Clinicians caring for children increasingly encounter practice guidelines. Guidelines have emerged as a driving force in American medicine. They are appearing more regularly in academic journals, and are often the basis of audits by health insurers. Pediatricians are no longer shielded from this component of the quality of care revolution.
Because of the expanded presence of guidelines in the daily work of clinicians, and the substantial expenditure of time and resources by government, medical societies, hospitals, and insurers in guideline-related activities, we convened a conference to review the status of pediatric practice guidelines. The goal of the conference was to establish a dialogue among key constituencies in the care of children. Participants included primary care providers, researchers, health insurers, representatives of professional societies and governmental agencies, and parents. Specific goals of the conference were to: (1) assess the status of guidelines in pediatric care—what guidelines exist, how are they perceived by clinicians, and how have they affected care; (2) to define the unique challenges for pediatric guidelines; and (3) to discuss research agendas and plan implementation strategies.
The conference was divided into five sections: (1) an overview of guidelines; (2) guidelines for preventive care; (3) guidelines addressing the management of children with illness; (4) parental perspectives on guidelines; and (5) practitioner views of guidelines. This commentary represents a summary of the discussions and our opinions about the clinical, research, and policy implications. These opinions, while we hope reflective of the discussion, are those of the authors and not the participants (see Appendix).
Analysis of medical practice reveals variation in care not easily accounted for by differences in patient and illness characteristics. For example, Perrin and others,1,2 in a series of investigations, have demonstrated that children with any medical condition are far more likely to be admitted to the hospital in Boston than in Rochester or New Haven. This variability in practice, coupled with concerns about the gap between published data and actual care, underlies the effort to introduce guidelines into the practice of medicine as one mechanism to improve quality.
Guidelines, according to the Institute of Medicine (IOM), are “systematically developed statements to assist practitioner and patient decisions about appropriate care for specified clinical outcomes.”3 Implicit in this definition are several challenges to traditional medicine and current practice. This definition implies that prior recommendations for care have not been “systematic,” that is, not based on rigorous review of scientific evidence or formal methods to achieve reliable consensus. It emphasizes the role of patient decision-making. Obviously for clinicians caring for children, this implies involving parents and when possible children in the guideline process. Finally, it assumes guidelines can be sufficiently specific to apply to particular patients in individual care settings. Each of these aspects of guidelines can create anxiety for practitioners.
The IOM definition of guidelines sidesteps several keys issues that continue to confound the development of guidelines and troubled conference participants, even though this conference did not focus on the methodology of guideline development. First, the definition does not specify who should develop guidelines and the value placed on the source of guidelines. Both parents and clinicians present at the conference strongly articulated the belief that organizations—such as the American Academy of Pediatrics (AAP)—have great credibility and respect, while others—such as pharmaceutical firms—carry little weight as impartial arbiters of good care. Second, specifying that guidelines need be “systematically developed” leaves vague the role of “scientific evidence” in determining content and quality of guidelines. In pediatrics, development of guidelines is difficult because clinical research in many areas of care is lacking. In some cases, such as assessing new technologies, developing sufficient evidence is extremely expensive and time-consuming.
The lack of data has led to widespread promulgation of expert opinion as “guidelines,” such as those related to many aspects of preventive services, often without distinction as to which statements are evidence-based and which are consensus-based. Guidelines should clearly define the mechanism through which they are developed, and the degree to which recommendations are based on evidence.
All of the conference participants acknowledged that practice guidelines are only one element of the quality revolution. Although this conference focused on guidelines, issues related to overall quality of care were discussed. Quality of care, as defined by the IOM, is “the degree to which health services for individuals and populations increase the likelihood of desired patient outcomes given the current state of knowledge.”4 As with the definition of guidelines, the definition of quality may raise concern among clinicians. Quality is a probabilistic notion, recognizing that in any individual case, the best care might not lead to the best outcome. The goals of quality are determined by patient (and parent) preferences, not only those of clinicians. Finally, recommendations to which particular approaches to care represent quality are bounded by the state of knowledge in the particular field.
