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      Perinatal encephalopathy, the syndrome of intracranial hypertension and associated diagnostic labels in the Commonwealth of Independent States: a systematic review

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          Abstract

          Background

          The WHO reports excessive rates of ill-defined neurological diagnoses and ineffective and potentially harmful drug treatments in children in the Commonwealth of Independent States (CIS). Collectively termed perinatal encephalopathy and the syndrome of intracranial hypertension (PE-SIH), these diagnoses are important contributors to perceived childhood morbidity and disability in the CIS. A systematic compilation of information on PE-SIH is lacking.

          Methods

          We systematically reviewed publications between 1970 and 2020 on PE-SIH in Azerbaijani, English, Russian and Ukrainian languages and summarised information on PE-SIH.

          Results

          We identified 30 publications (70% in Russian) published 1976–2017. The diagnosis of PE-SIH was either based on unreported criteria (67% of reports), non-specific clinical features of typically developing children or those with common developmental disorders (20% of reports) or cranial ultrasound (13% of reports). The reported proportion of children with PE-SIH in the study samples ranged from 31% to 99%. There were few published studies on reassessments of children diagnosed with PE-SIH, and these did not confirm neurological disease in the majority of children. Treatments included multiple unlicenced drugs without established effectiveness and with potential unwanted effects.

          Conclusion

          This review suggests that PE-SIH is a medical diagnostic label that is used in numerous children without substantive associated disease. The diagnosis and treatment of PE-SIH is a multidimensional, iatrogenic, clinical and public health problem in the CIS. With increasing use of evidence-based medicine guidelines in the region, it is hoped that PE-SIH will gradually disappear, but actions to accelerate this change are nevertheless needed.

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          Most cited references 36

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          Quality of hospital care for children in Kazakhstan, Republic of Moldova, and Russia: systematic observational assessment.

          Major concerns about the quality of basic hospital care for children have been raised in developing countries, but no formal assessment applying international standards has been done in the Commonwealth of Independent States. We assessed 17 hospitals in Kazakhstan, the Republic of Moldova, and the Russian Federation with a generic WHO hospital assessment framework adapted for use in the WHO European region. WHO management guidelines for paediatric care in peripheral hospitals were used as standards. Hospital access for children was generally good. Good health networks existed, and skilled and committed doctors cared for children. Case-fatality rates were low. However, unnecessary and lengthy hospital stays were common, and most children received excessive and ineffective treatment (in one country median number of drugs prescribed concurrently was 5, IQR 2-6). Several conditions were systematically overdiagnosed, especially neurological disease, or overinvestigated, such as acute diarrhoea. Reasons for these practices included absence of clear evidence-based clinical guidelines, regulations tying duration of admission to financial reimbursement, generalisation of disease-control methods from rare problems to common illnesses, and regulations maintaining financial and professional status of some subspecialties. Many disincentives to efficient practice existed. To improve quality of hospital care for children in the Commonwealth of Independent States, several issues must be addressed, including: adoption of international guidelines for inpatient management; complementary guidelines for outpatient management; reforms to health regulations governing admission and discharge criteria; improvement of quality of training, availability of medical information, and systems to promote and certify quality of care.
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            Health of children adopted from the former Soviet Union and Eastern Europe. Comparison with preadoptive medical records.

            Children born in the countries of the former Soviet Union and Eastern Europe are now a main source of international adoptions in the United States, but often little information is available about these children prior to adoption. To analyze the preadoptive medical reports of children adopted from Eastern Europe and the former Soviet Union and to compare these reports with their evaluations after arrival in the United States. Case series. A total of 56 children adopted from Eastern Europe and the former Soviet Union were evaluated in 2 international adoption clinics. Preadoptive medical records were available for 47 of these children. There were 43 (91%) of 47 medical reports available from the children's birth countries that included multiple unfamiliar neurologic diagnoses. Evaluations in the International Adoption Clinics frequently revealed growth delays (zscore < or = -1 for weight in 44% of children, height in 68%, and head circumference in 43%). Children had 1 month of linear growth lag for every 5 months in an orphanage (r=-0.48, P<.001). Developmental delays were also common (gross motor delays in 70% of children, fine motor in 82%, language in 59%, and social-emotional in 53%). While serious medical problems were found or corroborated in 11 (20%) of the 56 children evaluated in our clinics, neurologic diagnoses cited in preadoptive medical reports were not confirmed. Preadoptive medical records from these international adoptees included multiple diagnoses suggesting severe neurologic impairment. Although these diagnoses were not confirmed when the children were evaluated in the United States, substantial growth and developmental delays were identified.
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              Prophylactic drug management for febrile seizures in children

