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Nevin Manimala Statistics

Is local review of positron emission tomography scans sufficient in diffuse large B-cell lymphoma clinical trials? A CALGB 50303 analysis

Cancer Med. 2023 Feb 17. doi: 10.1002/cam4.5628. Online ahead of print.

ABSTRACT

BACKGROUND: Quantitative methods of Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) interpretation, including the percent change in FDG uptake from baseline (ΔSUV), are under investigation in lymphoma to overcome challenges associated with visual scoring systems (VSS) such as the Deauville 5-point scale (5-PS).

METHODS: In CALGB 50303, patients with DLBCL received frontline R-CHOP or DA-EPOCH-R, and although there were no significant associations between interim PET responses assessed centrally after cycle 2 (iPET) using 5-PS with progression-free survival (PFS) or overall survival (OS), there were significant associations between central determinations of iPET ∆SUV with PFS/OS. In this patient cohort, we retrospectively compared local vs central iPET readings and evaluated associations between local imaging data and survival outcomes.

RESULTS: Agreement between local and central review was moderate (kappa = 0.53) for VSS and high (kappa = 0.81) for ∆SUV categories (<66% vs. ≥66%). ∆SUV ≥66% at iPET was significantly associated with PFS (p = 0.03) and OS (p = 0.002), but VSS was not. Associations with PFS/OS when applying local review vs central review were comparable.

CONCLUSIONS: These data suggest that local PET interpretation for response determination may be acceptable in clinical trials. Our findings also highlight limitations of VSS and call for incorporation of more objective measures of response assessment in clinical trials.

PMID:36799072 | DOI:10.1002/cam4.5628

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Upper Urinary Tract Surgery through Robotic Single-Port System versus Multi-Port and LESS Systems: a Systematic Review and Meta-Analysis

J Endourol. 2023 Feb 17. doi: 10.1089/end.2022.0736. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to make a general comparison between the safety and feasibility of a novel robotic platform, da Vinci® SP system with conventional robotic multi-port (MP) and laparoendoscopic single-site (LESS) systems (da Vinci® Xi or Si) in three upper urinary tract procedures including robot-assisted partial nephrectomy (RAPN), robot-assisted pyeloplasty (RAP) and robotic adrenalectomy (RA).

MATERIALS AND METHODS: After systematically searched the literature up to August 2022 in PubMed®, Web of Science™ and the Cochrane Library and Scopus® database, we extracted and processed the data in eligible literature for operative time, warm ischemia time (WIT), morphine milligram equivalent (MME), postoperative complications and positive surgical margins (PSM).

RESULTS: A total of 738 patients who underwent robotic surgery for SP or MP from 10 articles were included in this meta-analysis. There was no statistically significant difference in operative time for either RAPN (SMD -0.16, 95% CI -0.39 to 0.08) or RA (SMD -0.51, 95% CI -1.08 to 0.06). However, for RALP, SP can save operation time (SMD -0.73, 95% CI -1.24 to -0.22).There was no difference in the incidence of postoperative complications after RAPN (OR 0.81, 95% CI 0.35 to 1.89), nor in the incidence of PSM (OR 1.09, 95% CI 0.49 to 2.41) between the two procedures. It is worth noting that although the SP system increases WIT (SMD 0.45, 95% CI0.27 to 0.63), which may be partly due to the learning curve, the SP has the benefit of reducing intraoperative pain in RAPN in regard of MME (SMD -0.40, 95% CI -0.71 to -0.09).

CONCLUSIONS: Due to issues with SP surgical instruments, such as the need for an additional robotic arm to manipulate the bulldog clamp, SP will increase WIT during RAPN procedure. Surgeons may extend the learning curve to overcome the growing warm ischemic injury.

PMID:36799070 | DOI:10.1089/end.2022.0736

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Can ChatGPT draft a research article? An example of population-level vaccine effectiveness analysis

J Glob Health. 2023 Feb 17;13:01003. doi: 10.7189/jogh.13.01003.

ABSTRACT

We reflect on our experiences of using Generative Pre-trained Transformer ChatGPT, a chatbot launched by OpenAI in November 2022, to draft a research article. We aim to demonstrate how ChatGPT could help researchers to accelerate drafting their papers. We created a simulated data set of 100 000 health care workers with varying ages, Body Mass Index (BMI), and risk profiles. Simulation data allow analysts to test statistical analysis techniques, such as machine-learning based approaches, without compromising patient privacy. Infections were simulated with a randomized probability of hospitalisation. A subset of these fictitious people was vaccinated with a fictional vaccine that reduced this probability of hospitalisation after infection. We then used ChatGPT to help us decide how to handle the simulated data in order to determine vaccine effectiveness and draft a related research paper. AI-based language models in data analysis and scientific writing are an area of growing interest, and this exemplar analysis aims to contribute to the understanding of how ChatGPT can be used to facilitate these tasks.

