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BACKGROUND: Children treated in a pediatric intensive care unit (PICU) often receive several drugs together, among them drugs defined as high-alert medications (HAMs). Those drugs carry a high risk of causing patient harm, for example, due to a higher potential for interactions. HAMs should therefore be administered with caution, especially in a PICU. OBJECTIVES: The objective of the current study was to identify drug-drug interactions involving HAMs that increase the risk of interaction-associated symptoms in pediatric intensive care. METHODS: In a retrospective study, we analyzed the electronic documentation of patients hospitalized for at least 48 h in a general PICU who received at least two different drugs within a 24-h interval. We assessed potential drug-drug interactions involving HAM on the basis of the two drug information databases UpToDate and drugs.com. Furthermore, we analyzed whether symptoms were observed after the administration of drug pairs that could lead to interaction-associated symptoms. For drug pairs involving HAM administered on at least 2% of patient days, and symptoms observed at least ten times after a respective drug pair, we calculated odds ratios, 95% confidence intervals, and p-values by using a univariate binary logistic regression. RESULTS: Among 315 analyzed patients, 81.3% (256/315) received drugs defined as high-alert medication for pediatric patients. Those high-alert medications were involved in 20,150 potential drug-drug interactions. In 14.0% (2830/20,150) of these, one or more symptoms were observed that could be a possible consequence of the interaction, resulting in 3203 observed symptoms affecting 56.3% (144/256) of patients receiving high-alert medication. The odds ratios for symptoms observed after a drug-drug interaction were increased for eight specific symptoms (each p ≤ 0.05), especially hemodynamic alterations and disturbances of electrolyte and fluid balance. The odds ratio was highest for decreased blood pressure observed after the administration of the drug pair fentanyl and furosemide (OR 5.06; 95% confidence interval 3.5-7.4; p < 0.001). Increased odds ratios for specific symptoms observed after drug-drug interactions resulted from eight combinations composed of eight different drugs: digoxin, fentanyl, midazolam, phenobarbital, potassium salts and vancomycin (high-alert medications), and the diuretics furosemide and hydrochlorothiazide (non-high-alert medications). The resulting drug pairs were: potassium salts-furosemide, fentanyl-furosemide, vancomycin-furosemide, digoxin-furosemide, digoxin-hydrochlorothiazide, fentanyl-phenobarbital, potassium salts-hydrochlorothiazide, and midazolam-hydrochlorothiazide. CONCLUSIONS: In a cohort of PICU patients, this study identified eight specific drug pairs involving high-alert medications that may increase the risk of interaction-associated symptoms, mainly hemodynamic alterations and electrolyte/fluid balance disturbances. If the administration of those drug pairs is unavoidable, patients should be closely monitored.
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BACKGROUND: Depending on the underlying etiology and epilepsy type, the burden of disease for patients with seizures can vary significantly. This analysis aimed to compare direct and indirect costs and quality of life (QoL) among adults with tuberous sclerosis complex (TSC) related with epilepsy, idiopathic generalized epilepsy (IGE), and focal epilepsy (FE) in Germany. METHODS: Questionnaire responses from 92 patients with TSC and epilepsy were matched by age and gender, with responses from 92 patients with IGE and 92 patients with FE collected in independent studies. Comparisons were made across the main QoL components, direct costs (patient visits, medication usage, medical equipment, diagnostic procedures, ancillary treatments, and transport costs), indirect costs (employment, reduced working hours, missed days), and care level costs. RESULTS: Across all three cohorts, mean total direct costs (TSC: 7602 [median 2620]; IGE: 1919 [median 446], P < 0.001; FE: 2598 [median 892], P < 0.001) and mean total indirect costs due to lost productivity over 3 months (TSC: 7185 [median 11,925]; IGE: 3599 [median 0], P < 0.001; FE: 5082 [median 2981], P = 0.03) were highest among patients with TSC. The proportion of patients with TSC who were unemployed (60%) was significantly larger than the proportions of patients with IGE (23%, P < 0.001) or FE (34%, P = P < 0.001) who were unemployed. Index scores for the EuroQuol Scale with 5 dimensions and 3 levels were significantly lower for patients with TSC (time-trade-off [TTO]: 0.705, visual analog scale [VAS]: 0.577) than for patients with IGE (TTO: 0.897, VAS: 0.813; P < 0.001) or FE (TTO: 0.879, VAS: 0.769; P < 0.001). Revised Epilepsy Stigma Scale scores were also significantly higher for patients with TSC (3.97) than for patients with IGE (1.48, P < 0.001) or FE (2.45, P < 0.001). Overall Quality of Life in Epilepsy Inventory-31 items scores was significantly lower among patients with TSC (57.7) and FE (57.6) than among patients with IGE (66.6, P = 0.004 in both comparisons). Significant differences between patients with TSC and IGE were also determined for Neurological Disorder Depression Inventory for Epilepsy (TSC: 13.1; IGE: 11.2, P = 0.009) and Liverpool Adverse Events Profile scores (TSC: 42.7; IGE: 37.5, P = 0.017) with higher score and worse results for TSC patients in both questionnaires. CONCLUSIONS: This study is the first to compare patients with TSC, IGE, and FE in Germany and underlines the excessive QoL burden and both direct and indirect cost burdens experienced by patients with TSC.
