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Nevin Manimala Statistics

Surgeons’ expectations of osteotomies around the knee

Arch Orthop Trauma Surg. 2021 Aug 17. doi: 10.1007/s00402-021-04100-x. Online ahead of print.

ABSTRACT

INTRODUCTION: High tibial osteotomy (HTO) is a valid and joint preserving surgical technique to treat medial degenerative osteoarthritis (OA) in young and active patients. A recent study shows that patients’ expectations of osteotomy around the knee are high, but OA progression and potential conversion to a total knee arthroplasty (TKA) were underestimated. The aim of this study was to investigate surgeons’ expectations of HTO and to compare the results to the patients’ expectations and actual outcomes reported in the literature.

METHODS: 461 surgeons were questioned online using the ‘Hospital for Special Surgery Knee Surgery Expectations Survey (HFSS-KSES)’ and a ten-item non-validated questionnaire to investigate the expectations of HTO. Two subgroups were formed to investigate differences regarding the surgeons’ experience. Statistical analysis was performed using IBM SPSS Statistics.

RESULTS: Surgeons’ expectations of HTO were rated between very and little important with pain reduction being the most important item on the HFSS-KSES. Furthermore, ‘improving the ability to walk’, ‘to perform daily activities’, ‘having confidence in the knee’, and ‘avoiding future degeneration’ were rated of high importance. An important difference regarding the experience was the lower expectations on delay/prevention of TKA of less-experienced surgeons.

CONCLUSION: Surgeons’ expectations of HTO are high but nevertheless different to the patients’ expectations reported in the literature. Also, expectations for the delay/prevention of TKA differed regarding the experience of surgeons. While pain reduction represents one of the most important items for surgeons and patients, the expected outcome regarding the delay/prevention of a TKA and returning to sports differs to the patients’ expectations and to the actual outcome reported in the literature. This should be considered when performing the preoperative informed consent.

PMID:34402929 | DOI:10.1007/s00402-021-04100-x

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Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn’s Disease: Results From the VISIBLE 2 Randomised Trial

J Crohns Colitis. 2021 Aug 17:jjab133. doi: 10.1093/ecco-jcc/jjab133. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: Report results from VISIBLE 2, a randomised, double-blind, placebo-controlled phase 3 trial evaluating a new subcutaneous [SC] vedolizumab formulation as maintenance treatment in adults with moderately to severely active Crohn’s disease [CD].

METHODS: Following open-label vedolizumab 300 mg intravenous induction therapy at Weeks 0 and 2, Week 6 clinical responders (≥70-point decrease in CD Activity Index [CDAI] score from baseline) were randomised 2:1 to receive double-blind maintenance vedolizumab 108 mg SC or placebo every 2 weeks until Week 50. Assessments at Week 52 included clinical remission [primary endpoint; CDAI≤150], enhanced clinical response [≥100-point decrease in CDAI from baseline], corticosteroid-free clinical remission among patients using a corticosteroid at baseline, clinical remission in anti-tumour necrosis factor [anti-TNF]-naïve patients, and safety.

RESULTS: Following vedolizumab intravenous induction, 275 patients were randomised to vedolizumab SC and 135 to placebo maintenance. At Week 52, 48.0% of patients receiving vedolizumab SC versus 34.3% receiving placebo were in clinical remission [p=0.008]. Enhanced clinical response at Week 52 was achieved by 52.0% versus 44.8% of patients receiving vedolizumab SC versus placebo, respectively [p=0.167]. At Week 52, 45.3% and 18.2% of patients receiving vedolizumab SC and placebo, respectively, were in corticosteroid-free clinical remission, and 48.6% of anti-TNF-naïve patients receiving vedolizumab SC and 42.9% receiving placebo were in clinical remission. Injection site reaction was the only new safety finding observed for vedolizumab SC [2.9%].

CONCLUSIONS: Vedolizumab SC is an effective and safe maintenance therapy in patients with CD who responded to two infusions of vedolizumab intravenous induction therapy.

