The Development of an Oncology Measure Set

“A Journey of a 1000 miles begins with a step”

Rodger J. Winn MDDirector, Cancer ProjectNational Quality Forum

Interesting Times in Oncology

• New technologies and biologic breakthroughs

• Increasing demand

• Emphasis on quality

• Concern about costs

Transformational times

• 1960-1980

– GROWTH

– AUTONOMY

• 1990-2000

– MANAGED CARE

• 2006

– VALUE-BASED PURCHASING

Value-based Purchasing

Goal: Obtain the Most Value

Value =Qualit

y

Cost

Emerging National Strategy forClosing the Quality Gap

Transparency - Create a marketplace rich in quality information (public reporting)

Payment Alignment - Reward providers for providing safe, effective, efficient care (P4P)

Consumer Engagement - Encourage patients to seek high value providers by having “skin in the game” (HSAs)

Executive Order 8/22/06

• Health Care Transparency: Empowering Consumers to Save on Quality Care

• Orders federal Agencies to:– Increase transparency on pricing– Increase transparency on quality– Encourage adoption of HIT– Provide options that promote quality and

efficiency in healthcare

Ensuring Quality Cancer Care

“The NCPB has concluded that for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care.”

Institute of Medicine

National Research Council

1999

The Four Parts of the Quality The Four Parts of the Quality GapGap

OveruseUnderuseMisuse/errorsWaste

Underuse: Adjuvant Tamoxifen for Breast Cancer

Percentage of Postmenopausal Women with Node (+) ER (+) Tumors Who

Received Tamoxifen Minnesota (1993) 59%

Massachusetts (1993-5) 63%

Guadagnoli et al: 1998

Underuse: Pain medication in patients with metastatic cancer

• ECOG survey of 1308 patients• 67% of patients had pain in the preceding week

36% had severe pain (inhibited function)• 42% (250 of 597) were not given adequate

analgesia• 3X more likely to receive inadequate pain

medication if a minority group memberCleeland, NEJM, 1994

Overuse: Chemotherapy use in the last 6 months of life

• 91 patients with metastatic breast cancer– Chemotherapy regimens

None 24%One 46%Two 16 %Three 10Four, five 3Six 1

Misuse: Hospital Surgical Volume and Operative Mortality

30 Day Mortality (%)

Volume Esophagus Pancreas

Very low 23.1 17.6

Low 18.9 15.4

Medium 16.9 11.6

High 11.7 7.5

Very high 8.1 3.8

Birkmeyer, NEJM, 2002

Progress

• When something new is found, people say it’s not true

• When it’s found to be true, people say it’s not important

• When it’s found to be important, people say it’s not new

William James

Quality Measurement

Purposes of measuring quality

• Accountability- public reporting–Drive selection, payment,

accreditation• Quality improvement- private

–Remedial action

• Surveillance- Generate information for policy decisions

Perspectives on quality

• Physicians focus on technical aspects of care

• Patients focus on health status, functional status, access, safety, communication, coordination of care, family inclusion, education, respect

• Purchasers focus on employee satisfaction, time out of work, health costs

IOM/NQF Aims of quality care

• Effective/Beneficial

• Timely

• Safe

• Patient-centered

• Efficient

• Equitable

Evidence linking care to outcomes

Measurement of a degree of adherence

Quality Indicator

Indicators, measurement, and measures

Measure

Types of quality indicators

• Types of indicators relate to realms of quality:

– Structure– Process Output– Outcomes– Patient experience

• Process and structural indicators should relate to outcomes. Outcome measures should loop back to process

Quality measure

• Quality measure: a mechanism to quantify the quality of a selected aspect of care by comparing it to a criterion– Requires a numerator and denominator

– Requires specifications

Surgical wound infection measures

• Assessment of incidence of surgical wound infections in 5804 wounds

• Rate by wound infection definition– CDC 19.2%– NINSS 12.3%– ASEPSIS >20 6.8%

Wilson, BMJ, 2005

Soundness of Measures

• In order to ensure that a measure will accomplish its aim of accurately assessing quality in a way that is meaningful, four areas must be addressed:– Importance– Scientific acceptability– Usability– Feasibility

Quality in the Oncology World:

A Comprehensive Measure Set

Disease Issues

• Multiple tumor types– Big four: Lung, colon, breast, prostate

• Multiple sub-types

• Multiple presentations

• Multiple stages

• Multiple therapeutic approaches

Disease Trajectory• Prevention• Screening• Diagnosis• Staging• Treatment• Surveillance• Survival• Recurrence• End-of-life care

Data Sources

• Administrative database– No staging– Lack of granularity

• Medical records– Multiple sites– Multiple physicians– May require patient contact

• Surveys– Not validated for oncology

Oncology Disciplines• Surgical• Surgical sub-specialties• Radiation• Medical• Pathology• Radiology• Nursing• Social Work• Pharmacy• Etc…….

Longitudinal Care

• To achieve optimal outcomes, i.e. survival, a series of appropriate processes must b e successfully completed:– Pathology reading, surgical procedure,

adjuvant RT, chemotherapy, and hormone therapy.