PMID:36798998 | DOI:10.7189/jogh.13.01003

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Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study

J Clin Sleep Med. 2023 Feb 17. doi: 10.5664/jcsm.10514. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Several studies have shown that patients with short sleep duration show a poor response to cognitive behavioral therapy for insomnia (CBT-I) but such studies have not included patients with comorbid conditions. The current study was conducted to determine whether pre-treatment sleep duration moderates the response of patients with major depression (MDD) and insomnia (ID) disorders to a combined CBT-I and antidepressant medication treatment.

METHODS: This study comprised a secondary analysis of a larger randomized trial that tested combined CBT-I/antidepressant medication treatment of patients with MDD and ID. Participants (N=99; 70 women; Mage = 47.712.4 yrs.) completed pre-treatment polysomnography and then were randomly assigned to a 12-week treatment with antidepressant medication combined with CBT-I or a sham therapy (CTRL). Short and longer sleepers were defined using total sleep time cutoffs of <5, <6 and <7 hours for short sleep. Insomnia and depression remission ascertained respectively from the Insomnia Severity Index and Hamilton Rating Scale for Depression were used to compare treatment responses of short and longer sleepers defined by the cutoffs mentioned.

RESULTS: Logistic regression analyses showed that statistically significant results were obtained only when the cutoff of <5 hours of sleep was used to define “short sleep.” Both the CBT-I recipients with < 5 hours of sleep (OR = 0.053; 95% CI = 0.006 – 0.499) and the CTRL group with ≥ 5 hours of sleep (OR = 0.149; 95% CI = 0.045 – 0.493) were significantly less likely to achieve insomnia remission than were CBT-I recipients with ≥ 5 hours of sleep. The shorter sleeping CBT-I group (OR = 0.118; 95% CI = 0.020 – 0.714) and longer sleeping CTRL group (OR = 0.321; 95% CI = 0.105 – 0.983) were also less likely to achieve insomnia and/or depression remission than was the longer sleeping CBT-I group with ≥ 5 hours of sleep.

CONCLUSIONS: Sleeping <5 hours may dispose comorbid MDD/ID patients to a poor response to combined CBT-I/medication treatments for their insomnia and depression. Future studies to replicate these findings and explore mechanisms of treatment response seem warranted.

CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Treatment of Insomnia and Depression (TRIAD); Identifier: NCT00767624; URL: https://clinicaltrials.gov/ct2/show/results/NCT00767624.

PMID:36798983 | DOI:10.5664/jcsm.10514

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Chronic pain is common and worsens daytime sleepiness, insomnia and quality of life in veterans with obstructive sleep apnea

J Clin Sleep Med. 2023 Feb 17. doi: 10.5664/jcsm.10516. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Chronic noncancer pain (CP) commonly co-occurs with obstructive sleep apnea (OSA) and may contribute to greater symptom burden. The study aims were to (1) characterize CP among veterans with OSA; and (2) examine differences in sleepiness (Epworth Sleepiness Scale, ESS), insomnia symptoms (Insomnia Severity Index [ISI]), and quality of life (Short Form Health Survey 20, SF-20) in veterans with OSA with or without pre-existing CP.

METHODS: An observational, cross-sectional, study of 111 veterans with newly diagnosed, untreated OSA was conducted. Descriptive statistics characterized the sample and comorbid CP outcomes. Regression analyses were performed to investigate associations between self-reported CP and sleep-related symptoms or quality of life while controlling for potential confounders.

RESULTS: CP was reported by 69.5% (95% CI: 61.8, 76.2) of participants. Having CP was associated with increased ESS (12.7 ± 5.5 vs 10.2 ± 5.2; p = 0.021) and ISI scores (18.1 ± 6.2 vs. 13.7 ± 7.4; p = 0.002), and worse quality of life across all SF-20 domains.

CONCLUSIONS: There is a high prevalence of CP among veterans with OSA and symptom burden is higher in patients with OSA and CP. Future investigations should address symptom response and burden to OSA treatment in comorbid OSA and CP to guide outcome expectancies and residual OSA symptom treatment plans.

