Letters to the Editor
Statements appearing here are those of the writers and do not represent the official position of the American Academy of Pediatrics, Inc. or its Committees. Comments on any topic, including the contents ofPediatrics,are invited from all members of the profession: those accepted for publication will not be subject to major editorial revision but generally must be no more than 400 words in length. The editors reserve the right to publish replies and may solicit responses from authors and others.
• • •
Letters should be submitted in duplicate in double-spaced typing on plain white paper with name and address of sender(s) on the letter. Send them to Jerold F. Lucey, MD, Editor, Pediatrics Editorial Office, Fletcher Allen Health Care, Burlington, VT 05401.
Oranges and Apples: Sedation and Analgesia
To the Editor.—
Cote´ et al1have performed a valuable service in their critical analysis of reported adverse sedation events. Some of the pitfalls inherent in this study are pointed out in the accompanying edito-rial. However, the editorial did not emphasize that once again the authors are combining analysis of patients given either analgesia and sedation—they are studying apples and oranges, and evalu-ating fruit salad.
The Cote´ study evaluated a selected sample, from a biased cohort, which lacked a denominator. In a larger, differently struc-tured study,297.7% of children receiving proper management of sedation and analgesia in an emergency room setting had no adverse events. All of the events that did occur in the remaining 2.3% were transient, minor, and easily managed. Even in that study, sedation and analgesia are combined, and yet every phy-sician, anesthesiologist—and grandmother— knows that sedation and analgesia are different. They are different in the goals sought, they may be different in the medications used, and different in the depth of neurologic alteration desired. They are also probably different in their complications.
For years, indeed for generations, chloral hydrate has been used for sedation—to provide sleep and thereby lessen anxiety. Chloral hydrate is not an analgesic. In situations where mild sedation, not analgesia, is desirable, chloral hydrate has been used widely and safely. For example, young children are often anxious about electroencephalograms (EEGs), and sleep is an important state of the brain in which to evaluate epileptic activity. Analgesic medications might even invalidate the EEG study. And yet we are no longer permitted to use chloral hydrate for sedation for EEGs without having a nurse (or physician) in attendance for monitor-ing. Why?
Where are the data on the incidence of adverse events after appropriate doses of chloral hydrate for such sedation? Where are the “critical events analyses” where only chloral hydrate or other medications for conscious sedation are used? In Table 1 of his article, Cote´ cites 3 examples of such adverse events. He cites 1 child who received 6000 mg of chloral hydrate. Why was the child given such a large dose, and what was the adverse event? A second child was “flown up from Mexico for a cardiology proce-dure and received 60 mg/kg of chloral hydrate. Depression, bra-dycardia, and arrest followed . . .” The implication is that the chloral hydrate caused the event. It is unlikely that the child did not receive other medications for the procedure, whatever it was. What was the role of the digoxin? A third child had an adverse event of unstated type, and “the mother had given 2 prescriptions of chloral hydrate at home.” What was dose? What was the event? What were its consequences?
As a result of Cote´’s work and that of others, children who require EEGs often get inadequate studies, without sleep. They are, for example, often sent away from Johns Hopkins for studies because it is fiscally unsound for us to subsidize a nurse to monitor each child because the additional costs will not be reim-bursed by insurance.
Have the recommendations of the Academy resulted in safer studies? Where are the data that chloral hydrate properly pre-scribed for sleep is an unsafe drug? What is the magnitude of the
risk to children? How does it compare with the risks of the procedures being performed at other sites? Does the quality of the studies performed elsewhere and their interpretation factor into the cost-effectiveness of the recommended monitoring?
Analgesia clearly may require more careful monitoring and more vigorous resuscitation than was done in the past. However, to lump sedation and analgesia together and develop a numerator of adverse events without any denominator is to lump together apples and oranges.
We need far better data in both the numerators and in the denominators of the risks of sedation, and separately of analgesia. We need to understand the risk/benefit equation of each before we accept the proscriptions that have been forced on us and the families we serve.
John M. Freeman, MD* Eileen P. G. Vining, MD†
Departments of *Pediatrics and †Neurology Johns Hopkins Medical Institutions
Baltimore, MD 21287-7247
REFERENCES
1. Cote´ CJ, Notterman DA, Karl HW, et al. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors.Pediatrics.
2000;105:805– 814
2. Pena BMG, Krauss B. Adverse events of procedural sedation and anal-gesia in a pediatric emergency department.Ann Emerg Med.1999;34: 483– 491
Adverse Effects of Lotrisone Cream Used in
Infants
To the Editor.—
In keeping with the Food and Drug Administration’s (FDA’s) mission to promote and protect public health by assuring the safety and effectiveness of drugs, we write to advise pediatricians and other health practitioners of important adverse events asso-ciated with the use of Lotrisone cream in children. Lotrisone cream was approved by the FDA for use in the United States in July 1984. It is marketed by Schering and is a combination of clotrimazole, USP, a synthetic antifungal agent, and betamethasone dipropi-onate, USP, a synthetic corticosteroid, for dermatologic use. It is labeled for twice-daily use for 2 weeks in tinea cruris and tinea corporis and 4 weeks in tinea pedis, dermatophyte infections resulting from Trichophyton rubrum,Trichophyton mentagrophytes,
Epidermophyton floccosum, andMicrosporum canis.1
cream. We must point out that underreporting is a well-recog-nized feature of spontaneous reporting systems such as this, so the numbers of adverse events may in fact be higher than reported.2 Although there are no efficacy data for children, usage data suggest that Lotrisone cream is widely used in children under 12. IMS Health’s National Prescription Audit Plus (NPA Plus), a survey of pharmacies for prescriptions dispensed in the continen-tal United States, showed that tocontinen-tal Lotrisone prescriptions ranged from 4.4 million in 1993 to 5 million in 1998. IMS Health’s National Disease and Therapeutic Index (NDTI), which surveys treatment patterns and diseases at patient visits to office-based medical practices in the continental United States, indicated that 20% of the Lotrisone prescriptions were for children aged 12 and under, 14% were for children aged 6 and under, and 7% were for infants⬍1 year old. NDTI data further showed that diaper dermatitis was the most frequently mentioned indication for Lotrisone cream pre-scriptions among children 0 to 2 years old. In addition 2 recent articles based on analysis of National Center for Health Statistics survey data3,4confirm the widespread prescribing of clotrimazole-betamethasone diproprionate in young children, particularly by pediatricians and nondermatologists.
