Doctors increasingly need to know how to find, evaluate and implement clinical policies. Our primer begins with this first of two articles.
Fam Pract Manag. 1999;6(2):28-32
One of the core assumptions in medicine, that physicians' decisions are correct, is under challenge. It's been shown repeatedly that doctors looking at the same X-ray will come to different conclusions about the correct reading or, given the same written summary of a patient's problem, will have different opinions about likely outcomes.1 Dartmouth Medical School has documented wide geographic variations in the rates of a broad array of medical and surgical procedures.2 While some variation may reflect a range of correct decisions, the magnitude of the variation that the Dartmouth Atlas and other works have revealed strongly suggests that many doctors' decisions are beyond the range of acceptable variation.
David Eddy, MD, PhD, considered by many the “father” of clinical policies, writes that variability in decisions occurs because doctors deal with complex problems and must make decisions under difficult conditions and with little support. The existence of variability is no reason to place blame. Doctors are understandably reacting to their different perceptions of patients' problems and the risks and benefits of different approaches to those problems. The real questions relate to which treatments work best and at what costs and risks. Unfortunately, clinical research often doesn't provide ready answers to questions about how best to approach given problems. As a result, doctors often lack good evidence to support their decision making. Eddy's solution is to improve doctors' capacity to make good decisions by making the necessary information available, teaching doctors the skills to use this information wisely and building processes that support good decisions — in other words, by developing and implementing clinical policies.1
Clinical policies — also known as clinical guidelines, clinical practice guidelines, practice parameters and practice policies — are sets of recommendations for the care of patients with specific conditions or diseases. A clinical policy anticipates a series of common clinical decisions that doctors will have to make and offers an appropriately considered, evidence-based approach to doing so. A clinical policy takes into account multiple considerations in making those decisions, including clinical outcomes, costs and patient preferences, and it distills best practice from the available evidence to help reduce variation in care. The best clinical policies report the evidence on which their recommendations are made and weight their recommendations based on the strength of the evidence.
Many clinical policies have been written recently. Some are superb, fairly synthesizing the outcomes-based information on an important topic and developing from the evidence simple management strategies for a broad spectrum of patients. Others are seriously flawed. Some of the difficulties are obvious — for example, many are based only on expert opinion and lack strong evidence supporting their recommendations — while others are subtle.
Nevertheless, organizations large and small are turning to clinical policies. As tools for guiding high-quality, cost-effective care, they're attractive not only to managed care organizations, health systems and hospitals but to large and small practices, too. Whether you're trying to select and implement clinical policies for an HMO, your hospital or your own practice, you need to know where to find them, how to evaluate competing policies and how to put them into practice. After all, even the best clinical policies will have no effect on patient care unless physicians actually use them.
In this article, we'll show you where to find high-quality clinical policies relating to a wide range of conditions and preventive services. In an upcoming issue, we'll present a framework for evaluating clinical policies and recommend a step-by-step process for implementing them.
A clinical policy offers an evidence-based approach to making a series of clinical decisions for patients with a given condition.
Doctors in a variety of settings need to know where to find good clinical policies, how to evaluate them and how to implement them.
The government is involved in writing, reviewing and disseminating clinical policies, particularly through the National Guideline Clearinghouse.
Primary-care specialty societies, such as the Academy, also are good sources of clinical policies.
What policies should I look for?
If your practice or organization decides it should be using clinical policies, the first question is which conditions or preventive services should be addressed. Generally, the answer is to identify problems that are common, costly or otherwise significant for you, problems for which local physician practice varies widely, or problems for which local physician practice differs from established “ideal” practice. Whether your population is a clinic's patien base or an HMO's membership, these criteria will lead you to problems for which you'll get the biggest bang for your clinical-policy buck.
Where should I look?
Specialty societies, government agencies, health care organizations, medical staffs and physician practices may write clinical policies for issues of interest to them. But entities with a particular point of view also write clinical policies as a way to push their own agendas. In fact, any entity with an interest in how a problem is managed may have written a policy about that problem. For example, pharmaceutical companies may write policies to increase sales of their products. Consulting firms such as Milliman & Robertson Inc. and InterQual develop and sell clinical policies in response to the market's need to curb rising health care costs and manage utilization more appropriately. Disease-or patient-advocacy groups may write policies to promote their points of view. Managed care organizations and other insurers may develop clinical policies based on their interest in cost-effective care. Specialty societies may develop clinical policies on topics that affect their members' practice patterns. Here's the bottom line: For any given clinical policy, understand who developed it and how. Any entity may produce excellent clinical policies, but you should be watchful for the biases they may reflect and the methodologies used in their development.