PMID:34402887 | DOI:10.1093/ecco-jcc/jjab133

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No-primer adhesive vs. self-adhesive resin: bonding strength following LED curing

J Orofac Orthop. 2021 Aug 17. doi: 10.1007/s00056-021-00340-z. Online ahead of print.

ABSTRACT

PURPOSE: The goal of this study was to compare the shear bond strength (SBS) and failure modes of three different adhesive resins following the use of two different dental curing light units.

METHODS: A total of 160 human premolars were randomly divided into four groups (N = 40 for each): group 1, Transbond™ XT (3M Unitek, Monrovia, CA, USA) adhesive paste; group 2, Heliosit Orthodontic paste with no primer; group 3, Maxcem Elite (Kerr, Orange, CA, USA) self-adhesive resin with prior etching; group 4, Maxcem Elite self-adhesive resin with no etching. Each group was further divided into 2 subgroups: half (named “a”) were cured with VALO LED (Ultradent Products, South Jordan, UT, USA), and the other half (named “b”) with the Elipar LED unit (3M Unitek LED, Monrovia, CA, USA). The brackets were submitted to SBS testing 24 h after bonding. Adhesive Remnant Index (ARI) scores and bonding time were also measured. Two-way analysis of variance (ANOVA) and Kruskal-Wallis tests were used for statistical analysis.

RESULTS: No significant differences in SBS were observed when comparing the two different LED devices within the same bonding material. The mean SBS of group 1 was significantly higher compared to groups 2, 3, and 4 (p < 0.001). Mean SBS values of groups 2 and 3 were significantly higher than that of group 4 (p < 0.001). ARI scores were significantly different in groups 4a and 4b compared to the other groups (p < 0.05). Group 4a showed significantly lower bonding time/tooth compared to the other groups except to groups 3a and 4b (p < 0.001).

CONCLUSIONS: Decreasing curing time using high-power LED device did not significantly affect SBS. However, the composite type did affect SBS.

PMID:34402921 | DOI:10.1007/s00056-021-00340-z

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RefRGim: an intelligent reference panel reconstruction method for genotype imputation with convolutional neural networks

Brief Bioinform. 2021 Aug 17:bbab326. doi: 10.1093/bib/bbab326. Online ahead of print.

ABSTRACT

Genotype imputation is a statistical method for estimating missing genotypes from a denser haplotype reference panel. Existing methods usually performed well on common variants, but they may not be ideal for low-frequency and rare variants. Previous studies showed that the population similarity between study and reference panels is one of the key factors influencing the imputation accuracy. Here, we developed an imputation reference panel reconstruction method (RefRGim) using convolutional neural networks (CNNs), which can generate a study-specified reference panel for each input data based on the genetic similarity of individuals from current study and references. The CNNs were pretrained with single nucleotide polymorphism data from the 1000 Genomes Project. Our evaluations showed that genotype imputation with RefRGim can achieve higher accuracies than original reference panel, especially for low-frequency and rare variants. RefRGim will serve as an efficient reference panel reconstruction method for genotype imputation. RefRGim is freely available via GitHub: https://github.com/shishuo16/RefRGim.

PMID:34402866 | DOI:10.1093/bib/bbab326

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Accuracy and Reproducibility of Frozen Section Diagnosis in Ovarian Tumors: A 10-Year Experience at a Tertiary Cancer Center

Arch Pathol Lab Med. 2021 Aug 17. doi: 10.5858/arpa.2020-0686-OA. Online ahead of print.

ABSTRACT

CONTEXT.—: Intraoperative consultation-frozen section diagnosis (FSD)-determines tumor pathology and guides the optimal surgical management of ovarian neoplasms intraoperatively.

OBJECTIVE.—: To evaluate the diagnostic accuracy of the FSD and analyze the discrepancy between the FSD and final diagnosis.

DESIGN.—: This is a retrospective study of 618 ovarian neoplasm FSDs from 2009 to 2018 at a tertiary health care center. The discrepant cases were reviewed and reevaluated by gynecologic and general surgical pathologists. The outcomes of interest were performing unnecessary procedure, returning for a second surgery, and 30-day postoperative mortality.

