Tag: statistics

Vet Comp Oncol. 2021 Feb 23. doi: 10.1111/vco.12688. Online ahead of print.

ABSTRACT

Feline oral squamous cell carcinoma (FOSCC) is a frequent and progressively invasive tumour. Early lesions are difficult to recognize based on the sole clinical examination and may be misinterpreted as non-neoplastic. Mutations of TP53 and epigenetic alterations of specific genes are present in FOSCC and may be early detected. Aim of this prospective study was to investigate the DNA methylation pattern of a 17-gene panel and TP53 mutational status of FOSCC cytological samples obtained by oral brushing. Results were compared with a control group, in order to validate this non-invasive procedure for the screening of FOSCC. In FOSCC, the same analyses were carried out on the corresponding histological sample, if available. Thirty-five FOSCC and 60 controls were included. Mutations of TP53 were detected in 17 FOSCC brushings (48%) and in none of the controls (P < 0.001). Six genes (ZAP70, FLI1, MiR124-1, KIF1A, MAGEC2, MiR363) were differentially methylated in FOSCC and were included in a methylation score. An algorithm based on TP53 mutational status and methylation score allowed to differentiate FOSCC from controls with a 69% sensitivity and a 97% specificity (accuracy, 86%). In 19 FOSCC histological samples, TP53 mutational status was fully concordant with brushings, and a positive methylation score was observed in all cases. These results are promising for the identification of FOSCC by oral brushing, although some factors may limit the accuracy of this technique, and further studies are required to assess its reproducibility in clinical practice. This article is protected by copyright. All rights reserved.

PMID:33624422 | DOI:10.1111/vco.12688

J Eval Clin Pract. 2021 Feb 23. doi: 10.1111/jep.13553. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess knowledge, attitudes, and perceived barriers (KAP) regarding e-cigarette use counselling among adolescent healthcare clinical staff in an urban system, and to compare results between providers and rooming staff.

METHODS: Primary care clinical staff (n = 169) completed an anonymous survey. Descriptive statistics and Chi-square tests were used to summarize data and compare KAP between medical providers and rooming staff.

RESULTS: Staff wanted to learn more about e-cigarettes (87.6%). The most common knowledge deficits were how to use the 5As + 5Rs model for tobacco cessation counselling (66.7%) and the chemical content of e-liquids (55.4%), with no differences across groups. Overall, 58% of providers expressed confidence in their ability to talk with adolescent patients about e-cigarette use. The most common barriers to counselling were low knowledge about e-cigarettes (74.0%) and how to refer adolescent patients for cessation support (43.8%).

CONCLUSIONS: Provider and rooming staff expressed similar educational needs surrounding e-cigarettes, counselling, and treatment for adolescent patients. Clinical staff expressed confidence in their ability to affect change. There were no differences in the identified knowledge gaps or barriers to care between rooming staff and providers, suggesting that the same educational format can be used to target both groups.

PMID:33624429 | DOI:10.1111/jep.13553

Hemodial Int. 2021 Feb 23. doi: 10.1111/hdi.12914. Online ahead of print.

ABSTRACT

INTRODUCTION: The purpose was to make longitudinal measurements of physical activity and study whether physical activity decreases over time in maintenance hemodialysis (MHD) patients.

METHODS: This was an observational study, where MHD patients were considered in a 12-month follow-up. Laboratory variables and physical activity were tested three times over 12-months in 124 hemodialysis patients. Physical activity was measured using the Human Activity Profile (HAP), the Stanford 7-day Physical Activity Recall Questionnaire (PAR), and walking speed. Repeated measure variance analysis was used to analyze changes of physical activity. The Bonferroni method was used to do pairwise comparisons.

FINDINGS: The proportion of decreased physical activity increased (P < 0.05). The maximal activity score (MAS), adjusted activity score (AAS), HAP dimension scores, and walking speed all decreased at the three time points studied (P < 0.001). At the same time, moderate physical activities and PAR values changed at three time points (P < 0.05). Pairwise comparisons showed that between the baseline and the 6-month follow-up, MAS, AAS, the scores of personal/household work, entertainment/social, independent exercise, leg effort, and back effort, all decreased(P < 0.05). Between the baseline and the 12-month follow-up, and between the 6-month follow-up and the 12-month follow-up, all the scores of HAP and walking speed decreased significantly (P < 0.001). Between the baseline and the 6-month follow-up, moderate physical activities and PAR values increased (P < 0.05). However, between the baseline and the 12-month follow-up, and between the 6-month follow-up and the 12-month follow-up, moderate physical activities and PAR did not change statistically.

