Nevin Manimala

Trials. 2023 Nov 29;24(1):771. doi: 10.1186/s13063-023-07762-7.

ABSTRACT

This manuscript is a master statistical analysis plan for each of three-cluster randomized controlled trials to evaluate the efficacy of attractive targeted sugar baits (ATSB) described in an already published protocol. The master SAP contains an overarching plan for all three trials, which can be adapted to trial-specific circumstances. The primary objective of the trials is to evaluate the efficacy of ATSB in the presence of universal vector control coverage with insecticide-treated nets (ITN) or indoor residual spraying (IRS) after two transmission seasons on clinical malaria incidence as compared with universal vector control coverage with ITN or IRS alone. The primary outcome measure is the incidence rate of clinical malaria, assessed in cohorts aged 12 months to less than 15 years (≥ 5 years to 15 years in Mali) during monthly follow-up visits. The primary unadjusted analysis will be conducted on the intention-to-treat analysis population without adjustment for any anticipated confounding variables. The primary outcome will be analyzed using a multi-level model constructed on a generalized linear model framework with a Poisson likelihood and a log link function. Random intercepts will be included for each study cluster and a fixed effect for study-arm. The analyst will be blinded to study arm assignment. Several secondary outcomes will be analyzed, as well as a pooled analysis (individual patient data meta-analysis) across the three trial sites. Additionally, a standard meta-analysis is expected to be conducted using combined data from all sites.

PMID:38031086 | DOI:10.1186/s13063-023-07762-7

BMC Public Health. 2023 Nov 29;23(1):2362. doi: 10.1186/s12889-023-17222-1.

ABSTRACT

BACKGROUND: Ebola virus disease is a medical condition whose consequent effects on quality of life of patients. In the history of infectious diseases, there have been pathologies that have had significant repercussions for caregivers, healthcare providers and the community.

OBJECTIVES: This study investigate determinants of quality of life among caregivers of adolescent and young adult Ebola survivors in Democratic Republic of the Congo.

METHODS: This was a cross sectional study. The study sites were the two health districts of Beni and Katwa, in North-Kivu province in the Eastern part of Democratic Republic of the Congo. The study period was from April to August 2022. Participants of the study were caregivers of adolescents and young adult Ebola virus survivors. Simple random sampling technique was used to select the 68 study participants. A questionnaire was administered. Data was collected using pretested questionnaire of WHO quality of life Bref (WHOQOL-BREF) and CommCare by Dimagi.Inc. lastest Version 2.52.1 and a sum of score of 78 or higher indicated a high level of life quality. To determine the quality of life of caregivers of adolescents and young adult EVD survivors, descriptive analysis was used. The Pearson correlation coefficient was utilized to check whether the predictor variables are multicollinear. The regression analysis produced the crude odds ratio (COR), adjusted odds ratio (aOR), 95% confidence interval (CI), and p-value. Statistical significance was defined as a p-value 0.05. The final multivariate model contained variables that were significant in the bivariate analysis. Prior to data collection, a research permit from National Ethical Committee of Research in Democratic Republic of the Congo was obtained. Written informed consents from literate or illiterate caregivers of adolescent and young adult Ebola survivors were obtained. Throughout the study, participants’ privacy and confidentiality were respected.

RESULTS: A total of 68 care givers participated in the study, with a majority 54/68(79.41%) having poor quality of life. Men were 3.17 times more likely to record good quality of life than women (p = 0.02); OR:(95% CI), 3.17: (1.2 – 8.36), With regards to place of residence, caregivers who lived in town were less likely to have good quality of life compared to those in rural (p = 0.01); OR: (95%CI), 0.25: (0.09 – 0.72).

CONCLUSION: The quality of life of caregivers of adolescent and young adult Ebola survivors in Democratic Republic of the Congo is poor. To be woman caregiver and to live in town are determinants associated with poor quality of life among caregivers of adolescent and young adult Ebola survivors.

PMID:38031082 | DOI:10.1186/s12889-023-17222-1

Virol J. 2023 Nov 29;20(1):279. doi: 10.1186/s12985-023-02245-2.

