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Nevin Manimala Statistics

Effect of Momordica charantia Administration on Anthropometric Measures and Metabolic Profile in Patients with Obesity: A Pilot Clinical Trial

J Med Food. 2022 May 4. doi: 10.1089/jmf.2021.0164. Online ahead of print.

ABSTRACT

The aim of this study was to evaluate the effect of Momordica charantia (MC) administration on anthropometric measures in patients with obesity. A randomized, double-blind, placebo-controlled pilot clinical trial was carried out in 24 patients with obesity. Twelve patients randomly received MC (2000 mg/day) for 12 weeks, and 12 patients received placebo. Body weight (BW), body mass index (BMI), waist circumference (WC), body fat percentage, as well as clinical and laboratory determinations, were evaluated before and after the intervention. Results showed that while reductions in BW, BMI, WC, and body fat percentage were observed in the MC group, these differences did not reach statistical significance. Significant decreases in triglycerides (TG) (1.9 ± 0.6 mM vs. 1.7 ± 0.7 mM, P ≤ .05) and very low-density lipoprotein (VLDL) (0.4 ± 0.1 mM vs. 0.3 ± 0.1 mM, P ≤ .05) levels were found after the intervention with MC. In contrast, significant increases in BW (83.0 ± 10.7 kg vs. 84.6 ± 9.1 kg, P ≤ .05) and BMI (31.9 ± 1.5 kg/m2 vs. 33.0 ± 1.3 kg/m2, P ≤ .05) were observed in the placebo group. In conclusion, no significant reductions in BW, BMI, WC, and body fat percentage were observed after MC administration; however, MC significantly decreased TG and VLDL levels. The protocol was registered at ClinicalTrials.gov with the identifier NCT04916379.

PMID:35507955 | DOI:10.1089/jmf.2021.0164

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Cervical Disc Replacement for Radiculopathy Versus Myeloradiculopathy: An MCID Analysis

Clin Spine Surg. 2022 May 1;35(4):170-175. doi: 10.1097/BSD.0000000000001313. Epub 2022 Apr 18.

ABSTRACT

STUDY DESIGN: Retrospective cohort study.

OBJECTIVES: The aim was to compare the minimally clinically important difference (MCID) across multiple patient-reported outcomes (PROs) in patients undergoing cervical disc replacement (CDR) for cervical spondylotic radiculopathy versus myeloradiculopathy.

SUMMARY OF BACKGROUND DATA: To date, a limited number of studies have demonstrated mostly similar results in patients with cervical spondylotic radiculopathy or myeloradiculopathy undergoing CDR. However, each of these previous studies have focused on statistically significant differences, which may not correlate with patient perceived improvements in outcomes or success.

METHODS: Patients who underwent 1 or 2-level CDR with radiculopathy versus myeloradiculopathy were identified, and prospectively collected data was retrospectively reviewed. Demographic variables, preoperative diagnosis, and operative variables were collected for each patient. The following PROs were prospectively collected: Neck Disability Index (NDI), visual analog scale (VAS)-Neck, VAS-Arm, Short Form-12 Health Survey (SF-12) Physical Component Score (PCS), SF-12 Mental Component Score (MCS), PROMIS Physical Function (PF). An MCID analysis of PROs for each diagnosis group was performed and the percentage of patients achieving the MCID was compared between the two diagnosis groups.

RESULTS: Eight-five patients, of which 56% had radiculopathy and 44% had myeloradiculopathy. MCID analysis demonstrated that at 6-week, 12-week, and final postoperative follow-up there was no significant difference in the percentage of patients with radiculopathy or myeloradiculopathy achieving the MCID for each PRO assessed. In both diagnosis groups the percentage of patients achieving the MCID for each PRO continued to increase from the 6-week to final postoperative follow-up except for the SF-12 MCS in patients with myeloradiculopathy.

CONCLUSIONS: The percentage of patients achieving the MCID was not significantly different at each postoperative period assessed in the radiculopathy and myeloradiculopathy groups treated with CDR. In addition, the percentage of patients achieving the MCID continued to increase from 6 weeks to final follow-up in both groups for almost all PROs assessed.