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PURPOSE: The Summary of Product Characteristics (SmPC) is required to provide unambiguous information on the authorized use of a medicinal product. Therefore, we performed a structured analysis of the information provided for pediatric patients in current SmPCs. METHODS: In the German SmPC of the medicinal products of 452 active substances, we analyzed for each of the listed indications whether information on pediatric use was available in Sects. 4.1-4.4 of the SmPC and, if so, whether it was unambiguous. Information was considered unambiguous if it indicated an exact age- or weight-related specification. The analysis also considered the type of marketing authorization and the date of marketing authorization, either before or after the Pediatric Regulation 2007 came into force. RESULTS: Among the 30,354 identified indications in 8464 SmPCs, unambiguous information was found for 72.4% (21,974/30,354) of the indications. Of these, 45.4% (9967/21,974) disclosed a contraindication for the entire population under 18 years of age. The proportion of unambiguous information was higher for medicinal products with centralized marketing authorization (86.5% [1449/1676]) than for those with a national one (71.6% [20,525/28,678]; p < 0.001). A higher proportion of unambiguous information was found for the marketing authorization period 2007-2021 compared with 1996-2006 (1996-2006: 63.8% [7466/11,694]; 2007-2021: 82.1% [12,349/15,040]; p < 0.001). CONCLUSION: For about a quarter of all indications, no or only ambiguous information was available for pediatric patients. The measures initiated in recent years to increase pediatric-specific information in SmPCs should be intensified in order to improve drug safety in children and adolescents.
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Aprobación de Drogas , Uso Fuera de lo Indicado , Pediatría , Humanos , Niño , Uso Fuera de lo Indicado/estadística & datos numéricos , Adolescente , Alemania , Preescolar , Lactante , Etiquetado de Medicamentos , Mercadotecnía/legislación & jurisprudenciaRESUMEN
PROBLEM: A seizure is a challenging situation for children with epilepsy. Little is known regarding the experience of children who perceive in advance that they are about to have a seizure. METHODS: From September 2020 to February 2021, we invited children with focal epilepsies aged 6-18 years to participate in a semi-structured interview. RESULTS: Of 52 children with focal epilepsies, 22 (42 %) said they perceive in advance that they are about to experience a seizure [11 with self-limited epilepsy with centro-temporal spikes (SELECTs), 11 with other focal epilepsies]. All 22/22 (100 %) children described physical symptoms such as headache or a numb feeling in one half of the body. Of those children, 17/22 (77 %) stated they try to do something about the seizure. Those strategies were perceived as helpful by 0/11 (0 %) children with SELECTs and 9/11 (86 %) children with other focal epilepsies (p < 0.001). Of the children with SELECTs 5/11 (45 %), and of those with other focal epilepsies 9/11 (86 %) stated they would like to know in the morning if they are to experience a seizure that day (n.s.). CONCLUSION: Children who perceive in advance that they are about to have a seizure are well able to describe their experience. Most children take measures to manage their seizures. Those measures were regarded as helpful by most children with other focal epilepsies, but by no child with SELECTs. Larger studies are necessary to determine the factors contributing to the child's perception as well as the nature of the support that they require.
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Epilepsias Parciales , Epilepsia , Niño , Humanos , Proyectos Piloto , Electroencefalografía , Convulsiones/diagnóstico , Epilepsias Parciales/diagnósticoRESUMEN
BACKGROUND: to assess the intuitiveness of parents' administration of pediatric emergency devices (inhalation, rectal, buccal, nasal, and auto-injector). METHODS: We invited parents without prior experience to administer the five devices to dummy dolls. We observed whether the parents chose the correct administration route and subsequently performed the correct administration procedures without clinically relevant errors. We interviewed parents for their self-assessment of their own administration performance and willingness to administer devices in actual emergencies. RESULTS: The correct administration route was best for the inhalation device (81/84, 96% of parents) and worst for the intranasal device (25/126, 20%). The correct administration procedures were best for the buccal device (63/98, 64%) and worst for the auto-injector device (0/93, 0%). Their own administration performance was rated to be best by parents for the inhalation device (59/84, 70%) and worst for the auto-injector device (17/93, 18%). The self-assessment of the correct administration overestimated the correct administration procedures for all the devices except the buccal one. Most parents were willing to administer the inhalation device in an emergency (67/94, 79%), while the fewest were willing to administration procedures the auto-injector device (28/93, 30%). CONCLUSIONS: Intuitiveness concerning the correct administration route and the subsequent correct administration procedures have to be improved for all the devices examined. The parents mostly overestimated their performance. Willingness to use a device in an actual emergency depended on the device.