ABSTRACT

INTRODUCTION: Viral load assessment for people living with HIV is key for monitoring treatment and achieving the 95-95-95. In this study, we aimed to assess the degree of viral suppression at different thresholds and treatment duration after the introduction of dolutegravir-based therapy in ten public hospitals in Sierra Leone.

METHODS: We used a cross-sectional study design to recruits patients aged 18 years or older between August 2022 and January 2023. Statistical analyses were performed using R-software. Logistic regression was used to assess factors independently associated with viral suppression. The level of significance was set at P < 0.05.

RESULTS: Of the 2,253 patients recruited, 1,720 (76%) were women and 1,705 (76%) were receiving a fixed dose combination of tenofovir, lamivudine and dolutegravir. The median age and duration of anti-retroviral therapy (ART) was 36.0 (IQR, 28.0-45.0) years and 40.9 (IQR, 14.4-79.6) months, respectively. Using a threshold of HIV RNA < 1000 copies/mL, 1,715 (88.4%) patients on ART for more than 6 months were virally suppressed. Viral suppression rates were higher with dolutegravir-based (1,277, 89.5%) than efavirenz-based (418, 86.2%) ART. HIV RNA was < 200 copies/mL in 1,643 (84.6%) patients or < 50 copies/mL in 1,487 (76.6%) patients or between 50 and 999 copies/mL in 228 (11.7%) patients. Viral suppression rates at different ART durations (months) were as follows: 84.2% (≤ 3), 88.8% (4-6), 90.9% (6-12), and 88.1% (> 12). Viral suppression rates were higher for patients aged 40 or older (40-50 years: aOR 2.05, 95%CI 1.41-3.04, P < 0.01; 50-60 years: aOR 2.51, 95%CI 1.53-4.35, P < 0.01; >60 years: aOR 2.69, 95%CI 1.28-6.63, P = 0.02). Men had 49% lower odds of viral suppression than women (aOR 0.50, 95% CI 0.38-0.67, P < 0.01).

CONCLUSION: We report a viral suppression rate of 88.4% among patients on treatment for at least 6 months, with higher rate of suppression with dolutegravir than efavirenz. Factors associated with virological suppression were age and gender, emphasizing the need for innovative differentiated ART delivery models to optimize viral suppression and achieve the 95% target.

PMID:38031075 | DOI:10.1186/s12985-023-02245-2

BMC Complement Med Ther. 2023 Nov 29;23(1):429. doi: 10.1186/s12906-023-04158-7.

ABSTRACT

INTRODUCTION: India has a multifaceted healthcare system and recognizes complementary and alternative systems of medicine (AYUSH) that cater to the healthcare needs of people. Multimorbidity requires frequent visits to physicians and long-term use of medications, due to which people tend to prefer AYUSH systems as they provide holistic patient-centered treatment. Hence, we aimed to estimate the prevalence of multimorbidity and assess its correlates among patients attending AYUSH primary care clinics in Delhi.

METHODS: A cross-sectional study was conducted among 943 patients aged ≥ 18 years attending various AYUSH primary care clinics in Delhi from September 2021 to February 2022, employing a stratified random sampling technique. Descriptive statistics such as frequency and proportion were used to report the prevalence of multimorbidity (two or more chronic conditions in an individual out of the 33 conditions listed as per the Multimorbidity Assessment Questionnaire for Primary Care). A multivariable logistic regression assessed the association between various socio-demographic characteristics and multimorbidity, presented as an adjusted odds ratio (AOR) with a 95% confidence interval (CI).

RESULTS: The prevalence of diabetes (14.7%) was found to be the highest (out of all included chronic conditions) among the patients attending various AYUSH primary care settings. The overall prevalence of multimorbidity was observed to be around 39.4%. We observed a higher likelihood of having multimorbidity among participants aged ≥ 70 years [AOR: 9.19 (95% CI: 3.75-22.54)], females [AOR: 1.57 (95% CI: 1.04-2.37)], and middle class [AOR: 2.23 (95% CI: 1.45-3.43)].

