If repealing Obamacare is off the table, can we turn attention to improving it through cost-effective clinical protocols?

Paul Krugman recently wrote an article in the New York Times posing the question: if repealing Obamacare is off the table (for now), should people on the “progressive” end of the political spectrum push for a single-payer “Medicare for all” system or just advocate for incremental improvements to the privatized Obamacare model?  He says if we were starting with a blank slate, he would favor the single payer model.  But, he argues, the politics of moving to single payer are too difficult, and the evidence from other countries suggests that a privatized model can achieve comparable outcomes.  Therefore, he argues that progressive politicians should turn their attention to other social policy priorities like subsidized child care and pre-kindergarten education.

I generally agree with Krugman’s proposal to focus on incremental improvements to Obamacare, particularly if the objective is just to maintain and improve access to health insurance.  But that’s not our only objective.  We should also care about the quality and cost of health care.

I’ve long felt that policy to increase access to care should be linked to policy to assure the cost-effectiveness and value of care. Insurance is, by its nature, a collective, cooperative thing. In the long run, the people who are covered under the same insurance risk pool are sharing a finite resource. If they understood that, they would rationally desire for there to be protections against the pooled resource being squandered by other people for low value purposes. In health insurance, such protections primarily take the form of benefit policies. Benefit policies may define which services are not covered because they are considered experimental or cosmetic. They may define limitations based on age, gender, or medical history. They may also set quantity limits on coverage, such as defining the number of physical therapy visits or inpatient psychiatric hospital days covered. They may set lifetime maximum dollar amounts. But, such insurance benefit policies are very blunt instruments.  Insurance companies also protect against low-value uses of health care services using “utilization management” programs, including requiring pre-authorization processes, where doctors are required to submit justifications for proposed services and insurance company employees judge whether the proposed services meet “appropriateness” criteria.  Such utilization management programs create conflict, and insurance companies generally establish criteria that are very loose to minimize the conflict.  As a result, such programs are also very blunt instruments.

Clinical protocols, in contrast, can be more precise instruments, taking into consideration the details of a patient’s clinical situation. Clinical protocols are typically developed by physicians, and are ideally supported by evidence from clinical research studies.  Clinical protocols can take many different forms, and go by different names including “guidelines,” “algorithms,” “care maps,” and “standards of care.”  Whenever we have tried to design clinical protocols, especially for complex and costly care processes such as for low back pain, congestive heart failure, cancer or the care of frail elderly patients, we discovered that different protocols can have very different costs and outcomes.  Thoughtful design, rigorous implementation and continual evaluation and improvement of clinical protocols can lead to large improvements of outcomes and large reductions in cost. But, cost effective protocols do deny some people some treatments that would have helped them a little (just not enough to be “worth” the cost). The whole premise of designing cost-effective protocols depends on the recognition and acceptance of the collective nature of insurance and the finite nature of the resources being shared. Furthermore, it is essential that the people for whom such protocols are applied trust the people and the process of creating and implementing the protocols. In for-profit, commercial insurance companies, there is a fundamental conflict of interest if the owners of the insurance company get to control the design and implementation of the protocols and if they get to keep the money saved from denying services that could have helped people — even a little.

In a single payer system, the entire country (or each state) is treated as a risk pool, and the government plays the role of protocol developer. Some people are OK with that, while others are loathe to assign such authority to governments.  If  we continue to have private insurance companies or accountable care organizations bearing the risk for populations of patients (as in the current Obamacare system), then such organizations can make decisions about clinical protocols.  In either case, we absolutely need to create structures and mechanisms to ensure that the people receiving the care trust the people and process used to create and implement cost-effective protocols.  Some private organizations, such as Group Health Cooperative of Puget Sound (now part of Kaiser Permanente), created some structures and processes designed to build this trust back in the 1990s.

Although most other advanced countries already accept cost-effectiveness and pursue the development and implementation of cost-effective protocols, and although there would be a huge opportunity to reduce cost and improve outcomes by doing so in the U.S., making this policy shift in the U.S. will be very difficult. The U.S. population has been taught to be wary of “rationing” and “death panels” and U.S. doctors have been taught to reject “cookbook medicine.” Nevertheless, moving the health policy discussion in that direction may, in the long term, do some good.   Politicians asking “what’s next” after the apparent end of the quest to repeal Obamacare should consider turning attention to bringing cost-effectiveness to health care through clinical protocols.

