OBJECTIVE: This study aims to determine the feasibility and effectiveness of a digital parenting program (called Naungan Kasih in Bahasa Melayu [Protection through Love]) delivered in Malaysia, with varying combinations of 2 components included to encourage engagement. The study is framed around the following objectives: (1) to determine the recruitment, retention, and engagement rates in each intervention condition; (2) to document implementation fidelity; (3) to explore program acceptability among key stakeholders; (4) to estimate intervention costs; and (5) to provide indications of the effectiveness of the 2 components.
METHODS: This 10-week factorial cluster randomized trial compares ParentText, a chatbot that delivers parenting and family violence prevention content to caregivers of preschool-aged children in combination with 2 engagement components: (1) a WhatsApp support group and (2) either 1 or 2 in-person sessions. The trial aims to recruit 160 primary and 160 secondary caregivers of children aged 4-6 years from 8 schools split equally across 2 locations: Kuala Lumpur and Negeri Sembilan. The primary outcomes concern the feasibility and acceptability of the intervention and its components, including recruitment, retention, and engagement. The effectiveness outcomes include caregiver parenting practices, mental health and relationship quality, and child development. The evaluation involves mixed methods: quantitative caregiver surveys, digitally tracked engagement data of caregivers' use of the digital intervention components, direct assessments of children, and focus group discussions with caregivers and key stakeholders.
RESULTS: Overall, 208 parents were recruited at baseline December 2023: 151 (72.6%) primary caregivers and 57 (27.4%) secondary caregivers. In January 2024, of these 208 parents, 168 (80.8%) enrolled in the program, which was completed in February. Postintervention data collection was completed in March 2024. Findings will be reported in the second half of 2024.
CONCLUSIONS: This is the first factorial cluster randomized trial to assess the feasibility of a hybrid human-digital playful parenting program in Southeast Asia. The results will inform a large-scale optimization trial to establish the most effective, cost-effective, and scalable version of the intervention.
TRIAL REGISTRATION: OSF Registries; https://osf.io/f32ky.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55491.
OBJECTIVE: To identify the available assessment instruments for measuring the empowerment of pregnant women and to describe the appraisal content and their psychometric properties.
METHODS: We searched nine bibliographic databases for original studies that focus on the measurement of empowerment in pregnant women. Arksey and O'Malley's methodology and PRISMA-ScR were selected to guide the implementation of this scoping review. The COSMIN criteria was employed to assess the methodological quality and the quality of psychometric properties.
RESULTS: A total of 23 studies were included and 13 instruments were extracted. Given comprehensive considerations, Kameda's prenatal empowerment scale may be deemed suitable. The included instruments comprehensively measured the attributes of empowerment, with a particular focus on facilitating women's choice and decision-making. Except for the four most recent self-designed questionnaires, the remaining instruments had been tested for reliability and/or validity.
CONCLUSION: There were heterogeneous results regarding the included instruments' appraisal content and psychometric properties. Future studies focusing on the development or validation of measurement instruments should be guided by influential and identical standards.
METHODS: The ASSERT study was a phase 3, double-blind, randomised, placebo-controlled trial that enrolled patients at 21 medical centres or hospitals in ten countries (Belgium, France, Germany, Italy, Malaysia, the Netherlands, Poland, Türkiye, the UK, and the USA). Eligible patients had a genetically confirmed diagnosis of Alagille syndrome, a history of significant pruritus, and elevated serum bile acids. Patients were randomly assigned (2:1) to receive oral odevixibat 120 μg/kg per day or placebo for 24 weeks (in a block size of six and stratified by age: <10 years and ≥10 years to <18 years) via a web-based system. Patients, clinicians, study staff, and people analysing the data were masked to treatment allocation. The primary efficacy endpoint was change in caregiver-reported scratching score (on the PRUCISION instrument; range 0-4) from baseline to weeks 21-24. The prespecified key secondary efficacy endpoint was change in serum bile acid concentration from baseline to the average of weeks 20 and 24. Outcomes were analysed in patients who received at least one dose of study drug (the full analysis set for efficacy outcomes and the safety analysis set for safety outcomes). This trial is registered on ClinicalTrials.gov (NCT04674761) and EudraCT (2020-004011-28), and is completed.
