Agreement between a regional pharmacovigilance centre and an adjudication committee regarding adverse drug reactions on a cohort of hospitalised children.

BACKGROUND AND PURPOSE: The EREMI project was set up to collect data on adverse drug reactions (ADRs) occurring due to off-label and/or unlicensed drugs prescribed to hospitalised children in France. These events were evaluated by a regional pharmacovigilance centre (RPC) and an adjudication committee (AC). The aim of this study was to assess the agreement between these two different entities on their evaluation of ADRs. EXPERIMENTAL APPROACH: The RPC first validated the ADRs and assessed their causality using the Naranjo scale. The AC assessed then ADRs using all available information, including the RPC evaluation. The agreement on severity and nature of ADRs, role of treatment (suspect or concomitant) and drug causality was calculated using Cohen's nonparametric kappa coefficient (k). KEY RESULTS: Three hundred and eighty-six events were reported in 219 children. The RPC excluded 65 events and validated 321 ADRs. Agreement was very good on nature of ADRs (k=0.85) and role of treatment (k=0.81), moderate on severity of ADRs (k=0.60) and very poor on drug causality (k=0.05). CONCLUSION AND IMPLICATIONS: Agreement between the RPC and the AC was not constant throughout this evaluation. They troubled to agree on severe ADRs and on drug causality.

Role of a behavioral therapy involving psychodrama for the treatment of sleep disorders in pediatric primary care.

BACKGROUND: Sleep disorders are common in young children. Our objective was to describe a psychodrama using puppets and to assess the interest of this approach for the treatment of sleep disorders in ambulatory pediatric patients. METHODS: This retrospective, observational, monocenter study was carried between 1st January 2014 and 31st December 2015. Children aged 12 months to 6 years with a sleep disorder confirmed according to the International Classification of Sleep Disorders-2 were recruited. The parents were questioned separately about their child's sleep rhythm and the family's quality of life (QoL). The child sitting on their parent's knee and, using puppets to represent the family members, the pediatrician reproduced the scenario that took place at home and demonstrated what should be changed. The parents were contacted by telephone 1-2 weeks after the therapy to determine whether the child's sleep patterns had improved. The primary endpoint was resolution of the sleep disorder. RESULTS: Thirty-eight children (mean age 27.2±14.0 months; mean duration of sleep disorder 12.7±9.5 months) were assessed. The most common sleep disorders were difficulties in falling asleep at evening bed-time (76.3%) and night-time wakening (76.3%). The main triggering factors were the birth of a sibling (30.8%) or an illness (30.8%). In the majority (52.2%) of families who were convinced that the psychodrama would work, an immediate and complete resolution of the sleep disorder was obtained within three days of the consultation. QoL improved in the majority of families after the consultation (QoL was average in 68.4% of families before the consultation vs. good in 84.2% after the consultation). Psychodrama was effective at bringing about an immediate and complete resolution of sleep disorders in children. This confirms the findings of other reports that show that behavioral therapy is effective in this context. CONCLUSIONS: This method could be adapted effectively by individual practitioners, enabling children to establish a good sleep pattern without the use of medications. A further large-scale, randomized, controlled trial is required to confirm these results.

Symptoms associated with teething and response to three treatments, including homeopathic medicine: a multicenter prospective observational study among 190 French pediatricians.

BACKGROUND: Primary tooth eruption in infants is associated with a range of local and systemic symptoms although this remains a subject of much debate. In addition, data are limited on the role of physicians in managing infant teething, and on the benefit of homeopathic treatments. METHODS: We conducted an observational, multicenter, prospective survey evaluating teething symptoms, and symptom course following routine medical management by French pediatricians in 597 infants aged from 3 to 24 months. We also examined the response to treatment with routinely prescribed teething medications; the homeopathic agent, Camilia® and topically applied gingival agents (Delabarre® or Dolodent®). RESULTS: Most infants (96.6%) had buccogingival symptoms and 93.3% had at least one general symptom. Fever (≥38 °C) was reported in 15.2% of infants. For teething, 212 infants were prescribed Camilia®, 172 a gingival solution (Delabarre® or Dolodent®) and 213 received Camilia® along with a gingival agent. Infants prescribed both a homeopathic and a gingival treatment had a significantly higher number of symptoms at presentation compared with those prescribed a single agent. There were no significant differences in symptom course across these three treatment groups. Systemic analgesics/antipyretics were prescribed in 68.8% of cases. Parent satisfaction with medical management and prescribed treatments was high. CONCLUSIONS: Teething is frequently associated with transient local and systemic upset in infants and is a significant concern to parents. Camilia® provides a similar benefit to topical therapy, and is frequently used by pediatricians in France.