CONCLUSION: Multimorbidity was evidently prevalent across AYUSH primary care settings, which cannot be overlooked. The results suggest behavioral change communication may be aimed at older individuals, females, and the middle class.

PMID:38031066 | DOI:10.1186/s12906-023-04158-7

BMC Med Imaging. 2023 Nov 29;23(1):198. doi: 10.1186/s12880-023-01158-4.

ABSTRACT

OBJECTIVE: Maxillary morphology has long been a subject of interest due to its possible impact on palatally and labially displaced canines. This study aims to conduct a comparison of the palate morphology between individuals with palatal and labially displaced canines and control subjects using statistical shape analysis on a coronal cross-sectional of CBCT images.

MATERIALS AND METHODS: Patients aged between 12 and 43 years with palatally or labially displaced canines referred to Hamadan School of Dentistry between 2014 and 2019 were recruited for this retrospective study. The sample included 29 palatally displaced canines (PDC), 20 labially displaced canines (LDC), and 20 control groups (CG). Initially, the maxillary palate coronal section was acquired and landmarked in the region between the right and the left first molar. Procrustes and principal component analyses were used to identify the primary patterns of palatal shape variation. Statistical tests were then performed to examine both shape and size differences.

RESULTS: According to the results of Hotelling’s T2 test, there is a significant difference between the mean shape of palate in PDC and CG (P = 0.009), while the difference between the PDC-LDC and LDC-CG groups is not significant. The longest full Procrustes distance was observed between PDC and CG (distance = 0.043), and the shortest full Procrustes distance was observed between LDC and CG (distance = 0.029). The first two principal components accounted for 84.47% of the total variance. The predictive accuracy of the discriminant analysis model showed that 72.46% of cases were correctly classified into the three study groups.

CONCLUSIONS: In terms of centroid size, there was no significant difference in the sectional area between the three groups, but the difference between the mean shape of palate in the PDC and CG groups was significant. The PDC group showed more prominent mid-palatal area in the molar region.

PMID:38031064 | DOI:10.1186/s12880-023-01158-4

BMC Pediatr. 2023 Nov 30;23(1):606. doi: 10.1186/s12887-023-04433-z.

ABSTRACT

BACKGROUND: Congenital abnormalities, as one of the fetal complications of placenta previa, may cause health problems or disability of the child throughout life. This study aimed to determine the relationship between placenta previa and congenital abnormalities.

METHODS: Potential articles were retrieved from three electronic databases (PubMed/Medline, Scopus, and Web of Sciences) up to 21 May 2023 without limit of time and language. A random effect model was applied for meta-analysis. The heterogeneity was calculated based on I² statistic and Cochrane Q-test. All analyses were conducted at the significance level of 0.05 using STATA software, version 14. The quality assessment of the included studies was performed using the improved Newcastle-Ottawa Scale.

RESULTS: In the initial search, 829 articles were retrieved. Finally, according to the inclusion criteria, eight studies were analyzed in the meta-analysis. A significant association was reported between placenta previa and risk of congenital abnormalities based on crude form (OR = 1.81, 95% CI = 1.34 to 2.28) and adjusted studies (OR = 6.38, 95% CI = 1.47 to 11.30). The high heterogeneity was observed among the studies reported based on adjusted and crude form, respectively (I² = 97.9%, P = 0.000) (I² = 80.6%, P = 0.000). Therefore, publication bias was not observed among studies. Seven studies of the included studies were of high quality.

CONCLUSION: Our study provides evidence that there is a positive and significant association between placenta previa and congenital malformations, including all structural anomalies, chromosomal defects, and congenital hypothyroidisms. Therefore, monitoring congenital abnormalities in the fetus of a mother with placenta previa is necessary.

PMID:38031046 | DOI:10.1186/s12887-023-04433-z

BMC Urol. 2023 Nov 29;23(1):197. doi: 10.1186/s12894-023-01368-6.

ABSTRACT

BACKGROUND: Although PCNL has been used for a long time to treat nephrolithiasis, there is still contradictory information concerning the use of the dilation method. In this study, we aimed to compare conventional sequential Amplatz dilatation (SAD) using ten dilators and a method using three dilators (12, 20, and 30 Fr), which we named “three-shot dilatation” (3SD), in terms of fluoroscopy time (FT), operation time, bleeding and stone-free rates.

