Tag: statistics

J Clin Pharm Ther. 2022 Mar 6. doi: 10.1111/jcpt.13629. Online ahead of print.

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Reports said immunotherapy is effective for the treatment of idiopathic recurrent miscarriage (RM). Immunotherapy is invasive, and lymphocyte therapy carries some risk of infection. Oral immunosuppressants have the advantages of simple administration and convenience; however, there is no statistical analysis of whether they can improve pregnancy outcomes in patients with idiopathic RM.

METHODS: Six databases were searched for studies on oral immunosuppressants and RM; 374 articles were identified. There were two oral immunosuppressants, cyclosporine A and prednisone; two studies were on cyclosporine A and three studies were on prednisone for RM.

RESULTS AND DISCUSSION: In total, 554 RM patients were included in this analysis, including 357 patients who received oral immunosuppressive agents and 197 patients who received basic treatment, placebo, or no treatment. Oral administration of cyclosporine A or prednisolone increases live birth rate (OR = 3.6, 95% CI: 2.1-6.15, p < 0.00001) and ongoing pregnancy rate (OR = 8.82, 95% CI: 2.91-26.75, p = 0.0001) in patients with idiopathic RM. Drug use reduced miscarriage rate (OR = 0.21, 95% CI: 0.08-0.52, p = 0.0007); however, there was significant heterogeneity (I² = 73%) and a moderate-to-severe risk of bias. There was no effect on premature birth rate (OR = 2.26, 95% CI: 0.96-5.31, p = 0.06). This meta-analysis cannot provide a reference for the duration of medication treatment because the selected studies had inconsistent durations.

WHAT IS NEW AND CONCLUSION: We did a statistical analysis and found that oral immunosuppressants (including cyclosporine A or prednisolone) can improve pregnancy outcomes in patients with idiopathic RM, increase live birth rate and ongoing pregnancy rate, and reduce miscarriage rate.

PMID:35249235 | DOI:10.1111/jcpt.13629

J Sleep Res. 2022 Mar 6:e13571. doi: 10.1111/jsr.13571. Online ahead of print.

ABSTRACT

Questionnaires for restless legs syndrome have rarely been validated against face-to-face interviews in the general population. We aimed to validate the modified Norwegian, seven-item Cambridge-Hopkins restless legs syndrome questionnaire and a single diagnostic question for restless legs syndrome. We also aimed to stratify validity at 65 years of age. Among a random sample of 1,201 participants from the fourth wave of the Trøndelag Health Study, 232 (19%) agreed to participate, out of whom 221 had complete data for analyses. Participants completed the questionnaires for restless legs syndrome immediately before attending a face-to-face interview using the latest diagnostic criteria. We calculated sensitivity, specificity, and Cohen’s kappa statistic (κ) of questionnaire- versus interview-based diagnoses. We found acceptable validity of the seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome (κ = 0.37, 95% confidence interval [CI] 0.23-0.51) and good validity of the single diagnostic question (κ = 0.47, 95% CI 0.35-0.58). We also found good validity through the combination of modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome items 2 and 5, while item 1 or 2 alone showed only acceptable validity. The single diagnostic question was significantly more valid among those aged <65 years (κ = 0.60 versus κ = 0.26). Both single- and two-item questionnaire-based diagnoses overestimated interview-based restless legs syndrome prevalence. The seven-item modified Cambridge-Hopkins diagnostic questionnaire for restless legs syndrome will be useful for epidemiological studies although low sensitivity may cause underestimation of true restless legs syndrome prevalence in the general population, especially among elderly. Brief questionnaire-based diagnoses of up to three items seem best utilised as an initial screen. Future studies should identify brief and even more valid questionnaire-based diagnoses for restless legs syndrome in order to estimate prevalence accurately in large epidemiological studies.

PMID:35249243 | DOI:10.1111/jsr.13571

CNS Drugs. 2022 Mar 6. doi: 10.1007/s40263-022-00909-1. Online ahead of print.

ABSTRACT

BACKGROUND: Use of muscle relaxants is rapidly increasing in the USA. Little is understood about the role of drug interactions in the known association between muscle relaxants and unintentional traumatic injury, a clinically important endpoint causing substantial morbidity, disability, and death.

