Developing Trustworthy Clinical Practice Guidelines.

What Does This Mean Regarding the Use of Imaging?

Michael A. Bettmann, MD, FACR, FAHAChair, American College of Radiology Appropriateness Criteria

Imaging Guidelines: Basic Imaging Guidelines: Basic ConcernsConcerns

Horizontal, rather then Vertical Horizontal, rather then Vertical Everyone uses imagingEveryone uses imaging Patients trust & often request imagingPatients trust & often request imaging Complexity is increasing, but so are Complexity is increasing, but so are

cost and availabilitycost and availability Risks of ionizing radiation are a Risks of ionizing radiation are a

concernconcern Studies on efficacy, outcome and Studies on efficacy, outcome and

relative utility are limitedrelative utility are limited

Medicare Part B Imaging Medicare Part B Imaging SpendingSpending

2000: $6.89 billion2000: $6.89 billion

2006: $14.11 billion2006: $14.11 billion

Projected Growth in Imaging Procedures (2000-2008)

Source: Sg2

281 299323

349374

401430

450471

Vo

lum

e o

f Im

agin

g

Pro

ced

ure

s (M

)

600

2000

500

400

300

200

100

02001 2002 2003 2004 2005 2006 2007 2008

Expected Growth 2002-2008Expected Growth 2002-2008MRIMRI CT ScanCT Scan UltrasounUltrasoun

ddX-RAYX-RAY

133%133% 122%122% 57%57% (9%)(9%)

Imaging service volume will continue to Imaging service volume will continue to increase as use of increase as use of

high-tech procedures drive growthhigh-tech procedures drive growth

CMS Reports Health Spending Decreased In 2008.CQ Today (1/6, Wayne) reports that a CMS spending report released Tuesday in the

journal Health Affairs showed that "national spending on healthcare grew in 2008 at the slowest rate in decades...but it still greatly outpaced the growth of the overall

economy." According to CMS, "total healthcare spending in 2008 was $2.3 trillion...a 4.4 percent increase over 2007 spending -- the lowest growth rate the agency has recorded

since it started tracking the statistic in 1960."         NPR 's (1/5, Rovner) "Morning Edition" added, "There's still more bad news, says

Rick Foster, the chief actuary at HHS. A major reason health spending slowed is that with the bad economy, many people simply couldn't afford medical care." He said, "In many cases they lost their employee-sponsored health benefits at the same time they lost their jobs. So that meant that the cost of care was much much higher because they

had to pay it out of pocket. So some people presumably scaled back on their purchases."

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Reasons for Inappropriate ImagingReasons for Inappropriate Imaging

Patient expectations and demands for imagingPatient expectations and demands for imaging Concerns of liability exposure if imaging not obtainedConcerns of liability exposure if imaging not obtained Conflict of interest presented by physician ownership of Conflict of interest presented by physician ownership of

imaging equipment (self-referral)imaging equipment (self-referral) Lack of specific guidance from Radiologists or other imagersLack of specific guidance from Radiologists or other imagers Lack of knowledge by ordering physicians and other Lack of knowledge by ordering physicians and other

providers (increasing number of exams ordered by non-providers (increasing number of exams ordered by non-physicians)-e.g., “customary practice”physicians)-e.g., “customary practice”

MedscapeMedscape (10/8/09, Lowry) reported, "Widespread (10/8/09, Lowry) reported, "Widespread media coverage of Natasha Richardson's death from a media coverage of Natasha Richardson's death from a head injury on March 18, 2009 prompted a huge head injury on March 18, 2009 prompted a huge increase in emergency department (ED) visits, increase in emergency department (ED) visits, investigators reported...at the American College of investigators reported...at the American College of

Emergency Physicians 2009 Scientific Assembly."Emergency Physicians 2009 Scientific Assembly."

Investigators "found that visits to the ED for head injury increased 73 % for the 10 days after March 18, compared with the 10 days before." But, "the number of serious head injuries did not [increase], nor did

the percentage of computed tomography (CT) scans that were performed." By March 31, however, visits were "back to the pre-

March 18 level."