FINDINGS: Between Feb 26, 2021, and Sept 9, 2022, 52 patients were randomly assigned to receive odevixibat (n=35) or placebo (n=17), all of whom were included in the analysis sets. The median age was 5·5 years (IQR 3·2 to 8·9). 27 (52%) of 52 patients were male and 25 (48%) were female. The mean scratching score was elevated at baseline in both groups (2·8 [SD 0·5] for odevixibat vs 3·0 [0·6] for placebo). Mean scratching scores at weeks 21-24 were 1·1 (0·9) for odevixibat and 2·2 (1·0) for placebo, representing a least-squares (LS) mean change of -1·7 (95% CI -2·0 to -1·3) for odevixibat and -0·8 (-1·3 to -0·3) for placebo, which was significantly greater for odevixibat than for placebo (difference in LS mean change from baseline -0·9 [95% CI -1·4 to -0·3]; p=0·0024). Odevixibat also resulted in significantly greater reductions in mean serum bile acids from baseline versus placebo (237 μmol/L [SD 115] with odevixibat vs 246 μmol/L [121] with placebo) to the average of weeks 20 and 24 (149 μmol/L [102] vs 271 μmol/L [167]; LS mean change -90 μmol/L [95% CI -133 to -48] with odevixibat vs 22 μmol/L [-35 to 80] with placebo; difference in LS mean change -113 μmol/L [95% CI -179 to -47]; p=0·0012). The most common treatment-emergent adverse events were diarrhoea (ten [29%] of 35 patients in the odevixibat group vs one [6%] of 17 in the placebo group) and pyrexia (eight [23%] vs four [24%]). Seven patients had serious treatment-emergent adverse events during the treatment period: five (14%) in the odevixibat group and two (12%) in the placebo group. No patients discontinued treatment and there were no deaths.
INTERPRETATION: Odevixibat could be an efficacious non-surgical intervention to improve pruritus, reduce serum bile acids, and enhance the standard of care in patients with Alagille syndrome. Longer-term safety and efficacy data of odevixibat in this population are awaited from the ongoing, open-label ASSERT-EXT study.
FUNDING: Albireo Pharma, an Ipsen company.
METHOD: A cross-sectional survey was conducted on caregivers of UC patients who sought cancer care. The modified caregiver strain index (MCSI) was used to assess FC burden.
RESULTS: Just over half (54.3%) of FCs had moderate/high MCSI scores (score 9-26). By demographics, FCs who were unemployed (OR = 5.55, 95%CI 1.50-20.60) and perceived their current health condition as moderate/poor (OR = 6.05, 95%CI 1.95-18.78) reported higher odds of increased FC burden. Patient performance status played a pivotal role in exacerbating FC burden, whereby the odds of higher FC burden was 13 times higher in caregivers of UC patients having an Eastern Cooperative Oncology Group (ECOG) performance rating score of 3-4 (OR = 13.06, 95%CI 1.44-111.26) than those with a score of 0. Perceived lower levels of confidence in care provision were significantly associated with a higher level of strain (OR = 6.76, 985%CI 1.02-44.90).
CONCLUSION: Care recipient performance status was a strong patient-related factor associated with higher FC burden regardless of duration of caregiving and other caregiver-related factors after adjusting for caregiver demographics.
METHODS: Students completed a three-station OSCE and a written self-reflection about their performance. These reflections were coded using a latent pattern content analysis, with categories defined as "doing well (≥ 50% on exam)" and "not doing well (< 50% on exam)" and compared to their actual OSCE exam scores, to determine the degree of alignment.
RESULTS: Two hundred sixty-nine students completed the OSCE and reflection. Students had a low degree of alignment between their self-reflections and actual OSCE performance. Low alignment was overwhelmingly prevalent and significant in high-achieving students with OSCE scores of ≥90%. Most common aspects students reflected on as indicators of performance were finishing on time and communicating effectively. High-achieving students reflected on aspects such as empathy, systematic questioning, and patient teach-back as aspects of their performance.
CONCLUSIONS: Student reflections on exam performance do not align with their actual performance, particularly amongst the high-achieving students. High-achieving students were more aware of the different aspects that affected their performance. To ensure that high-achieving students are aware of their strengths, educators should provide more targeted feedback mechanisms and positive reassurances to help these students become more confident in their decision-making skills.