• Composite measures

– all or none measures

Attribution

• Individual physician• Referring physician• Team• Facility/practice organization• Health plan

• Responsibility beyond currently recognized boundaries

Level of Evidence

• Cardiology: a few trials with thousands of subjects

Oncology: a thousand trials with a few subjects

• High-level evidence not available for most oncology processes

Current Oncology Quality Activities

National Goals and Priorities

Measure Development

NQF Endorsement

Measure selection

Implementation: data selection, aggregation, verification, standard setting

Public ReportingStandard Setting

Accountability QI

Cancer Quality Initiatives• ACoS Commission on Cancer• ASCO

– NICCQ: breast and colon measures piloted in five cities– QOPI

• State Cancer Plans• ACCC Standards for Oncology programs• NCCN Outcomes Project• College of American Pathologists• Kaiser Permanente-IHI-NCQA• NHPCO, National Consensus Project• AUA, AAD

Need for a common set of measures

• If measure development and endorsement not centralized may be counter-productive:

–Fragmented–Duplicative–Contradictory

• Measures require buy-in from all stakeholders: providers, consumers, payers, government

National Quality Forum

• A private, non-profit voluntary consensus standards setting organization

• Membership 350+ • Meets criteria of NTTAA 1995

– Measures acceptable to CMS

• Structured to give voice to all stakeholder constituencies

• Formal review, voting and appeal process

Quality Alliances

• Hospital Quality Alliance (HQA)

• Ambulatory Care Quality Alliance (AQA)

• Cancer Quality Alliance– 12 Founding Members– Promote synergies– Defining role in measure development

• Pharmacy Alliance

• Pediatrics Alliance

NQF-proposed Accountability Measures: Hospital Level

• Breast cancer– Post-breast conserving surgery RT, <70– Adjuvant chemotherapy for Stage I >1cm or

Stage II and III, ER negative, <70– Adjuvant hormone therapy, ER+ or PR+

• Colon cancer– Adjuvant chemotherapy, Stage III, <80– 11 required elements in path report

• Family Evaluation of Hospice Care

NICQQ

Breast Colon

Diagnostic 13 10

Surgery 4 4

Adjuvant Rx 16 10

Toxicity 2 0

Surveillance 1 1

Overall 36 25

NICQQ results: Breast

Adherence (%) Range (%)

Diagnosis 88 88-89

Surgery 87 85-88

Adjuvant RX 82 81-83

Toxicity 73 69-78

Surveillance 94 92-95

Overall 86 86-87

NICQQ Results: Colon

Adherence (%) Adherence (%)

Diagnosis 87 85-89

Surgery 93 91-95

Adjuvant Rx 64 62-67

Toxicity - -

Surveillance 50 46-55

Overall 78 76-79

QOPIQuality Oncology Practice Initiative

Oncology measures:Physician level

• QOPI: Structure

• Path report

• Chemo plan

• Flow sheet

• Patient consent

• QOPI: Process• Pain assessment; 1st, 2nd to last last, visits• Narcotic effectiveness assessed• Chemo intent documented• Smoking• Anti-emetics• EPO or Darbo documentation of Hb <11 g/dl• Adjuvant chemo/hormone recommended and

given: breast, colon, lung• Bisphosphonates given and check renal function• CEA• Growth factors with CHOP or R-CHOP• CD-20 and rituximab

Physician level oncology measures:

Physician level oncology measures

• QOPI- Outcome– None

• QOPI- Patient experience– None

• QOPI- Efficiency– Chemotherapy in last 2 weeks of life

• Clinical trials

Implementation

• Each data collection requires 80 – 150 charts

• Abstractors are usually data manager, nurse, sometimes clerical, not doctors– Trained by ASCO staff

• Data entered directly onto web form

• Takes one or two days of staff time

QOPI Results

• >2000 doctors

• 125 practices currently enrolled

• 10,000 charts abstracted

• Several practices measured 2 – 3 times

Report Card

Chemotherapy recommended for breast cancer patients <50 years with T2 or +ALN

89

96

100

82

84

86

88

90

92

94

96

98

100

Copyright 2004, 2005 American Society of Clinical Oncology. All rights reserved.

RGH

VCI

%

Process

Documented plan for chemotherapy,

including doses and time intervals

15

31

43

6372

80 82 8389

94 95100

0

10

20

30

40

50

60

70

80

90

100

Copyright 2004, 2005 American Society of Clinical Oncology. All rights reserved.

RGH VCI

%

Structure

Was Pain Assessed on One of the Last Two Visits Prior to Death?

30

5664 67 70 73

8087 88 90 93

97 100

0

10

20

30

40

50

60

70

80

90

100

Copyright 2004, 2005 American Society of Clinical Oncology. All rights reserved.

RGH VCI

%

Process

Pain rated (by number) on either visit

08

1319 21 22

27

43

54 5660

7180

90

100

0

10

20

30

40

50

60

70

80

90

100

Copyright 2004, 2005 American Society of Clinical Oncology. All rights reserved.

RGH

VCI

%

Process

Patient enrolled in hospice before death

252733333640

50505353545760606263

7880839193

100

01020304050

60708090

100

Yes

Mean=62%

Copyright 2004, 2005 American Society of Clinical Oncology. All rights reserved.

RGH

VCI

%

Structure/Process

Conclusions• We must instill a culture of quality in

oncology

• All disciplines and stakeholders must be involved

• Measurement of quality is an exacting science and oncology poses special difficulties

• New methods using information technology will be needed

• Physicians and enlightened professional organizations will have to lead the way