individual as unassociated with the process/program/system (via publication, conferences, etc.) then activities need to be presented as QA/QI initiative
Summary of Elements - Research vs. QA/QI
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QA/QI or Research?
The professor of a nutrition class at Alma Mater University intends to email a teaching evaluation survey to his class at the end of the semester. Identifiers will not be collected, but he will most likely know which student completes the survey given the information collected.
The head of Best Hospital would like to initiate a project involving in-person surveys completed by Best Hospital patients regarding their experience there for the purpose of improving services.
A faculty member at Hope Hospital proposes a project that utilizes patients to test a new shunt to see if it is as effective as that used for standard of care. The shunt is not yet FDA approved for use.
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QA/QI or Research?
An investigator collecting sensitive data regarding alcohol and drug use through focus groups hopes to yield results that can be used by rehabilitation clinics across the US.
A project involving the use of a new checklist during surgeries at Boston Hospital reminding surgeons to follow hospital policies is proposed. The checklist will be implemented at Boston Hospital if it is found to encourage adherence to policies and the results of the study will be shared with other hospitals so that they might implement similar checklists.
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QA/QI Can Be Research
QA/QIHuman Research
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Where to look
Purpose/aim statement should be clear– Aimed at improving local systems of care (non-
generalizable) vs. Research Question/Hypothesis?– Intent is to promote “betterment” of care, clinical outcome,
etc. vs. contribute to the advancement of field of study Procedures Study Tools (e.g., Questionnaires, surveys, etc.) Risks Benefits Sharing of research data/results
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Example Aims
QA/QI– …in order to improve value in post-acute care at Pilgrim Nursing Facilities– …to help U. Hospital drive high-value care and innovation in the post-acute
care space– Determine the source of contamination to help us understand and give us
the opportunity to improve our workflow and identify additional decontamination strategies
– Qualitatively evaluate the impact on safety, culture, acceptability and implementation of the checklist at Smith Clinics
Research– To develop a tool to be accepted by surgeons, nurses, and anesthesia
professionals in a variety of hospitals around the world– How do provider factors impact health care quality and costs?– To help all hospitals, care centers, insurance networks, etc.
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Logistics to consider
Why does it matter?– Reduce risk to participants (if HS research)– Save time (If not research)
Researchers Administrators Institutional review board Participants
Who is responsible for oversight?– Human Research - Institutional Review Board– QA/QI – Depending on the project (e.g., Institutional, clinical,
and/or administrative leadership)
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Logistics to consider (cont.)
Method for documenting that a non-research QA/QI determination? (know institutional policy)– Not Human Subjects Research Request /Reviewer
Worksheets/Determination Letter (HLMA IRBs)– Checklist for researcher to complete and maintain or submit– Other committee to submit QA/QI
What starts as QA/QI can be used for research later – If researcher determines that it would be of benefit outside of
institution, etc.– Within IRB submission Investigator should make it clear that the
data was collected as QA/QI, not as research
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Case 1: Hand Washing in Local High School
Is it Research?
Quality Improvement Initiative – Not Research
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Case 2: ICU Sedation
Is it Research?
Quality Improvement Initiative – Not Research
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Case 3: Web Based Learning
Is it Research?
Activity Constitutes Research
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Case 4: Admissions Survey
Is it Research?
Questions?
Leslie Howes, OHRA Director ([email protected])
QA/QI Specialists
Stanley Estime ([email protected]) Lisa Gabel ([email protected]) Alyssa Speier ([email protected])
OHRA: www.hsph.harvard.edu/ohra
See OHRA web site for department-assigned IRB Review Specialist and contact information
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