The Precautions section of the package insert includes a state-ment that “safety and efficacy have not been established in chil-dren under 12 years old” and specifically that “the use of Lo-trisone in diaper dermatitis is not recommended.” The Dosage and Administration section of the label also states that “Lotrisone cream should not be used with occlusive dressings,” an effect simulated by diapers in infants.
This review thus suggests that Lotrisone is widely used in children⬍12 years old, including for diaper dermatitis in infants, an indication and age group not recommended by the product labeling. Off-label use of drugs may often be appropriate and is not generally subject to FDA regulation. However, as stated in product labeling, the use of Lotrisone in diaper dermatitis is not recommended.
Lois La Grenade, MD, MPH Amarilys Vega, MD, MPH Markham C. Luke, MD, PhD Food and Drug Administration Rockville, MD 20857
REFERENCES
1. Lotrisone package insert. Kenilworth, NJ: Schering Corporation; 1994 2. Scott HD, Rosenbaum SE, Waters WJ, et al. Rhode Island physicians’
recognition and reporting of adverse drug reactions.Rhode Island Med-ical Journal. 1997;70:311–316
3. Smith ES, Fleischer AB Jr, Feldman SR. Nondermatologists are more likely than dermatologists to prescribe antifungal/corticosteroid products: An analysis of office visits for cutaneous fungal infections, 1990 –1994.J Am Acad Dermatol.1998;30:43– 47
4. Fleischer AB Jr, Feldman SR. Prescription of high-potency cortisteroid agents and clotrimazole-betamethasone diproprionate by pediatricians.
Clin Ther.1999;21:1725–1731
The Milliman-Robertson Length of Stay Debate
To the Editor.—
The recent article by Sills et al1asks whether the recent Milli-man and Robertson (M&R) Health Status Improvement and Man-agement (HSIM) publication2presents realistic length-of-stay cri-teria. The article does not directly answer the question posed. Faculty members in the Department of Pediatrics at the University of Texas at Houston provided contributions to the M&R HSIM, with the intention as stated by the authors “of focusing on best practice rather than median performance.” Even with best practice in mind, inspection of the histograms presented in Fig 1 demon-strates that the goal LOS was in fact modal in at least half of the 16 diagnoses. Reanalysis of the published data (Table 1) shows that the average of the “percentage of patients with LOS⬎M&R” for the 16 diagnoses equals 63%; thus, on average, 37% were dis-charged on or before the M&R goal LOS. Weighting the diagnoses by the number of patients with each diagnosis, 46% of actual patients were discharged on or before the M&R goal LOS. These published data demonstrate that even with retrospective applica-tion of 1999 guidelines to uncontrolled 1995 data in New York, which is characterized in the article as relatively “inefficient,” about 40% of the discharges met or exceeded the goal LOS. Much has changed since 1995, generally in the direction of improving outpatient management of many pediatric diseases. However, if the question to be answered by the article is whether the goal
TABLE 1. Pediatric M&R LOS Criteria: Are They Realistic?
Diagnosis n Percent of
Total Casesa
LOS⬎M&R % of Casesb
LOSⱕM&R % Casesc
LOSⱕM&R # Casesd
Appendectomy, complicated 1349 1.92% 73% 27% 364
Appendectomy, uncomplicated 4463 6.34% 67% 33% 1473
Appendicitis, no abcess 2774 3.94% 56% 44% 1221
Asthma 22 412 31.84% 50% 50% 11 206
Bronchiolitis 8048 11.43% 65% 35% 2817
Burn, major, noncritical 1558 2.21% 64% 36% 561
Cellulitis 2580 3.67% 66% 34% 877
Group 2591 3.68% 23% 77% 1995
Diabetic ketoacidosis 494 0.70% 69% 31% 153
Gastroenteritis 8320 11.82% 44% 56% 4659
Meningitis, bacterial 138 0.20% 91% 9% 12
Osteomyelitis 242 0.34% 86% 14% 34
Pneumonia 12 137 17.24% 48% 52% 6311
Pyelonephritis, acute 633 0.90% 62% 38% 241
Pyloromyotomy 587 0.83% 70% 30% 176
Sickle cell crisis 2060 2.93% 77% 23% 474
Total 70 386 100.00% 32 574
Average
By diagnosis (average ofb or ofc)
63% 37%
By number of patients (32 574/70 386)
46%
Source: See reference 1. aFrom Table 1 bFrom Figure 2 cCalculated as 100%-(2)
LOSs are “realistic,” as suggested by the title, then the data clearly indicate that the goal LOS was in fact achieved by patients with each illness, and that overall, almost half of the children went home by the goal LOS.
