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Nevin Manimala Statistics

Post-Run T2 Mapping Changes in Knees of Adolescent Basketball Players

Cartilage. 2021 Jun 15:19476035211021891. doi: 10.1177/19476035211021891. Online ahead of print.

ABSTRACT

OBJECTIVE: While articular cartilage defects are common incidental findings among adult athletes, the effect of running on the cartilage of adolescent athletes have rarely been assessed. This study aims to assess the variations in the articular cartilage of the knees in healthy adolescent basketball players using quantitative T2 MRI (magnetic resonance imaging).

DESIGN: Fifteen adolescent basketball players were recruited (13.8 ± 0.5 years old). Girls were excluded to avoid potential gender-related confounding effects. Players underwent a pre-run MRI scan of both knees. All participants performed a 30-minute run on a treadmill. Within 15 minutes after completion of their run, players underwent a second, post-run MRI scan. Quantitative T2 maps were generated using the echo modulation curve (EMC) algorithm. Pre-run scans and post-run scans were compared using paired t test.

RESULTS: Participants finished their 30-minute run with a mean running distance of 5.77 ± 0.42 km. Pre-run scans analysis found statistically significant (P < 0.05) changes in 3 regions of the knee lateral compartment representing the cartilaginous tissue. No differences were found in the knee medial compartment. Post-run analysis showed lower T2 values in the medial compartment compared to the pre-run scans in several weight-bearing regions: femoral condyle central (pre/post mean values of 33.9/32.2 ms, P = 0.020); femoral condyle posterior (38.1/36.8 ms, P = 0.038); and tibial plateau posterior (34.1/31.0 ms, P < 0.001). The lateral regions did not show any significant changes.

CONCLUSIONS: Running leads to microstructural changes in the articular cartilage in several weight-bearing areas of the medial compartment, both in the femoral and the tibial cartilage.

PMID:34128410 | DOI:10.1177/19476035211021891

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Invariance of the Household Food Insecurity Access Scale Across Different Groups of Adolescents and Young Adults

Food Nutr Bull. 2021 Jun 15:3795721211019634. doi: 10.1177/03795721211019634. Online ahead of print.

ABSTRACT

BACKGROUND: Cross-group comparisons of household food insecurity and its associations using multiple-item scales assume that scale scores can be interpreted as identical across groups. However, scores should not be interpreted as identical across groups without evidence of measurement invariance. Noninvariant measures indicate that the underlying construct may be different across groups.

OBJECTIVE: To determine whether the Household Food Insecurity Access Scale (HFIAS) is invariant across different groups of Ghanaian and South African youth aged 15 to 24.

METHODS: We analyzed cross-sectional quantitative data from 1437 and 4165 young South Africans and Ghanaians, respectively. Multi-group confirmatory factor analysis was used to examine whether the HFIAS was invariant across different groups of youth, including sex (male or female), age group (middle adolescence, late adolescence, or emerging adulthood), and receipt of child support grant (yes or no). We assessed 3 levels of invariance: configural, metric, and scalar. The model fit between nested models was compared using χ2 difference testing.

RESULTS: Invariance tests indicated that the HFIAS had configural, metric, and scalar invariance across different groups of Ghanaian and South African youth. Model fit statistics across all invariance levels indicated good fit of our hypothesized model with the observed data. χ2 difference testing results were not statistically significant across all nested models.

CONCLUSIONS: Food insecurity, as measured by the HFIAS, meant the same thing for different groups of Ghanaian and South African youth. Evidence of invariance means that the HFIAS scores could be interpreted as identical across youth groups in our study.

PMID:34128424 | DOI:10.1177/03795721211019634

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Nevin Manimala Statistics

Which Endoscopic Methods in Prepubertal Patients with 10-20 mm Bladder Stones: Transurethral Cystolithotripsy or Percutaneous Cystolithotripsy?

J Endourol. 2021 Jun 15. doi: 10.1089/end.2021.0269. Online ahead of print.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of transurethral cystolithotripsy(TUC) and percutaneous cystolithotripsy(PCC) in prepubertal patients with 10-20 mm bladder stones.

