Tag: statistics

JCI Insight. 2022 Oct 24;7(20):e160964. doi: 10.1172/jci.insight.160964.

ABSTRACT

BACKGROUNDAntigen-specific regulation of autoimmune disease is a major goal. In seropositive rheumatoid arthritis (RA), T cell help to autoreactive B cells matures the citrullinated (Cit) antigen-specific immune response, generating RA-specific V domain glycosylated anti-Cit protein antibodies (ACPA VDG) before arthritis onset. Low or escalating antigen administration under “sub-immunogenic” conditions favors tolerance. We explored safety, pharmacokinetics, and immunological and clinical effects of s.c. DEN-181, comprising liposomes encapsulating self-peptide collagen II259-273 (CII) and NF-κB inhibitor 1,25-dihydroxycholecalciferol.METHODSA double-blind, placebo-controlled, exploratory, single-ascending-dose, phase I trial assessed the impact of low, medium, and high DEN-181 doses on peripheral blood CII-specific and bystander Cit64vimentin59-71-specific (Cit-Vim-specific) autoreactive T cell responses, cytokines, and ACPA in 17 HLA-DRB1*04:01+ or *01:01+ ACPA+ RA patients on methotrexate.RESULTSDEN-181 was well tolerated. Relative to placebo and normalized to baseline values, Cit-Vim-specific T cells decreased in patients administered medium and high doses of DEN-181. Relative to placebo, percentage of CII-specific programmed cell death 1+ T cells increased within 28 days of DEN-181. Exploratory analysis in DEN-181-treated patients suggested improved RA disease activity was associated with expansion of CII-specific and Cit-Vim-specific T cells; reduction in ACPA VDG, memory B cells, and inflammatory myeloid populations; and enrichment in CCR7+ and naive T cells. Single-cell sequencing identified T cell transcripts associated with tolerogenic TCR signaling and exhaustion after low or medium doses of DEN-181.CONCLUSIONThe safety and immunomodulatory activity of low/medium DEN-181 doses provide rationale to further assess antigen-specific immunomodulatory therapy in ACPA+ RA.TRIAL REGISTRATIONAnzctr.org.au identifier ACTRN12617001482358, updated September 8, 2022.FUNDINGInnovative Medicines Initiative 2 Joint Undertaking (grant agreement 777357), supported by European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations; Arthritis Queensland; National Health and Medical Research Council (NHMRC) Senior Research Fellowship; and NHMRC grant 2008287.

PMID:36278483 | DOI:10.1172/jci.insight.160964

Cardiol Young. 2022 Oct 24:1-2. doi: 10.1017/S1047951122003304. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of the study is to determine the impact of obesity in children with CHD which is severe enough to require invasive catheterisation.

METHODOLOGY: This is a retrospective study in a cardiac catheterisation laboratory of a large paediatric hospital. The material consisted of 378 children from 2 to 19 years old who underwent heart catheterisation in the years 2011-2019. Their anthropometric data were collected, and the body mass index was calculated. The BMI centile was then calculated according to the Centers for Diseases Control (CDC). They were classified as overweight (85-95th centile), obese (> 95th centile), normal weight (5th-85 centile), and underweight (< 5th centile).

RESULTS: 18.7% of children were underweight, 54.76% were normal weight, 11.64% were overweight, and 14.81% were obese. Overall, 26.45% of the children were overweight. Boys were more likely to have increased body weight than girls, but the difference was not statistically significant. The percentage of increased weight was similar in children with acyanotic CHD as well as heart disease from other causes. On the contrary, children with cyanotic heart disease were more likely to be younger and have a higher percentage of underweight children.

CONCLUSIONS: The rates of obesity and overweight in children with CHD depend on the sex, age, and cardiopathy type. In addition, they agree with the findings that have been published in international series studies for children with CHD.

PMID:36278477 | DOI:10.1017/S1047951122003304

Rev Recent Clin Trials. 2022 Oct 19. doi: 10.2174/1574887118666221019100542. Online ahead of print.

ABSTRACT

BACKGROUND: There has been a concern in the quality of clinical trials conducted in terms of data integrity, accuracy or ethical conduct. This study aimed to assess the tangible gap existing in knowledge and application of rules and guidelines among Researcher, Research staff (RS) and Eth-ics Committee (EC) members – the three research stakeholders at the study sites.

