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Nevin Manimala Statistics

Side-ffects 15 Years after Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925

J Natl Cancer Inst. 2021 Jul 28:djab113. doi: 10.1093/jnci/djab113. Online ahead of print.

ABSTRACT

BACKGROUND: Uncertainty about the benefit/risk ratio of regional lymph node irradiation led to varying clinical protocols. We investigated long-term late side effects after internal mammary and medial supraclavicular (IM-MS) lymph node irradiation to improve shared decision-making.

METHODS: The multicentre EORTC trial (ClinicalTrials.gov, NCT00002851) randomized stage I-III breast cancer patients with involved axillary nodes and/or a medially located primary tumor. We analyzed late side effects, both longitudinally at every follow-up and cross-sectionally at 5-year intervals. All statistical tests were 2-sided.

RESULTS: Between 1996 and 2004, 46 departments from 13 countries accrued 4004 patients. Median follow-up was 15.7 years. Longitudinal follow-up data showed cumulative incidence rates at 15 years of 2.9% (95% confidence interval [CI] = 2.2%-3.8%) vs. 5.7% (95% CI = 4.7%-6.9%) (P<.001) for lung fibrosis, of 1.1% (95% CI = 0.7%-1.7%) vs. 1.9% (95% CI = 1.3%-2.6%) (P=.07) for cardiac fibrosis, and of 9.4% (95% CI = 8.0%-10.8%) vs. 11.1% (95% CI = 9.6%-12.7%) (P=.04) for any cardiac disease, when treated without or with IM-MS lymph node irradiation. There was no evidence for differences between left- and right-sided breast cancer (Wald chi-square test of treatment by breast side interaction, P=.33 and P=.35, for cardiac fibrosis and for any cardiac disease, respectively). The cumulative incidence probabilities of cross-sectionally reported side effects with a score of 2 or greater at 15 years were 0.1% (95% CI = 0.0%-0.5%) vs. 0.8% (95% CI = 0.4%-1.4%) for pulmonary (P=.02), 1.8% (95% CI = 1.1%-2.8%) vs. 2.6% (95% CI = 1.8%-3.7%) for cardiac (P=.15), and 0.0% (95% CI not evaluated) vs. 0.1% (95% CI = 0.0%-0.4%) for oesophageal (P=.16), respectively. No difference was observed in the incidence of second malignancies, contralateral breast cancer or cardiovascular deaths.

CONCLUSIONS: The incidence of late pulmonary side effects was statistically significantly higher after IM-MS lymph node irradiation, as were some of the cardiac events, without a difference between left- and right-sided treatments. Absolute rates and differences were very low, without increased non-breast cancer related mortality, even before introducing heart-sparing techniques.

PMID:34320651 | DOI:10.1093/jnci/djab113

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Nevin Manimala Statistics

Association between diastolic stress test and H2FPEF score

Arch Cardiol Mex. 2021 Jul 28. doi: 10.24875/ACM.21000053. Online ahead of print.

ABSTRACT

OBJECTIVE: Heart failure with preserved ejection fraction is a highly prevalent disease; some advances for improving the diagnosis are the development of the H2FPEF score and the diastolic stress test for the evaluation of diastolic function. The objective is to describe the clinical and echocardiographic characteristics of patients referred for stress tests, and the association between the H2FPEF score and the results of the diastolic test.

METHODS: This is an analytical, observational, retrospective study. An exercise stress test was performed. The Chi-square test was used to establish an association between H2FpEF score and diastolic stress test results. Patients over the age of 18, in sinus rhythm, with the left ventricular ejection fraction > 54%, with no more than mild diastolic dysfunction on the baseline echocardiogram were included in the study.

RESULTS: A total of 99 patients met the eligibility criteria. About 49.5% were women, median age was 62.2 years. The H2FPEF score was low in 27.2%, intermediate 71.7%, and 1% in the high range. There was a high prevalence of hypertension 58.6%, diabetes 12.1%, and coronary disease 20.2%. The stress test was positive for diastolic dysfunction in 36.4% of the patients. A statistically significant association was found between the H2FPEF score and the diastolic stress test (p = 0.02).

CONCLUSIONS: Although clinical scores such as H2FPEF help identify patients, a high percentage of patients are classified in the intermediate range. The diastolic stress test can help to make the diagnosis of diastolic function in this group of patients.