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Mutations within the Kv7.2 and Kv7.3 genes are well described causes for genetic childhood epilepsies. Knowledge on these channels in acquired focal epilepsy, especially in mesial temporal lobe epilepsy (mTLE), however, is scarce. Here, we used the rat pilocarpine model of drug-resistant mTLE to elucidate both expression and function by quantitative polymerase-chain reaction, immunohistochemistry, and electrophysiology, respectively. We found transcriptional downregulation of Kv7.2 and Kv7.3 as well as reduced Kv7.2 expression in epileptic CA1. Consequences were altered synaptic transmission, hyperexcitability which consisted of epileptiform afterpotentials, and increased susceptibility to acute GABAergic disinhibition. Importantly, blocking Kv7 channels with XE991 increased hyperexcitability in control tissue, but not in chronically epileptic tissue suggesting that the Kv7 deficit had precluded XE991 effects in this tissue. Conversely, XE991 resulted in comparable reduction of the paired-pulse ratio in both experimental groups implying preserved presynaptic Kv7.2 function of Schaffer collateral terminals. Consistent with Kv7.2/7.3 downregulation, the Kv7.3 channel opener ß-hydroxybutyrate failed to mitigate hyperexcitability. Our findings demonstrate that compromised Kv7 function is not only relevant in genetic epilepsy, but also in acquired focal epilepsy. Moreover, they help explain reduced anti-seizure efficacy of Kv7 channel openers in drug-resistant epilepsy.
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Epilepsia del Lóbulo Temporal , Animales , Niño , Humanos , Ratas , Regulación hacia Abajo , Epilepsia del Lóbulo Temporal/inducido químicamente , Epilepsia del Lóbulo Temporal/genética , Epilepsia del Lóbulo Temporal/metabolismo , Potenciales de la Membrana , Pilocarpina , Canal de Potasio KCNQ2/genética , Canal de Potasio KCNQ3/genéticaRESUMEN
OBJECTIVES: Complementary and alternative medicine (CAM) has gained increasing attention as a supportive treatment for chronic diseases such as epilepsy, migraine, autism, and cancer in children. This study aimed to determine the frequency, motivation, and outcomes of CAM in children with functional constipation. METHODS: From January 2018 till September 2019, parents of patients (0-18 years) who were treated for functional constipation (ROME IV-criteria) at our colorectal center were asked to complete a questionnaire on the utilization of CAM. Demographic data and clinical assessments were documented and analyzed for patients with and without CAM treatment. RESULTS: A total of 115 patients were included (mean age: 5.1 years; 49% males), of whom 29 (25%) used CAM as an alternative (4/29,14%) or in addition to conventional therapy (CT), including osteopathy (48%), homeopathy (45%), and natural/herbal remedies (17%). The main reason parents reported for the use of CAM was the urge to leave no treatment option unattempted (76%). Multivariate analysis also identified persistent constipation under CT (72%), adverse effects of CT (24%), and parental use of CAM themselves (83%) as independent variables associated with CAM use. Parents reported positive changes in stool frequency (38%) and fecal incontinence (21%) with CAM. The vast majority (93%) plan to use CAM in the future, and even non-CAM users showed high interest (60%). CONCLUSION: One in four children with functional constipation receives CAM. Significant improvement in stool frequency and continence is missing in the majority. However, parental interest in CAM remains high. Physicians should be aware of CAM when counseling families for functional constipation in children.