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The Humunculus is a metaphor for Clinical Process Improvement Frameworks

During the last 20 years, we have experienced wave after wave of new frameworks for improving health care.  Each had its own terminology, ardently promoted and enforced by its zealous advocates.  Each had a lifecycle that began with a long incubation period, followed by a period of explosive growth in popularity and influence, rapidly leading to unrealistic expectations, followed by a period of decline during which the framework was declared to have been ineffective.  We’ve been through health maintenance, outcomes management, clinical effectiveness, managed care, disease management, chronic care, care management, practice guidelines, care maps, evidence-based medicine, quality functional deployment, continuous quality improvement, re-engineering, total quality management, and six sigma.  We’re still in the thick of lean, patient-centered care,  value-based benefits, pay-for-performance and accountable care.

Four things I’ve noticed about this lifecycle of health care improvement frameworks:

  1. They are formulated by conceptual thinkers, but then get taken-over by more tactically-oriented people.  The tactical folks often focus too much on the tools, terminology and associated rituals.  The framework always gets “simplified” to be more suitable for mass consumption.  For example, continuous quality improvement somehow morphed into being primarily about assigning a timekeeper during team meetings and communicating progress on a felt-backed “story board,” rather than finding people with systems-thinking talent and applying that talent to understand sources of variation in complex processes.
  2. During the early part of the growth phase, the advocates are always desperate for examples of success, and shower a great deal of attention on early projects that are described using the terminology of the framework and that appear to have succeeded.  The desperation usually leads advocates to lower their standards of evidence during this phase.  This leads to over-promising and unrealistic expectations.  It stimulates lots of superficial imitation by people interested in hopping on the bandwagon.  And, it plants the seeds for the eventual decline, when people determine that their inflated expectations were not met.
  3. The decline phase, when the framework is declared to be ineffective, seems to always happen before the framework was ever really implemented in the way envisioned by the original formulators during the incubation phase.
  4. All the frameworks are really just restatements of the same underlying concepts, but with different terminology and tools, and different emphasis.  In other words, they all have the same anatomy, but different parts of the anatomy are emphasized.

This last point reminds me of the “humunculus,” also called the “little man.” When I was in medical school in the late 1980s, we used heavy text books that generally did a bad job of teaching the information. One notable exception was clinical neuroanatomy. We used a small, paperback text book playfully entitled “Clinical Neuroanatomy Made Ridiculously Simple” by Stephen Goldberg, MD. It contained a collection of clever drawings designed to explain the structures and functions of the brain and spinal cord. Perhaps the most famous of the drawings was the humunculus.

Cross section of somatosensory cortex, showing mapping to sensory input sources

This drawing was adapted from earlier work by an innovative neurosurgeon named Wilder Penfield, who invented new surgical procedures for patients with epilepsy during the late 1930s.  During those procedures, he used electrodes to stimulate different points on the surface of the brain.  He drew diagrams similar to the drawing above showing that the surface of the brain contained a little man hanging upside down. The diagram shows that a disproportionate portion of the brain surface is dedicated to the sense of touch and muscle movements in certain parts of the body.  Lots of brain surface is dedicated to highly sensitive and nimble areas like the lips, tongue, hands and feet.  Very little brain surface is dedicated to the arms, legs and back.  Many anatomic illustrators have drawn the humunculus as a cartoon character showing how this disproportional emphasis on different parts of the body looks on the little man.

The Humunculus

The humunculus is a great teaching tool, making it easy to remember these aspects of clinical neuroanatomy.  But, I think the humunculus is also a useful metaphor for the distorted emphasis that various health care improvement frameworks have placed on various parts of the underlying anatomy of health care improvement.



Health maintenance Preventive services
Outcomes Management Measurement of function, patient experience and health status
Clinical Effectiveness Measurement of outcomes in real world settings, rather than laboratory controlled conditions
Managed Care Prospective review of appropriateness of referrals, procedures and expensive drugs, and retrospective review of cost of care
Disease Management Role of nurses in training patients to be more effective in self-management
Chronic Care Teamwork in primary care clinic and importance of organizational and community environment
Care Management Role of nurses in coordinating services delivered by different providers and in different settings
Practice Guidelines Consensus about which ambulatory services are appropriate in which situations
Care Maps Consensus about the sequence of inpatient services for different diagnoses
Evidence-based Medicine Weight of scientific evidence about efficacy of a service (without regard to cost)
Quality Functional Deployment Focus on the demands made by patients
Continuous quality improvement Small experiments to determine if incremental process changes are improvements
Re-engineering Designing new processes from scratch, rather than making incremental changes
Total Quality Management Importance of organizational culture and management processes
Six Sigma Focus on reducing frequency of defects
Lean Focus on eliminating non-value-adding process steps and reducing cycle time
Patient-centered care Focus on the needs of patients and the involvement of patients in their own care
Value-based Benefits Financial incentives to motivate patients to comply with recommended treatments that reduce overall cost
Pay-for-performance Financial incentives to motivate individual physicians to improve quality and reduce cost
Accountable care Financial incentives to motivate health care organizations to improve quality and reduce cost

Over the years, I have assimilated the concepts, terminology and tools from these various improvement frameworks into an approach that attempts to achieve balance, with each aspect of the framework shown without over-emphasis.

