Coding for Developmental and Behavioral Disorders

This article provides information on changes to the criteria for reporting prolonged clinical staff services in office and other outpatient settings using codes 99415 and 99416. Time requirements for prolonged clinical staff service have changed for services provided in 2023. Prolonged service time is based on the amount of time spent by clinical staff that is beyond the typical clinical staff time for the related office or other outpatient evaluation and management (E/M) service. Prolonged clinical staff services may be reported for simultaneous services provided to 2 patients, but the time reported for each patient must have been devoted to the single patient. The following topics are discussed: – Defining prolonged clinical staff services – Changes to reporting in 2023 – Understanding time requirements for prolonged clinical staff services

Systematic Review and Meta-analysis: Real-World Accuracy of Children’s Developmental Screening Tests

Effective immunization programs have markedly diminished the incidence of vaccine-preventable diseases. As a result, there now exists in society a lower awareness of the actual risks associated with the diseases themselves and a greater prominence of the potential risks of adverse effects associated with vaccines.Concern regarding public reactions to new vaccine safety issues may place pressure on policymakers and/or health care providers to act quickly in response to new information. However, this concern must be tempered by the necessary caution required to assess the intended and unintended risks and benefits of any action undertaken. The interplay of these potentially competing demands is well illustrated by the recent safety concern involving the use of thimerosal in vaccines.Thimerosal is a mercury-containing compound that has been widely used as an antimicrobial agent in vaccines for over 60 years. Human exposure to mercury may have potentially significant health consequences. By mid-1999, the Food and Drug Administration (FDA) had discovered that children could be exposed to an amount of mercury from vaccines that exceeded 1 of 3 existing federal safety thresholds. After this realization, the organized medical and public health communities in the United States became involved in a series of urgent and intense discussions to determine an appropriate response to the issue. This manuscript describes and analyzes the process that led to the July 7, 1999, joint American Academy of Pediatrics (AAP)/US Public Health Service (PHS) statement on thimerosal,1 with the goal of suggesting improvements for managing similar vaccine safety concerns in the future.We conducted structured interviews with over 15 individuals involved in the discussions and negotiations leading to the joint AAP/PHS statement on thimerosal. The individuals represented both the governmental agencies and nongovernmental organizations involved, including the FDA, the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention (CDC), the National Vaccine Program Office (NVPO), the AAP, and the American Academy of Family Physicians (AAFP). Interviews were conducted through face-to-face meetings or by telephone between January and April 2001. Table 1 lists the individuals interviewed who allowed their identities to be published.The development and implementation of immunization policy in the United States is a cooperative effort among many entities in the public and private sectors (Table 2).The concern over thimerosal in vaccines originated from a confluence of independent events, 1 informal and 1 formal, within the FDA. In the spring of 1998, some individuals within the FDA's Center for Biologics Evaluation and Research (CBER) began to informally consider the increased number of recommended vaccines and the amount of substances, such as mercury, contained in them to which vaccine recipients were exposed. Available literature to help quantify their concern was limited.The formal identification of thimerosal as a concern arose through the FDA's efforts to comply with the Food and Drug Administration 2Modernization Act.2 As mandated by Congress, Section 413(a) of the Act required the FDA to compile a list of drugs and foods that contain "intentionally introduced" mercury compounds and to provide a quantitative and qualitative analysis of these compounds within 2 years of the Act's enactment.The FDA's previous formal review of thimerosal in biological products had occurred in 1976. The convergence of concerns over mercury in vaccines that occurred within the CBER beginning in April 1998 prompted the agency to reassess the risks of thimerosal.3One of the steps of this risk assessment was to investigate the potential exposure of humans to thimerosal in vaccines. Based on the information submitted by industry and FDA internal data, the CBER determined that thimerosal was present in over 30 licensed vaccines in the United States.4,5 The amount of mercury by weight present in each of these vaccines was calculated. The CBER then referred to the recommended childhood immunization schedule to determine the amount of mercury to which young children may be exposed. Of the vaccines that a child could receive in the first 2 years of life, those that contained thimerosal were the 2 available formulations of the hepatitis B vaccine and some formulations of the diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines. Looking at cumulative exposure over the first 6 months of life, an infant 6 months old who received all recommended vaccine doses on schedule could be exposed to up to 187.5 μg of mercury.Another step in the risk assessment process was to determine whether thimerosal actually constituted a true health risk; that is, whether there were data demonstrating that this amount of mercury could be potentially harmful to children. To identify whether there were any known health risks from exposure to thimerosal, the CBER conducted a literature review and queried the Vaccine Adverse Event Reporting System, a national surveillance system for voluntarily reported adverse events associated with vaccines. The CBER found that at low doses, thimerosal has been associated with rare hypersensitivity reactions, such as persistent skin sensitization at the site of vaccination. At very high doses (ie, 1000 times higher than levels found in vaccines), thimerosal has been reported to cause neurologic and renal toxicity.An early assessment of the health risks of all forms of mercury by the World Health Organization (WHO) found that insufficient information was available to perform risk calculations for human exposure to ethyl mercury compounds, the type of mercury contained in thimerosal.6 However, the WHO did note that the limited data available suggested that ethyl mercury was probably less hazardous than methyl mercury, because it is metabolized faster in the body.The WHO and 3 US governmental agencies—the FDA, the EPA, and the Agency for Toxic Substances and Disease Registry (ATSDR)—had developed independent guidelines for safe exposure to methyl mercury (Table 3).7–10 Because no guidelines exist for ethyl mercury exposure, the FDA used the guidelines for safe exposure to methyl mercury as a guide for determining whether the mercury (ethyl) dose from thimerosal in vaccines approached a level of concern or health risk.The existence of 3 differing US federal guidelines for methyl mercury was a source of confusion and contention in determining the appropriate response to concern regarding thimerosal in vaccines. Each agency developed their guidelines for different purposes. The most conservative of these guidelines was the level established by the EPA to serve as a warning of mercury in the environment to trigger additional investigation. The ATSDR guideline is set below levels that might cause an adverse health impact in those most sensitive to a particular substance. The FDA guidelines were developed as safe limits for long-term consumption of food contaminated with mercury, particularly fish, which is the main exposure route of humans to methyl mercury. No guidelines were available to assess the risk of exposure in bolus doses by intramuscular injection.Nevertheless, the existing methyl mercury guidelines were the best information available at the time for assessing risk from ethyl mercury exposure. The CBER calculated exposure limits for each of these guidelines based on the average weight at various percentiles in female infants between birth and 26 weeks of age (Table 4). Based on these calculations, the CBER determined that potential exposure to mercury from the recommended childhood vaccines in the first 6 months of life could exceed the EPA methyl mercury guideline, but not the ATSDR, FDA, or WHO guidelines. However, the CBER was unable to determine with certainty whether exposure to thimerosal in vaccines was harmful.In April 1999, results from the preliminary risk assessment were discussed at an internal FDA meeting, and participants realized that there was a clear need for additional data. The CBER began to consult with toxicologists both within the FDA and at the National Center for Environmental Health, and several vaccine researchers, including Neal Halsey, MD, Director of the Institute for Vaccine Safety at Johns Hopkins University. The FDA also initiated discussions with vaccine manufacturers regarding the need to develop thimerosal-free vaccines.3Dr Halsey was invited by the FDA to an internal meeting in mid-June 1999 where he was asked to provide feedback on the results of their preliminary risk assessment regarding thimerosal. On learning of the FDA data, and personally verifying the calculations of the levels of mercury to which children could be exposed, he believed that the issue warranted serious concern and urgent action. At the time, Dr Halsey was soon to complete his term as Chair of the AAP Committee on Infectious Diseases (COID). Dr Halsey previously worked within the CDC's immunization program and had been a member of the Advisory Committee on Immunization Practices (ACIP). As such, he had extensive experience and professional relationships within the US immunization policymaking arena. Beginning around June 24, 1999, Dr Halsey informed many of these contacts of his concern regarding the potential health effects of thimerosal and the results of the FDA's preliminary risk assessment. After notifying the Director of the CDC's National Immunization Program, Dr Halsey met with CDC personnel at the National Immunization Conference on June 25. He also informed several other individuals, including the incoming Chair of the COID, the Chair of the ACIP, and a member of the AAP Board of Directors. In addition to his concern regarding the potential health effects of mercury exposure in infants, Dr Halsey expressed the need for urgent action on the issue because the FDA was planning to send a letter to vaccine manufacturers in the beginning of July 1999 regarding the need to remove thimerosal from vaccines, at which point the information about thimerosal would become public. He believed that publicity surrounding this issue, without action on the part of the PHS and/or the AAP, could result in long-term damage to public confidence in the national immunization system.After Dr Halsey informed these initial contacts of his concerns regarding thimerosal, conversations began to occur among the parties. The Interagency Vaccine Group (IAG) held a conference call on June 28 and reviewed the information from the FDA's preliminary risk assessment. After this call, the IAG formed a special workgroup to address the thimerosal issue. CDC immunization officials also conferred with the AAP, vaccine companies, and internal CDC toxicologists.Significant differences of opinion surfaced regarding the accuracy of the exposure and risk-assessment information concerning thimerosal, its importance, and the need for any immediate discussion or action.To quickly bring representatives of several organizations involved in immunization policymaking together to discuss the issue, a meeting was organized by Dr Halsey and Dr Cooper for June 30, 1999, at the AAP offices in Washington, DC. The selection of the venue for this meeting was deliberate. The initial course of action for the government normally would have been for the ACIP and the National Vaccine Advisory Committee (NVAC) to meet to discuss the issue. However, governmental advisory boards are required by the Federal Advisory Committee Act to provide adequate public notice of meetings and publish meeting agendas in the Federal Register. Given how quickly some individuals believed a meeting should occur, it was not possible to officially convene these advisory bodies in such a short time frame. By having an informal meeting at the offices of the AAP, a frank discussion of the scientific and biological veracity of all available information could take place without delay. As a result, however, this meeting precluded the formal involvement of the ACIP and the NVAC.Drs Cooper and Halsey developed a list of invitees, which included representatives of the CDC, FDA, EPA, AAP, vaccine manufacturers, and toxicologic consultants. An initial goal of the meeting was to achieve consensus on a course of action, as many believed that public presentation of differing views would likely confuse practitioners and parents, and potentially undermine confidence in the national immunization system.At the meeting, FDA representatives shared the results of their preliminary risk assessment, outlining what was known and unknown about the issue and describing the difficulties in determining whether the level of mercury in vaccines should be of concern. Because of the complexities in interpreting the data regarding the potential risk of harm from thimerosal, there was disagreement among the parties present as to its significance. Disagreements