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Aim: To study if functional electrical stimulation (FES) of the peroneal nerve, which activates dorsiflexion, can improve body functions, activities, and participation and could be an effective alternative treatment in individuals with unilateral spastic cerebral palsy (CP). Method: A randomized cross‐over trial was performed in 25 children with unilateral spastic CP (classified in Gross Motor Function Classification System levels I and II) aged 4 to 18 years (median age at inclusion 9 years 8 months, interquartile range = 7 years–13 years 8 months), 15 patients were male. The study consisted of two 12‐week blocks of treatment, that is, conventional treatment (ankle foot orthosis [AFO] or adapted shoes) and FES, separated by a 6‐week washout period. Outcome measures included the Goal Attainment Scale (GAS), the Cerebral Palsy Quality of Life questionnaire, and a three‐dimensional gait analysis. Results: Eighteen patients completed the trial. The proportion of GAS goals achieved was not significantly higher in the FES versus the conventional treatment phase (goal 1 p = 0.065; goal 2 p = 1.00). When walking while stimulated with FES, ankle dorsiflexion during mid‐swing decreased over time (p = 0.006, average decrease of 4.8° with FES), with a preserved increased ankle range of motion compared to conventional treatment (p < 0.001, mean range of motion with FES +10.1° compared to AFO). No changes were found in the standard physical examination or regarding satisfaction with orthoses and feelings about the ability to dress yourself. In four patients, FES therapy failed; in 12 patients FES therapy continued after the trial. Interpretation: FES is not significantly worse than AFO; however, patient selection is critical, and a testing period and thorough follow‐up are needed. [ABSTRACT FROM AUTHOR]

Aim: To investigate spoken language comprehension (SLC), single‐word comprehension (SWC), functional communication development, and their determinants, in children with cerebral palsy. Method: This was a prospective cohort study in the Netherlands spanning 2 years 6 months. The main outcomes were SLC and SWC, assessed by the Computer‐Based instrument for Low motor Language Testing (C‐BiLLT) and the Peabody Picture Vocabulary Test‐III‐NL (PPVT‐III‐NL) respectively; and functional communication, measured by a subscale of the Focus on the Outcomes of Communication Under Six‐34 (FOCUS‐34). Linear mixed models were used to determine developmental trajectories, which were compared with norm and reference data. Potential determinants, for example intellectual functions, speech production, functional communication level (classified with the Communication Function Classification System, CFCS), and functional mobility, were added to assess their effects. Results: Children with cerebral palsy (n = 188; mean age 59 months, range 17–110) were monitored for 2 years 6 months. Developmental trajectories for SLC (C‐BiLLT) and SWC (PPVT‐III‐NL) were nonlinear; those for functional communication (FOCUS‐34) were linear. Compared with norm and reference groups, significantly delayed SLC, SWC, and functional communication development were found. Determinants for SLC and SWC were intellectual functions and functional communication level (CFCS); and for functional communication development (FOCUS‐34), speech production and arm–hand functioning. Interpretation: Children with cerebral palsy showed delayed SLC, SWC, and functional communication development compared with norm and reference groups. Remarkably, functional mobility was not associated with the development of SLC, SWC, or functional communication. What this paper adds: Children with cerebral palsy have delayed spoken language comprehension (SLC), single‐word comprehension (SWC), and functional communication development, compared to norm and reference data.Determinants for SLC and SWC development are intellectual functions and functional communication level.Determinants for functional communication development are speech production and arm–hand functioning.Functional mobility is not associated with SLC, SWC, or functional communication. What this paper adds: Children with cerebral palsy have delayed spoken language comprehension (SLC), single‐word comprehension (SWC), and functional communication development, compared to norm and reference data.Determinants for SLC and SWC development are intellectual functions and functional communication level.Determinants for functional communication development are speech production and arm–hand functioning.Functional mobility is not associated with SLC, SWC, or functional communication. Video Podcast: https://youtu.be/x09Tac7tsz0 [ABSTRACT FROM AUTHOR]

Background The impact of long-term occupational exposures on health in older adults is increasingly relevant as populations age. To date, no studies have reported their impact on survival free of disability in older adults. Aims We aimed to investigate the association between long-term occupational exposure and disability-free survival (DFS), all-cause mortality and cause-specific mortality in initially healthy older adults. Methods We analysed data from 12 215 healthy participants in the ASPirin in Reducing Events in the Elderly (ASPREE) study whose mean age was 75 years. Their work history was collated with the 'ALOHA-plus JEM' (Job Exposure Matrix) to assign occupational exposures. The primary endpoint, DFS, was a composite measure of death, dementia or persistent physical disability. The secondary endpoint, mortality, was classified according to the underlying cause. Cox proportional hazard models were used to calculate hazard ratios and 95% confidence intervals, adjusted for confounders. Results A total of 1835 individuals reached the DFS endpoint during the median 4.7 years follow-up period. Both ever-high and cumulative exposure to all dusts and all pesticides during a person's working years were associated with reduced DFS. Compared to no exposure, men with high exposure to dusts and pesticides had a reduced DFS. Neither of these exposures were significantly associated with all-cause mortality. Men with high occupational exposure to solvents and women exposed to dusts experienced higher all-cause and cancer-related mortality. Conclusions Long-term occupational exposure to all dusts and pesticides was associated with a reduced DFS and increased mortality in community-dwelling healthy older adults. [ABSTRACT FROM AUTHOR]

