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© 2015 American College of Physicians The information contained herein should never be used as a substitute for clinical judgment.

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© 2015 American College of Physicians

The information contained herein should never be used as a substitute for clinical judgment.

Discussants Series Assistant Editor Moderator

BEYOND THE GUIDELINES:

Medicine Grand Rounds

Should patients see their doctors for regular check-ups?

September 17, 2015

Ateev Mehrotra,MD, MPH

James Heffernan, MD, MPH

Eileen Reynolds, MD Howard Libman, MD

The Series Editors have no conflicts of interest to disclose.

Conflict of Interest DisclosureThe speakers have no financial relationships with a

commercial entity producing healthcare-related products and/or services.

Dr. Reynolds is President-Elect of SGIM but did not participate in the creation or approval of this guideline.

Eileen Reynolds, MDAteev Mehrotra, MD, MPHJames Heffernan, MD, MPHHoward Libman, MD

OUR PATIENT

• Healthy 70 year old woman• Sees her PCP once a year for a check-up

Medical History

OUR PATIENT

• Mild atypical neuropathy• Osteoarthritis s/p hip replacement• Elevated risk of breast cancer due to strong

family history• In the past 5 years, has been seen 6 times in

PCP’s office– 5 check ups– 1 visit for self limited abdominal pain

Past Medical and Surgical History

6

Year Exam/Test Results Outcome

2011Pap/HPV Normal Pneumovax BMD Osteopenia

2012

Sx: varicose vein pain Referred to vascular Had procedure

Referred to genetic counseling for breast cancer risk

Gail Model: 8% 5 year risk

Deferred medication; plan annual MRI and mammo

2013 Atypical skin finding Referred to derm Cryotherapy for 8 lesions

Interval Abnormal mammogram and MRI Bx: benign Routine follow up; all

handled by phone

2014

Again discussed breast cancer risk in light of bx and re-referred

Gail Model risk now 10.2%

Started exemastane 25 mg qd; annual follow up planned

Hepatitis C and lipids checked Tests normal/negative

2015

Ordered repeat BMD Osteopenia stable Given PCV13 pneumococcal vaccine

Fall, cognition, depression screens negative

CONTEXT, EVIDENCE, & GUIDELINES

• Annual check-ups / Periodic Health Exams (PHE) are covered by private insurance

• Affordable Care Act (ACA) provides for Wellness Exams under Medicare (2011)

• Costs are high• Benefits not convincingly shown• 2 attempts at comprehensive review

CONTEXT, EVIDENCE, & GUIDELINES• Systematic review for AHRQ (2007)• Reviewed 7039 articles; included 50 publications

from 33 studies– 10 RCTs, 23 observational studies

• “Overall the strength and consistency of the evidence varied widely among outcomes, as did the magnitude and direction of the results”

*Boulware LE, Marinopoulos S, Phillips KA, Hwang CW, Maynor K, Merenstein D, et al. Systematic review: the value of the periodic health evaluation. Ann Intern Med. 2007;146:289-300.

CONTEXT, EVIDENCE, & GUIDELINES• Findings: – PHE has beneficial effect on receipt of cervical cancer,

pap, colon cancer screening– PHE reduces patient worry– No effects found on cost, clinical outcomes, mortality

• Authors of AHRQ review concluded:– Findings “provide health care providers and payors with

justification for the continued implementation of the PHE”

*Boulware LE, Marinopoulos S, Phillips KA, Hwang CW, Maynor K, Merenstein D, et al. Systematic review: the value of the periodic health evaluation. Ann Intern Med. 2007;146:289-300.

CONTEXT, EVIDENCE, & GUIDELINES

• Cochrane review and meta analysis (2012)– Evaluate benefit to morbidity/mortality reduction– 14 RCTs included; total 182,880 subjects

• Primary endpoints: total and disease specific mortality• Secondary endpoints: morbidity; cost + utilization (admissions,

disability,referrals, tests/procedures, work absence)– No benefit of PHE found in any outcome– No heterogeneity in mortality results across 9 best trials

*Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345:e7191.