This framework puts the patient in the center, surrounded by the health care processes, which are surrounded by improvement processes.  It attempts to balance between focusing on care planning (the clinical decision-making regarding what services are needed) vs. focusing on care-delivery (the teamwork to execute the care plan and provide health care services to the patient).  It balances between measuring outcomes and measuring quality and cost performance.  It balances between implementing best practices through guidelines and protocols vs. improving practices through performance feedback and incentives. By avoiding a distorted over-emphasis on any one part of the anatomy, hopefully it can have greater lasting power than some of the more humunculus-like frameworks that have come and gone.   This framework is described more fully here.

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Using Eddy’s Explicit Method to Develop Practice Guidelines for Mammography in the 40-49 Age Group

Note that the following write-up is now almost 20 years old!  (How did that happen?)  Amazingly, the debate about the role and frequency of mammography in the 40-49 age group has raged on the entire time since then.  This case study demonstrates the real-world use of the “explicit method” proposed by one of my “health care heroes”, David Eddy.  Eddy’s approach involves using decision-analytic models and cost-effectiveness analysis to interpret evidence and incorporate our values to inform practice guideline development.  This case shows that the explicit method is not just a “purist” methodology.  It is a practical method of achieving agreement among physicians that started the process in angry disagreement.

In the last two decades, our field has largely retreated from difficult discussions about cost-effectiveness and the rational allocation of limited resources — the dreaded “R” word.  In the recent debates about health care reform, those opposing reform talked of “death panels” and berated the U.K.’s NICE program which espouses some of the same principles as we used in this case.  Such harsh talk has replaced the thoughtful, principled discussions we were having at the Henry Ford Health System and in the field in general back then.  True health care reform will require that we go back and cross at this light.

— R. Ward, MD   Jan 27, 2010


As shown in the newspaper clipping below, the role of mammography in the 40-49 age group has long been controvertial.

Many organizations recommend mammography during the 40’s, including the American Cancer Society, the American College of Radiology, the American College of Obstetricians and Gynecologists, the American Medical Women’s Association, the National Alliance of Breast Cancer Organizations, and the National Breast Cancer Coalition.  Other organizations argue that the benefits of mammography have not been proven, and therefore mammography should not be offered until age 50.  These organizations include the American College of Physicians, the American College of Family Practice, the U.S. Preventive Services Task Force, the National Women’s Health Network, the National Center for Medical Consumers, the Darmouth Center for the Evaluative Clinical Sciences, the Canadian National Task Force on the Periodic Examination, and the United Kingdom Public Health Policy Board.

Within Henry Ford Medical Group, this same debate was also raging.  In May, 1991, the HFMG Operations Committee approved a Consensus Guideline calling for bi-annual screening in 40-49 age group.  Then, in October, 1993, the HFMG Consensus Guideline was updated based on recently published results of the Canadian National Breast Screening Study.  The new consensus group formulated a recommendation which said “women age 40-49 not in a high risk group should carefully consider the risks and benefits before scheduling a mammogram.”  This draft was approved by the Clinical Practice Committee, but was subsequently rejected by the Operations Committee.  Strong letters of opposition were sent to HFMG leadership from the Department of Surgery and the Division of Breast Imaging.   This led to a decision by Clinical Practice Committee to re-do analysis using explicit methods.


A multi-disciplinary team was commissioned by the HFMG Clinical Practice Committee to use an explicit methodology to conduct a clinical policy analysis and develop specific clinical policy recommendations regarding the role of screening mammography for average risk women age 40-49.


A multi-disciplinary team was assembled to conduct the analysis and formulate policy recommendations.  This team included the Chairmen of the departments of Radiology, Obstetrics & Gynecology, and Surgery.  It also included the Division Head of Breast Imaging, two general surgeons from the breast clinic, a staff oncologist, a Division Head in Internal Medicine, the Clinical Director of Family Practice, the Section Head of Epidemiology, the Associate Medical Director of the Health Alliance Plan (HMO).   The team was led by the Director of the Center for Clinical Effectiveness.

