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Nevin Manimala Statistics

Prognostic factors in children with acute T-lymphoblastic leukemia: a single-center clinical study of the CCCG-ALL-2015 protocol

Zhongguo Dang Dai Er Ke Za Zhi. 2024 Oct 15;26(10):1078-1085. doi: 10.7499/j.issn.1008-8830.2402079.

ABSTRACT

OBJECTIVES: To explore the clinical characteristics of children with acute T-lymphoblastic leukemia (T-ALL) and analyze their relationship with prognosis.

METHODS: A retrospective analysis was conducted on the clinical data and follow-up results of 50 children with T-ALL who were treated using the CCCG-ALL-2015 protocol at the Department of Hematology and Oncology, Children’s Hospital of Nanjing Medical University from November 2015 to December 2019. Kaplan-Meier survival analysis and Cox regression analysis were employed to identify factors affecting prognosis.

RESULTS: Among the 50 T-ALL patients, there were 7 cases of relapse. There was no statistically significant difference in the baseline clinical data between the relapse group and the non-relapse group (P>0.05). However, the positive rate of minimal residual disease (MRD) (≥0.01%) on day 46 after induction remission therapy in the relapse group was significantly higher than that in the non-relapse group (P=0.037). The 5-year overall survival rate for the 50 patients was (87±5)%, and the 5-year event-free survival rate was (86±5)%. Multivariate Cox regression analysis indicated that the MRD level on day 46 after induction remission therapy was an independent prognostic factor (HR=0.104, 95%CI: 0.015-0.740, P=0.024).

CONCLUSIONS: MRD is of significant importance for the prognosis of T-ALL children. Personalized treatment should be provided based on MRD levels to prevent relapse and improve prognosis in these patients.

PMID:39467678 | DOI:10.7499/j.issn.1008-8830.2402079

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Characteristics of early cognitive development in children with Williams syndrome: a prospective cohort study

Zhongguo Dang Dai Er Ke Za Zhi. 2024 Oct 15;26(10):1053-1057. doi: 10.7499/j.issn.1008-8830.2404029.

ABSTRACT

OBJECTIVES: To investigate the early cognitive development characteristics of children with Williams syndrome (WS) at different age stages.

METHODS: From September 2018 to June 2023, 106 children diagnosed with WS at the Department of Pediatric Health Care, Children’s Hospital, Zhejiang University School of Medicine, aged 1 to <5 years, were prospectively enrolled. All children underwent Gesell developmental diagnostic assessments to analyze the cognitive development characteristics of WS children across different age groups.

RESULTS: The average age of the 106 WS children was (3.1±1.2) years; 58 were male, and 48 were female. There were no significant differences in developmental levels between males and females in the five domains of gross motor skills, fine motor skills, language, personal-social skills, and adaptive behavior (P>0.05). The incidence rates of mild, moderate, severe, and profound developmental disabilities among children of different age groups showed no significant differences (P>0.05). Comparisons of developmental levels in gross motor skills, language, personal-social skills, and adaptive behavior among different age groups were also not statistically significant (P>0.05). With the increase of age, the developmental level of fine motor skills showed a decreasing trend (P<0.05). There were no significant differences in verbal IQ and non-verbal IQ within each age group of WS children (P>0.05).

CONCLUSIONS: The overall developmental level of WS children stabilizes with age, and their early language abilities do not significantly exceed their non-verbal abilities.

PMID:39467674 | DOI:10.7499/j.issn.1008-8830.2404029

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A case-control study on the associations of parental smoking and alcohol consumption during the periconceptional period and their interactions with risk of congenital heart disease in offspring

Zhongguo Dang Dai Er Ke Za Zhi. 2024 Oct 15;26(10):1019-1026. doi: 10.7499/j.issn.1008-8830.2404116.

ABSTRACT

OBJECTIVES: To explore the associations of parental smoking and alcohol consumption during the periconceptional period and their interactions with risk of congenital heart disease (CHD) in offspring.