CONTEXT, EVIDENCE, & GUIDELINESForest plot showing effect of general health checks on total mortality

*Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345:e7191.

CONTEXT, EVIDENCE, & GUIDELINES• Cochrane review weaknesses– Age of the studies• 10 of 14 RCTs published before 1973

– Outcomes other than mortality often not reported

– Concern about bias in study populations

CONTEXT, EVIDENCE, & GUIDELINES

• “Choosing Wisely” campaign– “Things Providers and Patients Should Question”– Aims to raise awareness about high cost, low benefit

interventions• “Don’t perform routine general health checks for

asymptomatic adult patients”– Joins USPSTF (1985) and – Canadian Task Force (1979) suggesting targeted

approaches

ABIM Foundation and SGIM: 2013

*www.choosingwisely.org

QUESTIONS TO DISCUSSANTSTo help us decide how to apply this recommendation to our patient’s case we asked our discussants the following questions:

• What are the potential benefits of the periodic health exam?

• What are the potential costs of the periodic health exam?

• What patients should have a periodic health exam?

• What do you recommend for Ms. M?

OUR MODERATOR & DISCUSSANTSHoward Libman, MD (Moderator)

Director, HIV Program, Healthcare Associates, BIDMCChief, Education Section, Division of General Medicine & Primary Care, BIDMCProfessor of Medicine, Harvard Medical School

Ateev Mehrotra, MD, MPHAssociate Professor of Health Care Policy, Harvard Medical SchoolAssociate Professor of Medicine, Division of General Medicine & Primary Care, BIDMC

James Heffernan, MD, MPHPrimary Care Section Chief, Division of General Medicine & Primary Care, BIDMCAssociate Professor of Medicine, Harvard Medical School

Ateev Mehrotra, MD, MPH

Standard to Judge Any Intervention

Benefits Harms& Costs

Need to challenge long-standing practices and beliefs

• Hormone-replacement therapy • Antibiotics for bronchitis• Anti-arrythmics after a myocardial infarction• CABG superior to medical therapy• Ulcers as an infectious disease

• Targeted evidence-based preventive services • Targeted counseling for smoking, weight-loss• Health coaching and care coordination for chronic and

complex conditions• Visits with new symptoms • Having patients who have not seen their doctor for several

years come in for a visit to initiate or maintain a relationship

What am I not arguing against?

What am I arguing against?

• A specialized visit at some periodic basis focused on non-specific screening for illness or risk factors

Benefits of PHE• Mortality – no benefit• Morbidity – no benefit• Surrogate outcomes - ?

Should we even consider surrogate outcomes?• “We also chose not to focus on surrogate outcomes such as

changes in risk factors or delivery of preventive services, as these may be misleading because an improvement does not necessarily benefit the participant and because they do not measure harms.”

*Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345:e7191.

Surrogate outcomes

• Decreasing patient worry– Evidence mixed and placebo effect

• Increase delivery of preventive care– PHE inefficient method of delivering preventive care– Need for active outreach

*Boulware LE, Marinopoulos S, Phillips KA, Hwang CW, Maynor K, Merenstein D, et al. Systematic review: the value of the periodic health evaluation. Ann Intern Med. 2007;146:289-300.

Harms of overdiagnosis and treatment are important considerations

“…we know that all medical interventions can lead to harm. Possible harms from health checks are overdiagnosis, overtreatment, distress or injury from invasive follow-up tests, distress due to false positive test results, false reassurance due to false negative test results.”

*Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345:e7191.

Costs• #1 reason an adult sees a physician• $10 billion in direct medical costs & $3 billion in patient time• PCP time is a scare national resource– ~10% of PCP visits for PHE– In Massachusetts: ~50 day wait time for an appointment

*Mehrotra A, Zaslavsky AM, Ayanian JZ. Preventive health examinations and preventive gynecological examinations in the United States. Arch Intern Med. 2007;167:1876-83.*Ray KN, Chari AV, Engberg J, Bertolet M, Mehrotra A. Opportunity costs of ambulatory medical care in the United States. Am J Manag Care. 2015;21:567-74.

