Nevin Manimala

BMC Pharmacol Toxicol. 2022 Sep 14;23(1):70. doi: 10.1186/s40360-022-00612-3.

ABSTRACT

BACKGROUND: Although various pharmacological and nonpharmacological treatments are available for the chronic low back pain (CLBP), there is no consensus on the best optimal treatment for this condition. This study aimed to investigate the efficacy of co-administration of pregabalin and agomelatine versus pregabalin with placebo to treat CLBP.

METHODS: Forty-six CLBP patients without the surgical indication referred to the outpatient orthopedic clinic of Rasoul-e-Akram Hospital, Tehran, Iran, were randomly divided into two study groups: Group A [pregabalin (75 mg twice per day) + placebo] and Group B [pregabalin (75 mg twice per day) + agomelatine (25 mg per night)]. Patients were evaluated at weeks 0, 4, and 8. Outcome measures were the Persian versions of the Brief Pain Inventory (BPI) interference scale, Roland-Morris Disability Questionnaire (RMDQ), The Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Survey (SF-36), and General Health Questionnaire-28 (GHQ-28) were used.

RESULTS: At weeks 4 and 8 after the intervention, all evaluated measures showed significant improvement in both study groups (P < 0.01). The mean improvement of GHQ-28 was 3.7 ± 1.22 in group A and 13.1 ± 4.71 in group B. This difference was statistically significant (P = 0.003). Other outcomes did not vary substantially between the two research groups. Agomelatine treatment was well tolerated, with no significant adverse effects seen in patients. Liver tests of all patients were routine during the study period. Major adverse effect was not seen in any patient. The prevalence of Minor side effects was not significantly different between two study groups.

CONCLUSION: Compared with the pregabalin and placebo, co-administration of pregabalin and agomelatine had no added effect on improving pain scores in CLBP patients. However, the patients’ general health was significantly improved after the combined administration of pregabalin and agomelatine.

TRIAL REGISTRATION: The study protocol was registered in the Iranian Registry of Clinical Trials before starting the study (NO.IRCT20200620047852N1, Registration date: 23/06/2020).

PMID:36104745 | DOI:10.1186/s40360-022-00612-3

BMC Health Serv Res. 2022 Sep 14;22(1):1161. doi: 10.1186/s12913-022-08518-w.

ABSTRACT

BACKGROUND: Achieving equity in the distribution of health services is one major goal in the health system. This study aimed to determine equality in distributing health human resources (physicians) in the Qazvin University of Medical Sciences before and after the Health Transformation Plan (HTP) based on the Hirschman-Herfindahl index (HHI).

METHODS: In this descriptive-analytical study, the statistical population was general practitioners (GPs), specialists and subspecialists in the Qazvin University of Medical Sciences from 2011-to 2017. We extracted demographic statistics of the cities from the Statistical Center of Iran. Physicians’ statistics were obtained from the Curative Affairs Deputy at the Qazvin University of Medical Sciences. We assessed inequality using the HHI.

RESULTS: The highest number of GPs was in 2014, and specialists and subspecialists were in 2017. The lowest number of GPs, specialists, and subspecialists were in 2016, 2011 and 2015. The HHI for GPs in 2011-2017 was between 4300 and 5200. The lowest concentration for specialists before the HTP plan was the cardiologist with 3300, and after the HTP, the internal specialist with 3900. Also, the numerical value of this index for all subspecialty physicians after the HTP was 10,000, the highest level of concentration.

CONCLUSION: The values obtained from the HHI index indicate the high concentration and disproportionate and inequitable distribution of human resources in the health sector in this province. The number of specialists in some cities is still much less than acceptable, and some cities even have shortcomings in the critical specialists.

PMID:36104727 | DOI:10.1186/s12913-022-08518-w

BMC Endocr Disord. 2022 Sep 14;22(1):229. doi: 10.1186/s12902-022-01139-8.

ABSTRACT

BACKGROUND: IDegLira is a fixed-ratio combination of insulin degludec and liraglutide with proven efficacy against simpler regimens and non-inferiority against basal-bolus insulin therapy. However, the evaluation of its real-world effectiveness is hindered by technical issues and requires further exploration. Thus we aimed to compare effectiveness of insulin degludec/liraglutide (IDegLira) versus intensified conventional insulin therapy (ICT) for type 2 diabetes in a real-world setting.

