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Nevin Manimala Statistics

Relationships between intraoral ultrasonographic and histopathological findings in patients with tongue cancer

Head Neck. 2021 May 29. doi: 10.1002/hed.26763. Online ahead of print.

ABSTRACT

BACKGROUND: In this study, we aimed to investigate the relationships between histopathological and intraoral ultrasonographic (IUS) findings in patients with tongue cancer.

METHODS: IUS and histopathological findings in 46 patients with tongue cancer were considered for this study. We assessed the relationships between IUS findings regarding tumor thickness, margin type, border type, and internal echo intensity; internal/peripheral Doppler findings; and muscle invasion and histopathological findings regarding tumor thickness, differentiation, Yamamoto-Kohama (YK)-classification grade, blood vessel invasion, lymphatic invasion, perineural invasion, and muscle invasion.

RESULTS: Statistical associations were found between the following findings: between thickness determined through IUS measurement and that determined through histopathological measurement, between the IUS findings regarding tumor margin and border types and the histopathologically determined YK-classifications grades, and between a Doppler image of the internal area of tongue lesions and lymphatic invasion.

CONCLUSIONS: IUS findings may be used to predict histopathological findings about tumor thickness and YK-classification grades.

PMID:34050571 | DOI:10.1002/hed.26763

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Echo Time-Dependent Observed Lung T1 in Patients With Chronic Obstructive Pulmonary Disease in Correlation With Quantitative Imaging and Clinical Indices

J Magn Reson Imaging. 2021 May 28. doi: 10.1002/jmri.27746. Online ahead of print.

ABSTRACT

BACKGROUND: There is a clinical need for imaging-derived biomarkers for the management of chronic obstructive pulmonary disease (COPD). Observed pulmonary T1 (T1 (TE)) depends on the echo-time (TE) and reflects regional pulmonary function.

PURPOSE: To investigate the potential diagnostic value of T1 (TE) for the assessment of lung disease in COPD patients by determining correlations with clinical parameters and quantitative CT.

STUDY TYPE: Prospective non-randomized diagnostic study.

POPULATION: Thirty COPD patients (67.7 ± 6.6 years). Data from a previous study (15 healthy volunteers [26.2 ± 3.9 years) were used as reference.

FIELD STRENGTH/SEQUENCE: Study participants were examined at 1.5 T using dynamic contrast-enhanced three-dimensional gradient echo keyhole perfusion sequence and a multi-echo inversion recovery two-dimensional UTE (ultra-short TE) sequence for T1 (TE) mapping at TE1-5 = 70 μsec, 500 μsec, 1200 μsec, 1650 μsec, and 2300 μsec.

ASSESSMENT: Perfusion images were scored by three radiologists. T1 (TE) was automatically quantified. Computed tomography (CT) images were quantified in software (qCT). Clinical parameters including pulmonary function testing were also acquired.

STATISTICAL TESTS: Spearman rank correlation coefficients (ρ) were calculated between T1 (TE) and perfusion scores, clinical parameters and qCT. A P-value <0.05 was considered statistically significant.

RESULTS: Median values were T1 (TE1-5 ) = 644 ± 78 msec, 835 ± 92 msec, 835 ± 87 msec, 831 ± 131 msec, 893 ± 220 msec, all significantly shorter than previously reported in healthy subjects. A significant increase of T1 was observed from TE1 to TE2 , with no changes from TE2 to TE3 (P = 0.48), TE3 to TE4 (P = 0.94) or TE4 to TE5 (P = 0.02) which demonstrates an increase at shorter TEs than in healthy subjects. Moderate to strong Spearman’s correlations between T1 and parameters including the predicted diffusing capacity for carbon monoxide (DLCO, ρ < 0.70), mean lung density (MLD, ρ < 0.72) and the perfusion score (ρ > -0.69) were found. Overall, correlations were strongest at TE2 , weaker at TE1 and rarely significant at TE4 -TE5 .