PMID:34320623 | DOI:10.24875/ACM.21000053

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Nevin Manimala Statistics

Accurate Large-scale Phylogeny-Aware Alignment using BAli-Phy

Bioinformatics. 2021 Jul 28:btab555. doi: 10.1093/bioinformatics/btab555. Online ahead of print.

ABSTRACT

MOTIVATION: BAli-Phy, a popular Bayesian method that co-estimates multiple sequence alignments and phylogenetic trees, is a rigorous statistical method, but due to its computational requirements, it has generally been limited to relatively small datasets (at most about 100 sequences). Here we repurpose BAli-Phy as a “phylogeny-aware” alignment method: we estimate the phylogeny from the input of unaligned sequences, and then use that as a fixed tree within BAli-Phy.

RESULTS: We show that this approach achieves high accuracy, greatly superior to Prank, the current most popular phylogeny-aware alignment method, and is even more accurate than MAFFT, one of the top performing alignment methods in common use. Furthermore, this approach can be used to align very large datasets (up to 1000 sequences in this study).

AVAILABILITY: See https://doi.org/10.13012/B2IDB-7863273_V1 for datasets used in this study.

SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.

PMID:34320635 | DOI:10.1093/bioinformatics/btab555

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Nevin Manimala Statistics

Midfacial Soft Tissue Changes After Reduction Malarplasty: A Computed Tomographic Study

J Craniofac Surg. 2021 Jul 27. doi: 10.1097/SCS.0000000000008013. Online ahead of print.

ABSTRACT

BACKGROUND: The reduction malarplasty has become one of the most popular esthetic surgeries among Asian women to improve facial contour. However, it is still controversial whether midfacial soft tissue changes after surgery, and more studies are needed.

METHODS: This retrospective observational study reviewed 30 patients who underwent L-shaped reduction malarplasty during January 2018 and August 2019. The preoperative and postoperative soft tissue thickness and the angle of nasolabial fold of the midfacial were assessed using photographs, three-dimensional skull computerized tomography images, and the Wrinkle Severity Rating Scale.

RESULTS: The postoperative average level of nasolabial fold angle was lower than that observed in preoperative conditions, with the difference being statistically significant (t = -10.262, P < 0.001). The postoperative fifth and sixth layers of soft tissue in the midface were significantly higher than those observed in preoperative tissues.

CONCLUSIONS: Although L-shaped reduction malarplasty has evident effects on soft tissue changes of middle face, they are within acceptable ranges and do not affect patient satisfaction.

PMID:34320586 | DOI:10.1097/SCS.0000000000008013

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Nevin Manimala Statistics

Four years of prevocational Community Based Attachments in New Zealand: a review

N Z Med J. 2021 Jul 30;134(1539):56-62.

ABSTRACT

AIM: The aim of this study was to evaluate the learning environment of the 13-week Community Based Attachment (CBA) (or ‘rotation’) during the prevocational training years at a metropolitan hospital in New Zealand, and to compare the results with general hospital attachments’ scores using an internationally validated survey, the Postgraduate Hospital Educational Environment Measure (PHEEM).

METHOD: A retrospective analysis of data gathered from the PHEEM over four years was conducted. Responses from interns who undertook a CBA attachment at Waikato District Health Board (DHB) were compared with those who undertook a hospital-based attachment at the same DHB during that time period.

RESULTS: CBAs were rated significantly higher than the hospital-based attachments for all subscales (autonomy, teaching and social support) as well as the PHEEM total score. The majority of individual items also rated higher with the CBA cohort, with 26/40 items being statistically significant. Four items were rated higher by the hospital cohort; however, none were significantly different.

CONCLUSIONS: In this study, the CBA attachments appear to have provided valuable learning experiences for prevocational doctors at Waikato DHB. Resident medical officers (RMOs) who have undertaken CBAs confirm a positive, supportive learning environment with enthusiastic and motivated clinical supervisors.

PMID:34320615

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Nevin Manimala Statistics

Treatment Effects and Lip Profile Changes Following Surgical Mandibular Advancement Versus Premolar Extractions in Class II Div 1 Malocclusion: A Randomized Controlled Trial

J Craniofac Surg. 2021 Jul 27. doi: 10.1097/SCS.0000000000007986. Online ahead of print.