Based on information from the medical literature, internal HFMG data, and expert opinion of team members, a mathematical model was developed and refined in order to gain a greater understanding of the implications and shortcomings of existing scientific evidence and to estimate the health and economic outcomes (with ranges of uncertainty) for three alternative plans: (1) do not recommend mammography until age 50, (2) recommend a program of bi-annual mammography during the 40-49 period, and (3) recommend a program of annual mammography.


Results of Mammography Policy Analysis

As shown in the figure above, compared to not recommending mammograms, a program of 5 bi-annual mammograms for the 2,500 HFMG women entering their 40’s would add about $1.5 million to the net health care cost for the group (90% range of certainty: $918k – $2.1 million). This program could be expected to save between one and six lives, resulting in a gain of about 141 life years (43 – 244). This represents an expenditure of $440 thousand per life saved (undiscounted). With discounting of health and economic outcomes, this represents an incremental cost-effectiveness ratio of $34 thousand per life-year gained (15k – 120k). Earlier detection, in addition to saving lives, would permit the use of breast conserving procedures in about 2 more women, and would permit non-systemic treatment for 4 more women. In addition, such a program of bi-annual mammography could lead to added piece of mind for about 1,700 women receiving all negative screening results. On the down side, 59 more women would suffer the fear, inconvenience and risk associated with falsely positive mammogram leading to a negative biopsy, and an additional 650-950 women would suffer the unneeded worry associated with false positive mammogram results.

The full model results, presented in a table called a “balance sheet”, also shows the calculated health and economic outcomes associated with Plan C, offering annual mammography during the 40-49 age range.

Compared to bi-annual mammography, a program of 10 annual mammograms during the 40’s would cost an additional $900 thousand, saving an additional 0-1 lives for an estimated gain of 26 more life-years (1 – 58). This represents an expenditure of $1.4 million per life saved (undiscounted). With discounting, this represents an incremental cost-effectiveness ratio of $108 thousand per life-year gained (42k – 1.8 million).


On the basis if these estimates, the team recommended bi-annual screening mammograms in average risk women age 40-49. This guideline was intended to serve as a “best-practice”, “minimum practice”, and “maximum practice” guideline, as summarized in the following statement which was unanimously endorsed by the team: “Unless documented, patient-specific circumstances dictate otherwise, it is important to offer screening mammograms every two years during the 40-49 age period. More frequent mammograms are not routinely needed for average risk women during this age period.” This guideline statement was incorporated into the existing HFMG clinical preventive services guideline for breast cancer screening.


Shortly after this guideline was approved, a meta-analysis of mammography trials was published in JAMA. The abstract stated “The results of our meta-analysis suggest that screening mammography reduced breast cancer mortality by 26% (95% CI 17-34%) in women aged 50-74 years, but does not significantly reduce breast cancer mortality in women aged 40-49 years.” (emphasis added). The body of the manuscript stated “there were only three clinical trials in which women aged 40-49 years underwent two-view mammography and had 10-12 years of follow-up; in those, the relative risk for reduction in breast cancer mortality . . . was 0.73 (95% CI, 0.54 to 1.0) after 10-12 years of follow-up.” Although the abstract suggested the opposite conclusion as the HFMG clinical policy analysis, apparently based on a confidence interval that touched zero, the point estimate of mammography effectiveness in the 40-49 age group was actually more favorable than the HFMG analysis (27% vs. 25% risk reduction). The fact that the assumptions and calculated outcomes were explicitly documented in the HFMG made this potentially consensus-breaking piece of new information and put it in its appropriate context. This example also illustrates the decision-making criterion implied by the clinical trial and meta-analysis literature: if an intervention has a positive effect which is 95% or more likely to be greater than zero, then it is implicitly recommended, regardless of the magnitude of the outcome in relation or the cost. The explicit method permits policy-makers in health care organizations to use a more sophisticated and philosophically defensible criteria based on an assessment of benefits, costs, and the uncertainties associated with each.

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Improving Total Hip Replacement Surgery


Joint replacement is a costly and frequently performed inpatient procedure.  In 1995, Henry Ford Hospital carried out 280 total hip replacements and 225 total knee replacements.  To decrease unnecessary inpatient utilization and enhance functional outcomes of joint replacement surgery, Henry Ford Hospital established a multi-disciplinary improvement team, including representatives from Orthopedic Surgery, Physical Therapy, Home Health Care,  Social Work, Utilization Management, the Center for Clinical Effectiveness, and Marketing.


