Effectiveness of interventions for school-aged-children and adolescents with fetal alcohol spectrum disorder: a systematic review and meta-analysis.

PURPOSE: To describe allied health and educational interventions and their effectiveness for children and adolescents with fetal alcohol spectrum disorder (FASD). To appraise the quality and strength of studies. METHODS: Electronic databases were searched between 2005 and March 2022, identifying non-pharmacological studies supporting function, activity, or participation for FASD participants aged 5-18 years using any quantitative research design. Outcomes were coded using International Classification of Functioning, Disability and Health, family of Participation Related Constructs and behaviour categories. Multi-level random-effects meta-analysis examined intervention effects. Study methodological quality was evaluated using Cochrane risk of bias tools, RoBiNT, AMSTAR 2 and NHMRC Hierarchy levels of evidence. Certainty of findings were synthesised using GRADE approach. RESULTS: The systematic review included 25 studies with 735 participants, 10 of which were analysed by meta-analysis. Body function and structure, activity, behaviour, and sense of self outcomes were pooled. A small, positive effect favouring interventions was found (g = 0.29, 95% CI = 0.15-0.43), however the GRADE certainty was rated as low. No participation outcomes were identified. CONCLUSIONS: Some interventions targeting body function and structure, activity and behaviour outcomes were effective. Evidence of interventions that support children's and adolescent's participation as an outcome is lacking.Implications for rehabilitationTo address participation outcomes for children and adolescents with fetal alcohol spectrum disorder (FASD), it is important to understand their participation needs and directly measure these.Interventions identified targeted body function and structure, activity, and behaviour outcomes.Participation outcomes of children's/adolescent's attendance, involvement and preferences were not identified.A combination of individual- and context-focused interventions is recommended to maximise rehabilitation outcomes for children and adolescents with FASD.

A systematic review of video-modelling interventions for children and adolescents with attention-deficit hyperactivity disorder.

OBJECTIVE: To identify, appraise, and synthesise the evidence for video-modelling interventions for individuals with attention-deficit hyperactivity disorder (ADHD). METHOD: We searched four electronic databases. Two independent researchers screened abstracts and methodologically assessed data using the Kmet appraisal checklist. RESULTS: A total of 15 studies met the inclusion criteria (11 original studies and four follow-up studies). Of the 11 original studies, one was a randomised controlled trial, one was a controlled between-group comparative design, two were one group pre-test post-test studies, one was an experimental 2 × 2 factorial design, and six were single-case experimental design studies. Studies included 1-35 participants with ADHD aged 5-16 years. Three studies targeted behaviour, three targeted social play skills, two targeted social behaviour, one targeted social skills, one targeted goal orientation and friendship quality, targeted and one attention/comprehension of social behaviour. In four studies video-modelling was the whole intervention, with no other intervention components reported. Nine studies reported positive outcomes immediately after intervention, two studies reported mixed findings. All studies were found to have good or strong methodological quality. CONCLUSION: There is preliminary evidence to suggest video-modelling may be a promising intervention approach for targeting the social skills and behaviours of individuals with ADHD when used in conjunction with other intervention components. Future studies need to lower the risk of bias and use larger sample sizes before the efficacy of video-modelling interventions can be fully investigated.

Behavioural interventions to treat drooling in children with neurodisability: a systematic review.

AIM: To review the evidence for behavioural interventions to reduce drooling in children with neurodisability. METHOD: A detailed search in eight databases sought studies that: (1) included participants aged 0 to 18 years with neurodisability and drooling; (2) provided behavioural interventions targeting drooling or a drooling-related behaviour; and (3) used experimental designs. Two reviewers extracted data from full-text papers independently. Results were tabulated for comparison. The Risk of Bias assessment in N-of-1 Trials scale for single case experimental designs (SCEDs) and the Cochrane risk of bias assessment tool for randomized controlled trials (RCTs) were applied. RESULTS: Of an initial yield of 763, seven SCEDs and one RCT were included. Behavioural interventions included the use of reinforcement, prompting, self-management, instruction, extinction, overcorrection, and fading. Each assessed body functions or structures' outcomes (drooling frequency and severity); three included activity outcomes (mouth drying, head control, eye contact, and vocalizations) and none assessed participation or quality of life. While each study reported positive effects of intervention, risk of bias was high. INTERPRETATION: Low-level evidence suggests behavioural interventions may be useful for treatment of drooling in children with neurodisability. Well-designed intervention studies are urgently needed to determine effectiveness. WHAT THIS PAPER ADDS: Behavioural interventions used to treat drooling included reinforcement, prompting, self-management, extinction, overcorrection, instruction, and fading. Interventions targeted body structures and function-level outcomes and activity-level outcomes. Low-level evidence supports the use of behavioural intervention to treat drooling.