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Terapias Complementarias , Epilepsia , Niño , Masculino , Humanos , Preescolar , Femenino , Padres/psicología , Encuestas y Cuestionarios , Estreñimiento/terapiaRESUMEN
OBJECTIVE: The aim was to investigate the monitoring, interventions, and occurrence of critical, potentially life-threatening incidents in patients with Dravet syndrome (DS) and caregivers' knowledge about sudden unexpected death in epilepsy (SUDEP). METHODS: This multicenter, cross-sectional study of patients with DS and their caregivers in Germany consisted of a questionnaire and prospective diary querying the disease characteristics and demographic data of patients and caregivers. RESULTS: Our analysis included 108 questionnaires and 82 diaries. Patients with DS were 49.1% male (n = 53), with a mean age of 13.5 (SD ± 10.0 years) and primary caregivers were 92.6% (n = 100) female, with a mean age of 44.7 (SD ± 10.6 years). Monitoring devices were used regularly by 75.9% (n = 82) of caregivers, and most monitored daily/nightly. Frequently used devices were pulse oximeters (64.6%), baby monitors (64.6%), thermometers (24.1%), and Epi-Care (26.8%). Younger caregiver and patient age and history of status epilepticus were associated with increased use of monitoring, and 81% of monitor users reported having avoided a critical incident with nocturnal monitoring. The need for resuscitation due to cardiac or respiratory arrest was reported by 22 caregivers (20.4%), and most cases (72.7%) were associated with a seizure. Caregivers reported frequently performing interventions at night, including oropharyngeal suction, oxygenation, personal hygiene, and change of body position. Most caregivers were well informed about SUDEP (n = 102; 94%) and monitored for a lateral or supine body position; however, only 39.8% reported receiving resuscitation training, whereas 52.8% (n = 57) knew what to do in case the child's breathing or heart activity failed. SIGNIFICANCE: Critical incidents and the need for resuscitation are reported frequently by caregivers and may be related to high mortality and SUDEP rates in DS. Resuscitation training is welcomed by caregivers and should be continuously provided. Oxygen monitoring devices are frequently used and considered useful by caregivers.
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Epilepsias Mioclónicas , Muerte Súbita e Inesperada en la Epilepsia , Niño , Humanos , Masculino , Femenino , Adolescente , Adulto , Cuidadores , Estudios Prospectivos , Estudios Transversales , Muerte Súbita/epidemiología , Muerte Súbita/etiología , Epilepsias Mioclónicas/terapia , Alemania/epidemiologíaRESUMEN
We aimed to explore parents' perceptions of their children's medication use for inborn errors of metabolism (IEM), including the importance of medication intake, potential complications, and concerns about adverse drug reactions (ADR). Additionally, we aimed to determine expert-assessed clinically relevant drug-related problems, particularly those attributable to IEM. We interviewed 108 parents of 119 pediatric patients with IEM using a questionnaire relating to their perceptions regarding their children's IEM medication. In affected siblings, a questionnaire was used for each child. We performed medication analyses to evaluate the patient's complete medication regimen for clinically relevant drug-related problems, including medication for conditions other than IEM. It was very important to the parents of 85% of the patients to use IEM medication exactly as prescribed. The parents of 41% of patients perceived complications in their children's use of IEM medication. The parents of 47% of patients reported fears concerning ADR because of IEM medication. Parents observed ADR in 27% of patients because of IEM medication. In 44% of patients, medication for conditions other than IEM was inadequate because of drug-related problems not associated with the IEM; a safe alternative existed in 21% of patients. In summary, almost half of the parents of patients with IEM reported complications with their child's IEM medication intake and fears of ADR. Medication analyses showed that drug-related problems occurred regardless of IEM, emphasizing the general need to prescribe and dispense adequate, child-appropriate medication to minimize clinically relevant drug-related problems in pediatric patients.
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BACKGROUND: Parents of pediatric patients with type I diabetes require competence in hypoglycemia management and skills in glucagon administration to deal with potentially life-threatening severe hypoglycemia. We aimed to compare parents' subjective self-ratings to an objective expert assessment of competences and skills in dealing with severe hypoglycemia. METHODS: We interviewed 140 participants to assess their subjective self-ratings. The objective expert assessments used a standardized clinical case scenario of severe hypoglycemia and a practical demonstration of glucagon administration. RESULTS: The participants self-rated their competence in hypoglycemia management as good (5) or very good (6), and their skills in administering glucagon as acceptable (3) [Scale: very poor (1) to very good (6)]. In the standardized clinical case scenario, 1.4% (2/140) of participants named all relevant steps of severe hypoglycemia management. In the practical demonstration of glucagon administration, 92.9% (130/140) of participants committed at least one drug handling error; 52.1% (73/140) committed at least one drug handling error rated with high clinical risk. CONCLUSIONS: We found discrepancies regarding participants' subjective self-ratings compared to their performance in the respective objective expert assessments. These discrepancies indicate a lack of error awareness and the need for intervention studies to improve competence in hypoglycemia management and glucagon administration.
