Tag: statistics

Clin Oral Investig. 2022 May 2. doi: 10.1007/s00784-022-04514-w. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of this randomized clinical trial (RCT) was to explore the clinical survival of a new, Bis-GMA-free pit and fissure sealant (Helioseal F Plus) in comparison to an established control material (Helioseal F).

MATERIAL AND METHODS: This in vivo study was designed as a prospective, 2-year, two-centre RCT with a split-mouth design. The initial study population consisted of 92 adolescents who were followed up 1 month (N = 89), 6 months (N = 88), 1 year (N = 85) and 2 years (N = 82) after sealant application. The attrition rate was 10.9% after 2 years. At each examination, the sealant retention and presence of caries were recorded. The statistical analysis included the calculation of Kaplan-Meier survival curves, log-rank tests and a Cox proportional hazard regression model.

RESULTS: No adverse events during the application or any of the follow-up visits were documented. The proportion of completely intact sealants and those with minimal loss was almost identical in both groups at 85.9% (Helioseal F Plus) and 86.5% Helioseal F) after 2 years of observation. The regression analysis revealed operator dependency; no significant differences were found between the materials, the study centres, the chosen isolation technique and patient age or sex.

CONCLUSION: The newly developed sealant can be evaluated as at least equivalent in terms of survival and retention behaviour compared to the established control material.

CLINICAL RELEVANCE: The new sealant can be recommended for clinical use. With respect to the material properties (Bis-GMA-free, less light polymerisation time and better thixotropic behaviour), it offers additional advantages with clinical relevance.

PMID:35499655 | DOI:10.1007/s00784-022-04514-w

Mov Disord. 2022 May 2. doi: 10.1002/mds.29033. Online ahead of print.

ABSTRACT

BACKGROUND: Early diagnosis in patients with neurodegenerative disorders is crucial to initiate disease-modifying therapies at a time point where progressive neurodegeneration can still be modified.

OBJECTIVES: The objective of this study was to determine whether motor or non-motor signs of the disease occur as indicators of a prodromal phase of X-linked dystonia-parkinsonism (XDP), a highly-penetrant monogenic movement disorder with striking basal ganglia pathology.

METHODS: In addition to a comprehensive clinical assessment, sensor-based balance and gait analyses were performed in non-manifesting mutation carriers (NMCs), healthy controls (HCs), and patients with XDP. Gradient-boosted trees (GBT) methodology was utilized to classify groups of interest.

RESULTS: There were no clinically overt disease manifestations in the NMCs. Balance analysis, however, revealed a classification accuracy of 90% for the comparison of NMC versus HC. For the gait analysis, the best-performing GBT-based model showed a balanced accuracy of 95% (NMC vs. HC; walking at maximum speed). Using a separate analysis of genetic modifiers, several gait parameters correlated strongly with the estimated age at disease onset in the NMC group.

CONCLUSIONS: Our study unraveled balance and gait abnormalities in NMCs that preceded the onset of XDP. These findings demonstrate prodromal motor changes among NMCs who will develop XDP with a very high likelihood in the future. Gait abnormalities had a predictive value for the estimated age at onset highlighting the impact of genetic modifiers in personalized treatment in monogenic neurodegenerative disorders. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

PMID:35491955 | DOI:10.1002/mds.29033

Scand J Public Health. 2022 May 1:14034948221089769. doi: 10.1177/14034948221089769. Online ahead of print.

ABSTRACT

AIM: To analyse the associations between bullying victimisation, disability, and self-reported psychosomatic complaints in adolescents, and to investigate the role of support from parents and teachers in such associations.

METHODS: The study was based on Finnish and Swedish data from two waves (2013/2014 and 2017/2018) of the Health Behaviour in School-aged Children survey (n=16,057). Descriptive statistics were produced for four groups of adolescents: (a) bullied with disabilities; (b) not bullied with disabilities; (c) bullied without disabilities; and (d) not bullied without disabilities (reference group). Two multilevel multinomial logistic regression models were performed for the Finnish and Swedish samples separately. The first model analysed associations between psychosomatic complaints and bullying victimisation, controlling for a range of confounders. The second model analysed associations between psychosomatic complaints and social support from parents and teachers.

RESULTS: Across both countries, bullied adolescents with disabilities were more likely to self-report psychosomatic complaints than the reference group, even after adjusting for other potential confounders. Teacher support was identified as a potential protective factor as the odds ratio for psychosomatic complaints decreased when including teacher support as a factor in the model. The association with parent support showed mixed findings in Finland and Sweden.

CONCLUSIONS: Disability in combination with bullying victimisation generated the highest levels of self-reported psychosomatic complaints compared to adolescents that were not bullied nor had disabilities. High teacher support may be a protective factor against psychosomatic complaints for bullied and/or disabled adolescents.

