Bisogni, Sofia

Festini, Filippo

Olivini, Nicole

English

Florence Research

Copyright 2014 American Medical Association. All rights reserved.geographic variation in receipt of therapy, despite adjust-ment for clinical characteristics, may be explained not onlyby psychologist supply but also by parent, child, or pediatri-cian preferences for or comfort with nonpharmacologiccare.We acknowledge limitations common to analyses ofclaims data, including no information on services that werenot billed to commercial insurance and a limited ability todetermine severity of illness or clinical appropriateness fortherapy. We cannot comment on therapy receipt in thosesmaller and more rural counties that we excluded. Nonethe-less, our study is the first, to our knowledge, to documentthe substantial variation in receipt of therapy servicesamong US children treated with ADHD medications and isdirectly relevant to the ongoing public discourse about howthis common condition should be treated.Walid F. Gellad, MD, MPHBradley D. Stein, MD, PhDTeague Ruder, MARochelle Henderson, PhDSharon G. Frazee, PhD, MPHAteev Mehrotra, MD, MPHJulie M. Donohue, PhDAuthor Affiliations: Center for Health Equity Research and Promotion, VAPittsburgh Healthcare System, Pittsburgh, Pennsylvania (Gellad); RANDCorporation, Pittsburgh, Pennsylvania (Gellad, Stein, Ruder, Mehrotra); Divisionof General Medicine and Center for Pharmaceutical Policy and Prescribing,University of Pittsburgh, Pittsburgh, Pennsylvania (Gellad); Department ofPsychiatry, University of Pittsburgh School of Medicine, Pittsburgh,Pennsylvania (Stein); Express Scripts, St Louis, Missouri (Henderson, Frazee);Harvard Medical School, Department of Health Care Policy, Boston,Massachusetts (Mehrotra); Department of Health Policy andManagement,University of Pittsburgh Graduate School of Public Health, Pittsburgh,Pennsylvania (Donohue).Corresponding Author:Walid F. Gellad, MD, MPH, RAND Corporation, 4570Fifth Ave, Ste 600, Pittsburgh, PA 15213 (wgellad@rand.org).Published Online: September 22, 2014. doi:10.1001/jamapediatrics.2014.1647.Author Contributions:Dr Gellad andMr Ruder had full access to all of the datain the study and take responsibility for the integrity of the data and the accuracyof the data analysis.Study concept and design: Gellad, Henderson, Frazee, Mehrotra, Donohue.Acquisition, analysis, or interpretation of data: Gellad, Stein, Ruder, Henderson,Frazee, Donohue.Drafting of the manuscript: Gellad, Stein, Frazee.Critical revision of the manuscript for important intellectual content: Stein,Ruder, Henderson, Frazee, Mehrotra, Donohue.Statistical analysis: Ruder.Obtained funding: Gellad, Frazee, Donohue.Administrative, technical, or material support:Henderson, Frazee, Mehrotra.Study supervision: Gellad, Frazee.Conflict of Interest Disclosures:Drs Henderson and Frazee are employees ofand hold equity interest in Express Scripts.Funding/Support: This work was supported by Express Scripts through acontract to RAND Corporation, focused on examining geographic variation inprescription use. Dr Gellad was additionally supported by grant CDA 09-207from Veterans Affairs Health Services Research and Development.Role of the Funder/Sponsor: The funders had no role in the design andconduct of the study; collection, management, analysis, and interpretation ofthe data; preparation, review, or approval of themanuscript; and decision tosubmit themanuscript for publication.Disclaimer: This work represents the opinions of the authors alone and doesnot necessarily represent the views of the funders or the Department ofVeterans Affairs or the US Government.Previous Presentations: This work was presented at the 2013 annual meetingof the American Academy of Child & Adolescent Psychiatry; October 23, 2014;Orlando, Florida.1. Larson K, Russ SA, Kahn RS, Halfon N. Patterns of comorbidity, functioning,and service use for US childrenwith ADHD: 2007. Pediatrics. 2011;127(3):462-470.2. TheMTA Cooperative Group. Multimodal Treatment Study of Children withADHD. A 14-month randomized clinical trial of treatment strategies forattention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 1999;56(12):1073-1086.3. Feldman HM, Reiff MI. Clinical practice: attention deficit-hyperactivitydisorder in children and adolescents.N Engl J Med. 2014;370(9):838-846.4. Bussing R, Gary FA. Practice guidelines and parental ADHD treatmentevaluations: friends or foes?Harv Rev Psychiatry. 2001;9(5):223-233.5. dosReis S, Myers MA. Parental attitudes and involvement inpsychopharmacological treatment for ADHD: a conceptual model. Int RevPsychiatry. 