The team developed and implemented a best practice guideline in the form of a “care-map”, describing the default plan of care for delivering multi-disciplinary services to the patient for each day of the planned length of stay.   These interventions included outcomes assessments, tests & diagnostics, consults, treatments, procedures, medications, diet & nutrition, elimination goals, activity goals, and safety goals, skin condition goals, educational interventions and learning goals, and discharge planning.

To support the evaluation of the work of the team, comparative data was used.   These data included comparative outcomes data obtained through a collaborative Outcomes Measurement Consortium organized through the American Medical Group Association (AMGA).  Comparative process data was obtained through the Group Practice Improvement Network (GPIN).  In addition, a periodic audit process was used to measure variance from the care-map.  Additional process and outcomes data were collected and managed using software applications developed by the Center for Clinical Effectiveness:

  • Complications Tracking System used to enter and report on trends in various joint-replacement complications. This system was used to support the Department of Orthopedic Surgery morbidity and mortality conferences.
  • Outcomes data acquisition was accomplished using the “Flexi-Scan” forms scanning and study management software.
  • Cross-institutional pooling of outcomes data data pooling and quarterly analysis was accomplished by staff of the American Group Practice Association usuing the Flexi-Scan analytic dataset builder and other tools developed by the Center for Clinical Effectiveness.

Finally, patient satisfaction and subjective feedback data was obtained using patient focus groups arranged by Center for Clinical Effectiveness and staff from the Marketing Department.


The implementation of the care-map led to a further one-day reduction of the length-of-stay, as illustrated in the following figure.

Functional outcomes data revealed that hip replacement surgery led to rapid reduction in bodily pain to normal age and sex-adjusted levels. (Note that in the following graph, pain is expressed on the SF-36 pain scale, in which higher numbers represent better functional status, or less pain).

As shown in the following figure, physical function is also improved, although not as rapidly nor as dramatically as bodily pain.

The following figure shows the distribution in bodily pain and physical function, showing that although the average improvement is favorable, 15% of patients have worse pain one year after surgery, and 22% have worse physical function after surgery.

An analysis was conducted to identify baseline variables (collected prior to the surgery) which could predict failure to acheive improvement in pain and function.   As shown in the following table, mild pre-operative pain was among the strongest predictors of failure to achieve an improvement in pain.

In order to optimize the ability to predict which patients would fail to achieve a pain reduction from hip replacement, a neural network was trained based on 13 baseline variables collected from the patient before surgery.  The neural network was then used to calculate a predictive score for each of the patients.  The frequency distribution of predictive scores for patients that did achieve a pain benefit, as well as the distribution for those that did not experience a pain reduction are shown in the following figure.

If the neural network was perfectly predictive, these two distributions would not overlap at all.  A threshold predictive score was selected such that the model could be said to be 85% sure about making a prediction that a given patient would not achieve a pain reduction from surgery.  Of the 185 patients that experieced an improvement, only 2 had a neural network predictive score below 0.3.  Of the 36 patients that experienced an improvement, 13 of them had scores under 0.3.  So, for the 15 patients with a score below 0.3, 85% failed to experience a pain reduction.   The sensitivity of the model in predicting this type of treatment failure was 35%.   In other words, of 100 patients considering hip replacement therapy, about 15 of these will fail to achieve a pain reduction.  Of the 15, about 5 of these patients can be identified in advance using this neural network and using a cut-off threshold of 0.3.  If implemented in clinical practice, this model could lead to the elimination of the treatment cost and risk of complications associated with these 5 patients.  On the down side, approximately one patient who would have benefited from the surgery would have been incorrectly told that they were unlikely to benefit.  Such a patient would unnecessarily suffer pain that could have been relieved by the surgery.

As shown in the following figure, analysis also revealed that patients had unrealistic expectations of the time it would take for them to feel fully recovered after the surgery.

Finally, the data revealed that, compared to other institutions, Henry Ford experienced an unusually long physical function recovery period among patient receiving revision total hip replacement (operations on patients that had previously received hip replacement surgery).  Such data, shown in the following figure, led to a re-evaluation of Henry Ford’s approach to post-operative rehabilitation.