existed between organizations, within organizations, and among the toxicologists present at the meeting. Some participants believed strongly that the potential threat to health from thimerosal was significant; others believed that there was no clear evidence that thimerosal was harmful, particularly when compared with the clear health risks of delaying childhood vaccines. The 2 AAP committees represented at the meeting, the COID and the Committee on Environmental Health, were in sharp disagreement on this point. There was also a varied sense of exigency, with some participants believing that urgent action was required, whereas others thought the process should slow down to include other parties in the discussion and address perceived significant gaps in the scientific data. Actions proposed by participants at the meeting ranged from immediately stopping administration of all vaccines containing thimerosal to children under 6 months of age to encouraging vaccine manufacturers to expedite the elimination of thimerosal from vaccines.An overriding concern expressed by all parties at the meeting was the need to maintain the public's trust in the US immunization system by striking the appropriate balance between acknowledgment of the potential risk of harm from thimerosal and the actual risk of harm from not immunizing against vaccine-preventable diseases.It became clear during the June 30, 1999 meeting that no consensus would be reached that day regarding an appropriate course of action. Sharp disagreements regarding the clinical significance of thimerosal exposure were not resolved. Specific individuals who felt most strongly regarding the potential health risk of thimerosal exposure stated that they would independently make public statements if their respective organizations did not support their contentions. The meeting concluded with all participants agreeing that no statement would be released by any individual or organization until after the July 4th weekend, and that discussions between the PHS and the AAP would continue in an attempt to achieve a unified public statement. Leadership in both the AAP and the PHS believed that releasing a joint public statement was crucial for preserving the public's trust in the immunization system.PHS officials in the CDC and elsewhere believed that vaccine manufacturers should be encouraged to expedite the elimination of thimerosal from vaccines, but did not want to make any changes to the childhood immunization schedule. However, CDC officials also felt strongly that it would be in the best interests of the national immunization system and the public's trust for a statement to be developed jointly with the AAP. This prompted David Satcher, MD, PhD, the US Surgeon General and Assistant Secretary for Health, to be involved in the negotiations.After the June 30 meeting, there was significant debate within the AAP as to the appropriate course of action to be taken. Over the next several days, there was constant reconsideration and revision of positions taken among both individuals and committees.On review of available information and opinions, the AAP Board of Directors decided to put forth the position in their negotiations with the PHS that the birth dose of the hepatitis B vaccine be temporarily delayed. They considered the risk of disease to be low except for infants of HBsAg-positive mothers. The Board of Directors believed that hospitals should already have procedures in place to determine the hepatitis B status of mothers and treat the infants of HBsAg-positive status mothers appropriately.Other parties were informally involved in the discussions leading to the joint statement. The AAFP did not think the issue warranted such urgency and believed that the health effects data for methyl mercury on which the EPA guidelines were based were questionable.Many conference calls, meetings, and sharing of draft statements occurred within and between the AAP and the PHS over the course of the July 4, 1999 holiday weekend. The Surgeon General held several discussions with the AAP president to negotiate a compromise position. Although they were extremely concerned about both the short- and long-term consequences of delaying administration of the hepatitis B vaccine, PHS officials agreed to the recommendation to present a unified position to the public.The joint statement was officially released in the late afternoon of July 7, 1999,11 and was published in the MMWR Morbidity and Mortality Weekly Report on July 9, 1999.1First and foremost, it is clear that all parties involved in this process acted in the manner they believed was in the best interest of children in the United States. Even parties that differed most strongly never doubted the intent or purpose of those with whom they disagreed.Only 2 weeks transpired between the time that leaders of the major national organizations involved in US immunization policy learned about the issue of thimerosal in vaccines and the release of the joint AAP/PHS statement. During that time, these individuals and their organizations worked diligently to develop a response that they believed balanced the potential risk from exposure to thimerosal with the actual risk of vaccine-preventable disease and would ensure continued public confidence in the nations' immunization system. Considering the complexity of the information available and the gaps in information relevant to specific concerns, it is not surprising there was significant disagreement regarding the potential risk associated with thimerosal. To some, the process could be considered a success, in that compromise was reached and the "crisis" was addressed. However, others have publicly the that the recommendation to the birth dose of hepatitis B vaccine practitioners and put infants at risk for hepatitis B vaccine as to that the process was a of how not to public health of the IAG would have first learned of the thimerosal issue from FDA who would have informed the of its review of the thimerosal in vaccines. In this however, an individual of the government was the first to many of these soon the FDA should have is a of as is how information should have been other parties. The FDA was to an issue with the IAG when there were many surrounding the potential health risks In the FDA must be sensitive to issues to any under its IAG is to among federal agencies with vaccine issues through meetings and other To the IAG must achieve a balance between that are informed of and agencies to data to other parties the information is released to the public. such to be there must be confidence among the parties that their all from and shared efforts with each the must be as independent and to its of this issue is to ensure that the and of the are not under the or perceived or of any the through the that serious be by the Office of the Secretary for Health and Human to the of the of the including the of and the of meeting that occurred at the AAP offices in Washington, on June 30, 1999, was a in the discussions leading to the joint statement. the of this type of meeting and the in which it was organized was for the AAP, the of action was of the of the Board of are as to the of who or was concern expressed from many was the of vaccine industry representatives at the meeting. The meeting occurred the time of the vaccine safety in Congress, and in a environment in which of between industry and immunization policymakers had been Some participants at the meeting believed that having industry representatives at a meeting could have this may also have the of some meeting the of the vaccine industry to a immunization system be Vaccine manufacturers a of vaccine development and and their in different of immunization policy is concern is that some parties did not in this meeting such as the AAFP or representatives of hospitals that would be by the in the hepatitis B the of the 2 federal immunization advisory the ACIP and the did not in the initial thimerosal because of the perceived of the Federal Advisory Committee Act on meetings on very short The CDC and the have reviewed the and have found that exist for meetings on an to the birth dose of hepatitis B vaccine was not taken by any to the the risk of thimerosal exposure with the known risk of of hepatitis B disease was for However, in some leading to the joint AAP/PHS of the potential impact of delaying the birth dose of the hepatitis B vaccine did not receive some in of stopping the birth dose of hepatitis B vaccine, there was acknowledgment of the potentially significant of the of hospitals the the for this policy to these or the of procedures for determining the hepatitis B status of mothers. There to be effort to the existing literature on the impact of changes in immunization and the times for the of there was an confidence by some in the of hospitals to all mothers for hepatitis B status previous had of such of the impact of the joint statement on infant hepatitis B are now beginning to be have that some hospitals all with hepatitis B vaccine, including those to HBsAg-positive possible is the of information or of the recommendation by hospitals and Because of the of appropriate for and the hepatitis B status of this in policy has led to the of at 1 infant from hepatitis have also that many hospitals have not to doses of the hepatitis B vaccine the of thimerosal-free The of the first dose of hepatitis B vaccine at birth is illustrated by a recent that that children who received the first dose at birth were likely to complete the hepatitis B times of regarding immunization that all parties involved to the short- and long-term intended and unintended consequences of their proposed This type of analysis could take the of the and structured risk assessment process used by other government such as the of the major issues concern and urgency among all parties was the manner in which the would the issue. over the accuracy of in and for vaccine issues in is well However, an overriding issue is the of how should concern over the time of for public or individual health with policymaking must balance concern over the risk of public regarding safety issues with concern over the to ensure that information be to the public.The FDA the safety and of products they are for use and the process of a constant of products available to However, the of thimerosal an to FDA In the when thimerosal was for use in this there were limited available to assess for the of there is no for the FDA to vaccine with is in to some other federal such as the In was that be by the EPA years. Because no such process has been for the FDA, thimerosal not In for a containing mercury, the of most concern is on system At this time, the FDA has no for of the products it the FDA not have a to identify the cumulative amount of thimerosal, which children would receive over the course of the recommended immunization schedule. Each vaccine was for use as an independent agent and the amount of thimerosal contained in each individual vaccine no concern. was when the cumulative amount from all the vaccines contained in the recommended immunization schedule was calculated that concern that should consider to the FDA the to perform of vaccine In that the FDA its and the FDA develop a for of the cumulative amount of to which individuals may be exposed as a result of specific federal of the issues to all parties involved was the existence of differing federal for exposure to mercury from the EPA, the FDA, and the Although each agency had a different purpose in a specific safety the that there was no clear federal consensus on this issue was This allowed different parties to the discussion to over to support their federal agencies that have differing safety for exposure to specific to develop a federal consensus on safe exposure levels determine under which the different guidelines are to be than 1 federal is each agency should be with the for determining a different safety AAP is an organization for its to the of the health and of children. the internal debate that place within the AAP on this issue involved disagreement on the course of action that would be of to the children of the United AAP Board of Directors to its committees for and information regarding specific issues on which it must set However, the exists that the course of within the was in some than the Board of Directors on this issue from specific individuals were to the they may have represented the of the AAP is very that all be to maintain use of this in times of This help ensure that the consensus of than specific individuals, are to help guide the AAP Board of Directors regarding policy have on a of immunization The of these has been and At point efforts have been to information of those involved in immunization policy and in the or review of from the Institute of are now to in such committees for of and having their publicly and public if have the potential to cause significant and professional involvement of leading in the on childhood vaccines were to soon after the June 30, 1999, meeting at the AAP As such, concern over the manner in which any action or might be perceived in this type of environment a of concern and over many this was perceived as a course of action under by a process not in the best interests of the immunization system or children. This also to the development of a and the to act in interviewed but not of the parties involved in this As such, have an and assessment of the events that place in late June and early July However, there exists the that some information may not have been In these interviews were conducted 2 years after this process there may be some of the information process that in the in immunization as a result of concern to thimerosal was and Although there are significant differences of opinion regarding the of the the immunization system in the United States and was by the Program for and Health,