2008;20(2):135-141.6. Murray DW, Arnold LE, Swanson J, et al. A clinical review of outcomes of themultimodal treatment study of children with attention-deficit/hyperactivitydisorder (MTA). Curr Psychiatry Rep. 2008;10(5):424-431.COMMENT&RESPONSEUndertreated andUntreated PainShould Be Considered anAdverse Eventof Neonatal CircumcisionTo the Editor We read with great interest the article byEl Bcheraoui et al1 recently published in JAMA Pediatrics.We believe that the rates of adverse events of male circum-cision may have been underestimated. As a matter of fact,the authors did not mention intraoperative and postopera-tive pain as an adverse effect, especially in neonates. None-theless, authors in other studies consider undertreatingor untreating procedural pain to be an actual adverseevent.2An adverse event is defined as an injury related to medi-cal management, including failure to diagnose and treat. Un-treatedmale circumcision pain has been shown to determinelong-lastingnegative effects on future infant behavior.3 In ad-dition, current guidelines recommend analgesia for neonatalmale circumcision.4 Analgesia is now considered an integralpart of routine care whatever the invasive procedure is, par-ticularly in neonates and children.Unfortunately, it has been evidenced that analgesia forprocedural pain in children is not routine in neonatal malecircumcision.5 Relief from pain is a human right that shouldnever be violated, even if a neonate's parents give consent.We hope that future studies similar to that by El Bcheraouiet al1 will include intraoperative and postoperative painwhen estimating the risk of adverse effects for neonatalmale circumcision.Sofia Bisogni, RN, BSN, MSNNicole Olivini, MDFilippo Festini, RN, BSNAuthor Affiliations:Department of Health Sciences, University of Florence,Meyer Children Hospital, Florence, Italy.Corresponding Author: Filippo Festini, RN, BSN, Department of HealthSciences, University of Florence, Meyer Children Hospital, Viale Pieraccini 24,Florence, Italy 50139 (filippo.festini@unifi.it).Conflict of Interest Disclosures:None reported.Letters1076 JAMAPediatrics November 2014 Volume 168, Number 11 jamapediatrics.comDownloaded From: http://archpedi.jamanetwork.com/ by a UNIEVERSITA DEGLI STUDI DI FIRENZE User  on 11/24/2014Copyright 2014 American Medical Association. All rights reserved.1. El Bcheraoui C, Zhang X, Cooper CS, Rose CE, Kilmarx PH, Chen RT. Rates ofadverse events associated with male circumcision in USmedical settings: 2001to 2010. JAMA Pediatr. 2014;168(7):625-634.2. Chorney JM,McGrath P, Finley GA. Pain as the neglected adverse event. CMAJ.2010;182(7):732.3. Blank S, BradyM, Buerk E, et al. American Academy of Pediatrics. Task forceon circumcision. Pediatrics. 2012;130(3):e756-e785.4. Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on painresponse during subsequent routine vaccination. Lancet. 1997;349(9052):599-603.5. RosenM. Anesthesia for ritual circumcision in neonates. Paediatr Anaesth. 2010;20(12):1124-1127.InReplyWethankBisognietal for their comments recentlypub-lished in JAMAPediatrics about intraoperative andpostopera-tive pain as an adverse event (AE) to male circumcision (MC).Use of appropriate analgesia for pain management is a goodpractice that should be the standard of care during and afterany surgical procedure because it can substantially controlpain.1 Inaprospective studyof583neonatal circumcisionsper-formed between December 1, 2005, and December 1, 2008,whenappropriateanalgesiawasapplied,93.5%ofneonatescir-cumcised in the firstweekof life showedno indication of painonanobjective standardizedneonatal pain rating systemusedby the authors.2The recently published article,3 which found a low inci-dence of AEs (less than 0.5%) associated with MC in USmedi-cal settings during 2001 to 2010, is based on data fromahealthcare reimbursement claims database. This database capturesonlydiagnosesandproceduresbilledtothirdparties.Theanaly-sis studied the association between 41 AEs, not including painandMC.Asearchof thesamehealthcare reimbursementclaimsdatabase for the International Classification of Diseases, NinthRevisioncodes338.18(otheracutepostoperativepain)and338.19(other acute pain) detected 1 patientwith pain associatedwiththe MC procedure among 1 400 920 circumcised males. Tak-ing intoconsiderationthepossibility thatpainmaybeanunder-reported AE in the health care reimbursement claims’ data-base used for this analysis, a more thorough analysis of theassociation of pain and MC would require additional datasources, including informationrelatedtouseofandtypeofpaincontrolmethods.Aspreviouslyrecommended,3 futureresearch-ers studying the