In the HSIM, LOS was consistently presented as “goal LOS,” rather than “average LOS” or “maximum permissible LOS.” The goal LOSs were intended as “ambitious,” and to be applicable only to uncomplicated patients. Many contributors used the no-tion of goal LOS as analogous in part to the game of golf. If one considers pediatricians to be like golf pros providing professional services to the broad range of golfers, it should not be surprising that many or most receiving professional services (patients) do not achieve par. Less than 5% of the golfing population regularly shoots par on a given hole (G. Norman, personal communications, May 2000). However, I would submit that our problem in pediat-rics is not with those who set par at a particular number of strokes for a golf hole or golf course, but rather with those who would set the greens fees (or reimbursement) too low, would ask the golfers to leave the course after 72 strokes, and would hold the golf pros responsible for the diversity in the performance of the golfing population and their routine failure to achieve par. Those actions would be unacceptable in golf, and by analogy, I would suggest that the pediatric community should offer strong and informed resistance to both episodic and systematic misapplications of the “goal of LOS” to their patients.
Pediatric HSIM was developed as a compendium of best prac-tices within the continuum of care for pediatric patients, and was not intended to provide the detailed medical information neces-sary for diagnosis or for direct patient care. HSIM was not in-tended as guidelines in the sense of the Institute of Medicine or the Agency for Health Care Policy and Research usage of the term. While generally referred to in the article as “guidelines”, HSIM itself uses the word guideline only in the introductions, and only in a lower-case, generic sense. However, HSIM does systemati-cally cite and incorporate professional guidelines from the Amer-ican Academy of Pediatrics (AAP) and other pediatric bodies. Although many physicians may feel powerless and frustrated by the current healthcare environment, the AAP and other pediatric organizations exert great influence in the managed care arena by publishing clear statements as professional guidelines, which then form the basis for the recommendations appearing in the HSIM and other similar publications. By working with the commercial consultants who advise those who administratively “manage” or pay for pediatric health care, I believe that the pediatric commu-nity is paradoxically empowered to reassert professional stan-dards controlling the clinical practice of pediatrics and to serve and protect our patients in the changing health care environment.
John W. Sparks, MD Department of Pediatrics
University of Texas at Houston Medical School Houston, TX 77030
REFERENCES
1. Sills MR, Huang ZJ, Shao C, Guagliardo MF, Chamberlain JM, Joseph JG. Pediatric Milliman and Robertson length-of-stay criteria: are they realistic?Pediatrics.2000;105:733–737
2. Milliman & Robertson, Inc. Schibanoff JM, ed.Pediatric HSIM (Health Status Improvement and Management),1998. (Note that the original article did not cite the printed publication, copyright 1998, but rather the access of the authors to the M&R Web Site).
To the Editor.—
Neither the article on Milliman and Robertson (M&R) criteria for hospital length of stay (LOS) by Sills et al1nor the dueling commentaries2,3in the same issue discuss some simple points that may improve pediatricians understanding of some of the issues at stake.
1. The M&R criteria are properly used and understood as targets or goals for hospitalizations. They cannot be used as a sole determination of appropriateness of hospitalization, if for no other reason than the fact that they are totally insensitive to secondary diagnoses and complications, including psychoso-cial issues! But they might be appropriately used as a bench-mark, which cantriggeran appropriate utilization review, and
as a target for hospitals to use in the discharge planning pro-cess.
2. Given this understanding of how the M&R standards could be used, are they really so far off? Looking at the data in Fig 1, the discerning reader can easily see that data plots are almost all skewed—not normal— distributions. Therefore, the mean is not the best measure of central tendency, and the authors have appropriately presented the median and mode for each data set in Table 1. Looking at Table 1, one can see that the M&R criteria differ significantly from the median and modal values in only 4 out of 16 data sets.
The burn admission data shows a mode (1) that is less than M&R (3) and a median (5) slightly greater than M&R. This suggests a significant number of 1-day admissions, for unclear reasons. It is unlikely that all of these are attributable to obser-vation for smoke inhalation, and the data on this admission pattern clearly need a deeper analysis to determine the appro-priateness of very short admission.
The other areas of significant difference are for meningitis, osteomyelitis, and appendicitis.
3. For these 3 serious conditions, the mode is far above M&R targets. Why?
First, these 3 conditions are likely to have very significant complication rates, may be associated with underlying immune disorders (even appendicitis in systemic lupus erythematosus, for example), and can be caused by organisms that are difficult to treat (tuberculosis, salmonella, etc).
But perhaps most important is the fact that for M&R criteria to make any sense—and remember that they were developed by reputable physicians using a model for consensus develop-ment that is reasonable, if not perfect (3)— one has to have
aggressive home health services available for uncomplicated cases! With aggressive home health care, early discharge for these diagnoses can be done and is appropriate, but it is very unlikely that such services were readily available in New York in 1995! Even here in California, an “advanced” managed care market, good home health services for children, in particular, are relatively hard to come by. But this does not mean that we should not be striving to implement them.