Context: Parent/caregiver completing developmental screening questionnaires (DSQs) for children before 5 years of age is currently recommended. The DSQs recommended by the American Academy of Pediatrics (AAP) are the Ages and Stages Questionnaires (ASQ), Parents' Evaluation of Developmental Status (PEDS), and the Survey of Well-being of Young Children (SWYC). Nevertheless, their predictive validity has not been well-established.Objective: To assess in the current literature, the value of AAP-recommended DSQs (ASQ, PEDS, SWYC) administered between 0 and 5 years of age, for predicting long-term cognitive achievement and/or school performance (CA/SP), after 1 year or more of evaluation and at/or after age 5 years, in the general population.Data Sources: Cochrane, MEDLINE PubMed, CINAHL, EMBASE, Web of Science, Scielo, and Scopus databases (until March 2021).Study Selection: Two authors selected the studies. Forward and backward citation follow-up was done; authors of DSQ were contacted to identify additional studies.Data Extraction: Cohorts were identified, and authors of selected studies were contacted to corroborate and complete extracted data.Results: Thirty-two publications, corresponding to 10 cohorts, were included. All cohorts used ASQ. Only cohort using PEDS was identified but did not meet the inclusion criteria. No cohorts conducted with SWYC were identified. Associations between ASQ and CA/SP were extracted for eight cohorts. The odds ratios were >3, and the area under the curve was 0.66–0.87. A trade-off between sensitivity and specificity was observed.Limitations: Heterogeneity in population characteristics and in DSQ adaptations.Conclusions: A positive association between ASQ and later CA/SP was found in different social, cultural, and economic settings. Additional studies are necessary to determine the impact factors in the predictive capacity of DSQs.Systematic Review Registration: PROSPERO, identifier: CRD42020183883.