RESULTS.—: The sensitivity and the positive predictive value of the FSD were lower in borderline tumors than in benign and malignant epithelial ovarian tumors. Major and minor discrepancies were identified in 5.3% (33 of 618) and 12.3% of (76 of 618) cases, respectively. A root cause analysis of the major discrepant cases showed that sampling error accounted for 43% (14 of 33). The discrepancy distributions of gynecologic and general surgical pathologists were statistically similar in the overall cohort (P = .65). The overall κ for diagnostic agreement among gynecologic pathologists, general surgical pathologists, and final diagnosis was 0.18 (0.10-0.26, P < .001), implying only a slight overall agreement. Of the major discrepant cases, only 3 had a clinical implication. One overdiagnosed patient underwent unnecessary procedure and 2 underdiagnosed patients were recommended to return for a second surgery. No patient had 30-day postoperative mortality.

CONCLUSIONS.—: Frozen section diagnosis remains a definitive diagnostic tool in ovarian neoplasms and plays a crucial role in guiding intraoperative surgical management.

PMID:34402886 | DOI:10.5858/arpa.2020-0686-OA

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Trends in Differences in Health Status and Health Care Access and Affordability by Race and Ethnicity in the United States, 1999-2018

JAMA. 2021 Aug 17;326(7):637-648. doi: 10.1001/jama.2021.9907.

ABSTRACT

IMPORTANCE: The elimination of racial and ethnic differences in health status and health care access is a US goal, but it is unclear whether the country has made progress over the last 2 decades.

OBJECTIVE: To determine 20-year trends in the racial and ethnic differences in self-reported measures of health status and health care access and affordability among adults in the US.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional study of National Health Interview Survey data, 1999-2018, that included 596 355 adults.

EXPOSURES: Self-reported race, ethnicity, and income level.

MAIN OUTCOMES AND MEASURES: Rates and racial and ethnic differences in self-reported health status and health care access and affordability.

RESULTS: The study included 596 355 adults (mean [SE] age, 46.2 [0.07] years, 51.8% [SE, 0.10] women), of whom 4.7% were Asian, 11.8% were Black, 13.8% were Latino/Hispanic, and 69.7% were White. The estimated percentages of people with low income were 28.2%, 46.1%, 51.5%, and 23.9% among Asian, Black, Latino/Hispanic, and White individuals, respectively. Black individuals with low income had the highest estimated prevalence of poor or fair health status (29.1% [95% CI, 26.5%-31.7%] in 1999 and 24.9% [95% CI, 21.8%-28.3%] in 2018), while White individuals with middle and high income had the lowest (6.4% [95% CI, 5.9%-6.8%] in 1999 and 6.3% [95% CI, 5.8%-6.7%] in 2018). Black individuals had a significantly higher estimated prevalence of poor or fair health status than White individuals in 1999, regardless of income strata (P < .001 for the overall and low-income groups; P = .03 for middle and high-income group). From 1999 to 2018, racial and ethnic gaps in poor or fair health status did not change significantly, with or without income stratification, except for a significant decrease in the difference between White and Black individuals with low income (-6.7 percentage points [95% CI, -11.3 to -2.0]; P = .005); the difference in 2018 was no longer statistically significant (P = .13). Black and White individuals had the highest levels of self-reported functional limitations, which increased significantly among all groups over time. There were significant reductions in the racial and ethnic differences in some self-reported measures of health care access, but not affordability, with and without income stratification.

CONCLUSIONS AND RELEVANCE: In a serial cross-sectional survey study of US adults from 1999 to 2018, racial and ethnic differences in self-reported health status, access, and affordability improved in some subgroups, but largely persisted.

PMID:34402830 | DOI:10.1001/jama.2021.9907

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Trends in Gestational Diabetes at First Live Birth by Race and Ethnicity in the US, 2011-2019

JAMA. 2021 Aug 17;326(7):660-669. doi: 10.1001/jama.2021.7217.