Addressing Common Criticisms• Criticisms– Prior research looked at wrong outcomes – Prior research is too old & PHEs are different now

• Response– Correct next step is a new trial, not continuing to encourage PHE

• Rescue bias– “Discounts data by selectively finding faults in the experiment.”– “Suspicious of evidence that is inconsistent with apparently well-

confirmed principles.”

*Kaptchuk TJ. Effect of interpretive bias on research evidence. BMJ. 2003;326:1453-1455.

Relationships% PCPs who strongly agree or agree with the following

views on the annual physical examination

*Prochazka AV, Lundahl K, Pearson W, Oboler SK, Anderson RJ. Support of Evidence-Based Guidelines for the Annual Physical Examination: A Survey of Primary Care Providers. Arch Intern Med. 2005;165:1347-1352.

• 94% believe: improves relationship• 94% believe: provides valuable time for counseling• 74% believe: improves detection of subclinical illness• 66% believe: covered by insurance• 63% believe: has proven value

• 55% disagree: not recommended

Periodic Health Examination

Benefits Harms & Costs

MortalityMorbidity

Preventive careRelationships

OverdiagnosisSpendingPCP time

How to move forward?• Eliminate PHEs• Create “Primary care maintenance” visits – Limited to those with no PCP visits for several years– Focus on relationships and not on screening/testing

• Focus on better methods of delivering preventive care• Use savings for primary care interventions that have been shown

to been effective such as health coaching• To Ms. M. – Come in when she feels ill

James Heffernan, MD, MPH

“Not everything that can be counted counts, and not everything that counts can be counted.”

*Cameron WB. Informal Sociology: a Casual Introduction to Sociological Thinking. Random House. 1963, p.13.

So what ’s wrong with the evidence c ited by SGIM, especial ly the Cochrane review?• The “health checks” were NOT primary care visits

– Screening took place in a usual care site in only 4/14 studies• The number of “health checks” varied from 1-4, with more

than half the studies limited to one check• Most studies were initiated in the 1960s and 70s, and none

later than the 90s • Many of the screening tests known now to be ineffective

CXRs, spirometry, ECGs, urine analyses, various blood tests• Geriatric trials were not included• Loss to follow up not well described

The Bottom Line -- What was counted in the Cochrane review is largely irrelevant in the context of current primary care practice, and the review by Boulware et al. actually endorsed implementation

of the PHE in clinical practice.

*Krogsbøll LT, Jørgensen KJ, Grønhøj Larsen C, Gøtzsche PC. General health checks in adults for reducing morbidity and mortality from disease: Cochrane systematic review and meta-analysis. BMJ. 2012;345:e7191.

What does count, and what are the potential benefits of the periodic

health evaluation?

Valued Elements of the PHE

• Continuity relationship• Screening/counseling• Identification of new clinical issues• Care coordination• Education around emerging health information• Opportunity to focus attention on family and social issues, and

goals of care• Provide a haven for patients to discuss sensitive issues,

embarrassing concerns and, most importantly, matters of safety

Convenience survey, academic primary care faculty members 8/2015

The Value of the PHE for Ms. M• Ms. M. has received outstanding care• Age-appropriate preventive measures over time, based

on evolving evidence/recommendations– PCV and pharmacological breast cancer risk reduction

• Interventions for actinic skin lesions, varicose veins • Referral for abdominal pain when it arose• Evolution of an abiding and trusting relationship with

her PCP

The Nature of ContinuityContinuity of care is an iterative and cumulative process, a point missed entirely in SGIMs admonition against the PHE and not addressed by the studies cited

The Value of ContinuityStudy Evidence…

• 51 of 81 separate care outcomes were significantly improved with significantly lower cost and utilization for 35 of 41 cost variables in association with interpersonal continuity

