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CDM TOOLKITS THNEEDS THAT

EVERYONE NEEDS? Dr. Tracy Monk

Clin Asst Prof UBC Dept Family Med Head Dept Family Practice Royal Columbian Hospital

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Recap on Freewill . . . James and Bob and Jake: slaves to guidelines? vs free will Current legal environment

If you believe in the importance of free will of patients and providers for the future– pay attention to policy directions

Toolkit created with best intentions Significant implications for the future we should all

understand . . informed choices

If you believe in Evidence-informed care vs guideline compelled care Treating whole patients not their parts Treating patients not numbers Consider the implications of where you put patient data.

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First some definitions

Also

Talk diff from handout

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What’s a Thneeed? From the Lorax This is the Lorax

These are Thneeeds

All the truffula trees get chopped down to make thneeds . . . Sustainability parable

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What’s the CDM Toolkit? The Chronic Disease Management (CDM) Toolkit

is a Ministry of Health web site / data repository designed to assist practitioners in the management of patients with chronic diseases like diabetes and CHF according to best practices.

Creates report cards on the extent to which care provided is consistent with BC Clinical guidelines.

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Toolkit is a double-ended tool One end = GP office

- Pt. management, flow sheets, recall etc . . . - Practice profile, self audit report cards -> All potential features of office emr (ideal emr = allow

customization of flowsheet template for each patient – to reflect appropriate individualization after informed shared decision making )

Other end = Ministry of Health (MoH) -  Pooled data – enabling comparison (e.g. freq A1C meas) -  Quality Assurance framework – guideline as quality

template

Also being used as a mechanism for sharing info with a care team i.e. being used as an EHR or dataspine - Hosted by MoH

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What’s Quality Assurance? •  A movement which originated with industrial

assembly line manufacturing •  Quality = uniformity of product •  Elimination of unwanted variation •  Importance of measurement and feedback •  Issue – what if working as craftsman each

product different and custom built? -> trickier to define quality when it is precisely not

about doing things the same every time . . . . . .

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What’s a Guideline? Definition debated

Chambers' English Dictionary: a course that should be followed . . .

Wikipedia: A document that aims to streamline a process according to a set routine. By definition, following a guideline is never mandatory

CMA: a way to assist physicians in decision-making. Guidelines have the potential to improve outcomes and enhance efficiency.

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Margaret Thatcher on Guidelines

That: They are not the law. They are guidelines. Bax: Did they have to be followed? That: Of course they have to be followed, but they are not strict law. That is why they are guidelines and not law. They have to be applied according to the relevant circumstances. Bax: They are expected to be followed? That: Of course they have to be followed. They need to be followed for what they are, guidelines

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Key Questions: 1) Evidence: How good is the “evidence” in

evidence-based CDM guidelines? 2) Guidelines: What should they be? 3) Quality: Are CDM guidelines a suitable quality

assurance framework for judging and rewarding quality in primary care? If used in this way what are potential implications for:

- patients? - physicians? - Health Systems?

4) Value: What greatest value do GP’s provide to patients and Health Systems?

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1) EVIDENCE: How good is the “evidence” in evidence- based CDM guidelines? Potential Problems / Issues: a) Conflict of Interest in guideline creation b) Level of evidence, RCT (1a) vs. opinion (5)? c) What was studied? Surrogates or outcomes? d) Have recommendations been prioritized? e) Evidence “spin” f) Evidence in flux – e.g. WHI, ACCORD . . . g) The temptation of targets, with or without

evidence h) Evidence relevance to individual patient

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The Effect of Conflict of Interest on Research and Guidelines:

Can We Trust the Evidence in Evidence-Based Medicine?

As commercial interests play an ever larger role in directing our practice toward the latest tests and drugs, the ideals of family medicine—combining the art and science of medicine in the care of patients over time—are increasingly challenged.

The Journal of the American Board of Family Practice 18:414-418 (2005) Abramson and Starfield

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Can We Trust the Evidence in Evidence-Based Medicine? Cont’d

In this highly commercialized environment, how do we sustain the ideals that brought us to family medicine?

We now know enough about the limitations of "evidence" to be much more cautious about what passes for it.

The Journal of the American Board of Family Practice 18:414-418 (2005) Abramson and Starfield

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Prioritizing of guideline recommendations?

How often do we consider the relative differences in how much certain interventions improve outcomes for patients compared to others?

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Comparing Relative Impact of Some Lifestyle and Drug Interventions

On Mortality in Type 2 DM evidocs.ca

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Primary Prevention: Mortality benefits of lifestyle changes vs

RXes in pts with no Heart Dz 2008 BC Hypertension Guidelines Pt Handout

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Pedometers

Mike Allen- benefit of pedometers How often do we RX statin vs a

pedometer? Are we measuring how often we

remember to RX pedometers?

