Category: Statistics

Auris Nasus Larynx. 2021 Aug 1:S0385-8146(21)00201-7. doi: 10.1016/j.anl.2021.07.009. Online ahead of print.

ABSTRACT

OBJECTIVE: This study examined olfactory dysfunction in LATY136F knock-in mice and its pathogenic mechanism.

METHODS: The olfactory function of LATY136F knock-in mice was assessed by a behavioral test using cycloheximide solution, which has been used as a mice repellant because of its peculiar smell and unpleasant taste. The tests were administered to each group of LATY136F knock-in mice and WT mice at 8, 12, 16, 20, and 24 weeks of age. After the behavioral tests to evaluate olfactory function, the mice were sacrificed for evaluations by immunohistochemistry.

RESULTS: Behavioral tests to evaluate olfactory function showed that the LATY136F knock-in mice had a statistically significant level of olfactory dysfunction (P < 0.05). Histological analysis showed that the thickness of the olfactory epithelium in these mice was thinner than that in the age-matched wild type mice. There was no IgG4-RD like lesion in the olfactory epithelium of LATY136F knock-in mice. Olfactory marker protein and growth-associated protein 43 expressions in the olfactory epithelium of the LATY136F knock-in mice were markedly lesser than those in the wild type mice (P < 0.05).

CONCLUSION: The present study demonstrated that olfactory disturbances occurred in LATY136F knock-in mice. Furthermore, the mechanism was suggested to be reduced regeneration of the olfactory epithelium.

PMID:34348847 | DOI:10.1016/j.anl.2021.07.009

Clin Breast Cancer. 2021 Jul 13:S1526-8209(21)00180-4. doi: 10.1016/j.clbc.2021.07.003. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate factors contributing to positive surgical margins associated with reflector guidance for patients undergoing breast conserving therapy for malignancy.

MATERIALS AND METHODS: A retrospective IRB-approved review of our institutional database was performed for malignant breast lesions preoperatively localized from January 1, 2018 to December 31, 2020. The following data was recorded using electronic medical records: lesion type and grade, lesion location, reflector and wire placement modality, use of intraoperative ultrasound, margin status, patient age, family history, BMI, and final pathology. Statistical analysis was performed with univariate summary statistics and logistic regression. P < .05 was significant.

RESULTS: A total of 606 image-guided pre-surgical localizations were performed for lumpectomies of breast malignancies. A total of 352 of 606 (58%) wire localizations and 254 of 606 (42%) SCOUT reflector localizations were performed. Sixty out of 352 (17%) of wire-localized patients had positive surgical margins, whereas forty-eight out of 254 (19%) of reflector-localized patients had positive surgical margins. (OR = 1.12, P value: .59). For reflector guided cases, the use of intraoperative ultrasound (IOUS) was associated with decreased positive margin status (OR = 0 .28, 95% CI = [0.14, 0.58]) while in situ disease was associated with increased positive margin status (OR = 1.99, 95% CI = [1.05, 3.75]). No association between modality used for localization (mammography vs. ultrasound) and positive margin status was observed (OR = 0.63, 95% CI = [0.33, 1.19]). No association between positive margins and age, family history, tumor location and BMI was observed.

CONCLUSION: For reflector guided surgeries, the use of IOUS was associated with decreased positive margins, by contrast the presence of ductal carcinoma in situ was associated with increased positive margins. There was no statistically significant difference in surgical outcomes for reflector-guided localization compared to wire localizations of the breast.

PMID:34348869 | DOI:10.1016/j.clbc.2021.07.003

Public Health Nutr. 2021 Aug 5:1-28. doi: 10.1017/S1368980021003256. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the association between ultra-processed food intake and all-cause mortality in a representative sample of Spanish population.

DESIGN: Prospective cohort design in which follow-up lasted from baseline (1991) to mortality date or December 31st, 2017, whichever was first. Dietary information was collected using a validated frequency questionnaire and categorized following the NOVA classification according to the extent of food processing. The association between consumption of ultra-processed food and mortality was analysed using Cox models. Isocaloric substitution models were constructed to compare the health effects of the NOVA groups.

SETTING: Cohort from the DRECE study, representative of the Spanish population.

PARTICIPANTS: 4679 subjects between 5 and 59 years old.

