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Nevin Manimala Statistics

Does the Prone Position During the Shockwave Lithotripsy of Kidney Stones Improve the Stone-Free Rate? Results from a Randomized Clinical Trial

Urol J. 2023 Jan 25. doi: 10.22037/uj.v20i.7418. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to evaluate the impact of the skin-to-stone distance in the supine and prone positions on the outcome of shockwave lithotripsy of kidney stones.

METHODS: In a prospective randomized clinical trial study, 81 patients that candidates for shockwave lithotripsy (SWL) of kidney stones were randomly divided into two groups to perform SWL in the prone position (40 patients) or conventional supine position (41 patients). Demographic data, stone characteristics, skin-to-stone distances (SSD) in CT, SSD during SWL with an ultrasound probe in prone and supine positions, total shock wave rate, total energy (kilovolt), visual analog scale (VAS), complications (Clavien-Dindo scale system), and SWL success rate evaluated in two intervention and control groups. All statistical analysis was performed by independent T-test, Chi-Square test, Fisher exact test, paired T-test, and SPSS 22.0 software for windows. Results: There were no significant differences between demographic characteristics, SWL sessions, the median number of SWLs, the median SWL time, median total energy, VAS, and complications in the two groups. The SFR was numerically higher in the prone SWL group than in the supine SWL group (80% vs. 73.2%) but was not significantly different (p-value: 0.468). Also, the inline ultrasound (US) measuring of the SSD in the prone position was significantly different from US SSD measures in the supine position in the two groups (p-values=0.001 and 0.024). The mean SSD was lower in the US measurement during the SWL process that measured in supine and prone position than the CT measurement (73.5 vs. 101.1), which means the routine SSD measured by CT scan is higher than SSD in the US probe measurement during SWL.

CONCLUSION: The prone position SWL modification could be effective in obese patients with a BMI of more than 30 and increase the stone-free rate (p-value=0.039) with a similar safety profile and comparable VAS score. It seems the SSD measured by the ultrasound is a more accurate dynamic measurement during the SWL and needs to define the SSD according to the SSD calculation by the US probe of the therapy head. SFR was numerically higher in the prone compared with the supine treatment groups.

PMID:36695211 | DOI:10.22037/uj.v20i.7418

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Nevin Manimala Statistics

Sex Differences in Associations Between Socioeconomic Status and Incident Hypertension Among Chinese Adults

Hypertension. 2023 Jan 25. doi: 10.1161/HYPERTENSIONAHA.122.20061. Online ahead of print.

ABSTRACT

BACKGROUND: With rapid socioeconomic development and transition, associations between socioeconomic status (SES) and hypertension remained uncertain in China. We aimed to examine the health effects of SES on hypertension incidence and explore the sex differences among Chinese adults.

METHODS: We included 53 891 participants without hypertension from the China-PAR (Prediction for Atherosclerotic Cardiovascular Disease Risk in China) project. SES was evaluated by education level, occupation prestige, and household monthly per capita income, and categorized into low, medium, and high groups. Hazard ratios and their 95% CIs were calculated using Cox proportional hazards regression models.

RESULTS: Compared with high SES, participants with medium SES (hazard ratio, 1.142 [95% CI, 1.068-1.220]) or low SES (hazard ratio, 1.166 [95% CI, 1.096-1.241]) had increased risks of incident hypertension in multivariate analyses. Interactions between SES and sex on hypertension were observed, with more pronounced adverse effects of lower SES among females. The corresponding hazard ratios (95% CIs) for low SES group were 1.270 (1.155-1.397) for females and 1.086 (0.999-1.181) for males. Effects of occupation prestige on hypertension were the strongest among SES factors.

CONCLUSIONS: Our study provided the compelling evidence from China that lower SES was associated with incident hypertension and females were more susceptible. These findings will have substantial implications on future hypertension prevention and management, especially among females. Sex-specific approaches are warranted to reduce socioeconomic disparities.

PMID:36695186 | DOI:10.1161/HYPERTENSIONAHA.122.20061

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Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association

Circulation. 2023 Jan 25. doi: 10.1161/CIR.0000000000001123. Online ahead of print.

ABSTRACT

BACKGROUND: The American Heart Association, in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, diet, and weight) and health factors (cholesterol, blood pressure, and glucose control) that contribute to cardiovascular health. The Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, congenital heart disease, rhythm disorders, subclinical atherosclerosis, coronary heart disease, heart failure, valvular disease, venous disease, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs).