Cerebral palsy (CP) is a major cause of childhood disability. Children with CP often lack motor skills to effectively perform activities of daily living. The aim is to assess the effectiveness of a functional intensive therapy program focused on improving individual goals in the domain of mobility and self-care in children and adolescents with CP. Thirty-five CP patients, aged 11–19 years, GMFCS I–IV, received daily 6–7 h of functional therapy for 15 days. Outcomes were assessed at baseline, immediately after the program and at three months follow-up. Significant post-intervention improvement was seen on all primary and secondary outcome measures; personal goals (GAS score; COPM performance and COPM satisfaction), daily activities (ACTIVLIM), hand function (ABILHAND-Kids), mobility (ABILOCO-Kids; GMFM-66-IS score). There was no loss to follow up during the program and after three months. At follow-up, improvements were retained except for ABILOCO and GMFM-66-IS. Functional intensive therapy appears feasible and seems to be effective in improving treatment goals focused on mobility and self-care, even in older and more severely affected children and adolescents with CP. After three months, these possible effects were still present. Short intensive functional training is feasible and showing no loss to follow up in the older and more severely affected children and adolescents with cerebral palsy (CP). Short intensive functional training appears effective in improving individual goals in children and adolescents with CP and improvements endorse three months. Short intensive functional training seems to be effective on both mobility and self-care domains of the ICF-CY. [ABSTRACT FROM AUTHOR]

Risk-reducing salpingo-oophorectomy (RRSO) is advised before 40–45 years of age for BRCA1/2 mutation carriers. This study describes the effect of RRSO on lipid determinants, hemoglobin A1c (HbA1c) and C-reactive protein (CRP). A total of 142 women with increased risk of ovarian cancer were included, 92 premenopausal and 50 postmenopausal. Serum levels of low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol and total cholesterol, triglycerides, HbA1c and CRP were determined at three points in time: before (T0) and 6 weeks (T1) and 7 months (T2) following RRSO. The Hot Flush Rating Scale was administered at the same time points. In premenopausal women, levels of HDL-cholesterol, the cholesterol ratio and HBA1c increased significantly over time, although still staying within the reference range. In this group, hot flushes increased over time (p < 0.001). In postmenopausal women, no significant changes were observed following RRSO. At T2, serum LDL-cholesterol, triglycerides, HbA1c and CRP were significantly lower in premenopausal women compared to postmenopausal women, whereas HDL was increased. Seven months after RRSO, the lipid profile in premenopausal women had changed, although still staying within the reference range. For postmenopausal women, we did not observe any significant changes. Our results do not suggest a worsening of cardiovascular risk within 7 months of RRSO. [ABSTRACT FROM AUTHOR]

The authors comment on the article "Epistemic rights and responsibilities of digital simulacra for biomedicine" by M. Cho and N. Martinez-Martin which outlines challenges and limitations of incorporating digital simulacra in healthcare. They discuss the nonhypothesis-driven approach and the principle of data minimalization, the bias-reducing potential of the approach, and the nonhypothesis-driven approach against the traditional biomedical scientific methods and the logic of clinical reasoning.

BACKGROUND: Increasingly, risk of bias tools are used to evaluate epidemiologic studies as part of evidence synthesis (evidence integration), often involving meta-analyses. Some of these tools consider hypothetical randomized controlled trials (RCTs) as gold standards. METHODS: We review the strengths and limitations of risk of bias assessments, in particular, for reviews of observational studies of environmental exposures, and we also comment more generally on methods of evidence synthesis. RESULTS: Although RCTs may provide a useful starting point to think about bias, they do not provide a gold standard for environmental studies. Observational studies should not be considered inherently biased vs. a hypothetical RCT. Rather than a checklist approach when evaluating individual studies using risk of bias tools, we call for identifying and quantifying possible biases, their direction, and their impacts on parameter estimates. As is recognized in many guidelines, evidence synthesis requires a broader approach than simply evaluating risk of bias in individual studies followed by synthesis of studies judged unbiased, or with studies given more weight if judged less biased. It should include the use of classical considerations for judging causality in human studies, as well as triangulation and integration of animal and mechanistic data. CONCLUSIONS: Bias assessments are important in evidence synthesis, but we argue they can and should be improved to address the concerns we raise here. Simplistic, mechanical approaches to risk of bias assessments, which may particularly occur when these tools are used by nonexperts, can result in erroneous conclusions and sometimes may be used to dismiss important evidence. Evidence synthesis requires a broad approach that goes beyond assessing bias in individual human studies and then including a narrow range of human studies judged to be unbiased in evidence synthesis. https://doi.org/10.1289/EHP6980, Introduction Evidence synthesis (or evidence integration) is widely used to summarize findings of epidemiologic studies of environmental and occupational exposures. Such syntheses are part of systematic reviews of observational epidemiologic [...]