4. The reason we need to try to minimize hospital admission time is not just to reduce costs. Hospital admissions are a major stress on children and families, and expose patients to the all-too-common complications of nasty, drug-resistant nosoco-mial infections and iatrogenic medication errors. One should not forget this in the midst of arguments about who is getting paid for what.
The authors have made a good effort, but with old data from a place (New York) and time (1995) which are not a fair comparison to reality in other parts of the country in the year 2000. In the future, investigators should be encouraged to examine compari-son data from more “managed” markets, to look at the availability of home health care in relation to the data, and to present the rates of secondary diagnoses or complication diagnoses versus uncom-plicated cases when analyzing their results.
Meanwhile, used properly as a set of targets for achieving reasonable, early hospital discharges, but not as sole criteria for determining the medical necessity of length of hospital stay, the M&R criteria are not as bad as some would assert,2though con-tinued efforts to improve them, like all other benchmarks, also makes good sense.
John M. Goldenring, MD, MPH, FAAP San Diego, CA 92131
REFERENCES
1. Sills MR, Zkihuan JH, Cheng S, Guagliardo MF, Chamberlain JM, Joseph JG. Pediatric Milliman and Robertson length-of-stay criteria: are they realistic?Pediatrics.2000;105:733–737
2. Bauchner H, Vinci R, Chessare J. Milliman and Robertson— going in the wrong direction.Pediatrics.2000;105:858 – 859
3. Yetman RJ. Patient care guidelines in pediatrics.Pediatrics.2000;105: 859 – 860
To the Editor.—
concerns about the study’s results that show New Yorkaverage lengths of stay during 1995 were in excess of 1998 published inpatientgoalLengths of Stay (GLOS) in M&R Care Guidelines’ Pediatric Health Status Improvement and Management (HSIM) publi-cation. This result is the only possible result because the average length of stay (LOS) in any statewide hospital database must be, by definition, in excess of the GLOS. The GLOS represents the best achievable LOS; thus, the average of all stays, by definition, must be longer than the best achievable.
However, we do not agree with the Sills conclusions regarding the impact of GLOS on patient care. We believe the Sills conclu-sions are based on a misunderstanding of the definition of GLOS, which is an outcome measurement of each inpatient Guideline. We believe that Sills also misunderstands how the GLOS relates to a historical average LOS.
The study’s conclusions should be reconsidered based on the following 5 points:
1. GLOS does not equal average LOS and can only be achieved in a percentage of patients admitted with each diagnosis. 2. The GLOS is only a small part of the inpatient Guidelines. The
majority of the inpatient content is clinical content. The Pedi-atric HSIM publication also presents clinical content across the continuum of pediatric care. As pointed out in the response by Bauchner et al in their comments on page 858, Pediatric HSIM also includes Guidelines on anticipatory guidance, subspecialty care, chemotherapy, immunizations, neonatology, and compre-hensive management of chronic disease.
3. All M&R Care Guidelines, including the Pediatric HSIM pub-lication, are evidence-based. This point is included in Dr Yet-man’s commentary on page 859.
4. M&R Care Guidelines is committed to improving both the quality and efficiency of health care to children.
5. M&R Care Guidelines is scrupulous in how information is presented in its publications so that the content may be readily understood and used appropriately. M&R Care Guidelines is very diligent in presenting information and providing training on appropriate use to users of M&R Care Guidelines. We include explicit language in the Guidelines themselves, on our web page (www.mnr.com), in our training programs, and as a part of our licensing agreements.
DEFINITION OF GOAL LENGTH OF STAY We explicitly define the Goal Length of Stay (GLOS) in the Pediatric HSIM publication. The following 2 paragraphs are taken from the introduction to the inpatient Guidelines section:
“Goal length-of-stay: The expected length of inpatient hospi-talization required to manage each condition is listed. This length-of-stay assumes that treatment and healing occur with-out significant complications. Should treatment and healing not occur in the timeframes outlined, the guidelines become appropriate when the patient’s stage of recovery reaches a level of acute care similar to those listed.”1
“We reiterate that the purpose of the inpatient guidelines is to define care for patients who recover from their illness as well as can be expected and without complications. For some conditions, the presentation can be highly variable. For the more extreme presentation of these conditions, the optimal recovery timetable described herein is optimistic. The pa-tient’s clinical status on each day of recovery defines where on the guideline the patient falls. When the patient’s clinical status does not allow progression to the guideline’s next day of recovery, the ambitious goal length-of-stay listed will not be fulfilled.”2
The Sills analysis used functional LOS: Functional LOS is equal to M&R’s GLOS plus 1 day. The M&R GLOS is counted the way the health care industry counts hospital days; that is, overnight stays in the hospital. Each inpatient M&R Care Guideline includes clinical information for each functional day in the hospital. The clinical information includes both the day of admission or surgery and the day of discharge; thus, the GLOS is always 1 day less than the number of days the patient is functionally in the hospital. This definition is consistent with what Sills defines as the functional LOS.
OVEREMPHASIS OF DIFFERENCE BETWEEN GLOS AND AVERAGE LENGTH OF STAY
We take exception to their statement in the discussion on page 736 where Sills describes the “discrepancy between M&R guide-lines and observed LOS data.” First of all, the GLOS is one mea-surement goal within the Guideline and is achieved only if the patient has optimal recovery, no complications, meets the dis-charge criteria, and goes home to a safe environment with ade-quate follow-up care. Second, Sills’ analysis shows that a signifi-cant number of the patients in this study in New York in 1995 did go home at the M&R “functional LOS.”
