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Nevin Manimala Statistics

CBCRisk model to determine the risk of contralateral breast cancer in sporadic breast cancer

Cir Esp (Engl Ed). 2021 Nov 8:S2173-5077(21)00259-3. doi: 10.1016/j.cireng.2021.10.008. Online ahead of print.

ABSTRACT

INTRODUCTION: The great majority of breast cancer (BC) cases are diagnosed in women who have no known family history of the disease and are not carriers of any risk mutation. During the past few decades an increase in the number of contralateral prophylactic mastectomy (CPM) has been produced in these patients. The CBCRisk model calculates the absolute risk of suffering from contralateral breast cancer (CBC); thus, it can be used to counselling patients with sporadic breast cancer.

METHOD: An observational, retrospective study including sporadic breast cancer patients treated with contralateral prophylactic mastectomy has been conducted between 2017 and 2019. A descriptive and comparative study with one variation of logistic regression has been carried out in order to identify predictive factors of occult tumors (OT) and medium/high risk damage (MHRD). Evaluation of the CBCRisk model published in 2017 and different limit values for the CPM recommendation.

RESULTS: 42 patients were selected. Incidence of MHRD and OT was lower than that described in the literatura (9.52%MHRD, 2.38%OT). None of the evaluated variables reached statistical significance for predicting injuries. The average value of CBCRisk 5 years ahead found in patients with pathological findings was 2.08 (DE 0.97), higher than the average value of the whole group (1.87 ± 0.91) and the subgroup without pathological findings (1.84 ± 0.91). Only values >3 for CBCRisk were considered statistically significant (P = .04) for the prediction of histological lesions.

CONCLUSION: Patients with sporadic breast cancer should be adequately informed about the estimated risks and benefits of undergoing a contralateral prophylactic mastectomy. The CBCRisk may be useful for the counseling of these patients, but it requires validation in larger and prospective cohorts.

PMID:34764058 | DOI:10.1016/j.cireng.2021.10.008

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Medium-term outcome after stented and un-stented distal urethroplasty: A retrospective analysis on redo-urethroplasty need and cosmetic results

Actas Urol Esp (Engl Ed). 2021 Nov 8:S2173-5786(21)00117-7. doi: 10.1016/j.acuroe.2020.10.015. Online ahead of print.

ABSTRACT

INTRODUCTION: Long-term complication rates after distal hypospadias repair can be close to 20%. There are no available guidelines regarding the need for a catheter in distal urethroplasty. We report a retrospective analysis on medium-term redo-urethroplasty rate and cosmetic results after a two-years pilot study on stented/un-stented distal urethroplasties.

MATERIALS AND METHODS: A total of 11 stented (Group A) and 17 un-stented (Group B) Snodgrass-procedures were performed by the same pediatric surgeon at our Institution (2011-2013). The median age at surgery was 2.1 years (range 1-8.5). Inclusion criteria were primitive distal defect, same surgeon in both interventions, catheter-free discharge. The median follow-up was 6.4 years (range 1.5-8.1). All patients received at least one post-operative clinical-cosmetic examination (HOSE). The aim of our study was to compare medium-term complications and redo-urethroplasty rates before starting a randomized study. A retrospective analysis was performed. We used Fisher’s exact-test (P < 0.05) for statistical analysis.

RESULTS: Of 28 complications, 5 required redo-surgery: 2/11 stented-cases, 3/17 un-stented. Cosmetic results were satisfactory in both groups. These results were not statistically significant (P = 1.000).

CONCLUSION: Long-term follow-up is mandatory to know redo-urethroplasty rate and cosmetic outcome after distal stented/un-stented repair. Further studies are needed to evaluate the role of catheter placement and the definitive outcome in distal urethroplasty.

PMID:34764052 | DOI:10.1016/j.acuroe.2020.10.015

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Identifying outcome measures for atrial fibrillation value-based contracting using the Delphi method

Res Social Adm Pharm. 2021 Oct 29:S1551-7411(21)00361-2. doi: 10.1016/j.sapharm.2021.10.008. Online ahead of print.

ABSTRACT

BACKGROUND: Value-based contracts that tie payments for pharmaceuticals to predefined outcomes aim to promote value through shared risk and aligned incentives between manufacturers and payers.