ABSTRACT

No randomized controlled trial has compared the treatment outcome between surgical mandibular advancement and premolar extractions in class II malocclusion. This 2-arm parallel randomized controlled trial evaluated the treatment effects and lip profile changes in skeletal class II adult patients subjected to bilateral sagittal split ramus osteotomy for mandibular advancement and those treated with premolar extractions. Seventy skeletal class II patients were accessed and forty-six subjects who fulfilled inclusion criteria were distributed randomly into Group CG (patients: 23, mean age: 21.28 ± 2.69 years) and Group SG (patients: 23, mean age: 21.15 ± 2.64 years). Group CG was subjected to extraction of maxillary first premolars and mandibular second premolars followed by implant supported space closure and Group SG was managed by surgical mandibular advancement. Skeletal, dental, and soft-tissue changes were analyzed. The study was single-blinded (statistical analyzer). Groups were closely matched for baseline parameters. In the present trial there was no loss to follow-up. Though overjet and overbite were optimized in both the groups but significant improvement was seen in surgical cases. Group CG demonstrated statistically significant point “A” remodeling, dentoalveolar changes, and increase in nasolabial angle. Group SG exhibited significant sagittal and vertical skeletal improvement and lip position change. Surgical mandibular advancement was found to be a better treatment modality compared to premolars extraction for managing skeletal class II div 1 malocclusion as it permits greater improvement of the profile and skeletal relationship.

PMID:34320575 | DOI:10.1097/SCS.0000000000007986

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Nevin Manimala Statistics

A New Method for Anterior Boundary Demarcation of the Nasopharynx in Three-Dimensional Analysis

J Craniofac Surg. 2021 Jul 27. doi: 10.1097/SCS.0000000000008033. Online ahead of print.

ABSTRACT

Three-dimensional (3D) measurements of the upper airway have been extensively applied and researched, but the division of the airway is carried out in various ways, especially when demarcating the anterior boundary of the nasopharynx. The present study was to propose a new method based on the anatomical definition for the anterior boundary demarcation of the nasopharynx used in three-dimensional analysis. Twenty computed tomography scans (age 9.5 ± 2.5 years, 11 males, and 9 females) of head and neck were randomly selected and transferred to Materialism’s interactive medical image control system 19.0 for segmentation of the nasopharynx. Precise localization of the reference points that determining the nasopharyngeal anterior and inferior boundaries was managed by recording their coordinates in the interface of the software. The area of the anterior and the inferior boundaries, and the volume of the nasopharynx were measured and repeated with a 2-week interval for the consistency test. Both the interobserver reliability as well as the intra-observer reliability were very high (intraclass correlation coefficients, 0.985-0.997). Paired t test showed no significant difference between the first and the second examinations. This new simple method proposed for demarcation of the nasopharyngeal anterior boundary was based on the innate anatomical boundary, which was statistically reliable, technically convenient, and clinically reasonable.

PMID:34320585 | DOI:10.1097/SCS.0000000000008033

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Nevin Manimala Statistics

Rapid Inhibition Accuracy and Leg Strength Are Required for Community-Dwelling Older People to Recover Balance From Induced Trips and Slips: An Experimental Prospective Study

J Geriatr Phys Ther. 2021 Jul 26. doi: 10.1519/JPT.0000000000000312. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Falls can result in bone fractures and disability, presenting a serious threat to quality of life and independence in older adults. The majority of falls in community-living older adults occur while walking and are often caused by trips and slips. The study aimed to identify the specific sensorimotor and psychological factors required for older adults to recover balance from trips and slips.

METHODS: Forty-one older adults aged 65 to 87 years were assessed on sensorimotor (knee extension strength, proprioception, postural sway, and edge contrast sensitivity), reaction (simple reaction time, stepping, and catching reaction inhibition), and psychological (general anxiety and concern about falling) measures. Using a harness system, participants walked at 90% of their usual pace on a 10-m walkway that could induce trips and slips in concealed and changeable locations. Post-perturbation responses resulting in more than 30% of body weight being recorded by the harness system were defined as falls. Poisson regressions were used to test associations between the sensorimotor, reaction, and psychological measures and number of falls.

RESULTS: Fifty-one falls occurred in 25 of 41 participants. Poisson regression revealed body mass index, lower-limb proprioception, knee extension strength, rapid inhibition accuracy, concern about falling, and anxiety were significantly associated with the rate of falls. Other measures including postural sway were not statistically significant. Using stepwise Poisson regression analyses, normalized knee extension strength (rate ratio [RR]: 0.68, 95% confidence interval [CI]: 0.47-0.98), and rapid inhibition accuracy (RR: 0.64, 95% CI: 0.46-0.87) were independently associated with falls.