METHOD: A validated e-questionnaire with details for demography, role, years of experience, affilia-tion and questions on knowledge and understanding about their clinical research functions based on the New Drugs and Clinical Trials (NDCT) Rules 2019, including: ‘Role and responsibility, Regula-tions, Reporting timelines, Documentation, Conflict of interest and Miscellaneous’ was circulated among the seven research sites of one organization with their fourteen Institutional ECs as part of the planned annual survey. Responses with >60% correct answers were arbitrarily considered to rep-resent adequate knowledge Results Of 201participants, there were 27.4% Researchers, 50.2% were from the EC and 22.4% RS. A greater proportion of Researchers had >5 years (43.6%) of experience. The mean ±SD of correct an-swers obtained was 66.9±14.77 and was statistically significant (p<0.05) among the groups, highest for EC members (71.4±11.51), those with 2-5 years of experience (68.4±14.40), and least for the RS (56.8±11.93). Researchers (> 90%) were aware of their role in the clinical trial agreement and importance of the trial registration in Clinical Trials Registry-India. There were gaps in the Informed Consent (IC) process and post-trial access. Awareness regarding the IC process was adequate among the RS (84%). Awareness that the re-sponsibility of all delegation at site finally lies with the Researchers was adequate (60%) but 20% wrongly believed that the sponsor can have access to subject identification details. Deficiencies were noted regarding documentation, NDCT rules -2019 and serious adverse event (SAE) reporting process. Five percent answered that Data Clarification Forms were generated after reviewing the case report forms. The awareness that NDCT rules-2019 was not for medical devices, student pro-jects or Investigator Initiated Studies was inadequate (56%). The EC members’ awareness in roles and responsibilities was adequate (≥ 90%). Knowledge gaps were noted in EC monitoring of the ongoing trials (32%), and SAE reporting on SUGAM portal (8.8%), where stakeholders can access the regulator’s web services using a single window interface for clinical trial related activities. Conclusion There are gaps in the knowledge of the 3 stakeholders at site. Identifying and rectifying the gray areas will have the site better placed in performance. There is a need for regular training and assess-ments.

PMID:36278456 | DOI:10.2174/1574887118666221019100542

Transfusion. 2022 Oct 24. doi: 10.1111/trf.17155. Online ahead of print.

ABSTRACT

BACKGROUND: Myelodysplastic syndrome (MDS) is a marrow failure disease. As patients often require chronic transfusion, many develop red blood cell (RBC) alloimmunization or immune-mediated platelet refractoriness. MDS represents a spectrum of diseases with specific categorizations and genetic abnormalities, and we set out to determine if these characteristics predispose patients to antibody formation.

STUDY DESIGN AND METHODS: A natural language search identified MDS patients with pre-transfusion testing from 2015 to 2020. Marrow reports, cytogenetic results, and next-generation sequencing panels were gathered. Transfusion history and testing were collected from the laboratory information system.

RESULTS: The group consisted of 226 biopsy-proven MDS patients. The prevalence of RBC alloimmunization was 11.1% (25 of 226). Half (23 of 46) of all RBC alloantibodies were against Rh (C, c, E, e) and Kell (K) antigens. There was a relative enrichment for JAK2 positivity among the RBC alloimmunized group. A total of 7.1% (16 of 226) of patients had immune-mediated platelet refractoriness and had increased transfusion requirements (p ≤ 0.01). No disease type or genetic abnormality was significantly associated with alloimmunization or immune-mediated platelet refractoriness.

DISCUSSION: While JAK2 specific mutations were enriched among RBC alloimmunized patients, this association failed to reach statistical significance in our single-center cohort. Further study using larger patient cohorts is warranted. Overall, this cohort of MDS patients had very similar RBC alloimmunization prevalence and anti-RBC antibody specificities as other recent literature. Our data reinforce the finding that MDS patients are at greater risk for alloimmunization and support the use of extended phenotype matching for these at-risk patients.

PMID:36278434 | DOI:10.1111/trf.17155

Clin Oral Implants Res. 2022 Oct 24. doi: 10.1111/clr.14015. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the association between different vertical levels of the abutment margin and residual cement prevalence in cement-retained implant restorations with customized abutments.

