Quality and reporting of cluster randomised controlled trials evaluating occupational therapy interventions: A systematic review

Background: Growing use of the cluster randomised control trials (RCTs) in healthcare research requires careful attention to study designs, with implications for the development of an evidence-base for practice. Objective: To investigate the characteristics, quality and reporting of cluster-RCTs evaluating occupational therapy interventions to inform future research design. Methods: An extensive search of cluster-RCTs evaluating occupational therapy was conducted in several databases. Results: Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster-RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomised and five reported ICCs (50%): protocols had higher compliance. Risk of bias was most evident in blinding of participants. Statistician involvement was associated with improved trial quality and reporting. Conclusions: Quality of cluster-RCTs of occupational therapy interventions is comparable to those from other areas of health research and needs improvement

A systematic review of evidence for the psychometric properties of the Strengths and Difficulties Questionnaire

This paper synthesised evidence for the validity and reliability of the Strengths and Difficulties Questionnaire in children aged 3-5. A systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines was carried out. Study quality was rated using the Consensus-based Standards for the Selection of Health Measurement Instruments. 41 studies were included (56 manuscripts). Two studies examined content and cultural validity, revealing issues with some questions. Six studies discussed language validations with changes to some wording recommended. There was good evidence for discriminative validity (Area Under the Curve ≥0.80), convergent validity (weighted average correlation coefficients ≥0.50, except for the Prosocial scale), and the 5-factor structural validity. There was limited support for discriminant validity. Sensitivity was below 70% and specificity above 70% in most studies that examined this. Internal consistency of the total difficulty scale was good (weighted average Cronbach’s alpha parents’ and teachers’ version 0.79 and 0.82) but weaker for other subscales (weighted average parents’ and teachers’ range 0.49-0.69 and 0.69-0.83). Inter-rater reliability between parents was moderate (correlation coefficients range 0.42-0.64) and between teachers strong (range 0.59-0.81). Cross-informant consistency was weak to moderate (weighted average correlation coefficients range 0.25-0.45). Test-retest reliability was mostly inadequate. In conclusion, the lack of evidence for cultural validity, criterion validity and test-retest reliability should be addressed given wide-spread implementation of the tool in routine clinical practice. The moderate level of consistency between different informants indicate that an assessment of a pre-schooler should not rely on a single informant

Cluster-randomised controlled trial of an occupational therapy intervention for children aged 11-13 years, designed to increase participation in order to prevent symptoms of mental illness

Background: The impact of occupational therapy on mental health outcomes for children is largely unexplored. The aim of this study was to investigate an evidence-based occupational therapy intervention designed to increase participation in daily occupations in order to prevent symptoms of mental illness for children and run in schools. Methods: The study used a pragmatic, cluster-randomised controlled trial design with two arms. Fourteen clusters (schools), equating to 151 child participants, were stratified by school decile-rank category and block randomised. Blinding of participants post-randomisation was not feasible; however, outcomes assessors were blinded. Outcomes were measured at baseline, after the parallel and crossover phases, and at follow-up; and were anxiety symptoms (primary), depression symptoms, self-esteem, participation and wellbeing. Intention-to-Treat analysis was applied -mixed linear modelling was used to account for clusters and repeated measures, and to adjust for covariates identified. Results: This trial found significant positive effects of the intervention on child-rated satisfaction with their occupational performance and teacher-rated child anxiety. No evidence was found to support the effect of the intervention on anxiety and depression symptoms, self-esteem and wellbeing. Conclusions: This was the first known cluster-randomised controlled trial to investigate an occupational therapy intervention promoting emotional wellbeing in a non-clinical sample of children. No compelling evidence was found to support the use of the intervention in schools in its current format, however, results were promising that the focus on occupations influenced participation. Recommendations are made to redesign the intervention as an embedded intervention in the classroom, co-taught by teachers and including parental involvement

Concurrent validity of the strengths and difficulties questionnaire in an indigenous pre-school population

The strengths and difficulties questionnaire (SDQ) is a frequently used tool for universal screening of pre-schoolers’ behavioural and emotional problems. However, evidence for its concurrent validity is equivocal and has not been tested in a Māori population. We aimed to evaluate the concurrent validity of the strengths and difficulties questionnaire (SDQ) in Māori pre-schoolers (tamariki), aged 4 and 5. We carried out a prospective study of 225 tamariki (46% female) for whom a recent SDQ was available from the New Zealand Ministry of Health’s Before School Check database. A trained nurse carried out a standardised wellbeing and behavioural assessment for these children. Sensitivity, specificity, positive predictive and negative predictive values were calculated, using optimal total difficulty scale threshold values published for the SDQ (parent version SDQ-P; teacher version SDQ-T). Primary outcome: an assessment-based child referral to Child and Adolescent Mental Health Services or to a Paediatric outpatient service. Secondary outcomes: assessment-based parental referral to a parenting programme and combined referral. The optimal thresholds for child referral were low for the SDQ-P (13) and SDQ-T (7). Child referral SDQ-P: sensitivity 62%, specificity 83%, positive predictive value 0.35, negative predictive value 0.94. Child referral SDQ-T: sensitivity 77%, specificity 78%, positive predictive value 0.31, negative predictive value 0.96. The findings demonstrate optimal threshold values for referral for Māori on the SDQ-P and SDQ-T are much lower when compared to published thresholds (17 vs. 16). Sensitivity values were also low. A surveillance approach for the assessment of psychosocial problems is recommended for pre-schoolers. Keywords: ValidationStrengths and difficulties questionnaire Māori Pre-school Screenin

Metabolic response to a ketogenic breakfast in the healthy elderly.