METHODS: The study included patients who underwent PCNL with the SAD and 3SD methods. A different surgeon with extensive endourology experience applied each technique. One of the surgeons operated on the patients using the SAD method with ten dilators, and the other surgeon performed the operations using the 3SD method involving three Amplatz dilators (12, 20, and 30 Fr).

RESULTS: A total of 283 patients, 138 in the 3SD group and 145 in the SAD group, were included in the study. The mean age of the patients was 47.32 ± 13.71 years. There was no statistically significant difference between the two groups regarding preoperative characteristics (p > 0.05). The FTs of access 2, total access, and total operation were significantly shorter in the 3SD group (p = 0.0001). The decrease in hemoglobin was statistically significant in the 3SD group compared to the SAD group (p = 0.022), while the blood transfusion requirements of the groups were similar (p = 0.176). There was no statistically significant difference between the two groups regarding stone-free rates (p = 0.973). In four patients in the SAD group, re-access was necessary due to the loss of passage due to the guide wire slipping out of its place.

CONCLUSION: Intraoperative FT can be shortened using the described 3SD method without compromising surgical safety. However, this method can be used as an intermediate step in the transition to one-shot dilation by surgeons experienced in performing SAD.

PMID:38031043 | DOI:10.1186/s12894-023-01368-6

BMC Neurol. 2023 Nov 29;23(1):424. doi: 10.1186/s12883-023-03470-6.

ABSTRACT

BACKGROUND: Sestrin2 is a highly conserved stress-inducible protein with neuroprotective properties. Herein, we investigated the prognostic significance of serum sestrin2 in human intracerebral hemorrhage (ICH).

METHODS: In this prospective observational longitudinal study, we enrolled 126 patients with supratentorial ICH as cases together with 126 healthy individuals as controls. Severity indicators were National Institutes of Health Stroke Scale (NIHSS) and hematoma volume. Prognostic parameters were early neurologic deterioration (END) and post-stroke 6-month poor prognosis [modified Rankin Scale (mRS) scores of 3-6]. Multivariate analysis was performed to assess relations of serum sestrin2 levels to severity and prognosis.

RESULTS: Patients had statistically significantly higher serum sestrin2 levels than controls. Serum sestrin2 levels of patients were independently correlated with NIHSS scores and hematoma volume, as well as were substantially elevated in order of mRS scores from 0 to 6. Serum sestrin2 was identified as an independent predictor of END and poor prognosis. Based on the receiver operating characteristic curve, serum sestrin2 had a similar predictive ability for END and poor prognosis, as compared to NIHSS scores and hematoma volume. Prediction models of END and poor prognosis, in which serum sestrin2, NIHSS scores and hematoma volume were integrated, were visually described via nomogram, were reliable and stable under calibration curve and were of clinical benefit using decision curve analysis. Also, prediction model of poor prognosis showed dramatically higher discriminatory efficiency than any of NIHSS scores, hematoma volume and serum sestrin2.

CONCLUSION: Serum sestrin2 levels, which are obviously increased following acute ICH, are independently related to illness severity and poor clinical outcomes, substantializing serum sestrin2 as a clinically valuable prognostic biomarker of ICH.

PMID:38031041 | DOI:10.1186/s12883-023-03470-6

BMC Pregnancy Childbirth. 2023 Nov 29;23(1):824. doi: 10.1186/s12884-023-06139-7.

ABSTRACT

OBJECTIVE: This study assessed the impacts of in vitro culture times of cleavage embryos on clinical pregnancy outcomes.

METHODS: This retrospective cohort study was performed at the Reproductive Medicine Department of Hainan Modern Women and Children’s Hospital in China between January 2018 and December 2022. Patients who first underwent frozen embryo transfer with in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycles on day 3 were included. According to the time of embryo culture after thawing, the embryos were divided into long-term culture group(18-20 h) and short-term culture group (2-4 h). The clinical pregnancy rate was regarded as he primary outcome. To minimize confounding factors and reduce selection bias, the propensity score matching was used to balance the effects of known confounding factors and to reduce selection bias. Stratified analyses and multiple logistic regression analyses were used to evaluate the risk factors affecting the clinical pregnancy outcomes after matching.