RESULTS: Average consumption of ultra-processed food was 370.8 grams/day (24.4% of energy intake). After a median follow-up of 27 years, 450 deaths occurred. Those who consumed the highest amount of ultra-processed foods had higher risk of mortality. For every 10% of the energy intake from ultra-processed foods consumption, an increase of 15% in the hazard of all-cause mortality was observed (HR, 1.15; 95%CI, 1.03-1.27; p-value= 0.012). Substitution of ultra-processed foods with minimally processed foods was significantly associated with a decreased risk of mortality.

CONCLUSIONS: An increase in ultra-processed foods consumption was associated with higher risk of all-cause mortality in a representative sample of the Spanish population. Moreover, the theoretical substitution of ultra-processed food with unprocessed or minimally processed foods leads to a decrease in mortality. These results support the need to promote diets based on unprocessed or minimally processed foods.

PMID:34348832 | DOI:10.1017/S1368980021003256

Epidemiology. 2021 Sep 1;32(5):744-755. doi: 10.1097/EDE.0000000000001393.

ABSTRACT

BACKGROUND: Cross-sectional measures of body mass index (BMI) are associated with cardiovascular disease (CVD) incidence, but less is known about whether weight change affects the risk of CVD.

METHODS: We estimated the effect of 2-y weight change interventions on 7-y risk of CVD (CVD death, myocardial infarction, stroke, hospitalization from coronary heart disease, and heart failure) by emulating hypothetical interventions using electronic health records. We identified 138,567 individuals with 45-69 years of age without chronic disease in England from 1998 to 2016. We performed pooled logistic regression, using inverse-probability weighting to adjust for baseline and time-varying confounders. We categorized each individual into a weight loss, maintenance, or gain group.

RESULTS: Among those of normal weight, both weight loss [risk difference (RD) vs. weight maintenance = 1.5% (0.3% to 3.0%)] and gain [RD = 1.3% (0.5% to 2.2%)] were associated with increased risk for CVD compared with weight maintenance. Among overweight individuals, we observed moderately higher risk of CVD in both the weight loss [RD = 0.7% (-0.2% to 1.7%)] and the weight gain group [RD = 0.7% (-0.1% to 1.7%)], compared with maintenance. In the obese, those losing weight showed lower risk of coronary heart disease [RD = -1.4% (-2.4% to -0.6%)] but not of stroke. When we assumed that chronic disease occurred 1-3 years before the recorded date, estimates for weight loss and gain were attenuated among overweight individuals; estimates for loss were lower among obese individuals.

CONCLUSION: Among individuals with obesity, the weight-loss group had a lower risk of coronary heart disease but not of stroke. Weight gain was associated with increased risk of CVD across BMI groups. See video abstract at, http://links.lww.com/EDE/B838.

PMID:34348396 | DOI:10.1097/EDE.0000000000001393

Rofo. 2021 Aug 4. doi: 10.1055/a-1541-8265. Online ahead of print.

ABSTRACT

PURPOSE: Evaluation of the diagnostic accuracy of a checklist-style structured reporting template in the setting of whole-body multislice computed tomography in major trauma patients depending on the level of experience of the reporting radiologist.

MATERIALS AND METHODS: A total of 140 major trauma scans with the same protocol were included in this retrospective study. In a purely trial-intended reading, the trauma scans were analyzed by three radiologists with different levels of experience (resident, radiologist with 3 years of experience after board certification, and radiologist with 7 years of experience after board certification). The aim was to fill in the checklist 1 template within one minute to immediately diagnose management-altering findings. Checklist 2 was intended for the analysis of important trauma-related findings within 10 minutes. Reading times were documented. The final radiology report and the documented injuries in the patient’s medical record were used as gold standard.

RESULTS: The evaluation of checklist 1 showed a range of false-negative reports between 5.0 % and 11.4 % with the resident showing the highest accuracy. Checklist 2 showed overall high diagnostic inaccuracy (19.3-35.0 %). The resident’s diagnostic accuracy was statistically significantly higher compared to the radiologist with 3 years of experience after board certification (p = 0.0197) and with 7 years of experience after board certification (p = 0.0046). Shorter average reporting time resulted in higher diagnostic inaccuracy. Most of the missed diagnoses were fractures of the spine and ribs.