ABSTRACT

IMPORTANCE: Gestational diabetes is associated with adverse maternal and offspring outcomes.

OBJECTIVE: To determine whether rates of gestational diabetes among individuals at first live birth changed from 2011 to 2019 and how these rates differ by race and ethnicity in the US.

DESIGN, SETTING, AND PARTICIPANTS: Serial cross-sectional analysis using National Center for Health Statistics data for 12 610 235 individuals aged 15 to 44 years with singleton first live births from 2011 to 2019 in the US.

EXPOSURES: Gestational diabetes data stratified by the following race and ethnicity groups: Hispanic/Latina (including Central and South American, Cuban, Mexican, and Puerto Rican); non-Hispanic Asian/Pacific Islander (including Asian Indian, Chinese, Filipina, Japanese, Korean, and Vietnamese); non-Hispanic Black; and non-Hispanic White.

MAIN OUTCOMES AND MEASURES: The primary outcomes were age-standardized rates of gestational diabetes (per 1000 live births) and respective mean annual percent change and rate ratios (RRs) of gestational diabetes in non-Hispanic Asian/Pacific Islander (overall and in subgroups), non-Hispanic Black, and Hispanic/Latina (overall and in subgroups) individuals relative to non-Hispanic White individuals (referent group).

RESULTS: Among the 12 610 235 included individuals (mean [SD] age, 26.3 [5.8] years), the overall age-standardized gestational diabetes rate significantly increased from 47.6 (95% CI, 47.1-48.0) to 63.5 (95% CI, 63.1-64.0) per 1000 live births from 2011 to 2019, a mean annual percent change of 3.7% (95% CI, 2.8%-4.6%) per year. Of the 12 610 235 participants, 21% were Hispanic/Latina (2019 gestational diabetes rate, 66.6 [95% CI, 65.6-67.7]; RR, 1.15 [95% CI, 1.13-1.18]), 8% were non-Hispanic Asian/Pacific Islander (2019 gestational diabetes rate, 102.7 [95% CI, 100.7-104.7]; RR, 1.78 [95% CI, 1.74-1.82]), 14% were non-Hispanic Black (2019 gestational diabetes rate, 55.7 [95% CI, 54.5-57.0]; RR, 0.97 [95% CI, 0.94-0.99]), and 56% were non-Hispanic White (2019 gestational diabetes rate, 57.7 [95% CI, 57.2-58.3]; referent group). Gestational diabetes rates were highest in Asian Indian participants (2019 gestational diabetes rate, 129.1 [95% CI, 100.7-104.7]; RR, 2.24 [95% CI, 2.15-2.33]). Among Hispanic/Latina participants, gestational diabetes rates were highest among Puerto Rican individuals (2019 gestational diabetes rate, 75.8 [95% CI, 71.8-79.9]; RR, 1.31 [95% CI, 1.24-1.39]). Gestational diabetes rates increased among all race and ethnicity subgroups and across all age groups.

CONCLUSIONS AND RELEVANCE: Among individuals with a singleton first live birth in the US from 2011 to 2019, rates of gestational diabetes increased across all racial and ethnic subgroups. Differences in absolute gestational diabetes rates were observed across race and ethnicity subgroups.

PMID:34402831 | DOI:10.1001/jama.2021.7217

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Association of Race and Ethnicity and Medicare Program Type With Ambulatory Care Access and Quality Measures

JAMA. 2021 Aug 17;326(7):628-636. doi: 10.1001/jama.2021.10413.

ABSTRACT

IMPORTANCE: There are racial inequities in health care access and quality in the United States. It is unknown whether such differences for racial and ethnic minority beneficiaries differ between Medicare Advantage and traditional Medicare or whether access and quality are better for minority beneficiaries in 1 of the 2 programs.

OBJECTIVE: To compare differences in rates of enrollment, ambulatory care access, and ambulatory care quality by race and ethnicity in Medicare Advantage vs traditional Medicare.