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Improving Adult Flu Immunization


The US Preventive Services Task Force established national evidence-based guidelines for adult immunization as part of their 1993 and 1996 review processes. After a review by Henry Ford Health System (HFHS) general internists, family practitioners, and infectious disease specialists, these guidelines were endorsed by the HFHS Prevention Committee. The Prevention Committee’s recommendations were subsequently accepted by the Henry Ford Medical Group Clinical Practice Committee and by the Health Alliance Plan Quality Management Committee to form practice guidelines for the medical group and health plan, respectively.


A multi-faceted implementation approach was used to improve immunization performance within the Henry Ford Medical Group, one of the provider groups that serve the Health Alliance Plan. Multi-faceted implementation efforts have been found to be most effective for improvement processes that involve behavior change. The implementation effort involved staff training, patient and member education, continual quality improvement, and medical informatics facets.

  • Staff Training.  All senior medical staff within the Henry Ford Medical Group were sent a copy of internal adult immunization guidelines, which were incorporated into a larger preventive health services manual. In addition to this mailing, a number of clinicians had the opportunity to discuss these guidelines in an on-site continuing medical education program on the provision of preventive health services.
  • Patient education was accomplished by publishing an article in the Health Alliance Plan’s member newsletter, which is mailed to all health plan members. A slogan and cartoon character were also developed for a program to promote immunization compliance. This content was incorporated into posters and tent cards, which were placed in clinics lobbies and waiting areas.
  • Local continuous quality-improvement teams were established to develop and implement process changes. These teams launched Saturday morning walk-in flu immunization clinics during flu season. By using this approach to immunization, wait times were reduces and patients were able to avoid setting up an appointment to get the immunization.
  • Medical informatics approaches were pursued, leveraging the capabilities of the clinical information system and data depositories that are available within the insitution. Computer-generated reports were created, listing immunization status for HFHS adult patients. These reports were used by staff of the Saturday morning walk-in flu clinics. In addition, computer-generated reminder postcards and letters to patients at high risk for influenza were printed and mailed.


These mailings were formally evaluated in a randomized trial conducted during the first year of the HFHS flu immunization program. The entire patient population for whom flu immunizations were indicated were randomized into four groups. The control group (usual care) received only the posters and tent cards in the clinic. Patients in each of three treatment groups received this same clinic-based intervention and either (1) a generic postcard, (2) a tailored postcard, or (3) a tailored letter containing an explicit statement of why flu immunization was indicated for them. Indications included age over 65 and the presence of one of a number of disease states, as ascertained from diagnosis coding of ambulatory visits and inpatient admissions. These letters or postcards were addressed from the patients’ primary care clinicians. The results of randomized trial showed a 5 percentage point increase in the rates of immunization in the patient population receiving the tailored letter compared to those receiving usual care.

The cost of the letter, including printing and postage, was 42 cents. The vaccine costs just over $4.00. From the literature, it is known that annual hospital costs are reduced from an average of $355 to $215 as a result of flu immunization. Therefore, during a non-epidemic year, the flu immunization program was calculated to save the HFHS over $180,000, net of the cost of the intervention. During an epidemic year, this savings is increased to almost $400,000. Therefore, the flu immunization project serves as an example of a clinical-practice improvement effort that simultaneously benefits the health status of patients and reduces health care cost.

The National Committee for Quality Assurance (NCQA) adopted in 1996 a new adult immunization performance measure which is included in the Health Plan and Employer Data and Information Set (HEDIS 3.0). These quality indicators have been reported by hundreds of health plans across the country, and are compiled in the NCQA Quality Compass, a national health plan quality database.

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Establishing Best Practices (Practice Guidelines & Protocols)

Best practices, also known as “practice policies” are defined as “preformed recommendations issued for the purpose of influencing decisions about health interventions.”  The term best practice does not itself specify an intended degree of flexibility. Some best practices are intended to be “standards,” with little intended flexibility. Others are intended to serve as “guidelines,” and still others are intended to describe “options.”

Best practices come in many forms. Practice policies established by health care providers or managed care organizations include:

  1. Care Maps or Critical Paths — describe an intended sequence of medical, nursing, and other interventions by day-of-stay during an inpatient admission for a particular condition.
  2. Practice Guidelines — describe the appropriate role of medical interventions for particular indications (including formulary and benefits design).
  3. Credentials — describe the appropriate qualifications of the medical professionals authorized to perform a procedure or service.
  4. Benefits Design/Technology Assessments — the process of determining under which clinical conditions interventions and medical technologies should be covered by the health plan subscriber contract.
  5. Disease Management Protocol/Algorithms — describe the intended sequence of a whole array of medical, nursing, and administrative interventions related to the multi-disciplinary, multi-setting management of a particular condition, including any decision logic and process flow information.