A recent editorial (British Medical Journal, 1971) discussed the value of universal neurological screening of the newborn in the light of criteria accepted as generally applicable to all screening procedures: firstly, that a reliable screening test should not give many false negative or positive results; secondly, that early detection is worth while because early treatment has proved advant ageous; and finally, that the use of medical and other resources is a reasonable priority in terms of total supply of these resources and the demands made on them. (It was estimated that a 15-minute neonatal neurological examination on every new born would take up 470 hours per year of all practising paediatricians and senior paediatric registrars.) The editorial noted that none of the requirements had been fulfilled for neonatal neurological screen ing but went on to say that 'It is now widely accepted that all children should have periodic developmental screening tests beginning at, say, 6 weeks, 6 months, and 10 months'. Clear and practicable schemes have been devised for doing these tests (Sheridan, 1968; Egan, Ulingworth, and MacKeith, 1969). We can find no published evidence showing how effective developmental screening (or even full developmental examination) is in detecting abnor malities. The screening schemes in current use (Frankenberg and Dodds, 1967; Sheridan, 1968; Egan et al, 1969) presume a degree of effectiveness based on the admittedly reasonable assumption that a proportion of infants with neurological, auditory, and visual defects will present as developmental delay (Gesell and Amatruda, 1941). Frankenberg and Dodds claim to have undertaken both reli ability and validity studies on the Denver scale. Estimates of the former were based on the results of two tests separated by an interval of one week and undertaken by the same examiner on 20 children whose ages ranged from 2J months to 5 J years (test retest reliability) and the percentage agreement between different examiners of the same subject (examiner reliability); estimates of the validity were based on correlations between results of examination with the Denver scale and examination with the Yale developmental schedule (itself a developmental examination based on Gesell, with the additional items from various IQ tests). Im portant as these parameters are they clearly give no indication of the ability of developmental screening to detect clinical handicap in infancy. Assessment of reliability (or effectiveness) in this context can be determined only from concordance studies between the results of developmental screening and definitive clinical examination of the same popu lation. Similarly, there is no published evidence to support the criterion of advantageous early therapy in respect of infant developmental screening be cause of the considerable ethical and practical difficulties of undertaking controlled trials of early treatment. In this situation one must therefore be guided by the opinion of experts and accept that early treatment is of value. Finally, it would seem plausible to argue that the reasonableness of developmental screening as a priority can only be approached when evidence of the reliability and efficacy of the procedure has been measured. Thus, in view of the current absence of evidence to support any of the above criteria for de velopmental screening, we felt that the one aspect which needed to be looked at urgently was that of the reliability and effectiveness of developmental examination. Such a study forms the basis of this paper. A full developmental examination procedure is time consuming and requires considerable training and expertise for its application and interpretation. These qualifications make it unsuitable for routine use on large populations of apparently healthy children. An attempt has been made to overcome this problem by devising simplified developmental tests of items abstracted (somewhat arbitrarily) from the battery of observations in the full diagnostic 94

