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Nevin Manimala Statistics

CO2 automated angiography in endovascular aortic repair preserves renal function to a greater extent compared with iodinated contrast medium. Analysis of technical and anatomical details

Ann Vasc Surg. 2021 Nov 13:S0890-5096(21)00873-6. doi: 10.1016/j.avsg.2021.10.039. Online ahead of print.

ABSTRACT

OBJECTIVES: Contrast induced nephropathy occurs in up to 7.5% of cases in endovascular aortic repair (EVAR). Carbon Dioxide (CO2) has been proposed as an alternative agent to iodinated contrast medium (ICM); however, specific protocols are not universally adopted, and the visualization of the renal arteries may be suboptimal in some cases. The aim of this study was to analyze our CO2-EVAR experience with automatic injections, in order to identify the anatomical characteristics associated with the best visualization of all the aortic vessels, with particular attention to the lowest renal artery (LoRA).

METHODS: From 2016 to 2019, all EVAR performed with either CO2 or ICM were analyzed and compared. CO2-EVAR was performed using an automated injector (600 mmHg pressure; 100 cc volume); a small amount of ICM was injected in case of difficulty in LoRA visualization or doubts at the completion angiogram. Clinical and CT-Scan preoperative characteristics were considered. The study endpoints were technical success, amount of ICM and radiation dose, postoperative renal function and possible CO2-related adverse events. Statistical analysis was by Fisher’s exact, t-Student, Mann-Whitney tests and ROC curve.

RESULTS: In the considered period, 321 EVAR procedures, 72 (22.4%) with CO2 and 249 (77.6%) with ICM, were performed. The two groups were similar for clinical characteristics and preoperative renal function. ICM was injected in a significantly lower amount in the CO2-EVAR group (52.8 ± 6.1 vs. 88.1 ±9.2 cc, p<0.001), which received a significantly higher mean radiation dose (Total DAP: 500550.8 ± 377394.6 mGy/cm2 CO2-EVAR vs. 332301.8 ±230139.3 mGy/cm2 ICM-EVAR, p=0.001). Postoperative eGFR decreased significantly less in the CO2-EVAR (2.3 ± 1.1 ml/min) compared with the ICM-EVAR group (10.6 ±5.3 ml/min), p<0.001. LoRA was correctly visualized in 50/72 (69.4%) cases of CO2-EVAR, which had a significantly longer proximal neck [Median (IQR): 30 (14) vs. 18 (15) mm, p=0.001]. At ROC curve, a proximal neck length >24.5 mm was predictive of LoRA visualization (72.1% sensitivity, 73.8% specificity). Three CO2-EVAR cases had intraoperative transient hypotension with no consequences. Sixteen/72 (22.2%) CO2-EVAR procedures were performed using 0 cc of ICM.

CONCLUSIONS: CO2-EVAR by automated injections is safe and requires a lower amount of ICM if compared with ICM-EVAR, with a consequent significant benefit on postoperative renal function. If specific anatomical situations are present, ICM may be completely unnecessary. The radiation dose is however significantly higher, therefore procedural protocols need further refinements.

PMID:34785338 | DOI:10.1016/j.avsg.2021.10.039

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The long-term failure of RYGB surgery in improving T2DM is related to hyperinsulinism

Ann Anat. 2021 Nov 13:151855. doi: 10.1016/j.aanat.2021.151855. Online ahead of print.

ABSTRACT

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is the gold standard method for bariatric surgery and leads to substantial improvements in Type 2 Diabetes mellitus. However, many patients experience relapses in diabetes five years after undergoing this aggressive surgical procedure. We focus on beta-cell population changes and absorptive intestinal consequences after RYGB in a healthy nonobese animal model after a long survival period.

METHODS: For our purpose, we use three groups of Wistar rats: RYGB-operated, surgical control (Sham) and fasting control. We measure alpha-, beta-cell mass; transcription (Arx, and Pdx-1) and proliferation (Ki67) factors; glucose tolerance and insulin release after oral glucose tests; histological adaptive changes in the jejunum; and intestinal glucose transporters.

RESULTS: Our results showed an early increase in insulin secretion after surgery, that decrease at the end of the study. The beta-cell mass reduces twenty-four weeks after RYGB, which coincides with decrease of Pdx-1 transcription promoter factor. These was coincident with an increase in alpha-mass and a high expression of Arx in RYGB group.

