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Nevin Manimala Statistics

Sample size determination for adaptive crossover trial in detecting gene-drug interactions

Stat Methods Med Res. 2023 Jul 11:9622802231181704. doi: 10.1177/09622802231181704. Online ahead of print.

ABSTRACT

Parallel design and crossover design are two of the most frequently used designs for studying drug-gene interactions. Due to the concerns of statistical power and ethics, it is often more prudent to use the crossover design while allowing the patients to have choices of not switching the treatment if the first stage treatment is effective. This complicates the calculation of the required sample size to achieve pre-specified statistical power. We propose a method to determine the required sample size with a closed-form formula. The proposed approach is applied to determine the sample size of an adaptive crossover trial in studying gene-drug interaction in treating atrial fibrillation, the most common cardiac arrhythmia in clinical practice. Our simulation study confirms the power achieved by the sample size determined using the proposed approach. Issues related to the adaptive crossover trial are also discussed and practical guidelines are provided.

PMID:37431594 | DOI:10.1177/09622802231181704

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Nevin Manimala Statistics

Is There a Relationship Between Vertical Facial Development And Nasal Cavity?

Curr Med Imaging. 2023 Jul 11. doi: 10.2174/1573405620666230711090648. Online ahead of print.

ABSTRACT

BACKGROUND: There are no studies investigating the relationship between cone beam computed tomography (CBCT) and nasal passage findings and vertical facial development. The aim of this study is to determine the relationship between nasal cavity anatomy and vertical development of patients.

METHODS: A total of 60 CBCTs were examined, and Class I malocclusion individuals were divided into two groups (30 each) according to vertical facial development. All nasal cavity findings were recorded in the study. Vertical facial development, nasal septum, nasal cavity width, thickness and angle were evaluated. Mann-Whitney U Test was used, and Student’s t test was used for the comparison of two groups with normal distribution. Significance was evaluated at p<0.01 and p<0.05 levels.

RESULTS: Statistical analysis showed a relationship between vertical facial development and nasal cavity findings. Nasal septum deviation was mild to moderate in the hyperdivergent group, while septal deviation was absent in the hypodivergent group. A statistically significant difference was found in the width, distance (x-y) and angle of the nasal cavity from the hyperdivergent group in Class I vertical subgroups (p<0.05).

CONCLUSION: When compared between low-angle and high-angle groups, statistically significant differences were observed in anterior face height, nasal passage angle, and distance between the outermost points of the nasal cavity.

PMID:37431582 | DOI:10.2174/1573405620666230711090648

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Nevin Manimala Statistics

Evaluation of patient participation in relation to the implementation of a person-centered nursing shift handover

Worldviews Evid Based Nurs. 2023 Jul 11. doi: 10.1111/wvn.12666. Online ahead of print.

ABSTRACT

BACKGROUND: It has been suggested that nursing shift-to-shift handover should be a more team-based dialogue with and for the patient rather than about a patient.

AIM: The aim of this study was to evaluate patient participation in relation to the implementation of the person-centered handover (PCH).

METHOD: A pretest-posttest design was used without a comparison group, including patients from nine units in a university hospital at pretest (n = 228) and after implementing PCH (posttest, n = 253) per the framework integrated-Promoting Action on Research Implementation in Health Services. The PCH is inspired by an Australian bedside handover model. The Patient Preferences for the Patient Participation tool was used to rate the preference for and experience of participation on 12 items, combined into three levels of preference-based participation (insufficient-fair-sufficient).

RESULTS: There were no differences regarding experience or preference-based participation between patients at pretest-posttest; however, posttest patients experienced participation in the item Reciprocal communication to a lesser extent than the pretest patients. Only 49% of the posttest group received PCH; of those not receiving PCH, some would have wanted PCH (27%), while some would have declined (24%). Patients receiving PCH had sufficient participation (82%), to a greater extent, regarding the item Sharing one’s symptoms with staff than patients at pretest (72%). Patients receiving PCH also had sufficient participation, to a greater extent, than patients at posttest who did not receive, but would have wanted PCH, regarding four items: (1) sharing one’s symptoms with staff, (2) reciprocal communication, (3) being told what was done, and (4) taking part in planning.

LINKING EVIDENCE TO ACTION: Most patients want to be present at PCH. Therefore, nurses should ask for the patients’ preferences regarding PCH and act accordingly. Not inviting patients who want PCH could contribute to insufficient patient participation. Further studies are needed to capture what assistance nurses would want in identifying and acting in alignment with patient preferences.

PMID:37431567 | DOI:10.1111/wvn.12666

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Nevin Manimala Statistics

Attention, Externalizing and Internalizing Problems Mediated Differently on Internet Gaming Disorder Among Children and Adolescents With a Family History of Addiction as an Adverse Childhood Experience

J Korean Med Sci. 2023 Jul 10;38(27):e221. doi: 10.3346/jkms.2023.38.e221.