PMID:35507951 | DOI:10.1097/BSD.0000000000001313

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Vasorelaxant effect of monoterpene carvacrol on isolated human umbilical artery

Can J Physiol Pharmacol. 2022 May 4. doi: 10.1139/cjpp-2021-0736. Online ahead of print.

ABSTRACT

Carvacrol is the main compound of essential oils extracted primarily from Thymus and Origanum species. Its various biological activities were confirmed: antioxidant, anti-inflammatory, antibacterial, antifungal, anti-tumour, antinematodal and vasorelaxant action. Although vasodilation mediated by carvacrol was previously described, the exact mechanism of its action has not yet been established. Hence, the aim of this study was to investigate carvacrol vasoactivity on human umbilical arteries (HUA) and different pathways involved in its mechanism of action using tissue bath methodology. Carvacrol caused a significant decrease in vascular tension of 5-HT-pre-contracted umbilical arteries, with EC50 of 442.13 ± 33.8 µM (mean ± standard error of the mean – SEM). At 300 µM, carvacrol shifted downward the 5-HT concentration-response curve with statistical significance of p < 0.001 obtained for the four highest concentrations. At concentration of 1 mM, carvacrol completely abolished BaCl2-induced contraction in Ca2+-free Krebs-Ringer bicarbonate solution (p < 0.001). Isopentenyl pyrophosphate, the antagonist of TRPV3 channel, was able to decrease the efficacy of carvacrol (p < 0.001). The vasorelaxant effect of carvacrol seems to involve the blocking of L-type of Ca2+ channels on smooth muscle cells. However, the role of TRPV3 channels in carvacrol-induced vasodilation of HUA cannot be excluded either.

PMID:35507953 | DOI:10.1139/cjpp-2021-0736

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Demonstration and Acceptability of a Safer Conception Intervention for Men With HIV in South Africa: Pilot Cohort Study

JMIR Form Res. 2022 May 4;6(5):e34262. doi: 10.2196/34262.

ABSTRACT

BACKGROUND: Many men with HIV (MWH) want to have children. HIV viral suppression minimizes sexual HIV transmission risks while allowing for conception and optimization of the health of men, their partners, and their infants.

OBJECTIVE: This study developed and evaluated the feasibility and acceptability of an intervention to promote serostatus disclosure, antiretroviral therapy (ART) uptake and adherence, and viral suppression among MWH who want to have children in South Africa.

METHODS: We developed a safer conception intervention (Sinikithemba Kwabesilisa or We give hope to men) to promote viral suppression via ART uptake and adherence, HIV serostatus disclosure, and other safer conception strategies for MWH in South Africa. Through 3 counseling and 2 booster sessions over 12 weeks, we offered education on safer conception strategies and aided participants in developing a safer conception plan. We recruited MWH (HIV diagnosis known for >1 month), not yet accessing ART or accessing ART for <3 months, in a stable partnership with an HIV-negative or unknown-serostatus woman, and wanting to have a child in the following year. We conducted an open pilot study to evaluate acceptability based on patient participation and exit interviews and feasibility based on recruitment and retention. In-depth exit interviews were conducted with men to explore intervention acceptability. Questionnaires collected at baseline and exit assessed disclosure outcomes; CD4 and HIV-RNA data were used to evaluate preliminary impacts on clinical outcomes of interest.

RESULTS: Among 31 eligible men, 16 (52%) enrolled in the study with a median age of 29 (range 27-44) years and a median time-since-diagnosis of 7 months (range 1 month to 9 years). All identified as Black South African, with 56% (9/16) reporting secondary school completion and 44% (7/16) reporting full-time employment. Approximately 44% (7/16) of participants reported an HIV-negative (vs unknown-serostatus) partner. Approximately 88% (14/16) of men completed the 3 primary counseling sessions. In 11 exit interviews, men reported personal satisfaction with session content and structure while also suggesting that they would refer their peers to the program. They also described the perceived effectiveness of the intervention and self-efficacy to benefit. Although significance testing was not conducted, 81% (13/16) of men were taking ART at the exit, and 100% (13/13) of those on ART were virally suppressed at 12 weeks. Of the 16 men, 12 (75%) reported disclosure to pregnancy partners.