GUIDELINES FOR PREVENTIVE CARE
The preventive health supervision “guidelines” cover the number and timing of routine health maintenance visits, the content of the visits, immunization schedule, and screening tests. Major health promotion preventive guidelines are the AAP health supervision guidelines,5Bright Futures,6Early Periodic Screening Diagnosis and Treatment(EPSDT),7Guidelines for Adolescent Preventive Services (GAPS),8 and the Guide to Clinical Preventive Services.9 Summaries of these guidelines appear below:
The health supervision guidelines of the AAP were revised in August 1995 by the Committee on Practice and Ambulatory Medicine. This preventive guide covers infancy, early childhood, middle childhood and adolescence, ending at age 21 years.
Bright Futures is a joint effort of the Maternal and Child Health Bureau and Health Care Financing Administration. It is a comprehensive guide encompassing health promotion, reflecting what families and communities need to do to ensure the health and well-being of children, as well as the role of physicians and other care providers.
EPSDT is a combination of a practice guideline and regulatory policy. Medicaid recipients under the age of 21 are expected to be cared for according to EPSDT.
GAPS is from the American Medical Association and emphasizes contemporary causes of adolescent morbidity and mortality.
The Guide to Clinical Prevention Services is a recently released report from the United States Preventive Services Task Force. The task force considers 64 conditions for which screening or counseling may apply, and 6 conditions for which immunization or chemoprophylaxis may be important. The strength of the scientific evidence, for and against each recommendation, is presented.
Conference participants noted that the preventive health supervision recommendations represent a composite of practice guidelines as defined by the IOM and less systematically developed policy statements. They vary in the degree to which scientific evidence was available for formulating the recommendations. For example, the health supervision guideline of the AAP includes recommendations about immunizations, lead screening and vision screening, about which substantial evidence exists, and recommendations for anticipatory guidance and periodicity of visits, about which less information is available. The US Preventive Services Task Force recommendations are based on formal literature synthesis, and recommendations are accompanied by a “grade” of the strength of the evidence.
Concerted efforts to enhance adherence by clinicians with recommended preventive care guidelines have increased over the past decade. For example, the immunization schedule is now published twice each year. Initial efforts of states to promote EPSDT have been enhanced. Managed care organizations are now expanding their implementation activities, with mailings of guidelines to physicians and chart audits. Overall, the goal of these initiatives is to close the gap between practice and knowledge. Widespread emphasis on strengthening immunization rates, audits of preventive practices by many managed care organizations, an incipient public/private initiative in support of the Bright Futures, incorporation of many recommendations into mandated insurance regulations, published performance measures and focused regional implementation efforts, are likely to be successful. One particularly exciting intervention entails a method of focused audit and feedback to practitioners of their preventive care performance, coupled with a “continuous quality improvement” approach to improve office preventive care processes (C. Lannon, personal communication, March 15, 1996).
Despite this heightened emphasis on implementation, meeting participants raised concerns and offered guidance regarding successful strategies to foster adoption of recommendations. First, participants were troubled by the existence of conflicting recommendations, and felt such conflict would limit adoption. For example, in Massachusetts, the EPSDT guidelines still mandate a visit at 30 months of age, although that has been eliminated in the new AAP health supervision guidelines. Second, practitioners were unaware of some of the recommendations, and frustrated by the sheer volume of information they receive. They felt the need for an integration of recommendations into a concise and usable format. Third, practitioners were wary of recommendations at great variance with practice, such as the 1991 recommendations for lead screening,10 and felt the basis for making such recommendations must be substantially stronger than recommendations for minor modifications in care if they are to be adopted. Last, practitioners asked those responsible for guideline implementation to be aware of the limitations imposed by two practical considerations: time and cost. Expanding the list of preventive services or implementing practice guidelines related to illness, may be both time-consuming as well as expensive. Given the current emphasis on efficiency, capitation, and managed care, accomplishing all of these goals simultaneously may be exceedingly difficult.
