We herein present a preliminary practical algorithm for evaluating complementary and alternative medicine (CAM) for children which relies on basic bioethical principles and considers the influence of CAM on global child healthcare. CAM is currently involved in almost all sectors of pediatric care and frequently represents a challenge to the pediatrician. The aim of this article is to provide a decision-making tool to assist the physician, especially as it remains difficult to keep up-to-date with the latest developments in the field. The reasonable application of our algorithm together with common sense should enable the pediatrician to decide whether pediatric (P)-CAM represents potential harm to the patient, and allow ethically sound counseling. In conclusion, we propose a pragmatic algorithm designed to evaluate P-CAM, briefly explain the underlying rationale and give a concrete clinical exampl

Fanconi, Sergio

Renella, Raffaele

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Eur J Pediatr (2006) 165: 437–441DOI 10.1007/s00431-006-0093-4ORIGINAL PAPERRaffaele Renella . Sergio FanconiDecision-making in pediatrics: a practical algorithm to evaluatecomplementary and alternative medicine for childrenReceived: 15 August 2005 / Revised: 21 December 2005 / Accepted: 30 December 2005 / Published online: 19 April 2006# Springer-Verlag 2006Abstract We herein present a preliminary practical algo-rithm for evaluating complementary and alternative med-icine (CAM) for children which relies on basic bioethicalprinciples and considers the influence of CAM on globalchild healthcare. CAM is currently involved in almost allsectors of pediatric care and frequently represents achallenge to the pediatrician. The aim of this article is toprovide a decision-making tool to assist the physician,especially as it remains difficult to keep up-to-date with thelatest developments in the field. The reasonable applicationof our algorithm together with common sense shouldenable the pediatrician to decide whether pediatric (P)-CAM represents potential harm to the patient, and allowethically sound counseling. In conclusion, we propose apragmatic algorithm designed to evaluate P-CAM, brieflyexplain the underlying rationale and give a concrete clinicalexample.Keywords Algorithm . Alternative . Complementary .PediatricAbbreviations CAM: Complementary and alternativeMedicine . CAN: Child abuse and neglect .CME: Continuing medical education . p-CAM:Pediatric complementary and alternative medicineIntroductionComplementary and alternative medicine (CAM) is used inthe prevention of, but also as therapy for, acute [2, 15] andchronic diseases in children [14, 16] and has recently beenintegrated into the research agendas of pediatric academicsocieties as a priority [3]. Recent surveys indicate that up to50% of patients requiring in- or out-patient care in aEuropean hospital use CAM [18], but these approaches areoften not openly discussed with healthcare teams [5].Because of the significant number of different approachesand perspectives, and abundance of information of varyingquality, CAM therapies frequently represent a challenge tothe office pediatrician [9, 10, 17]. Medical school curriculaand post-graduate continuing medical education (CME)programs have only recently introduced teaching programsthat include decision-making in the area of pediatric CAM(p-CAM) [4]. On the front-line, pediatricians often facemisinformed/uninformed parents, who rely on sources ofinformation (family, friends or the internet) who may beunaware of potential risks [12, 13].Attempts have been made to provide the practitionerwith reproducible and valuable scientific data on “main-stream” p-CAM, such as acupuncture, homeopathy andherbal remedies, but many therapies remain uninvestigated[1]. Furthermore, some experts suggest that some p-CAMtherapies may not be amenable to the usual scientificevaluation process. Other authors discuss liability issues,medical misconduct and malpractice that p-CAM couldimply [4]. Unfortunately, very few authors offer pragmaticdecision-making strategies that could help the pediatricianand the patient.As it remains difficult to keep up-to-date with the latestdevelopments in this field, and only a few well-designedstudies clearly attest to the benefits of CAM, we proposehere a pragmatic algorithm designed to evaluate CAM inthe pediatric setting.R. Renella . S. FanconiDepartment of Pediatrics, University Hospital of Lausanne,Lausanne, SwitzerlandR. Renella (*)Département medico-chirurgical de Pédiatrie,Centre Hospitalier Universitaire Vaudois,Avenue du Bugnon,1011 Lausanne, Switzerlande-mail: raffaele.renella@hospvd.chTel.: +41-21-3143604Fax: +41-21-3143645Building the algorithmWith the aim of offering a practical decision-makingstrategy, we reviewed the existing literature and observedcommon trends and views that we used to establish analgorithm applicable to any patient and therapy. Unfortu-nately, our search of the literature did not retrieve anyprevious attempt to establish a similar decision-makingtool which could provide the pediatrician with a cleareroverview of types of therapies his patient may desire toembark on. The attention of the community, however,seems to be focused on describing the position of thepediatric patient and his family within the context of p-CAM [6] and on the potential legal consequences of p-CAM application in children (liability and malpracticeconcerns). An office-based pediatrician can hardly keepup-to-date with the integrality of the most recent literaturein this field and thus should be provided with practical toolsfor decision-making. The healthcare management commu-nity has already adopted this pragmatic attitude [16].Furthermore, we also took into account the fact that, inmost countries, pediatricians are required to declarepotential situations of childhood abuse and neglect.When observing behavior in his practice that might pointtowards abuse or neglect, the pediatrician might berequired by law to refer the situation to the competentjudiciary instances, depending on national or locallegislation. This compulsory