ORIGINAL ARTICLE
Pediatric Practice Guidelines: Implications for Nurse Practitioners /
Deborah
Callender,
MS,
RNCS,
CPNP
T
1 he increasing complexity of health. care and a desire to increase quality and control costs have led to the current initiatives that are spawning practice guidelines at a dizzying pace. Promises of cost savings, improved evidenced-based clinical practice, and outcomes monitoring will continue to position practice guidelines as a driving force in American health care. However, the benefits and drawbacks these guidelines offer nurse practitioners (NITS) in day-to-day practice is not well understood. If practice guidelines are to serve their putative purpose of helping clinicians improve patient care and save health care dollars, they must be developed by a welldesigned methodology and their intricacies thoroughly understood by practitioners. Equally important, guidelines must be willingly applied in practice and bear the scrutiny of evaluation over time. The following discussion is specifically targeted to NPs providing pediatric primary care, who increasingly are expected to be faced with practice guidelines that they must use appropriately in the provision of high-quality, cost-effective clinical care. understand what practice guidelines are and how they are developed and be willing to put them into practice. This discussion begins with a description of practice guidelines specific to pediatrics, The terminoiogy used in reference to these “clinical tools” are differentiated and their historic and contemporary influences are summarized. The complexity of guideline development and attributes of a quality practice guideline are described. Finally, the pivotal roles nurse practitioners can play in putting guidelines into practice are suggested. j Pediatr Health Care. (1999). 73,
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PRACTICE GUIDELINES
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Guidelines are not new in the field of Ipediatrics. For many years guidelines have appeared as lists of indication.s, contraindications, medications of choice, consensus statements, protocols, and other statements cited by health professionals. For example, the Ameri’can Academy of Pediatrics (AAP) has been publishing guidelines for more than 50 years, beginning with the Report of the Committee on Immunization Procedures (AAP, 1938). Practice guidelines developed or endorsed by pediatric nurse practitioners appear regularly in the Journal of Pediatric J-&T&ZCare. What is novel is the current health care environment that is positioning guidelines as a driving force in
Deborah Callender is a Pediatric Nurse Practitioner at Sfafford Pediatrics in Stafford, Va, and a Doctoral in the College of Nursing and Health Science at George Mason University in Fairfax, Va. Reprint requests: Deborah Copyright
Callender,
MS, RNCS, CPNP, 8921 Applecross
0 1999 by the National Association + 0
of Pediatric Nurse Associates
Lane, Springfield,
Student
VA 22153.
& Practitioners.
25/l/94516
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TABLE 1 Practice guidelines for health promotion and preventative care Available
guidelines
Description
Health Supervision Anticipatory Guidance
Bright Futures
Guidelines for Adolescent Preventive Services (GAPS)
Guide to Clinical Preventive Services
AAP, American Administration;
Academy
Third edition released in 1995 by the AAF! This preventive guide covers infancy, early and middle childhood, and adolescence through age 21 years. It offers selected biomedical, developmental, and psychosocial approaches to caring for families with children whose health and adaptation are within the normal range (AAP Committee on Practice and Ambulatory Medicine, 1995). Joint effort of the MCHB and HCFA. Bright Futures is a comprehensive guide encompassing health promotion and disease prevention supporting the recommendations of Healthy People 2000. It emphasizes what families and communities must do to ensure the health and well-being of children, and the need for coordinated efforts among health, education, and human service providers (Green, 1994). Developed by the AMA, GAPS emphasizes the contemporary causes of adolescent morbidity and mortality. GAPS addresses the delivery of health services, health guidance, and screening and immunizations for teens aged 11 to 21 years (Elster & Kuznets, 1994). Second edition released in 1996 by the United States Preventive Services Task Force. Considers 64 conditions for which screening or counseling may apply, and 6 conditions for which immunization or chemoprophylaxis may be important. Presents the strength of scientific evidence for and against each recommendation. Covers infancy through old age (U.S. Preventive Services Task Force, 1996).
of Pediatrics; AMA, American Medical Association; and Child Health Bureau.