METHODS: The parents of children with simple CHD aged 0 to 1 year (n=683) were recruited as the case group, while the parents of healthy children aged 0 to 1 year (n=740) served as the control group. A case-control study was conducted, and a questionnaire was used to collect information on perinatal exposures. After controlling for relevant confounding factors using multivariate logistic regression analysis and propensity score matching, the associations of parental smoking and alcohol consumption during the periconceptional period and their interactions with CHD were examined, as well as the cumulative effects of smoking and drinking on CHD risk.

RESULTS: Maternal active smoking (OR=2.91, 95%CI: 1.60-5.30), passive smoking (OR=1.94, 95%CI: 1.56-2.42), and alcohol consumption (OR=2.59, 95%CI: 1.89-3.54), as well as paternal smoking (OR=1.52; 95%CI: 1.22-1.90) and drinking (OR=1.48, 95%CI: 1.19-1.84), were associated with an increased risk of CHD in offspring. There was no interaction between parental smoking and drinking behaviors during the periconceptional period concerning the risk of CHD in offspring (P>0.05). The more parents’ smoking and drinking behaviors during the perinatal pregnancy, the higher the risk of CHD in their offspring (OR=1.50, 95%CI: 1.36-1.65).

CONCLUSIONS: Parental smoking and alcohol consumption during the periconceptional period are associated with the occurrence of CHD in offspring, and there is a cumulative effect on CHD risk, suggesting that reducing tobacco and alcohol exposure during the periconceptional period may lower the incidence of CHD.

PMID:39467669 | DOI:10.7499/j.issn.1008-8830.2404116

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Naloxone Coprescribing and the Prevention of Opioid Overdoses: Quasi-Experimental Metacognitive Assessment of a Novel Education Initiative

JMIR Med Educ. 2024 Oct 28;10:e54280. doi: 10.2196/54280.

ABSTRACT

BACKGROUND: Critical evaluation of naloxone coprescription academic detailing programs has been positive, but little research has focused on how participant thinking changes during academic detailing.

OBJECTIVE: The dual purposes of this study were to (1) present a metacognitive evaluation of a naloxone coprescription academic detailing intervention and (2) describe the application of a metacognitive evaluation for future medical education interventions.

METHODS: Data were obtained from a pre-post knowledge assessment of a web-based, self-paced intervention designed to increase knowledge of clinical and organizational best practices for the coprescription of naloxone. To assess metacognition, items were designed with confidence-weighted true-false scoring. Multiple metacognitive scores were calculated: 3 content knowledge scores and 5 confidence-weighted true-false scores. Statistical analysis examined whether there were significant differences in scores before and after intervention. Analysis of overall content knowledge showed significant improvement at posttest.

RESULTS: There was a significant positive increase in absolute accuracy of participant confidence judgments, confidence in correct probability, and confidence in incorrect probability (all P values were <.05). Overall, results suggest an improvement in content knowledge scores after intervention and, metacognitively, suggest that individuals were more confident in their answer choices, regardless of correctness.

CONCLUSIONS: Implications include the potential application of metacognitive evaluations to assess nuances in learner performance during academic detailing interventions and as a feedback mechanism to reinforce learning and guide curricular design.

PMID:39467302 | DOI:10.2196/54280

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Mobile-Based Platform With a Low-Calorie Dietary Intervention Involving Prepackaged Food for Weight Loss for People With Overweight and Obesity in China: Half-Year Follow-Up Results of a Randomized Controlled Trial

JMIR Mhealth Uhealth. 2024 Oct 28;12:e47104. doi: 10.2196/47104.

ABSTRACT

BACKGROUND: Obesity is a rapidly increasing health problem in China, causing massive economic and health losses annually. Many techniques have emerged to help people with obesity better adhere to intervention programs and achieve their weight loss goals, including food replacement and internet-delivered weight loss consultations. Most studies on weight loss interventions mainly focused on the change in body weight or BMI; however, body fat, especially visceral fat mass, is considered the main pathogenic factor in obesity. In China, more reliable evidence is required on this topic. Moreover, it is unclear whether an integrated weight loss program combining food replacement products, mobile app-based platforms, and daily body composition monitoring using a wireless scale is useful and practical in China.