A number of methods are used to develop best practices, as described below.

Consensus-based Methods

Consensus-based methods are by far the most common methods to establish best practices. Consensus methods involve a discussion by people who have expertise or who are stakeholders in the policy issue, leading to a near unanimous conclusion about which policy alternative is best. Consensus methods offer the advantages of requiring the minimum amount of effort to develop, and are appropriate for simple practices for which there is little debate. Consensus methods have also been employed for complex algorithms, where the sheer number of distinct policy “nodes” precludes the use of more comprehensive methods. Achieving consensus often requires the creation of ad hoc multi-disciplinary teams to frame the issues, prepare a best practice proposal, take the proposal through various institutional approval processes, solicit input from stakeholders, and prepare and disseminate a final report.

Evidence-based Methods and the Explicit Approach

More rigorous methods of developing best practices include evidence-based methods and the “explicit approach” proposed by David Eddy, MD, PhD.   Evidence-based methods involve a formal analysis of the available empirical evidence regarding the effectiveness of the alternative interventions.  The explicit approach requires an explicit description of the probabilities or magnitudes of the outcomes associated with the alternative interventions, and a description of the methods used to make these estimates.  Such methods are particularly useful when the policy issue involves the resolution of disagreements about the scientific evidence or cost-effectiveness of policy alternatives. These disagreements are resolved by convening evidence-based clinical policy analysis teams to accomplish all of the same tasks as a consensus team, but with three additional tasks: (1) literature review, which involves the formal search and interpretation of relevant published and unpublished studies; (2) meta-analysis, which involves the use of formal quantitative methods for research synthesis and integration, and (3) decision analytic modeling, which is used to calculate estimates of the expected magnitude and uncertainty of health and economic outcomes associated with all relevant policy alternatives. The results of these estimates are summarized on a “balance sheet,” which presents alternative interventions as columns and relevant health and economic outcomes as rows. Finally, the decision-maker faces the task of valuing the health and economic outcomes in order to make the value judgement about which alternative intervention is most desirable.

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The Managed Care College and Pediatric Asthma Management

The Managed Care College

The Managed Care College is a comprehensive professional development program that is intended to go beyond the transfer of information. It attempts to persuade clinicians that change is necessary and desirable, to provide leadership and guidance in seeking change, to create opportunities to collaborate with colleagues in planning and implementing change, and to provide ongoing provider performance feedback to monitor change. The College is an on-site, continuous program. The notion behind the College was that continuing medical education should not be removed from everyday clinical practice, but instead should be a part of it. The College offers a variety of courses, ranging from clinical epidemiology to customer oriented service provision. There is also a series of courses directed at specific conditions.

Pediatric Asthma Management Course

One of the courses within the Managed Care College focused on the ambulatory management of pediatric patients with bronchial asthma.  Within the context of this asthma course, and with guidance from course faculty, the participants did the following:

  • Completed directed reading and received a lecture to review the epidemiology and pathophysiology of asthma,
  • Agreed on a definition of pediatric asthma, based on billing codes.  To inform this process, participants conducted a chart review from an initial computer-generated list of their own asthma patients to identify coding issues.  Based on agreed-upon definitions, a registry of asthma patients was established for each participant.
  • Studied and discussed the implications of a computer-generated list of their own patients in the asthma registry, flagging patients with a recent emergency room visits and admissions and those who had submitted no claims for inhaled steroids, a preventive treatment for asthma. The list also identified the 20% of patients who had been seen by an allergy specialist, or who had poor continuity of care by primary care clinicians.
  • Reviewed externally developed guidelines for patients with bronchial asthma. These guidelines were then discussed within the context of specific patient scenarios to evaluate the appropriateness and feasibility of adapting them within the HFHS.
  • Developed a clinical-process flowchart to identify barriers to implementation of asthma guidelines, with special focus on barriers to patient education.

With this as background information about their own clinical practices, and after having reviewed a number of externally developed guidelines, the class adapted the National Heart, Lung, and Blood Institutes guidelines for the diagnosis and management of pediatric asthma. Ultimately, after several reviews and approvals, those guidelines became the guidelines adapted by the entire HFHS. As part of these guidelines, some specific tools were developed. For example, a standardized “zone sheet” was developed, including an action plan for the patient to follow depending upon their self-measurement of peak expiratory flow rate. A peak-flow diary was also created to record results of self-monitoring.


As part of a formal program evaluation of the Managed Care College, pre- and post-surveys were administered to all course enrollees.