METHODS: One hundred and nine single-unit cement-retained implant restorations with a screw-access channel were included. The crowns were intraorally cemented on the abutments, and excess cement was removed. The abutment-crown complex was unscrewed, and the abutment-crown complex and peri-implant tissue were photographed. Residual cement presence was recorded by dividing the abutment-crown complex and peri-implant tissue into 4 quadrants: mesial, distal, buccal, and lingual. The prevalence of residual cement was compared according to the height of the custom abutment margin of the corresponding quadrant. A multilevel model was used for statistical analysis (α=.05).

RESULTS: Cement remnants were discovered on 72.48% of the dental implants. When the restoration quadrants were compared, cement remnants were present on 51.38%, 39.45%, 20.18%, and 17.43% of the mesial, distal, buccal, and lingual surfaces, respectively (P<.01). Regarding the abutment margin level, cement residues were found in 60.22% and 61.4% of the 0.5 mm subgingival and ≥1 mm subgingival margin groups, respectively, which were significantly more than those in the supragingival (23.65%) and equigingival (26.59%) margin groups (P<.01). After adjustment for confounding factors, the adjusted odds ratio (with 95% confidence interval) for residual cement in the subgingival margin groups was 3.664 (1.71, 7.852) when compared to the supragingival and equigingival margin groups.

CONCLUSIONS: The risk of residual cement occurrence was 3.66-fold higher with a subgingival abutment margin than with supragingival and equigingival abutment margins.

PMID:36278423 | DOI:10.1111/clr.14015

Work. 2022 Oct 17. doi: 10.3233/WOR-211289. Online ahead of print.

ABSTRACT

BACKGROUND: Police officers are exposed to specific occupational tasks, which require lifting, trunk flexion and rotation, carrying weight, and frequent standing periods, which may be associated with an increased risk of experiencing low back pain (LBP).

OBJECTIVE: To describe the prevalence and intensity of chronic LBP (CLBP) in Brazilian Federal Highway Police officers (FHPO) from Rio Grande do Sul state and evaluate its associated factors.

METHODS: A total of 208 FHPO participated in this study. The participants answered an electronic questionnaire containing sociodemographic, behavioral, and occupational questions, and CLBP history. Data analyzes comprised descriptive statistics and Poisson regression models.

RESULTS: Most of the FHPO were male, aged 41 or more, lived with a partner and were physically active. Sixty-seven percent of FHPO had CLBP, and the median pain intensity was 3.0 (IQR = 0- 5). Participants who lived with a partner were less likely to report CLBP (PR) = 0.80; 95% CI = 0.64; 0.99). On the other hand, those who worked as FHPO for more than 11 years were more likely to report CLPB (PR = 1.32; 95% CI = 1.06; 1.63), and high pain intensity (β= 0.95; 95% CI = 0.19; 1.71).

CONCLUSIONS: The high CLBP prevalence among FHPO from Rio Grande do Sul state indicates a need to highlight the importance for police organizations to promote CLBP prevention and implement workplace management programs.

PMID:36278387 | DOI:10.3233/WOR-211289

Work. 2022 Oct 17. doi: 10.3233/WOR-211235. Online ahead of print.

ABSTRACT

BACKGROUND: Taxi drivers are prone to musculoskeletal problems and can suffer from cardiovascular disease, respiratory disease, and psychosocial problems. For occupational health and safety it is crucial to know the risk factors and initiatives to be taken for protection.

OBJECTIVES: This study was carried out to evaluate the opinions of taxi drivers regarding occupational risks and prevention strategies.

METHODS: This was a descriptive and cross-sectional study including 524 taxi drivers. A questionnaire was developed to determine the opinions of taxi drivers regarding occupational risks and intervention strategies. For the analysis of data, Mann-Whitney U (Z-table value), descriptive statistics (number, percentage) and Chi-square (χ2) test between dependent and independent variables were used.

RESULTS: Among the taxi drivers, the occupation was reported to be risky for musculoskeletal system disorders by 67%, for cardiovascular diseases by 68.3%, for respiratory diseases by 46.9% and for psychosocial problems by 63.3%. When the opinions of taxi drivers regarding prevention from these risks were examined, 30.2% of them stated prevention from musculoskeletal system disorders, 34.0% from cardiovascular diseases, 31.3% from respiratory diseases and 40.1% from psychosocial problems. It was a prominent finding to see a decrease in the number of drivers who stated to show prevention behavior towards these risks compared to their states of recognizing them.CONCLUSİON:Drivers were insufficient both in recognizing health risks of their jobs and implementing intervention strategies. Education concerning health risks of their jobs and prevention from these risks is required.