GUIDELINES FOR MANAGEMENT OF CHILDHOOD ILLNESS
Numerous guidelines exist for the management of children with acute or chronic illness.10-22 For example, guidelines have been developed by the AAP and Agency for Health Care Policy and Research (AHCPR) (Table). The guidelines developed by the AAP and AHCPR represent high levels of methodological quality. They are evidence-based, and undergo an extensive review process before their dissemination. Their principal methodological limitations stem from limited research data, their minimal opportunity for incorporation of patient and parent perspectives, and (for some guidelines) the lack of information about economic implications of adherence to the guideline. The AAP guidelines may also be limited since only one or two disciplines (pediatrics and family practice) have participated in their development.
The level of methodological quality may not be as good in locally developed guidelines. Such local activities appear widespread, especially among larger, academic institutions and health insurers. Anecdotal reports indicate such organizations are increasingly using national guidelines as the basis for their local activities, both to assure quality in the guideline and to save cost in development.
The methodological strength of practice guidelines stands in contrast to the effectiveness with which these guidelines have been disseminated and implemented. Successful implementation requires that practitioners be aware of guidelines, that they be accepted as the right course of action, that they be used, and that their use be reinforced. Most practitioners were not aware of many of the guidelines. Even some conference participants, many of whom are active in the field, could not easily locate guidelines released by federal agencies and professional societies. Only the asthma guideline released by the National Institutes of Health was broadly recognized by all conference participants.11 The asthma guideline, older than many of the pediatric specific guidelines, was mailed to nearly all physicians in the United States with support from the pharmaceutical industry, in some measure because adherence to these recommendations would enhance the sale of some drugs. Participants recommended alternative strategies for dissemination, including the regular and prominent publication of guidelines in Pediatrics and the availability of guidelines via the Internet.
Awareness of guidelines, albeit an important first step, is not sufficient to change practice. Practitioners present at the conference again emphasized the need to “get their attention.” They emphasized the importance of making change easy through tools such as flow sheets and reminders. Several surmised that practice specific factors such as working in a group that discusses care on a regular basis could promote adoption of change. Most of the practitioners felt the absence of rigorous trials linking improvement in practice to improvement in outcomes was not a major obstacle to adoption of guideline recommendations, if the development of the guideline was evidence based, produced by a credible source, and practical.
PARENTAL PERSPECTIVE OF PRACTICE GUIDELINES
A unique aspect of the conference was the participation of six parents. The parents, all with children under the age of 18, from the Boston area, were chosen by the course directors. None had ever participated in a similar meeting. These parents adamantly felt they should have access to all important sources of information relevant to the care of their children. In particular, when a guideline exists for a particular medical problem and the clinician is familiar with it, the guideline should be shared with families; such information should be presented in nontechnical language so that parents can understand it and references should be available.
This group of parents also believed parents should be involved in all aspects of guideline development, dissemination, and adoption. Such an approach has been used by the AHCPR. Several nonparent participants highlighted the difficulty in the technical review of the scientific evidence. These participants suggested parents should help define outcomes that are relevant to children and their families and be involved in preparing documents that will be given to families.
Both the parents and many of the participants felt that parents could also be helpful in guideline implementation. By providing parents with guidelines it may be possible that they could become “agents of change.” Because changing physician behavior is quite difficult,23-25 many participants felt that this was worthy of further study.
The conference only considered the role of the patient—especially the older pediatric patient—in guideline activities in passing. The same concerns raised by parents should be applied to older children and adolescents—they should be aware of guideline recommendations, and given sufficient information needed to make choices about their care.
PRACTITIONER VIEWS OF GUIDELINES
Unfortunately, there is little published information about what clinicians know about practice guidelines. Clinicians participating in the conference universally articulated a desire to deliver the best possible care for their patients. Their enthusiasm was tempered by competition for their time, a competition made more intense with the increased role of managed care. In addition, they were skeptical of the motivation for guidelines, fearing a “hidden agenda” of cost reduction in the guise of quality improvement. Those working in less structured settings—solo practices or groups with little formal sharing across peers—appeared more skeptical of guidelines than those in more structured care arrangements. All felt adamant that the impact of guidelines on patient flow is important and must be considered when guidelines are promulgated. As noted throughout, clinicians valued the credibility of the source of data and those changes that could be easily implemented.