OBJECTIVE: In this 2-arm, parallel-designed, randomized study, we explored the effectiveness and safety of the Metawell (Weijian Technologies Inc) weight loss program in China, which combines prepackaged biscuits, a wireless scale, and a mobile app.

METHODS: Participants in the intervention group were guided to use food replacement products and a scale for weight loss and monitoring, whereas participants in the control group received printed material with a sample diet and face-to-face education on weight loss at enrollment. The intervention lasted for 3 months, and follow-up visits were conducted at months 3 and 6 after enrollment. Dual-energy x-ray absorptiometry and quantitative computed tomography were used to assess body fat. A multilevel model for repeated measurements was used to compare differences between the 2 groups.

RESULTS: In total, 220 patients were randomly assigned to intervention (n=110) and control (n=110) groups. Participants in the intervention group had significantly greater decreases in BMI, total body fat, visceral adipose area, and subcutaneous adipose area (all P<.001) than those in the control group. However, the rate of change in lean mass was not significantly different between the 2 groups (P=.62). Further, 35 participants in the intervention group reported adverse events. Constipation was the most frequently reported adverse event (11/110), followed by dizziness (6/110), hypoglycemia (4/110), fatigue (3/110), and gastritis (3/35).

CONCLUSIONS: The Metawell program was effective for weight loss. After the intervention, participants in the intervention group lost more body weight and body fat while retaining muscle mass than those in the control group.

PMID:39467299 | DOI:10.2196/47104

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Comparative Effectiveness and Safety of Atorvastatin Versus Rosuvastatin : A Multi-database Cohort Study

Ann Intern Med. 2024 Oct 29. doi: 10.7326/M24-0178. Online ahead of print.

ABSTRACT

BACKGROUND: Rosuvastatin and atorvastatin are the most widely prescribed moderate- to high-intensity statins. However, evidence on their efficacy and safety during actual use is limited.

OBJECTIVE: To compare the real-world effectiveness and safety of rosuvastatin and atorvastatin.

DESIGN: Active comparator cohort study using target trial emulation.

SETTING: The China Renal Data System (CRDS) and UK Biobank (UKB) databases.

PARTICIPANTS: Adults newly prescribed rosuvastatin or atorvastatin.

MEASUREMENTS: The primary outcome was all-cause mortality. Cox proportional hazards regressions were used after 1:1 multilevel propensity score matching.

RESULTS: Among the 285 680 eligible participants in both databases, 6-year all-cause mortality was lower for rosuvastatin than for atorvastatin (2.57 vs. 2.83 per 100 person-years in the CRDS database and 0.66 vs. 0.90 per 100 person-years in the UKB database), with differences in cumulative incidence of -1.03% (95% CI, -1.44% to -0.46%) in the CRDS database and -1.38% (CI, -2.50% to -0.21%) in the UKB database. For secondary outcomes in both databases, rosuvastatin conferred lower risks for major adverse cardiovascular events and major adverse liver outcomes. In the UKB database, the risk for development of type 2 diabetes mellitus was higher with rosuvastatin, and the 2 medications carried similar risks for development of chronic kidney disease and other statin-related adverse effects.

LIMITATION: Possible residual confounding.

CONCLUSION: This study found differences in risks for some important outcomes associated with rosuvastatin and atorvastatin. The differences were relatively small, and many did not meet traditional standards for statistical significance. Further research is needed to understand whether these findings can be used with confidence in clinical practice.

PRIMARY FUNDING SOURCE: National Key R&D Program of China and National Natural Science Foundation of China.

