Tag: statistics

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

Invest Radiol. 2021 May 19. doi: 10.1097/RLI.0000000000000791. Online ahead of print.

ABSTRACT

BACKGROUND: The potential of deep learning to support radiologist prostate magnetic resonance imaging (MRI) interpretation has been demonstrated.

PURPOSE: The aim of this study was to evaluate the effects of increased and diversified training data (TD) on deep learning performance for detection and segmentation of clinically significant prostate cancer-suspicious lesions.

MATERIALS AND METHODS: In this retrospective study, biparametric (T2-weighted and diffusion-weighted) prostate MRI acquired with multiple 1.5-T and 3.0-T MRI scanners in consecutive men was used for training and testing of prostate segmentation and lesion detection networks. Ground truth was the combination of targeted and extended systematic MRI-transrectal ultrasound fusion biopsies, with significant prostate cancer defined as International Society of Urological Pathology grade group greater than or equal to 2. U-Nets were internally validated on full, reduced, and PROSTATEx-enhanced training sets and subsequently externally validated on the institutional test set and the PROSTATEx test set. U-Net segmentation was calibrated to clinically desired levels in cross-validation, and test performance was subsequently compared using sensitivities, specificities, predictive values, and Dice coefficient.

RESULTS: One thousand four hundred eighty-eight institutional examinations (median age, 64 years; interquartile range, 58-70 years) were temporally split into training (2014-2017, 806 examinations, supplemented by 204 PROSTATEx examinations) and test (2018-2020, 682 examinations) sets. In the test set, Prostate Imaging-Reporting and Data System (PI-RADS) cutoffs greater than or equal to 3 and greater than or equal to 4 on a per-patient basis had sensitivity of 97% (241/249) and 90% (223/249) at specificity of 19% (82/433) and 56% (242/433), respectively. The full U-Net had corresponding sensitivity of 97% (241/249) and 88% (219/249) with specificity of 20% (86/433) and 59% (254/433), not statistically different from PI-RADS (P > 0.3 for all comparisons). U-Net trained using a reduced set of 171 consecutive examinations achieved inferior performance (P < 0.001). PROSTATEx training enhancement did not improve performance. Dice coefficients were 0.90 for prostate and 0.42/0.53 for MRI lesion segmentation at PI-RADS category 3/4 equivalents.

CONCLUSIONS: In a large institutional test set, U-Net confirms similar performance to clinical PI-RADS assessment and benefits from more TD, with neither institutional nor PROSTATEx performance improved by adding multiscanner or bi-institutional TD.

PMID:34049336 | DOI:10.1097/RLI.0000000000000791

J Nurs Res. 2021 May 27. doi: 10.1097/JNR.0000000000000437. Online ahead of print.

ABSTRACT

BACKGROUND: Urinary catheters (UCs) with a closed urinary drainage system have been widely used in patients for many years. However, the frequency of replacing and operating these devices may be associated with catheter-associated urinary tract infection (CAUTI).

PURPOSE: This study was designed to compare the incidence of CAUTI by replacement time (every 14 or ≥ 15 days) of the urinary drainage system.

METHODS: This 1-year prospective, nonrandomized controlled study was conducted in a major teaching hospital. The Transparent Reporting of Evaluations with Nonrandomized Designs Statement checklist was used. All of the patients with UCs were divided into two groups based on each patient’s preference with regard to replacement time of the urinary drainage system.

RESULTS: Five hundred sixty-two patients were evaluated, and 341 patients with UCs were enrolled as participants in the study. In the per-protocol analysis, 16 patients (22.2%; 9.3 episodes/1,000 catheter-days) in the 14-day group and 15 patients (17.9%; relative risk = 1.24, 95% confidence interval [0.66, 2.34]) in the ≥ 15-day group (7.7 episodes/1,000 catheter-days; incidence density ratio 1.20, 95% confidence interval [0.60, 2.43]) had CAUTIs. A comparison of cleanliness within urinary bags showed no significant intergroup difference (p > .05). In the intention-to-treat analysis, the incidence of CAUTI between the two groups was also not significantly different (p > .05).

CONCLUSIONS: No statistically significant difference in the incidence of CAUTI was identified between patients who used the 14-day replacement interval and those who used the ≥ 15-day replacement interval for their urinary drainage system.

PMID:34049325 | DOI:10.1097/JNR.0000000000000437

Otol Neurotol. 2021 May 26. doi: 10.1097/MAO.0000000000003204. Online ahead of print.

ABSTRACT

OBJECTIVE: To examine if performing stapedotomy as the first case of the day provides improved outcomes compared with those performed later in the day.

STUDY DESIGN: Retrospective chart review.

SETTING: Tertiary referral center.

PATIENTS: Adult patients undergoing stapedotomy for otosclerosis.

MAIN OUTCOME MEASURES: Patients were separated into either a first case group or a later case group based on surgical start time. Audiologic outcomes and complications were compared between the two groups.

RESULTS: The first case group had a smaller postoperative air-bone gap (ABG) compared with the later case group of 9.81 dB HL compared with 11.73dB HL and 3.79 dB HL compared with 6.29 dB HL at 1000 and 2000 Hz, respectively (p = 0.03, p < 0.01). The mean postoperative ABG was 10.63 dB HL for the first start group compared with 12.12 dB HL for the later start group, which was statistically significant (p = 0.05).

CONCLUSIONS: First start stapedotomy is associated with slightly improved audiologic outcomes compared with those starting later in the day, although both groups had significantly improved postoperative outcomes overall. There was no significant difference in complications when comparing stapedotomy by case start time.

PMID:34049326 | DOI:10.1097/MAO.0000000000003204

Otol Neurotol. 2021 May 26. doi: 10.1097/MAO.0000000000003200. Online ahead of print.

ABSTRACT

OBJECTIVE: Characterize the speech recognition and sound source localization of patients with unilateral Meniere’s disease who undergo labyrinthectomy for vertigo control with simultaneous or sequential cochlear implantation.

DATABASES REVIEWED: PubMed, Embase, and Cochrane databases.

METHODS: The search was performed on May 6, 2020. The keywords utilized included: “Meniere’s disease AND cochlear implant”; “cochlear implant AND single sided deafness”; “cochlear implant AND vestibular”; and “labyrinthectomy AND cochlear implant”. Manuscripts published in English with a publication date after 1995 that assessed adult subjects (≥18 years of age) were included for review. Subjects must have been diagnosed with Meniere’s disease unilaterally and underwent labyrinthectomy with simultaneous or sequential cochlear implantation. Reported outcomes with cochlear implant (CI) use included speech recognition as measured with the Consonant-Nucleus-Consonant (CNC) word test and/or sound source localization reported in root-mean squared (RMS) error. The method of data collection and study type were recorded to assess level of evidence. Statistical analysis was performed with Wilcoxon signed ranks test.

RESULTS: Data from 14 CI recipients met the criteria for inclusion. Word recognition comparisons between the pre-operative interval and a post-activation interval demonstrated a significant improvement with the CI (p = 0.014), with an average improvement of 23% (range -16-50%). Sound source localization post-operatively with the CI demonstrated an average RMS error of 26° (SD 6.8, range 18.7-43.1°) compared to the 42° (SD 19.1, range 18-85°) in the pre-operative or CI off condition, these two conditions were not statistically different (p = 0.148).

CONCLUSION: Cochlear implantation and labyrinthectomy in adult patients with Meniere’s disease can support improvements in speech recognition and sound source localization for some CI users, though observed performance may be poorer than traditional CI candidates.

PMID:34049331 | DOI:10.1097/MAO.0000000000003200