              Febrile seizures occurring in a child older than one month during an episode of fever affect 2% to 4% of children in Great Britain and the United States and recur in 30%. Rapid‐acting antiepileptics and antipyretics given during subsequent fever episodes have been used to avoid the adverse effects of continuous antiepileptic drugs. To evaluate primarily the effectiveness and safety of antiepileptic and antipyretic drugs used prophylactically to treat children with febrile seizures; but also to evaluate any other drug intervention where there was a sound biological rationale for its use. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2016, Issue 7); MEDLINE (1966 to July 2016); Embase (1966 to July 2016); Database of Abstracts of Reviews of Effectiveness (DARE) (July 2016). We imposed no language restrictions. We also contacted researchers in the field to identify continuing or unpublished studies. Trials using randomised or quasi‐randomised participant allocation that compared the use of antiepileptic, antipyretic or other plausible agents with each other, placebo or no treatment. Two review authors (RN and MO) independently applied predefined criteria to select trials for inclusion and extracted the predefined relevant data, recording methods for randomisation, blinding and exclusions. For the 2016 update a third author (MC) checked all original inclusions, data analyses, and updated the search. Outcomes assessed were seizure recurrence at 6, 12, 18, 24, 36, and 48 months and at age 5 to 6 years in the intervention and non‐intervention groups, and adverse medication effects. We assessed the presence of publication bias using funnel plots. We included 40 articles describing 30 randomised trials with 4256 randomised participants. We analysed 13 interventions of continuous or intermittent prophylaxis and their control treatments. Methodological quality was moderate to poor in most studies. We found no significant benefit for intermittent phenobarbitone, phenytoin, valproate, pyridoxine, ibuprofen or zinc sulfate versus placebo or no treatment; nor for diclofenac versus placebo followed by ibuprofen, acetaminophen or placebo; nor for continuous phenobarbitone versus diazepam, intermittent rectal diazepam versus intermittent valproate, or oral diazepam versus clobazam. There was a significant reduction of recurrent febrile seizures with intermittent diazepam versus placebo or no treatment, with a risk ratio (RR) of  0.64 (95% confidence interval (CI) 0.48 to 0.85 at six months), RR of 0.69 (95% CI 0.56 to 0.84) at 12 months, RR 0.37 (95% CI 0.23 to 0.60) at 18 months, RR 0.73 (95% CI 0.56 to 0.95) at 24 months, RR 0.58 (95% CI 0.40 to 0.85) at 36 months, RR 0.36 (95% CI 0.15 to 0.89) at 48 months, with no benefit at 60 to 72 months. Phenobarbitone versus placebo or no treatment reduced seizures at 6, 12 and 24 months but not at 18 or 72 month follow‐up (RR 0.59 (95% CI 0.42 to 0.83) at 6 months; RR 0.54 (95% CI 0.42 to 0.70) at 12 months; and RR 0.69 (95% CI 0.53 to 0.89) at 24 months). Intermittent clobazam compared to placebo at six months resulted in a RR of 0.36 (95% CI 0.20 to 0.64), an effect found against an extremely high (83.3%) recurrence rate in the controls, which is a result that needs replication. The recording of adverse effects was variable. Lower comprehension scores in phenobarbitone‐treated children were found in two studies. In general, adverse effects were recorded in up to 30% of children in the phenobarbitone‐treated group and in up to 36% in benzodiazepine‐treated groups. We found evidence of publication bias in the meta‐analyses of comparisons for phenobarbitone versus placebo (eight studies) at 12 months but not at six months (six studies); and valproate versus placebo (four studies) at 12 months, with too few studies to identify publication bias for the other comparisons. Most of the reviewed antiepileptic drug trials are of a methodological quality graded as low or very low. Methods of randomisation and allocation concealment often do not meet current standards; and treatment versus no treatment is more commonly seen than treatment versus placebo, leading to obvious risks of bias. Trials of antipyretics and zinc were of higher quality. We found reduced recurrence rates for children with febrile seizures for intermittent diazepam and continuous phenobarbitone, with adverse effects in up to 30%. Apparent benefit for clobazam treatment in one trial needs to be replicated to be judged reliable. Given the benign nature of recurrent febrile seizures, and the high prevalence of adverse effects of these drugs, parents and families should be supported with adequate contact details of medical services and information on recurrence, first aid management and, most importantly, the benign nature of the phenomenon. Prophylactic drug management for febrile seizures in children