PMID:39467290 | DOI:10.7326/M24-0178

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Empowering Social Growth Through Virtual Reality-Based Intervention for Children With Attention-Deficit/Hyperactivity Disorder: 3-Arm Randomized Controlled Trial

JMIR Serious Games. 2024 Oct 28;12:e58963. doi: 10.2196/58963.

ABSTRACT

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) usually begins in childhood and is often accompanied by impairments in social functioning. Virtual reality (VR) has emerged as an adjunctive tool to embed in social skills training to enhance the social skills of children with ADHD, but its effectiveness requires further investigation.

OBJECTIVE: This study aims to enhance the social skills of children with ADHD by examining the feasibility and effectiveness of VR-based training in comparison to traditional social skills training.

METHODS: A 3-arm randomized controlled trial was conducted with 90 children with ADHD aged 6-12 years. Participants were randomly assigned to 3 weeks of 12-session VR-based social skills training, traditional social skills training, or a waitlist control group of equivalent duration. Outcome measures included assessments by a clinical psychologist who was blinded to group assignments, the Social Skills Improvement System Rating Scale, the Behavior Rating Inventory of Executive Function, and the Simulator Sickness Questionnaire, conducted at baseline and after the intervention.

RESULTS: The preliminary results support the feasibility and acceptability of VR training for children with ADHD aged 6-12 years. Analysis showed that the VR and traditional social skills training groups experienced a statistically significant improvement in the clinical psychologist assessment of social skills and parent-rated self-control, initiative, and emotional control after the intervention compared with baseline. The VR group performed significantly better than the traditional social skills group on social skills assessed by clinical psychologists (F2,85=76.77; P<.001) and on parent-rated self-control (F2,85=18.77; P<.001), initiative (F2,85=11.93; P<.001), and emotional control (F2,85=17.27; P<.001). No significant between-group differences were found for parent-rated cooperation and inhibition (all P>.05).

CONCLUSIONS: The findings provide preliminary evidence supporting the feasibility and superior effectiveness of VR-based social skills training compared to traditional approaches for enhancing social skills and related executive functions in children with ADHD. These results suggest that VR may be a valuable tool to embed within social skills interventions for this population. Further research is warranted to explore the long-term impacts and generalizability of these benefits.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05778526; https://clinicaltrials.gov/study/NCT05778526.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/48208.

PMID:39467288 | DOI:10.2196/58963

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Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial

JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.

ABSTRACT

BACKGROUND: Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients’ short-term physical function.

OBJECTIVE: Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).

METHODS: CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).

RESULTS: CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.

CONCLUSIONS: We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/54451.

PMID:39467285 | DOI:10.2196/54451

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Using Existing Clinical Data to Measure Older Adult Inpatients’ Frailty at Admission and Discharge: Hospital Patient Register Study

JMIR Aging. 2024 Oct 28;7:e54839. doi: 10.2196/54839.

ABSTRACT

BACKGROUND: Frailty is a widespread geriatric syndrome among older adults, including hospitalized older inpatients. Some countries use electronic frailty measurement tools to identify frailty at the primary care level, but this method has rarely been investigated during hospitalization in acute care hospitals. An electronic frailty measurement instrument based on population-based hospital electronic health records could effectively detect frailty, frailty-related problems, and complications as well be a clinical alert. Identifying frailty among older adults using existing patient health data would greatly aid the management and support of frailty identification and could provide a valuable public health instrument without additional costs.

OBJECTIVE: We aim to explore a data-driven frailty measurement instrument for older adult inpatients using data routinely collected at hospital admission and discharge.

METHODS: A retrospective electronic patient register study included inpatients aged ≥65 years admitted to and discharged from a public hospital between 2015 and 2017. A dataset of 53,690 hospitalizations was used to customize this data-driven frailty measurement instrument inspired by the Edmonton Frailty Scale developed by Rolfson et al. A 2-step hierarchical cluster procedure was applied to compute e-Frail-CH (Switzerland) scores at hospital admission and discharge. Prevalence, central tendency, comparative, and validation statistics were computed.

