Tag: statistics

Neurol Sci. 2022 May 24. doi: 10.1007/s10072-022-06136-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Evidence is emerging about an extra-pulmonary involvement of SARS-CoV-2, including the nervous system. Autonomic dysfunction in patients recovering from acute coronavirus disease 2019 (COVID-19) has been recently described. Dysautonomic symptoms have been reported in the acute phase of the disease, but clear evidence is lacking, especially in the non-critical forms of the infection.

OBJECTIVE: The aim of this study is to assess the prevalence of dysautonomia in acute, non-critically ill COVID-19 patients.

METHODS: In this observational, cross-sectional study, we compared 38 non-critically ill patients with acute COVID-19 (COVID + group) to 38 healthy volunteers (COVID – group) in order to assess the prevalence of signs and symptoms of dysautonomia through the administration of the composite autonomic symptom score 31 (COMPASS-31) and an active standing test. Comparisons between groups were performed by means of both univariate and multivariate analyses.

RESULTS: The prevalence of orthostatic hypotension was significantly higher in the COVID + group. Higher total scores of COMPASS-31 were observed in the COVID + group than controls. Significant differences between groups emerged in the secretomotor, orthostatic intolerance, and gastrointestinal COMPASS-31 domains. All these results maintained the statistical significance after the adjustment for concomitant drugs with a known effect on the autonomic nervous system assumed by the study participants, except for the differences in the gastrointestinal domain of COMPASS-31.

CONCLUSION: Our results suggest that an autonomic dysfunction could be an early manifestation of COVID-19, even in the contest of mild forms of the infection.

PMID:35608736 | DOI:10.1007/s10072-022-06136-2

Ther Innov Regul Sci. 2022 May 24. doi: 10.1007/s43441-022-00416-x. Online ahead of print.

ABSTRACT

BACKGROUND: Decentralized clinical trials offer the promise of reduced patient burden, faster and more diverse recruitment, and have received regulatory support during the COVID-19 pandemic. However, lack of data accuracy or data validation poses a challenge for fully decentralized trials. A mixed data collection modality where onsite measurements are collected at key time points and decentralized measurements are taken at intermediate time points is attractive operationally. To date, the impact of decentralized measurements (which could presumably be less accurate) taken at intermediate time points on statistical inference on the primary or other key time points has not been evaluated.

METHODS: In this article we evaluate the estimation and statistical inference for three scenarios: (1) all onsite measurements, (2) a mixture of onsite and decentralized measurements, and (3) all decentralized measurements, in the setting of a chronic weight management trial. We consider scenarios where decentralized measurements have additional within- and between-subject variabilities and/or bias.

RESULTS: In the mixed modality setting, simulation studies showed that the estimation and inference for the key time points with onsite measurements have good properties and are not impacted by the additional variability and bias from intermediate decentralized measurements. However, estimates for intermediate decentralized time points for the mixed modality and estimates for the all decentralized modality measurements have increased variability and bias.

CONCLUSION: Mixed modality trials can help achieve the benefits of decentralized clinical trials by reducing the number of onsite visits with little impact on statistical inferences for various estimands, compared to traditional (all onsite) clinical trials.

PMID:35608729 | DOI:10.1007/s43441-022-00416-x

J Endocrinol Invest. 2022 May 24. doi: 10.1007/s40618-022-01816-4. Online ahead of print.

ABSTRACT

BACKGROUND: Klinefelter syndrome (KS) is frustratingly under-diagnosed. KS have a broad spectrum of clinical features, making it difficult to identify. OBJECTIVE: We describe KS clinical presentation in a large Italian cohort.

DESIGN: This is the first observational cohort study within a national network, the Klinefelter ItaliaN Group (KING). Primary outcomes were to describe the basic clinical features and the actual phenotype of KS in Italy. Secondary outcomes were to determine age at diagnosis and geographical distribution.

METHODS: We performed a basic phenotyping and evaluation of the hormonal values of 609 adult KS patients.

RESULTS: Mean age at diagnosis was 37.4 ± 13.4 years. The overall mean testicular size was 3 ml, and 2.5 ml in both testes in untreated KS group. BMI was 26.6 ± 5.8 kg/m², and 25.5% of KS had metabolic syndrome (MetS). LH and FSH were increased, and mean total testosterone were 350 ± 9.1 ng/dl. A descriptive analysis showed that 329 KS patients were evaluated in Northern Italy, 76 in Central and 204 in Southern Italy. Analysis of variance demonstrated significant statistical differences (p < 0001) between the age at diagnosis of the three geographical groups. Compared with the expected number among male patients matched for age in Italy, only 16% of KS patients received a diagnosis.

