Nevin Manimala

Hum Vaccin Immunother. 2024 Dec 31;20(1):2326295. doi: 10.1080/21645515.2024.2326295. Epub 2024 Mar 20.

ABSTRACT

Despite the ongoing global vaccination campaign aimed at preventing human papillomavirus (HPV) related health issues, the uptake of the HPV vaccine remains unacceptably low in developing regions, particularly in sub-Saharan Africa (SSA). Therefore, this systematic review and meta-analysis aimed at determining the pooled prevalence and associated factors of HPV vaccine uptake among adolescent school girls in SSA. Electronic bio-medical databases were explored. Pooled prevalence, publication bias, meta-regression, sub-group, and sensitivity analysis were performed. The estimated pooled prevalence of HPV vaccine uptake was 28.53% [95% CI: (5.25, 51.81)]. Having good knowledge and a positive attitude was significantly associated with HPV vaccine uptake in SSA. Subgroup analysis revealed the highest uptake was 62.52% from Kenya and the lowest was 3.77% in Nigeria. The HPV vaccine uptake is low. It underscores the need for community education, school-based immunization, and education programs that promote the uptake of the vaccine to increase coverage.

PMID:38505959 | DOI:10.1080/21645515.2024.2326295

Stat Methods Med Res. 2024 Mar 20:9622802241239008. doi: 10.1177/09622802241239008. Online ahead of print.

ABSTRACT

Platform trials are randomized clinical trials that allow simultaneous comparison of multiple interventions, usually against a common control. Arms to test experimental interventions may enter and leave the platform over time. This implies that the number of experimental intervention arms in the trial may change as the trial progresses. Determining optimal allocation rates to allocate patients to the treatment and control arms in platform trials is challenging because the optimal allocation depends on the number of arms in the platform and the latter typically varies over time. In addition, the optimal allocation depends on the analysis strategy used and the optimality criteria considered. In this article, we derive optimal treatment allocation rates for platform trials with shared controls, assuming that a stratified estimation and a testing procedure based on a regression model are used to adjust for time trends. We consider both, analysis using concurrent controls only as well as analysis methods using concurrent and non-concurrent controls and assume that the total sample size is fixed. The objective function to be minimized is the maximum of the variances of the effect estimators. We show that the optimal solution depends on the entry time of the arms in the trial and, in general, does not correspond to the square root of k allocation rule used in classical multi-arm trials. We illustrate the optimal allocation and evaluate the power and type 1 error rate compared to trials using one-to-one and square root of k allocations by means of a case study.

PMID:38505941 | DOI:10.1177/09622802241239008

J Biosoc Sci. 2024 Mar 20:1-19. doi: 10.1017/S0021932024000063. Online ahead of print.

ABSTRACT

Increasing prevalence of non-communicable diseases (NCDs) has become the leading cause of death and disability in Bangladesh. Therefore, this study aimed to measure the prevalence of and risk factors for double and triple burden of NCDs (DBNCDs and TBNCDs), considering diabetes, hypertension, and overweight and obesity as well as establish a machine learning approach for predicting DBNCDs and TBNCDs. A total of 12,151 respondents from the 2017 to 2018 Bangladesh Demographic and Health Survey were included in this analysis, where 10%, 27.4%, and 24.3% of respondents had diabetes, hypertension, and overweight and obesity, respectively. Chi-square test and multilevel logistic regression (LR) analysis were applied to select factors associated with DBNCDs and TBNCDs. Furthermore, six classifiers including decision tree (DT), LR, naïve Bayes (NB), k-nearest neighbour (KNN), random forest (RF), and extreme gradient boosting (XGBoost) with three cross-validation protocols (K2, K5, and K10) were adopted to predict the status of DBNCDs and TBNCDs. The classification accuracy (ACC) and area under the curve (AUC) were computed for each protocol and repeated 10 times to make them more robust, and then the average ACC and AUC were computed. The prevalence of DBNCDs and TBNCDs was 14.3% and 2.3%, respectively. The findings of this study revealed that DBNCDs and TBNCDs were significantly influenced by age, sex, marital status, wealth index, education and geographic region. Compared to other classifiers, the RF-based classifier provides the highest ACC and AUC for both DBNCDs (ACC = 81.06% and AUC = 0.93) and TBNCDs (ACC = 88.61% and AUC = 0.97) for the K10 protocol. A combination of considered two-step factor selections and RF-based classifier can better predict the burden of NCDs. The findings of this study suggested that decision-makers might adopt suitable decisions to control and prevent the burden of NCDs using RF classifiers.