RESULTS: General characteristics between two groups were comparable after matching. In the long-term culture group, 266/381 (69.81%) embryos had more than 10 blastomeres, and 75/381 (19.68%) reached the morula stage. After overnight culture, the implantation rate (27.97% vs. 14.28%, P = 0.018) and clinical pregnancy rate (38.46% vs. 22.5%, P = 0.05) were increased in the group with proliferating blastomeres. The long-term culture group trended to have a higher clinical pregnancy rate compared with the short-term culture group (35.74% vs. 29.79%). No statistical differences in clinical pregnancy outcomes between the two groups were observed after matching, including the rates of implantation (25.46% vs23.98%), miscarriages (25% vs. 22.85%), ongoing pregnancy rate (76.2% vs. 77.15%) and live birth rate (26.8% vs. 22.98%). Stratified analyses were performed according to the age of the patients. After matching, there were no significant differences in the clinical pregnancy, implantation and miscarriage rates between the two groups for patients > 35 or ≤ 35 years of age. Subgroup analyses were performed according to the quality of the transferred embryos. There were no significant differences in the clinical outcomes, between two groups after embryos transferred with the same quality. Multivariate Logistic regression analysis was used to evaluate the influencing factors of clinical pregnancy outcomes after matching. Culture time was not found to be an independent predictor for clinical pregnancy [OR 0.742, 95%CI 0.487 ~ 1.13; P = 0.165]. The age of oocyte retrieval [OR 0.906, 95%CI 0.865 ~ 0.949; P <0.001] and the number of high-quality embryos transferred [OR 1.787, 95%CI 1.256 ~ 2.543; P = 0.001] were independent factors affecting clinical pregnancy outcomes.

CONCLUSIONS: In vitro 18-20 h culture of embryos with either good-or non-good-quality will not adversely affect the clinical pregnancy.

PMID:38031033 | DOI:10.1186/s12884-023-06139-7

BMC Oral Health. 2023 Nov 29;23(1):945. doi: 10.1186/s12903-023-03464-3.

ABSTRACT

BACKGROUND: Nonsyndromic cleft lip and/or without cleft palate (NSCL/P) with or without hypodontia is a common developmental aberration in humans and animals. This study aimed to identify the loss of heterozygosity (LOH) involved in hypodontia and NSCL/P pathogenesis.

METHODS: This is a cross-sectional study that conducted genome-wide copy number analysis using CytoScan 750K array on salivary samples from Malay subjects with NSCL/P with or without hypodontia aged 7-13 years. To confirm the significant results, simple logistic regression was employed to conduct statistical data analysis using SPSS software.

RESULTS: The results indicated the most common recurrent copy neutral LOH (cnLOH) observed at 1p33-1p32.3, 1q32.2-1q42.13 and 6p12.1-6p11.1 loci in 8 (13%), 4 (7%), and 3 (5%) of the NSCL/P subjects, respectively. The cnLOHs at 1p33-1p32.3 (D1S197), 1q32.2-1q42.13 (D1S160), and 6p12.1-6p11.1 (D1S1661) were identified observed in NSCL/P and noncleft children using microsatellite analysis markers as a validation analysis. The regions affected by the cnLOHs at 1p33-1p32.3, 1q32.2-1q42.13, and 6p12.1-6p11.1 loci contained selected genes, namely FAF1, WNT3A and BMP5, respectively. There was a significant association between the D1S197 (1p33-32.3) markers containing the FAF1 gene among NSCL/P subjects with or without hypodontia compared with the noncleft subjects (p-value = 0.023).

CONCLUSION: The results supported the finding that the genetic aberration on 1p33-32.3 significantly contributed to the development of NSCL/P with or without hypodontia. These results have an exciting prospect in the promising field of individualized preventive oral health care.

PMID:38031027 | DOI:10.1186/s12903-023-03464-3