Tag: statistics

Environ Int. 2021 Mar 19;153:106524. doi: 10.1016/j.envint.2021.106524. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: The growing impact of the COVID-19 pandemic has heightened the urgency of identifying individuals most at risk of infection. Per- and poly-fluoroalkyl substances (PFASs) are manufactured fluorinated chemicals widely used in many industrial and household products. The objective of this case-control study was to assess the association between PFASs exposure and COVID-19 susceptibility and to elucidate the metabolic dysregulation associated with PFASs exposure in COVID-19 patients.

METHODS: Total 160 subjects (80 COVID-19 patients and 80 symptom-free controls) were recruited from Shanxi and Shandong provinces, two regions heavily polluted by PFASs in China. Twelve common PFASs were quantified in both urine and serum. Urine metabolome profiling was performed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).

RESULTS: In unadjusted models, the risk of COVID-19 infection was positively associated with urinary levels of perfluorooctanesulfonic acid (PFOS) (Odds ratio: 2.29 [95% CI: 1.52-3.22]), perfluorooctanoic acid (PFOA) (2.91, [1.95-4.83], and total PFASs (∑ (12) PFASs) (3.31, [2.05-4.65]). After controlling for age, sex, body mass index (BMI), comorbidities, and urine albumin-to-creatinine ratio (UACR), the associations remained statistically significant (Adjusted odds ratio of 1.94 [95% CI: 1.39-2.96] for PFOS, 2.73 [1.71-4.55] for PFOA, and 2.82 [1.97-3.51] for ∑ (12) PFASs). Urine metabolome-PFASs association analysis revealed that 59% of PFASs-associated urinary endogenous metabolites in COVID-19 patients were identified to be produced or largely regulated by mitochondrial function. In addition, the increase of PFASs exposure was associated with the accumulation of key metabolites in kynurenine metabolism, which are involved in immune responses (Combined β coefficient of 0.60 [95% CI: 0.25-0.95, P = 0.001]). Moreover, alternations in PFASs-associated metabolites in mitochondrial and kynurenine metabolism were also correlated with clinical lab biomarkers for mitochondrial function (serum growth/differentiation factor-15) and immune activity (lymphocyte percentage), respectively.

CONCLUSION: Elevated exposure to PFASs was independently associated with an increased risk of COVID-19 infection. PFASs-associated metabolites were implicated in mitochondrial function and immune activity. Larger studies are needed to confirm our findings and further understand the underlying mechanisms of PFASs exposure in the pathogenesis of SARS-CoV2 infection.

PMID:33773143 | DOI:10.1016/j.envint.2021.106524

Ecotoxicol Environ Saf. 2021 Mar 24;215:112165. doi: 10.1016/j.ecoenv.2021.112165. Online ahead of print.

ABSTRACT

BACKGROUND: Exposure to metals/metalloids, including essential and nonessential elements, has been associated to male reproductive health in animals. However, findings from human studies are inconsistent.

OBJECTIVES: To investigate the impact of exposure to multiple metals/metalloids at environmental levels on the conventional human semen-quality parameters.

MATERIALS AND METHODS: Men living in rural or industrial areas were recruited by personalized letters. No exclusion criteria were applied. Each man provided one semen sample and one blood sample. We analyzed the semen sample both to determine conventional sperm parameters (concentration, progressive motility and normal forms) and to quantify lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As), nickel (Ni), vanadium (V) and selenium (Se) levels. The levels of these metals/metalloids were also quantified in venous blood and spermatozoa samples. Associations between the blood/seminal plasma metal/metalloid levels and semen quality parameters were assessed using confounder adjusted logistic regression models. Correlation and interactions between blood/seminal plasma and semen metal/metalloid levels were investigated using the Spearman’s correlation.

RESULTS: We found a positive association of seminal plasma cadmium level with lower Total count (OR = 4.48, 95%CI 0.25-80); whereas lead (OR = 4.51, 95%CI 0.86-23) and cadmium (OR = 3.45, 95%CI 0.77-16) seminal plasma levels had a positive association with progressive sperm motility. Overall, these associations remained suggestive after adjustment, though statistically unstable risks. Finally, we found weak interactions between beneficial effects of Se and detrimental ones only for Cd and Pb blood level on sperm concentration, total sperm count and progressive sperm motility.