RESULTS: Mean patient age at admission was 78.4 (SD 7.9) years, with more women admitted (28,018/53,690, 52.18%) than men (25,672/53,690, 47.81%). Our 2-step hierarchical clustering approach computed 46,743 inputs of hospital admissions and 47,361 for discharges. Clustering solutions scored from 0.5 to 0.8 on a scale from 0 to 1. Patients considered frail comprised 42.02% (n=19,643) of admissions and 48.23% (n=22,845) of discharges. Within e-Frail-CH’s 0-12 range, a score ≥6 indicated frailty. We found a statistically significant mean e-Frail-CH score change between hospital admission (5.3, SD 2.6) and discharge (5.75, SD 2.7; P<.001). Sensitivity and specificity cut point values were 0.82 and 0.88, respectively. The area under the receiver operating characteristic curve was 0.85. Comparing the e-Frail-CH instrument to the existing Functional Independence Measure (FIM) instrument, FIM scores indicating severe dependence equated to e-Frail-CH scores of ≥9, with a sensitivity and specificity of 0.97 and 0.88, respectively. The area under the receiver operating characteristic curve was 0.92. There was a strong negative association between e-Frail-CH scores at hospital discharge and FIM scores (rs=-0.844; P<.001).

CONCLUSIONS: An electronic frailty measurement instrument was constructed and validated using patient data routinely collected during hospitalization, especially at admission and discharge. The mean e-Frail-CH score was higher at discharge than at admission. The routine calculation of e-Frail-CH scores during hospitalization could provide very useful clinical alerts on the health trajectories of older adults and help select interventions for preventing or mitigating frailty.

PMID:39467281 | DOI:10.2196/54839

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Predicting Proximal Humerus Fracture Mechanical Complications: Are Computed Tomography Hounsfield Units the Answer?

J Am Acad Orthop Surg. 2024 Oct 17. doi: 10.5435/JAAOS-D-24-00594. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose was to determine whether computed tomography (CT) Hounsfield units (HU) as a proxy for bone quality can predict postoperative complications following surgical treatment of proximal humerus fractures.

METHODS: Sixty-six patients with 2-, 3-, or 4-part proximal humerus fractures who underwent surgical fixation at single institution and had complete radiographic data available were included. Radiographic measurements included the deltoid tuberosity index (DTI) on preoperative anterior-posterior shoulder radiographs, and the HU value from the surgical proximal humerus was determined by measuring the humeral head at the midaxial/coronal/sagittal CT image using a circle-type region of interest (≥35 mm2). Postoperative complications recorded were implant failure, development of osteonecrosis, nonunion, and acute periprosthetic fracture. Patients with and without complications were statistically compared, and binary logistic regression was performed to determine whether preoperative proximal humerus CT HU were predictive of complications.

RESULTS: Eight patients (12.1%) developed 11 overall complications, with three patients experiencing multiple complications each. Complications included osteonecrosis (4), implant failure (5), nonunion (1), and acute periprosthetic fracture (1). No difference was observed in demographics or Neer or AO/OTA classification between those with and without complications. Patients with complications had markedly lower DTI and overall HU as well as HU in the coronal and sagittal planes. Regression analysis for average DTI demonstrated a higher DTI and had a 10 times decreased risk of complication (P = 0.040, odds ratio = -10.5, 95% confidence interval, 0.000 to 0.616). Regression analysis for average total HU also found a higher HU associated with a decreased risk of complications (P = 0.034, odds ratio = -0.020, 95% confidence interval, 0.980 to 0.962). Logistic regression analysis, including age, age-adjusted Charlson Comorbidity Index, mean DTI, and mean total HU, only found mean total HU to be notable within the model.

DISCUSSION: CT HU may identify patients with poorer bone quality and thus help predict postoperative complications.

LEVEL OF EVIDENCE: Diagnostic Level III.

PMID:39467278 | DOI:10.5435/JAAOS-D-24-00594