Figure 1 clearly shows that the M&R functional LOS is identical to or 1 day less than the mode LOS in most of the diagnoses.This demonstrates that in this population a percentage of patients did achieve M&R’s GLOS.Table 1 shows for all diagnoses except “Appendectomy, complicated” that many patients achieved either the GLOS or GLOS plus one day.
QUALITY AND EFFICIENCY
We believe that the issue of efficiency must be looked at when developing Guidelines for inpatient care. References 11–19 in the Sills article are good examples of the kind of excellent work that supports our belief. We reject the notion that longer lengths of stay represent better patient care. We believe that the best quality is achieved when the patient is able to recover quickly. Potentially avoidable days of hospital care may not be safe for the patient. One cannot make the implicit assumption that better care is pro-vided when the patients stay in hospitals longer. Safety issues recently presented in the Institute of Medicine study3support efficient use of hospitalization. In addition, 2 studies in 1999 show that the rates of nosocomial infection are lower in the home than in the hospital.4Rates of nosocomial infection in the hospital are 5% to 10% while only 2% in nonhospital settings.5These do not support the notion that more inpatient care is better care.
CHART REVIEWS AND DATA SUGGEST SIGNIFICANT OVERUSE OF INPATIENT RESOURCES
M&R’s physician and nurse consultants have completed ⬎75 000 inpatient chart reviews over the last 10 years. Potentially avoidable days for client organizations in these reviews ranged from 10% to⬎50%. The causes of these potentially avoidable days are many, including delays in hospital services, delays in consul-tations, delays in transfer, inability to arrange posthospital home care, or skilled nursing facilities. In ⬎75 000 chart reviews that M&R has completed, we have found that most potentially avoid-able days related to the last day of admission.
An analysis of all health maintenance organization (HMO) hospital discharges in the state of California in 1997 showed that, for diagnoses for which an M&R inpatient Guideline was avail-able, 41.8% of pediatric discharges met the GLOS.6In the state of Washington, the comparable percentage was 43.5%.7These per-centages represent performance as of several years ago in a mix of health plans with varying degrees of efficiency. Also, the percent-ages include patients with significant complications and comor-bidities, for whom the Guidelines are not suitable for management to the GLOS. In this light, we believe the observed percentage of adherence to GLOSs to be consistent with our definition of the goal as a target attainable for a large percentage of patients re-ceiving optimally managed care.
EVIDENCE-BASIS FOR M&R CARE GUIDELINE DEVELOPMENT
M&R Care Guidelines are evidence-based and have been since our initial Guidelines were first published in 1990. We have al-ways used current best evidence. As Dr Yetman said in his com-mentary:
levels of evidence. Level 1 evidence included recommenda-tions based on scientifically rigorous, highly controlled stud-ies (randomized, controlled trials). Ideally, randomized, con-trolled trials would be available to answer all questions in the pediatric care arena, but unfortunately for medicine (and for pediatrics in particular), this level of evidence is rare for many of the most basic questions. When Level I data were not available, we turned to Level II evidence (consisting of non-randomized but published research) and Level III evidence (primarily unpublished evidence, quality improvement project, large databases, and expert opinion) as the basis of the recommendations found in the guidelines. Annotations for the sources of information are included with each guide-line. Nothing in medicine, of course, stands still and the development and updating of guidelines is an ongoing pro-cess. It includes continuous research and verification of infor-mation from a wide variety of sources—among them clini-cians, practicing physicians in managed care environments, medical school physicians, specialty societies, data from hos-pitals and health plans, and input from guideline users.”
In 1999, our Inpatient and Surgical Care publication included annotation and a grading of the evidence used to develop the Guideline. We categorize evidence into three grade levels with the Guidelines. This annotation accompanies each Guideline. We are expanding the annotations of our evidence base to all of our publications to be released in 2000.
BACKGROUND ON M&R CARE GUIDELINES M&R Care Guidelines are developed within a division of Mil-liman & Robertson, Inc. MilMil-liman & Robertson, Inc. is an interna-tional consulting firm with 4 major disciplines serving the health care, insurance, employee benefits, and financial services indus-tries. Milliman & Robertson is a privately held corporation that values its independence from special interests. Our Guideline development process is explicitly designed to avoid external spe-cial interest influence in the Guideline development process. This allows us to complete our research and development indepen-dently, which has been a challenge for many others trying to accomplish this Guideline development. The M&R Care Guide-lines division consists of 50 employees with 12 clinical full-time clinicians including doctors and nurses with strong academic, clinical, managed care, delivery system, and information system backgrounds.
As described above, we use an evidence-based approach to our Guideline development. Our approach is uniquely different from most clinical groups that approach the Guideline development process, because our Guidelines look at both quality of care and the efficiency of that care. We believe very strongly that every clinical decision is a resource decision and every resource decision is a clinical decision, and thus we must include both perspectives in Guideline development.
Most of our Guidelines, including Pediatric HSIM and Primary and Pharmaceutical Care, include both clinical information and resource information to facilitate decision-making in care pro-cesses. Our inpatient care Guidelines include information perti-nent to all aspects of recovery from inpatient care including case management information to assist care planners in preadmission and discharge planning. In addition, we present day-by-day ex-pected care that follows the most common clinical progression of the patient. Each includes Guideline discharge criteria in the last day of the Guideline to assist providers in making the decision if the patient is ready to go home or to another level of care. The home health care Guidelines follow each inpatient care Guideline to assist providers if home health care is indicated.