Back to table of contents Next article Clinical & Research NewsFull AccessShort, Intensive ADHD Treatments are Not Long-Term PanaceaJun YanJun YanPublished Online:15 May 2009https://doi.org/10.1176/pn.44.10.0001aShort-term, intensive treatments for children with attention-deficit/hyperactivity disorder (ADHD), whether medication management or behavioral interventions or the combination, may have immediate clinical benefits, but the benefits disappear over time as patients return to usual care in the community, new data from a long-term study show.The Collaborative Multisite Multi-modal Treatment Study of Children With ADHD, known as the MTA study, began in the 1990s and enrolled 579 children aged 7 to 9 diagnosed with combined-type ADHD. During the initial treatment phase, the study participants were randomized to one of four treatments for 14 months: medication management (primarily with methylphenidate), behavioral interventions, a combination of methylphenidate and behavioral interventions, and usual community care in which the majority of patients received medications from their physicians. After the 14 months of these interventions, all patients went on to community care. The study investigators continued to follow these patients and assessed their outcomes at two, three, six, and eight years after the initial randomization.Immediately after the 14-month randomized interventions, all four groups had symptom reduction and functional improvement from baseline. Groups receiving intensive medication management, either alone or in combination with behavioral interventions, had significantly larger symptom improvements than the groups receiving behavioral interventions alone or community care.The combination group had the best outcomes on social skills, parent-child relations, and a few other measures, which were statistically significant compared with other groups, at the end of the 14-month intensive treatments. Both the combination treatment and medication management groups improved significantly more than the behavioral intervention and usual-care groups at the time. However, the advantages of medication management and combination treatment diminished after the interventions stopped, and the differences among the initially randomized groups were no longer significant at the three-year follow-up, or 22 months after the end of the study interventions.Long-Term Outcomes ConvergeAt the eight-year follow-up, about three-quarters of the original study participants, now up to age 17, were evaluated. The types of treatment they received eight years before did not significantly predict outcomes, including ADHD symptoms, behavioral and functional assessments, academic performance, and social functioning. The follow-up data were published online in the Journal of the American Academy of Child and Adolescent Psychiatry on March 23.Despite improvements from baseline, all four groups in their adolescence still had more symptoms, such as hyperactivity and impulsivity, and more functional impairments, such as lower academic performance and behavioral problems, than did their peers of the same age and similar characteristics who had never had ADHD.Medication use in the previous year was not associated with significantly better functioning at the eight-year assessment. About 20 percent of study participants were not medicated at any of the evaluation points during the study, while 17 percent were still taking stimulants at the eight-year follow-up. Among the patients who were medicated during the intervention phase eight years earlier, 62 percent had stopped taking ADHD medications in subsequent years, which may in part account for the loss of treatment benefits seen in the 14-month analyses."These findings are not really surprising," said Brooke Molina, Ph.D., an associate professor of psychiatry at the University of Pittsburgh Medical Center, in an interview with Psychiatric News. She was the lead author of the eight-year study.Children Don't Outgrow SymptomsOne of the important messages from the study, she explained, is "the many differences between children with and without ADHD. It used to be believed that these children could outgrow the behavioral and developmental symptoms in their adolescence. The data show that, as a group, they still lag behind [their peers]."The results do not imply, however, that medications do not work for ADHD patients. "The study demonstrated strong acute effects of the medication treatment in 1999," Molina noted, referring to the results at the end of the 14-month intervention phase."The message is not that treatments do not work." Rather, the study showed that a one-year intensive therapy in childhood does not make much difference in the long run compared with less-intensive treatment." [ADHD] is a chronic disorder that cannot be cured by one-year intensive treatment," she said. In the context of long-term adverse effects of stimulant use, such as growth suppression, "medications are not the panacea for the long-term health of these children. We need to develop more treatment options with long-term effectiveness and palatability with teens."David Fassler, M.D., a child psychiatrist and clinical professor of psychiatry at the University of Vermont School of Medicine, echoed this interpretation. "The study results should be interpreted with caution," he told Psychiatric News. "Treatment conditions were no longer randomized" in most of the follow-up period, he noted, and the dropout rate at eight years should be taken into consideration. Nonetheless, he noted that the findings are generally consistent with clinical experience."For many children with ADHD, treatment will vary over time and often include periods on and off medication, as well as working with the child, parents, and, ideally, the school," said Fassler, who is also APA's secretary-treasurer. "Ultimately, treatment is most effective when it's closely monitored and individualized to the needs of the child and family."In addition, Molina recommended that parents and clinicians regularly reexamine the effects of medication therapy in children with ADHD and carefully consider whether to continue it. "Some children may continue to derive benefits from treatment," she said. "However, it is extremely important that we do not automatically leave patients on medications for years without reevaluation."The MTA study was funded by the National Institute of Mental Health.An abstract of "MTA at 8 Years: Prospective Follow-up of Children Treated for Combined-Type ADHD in a Multisite Study" is posted at<journals.lww.com/jaacap/Abstract/publishahead/MTA_at_8_Years__Prospective_Follow_up_of_Children.99835.aspx>.▪ ISSUES New Archived