DATA CONCLUSION: In COPD patients, the increase of T1 (TE) with TE occurred at shorter TEs than previously found in healthy subjects. Together with the lack of correlation between T1 and clinical parameters of disease at longer TEs, this suggests that T1 (TE) quantification in COPD patients requires shorter TEs. The TE-dependence of correlations implies that T1 (TE) mapping might be developed further to provide diagnostic information beyond T1 at a single TE.

LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY: Stage 1.

PMID:34050576 | DOI:10.1002/jmri.27746

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Nevin Manimala Statistics

Bayesian phase II clinical trial design with noncompliance

Stat Med. 2021 May 28. doi: 10.1002/sim.9041. Online ahead of print.

ABSTRACT

Noncompliance issue is common in early phase clinical trials; and may lead to biased estimation of the intent-to-treat effect and incorrect conclusions for the clinical trial. In this work, we propose a Bayesian approach for sequentially monitoring the phase II randomized clinical trials that takes account for the noncompliance information. We adopt the principal stratification framework and propose to use Bayesian additive regression trees for selecting useful baseline covariates and estimating the complier average causal effect (CACE) for both efficacy and toxicity outcomes. The decision of early termination or not is then made adaptively based on the estimated CACE from the accumulated data. Simulation studies have confirmed the excellent performance of the proposed design in the presence of noncompliance.

PMID:34050539 | DOI:10.1002/sim.9041

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Time to integrate oral health screening into medicine? A survey of primary care providers of older adults and an evidence-based rationale for integration

Gerodontology. 2021 May 28. doi: 10.1111/ger.12561. Online ahead of print.

ABSTRACT

OBJECTIVE: Primary care providers were assessed regarding their training and interest to screen oral conditions in patients ≥55 years old.

BACKGROUND: Oral health (OH) is an essential component of overall health and can affect systemic health. Medical/dental integration in older adults is underdeveloped.

METHODS: A brief survey assessed primary care providers’ self-reported skills, practices and barriers towards integrating OH screening into adult primary care. Data were collected using Survey Monkey® . Respondents were physicians and advanced practice providers (APPs) working at a large mid-western safety-net hospital. Descriptive statistics, T-tests and Chi-squared tests were reported.

RESULTS: Eighty-two of 202 participants (41%) completed the survey. Most respondents were female (75%). A majority were physicians (68%); the remainder APPs. All providers (100%) reported OH was important or extremely important to overall health. More physicians (93%) reported not being well-trained to address adult OH issues and perceived less medical-oral health integration in their practice (16%) compared to APPs (P < .05). Time was more of a barrier with APPs (74%), compared to physicians (51%), to integrate OH screening activities (P < .05). Most providers reported other barriers such as inadequate OH training and insurance coverage. Providers endorsed that OH should be assessed frequently (56%) including providing referrals to dentists (77%) and educating patients on oral-systemic issues (63%). More female than male providers endorsed dental referrals and educating patients (P < .05).

CONCLUSION: Primary care providers embraced greater medical/dental integration for older adults. Instituting OH activities appears to be supported. Future interventions that are feasible in primary care settings are examined.

PMID:34050554 | DOI:10.1111/ger.12561

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A matched pair analysis of oncological outcomes in human papillomavirus-negative oropharyngeal squamous cell carcinoma: Transoral surgery versus radiotherapy or concurrent chemoradiation

Head Neck. 2021 May 29. doi: 10.1002/hed.26771. Online ahead of print.

ABSTRACT

BACKGROUND: With the termination of RTOG 1221, there remains a lacuna regarding the optimal treatment for human papillomavirus (HPV)-negative oropharyngeal squamous cell carcinoma (OPSCC).

METHODS: Matched pair analysis with propensity score matching (PSM) between Arm I (transoral surgery [TOS] + risk-stratified adjuvant treatment) and Arm II (nonsurgical treatment – radiation/chemoradiation) in HPV(-) OPSCC.