PMID:38505939 | DOI:10.1017/S0021932024000063

Curr Med Res Opin. 2024 Mar 20:1-13. doi: 10.1080/03007995.2024.2331159. Online ahead of print.

ABSTRACT

Objectives: To address the need for faster pain relief of over-the-counter (OTC) analgesic users, a novel drug delivery technology was developed to achieve faster absorption of orally administered acetaminophen with the goal of delivering earlier onset of pain relief. Previous development studies suggested that a 1000 mg dose of this fast-acting acetaminophen (FA-acetaminophen) formulation provided faster absorption and onset of action versus, commercially available OTC fast-acting analgesics, 1000 mg of extra-strength acetaminophen (ES-acetaminophen) or 400 mg of liquid-filled ibuprofen capsules (LG-ibuprofen). This study was designed as the definitive trial evaluating the onset of pain relief of FA-acetaminophen versus these same OTC comparators.Methods: This single-dose, randomized, double-blind, placebo- and active-controlled clinical trial compared analgesic onset, overall efficacy, and safety of FA-acetaminophen 1000 mg, ES-acetaminophen 1000 mg, LG-ibuprofen 400 mg, and placebo over 4 hours in a postsurgical dental pain model. Following removal of 3 to 4 impacted third molars, 664 subjects with moderate-to-severe pain were randomized in a 4:4:2:1 ratio to FA-acetaminophen (249), ES-acetaminophen (232), LG-ibuprofen (124), or placebo (59). Mean age was 18.9 years; 45.5% were male; 57.5% had severe baseline pain intensity. Subjects stopped a first stopwatch if/when they had perceptible pain relief and a second stopwatch if/when their pain relief became meaningful to them. Pain intensity difference (PID) and pain relief (PAR) were obtained using an 11-point numerical rating scale.Findings: FA-acetaminophen 1000 mg had faster median time to onset of pain relief (15.7 minutes) compared to ES-acetaminophen 1000 mg (20.2 minutes, p = 0.035), LG-ibuprofen 400 mg (23.2 minutes, p < 0.001), and placebo (non-estimable), statistically greater mean PAR and PID scores than other treatment groups at 15 and 30 minutes, and a statistically greater percentage of subjects with confirmed perceptible pain relief at 15 and 20 minutes. At 25 minutes, FA-acetaminophen 1000 mg had a statistically significantly greater percentage of subjects with confirmed perceptible pain relief than LG-ibuprofen 400 mg and placebo. No clinically significant adverse events were reported.Conclusions: This study supports previous studies, demonstrating faster onset of analgesia with FA-acetaminophen 1000 mg compared to OTC ES-acetaminophen 1000 mg and OTC LG-ibuprofen 400 mg.ClinicalTrials.gov Identifier: NCT03224403 https://clinicaltrials.gov/ct2/show/NCT03224403.

PMID:38505928 | DOI:10.1080/03007995.2024.2331159

Am Surg. 2024 Mar 20:31348241238323. doi: 10.1177/00031348241238323. Online ahead of print.

ABSTRACT

BACKGROUND: The 2014 expansion of Medicaid under the Affordable Care Act (ACA) reshaped healthcare delivery in the United States. This study assessed how Medicaid expansion affected in-hospital mortality in patients with extreme risk of mortality (EROM) from traumatic injuries.

METHODS: Data from inpatients aged 18-64 years, registered in the National Inpatient Sample between 2007 and 2020, and identified with trauma-related All-Patient Refined Diagnosis Related Groups (APRDRG) codes, were analyzed. Within this group, a subset of patients was selected based on the APRDRG classification identifying them as at EROM for the principal unit of analysis. The cohort was divided into high-implementation (HIR) and low-implementation (LIR) regions based on Medicaid expansion coverage. In-hospital mortality was assessed using interrupted time-series analysis. Sensitivity analyses considered seasonality, autocorrelation, and exogenous events.