declaration may place thephysician in a conflicting position with regards to hispatient. A valuable attitude in these moments is, in ouropinion, to apply common sense with the aim of neverinterrupting the lines of communication with the patientand his family.The bioethical principlesAll decisions that keep in mind the four basic principles ofbioethics (autonomy, beneficence, nonmaleficence andjustice) can generally be considered to be correct anddefendable in the face of professional and legal authorities,especially when common sense is applied [7]. Even if weconsciously oversimplify the philosophical underpinnings,these principles allow us to establish two conceptualdimensions by which to grade and evaluate the therapy ofconcern, namely safety and efficacy. A simple diagram, aspresented in Fig. 1, can be drawn and used for an initialimpression [7]. All therapies, conventional or P-CAM, canbe inserted, thereby allowing a comprehensive picture ofthe options, may they be ongoing or prospective. Thisdiagram has already been used extensively to measure therisk of malpractice liability associated to CAM in adults[8], and some authors have mentioned its potential in thepediatric setting [4]. This conceptual diagram shouldconstitute the core of the algorithm.In reality, only very few therapies can be classified intothe straightforward Encourage and Discourage zones ofthe diagram, which represent de facto no decisionaldilemma. To simplify decision-making, we consideredthat unsafe therapies should be discouraged, while safetherapies could be tolerated even if ineffective, but only ifthey do not interfere with or interrupt an ongoing effectiveapproach. Safe but ineffective therapy should be toleratedas a complement, but not as exclusive strategy.In our understanding, an unlimited quantity of clinicalexamples would be necessary to illustrate and thoroughlydiscuss these gray-zones defined by unsafe/effective andsafe/ineffective CAM therapies. Such in-depth analysisoverrides the scope of our article and algorithm, and webelieve in the necessity of leaving the pediatrician and thepatient maneuvering room for discussion and reflectionwithin the boundaries of the trust-based patient-physicianrelationship.The algorithmFigure 2 summarizes our decision-making algorithm. Wehave classified the above-mentioned conditional questionsinto a logical order of priority.Initial questions should assess situations from which thechild could be diverted or even induced to abandon a vitalongoing therapy. In such cases, the pediatrician shoulddiscourage proceeding to – or continuing – the CAMtherapy under discussion. Child abuse and neglect (CAN)should in any such case be clearly discussed, excluded ordeclared to legal authorities.As a second priority, the pediatrician should verify if aninformed decision of the parents, and eventually of thechild, has been taken. Some questions that may be posedare the following. How much do the parents know aboutthe therapeutic project? Have the parents (and the child)Efficacy DiscourageEncourageTolerate Re-assess Discourage Re-assess Safety Fig. 1 Core “Safety-Efficacy” diagram based on bioethical prin-ciples. This diagram is a simplified and modified version of theliability risk analysis as presented by Cohen and Eisenberg [3].Comment: In doubtful situations, we recommend grading the qualityof the discussed therapy as unsure or inefficacious. This cautiousattitude can be adopted, given that most common therapies in P-CAM have not been studied in randomized controlled trials and,consequently, evidence is not available to make an educateddecision; thus, common sense should prevail438understood and measured potential risks and eventualbenefits? Have they weighed any potential social orreligious impact? What would the quality of life be forthe child and his/her family if a new p-CAM therapy isstarted? Is there awareness of the associated economiccosts? We should never neglect any potential social andeconomic implications. In fact, a safe and effective – butexpensive – treatment may represent possible economichardship to the family.Only after having answered these two fundamentalquestions, should the pediatrician evaluate safety andefficacy as described in Fig. 1. In doubtful situations, wheneither efficacy or safety are uncertain, the caregivermay schedule a re-assessment of the situation and offerfollow-up.We recommend verifying whether or not evidence, or areasonable consensus, supports the application of thetherapy and can be found in the scientific literature. It is anabsolute necessity that this crucial step of the algorithm bediscussed openly with the patient and his/her family andthat the discussion and conclusions (if any) subsequentlybe recorded in the patient’s personal chart. Moreover, wesuggest that an update of information be obtained regularly.If this is the case, a new p-CAM can be encouraged. If it isnot the case, we suggest tolerating the initiation of the newp-CAM therapy and following the evolution of the child’shealth and his/her family’s situation with regular assess-ments, informing the patient and his family of potentialhazards and socio-economical issues.Application of the algorithm: case presentationA 6-year-old girl known as having chronic childhoodasthma (in a context of familial atopy) and her parentscome to your general pediatric office. They explain theirintent to start an herbal oil massage therapy based on anancestral Alpine village tradition. They have heard of itfrom a neighbor. They request your opinion about this idea.The pediatrician’s point of view is that this idea mayhave arisen from the frustrations felt by the child and thefamily during the frequent acute episodes, which he has notsuccessfully prevented to date. Puzzled as to what to say,and concerned not to allow a hazardous therapy to begin,he decides to use the described algorithm to help him withthis situation.Before applying the algorithm, he establishes a completerecent history and obtains more details about the massagetherapy. It consists of sunflower oil in which herbs andflowers, collected in the fields of