• In review of preventable admissions, increase in continuity metric of 0.1 associated with 2% reduction of preventable hospitalization

• 0.1 increase in COC score 7% overall reduction in “overused procedures”

*Saultz JW, Lochner J. Interpersonal continuity of care and care outcomes: a critical review. Ann Fam Med. 2005;3:159-166. *Nyweide DJ, Anthony DL, Bynum JP, Strawderman RL, Weeks WB, Casalino LP, et al. Continuity of care and the risk of preventable hospitalization in older adults. JAMA Intern Med. 2013;173:1879-1885. *Romano MJ, Segal JB, Pollack CE. The Association Between Continuity of Care and the Overuse of Medical Procedures. JAMA Intern Med. 2015;175:1148-1154.

The Value of Continuity…and more study evidence…

• Retrospective cohort review of hospitalizations, ED visits, complications and costs of care associated with the Bice-Boxerman continuity-of-care (COC) index– Based on claims data of Medicare beneficiaries experiencing

a 12-month episode of care for CHF, COPD or DM• Higher levels of continuity associated with lower odds of

inpatient hospitalization, ED visits, complications and total costs for CHF, COPD and DM

* Hussey PS, Schneider EC, Rudin RS, Fox DS, Lai J, Pollack CE. Continuity and the Costs of Care for Chronic Disease. JAMA Intern Med. 2014:174:742-748.

Continuity & Costs of CareOR for Hospitalizations, ED Visits, and Complications with 0.1 Increase in COC Index CHF COPD DM

Inpatient Hospitalization 0.94 0.95 0.95

ED Visits 0.92 0.93 0.94

Complications Related to CHF/COPD/DM, Comorbidities, & Patient Safety 0.92-0.96

Percentage Change in Costs with 0.1 Increase in COC IndexTotal Costs 4.7 – 6.3% lower

Inpatient Hospitalization 4.6 - 6.1% lower

ED Visits 5.8 - 6.2% lower

Complications Related to CHF/COPD/DM, Comorbidities, & Patient Safety

4.1 - 9.8% lower

Odds ratios for incidence, all P < .0001Cost reductions, all P < .01

*Hussey PS, Schneider EC, Rudin RS, Fox DS, Lai J, Pollack CE. Continuity and the Costs of Care for Chronic Disease. JAMA Intern Med. 2014:174:742-748.

The Value of Continuity

• Continuity of care and the PHE are not strictly synonymous, but the PHE remains the anchor of the continuity relationship

• Studies of the value of continuity are far better evidence of the worth of the PHE than the outdated and off-point studies cited by SGIM

Other Benefits of the PHE• There are 55 USPSTF Grade A and B recommendations for screening• Many of the screens do not require a visit, but where better to

oversee, discuss and counsel than through the PHE? • “There is always something…”

– Nevus malignant melanoma– Low anterior cervical lymph node Hodgkins disease– Patient who feels comfortable enough to share history of childhood

abuse only after 3 years of care • Personal bond benefiting both the patient and the PCP

*U.S. Preventive Services Task Force. A and B Recommendations. Available from: http://www.uspreventiveservicestaskforce.org/Page/Name/uspstf-a-and-b-recommendations/ *Wong CJ, Gaster B, Dugdale DC. Choosing Wisely: In defense of the preventive health visit. Am J Prev Med. 2014;47:653-655.

What are the potential costs of the periodic health evaluation?

Costs of the PHEDirect and indirect costs of the PHE itself

• Cost of an individual PHE is modest, but the aggregate annual cost of PHEs exceeds $10 billion

• Indirect costs: time off from work, parking, etc.But, compared to what?• Total US health expenditures in 2013 $2.9 trillion– Hospital care: $936 billion – Physician and clinical services: $586.7 billion

• Impressive growing evidence of cost savings related to COC…

5% reduction = $46.8 billion(PHE = 1.7%)

*Centers for Medicare & Medicaid Services. National Health Expenditure Data - Historical 2014. Available from: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and- Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html.