OBJECTIVE: We examined potential associations between concomitant drugs (i.e., precipitants) taken with muscle relaxants (affected drugs, i.e., objects) and hospital presentation for unintentional traumatic injury.

METHODS: In a series of self-controlled case series studies, we screened to identify drug interaction signals for muscle relaxant + precipitant pairs and unintentional traumatic injury. We used Optum’s de-identified Clinformatics^® Data Mart Database, 2000-2019. We included new users of a muscle relaxant, aged 16-90 years, who were dispensed at least one precipitant drug and experienced an unintentional traumatic injury during the observation period. We classified each observation day as precipitant exposed or precipitant unexposed. The outcome was an emergency department or inpatient discharge diagnosis for unintentional traumatic injury. We used conditional Poisson regression to estimate rate ratios adjusting for time-varying confounders and then accounted for multiple estimation via semi-Bayes shrinkage.

RESULTS: We identified 74,657 people who initiated muscle relaxants and experienced an unintentional traumatic injury, in whom we studied concomitant use of 2543 muscle relaxant + precipitant pairs. After adjusting for time-varying confounders, 16 (0.6%) pairs were statistically significantly and positively associated with injury, and therefore deemed signals of a potential drug interaction. Among signals, semi-Bayes shrunk, confounder-adjusted rate ratios ranged from 1.29 (95% confidence interval 1.04-1.62) for baclofen + sertraline to 2.28 (95% confidence interval 1.14-4.55) for methocarbamol + lamotrigine.

CONCLUSIONS: Using real-world data, we identified several new signals of potential muscle relaxant drug interactions associated with unintentional traumatic injury. Only one among 16 signals is currently reported in a major drug interaction knowledge base. Future studies should seek to confirm or refute these signals.

PMID:35249204 | DOI:10.1007/s40263-022-00909-1

J Card Surg. 2022 Mar 6. doi: 10.1111/jocs.16381. Online ahead of print.

ABSTRACT

AIMS: In the clinical practice a noteworthy proportion of severe symptomatic aortic stenosis patients presents with low-flow low-gradients features, these having reported a less favorable prognosis even when surgically or transcatheter treated.

METHODS AND RESULTS: We retrospectively analyzed the prospectively collected data on 1051 consecutive patients undergone balloon-expandable transcatheter aortic valve replacement at our Institution from January 2008 to January 2020. We divided the population according with a mean aortic gradient (MAG) < or ≥40 mmHg and we performed a propensity-matched analysis based on the Society of Thoracic Surgery Score and age, obtaining two homogeneous groups of 314 patients each (Groups A and B, respectively). We then analyzed the outcomes of the two groups by implementing adjusted Cox models adjusted for significant clinical differences between the two groups, such as sex, ejection fraction, comorbidities and other variables not included in the propensity-matched analysis. The only variable associated with both cardiovascular and all-cause events was an ejection fraction ≤35%. Finally, a sensitivity analysis found that an ejection fraction ≤35% was associated with an increase cardiovascular and all-cause mortality only in patients with an indexed end-diastolic volume >97 ml/m² (p = .0438 and .3363, respectively).

CONCLUSIONS: In our series a MAG <40 mmHg was not found to be per se an independent risk factor for cardiac and all-cause mortality after transcatheter aortic valve replacement. The ejection fraction was found to be an independent risk factor only in the context of enlarged left ventricular dimensions.

PMID:35249231 | DOI:10.1111/jocs.16381

Environ Sci Pollut Res Int. 2022 Mar 6. doi: 10.1007/s11356-021-18396-0. Online ahead of print.

ABSTRACT

The COVID-19 pandemic has placed the world’s population in a state of unprecedented public health and global health vulnerability. Risks to public and global health have escalated due to COVID-19 contamination. This has raised the statistics of inequity and environmental concerns. A possible outlook entails reducing the pandemic consequences by prioritizing development, biodiversity, and adaptability, offering buffer solutions. It contains vital methods for studying, comprehending, and unraveling events-examining early responses to COVID-19, sustainability, and development, relating them with overall Coronaviruses reaction. This study maps out environmental, socioeconomic, and medical/technological issues using as statistical techniques multiple correspondence analysis and validated cluster analysis. The findings encourage rapid, long-term development policy involvement to address the pandemic. The resulting crises have highlighted the necessity for the revival of health justice policies anchored in distinctive public health ethical patterns in response to them. As a general rule, resilience and preparedness will be targeted at developing and vulnerable nations and are prone to include access to vaccines, public health care, and health investment. Our findings show the relevance of innovating on sustainable development routes and yardsticks. Sustainable global health requires crucial measures in prevention, preparation, and response. Long-term policy recommendations are needed to address pandemics and their interrelated crises and foster sustained growth and socioecological protection.