METHODS: We conducted a Delphi study among diverse stakeholders (patients, providers, payers, pharmacy benefits managers, pharmaceutical company representatives) to identify top meaningful outcomes for inclusion in value-based contracts for atrial fibrillation medications. The final panel (n = 55) rated the importance of each outcome on a 5-point Likert scale and selected their top 3 most meaningful outcomes. Non-patient participants rated the feasibility of collecting each outcome on a 5-point Likert scale. Consensus was defined as ≥75% agreement (Likert scores ≥4/5 or selection of an outcome as most meaningful). Differences between stakeholder groups were examined using Fisher’s Exact Test.

RESULTS: Consensus was achieved for importance of 10 outcomes (Likert scale), where “preventing stroke or mini-stroke” reached 100% agreement (55/55). Eighty-one percent (44/54) of participants selected “preventing stroke or mini-stroke” as the most meaningful outcome (rank order question). The measures rated as most feasibly collected were “reducing hospitalizations” (97%, 36/37) followed by “preventing stroke or mini-stroke” and “reducing emergency department visits” (both 92%, 34/37). There were statistically significant differences between patients and non-patients [0% (0/17) vs 22% (8/37), P = 0.047] and patients and providers [0% (0/17) vs 39% (7/18), P = 0.008] in selection of “improving health-related quality of life” as a most meaningful outcome.

CONCLUSIONS: These findings will inform the design of atrial fibrillation value-based pharmaceutical contracts and provide additional insight into preferences for outcomes which could be used to improve the quality of atrial fibrillation care.

PMID:34764046 | DOI:10.1016/j.sapharm.2021.10.008

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Effect of acupressure at the BL67 spot on the spontaneous rotation of fetus with breech presentation: A randomized controlled trial

Explore (NY). 2021 Oct 23:S1550-8307(21)00219-6. doi: 10.1016/j.explore.2021.10.005. Online ahead of print.

ABSTRACT

BACKGROUND: Breech is a common fetal presentation in preterm pregnancies. This study aimed to investigate the effect of acupressure at the BL67 point on the spontaneous rotation of fetus with breech presentation.

METHODS: An unblind, two-armed randomized controlled trial was carried out from September 2017 to April 2020. Research participants were 138 pregnant women at 32 to 35 weeks of gestational age that had fetal breech presentation confirmed by ultrasound. They were randomly assigned into intervention and control groups (n=69 in each group). The intervention group received acupressure at the BL67 point on both feet for 10 minutes daily and for two consecutive weeks. The control group received routine care. Demographic and midwifery data questionnaires were used for data collection.

RESULTS: The spontaneous rotation of fetus with breech presentation into cephalic was observed in the majority of participants in the intervention group (82.6%) compared to the control group (17.4%) (p<0.001). Statistically significant differences in the fetal presentation at delivery was observed between the groups (84.1% cephalic vs. 18.8% breech, p<0.001). Regarding the type of delivery, cesarean section was reported mostly (85.5%) in the control group compared to the intervention group (21.7%) (p<0.001). However, the first- and fifth-minute Apgar scores of newborns had no statistically significant differences between the groups (p=0.773).

CONCLUSION: It is suggested to incorporate acupressure at the BL67 point into the care process for pregnant women to help with the reduction of the rate of cesarean section and avoid its related complications.

PMID:34764014 | DOI:10.1016/j.explore.2021.10.005

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Quality assessment of cold chain storage facilities for regulatory and quality management compliance in a developing country context

Int J Health Plann Manage. 2021 Nov 11. doi: 10.1002/hpm.3385. Online ahead of print.

ABSTRACT

BACKGROUND: Supply chain management is essential for cold chain medicines since they are temperature-controlled and must be maintained within a specific temperature range to ensure product integrity and quality. In Nigeria, guidelines that address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the chaotic medicines distribution system, this study examined the quality of practice of supply chain management of cold chain products in line with the World Health Organisation’s Expert Committee report on Specifications for Pharmaceutical Preparations.

METHODS: The study was set in Abuja Nigeria and descriptive survey was used to explore cold chain supply management. A checklist developed from regulatory requirements stipulated by the World Health Organisation covering documentations, storage and distribution guidelines was used to assess supply chain management of cold chain medicines across various facilities. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 25.