SUMMARY
Milliman & Robertson, Inc. goes to great lengths to provide information on the appropriate use of the Guidelines and the GLOS. Pediatric HSIM contains the statement, “Goal length of stay assumes no complications. Patients can be discharged to outpa-tient care when all the criteria for the last day of hospitalization have been met.” Milliman & Robertson provides guideline train-ing, consultation in medical management, publications such as the Questions & Answers brochure, information on its web site (www.mnr.com), and an annual Users Forum to educate doctors
and nurses on the appropriate use of the guidelines. We respond directly to providers or others on any concerns they raise.
In response to Sills’ last paragraph, we would agree that more research needs to be conducted in the area of LOS and its effect on patients and family. However, one must not make the assumption in this argument that long hospital stays equate to better outcomes and/or greater patient satisfaction. Sills et al refer to the publica-tion of Hay et al.8We agree that Hay et al is important research because it challenges the widely believed but not proven assump-tion that longer hospital stays produce better outcomes. In stable, low-risk patients with upper gastrointestinal tract hemorrhage, “the absolute number of preventable life-threatening iatrogenic events (catheter-associated sepsis) exceeded the number of major bleeding recurrences for the control group.” The patients who were discharged earlier experienced better outcomes because they did not have hospital-related complications. We believe that many patients in the New York State sample were subject to similar unnecessary complications.
We are hopeful that further studies and guideline work con-ducted by others in addition to M&R Care Guidelines will also focus on the LOS as one of several outcome indicators. We will continue to include that as one of our indicators while at the same time doing our best to ensure proper understanding and use of the GLOS in providing quality and efficient care to children and other patient populations.
James Schibanoff, MD Editor-in-Chief
M&R Care Guidelines Seattle, WA 98104
Richard L. Liliedahl, MD Chief Medical Officer M&R Care Guidelines Seattle, WA 98104
REFERENCES
1.Pediatric HSIM, Chapter VI, Inpatient Guidelines:December 1998:6.1 2.Pediatric HSIM, Chapter VI, Inpatient Guidelines,December 1998:6.2 3. Committee on Quality of Health Care in American, Institute of
Medi-cine.To Err is Human, Building a Safer Health System.Washington, DC: National Academy Press; 1999
4. Bergogne-Berezin E. Current guidelines for the treatment and preven-tion of nosocomial infecpreven-tions.Drugs.1999;58:51– 67
5. Hoffman-Terry ML, Fraimow HS, Fox TR, et al. Adverse effects of outpatient parenteral therapy.Am J Med.1999;106:44 – 49
6.1997 Patient Discharge Data for California, Public Use Version A. Sacra-mento, CA: Office of Statewide Health Planning and Development, State of California; 1999
7.1997 Comprehensive Hospital Abstract Reporting System (CHARS) Public Data File.Olympia, WA: Washington State Department of Health; 1999 8. Hay JA, Maldonado L, Weingarten SR, Ellrodt AG. Prospective evalu-ation of a clinical guidelines recommending hospital length of stay in upper gastrointestinal tract hemorrhage.JAMA.1997;278:2151–2156
To the Editor.—
Sills et al’s article comparing Milliman and Robertson (M&R) length-of-stay (LOS) criteria to New York state LOS observations for comparable diagnoses is a welcome addition to the debate on medical management guidelines. Unfortunately the analysis is flawed by the fact that a day to M&R is not the same as a day to the rest of us. As stated to me in private conversation with prin-ciples from M&R and loosely in the introduction to the new
Pediatric HSIM Guidelines,an M&R day is a phase in the treatment of a specific condition and not necessarily 24 hours. This means that an M&R day is not complete until all the items in that phase have been accomplished. For instance, if a guideline says that a child is afebrile by day 2, that means that the child does not enter day 2 until he is afebrile. For many conditions this may take several days. Thus Sills et al are comparing a 24-hour day to an arbitrary phase in the course of treatment for the same illness.
payers who have not been educated in the proper use of the guidelines. I believe M&R has done little to remedy this problem. It is a defect in their product that is critical, and has caused pain and suffering to an unknown number of patients, families, and physicians. Such a defect in any other product, once discovered, would bring prompt modification or recall. Why hasn’t M&R rectified this problem? I believe it is because this product was designed specifically to save money and not to improve the qual-ity of care delivered to pediatric patients.
I commend Sills et al for their effort and hope it brings this topic to the attention of a broader number of people who will raise their voices for action to correct this problem.
Edward O. Cox, MD, FAAP Pediatric Ambulatory Care DeVos Children’s Hospital Grand Rapids, MI 49503
To the Editor.—
The recent article by Sills et al [Pediatrics.2000;105:733–737] and accompanying commentaries by Dr Bauchner et al and Dr Yetman deserve some clarifications and comments. The Milliman and Robertson (M&R) pediatric guidelines [Pediatric HSIM,December 1998] are seriously flawed with respect to the length-of-stay (LOS) guidelines, particularly for serious infections. Sills et al have cor-rectly noted that “many length of stay guidelines are not rigor-ously evidence-based.” They have assumed that the LOS guide-lines were developed by the Department of Pediatrics at the University of Texas Medical School at Houston and reflect the local management practices within that institution. Such is not the case. Although we at the University of Texas are committed to providing high-quality care that is cost-effective, the M&R LOS guidelines do not reflect our practice. Indeed, many of us feel that the M&R LOS guidelines do not conform to standard of care and reflect poor practice rather than “best practice.” M&R have stated that “the guidelines are a picture of what is possible and—most important—what is now being done” [M&R, June 1998]. They say the guidelines are based on actual practices of physicians. One wonders where they might find competent pediatricians whose practice conforms to these guidelines.