METHODS: This retrospective cohort study from an outpatient clinic in Hungary included people who initiated IDegLira due to inadequate glycaemic control (HbA1c > 7.0% [53.0 mmol/mol]) with oral and/or injectable antidiabetic drugs. Data were compared with a historical cohort who initiated ICT. Outcomes included HbA1c, body weight, and hypoglycaemia differences over 18 months of follow-up.

RESULTS: Data were included from 227 and 72 people who initiated IDegLira and ICT, respectively. Estimated mean difference (MD) in HbA1c at 18 months favoured IDegLira versus ICT (MD 0.60, 95% CI 0.88-0.32 [MD 6.6 mmol/mol, 95% CI 9.6-3.5]). More people reached target HbA1c ≤7.0% (53.0 mmol/mol) with IDegLira than ICT (odds ratio 3.36, 95% CI 1.52-7.42). IDegLira treatment was associated with weight loss compared with gain for ICT (MD 6.7 kg, 95% CI 5.0-8.5). The hazard ratio for hypoglycaemia comparing IDegLira with ICT was 0.18 (95% CI 0.08-0.49).

CONCLUSIONS: Treatment with IDegLira over 18 months resulted in greater HbA1c reductions, weight loss versus gain, and a lower rate of hypoglycaemia versus ICT in people with type 2 diabetes.

PMID:36104712 | DOI:10.1186/s12902-022-01139-8

BMC Med. 2022 Sep 15;20(1):307. doi: 10.1186/s12916-022-02499-7.

ABSTRACT

BACKGROUND: Gestational diabetes (GDM) is prevalent and benefits from timely and effective treatment, given the short window to impact glycemic control. Clinicians face major barriers to choosing effectively among treatment modalities [medical nutrition therapy (MNT) with or without pharmacologic treatment (antidiabetic oral agents and/or insulin)]. We investigated whether clinical data at varied stages of pregnancy can predict GDM treatment modality.

METHODS: Among a population-based cohort of 30,474 pregnancies with GDM delivered at Kaiser Permanente Northern California in 2007-2017, we selected those in 2007-2016 as the discovery set and 2017 as the temporal/future validation set. Potential predictors were extracted from electronic health records at different timepoints (levels 1-4): (1) 1-year preconception to the last menstrual period, (2) the last menstrual period to GDM diagnosis, (3) at GDM diagnosis, and (4) 1 week after GDM diagnosis. We compared transparent and ensemble machine learning prediction methods, including least absolute shrinkage and selection operator (LASSO) regression and super learner, containing classification and regression tree, LASSO regression, random forest, and extreme gradient boosting algorithms, to predict risks for pharmacologic treatment beyond MNT.

RESULTS: The super learner using levels 1-4 predictors had higher predictability [tenfold cross-validated C-statistic in discovery/validation set: 0.934 (95% CI: 0.931-0.936)/0.815 (0.800-0.829)], compared to levels 1, 1-2, and 1-3 (discovery/validation set C-statistic: 0.683-0.869/0.634-0.754). A simpler, more interpretable model, including timing of GDM diagnosis, diagnostic fasting glucose value, and the status and frequency of glycemic control at fasting during one-week post diagnosis, was developed using tenfold cross-validated logistic regression based on super learner-selected predictors. This model compared to the super learner had only a modest reduction in predictability [discovery/validation set C-statistic: 0.825 (0.820-0.830)/0.798 (95% CI: 0.783-0.813)].

CONCLUSIONS: Clinical data demonstrated reasonably high predictability for GDM treatment modality at the time of GDM diagnosis and high predictability at 1-week post GDM diagnosis. These population-based, clinically oriented models may support algorithm-based risk-stratification for treatment modality, inform timely treatment, and catalyze more effective management of GDM.

PMID:36104698 | DOI:10.1186/s12916-022-02499-7

BMC Geriatr. 2022 Sep 14;22(1):750. doi: 10.1186/s12877-022-03429-1.

