PUBLICATIONS - RESEARCH DESIGN AND STATS

Introduction to Clinical Practice Guidelines

Introduction

Definition

Policymakers and Clinical Practice Guidelines

Development of Clinical Practice Guidelines

Agency for Healthcare Research and Quality

Health Insurance Companies

Other Sources of Development

The Validity of Clinical Practice Guidelines

Classification of Development Methodologies

Informal Consensus Development

Formal Consensus Development

Evidence-based Approach

Explicit Guideline Development

Are Clinical Practice Guidelines Helpful or Harmful?

The Medical Community

The Health Insurance Coverage Community

The Patient Community

Enforcement and Litigation

Limitations of Clinical Practice Guidelines

Utility of Clinical Practice Guidelines


Introduction to Clinical Practice Guidelines

Introduction

Life care planners must base recommendations upon reasonable, ethical, and appropriate analyses of patient-specific needs. How are these analyses generated? Where can life care planners obtain such information? What is meant by “clinical practice guidelines”?

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Definition

Definitions of clinical practice guidelines vary slightly from one another, but are very similar in intent. For example:

“Practice guidelines are statements that are systematically developed to assist practitioner and patient decisions about appropriate healthcare for certain clinical diagnoses. They are intended to be flexible: deviations are expected, acceptable and justified depending upon individual characteristics and circumstances.” (Callender, 1999)

“…systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific circumstances.” (Institute of Medicine, 1990)

The Joint Commission of Accreditation of Healthcare Organizations (2000) defines clinical practice guidelines as, "…descriptive tools or standardized specifications for care of the typical individual in the typical situation, developed through a formal process that incorporates the best scientific evidence of effectiveness with expert opinion. Synonyms include clinical criteria, parameter, protocol, algorithm, review criteria, preferred practice pattern and guideline.”

The American Medical Association (Hirshfeld, 1990) has not yet formulated a universally accepted definition of clinical practice guidelines, but has defined what it refers to as “practice parameters.” These parameters have been established as, “recommendations for patient management that may identify a particular management strategy or a range of management strategies.”

Wyer (2002) asserts that clinical practice guidelines are not:

*Decision rules

*Computerized support systems

*Decision analyses

*Cost-effectiveness analyses

Oetgen and Wiley (1996) note that the development of formal practice guidelines was initiated in the 1980s as a result of three primary forces. First, health care costs assumed by the federal government were expanding at an ever-increasing rate. With Medicare expenditures soaring, Congress became interested in developing a methodology for analyzing physician services for medical necessity and effectiveness.

Secondly, a wider database which incorporated medical outcomes research findings was being utilized more efficiently by health care professionals and health policy administrators.

Third, as more data was amassed, it became apparent that inappropriate care practices were going unchecked and causing harm to patients. In addition, inequalities in access to care and necessary treatment were recognized.

While most definitions of clinical practice guidelines are similar, not all organizations and fields of expertise are in agreement regarding the appropriate use of guidelines in practice.

The Purpose of Clinical Practice Guidelines

The Joint Commission of Accreditation of Healthcare Organizations (JCAHO, 2000) and MacLean (2002) assert that the purpose of clinical practice guidelines is to:

*To improve outcomes and quality of care provided to patients

*To reduce undesirable variations in care and treatment by providing continuity of care

*To reduce inflation of healthcare costs and identify the most effective practices considering costs and resources expended (money, effort, and risk)

*To manage quality by setting measurable standards

Amon (2000) points out that the notion of established clinical practice guidelines is not a new concept but, “What is new is the emphasis placed on systematic, evidence-based guidelines and the structure, process, and incentives that support their effective use and as a mechanism of internal assessment of such guidelines.”

Ultimately, clinical practice guidelines serve as recommendations for patient care and injury/disability management. The purpose of these recommendations is to guide the decision-making process of professionals contemplating the most beneficial medical and therapeutic interventions.