Background Seizures occurring with a fever in children are common and affect about one in thirty under the age of six years. On average, one out of three children who have had a febrile seizure will have at least one more. We reviewed the evidence about the effect of drugs to prevent seizures (antiepileptics), drugs to lower temperature (antipyretics) and zinc on children with febrile seizures. Objective We wanted to know in how many children these drugs would prevent a recurrence or bring unwanted effects. Methods We included 30 studies with a total of 4256 children in the review. Children who had had at least one febrile seizure were put into groups who either had the study treatment or not. The studies recorded any further seizures at various time intervals between 6 months and up to 6 years of age in each group. Unwanted medication effects were also noted. Results The quality of study design and evidence provided by these studies was often low or very low for the antiepileptic drugs. Poor methods known to lead to obvious risks of bias were used. This was to do with the way children were put in each group and how random this allocation was. Other issues included whether the parents and/or doctors knew which group each child was in or perhaps if the study was of treatment compared to no treatment. The quality of trials of antipyretics or zinc was better, with the evidence graded moderate to high. Zinc therapy gave no benefit. Nor was there benefit in treating children just at the time of the fever with either antipyretic drugs or most antiepileptic drugs. At times a significant result was noted. In statistics this means there was a less than 1 in 20 chance of this happening by chance. For example, at times between 6 and 48 months follow‐up, intermittent diazepam (an antiepileptic drug) led to a reduction in the number of recurrent seizures by about a third. Continuous phenobarbitone resulted in significantly fewer recurrences at 6, 12 and 24 months, but not at 18 and 60 to 72 months However, as recurrent seizures are only seen in about a third of children anyway this means that up to 16 children would have to be treated over a year or two to save just one child a further seizure. As febrile seizures are not harmful we viewed these significant findings (in the statistical sense) to be unimportant. This is particularly so as adverse effects of the medications were common. Lower comprehension scores in phenobarbitone‐treated children were found in two studies. In general, adverse effects were recorded in up to about a third of children in both the phenobarbitone and benzodiazepine‐treated groups. The benefit found for treatment with clobazam in one study published in 2011 needs to be repeated to show that this finding is reliable. Author’s conclusions Neither continuous nor intermittent treatment with zinc, antiepileptic or antipyretic drugs can be recommended for children with febrile seizures. Febrile seizures can be frightening to witness. Parents and families should be supported with adequate contact details of medical services and information on recurrence, first aid management and, most importantly, the benign nature of the phenomenon. The evidence is current to 21 July 2016.
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                Author and article information

                Journal
                Arch Dis Child
                Arch. Dis. Child
                archdischild
                adc
                Archives of Disease in Childhood
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0003-9888
                1468-2044
                October 2020
                12 June 2020
                : 105
                : 10
                : 921-926
                Affiliations
                [1 ] departmentDepartment of Pediatrics Developmental Pediatrics Division , Ankara University Faculty of Medicine , Ankara, Turkey
                [2 ] departmentDepartment of Medical Rehabilitation , Baku Children's Rehabilitation Centre , Baku, Azerbaijan
                [3 ] departmentClinical Neurosciences , University of Southampton Faculty of Medicine , Southampton, UK
                [4 ] departmentDepartment of Pediatrics , Yale University School of Medicine , New Haven, Connecticut, USA
                [5 ] departmentRegional Office for Europe , World Health Organization , Copenhagen, Denmark
                Author notes
                [Correspondence to ] Dr Revan Mustafayev, Department of Pediatrics Developmental Pediatrics Division, Ankara University Faculty of Medicine, Ankara 06620, Turkey; revanmus@ 123456hotmail.com
                Article
                archdischild-2018-315994
                10.1136/archdischild-2018-315994
                7513255
                32532707
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

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