ABSTRACT

BACKGROUND: This study aimed to examine the factors associated with internet gaming disorder (IGD) and the mediating role of pediatric symptoms (attention, externalizing problems and internalizing problems) in children and adolescents with a family history of addiction as an adverse childhood experience (ACE).

METHODS: A total of 2,586 children and adolescents (mean age = 14.04 ± 2.34; age range = 11-19 years; 50.5% boys) completed the Internet Game Use-Elicited Symptom Screen and the Pediatric Symptom Checklist-17. IBM SPSS Statistics 21 was used to calculate descriptive statistics and Pearson correlation coefficients and to conduct multiple regression analyses. Mediation analysis was performed using the Sobel test and the SPSS PROCESS macro. Serial multiple mediation analysis was performed using bootstrapping with 5,000 replications.

RESULTS: The higher levels of Attention problems (β = -0.228, P < 0.001) and externalizing problems (β = -0.213, P < 0.001) were associated with IGD. Furthermore, the indirect effect of the independent variable on the dependent variable through the mediators was significant (Sobel’s T: Z = -5.006, P < 0.001). These findings suggest that attention and externalizing problems mediate the effect of family history of addiction on IGD.

CONCLUSION: This study demonstrated the associations among the family history of addiction, IGD, and pediatric symptoms (attention, externalizing problems, and internalizing problems) among Korean children and adolescents. Therefore, we need to pay attention to pediatric symptoms and develop systematic alternatives to improve mental health among Korean children and adolescents with a family history of addiction as ACEs.

PMID:37431544 | DOI:10.3346/jkms.2023.38.e221

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Nevin Manimala Statistics

Psychological Distress and Perceived Burden in Parents of Korean Children With IgE-Mediated Food Allergy

J Korean Med Sci. 2023 Jul 10;38(27):e208. doi: 10.3346/jkms.2023.38.e208.

ABSTRACT

BACKGROUND: Food allergy (FA) can have a profound effect on quality of life (QoL), stress, and anxiety in the family. We aimed to validate the Korean version of the Food Allergy Quality of Life-Parental Burden (FAQL-PB) and identify factors related to the parental psychosocial burden of caring for children with FAs.

METHODS: Parents of children aged between 6 months and 17 years with immunoglobulin E (IgE)-mediated FAs from the Pediatric Allergy Department of five university hospitals in Korea were enrolled in the study. Parents were asked to complete the FAQL-PB, Food Allergy Independent Measure-Parent Form (FAIM-PF), Child Health Questionnaire-Parents Form 28 (CHQ-PF28), Beck’s Anxiety Inventory, Connor-Davidson Resilience Scale, and Patient Health Questionnaire-9 for depression. Statistical analyses included internal consistency, test-retest reliability, concurrent validity, discriminative validity, and logistic regression analyses.

RESULTS: A total of 190 parents were enrolled. Social activity limitation was the item with the highest FAQL-PB scores. The Cronbach’s α for each item was higher than 0.8. The test-retest reliability was good (intra-class correlation coefficient, 0.716; 95% confidence interval [CI], 0.100-0.935). An increase in the FAQL-PB was significantly associated with an increase in the FAIM-PF (β = 0.765, P < 0.001) (concurrent validity). There was a positive correlation between parental burden, anxiety, and depression, while resilience was inversely correlated with parental burden (all P < 0.001). The total FAQL-PB score in parents of children who had experienced anaphylaxis was significantly higher than that in parents of children who did not experience it (P = 0.008). When adjusting for age, sex, and underlying diseases, anaphylaxis (β = 9.32; 95% CI, 2.97 to 15.68), cow’s milk (CM) allergy (β = 8.24; 95% CI, 2.04 to 14.44), soybean allergy (β = 13.91; 95% CI, 1.62 to 26.20), higher anxiety (β = 1.05; 95% CI, 0.07 to 1.41), higher depression (β = 2.15; 95% CI, 1.61 to 2.69), and lower resilience (β = -0.42; 95% CI, -0.61 to -0.2) were significantly associated with greater parental burden in children with IgE-mediated FAs.

CONCLUSION: FAQL-PB is a reliable and valid tool for use in Korea. Anaphylaxis, CM or soybean allergies, more anxiety and depression symptoms, and lower resilience are associated with poorer QoL in parents of children with FAs.

PMID:37431540 | DOI:10.3346/jkms.2023.38.e208

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Nevin Manimala Statistics

Controlling modified Tardieu scale assessment speeds to match joint angular velocities during walking impacts spasticity assessment outcomes

Clin Rehabil. 2023 Jul 11:2692155231187203. doi: 10.1177/02692155231187203. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate whether tailoring the speed of the Modified Tardieu Scale to reflect an individual’s joint angular velocity during walking influences spasticity assessment outcomes.