ABSTRACT

BACKGROUND: Previous studies exploring usual alcohol consumption and falls risk were scarce in China. In addition, the dose-response relationship has not been explored so far. This study aims to estimate the association between usual alcohol consumption and risk of falls among middle-aged and older Chinese adults based on data from the China Health and Retirement Longitudinal Study (CHARLS), which is representative of the population of the entire country.

METHODS: Baseline survey data in 2015 and follow-up data in 2018 in CHARLS were utilized. Alcohol consumption was calculated in grams per day (gr/day) according to self-reported drinking data and categorized accordingly to The Dietary Guidelines for Chinese Residents (DGC) 2016. Fall was obtained from self-reported information. Multivariable logistic regression analyses were performed to estimate the association of usual alcohol consumption with risk of falling. The dose-response relationship was also explored using restricted cubic splines.

RESULTS: A total of 12,910 middle-aged and older participants were included from the CHARLS 2015, of which 11,667 were followed up in 2018. We found that former, moderate, and excessive drinkers were at higher fall risk compared to never drinkers (former: OR, 1.24; 95% CI, 1.05-1.46; moderate: OR, 1.22; 95% CI, 1.06-1.41; excessive: OR, 1.36; 95% CI, 1.15-1.61) in the longitudinal analysis. Similarly, individuals with moderate and excessive alcohol consumption were at increased risk of falling in the cross-sectional analysis (moderate: OR, 1.18; 95% CI, 1.02-1.37; excessive: OR, 1.32; 95% CI, 1.11,1.57). No significant increased risk of falls was found for former drinkers (former: OR, 1.13; 95% CI, 0.96-1.34). We observed a significant non-linear relationship.

CONCLUSIONS: Our study suggests that usual alcohol consumption was associated with a higher risk of falls, highlighting the key role of alcohol intake on the fall risk, which needed consideration in developing intervention and prevention strategies for reducing falls among middle-aged and older Chinese adults.

PMID:36104686 | DOI:10.1186/s12877-022-03429-1

BMC Med Imaging. 2022 Sep 14;22(1):166. doi: 10.1186/s12880-022-00875-6.

ABSTRACT

OBJECTIVE: This study is aimed to explore the value of mammography-based radiomics signature for preoperative prediction of triple-negative breast cancer (TNBC).

MATERIALS AND METHODS: Initially, the clinical and X-ray data of patients (n = 319, age of 54 ± 14) with breast cancer (triple-negative-65, non-triple-negative-254) from the First Affiliated Hospital of Soochow University (n = 211, as a training set) and Suzhou Municipal Hospital (n = 108, as a verification set) from January 2018 to February 2021 are retrospectively analyzed. Comparing the mediolateral oblique (MLO) and cranial cauda (CC) mammography images, the mammography images with larger lesion areas are selected, and the image segmentation and radiomics feature extraction are then performed by the MaZda software. Further, the Fisher coefficients (Fisher), classification error probability combined average correlation coefficients (POE + ACC), and mutual information (MI) are used to select three sets of feature subsets. Moreover, the score of each patient’s radiomics signature (Radscore) is calculated. Finally, the receiver operating characteristic curve (ROC) is analyzed to calculate the AUC, accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of TNBC.

RESULTS: A significant difference in the mammography manifestation between the triple-negative and the non-triple-negative groups (P < 0.001) is observed. The (POE + ACC)-NDA method showed the highest accuracy of 88.39%. The Radscore of triple-negative and non-triple-negative groups in the training set includes – 0.678 (- 1.292, 0.088) and – 2.536 (- 3.496, – 1.324), respectively, with a statistically significant difference (Z = – 6.314, P < 0.001). In contrast, the Radscore in the validation set includes – 0.750 (- 1.332, – 0.054) and – 2.223 (- 2.963, – 1.256), with a statistically significant difference (Z = – 4.669, P < 0.001). In the training set, the AUC, accuracy, sensitivity, specificity, positive predictive value and negative predictive value of TNBC include 0.821 (95% confidence interval 0.752-0.890), 74.4%, 82.5%, 72.5%, 41.2%, and 94.6%, respectively. In the validation set, the AUC, accuracy, sensitivity, specificity, positive predictive value and negative predictive value of TNBC are of 0.809 (95% confidence interval 0.711-0.907), 80.6%, 72.0%, 80.7%, 55.5%, and 93.1%, respectively.