METHODS: Following PRISMA guidelines, we conducted search over six databases, including Scopus, PubMed, etc., between November 4, 2021 and November 11, 2021 for studies that investigated how SEC indicators predict emotional health risks during Covid-19, after obtaining approval from PROSPERO (ID: CRD42021288508). Using Covidence as the platform, 362 articles (324 cross-sectional/repeated cross-sectional and 38 longitudinal) were included in this review according to the eligibility criteria. We categorized SEC indicators into 'actual versus perceived' and 'static versus fluid' classes to explore their differential effects on emotional health.
RESULTS: Out of the 1479 SEC indicators used in these 362 studies, our results showed that 43.68% of the SEC indicators showed 'expected' results (i.e., higher SEC predicting better emotional health outcomes); 51.86% reported non-significant results and 4.46% reported the reverse. Economic concerns (67.16% expected results) and financial strains (64.16%) emerged as the best predictors while education (26.85%) and living conditions (30.14%) were the worst.
CONCLUSIONS: This review summarizes how different SEC indicators influenced emotional health risks across 98 countries, with a total of 5,677,007 participants, ranging from high to low-income countries. Our findings showed that not all SEC indicators were strongly predictive of emotional health risks. In fact, over half of the SEC indicators studied showed a null effect. We found that perceived and fluid SEC indicators, particularly economic concerns and financial strain could best predict depressive and anxiety symptoms. These findings have implications for policymakers to further understand how different SEC classes affect mental health during a pandemic in order to tackle associated social issues effectively.
METHODOLOGY: A review was performed on various ultrasound parameters using five databases. Systematic review tools were utilized to eliminate duplicates and identify relevant results. Reviewers used the Quality Assessment of Diagnostic Accuracy Results [QUADAS-2] to evaluate the bias and applicability of the study outcomes.
RESULT: Between 2012 and 2023, eleven studies were conducted to evaluate the performance of the different ultrasound parametric procedures in detecting prostate cancer using grayscale TRUS, SWE, CEUS, and mpUS. The high sensitivity of these procedures was found at 55%, 88.6%, 81%, and 74%, respectively. The specificity of these procedures was found to be 93.4%, 97%, 88%, and 59%, respectively. This high sensitivity and specificity may be associated with the large lesion size. The studies revealed that the sensitivity of these procedures in diagnosing clinically significant prostate cancer was 55%, 73%, 70%, and 74%, respectively, while the specificity was 61%, 78.2%, 62%, and 59%, respectively.
CONCLUSIONS: The mpUS procedure provides high sensitivity and specificity in PCa detection, especially for clinically significant prostate cancer.
METHODS: We combined data from 21 prospective cohorts across six continents (N = 31,680) and conducted cohort-specific Cox proportional hazard regression analyses in a two-step individual participant data meta-analysis.
RESULTS: A one-standard-deviation increase in LIBRA score was associated with a 21% higher risk for dementia. The association was stronger for Asian cohorts compared to European cohorts, and for individuals aged ≤75 years (vs older), though only within the first 5 years of follow-up. No interactions with sex, education, or socioeconomic position were observed.
DISCUSSION: Modifiable risk and protective factors appear relevant for dementia risk reduction across diverse geographical and sociodemographic groups.
HIGHLIGHTS: A two-step individual participant data meta-analysis was conducted. This was done at a global scale using data from 21 ethno-regionally diverse cohorts. The association between a modifiable dementia risk score and dementia was examined. The association was modified by geographical region and age at baseline. Yet, modifiable dementia risk and protective factors appear relevant in all investigated groups and regions.
OBJECTIVE: To compare the ability of the prehospital GCS and GCS-M to predict 30-day mortality and severe disability in trauma patients.
DESIGN: We used the Pan-Asia Trauma Outcomes Study registry to enroll all trauma patients >18 years of age who presented to hospitals via emergency medical services from 1 January 2016 to November 30, 2018.
SETTINGS AND PARTICIPANTS: A total of 16,218 patients were included in the analysis of 30-day mortality and 11 653 patients in the analysis of functional outcomes.
OUTCOME MEASURES AND ANALYSIS: The primary outcome was 30-day mortality after injury, and the secondary outcome was severe disability at discharge defined as a Modified Rankin Scale (MRS) score ≥4. Areas under the receiver operating characteristic curve (AUROCs) were compared between GCS and GCS-M for these outcomes. Patients with and without traumatic brain injury (TBI) were analyzed separately. The predictive discrimination ability of logistic regression models for outcomes (30-day mortality and MRS) between GCS and GCS-M is illustrated using AUROCs.