PMID:35249187 | DOI:10.1007/s11356-021-18396-0

Dermatol Ther (Heidelb). 2022 Mar 6. doi: 10.1007/s13555-022-00697-y. Online ahead of print.

ABSTRACT

INTRODUCTION: Several techniques, including the use of radiofrequency (RF) devices, are currently utilized for the treatment of skin aging. This study aimed to evaluate the anti-aging effects imparted by a home-based RF beauty device and to compare these results with those of a marketed anti-aging cosmetic in vivo.

METHODS: Thirty-three women aged 35-60 years were enrolled in this randomized, controlled, split-face trial. This study involved a 12-week trial with five repeated measurements (at baseline, 2, 4, 8 and 12 weeks). One side of the face was randomly selected to be part of the experimental group and treated with the RF beauty device, while the other side was considered as control and was treated with an anti-aging cosmetic. Treatment safety was evaluated. Skin wrinkles, hydration, radiance, elasticity, color and thickness were evaluated using noninvasive equipment.

RESULTS: Thirty-two participants completed the study; one withdrew for personal reasons. Compared with the anti-aging cosmetic-treated facial side, the experimental side showed statistically significant improvements in wrinkles, skin radiance, color and thickness (p < 0.05).

CONCLUSIONS: The home-based RF beauty device was safe and effective for rejuvenation. The device was more effective than the commercially available anti-aging cosmetics.

PMID:35249173 | DOI:10.1007/s13555-022-00697-y

J Med Syst. 2022 Mar 5;46(4):20. doi: 10.1007/s10916-022-01806-2.

ABSTRACT

Adoption of Artificial Intelligence (AI) algorithms into the clinical realm will depend on their inherent trustworthiness, which is built not only by robust validation studies but is also deeply linked to the explainability and interpretability of the algorithms. Most validation studies for medical imaging AI report the performance of algorithms on study-level labels and lay little emphasis on measuring the accuracy of explanations generated by these algorithms in the form of heat maps or bounding boxes, especially in true positive cases. We propose a new metric – Explainability Failure Ratio (EFR) – derived from Clinical Explainability Failure (CEF) to address this gap in AI evaluation. We define an Explainability Failure as a case where the classification generated by an AI algorithm matches with study-level ground truth but the explanation output generated by the algorithm is inadequate to explain the algorithm’s output. We measured EFR for two algorithms that automatically detect consolidation on chest X-rays to determine the applicability of the metric and observed a lower EFR for the model that had lower sensitivity for identifying consolidation on chest X-rays, implying that the trustworthiness of a model should be determined not only by routine statistical metrics but also by novel ‘clinically-oriented’ models.

PMID:35249179 | DOI:10.1007/s10916-022-01806-2

J Cancer Res Clin Oncol. 2022 Mar 6. doi: 10.1007/s00432-022-03962-x. Online ahead of print.

ABSTRACT

PURPOSE: The majority of suspected malignant changes in the oral mucosa are detected by dentists in private practice. Statements regarding the effectiveness of visual examination of the oral cavity for early detection are not necessarily transferable between different health care systems. Our clinical-epidemiological and methodological aim was thus to conduct a prospective regional study in dental practices under everyday conditions, assess the frequency and type of oral mucosal changes, and evaluate the dental examination methodology.

METHODS: A prospective observational study was conducted, combining a feasibility study of early detection of oral cancer and its documentation with phase I ‘modelling’ to conceptualize complex interventions in health services research. Dentists in private practice continuously recruited patients over 6 months and used two different sheets for the documentation of suspicious lesions. Statistical analysis involved descriptive statistics and tests for differences (Welch test) or association (Chi-squared test).

RESULTS: Twenty-five dentists (mean age: 50 years, 24% females) participated in this study. Eleven dentists achieved the overall aim of recruiting 200 patients. Around 4200 patients (mean age: 52 years, 57.5% females) participated. The prevalence of suspicious lesions was 8.5%.