PMID:35491912 | DOI:10.1177/14034948221089769

Vascular. 2022 Apr 30:17085381221094943. doi: 10.1177/17085381221094943. Online ahead of print.

ABSTRACT

BACKGROUND: Acute peripheral arterial ischemia (APAI) is an acute ischemic condition that develops as a result of embolism or thrombosis, and its morbidity and mortality are still high today. The objective of this study is to determine the effect of preoperative Neutrophil-to-Lymphocyte ratio (NLR) on mortality in patients admitted with the diagnosis of APAI.

METHODS: 178 patients who were diagnosed with acute peripheral arterial occlusion and underwent emergency embolectomy were evaluated retrospectively over a 7-year period. Patient demographics, clinical history, risk factors, comorbidity, and hemogram sub-parameters were documented. The endpoint of the patients was determined as death.

RESULTS: A total of 178 patients were identified with a mean age 74.29±14.71 (range 28-111) years; among them, 105 (59%) were female. 18% patients (32/178) died within 30 days. Lower extremity involvement was present in 124 (69.7%) of the patients. A statistically significant difference was found between the mortality rates and blood parameters of the patients included in the study in terms of white blood count C-reactive protein (CRP), and age among those with normal distribution. Neutrophil, NLR, procalcitonin, lactate, aspartate aminotransferase, and urea; It was statistically significant in terms of mortality in our patients with APAI. NLR values of the deceased were determined as 7.98 ± 6.85.

CONCLUSIONS: APAI patients with high NLRs had significantly higher risks of 30-day mortality. The NLR can be used as a prognostic marker in these patients and warrants further investigation.

PMID:35491879 | DOI:10.1177/17085381221094943

Circ Arrhythm Electrophysiol. 2022 May 2:CIRCEP121010075. doi: 10.1161/CIRCEP.121.010075. Online ahead of print.

ABSTRACT

BACKGROUND: Maximal left ventricular wall thickness (MLVWT) is a risk factor for sudden cardiac death (SCD) in hypertrophic cardiomyopathy (HCM). In adults, the severity of left ventricular hypertrophy has a nonlinear relationship with SCD, but it is not known whether the same complex relationship is seen in childhood. The aim of this study was to describe the relationship between left ventricular hypertrophy and SCD risk in a large international pediatric HCM cohort.

METHODS: The study cohort comprised 1075 children (mean age, 10.2 years [±4.4]) diagnosed with HCM (1-16 years) from the International Paediatric Hypertrophic Cardiomyopathy Consortium. Anonymized, noninvasive clinical data were collected from baseline evaluation and follow-up, and 5-year estimated SCD risk was calculated (HCM Risk-Kids).

RESULTS: MLVWT Z score was <10 in 598 (58.1%), ≥10 to <20 in 334 (31.1%), and ≥20 in 143 (13.3%). Higher MLVWT Z scores were associated with heart failure symptoms, unexplained syncope, left ventricular outflow tract obstruction, left atrial dilatation, and nonsustained ventricular tachycardia. One hundred twenty-two patients (71.3%) with MLVWT Z score ≥20 had coexisting risk factors for SCD. Over a median follow-up of 4.9 years (interquartile range, 2.3-9.3), 115 (10.7%) had an SCD event. Freedom from SCD event at 5 years for those with MLVWT Z scores <10, ≥10 to <20, and ≥20 was 95.6%, 87.4%, and 86.0, respectively. The estimated SCD risk at 5 years had a nonlinear, inverted U-shaped relationship with MLVWT Z score, peaking at Z score +23. The presence of coexisting risk factors had a summative effect on risk.

CONCLUSIONS: In children with HCM, an inverted U-shaped relationship exists between left ventricular hypertrophy and estimated SCD risk. The presence of additional risk factors has a summative effect on risk. While MLVWT is important for risk stratification, it should not be used either as a binary variable or in isolation to guide implantable cardioverter defibrillator implantation decisions in children with HCM.

PMID:35491873 | DOI:10.1161/CIRCEP.121.010075

Workplace Health Saf. 2022 May 2:21650799221085466. doi: 10.1177/21650799221085466. Online ahead of print.

ABSTRACT

BACKGROUND: Although studies suggest that cancer survivors face workplace obstacles, to date there has been little empirical research regarding the personal and environmental factors that can help cancer survivors adjust to work. The purpose of this study was to examine how working survivors’ resilience and job meaningfulness were related to their well-being outcomes, including lower cancer-related intrusive thoughts, fatigue, and presenteeism.

