Quantitative Assessment of Drug Treatment Side Effects in Children with Idiopathic Thrombocytopenic Purpura (ITP).
Notice bibliographique
Résumé
Abstract Most studies of childhood ITP focus on platelet count as the sole outcome measure. Although side effects of drug treatment for ITP are mentioned in some studies, serial quantitative measures of drug toxicity over time have not been measured. We hypothesized that it was possible to develop a valid instrument to quantitate drug side effects in children with ITP for use in future clinical trials and to assist with patient management. Accordingly, we designed a “Childhood ITP Symptom Checklist” for completion by parents of children with ITP daily for 7 days following initiation of therapy. Parents were asked to rate on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe) the severity of 11 possible side effects (headache, hyperphagia, vomiting, moodiness, fever, insomnia, chills, fatigue, leg/arm pain, abdominal pain, nausea). Seventy-four children (50 male) with ITP (46 newly-diagnosed and 28 established) were enrolled from six centers across North America. Age ranged from 6 mo to 17 yr (median 4 yr). Median platelet count on day 0 (when drug therapy was initiated) was 9,000 per mm3 (range 1 to 75,000 per mm3). Fourteen patients received corticosteroids, 28 intravenous immunoglobulin (IVIG), 20 anti-D immunoglobulin, 2 multiple drugs, and 10 no drug therapy. Parent acceptance of and compliance with the instrument was good. All 11 side effects were noted in patients in each group, but the percentage of patients with side effects and the severity and time course varied greatly. Severe or very severe (S/VS) complications were seen with each drug therapy. IVIG-treated patients had maximal side effects on day 1 including headache (in 54% of patients, S/VS 25%), vomiting (36%, 14% S/VS), fever (50%, 14% S/VS), chills (33%, 7% S/VS), and nausea (41%, 11% S/VS). Side effects diminished on day 2 and were minimal thereafter. Toxicity with anti-D was similar, but the profile differed, being maximal on day 0, continuing throughout the week, but not usually S/VS. Thirty-three percent of children receiving anti-D had headache, 38% fever (worse on day 1), 25% chills, and 22% nausea. The side effects were different with corticosteroids. Hyperphagia occurred throughout the entire 7 days in at least 50% of patients and was sometimes S/VS. Moodiness occurred daily and was S/VS one-third of the time. Moodiness and insomnia as well as fatigue were also commonly reported in other patient groups (including no drug therapy). Mild arm/leg pain and abdominal pain were seen with all treatments but was more persistent with corticosteroids. Mild to moderate headache, fever, and insomnia was noted in 10–30% of patients irrespective of therapy received. We conclude that the nature, timing, and severity of side effects reported by parents of children with ITP can be scored using an instrument such as the one employed here. Further research should determine the specific effect of drug dose and treatment schedule, relationships among different side effects, and the impact of these toxicities on the child’s and family’s quality of life.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,012 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».