CONCLUSIONS: The analysis of all data showed beta-cell mass transdifferentiation into alpha-cell mass in RYGB rats. Due to long-term exhaustion of the beta-cell population by hyperinsulinism derived from digestive tract adaptation to surgery.

PMID:34785322 | DOI:10.1016/j.aanat.2021.151855

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Nevin Manimala Statistics

MIRROR-TCM: Multisite replication of a randomized controlled trial – Transitional care model

Contemp Clin Trials. 2021 Nov 13:106620. doi: 10.1016/j.cct.2021.106620. Online ahead of print.

ABSTRACT

In the U.S., older adults hospitalized with acute episodes of chronic conditions often are rehospitalized within 30 days of discharge. Numerous studies reveal that poor management of the complex needs of this population remains the norm. METHODS: This prospective, intent-to-treat, randomized controlled trial (RCT) will assess the effects of replicating the rigorously studied Transitional Care Model (TCM) in four U.S. healthcare systems. The TCM is an advanced practice registered nurse led, team-based, care management intervention that supports older adults throughout vulnerable care episodes that span hospital to home. This RCT will compare health and economic outcomes demonstrated by at-risk older adults hospitalized with heart failure, chronic obstructive pulmonary disease or pneumonia randomized to receive usual discharge planning (control group, N = 800) to those observed by a similar group of older adults randomized to receive the TCM protocol (N = 800). The primary outcome is number of rehospitalizations at 12 months post-discharge, with secondary resource use outcomes measured at multiple intervals. Patient experience with care, health and quality of life outcomes will be assessed at 90 days post-discharge. DISCUSSION: Based on health and economic benefits demonstrated in multiple NIH funded RCTs, the study team hypothesizes that the intervention group, both within and across participating health systems, will have decreased acute care resource use and costs at 12 months and better ratings of the care experience and health and quality of life through 90 days post-discharge compared to the control group. The impact of COVID-19 on implementation of this study also is discussed.

PMID:34785306 | DOI:10.1016/j.cct.2021.106620

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Human Dermal Allograft Superior Capsule Reconstruction with Graft Length determined at Glenohumeral Abduction Angles of 20 and 40 degrees Decreases Joint Translation and Subacromial Pressure without Compromising Range of Motion: A Cadaveric Biomechanical Study

Arthroscopy. 2021 Nov 13:S0749-8063(21)00982-8. doi: 10.1016/j.arthro.2021.11.007. Online ahead of print.

ABSTRACT

PURPOSE: To compare the biomechanical effects of superior capsule reconstruction graft fixation length determined at 20° and 40° glenohumeral (GH) abduction. .

METHODS: Humeral translation, rotational range of motion (ROM) and subacromial contact pressure were quantified at 0°, 30°, and 60° of GH abduction in the scapular plane in 6 cadaveric shoulders for: intact; massive rotator cuff tear; SCR with a dermal allograft fixed at 20° GH abduction (SCR 20); and SCR fixed at 40° GH abduction (SCR 40). Statistical analysis was conducted using repeated measures ANOVA and paired t-test (P < 0.05).

RESULTS: Massive cuff tear significantly increased total ROM compared to intact at 0° and 60° abduction. SCR 20 or SCR 40 did not affect ROM. Compared to intact, the massive cuff tear significantly increased superior translation an average of 4.6 ± 0.5 mm at 9/12 positions (P ≤ 0.002). Both SCR 20 and SCR 40 reduced superior translation compared to massive cuff tear (P < 0.05); however, SCR 40 significantly decreased superior translation compared to SCR 20 at 0° abduction (P ≤ 0.046). Peak subacromial pressure for massive cuff tear increased an average of 486.8 ± 233.9 kPa relative to intact at 5/12 positions (P ≤ 0.037).; SCR 20 reduced peak subacromial pressure at 2/12 positions (P ≤ 0.012) while SCR 40 achieved this at 6/12 (P ≤ 0.024).

CONCLUSION: SCR with dermal allograft fixed at 20° or 40° of GH abduction decreases GH translation and subacromial pressure without decreasing range of motion.