DESIGN, SETTING, AND PARTICIPANTS: Exploratory observational cohort study of a nationally representative sample of 45 833 person-years (26 887 persons) in the Medicare Current Beneficiary Survey from 2015 to 2018, comparing differences in program enrollment and measures of access and quality by race and ethnicity.

EXPOSURES: Minority race and ethnicity (Black, Hispanic, Native American, or Asian/Pacific Islander) vs White or multiracial; Medicare Advantage vs traditional Medicare enrollment.

MAIN OUTCOMES AND MEASURES: Six patient-reported measures of ambulatory care access (whether a beneficiary had a usual source of care in the past year, had a primary care clinician usual source of care, or had a specialist visit) and quality (influenza vaccination, pneumonia vaccination, and colon cancer screening).

RESULTS: The final sample included 6023 persons (mean age, 68.9 [SD, 12.6] years; 57.3% women) from minority groups and 20 864 persons (mean age, 71.9 [SD, 10.8] years; 54.9% women) from White or multiracial groups, who accounted for 9816 and 36 017 person-years, respectively. Comparing Medicare Advantage vs traditional Medicare among minority beneficiaries, those in Medicare Advantage had significantly better rates of access to a primary care clinician usual source of care (79.1% vs 72.5%; adjusted marginal difference, 4.0%; 95% CI, 1.0%-6.9%), influenza vaccinations (67.3% vs 63.0%; adjusted marginal difference, 5.2%; 95% CI, 1.9%-8.5%), pneumonia vaccinations (70.7% vs 64.6%; adjusted marginal difference, 6.1%; 95% CI, 2.7%-9.4%), and colon cancer screenings (69.4% vs 61.1%; adjusted marginal difference, 7.1%; 95% CI, 3.8%-10.3%). Comparing minority vs White or multiracial beneficiaries across both programs, minority beneficiaries had significantly lower rates of access to a primary care clinician usual source of care (adjusted marginal difference, 4.7%; 95% CI, 2.5%-6.8%), specialist visits (adjusted marginal difference, 10.8%; 95% CI, 8.3%-13.3%), influenza vaccinations (adjusted marginal difference, 4.3%; 95% CI, 1.2%-7.4%), and pneumonia vaccinations (adjusted marginal difference, 6.4%; 95% CI, 3.9%-9.0%). The interaction of race and ethnicity with insurance type was not statistically significant for any of the 6 outcome measures.

CONCLUSIONS AND RELEVANCE: In this exploratory study of Medicare beneficiaries in 2015-2018, enrollment in Medicare Advantage vs traditional Medicare was significantly associated with better outcomes for access and quality among minority beneficiaries; however, minority beneficiaries were significantly more likely to experience worse outcomes for most access and quality measures than White or multiracial beneficiaries in both programs.

PMID:34402828 | DOI:10.1001/jama.2021.10413

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US Health Care Spending by Race and Ethnicity, 2002-2016

JAMA. 2021 Aug 17;326(7):649-659. doi: 10.1001/jama.2021.9937.

ABSTRACT

IMPORTANCE: Measuring health care spending by race and ethnicity is important for understanding patterns in utilization and treatment.

OBJECTIVE: To estimate, identify, and account for differences in health care spending by race and ethnicity from 2002 through 2016 in the US.

DESIGN, SETTING, AND PARTICIPANTS: This exploratory study included data from 7.3 million health system visits, admissions, or prescriptions captured in the Medical Expenditure Panel Survey (2002-2016) and the Medicare Current Beneficiary Survey (2002-2012), which were combined with the insured population and notified case estimates from the National Health Interview Survey (2002; 2016) and health care spending estimates from the Disease Expenditure project (1996-2016).

EXPOSURE: Six mutually exclusive self-reported race and ethnicity groups.

MAIN OUTCOMES AND MEASURES: Total and age-standardized health care spending per person by race and ethnicity for each year from 2002 through 2016 by type of care. Health care spending per notified case by race and ethnicity for key diseases in 2016. Differences in health care spending across race and ethnicity groups were decomposed into differences in utilization rate vs differences in price and intensity of care.