Mass. Medical Society 2008 Mass. Medical Society 2008 Investigation of Defensive Investigation of Defensive

MedicineMedicine Liability Premiums=$26,000,000,000/yearLiability Premiums=$26,000,000,000/year 2000% increase vs. 19752000% increase vs. 1975 Annual growth rate =12%, 4x inflationAnnual growth rate =12%, 4x inflation 83% of physicians practiced defensive medicine Defensive Practice: Defensive Practice: ImagingImaging: Plain x-rays 22%, : Plain x-rays 22%, CT 28%, CT 28%, MR 27%MR 27%

US 24%, US 24%, OtherOther: specialty referral/ consult 28%, : specialty referral/ consult 28%,

laboratory laboratory studies 18%, studies 18%,

hospital admission 13%hospital admission 13%28%: Liability concerns affected their care of patients “a lot”28%: Liability concerns affected their care of patients “a lot”

Economist Estimates US Spends Up To $60 Billion Annually On Defensive Medicine.

In the New York Times (9/22) Economic Scene column, David Leonhardt wrote that, according to Harvard economist Amitabh Chandra, "$60 billion a year, or about three

percent of overall medical spending, is a reasonable upper-end estimate" of what is spent on defensive medicine in the US. Some "medical researchers have estimated that only

two to three percent of cases of medical negligence lead to a malpractice claim." In fact, "all told, jury awards, settlements and administrative costs...add up to less than $10 billion

a year," an amount equaling "less than one-half of a percentage point of medical spending." Nevertheless, Leonhardt argued that the current "malpractice system does"

indeed "affect the morale of doctors," leaving "them wondering when they will be publicly accused of doing the very thing they've sworn not to do: harm patients."

Lack of Knowledge by Referring CliniciansLack of Knowledge by Referring Clinicians

Most physicians want to do the right thing for Most physicians want to do the right thing for their patientstheir patients

Medical Imaging is increasingly complexMedical Imaging is increasingly complex Best imaging practices can change rapidly – CT Best imaging practices can change rapidly – CT

for pulmonary embolus, non-contrast CT for renal for pulmonary embolus, non-contrast CT for renal stones, PET/CT for cancer imagingstones, PET/CT for cancer imaging

Physicians can’t possibly keep up with all areas of Physicians can’t possibly keep up with all areas of medicinemedicine

Non-physician practitioners provide increasing Non-physician practitioners provide increasing amounts of care, and they order imaging studiesamounts of care, and they order imaging studies

The American College of The American College of Radiology Radiology

Appropriateness Criteria™Appropriateness Criteria™ Based on best-available clinical dataBased on best-available clinical data Intended uses:Intended uses: 1. Education1. Education 2. Clinical decision guidance:2. Clinical decision guidance:

In a specific situation, if the clinician is In a specific situation, if the clinician is considering an imaging study, what considering an imaging study, what study (or studies) are most likely to study (or studies) are most likely to provide the necessary information?provide the necessary information?

The American College of The American College of Radiology Radiology

Appropriateness Criteria™Appropriateness Criteria™ Based on best-available clinical dataBased on best-available clinical data 170 topics, with 800 clinical variants170 topics, with 800 clinical variants Intended uses:Intended uses: 1. Education1. Education 2. Clinical decision guidance:2. Clinical decision guidance:

In a specific situation, if the clinician is In a specific situation, if the clinician is considering an imaging study, what study (or considering an imaging study, what study (or studies) are most likely to provide the necessary studies) are most likely to provide the necessary information?information?

ORGANIZATIONORGANIZATION Task Force formed late 1993Task Force formed late 1993 Quality and Safety CommissionQuality and Safety Commission Chair: Michael A. Bettmann, MDChair: Michael A. Bettmann, MD 20 expert panels20 expert panels

10 diagnostic10 diagnostic 10 therapeutic10 therapeutic

EXPERT PANELSEXPERT PANELS

Bone MetsBone Mets BreastBreast Brain MetsBrain Mets Gyn (new)Gyn (new) Head & Neck (new)Head & Neck (new)

Hodgkin’sHodgkin’s Lung Lung ProstateProstate Rectal/AnalRectal/Anal

Diagnostic

BreastBreast Cardiac Cardiac GastrointestinalGastrointestinal MusculoskeletalMusculoskeletal NeurologicNeurologic

PediatricPediatric ThoracicThoracic UrologicUrologic VascularVascular Women’sWomen’s

TherapeuticInterventional Radiology

Radiation Oncology

Appropriateness criteria and related measures should be developed in accordance with the following principles:

1. Based on the tenets of evidence-based medicine, defined broadly as a blend of the highest level of evidence available with expert opinion. Evidence used to develop the criteria should be referenced for the end user. When risks and benefits are not clearly delineated by the evidence or available evidence is limited, there should be a compelling need and rationale for use.