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BACKGROUND: Children are often treated off-label and are at a disadvantage in pharmacotherapy. The aim of this study was to implement and evaluate a quality assurance measure (PaedPharm) for pediatric pharmacotherapy whose purpose is to reduce medication-related hospitalizations among children and adolescents. METHODS: PaedPharm consisted of the digital pediatric drug information system PaedAMIS, pediatric pharmaceutical quality circles (PaedZirk), and an adverse drug event (ADE) reporting system (PaedReport). The intervention was implemented in a cluster-randomized trial (DRKS 00013924) in 12 regions, with a pediatric and adolescent medicine clinic in each and a total of 152 surrounding private practitioners, in 6 sequences over 8 quarters. In addition to the proportion of ADE-related hospital admissions (primary endpoint), comprehensive process evaluation included other endpoints such as coverage, user acceptance, and relevance to practice. RESULTS: 41 829 inpatient admissions were recorded, of which 5101 were patients of physicians who participated in our study. 4.1% of admissions were ADE-related under control conditions, and 3.1% under intervention conditions (95% CI: [2.3; 5.9] and [1.8; 4.5], respectively). A model-based comparison yielded an intervention effect of 0.73 (population-based odds ratio; [0.39; 1.37]; p = 0.33). PaedAMIS achieved moderate user acceptance and PaedZirk achieved high user acceptance. CONCLUSION: The introduction of PaedPharm was associated with a decrease in medication-related hospitalizations that did not reach statistical significance. The process evaluation revealed broad acceptance of the intervention in outpatient pediatrics and adolescent medicine.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hospitalización , Adolescente , Niño , Humanos , Hospitales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & controlRESUMEN
BACKGROUND: This study measured sleep quality among caregivers of patients with Dravet syndrome (DS) and assessed the impacts of mental health problems and caregiver burden on sleep quality. METHODS: This multicenter, cross-sectional study of patients with DS and their caregivers throughout Germany consisted of a questionnaire and a prospective 4-week diary querying disease characteristics, demographic data, living conditions, nocturnal supervision, and caregivers' work situations. Sleep quality was assessed using the Pittsburgh Sleeping Quality Index (PSQI). The Hospital Anxiety and Depression Scale (HADS) and the Burden Scale for Family Caregivers (BSFC) were used to measure anxiety, symptoms of depression, and caregiver burden. RESULTS: Our analysis included 108 questionnaires and 82 four-week diaries. Patients with DS were 49.1% male (n = 53), with a mean age of 13.5 ± 10.0 years. Caregivers were 92.6% (n = 100) female, with a mean age of 44.7 ± 10.6 years. The overall mean PSQI score was 8.7 ± 3.5, with 76.9% of participants (n = 83) scoring 6 or higher, indicating abnormal sleep quality. The HADS for anxiety and depression had overall mean scores of 9.3 ± 4.3 and 7.9 ± 3.7, respectively; 61.8% and 50.9% of participants scored above the cutoff value of 8 for anxiety and depression, respectively. Statistical analyses revealed caregiver anxiety levels and patients' sleep disturbances as major factors influencing PSQI scores. The overall mean BSFC score of 41.7 ± 11.7 indicates a moderate burden, with 45.3% of caregivers scoring 42 or higher. CONCLUSIONS: Sleep quality is severely affected among caregivers of patients with DS, correlating with anxiety, comorbidities, and patients' sleep disturbances. A holistic therapeutic approach should be implemented for patients with DS and their caregivers, focusing on the sleep quality and mental health of caregivers. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00016967. Registered 27 May 2019, http://www.drks.de/DRKS00016967.
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Epilepsias Mioclónicas , Trastornos del Sueño-Vigilia , Humanos , Masculino , Femenino , Preescolar , Niño , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Calidad de Vida/psicología , Carga del Cuidador , Calidad del Sueño , Depresión/psicología , Estudios Transversales , Estudios Prospectivos , Ansiedad , Cuidadores/psicología , Encuestas y Cuestionarios , Alemania , Atención al PacienteRESUMEN
BACKGROUND: Owing to complex treatment, critically ill children may experience alterations in their vital parameters. We investigated whether such hemodynamic alterations were temporally and causally related to drug therapy. METHODS: In a university pediatric intensive care unit, we retrospectively analyzed hemodynamic alterations defined as values exceeding the limits set for heart rate (HR) and blood pressure (BP). For causality assessment, we used the World Health Organization-Uppsala Monitoring Center (WHO-UMC) system, which categorizes the probability of causality as "certain," "probable," "possible," and "unlikely." RESULTS: Of 315 analyzed patients with 43,200 drug prescriptions, 59.7% experienced at least one hemodynamic alteration; 39.0% were affected by increased HR, 19.0% by decreased HR, 18.1% by increased BP, and 16.2% by decreased BP. According to drug information databases, 83.9% of administered drugs potentially lead to hemodynamic alterations. Overall, 88.3% of the observed hemodynamic alterations had a temporal relation to the administration of drugs; in 80.2%, more than one drug was involved. Based on the WHO-UMC system, a drug was rated as a "probable" causing factor for only 1.4% of hemodynamic alterations. For the remaining alterations, the probability ratings were lower because of multiple potential causes, e.g., several drugs. CONCLUSIONS: Critically ill children were frequently affected by hemodynamic alterations. The administration of drugs with potentially adverse effects on hemodynamic parameters is often temporally related to hemodynamic alterations. Hemodynamic alterations are often multifactorial, e.g., due to administering multiple drugs in rapid succession; thus, the influence of individual drugs cannot easily be captured with the WHO-UMC system.