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Evidence “spin” What happened to the valid POEMs? A survey of review

articles on the treatment of type 2 diabetes Shaughnessy et al BMJ  2003;327:266

Assessed 35 review articles of UKPDS data •  Only 6 included the POEM that tight blood glucose control had

no effect on overall mortality •  Only 5 reported that diabetic patients with hypertension benefit

more from good blood pressure control than good blood glucose control.

•  13 recommended drugs as first line treatment for which we do not have patient oriented outcomes data.

(POEM= Patient Oriented Evidence that Matters)

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What happened to the valid POEMs?

Conclusion – The evidence was “spun” Review articles on the treatment of type 2

diabetes have not accurately transmitted the valid POEM results of the UKPDS to clinicians.

Clinicians relying on review articles written by experts may be misled.

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Quote: John Ralston Saul

“Doubt is the only human activity capable of controlling the use of power in a positive way. Doubt is central to understanding”

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“Evidence” relevance to individual?

Age as an example . . .

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Preventive health care in elderly people needs rethinking

Mangin, Sweeney, Heath BMJ Aug 2007;335:285-287

Prevention has side effects other than the hazards of the treatment.

Evidence for the effects of prevention of heart disease with drugs is scant in elderly people. . . We are using data from young pts

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PROSPER Pravastatin in elderly individuals at risk of vascular dz

Pravastatin showed no benefit over placebo for any outcome in elderly women

Although overall decreased cardiac events, rates of cancer diagnosis and death were higher in the treatment group than in the placebo group

Substitution of mode of death? Mangin et al conclude: -> selecting for another cause of death

unknowingly, and without the patient's informed consent.

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Prevention may not be beneficial T Reynolds, Consultant Chemical Pathologist Queen's Hospital

BMJ Rapid Response Aug 2007 Competing interests: I run a 'lipid' clinic

Many elderly patients are referred to my lipid clinic because they do not meet Government LDL targets despite high doses of statin and the consequent myalgia.

Frequently after a discussion of the meaning of risk, these patients opt not to be treated

The main casualty of target-based medicine is common sense.

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Point of contrast

Federal Primary Care Policy Paper

Why Health Care Renewal Matters: Lessons from Diabetes

A Health Outcomes Report: March 2007 Federal Primary Care Policy paper: Health Council of Canada

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Federal Primary Care Policy paper: Health Council of Canada

Given the known benefits of medication to control blood sugar, the level of prescribing in Canada seems low, esp. for the drug combinations recommended by experts.

Less than 1/4 of seniors with DM received meds to reduce cholest, despite the known benefits of these medications.

We know that specialists are more likely than family physicians to prescribe appropriate medications to improve cardiovascular health.

(more in syllabus)

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Gist and Q More A1Cs must be measured and more meds be RXed

across our whole population . . . -> Re-design the system to ensure care as defined in guideline

is delivered to all.

Question: Is our goal simply to test and Rx MORE, or is it to test and Rx MORE APPROPRIATELY?

We do not appear to have effectively conveyed to policy makers the key value we as GP’s provide to the system . . .

Doing right amount of less? Trying to find safe and appropriate dose of healthcare for

each patient . . .

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Quote: Trisha Greenhalgh UK Evidence-Based Medicine expert and Professor of Primary Care

“Without a doubt we’re in an era where the cozy promise of evidence-based medicine (just do the right clinical trials and the policies will fall out of the evidence) is being proven a fallacy . . .

. . . evidence goes fuzzy as it gets tugged about around the policymaking table . . .”

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2) CDM GUIDELINES: What should they be? a. The Standard of care b. Useful starting point in delivering evidence-informed care

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EBM Guidelines: and patient

Sackett defines evidence-based medicine as “the integration of best research evidence with clinical expertise and patients’ values.”

Guidelines about guidelines say that guidelines are supposed to incorporate patient values and provide info about benefits and harms

Currently guidelines don’t

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Guidelines: Current Status Much excellent work going on Potential Concerns • GPAC “Permit” exceptions -> implies

guideline is the standard of care and that not applying it has to be justified

•  Toolkit – built to report degree to which care is compliant with BC guideline

• What are implications of uploading your patient data out of your emr to toolkit?

Tacit acceptance of guideline as standard of care & quality framework?