Developmental problems in children can be alleviated to a great extent with early detection and intervention through periodic screening for developmental delays during pre-school ages. Currently, there is no established system for developmental screening of children in Sri Lanka. Although some developmental norms, which are similar to those of Denver Developmental Screening Test-II (DDST-II), have been introduced into the Sri Lankan Child Health Developmental Record (CHDR), those norms have not been standardized to the Sri Lankan child population. The aim of this research was to establish Sri Lankan norms for DDST-II and to test the universal and regional applicability of developmental screening tests by comparing the Sri Lankan norms with the norms of DDST-II and DDST-Singapore norms, the geographically nearest standardization of DDST-II. The norms were also compared with the milestones already available in the CHDR. DDST-II was adapted and standardized on a sample of 4251 Sri Lankan children aged 0-80 months. Thirteen public health nursing sisters were trained to collect the data as part of their routine work. The 25th, 50th, 75th and 90th percentile ages of acquiring each developmental milestone were then calculated using logistic regression. The Denver Developmental Screening Test for Sri Lankan Children (DDST-SL) was created. Most of the established DDST-SL norms were different to the comparable norms in DDST-II, DDST-Singapore and the CHDR. In view of the results of the study, it is imperative that developmental screening tests are used in context and are adapted and standardized to the populations in question before utilization.

Currently more than 15% of children have an emotional, behavioral, or developmental concern. In spite of recommendations by the American Academy of Pediatrics and the Centers for Disease Control and Prevention to conduct universal developmental surveillance and screening with children at 9, 18, and 24 months of age, fewer than 30% of children under 6 years of age ever receive a developmental screening. Children in low-income and diverse communities are even less likely to be screened by a medical provider and/or referred for further diagnostic evaluation when predictive concerns are identified. As part of a cross-agency collaborative effort involving a family resource center, a child care resource and referral agency, a regional center for developmental disabilities, and a master's degree program in early childhood education, the Mobile Developmental Screening Van Project conducted outreach to provide free developmental screening with families of children 0-8 years of age in diverse and low-income communities within the greater Los Angeles County. Using the Parent Evaluation of Developmental Status (PEDS) screening tool, 94 children were screened over the course of 6 months, with 33% showing 2 or more predictive concerns that resulted in referrals for further diagnostic evaluation. The feasibility of reaching families in hard to reach communities using a mobile screening van, as well as study limitations and recommendations for next steps, are discussed.