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Enfermedad Crítica , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Humanos , Niño , Presión Sanguínea , Frecuencia Cardíaca , Estudios Retrospectivos , Cuidados CríticosRESUMEN
To assess the use of oral contraceptives (OC) in adolescents, using data from a longitudinal, population-based pediatric cohort study (LIFE Child). We also investigated associations between OC use and socioeconomic status (SES), and associations between OC use and potential adverse drug reactions such as effects on blood pressure. We included 609 female participants of the LIFE Child cohort, aged ≥13 to <21 years, who visited the study center between 2012 and 2019. Data collection compromised drug use in the past 14 days, SES, and anthropometric data such as blood pressure. An analysis of covariance was used to detect potential associations between participants' blood pressure and OC. Multivariate binary logistic regression was used to obtain odds ratios (aOR) adjusted for age and 95% confidence intervals (95% CI). The prevalence of OC use was 25.8%. OC intake was less common in participants with a high SES (aOR 0.30, 95% CI 0.15, 0.62). The mean age at OC initiation did not change between 2012 and 2019. We observed an increased use of second-generation OC (2013: 17.9%, 2019: 48.5%; p = 0.013) and a decreased use of fourth-generation OC (2013: 71.8%, 2019: 45.5%; p = 0.027). We found a higher systolic (mean: 111.74 mmHg, p < 0.001) and diastolic (69.15 mmHg, p = 0.004) blood pressure in OC users compared to non-users (systolic: 108.60 mmHg; diastolic: 67.24 mmHg). Every fourth adolescent took an OC. The share of second-generation OC increased during the study period. OC intake was associated with low SES. OC users had a slightly higher blood pressure than non-users.
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AIM: Chronic conditions can influence the situation of healthy siblings of affected children. We investigated the opinion of the affected child about the situation of their healthy sibling and the sibling relationship. METHODS: We performed a semi-structured interview with epilepsy or asthma patients aged 6-18 years and asked them to draw a picture: "Epilepsy/Asthma, my siblings and me." RESULTS: Of the 58 children with epilepsy, 67%, and of the 40 children with asthma, 60% thought that their siblings were worried about the condition. Among other aspects, they addressed helplessness during a seizure. Of the children with epilepsy, 83% and of those with asthma, 95% assumed that their siblings were not disadvantaged because of the participant's condition. Of the patients with epilepsy, 91% and of those with asthma, 93% thought that the sibling relationship would not be different without the condition. Of the participants with epilepsy, 86% and of those with asthma, 93% drew a picture; 30% with epilepsy and 14% with asthma visualised an interaction with their siblings in context of a seizure or episode of dyspnoea. CONCLUSION: According to the affected children, the condition worries their siblings but does not affect the siblings' lives or the sibling relationship.
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Asma , Epilepsia , Humanos , Niño , Adolescente , Hermanos , Relaciones entre Hermanos , ConvulsionesRESUMEN
OBJECTIVE: Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest antiseizure effects also beyond these three epilepsy syndromes. METHODS: In a retrospective multicenter study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers. RESULTS: The study cohort comprised 311 patients with epilepsy with a median age of 11.3 (0-72) years (235 children and adolescents, 76 adults). Therapy with CBD was off-label in 91.3% of cases due to age, epilepsy subtype, lack of adjunct therapy with clobazam, and/or higher dose applied. CBD titration regimens were slower than recommended, with good tolerability of higher doses particularly in children. Of all patients, 36.9% experienced a reduction in seizure frequency of >50%, independent of their epilepsy subtype or clobazam co-medication. The median observation period was 15.8 months. About one third of all patients discontinued therapy within the observation period due to adverse effects or lack of efficacy. Adverse effects were reported frequently (46.9%). SIGNIFICANCE: Our study highlights that CBD has an antiseizure effect comparable to other antiseizure medications with a positive safety profile independent of the epilepsy subtype. Comedication with clobazam was not associated with a better outcome. Higher doses to achieve seizure frequency reduction were safe, particularly in children. These findings call for further trials for an extended approval of CBD for other epilepsy subtypes and for children <2 years of age.
