expanding research and evaluation designs…for qii carolyn m. clancy, md director, ahrq september...

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Expanding Research and Expanding Research and Evaluation Designs…for QII Evaluation Designs…for QII Carolyn M. Clancy, MD Carolyn M. Clancy, MD Director, AHRQ Director, AHRQ September 13, 2005 September 13, 2005

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Page 1: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Expanding Research and Expanding Research and Evaluation Designs…for QIIEvaluation Designs…for QII

Carolyn M. Clancy, MDCarolyn M. Clancy, MD

Director, AHRQDirector, AHRQ

September 13, 2005September 13, 2005

Page 2: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005
Page 3: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Are We Making Any Are We Making Any Progress?Progress?

Second annual reports focus on quality of Second annual reports focus on quality of and disparities in health care in Americaand disparities in health care in America

–Quality ReportQuality Report finds finds that quality is improving that quality is improving and identifies areas and identifies areas which are in need of which are in need of major improvementsmajor improvements

–Disparities ReportDisparities Report indicates that there are indicates that there are pervasive disparities pervasive disparities related to race, related to race, ethnicity, and ethnicity, and socioeconomic statussocioeconomic status

Page 4: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Preliminary NHQR Highlights Preliminary NHQR Highlights 20052005

Health Care Quality Continues To Improve at a Health Care Quality Continues To Improve at a Modest Pace Across Most Measures of QualityModest Pace Across Most Measures of Quality– 10:1 ratio of measures improved to declined10:1 ratio of measures improved to declined

– Overall improvement rate: 2.8%Overall improvement rate: 2.8%

Health Care Quality Improvement Is Variable, With Health Care Quality Improvement Is Variable, With Notable Areas of High Performance Notable Areas of High Performance – Patient safety: 10.2%Patient safety: 10.2%

– QIO Measures: 9.2%QIO Measures: 9.2%

– Effectiveness measures: 2.8%Effectiveness measures: 2.8% High improvement subset: 5.4%High improvement subset: 5.4%

Page 5: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

RAND Study: Quality of Health RAND Study: Quality of Health Care Often Not OptimalCare Often Not Optimal

Doctors provide appropriate health Doctors provide appropriate health care only about half the timecare only about half the time

Percentage of timePercentage of time

Alcohol dependenceAlcohol dependenceHip fractureHip fracturePeptic ulcerPeptic ulcer

DiabetesDiabetesLow back painLow back painPrenatal carePrenatal careBreast cancerBreast cancer

CataractsCataracts

11%11%23%23%

33%33%45%45%

69%69%73%73%76%76%79%79%

E. McGlynn, S. Asch, J. Adams, et al., The Quality of Health Care Delivered E. McGlynn, S. Asch, J. Adams, et al., The Quality of Health Care Delivered to Adults in the United States, to Adults in the United States, N Engl J MedN Engl J Med, 2003, 2003

Page 6: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

55%

44%

Public Perceptions

2004 2000*

Percent who say they are dissatisfied with the quality of health care in this country…

4%

40%

38%

17%

Has the quality of health care in this country…

Gotten worse

Gotten better

Stayed about the same

Don’t Know

Source: Kaiser Family Foundation / Agency for Healthcare Research and Quality / Harvard School of Public Health Source: Kaiser Family Foundation / Agency for Healthcare Research and Quality / Harvard School of Public Health National Survey on Consumers’ National Survey on Consumers’ Experiences with Patient Safety and Quality Information, Experiences with Patient Safety and Quality Information, November 2004 (Conducted July 7 – September 5, 2005).November 2004 (Conducted July 7 – September 5, 2005).

* * Gallup Poll conducted September 11-13, 2000 with 1,008 U.S. adults.Gallup Poll conducted September 11-13, 2000 with 1,008 U.S. adults.

Page 7: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005
Page 8: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

AHRQ’s Mission AHRQ’s Mission

To improve the safety and To improve the safety and quality, efficiency and quality, efficiency and

effectiveness of health care effectiveness of health care for all Americansfor all Americans

Page 9: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Answers must be:Answers must be:

TimelyTimely ValidValid ConvincingConvincing PracticalPractical

Page 10: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Publication

Bibliographic databases

Submission

Reviews, guidelines, textbook

Negative results

variable

0.3 year

6. 0 - 13.0 years50%

46%

18%

35%

0.6 year

0.5 year

9.3 years

It takes 17 years to turn 14 per cent of original research to the benefit of patient care

Dickersin, 1987

Koren, 1989

Balas, 1995

Poynard, 1985

Kumar, 1992

Kumar, 1992

Poyer, 1982

Antman, 1992

Negative results

Lack of numbers Expert

opinion

Inconsistentindexing

17:14

Original research

Acceptance

Implementation

Balas, 2002Balas, 2002

Page 11: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Treatments Thought to Work Treatments Thought to Work but Shown Ineffectivebut Shown Ineffective

Sulphuric acid for scurvySulphuric acid for scurvy Leeches for almost anythingLeeches for almost anything Insulin for schizophreniaInsulin for schizophrenia Vitamin K for myocardial Vitamin K for myocardial

infarctioninfarction HRT to prevent HRT to prevent

cardiovascular diseasecardiovascular disease Flecainide for ventricular Flecainide for ventricular

tachycardiatachycardia Routine blood tests prior to Routine blood tests prior to

surgerysurgery ABMT for late stage Breast ABMT for late stage Breast

CACABMJFebruary 28 2004; 324:474-5.BMJFebruary 28 2004; 324:474-5.