HCFA, Health Care Financing
MCHB, Maternal
both the clinical and policy arenas. Increasingly, the systematic process for development of guidelines and the use of rigorous analysis of evidence to support conclusions is being emphasized. Because they are vehicles for evidencedbased practice, clinical practice guidelines are becoming a major component of the quality of care revolution in pediatric primary care. Practice guidelines specific to pediatric health service span the full continuum of care and involve a wide range of clinical topics across primary, secondary, and tertiary levels of service. Most of these recommendations can be grouped into 1 of 3 categories of practice: those pertaining to preventive care, those pertaining to the management of childhood illness, and those pertaining to perinatal and newborn care. Many groups have authored guidelines; they have been developed by professional societies, governmental agencies, research organizations, health insurers,
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managed care organizations (MCOs), and individual hospitals. Increasingly, guidelines are being developed through collaborative initiatives involving multidisciplinary teams with an emphasis on involving the clinicians who must implement them in day-to-day practice within the various settings in which pediatric care is delivered. Guidelines pertaining to health promotion and prevention delineate the sequence and timing of routine health maintenance visits, the content of those visits, immunization schedules, screening tests, and topics for anticipatory guidance. Table 1 summarizes the major preventive guidelines used in well child care. Numerous guidelines also exist for the diagnosis and management of children with acute or chronic illness. Presently under development are practice guidelines on attention deficit hyperactivity disorder, congenital dysplasia of the hip, diabetes, minor head
trauma, severe head trauma, and urinary tract infection (Bauchner, Homer, & Adams, 1997). Table 2 lists authors and guidelines pertaining to childhood illness. Finally, a multitude of guidelines exist in the field of newborn. care, ranging from the prevention of perinatal infection and screening for metabolic disorders to the management of respiratory distress syndrome and coordinating discharge from the neonatal intensive care unit. A discussion of these guidelines along with a table listing more than 30 of the major guidelines in current use by clinicians involved in perinatal and newborn care can be found in a review article by Merritt, Palmer, Bergman, and Shiono (1997).
DEFINITIONS AND TERMINOLOGY The Institute of Medicine defines clinical practice guidelines as “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (Field & Lohr, 1990, p. 8). Unfortunately, the term “practice guideline” has been subject to a wide variety of interpretations. In fact, authors of these documents have generated an array of concepts and phrases in an attempt to differentiate among the types and purposes of these statements. Clinicians can become easily confused by the many terms used in reference to similar or dissimilar entities. NIPS need to understand the differences among clinical practice guidelines, clinical standards or protocols, clinical options, and critical pathways. Eddy (1990) notes that different practice statement terms fall into 1 of 3 categories with respect to their intended degree of flexibility. Guidelines are intended to be flexible. Practice guidelines should be followed in most cases, but depending on individual characteristics or local circumstances, deviations from the guideline are expected and justified. Guidelines become most helpful when gaps in the scientific evidence, a moderate degree of clinical uncertainty, or wide variation of practice patterns and opinions among expert clinicians exist. The terms pructice guideline, practice parameter, and consensus report are used interchangeably. An example of a guideline is the otitis
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media with effusion (OME) clinical practice guideline (Stool et al., 1994). Protocolsor standards are intended to be inflexible. They define correct practice and recommend practice patterns that are based on consistently observed outcomes and that result in uniformly accepted health consequences (Eddy, 1990). Gonococcal ocular prophylaxis and phenylketonuria screening of newborn infants are examples of protocols or standards. Clinical protocols or standards should be followed precisely as written and may carry a certain degree of legal accountability. The third category, options, are so flexible that they provide virtually no guidance when making a decision. Calling an intervention an option means that some practitioners use it, others do not use it, and little scientific basis exists for deciding which choice is correct (Eddy, 1990). An example of an option is, “The administration of an antipyretic/analgesic such as acetaminophen along with the administration of childhood immunizations.” This action might be appropriate, yet some clinicians would disagree, and little scientific evidence exists to support either point of view.