CONCLUSIONS: These preliminary data suggest that safer conception care is acceptable to men and has the potential to reduce HIV incidence among women and their children while supporting men’s health. Approximately half of the men who met the screening eligibility criteria were enrolled. Accordingly, refinement to optimize uptake is needed. Providing safer conception care and peer support at the community level may help reach men.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03818984; https://clinicaltrials.gov/ct2/show/NCT03818984.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1007/s10461-017-1719-4.

PMID:35507406 | DOI:10.2196/34262

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Impact of a Machine Learning-Based Decision Support System for Urinary Tract Infections: Prospective Observational Study in 36 Primary Care Practices

JMIR Med Inform. 2022 May 4;10(5):e27795. doi: 10.2196/27795.

ABSTRACT

BACKGROUND: There is increasing attention on machine learning (ML)-based clinical decision support systems (CDSS), but their added value and pitfalls are very rarely evaluated in clinical practice. We implemented a CDSS to aid general practitioners (GPs) in treating patients with urinary tract infections (UTIs), which are a significant health burden worldwide.

OBJECTIVE: This study aims to prospectively assess the impact of this CDSS on treatment success and change in antibiotic prescription behavior of the physician. In doing so, we hope to identify drivers and obstacles that positively impact the quality of health care practice with ML.

METHODS: The CDSS was developed by Pacmed, Nivel, and Leiden University Medical Center (LUMC). The CDSS presents the expected outcomes of treatments, using interpretable decision trees as ML classifiers. Treatment success was defined as a subsequent period of 28 days during which no new antibiotic treatment for UTI was needed. In this prospective observational study, 36 primary care practices used the software for 4 months. Furthermore, 29 control practices were identified using propensity score-matching. All analyses were performed using electronic health records from the Nivel Primary Care Database. Patients for whom the software was used were identified in the Nivel database by sequential matching using CDSS use data. We compared the proportion of successful treatments before and during the study within the treatment arm. The same analysis was performed for the control practices and the patient subgroup the software was definitely used for. All analyses, including that of physicians’ prescription behavior, were statistically tested using 2-sided z tests with an α level of .05.

RESULTS: In the treatment practices, 4998 observations were included before and 3422 observations (of 2423 unique patients) were included during the implementation period. In the control practices, 5044 observations were included before and 3360 observations were included during the implementation period. The proportion of successful treatments increased significantly from 75% to 80% in treatment practices (z=5.47, P<.001). No significant difference was detected in control practices (76% before and 76% during the pilot, z=0.02; P=.98). Of the 2423 patients, we identified 734 (30.29%) in the CDSS use database in the Nivel database. For these patients, the proportion of successful treatments during the study was 83%-a statistically significant difference, with 75% of successful treatments before the study in the treatment practices (z=4.95; P<.001).

CONCLUSIONS: The introduction of the CDSS as an intervention in the 36 treatment practices was associated with a statistically significant improvement in treatment success. We excluded temporal effects and validated the results with the subgroup analysis in patients for whom we were certain that the software was used. This study shows important strengths and points of attention for the development and implementation of an ML-based CDSS in clinical practice.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04408976; https://clinicaltrials.gov/ct2/show/NCT04408976.

PMID:35507396 | DOI:10.2196/27795

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Volume-Outcome Associations for Parathyroid Surgery in England: Analysis of an Administrative Data Set for the Getting It Right First Time Program

JAMA Surg. 2022 May 4. doi: 10.1001/jamasurg.2022.1353. Online ahead of print.

ABSTRACT

IMPORTANCE: Previous studies have suggested an association between surgical volume and patient outcomes for parathyroid surgery. However, most previous studies are relatively small and the literature is dominated by studies form the US, which might not be readily generalizable to other settings.

OBJECTIVE: To investigate volume-outcome associations for parathyroid surgery in England.