Costs of the PHEDirect and indirect costs of the PHE itself

More, compared to what?• What is the value, and what are the costs of…?– Six month in-office “OCP checks” by a gynecologist for a

26 year old woman– Radiographs/MRI before a patient is seen in an orthopedic

office, before assessment of the clinical issue– Annual follow up with an oncologist 7 years after surgical

cure of a low-grade malignancy– Annual follow up with a cardiologist (likely with an

echocardiogram) for low grade aortic stenosis

Other Costs of the PHE:• Non-evidence based testing does occur…• These costs appear to be more than offset by the reduction in

more expensive procedures when there is higher continuity of care

• The “crowding out phenomenon”• Providing access to timely care is far better addressed in global

redesign into modern care models such as the PCMH

T h e W o r k l o a d o f P r i m a r y C a r e i n t h e T r a d i ti o n a l ( P r e - P C M H ) M o d e l

• 7.4 hr/day to do prevention • 10.6 hr/day to do chronic disease management • 5.6 hr/day to manage acute issues…

*Yarnall KS, Pollak KI, Østbye T, Krause KM, Michener JL. Primary care: is there enough time for prevention? Am J Public Health. 2003;93:635-641.*Østbye T, Yarnall KS, Krause KM, Pollak KI, Gradison M, Michener JL. Is there time for management of patients with chronic diseases in primary care? Ann Fam Med. 2005;3:209-214.

The Putative Evolving Solution

1. Team-based care2. Proactive population management• Preventive and wellness services for all patients• Chronic disease management• Increased use of technology

3. Care management of our sickest patients4. Patient engagement5. Aggressive panel/roster/schedule mgt.6. Continuing important role for the PHE

Practice Transformation to Modern Care Models, e.g., PCMH

GroupHealth, Seattle• Mature PCMH, arguably most successful in the US• Strong commitment to proactive population and chronic

disease management• Innovative use of and reimbursement for non-office based

care – email, phone, etc. • Better access, longer visits, fewer patients/session• Improved physician retention• The PHE – “Well-Care Visit” -- is a cornerstone of the care

package offered and delivered

GroupHealth, Seattle

Age Women Men

18-21 1 1

22-49 4 4

50-64 2 2

65+ 1 1

Recommended Interval for Well-Care Visits (years)

*GroupHealth. Adult Well-Care Visits, Screenings, and Immunizations 2014 . Available from: http://www.ghc.org/healthAndWellness/index.jhtml?item=/common/healthAndWellness/tests/recommendedTests/adultTests.html

What patients should have a periodic health evaluation?

Everyone should have an initial health evaluation with a primary care provider and then follow up PHEs at intervals determined by the patient’s evolving risk profile, needs and wishes.

What do you recommend for Ms. M?

Ms. M. has received outstanding care and has a wonderful partnership with her primary care physician. Happily, she has no chronic conditions for which she needs to be routinely seen. I would encourage her to continue PHEs on a schedule that works for her and for her PCP.

Final Thoughts…• SGIM’s admonition against the PHE is celebrated more in the breach

than in the performance• Patients and PCPs continue to value and benefit in a multifaceted

way from the PHE• The PHE has not been shown to be of low value, high risk or high cost

and should not have been singled out for abandonment; rather, the PHE should continue to serve as a high-level capstone activity in evolving models of primary care

• Cutting this core activity out of primary care will not materially improve access and will poison the well for existing PCPs and for trainees interested in primary care

We would like to thank…

Our Patient, Ms. M

Ateev Mehrotra, MD, MPH & James Heffernan, MD, MPH

Last Minute Productions

BIDMC Media Services

Lizzie Williamson

Risa Burns, MD, MPHDeborah Cotton, MD, MPH

Howard Libman, MDEileen Reynolds, MDGerald Smetana, MD

© 2015 American College of Physicians

The information contained herein should never be used as a substitute for clinical judgment.