RESULTS: Unmatched comparison of Arm I (n = 57) and Arm II (n = 89) indicated significantly better overall survival (OS) and disease-free survival (DFS) for Arm I. PSM by matched pairs (n = 48, 24 each arm) indicated 5-year OS at 80% and 72.1%, respectively, for Arm I and II (p > 0.05) and corresponding DFS at 65.3% and 33.4% (p > 0.05). Subgroup analysis did not demonstrate statistical difference in outcomes in stage II and III, but stage IV tumors had significantly better outcomes in Arm I than Arm II (4-year OS: 100% vs. 21%, p = 0.04; DFS: 75% vs. 14.3%, p = 0.04).

CONCLUSIONS: TOS +/- adjuvant was found to have oncological outcomes at par with nonsurgical modalities in stage I-III OPSCC, whereas a distinct survival advantage was noted in case of stage IV tumors.

PMID:34050557 | DOI:10.1002/hed.26771

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Dynamics in oral health-related factors of Indigenous Australian children: A network analysis of a randomized controlled trial

Community Dent Oral Epidemiol. 2021 May 28. doi: 10.1111/cdoe.12661. Online ahead of print.

ABSTRACT

OBJECTIVES: Network analysis is an innovative, analytic approach that enables visual representation of variables as nodes and their corresponding statistical associations as edges. It also provides a new way of framing oral health-related questions as complex systems of variables. We aimed to generate networks of oral health variables using epidemiological data of Indigenous children, and to compare network structures of oral health variables among participants who received immediate or delayed delivery of an oral health intervention.

METHODS: Epidemiological data from 448 mother-child dyads enrolled in a randomized controlled trial of dental caries prevention in South Australia, Australia, were obtained. Networks were estimated with nodes representing study variables and edges representing partial correlation coefficients between variables. Data included dental caries, impact on quality of life, self-rated general health, self-rated oral health, dental service utilization, knowledge of oral health, fatalism and self-efficacy in three time points. Communities of nodes, centrality, clustering coefficient and network stability were estimated.

RESULTS: The oral health intervention interacted with the network through self-rated general health and knowledge of oral health. Networks depicting groups shortly after receiving the intervention presented higher clustering coefficients and a similar arrangement of nodes. Networks tended to return to a preintervention state.

CONCLUSION: The intervention resulted in increased connectivity and changes in the structure of communities of variables in both intervention groups. Our findings contribute to elucidating dynamics between variables depicting oral health networks over time.

PMID:34050531 | DOI:10.1111/cdoe.12661

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Nevin Manimala Statistics

Antiplatelet Medications Are Associated With Bleeding and Decompensation Events Among Patients With Cirrhosis

J Clin Gastroenterol. 2021 May 28. doi: 10.1097/MCG.0000000000001558. Online ahead of print.

ABSTRACT

BACKGROUND: In an aging population with cardiovascular comorbidities, anticoagulant (AC), antiplatelet (AP), and nonsteroidal anti-inflammatory drug (NSAID) use are increasing. It remains unclear whether these agents pose increased bleeding risk in cirrhosis. This study aimed to assess the association between these medications and bleeding and portal hypertension complications in cirrhosis.

METHODS: The IMS PharMetrics database was used to identify privately insured adults diagnosed with cirrhosis from 2007 to 2015, stratified as compensated or decompensated based on the presence of portal hypertensive complications 1 year before cirrhosis diagnosis. Bleeding or decompensation outcomes were assessed 6 to 18 months after cirrhosis diagnosis using a landmark analysis design. Multivariable Cox proportional hazards regression modeling assessed associations between AC, AP, and NSAID drug exposures and outcomes adjusting for covariates.

RESULTS: A total of 18,070 cirrhosis patients were analyzed; 57% male; 74% ages 50 to 64 years; 34% with a prior decompensation. Overall, 377 (2%) had claims for ACs; 385 (2%) APs; and 1231 (7%) NSAIDs. APs were associated with increased bleeding [adjusted hazard ratio (aHR)=1.31; 95% confidence interval (CI): 1.00, 1.72] and decompensation events (aHR=1.44; 95% CI: 1.06, 1.95) in a 9-month landmark analysis. NSAIDs were significantly associated with bleeding events (aHR=1.29; 95% CI: 1.06, 1.57) on 3-month landmark analysis. No statistically significant associations were seen between ACs and bleeding or decompensation outcomes in adjusted analyses.