DESIGN, SETTING, AND PARTICIPANTS: Cohort study that included all National Health Service hospital trusts in England with secondary analysis of administrative data using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10). Participants included all adult, elective hospital admissions for parathyroid surgery without a diagnosis of multiple endocrine neoplasia, parathyroid cancer, or kidney disease over a 5-year period (April 2014-March 2019 inclusive).

EXPOSURES: The number of procedures conducted in the year prior to the index procedure by each surgeon and each hospital trust.

MAIN OUTCOMES AND MEASURES: Repeat parathyroid surgery within 1 year of the index procedure.

RESULTS: This study included data for 17 494 participants who underwent parathyroidectomies conducted across 125 hospital trusts. The median (IQR) age of patients was 62 (53-71) years, and 13 826 were female (79.0%). Across the period, the number of surgeons conducting parathyroid surgery changed little (280 in 2014-2015 and 2018-2019), although the number of procedures conducted rose from 3331 to 3848 per annum. Repeat parathyroid surgery at 1 year was significantly associated with surgeon volume (odds ratio [OR], 0.99; 95% CI, 0.98-0.99), but not trust volume, in the previous 12 months. Extended length of stay (OR, 0.98; 95% CI, 0.98-0.99), hypoparathyroidism/calcium disorder (OR, 1.0; 95% CI, 0.99-1.0), and postprocedural complications (OR, 0.99; 95% CI, 0.99-1.0) were also associated with lower surgeon volume.

CONCLUSIONS AND RELEVANCE: In this cohort study, higher surgeon annual volume was associated with decreased rates of repeat parathyroid surgery. A minimum volume threshold of 20 procedures per annum should improve patient outcomes, although possible negative effects on access to services should be monitored.

PMID:35507350 | DOI:10.1001/jamasurg.2022.1353

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An Atlas of Genetic Correlations and Genetically Informed Associations Linking Psychiatric and Immune-Related Phenotypes

JAMA Psychiatry. 2022 May 4. doi: 10.1001/jamapsychiatry.2022.0914. Online ahead of print.

ABSTRACT

IMPORTANCE: Certain psychiatric and immune-related disorders are reciprocal risk factors. However, the nature of these associations is unclear.

OBJECTIVE: To characterize the pleiotropy between psychiatric and immune-related traits, as well as risk factors of hypothesized relevance.

DESIGN, SETTING, AND PARTICIPANTS: This genetic association study was conducted from July 10, 2020, to January 15, 2022. Analyses used genome-wide association (GWA) statistics related to 14 psychiatric traits; 13 immune-related phenotypes, ie, allergic, autoimmune, and inflammatory disorders; and 15 risk factors related to health-related behaviors, social determinants of health, and stress response. Genetically correlated psychiatric-immune pairs were assessed using 2-sample mendelian randomization (MR) with sensitivity analyses and multivariable adjustment for genetic associations of third variables. False discovery rate correction (Q value < .05) was applied for each analysis.

EXPOSURES: Genetic associations.

MAIN OUTCOMES AND MEASURES: Genetic correlations and MR association estimates with SEs and P values. A data-driven approach was used that did not test a priori planned hypotheses.

RESULTS: A total of 44 genetically correlated psychiatric-immune pairs were identified, including 31 positive correlations (most consistently involving asthma, Crohn disease, hypothyroidism, and ulcerative colitis) and 13 negative correlations (most consistently involving allergic rhinitis and type 1 diabetes). Correlations with third variables were especially strong for psychiatric phenotypes. MR identified 7 associations of psychiatric phenotypes on immune-related phenotypes that were robust to multivariable adjustment, including the positive association of (1) the psychiatric cross-disorder phenotype with asthma (odds ratio [OR], 1.04; 95% CI, 1.02-1.06), Crohn disease (OR, 1.09; 95% CI, 1.05-1.14), and ulcerative colitis (OR, 1.09; 95% CI, 1.05-1.14); (2) major depression with asthma (OR, 1.25; 95% CI, 1.13-1.37); (3) schizophrenia with Crohn disease (OR, 1.12; 95% CI, 1.05-1.18) and ulcerative colitis (OR, 1.14; 95% CI, 1.07-1.21); and a negative association of risk tolerance with allergic rhinitis (OR, 0.77; 95% CI, 0.67-0.92).