Governmental entities at all levels are involved in producing and disseminating clinical policies. Some local and state governments write policies for use in their areas. At the federal level, a number of agencies share the work of writing, reviewing and disseminating policies.
Perhaps the best place to start is with the Agency for Health Care Policy and Research (AHCPR). For several years, the agency crafted complete clinical policies. By visiting http://www.ahcpr.gov/clinic, you can obtain AHCPR clinical policies on 18 topics: acute pain management, urinary incontinence, pressure ulcer prevention, pressure ulcer treatment, cataracts, depression, sickle-cell disease in infants, benign prostatic hyperplasia, cancer pain management, unstable angina, heart failure, otitis media with effusion, mammography, acute low-back problems, stroke rehabilitation, cardiac rehabilitation, smoking cessation, and recognition and assessment of Alzheimer's disease.
In the past two years, the agency has stopped developing clinical policies and has been supporting evidence-based practice centers (EPCs), which develop evidence and technology assessments on clinical topics that are common, expensive or significant for the Medicare and Medicaid programs. EPCs do the necessary preliminary work to search for and organize the evidence so that other organizations can produce clinical policies.
Most recently, AHCPR, in conjunction with the AMA and the American Association of Health Plans, has developed an online clearinghouse for clinical policies created by other sources. Officially launched just last month, the National Guideline Clearinghouse (NGC) (http://www.guideline.gov) identifies itself as a web site “intended to make evidence-based clinical practice guidelines and related ... materials widely available.” The site's content includes “objective summaries and factual comparisons of the guidelines,” but the NGC doesn't judge the accuracy or quality of individual clinical policies.
Despite this caveat, the NGC is an impressive resource. At press time (the database is updated frequently), it summarized and compared 222 policies related to specific conditions, including mental disorders, and 181 policies related to treatments and interventions. Users can search the site for guidelines on specific topics; browse lists of guidelines grouped by conditions, treatments/interventions or developing organizations; or compare clinical policies according to 22 criteria (see “An NGC comparison of clinical policies”). The policy-comparison feature is particularly helpful in that it describes the methods used to collect evidence in support of the policies.
Another helpful source is the United States Preventive Services Task Force, which is staffed by the AHCPR. It has produced excellent reviews of the evidence for a variety of preventive services and complete summaries of recommended preventive services by age and gender grouping. Its work appears in the Guide to Clinical Preventive Services, now in its second edition, which may be searched from the AHCPR web site (http://www.ahcpr.gov/clinic) or ordered from the Academy (800-944-0000; item number 1912). The Centers for Disease Control and Prevention (CDC) has written clinical policies since its inception, first related to communicable diseases but, more recently, for the whole range of problems reflected in CDC's broad public-health mission. On its web site, the CDC offers its Prevention Guidelines Database (http://aepo-xdv-www.epo.cdc.gov/wonder/prevguid/library/library.htm), which includes more than 400 guidelines for the prevention and control of public-health threats.
Preventive services policies also have been compiled through the Put Prevention Into Practice (PPIP) program sponsored by the Office of Disease Prevention and Health Promotion of the U.S. Department of Health and Human Services in collaboration with other organizations, including the AAFP (for more information, visit http://www.ahrq.gov/clinic/ppipix.htm). Among the PPIP materials is the Clinician's Handbook of Preventive Services, second edition, which also is available from the Academy (800-944-0000; item number 1980).
An NGC comparison of clinical policies
A helpful feature of the National Guideline Clearinghouse is the web site's “guideline comparison” function. Users identify two or three clinical policies on a given condition, and the site generates a tabular comparison of those policies that includes their titles, whether the policies were adapted from other sources, their length, the developing organizations, the funding sources, the names of the developing committees, the committees' membership, the conditions covered, the clinical specialties intended as the audience, the policies' objectives, their target populations, descriptions of the committees' review methods, the outcomes considered, whether costs were analyzed, descriptions of the methods of collecting evidence, and the methods used to assess the quality and strength of the evidence. Though not full evaluations of the policies (which we'll discuss in the second part of this article), these comparisons offer a useful look at what different policies have to offer. Here's part of a sample comparison:
|Am Coll Prev Med 1998 Feb||US Prev Serv Task Force 1996|
|TITLE:||Adult immunizations||Adult immunizations - including chemoprophylaxis against influenza A|
|LENGTH:||3 pages||23 pages|
|DEVELOPERS:||American College of Preventive Medicine - Medical Specialty Society||United States Preventive Services Task Force - Federal Government Agency|
|DISEASE/CONDITION:||Influenza, pneumonia, meningitis, hepatitis B, tetanus, diphtheria, measles, mumps, congenital rubella syndrome||Influenza, pneumococcal disease, tetanus, diphtheria, measles, mumps, rubella, hepatitis B, hepatitis A|
Other useful sources of clinical policies include the primary care medical societies, including the AAFP. The Academy has developed its own policies for three topics, co-developed policies with other organizations and coordinated the placement of family physicians on clinical policy committees assembled by other groups.