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Guidelines Future? •  Level of Evidence * • Conflict of Interest declaration * •  Prioritize recommendations •  Incorporate patient values •  Provide info for informed shared decision

making ( www.evidocs.ca/riskcalc ) •  Starting point for evidence-informed care,

not defining the standard-of-care or quality framework

* In newest BC CKD guideline

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Guidelines the Future? Excerpt from new CKD guidelines

These Clinical Practice Guidelines (CPGs) are not intended to define a standard of care and should not be construed as one.

Neither should they be interpreted as prescribing an exclusive course of management.

Variation in practice will inevitability and appropriately occur when clinicians take into account the needs of individual patients.

Every health care professional making use of these CPG's is responsible for evaluation of the appropriateness of applying them.”

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3) QUALITY:

We are at a crossroads here and now . . . How we define quality, and what we measure, matters What is Quality in Primary Care? a) Delivering a CDM Guideline? b) Delivering individualized evidence-informed care

incorporating comorbidities & patient values as determined within a central GP/Patient partnership over time?

If the Guideline is defined as quality what are potential implications for:

-patients? - physicians? - Health Systems?

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Performance Measurement in Search of a Path Rodney Hayward, NEJM 2007, 356; 951-952

Performance measurements are fundamentally different from clinical guidelines.

The reasons that guidelines often make poor performance measures are nonintuitive and easily forgotten by those who do not take care of patients.

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Performance Measurement in Search of a Path cont’d Rodney Hayward, NEJM 2007, 356; 951-952

Many of forces at play: It is a political high-stakes process selecting

performance measures, and influential parties often have strong and understandable incentives to advocate for particular measures and press for focus on particular diseases

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Building strong condition brands Journal of Medical Marketing (2007) 7, 341–351.

Condition branding is the deliberate management of patient, physician, payer and other stakeholder knowledge about a condition in order to improve how the condition is treated.

Condition branding is becoming a necessity in the increasingly fierce 'war of conditions'.

The list of conditions about which patients are urged to talk to their doctor is growing by the day,

Only conditions with strong brand equity among key stakeholders will be able to obtain the resources they seek.

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Performance Measurement in Search of a Path Rodney Hayward, NEJM 2007, 356; 951-952

Our experience with performance measurement over the past two decades has shown that what you measure improves, but unfortunately, we often settle for measuring that which is easy to gauge and then sit back and celebrate the improvements in our “measures.”

As a result, we risk wasting both resources and opportunities.

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UK’s Quality Outcomes Framework (QOF)

A recent global example of the use of CDM Guidelines to measure quality in primary care . . . Guidelines embedded in emr and compliance with guideline template measured and rewarded by Ministry . . .

Some lessons learned . . . First step to potential problems = How quality is defined

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Measuring performance and missing the point? Heath et al  BMJ Nov 2007

The Quality and Outcomes Framework (QOF) diminishes the responsibility of doctors to think, to the potential detriment of patients

Evidence based care was never meant to be a substitute for clinical judgment . . . mechanistic blanket management strategies, embedded into computer software, become fixed.

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Measuring performance and missing the point? Cont’d

The whole initiative is based on reductive linear reasoning that views the body as a machine and assumes that a standardised treatment will produce an equally standard unit of beneficial outcome.

This initiative is driving hugely increased prescribing of some drugs.

What are the lost opportunity costs for other healthcare interventions?

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The Quality and Outcomes Framework: what have you done to yourselves?”

Mangin et et Br J GP June 2007

The focus has shifted from patients and the diseases that make them suffer, to the diseases themselves and their measurement within the patient.

QOF by its nature promotes simplicity over complexity and measurability over meaningfulness

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The Quality and Outcomes Framework: what have you done to yourselves?”

Mangin et et Br J GP June 2007

By following a medicine-by-numbers path under the QOF, the profession cannot lay claim to its own knowledge base and priorities.

At what point do we switch from educated professional to technician?

This loss of professionalism has profound implications and may result in a change in professional values. . .

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QoF: What have you done to yourselves? Conclusions

We do have an alternative. Most GPs wish to do a good job. Most recognize that where there is clear evidence that a particular course of action or inaction will result in benefit or harm, then their role as advocate for their patients is to make them aware of those options.

We can advocate for a system which promotes evidence-informed care . . . and provides options and their uncertainties for GPs and patients to interpret for themselves

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Hopes for the Future? •  Prevention should be targeted where it makes both

common sense, and a meaningful difference in the lives of patients, rather than just a measurable difference in a data repository.

•  Placing fair value on the integrative work of general practice should acknowledge the complexity of our practice more broadly than a small disease-focused subset. (some important positive steps taken)

•  Quality should be defined in a manner which reflects the importance of the key attributes of strong primary care:

- continuity - coordination - comprehensiveness and - filtration •  Relationship based care

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4) Value: What greatest value do GP’s provide to Patients and Health Systems?