RESULTS: The results from this study showed that most of the storage facilities assessed (66.7%) did not meet up to the required standards of quality management for cold chain products. In addition, 50.4% of retail and hospital pharmacy facilities performed poorly in cold chain management practices. Many of aspects of quality management guidelines and regulations were not met by the facilities. Most facilities (66.7%) do not have their equipment calibrated, 43.6% of the hospital and retail pharmacies assessed do not have an automated system to cater for power failure while 37.6% do not perform a temperature check on cold chain products before receiving from suppliers.

CONCLUSION: The study has shown that the levels of the supply chain assessed for quality management and regulatory compliance performed poorly. There was limited availability and use of validated quality monitoring systems for cold chain medicines in these facilities.

PMID:34763368 | DOI:10.1002/hpm.3385

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Ambulance ramping, system pressure, and hospitals in crisis: what does the data tell us?

Med J Aust. 2021 Nov 11. doi: 10.5694/mja2.51335. Online ahead of print.

NO ABSTRACT

PMID:34763362 | DOI:10.5694/mja2.51335

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Effect of diminutive adenoma with high-grade dysplasia on surveillance colonoscopy interval

Dig Dis. 2021 Nov 11. doi: 10.1159/000520829. Online ahead of print.

ABSTRACT

Background Colonoscopy surveillance guidelines set the surveillance schedule based on polyp characteristics. Polyps with high-grade dysplasia (HGD) require 3 years of follow-up regardless of size. However, it is unclear whether patients with diminutive polyps (≤5 mm) with HGD have a higher risk. We evaluated the effect of diminutive adenoma with HGD on adenoma occurrence. Methods From Jan 2015 to Dec 2017, patients who underwent index and surveillance colonoscopy were retrospectively screened. The patients were grouped into no adenoma group, low-risk (patients with ≤2 low-grade dysplasia (LGD)), diminutive HGD and high-risk (HGD >5 mm, ≥3 adenomas) groups according to the index colonoscopy results. Each group was analyzed using logistic analysis. Results The mean follow-up period was 22.47 months. Altogether, 610 (50.45%) patients had LGD and 152 (12.5%) had HGD. Among them, 61(5.0%) patients had a diminutive polyp with HGD. Analysis of the risks of developing advanced adenoma in the surveillance colonoscopy showed that compared to no adenoma group, the diminutive HGD group did not show a significant risk (odds ratio [OR]=1.503 [0.449-5.027], p=0.509), while the high-risk group showed a significant risk (odds ratio [OR]=2.044 [1.015-4.114], p=0.045). Conclusions Diminutive adenoma with HGD increased the risk of adenoma on surveillance colonoscopy, In the case of advanced adenoma, the risk was increased, but it was not statistically significant.

PMID:34763334 | DOI:10.1159/000520829

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Effect of time-restricted feeding on body composition and cardio-metabolic risk in middle-aged women in Taiwan

Nutrition. 2021 Sep 30;93:111504. doi: 10.1016/j.nut.2021.111504. Online ahead of print.

ABSTRACT

OBJECTIVES: We sought to investigate the effects of time-restricted feeding (TRF) and a traditional weight-loss method on body composition and cardio-metabolic risk factors in middle-aged women.

METHODS: In a single-center, randomized, open-label, parallel-group design, women ages 40 to 65 y with body mass index ≥ 24 kg/m2 or waist circumference > 80 cm were recruited. They were guided to a daily low-calorie diet of 1400 kcal and randomly assigned into a TRF group (limit 8 h of eating time and fasting for 16 h) or a non-TRF group (traditional weight-loss method, unrestricted eating time) for 8 wk. Body composition, blood pressure, blood biochemical variables, and insulin resistance status were measured before and after intervention.