Broader studies of practice change in pediatrics confirm the enthusiasm of pediatricians for improvement. These studies also indicate, however, that performance is often not at the level that practitioners believe occurs in their office. Studies contrasting implementation of hepatitis B with Haemophilus influenzae type B immunization recommendations also show that the nature of the recommendation—either the ease with which it can be implemented, or the perceived value of the intervention—does affect adherence.
A traditional summary of such a conference would be to develop separate recommendations for policy and research. The recommendations from this conference differ from the traditional approach, in that the research and policy agendas are not distinct. In addition, it is important to recall that practice guidelines are just one part of the effort to improve the quality of care for children and families.
Parents, practitioners, and, when feasible patients, should be directly involved in the development of practice guidelines both as a matter of equity and as a means to develop effective implementation strategies.
Strategies aimed at practice change should be rigorously evaluated to assess their cost-effectiveness.
Quality of care improvement initiatives for children should include dissemination and implementation of pediatric practice guidelines as one strategy among many.
The development of strategies for practice change that are sustainable and effective at the office based level should be the highest priority for those seeking to improve care for children.
Sources of funding for such initiatives and evaluations must be identified or developed. Although efforts to support these activities must be broad-based and include both public and private sources, the information derived must remain in the public domain.
Evaluation of practice change should include measures of processes and, where feasible, outcomes of care. Further development and validation of valid outcome measures for child health remains a crucial improvement and research agenda.
Greater emphasis on clinical research of common pediatric conditions and preventive service interventions is essential for the advancement of evidence-based medicine for children.
Differences in the preventive service recommendations should be reconciled. These guidelines should also clarify the methods by which they are developed, and the basis for the recommendations made.
Pediatric practice guidelines are here to stay. Clinicians need to become familiar with how guidelines are developed, the different types of guidelines, and how to incorporate them into their practices.
Conference Participants (Excluding Parents)
George Askew, MD, Jonathan A. Benjamin, MD, David A. Bergman, MD, Hank Bernstein, DO, Carolyn M. Clancy, MD, James R. Cooley, MD, Judy Derman, MHS, Carolyn G. DiGuiseppi, MD, Ralph Earle, Jr, MD, Leonard M. Finn, MD, Gary L. Freed, MD, MPH, James W. Hanson, MD, Carla T. Herrerias, MPH, J. Allen Johnson, MD, Kathleen A. Kearney, PhD, Edward Keenan, MD, Woodie Kessel, MD, Lawrence C. Kleinman, MD, MPH, Carole M. Lannon, MD, Paula Lozano, MD, MPH, Jerold F. Lucey, MD, T. Allen Merritt, MD, Lawrence F. Nazarian, MD, Cindy J. Osman, MD, Sean Palfrey, MD, R. Heather Palmer, MD, Peter D. Rappo, MD, Robert H. Sebring, PhD, Patricia H. Shiono, PhD, Lisa Simpson, MD, Jan Snyder, Richard C. “Mort” Wasserman, MD, Robert A. Witzburg, MD, Barry Zuckerman, MD, and Pam Zuckerman, MD.
The conference was supported with grants from the David and Lucile Packard Foundation, Center for the Future of Children, the Maternal and Child Health Bureau, and Connaught Laboratories.
We appreciate the time and effort of the conference participants, particularly the parents. The comments of Pat Shiono and Woodie Kessell were invaluable.
- Received October 2, 1996.
- Accepted October 8, 1996.
Reprint requests to (H.B.) Boston City Hospital, Maternity 415, 818 Harrison Ave, Boston, MA 02118.
Guidelines from Agency for Health Care Policy Research are available by calling 1-800-358-9295; guidelines from the American Academy of Pediatrics are available by calling 1-847-228-5005 (ask for Publications).
- IOM =
- Institute of Medicine •
- AAP =
- American Academy of Pediatrics •
- EPSDT =
- Early Periodic Screening Diagnosis and Treatment •
- GAPS =
- Guidelines for Adolescent Preventive Services •
- AHCPR =
- Agency for Health Care Policy and Research
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- Copyright © 1997 American Academy of Pediatrics