Nevin Manimala

Biom J. 2022 Sep 22. doi: 10.1002/bimj.202200035. Online ahead of print.

ABSTRACT

Web surveys have replaced Face-to-Face and computer assisted telephone interviewing (CATI) as the main mode of data collection in most countries. This trend was reinforced as a consequence of COVID-19 pandemic-related restrictions. However, this mode still faces significant limitations in obtaining probability-based samples of the general population. For this reason, most web surveys rely on nonprobability survey designs. Whereas probability-based designs continue to be the gold standard in survey sampling, nonprobability web surveys may still prove useful in some situations. For instance, when small subpopulations are the group under study and probability sampling is unlikely to meet sample size requirements, complementing a small probability sample with a larger nonprobability one may improve the efficiency of the estimates. Nonprobability samples may also be designed as a mean for compensating for known biases in probability-based web survey samples by purposely targeting respondent profiles that tend to be underrepresented in these surveys. This is the case in the Survey on the impact of the COVID-19 pandemic in Spain (ESPACOV) that motivates this paper. In this paper, we propose a methodology for combining probability and nonprobability web-based survey samples with the help of machine-learning techniques. We then assess the efficiency of the resulting estimates by comparing them with other strategies that have been used before. Our simulation study and the application of the proposed estimation method to the second wave of the ESPACOV Survey allow us to conclude that this is the best option for reducing the biases observed in our data.

PMID:36136044 | DOI:10.1002/bimj.202200035

Mol Pharm. 2022 Sep 22. doi: 10.1021/acs.molpharmaceut.2c00573. Online ahead of print.

ABSTRACT

A pair of popular thermodynamic models for pharmaceutical applications, namely, the perturbed-chain statistical associating fluid theory (PC-SAFT) equation of state and the conductor-like screening model for real solvents (COSMO-RS) are thoroughly benchmarked for their performance in predicting the solubility of active pharmaceutical ingredients (APIs) in pure solvents. The ultimate goal is to provide an illustration of what to expect from these progressive frameworks when applied to the thermodynamic solubility of APIs based on activity coefficients in a purely predictive regime without specific experimental solubility data (the fusion properties of pure APIs were taken from experiments). While this kind of prediction represents the typical modus operandi of the first-principles-aided COSMO-RS, PC-SAFT is a relatively highly parametrized model that relies on experimental data, against which its pure-substance and binary interaction parameters (k_ij) are fitted. Therefore, to make this benchmark as fair as possible, we omitted any binary parameters of PC-SAFT (i.e., k_ij = 0 in all cases) and preferred pure-substance parameter sets for APIs not trained to experimental solubility data. This computational approach, together with a detailed assessment of the obtained solubility predictions against a large experimental data set, revealed that COSMO-RS convincingly outperformed PC-SAFT both qualitatively (i.e., COSMO-RS was better in solvent ranking) and quantitatively, even though the former is independent of both substance- and mixture-specific experimental data. Regarding quantitative comparison, COSMO-RS outperformed PC-SAFT for 9 of the 10 APIs and for 63% of the API-solvent systems, with root-mean-square deviations of the predicted data from the entire experimental data set being 0.82 and 1.44 log units, respectively. The results were further analyzed to expand the picture of the performance of both models with respect to the individual APIs and solvents. Interestingly, in many cases, both models were found to qualitatively incorrectly predict the direction of deviations from ideality. Furthermore, we examined how the solubility predictions from both models are sensitive to different API parametrizations.

PMID:36136040 | DOI:10.1021/acs.molpharmaceut.2c00573

Milbank Q. 2022 Sep 22. doi: 10.1111/1468-0009.12582. Online ahead of print.

ABSTRACT

Policy Points Social determinants of health are an important predictor of future health care costs. Medicaid must partner with other sectors to address the underlying causes of its beneficiaries’ poor health and high health care spending.