The latest attempt at the evaluation and management (E/M) documentation guidelines has been put on hold. A newly formed Current Procedural Terminology (CPT) Editorial E/M Workgroup was developed as an outgrowth of the failed Centers for Medicare and Medicaid Services (CMS) E/M Documentation Guideline (EMDG) Project, which used clinical examples to guide physicians to pick the appropriate level of service. After Secretary Thompson halted the EMDG Project, the Medicare Payment Advisory Commission (MedPAC) and the Practicing Physician Action Group (PPAG) determined that perhaps it was not just the documentation guidelines that needed fixing, but the E/M codes themselves needed to be reevaluated as well. Therefore, the charge of the new workgroup will be to evaluate the current levels of E/M codes and make changes as necessary so that the codes more clearly describe what physicians do and to improve the ability of physicians to accurately use the codes in submitting claims.The workgroup will conduct surveys of practicing physicians, review Medicare and private sector utilization data, collect oral and written testimonies, and review other data as available. Initial panel review of the workgroup recommendations will be in August 2002 during the CPT meeting in Washington, DC. The final workgroup review, after input from the CPT Advisory Committee, will be in November 2002 at the CPT meeting in New Orleans. The workgroup will be expected to meet 5 or 6 times in the Chicago or DC areas.The American Academy of Pediatrics (AAP) was named as one of 7 specialty societies (along with the American Academy of Family Physicians, American College of Physicians-American Society of Internal Medicine, American Urological Association, American Academy of Neurology, American College of Surgeons, and American Orthopaedic Association) to have a representative on this new workgroup. The AAP Executive Committee picked Stuart Cohen, MD, as the AAP representative. Dr Cohen is a primary care pediatrician in the San Diego area who was on the Task Force on Reimbursement and is currently on the American Medical Association (AMA) House of Delegates for the AAP.The AAP had the opportunity to provide comments to the CMS about the November 1, 2001, release of the final rule. The following briefly summarizes some of the issues affecting pediatrics.The AAP emphasized its concerns about the 5.4% decrease in the 2002 conversion factor. The AAP urged the CMS to support the Medicare Physician Payment Fairness Act of 2001, which would decrease the conversion factor 0.9% instead of 5.4%.When contracting with carriers, it is important for pediatricians to remember that the resource-based relative value scale (RBRVS) is an adjustment factor for Medicare, which does not relate to children.CPT codes 90471 and 90472 have been before the AMA/Specialty Society Relative Value Scale (RVS) Update Committee (RUC) on several occasions, and in February 2001, the RUC again recommended work relative value units (RVUs) of 0.17 and 0.15, respectively. When the CMS published the 2002 final rule, however, it printed only the practice expense (PE) and professional liability insurance (PLI) RVUs, completely disregarding the RUC work recommendations with the statement that "[immunization administration services] are services performed by a nurse and have no physician work." The failure of the CMS to print work RVUs results in a considerable undervaluing of the service of immunization administration for 2002. It also incorrectly leads observers to believe that there is no physician work inherent in the administration of immunizations. In its comments, the CMS suggested that the physician work is already accounted for within the work RVUs of the preventive medicine codes. This is not the case, however, because the vignettes used to value preventive medicine services make no reference to the physician work of counseling and obtaining informed consent during the administration of immunizations.Over the past few years, the CMS has asked for "real" evidence demonstrating why physician work values should be published for the service of immunization administration. The primary charge of the RUC is to determine the existence of work and practice expense for each code presented. The RUC has agreed on several occasions that immunization administration does require physician work. The AAP believes that the validation process used by the RUC should be sufficient to assuage the concern of the CMS that the work involved in the administration of immunizations is "real" work.Federal and state law and medical ethics demand that pediatricians provide information and counsel parents and guardians about the risks and benefits of the immunizations that their children are scheduled to receive. The administration of immunizations to children is a very different service than the administration of immunizations to adults. At the time each dose is administered, physicians are required to explain the benefits to the patient and the community as well as the possibility of adverse reactions to vaccines; these are mandatory components of the National Childhood Vaccine Injury Act. In some cases, children also may receive vaccines from a variety of sources (eg, public health departments, influenza clinics). This further complicates the pediatrician's task of trying to form a comprehensive vaccine history using scattered records to piece together one child's medical history.With the increase in the amount of misinformation disseminated by anti-vaccine groups, the time that physicians spend on education and cognitive discussion has increased. Additionally, because children receive more vaccines than adults do, pediatricians must not experience any "missed opportunities" to immunize a patient. This means that many vaccines are administered during the course of an otherwise standard "sick" visit, rather than just exclusively during well-child examinations. By failing to publish the RUC-recommended work RVUs for 90471 and 90472, the CMS is, in essence, unilaterally determining payment policy for the service of immunization administration.Additionally, the CMS has changed 90471 and 90472 from "noncovered" to "active" status. Now carriers who use RBRVS to determine fee schedules will be compelled to use incomplete information for 90471 and 90472 when determining reimbursement for immunization administration. Because work RVUs typically account for close to 55% of a code's total RVUs, physicians who provide immunizations to their patients will be losing out on 55% of the reimbursement for that service. The AAP took action in December by posting a sample letter about vaccine fees on the Members Only Section of the AAP Web site (http://www.aap.org/moc) under "What's New." Pediatricians were given the opportunity to fax this letter to their senators and representatives to ask for assistance.The AAP was disappointed with the failure of the CMS to recognize codes 99289, physician constant attention of the critically ill or injured patient during an interfacility transport (first 30–74 minutes), and 99290, each additional 30 minutes, and the subsequent decision to create 2 new Health Care Financing Administration Common Procedure Coding System (HCPCS) Level II codes, G0240 and G0241, for use in the Medicare population. Furthermore, the relative values that the CMS assigned the new G codes (4.0 and 2.0, respectively) were not in line with the RUC-recommended values for that service (4.8 and 2.4, respectively).The CMS had several reasons for not recognizing these codes. It is the intent of the AAP to revise the codes, with the hope that the CMS will be receptive to working with the AAP in that endeavor.