RESULTS: Body weight, body mass index, waist circumference, and body fat mass decreased significantly in both groups after 8 wk of intervention (P < 0.05). Body weight decreased more in the TRF group than the non-TRF group (-4.1% ± 2.8% versus -2.4% ± 2.5%; P = 0.012), as did diastolic blood pressure (75.3 ± 11.2 mm Hg versus 70.5 ± 9.4 mm Hg; P = 0.012). There were no statistical differences between the two groups in total cholesterol, triacylglycerols, high- or low-density lipoprotein cholesterol, and fasting insulin level. However, fasting glucose and insulin resistance status increased significantly for the TRF group after the intervention (respectively, 88.3 ± 7.6 mg/dL versus 92.6 ± 9.6 mg/dL, P = 0.003; 1.7 ± 0.7 versus 2.1 ± 1.0, P = 0.048).

CONCLUSION: The weight loss and reduction in diastolic blood pressure using the TRF method were better than with the traditional weight-loss method. However, this method may increase fasting glucose levels and adverse insulin resistance status.

PMID:34763309 | DOI:10.1016/j.nut.2021.111504

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Sex differences in the association between nonalcoholic fatty liver disease and Parkinson’s disease

Parkinsonism Relat Disord. 2021 Nov 5;93:19-26. doi: 10.1016/j.parkreldis.2021.10.030. Online ahead of print.

ABSTRACT

BACKGROUND: The association between nonalcoholic fatty liver disease (NAFLD) and Parkinson’s disease (PD) remains uncertain. This study sought to assess the sex-specific association between NAFLD and PD risk considering that sex is an important factor in both conditions.

METHODS: We included 2,651,169 men and 2,998,904 women (≥40 years of age) who underwent health examinations in 2009 using database of the Korean National Health Insurance Service. To define NAFLD, the Fatty Liver Index (FLI) was used and a score of at least 60 points was regarded as suggesting the presence of NAFLD. Cox proportional hazards analyses were performed to evaluate the association between the presence of NAFLD/each component of FLI and the risk of PD. All analyses were stratified by sex.

RESULTS: The median follow-up duration was 7.3 years in both men and women. Of the total study population, 23,233 patients with PD (10,578 men and 12,655 women) were identified. Among men, a decreased risk of PD was observed in those with NAFLD [adjusted hazard ratio (aHR): 0.86, 95% confidence interval (CI): 0.82-0.91]. In contrast, among women, an increased risk of PD was observed in those with NAFLD (aHR: 1.09, 95% CI: 1.02-1.16). This different association according to sex was more prominent among younger participants but was not significant in the old age group.

CONCLUSIONS: NAFLD defined by FLI is differently associated with the risk of PD by sex (i.e., low risk of PD in men with NAFLD vs. high risk of PD in women with NAFLD).

PMID:34763304 | DOI:10.1016/j.parkreldis.2021.10.030

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Yoga and Pilates compared to pelvic floor muscle training for urinary incontinence in elderly women: A randomised controlled pilot trial

Complement Ther Clin Pract. 2021 Oct 26;46:101502. doi: 10.1016/j.ctcp.2021.101502. Online ahead of print.

ABSTRACT

BACKGROUND: and purpose: There is limited evidence from randomised controlled trials (RCTs) regarding the use of yoga and Pilates for the management of urinary incontinence (UI) in women. This study aims to investigate the preliminary effects of using Pilates and yoga to manage UI.

MATERIALS AND METHODS: An assessor-blinded, prospective, three-arm parallel-group randomised controlled pilot trial was conducted in three elderly care centres in Hong Kong. Thirty women aged 60 years or above were included in the study. Study centres were randomly assigned to each of the three interventions (yoga, Pilates and pelvic floor muscle training [PFMT; standard care control]). Study interventions were provided once a week for four weeks, followed by unsupervised CD-guided home exercises for eight weeks. Outcomes included the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-h pad test, and feasibility measures such as adherence to the intervention programme, recruitment and retention rates and safety. Outcomes were assessed at baseline, 4 and 12 weeks. Statistical analysis was performed using two-way repeated measures analysis of covariance.

RESULTS: All three interventions demonstrated a statistically significant effect on ICIQ-SF scores from baseline to weeks 4 and 12. Significant effects in UI were reported for yoga compared with Pilates (mean: -2.93, 95% CI -5.35, -0.51; p = 0.02).

CONCLUSION: Yoga poses intended to address the pelvic floor and core muscles were found to have superior benefits over Pilates exercises in terms of improved continence measured with the ICIQ-SF.

PMID:34763295 | DOI:10.1016/j.ctcp.2021.101502