OBJECTIVE: To determine whether the metabolism of glucose or ketones differs in the healthy elderly compared to young or middle-aged adults during mild, short-term ketosis induced by a ketogenic breakfast. DESIGN AND PARTICIPANTS: Healthy subjects in three age groups (23 +/- 1, 50 +/- 1 and 76 +/- 2 y old) were given a ketogenic meal and plasma beta -hydroxybutyrate, glucose, insulin, triacylglycerols, total cholesterol, non-esterified fatty acids and breath acetone were measured over the subsequent 6 h. Each subject completed the protocol twice in order to determine the oxidation of a tracer dose of both carbon-13 (13C) glucose and 13C-beta-hydroxybutyrate. The tracers were given separately in random order. Apolipoprotein E genotype was also determined in all subjects. RESULTS: Plasma glucose decreased and beta-hydroxybutyrate, acetone and insulin increased similarly over 6 h in all three groups after the ketogenic meal. There was no significant change in cholesterol, triacylglycerols or non-esterified fatty acids over the 6 h. 13C-glucose and 13C-beta-hydroxybutyrate oxidation peaked at 2-3 h postdose for all age groups. Cumulative 13C-glucose oxidation over 24 h was significantly higher in the elderly but only versus the middle-aged group. There was no difference in cumulative 13C-beta-hydroxybutyrate oxidation between the three groups. Apolipoprotein E (epsilon 4) was associated with elevated fasting cholesterol but was unrelated to the other plasma metabolites. CONCLUSION: Elderly people in relatively good health have a similar capacity to produce ketones and to oxidize 13C-beta-hydroxybutyrate as middle-aged or young adults, but oxidize 13C-glucose a little more rapidly than healthy middle-aged adult

Foot and ankle muscle strength in people with gout: a two-arm crosscross-sectional study

Background Foot and ankle structures are the most commonly affected in people with gout. However, the effect of gout on foot and ankle muscle strength is not well understood. The primary aim of this study was to determine whether differences exist in foot and ankle muscle strength for plantarflexion, dorsiflexion, inversion and eversion between people with gout and age- and sex-matched controls. The secondary aim was to determine whether foot and ankle muscle strength was correlated with foot pain and disability. Methods Peak isokinetic concentric muscle torque was measured for ankle plantarflexion, dorsiflexion, eversion and inversion in 20 participants with gout and 20 matched controls at two testing velocities (30°/s and 120°/s) using a Biodex dynamometer. Foot pain and disability was measured using the Manchester Foot Pain and Disability Index (MFPDI). Findings Participants with gout demonstrated reduced muscle strength at both the 30°/s and 120°/s testing velocities for plantarflexion, inversion and eversion (P < 0.05). People with gout also displayed a reduced plantarflexion-to-dorsiflexion strength ratio at both 30°/s and 120°/s (P < 0.05). Foot pain and disability was higher in people with gout (P < 0.0001) and MFPDI scores were inversely correlated with plantarflexion and inversion muscle strength at the 30°/s testing velocity, and plantarflexion, inversion and eversion muscle strength at the 120°/s testing velocity (all P < 0.05). Interpretation People with gout have reduced foot and ankle muscle strength and experience greater foot pain and disability compared to controls. Foot and ankle strength reductions are strongly associated with increased foot pain and disability in people with gout

Foot-related pain and disability and spatiotemporal parameters of gait during self-selected and fast walking speeds in people with gout: A two-arm cross sectional study

Objectives To examine gait parameters in people with gout during different walking speeds whileadjusting for body mass index (BMI) and foot-pain, and to determine the relationship between gait parameters and foot-pain and disability. Method Gait parameters were measured using the GAITRite™ walkway in 20 gout participants and 20 age- and sex-matched controls during self-selected and fast walking speeds. Foot-pain and disability was measured using the Manchester Foot Pain and Disability Index (MFPDI) which contains four domains relating to function, physical appearance, pain and work/leisure. Results At the self-selected speed, gout participants demonstrated increased step time (p=0.017), and stance time (p=0.012), and reduced velocity (p=0.031) and cadence (p=0.013). At the fast speed, gout participants demonstrated increased step time (p=0.007), swing time (p=0.005) and stance time (p=0.019) and reduced velocity (p=0.036) and cadence (p=0.009). For participants with gout, step length was correlated with total MFPDI (r=-0.62, p=0.008), function (r=-0.65, p=0.005) and physical appearance (r=-0.50, p=0.041); stride length was correlated with total MFPDI (r=-0.62, p=0.008), function (r=-0.65, p=0.005) and physical appearance (r=-0.50, p=0.041); and velocity was correlated with total MFPDI (r=-0.60, p=0.011), function (r=-0.63, p=0.007) and work/leisure (r=-0.53, p=0.030). Conclusion Gait patterns exhibited by people with gout are different from controls during both selfselected and fast walking speeds, even after adjusting for BMI and foot-pain. Additionally, gait parameters were strongly correlated with patient-reported functional limitation, physical appearance and work/leisure difficulties, while pain did not significantly influence gait in people with gout