CONTEXT: Social determinants of health are an important predictor of future health care costs but little is known about their impact on Medicaid spending. This study analyzes the role of social determinants of health (SDH) in predicting future health care costs for adult Medicaid beneficiaries with similar past morbidity burdens and past costs.

METHODS: We enrolled into a prospective cohort study 8,892 adult Medicaid beneficiaries who presented for treatment at an emergency department or clinic affiliated with two hospitals in Washington, DC, between September 2017 and December 31, 2018. We used SDH information measured at enrollment to categorize our participants into four social risk classes of increasing severity. We used Medicaid claims for a 2-year period; 12 months pre- and post-study enrollment to measure past and future morbidity burden according to the Adjusted Clinical Groups system. We also used the Medicaid claims data to characterize total annual Medicaid costs one year prior to and one year after study enrollment.

RESULTS: The 8,892 participants were primarily female (66%) and Black (91%). For persons with similar past morbidity burdens and past costs (p < 0.01), the future morbidity burden was significantly higher in the upper two social risk classes (1.15 and 2.04, respectively) compared with the lowest one. Mean future health care spending was significantly higher in the upper social risk classes compared with the lowest one ($2,713, $11,010, and $17,710, respectively) and remained significantly higher for the two highest social risk classes ($1,426 and $3,581, respectively), given past morbidity burden and past costs (p < 0.01). When we controlled for future morbidity burden (measured concurrently with future costs), social risk class was no longer a significant predictor of future health care costs.

CONCLUSIONS: SDH are statistically significant predictors of future morbidity burden and future costs controlling for past morbidity burden and past costs. Further research is needed to determine whether current payment systems adequately account for differences in the care needs of highly medically and socially complex patients.

PMID:36134645 | DOI:10.1111/1468-0009.12582

Integr Environ Assess Manag. 2022 Sep 22. doi: 10.1002/ieam.4688. Online ahead of print.

ABSTRACT

Pesticide surface water monitoring data have rarely been used as the only quantitative measure of exposure because the available monitoring data for most pesticides has not been considered robust enough for direct use in pesticide exposure assessments due to infrequent sampling. The cost of daily sample collection and analysis prohibits high sampling frequency for most monitoring programs. In this context, a common question raised in assessments is how likely peak concentrations (i.e., annual maximums) may be missed if sampling intervals are greater than daily. The US Geological Survey developed the statistical model ‘seasonal wave with streamflow adjustment and extended capability’ (SEAWAVE-QEX) to address the need to estimate infrequently occurring pesticide concentrations, such as annual maximum daily concentrations, for sites with non-daily monitoring data. This study compares the results of two post-processing methods and evaluates the capability of SEAWAVE-QEX to estimate annual maximum concentrations of three commonly used herbicides and one metabolite in a catchment in Belgium. The study concludes that the appropriateness of using SEAWAVE-QEX to estimate annual maximum concentrations is dependent on pesticide characteristics and usage and that the model can be particularly sensitive to non-flow correlated exposure events (e.g., point source contributions or drift). This article is protected by copyright. All rights reserved. © 2022 SETAC.

PMID:36134644 | DOI:10.1002/ieam.4688

Nutr Hosp. 2022 Sep 20. doi: 10.20960/nh.04074. Online ahead of print.

ABSTRACT

INTRODUCTION: several studies have questioned body mass index (BMI) as an accurate diagnostic tool for obesity and therefore a predictor of cardiovascular risk. But BMI is widely used currently.

OBJECTIVE: we analyzed the sensitivity and specificity of BMI and compared cardiovascular risk factors in middle-income urban participants in Guanajuato, Mexico, at different ages.

DESIGN: an analytical and cross-sectional study was carried out in 385 apparently healthy subjects, stratified by age ranges (20 to 59 years old). A high global CVD risk was obtained with the Framingham risk score (Framingham Risk Score > 20 %). The odds ratio was used to assess the association between high global CVD risk and the dietetic and anthropometric variables. Sensitivity, specificity, and correlation statistical analyses were carried out between BMI and other anthropometric variables with high cardiovascular risk, and this was integrated to derive recommendations to improve risk factor detection (p < 0.05 and power of 80 %).