MATERIALS AND METHODS: The files of patients the age of 12 and under who were admitted our clinic for bladder stones from January 2007 to January 2021 were reviewed retrospectively. Inclusion criteria were patients who were 12 years of age and under with 10-20 mm bladder stones, and who underwent endoscopic surgery(TUC or PCC). None of the patients had prior bladder or stone surgery. The patients were divided into two groups(Group 1:PCC group, and Group 2:TUC group) and collected data(preoperative, intraoperative, and postoperative characteristics) were compared between the groups.

RESULTS: This present study was enrolled 51 patients(21 patients in Group 1 and 30 patients in Group 2).The mean ages of the groups were similar (Group 1:4.7±3.6; Group 2:4.6±3.2; p:0.936). The mean stone size was 15.8±3.5 in Group 1, and 12.1±2.4 mm in Group 2. It was higher in the PCC group than TUC group(p<0.001). The operative time was lower in Group 1 than Group 2(36.4±12.9 min vs. 42.7±16.3 min, respectively), but there was no statistically significance difference between the groups (p:0.117).We achieved SFR for all the patients in both groups. Complications were observed in four (7.7%) cases. One female patient was in Group 1 and three male patients were in Group 2. There was no difference for complication rates between the groups(p:0.634).

CONCLUSIONS: Endoscopic surgeries have almost become a routine method in the treatment of bladder stones. Despite larger stone size, PCC provides similar SFR compared with TUC along with a tendency of shorter operative time. However, the use of the TUC method in toddler males could increase the risk of postoperative urinary retention. Hence, stone size and patient age should be considered in the selection of a surgical approach.

PMID:34128398 | DOI:10.1089/end.2021.0269

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The Impact of Surgical Posterior Nasal Nerve Cryoablation on Symptoms and Disease-Specific Quality of Life in Patients With Chronic Rhinitis

Ear Nose Throat J. 2021 Jun 15:1455613211018576. doi: 10.1177/01455613211018576. Online ahead of print.

ABSTRACT

OBJECTIVE: Preliminary data have demonstrated long-term efficacy of posterior nasal nerve (PNN) cryoablation in reducing rhinitis symptoms for patients with allergic rhinitis (AR) and nonallergic rhinitis (NAR). We sought to evaluate the impact of procedural cryoablation of the PNN on quality of life (QOL) in patients with AR and NAR.

METHODS: Adult patients undergoing PNN cryoablation for AR or NAR after appropriate medical therapy were included for analysis. Demographics, medical therapies, baseline rhinitis symptom (total nasal symptom score [TNSS]), and disease-specific QOL (mini-rhinoconjunctivitis quality of life questionnaire [mini-RQLQ]) were recorded. The Wilcoxon signed-rank test was used to test for significant changes in baseline test scores posttreatment. Absolute and relative improvement in outcomes was determined for each participant. Secondary outcomes were assessed with univariate and multivariate analyses.

RESULTS: Fourteen patients were enrolled with a mean follow-up of 16.5 weeks. The TNSS and mini-RQLQ scores significantly improved after PNN cryoablation (median δs [interquartile range]: -4 [3] and -1.61 [1.08], respectively; both P = .0002). The minimal clinically important difference for the TNSS and mini-RQLQ was obtained in 92.9% of patients in each category. Relative mean percentage (%) improvement after PNN cryoablation in the TNSS and mini-RQLQ was 40.7% and 40.5% (standard deviation = 24.9 and 29.5, respectively), respectively, for all patients. Patients with NAR (n = 10) reported mean improvement of 41.3% (29.1) as measured by the TNSS and 49.6% (25.9) by mini-RQLQ. Patients with AR reported mean percentage improvement in TNSS and mini-RQLQ scores of 39.5% (12.1) and 24.6% (28.5), respectively. Patients who had been prescribed a nasal anticholinergic for management prior to PNN cryoablation had statistically significantly increased improvement in mini-RQLQ scores from pre- to post-procedure (P = .0387).

CONCLUSION: Surgical cryoablation of the PNN significantly improves both symptoms and disease-specific QOL in majority of patients with AR and NAR.