PMID:34785299 | DOI:10.1016/j.arthro.2021.11.007

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Representation of Chronic Kidney Disease in Randomized Controlled Trials among Patients with Heart failure with Reduced Ejection Fraction: A Systematic Review

Curr Probl Cardiol. 2021 Nov 13:101047. doi: 10.1016/j.cpcardiol.2021.101047. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with advanced chronic kidney disease (CKD) have largely been excluded from randomized control trials (RCTs) in heart failure (HF). This creates a paucity of high quality evidence for guideline directed medical therapy (GDMT), particularly in patients with heart failure with reduced ejection fraction (HFrEF) and CKD.

METHODS: This is a systematic review looking at the patterns and rates of inclusion of CKD in RCTs among patients with HFrEF. The search included RCTs from January 2010 to December 2020. A heat map was constructed to reflect the stages of CKD stages. The percentage of studies that included advanced CKD (stages 4 to 5) was recorded and log transformed, and then fitted into a time regression model. A p value of <0.05 was considered statistically significant.

RESULTS: Out of the 3052 screened, 706 studies were included in the analysis. Only 61% of the RCTs reported at least some information on kidney function. There was a trend of increase in percentage of studies that included CKD stages 4 to 5 from years 2010 to 2020. This was confirmed with a statistically significant linear trend p=0.02 while the percentage of studies that included dialysis and kidney transplant recipients remained consistently low.

CONCLUSION: There is a paucity of high-quality evidence for GDMT in the HFrEF population with CKD, particularly in those with advanced non-dialytic CKD, those on maintenance dialysis and kidney transplant recipients. There is a pressing need for wider inclusion of patients with advanced CKD in RCTs of GDMT in HFrEF.

PMID:34785259 | DOI:10.1016/j.cpcardiol.2021.101047

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Definitions of Central Tumors in Radiologically Node-negative, Early-stage Lung Cancer for Preoperative Mediastinal Lymph Node Staging: A Dual-institution, Multi-reader Study

Chest. 2021 Nov 13:S0012-3692(21)04288-4. doi: 10.1016/j.chest.2021.11.005. Online ahead of print.

ABSTRACT

BACKGROUND: Definitions for central lung cancer have been ambiguous in guidelines, causing difficulty in selecting candidates for invasive mediastinal staging among patients with radiologically node-negative, early-stage lung cancer.

RESEARCH QUESTION: What is the optimal definition for central lung cancer, which is robust to inter-reader and institutional variation, to select candidates for invasive mediastinal staging among those with clinical T1N0M0 lung cancer?

STUDY DESIGN AND METHODS: Two retrospective cohorts were evaluated for the associations of central lung cancer according to 13 definitions based on chest CT with occult nodal metastasis. Univariable and multivariable ordinal logistic regression analyses were performed with the pathological N category as an ordinal outcome. Robust definitions, which retained statistical significance across multi-reader, dual-institutional datasets, were identified. For these definitions, binary diagnostic performance and inter-reader agreement were investigated.

RESULTS: In the two cohorts, 807 patients (median age, 63 years; interquartile range, 56-71 years; 410 women; 33 pN1, 48 pN2, and 1 pN3) and 510 patients (median age, 65 years; interquartile range, 58-71 years; 267 women; 33 pN1, 20 pN2, and no pN3) were included, respectively. Three definitions robust to inter-reader variation and dataset heterogeneity were identified: definition 7 (concentric lines arising from the midline, inner one-third, medial margin; adjusted odds ratio [OR], 2.01; 95% confidence interval [CI], 1.13-3.51; P=0.02), definition 10 (location index-based inner one-third, center; adjusted OR, 3.60; 95% CI, 1.49-8.25; P=0.003), and definition 12 (location index-based inner one-third, medial margin; adjusted OR, 3.57; 95% CI, 1.91-6.52; P<0.001). Definition 12 showed higher inter-reader agreement than definition 7 (Cohen κ, 0.80 vs. 0.66; P=0.005). Nevertheless, the sensitivity and positive predictive value of the three definitions were below 50%.

INTERPRETATION: Three definitions exhibited robust associations with occult nodal metastasis. However, selecting candidates for invasive mediastinal staging solely based on a central tumor location would be suboptimal.

PMID:34785237 | DOI:10.1016/j.chest.2021.11.005

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Nevin Manimala Statistics

Determining macrophyte species richness and dark diversity sources – A novel approach to improve the biodiversity estimation based on species traits

Sci Total Environ. 2021 Nov 13:151496. doi: 10.1016/j.scitotenv.2021.151496. Online ahead of print.