CONCLUSION: It became apparent that a study in cooperation with dentists in private practice to generate clinical-epidemiological data on the early detection of oral mucosal lesions under everyday conditions can be carried out successfully. Further studies with a corresponding level of evidence should be carried out to be able to draw conclusions about the effectiveness of the early detection measure under everyday practice conditions.

PMID:35249159 | DOI:10.1007/s00432-022-03962-x

Mol Cell Pediatr. 2022 Mar 5;9(1):4. doi: 10.1186/s40348-022-00136-0.

ABSTRACT

BACKGROUND: Cystic fibrosis (CF) is the most common genetic disorder in the Caucasian population. Despite remarkable improvements in morbidity and mortality during the last decades, the disease still limits survival and reduces quality of life of affected patients. Moreover, CF still represents substantial economic burden for healthcare systems. Inflammation and infection already start in early life and play important roles in pulmonary impairment. The aim of this study is to analyze the potential role of DMBT1, a protein with functions in inflammation, angiogenesis, and epithelial differentiation, in CF.

RESULTS: Immunohistochemically DMBT1 protein expression was upregulated in lung tissues of CF patients compared to healthy controls. Additionally, pulmonary expression of Dmbt1 was approximately 6-fold increased in an established transgenic mouse model of CF-like lung disease (ENaC tg) compared to wild-type mice as detected by qRT-PCR. Since acetylcysteine (ACC) has been shown to reduce inflammatory markers in the airways, its potential influence on DMBT1 expression was analyzed. A549 cells stably transfected with an expression plasmid encoding the largest (8kb) DMBT1 variant (DMBT1+ cells) or an empty vector control (DMBT1- cells) and incubated with ACC both showed significantly reduced DMBT1 concentrations in the culture medium (p = 0.0001). To further elucidate the function of DMBT1 in pulmonary airways, respiratory epithelial cells were examined by phase contrast microscopy. Addition of human recombinant DMBT1 resulted in altered cilia motility and irregular beat waves (p < 0.0001) suggesting a potential effect of DMBT1 on airway clearance.

CONCLUSIONS: DMBT1 is part of inflammatory processes in CF and may be used as a potential biomarker for CF lung disease and a potential tool to monitor CF progression. Furthermore, DMBT1 has a negative effect on ciliary motility thereby possibly compromising airway clearance. Application of ACC, leading to reduced DMBT1 concentrations, could be a potential therapeutic option for CF patients.

PMID:35249163 | DOI:10.1186/s40348-022-00136-0

Oral Maxillofac Surg. 2022 Mar 5. doi: 10.1007/s10006-022-01050-5. Online ahead of print.

ABSTRACT

INTRODUCTION: Three-dimensional facial scans have recently begun to play an increasingly important role in the peri-therapeutic management of oral and maxillofacial and head and neck surgery cases. Face scan images can be generated by optical facial scanners utilizing line-laser, stereophotography, or structured light modalities, as well as from volumetric data: for example, from cone beam computed tomography (CBCT). This study aimed to evaluate whether two low-cost procedures for the creation of three-dimensional face scan images were capable of producing sufficiently accurate data sets for clinical analysis.

MATERIALS AND METHODS: Fifty healthy volunteers were included in the study. Two test objects with defined dimensions (Lego bricks) were attached to the forehead and the left cheek of each volunteer. Facial anthropometric values (i.e., the distances between the medial canthi, the lateral canthi, the nasal alae, and the angles of the mouth) were first measured manually. Subsequently, face scans were performed with a smart device and manual photogrammetry and the values obtained were compared with the manually measured data sets.

RESULTS: The anthropometric distances deviated, on average, 2.17 mm from the manual measurements (smart device scanning deviation 3.01 mm, photogrammetry deviation 1.34 mm), with seven out of eight deviations being statistically significant. For the Lego brick, from a total of 32 angles, 19 values demonstrated a significant difference from the original 90° angles. The average deviation was 6.5° (smart device scanning deviation 10.1°, photogrammetry deviation 2.8°).

CONCLUSION: Manual photogrammetry demonstrated greater accuracy when creating three-dimensional face scan images; however, smart devices are more user-friendly. Dental professionals should monitor camera and smart device technical improvements carefully when choosing and adequate technique for 3D scanning.

PMID:35249150 | DOI:10.1007/s10006-022-01050-5