CONCLUSION: Physical activity decreased in hemodialysis patients in the 12-month follow-up.

PMID:33624415 | DOI:10.1111/hdi.12914

Eur J Neurosci. 2021 Feb 23. doi: 10.1111/ejn.15159. Online ahead of print.

ABSTRACT

SARS-CoV2 infection is a systemic disease that may involve multiple organs, including the central nervous system (CNS). Aims of our study are to describe prevalence and clinical features of neurological manifestations, mortality and hospital discharge in subjects hospitalized with COVID-19. All individuals admitted for to our hospital COVID-19 were retrospectively included. Patients were classified according to the symptoms at hospital entry in 1) isolated respiratory, 2) combined respiratory and neurologic, 3) isolated neurologic and 4) stroke manifestations. Descriptive statistics and non-parametric tests to compare the groups were calculated. Kaplan Meier probability curves and multivariable Cox regression models for survival and hospital discharge were applied. The analysis included 901 patients: 42.6% showed a severe or critical disease with an overall mortality of 21.2%. At least one neurological symptom or disease was observed in 30.2% of subjects ranging from dysgeusia/anosmia (9.1%) to post-infective diseases (0.8%). Patients with respiratory symptoms experienced a more severe disease and a higher in-hospital mortality compared to those who showed only neurologic symptoms. Kaplan Meier estimates displayed a statistically significant different survival among groups (p=0.003): subjects with stroke had the worst. After adjusting for risk factors such as age, sex and comorbidity, individuals with isolated neurologic manifestations exhibited a better survival (aHR 0.398, 95% CI 0.206-0.769, p=0.006). Neurologic manifestations in COVID-19 are common but heterogeneous and mortality in subjects with isolated neurologic manifestations seems lower than in those with respiratory symptoms.

PMID:33624380 | DOI:10.1111/ejn.15159

Pharm Stat. 2021 Feb 23. doi: 10.1002/pst.2104. Online ahead of print.

ABSTRACT

A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristics. Often, however, clinical questions also arise regarding the treatment effect in subpopulations of patients, which would experience clinical or disease related events post-randomization. Events that occur after treatment initiation and potentially affect the interpretation or the existence of the measurements are called intercurrent events in the ICH E9(R1) guideline. If the intercurrent event is a consequence of treatment, randomization alone is no longer sufficient to meaningfully estimate the treatment effect. Analyses comparing the subgroups of patients without the intercurrent events for intervention and control will not estimate a causal effect. This is well known, but post-hoc analyses of this kind are commonly performed in drug development. An alternative approach is the principal stratum strategy, which classifies subjects according to their potential occurrence of an intercurrent event on both study arms. We illustrate with examples that questions formulated through principal strata occur naturally in drug development and argue that approaching these questions with the ICH E9(R1) estimand framework has the potential to lead to more transparent assumptions as well as more adequate analyses and conclusions. In addition, we provide an overview of assumptions required for estimation of effects in principal strata. Most of these assumptions are unverifiable and should hence be based on solid scientific understanding. Sensitivity analyses are needed to assess robustness of conclusions.

PMID:33624407 | DOI:10.1002/pst.2104

Obes Rev. 2021 Feb 23:e13218. doi: 10.1111/obr.13218. Online ahead of print.