DESIGN: Observational trial.

SETTING: Inpatient and outpatient neurological hospital department.

SUBJECTS: Ninety adults with lower-limb spasticity.

INTERVENTIONS: N/A.

MAIN MEASURES: The Modified Tardieu Scale was used to assess the gastrocnemius, soleus, hamstrings and quadriceps. The V1 (slow) and V3 (fast) movements were completed as per standardised testing. Two additional assessments were completed, reflecting joint angular velocities during walking based on (i) a healthy control database (controlled velocity) and (ii) the individual’s real-time joint angular velocities during walking (matched velocity). The agreement was compared using Cohen’s and Weighted Kappa statistics, sensitivity and specificity.

RESULTS: There was poor agreement when rating trials as spastic or not spastic at the ankle joint (Cohen’s Kappa = 0.01-0.17). Trials were classified as spastic during V3 and not spastic during the controlled conditions in 81.6-85.1% of trials when compared to stance phase dorsiflexion angular velocities and 48.0-56.4% when compared to swing phase dorsiflexion angular velocities. The severity of muscle reaction demonstrated poor agreement at the ankle (Weighted Kappa = 0.01-0.28). At the knee, there was a moderate-excellent agreement between the V3 and controlled conditions when rating a trial as spastic or not spastic (Cohen’s Kappa = 0.66-0.84) and excellent agreement when comparing severity (Weighted Kappa = 0.73-0.94).

CONCLUSION: The speed of assessment impacted spasticity outcomes. It is possible that the standardised protocol may overestimate the impact spasticity has on walking, especially at the ankle.

PMID:37431534 | DOI:10.1177/02692155231187203

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Nevin Manimala Statistics

First trimester screening for pre-eclampsia and targeted aspirin prophylaxis: a cost-effectiveness cohort study

BJOG. 2023 Jul 11. doi: 10.1111/1471-0528.17598. Online ahead of print.

ABSTRACT

OBJECTIVE: Investigate cost-effectiveness of first trimester pre-eclampsia screening using the Fetal Medicine Foundation (FMF) algorithm and targeted aspirin prophylaxis in comparison with standard care.

DESIGN: Retrospective observational study.

SETTING: London tertiary hospital.

POPULATION: 5957 pregnancies screened for pre-eclampsia using the National Institute for Health and Care Excellence (NICE) method.

METHODS: Differences in pregnancy outcomes between those who developed pre-eclampsia, term pre-eclampsia and preterm pre-eclampsia were compared by the Kruskal-Wallis and Chi-square tests. The FMF algorithm was applied retrospectively to the cohort. A decision analytic model was used to estimate costs and outcomes for pregnancies screened using NICE and those screened using the FMF algorithm. The decision point probabilities were calculated using the included cohort.

MAIN OUTCOME MEASURES: Incremental healthcare costs and QALY gained per pregnancy screened.

RESULTS: Of 5957 pregnancies, 12.8% and 15.9% were screen-positive for development of pre-eclampsia using the NICE and FMF methods, respectively. Of those who were screen-positive by NICE recommendations, aspirin was not prescribed in 25%. Across the three groups, namely, pregnancies without pre-eclampsia, term pre-eclampsia and preterm pre-eclampsia there was a statistically significant trend in rates of emergency caesarean (respectively 21%, 43% and 71.4%; P < 0.001), admission to neonatal intensive care unit (NICU) (5.9%, 9.4%, 41%; P < 0.001) and length of stay in NICU. The FMF algorithm was associated with seven fewer cases of preterm pre-eclampsia, cost saving of £9.06 and QALY gain of 0.00006/pregnancy screened.

CONCLUSIONS: Using a conservative approach, application of the FMF algorithm achieved clinical benefit and an economic cost saving.

PMID:37431533 | DOI:10.1111/1471-0528.17598

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Nevin Manimala Statistics

Effects of White Chicken Eggshell Powder on Compressive Strength, Water Solubility, and Setting Time of Calcium-Enriched Mixture

Iran Endod J. 2023;18(3):152-158. doi: 10.22037/iej.v18i3.39798.

ABSTRACT

INTRODUCTION: The present study aimed to evaluate the effects of adding chicken eggshell powder (CESP) to calcium-enriched mixture (CEM) cement on its compressive strength (CS), solubility, and setting time.

MATERIALS AND METHODS: In this study, CESP was added at weight percentages of 3% and 5% to the powder component of the CEM cement. To measure the CS, a total of 36 samples (height, 6 mm; diameter, 4 mm) were tested in a universal testing machine. The setting time was assessed for 18 disk-shaped samples (diameter, 10 mm; height, 1 mm). Additionally, solubility test was performed on 18 samples (diameter, 8 mm; height, 1 mm) after 24 hours, 72 hours, seven days, and 14 days under dehydration conditions by calculating the weight changes; the results were then subjected to a normality test. Next, for the comparison of different test groups, parametric ANOVA test and post-hoc Tukey’s multiple comparison test were performed at a significance level of 0.05.