Author(s): S. Buitink (corresponding author) [1, 2]; A. Corstanje [2]; H. Falcke [2, 3, 4, 5]; J. R. Hrandel [2, 4]; T. Huege [6]; A. Nelles [2, 7]; J. P. [...]

Aim: To investigate the predictive value of motor testing at 1 year for motor and mental outcome at 2 years after perinatal hypoxic-ischaemic encephalopathy (HIE) in term neonates. Method: Motor and mental outcome at 2 years was assessed with the Bayley Scales of Infant Development, 2nd edition (BSID-II) in 32 surviving children (20 males, 12 females; mean gestational age 40.2 wk, SD 1.4; mean birthweight 3217g, SD 435) participating in a prospective cohort study of HIE. The predictive value of three motor tests (Alberta Infant Motor Scale [AIMS], BSID-II, and the Neurological Optimality Score [NOS]) at 1 year was analysed, in addition to predictions based on neonatal Sarnat staging and magnetic resonance imaging (MRI). Poor motor test results were defined as an AIMS z-score of less than -2, a psychomotor developmental index of the BSID-II of less than 70, or a NOS of less than 26. Poor motor and poor mental outcome at 2 years was defined as a psychomotor developmental index or mental developmental index of the BSID-II of less than 70. Results: Twelve children, all with Sarnat grade II, had a poor motor outcome and 12 children, of whom one had Sarnat grade I, had a poor mental outcome at 2 years. Nine children had cerebral palsy, of whom five had quadriplegia, three had dyskinesia, and one had hemiplegia. Poor motor tests at 1 year increased the probability of a poor motor outcome from 71% (range 92 to 100%), and a poor mental outcome from 59% (range 77 to 100%) in children with Sarnat grade II and abnormal MRI, assessed with the AIMS and BSID-II or NOS respectively. Interpretation: Additional motor testing at 1 year improves the prediction of motor and mental outcome at 2 years in children with Sarnat grade II and abnormal MRI. (Contains 5 tables.)

To identify determinants of spoken language comprehension (SLC) in children with cerebral palsy (CP). Cross-sectional data of 207 children with CP were included: 82 toddlers (18 months–3;11 years), 59 preschool children (4;0–5;11 years), and 66 schoolchildren (6;0–8;11 years), across all Gross Motor Function Classification System (GMFCS) levels. SLC was assessed using the Computer-Based instrument for Low motor Language Testing (C-BiLLT). Potential determinants were retrieved from medical files and through parental questionnaires. Per developmental stage, multivariable regression analyses were used to assess determinants of SLC. Fifty-nine percent of the children showed below average SLC. Significant determinants for SLC differed per developmental stage. In toddlers: age, motor type, functional communication and speech function (R2 = 0.637); in preschool children: functional communication, speech function and language activities (R2 = 0.820), and in schoolchildren: functional communication, intellectual functioning and arm-hand functioning (R2 = 0.807). For all developmental stages, functional mobility was not a significant determinant. A large proportion of children with CP across all GMFCS levels have SLC impairments. Findings indicate that SLC is strongly determined by functional communication classified with CFCS. We recommend standardized assessment and monitoring of SLC in all children with CP. Children across all GMFCS levels can experience difficulties in spoken language comprehension. At all developmental stages, functional communication (classified with CFCS) is an important determinant of spoken language comprehension. Standardized assessment and monitoring of spoken language comprehension, language production, speech, and communication of all children with CP, is strongly recommended. When children show below average performances, especially in spoken language comprehension, intervening with speech and language therapy and guidance for parents, is advised. [ABSTRACT FROM AUTHOR]

To assess attainment of individual treatment goals one year after intrathecal baclofen (ITB) pump implantation in individuals with dyskinetic cerebral palsy (CP). A multi-center prospective cohort study was conducted including 34 non-walking individuals with severe dyskinetic CP, classified as Gross Motor Function Classification System (GMFCS) IV/V, aged 4–24 years, 12 months after pump implantation. The main outcome measure was Goal Attainment Scaling (GAS). Predictors of GAS results were analyzed. Complications were registered systematically. Seventy-one percent of individuals with dyskinetic CP fully achieved one or more treatment goals. One or more treatment goals were partially achieved in 97% of individuals. Two factors were found to be associated with attainment of goals: Dyskinesia Impairment Scale (DIS) score at baseline and the difference in pain score between baseline and follow-up. These two variables explain 30% of the variance in the outcome. Intrathecal baclofen is effective in achieving individual treatment goals in children and young adults with dyskinetic CP after nine to 12 months of ITB treatment. A positive outcome on treatment goals is, for a small part, associated with higher severity of dystonia at baseline and with improvement of pain during treatment. Dutch Trial Register, number NTR3642. Intrathecal baclofen treatment is effective in attainment of personal treatment goals, one year after pump implantation in patients with dyskinetic cerebral palsy. A positive outcome on treatment goals is, for a small part, related to higher severity of dystonia at the start and on improvement of pain during treatment. [ABSTRACT FROM AUTHOR]