ABSTRACT

Obesity management guidelines consistently advise aerobic training for weight loss, whereas recommendations for other training modalities are sparse. This systematic review and network meta-analysis (NMA) aimed to compare the long-term effects of different training modalities on anthropometric outcomes in patients with obesity. MEDLINE, Cochrane CENTRAL, and Web of Science were searched to identify the following: (1) randomized controlled trials (RCTs); (2) conducted in adults with a mean body mass index (BMI) ≥30 kg/m² ; (3) comparing aerobic, resistance, combined, or high-intensity interval training head-to-head or to control for ≥6 months; and (4) reporting changes in body weight (BW), BMI, waist circumference (WC), fat mass (FM), or fat-free mass (FFM). Random-effects NMA models were fitted in a frequentist approach. GRADE framework was used to assess certainty of evidence. Thirty-two RCTs with 4774 participants with obesity were included in this review. Aerobic training was ranked as best for improving BW, BMI, and WC and combined training for improving FM, as well as equally with resistance training most effective for improving FFM. Low to moderate certainty of evidence supports use of aerobic training to improve anthropometric outcomes in obesity, and its combination with resistance training provides additional benefit for reducing FM and increasing FFM.

PMID:33624411 | DOI:10.1111/obr.13218

Eur J Haematol. 2021 Feb 23. doi: 10.1111/ejh.13606. Online ahead of print.

ABSTRACT

We conducted a retrospective study to analyze the prognostic factors impacting the overall survival (OS) and progression-free survival (PFS) of diffuse large B cell lymphoma (DLBCL) patients undergoing first-line therapy and admitted to intensive care unit (ICU) compared to a control cohort who did not required ICU admission. Between January 1, 2008, and December 31, 2018, 828 patients were diagnosed with DLBCL at our institution, including 72 patients who were required ICU admission during disease course. Among them, forty-five patients undergoing homogeneous first-line therapy with /R-CHOP-like regimen and ICU-admitted were selected for the present analysis. Control “non-ICU” DLBCL patients were matched by age, IPI score and treatment received. The median age at ICU admission was 65 years, 97.8% of patients displayed advanced-stage disease (III/IV), and 84.4% had a high IPI score (3 – 5). The main reasons for ICU admission were acute respiratory failure (40.0%) and septic shock (33.3%). The ICU mortality rate was 33.3%. The 2-year PFS was lower in ICU survivors patients than in non-ICU patients: 31.7% (95% CI 18.5 – 54.1) vs 60.8% (95% CI 51.2 – 72.1, p=0.00049). Admission to the ICU is an event that clearly impacts the outcomes of patients with DLBCL, until two years after the event. ICU prognosis seems mainly related to critical patient severity at admission rather than lymphoma-related prognostic factors (IPIs), suggesting that ICU admission criteria should not be based only on the lymphoma prognosis.

PMID:33624346 | DOI:10.1111/ejh.13606

Magn Reson Med. 2021 Feb 23. doi: 10.1002/mrm.28715. Online ahead of print.

ABSTRACT

PURPOSE: Spin-echo (SE) functional MRI (fMRI) can be highly advantageous compared to gradient-echo (GE) fMRI with respect to magnetic field-inhomogeneity artifacts. However, at 3T, the majority of blood oxygenation level-dependent (BOLD) fMRI experiments are performed using T2∗ -weighted GE sequences because of their superior sensitivity compared to SE-fMRI. The presented SE implementation of a highly accelerated GE pulse sequence therefore aims to improve the sensitivity of SE-fMRI while profiting from a reduction of susceptibility-induced signal dropout.

METHODS: Spin-echo MR encephalography (SE-MREG) is compared with the more conventionally used spin-echo echo-planar imaging (SE-EPI) and spin-echo simultaneous multislice (SE-SMS) at 3T in terms of capability to detect neuronal activations and resting-state functional connectivity. For activation analysis, healthy subjects underwent consecutive SE-MREG (pulse repetition time [TR] = 0.25 seconds), SE-SMS (TR = 1.3 seconds), and SE-EPI (TR = 4.4 seconds) scans in pseudorandomized order applied to a visual block design paradigm for generation of t-statistics maps. For the investigation of functional connectivity, additional resting-state data were acquired for 5 minutes and a seed-based correlation analysis using Stanford’s FIND (Functional Imaging in Neuropsychiatric Disorders) atlas was performed.

RESULTS: The increased sampling rate of SE-MREG relative to SE-SMS and SE-EPI improves the sensitivity to detect BOLD activation by 33% and 54%, respectively, and increases the capability to extract resting-state networks. Compared with a brain region that is not affected by magnetic field inhomogeneities, SE-MREG shows 2.5 times higher relative signal strength than GE-MREG in mesial temporal structures.