RELATIONSHIP / CONTINUITY GP/Pt partnership= A relationship of trust over time

which is a locus for:

-  Informed shared decision-making -  Coordination of care -  Filtration i.e. Doing the right amount of less -  Evidence- informed care: i.e. Individualizing guideline

care based on co-morbidities and patient values

Keys to improved outcomes and decr costs i.e. sustainability . . . (Needs not Thneeds?)

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END ”Teaching novices a set of rules as the only way

to do things is misleading, and restricting experts to follow those rules can be dangerous.

The path to expertise depends on learning the situations that generated the rules, understanding when to apply the rules, and when to break them.

The whole point of having experts is to leverage their expertise, not to keep them from using it.”

Gary Klein -How People Make Decisions

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Extra Slides

For

Discussion

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Quote: Janice Gross Stein Re: Accountability and performance measurement

from: “The Cult of Efficieny” “What we count matters. The choice of measures

very much depends not only on what we are measuring, but why we are measuring . . .The voices of those who are to be held accountable are essential. . . we need to understand clearly

- why we are counting and - what we are counting, - who chooses the measures and - how they are chosen, - how the measurers and measures are

politically connected, and - what incentives these measures will create.

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Contribution of Primary Care to Health Systems and Health

Starfield et al The Milbank Quarterly, Vol. 83, No. 3, 2005. 457–502)

The evidence is strong regarding the benefits of an ongoing relationship with a particular provider rather than with a particular place, or no place at all.

People who report a particular doctor as their regular source of care:

- receive more appropriate preventive care, - are more likely to have their problems recognized, - have fewer diagnostic tests and fewer prescriptions, - have fewer hospitalizations and visits to emergency

departments, - are more likely to have more accurate diagnoses and

lower costs of care than are people having a particular place or people having no

place at all as their regular source of care

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Professionalism: Use It or Lose It Jock Murray, Can J Gen Int Med Vol 2, 4, 2007 p34

•  The de-professionalization of medicine has been evident for some time . . . physicians have developed a siege mentality bruised by intrusion into their decisions about patients.

•  This is not paranoia •  There is an increasing desire by other parties to have

physicians function as skilled employees rather than as professionals

•  There are people outside the profession who want to redefine our role of physicians in a way that serves their interests

•  There are increasing external controls over the profession and its members

•  There are increasing incentives that reward physicians for serving the “system” but in ways that may not best serve our patients.

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Professionalism: Use It or Lose It •  It is in the interest of the patients we are privileged to serve

that we defend medical professionalism. •  A “call to professionalism” is not:

–  “resistance to change.” –  a veiled attempt to protect the power and status of

physicians. –  an endeavour to return to another age characterized by

elitism and self-interest •  If we want professionalism to flourish, we must live it daily •  If we don’t understand & defend it, we will see the elements

of our professionalism whittled and negotiated away. •  If we don’t use it, we will lose it.

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BMJ, April 2008

• Placebo effects produce statistically and clinically significant improvement and the patient-physician relationship is the most robust component of the placebo effect

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High and Rising Health Care Costs. Part 4: Can Costs Be Controlled While Preserving Quality?

Bodenheimer et al Ann Int med July 2005, Vol 143, 1, 26-31 •  Informed shared decision making has strong evidence to

support that it results in improved quality and reduced costs

•  High-quality shared decision making requires - patients who can engage in discussions as informed

partners - evidence-based info that allows physicians to

accurately inform patients of available options and their consequences.

•  For chronic illnesses, such as diabetes, shared decision making is associated with better health-related behaviors and improved clinical outcomes.”

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Contribution of Primary Care to Health Systems and Health

Starfield et al The Milbank Quarterly, Vol. 83, No. 3, 2005. 457–502

Specialists are better at adhering to guidelines and focus on specific disease-related measures

Primary care physicians focus more on multiple aspects of health and have better general/generic outcomes

Comorbidity is common and causes more visits to both generalists and specialists than do most specific conditions

If the interest is in patients’ health as the focus of health services, primary care provides better care by focusing not primarily on the condition, but on the condition in the context of the patient’s other health problems.

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Clinical practice guidelines and conflict of interest

CMAJ, November 22, 2005; 173 (11).and JAMA. 2002;287:612-617

CMAJ: A 2004 report on more than 200 guidelines (from various countries) found that: –  more than 1/3 of the authors declared financial links

to relevant drug companies, with 70% of panels being affected.