RESULTS: Analysis encompassed 70 381 trauma inpatient stays, corresponding to 346 659 patients based on National Inpatient Sample weighting. There was a consistent monthly decline in in-hospital mortality of .08% (95% CI: -.103 to -.048; P < .001) prior to Medicaid expansion, a trend unaffected by expansion. This pattern persisted across both LIR and HIR Medicaid implementation regions. Although Medicaid enrollment increased in HIR, that in LIR remained unchanged.

DISCUSSION: Over the study period, the in-hospital mortality among severely injured patients consistently decreased, and this trend was not influenced by Medicaid expansion. The statistical models and results from this study can offer valuable guidance to policymakers and healthcare leaders as they formulate more efficient and effective policies.

PMID:38505915 | DOI:10.1177/00031348241238323

J Long Term Eff Med Implants. 2024;34(3):55-63. doi: 10.1615/JLongTermEffMedImplants.2023048690.

ABSTRACT

Robotic arm-assisted total knee arthroplasty (RATKA) represents a haptic assistive robotic arm used for bone preparation. The purpose of this study was to present implant survivorship, complications and evaluate patients’ satisfaction, clinical and functional outcome of RATKA with a minimum of 1-year follow-up. The Oxford Knee Score was recorded preoperatively and at last follow-up. Patients’ satisfaction rates, as well as complications and re-operations were studied. Anatomical alignment including varus, valgus deformities and flexion, extension, pre-and postoperatively were evaluated. A total of 156 patients with mean age = 71.9 years were included in the study. The mean follow-up was 35.7 months, while one revision was performed due to infection. Statistically significant improvement of the Oxford Knee Score, as well as of the knee alignment deformities were recorded, while 99.4% of patients reported to be “very satisfied” or “satisfied” with the procedure. RATKA seems to be a safe, as well as reproductible procedure at short-and mid-term follow-up, while the accurate implant positioning may lead to favorable long-term outcomes.

PMID:38505894 | DOI:10.1615/JLongTermEffMedImplants.2023048690

J Long Term Eff Med Implants. 2024;34(3):27-36. doi: 10.1615/JLongTermEffMedImplants.2023048783.

ABSTRACT

Ramus frame dental implants were retrospectively studied in 360 adults with severely atrophic edentulous mandibles. Patient records up to 12 years post-treatment were independently reviewed after a single clinician surgically placed titanium long-arm (“Tatum”) ramus frame implants and immediately loaded them with a mandibular overdenture. A total of 11 ramus frames were removed at 19 to 109 months post-treatment, mostly due to supramucosal bar fracture (N = 6) or mobility (N = 3). Kaplan-Meier product-limit analysis revealed the post-treatment survival probability for functional ramus frame implants to be 99.3% at 2 years (266 patients), 98.9% at 3 years (223 patients), 97.9% at 4 years (198 patients), 96.9% at 5 years (160 patients), 96.9% at 6 years (123 patients), 95.0% at 7 years (86 patients), 95.0% at 8 years (67 patients), 93.3% at 9 years (43 patients), and 91.1% at 10 years (25 patients). No statistically significant differences in functional ramus frame implant survival were found relative to patient gender, smoking, presence of natural maxillary teeth, or compliance with semi-annual maintenance care. Fracture of endosseous anterior feet/posterior arms was the most frequent implant-related complication on 29 implants, which were left in place, repaired, or replaced in situ without implant removal. At 5 years, the ramus frame implant functional survival probability without any implant-related biological or mechanical complication was 88.9%. Ramus frame dental implants, immediately loaded with a fully implant-borne mandibular overdenture, exhibited a high degree of long-term functional survival and safety in severely atrophic edentulous human mandibles.

PMID:38505891 | DOI:10.1615/JLongTermEffMedImplants.2023048783

Phytother Res. 2024 Mar 19. doi: 10.1002/ptr.8189. Online ahead of print.