Page 12: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Expanding Research and Expanding Research and Evaluation Designs…for QII Evaluation Designs…for QII

Carolyn M. Clancy, M.D.Carolyn M. Clancy, M.D.Director, AHRQDirector, AHRQ

September 13, 2005September 13, 2005DRAFT – Denise D and David Atkins – 9/7/05DRAFT – Denise D and David Atkins – 9/7/05

Page 13: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005
Page 14: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

““Health services research has not yet been Health services research has not yet been sufficiently helpful in meeting the sufficiently helpful in meeting the challenge of improving care in part challenge of improving care in part because it has over-constrained both its because it has over-constrained both its methods and its favorite topics….HSR methods and its favorite topics….HSR should become more effectively part of should become more effectively part of the solution. To do that will require that the solution. To do that will require that we enrich our portfolio of methods and we enrich our portfolio of methods and broaden our area of inquiry.”broaden our area of inquiry.”

--Berwick, HSR, 40:2 (April 2005)--Berwick, HSR, 40:2 (April 2005)

Page 15: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Challenges to the RCT Challenges to the RCT ParadigmParadigm

The intervention targets are not patients The intervention targets are not patients directly, directly,

Interventions are complex Interventions are complex Interventions change, and Interventions change, and Where the setting is an essential Where the setting is an essential

component of the question and component of the question and intervention.   intervention.   

Page 16: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

AHRQ Research Study: Computerized AHRQ Research Study: Computerized Physician Order Entry SystemsPhysician Order Entry Systems

Major Finding:Major Finding: While computerized physician order entry (CPOE) While computerized physician order entry (CPOE) is expected to significantly reduce medication errors, systems must is expected to significantly reduce medication errors, systems must be implemented thoughtfully to avoid facilitating certain types of be implemented thoughtfully to avoid facilitating certain types of errorserrors

Study looked at clinicians’ experience in using one CPOE system at Study looked at clinicians’ experience in using one CPOE system at a major urban teaching hospitala major urban teaching hospital

Implementation problems can be minimized through testing before Implementation problems can be minimized through testing before products are marketed and through adaptation to meet the needs of products are marketed and through adaptation to meet the needs of individual clinical settingsindividual clinical settings

R. Koppel, J. Metlay, A. Cohen, et al., Role of computerized physician order entry systems in R. Koppel, J. Metlay, A. Cohen, et al., Role of computerized physician order entry systems in facilitating medication errors,facilitating medication errors, Journal of the American Medical AssociationJournal of the American Medical Association, March 9, 2005, March 9, 2005

Page 17: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Current QI evaluation questions Current QI evaluation questions AHRQ and others are askingAHRQ and others are asking

Can a regional health information organization Can a regional health information organization improve interoperability of health information improve interoperability of health information technology systems and improve patient safety technology systems and improve patient safety and quality of care?and quality of care?

Can pay for performance improve quality?Can pay for performance improve quality? Do changes in hospital culture reduce medical Do changes in hospital culture reduce medical

errors?errors? What QI strategies work for reducing disparities?What QI strategies work for reducing disparities?

– Different strategies for different populations and Different strategies for different populations and settings?settings?

– Same strategies? Same strategies?

Page 18: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Current QI evaluation questions Current QI evaluation questions AHRQ and others are asking - 2AHRQ and others are asking - 2

When should coverage be linked with When should coverage be linked with development of better evidence (‘decision-based development of better evidence (‘decision-based evidence making’)?evidence making’)?

[In an action-oriented world how to identify a [In an action-oriented world how to identify a control group?]control group?]

Can evidence for the effectiveness of team Can evidence for the effectiveness of team training in obstetrics be developed as training is training in obstetrics be developed as training is provided?provided?

For which questions is a registry useful? What For which questions is a registry useful? What methods will help us take advantage of new methods will help us take advantage of new sources of electronic data?sources of electronic data?

Page 19: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Galaxies of Evaluation Designs That May Inform Galaxies of Evaluation Designs That May Inform QII Evaluation Designs and MethodsQII Evaluation Designs and Methods

[1] For purposes of this chart, intervention evaluation research is defined as studies designed to Answer the Questions: Does the Intervention Work? For Whom or What? Under What Conditions?

RCT

HSR: 2° data Analysis

Medical/clinical/HSR Galaxy

Behavioral/Social Science Galaxy

Action Research—

K Lewin

PDSA/SPCDeming/

Shewhart

RCT

Quasi-exp

Case reports

Case studies

Qualita-tive

methods

Systems Science

Case-Control

ITS/MBS

QIIEvaluation Research

Cohort study

RD

GRT

Page 20: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005
Page 21: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005

Questions? Questions?

Contact Contact

[email protected]@AHRQ.GOV

Page 22: Expanding Research and Evaluation Designs…for QII Carolyn M. Clancy, MD Director, AHRQ September 13, 2005