PMID:34128402 | DOI:10.1177/01455613211018576

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A Nationwide Study on the Incidence of Breast Cancer in Korean Women with Osteoporosis Receiving Raloxifene Treatment

J Breast Cancer. 2021 May 14. doi: 10.4048/jbc.2021.24.e28. Online ahead of print.

ABSTRACT

PURPOSE: Raloxifene is a selective estrogen receptor modulator (SERM), and raloxifene treatment for osteoporosis is reimbursable under the Korean National Health Insurance. Evidence suggests that SERMs use reduces the risk of breast cancer in Asian population. Herein, we retrospectively investigated the protective effect of raloxifene on breast cancer rates in Korean population.

METHODS: Using the Health Insurance Review and Assessment Service database, we selected women with osteoporosis aged 50 years and above. Patients treated for at least 2 years with raloxifene were assigned to the user group, whereas the remaining patients were assigned to the non-user group. The effect on breast cancer risk was assessed using the Cox proportional-hazards model with a time-dependent covariate to adjust for immortal time bias.

RESULTS: A total of 322,870 women who were registered between 2010 and 2011 were included. The user group comprised 0.7% (n = 2,307) of the total population. The mean age was 65.7 ± 8.0 years and 67.2 ± 8.6 years in the user and non-user groups, respectively (p < 0.001). There was no difference in the previous use of estrogen replacement between the 2 groups (p = 0.087). The incidence of breast cancer per 1,000 person-years was 0.49 (n = 8) and 0.68 (n = 1,714) in the user and non-user groups, respectively (hazard ratio [HR], 0.63, 95% confidence interval [CI], 0.32-1.27). HR decreased with increase in the treatment duration, but this change was not statistically significant (HR, 1.00, 95% CI, 0.32-3.11 in 2-3 years; HR, 0.63, 95% CI, 0.20-1.94 in 3-4 years; and HR, 0.41, 95% CI, 0.10-1.65 in 4-5 years).

CONCLUSION: Long-term treatment with raloxifene in women with osteoporosis was not significantly associated with a reduction in breast cancer rates. However, further investigation is required for a conclusive proof.

PMID:34128366 | DOI:10.4048/jbc.2021.24.e28

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Programmed Death Ligand 1 Immunohistochemistry in Triple-Negative Breast Cancer: Evaluation of Inter-Pathologist Concordance and Inter-Assay Variability

J Breast Cancer. 2021 May 26. doi: 10.4048/jbc.2021.24.e29. Online ahead of print.

ABSTRACT

PURPOSE: The programmed death ligand 1 (PD-L1) SP142 assay with a 1% immune cell (IC) cutoff is approved for the selection of advanced triple-negative breast cancer (TNBC) patients for atezolizumab treatment. We aimed to evaluate the interobserver concordance of PD-L1 scoring and inter-assay variability of various PD-L1 assays in TNBC.

METHODS: Thirty patients with primary TNBC were selected, and SP142, SP263, 22C3, and E1L3N assays were performed. PD-L1 staining in ICs and tumor cells (TCs) was scored by 10 pathologists who were blinded to the assay. The interobserver concordance among pathologists and the inter-assay variability of the four PD-L1 assays were analyzed. For SP142, the intraobserver concordance among the six pathologists was analyzed after training.

RESULTS: The adjusted means of PD-L1 IC scoring ranged from 6.2% to 12.9% for the four assays; the intraclass correlations showed moderate (0.584-0.649) reader concordance. The PD-L1 IC scoring with a 1% cutoff resulted in identical scoring in 40.0%-66.7% of cases and a poor to moderate agreement (Fleiss κ statistic [FKS] = 0.345-0.534) for the four assays. The SP142 assay had the widest range of positive rate (56.5%-100.0%), lowest number of cases with identical scoring, and lowest FKS at 1% cutoff. Pairwise comparison of adjusted means showed significantly decreased PD-L1 staining in SP142 compared with the other assays in both ICs and TCs. As for the intraobserver concordance in the SP142 assay, the overall percent agreement was 87.8% with a 1% IC cutoff. After training, the proportion of cases with identical scoring at a 1% IC cutoff increased to 70.0%; the FKS also increased to 0.610.