METHODS: We recruited 200 full-time employed cancer survivors from online participant panels using Qualtrics. Participants responded to an online survey that measured their resilience, job meaningfulness, job-related psychological distress, and well-being outcomes. We conducted descriptive statistical analysis, confirmatory factor analysis, and moderated mediated analysis to examine the psychological process in which resilience and job meaning are associated with cancer survivors’ mental health and work outcomes. Findings: The relationship between cancer survivors’ resilience and their well-being outcomes depended on job meaningfulness. For survivors whose jobs were not highly meaningful, their resilience was related to reduced job-related psychological distress, which, in turn, was related to lower intrusive thoughts, fatigue, and presenteeism. For survivors with highly meaningful jobs, they did not need to rely on resilience to protect them from workplace psychological distress and other negative outcomes. Conclusion/Application to Practice: It is important for working cancer survivors to develop resilience, especially when they do not perceive their work as highly meaningful. Successful resilience-building interventions can buffer the negative impact of low job meaningfulness and help working survivors achieve better outcomes. In addition, organizations can actively help enrich survivors’ jobs to increase perceived meaningfulness.

PMID:35491877 | DOI:10.1177/21650799221085466

Expert Rev Pharmacoecon Outcomes Res. 2022 Apr 30. doi: 10.1080/14737167.2022.2073222. Online ahead of print.

ABSTRACT

BACKGROUND: Numerous studies have provided evidence to the literature on the demand side of the determinants of health care expenditure by employing the Grossman model. However, understanding the supply side of the determinants of health care expenditure will be of crucial importance in improving health outcomes.

METHODS: This study has used the panel data of 15 Middle – East region countries for the time period of 2000 – 2016 periods. Initially, Grossman’s model of the demand for care is estimated. Furthermore, a Parallel model of the supply of care is estimated for contradistinction analysis. Finally, an integrated partial least square structural equation model is being developed.

RESULTS: Results show that the relative wage rate and ageing variables are the only indicators that are statistically significant with theoretically consistent signs as postulated by Grossman’s theoretical model. The opposite is true with schooling and the proxy of the medical care relative prices. However, in the parallel model, all the four drivers of the demand for care are statistically significant determinants of health care spending.

CONCLUSIONS: Therefore, expansion of health insurance coverage particularly for the elderly cohort of the population could be a promising mechanism to boost the demand for care and eventually improve health outcomes.

PMID:35491846 | DOI:10.1080/14737167.2022.2073222

Ann Parasitol. 2022;68(1):93-101. doi: 10.17420/ap6801.413.

ABSTRACT

The purpose of this research was to describe the malaria situation in Bushehr province from 2011 to 2018. The current study is a descriptive cross-sectional study based on available data. Between 2011 and 2018, 715 malaria patients were registered in the Bushehr province. The data were analyzed using IBM SPSS Statistics version 22. Male patients made up 92.7% of the total, while female patients made up 7.3%. The age group of 20-29 years had the highest frequency of malaria patients (42.3%), while the age group of over 50 years had the lowest frequency patients (2.5%). Regarding nationality, (96.9%) of malaria patients were Afghans, (2.2%) were Pakistanis, (0.8%) were Iranians, and (0.1%) were Indians. The disease was reported to be the most prevalent in 2017 and the least common in 2013 (29.6% and 2.6%). During this time, malaria prevalence has risen and fallen. Bushehr county had the greatest malaria prevalence (42%) and was followed by Kangan county (20.1%) and Asaluyeh county (12.9%). In terms of parasites, Plasmodium vivax was responsible for (94%) of the cases, P. falciparum for (2.4%), and mixed infection (P. vivax and P. falciparum) for (3.6%). Regarding disease transmission, (93.6%) was imported, (1%) was relapse, (0.4%) was indigenous, and (1.3%) was relapse and imported. Bushehr province is at risk of transmitting malaria due to suitable climatic conditions for the reproduction of vector mosquitoes. As well, it confronts the threat of imported malaria, which has caused concern in recent years as a result of the increase of job-seeking migrants. Strategies of malaria control, basic measures in the field of timely diagnosis and rapid and complete treatment of patients, especially in foreign nationals, vectors control, and preventive approaches are required to eliminate malaria in this province.

PMID:35491835 | DOI:10.17420/ap6801.413

Int J Risk Saf Med. 2022 Apr 21. doi: 10.3233/JRS-210054. Online ahead of print.

ABSTRACT

BACKGROUND: Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities.

OBJECTIVE: This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years).

METHODS: A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes ‘nervous system’ or ‘gastrointestinal’ disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports.

RESULTS: 107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for ‘altered state of consciousness’: ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2) and IC = 1.29 (0.93-1.66).

CONCLUSIONS: The disproportionality reporting of ‘altered state of consciousness’, a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.

PMID:35491805 | DOI:10.3233/JRS-210054

Int J Risk Saf Med. 2022 Apr 26. doi: 10.3233/JRS-210024. Online ahead of print.

ABSTRACT

BACKGROUND: As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications.

OBJECTIVE: This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom.

METHODS: English Tweets for 35 drug-event pairs for the period 2017-2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher’s exact test to assess the distribution and proportion of AEs from the two data sources.

RESULTS: Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent.

CONCLUSION: Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.

PMID:35491804 | DOI:10.3233/JRS-210024