RESULTS: In 2016, an estimated $2.4 trillion (95% uncertainty interval [UI], $2.4 trillion-$2.4 trillion) was spent on health care across the 6 types of care included in this study. The estimated age-standardized total health care spending per person in 2016 was $7649 (95% UI, $6129-$8814) for American Indian and Alaska Native (non-Hispanic) individuals; $4692 (95% UI, $4068-$5202) for Asian, Native Hawaiian, and Pacific Islander (non-Hispanic) individuals; $7361 (95% UI, $6917-$7797) for Black (non-Hispanic) individuals; $6025 (95% UI, $5703-$6373) for Hispanic individuals; $9276 (95% UI, $8066-$10 601) for individuals categorized as multiple races (non-Hispanic); and $8141 (95% UI, $8038-$8258) for White (non-Hispanic) individuals, who accounted for an estimated 72% (95% UI, 71%-73%) of health care spending. After adjusting for population size and age, White individuals received an estimated 15% (95% UI, 13%-17%; P < .001) more spending on ambulatory care than the all-population mean. Black (non-Hispanic) individuals received an estimated 26% (95% UI, 19%-32%; P < .001) less spending than the all-population mean on ambulatory care but received 19% (95% UI, 3%-32%; P = .02) more on inpatient and 12% (95% UI, 4%-24%; P = .04) more on emergency department care. Hispanic individuals received an estimated 33% (95% UI, 26%-37%; P < .001) less spending per person on ambulatory care than the all-population mean. Asian, Native Hawaiian, and Pacific Islander (non-Hispanic) individuals received less spending than the all-population mean on all types of care except dental (all P < .001), while American Indian and Alaska Native (non-Hispanic) individuals had more spending on emergency department care than the all-population mean (estimated 90% more; 95% UI, 11%-165%; P = .04), and multiple-race (non-Hispanic) individuals had more spending on emergency department care than the all-population mean (estimated 40% more; 95% UI, 19%-63%; P = .006). All 18 of the statistically significant race and ethnicity spending differences by type of care corresponded with differences in utilization. These differences persisted when controlling for underlying disease burden.

CONCLUSIONS AND RELEVANCE: In the US from 2002 through 2016, health care spending varied by race and ethnicity across different types of care even after adjusting for age and health conditions. Further research is needed to determine current health care spending by race and ethnicity, including spending related to the COVID-19 pandemic.

PMID:34402829 | DOI:10.1001/jama.2021.9937

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High estradiol and low testosterone levels are associated with critical illness in male but not in female COVID-19 patients: a retrospective cohort study

Emerg Microbes Infect. 2021 Aug 17:1-32. doi: 10.1080/22221751.2021.1969869. Online ahead of print.

ABSTRACT

Male sex was repeatedly identified as a risk factor for death and intensive care admission. However, it is yet unclear whether sex hormones are associated with disease severity in COVID-19 patients. In this study, we analyzed sex hormone levels (estradiol and testosterone) of male and female COVID-19 patients (n=50) admitted to an intensive care unit (ICU) in comparison to control non-COVID-19 patients at the ICU (n=42), non-COVID-19 patients with the most prevalent comorbidity (coronary heart diseases) present within the COVID-19 cohort (n=39) and healthy individuals (n=50). We detected significantly elevated estradiol levels in critically ill male COVID-19 patients compared to all control cohorts. Testosterone levels were significantly reduced in critically ill male COVID-19 patients compared to control cohorts. No statistically significant differences in sex hormone levels were detected in critically ill female COVID-19 patients, albeit similar trends towards elevated estradiol levels were observed. Linear regression analysis revealed that among a broad range of cytokines and chemokines analyzed, IFN-γ levels are positively associated with estradiol levels in male and female COVID-19 patients. Furthermore, male COVID-19 patients with elevated estradiol levels were more likely to receive ECMO treatment. Thus, we herein identified that disturbance of sex hormone metabolism might present a hallmark in critically ill male COVID-19 patients.Trial registration: ClinicalTrials.gov identifier: NCT04979091..

PMID:34402750 | DOI:10.1080/22221751.2021.1969869