CONCLUSIONS: Our findings suggest that environmental exposure to Pb and Cd contributes to a decline in human semen quality, whereas Se can have beneficial effects. Measurements of metals/metalloids in the seminal fluid may be more predictable of semen quality than conventional blood measurements.

PMID:33773149 | DOI:10.1016/j.ecoenv.2021.112165

Lancet Infect Dis. 2021 Mar 24:S1473-3099(21)00127-4. doi: 10.1016/S1473-3099(21)00127-4. Online ahead of print.

ABSTRACT

BACKGROUND: Although several COVID-19 vaccines have been developed so far, they will not be sufficient to meet the global demand. Development of a wider range of vaccines, with different mechanisms of action, could help control the spread of SARS-CoV-2 globally. We developed a protein subunit vaccine against COVID-19 using a dimeric form of the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein as the antigen. We aimed to assess the safety and immunogenicity of this vaccine, ZF2001, and determine the appropriate dose and schedule for an efficacy study.

METHODS: We did two randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials. Phase 1 was done at two university hospitals in Chongqing and Beijing, China, and phase 2 was done at the Hunan Provincial Center for Disease Control and Prevention in Xiangtan, China. Healthy adults aged 18-59 years, without a history of SARS-CoV or SARS-CoV-2 infection, an RT-PCR-positive test result for SARS-CoV-2, a history of contact with confirmed or suspected COVID-19 cases, and severe allergies to any component of the vaccine were eligible for enrolment. In phase 1, participants were randomly assigned (2:2:1) to receive three doses of the vaccine (25 μg or 50 μg) or placebo intramuscularly, 30 days apart. In phase 2, participants were randomly assigned (1:1:1:1:1:1) to receive the vaccine (25 μg or 50 μg) or placebo intramuscularly, 30 days apart, in either a two-dose schedule or a three-dose schedule. Investigators, participants, and the laboratory team were masked to group allocation. For phase 1, the primary outcome was safety, measured by the occurrence of adverse events and serious adverse events. For phase 2, the primary outcome was safety and immunogenicity (the seroconversion rate and the magnitude, in geometric mean titres [GMTs], of SARS-CoV-2-neutralising antibodies). Analyses were done on an intention-to-treat and per-protocol basis. These trials are registered with ClinicalTrials.gov (NCT04445194 and NCT04466085) and participant follow-up is ongoing.