TABLE 2 Practice guidelines for acute and chronic illness in children Available
guidelines
Acute and chronic asthma Fever in young children Castroenteritis Hearing screening HIV disease Infectious diseases Neonatal hyperbilirubinemia Otitis media with effusion Pain Sickle cell disease Simple febrile seizures diagnostic evaluation Attention deficit hyperactivity disorder Congenital dysplasia of the hip Diabetes Minor head trauma/severe head trauma Urinary tract infectionradiologic evaluation AAP, American Academy Institutes of Health.
Source
NIH, National Heart, Lung and Blood Institute (1997) Baraff et al. (1993) AAP, Provisional Committee on Quality Improvement, Subcommittee on Acute Castroenteritis (1996) NIH (1993) El-Sadr et al. (1994) AAP (1997) AAP, Provisional Committee on Quality Improvement and Subcommittee on Hyperbilirubinemia (1994) Stool et al. (1994) AHCPR, Acute Pain Management Guideline Panel (1992) AHCPR (1993) AAP, Provisional Committee on Quality Improvement, Subcomm&ee on Febrile Seizures (1996) AAP (under development) AAP (under development) AAP (under development) AAP (under development) AAP (under development)
of Pediatrics; AHCPR, Agency for Health Care Policy and Research; N/H, National
hospital diagnoses, stipulate goals for patients, and provide the corresponding ideal sequence and timing of staff actions for achieving those goals. They are also referred to as critical paths, clinical pathways, and care paths (Pearson, Goulart-Fisher, & Lee, 1995). Practitioners providing primary care or discharge planning for high-risk neonates may encounter critical pathways like the one described by Neidig, Megel, and Koehler (1992).
accountability.
Critical pathways outline key events associated with managing a specific disease. Whereas guidelines usually address the appropriateness of care by delineating the indications for tests or treatments, critical pathways tend to focus on the quality and efficiency of care after decisions have already been made to admit the patient to the hospital or perform a procedure. Critical pathways are developed primarily for
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DRIVING FORCES IN GUIDELINE DEVELOPMENT The practice guideline movement began with the research findings of Wennberg and Gittelsohn (1973), who were the first to determine, within small geographic areas, that the rate of surgeries correlated with the numbers of surgeons and hospital beds rather than with differences among patients. Similar variability in pediatric practice was also reported in the 1980s. Researchers showed that children with any medical condition were far more likely to be admitted to the hospital in Boston than in Rochester or New Haven (Perrin et al.,
1989). In Vermont, the chances of having one’s tonsils removed as a child were 8% in one community and 70% in another community (Wennberg, 1984). These conclusions helped define 2 previously unrecognized problems in the American health system; (a) widely varying practice patterns among practitioners, and (b) the lack of adequate outcome measures for specific treatment modalities. Responding to these concerns in 1989, the 1Olst Congress created the Agency for Health Care Policy and Research (AHCPR) through Public Law 101-239. The AHCPR’s first mission was to promote and update the development and review of clinically relevant guidelines to assist health practitioners in the prevention, diagnosis, treatment, and management of clinical conditions. AHCPR’s overall aim was to reduce unnecessary practice pattern variation with the hope that this step would foster quality and cost containment in health care (Leape, 1990). The AHCPR has been recognized as the stimulant for “gold standard” practice guidelines and the source of unbiased,
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ORIGINAL
TABLE 3
ARTICLE
Eight attributes
Callender
of good
Attributes
Defining
Validity
Reliability/ reproducibility
Clinical applicability
Clinical flexibility Clarity
Development in a multidisciplinary process
Scheduled
review
Documentation
practice
guidelines characteristics
Practice guidelines are valid if, when followed, they lead to the health and cost outcomes projected for them. A prospective assessment of validity will consider the projected health outcomes and costs of alternative courses of action, the relationship between the evidence and recommendations, the substance and quality of the scientific and clinical evidence cited, and the means used to evaluate the evidence. Practice guidelines are reliable and reproducible (a) if, given the same evidence and methods for guideline development, another set of experts would produce essentially the same statements, and (b) if, given the same clinical circumstances, the guidelines are interpreted and applied consistently by practitioners or other appropriate parties. A prospective assessment of reliability may consider the results of independent external reviews and pretests of the guidelines. Practice guidelines should be as inclusive of appropriately defined patient populations as scientific and clinical evidence and expert judgment permit, and they should explicitly state the populations to which statements apply. Practice guidelines should identify the specifically known or generally expected exceptions to their recommendations. Practice guidelines should use unambiguous language, define terms precisely, and use logical, easy-to-follow modes of presentation. Practice guidelines should be developed by a process that includes participation by representatives of key affected groups. Participation may include serving on panels that develop guidelines, providing evidence and viewpoints to the panels, and reviewing draft guidelines. Practice guidelines should include statements about when they should be reviewed to determine whether revisions are warranted, given new clinical evidence or changing professional consensus. The procedures followed in developing guidelines, the participants involved, the evidence used, the assumptions and rationales accepted, and the analytic methods employed should be meticulously documented and described.