AQA Principles for AQA Principles for Appropriateness CriteriaAppropriateness Criteria

2. Adequately characterize a clear definition of risks and benefits as they apply to the specific treatment, test or procedure, explicitly in the context of the current evidence and resources. This process includes defining the methods for evaluating each of these parameters and fairly balancing cost and quality considerations. Alternatives/scenarios for which there is clear evidence of harm should also be listed.

3. Provide a balance of scenarios that cover potential overuse and misuse, while highlighting any areas of potential underuse. Address primarily the most important (e.g., economical and clinical) alternatives/scenarios for the treatment, test or procedure.

4. Review periodically for new evidence, change in clinical guidelines and/ or recommendations or available resources.

EXPERT PANEL COMPOSITIONEXPERT PANEL COMPOSITION

Chaired by acknowledged expertChaired by acknowledged expert +/- 12 members+/- 12 members Broad representationBroad representation

GeographicGeographic All imaging modalitiesAll imaging modalities Academic/community practicesAcademic/community practices

Participation from non-radiologic specialistsParticipation from non-radiologic specialists

INVOLVEMENT OF OTHER INVOLVEMENT OF OTHER SPECIALTIESSPECIALTIES

ACR formally invites other specialty societies to ACR formally invites other specialty societies to send representatives to panelssend representatives to panels

Over 60 physicians from more than 19 societies Over 60 physicians from more than 19 societies now serving now serving

Example: Thoracic Imaging Panel includesExample: Thoracic Imaging Panel includes Society of Thoracic SurgeonsSociety of Thoracic Surgeons American College of Chest PhysiciansAmerican College of Chest Physicians

CRITERIA DEVELOPMENTCRITERIA DEVELOPMENT

Panelist selected as Topic AuthorPanelist selected as Topic Author Formally reviews and selects available Formally reviews and selects available

literatureliterature Develops evidence table with rating of Develops evidence table with rating of

selected articlesselected articles Based on selected articles, develops Based on selected articles, develops

narrative of topicnarrative of topic Develops draft ratings table, with relevant Develops draft ratings table, with relevant

imaging modalities and suggested ratings imaging modalities and suggested ratings (1=least appropriate, (1=least appropriate,

9= most appropriate)9= most appropriate) Review by panel chair, then review by panel, Review by panel chair, then review by panel,

then voting (modified Delphi method) by all then voting (modified Delphi method) by all panel memberspanel members

Each topic formally reviewed and updated Each topic formally reviewed and updated every 2 yearsevery 2 years

CRITERIA DEVELOPMENTCRITERIA DEVELOPMENT

Evidence tableEvidence table Summarizes most important, Summarizes most important,

relevant peer-reviewed articles relevant peer-reviewed articles from systematic searchfrom systematic search

Indicates type of article Indicates type of article Rates article based onRates article based on

1.type of study 1.type of study

2.strength of evidence2.strength of evidence Becomes basis of developing the Becomes basis of developing the

narrative for each clinical conditionnarrative for each clinical condition

CRITERIA DEVELOPMENTCRITERIA DEVELOPMENT

Consensus-Building Process

Modified Delphi techniqueModified Delphi technique Three voting roundsThree voting rounds Consensus defined as 80% agreementConsensus defined as 80% agreement

As per Rand methodology, decisions based on As per Rand methodology, decisions based on scientific evidence supplemented as scientific evidence supplemented as necessary by expert opinion.necessary by expert opinion.

SAMPLE TOPIC

Clinical Condition: Low Back Pain

Variant 1: Uncomplicated. No red flags. (Red flags defined in text.)