– ½ of guidelines provided no info about conflict of interest.

JAMA 2002: -  7% of authors thought that their own relationships

with the pharmaceutical industry influenced the recommendations

-  19% thought that their coauthors' recommendations were influenced by their relationships.

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“Lorax” Lessons/“Animal Farm” Facts •  Evidence sometimes isn’t all it pretends to be •  Some guidelines are more equal than others e.g. Childhood Vaccine guidelines •  Not all recommendations in a guideline are

equal to each other . . . Some are more equal •  Just because it was written in a guideline today

doesn’t mean it will be true tomorrow •  There is an important difference between making

a meaningful vs. a purely measurable difference in the lives of our patients . . .

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EBM Guidelines and Physicians The Proliferation of Clinical Practice Guidelines:

Professional Development or Medicine-by-Numbers? S. Genuis, Jof Am Board of Family Practice 18:419-425 (2005)

Although many potential benefits in improved care. . . The increasing tendency to regard authoritative

documents as dogma may hinder ongoing medical progress and facilitate the adoption of a "follow-the-recipe" approach.

WHI demonstrated the shortcomings of a standard-of-care approach to management decisions.

A healthy tension between physician autonomy and recommended practice guidelines needs to be cultivated

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Performance Measurement

Measurement and feedback can be helpful tools in learning and change

Time to move to a higher level of quality i.e. more patient centered and clinically focussed?

What we measure, how we measure and what is inferred from the measurements really matters . .

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"It is an art of no little importance to administer medicines properly: but, it is an art of much greater and more difficult acquisition to know when to suspend or altogether to omit them."

- Philippe Pinel, 1745-1826

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Surrogate markers vs outcomes The Rosaglitazone Story

Clifford Rosen- Chair of FDA's Advisory Panel “Committee approved this "new 'wonder drug,'

prematurely and for the wrong reasons.” Among the studies evaluated, two of the largest

"failed to find a significant reduction in cardiovascular events even with excellent glucose control."

-> Recommends that the “FDA shift its primary efficacy end point away from surrogates, like A!C, to clinical outcomes.”

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Pay-for-Performance Principles That Promote Patient-Centered Care: An Ethics Manifesto Snyder et al, Annals of Internal Medicine Dec 2007, Vol 147, 11, 792-794

Pay-for-performance programs are growing, but little evidence exists on their effectiveness or on their potential unintended consequences and effects on the patient–physician relationship.

Concerns are not just about Payment for Performance itself, but also center on:

How Quality is defined We are concerned about using a limited set of clinical

practice parameters to assess quality. A system that judges performance according to a

limited but easily measured set of standards does not serve the interests of comprehensive care.

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Evidence in flux e.g HRT WHI results

How good was the good – how bad was the bad? Cases per 1,000 women per year

HRT Placebo Relative risk change

Change in cases per yr

Breast CA 3.8 3.0 26% 0.8 / 1,000 Heart Dz 3.7 3.0 23% 0.7 / 1,000 Stroke 2.9 2.1 38% 0.8 / 1,000 Blood Clots 2.6 1.3 100% 1.3 / 1,000 Hip FX 1.0 1.5 33% 0.5 / 1,000 Colon CA 1.0 1.6 37% 0.6 / 1,000

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Fatal and Non-Fatal MI prevented per 100 Type2 DMs over 5 yrs

Limitations of graphs. For practical purposes when comparing lifestyle with drug had to present epidemiological data for lifestyle with randomized control trial evidence for drugs.

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Federal Primary Care Policy Paper cont’d

A Canadian study found that 14% of people with diabetes who had high blood sugar were taking no medications and an additional 50% were taking just one medication to help control their blood sugar.

Although the rates of stroke and heart attack among people with diabetes have been declining, it appears that control of key risk factors for these cardiovascular complications continues to be poor.

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The Tension between Needing to Improve Care and Knowing How to Do It

Auerbach et al NEJM Aug 9, 2007; 357:6

“Just as in the rest of medicine, we must pursue the solutions to quality problems in a way that does not: -  blind us to harms -  squander scarce resources, or -  delude us about the effectiveness of

our efforts.” (Sometimes HC -Sometimes QA . . . )

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The paradox of the parts and the whole in understanding and improving general practice

Stange, Int J Quality Health Care. 2002;14:267–268 Problem with “disease focussed” vs “person-

focussed” approach to quality and measurement - misses what is uniquely important about FP:

care of the whole person , not just parts . . . -  may have unintended detrimental consequences

by devaluing fundamental aspects of the generalist approach that are essential to its success.

-  (Indictors we are using would be better for spec.)