RESULTS: a high global CVD risk was found in 4 % of the sample. BMI ≥ 30 kg/m2 had a sensitivity of 77 % for the detection of high cardiovascular risk; waist circumference ≥ 90 cm (men) or ≥ 80 cm (women) and body fat percentage ≥ 2 5% (men) or ≥ 35 % (women) had a sensitivity of 100 %. BMI showed a significant association with high global CVD risk (OR = 6.1; 95 % CI, 1.6-22.6, p < 0.01), but was not able to predict high global CVD risk in at least 30 % of the cases. There was not significative difference by age group for waist circumference, body fat percentage, total cholesterol, and low-density lipoprotein. Regarding the comparison of dietary intake of the stratified population by age group, intake of cholesterol, added sugars, fiber, sodium were highest in the 20 years group.

CONCLUSIONS: a higher intake of cholesterol, simple sugars, and sodium was observed in the 20-year-old age group. The use of BMI with waist circumference and percentage of body fat used together allow a better assessment of cardiovascular risk. We need to integrate this new recommendation to increase early detection of main risk factors for cardiovascular disease.

PMID:36134593 | DOI:10.20960/nh.04074

Nutr Hosp. 2022 Sep 21. doi: 10.20960/nh.04076. Online ahead of print.

ABSTRACT

BACKGROUND: maternal obesity is associated with an increase of both maternal and fetal complications as macrosomia.

AIM: to assess the quality of diet in a cohort of pregnant women in terms of Mediterranean diet (MD) adherence and to examine the association between diet quality, obesity, weight gain and fetal growth and perinatal complications.

METHODS: Mediterranean Diet Adherence Screener (MEDAS) was applied to assess diet quality in 542 pregnant women. Fetal biometric measurements at third-trimester ultrasound were collected and perinatal outcomes were recorded.

RESULTS: only 35 % of pregnant women presented a good quality of diet, in terms of adherence to MD. Diet quality significantly increased with lower values of body mass index (BMI) and higher maternal age. Higher BMI was significantly associated with a higher abdominal circumference and estimated fetal weight at the third trimester, a higher risk of hypertension disorder, induction of labor and a higher birthweight. A statistically significant association between diet quality and ultranosographic measures or perinatal outcome was not found. However, a higher weight gain across gestation was significantly associated with a higher risk of gestational diabetes, a higher gestational age at delivery and a higher birthweight.

CONCLUSION: most of our pregnant women did not showed a great diet quality, but there was no evidence that diet quality affected pregnancy complications. On the contrary, pre-pregnancy BMI was related to fetal and neonatal growth and obstetric outcomes, similarly to weight gain across gestation.

PMID:36134591 | DOI:10.20960/nh.04076

Nutr Hosp. 2022 Sep 19. doi: 10.20960/nh.03969. Online ahead of print.

ABSTRACT

BACKGROUND: type 2 diabetes (T2D) is a risk factor for nonalcoholic fatty liver disease (NAFLD).

OBJECTIVE: to evaluate the prevalence of NAFLD in a cohort of patients with T2D.

METHODS: an observational, descriptive study performed between May 2018 and December 2019 at the Endocrinology and Nutrition Unit. The χ² test was performed for qualitative variables and a non-parametric test for the comparison of medians of quantitative variables. Steatosis degree was defined by the coefficient attenuated parameter (CAP): (S0: < 248 dB/m; S1: 248-268 dB/m; S2: 268-288 dB/m; S3: > 288 dB/m) or stiffness: F0-F1: < 8 kPa; F2: 8-10 kPa; F3: 10-15 kPa; F4: > 15 kPa, using transient elastography (TE) (FibroScan®). A univariate analysis was performed and subsequently a multivariate analysis with statistically significant variables used to study the predictive factors of intense steatosis and advanced fibrosis.