Adapted with permission from Field, M., & Lohr, K. (Eds.). (7 990). Clinicalpracticeguide/inest directions for a newprogram. Washington, DC: National Academy Press, p. 10. Copyright 1990 by the National Academy of Sciences. Courtesy of the National Academy Press, Washington, DC.
science-based information about what works and what does not work in health care. In 1996, the AHCPR ended its direct sponsorship of guideline development and began its clinical improvement program. The new roles are to fund and provide technical support to professional groups involved in guideline efforts and to coordinate 3 new initiatives: creation of evidencebased practice centers, forming a national guideline clearinghouse, and setting a plan for research and evalua-
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tion on the development and use of guidelines (McCormick, Cummings, & Kovner, 1997). During the past decade, managed care has become a powerful driving force in the practice guideline movement. This phenomenon has occurred because guideline-based practice promotes uniformity in the practice patterns of clinicians so that clinical outcomes and practitioner performance can be more accurately measured. The outcome and performance data are
then used to set policy and drive management decisions as MCOs attempt to determine the best use of resources for groups of patients. Through the efforts of MCOs, insurers, and health policy makers, the entire health care system is undergoing reorganization to include the structures, processes, and incentives to promote the use of “clinical tools” such as practice guidelines. As integrated delivery systems and medical information systems are refined and expanded, an unprecedented opportunity to promote the use of guidelines is on the horizon (Simpson, Kamerow, & Fraser, 1998).
COMPLEXITY OF DEVELOPING A QUALITY PRACTICE GUIDELINE Practice guidelines must be based on scientific evidence and a rigorous development process. The methodology involved in developing a “gold standard” practice guideline along with a set of criteria practitioners can use to judge the adequacy of a guideline highlight the rigor and complexity of guideline development.
The Otitis Media With Effusion Guideline Developing the otitis media with effusion (OME) practice guideline was a complex and controversial endeavor. The entire project took more than 3 years and attracted attention for a variety of reasons. First, middle ear disease is a complex clinical topic for practice guideline development because the diagnosis bears a high degree of medical uncertainty. Second, this contract was the first to be awarded to a consortium of medical specialty societies that involved such a large multidisciplinary working group. Organizational and political controversies could easily have hampered the overall quality or eventual completion of the project. Finally, the price tag was high, generating expenditures in excess of $800,000 for the federal government (Sebring & Herrerias, 1996). The OME guideline was developed by the AAP, under contract with the AHCPR and in consortium with the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the Department of Pediatric Otolaryngology at the University of Pittsburgh. The Consortium convened a
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19-member panel that included 11 physicians, a pediatric nurse practitioner, a school nurse practitioner, a public health nurse, an audiologist, a speech/language pathologist, a psychologist, a health policy analyst, and a consumer. First, the panel narrowed, defined, and structured the problem. Next, they identified the important interventions and health outcomes. Extensive literature searches were conducted and critical reviews and syntheses were used to evaluate empirical evidence and significant outcomes. Peer review and field review were undertaken to evaluate the validity, reliability, and utility of the guideline in clinical practice. Explicit scientific methods and expert clinical judgment ‘were used to develop specific statements on patient assessment and management. The OME guideline reflects the state of knowledge on effective and appropriate care at the time of publication. Periodic review, updating, and revisions are planned to respond to inevitable changes in the state of scientific information and technology (Stool et al., 1994).