PMID:36278386 | DOI:10.3233/WOR-211235

Work. 2022 Oct 20. doi: 10.3233/WOR-211161. Online ahead of print.

ABSTRACT

BACKGROUND: The COVID-19 pandemic has brought many restrictions that affected Turkey as well as other countries around the world. Restrictions on education, sports activities and social activities affected students physically and psychologically.

OBJECTIVE: The aim of this study is to investigate the impact of the COVID-19 pandemic on weight gain, physical activity, and mental health among university students.

METHODS: The study included students of Pamukkale University aged between 18-25 years. Participants answered the online survey about changes in body composition and physical activity habits during the pandemic. International Physical Activity Questionnaire (IPAQ) was used to assess physical activity levels. Beck Depression Scale (BDS) was used to assess the mental health.

RESULTS: 848 (546 females, 302 males) students average aged 20,72±1,63 years were included in the study. When the physical activity times before and during the pandemic were compared, a statistically significant difference was found (p < 0.05). Multivariate analyses showed that higher BDS scores (p = 0.000) were significantly associated with increased weight gain. But there was no significant association with age and changes in physical activity time.

CONCLUSIONS: The results of the study showed that the COVID-19 pandemic has a negative effect on the physical activity level, weight gain and mental health of university students. Students reported an increase in weight during the pandemic. Also, the increase in depressive symptoms is related to higher levels of weight gain. Therefore, physical activity and mental health programmes should be offered to university students as an educational and health policy.

PMID:36278383 | DOI:10.3233/WOR-211161

Work. 2022 Oct 21. doi: 10.3233/WOR-211155. Online ahead of print.

ABSTRACT

BACKGROUND: Supported Employment (SE) has shown better results in the employment rate for persons with disabilities than other methods within vocational rehabilitation, but how SE affects the employment rate for subgroups in the interventions needs further attention.

OBJECTIVE: To examine previous research regarding the influence of intersecting statuses on the employment rate in SE for people with psychiatric, neuropsychiatric, or intellectual disabilities according to type of diagnosis, sex, race/ethnicity, age, level of education and previous work history.

METHODS: A systematic literature search was conducted in nine databases including peer-reviewed articles from 2000 to April 2021. Articles presenting the employment rate in SE interventions according to the intersecting statuses listed in the objective were included.

RESULTS: The searches identified 3777 unique records, of which 53 articles were included in data extraction. In most of the included articles, intersecting statuses did not affect the employment rate for people in the SE interventions with psychiatric disabilities. Few studies have examined neuropsychiatric and intellectual disabilities. A majority of the studies subjected to full-text analysis were excluded due to a lack of reporting of the effects of intersecting statuses on the employment rate. The studies that reported on the effects of intersecting statuses on the employment rate often had small samples and lacked statistical power.

CONCLUSIONS: Intersecting statuses do not appear to affect the employment rate for people receiving SE interventions, but systematic reviews with pooled samples need to be undertaken because of the low reporting rate and underpowered sample sizes in existing studies.

PMID:36278382 | DOI:10.3233/WOR-211155

Work. 2022 Oct 18. doi: 10.3233/WOR-211110. Online ahead of print.

ABSTRACT

BACKGROUND: Quality of life is currently one of the basic conceptual categories in many research disciplines. The authors of the present study are convinced that measurement of quality of life in reference to people living on the poverty line deserves special attention.

OBJECTIVE: The aim of the study was to identify relationships between the quality of life and sociodemographic variables in low-income Wrocław residents.

METHODS: The research was conducted in Wrocław (Poland) and involved 1215 respondents aged 18-64 years, whose monthly gross income per capita in the household did not exceed 1043 PLN. The respondents’ quality of life was assessed with The World Health Organization Quality of Life Questionnaire with additional questions on respondents’ social and demographic status.

RESULTS: The Wrocław residents most often assessed their quality of life as average or below average. They rated their health-related quality of life in the social domain as the highest, and in the physical domain as the lowest. Age, household size, stable source of income, savings, and indebtedness were significantly correlated with the quality of life of Wrocław residents under study. Among the respondents, statistically significant relationships between perceived health condition assessment and age, professional status, stable source of income, and debt were also identified.

CONCLUSIONS: The results of the study indicate that public health programs and other activities related to quality of life management should be directed to individuals and social groups particularly threatened by low quality of life, i.e. people living on the income poverty line.

PMID:36278380 | DOI:10.3233/WOR-211110