RESULTS: n = 104 patients with T2D; 84 (80.7 %) were obese. TE demonstrated advanced fibrosis in 20 % and intense steatosis (S3) in more than 50 %. Lower total bilirubin (OR: 0.028; 95 % CI: (0.002-0.337); p = 0.005) was found to be an independent factor for S3 steatosis in the multivariate analysis. BMI ((OR: 1.497; 95 % CI: (1.102-2.034); p = 0.01)) was a predictive factor for advanced fibrosis in a multivariate analysis.

CONCLUSIONS: NAFLD-associated intense steatosis and NAFLD-associated fibrosis were commonly found in patients with T2DM and obesity. Diabetic patients should be screened for liver disease as one more target organ.

PMID:36134588 | DOI:10.20960/nh.03969

J Clin Pharm Ther. 2022 Sep 22. doi: 10.1111/jcpt.13779. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Infliximab is an anti-tumour necrosis factor agent used in the treatment of inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis. While the use of infliximab is well established in the treatment of IBD, there are now four recently FDA-approved infliximab biosimilars that are increasingly used due to their cost-benefit for patients, institutions and payors. In addition, shortening the length of infliximab infusions from 120 min (standard infusion) to 60 min or less (rapid infusion) has been shown to safely provide further cost-benefit while also improving patient convenience. The safety of rapid infusions has been well-established for the infliximab reference product, however, there are limited data available regarding the safety of rapid infusions for infliximab biosimilars. The purpose of this study was to compare the incidence and severity of infusion reactions among patients with IBD receiving rapid infusion of infliximab reference product compared with infliximab biosimilar.

METHODS: This was a retrospective analysis of electronic health record data of patients with a diagnosis of IBD receiving an infliximab reference product or infliximab biosimilar infusion between December 2020 and December 2021. Patient-level variables included demographics, immunomodulator use, IBD-related hospitalization and infliximab trough concentration and antibody levels. Infusion-related variables of interest included total number of infusions, drug, dose, dosing interval, infusion time and use of pre-medications. Infusion-related reactions were defined as safety concerns documented by the administering nurse (anaphylaxis, shortness of breath, hypotension, swelling, rash, pruritus, hives, flushing, chest pain, muscle pain, joint pain, fevers, chills, headache or hypertension) or administration of emergency medications. Fisher’s exact test was used to compare reaction rates.

RESULTS AND DISCUSSION: A total of 188 patients met inclusion criteria for analysis, and a total of 1124 infusions were administered during the study period. There were no statistically significant differences among any of the pre-specified outcomes. There were no differences in the incidence of infusion reactions among rapid infusion (60 min) infliximab and infliximab biosimilars (p = 0.863). Additionally, there were no differences in the incidence of infusion reactions among standard infusion (120 min) infliximab and infliximab biosimilars (p = 0.993). Finally, there were no differences among the rate of infusion reactions between rapid infusion of infliximab biosimilars and standard infusion of infliximab biosimilars (p = 0.536). Eight patients experienced safety issues, with three patients requiring emergency medications (1.6% of 188 patients).

WHAT IS NEW AND CONCLUSIONS: Rapid infusions of infliximab biosimilars were not associated with an increase in the incidence of infusion reactions compared with: rapid infusion of infliximab reference product, standard infusion of infliximab biosimilars, or standard infusion of infliximab reference product. This should reassure clinicians that rapid infusions of infliximab biosimilars are safe in clinical practice.

PMID:36134561 | DOI:10.1111/jcpt.13779

J Glob Health. 2022 Sep 23;12:05044. doi: 10.7189/jogh.12.05044.