CONCLUSION: The concordance of PD-L1 IC scoring among pathologists was low, at the 1% cutoff for the SP142 assay without training. SP142 showed the lowest PD-L1 expression in both IC and TC.

PMID:34128367 | DOI:10.4048/jbc.2021.24.e29

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Lifestyle interventions can reduce the risk of Barrett’s esophagus: a systematic review and meta-analysis of 62 studies involving 250,157 participants

Cancer Med. 2021 Jun 15. doi: 10.1002/cam4.4061. Online ahead of print.

ABSTRACT

BACKGROUND: Barrett’s esophagus (BE) is a well-established risk factor for esophageal adenocarcinoma. Our objective was to investigate the effectiveness of lifestyle interventions on BE risk.

METHODS: We searched PubMed, Embase, and Web of Science up to 30 September 2020. The summary relative risks (RRs) and 95% confidence intervals (CIs) for the highest versus lowest categories of exposure were assessed. Analyses of subgroup, dose-response, sensitivity, and publication bias were conducted.

RESULTS: Sixty-two studies were included that involved more than 250,157 participants and 22,608 cases. Seven lifestyle factors were investigated: smoking, alcohol, body mass index (BMI), physical activity, sleep time, medication, and diet. We observed statistically significant increased BE risks for smoking (RR = 1.35, 95% CI = 1.16-1.57), alcohol intake (RR = 1.23, 95% CI = 1.13-1.34), body fatness (RR = 1.08, 95% CI = 1.03-1.13), less sleep time (RR = 1.76, 95% CI = 1.24-2.49), and proton pump inhibitors use (RR = 1.64, 95% CI = 1.17-2.29). Reduced risks of BE were found for aspirin (RR = 0.70, 95% CI = 0.58-0.84) and the intake of vitamin C (RR = 0.59, 95% CI = 0.44-0.80), folate (RR = 0.47, 95% CI = 0.31-0.71), and fiber (RR = 0.95, 95% CI = 0.93-0.97). The quality of most included studies was high and the subgroup analysis according to the quality score showed significant results (p < 0.05). There was no publication bias for smoking and alcohol. Although the analysis suggested significant evidence of publication bias for BMI, sensitivity analysis showed that the changes in the recalculated RRs were not significant.

CONCLUSIONS: The large meta-analysis revealed that lifestyle modifications could reduce the risks of BE and, consequently, esophageal adenocarcinoma.

PMID:34128354 | DOI:10.1002/cam4.4061

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Comparative efficacy and safety of preserved versus preservative-free beta-blockers in patients with glaucoma or ocular hypertension: a systematic review

Acta Ophthalmol. 2021 Jun 14. doi: 10.1111/aos.14926. Online ahead of print.

ABSTRACT

Preservative-free topical medications have been introduced for glaucoma care to reduce ocular adverse events associated with preservatives. This is a systematic review and meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of beta-blockers, or combination using beta-blockers, with and without preservatives. PubMed, EMBASE and Web of Science were examined. Risk of bias was assessed using the Cochrane Handbook for Systematic Reviews. The primary outcome was change in intraocular pressure (IOP) from baseline to final follow-up. Secondary outcomes included ocular and systemic side effects, and other clinical and quality of life outcomes. Of 242 records identified, seven RCTs (1125 patients) were included. The follow-up period ranged from one to 12 months. Timolol was used in five studies, and two studies used a combination (timolol with bimatoprost or dorzolamide). The difference in mean change (MD) in IOP between the preservative-free and the preserved drugs was statistically significant but not clinically relevant: (MD 0.29 mmHg, 95% confidence interval 0.07-0.51 mmHg, p = 0.010; moderate-certainty evidence). Regarding adverse events: Level of evidence for all ocular surface outcome was low or very low and reported in few studies. No significant difference was observed on ocular surface symptoms. Tear break-up time (TBUT) was better with preservative-free drops (p < 0.001). Schirmer’s test was better in the preservative-free group (p < 0.001). Level of evidence for all ocular surface outcomes was low or very low. There was no difference in other secondary outcomes. We found no clinically relevant difference in mean change in IOP between the preserved and the preservative-free treatments. Data on adverse events used different methods and were incompletely reported. Although some measures of ocular surface health favoured preservative-free medications, more evidence is needed. The increasing use of preservative-free drops may be associated with better ocular surface and tolerability, but strong evidence from RCTs would be welcome.