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Policymakers and Clinical Practice Guidelines

Policymakers sometimes have a slightly different perspective with regard the purpose and utility of clinical practice guidelines. In general, policymakers are interested in:

*Reducing the incidence of inappropriate care

*Minimizing wide variations in level of care and/or therapy

*Maximizing the value of each health care dollar spent toward recovery and rehabilitation

If these purposes appear to be similar to those espoused by JCAHO and MacLean, they are. However, the way each group determines that it will accomplish its goal may differ enormously. The same set of clinical practice guidelines used to treat and rehabilitate patients may also be used to determine “medical necessity,” “cost-effective” treatment, and to establish standardization of care. In order for life care planners to better appreciate the capacity of clinical practice guidelines, the scientific data upon which they are based and the process by which they are developed must be understood.

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Development of Clinical Practice Guidelines

Clinical practice guidelines have been developed through the collaborative efforts of many committees, organizations, and federal agencies.

Agency for Healthcare Research and Quality

In 1999 President Clinton reauthorized the Agency for Healthcare Research and Quality (AHRQ), which is a branch of the U.S. Department of Health and Human Services agency. The following statement was extracted directly from the Agency’s website (http://www.ahcpr.gov/about/ahrqfact.htm ):

“The legislation also positions the Agency as a ‘science partner,’ working collaboratively with the public and private sectors to improve the quality and safety of patient care.

Under the legislation AHRQ will:

*Meet the information needs of its customers—patients and clinicians, health system leaders, and policymakers—so that they can make more informed healthcare decisions.

*Build the evidence base for what works and doesn't work in healthcare and develop the information, tools, and strategies that decision-makers can use to make good decisions and provide high-quality healthcare based on evidence.

*Develop scientific knowledge in these areas but will not mandate guidelines or standards for measuring quality.”

Health Insurance Companies

For many years health insurance companies have been utilizing practice guidelines as a way of making claims decisions and selecting care providers. Over time, the guidelines referenced by health insurance companies have become more well defined and, in some cases, more reflective of clinical input from physician organizations.

Other Sources of Development

Amon (2000) notes that more than 35 medical groups, physician organizations, and specialty associations have developed clinical practice guidelines, including the American Medical Association and the Council of Medical Specialty Societies. In addition, independent and academic research centers, such as the RAND Corporation and the Institute of Medicine, are working to establish protocols for the development of guidelines.

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The Validity of Clinical Practice Guidelines

As you read about the following classifications of practice guidelines, consider each category with respect to the discussion of validity. The validity of a specific set of clinical practice guidelines depends upon the methodology utilized by the developers in identifying appropriate components of the final document. Further, the purpose for which the developers created the practice guidelines should be considered. If the foundations (i.e., methodology and purpose) are faulty, little credibility may be invested in the product.

Classification of Development Methodologies

Amon (2000) describes a classification system consisting of four categories; informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development.

Informal Consensus Development

Informal consensus development is the simplest, most commonly employed method of developing practice guidelines. In most cases, a panel of field experts meets to discuss the relevant issues and form a consensus through discussion and debate. There are positive aspects to this method in that the process is uncomplicated and decisions may be made in a brief period of time.

However, there are several disadvantages to this method. Many times, consensus opinion is reached without providing an explanation to others as to how recommendations were reached, without explicitly linking knowledge within the field (scientific, clinical, or otherwise), and without documenting the methodology utilized to arrive at the summative consensus.

Amon (2000) provides an example of such non-disclosure by explaining that insurance companies often utilize sophisticated methods of analyses, but because of proprietary concerns, they will not disclose the analytical methodology relied upon to develop guidelines. Unfortunately, when life care planners do not have access to such information significant limitations may be imposed upon the practical usefulness of these guidelines.

Formal Consensus Development

The primary difference between informal and formal consensus development is that the latter typically involves structured workshop sessions held over several days and efforts are made to document the methodology applied throughout the process. In general, formal procedures include detailed literature reviews, debate, and votes by a panel of experts recognized in the field.