FINDINGS: Between June 22 and July 3, 2020, 50 participants were enrolled into the phase 1 trial and randomly assigned to receive three doses of placebo (n=10), the 25 μg vaccine (n=20), or the 50 μg vaccine (n=20). The mean age of participants was 32·6 (SD 9·4) years. Between July 12 and July 17, 2020, 900 participants were enrolled into the phase 2 trial and randomly assigned to receive two doses of placebo (n=150), 25 μg vaccine (n=150), or 50 μg vaccine (n=150), or three doses of placebo (n=150), 25 μg vaccine (n=150), or 50 μg vaccine (n=150). The mean age of participants was 43·5 (SD 9·2) years. In both phase 1 and phase 2, adverse events reported within 30 days after vaccination were mild or moderate (grade 1 or 2) in most cases (phase 1: six [60%] of ten participants in the placebo group, 14 [70%] of 20 in the 25 μg group, and 18 [90%] of 20 in the 50 μg group; phase 2: 37 [25%] of 150 in the two-dose placebo group, 43 [29%] of 150 in the two-dose 25 μg group, 50 [33%] of 150 in the two-dose 50 μg group, 47 [31%] of 150 in the three-dose placebo group, 72 [48%] of 150 in the three-dose 25 μg group, and 65 [43%] of 150 in the three-dose 50 μg group). In phase 1, two (10%) grade 3 or worse adverse events were reported in the 50 μg group. In phase 2, grade 3 or worse adverse events were reported by 18 participants (four [3%] in the two-dose 25 μg vaccine group, two [1%] in the two-dose 50 μg vaccine group, two [1%] in the three-dose placebo group, four [3%] in the three-dose 25 μg vaccine group, and six [4%] in the three-dose 50 μg vaccine group), and 11 were considered vaccine related (two [1%] in the two-dose 25 μg vaccine group, one [1%] in the two-dose 50 μg vaccine group, one [1%] in the three-dose placebo group, two [1%] in the three-dose 25 μg vaccine group, and five [3%] in the three-dose 50 μg vaccine group); seven participants reported serious adverse events (one [1%] in the two-dose 25 μg vaccine group, one [1%] in the two-dose 50 μg vaccine group, two [1%] in the three-dose placebo group, one [1%] in the three-dose 25 μg vaccine group, and two [1%] in the three-dose 50 μg vaccine group), but none was considered vaccine related. In phase 2, on the two-dose schedule, seroconversion rates of neutralising antibodies 14 days after the second dose were 76% (114 of 150 participants) in the 25 μg group and 72% (108 of 150) in the 50 μg group; on the three-dose schedule, seroconversion rates of neutralising antibodies 14 days after the third dose were 97% (143 of 148 participants) in the 25 μg group and 93% (138 of 148) in the 50 μg group. In the two-dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the second dose were 17·7 (95% CI 13·6-23·1) in the 25 μg group and 14·1 (10·8-18·3) in the 50 μg group. In the three-dose groups in phase 2, the SARS-CoV-2-neutralising GMTs 14 days after the third dose were 102·5 (95% CI 81·8-128·5) in the 25 μg group and 69·1 (53·0-90·0) in the 50 μg group.

INTERPRETATION: The protein subunit vaccine ZF2001 appears to be well tolerated and immunogenic. The safety and immunogenicity data from the phase 1 and 2 trials support the use of the 25 μg dose in a three-dose schedule in an ongoing phase 3 trial for large-scale evaluation of ZF2001’s safety and efficacy.

FUNDING: National Program on Key Research Project of China, National Science and Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences, and Anhui Zhifei Longcom Biopharmaceutical.

TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.

PMID:33773111 | DOI:10.1016/S1473-3099(21)00127-4

Nurs Open. 2021 Mar 27. doi: 10.1002/nop2.844. Online ahead of print.

ABSTRACT

AIM: This study aimed to determine effectiveness of peanut ball on the duration of the stages of labour and frequency of caesarean section.

DESIGN: A systematic review and meta-analysis.

METHOD: A comprehensive electronic search was carried out with no time limit until December 2020. Collected data were analysed using software RevMan- version 5.3. Heterogeneity was assessed using I² , T² , and ² . GRADE approach was used to assess the certainty of evidence.

RESULTS: The meta-analysis on six clinical trials with 645 participants showed no statistically significant difference between the two groups in caesarean surgery rate (RR = 0.82) and length of the first (MD = -15.64).

CONCLUSIONS: Therefore, further clinical trials with stronger evidence should be carried out to assess the effectiveness of peanut ball on caesarean surgery rate and length of first and second stages of labour.

PMID:33773071 | DOI:10.1002/nop2.844

J Int AIDS Soc. 2021 Mar;24(3):e25691. doi: 10.1002/jia2.25691.

ABSTRACT

INTRODUCTION: As the leading sexually transmitted infection worldwide, human papillomavirus (HPV) may disproportionately affect transwomen. We aimed to estimate anal HPV prevalence, especially focusing on high-risk (hr)-HPV types and evaluate their associated factors among transwomen living in Rio de Janeiro, Brazil.

METHODS: Transwomen enrolled in a respondent-driven sampling (RDS)-based survey conducted between August 2015 and January 2016 self-collected anal samples, which were promptly stored at minus 80°C. After DNA extraction, HPV detection and genotyping were performed using the PapilloCheck test. We estimated HPV prevalences and evaluated the correlates of anal hr-HPV infection using a regression logistic model.