ABSTRACT

Turmeric has been gaining popularity as a treatment option for digestive disorders, although a rigorous synthesis of efficacy has not been conducted. This study aimed to summarize the evidence for the efficacy and safety of turmeric in the treatment of digestive disorders, including inflammatory bowel diseases (IBD), irritable bowel syndrome (IBS), dyspepsia, gastroesophageal reflux disease, and peptic ulcers. Literature searches were conducted in Medline, EMBASE, AMED, the Cochrane Central Register of Control Trials, and Dissertation Abstracts from inception to November 15, 2021. Dual independent screening of citations and full texts was conducted and studies meeting inclusion criteria were retained: randomized controlled trials (RCT) and comparative observational studies evaluating turmeric use in people of any age with one of the digestive disorders of interest. Extraction of relevant data and risk of bias assessments were performed by two reviewers independently. Meta-analysis was not conducted due to high heterogeneity. From 1136 citations screened, 26 eligible studies were retained. Most studies were assessed to have a high risk of bias, and many had methodological limitations. Descriptive summaries suggest that turmeric is safe, with possible efficacy in patients with IBD or IBS, but its effects were inconsistent for other conditions. The efficacy of turmeric in digestive disorders remains unclear due to the high risk of bias and methodological limitations of the included studies. Future studies should be designed to include larger sample sizes, use rigorous statistical methods, employ core outcome sets, and adhere to reporting guidance for RCTs of herbal interventions to facilitate more meaningful comparisons and robust conclusions.

PMID:38503513 | DOI:10.1002/ptr.8189

Heart. 2024 Mar 19:heartjnl-2023-323474. doi: 10.1136/heartjnl-2023-323474. Online ahead of print.

ABSTRACT

BACKGROUND: We assessed the prevalence and diagnostic value of ECG abnormalities for cardiomyopathy surveillance in childhood cancer survivors.

METHODS: In this cross-sectional study, 1381 survivors (≥5 years) from the Dutch Childhood Cancer Survivor Study part 2 and 272 siblings underwent a long-term follow-up ECG and echocardiography. We compared ECG abnormality prevalences using the Minnesota Code between survivors and siblings, and within biplane left ventricular ejection fraction (LVEF) categories. Among 880 survivors who received anthracycline, mitoxantrone or heart radiotherapy, logistic regression models using least absolute shrinkage and selection operator identified ECG abnormalities associated with three abnormal LVEF categories (<52% in male/<54% in female, <50% and <45%). We assessed the overall contribution of these ECG abnormalities to clinical regression models predicting abnormal LVEF, assuming an absence of systolic dysfunction with a <1% threshold probability.

RESULTS: 16% of survivors (52% female, mean age 34.7 years) and 14% of siblings had major ECG abnormalities. ECG abnormalities increased with decreasing LVEF. Integrating selected ECG data into the baseline model significantly improved prediction of sex-specific abnormal LVEF (c-statistic 0.66 vs 0.71), LVEF <50% (0.66 vs 0.76) and LVEF <45% (0.80 vs 0.86). While no survivor met the preset probability threshold in the first two models, the third model used five ECG variables to predict LVEF <45% and was applicable for ruling out (sensitivity 93%, specificity 56%, negative predictive value 99.6%). Calibration and internal validation tests performed well.

CONCLUSION: A clinical prediction model with ECG data (left bundle branch block, left atrial enlargement, left heart axis, Cornell’s criteria for left ventricular hypertrophy and heart rate) may aid in ruling out LVEF <45%.

PMID:38503487 | DOI:10.1136/heartjnl-2023-323474

Br J Ophthalmol. 2024 Mar 19:bjo-2023-324243. doi: 10.1136/bjo-2023-324243. Online ahead of print.

ABSTRACT

AIMS: To report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.

METHODS: Overall, 168 children aged 6-13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year).

RESULTS: After 1 year, mean changes in SER were significantly lower in the DDM group (-0.47±0.37 D) than in the SV group (-0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6-9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively.

CONCLUSIONS: After 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation.

TRIAL REGISTRATION NUMBER: NCT05340699.

PMID:38503477 | DOI:10.1136/bjo-2023-324243