Tag: pubmed

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

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

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

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

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

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

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

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

J Clin Gastroenterol. 2021 May 28. doi: 10.1097/MCG.0000000000001402. Online ahead of print.

ABSTRACT

GOAL: We sought to quantify the independent effects of age, sex, and race/ethnicity on risk of colorectal cancer (CRC) and advanced neoplasia (AN) in Veterans.

STUDY: We conducted a retrospective, cross-sectional study of Veterans aged 40 to 80 years who had diagnostic or screening colonoscopy between 2002 and 2009 from 1 of 14 Veterans Affairs Medical Centers. Natural language processing identified the most advanced finding and location (proximal, distal). Logistic regression was used to examine the adjusted, independent effects of age, sex, and race, both overall and in screening and diagnostic subgroups.

RESULTS: Among 90,598 Veterans [mean (SD) age 61.7 (9.4) y, 5.2% (n=4673) were women], CRC and AN prevalence was 1.3% (n=1171) and 8.9% (n=8081), respectively. Adjusted CRC risk was higher for diagnostic versus screening colonoscopy [odds ratio (OR)=3.79; 95% confidence interval (CI), 3.19-4.50], increased with age, was numerically (but not statistically) higher for men overall (OR=1.53; 95% CI, 0.97-2.39) and in the screening subgroup (OR=2.24; 95% CI, 0.71-7.05), and was higher overall for Blacks and Hispanics, but not in screening. AN prevalence increased with age, and was present in 9.2% of men and 3.9% of women [adjusted OR=1.90; 95% CI, 1.60-2.25]. AN risk was 11% higher in Blacks than in Whites overall (OR=1.11; 95% CI, 1.04-1.20), was no different in screening, and was lower in Hispanics (OR=0.74; 95% CI, 0.55-0.98). Women had more proximal CRC (63% vs. 39% for men; P=0.03), but there was no difference in proximal AN (38.3% for both genders).

CONCLUSIONS: Age and race were associated with AN and CRC prevalence. Blacks had a higher overall prevalence of both CRC and AN, but not among screenings. Men had increased risk for AN, while women had a higher proportion of proximal CRC. These findings may be used to tailor when and how Veterans are screened for CRC.

PMID:34049372 | DOI:10.1097/MCG.0000000000001402

Invest Radiol. 2021 May 27. doi: 10.1097/RLI.0000000000000796. Online ahead of print.

ABSTRACT

OBJECTIVES: The objectives of this exploratory study were to investigate the feasibility of multidimensional diffusion magnetic resonance imaging (MddMRI) in assessing diffusion heterogeneity at both a macroscopic and microscopic level in prostate cancer (PCa).

MATERIALS AND METHODS: Informed consent was obtained from 46 subjects who underwent 3.0-T prostate multiparametric MRI, complemented with a prototype spin echo-based MddMRI sequence in this institutional review board-approved study. Prostate cancer tumors and comparative normal tissue from each patient were contoured on both apparent diffusion coefficient and MddMRI-derived mean diffusivity (MD) maps (from which microscopic diffusion heterogeneity [MKi] and microscopic diffusion anisotropy were derived) using 3D Slicer. The discriminative ability of MddMRI-derived parameters to differentiate PCa from normal tissue was determined using the Friedman test. To determine if tumor diffusion heterogeneity is similar on macroscopic and microscopic scales, the linear association between SD of MD and mean MKi was estimated using robust regression (bisquare weighting). Hypothesis testing was 2 tailed; P values less than 0.05 were considered statistically significant.

RESULTS: All MddMRI-derived parameters could distinguish tumor from normal tissue in the fixed-effects analysis (P < 0.0001). Tumor MKi was higher (P < 0.05) compared with normal tissue (median, 0.40; interquartile range, 0.29-0.52 vs 0.20-0.18; 0.25), as was tumor microscopic diffusion anisotropy (0.55; 0.36-0.81 vs 0.20-0.15; 0.28). The MKi could not be predicted (no significant association) by SD of MD. There was a significant correlation between tumor volume and SD of MD (R2 = 0.50, slope = 0.008 μm2/ms per millimeter, P < 0.001) but not between tumor volume and MKi.

CONCLUSIONS: This explorative study demonstrates that MddMRI provides novel information on MKi and microscopic anisotropy, which differ from measures at the macroscopic level. MddMRI has the potential to characterize tumor tissue heterogeneity at different spatial scales.

PMID:34049334 | DOI:10.1097/RLI.0000000000000796