CONCLUSION: Our findings suggest rapid inhibition accuracy and adequate leg strength are required for older adults to recover balance from trips and slips. The mechanisms for balance recovery during daily life activities are likely different from those for static balance, suggesting the need for task-specific assessments and interventions for fall prevention in older adults.

PMID:34320534 | DOI:10.1519/JPT.0000000000000312

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The Persistence of Blast- Versus Impact-Induced Concussion Symptomology Following Deployment

J Head Trauma Rehabil. 2021 Jul 26. doi: 10.1097/HTR.0000000000000715. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine the persistence of concussion-related symptoms following injury as a function of mechanism of injury (high-level blast [HLB] vs impact) and low-level blast (LLB) exposure among Marines.

SETTING: Upon return from deployment and approximately 6 months later, respectively, Marines completed the Post-Deployment Health Assessment and Post-Deployment Health Re-Assessment in an operational or clinic setting.

PARTICIPANTS: Data from active duty enlisted Marines who completed both assessments (n = 102 075) and who reported a potentially mild traumatic brain injury (mTBI)-inducing event and completed an mTBI screen (n = 8106) were analyzed.

DESIGN: This was a retrospective cohort study of Marines deployed between 2008 and 2012. Marines were categorized into groups with relatively high versus low risk for occupational risk of LLB exposure. A mixed model analysis of variance was used to examine the number of symptoms Marines reported experiencing during deployment as a function of probable concussion, HLB exposure, occupational risk, type of symptom, and time of measurement.

MAIN MEASURES: Self-reported deployment exposures including HLB, probable mTBIs, and occupational risk of LLB exposure were identified. Outcomes included the proportion of neurological, musculoskeletal, and immunological symptoms for which Marines reported seeking care during and following deployment were analyzed.

RESULTS: Probable HLB-induced mTBIs (vs impact-induced) were associated with significantly more neurological symptoms at return from deployment and approximately 6 months later. Although symptom reporting decreased at statistically equivalent rates regardless of mechanism of injury, those with a probable HLB-induced concussion continued to report elevated symptomology post-deployment. Additionally, Marines with probable concussion working in occupations with LLB exposure reported elevated levels of persistent neurological symptoms. Both HLB and LLB exposure were associated with neurological symptoms that persisted following deployment.

CONCLUSION: These findings suggest that blast-induced brain injuries may be fundamentally different from impact-induced injuries, and that additional screening and symptomatic treatment for blast-exposed patients may be warranted.

PMID:34320556 | DOI:10.1097/HTR.0000000000000715

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Nevin Manimala Statistics

Relationship between Chronic Kidney Disease, Time-in-Therapeutic Range, and Adverse Outcomes in Atrial Fibrillation: A post hoc Analysis from the AMADEUS Trial

Cerebrovasc Dis. 2021 Jul 28:1-7. doi: 10.1159/000517608. Online ahead of print.

ABSTRACT

BACKGROUND: The benefit of anticoagulation therapy in atrial fibrillation (AF) and chronic kidney disease (CKD) remains controversial. We aimed to evaluate the impact of renal function on the quality of anticoagulation control, and the effects of both these factors on outcomes in AF.

METHODS: Post hoc analysis of the AMADEUS trial. Trial-related outcomes were adjudicated and we studied the composite of first stroke/major bleeding/all-cause mortality, ischaemic stroke, major bleeding, all-cause mortality, and cardiovascular mortality.

RESULTS: We included 2,282 vitamin K antagonist (VKA)-treated patients {n = 787 (34.5%) females; median age 72 (interquartile ranges [IQR] 64-77) years}. Median follow-up was 365 (IQR 189-460) days. There were 1,922 (84.2%) non-CKD and 360 (15.8%) CKD patients. Renal function was inversely correlated with time-in-therapeutic range (r = -0.047, p = 0.025). There was no statistical difference in terms of crude study outcomes based on renal function. Multivariable regression analysis demonstrated that moderate renal failure with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 (p = 0.032) and percentage of time-in-therapeutic range (p = 0.011) were independent predictors for the composite outcome of stroke, major bleeding, and all-cause mortality.

CONCLUSION: Deteriorated renal function has a small negative impact on the quality of anticoagulation control with VKA which is linked to poor outcomes in AF. However, moderate renal failure itself was an independent risk factor for increased risk of stroke, major bleeding, and all-cause mortality amongst patients with AF.

PMID:34320504 | DOI:10.1159/000517608