METHODS: The American Heart Association, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2023 Statistical Update is the product of a full year’s worth of effort in 2022 by dedicated volunteer clinicians and scientists, committed government professionals, and American Heart Association staff members. The American Heart Association strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year’s edition includes additional COVID-19 (coronavirus disease 2019) publications, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains.

RESULTS: Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics.

CONCLUSIONS: The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.

PMID:36695182 | DOI:10.1161/CIR.0000000000001123

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Epidemiology of hamstring injuries in 538 cases from a (blinded) Multi Sports Club

Phys Sportsmed. 2023 Jan 25. doi: 10.1080/00913847.2023.2170684. Online ahead of print.

ABSTRACT

OBJECTIVES: : Hamstring injuries are the most common muscle injuries in team sports. The aims of this study were to describe the epidemiology of hamstring muscle injuries in the professional and amateur sport sections of a multi-sport club (blinded for reviewers) and to determine any potential correlation between return-to-play (RTP) and injury location, severity of connective tissue damage, age, sex, and athlete’s level of competition.

METHODS: : This descriptive epidemiological study with data collected from September 2007 to September 2017 stored in the (blinded for reviewers) database. The study included non-contact hamstring injuries sustained during training or competition.

RESULTS: : A total of 538 hamstring injuries were reported in the club’s database, of which 240 were structurally verified by imaging as hamstring injuries. The overall incidence for the 17 sports studied was 1.29 structurally verified hamstring injuries per 100 athletes per year. The muscle most commonly involved in hamstring injuries was the biceps femoris, and the connective tissue most frequently involved was the myofascial. There was no evidence of a statistically significant association between age and RTP after injury, and no statistically significant difference between sex and RTP. However, the time loss by professionals was shorter than for amateurs, and proximal hamstring injuries took longer RTP than distal ones.

CONCLUSION: In the 17 sports practiced at multi-sport club, the incidence of hamstring injury was 1.29 per 100 athletes per year. Players from sports in which high speed sprinting and kicking are necessary, and amateurs, were at higher risk of suffering a hamstring injury. In addition, proximally located hamstring injuries involving tendinous connective tissue showed the longest RTP time. Age did not seem to have any influence on RTP. Documenting location and the exact tissue involved in hamstring injuries may be beneficial for determining the prognosis and RTP.

PMID:36695100 | DOI:10.1080/00913847.2023.2170684

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Effectiveness of peer-led education interventions on contraceptive use, unmet need, and demand among adolescent girls in Gedeo Zone, South Ethiopia. A cluster randomized controlled trial

Glob Health Action. 2023 Dec 31;16(1):2160543. doi: 10.1080/16549716.2022.2160543.

ABSTRACT

BACKGROUND: Peer-led education interventions are assumed to be an effective means of increasing contraceptive utilization and demand in adolescents. However evidence is lacking on whether peer-led education is effective in promoting the demand for and use of contraceptives in adolescent girls, especially in resource-limited settings.

OBJECTIVE: The present study evaluated the effectiveness of peer-led education interventions in improving contraceptive use, unmet needs, and demand among sexually active secondary school adolescent girls in Gedeo Zone, South Ethiopia.

METHODS: A single-blinded cluster randomised controlled trial study was performed in six randomly selected secondary schools in the Gedeo Zone, southern Ethiopia. A total of 224 participants were recruited and randomly assigned to the intervention and control groups. The intervention group received peer-led education intervention for six months. A pre-tested and validated questionnaire was used to measure contraceptive use, unmet need, and contraceptive demand. A generalised estimating equation (GEE) model was used to examine the effectiveness of the intervention.

RESULT: After six months of intervention, the Differences-in-difference in contraceptive use, unmet need, and contraceptive demand between the intervention and control groups were 25.1%, 7.4%, and 17.7%, respectively. There was a statistically significant difference in contraceptive use [AOR = 8.7, 95% CI: (3.66, 20.83), unmet need for contraceptives [AOR = 6.2, 95% CI: (1.61, 24.36)] and contraceptive demand [AOR = 6.1, 95% CI: (2.43, 15.11)] between the intervention and control groups.

CONCLUSIONS: School-based peer education intervention effectively improved contraceptive use and unmet needs in a low-resource setting and created demand in sexually active adolescent girls. These results support the potential utility of this approach in similar settings for the promotion of contraception use and demand.