CONCLUSIONS: These data are the results of the only national database available that collects the clinical and hormonal data of the KS patients, currently referred at the KING centers. In Italy the typical KS patient is overweight, with small testes, and elevated LH and FSH. Only 25.5% of them are diagnosed with MetS. Early detection and timely treatment are mandatory.

PMID:35608733 | DOI:10.1007/s40618-022-01816-4

World J Pediatr. 2022 May 24. doi: 10.1007/s12519-022-00566-w. Online ahead of print.

NO ABSTRACT

PMID:35608720 | DOI:10.1007/s12519-022-00566-w

Arch Gynecol Obstet. 2022 May 24. doi: 10.1007/s00404-022-06605-1. Online ahead of print.

ABSTRACT

OBJECTIVES: Sentinel lymph node (SLN) biopsy is widely accepted in the surgical staging of early vulvar cancer, although the most accurate method for its identification is not yet defined. This meta-analysis aimed to determine the technique with the highest pooled detection rate (DR) for the identification of SLN and compare the average number of SLNs detected by planar lymphoscintigraphy (PL), single-photon emission computed tomography/computed tomography (SPECT/CT), blue dye and indocyanine green (ICG) fluorescence.

METHODS: The meta-analysis was conducted according to the PRISMA guideline. The search string was: “sentinel” and “vulv*”, with date restriction from 1st January 2010 until Dec 31st, 2020. Three investigators selected studies based on: (1) a study cohort or a subset of a minimum of 10 patients with vulvar cancer undergoing either PL, SPECT/CT, blue-dye, or ICG fluorescence for the identification of SLN; (2) the possibility to extrapolate the DR or the average number of SLNs detected by a single technique (3) no evidence of other malignancies in the patient history.

RESULTS: A total of 30 studies were selected. In a per-patient and a per-groin analysis, the DR for SLN of PL was respectively 96.13% and 92.57%; for the blue dye was 90.44% and 66.21%; for the ICG, the DR was 91.90% and 94.80%. The pooled DR of SPECT/CT was not calculated, since only two studies were performed in this setting. At a patient-based analysis, no significant difference was documented among PL, blue dye, and ICG (p = 0.28). At a per-groin analysis, PL and ICG demonstrated a significantly higher DR compared to blue dye (p < 0.05). The average number of SLNs, on a per-patient analysis, was available only for PL and ICG with a median number of 2.61 and 1.78 lymph nodes detected, respectively, and no significant statistical difference.

CONCLUSIONS: This meta-analysis favors the use of ICG and PL alone and in combination over blue dye for the identification of the SLN in vulvar cancer. Future studies may investigate whether the combined approach allows the highest DR of SLN in patients with vulvar cancer.

PMID:35608701 | DOI:10.1007/s00404-022-06605-1

Sex Transm Dis. 2022 May 24. doi: 10.1097/OLQ.0000000000001650. Online ahead of print.

ABSTRACT

BACKGROUND: This study aimed to examine variations in the incidence rates of STIs (i.e., chlamydia, gonorrhea, and syphilis) across the urban-rural and area-deprivation continua from January of 2013 through December of 2018 in Yakima County, Washington. The rates of STIs has been increasing in the United States in the past decade. Historically, Yakima County has higher rates of STIs than state and national rates. Additionally, Yakima County contains rural areas and areas with greater deprivation which face gaps in access to care.

METHODS: The Washington State Department of Health Database Surveillance System was utilized to conduct the study. The dataset included diagnosed cases of chlamydia, gonorrhea, and syphilis with positive laboratory test results for the duration of the study period. Incidence rates of STIs were calculated and statistically analyzed across the urban-rural and area-deprivation continua using Rural-Urban Commuting Area codes and the Area Deprivation Index.

RESULTS: The incidence rates of STIs increased from January of 2013 through December of 2018. STI rates did not differ in micropolitan, small town, and rural block groups compared to the metropolitan block groups. Most-deprived block groups had significantly higher STI rates compared to less-deprived block groups.

CONCLUSIONS: There is a need for increased STI intervention in higher deprivation areas including STI education. Public health officials and health care providers should be aware of these risk factors and tailor interventions to the neighborhood they serve.

PMID:35608077 | DOI:10.1097/OLQ.0000000000001650

Ergonomics. 2022 May 24:1-49. doi: 10.1080/00140139.2022.2079727. Online ahead of print.

ABSTRACT

Excessive mental workload reduces operators’ performance and threatens the safety of nuclear power plants (NPPs) in severe accident management (SAM). Given the lack of suitable mental workload measurement methods for SAM tasks, we proposed a Domain- and Task-Analytic Workload (DTAW) method to predict SAM workload. The DTAW method is developed in three stages: scenario construction based on work domain analysis, task analysis, and workload estimation with eight workload components scored through task-analytic and projective methods. To demonstrate its utility, we applied the method to construct two SAM scenarios and predict the mental workload demand of operators in these scenarios as compared to two design basis accident scenarios. With statistical analysis, the DTAW method can predict the overall subjective workload rated by NPP operators, be used to identify high-load tasks, cluster tasks with similar workload patterns, and provide direct implications for improving SAM strategies and supporting systems.