Variant 2: Low velocity trauma, osteoporosis, and/or age >70

Variant 3: Suspicion of cancer, infection, or immunosuppression

Variant 4: Radiculopathy

Variant 5: Prior lumbar surgery

Variant 6: Cauda equina syndrome

SAMPLE VARIANT TABLESAMPLE VARIANT TABLE Clinical ConditionClinical Condition: Low Back Pain : Low Back Pain Variant 2Variant 2:: Low velocity trauma, Low velocity trauma,

osteoporosis, and/or age >70. osteoporosis, and/or age >70.

Radiologic ProcedureRadiologic Procedure RatingRating CommentsComments RRL*RRL*

MRI lumbar spine without contrastMRI lumbar spine without contrast 88 NoneNone

CT lumbar spine without contrastCT lumbar spine without contrast 66MRI preferred. CT useful if MRI MRI preferred. CT useful if MRI contraindicated or unavailable.contraindicated or unavailable.

MedMed

X-ray lumbar spineX-ray lumbar spine 66 LowLow

NUC bone scan targetedNUC bone scan targeted 44 MedMed

MRI lumbar spine without and with MRI lumbar spine without and with contrastcontrast

33 NoneNone

CT myelography lumbar spineCT myelography lumbar spine 11Usually accompanied by plain film Usually accompanied by plain film myelogram.myelogram.

MedMed

X-ray myelography lumbar spineX-ray myelography lumbar spine 11 Usually done in conjunction with CT.Usually done in conjunction with CT. LowLow

Rating Scale:Rating Scale:  1=Least appropriate, 9=Most appropriate  1=Least appropriate, 9=Most appropriate*Relative *Relative Radiation Radiation

LevelLevel

Clinical Condition: HeadacheClinical Condition: Headache Variant 5: Headache, suspected intracranial complication of Variant 5: Headache, suspected intracranial complication of

sinusitis and/or mastoiditis.sinusitis and/or mastoiditis. (See also ACR Appropriateness (See also ACR Appropriateness Criteria® on “Sinonasal Disease”) Criteria® on “Sinonasal Disease”)

Radiologic Procedure Radiologic Procedure Rating Rating Comments Comments RRL*RRL*

MRI head without and with contrast 8 MRI head without and with contrast 8 See statement regarding contrast in text See statement regarding contrast in text underunder

“ “Anticipated Exceptions”Anticipated Exceptions” None None

CT head without contrast CT head without contrast 7 Sinus imaging may also be indicated. 7 Sinus imaging may also be indicated. Med Med

MRI head without contrast MRI head without contrast 7 7 None None

CT head without and with contrast 6 CT head without and with contrast 6 Sinus imaging may also be indicated. Sinus imaging may also be indicated. Med Med

Rating Scale: 1=Least appropriate, 9=Most appropriate Rating Scale: 1=Least appropriate, 9=Most appropriate

*Relative Radiation Level *Relative Radiation Level

Solitary Pulmonary Solitary Pulmonary NoduleNodule

Clinical setting: incidental finding on another Clinical setting: incidental finding on another imaging studyimaging study

Four Variants: Low clinical suspicion for Four Variants: Low clinical suspicion for cancer,<1cmcancer,<1cm

High clinical suspicion for High clinical suspicion for cancer,<1cmcancer,<1cm

Low clinical suspicion for cancer, Low clinical suspicion for cancer, ≥1cm≥1cm

High clinical suspicion for High clinical suspicion for cancer,≥1cmcancer,≥1cm

Breast Imaging ACR Breast Imaging ACR Appropriateness Criteria:Appropriateness Criteria:

1. Non-palpable breast mass (7 1. Non-palpable breast mass (7 variants)variants)

2. Palpable breast mass (10 variants)2. Palpable breast mass (10 variants)

3. Breast microcalcifications (18 3. Breast microcalcifications (18 variants)variants)

4. Stage I breast cancer (1 variant)4. Stage I breast cancer (1 variant)

Guidelines for Imaging Guidelines for Imaging UtilizationUtilization

Encourage expansion of available Encourage expansion of available scientific literature.scientific literature.

Encourage collaborative development Encourage collaborative development & acceptance of guidelines-balance of & acceptance of guidelines-balance of clinical and imaging expertise.clinical and imaging expertise.

Incorporate AC into decision support Incorporate AC into decision support systems and CPOE systems-alternative systems and CPOE systems-alternative to RBMs, lack of guidance or support.to RBMs, lack of guidance or support.