  • At the end of the course, enrollees were more likely to agree that they understood the “zone sheets.”
  • Enrollees were also more likely to indicate that home monitoring of peak expiratory flow rates was important, consistent with the practice guideline.
  • Sixty four percent of enrollees indicated that their participation in the course changed their approach to the management and treatment of patients with asthma.
  • Almost three-quarters agreed with the statement that participation in the course increased the percentage of patients for whom they recommend home monitoring of peak flows.
  • About 63% said the course increased the percentage of patients for whom they prescribed preventive or maintenance medications.
  • Just over 50% indicated that participation increased the frequency with which their patients with asthma received education.
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CQI Methods Used Improve the Quality of Cervical Cancer Screening

A baseline evaluation of “Pap” smears done in a large multi-specialty group practice revealed that over 25% of samples were designated “less than optimal” because of the absence of observed endocervical cells, an indicator of sample adequacy. In addition, there was a large variation in the rates of sample adequacy achieved by different physicians and at different clinic sites.

In response to these concerns about sample adequacy, clinical leaders encouraged the formation of a multidisciplinary clinical quality improvement team to work to improve the process by which cervical cytology samples were obtained and assessed for adequacy. This team included cytopathology staff, obstetrician-gynecologists, internists and clinical effectiveness staff.

The team used a quality improvement framework developed at Hospital Corporation of America (HCA), described by the acronym “FOCUS-PDCA.”  The team prepared process flow charts and identified an initial improvement in the design of the cytology requisition form to provide data required for future analyses of Pap smear adequacy and management of cervical neoplasia.  The team also defined and implemented a new, more reproducible operational definition of the key quality characteristic: the proportion of samples with at least five observed endocervical cells.  Although no direct relationship between observed endocervical cells and decreased cervical cancer mortality has been demonstrated, the team conducted a retrospective analysis which showed an increased prevalence of abnormalities found in samples with endocervical cells (14.9% vs. 6.3%), and for mild abnormalities (11.9% vs. 5.2%), and also an increased prevalence of severe abnormalities found (3.0% vs 0.8%).

The team then prepared “run charts,” plotting monthly sample adequacy rates over a two-year period, stratified by clinic location and specialty.  Then, based on a literature review and input form consultants, an “Ishikawa diagram” was prepared, outlining the known factors that could cause inadequate samples.  A study conducted in the Netherlands found that the cytobrush, a plastic sampling tool with a tip which resembles a pipe cleaner, together with a wooden spatula, produced a higher proportion of samples with endocervical cells in the hands of paramedical sample takers when compared to other commonly used tools, including the cotton swab traditionally used within the institution.  The team conducted a retrospective study and a second prospective study which confirmed these findings.

Based on these results, the team prepared a cost-benefit analysis, and drafted a proposal for an intitutional clinical practice policy calling for sampling using the cytobrush and wooden spatula for screening Pap smears for non-pregnant women.  The policy was approved, and was communicated to the primary care medical staff through a series of scripted 13-minute slide presentations presented at local staff meetings at clinic sites throughout the institution.

Two approaches were used to assess the success of these staff training efforts. First, the team conducted a survey of clinic nurses and assistants to determine which sampling tools each internist and obstetrician-gynecologist used during each month of the study period. The survey was repeated to update information on two occasions.  These surveys revealed a dramatic transition from traditional sampling methods using a spatula, with or without a cotton swab, to methods using the cytobrush.  Second, the team confirmed this survey data by tracking orders for cytobrushes through the purchasing department, revealing that the overall volume of cytobrushes being ordered was consistent with the volume implied by merging survey data with physician-specific Pap smear volume data.

To assess the impact of changes in methods of sampling, the team used a “run chart” to track the proportion of inadequate Pap smears each month.  The run chart shows that the proportion of inadequate smears plunged from baseline levels of 20-25% per month to less than 10%. Possibly due to a decrease in the number of repeat Pap smears needed, the overall volume of Pap smears dropped by more than 10%. Consequently, the number of women who received a Pap smear report with the “less than optimal”designation was cut by well over 50%.

The estimated economic impact of these changes was favorable. On an annual basis, the additional costs from using a more expensive sampling tool was $15,000. The cost of additional physician sampling time for a “two tool” method added $11,000. The cost of added physician cytopathologist interpretation due to discovering an additional 1068 abnormalities added $20,000. However, these costs were far outweighed by a savings of $158,000 from fewer repeat visits and fewer repeat Pap interpretations, leading to a net savings of $212,000 per year.

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