RESULTS: Out of 345 transwomen, 272 (78.8%) were included in this analysis (122 [44.9%] HIV-positive). No participant had ever received HPV vaccination. Among participants enrolled, 212 (77.9%) were positive for any anal HPV type and 165 (60.7%) for hr-HPV. Most common hr-HPV were as follows: HPV16 (17.6%), HPV68 (14.7%), HPV39 (14.3%), HPV56 (12.5%), HPV51 (11.4%) and HPV52 (11.0%). HIV-positive transwomen had three times the odds of having an hr-HPV compared to HIV-negative transwomen. Participants who had a current rectal Neisseria gonorrhoeae infection had 3.7 times the odds of being coinfected with hr-HPV. Among HIV-positive transwomen, neither antiretroviral therapy use, undetectable viral load, current and nadir CD4 counts were associated with anal hr-HPV infection.

CONCLUSIONS: Brazilian transwomen in our study exhibit some of the highest population-specific rates of HPV and hr-HPV. There is an urgent need to elucidate the burden of HPV infection, prevalence of HPV-related diseases and access to and uptake of HPV vaccination among transwomen, especially from low- and middle-income settings.

PMID:33773075 | DOI:10.1002/jia2.25691

Influenza Other Respir Viruses. 2021 Mar 27. doi: 10.1111/irv.12856. Online ahead of print.

ABSTRACT

BACKGROUND: Seasonal influenza vaccination is recommended for patients with chronic respiratory conditions, but uptake is suboptimal. We undertook a comprehensive mixed methods study in order to examine the barriers and enablers to influenza vaccination in patients with chronic respiratory conditions.

METHODS: Mixed methods including a survey (n = 429) which assessed sociodemographics and the psychological factors associated with vaccine uptake (ie confidence, complacency, constraints, calculation and collective responsibility) with binary logistic regression analysis. We also undertook focus groups and interviews (n = 59) to further explore barriers and enablers to uptake using thematic analysis.

RESULTS: The survey analysis identified that older participants were more likely to accept the vaccine, as were those with higher perceptions of collective responsibility around vaccination, lower levels of complacency and lower levels of constraints. Thematic analysis showed that concerns over vaccine side effects, lack of tailored information and knowledge, and a lack of trust and rapport with healthcare professionals were key barriers. In contrast, the importance of feeling protected, acceptance of being part of an at-risk group and feeling a reduced sense of vulnerability after vaccination were seen as key enablers.

CONCLUSIONS: Our findings showed that the decision to accept a vaccine against influenza is influenced by multiple sociodemographic and psychological factors. Future interventions should provide clear and transparent information about side effects and be tailored to patients with chronic respiratory conditions. Interactions between patients and their healthcare providers have a particularly important role to play in helping patients address their concerns and feel confident in vaccination.

PMID:33773079 | DOI:10.1111/irv.12856

Liver Transpl. 2021 Mar 26. doi: 10.1002/lt.26057. Online ahead of print.

ABSTRACT

Organ shortage continues to limit our ability to provide transplant to all in need of liver transplantation. The current urgency-based system is based on the laboratory MELD-Na score, which efficiently and effectively rank orders patients by their estimated risk for 90-day waitlist mortality, with a c-statistic of 0.88.¹ MELD-Na is agnostic to factors such as age, etiology of liver disease, and co-morbidity, as well as one’s expected post-transplant survival. Transplant centers are entrusted, according to the Final Rule, to ensure that candidates meet a minimal threshold of utility where liver transplant would benefit the patient.

PMID:33773023 | DOI:10.1002/lt.26057

Int J Dent Hyg. 2021 Mar 26. doi: 10.1111/idh.12499. Online ahead of print.

ABSTRACT

OBJECTIVES: The authors hypothesize that periodontal and peri-implant inflammatory parameters are poorer in adult patients with tongue-piercing compared with controls. The aim was to assess the influence of tongue-piercing on periodontal and peri-implant health status in adults.