CONCLUSION: In summary, we firmly believe that this mammography-based radiomics signature could be useful in the preoperative prediction of TNBC due to its high value.

PMID:36104679 | DOI:10.1186/s12880-022-00875-6

BMC Infect Dis. 2022 Sep 14;22(1):737. doi: 10.1186/s12879-022-07572-3.

ABSTRACT

BACKGROUND: Outbreaks of new HIV transmission among people who inject drugs (PWID) are a major public health concern. Oral daily PrEP, has been identified as a critical addition to the biomedical toolkit for this population. However, limited research on the acceptability of long-acting injectable PrEP has been conducted with this population.

METHODS: We conducted a cross sectional multi-site survey with 1127 participants from May 2019-February 2020 to assess the acceptability of novel PrEP regimens. We computed bivariate and multivariable logistic regressions to evaluate correlates of the outcome variable: acceptability of 3-month injectable-PrEP. SAS v.9.4 was used to conduct statistical analysis.

RESULTS: Limited knowledge of or use of PrEP, past or present, was evident within the sample. Injection drug use in the past six months was significantly associated with LA injectable PrEP acceptability, with the odds of acceptability being 1.885 (CI: 1.376, 2.582) times greater than those who did not inject drugs. After adjusting for confounders, injection drug use was significantly associated with the outcome, such that the odds of acceptability of LA injectable PrEP were 1.705 (CI: 1.198, 2.427) times greater among PWID compared to those who did not inject drugs (p < 0.03). The results demonstrate acceptability (38.2%) in a durable (3-month) injectable PrEP modality among participants who also identified as PWID.

CONCLUSIONS: PrEP promotion efforts among PWID to increase access to long-acting injectable PrEP are necessary. Through efforts to increase acceptance and regular use of long-acting injectable PrEP, public health strategies may be able to effectively lessen chances of future HIV outbreaks among PWID.

PMID:36104676 | DOI:10.1186/s12879-022-07572-3

BMC Infect Dis. 2022 Sep 14;22(1):735. doi: 10.1186/s12879-022-07701-y.

ABSTRACT

BACKGROUND: The clinical course of coronavirus disease (COVID-19) is diverse, and the usefulness of phenotyping in predicting the severity or prognosis of the disease has been demonstrated overseas. This study aimed to investigate clinically meaningful phenotypes in Japanese COVID-19 patients using cluster analysis.

METHODS: From April 2020 to May 2021, data from inpatients aged ≥ 18 years diagnosed with COVID-19 and who agreed to participate in the study were collected. A total of 1322 Japanese patients were included. Hierarchical cluster analysis was performed using variables reported to be associated with COVID-19 severity or prognosis, namely, age, sex, obesity, smoking history, hypertension, diabetes mellitus, malignancy, chronic obstructive pulmonary disease, hyperuricemia, cardiovascular disease, chronic liver disease, and chronic kidney disease.

RESULTS: Participants were divided into four clusters: Cluster 1, young healthy (n = 266, 20.1%); Cluster 2, middle-aged (n = 245, 18.5%); Cluster 3, middle-aged obese (n = 435, 32.9%); and Cluster 4, elderly (n = 376, 28.4%). In Clusters 3 and 4, sore throat, dysosmia, and dysgeusia tended to be less frequent, while shortness of breath was more frequent. Serum lactate dehydrogenase, ferritin, KL-6, D-dimer, and C-reactive protein levels tended to be higher in Clusters 3 and 4. Although Cluster 3 had a similar age as Cluster 2, it tended to have poorer outcomes. Both Clusters 3 and 4 tended to exhibit higher rates of oxygen supplementation, intensive care unit admission, and mechanical ventilation, but the mortality rate tended to be lower in Cluster 3.

CONCLUSIONS: We have successfully performed the first phenotyping of COVID-19 patients in Japan, which is clinically useful in predicting important outcomes, despite the simplicity of the cluster analysis method that does not use complex variables.