PMID:36695098 | DOI:10.1080/16549716.2022.2160543

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Pre-Paid Phone Distribution: A Tool for Improving Healthcare Engagement for People with Substance Use Disorder

Subst Use Misuse. 2023 Jan 25:1-5. doi: 10.1080/10826084.2023.2170184. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic drove significant disruptions in access to substance use disorder (SUD) treatment and harm reduction services. Healthcare delivery via telemedicine has increasingly become the norm, rendering access to a phone essential for engagement in care.

METHODS: Adult patients with SUD who lacked phones (n = 181) received a free, pre-paid phone during encounters with inpatient and outpatient SUD programs. We evaluated changes in healthcare engagement including completed in-person and telemedicine outpatient visits and telephone encounters 30 days before and after phone receipt. We used descriptive statistics, where appropriate, and paired t-tests to assess the change in healthcare engagement measures.

RESULTS: Patients were predominantly male (64%) and white (62%) with high rates of homelessness (81%) and opioid use disorder (89%). When comparing 30 days before to 30 days after phone receipt, there was a significant increased change in number of telemedicine visits by 0.3 (95% CL [0.1,0.4], p < 0.001) and telephone encounters by 0.2 (95% CL [0.1,0.3], p = 0.004). There was no statistically significant change in in-person outpatient visits observed.

CONCLUSIONS: Pre-paid phone distribution to patients with SUD was associated with an increased healthcare engagement including telemedicine visits and encounters.

PMID:36695079 | DOI:10.1080/10826084.2023.2170184

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Exploring the Overlap Between Alopecia Areata and Major Depressive Disorder: Epidemiological and Genetic Perspectives

J Eur Acad Dermatol Venereol. 2023 Jan 25. doi: 10.1111/jdv.18921. Online ahead of print.

ABSTRACT

BACKGROUND: Research suggests that Alopecia areata (AA) and Major Depressive Disorder (MDD) show substantial comorbidity. To date, no study has investigated the hypothesis that this is attributable to shared genetic etiology.

OBJECTIVES: To investigate AA-MDD comorbidity on both the epidemiological and the molecular genetic levels.

METHODS: First, epidemiological analyses were performed using data from a cohort of adult German health insurance beneficiaries (n=1.855 million) to determine the population-based prevalence of AA-MDD comorbidity. Second, analyses were performed to determine the prevalence of MDD in a clinical AA case-control sample with data on psychiatric phenotypes, stratifying for demographic factors to identify possible contributing factors to AA-MDD comorbidity. Third, the genetic overlap between AA and MDD was investigated using a polygenic risk score (PRS) approach and linkage disequilibrium score (LDSC) regression. For PRS, summary statistics from a large MDD GWAS meta-analysis (PGC-MD2) were used as the training sample, while a Central European AA cohort, including the above-mentioned AA patients, and an independent replication US-AA cohort were used as target samples. LDSC was performed using the summary statistics of the PGC-MD2 and the largest AA meta-analysis to date.

RESULTS: High levels of AA-MDD comorbidity were reported in the population-based (MDD in 24% of AA patients), and clinical samples (MDD in 44% of AA patients). MDD-PRS explained a modest proportion of the variance in AA case-control status (R2 =1%). This signal was limited to the major histocompatibility complex (MHC) region on chromosome 6. LDSC regression (excluding MHC) revealed no significant genetic correlation between AA and MDD.

CONCLUSIONS: As in previous research, AA patients showed an increased prevalence of MDD. The present analyses suggest that genetic overlap may be confined to the MHC region, which is implicated in immune function. More detailed investigation is required to refine understanding of how the MHC is involved in the development of AA and MDD comorbidity.

PMID:36695075 | DOI:10.1111/jdv.18921

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Efficacy and safety of etrasimod, a sphingosine 1-phosphate receptor modulator, in adults with moderate-to-severe atopic dermatitis (ADVISE)

J Eur Acad Dermatol Venereol. 2023 Jan 25. doi: 10.1111/jdv.18914. Online ahead of print.

ABSTRACT

BACKGROUND: Etrasimod is an oral, selective, sphingosine 1-phosphate (S1P) receptor1,4,5 modulator in development for immune-mediated inflammatory disorders. Efficacy and safety of orally administered S1P receptor modulation in atopic dermatitis (AD) has not yet been examined.

OBJECTIVE: To assess the efficacy and safety of etrasimod monotherapy in adults with moderate-to-severe AD.