While it is a more structured attempt to define practice guidelines, this method of development is, nonetheless, based upon expert opinion and the “tools” with which they choose to evaluate the relevant issues. For example, if a group of experts in the health insurance industry were to perform in-depth literature reviews, analyze claims data, debate, vote, and publish practice guidelines, should life care planners deem the product valid? Consider the fact that research literature may be flawed or irrelevant and that insurance claims data is often erroneous. As with an informal process, expert opinion ultimately determines the form of the guidelines.

Evidence-based Approach

The evidence-based approach emphasizes the need to distinguish between guidelines derived from a scientific foundation, and those based upon expert opinion. This method includes a formal evaluation and analysis of scientific evidence, an exchange of information among panel members, and open forums that seek to reach a wide audience.

While this process increases the scientific rigor of practice guideline development methodology, it may be limited by the lack of acceptable “evidence” reported in the research literature. Anon (2000) reports that a very small percentage (only about 10 percent) of current medical interventions have been validated through well-designed clinical studies. Because of this, neutral recommendations may be made but are not likely be useful for large numbers of practitioners.

Explicit Guideline Development

Professionals employing this method of development outline the benefits, harms, and costs of potential interventions then calculate explicit numerical probabilities of each outcome. Estimates may be generated using scientific evidence, mathematical models, or expert opinion, but the sources of each recommendation are distinctly cited.

Amon (2000) describes a “balance sheet” which is created to display the alternatives to interested parties (i.e., patients, families, physicians, payers, etc.). This “objective” data is then compared with the preferences and desires of the patient in order to arrive upon decisions.

This approach is becoming more popular, but because it is still a relatively new method of guideline development, published reviews and critiques are limited.

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Are Clinical Practice Guidelines Helpful or Harmful?

The manner in which clinical practice guidelines should best be utilized is somewhat controversial and depends in large part upon the goals of the particular group stating a position on the issue.

The Medical Community

Physicians groups have expressed concerns that practice guidelines may be encouraging reliance upon “cookbook medicine,” rather than sound clinical judgements based upon patient-specific factors (Amon, 2000). Some view the advocacy of practice guidelines as an effort to standardize care which is an obstacle in providing individualized care to patients within a specific demographic or practice setting.

Professionals in the health industry are concerned that practice guidelines may:

*interfere with their ability to exercise clinical judgement

*cite unreasonable recommendations, particularly when prepared by non-practitioners, payers, or those unfamiliar with clinical practice

*be used to deny coverage of physician recommended procedures

*be inappropriately used to rate physician competence

*serve as evidence in malpractice cases

*threaten specialty areas of practice through intervening guidelines of other groups

*become compulsory standards

*obstruct physicians’ attempts to obtain malpractice insurance unless they are compliant with all guidelines

The Health Insurance Coverage Community

There is little doubt that rising costs of health insurance coverage, emergency/trauma treatment, acute medical care, and rehabilitation certainly provides a powerful motivation for considering alternatives to the system currently utilized.

As mentioned earlier, some health insurance companies will not disclose the methodology employed to analyze and develop practice guidelines because of proprietary concerns.

The Patient Community

Even when pleased with their medical professionals of choice, patients often seek reassurances that the care and treatments they are receiving from their personal providers are, indeed, appropriate and comparable to the treatments prescribed by other professionals. Practice guidelines may provide some level of comfort to patients and families and allow for improved communication, education, and compliance with recommended interventions.

However, patients also recognize that practice guidelines may be inappropriately applied to their specific case and used as a basis for denial of claims, provider groups, or coverage. Practice guidelines developed to maximize outcomes for a target population may not adequately meet the needs of individual patients within that group.