CONCLUSIONS AND RELEVANCE: Results of this genetic association study suggest that genetic liability for psychiatric disorders was associated with liability for several immune disorders, suggesting that vertical pleiotropy related to behavioral traits (or correlated third variables) contributes to clinical associations observed in population-scale data.

PMID:35507366 | DOI:10.1001/jamapsychiatry.2022.0914

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Evaluation of Trends in Alcohol Use Disorder-Related Mortality in the US Before and During the COVID-19 Pandemic

JAMA Netw Open. 2022 May 2;5(5):e2210259. doi: 10.1001/jamanetworkopen.2022.10259.

NO ABSTRACT

PMID:35507347 | DOI:10.1001/jamanetworkopen.2022.10259

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Transitional Care Interventions for Older Residents of Long-term Care Facilities: A Systematic Review and Meta-analysis

JAMA Netw Open. 2022 May 2;5(5):e2210192. doi: 10.1001/jamanetworkopen.2022.10192.

ABSTRACT

IMPORTANCE: Residents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents.

OBJECTIVE: To assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association.

DATA SOURCES: MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology.

STUDY SELECTION: Controlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria.

DATA EXTRACTION AND SYNTHESIS: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest.

MAIN OUTCOMES AND MEASURES: The primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity.

RESULTS: Of 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals.

CONCLUSIONS AND RELEVANCE: Emerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

PMID:35507344 | DOI:10.1001/jamanetworkopen.2022.10192

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Rotating Night Shift Work and Healthy Aging After 24 Years of Follow-up in the Nurses’ Health Study

JAMA Netw Open. 2022 May 2;5(5):e2210450. doi: 10.1001/jamanetworkopen.2022.10450.

ABSTRACT

IMPORTANCE: Rotating night shift work is associated with higher mortality. Whether it is also associated with overall health among those who survive to older ages remains unclear.

OBJECTIVE: To examine whether rotating night shift work is associated with healthy aging after 24 years of follow-up in the Nurses’ Health Study, a cohort study among registered female nurses.

DESIGN, SETTING, AND PARTICIPANTS: For this cohort study, a composite healthy aging phenotype was ascertained among 46 318 participants who were aged 46 to 68 years and free of major chronic diseases in 1988 when the history of night shift work was assessed. In a secondary analysis in which cognitive function decline was considered in the healthy aging definition, 14 273 nurses were involved. Data were analyzed from March 1 to September 30, 2021.

EXPOSURES: Duration of rotating night shift work.

MAIN OUTCOMES AND MEASURES: Healthy aging was defined as reaching at least 70 years of age and being free of 11 major chronic diseases, memory impairment, physical limitation, or deteriorated mental health.

RESULTS: Of 46 318 female nurses (mean [SD] age at baseline, 55.4 [6.1] years), 3695 (8.0%) achieved healthy aging after 24 years of follow-up. After adjusting for established and potential confounders, compared with women who never worked rotating night shifts, the odds of achieving healthy aging decreased significantly with increasing duration of night shift work. The odds ratios were 0.96 (95% CI, 0.89-1.03) for 1 to 5 years, 0.92 (95% CI, 0.79-1.07) for 6 to 9 years, and 0.79 (95% CI, 0.69-0.91) for 10 or more years of night shift work (P = .001 for trend). This association did not differ substantially by age and lifestyles and was consistent for 4 individual dimensions of healthy aging. Results were similar in a secondary analysis, with an odds ratio of 0.73 (95% CI, 0.60-0.89; P < .001 for trend) comparing 10 or more years of night shift work vs no night shift work.

CONCLUSIONS AND RELEVANCE: In this cohort study, rotating night shift work was associated with decreased probability of healthy aging among US female nurses. These data support the notion that excess night shift work is a significant health concern that may also lead to deteriorated overall health among older individuals.

PMID:35507343 | DOI:10.1001/jamanetworkopen.2022.10450