CONCLUSION: SE-MREG offers a viable possibility for whole-brain fMRI with consideration of brain regions that are affected by strong susceptibility-induced magnetic field gradients.

PMID:33624352 | DOI:10.1002/mrm.28715

Psychooncology. 2021 Feb 23. doi: 10.1002/pon.5665. Online ahead of print.

ABSTRACT

OBJECTIVES: To examine if baseline stigma predicts psychological distress at 3 months and 6 months follow-up among patients newly diagnosed with lung cancer.

METHODS: This longitudinal study was nested within a larger randomised controlled trial. Eligible participants were recruited via respiratory and oncology out-patient clinics in Australia (n=194). Consenting participants were asked to complete surveys at baseline, 3 months and 6 months post-recruitment. Measures included lung cancer stigma (Cataldo Lung Cancer Stigma Scale) and psychological distress (General Health Questionnaire 12).

RESULTS: One-hundred and ninety-four participants were included for analysis. Most were male (57.7%) with a mean age of 68 years (SD=8.8). A significant relationship between baseline lung cancer stigma and psychological distress at six months was found, where a one unit increase in lung cancer stigma increases psychological distress by 0.044 when adjusting for age, gender, smoking status, baseline GHQ-12 scores and intervention allocation (as part of the larger trial; p=0.001; β=0.044, 95% CI=0.010, 0.079).

CONCLUSION: Temporal links between lung cancer stigma and psychological distress was found at 6 months, suggesting stigma-related experiences may have a delayed impact. Development of routine lung cancer stigma assessments is recommended to identify those at risk of psychological distress. This article is protected by copyright. All rights reserved.

PMID:33624377 | DOI:10.1002/pon.5665

Pain Ther. 2021 Feb 23. doi: 10.1007/s40122-021-00238-z. Online ahead of print.

ABSTRACT

INTRODUCTION: Multidisciplinary patient-reported outcomes are a critical part of assessing patients to better understand their well-being during treatment. The use of multidisciplinary patient-reported outcomes is recommended in many areas of medicine. The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) has been utilized as a common measurement language across universally relevant domains, including pain, mood, sleep, social participation, and function.

METHODS: Retrospective analysis of prospectively collected data was performed. Subjects were identified and consecutively enrolled upon entry into chronic pain centers across 24 sites in the United States. The PROMIS-29 v2.1 and the numerical rating scale (NRS) were recorded. The pain impact score and the Health Utilities Index Mark 3 (HUI-3) were calculated. Statistical differences were assessed between genders and among age groups comprising subjects less than 40, 41-60, 61-80, and over 80 years of age.

RESULTS: A total of 19,546 patients were assessed over the enrollment period from 2018 to 2020. The PROMIS-29 v2.1 was evaluated across the seven domains, along with the numerical rating sale (NRS). The mean scores of the population for PROMIS SF v1.0 Pain Interference 4a, PROMIS SF v1.0 Sleep Disturbance 4a, PROMIS SF v1.0 Fatigue 4a, PROMIS SF v1.0 Anxiety 4a, PROMIS SF V1.0 Depression 4a, PROMIS SF v2.0 Ability to Participate in Social Roles and Activities 4a, and PROMIS SF v1.0 Physical Function 4a, measuring pain interference, sleep disturbance, fatigue, anxiety, depression, social participation, and physical function, were 64.61, 57.19, 58.50, 53.94, 54.45, 40.06, and 36.23, respectively. Pain intensity was 6.38 on an 11-point NRS scale. The pain impact score (PIS) and health utilities index mark 3 (HUI-3) scores, calculated across the designated age groups, were 33.19 and 0.67, respectively. Statistical differences were observed for the domains of sleep disturbance and physical function for age groups less than 40 and greater than 80 years of age.

CONCLUSION: This data set is the first published normative data set describing the PROMIS-29 assessment in the chronic pain population. The patient population is more homogeneous than expected, and females were found to have higher levels of dysfunction.

PMID:33624253 | DOI:10.1007/s40122-021-00238-z