Cal lender
the national asthma guidelines (National Institutes of Health, National Heart, Lung and Blood Institute, 1997). The first set of guidelines, issued in 1991, set the stage for changes in the clinical care of children with asthma and stimulated a variety of research endeavors to increase the scientific evidence related to the diagnosis and management of asthma. The second set of national asthma guidelines reflect the progress after 6 years of experience with the previous recommendations.
Eight Attributes of a Quality Practice Guideline Being able to judge the quality of a practice guideline and understand the methods used to produce one is important. A set of criteria has been developed that can be used by NPs who are being asked to either develop, disseminate, implement, or evaluate a practice guideline, Through their work with the Institute of Medicine, Field and Lohr (1990) proposed 8 attributes of a high-quality guideline: validity, reliability, applicability, flexibility, clarity, development in a multidisciplinary process, scheduled review, and careful documentation. These 8 attributes and their defining characteristics appear in Table 3. Understanding that guideline development and refinement is an evolutionary process is important. Also, most guidelines are unlikely to “score high” on all 8 attributes simultaneously, especially at the outset. As new scientific evidence becomes available and dayto-day practical clinical experience with the guideline mounts, and after cost and quality outcome studies are conducted, many guidelines can be expected to need revision or redesign. Such revision and redesign has already occurred with
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Despite their specificity, clarity, and credibility, even a quality practice guideline will not automatically produce significant change in the clinical practice of practitioners (Mittman, Tonesk, & Jacobson, 1992). The success of any guideline depends not only on its proper development but also on its widespread adoption in routine clinical practice. Until the recommendations of a practice guideline are put into practice, it is nothing more than “words without action.”
PUTTING GUIDELINES INTO PRACTICE During the past decade far more attention has been devoted to guideline development than to implementation. Implementing a guideline involves taking a set of practice recommendations into the world of day-to-day practice in a variety of health care settings. NPs can play pivotal roles in the implementation and refinement of quality pedi-
atric practice guidelines by promoting and evaluating their use in their clinical encounters with children and their families. By participating in dissemination and implementation and by mediating the cost-quality paradox, NPs can make valuable contributions to the practice guideline movement.
IDissemination Dissemination is the vital link between the guideline development process and guideline implementation. Dissemination focuses on enhancing awareness and general understanding about a guideline when it is initially published, adopted, or updated. The first steps are access and exposure. NPs can gain access to pediatric practice guidelines through government agencies such as the NIH and AHCPR. The AAP publishes pediatric practice parameters in their journal, Pediatrics, as they become available or are updated. The AAP also makes their various practice parameters and guide lines available to all pediatric health professionals in books, on CD-ROM, and through their web site at www,aap. org/policy/paramtoc.html. The AHCPR, in partnership with the American Association of Health Plans and the American Medical Association, has developed the National Guideline Clearinghouse, which provides online access to guidelines. The National Guideline Clearinghouse includes the following: (a) information about each guideline and how it was developed; (la) information on how to obtain the full text of the guideline; (c) comparisons of guidelines that cover similar topic areas, including areas of agreement and disagreement; and (d) electronic mail groups through which registered users may exchange information about aspects of guideline development, content, and implementation (AHCPR, 1998). The Web site address is wwwguidelinegov.