Young children from impoverished backgrounds experience high levels of family and environmental stress, adversely impacting developmental functioning. Early identification provides a pathway to solutions, but many children are never assessed. In addition, the child-serving workforce lacks resources and expertise to use traditional measures. Furthermore, existing measures do not account for the substantial influence of a child's ecology. To bridge these gaps, we developed the Neurodevelopmental Ecological Screening Tool (NEST) and conducted a pilot study (n=60) to test its feasibility for use with caregivers of children ages 3-5 in low-resource settings. We developed an item pool across three domains (child, caregiver, environment), vetted it with experts, and conducted cognitive interviewing with parents (n=15) and case managers (n-10). Simultaneously, we built an online, user-friendly delivery platform. We used a one parameter Item Response Model and a Rasch-based Rating Scale Model (RSM) and fit confirmatory factor analytic (CFA) models to test for unidimensional and construct validity. The results support the feasibility of screening children from low SES populations within low-resource settings using an ecological perspective and supports the work of child-serving paraprofessionals in identifying and addressing risks in the lives of young children.

Children are often only identified with a developmental delay when they enter primary school due to developmental delays hindering academic progress. Detection of at-risk children in low-income communities is typically unavailable due to several challenges. This study validated an mHealth-based developmental screening tool as a potential time- and cost-effective way of delivering services for preschool children. This cross-sectional within-subject study screened 276 preschool children from low-income communities using the mHealth Parents' Evaluation of Developmental Status (PEDS) tools. The mHealth PEDS tools' performance was then evaluated by comparing caregiver concerns according to the PEDS tools with results obtained using a reference standard assessment tool, the Vineland-3. The mHealth PEDS tools identified 237 (85.9%) of children at risk of developmental delay compared to 80.1% (n = 221) of children identified with a developmental delay using the Vineland-3. Sensitivity of the PEDS tools was high (92.6%) with low specificity (22.5%) using US standardised criteria. Literacy skills were found to be most delayed, according to the PEDS: DM (89.3%; n = 142) and Vineland-3 (87.1%; n = 134). Low specificity of the prescribed criteria may require the implementation of adapted referral criteria within low socio-economic status (SES) settings. The mHealth PEDS tools may still be valuable for preschool developmental surveillance of children within low SES settings. It is recommended, however, that children who are identified with a developmental concern undergo a second screen to reduce false positives.

Limited data exist about the ideal timing of developmental screening for young children entering foster care, and current best practice recommends screening by 1 month into care to prioritize resources for evaluation. Therefore, we aimed to: (1) compare detection rates for potential developmental delay (DD) at foster care entry before and after implementation of a developmental screen and (2) examine accuracy of developmental screening when performed at entry and 1 month into care. Charts of 124 children <6 years evaluated for an initial foster care health assessment (IFCHA) were reviewed to determine baseline detection rates for potential DD. The Parents’ Evaluation of Developmental Status (PEDS) screening tool was then prospectively administered to 167 children <6 years during their IFCHA to determine detection rates. One month following the IFCHA, caregivers were re-contacted, and the screen was re-administered. Accuracy of the initial PEDS screen was compared to the 1 month PEDS screen by calculation of sensitivity and specificity. At baseline, potential DD was detected in 34 % of children at the IFCHA compared to 46 % after implementation of the PEDS (P = 0.041). Compared to the 1 month screen, the early screen had a sensitivity of 75 % and specificity of 88 %. Use of a developmental screening tool at foster care entry increased detection of potential DD, and the results remained consistent with screening 1 month later. These results support use of a developmental screen for children in foster care and suggest that screening be performed as early as possible to expedite necessary evaluations and referrals.

Functional Behavior Assessment (FBA) and behavior interventions have been effective in the management of challenging behavior among children with developmental disabilities including autism spectrum disorders. Research suggests the need for valid measurement instruments for verifying, calibrating and scoring competence in FBA and behavior interventions. The validation for the Ability in Behaviour Assessment and Interventions for Teachers (ABAIT) adopted the Delphi method for developing consensus followed by the application of Rasch Measurement Model (RMM). RMM among 292 special educators reported appropriate infit (0.84-1.11), outfit (0.94-1.05), and item separation reliability (0.99), though some items reported low point-biserial correlation. The ABAIT was developed with expert consensus and was found to have a suitable fit with RMM.

Sleep Problems—Autism Toolkit

In 2004, the American Academy of Pediatrics (AAP) Board of Directors formed the Task Force on Mental Health and charged it with developing strategies to improve the quality of child and adolescent mental health* services in primary care. The task force acknowledged early in its deliberations that enhancing the mental health care that pediatricians and other primary care clinicians† provide to children and adolescents will require systemic interventions at the national, state, and community levels to improve the financing of mental health care and access to mental health specialty resources. Systemic strategies toward achieving these improvements are the subject of other publications of the task force: “ Strategies for System Change in Children's Mental Health: A Chapter Action Kit ” (chapter action kit),1 “Improving Mental Health Services in Primary Care: Reducing Administrative and Financial Barriers to Access and Collaboration,”2 and “Enhancing Pediatric Mental Health Care: Strategies for Preparing a Community.”3 The task force also recognized that enhanced mental health practice will require competencies not currently achieved by many primary care clinicians; in the policy statement “The Future of Pediatrics: Mental Health Competencies for Pediatric Primary Care,”4 the task force collaborated with the AAP Committee on Psychosocial Aspects of Child and Family Health to outline these competencies and propose strategies for achieving them. This report offers strategies for preparing the primary care practice itself for provision of enhanced mental health care services. The task force proposes incrementally applying chronic care principles to the care of children with mental health and substance abuse problems as primary care clinicians apply them to the care of children with chronic medical conditions such as asthma. Most primary care clinicians will find that significant gaps exist between their current practice and the proposed ideal. The task force offers guidance in … Address correspondence to Jane Meschan Foy, MD, Department of Pediatrics, Wake Forest University School of Medicine, Medical Center Blvd, Winston-Salem, NC 27157. E-mail: jmfoy{at}wfubmc.edu