CONCLUSION: By using a structured reporting template in the setting of major trauma computed tomography, less experienced radiologists reach a higher diagnostic accuracy compared to experienced readers.

KEY POINTS: · In the setting of a pure trial reading, the diagnostic inaccuracy of template-based reporting of major trauma CT examinations is high.. · Fractures in general and especially of the vertebral bodies and ribs were the most commonly missed diagnoses.. · In a study setting, less experienced radiologists seem to reach a higher diagnostic accuracy when using a structured reporting approach..

CITATION FORMAT: · Dendl LM, Pausch AM, Hoffstetter P et al. Structured Reporting of Whole-Body Trauma CT Scans Using Checklists: Diagnostic Accuracy of Reporting Radiologists Depending on Their Level of Experience. Fortschr Röntgenstr 2021; DOI: 10.1055/a-1541-8265.

PMID:34348402 | DOI:10.1055/a-1541-8265

Med Princ Pract. 2021 Jun 23. doi: 10.1159/000517976. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of the study was to ascertain the effect of nasal polyposis on cardiac functions.

MATERIAL AND METHODS: A prospective randomized interventional open-label endpoint-controlled study was conducted in an academic tertiary care hospital. Thirty-one patients with chronic rhinosinusitis with nasal polyposis were enrolled and administered fluticasone furoate nasal spray for 3 weeks before randomly segregation into surgical or medical group. The treatment continued for 3 months in both groups. The SNOT-22 (Sino-Nasal Outcome Test-22) score, polyp grade, and right ventricular and pulmonary arterial functions were recorded in both groups before and after 3 months of the intervention.

RESULTS: Both groups had significant improvement in SNOT-22 scores after 3 months of intervention. Both groups showed improvement in cardiac functions, but statistical significance was found only in subjects who underwent surgery.

CONCLUSION: Nasal polyp affects cardiac functions, and this needs further evaluation and research through studies on large samples.

PMID:34348323 | DOI:10.1159/000517976

Pain. 2021 Aug 3. doi: 10.1097/j.pain.0000000000002426. Online ahead of print.

ABSTRACT

Several different reporting biases cited in scientific literature have raised concerns about the overestimation of effects and the subsequent potential impact on the practice of evidence-based medicine and human health. Up to 7-8% of the population experiences neuropathic pain, and established treatment guidelines are based predominately on published, clinical trial results. Therefore, we examined published randomized controlled trials (RCTs) of first-line drugs for neuropathic pain and assessed the relative proportions with statistically significant (i.e., positive) and non-significant (i.e., negative) results and their rates of citation. We determined the relationships between reported study outcome and the frequency of their citations with journal impact factor, sample size, time to publication after study completion, and study quality metrics. We also examined the association of study outcome with maximum study drug dosage and conflict of interest. We found that of 107 published RCTs, 68.2% reported a statistically significant outcome regarding drug efficacy for chronic peripheral and central neuropathic pain. Positive studies were cited nearly twice as often as negative studies in the literature (P=0.01), despite similar study sample size, quality metrics, and publication in journals with similar impact factors. The time to publication, journal impact factor, and conflict of interest did not differ statistically between positive and negative studies. Our observations that negative and positive RCTs were published in journals with similar impact at comparable time-lags after study completion are encouraging. However, the citation bias for positive studies could affect the validity and generalization of conclusions in literature and potentially influence clinical practice.

PMID:34348355 | DOI:10.1097/j.pain.0000000000002426

Sex Med. 2021 Aug 1;9(5):100416. doi: 10.1016/j.esxm.2021.100416. Online ahead of print.

ABSTRACT

INTRODUCTION: Men suffering from one sexual problem sometimes report having another sexual problem, but few studies have determined concordance rates among dysfunctions in non-clinical samples.

AIM: This study determined comorbidities among sexual dysfunctions based on an internet convenience sample of 4432 men from Hungary, the USA, and other world regions that visit social media fora.

METHOD: Participants completed an online 55-item questionnaire that included questions assessing erectile dysfunction (ED), premature ejaculation (PE), delayed ejaculation (DE), and lack of sexual interest (LSI).

MAIN OUTCOME MEASURES: Concordance rates and odds ratios among sexual dysfunctions.