For more information on the Academy's work related to clinical policies, visit https://www.aafp.org/online/en/home/clinical/clinicalrecs/guidelines.html. There you'll find complete, evidence-based policies on the use of antepartum oxytocin, treatment of otitis media with effusion in young children (developed with the American Academy of Pediatrics [AAP]), and a trial of labor versus elective repeat cesarean section for women who have had a previous cesarean section. The site also offers Academy recommendations, based on expert opinion, related to periodic health exams; neonatal circumcision; water fluoridation; hepatitis B pre-exposure vaccination and postexposure prophylaxis; HIV infection, prevention, testing, reporting and education; and adolescent immunizations.
The AAP also develops primary care policies. Currently, it offers “practice parameters” on managing acute gastroenteritis in young children, managing hyperbilirubinemia in healthy term newborns, and neurodiagnostic evaluation of a young child with a first simple febrile seizure, as well as the otitis media policy developed with the AAFP. To obtain these clinical policies, visit https://www.aafp.org/online/en/home/clinical/clinicalrecs/guidelines.html.
Another source of clinical policies useful in family practice is the American College of Obstetrics and Gynecology (ACOG), which offers a set of Educational/Practice Bulletins. The bulletins are 8- to 10-page statements that summarize current information on techniques and clinical management guidelines for ob-gyn practice. The bulletins are developed using a less rigorous methodology than some other clinical policies. According to the description on ACOG's web site, they are “written and reviewed by authorities in the specialty.” The bulletins are available from the web site (http://sales.acog.com) or by calling 800-762-2264.
The American College of Physicians- American Society of Internal Medicine (ACPASIM) also has clinical policies available. The association's Clinical Practice Guidelines, published in 1995, contains the ACP's clinical policies for 19 conditions. For more information, contact the organization at http://www.acponline.org/ or call 800-523-1546, ext. 2600.
Finally, the AMA serves as a clearinghouse for clinical policies on a number of topics. The organization annually publishes a 200-page Clinical Practice Guidelines Directory, which includes about 2,000 entries. The directory may be ordered through the AMA's online catalog (see http://www.ama-assn.org/) or by calling 800-621-8335.
Many disease organizations have developed clinical policies. For example, the American College of Cardiology and the American Heart Association offer a clinical policy for the evaluation and management of heart failure, and the National Kidney Foundation offers a policy for the treatment of anemia in chronic renal failure. If the clinical area you want to address has an associated disease organization, you might want to see how that group recommends managing patients with the condition.
But here's a word of warning: Some disease organizations may not have a clear idea of the prevalence or severity of the conditions commonly seen in family medicine. This can lead the disease groups to recommend complex management strategies or protocols that may not fit most family practices' patient populations. Remember that bias need not spring from bad intent to be present and problematic.
Another source of clinical policies is consulting firms, although there has been considerable controversy surrounding the use of their products. Perhaps the best-known examples of these firms are InterQual (http://www.interqual.com) and Milliman & Robertson Inc. (http://www.milliman.com).
InterQual's criteria for inpatient care are commonly used in admission and discharge decisions. In addition to these criteria, InterQual also offers other resource guides that cover indications for primary and specialty care management, imaging, surgery and other services.
Milliman & Robertson's policies for ambulatory, primary and pharmaceutical care provide “benchmarks for the diagnosis, imaging, treatment and referral point for over 160 common outpatient conditions,” according to the firm's web site. The company also offers policies related to inpatient and surgical care, workers' compensation, home care and other areas.
Of course, comparatively comprehensive collections of policies like these don't come cheap. As an example, Milliman & Robertson's primary care policies sell for $500 a copy. InterQual's products are available for a yearly licensing fee.
Clearly, physicians working to improve care and manage its cost have a rich supply of clinical policies to choose from. But finding them is only the beginning. The real work comes when committees start evaluating clinical policies and developing plans for implementing them so that they will change physician behavior rather than collect dust on a shelf. In an upcoming article, we'll give you a methodology for evaluating clinical policies and making them part of practice. Stay tuned.