CONCLUSIONS: AP use was associated with increased bleeding and decompensation events among privately insured patients with cirrhosis. NSAID use was associated with significant early bleeding, but not decompensations. Lastly ACs were not associated with bleeding or decompensation outcomes.

PMID:34049373 | DOI:10.1097/MCG.0000000000001558

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Substituting Meat or Dairy Products with Plant-Based Substitutes Has Small and Heterogeneous Effects on Diet Quality and Nutrient Security: A Simulation Study in French Adults (INCA3)

J Nutr. 2021 May 28:nxab146. doi: 10.1093/jn/nxab146. Online ahead of print.

ABSTRACT

BACKGROUND: Plant-based substitutes are designed to have the same use as animal-based foods in the diet and could therefore assist the transition toward more plant-based diets. However, their nutritional impact has not been characterized.

OBJECTIVES: We assessed and compared the effects of plant-based substitutes on the nutritional quality of the diet.

METHODS: We simulated separately the substitution of meat, milk, and dairy desserts with 96 plant-based substitutes in the diets of 2121 adults (18-79 y old) from the cross-sectional French Third Individual and National Study on Food Consumption Survey (INCA3; 2014-2015). The quality of initial individual diets and the 203,616 substituted diets was evaluated using the Probability of Adequate Nutrient Intake (PANDiet) scoring system, which assesses the probability of adequate (sufficient and not excessive) nutrient intake; also, nutrient security was evaluated using the SecDiet scoring system, which assesses the risk of overt deficiency.

RESULTS: Impacts on PANDiet depended on both the food substituted and the types of substitutes. Soy-based substitutes provided a slight improvement in diet quality (0.8% increase of the PANDiet score when substituting meat), whereas cereal-based substitutes resulted in a 1.1% decrease. Globally, substitutions led to better adequacies for fiber, linoleic acid, α-linolenic acid, vitamin E, folate, and SFAs, but lower adequacies regarding vitamin B-12 and riboflavin, as well as bioavailable zinc and iron when substituting meat, and calcium and iodine when substituting milk/dairy desserts. When they substituted dairy products, calcium-fortified substitutes allowed maintenance of calcium adequacy but there was a higher risk of iodine deficiency when substituting dairy, which may warrant iodine fortification. Substitutions modified the energy share of ultra-processed foods from 29% to 27%-40%, depending on the food substituted and the substitute used.

CONCLUSIONS: Plant-based substitutes had a small effect on overall diet quality and heterogeneous impacts on nutrient adequacy and security. Plant-based substitutes that include legumes appear more nutritionally adequate to substitute animal products than do other substitutes.

PMID:34049399 | DOI:10.1093/jn/nxab146

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Clinical PET/CT utilization during the COVID-19 pandemic: initial experience at Yale University

Nucl Med Commun. 2021 May 26. doi: 10.1097/MNM.0000000000001445. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine temporal changes in PET/CT utilization during the COVID-19 pandemic and examine the impact of epidemiologic, demographic and oncologic factors on PET/CT utilization.

METHODS: PET-CT utilization between 1 January 2020 and 15 June 2020 at a tertiary academic center was assessed using change-point-detection (CPD) analysis. COVID-19 epidemiologic trend was obtained from Connecticut Department of Public Health records. Demographic and oncologic data were gathered from electronic medical records and PET-CT scans by four reviewers in consensus.

RESULTS: A total of 1685 cases were reviewed. CPD analysis identified five distinct phases of PET-CT utilization during COVID-19, with a sharp decline and a gradual recovery. There was a 62.5% decline in case volumes at the nadir. These changes correlated with COVID-19 epidemiologic changes in the state of Connecticut, with a negative correlation between COVID-19 cases and PET-CT utilization (τ = -0.54; P value < 0.001). Statistically significant differences in age, race, cancer type and current and prior scan positivity were observed in these five phases. A greater percentage of young patients and minorities were scanned during the pandemic relative to baseline. PET/CT scanning was less impacted for hematologic malignancies than for solid cancers, with less profound decline and better recovery.