RESULTS: Approximately 8% of men suffered from two or more sexual problems; men with a severe sexual problem were significantly more likely to suffer from a second sexual problem; concordance between PE and erectile dysfunction ranged from 23-29%, with subtypes of lifelong vs acquired PE showing patterns similar to one another; and most men with delayed ejaculation reported minimal problems with LSI, although LSI was generally key to understanding all other dysfunctions.

CONCLUSION: The percentage of men with one sexual problem having a second sexual problem was substantial, ranging from 23-40%. These findings will help clinicians better understand the intertwined nature of sexual problems and assist them in developing management protocols that address concomitant inadequacies in sexual response. Rowland DL, Oosterhouse LB, Kneusel JA, et al. Comorbidities Among Sexual Problems in Men: Results From an Internet Convenience Sample. Sex Med 2021;XX:XXXXXX.

PMID:34348218 | DOI:10.1016/j.esxm.2021.100416

Photodiagnosis Photodyn Ther. 2021 Aug 1:102472. doi: 10.1016/j.pdpdt.2021.102472. Online ahead of print.

ABSTRACT

Background Photodynamic therapy (PDT) mediated by 5-aminolevulinic acid (5-ALA) is a possible minimally-invasive treatment for cervical intraepithelial neoplasia (CIN). The present study was carried out to investigate the effect of 5-ALA-PDT on CIN2 and the influencing factors of 5-ALA-PDT. Methods Patients diagnosed as CIN2 who met the inclusion criteria were enrolled in this study sequentially from January 2019 to April 2020. Patients were treated by PDT or cryotherapy according to their intentions. The primary endpoint was pathological regression. The secondary endpoint was HPV clearance. Affecting factors of the efficacy of PDT and adverse events were also assessed during treatment. Results A total of 210 patients were enrolled, including 97 patients in PDT group and 101 patients in cryotherapy group, with 12 patients excluded. There was no statistical difference in population characteristics. The pathological regression rate in PDT group was 92.0% (80/87), compared with 81.4% (79/97) in cryotherapy group (P <0.05). The HPV clearance rate was 64.4% (56/87) in PDT group and 57.8% (56/97) in cryotherapy group (P =0.36). The main side effects of PDT were abdominal pain (24.1%, 21/87) and increased vaginal secretions (23.0%, 20/87). On univariate analysis, the risk for lesions persisting at 6 months after PDT was increased by recurrent genital tract inflammation (P =0.004), smoking or passive smoking (P =0.020), and multicentric lesions (P = 0.020). Conclusion PDT can be a safe and efficient treatment for CIN2. Risk factors for persisting HSIL after PDT include recurrent genital tract inflammation, smoking or passive smoking, and multicentric lesions.

PMID:34348187 | DOI:10.1016/j.pdpdt.2021.102472

Med Image Anal. 2021 Jul 27;73:102187. doi: 10.1016/j.media.2021.102187. Online ahead of print.

ABSTRACT

Radiation exposure in positron emission tomography (PET) imaging limits its usage in the studies of radiation-sensitive populations, e.g., pregnant women, children, and adults that require longitudinal imaging. Reducing the PET radiotracer dose or acquisition time reduces photon counts, which can deteriorate image quality. Recent deep-neural-network (DNN) based methods for image-to-image translation enable the mapping of low-quality PET images (acquired using substantially reduced dose), coupled with the associated magnetic resonance imaging (MRI) images, to high-quality PET images. However, such DNN methods focus on applications involving test data that match the statistical characteristics of the training data very closely and give little attention to evaluating the performance of these DNNs on new out-of-distribution (OOD) acquisitions. We propose a novel DNN formulation that models the (i) underlying sinogram-based physics of the PET imaging system and (ii) the uncertainty in the DNN output through the per-voxel heteroscedasticity of the residuals between the predicted and the high-quality reference images. Our sinogram-based uncertainty-aware DNN framework, namely, suDNN, estimates a standard-dose PET image using multimodal input in the form of (i) a low-dose/low-count PET image and (ii) the corresponding multi-contrast MRI images, leading to improved robustness of suDNN to OOD acquisitions. Results on in vivo simultaneous PET-MRI, and various forms of OOD data in PET-MRI, show the benefits of suDNN over the current state of the art, quantitatively and qualitatively.

PMID:34348196 | DOI:10.1016/j.media.2021.102187