PMID:36798982 | DOI:10.5664/jcsm.10516

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Interaction between Hypertension and Periodontitis

Oral Dis. 2023 Feb 16. doi: 10.1111/odi.14543. Online ahead of print.

ABSTRACT

OBJECTIVE: The possible association between hypertension and periodontitis and the effect of hypertension on periodontal treatment were investigated by evaluating salivary and gingival crevicular fluid (GCF) interleukin (IL)-6 and C reactive protein (CRP) levels.

METHODS: Forty-two healthy individuals without any previously diagnosed systemic disease [10 periodontally healthy (control) and 10 periodontitis (CP)] and subjects with hypertension [13 periodontally healthy (HP) and 9 with periodontitis (CP + HP)] participated in the study. GCF and saliva samples were obtained at baseline and four weeks after Phase I periodontal treatment. Biochemical parameters were analyzed using ELISA.

RESULTS: Before the periodontal treatment, significantly higher GCF IL-6 and CRP levels were detected in CP+HP and CP groups compared to HP and control groups (p<0.01). Salivary CRP level in CP+HP group was found to be higher than the control group (p<0.05). Statistically significant gingival and plaque index measurements (p<0.01) might suggest a possible effect of hypertension on periodontal status. Periodontal treatment significantly improved the clinical indices, however biochemical parameters did not change after the treatment.

CONCLUSION: The association of hypertension with periodontitis through local salivary and GCF inflammatory mediators might be possible in disease process.

PMID:36798972 | DOI:10.1111/odi.14543

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The association between adverse events of COVID-19 vaccination and anxiety and willingness to receive a booster dose

Hum Vaccin Immunother. 2023 Feb 16:2176643. doi: 10.1080/21645515.2023.2176643. Online ahead of print.

ABSTRACT

Many countries have initiated a booster dose for COVID-19 vaccination. However, little is known about the association between adverse events to vaccination and individual psychological status and willingness to receive the booster dose. From December 1, 2021 to February 1, 2022, 474 participants answered a questionnaire in a university town in China, and information about previous adverse events, anxiety status, and vaccination intention were collected. Chi-square test and logistic regression models were used to analyze the factors associated with willingness to receive booster dose of vaccine. Previous adverse events, such as pain at the injection site, fatigue, muscle pain and headache were associated with anxiety of the participants. About 76.2% of the participants were willing to receive booster dose of vaccine. However, adverse event was not associated with their willingness to receive the booster dose. Participants with age ≤25 were less willing to receive the booster dose, although the association was not statistically significant in the multivariable model. In conclusion, the adverse events of COVID-19 vaccination were associated with psychology status of the vaccinated people. It is still necessary to strengthen the public education on COVID-19 vaccination to improve the vaccination willingness of people, especially among the young people.

PMID:36798968 | DOI:10.1080/21645515.2023.2176643

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Differences in femoral neck and trochanteric structure in elderly women prior to hip fracture: Role in hip fracture prediction

J Bone Miner Res. 2023 Feb 16. doi: 10.1002/jbmr.4789. Online ahead of print.

ABSTRACT

We examine the hypothesis that DXA structural variables measured at the femoral neck and trochanter cross sections will improve prediction of fractures at these sites in addition to areal BMD (aBMD). We present an analysis of the internal distribution of bone at the site of these fractures using baseline hip DXA measurement of 1,151 participants, mean age (SD) 75 (3), in the 15-year Perth Longitudinal Study of Aging in Women. Structural differences at the femoral neck (FN) and trochanter (TR) cross sections were compared in 69 participants who went on to sustain femoral neck fracture (FNF) and 59 participants who went on to sustain trochanter fracture (TRF), on average ten years later, to those who did not fracture. The new structural variables, in addition to aBMD and bone width (W), were Sigma (distribution of bone within scanned area) and Delta (distance between centre-of-mineral mass and geometric centre). At baseline, compared to Non-fracture cases, FNF cases had a FNaBMD 7% lower, a FNWidth 3% higher and a FNDelta 29% higher, associated with bone loss in superior segment. In Cox proportional hazard analysis for FNF, age (HR 1.39), THaBMD (0.79) and Delta (1.70) were significant. Addition of FN Delta to the base case of THaBMD and age improved the C statistic from 0.62 to 0.69, P =0.01. At baseline, TRF cases had a 15% reduction in TRaBMD with minor increases in Sigma (1%) and Width (2%). In Cox analysis for TRF neither addition of Sigma nor Width improved age and THaBMD as predictors and did not alter the C- statistic of 0.81. Adding measurement of FN Delta, which is an assessment of superior sector bone loss, to hip aBMD and age substantially improves clinical FNF prediction in older women. This article is protected by copyright. All rights reserved.