ABSTRACT

BACKGROUND: There is considerable policy, clinical and public interest about whether children should be vaccinated against SARS-CoV-2 and, if so, which children should be prioritised (particularly if vaccine resources are limited). To inform such deliberations, we sought to identify children and young people at highest risk of hospitalization from COVID-19.

METHODS: We used the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) platform to undertake a national incident cohort analysis to investigate the risk of hospitalization among 5-17 years old living in Scotland in risk groups defined by the living risk prediction algorithm (QCOVID). A Cox proportional hazard model was used to derive hazard ratios (HR) and 95% confidence intervals (CIs) for the association between risk groups and COVID-19 hospital admission. Adjustments were made for age, sex, socioeconomic status, co-morbidity, and prior hospitalization.

RESULTS: Between March 1, 2020 and November 22, 2021, there were 146 183 (19.4% of all 752 867 children in Scotland) polymerase chain reaction (PCR) confirmed SARS-CoV-2 infections among 5-17 years old. Of those with confirmed infection, 973 (0.7%) were admitted to hospital with COVID-19. The rate of COVID-19 hospitalization was higher in those within each QCOVID risk group compared to those without the condition. Similar results were found in age stratified analyses (5-11 and 12-17 years old). Risk groups associated with an increased risk of COVID-19 hospital admission, included (adjusted HR, 95% CIs): sickle cell disease 14.35 (8.48-24.28), chronic kidney disease 11.34 (4.61-27.87), blood cancer 6.32 (3.24-12.35), rare pulmonary diseases 5.04 (2.58-9.86), type 2 diabetes 3.04 (1.34-6.92), epilepsy 2.54 (1.69-3.81), type 1 diabetes 2.48 (1.47-4.16), Down syndrome 2.45 (0.96-6.25), cerebral palsy 2.37 (1.26-4.47), severe mental illness 1.43 (0.63-3.24), fracture 1.41 (1.02-1.95), congenital heart disease 1.35 (0.82-2.23), asthma 1.28 (1.06-1.55), and learning disability (excluding Down syndrome) 1.08 (0.82-1.42), when compared to those without these conditions. Although our Cox models were adjusted for a number of potential confounders, residual confounding remains a possibility.

CONCLUSIONS: In this national study, we observed an increased risk of COVID-19 hospital admissions among school-aged children with specific underlying long-term health conditions compared with children without these conditions.

PMID:36134546 | DOI:10.7189/jogh.12.05044

Global Spine J. 2022 Sep 22:21925682221127997. doi: 10.1177/21925682221127997. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective Comparative Study.

OBJECTIVES: To compare the outcomes of microendoscopic discectomy (MED) versus full-endoscopic discectomy (FED) for treating L4/5 lumbar disc herniation (LDH).

METHODS: A retrospective study was performed on patients with L4/5 LDH treated using MED (n = 249) or FED (n = 124). A 16-mm tubular retractor and endoscope was used for MED, while a 4.1-mm working channel endoscope was used for FED. Patient background and operative data were collected. The Oswestry Disability Index (ODI) and European Quality of Life-5 Dimensions (EQ-5D) scores were recorded preoperatively and at 1 and 2 years postsurgery.

RESULTS: The background data of the two groups were similar. The mean operation times for MED and FED were 59.3 and 47.7 min (respectively), and the mean volumes of removed nucleus pulposus were .65 and 1.03 g, respectively. These differences were significant (P < .001). Six dural tears and one postoperative hematoma were observed in the MED group; none were observed in the FED group. During the follow-up period, 16 MED and 7 FED patients required re-operation due to recurrence (P = 1.00). Although the ODI and EQ-5D scores significantly improved at 1 and 2 years postsurgery in both groups, the differences were not statistically significant.

CONCLUSIONS: Operative outcomes were almost identical in both groups. We did not observe any operative or postoperative complications in FED. We, therefore, recommend FED as the first option for the treatment of L4/5 LDH since it has a better safety profile and is minimally invasive.

PMID:36134544 | DOI:10.1177/21925682221127997