DISCUSSION: PET-CT cancer imaging was vulnerable to the COVID-19 pandemic at our institution. Epidemiologic, demographic and oncologic factors affected PET-CT utilization.

PMID:34049340 | DOI:10.1097/MNM.0000000000001445

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Outcomes of Primary Trabeculectomy from Two Same-Centre Cohorts Ten Years Apart

J Glaucoma. 2021 May 27. doi: 10.1097/IJG.0000000000001887. Online ahead of print.

ABSTRACT

PRECIS: Trabeculectomy can effectively lower IOP. A more junior surgeon profile is emerging. MMC has replaced 5-FU intra-operatively with comparable success rates and a decrease in post-operative antimetabolite administration.

PURPOSE: We compare 2-year outcomes for primary trabeculectomy in two cohorts, ten years apart, performed at a large UK teaching hospital.

METHODS: Consecutive case series of trabeculectomies at Manchester Royal Eye Hospital between 2004-2005(Cohort-1/C1) and 2014-2015(Cohort-2/C2). Pre- and post-operative data was collected for IOP outcomes and complications. Success was defined as IOP ≥6▒mmHg and ≤21▒mmHg, ≤18▒mmHg, ≤16▒mmHg, ≤14▒mmHg or ≤12▒mmHg with/without a ≥20% decrease from pre-operative IOP. Need for and absence of post-operative anti-hypertensive medication defined qualified and complete success respectively.

RESULTS: 186 cases were analysed [52(C1),134(C2)]. Mean pre-operative IOP was 24±10▒mmHg(C1), 21±7▒mmHg(C2) (P=0.01). 34 (79%), 33 (77%), 33 (77%), 29 (67%) and 25 (58%) patients in C1 and 88 (70%), 82 (65%), 73 (58%), 64 (51%) and 40 (32%) patients in C2 achieved complete success for IOP ≤21▒mmHg (P=0.33), ≤18▒mmHg (P=0.22), ≤16▒mmHg (P=0.04), ≤14▒mmHg (P=0.09) or ≤12▒mmHg (P=0.004). Similarly, 43(93%), 40(87%),40(87%), 35(76%) and 27(59%) in C1 and 123(98%), 116(92%), 106(84%), 87(69%) and 58(49%) in C2 achieved qualified success (P=0.34,0.37,0.83,0.48,0.19). 32(74%), 31(72%),31(72%), 28(65%) and 24(56%) in C1 and 64(51%), 63(50%), 61(48%), 54(43%) and 39(31%) in C2 achieved complete success with ≥20% reduction from pre-operative IOP and IOP of ≤21▒mmHg(P=0.01), ≤18▒mmHg(P=0.02), ≤16▒mmHg(P=0.01), ≤1▒mmHg(P=0.02) or ≤12▒mmHg(P=0.006). By same definition, 37(80%), 36(78%), 36(78%), 33(72%) and 26(57%) in C1 and 94(75%), 93(74%), 90(71%), 75(60%) and 58(46%) in C2 achieved qualified success(P=0.55,0.69,0.48,0.20,0.30). Mean IOP at 2-years was 13±5▒mmHg(C1) and 13±4▒mmHg(C2)(P=0.35). 62% had intra-operative 5-fluorouracil(5-FU) in C1; only mitomycin C(MMC) was used in C2(P<0.0001). Post-operative 5-FU was administered in 54% versus 22% in C1 and C2, respectively(P<0.0001). Needling rates were not statistically different (42%(C1), 54%(C2))(P=0.22).

CONCLUSIONS: Trabeculectomy is effective in lowering IOP with success comparable across various definitions. MMC replaced 5-FU as intra-operative antimetabolite resulting in reduced need for post-operative antimetabolite but not increased complications.

PMID:34049346 | DOI:10.1097/IJG.0000000000001887