PMID:36104674 | DOI:10.1186/s12879-022-07701-y

BMC Pediatr. 2022 Sep 14;22(1):547. doi: 10.1186/s12887-022-03591-w.

ABSTRACT

BACKGROUND: Preterm birth is serious public health worldwide, and early prediction of preterm birth in pregnant women may provide assistance for timely intervention and reduction of preterm birth. This study aimed to develop a preterm birth prediction model that is readily available and convenient for clinical application.

METHODS: Data used in this case-control study were extracted from the National Vital Statistics System (NVSS) database between 2018 and 2019. Univariate and multivariate logistic regression analyses were utilized to find factors associated with preterm birth. Odds ratio (OR) and 95% confidence interval (CI) were used as effect measures. The area under the curve (AUC), accuracy, sensitivity, and specificity were utilized as model performance evaluation metrics.

RESULTS: Data from 3,006,989 pregnant women in 2019 and 3,039,922 pregnant women in 2018 were used for the model establishment and external validation, respectively. Of these 3,006,989 pregnant women, 324,700 (10.8%) had a preterm birth. Higher education level of pregnant women [bachelor (OR = 0.82; 95%CI, 0.81-0.84); master or above (OR = 0.82; 95%CI, 0.81-0.83)], pre-pregnancy overweight (OR = 0.96; 95%CI, 0.95-0.98) and obesity (OR = 0.94; 95%CI, 0.93-0.96), and prenatal care (OR = 0.48; 95%CI, 0.47-0.50) were associated with a reduced risk of preterm birth, while age ≥ 35 years (OR = 1.27; 95%CI, 1.26-1.29), black race (OR = 1.26; 95%CI, 1.23-1.29), pre-pregnancy underweight (OR = 1.26; 95%CI, 1.22-1.30), pregnancy smoking (OR = 1.27; 95%CI, 1.24-1.30), pre-pregnancy diabetes (OR = 2.08; 95%CI, 1.99-2.16), pre-pregnancy hypertension (OR = 2.22; 95%CI, 2.16-2.29), previous preterm birth (OR = 2.95; 95%CI, 2.88-3.01), and plurality (OR = 12.99; 95%CI, 12.73-13.24) were related to an increased risk of preterm birth. The AUC and accuracy of the prediction model in the testing set were 0.688 (95%CI, 0.686-0.689) and 0.762 (95%CI, 0.762-0.763), respectively. In addition, a nomogram based on information on pregnant women and their spouses was established to predict the risk of preterm birth in pregnant women.

CONCLUSIONS: The nomogram for predicting the risk of preterm birth in pregnant women had a good performance and the relevant predictors are readily available clinically, which may provide a simple tool for the prediction of preterm birth.

PMID:36104673 | DOI:10.1186/s12887-022-03591-w

Can J Microbiol. 2022 Sep 14. doi: 10.1139/cjm-2022-0125. Online ahead of print.

ABSTRACT

In this study, Illumina MiSeq/NovaSeq high-throughput sequencing technology was used to sequence the terminal DNA fragments of microbial communities in Wuliangye pit mud. The results showed that there were 5 dominant bacterial phyla and 13 dominant bacterial genera in the pit mud, which belonged to 4 phyla, mainly Firmicutes. There were 3 dominant fungal phyla and 5 dominant fungal genera in cellar mud, which belonged to 2 phyla and concentrated in Ascomycota. According to the statistical data, the low pH value cellar pool is more conducive to the enrichment of acid-resistant or acid-biased bacteria, which is the key to flavor formation. In addition, the components of ammonium nitrogen, available phosphorus and available potassium in pit mud need to be replenished in time. In addition, sampling time, fermentation time, temperature and other external environments also have certain effects on microbial diversity and abundance in the pit. With the use of cellars, various types of microorganisms are constantly evolving to adapt to the environment inside the pits. The succession rule of microbe in pit mud was preliminarily revealed, which provided the basis for improving the quality and technical development of Wuliangye.

PMID:36103727 | DOI:10.1139/cjm-2022-0125