PMID:35608031 | DOI:10.1080/00140139.2022.2079727

Int Wound J. 2022 May 24. doi: 10.1111/iwj.13782. Online ahead of print.

ABSTRACT

The objective of this study was to assess the viability and acceptability of an innovative Virtual Wound Care Command Centre where patients in the community, and their treating clinicians, have access to an expert wound specialist service that comprises a digitally enabled application for wound analysis, decision-making, remote consultation, and monitoring. Fifty-one patients with chronic wounds from 9 centres, encompassing hospital services, outpatient clinics, and community nurses in one metropolitan and rural state in Australia, were enrolled and a total of 61 wounds were analysed over 7 months. Patients received, on average, an occasion of service every 4.4 days, with direct queries responded to in a median time of 1.5 hours. During the study period, 26 (42.6%) wounds were healed, with a median time to healing of 66 (95% CI: 56-88) days. All patients reported high satisfaction with their wound care, 86.4% of patients recommended the Virtual Wound Care Command Centre with 84.1% of patients reporting the digital wound application as easy to use. Potential mean travel savings of $99.65 for rural patients per visit were recognised. The data revealed that the Virtual Wound Care Command Centre was a viable and acceptable patient-centred expert wound consultation service for chronic wound patients in the community.

PMID:35607997 | DOI:10.1111/iwj.13782

Autism Res. 2022 May 24. doi: 10.1002/aur.2759. Online ahead of print.

ABSTRACT

Bayesian models of autism suggest that alterations in context-sensitive prediction error weighting may underpin sensory perceptual alterations, such as hypersensitivities. We used an auditory oddball paradigm with pure tones arising from high or low uncertainty contexts to determine whether autistic individuals display differences in context adjustment relative to neurotypicals. We did not find group differences in early prediction error responses indexed by mismatch negativity. A dimensional approach revealed a positive correlation between context-dependent prediction errors and subjective reports of auditory sensitivities, but not with autistic traits. These findings suggest that autism studies may benefit from accounting for sensory sensitivities in group comparisons. LAY SUMMARY: We aimed to understand if autistic and non-autistic groups showed differences in their electrical brain activity measured by electroencephalography (EEG) when listening to surprising tones infrequently embedded in a statistical pattern. We found no differences between the autistic and the non-autistic group in their EEG response to the surprising sound even if the pattern switched, indicating their ability to learn a pattern. We did find that, as subjective sensory sensitivities (but not autistic traits) increased, there were increasingly large differences between the EEG responses to surprising tones that were embedded in the different statistical patterns of tones. These findings show that perceptual alterations may be a function of sensory sensitivities, but not necessarily autistic traits. We suggest that future EEG studies in autism may benefit from accounting for sensory sensitivities.

PMID:35607992 | DOI:10.1002/aur.2759

Hypertension. 2022 May 24:101161HYPERTENSIONAHA12118881. doi: 10.1161/HYPERTENSIONAHA.121.18881. Online ahead of print.

ABSTRACT

BACKGROUND: Recent hypertension guidelines have recommended lower blood pressure (BP) targets in high-risk patients. However, there are no specific guidelines based on age or systolic and diastolic blood pressure (SBP and DBP, respectively). We aimed to assess the effects of age-related BP on development of end-stage renal disease (ESRD) in patients with diabetes.

METHODS: A total of 2 563 870 patients with diabetes aged >20 years were selected from the Korean National Health Screening Program from 2009 to 2012 and followed up until the end of 2019. Participants were categorized into age and BP groups, and the hazard ratios for ESRD were calculated.

RESULTS: During a median follow-up of 7.15 years, the incidence rates of ESRD increased with increasing SBP and DBP. The hazard ratio for ESRD was the highest in patients younger than 40 years of age with DBP≥100 mm Hg. The effect of SBP and DBP on ESRD development was attenuated with age (interaction P was <0.0001 for age and SBP, and 0.0022 for age and DBP). The subgroup analysis for sex, antihypertension medication, and history of chronic kidney disease showed higher hazard ratios for ESRD among males, younger than 40 years, not taking antihypertension medications and chronic kidney disease compared to those among females, older than 40 years, antihypertension medication, and nonchronic kidney disease groups.

CONCLUSIONS: Higher SBP and DBP increase the risk of developing ESRD in patients with diabetes, and in particular, younger individuals face greater risk. Therefore, intensive BP management is warranted in younger patients to prevent ESRD.

PMID:35607989 | DOI:10.1161/HYPERTENSIONAHA.121.18881