[Feasibility study of a call centre to reduce non-scheduled visits and unjustified consultations in pediatric emergencies units]. / Réduction des consultations non programmées et non justifiées dans le cadre des urgences pédiatriques grâce à une plateforme téléphonique.

INTRODUCTION: Non-justified and non-scheduled visits to emergency units are ever increasing and consequently overburden their staff. Because it seems necessary to meet this heavy demand of urgent health care, a possible solution could be to set up phone call centers dedicated to pediatric care. First, when people call the emergency number, the SAMU doctors will field these calls and immediately determine the degree of urgency of the situation before transferring the call to the appropriate standardized call center who will then advise the caller as to how to proceed. OBJECTIVE: To access the technical feasibility of setting up this call center which will be in place with the already existing emergency call system and also to ascertain if the system will indeed reduce the number of unnecessary emergency medical consultations. METHODS: The standardized information and advice given by this call center concerning fever, diarrhoea, crying, head trauma, respiratory obstruction in the young infant comes from the consensus of the association of Courlygones pediatric doctors. As a follow up to the initial contact with the caller, nurses call the families back seven days later to find out if the families did finally take their child to the emergency room or not and also to see if the callers retained the necessary advice given through the call center. Finally, the nurses request that the families assess their own satisfaction will this new call service. RESULTS: Over a period of 97 days, 250 calls were fielded. In 84% of the cases (n=210/250), calls came from parents and most of them (109/198, 55.05%) had only a single child. On average, each call lasted between 5 to 8 minutes. 97% of the callers (n=178/183) were satisfied by the advice given. Following the call, 128 callers /215 (59.53%) asked an additional medical advice within 20 h and 61.71% (n=79/128) of them actually took their child to a scheduled medical consultation. Only 2.34% of the 128 callers were finally hospitalized. DISCUSSION: Our results confirm the technical feasibility to set up a call centre dedicated to paediatrics and its positive impact on the number of non-scheduled and non-justified visits to emergency units.

[Recurrent upper respiratory tract infections and otitis in children]. / Rhinopharyngites et otites à répétition de l'enfant.

Recurrent upper respiratory tract infections should be considered as a normal process in infants who build immune defenses in an environment where they meet viruses. Nasal lavage with saline serum and the blowing when possible are the only treatment justified in all the cases. Antibiotic treatment is not justified. It does not shorten the course and does not prevent complications. Recurrent otitis media (three episodes in six months or four in one year) are the most common complication. Bacterial superinfections are due to bacteria who colonise nasopharynx. Facilitating factors for recurrent ENT infections in children are individual: age, sex, martial deficiency, gastro-oesophageal reflux, adenoid growths. Other facilitating factors are environmental: absence or short duration of breast-feading, pollution, passive smoking, day care center. In the great majority of cases, laboratory tests are unnecessary. The most important is to reassure because recurrent upper respiratory infections improve with time. Different facilitating factors previously described have to be taken into account and should allow to decrease the number of episodes.

A simple tool to evoke physicians' real training needs.

Commonly used methods for identifying the training needs of general practitioners do not enable the real needs felt during interviews with patients during office visits to be detected. In this study, the authors evaluate how physicians' use of a personal-office-visit diary affects the level of specificity of their expressed training needs. In 1999, the authors carried out a controlled intervention trial using a random sample of 1,038 general practitioners from a region of France, randomized to intervention and control groups. The practitioners in the intervention group were asked to identify their training needs using a personal-office-visit diary. The level of specificity for their expressed needs was compared with that of the expressed needs of the practitioners in the control group. The use of the diary was associated with a significantly higher level of specificity in the training needs identified by the general practitioners who participated. Independent of the intervention, practitioners under 40 years of age, those in urban practice, and those who were members of a continuing medical education (CME) association expressed their training needs with higher specificity. The personal-office-visit diary would seem to be a simple, inexpensive, and useful tool for more specifically identifying training needs, which could help establish more appropriate and better-targeted training programs. However, it should be assessed further by those involved in CME for general practitioners.