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Enforcement and Litigation

Some groups believe that the underlying impetus for rising health care costs rests with physicians. Following this logic, these groups seek to develop enforcement policies which penalize physicians (through denial of reimbursement for services, pre-certifications, or reasonable malpractice coverage) who do not comply with the established guidelines. Further, physicians failing to comply with guidelines may be subjected to medical review and/or confront challenges when acquiring licensure, specialty practice re-certification, and hospital privileges (Amon, 2000).

Many physicians groups object to the publication of practice guidelines because of the probability that they will be submitted as “evidence” in litigated cases against professionals who exercise clinical judgments beyond the stated guidelines. They are concerned that deviations from the practice guidelines will be argued to constitute substandard care or negligence.

Oetgen and Wiley (1996) report that no jurisdictions have allowed guidelines to be submitted as the sole piece of evidence regarding standards of care. In fact, Oetgen and Wiley (1996) state that the presentation of practice guidelines in most jurisdictions necessitates the appearance of an expert witness who must explain the guidelines to the jury/judge, discuss their validity and relevance, and participate in cross-examination, if requested by the opposing counsel.

While physicians should not be expected to comply with erroneous guidelines, professionals who administer inappropriate care must be identified and prevented from harming patients. Consider the notion that although guidelines may not be entirely valid in every patient’s circumstance, they may provide a limited measure of professional competence in cases where obvious infractions are committed.

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Limitations of Clinical Practice Guidelines

There are three primary areas in which clinical practice guidelines are limited (Amon, 2000). First, medical science is not able to unequivocally define “optimal” care, even with advancing technologies and an ever-growing databank of knowledge. For example, a review of research literature in nearly any aspect of disability will result in few studies involving minority groups, patients who do not fit the “stereotypical” profile, or those from rural communities.

As discussed previously, it is very difficult to design true experimental research studies (i.e., multiple randomized clinical trials with large numbers of participants) involving human subjects. Most studies are inherently limited in their ability to offer undisputed results, validity, practical significance, and generalizability. Certainly, the existing body of research may be used to determine the most probable benefits of interventions, it is not possible to state that practice guidelines based upon these studies are indisputably accurate and appropriate for all patients.

Second, the methodology of practice guideline development is questionable. While efforts are made to perform thorough review s of the existing literature and to integrate objective expert opinion, the resulting recommendations cannot be deemed to be “right” or to accurately reflect optimum care; these guidelines continue to represent what experts identify as being the best course of action.

Third, patients are unique individuals with factors distinguishing them from the average subject as defined within a set of practice guidelines. The recommended course of action for the average patient with a given diagnosis may be inappropriate and/or harmful to a specific patient with a unique medical and rehabilitation history, comorbidities, and lifestyle.

Patients respond differently to treatments and interventions which requires physicians to make necessary adjustments in recommendations. In addition, patients have unique preferences, motivations, and tolerances for certain types of treatment and may/may not have adequate support to maintain recommended interventions over time.

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Utility of Clinical Practice Guidelines

While clinical practice guidelines cannot account for all of the individual variations patients represent, they can serve as a foundation for initial care and treatment. Amon (2000) asserts:

Limitations of practice guidelines are not a problem, as long as they are communicated honestly in the working of the recommendations and rational. Honest uncertainty is communicated in the rationale by stating clearly which parts of the recommendations are based on science and the quality of the evidence, and which recommendations are based on opinion and how that opinion was gathered.”

When reviewing clinical practice guidelines, life care planners must actively question:

*the goals of the group who developed them

*the methodology of development

*the language within the document (flexible or absolutist?)

*the degree to which inherent limitations are acknowledged

*the degree to which the guidelines apply to an individual patient

Clinical practice guidelines serve as one of the resources to be considered when developing a life care plan. Like any other source, professionals must view all practice guidelines with a critical eye, question the validity of the recommendations, and recognize the limitations of the development methodology. Most importantly, life care planners must determine whether specific practice guidelines are applicable and appropriate for the individual with whom we are working.

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