RESULTS: The addition of 5% CESP to the CEM cement significantly reduced its setting time and water solubility (P=0.02 and P=0.01, respectively). Moreover, it significantly increased the CS over a 21-day period (P<0.001). Additionally, the addition of 3% CESP also resulted in a significant increase in CS (P<0.001). While 3% CESP reduced setting time and water solubility, the difference was not statistically significant.

CONCLUSION: The findings suggest that the addition of 5% CESP to CEM cement has the potential to improve its sealing ability, durability, and ability to withstand chewing forces in endodontic treatments. These results highlight the relevance of CESP as an additive for cement modifications and indicate its potential clinical implications.

PMID:37431529 | PMC:PMC10329759 | DOI:10.22037/iej.v18i3.39798

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Nevin Manimala Statistics

Effect of Silver Nanoparticles of Herbal Origin on the Compressive and Push-out Bond Strengths of Mineral Trioxide Aggregate

Iran Endod J. 2023;18(3):159-164. doi: 10.22037/iej.v18i3.31364.

ABSTRACT

INTRODUCTION: The purpose of this in vitro study was to investigate the effect of incorporating silver nanoparticles (AgNPs) of herbal origin into mineral trioxide aggregate (MTA) on the push-out bond strength (PBS) and compressive strength (CS) in simulated furcal area perforations.

MATERIALS AND METHODS: In this in vitro study, simulated furcal area perforations (1.3 mm in diameter and 2 mm in depth) were created in 40 extracted human lower molar teeth, which were divided into two groups (n=20): MTA alone and MTA combined with AgNPs (2% wt). Using a universal testing machine, PBS was evaluated by performing push-out tests, while CS was assessed using cylindrical specimens. The normal distribution of data was checked using the Kolmogorov-Smirnov test, and statistical analysis was performed using two-way ANOVA.

RESULTS: The CS results showed no significant difference between the MTA group at 4 and 21 days (P=0.297), but a significant difference was observed in the nanosilver/MTA group (P=0.013). However, there was no significant difference in the push-out bond strength among the study groups (P>0.05).

CONCLUSION: The incorporation of herbal origin silver nanoparticles did not significantly affect the PBS or CS of MTA.

PMID:37431522 | PMC:PMC10329756 | DOI:10.22037/iej.v18i3.31364

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Nevin Manimala Statistics

Factors Associated with Self-Management of Peritoneal Dialysis Patients in Urumqi of Xinjiang of China: A Cross-Sectional Survey

Patient Prefer Adherence. 2023 Jul 5;17:1573-1589. doi: 10.2147/PPA.S415593. eCollection 2023.

ABSTRACT

PURPOSE: To explore the factors associated with self-management of Peritoneal Dialysis (PD) patients and methods of acquiring PD knowledge.

DESIGN: Cross-sectional survey design.

SETTING: Urumqi, Xinjiang, China.

PATIENTS: 131 Chinese maintenance Peritoneal Dialysis (PD) patients.

METHODS: This cross-sectional study was conducted from October 2019 to March 2020 in the First Affiliated Hospital of Xinjiang Medical University of China. 131 PD patients were recruited. Data were collected, including demographic characteristics, clinical dialysis data, self-management ability scale, and methods to obtain PD knowledge. A self-management questionnaire was used for the evaluation of self-management ability.

RESULTS: The score of the self-management ability of PD patients in Xinjiang, China, was (57.6±13.7) points, which was at the middle level in China. There was no statistically significant difference in the self-management ability scores of patients with different ages, sex, ethnicity, marital status, pre-dialysis status, PD time, PD procedures, self-care ability, PD satisfaction, and 24-hour average urine output (P>0.05). There were significant differences in the self-management ability scores of patients with different education levels, occupations, and medical insurance forms (P<0.05). The self-management ability of PD patients was positively correlated with the disease course of uremia and attending lectures on PD knowledge (P<0.05). The main factor affecting self-management ability was education level. There 73.28% of patients considered that it was necessary to establish a WeChat group for PD patients, and 65.7% believed that establishing a WeChat group for PD patients could facilitate communication between patients and enhance treatment confidence.

CONCLUSION: The study surveyed PD patients who have certain self-management ability. For patients with different education levels, different health education methods should be adopted to promote the improvement of patients’ self-management ability. Furthermore, WeChat is essential for Chinese PD patients to obtain disease-related information.

PMID:37431511 | PMC:PMC10329827 | DOI:10.2147/PPA.S415593