PMID:36798967 | DOI:10.1002/jbmr.4789

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Genome-wide association study identifies WWC2 as a possible locus associated with persistent pulmonary hypertension of the newborn in the Thai population

Transl Pediatr. 2023 Jan 31;12(1):1-12. doi: 10.21037/tp-22-280. Epub 2023 Jan 16.

ABSTRACT

BACKGROUND: There is known to be significant genetic involvement in persistent pulmonary hypertension of the newborn (PPHN), but to date there is not a clear understanding of this situation, and clarifying that involvement would be of considerable assistance in devising effective treatments for the disease. This case-control study was undertaken to search for genetic variants associated with PPHN in the Thai population using a genome-wide association study (GWAS).

METHODS: A 659,184 single nucleotide polymorphisms from 387 participants (54 PPHN cases and 333 healthy participants) were genotyped across the human genome using an Illumina Asian Screening Array-24 v1.0 BeadChip Array. After quality control, we obtained 443,063 autosomal SNPs for the GWAS analysis. The FaST-LMM and R packages were used for all statistical analyses.

RESULTS: For the case-control analysis, the genomic inflation factor (λ) was 1.016, rs149768622 T>C in the first intron of WWC2 gene showed the strongest association with a P value of 3.76E-08 and odds ratio (OR) of 13.24 (95% CI: 3.91-44.78). The variants at the LOC102723906/LOC105377599, CADM4, GPM6A, CIT, RIMBP2, LOC105374510, LOC105375193, PTPRN2, CDK14, and LCORL loci showed suggestive evidence of associations with PPHN (P<1E-05).

CONCLUSIONS: This GWAS found that rs149768622 T>C in the WWC2 gene was possibly associated with PPHN. However, replication and functional studies are needed to validate this association and further explore the role(s) of the WWC2 gene in PPHN.

PMID:36798934 | PMC:PMC9926135 | DOI:10.21037/tp-22-280

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A dose planning study for cardiac and lung dose sparing techniques in left breast cancer radiotherapy: Can free breathing helical tomotherapy be considered as an alternative for deep inspiration breath hold?

Tech Innov Patient Support Radiat Oncol. 2023 Jan 26;25:100201. doi: 10.1016/j.tipsro.2023.100201. eCollection 2023 Mar.

ABSTRACT

PURPOSE: To investigate the possibility to be able to offer left sided breast cancer patients, not suitable for DIBH, an organ at risk saving treatment.

MATERIALS AND METHODS: Twenty patients receiving radiotherapy for left breast cancer in DIBH were enrolled in the study. Planning CT scans were acquired in the same supine treatment position in FB and DIBH. 3DCRT_DIBH plans were designed and optimized using two parallel opposed tangent beams (with some additional segments) for the breast and chest wall and anterior-posterior fields for regional lymph nodes irradiation. Additionally, FB helical tomotherapy plans were optimized to minimize heart and lung dose. All forty plans were optimized with at least 95% of the total CTV covered by the 95% of prescribed dose of 50 Gy in 25 fractions.

RESULTS: HT_FB plans showed significantly better dose homogeneity and conformity compared to the 3DCRT_DIBH specially for regional nodal irradiation. The heart mean dose was almost comparable in 3DCRT_DIBH and HT_FB while the volume (%) of the heart receiving 25 Gy had a statistically significant reduction from 7.90 ± 3.33 in 3DCRT_DIBH to 0.88 ± 0.66 in HT_FB. HT_FB was also more effective in left descending artery (LAD) mean dose reduction about 100% from 30.83 ± 9.2 Gy to 9.7 ± 3.1. The ipsilateral lung volume receiving 20 Gy has a further reduction of 43 % in HT_FB compared with 3DCRT_DIBH. For low dose comparison, 3DCRT_DIBH was superior for contralateral organ sparing compared to the HT_FB due to the limited angle for dose delivery.

CONCLUSION: For patients who cannot be a candidate for DIBH for any reason, HT in free breathing may be a good alternative and provides heart and ipsilateral lung dose sparing, however with the cost of increased dose to contralateral breast and lung.

PMID:36798947 | PMC:PMC9926227 | DOI:10.1016/j.tipsro.2023.100201