Sills et al demonstrate that the M&R guidelines frequently fail to reflect practice in New York state. However, the guidelines they discuss are not the only ones that are problematic. There are others that are even more outrageous: endocarditis, 3 days in hospital; brain abscess, 3 days in hospital postop; neonatal sepsis, 3 days in hospital; neonatal bacterial meningitis, 5 days in hospital; etc. M&R state that their guidelines are based on evidence including the medical literature. Where might one find randomized, con-trolled trials demonstrating the safety/efficacy of managing pedi-atric endocarditis with a 3-day hospital stay?
The commentary by Bauchner et al appropriately points out that these LOS guidelines fail to “meet most of the methodologic standards established for guidelines” and that the length of stay guidelines in many cases “might represent unethical care.” In fact, even aspiring to these LOS goals might cause injury, as in the case of the 1-day recommendation for management of diabetic ketoac-idosis in coma.
The commentary by Dr Yetman, who is employed by M&R as well as the University of Texas, says that his guidelines “apply to most patients in most situations.” However, it is clear that many of the LOS guidelines would rarely apply to any patient with the conditions listed above.
It should further be pointed out that a number of individuals including myself, listed by M&R as “Contributing Authors,” did not author sections and were not asked to be, nor agreed to be, “Contributing Authors.” Legal action has been initiated against M&R and Dr Yetman to undo the damage associated with these dangerous, arbitrary, and invalid LOS guidelines and the unau-thorized listing of individuals as “Contributing Authors” who, in fact, were vehemently opposed to their content.
Thomas G. Cleary, MD Department of Pediatrics
University of Texas at Houston Medical School Houston, TX 77805-3354
In Reply.—
We appreciate the comments of Drs Cleary, Cox, Goldenring, Sparks, and Schibanoff and Liliedahl in response to our manu-script. The debate reflected in these letters about whether the Milliman & Robertson (M&R) guidelines are reasonable is wel-come and was, indeed, the point of the article. These letters raise 4 general issues that remain unresolved and require further inves-tigation.
The first issue is how the M&R guidelines were developed. As the letters make clear, there is debate about the evidentiary basis for the length-of-stay (LOS) guidelines. Schibanoff and Liliedahl of M&R contend the guidelines were developed at the University of Texas at Houston based on “current best evidence.” On the other hand, Dr Cleary, Professor of Pediatrics at that same institution, echoes Baucher et al’s editorial opinion1that the techniques used fail to meet “methodologic standards established for guidelines,” further contending that many “authors” listed did not contribute or agree to be listed as authors.
A second issue concerns how the guidelines are being applied in practice. Dr Cox’s letter points out that an “M&R day” is not the traditional Copernican 24-hour day, but rather a “phase in the treatment of a specific condition,” so that a “day” is not completed until the criteria for that phase are met. However, Dr Cox also suggests that many payers use the 24-hour day when implement-ing M&R’s guidelines and that “M&R has done little to remedy this problem . . . caus[ing] pain and suffering to an unknown num-ber of patients, families, and physicians.” Dr Goldenring recom-mends the guidelines be used as a “benchmark” for utilization review, not as a “sole determination of the appropriateness of hospitalization.” Dr Sparks recommends that “the pediatric com-munity should offer strong and informed resistance” to applica-tion of M&R criteria to their patients. The conflicting reports of how guidelines should be used and are being used underscore the importance of exploring how, in fact, they are being implemented in hospitals providing care for children.
The third issue, which naturally follows that of implementa-tion, is the question of impact: what are the consequences of the guidelines, as implemented, for patients, families, physicians, and health care institutions? The letters by Drs Sparks, Goldenring, and Schibanoff and Liliedahl note that many patients did achieve M&R LOS guidelines. Even when some or even when a majority of patients meet criteria, uncompensated care still may be required by a large number of children. What is an acceptable burden of uncompensated care? And, just as importantly, who bears the financial, social, and health quality burdens of this uncompen-sated care? Although these questions are hardly new, they gain new urgency as payers gain prominence in the health care indus-try. The potential impact of LOS guidelines on hospitals caring for children is a particularly important topic for additional research, which we recently explored in an abstract presentation.2
Finally, given that efficient care can benefit all parties involved, what barriers exist to achieving that efficiency? Variations in ill-ness severity challenge guidelines for all age groups. Pediatric guidelines face the additional challenges of variations in patient size and age, as well as family circumstances and social disadvan-tage. Finally, the issue of geographic variations in resources, such as home health services, makes uniform application of guidelines difficult.
In summary, the four issues raised by the letters represent important and open opportunities for further research.