METHODS: In this phase 2, randomized, double-blind, placebo-controlled trial, participants (≥18 years) with moderate-to-severe AD defined as baseline validated Investigator’s Global Assessment (vIGA-AD) score ≥3, Eczema Area and Severity Index (EASI) score ≥16, and body surface area involvement ≥10% were randomized 1:1:1 to once-daily oral etrasimod 1 mg, 2 mg, or placebo for 12 weeks. The primary outcome was percent change in EASI score from baseline at week 12, assessed in the Full Analysis Set (all randomized participants). Key secondary outcomes were achievement of a vIGA-AD score of 0 or 1 with a ≥2-point improvement from baseline and EASI-75 response at week 12. Safety was assessed during the double-blind period.

RESULTS: 140 participants were randomized to etrasimod 2 mg (n=47), 1 mg (n=47), or placebo (n=46). At week 12, percent change in EASI score was -57.2% in the etrasimod 2-mg group vs -48.4% in the placebo group (P=.18). A significantly greater proportion of participants receiving etrasimod 2 mg achieved vIGA-AD scores of 0 or 1 with a ≥2-point improvement at week 12 vs placebo (29.8% vs 13.0%; P=.045); however, EASI-75 response was not statistically significant vs placebo. Treatment-emergent adverse events occurred in 59.6%, 40.4%, and 47.8% of participants receiving etrasimod 2 mg, 1 mg, and placebo, respectively. There were no serious AEs or deaths.

CONCLUSIONS: The primary outcome was not met, though efficacy was observed for etrasimod 2 mg on several clinician- and patient-assessed measures, and both 1-mg and 2-mg doses were well tolerated, warranting further clinical investigation in AD.

PMID:36695074 | DOI:10.1111/jdv.18914

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Nevin Manimala Statistics

Proportion of Infant Neurodevelopment Trials Reporting a Null Finding: A Systematic Review

Pediatrics. 2023 Jan 25:e2022057860. doi: 10.1542/peds.2022-057860. Online ahead of print.

ABSTRACT

CONTEXT: Discovering new interventions to improve neurodevelopmental outcomes is a priority; however, clinical trials are challenging and methodological issues may impact the interpretation of intervention efficacy.

OBJECTIVES: Characterize the proportion of infant neurodevelopment trials reporting a null finding and identify features that may contribute to a null result.

DATA SOURCES: The Cochrane library, Medline, Embase, and CINAHL databases.

STUDY SELECTION: Randomized controlled trials recruiting infants aged <6 months comparing any “infant-directed” intervention against standard care, placebo, or another intervention. Neurodevelopment assessed as the primary outcome between 12 months and 10 years of age using a defined list of tools.

DATA EXTRACTION: Two reviewers independently extracted data and assessed quality of included studies.

RESULTS: Of n = 1283 records screened, 21 studies (from 20 reports) were included. Of 18 superiority studies, >70% reported a null finding. Features were identified that may have contributed to the high proportion of null findings, including selection and timing of the primary outcome measure, anticipated effect size, sample size and power, and statistical analysis methodology and rigor.

LIMITATIONS: Publication bias against null studies means the proportion of null findings is likely underestimated. Studies assessing neurodevelopment as a secondary or within a composite outcome were excluded.

CONCLUSIONS: This review identified a high proportion of infant neurodevelopmental trials that produced a null finding and detected several methodological and design considerations which may have contributed. We make several recommendations for future trials, including more sophisticated approaches to trial design, outcome assessment, and analysis.

PMID:36695068 | DOI:10.1542/peds.2022-057860

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Propensity score matching after multiple imputation when a confounder has missing data

Stat Med. 2023 Jan 25. doi: 10.1002/sim.9658. Online ahead of print.

ABSTRACT

One of the main challenges when using observational data for causal inference is the presence of confounding. A classic approach to account for confounding is the use of propensity score techniques that provide consistent estimators of the causal treatment effect under four common identifiability assumptions for causal effects, including that of no unmeasured confounding. Propensity score matching is a very popular approach which, in its simplest form, involves matching each treated patient to an untreated patient with a similar estimated propensity score, that is, probability of receiving the treatment. The treatment effect can then be estimated by comparing treated and untreated patients within the matched dataset. When missing data arises, a popular approach is to apply multiple imputation to handle the missingness. The combination of propensity score matching and multiple imputation is increasingly applied in practice. However, in this article we demonstrate that combining multiple imputation and propensity score matching can lead to over-coverage of the confidence interval for the treatment effect estimate. We explore the cause of this over-coverage and we evaluate, in this context, the performance of a correction to Rubin’s rules for multiple imputation proposed by finding that this correction removes the over-coverage.

PMID:36695043 | DOI:10.1002/sim.9658