METHODS: Test and control groups comprised of individuals with and without tongue-piercing, respectively. A questionnaire was used to collect information about gender, age, duration of tongue piercing and implants in function, jaw location of the implant, reasoning for wearing the tongue-ornament, and oral hygiene and ornament cleaning habits. Full-mouth and peri-implant plaque index (PI), gingival index (GI), clinical attachment loss (CAL), probing depth (PD) and marginal/crestal bone loss (MBL and CBL, respectively) on mesial and distal surfaces of teeth/implants were recorded. The material (plastic or metal) from which, the bar and ball-ends of the ornament were fabricated was also recorded. A P<0.01 was considered statistically significant.

RESULTS: Forty-eight and 49 individuals were included in the test- and control-groups, respectively. There was no difference in PI, GI, PD, CAL and MBL (mesial and distal) among individuals in the test and control groups. In the test group, peri-implant PI (P<0.01), GI (P<0.01), PD (P<0.01) and mesial (P<0.01) and distal (P<0.01) CBL were significantly higher in the anterior mandible compared with implants in other jaw locations. In the control-group, there was no difference in peri-implant PI, GI, PD and CBL around implants placed in both jaws.

CONCLUSION: Wearing tongue piercings could increase the risks of periodontal and peri-implant diseases particularly in the mandibular anterior segment.

PMID:33773044 | DOI:10.1111/idh.12499

Anat Rec (Hoboken). 2021 Mar 26. doi: 10.1002/ar.24626. Online ahead of print.

ABSTRACT

The quantification of cranial sexual dimorphism (CSD) among modern humans is relevant in evolutionary studies of morphological variation and in a forensic context. Despite the abundance of quantitative studies of CSD, few have specifically examined intra-sex variability. Here we quantify CSD in a geographically homogeneous sample of adult crania, which includes Italian individuals from the 19^th and 20^th centuries. Cranial morphology is described with 92 3D landmarks analyzed using Procrustean geometric morphometrics (PGMM). Size and shape variables are used to compare morphological variance between sexes in the whole cranium and four individual regions. The same variables, plus Procrustes form, are used to quantify average sex differences and explore classification accuracy. Our results indicate that: i) as predicted by Wainer’s rule, males present overall more variance in size and shape, albeit this is statistically significant only for total cranial size; ii) differences between sexes are dominated by size and to a lesser extent by Procrustes form; iii) shape only accounts for a minor proportion of variance; iv) the cranial base shows almost no dimorphism for shape; and v) facial Procrustes form is the most accurate predictor of skeletal sex. Overall, this study suggests developmental factors underlying differences in CSD among cranial regions; stresses the need for population-specific models that describe craniofacial variation as the basis for models that facilitate the estimation of sex in unidentified skeletal remains; and provides one of the first confirmations of ‘Wainer’s rule’ in relation to sexual dimorphism in mammals specific to the human cranium.

PMID:33773067 | DOI:10.1002/ar.24626

J Nurs Manag. 2021 Mar 27. doi: 10.1111/jonm.13316. Online ahead of print.

ABSTRACT

AIM: To determine the effectiveness of information technology interventions on hand hygiene compliance among healthcare professionals.

BACKGROUND: Performing hand hygiene is the optimal approach to prevent the transmission of healthcare-associated infections. However, results regarding the effectiveness of information technology interventions on hand hygiene compliance were inconsistent to date.

EVALUATION: A search for studies published up to May 2020 was undertaken. A meta-analysis was conducted using RevMan 5.3 software.

KEY ISSUES: The most commonly used information technology systems were: automated training, electronic counting devices and remote monitoring, real-time hand hygiene reminders and feedback, and automated monitoring. These four types of technology systems can significantly improve hand hygiene compliance among healthcare professionals (odds ratio = 3.06, p < .001).

CONCLUSION: The four types of information technology can be effectively used to change the hand hygiene behavior. Because the information systems can monitor personnel and conduct statistical analyses automatically, they save labor costs of human monitors, are more time efficient, and eliminate accompanying human error.

IMPLICATIONS FOR NURSING MANAGEMENT: The use of the four types of information technology is convenient and could reduce healthcare-associated infections; thus, they could be widely used in the future as the key to increase hand hygiene compliance rate.

PMID:33772923 | DOI:10.1111/jonm.13316