MAIN RESULTS: The primary outcome for 30-day mortality was 1.04% and the AUROCs and 95% confidence intervals for prediction were GCS: 0.917 (0.887-0.946) vs. GCS-M:0.907 (0.875-0.938), P = 0.155. The secondary outcome for poor functional outcome (MRS ≥ 4) was 12.4% and the AUROCs and 95% confidence intervals for prediction were GCS: 0.617 (0.597-0.637) vs. GCS-M: 0.613 (0.593-0.633), P = 0.616. The subgroup analyses of patients with and without TBI demonstrated consistent discrimination ability between the GCS and GCS-M. The AUROC values of the GCS vs. GCS-M models for 30-day mortality and poor functional outcome were 0.92 (0.821-1.0) vs. 0.92 (0.824-1.0) ( P = 0.64) and 0.75 (0.72-0.78) vs. 0.74 (0.717-0.758) ( P = 0.21), respectively.
CONCLUSION: In the prehospital setting, on-scene GCS-M was comparable to GCS in predicting 30-day mortality and poor functional outcomes among patients with trauma, whether or not there was a TBI.
OBJECTIVE: This study aimed to compare the effects of self bladder emptying and indwelling Foley bladder catheterization for planned cesarean delivery on the rate of postpartum urinary retention and maternal satisfaction.
STUDY DESIGN: A randomized controlled trial was conducted in a tertiary university hospital from January 10, 2022 to March 22, 2023. A total of 400 participants scheduled for planned cesarean delivery were randomized: 200 each to self bladder emptying or indwelling Foley catheter. The primary outcomes were postpartum urinary retention (overt and covert) and maternal satisfaction with allocated bladder care. Analyses were performed using t test, Mann-Whitney U test, chi-square test, or Fisher exact test, as appropriate. Logistic regression was used to adjust for differences in characteristics.
RESULTS: Postpartum urinary retention rates were 1 per 200 (0.6%) and 0 per 200 (P>.99) (a solitary case of covert retention) and maternal satisfaction scores (0-10 visual numerical rating scale), expressed as median (interquartile range) were 9 (8-9.75) and 8 (8-9) (P=.003) in the self bladder emptying and indwelling Foley catheter arms, respectively. Regarding secondary outcomes, time to flatus passage, satisfactory ambulation, urination, satisfactory urination, satisfactory breastfeeding, and postcesarean hospital discharge was quickened in the self bladder emptying group. Pain scores at first urination were decreased and no lower urinary tract symptom was more likely to be reported with self bladder emptying. Surgical field view, operative blood loss, duration of surgery, culture-derived urinary tract infection, postvoid residual volume, and pain score at movement were not different. There was no bladder injury.
CONCLUSION: Self bladder emptying increased maternal satisfaction without adversely affecting postpartum urinary retention. Recovery was enhanced and urinary symptoms were improved. The surgeon was not impeded at operation. No safety concern was found.
METHODS: Ninety plasma and 41 urine samples were collected at Week 4 of treatment. Drug concentrations were measured using a validated HPLC-UV method. MassARRAY® SNP genotyping was used to investigate genetic factors, including P-glycoprotein (ABCB1), solute carrier organic anion transporter B1 (SLCO1B1), arylacetamide deacetylase (AADAC) and N-acetyl transferase (NAT2). Clinically relevant covariates were also analysed.
RESULTS: A two-compartment model for isoniazid and a one-compartment model for rifapentine with transit compartment absorption and first-order elimination were the best models for describing plasma and urine data. The estimated (relative standard error, RSE) of isoniazid non-renal clearance was 3.52 L·h-1 (23.1%), 2.91 L·h-1 (19.6%), and 2.58 L·h-1 (20.0%) in NAT2 rapid, intermediate and slow acetylators. A significant proportion of the unchanged isoniazid was cleared renally (2.7 L·h-1; 8.0%), while the unchanged rifapentine was cleared primarily through non-renal routes (0.681 L·h-1; 3.6%). Participants with the ABCB1 mutant allele had lower bioavailability of rifapentine, while food prolonged the mean transit time of isoniazid.
CONCLUSIONS: ABCB1 mutant allele carriers may require higher rifapentine doses; however, this must be confirmed in larger trials. Food did not affect overall exposure to isoniazid and only delayed absorption time.