PMID:34128326 | DOI:10.1111/aos.14926

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Pediatric oncology clinician communication about sexual health with adolescents and young adults: A report from the children’s oncology group

Cancer Med. 2021 Jun 15. doi: 10.1002/cam4.4077. Online ahead of print.

ABSTRACT

BACKGROUND: Sexual health (SH) is an important concern for adolescents and young adults (AYAs). This study determined current SH communication practices, barriers, and additional resources needed among pediatric oncology clinicians who treat AYAs.

METHODS: A cross-sectional survey was developed by the Children’s Oncology Group (COG) AYA Committee and sent to pediatric oncologists (n = 1,987; 85.9%) and advanced practice providers (APPs, n = 326; 14.1%) at 226 COG institutions. Responses were tabulated and compared using tests of proportion and trend.

RESULTS: The sample comprised 602 respondents from 168 institutions and was proportionally representative (468 oncologists [77.7%], 76 APPs [12.6%], 58 unidentified [9.6%]; institutional and provider response rates 74.3% and 26.2%, respectively). Almost half of respondents (41.7%) reported no/small role in SH care. Medical topics were discussed most often, including contraception (67.2%), puberty (43.5%), and sexual activity (37.5%). Topics never/rarely discussed included gender identity (64.5%), sexual orientation (53.7%), and sexual function (50.3%). Frequently cited communication barriers included lack of time, low priority, perceived patient discomfort, and the presence of a parent/guardian. Respondents endorsed the need for further education/resources on sexual function (66.1%), gender identity/sexual orientation (59.5%), and body image (46.6%). Preferred education modalities included dissemination of published guidelines (64.7%), skills training modules (62.9%), and webinars (45.3%). By provider type, responses were similar overall but differed for perception of role, barriers identified, and resources desired.

CONCLUSIONS: Many pediatric oncology clinicians play minimal roles in SH care of AYAs and most SH topics are rarely discussed. Provider-directed education/training interventions have potential for improving SH care of AYA cancer patients.

PMID:34128352 | DOI:10.1002/cam4.4077

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Propensity-score-based meta-analytic predictive prior for incorporating real-world and historical data

Stat Med. 2021 Jun 14. doi: 10.1002/sim.9095. Online ahead of print.

ABSTRACT

As the availability of real-world data sources (eg, EHRs, claims data, registries) and historical data has rapidly surged in recent years, there is an increasing interest and need from investigators and health authorities to leverage all available information to reduce patient burden and accelerate both drug development and regulatory decision making. Bayesian meta-analytic approaches are a popular historical borrowing method that has been developed to leverage such data using robust hierarchical models. The model structure accounts for various degrees of between-trial heterogeneity, resulting in adaptively discounting the external information in the case of data conflict. In this article, we propose to integrate the propensity score method and Bayesian meta-analytic-predictive (MAP) prior to leverage external real-world and historical data. The propensity score methodology is applied to select a subset of patients from external data that are similar to those in the current study with regards to key baseline covariates and to stratify the selected patients together with those in the current study into more homogeneous strata. The MAP prior approach is used to obtain stratum-specific MAP prior and derive the overall propensity score integrated meta-analytic predictive (PS-MAP) prior. Additionally, we allow for tuning the prior effective sample size for the proposed PS-MAP prior, which quantifies the amount of information borrowed from external data. We evaluate the performance of the proposed PS-MAP prior by comparing it to the existing propensity score-integrated power prior approach in a simulation study and illustrate its implementation with an example of a single-arm phase II trial.

PMID:34126656 | DOI:10.1002/sim.9095