REFERENCES
1. Bauchner H, Vinci R, Chessare J. Milliman and Robertson— going in the wrong direction.Pediatrics.2000;105:858 – 859
2. Joseph JG. Are some hospitals being disadvantaged by use of LOS guidelines? Relationship of selected hospital and patient characteristics to performance in achieving pediatric LOS guidelines. AHSR Annual Meeting, June 2000, Los Angeles, CA. Abstract 373
The Management of Minor Closed Head Injury in
Children
To the Editor.—
management of minor closed head injuries in children.1Although it is important for pediatricians to be aware of the indications for radiologic investigation and/or neurosurgical intervention, ap-propriate counseling regarding an adequate amount of recovery time needs to be given to prevent further brain injury.2
In the United States, 500 000 head injuries are reported per year and 10% of these occur during recreational sports.3 Although some patients with mild concussions experience loss of conscious-ness, many have headaches and abnormalities in motor function, vision, sensation, thought processing, memory, or behavior. These symptoms may take days or weeks to disappear.4Pediatricians are frequently involved in the early assessment period in the sport setting, emergency department, or private clinics. Unfortunately, many will unknowingly permit return to recreational activities before full neurologic recovery has occurred. Should the child or adolescent incur a second head injury before symptoms resolve, there is increased risk for second-impact syndrome. This disorder occurs when a second, often minor, head injury occurs in an individual who has not recovered from a previous concussion. The second impact can lead to a rapid and progressive neurologic collapse accompanied by coma, respiratory failure, and eventual death. The pathophysiology is thought to be related to a disrupted autoregulation of cerebral blood flow leading to increased vascu-lar congestion within the cranium. This results in high intracranial pressure followed by uncal and cerebellar herniation through the foramen magnum. Second-impact syndrome and the effects of cumulative head injury are particularly concerning when athletes minimize neurologic symptoms in hopes of gaining clearance to return to sports.
Pediatricians must be sure the child is medically ready to resume full activities and exposure to further injury. Several guidelines have been published that discuss return-to-play criteria based on the number and severity of concussions.5–7Although variations exist, all guidelines concur that no athlete should return to sport until all concussive symptoms have resolved at rest and with exertion.8
Children with minor head trauma should be assessed for ra-diologic or neurosurgical intervention. In addition, children with head injuries not requiring radiologic or neurosurgical interven-tion must be carefully evaluated and closely monitored. Patients, parents, and coaches must understand the need to have full res-olution of all neurologic symptoms before a safe return to contact or collision sports is possible. The lack of evidence for more severe injury should not be interpreted as evidence of no injury.
Claire M. A. LeBlanc, MD
Canadian Paediatric Society Delegate Children’s Hospital of Eastern Ontario Department of Rheumatology
Ottawa, Ontario, K1H 8L1, Canada
REFERENCES
1. American Academy of Pediatrics, Committee on Quality Improvement and American Academy of Family Physicians Commission on Clinical Qualities and Research. The management of minor closed head injury in children.Pediatrics.1999;104:1407–1415
2. Cantu RC. Minor head injuries in sports.Adolesc Med State of the Art Rev.
1991;2:141–154
3. Genuardi FJ, King WD. Inappropriate discharge instructions for youth athletes hospitalized for concussion. 1995;95:216 –218
4. Cantu RC. Head and spine injuries in youth sports.Clin Sports Med.
1995;14:517–531
5. Cantu RC. Guidelines for return to contact sports after cerebral concus-sion.Phys Sportsmed.1986;14:75– 83
6. Colorado Medical Society Sports Medicine Committee.Guidelines for the Management of Concussion in Sport, Revised.Denver, CO: Colorado Med-ical Society, 1991
7. American Academy of Neurology. Practice parameter: the management of concussion in sports (summary statement). Neurology. 1997;48: 581–585
8. Wojtys EM, Hovda D, Landry G et al. Concussion in sports.Am J Sports Med.1999;27:676 – 687
In Reply.—
The letter from Dr LeBlanc provides useful and complementary information, regarding children engaged in sports at the time of injury, to the recommendations contained within the guideline for minor closed head injury in children. The case defined in our guideline fits most closely with grade 1 sports-related head injury within the references cited by LeBlanc; that is, minor head injury without neurologic findings on examination. However, our guide-line also includes children suffering a “brief loss of consciousness (LOC) defined as less than one minute.” The inclusion of LOC places these cases into grade 2. In the sports-related guidelines referenced by LeBlanc, children whose symptoms resolve within minutes (grade 1) may return to play. For those suffering LOC (grade 2), return to play is not recommended until appropriate evaluation by a physician is completed and the symptoms of any concussion have completely resolved.
It is worth noting that in the Genuardi and King articles cited by LeBlanc, appropriate discharge instructions were provided to youths hospitalized for minor head injury in only 30% of those instances where they were indicated. However, instructions were found to be appropriate in all cases where the extent of injury was defined as grade 1.
One should also note that second-impact syndrome, mentioned by Dr. LeBlanc and defined as fatal brain swelling occurring after minor head injury in those who still have symptoms from a previous head injury, has only been described in adolescents and adults. This potential in adolescents and adults is important to bear in mind and certainly underscores the importance of allow-ing symptoms of injury to resolve before riskallow-ing additional injury, though no reports in the literature describe second-impact syn-drome in younger children.
Though not explicitly discussed by the subcommittee on head injury in the formation of our guideline, the recommendation to not recommend return to sport until symptoms of concussion have cleared is consistent with the recommendations contained within the guideline on minor head injury in children and should be viewed as a complementary piece of information to our guide-line.
John B. Coombs, MD
Chairman, Subcommittee on Minor Head Injury AAP Committee on Quality Improvement
Robert Davis, MD, MPH Consultant to the Subcommittee