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Cannabidiol , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Epilepsia , Niño , Adulto , Adolescente , Humanos , Adulto Joven , Persona de Mediana Edad , Anciano , Cannabidiol/uso terapéutico , Anticonvulsivantes , Estudios Retrospectivos , Epilepsia/tratamiento farmacológico , Convulsiones/tratamiento farmacológico , Clobazam/uso terapéutico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/tratamiento farmacológicoRESUMEN
BACKGROUND: The development and approval of disease modifying treatments have dramatically changed disease progression in patients with spinal muscular atrophy (SMA). Nusinersen was approved in Europe in 2017 for the treatment of SMA patients irrespective of age and disease severity. Most data on therapeutic efficacy are available for the infantile-onset SMA. For patients with SMA type 2 and type 3, there is still a lack of sufficient evidence and long-term experience for nusinersen treatment. Here, we report data from the SMArtCARE registry of non-ambulant children with SMA type 2 and typen 3 under nusinersen treatment with a follow-up period of up to 38 months. METHODS: SMArtCARE is a disease-specific registry with data on patients with SMA irrespective of age, treatment regime or disease severity. Data are collected during routine patient visits as real-world outcome data. This analysis included all non-ambulant patients with SMA type 2 or 3 below 18 years of age before initiation of treatment. Primary outcomes were changes in motor function evaluated with the Hammersmith Functional Motor Scale Expanded (HFMSE) and the Revised Upper Limb Module (RULM). RESULTS: Data from 256 non-ambulant, pediatric patients with SMA were included in the data analysis. Improvements in motor function were more prominent in upper limb: 32.4% of patients experienced clinically meaningful improvements in RULM and 24.6% in HFMSE. 8.6% of patients gained a new motor milestone, whereas no motor milestones were lost. Only 4.3% of patients showed a clinically meaningful worsening in HFMSE and 1.2% in RULM score. CONCLUSION: Our results demonstrate clinically meaningful improvements or stabilization of disease progression in non-ambulant, pediatric patients with SMA under nusinersen treatment. Changes were most evident in upper limb function and were observed continuously over the follow-up period. Our data confirm clinical trial data, while providing longer follow-up, an increased number of treated patients, and a wider range of age and disease severity.
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Atrofia Muscular Espinal , Atrofias Musculares Espinales de la Infancia , Niño , Humanos , Estudios Prospectivos , Atrofias Musculares Espinales de la Infancia/tratamiento farmacológico , Sistema de Registros , Progresión de la Enfermedad , Extremidad SuperiorRESUMEN
Children and adolescents are exposed to medicines and supplements, but only a few studies have evaluated the actual intake in routine care. Thus, we performed a pharmacoepidemiological evaluation of a longitudinal population-based pediatric cohort study (LIFE Child) conducted at the University Hospital of Leipzig between 2014 and 2019. We analyzed all visits of the participants of the LIFE Child cohort between 1 January 2014 and 31 December 2019. Participants were asked to bring their medicines and supplements to their appointments at the study center. If they had not brought the preparations with them, attempts were made to obtain the relevant information during a telephone call after the visit to the study center. Furthermore, the participants and their parents were interviewed on medicine and supplement use and on sociodemographic and socioeconomic data during their visit to the study center. Associations of medicine and supplement use with age, sex, and socioeconomic status were analyzed using multivariate binary logistic regressions to obtain adjusted odds ratios (aOR) and 95% confidence intervals (95% CI). Furthermore, the number of the respective visit was included as possible confounder in the multivariate model. We included 3602 participants who visited the study center 11,906 times. The intake of 9759 medicines and supplements was recorded. Based on the evaluation of all study visits, 49% of the children and adolescents took at least one medicine or supplement. Self-medication accounted for 28% of the medicines and supplements. The prevalence of overall intake increased from 45% in 2014 to 53% in 2019 (aOR 2.63, 95% CI 2.23, 3.09). The prevalence was the highest (77%) in children aged 0- < 3 years, owing mainly to vitamin D. The prevalence of medicine use was higher in females (40%; aOR 1.18, 95% CI 1.10, 1.28) than in males (35%), owing mainly to the intake of ibuprofen and hormonal contraceptives in adolescent females. A high socioeconomic status was a predictor of lower medicine (aOR 0.80, 95% CI 0.68, 0.95) and higher supplement (aOR 1.47, 95% CI 1.09, 1.98) use. CONCLUSION: Half of all children and adolescents took at least one medicine or supplement. The intake varied depending on age and sex. Furthermore, high socioeconomic status was associated with a decreased probability of medicine intake. WHAT IS KNOWN: ⢠Half of all children and adolescents in Germany are exposed to medicines and supplements. ⢠Data on the actual intake are scarce as most studies focus on prescribed medicines. WHAT IS NEW: ⢠The prevalence of medicine/supplement use rose from 2014 (45%) to 2019 (53%). The prevalence was age-dependent: it was the highest in children aged < 3 years, and the lowest in children aged 6-< 9 years. Females took medicines more frequently than males. ⢠High socioeconomic status was associated with lower medicine and higher supplement use. Self-medication accounted for 28% of all preparations.