ABSTRACT

Biodiversity measures deliver valuable ecological information by reflecting a range of ecosystem processes. However, the accuracy of environmental assessment based on species patterns may often be affected by insufficient survey details. The comprehensive evaluation of plant taxa richness in rivers requires an extensive sampling effort. The use of Hill numbers and Chao estimators improves species diversity assessment based on a feasible number of samples. The aim of this work was to identify macrophyte groups, associated with various species traits, which are rich in species, as well as those whose detection is particularly difficult as it requires an exceptional sampling effort (sources of dark diversity). Analyses were performed with the use of Hill numbers and Chao estimators. It was shown that the field identification of all estimated macrophytes is particularly difficult for low trophy indicators and generally submerged plants, as well as for small-leaved species. A field survey encompassing the full (expected) macrophyte diversity encountered within a river is easiest to perform in the case of free-floating plants and large-leaved macrophytes, as well as for species with high trophic tolerance. The study proved that ecological assessment of rivers based on a small number of sampling units may lead to incorrect diversity estimates. Conversely, the estimation of diversity patterns at the level of the Shannon and Simpson indices does not require extensive sampling, and the extrapolation approach is not needed. The effectiveness of diversity assessment in fluvial ecosystems can be increased by extrapolation of gray diversity which can be considered in planning of monitoring programs. Moreover even estimated dark diversity bight be already efficient to identify ecological pattern and when comparing biodiversity across regions and ecosystems.

PMID:34785227 | DOI:10.1016/j.scitotenv.2021.151496

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Nevin Manimala Statistics

Toxicity and Efficacy of Local Ablative, Image-guided Radiotherapy in Gallium-68 Prostate-specific Membrane Antigen Targeted Positron Emission Tomography-staged, Castration-sensitive Oligometastatic Prostate Cancer: The OLI-P Phase 2 Clinical Trial

Eur Urol Oncol. 2021 Nov 13:S2588-9311(21)00184-X. doi: 10.1016/j.euo.2021.10.002. Online ahead of print.

ABSTRACT

BACKGROUND: Local ablative radiotherapy (aRT) of oligometastatic prostate cancer (PCa) is very promising and has become a focus of current clinical research.

OBJECTIVE: We hypothesize that aRT is safe and effective in gallium-68 prostate-specific membrane antigen targeted positron emission tomography (PSMA-PET)-staged oligometastatic PCa patients.

DESIGN, SETTING, AND PARTICIPANTS: A nonrandomized, prospective, investigator-initiated phase 2 trial recruited patients with oligometastatic PCa (five or fewer lymph node or osseous metastases) after local curative therapy, without significant comorbidity and androgen deprivation therapy (ADT), at two German centers from 2014 to 2018.

INTERVENTION: All PSMA-PET-positive metastases were treated with aRT. No systemic therapy was initiated.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was treatment-related toxicity (grade ≥2) 24 mo after aRT. A one-sided single-sample test of proportions was planned to test whether the endpoint occurs in <15% of the patients. Key secondary endpoints were time to progression of prostate-specific antigen (PSA) and time to ADT, which were associated with potential prognostic factors by Cox regression.

RESULTS AND LIMITATIONS: Of 72 patients, 63 received aRT (13% dropout rate). The median follow-up was 37.2 mo. No treatment-related grade ≥2 toxicity was observed 2 yr after treatment. The median time to PSA progression and time to ADT were 13.2 and 20.6 mo, respectively. Of the patients, 21.4% were free of PSA progression after 3 yr.

CONCLUSIONS: It was observed that aRT is safe, and midterm PSA progression and ADT-free time were achieved in one of five patients. Randomized clinical trials are indicated to further evaluate the option of delaying ADT in selected patients.

PATIENT SUMMARY: In this clinical trial, 63 patients with up to five metastases of prostate cancer without androgen deprivation therapy were included. We showed that local ablative radiotherapy is safe and that one in five patients had no recurrent prostate-specific antigen value after 3 yr. Local ablative radiotherapy might be an option to avoid systemic therapy in selected patients.

PMID:34785189 | DOI:10.1016/j.euo.2021.10.002

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Nevin Manimala Statistics

Resonant Voice: Perceptual and Acoustic Analysis After an Intensive Lessac Kinesensic Training Workshop

J Voice. 2021 Nov 13:S0892-1997(21)00312-X. doi: 10.1016/j.jvoice.2021.09.021. Online ahead of print.