association between AEs andMC should con-siderusingadditionaldata sources toascertainAEs that arenotcaptured in data from reimbursement claims.Charbel El Bcheraoui, PhDKenneth L. Dominguez, MDPeter H. Kilmarx, MDAuthor Affiliations: Epidemic Intelligence Service, Division of Applied Sciences,Scientific Education, and Professional Development Program, Office ofSurveillance, Epidemiology, and Laboratory Services, Centers for DiseaseControl and Prevention, Atlanta, Georgia (El Bcheraoui); Division of HIV/AIDSPrevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TBPrevention, Centers for Disease Control and Prevention, Atlanta, Georgia (ElBcheraoui, Dominguez, Kilmarx); Institute for Health Metrics and Evaluation,University of Washington, Seattle (El Bcheraoui).Corresponding Author: Charbel El Bcheraoui, PhD, Institute for Health Metricsand Evaluation, University of Washington, 2301 Fifth Ave, Ste 600, Seattle, WA98121 (charbel@uw.edu).Conflict of Interest Disclosures:None reported.1. Pergolizzi JV, Pappagallo M, LeQuang J, Labhsetwar S, Taylor R. New healthcare measures: emphasis on better management of postsurgical pain andpostoperative nausea and vomiting.Hosp Pract (1995). 2014;42(1):65-74.2. Banieghbal B. Optimal time for neonatal circumcision: an observation-basedstudy. J Pediatr Urol. 2009;5(5):359-362.3. El Bcheraoui C, Zhang X, Cooper CS, Rose CE, Kilmarx PH, Chen RT. Rates ofadverse events associated with male circumcision in USmedical settings: 2001to 2010. JAMA Pediatr. 2014;168(7):625-634.NebulizedHypertonic Saline for BronchiolitisTo theEditorWereadwith interest thestudybyWuetal1 recentlypublished inJAMAPediatrics, examiningtheeffectofnebulizedhypertonicsalinevsnormalsalineadministrationin infantswithbronchiolitis.Wecommend the authors forundertaking a largerandomizedclinical trial tocomplementexistingevidenceof thedecreasinglengthofstaywithhypertonicsalineuse.2-5However,wehaveconcernsregardingthestudyanalysisandinterpretationandbelievecautious interpretationof the findings iswarranted.While3447patientswerediagnosedwithbronchiolitisdur-ing the studyperiod, only 1254patientswereassessed for eligi-bility.Therewasnoexplanationwhya largenumberofpatientswas not assessed; thismay have affected the population stud-ied,potentially skewing thedata towardamoremild tomoder-ate spectrumof illness (indicatedby the reportedpretreatmentRespiratoryDistressAssessment Instrument scores). The largenumberofchildrendischargedfromtheemergencydepartmentmayalso reflectmilderdisease.Unfortunately, the lackofmini-mumormaximum severity criteria for study entry and lack ofstratificationofseverityconfoundstheefficacyofhypertonicsa-line use in a diseasewith a known spectrumof severity.Wequestion theclinical significanceof length-of-staydatawhenmeasured indaysbecausethis isabluntmeasure forshortadmissions.Giventhatthestudywasunderpoweredforthisout-come, we suggest using hours instead of days, with a survivalanalysis to investigatetimefromemergencydepartmentpresen-tationtodischarge.Theadvantagewouldbetheuseofdatafromall randomized patients in the analysis, not only admitted pa-tients,presentinga richerdata setwithmoreclinical relevance.Additionally, as the length-of-staydataarenotnormallydistrib-uted, itwouldhavebeenmore informative to report themedianandinterquartilerangeratherthanmeanandstandarddeviation.Wearealsoconcernedthat theRespiratoryDistressAssessmentInstrumentscoreduringadmissionwasassessedatdailypointsonlyandwasnotreflectiveofpretreatmentseverityorposttreat-mentoutcome. Intherelevantanalyses, theauthorsonlyappeartoconsiderthepre-andpostmeasurementsofthefirsttreatment.To conclude,while hypertonic saline use in childrenwithbronchiolitis in the emergency department appears to de-crease admission to the hospital, it remains unclear whetherthis applies to all cases of bronchiolitis, irrespective of sever-ity, given the lack of stratification. As β-agonist and nebu-lized saline administration are not universal for bronchiolitisin all settings, this would be important information to allowgeneralizability of findings.Victoria Louise Heaton, MBBSNatalie Boon Lin Tan, MBBS, BSci, LLBLaura Marco, MBBSLettersjamapediatrics.com JAMAPediatrics November 2014 Volume 168, Number 11 1077Downloaded From: http://archpedi.jamanetwork.com/ by a UNIEVERSITA DEGLI STUDI DI FIRENZE User  on 11/24/2014

Undertreated and untreated pain should be considered an adverse event of neonatal circumcision

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Undertreated and untreated pain should be considered an adverse event of neonatal circumcision

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