a nearby Alpine region,have been immersed for 3 years and stored in a cold andhumid cellar. The specifications of the types of herbs andflowers are unknown to the family. The massage consists ofthe direct application of this mix to small surfaces of theface and the pectoral region once a day in the morning.Step 1:The pediatrician asks the parents about their feelingson the actual standard and proven therapy he hasintroduced. Will they stop giving the evidence-basedinhalations and the leukotriene antagonist (montelu-kast) he has prescribed? Will they reduce therecommended preventive inhalations? The parentsconfirm their trust in the efficacy of the ongoingtherapy for the acute episodes and certainly willcontinue with the preventive inhalations, but theythink it might not be enough to help their child. The girlagrees and mentions her sadness, saying that the drugsalready used do not work well enough.Step 2:The pediatrician follows the algorithm and tries tounderstand why the family thinks this new therapymight help. They mention 20 children in the Alpinevillage and surroundings who “have noticed animprovement with their asthma after the massagetherapy started”. They also mention that they have readon the internet that some mountain flowers have ananti-asthmatic effect. They tell the physician that theywill go back to the Alpine village and ask the old ladywho prepares the oils for details. Both parents arephysicians themselves and clearly state they do notknow the exact mechanism of action of the massages,but they think that trying it out will tell them if it helpstheir daughter.Tolerate and Re-assess Discourage or Declare to Legal Instance Discourage Inform the parents/child Discourage or yes Encourage Safety? Efficacy?  Abandon of vital therapy? Diversion from preventive therapy? yes Educated/informed decision of parents/child? no no yes no doubtful Evidence - Consensus? Tolerate and Re-assess Inform the parents/child yes no as in Figure.1 no Get informed and  inform the parents/child Financial - Social Implications? yes Fig. 2 Decision-making algorithm439Step 3:The pediatrician returns to the algorithm and asksabout the price of the oil mixture. The parents say itwill cost 20 Euros per month, and state it will not be aburden for the household budget. He enquires aboutthe potential effects of the new therapy on the child’slife and on the family’s life. They say that the massagewill be performed by one of the parents for 10 min inthe morning before breakfast. The smell is said to bepleasant.Step 4:The pediatrician continues with the algorithm and tellsthe parents he has doubts on the efficacy of thetreatment. He suggests he will have a look in theexisting medical literature and asks for details aboutthe underlying rationale. The parents give him thephone number of the old lady who prepares the oils. Hethen asks about the potential risk that the oils used inthe massages might increase the skin problems in theirchild? He explains his concerns that the massage mightburn the skin, induce irreversible lesions, increase heratopic dermatitis or even cause infections. The parentsstate that the 20 children treated had no suchcomplications, and that they will carefully screen forany secondary effect.In summary, the pediatrician’s impression is that he hasdoubts about safety and efficacy of this therapy in thisatopic child. He discusses his concerns openly with thefamily and reschedules an appointment after he has hadtime to look for evidence or consensus on such therapy inthe literature and after having had more details on themassage oil from the producer.We believe that the rational application of our algorithmallows the pediatrician to ask all of the essential questionsand to establish a plan on how to proceed with the situation.In the case presented here, the pediatrician will be able toobtain a clear picture of the new therapy, anticipatepotential risks for the child and establish a plan for follow-up. Most importantly, he will achieve this by openlydiscussing his concerns with the family, thus providing astimulus for the parents themselves to reflect on whether –or not – to start this new approach in the hope of relievingtheir daughter’s health issues.The reality of actual patient-doctor communicationas a limitationOne major problem is the fact that patients and their parentsseem to consider discussing p-CAM therapies withhealthcare providers a taboo [5, 14, 18]. A recent reviewof the literature on the topic highlights the importance ofoffering patients and parents space within the therapeuticrelationship [11] and respecting a few simple rules. One ofthese rules could be to remain open to the idea that theremay be different, equally interesting paths to a child’s goodhealth. We believe that the pediatric practitioner isindispensable in improving the awareness of, and provid-ing education on, p-CAM therapies and that by doing so hemay increase the ease at which the topic can be openlydiscussed with patients and parents. We also hope that anapproach attempting to simplify and provide a practicaldecision-making will contribute to the integration ofp-CAM in the pediatric routine.ConclusionIn conclusion, we have established a pragmatic algorithmfor decision-making in p-CAM. The application ofbioethical principles added to basic pediatric fundamentalscan help the physician in dealing with this field and allowdebate between specialists and p-CAM therapists as to howto integrate p-CAM in everyday clinical practice. Thereasonable application of our algorithm along withcommon sense should enable the pediatrician both todecide whether or not p-CAM is potentially harmful to thepatient and to provide ethically sound counseling.References1. 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Decision-making in pediatrics: a practical algorithm to evaluate complementary and alternative medicine for children

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Decision-making in pediatrics: a practical algorithm to evaluate complementary and alternative medicine for children

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