Application site adverse events associated with the buprenorphine transdermal system: a pooled analysis.

OBJECTIVE: To characterize the profile of application site reactions (ASRs) for patients treated with the buprenorphine transdermal system (BTDS) in chronic pain studies. METHODS: The incidences of ASRs during treatment with BTDS were examined using (a) integrated data from 16 controlled and uncontrolled Phase III chronic pain studies (N = 6566), (b) a subset of integrated data that focused on the double-blind phases of five enriched, placebo-controlled studies (n = 1806) and (c) data from an international postmarketing drug safety database. These data were compared with the ASR data reported in the full prescribing information of other transdermal patches marketed in the US. RESULTS: Among the 6566 patients, the overall incidence of ASRs was 23.4%, of which 98.3% were mild to moderate in intensity, none were serious and 4.4% led to treatment discontinuation. Rates of severe and inflammatory ASRs were low. Among the 1806 patients, ASR rates were higher with BTDS (16.6%) than placebo transdermal system (12.7%). Among the 6566 patients, the 1806 patients, and the postmarketing data, the most common ASRs seen were pruritus, erythema and rash. Incidences of most ASRs for other selected transdermal products were 17% or lower. CONCLUSION: Incidence rates of ASRs in patients treated with BTDS were low and infrequently led to discontinuation. Severe and inflammatory-type ASRs were not common. The ASR profile of BTDS was comparable with those of other transdermal patches.

Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.

Two multicenter, randomized, double-blind, crossover studies with identical designs evaluated the efficacy of oral extended-release hydromorphone (HHER) administered q24h compared with immediate-release hydromorphone (HHIR) dosed four times daily in patients with persistent moderate to severe pain. Patients titrated to a stable HHER dose were randomized to individualized doses of HHER or HHIR for 3 to 7 days before crossover to the second treatment. Primary efficacy end point was the mean of average pain intensity (API) scores, rated on a 0- to 10-point numeric scale, over the last 2 days before the pharmacokinetics/pharmacodynamics day of each double-blind period. Difference between treatments (HHER - HHIR) in study 1 was 0.17 with a 90% confidence interval (CI) (-0.01, 0.34); in study 2, difference was 0.07 with a 90% CI (-0.12, 0.26). There were no significant differences between treatments in API scores or amount of rescue medication used at any time interval within the 24-hour dosing period. No reduction in pain control occurred in patients administered HHER at the end of the 24-hour dosing period. Most treatment-emergent adverse events were opioid-related. In these studies, HHER administered q24h and HHIR dosed four times daily provided comparable analgesia at an equivalent total daily dose.

The dose response and effects of dexamethasone on bupivacaine microcapsules for intercostal blockade (T9 to T11) in healthy volunteers.

Biodegradable microcapsules containing bupivacaine/dexamethasone produce an anesthetic duration of 7-11 days in animal models. In this investigation, we explored the effect of increasing doses (Part 1) and the effect of including dexamethasone (Part 2) on the onset, density, and duration of analgesia and anesthesia produced by bupivacaine microcapsules. Concentrations ranging from 0.3125% to 5.0% in microcapsules were compared with 0.25% aqueous bupivacaine (bilateral injection, three intercostal nerves, 2 mL per nerve) (Part 1). Part 2 compared 2.5% microcapsules with or without the inclusion of dexamethasone by unilateral blockade. Sensory block was assessed by pinprick, temperature sensation, and subjective numbness (0, not numb; 10, totally numb). Pharmacodynamic assessments and plasma drug concentrations of bupivacaine and dexamethasone were measured for 96 h. The onset time was reduced and the duration of analgesia increased over the 0.3125%-5.0% dose range (P < 0.02). Onset with 2.5% microcapsules approximated that of 0.25% aqueous bupivacaine. Microcapsule block duration increased to at least 96 h and was significantly longer than aqueous bupivacaine (P < 0.001). Inclusion of dexamethasone increased the duration of pinprick anesthesia in 2.5% microcapsules (P = 0.03). We conclude that bupivacaine/dexamethasone microcapsules are well tolerated and demonstrate a dose-related effect in onset and duration of intercostal blockade. Inclusion of dexamethasone increases intercostal block anesthesia.