Implementation NPs, along with pediatricians and other pediatric health care professionals, must be willing to use practice guidelines in the settings in which they deliver health care to children and their families. Only then can the practical contingencies, strengths, and weaknesses of a particular guideline be brought to light so that assessments
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and conclusions about its effectiveness can follow. NPs can also be instrumental in adapting national guidelines to meet local needs. For example, the full array of counseling recommendations included in the Guidelines for Adolescent Preventive Services (GAPS) (Elster & Kuznets, 1994) may be more easily assimilated and adopted in their entirety by NFs in school-based health centers who have more frequent and ongoing contact with teens. NPs in the traditional pediatric ambulatory clinic, at which office visits are brief and access for follow-up is more difficult for teens, may need to streamline or modify the recommendations. They may need to refer their clients or network with other providers and resources available in their particular community to ensure that their adolescent clientele obtain all the recommended health counseling services. As NPs gain experience with a practice guideline in their particular setting, they should participate in the revision or updating of the recommendations. Their practical experience is as important to the guideline refinement process as is the introduction of new scientific evidence. Opportunities to participate in the review, redesign, or updating of a practice guideline may occur in the health care system, professional societies, or national initiatives.
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costs be lowered and quality tained or improved?
main-
SUMMARY We can anticipate encountering practice guidelines more often, not less often, in the future. NPs are encouraged to participate in the development, dissemination, implementation, and evaluation of practice guidelines pertaining to pediatric primary care. Perhaps as medical information systems integrate these documents into computer-based diagnostic and therapeutic decision support, they can help us stay current in practice by enabling us to keep up with new scientific evidence, which is increasing at an exponential rate. Quality guidelines can be an aid in making pediatric health care more appropriate and effective. Overall, the practice guideline movement can be viewed as a positive force in health care as long as a balance is maintained between two equally important goals: cost containment and quality improvement. 1 gratefully acknowledge the assistance provided by Carole Stone, MSN, CPNP, Faculty, Catholic University of America, in the development and review of the manuscript for this article.
REFERENCES Agency for Health Care Policy and Research. (1998, May 19). Development and implementation ofthe Nntional GuidelineClearinghouse. Fact Sheet [On-line]. Available: http://www.ahcpr.gov/ clinic/ngcfact.htm Agency for Health Care Policy and Research, Acute Pain Management Guideline Panel. (1992). Op-
the Cost-Quality
Finally, NPs have an important role as mediators in the cost-quality paradox that is arising out of the practice guideline movement, particularly as it is being embraced by some managed care initiatives. Some managed care organizations and insurance companies embrace or impede the use of practice guidelines through incentives or disincentives to providers or through reimbursement decisions enacted primarily to contain costs. Some pediatric guidelines cannot be appropriately implemented because of deterrents such as time constraints, poor payment, or lack of reimbursement altogether. NPs can use practice guidelines to influence organizational policies and management decisions concerning well-documented, preferable, evidence-based practice for pediatric primary care. In this way, NPs can be mediators in the
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difficult balancing act that must occur in trying to simultaneously achieve the seemingly incompatible goals of cost containment and quality improvement. Controversies arise as guidelines are used to simultaneously cut costs and improve quality (Pauly, 1995). Some guidelines will save money by reducing the use of inappropriate services. Other guidelines may increase cost by encouraging more use of underutilized services, or some will shift costs from one service or place or payer to another. For example, the wider adoption and implementation of GAPS (Elster & Kuznets, 1994) by practitioners in school-based health centers would result in the delivery of substantially more health services
improve”ment.
to adolescent populations, initially driving up costs. However, if the guidelines succeed in promoting health and preventing morbidity and mortality among teens, ultimately the improved appropriateness and hence value would justify the costs. NPs must prepare to use this type of logic as they engage in debates concerning the balance of cost and quality as guidelines are applied in pediatric care. The following questions may be helpful in framing this issue. Will implementation of the guideline actually improve the health of the patient? Will quality be improved sufficiently to justify increased costs? Will
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Thank You, VIPs! NAPNAP’s Program Committee and Executive Board wish to extend a special thank you to the VIPs (Volunteers: Interested and Participating) who provided assistance at NAPNAP’s 20th Annual Conference in San Antonio. The VIPs monitored educational sessions, provided audiovisual assistance, and introduced speakers. Several speakers commented on the excellent contributions made by the VIPs. We couldn’t do it without them!
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