Asunto(s)
Suplementos Dietéticos , Vitaminas , Adolescente , Niño , Estudios de Cohortes , Femenino , Humanos , Lactante , Masculino , Clase Social , Vitamina D/uso terapéuticoRESUMEN
OBJECTIVES: This study aimed to compare assessment methods to determine adverse drug reactions (ADRs) at nonelective hospital admission in pediatric patients, to investigate the interrater reliability of assessment methods in pediatric care, and to analyze symptoms related to ADRs and (suicidal) drug intoxications. METHODS: For 1 year, the medical records of nonelective patients admitted to a university pediatric department were evaluated for potential ADRs using 4 assessments methods by 1 experienced rater. Krippendorff α was calculated from a sample of 14 patients evaluated by 4 experienced raters to determine interrater reliability. RESULTS: In 1831 nonelective hospital admissions, 63.4% (1161 of 1831) of patients had received at least one drug before admission. We found a potential causal relationship between drugs and symptoms documented at admission and thus potential ADRs according to Naranjo in 23.3% (271 of 1161) of those patients, World Health Organization - Uppsala Monitoring Centre (WHO-UMC) in 22.5% (261 of 1161), Koh in 21.7% (252 of 1161), and Begaud in 16.5% (192 of 1161). The probability rating of the potential causal relationships varied considerably between the methods (Naranjo-Begaud, P < 0.01; Naranjo-Koh, P < 0.001; Koh-Begaud, P < 0.01; Begaud-WHO-UMC, P < 0.01). Acceptable interrater reliability (α ≥ 0.667) was only obtained for WHO-UMC (α = 0.7092). The most frequently identified definite ADR was sedation in 1.5% of all nonelective patients with medication before hospital admission. In 1.2% (22 of 1831) of all nonelective admissions, we found drug intoxications with suicidal intent. CONCLUSIONS: The assessment methods showed a high variability in the determination of a potential causal relationship between drug and documented symptom, in the classification of the probability of ADRs, and suboptimal interrater reliability. Thus, their feasibility in pediatric patients is limited.
Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Adolescente , Niño , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/diagnóstico , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/etiología , Hospitalización , Hospitales , Humanos , Reproducibilidad de los ResultadosRESUMEN
Experienced drug-handling problems and inadequately considered expectations for drug therapy have an unfavorable influence on therapy. We performed a questionnaire survey in (i) parents of 0-5-year-old children and (ii) 6-17-year olds and their parents. We assessed (A) experienced drug-handling problems and (B) expectations for drug therapy. (i) Forty-six parents and (ii) 103 children and their parents participated in the study. Experienced drug-handling problems were described by (i) 100% of parents and (ii) 62% of children and 70% of parents. Problems concerned with the preparation of the drug, dosing, compliance with the time interval, and acceptance. (i) Sixty-five percent of parents preferred a peroral route of drug administration, while (ii) 74% of children and 86% of parents did so. Preferred characteristics of peroral drug formulations, e.g., liquid versus solid drug formulations or flavor, were highly heterogeneous. Preferences of 6-17-year-old children and their parents matched in 43 to 66%. Conclusion: Most children and their parents had already experienced drug-handling problems. Preferences concerning the ideal pediatric drug were highly heterogeneous and in about half of cases, preferences of children and their parents differed. Thus, the children should be approached directly. If information is solely gained from parents, the children's needs might remain unmet. What is Known: ⢠Pediatric drug administration is complex and therefore error-prone. ⢠Experiences and expectations of children and their parents should be considered. What is New: â¢Most pediatric patients and their parents have already experienced drug-handling problems. ⢠Expectations concerning the ideal pediatric drug are highly heterogeneous. Parents are often insufficiently aware of those expectations in their children.