ABSTRACT

OBJECTIVE: To investigate whether actors’ and actresses’ voices post an Intensive Lessac Kinesensic Training Workshop – ILKTW can be perceptually identified as more resonant, and to assess if the Acoustic Voice Quality Index (AVQI), the Acoustic Breathing Index (ABI), and their acoustic measures are able to indicate the classified voices as more resonant.

METHODS: Eight vocally healthy English first-language actors and actresses, participants of the same ILKTW, were asked to sustain the vowel /a/ and to read a piece of the Rainbow Passage, pre and postworkshop, at a self-selected habitual frequency and intensity. The readings were divided into initial and final parts, both with 34 syllables, and combined with the vowel /a/ (3s). The pre and postworkshop recordings (pairs of the initial and final parts followed by the /a/ vowel) of each participant were randomly presented to a voice expert who rated the samples as more resonant or similar. The same samples were analyzed using the AVQI and ABI scripts.

RESULTS: 87,5% of the initial parts and 100% of the final in postworkshop were rated by the voice expert as more resonant. Tilt was higher for the postworkshop initial parts (P = 0.036), but a correlation with the perceptual rating wasn’t found. HNR was higher (P = 0.018) and jitter was lower (P = 0.017) for the postworkshop final parts. The statistical analysis comparing the perceptive and acoustic data for the final samples couldn’t be applied.

CONCLUSION: It seems that the ILKTW has a positive impact on the development of a resonant voice and that the perceptual auditory rating was more effective to describe resonant voices than the AVQI, ABI, and its acoustic measures.

PMID:34785115 | DOI:10.1016/j.jvoice.2021.09.021

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Vocal Sensory Symptoms, Vocal Fatigue and Vocal Habits in University Professors

J Voice. 2021 Nov 13:S0892-1997(21)00300-3. doi: 10.1016/j.jvoice.2021.09.002. Online ahead of print.

ABSTRACT

PURPOSE: To identify vocal sensory symptoms, vocal fatigue, and vocal habits, compare and correlate them in university professors who have passed or failed a screening related to vocal symptoms.

STUDY DESIGN: Cross-sectional, quantitative, non-randomized study.

METHODS: The professors responded to four vocal self-assessment Patient-Reported Outcome Measures (PROM): the Brazilian validated version of the Voice Symptom Scale (VoiSS), the Brazilian version (not validated) of the Vocal Tract Discomfort Scale, the Brazilian validated version of the Vocal Fatigue Index and the validated version of the Vocal Health and Hygiene Questionnaire (“Questionário de Saúde e Higiene Vocal – QSHV,” in Portuguese). After the PROM’s application, the professors were divided into two groups from the VoiSS cutoff point. G1 was formed by professors who passed in the VoiSS screening, that is, those who achieved a total score below 16 points, and G2, formed by professors who failed, that is, those who achieved 16 points or more. The Mann-Whitney U test was used to compare the values of PROM between G1 and G2 groups, and the Spearman correlation test was used to correlate the PROM with one another.

RESULTS: One hundred and two professors filled in the PROM, 23 from G1 and 79 from G2. Results showed that the total scores of all PROM used exceeded their cutoff scores in the overall sample. It was also observed that professors who failed the screening through VoiSS presented higher scores of vocal sensory symptoms and vocal fatigue, however no differences regarding knowledge on vocal health and hygiene were noticed. In G1, the protocols showed significant correlations ranging from moderate to very strong with one another, but the QSHV showed no correlation with any of the instruments. In G2, the protocols presented weak to strong correlation ratios, and the QSHV reported correlation with all protocols, except for Vocal Fatigue Index.

CONCLUSION: University professors presented scores higher than the cut-off point suggested by the literature for vocal sensory symptoms, vocal fatigue and knowledge on vocal health and hygiene. Professors who failed the screening performed through VoiSS achieved higher scores of vocal discomfort and fatigue, but also presented a high score for knowledge on vocal hygiene. There was a moderate to very strong statistical correlation among the vocal symptoms, discomforts, vocal fatigue and vocal habits in professors who failed the screening through VoiSS, however among those professors who passed the screening, knowledge on vocal health and hygiene showed no correlation with the PROM analyzed.

PMID:34785114 | DOI:10.1016/j.jvoice.2021.09.002