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Purpose: The purpose of this study was to assess the clinical empathy of a cohort of medical students spanning 4 years of undergraduate study and to identify factors associated with empathy., Methods: A cross-sectional study to assess the empathy of undergraduate medical students at the University College of Medical Sciences and GTB Hospital in Delhi, India, was conducted using the Jefferson Scale of Empathy-Student Version. Demographic data were obtained using a pre-tested, semi-open-ended questionnaire., Results: Of the 600 students, 418 participated in the survey (69.7%). The mean empathy score was 96.01 (of a maximum of 140), with a standard deviation of 14.56. The empathy scores decreased from the first to the third semester, plateaued at the fifth semester, and rose again in the seventh semester. Empathy was found to be significantly associated with the gender of the participant, with females having higher scores (P<0.001). The age of the participant, place of residence, whose decision it was for the student to enroll in an MBBS (bachelor of medicine and bachelor of surgery) program, and the choice of future specialty were not significantly associated with students' empathy scores., Conclusion: The study found significant gender differences in empathy among the participants. The empathy scores tended to decline initially and then rebound over time. The mean empathy levels found in this study are lower than those reported in most similar studies around the world; therefore, further studies are needed to analyze and address the underlying factors associated with this discrepancy.

Introduction: The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings., Methods: EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings., Results: After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA 1c ) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA 1c (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m 2 ), all p < 0.0001. Reductions in HbA 1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%)., Conclusion: Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA 1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification., Trial Registration: ClinicalTrials.gov identifier, NCT01226966., Funding: Novo Nordisk A/S.

Background: Weakness of the shoulder girdle muscles has been reported in patients with chronic lateral elbow tendinopathy. The aim of this study was to assess the short- and long-term effects of a conventional treatment plus scapular exercises program in patients with chronic lateral elbow tendinopathy. Methods: A single-group prestudy and poststudy were conducted. The primary outcome was the Patient-Rated Tennis Elbow Evaluation questionnaire score. Secondary outcomes were grip strength; Disabilities of the Arm, Shoulder, and Hand questionnaire score; Visual Analogue Scale score at rest and at grip, and presence of scapular dyskinesis. Results: A total of 65 patients (72.3% females), with a mean age of 41.8 years, were analyzed. At the end of 6 weeks, the results showed clinically and statistically significant differences (P< .05). At 1-year follow-up, the differences were: Patient-Rated Tennis Elbow Evaluation -31 points (P<.001); grip strength +33.6% (P<.001); Disabilities of the Arm, Shoulder, and Hand -34.2 points (P < .001); Visual Analogue Scale at rest -2.5 cm (P < .001); and Visual Analogue Scale at grip -2.3 cm (P < .001). Conclusion: At the end of 6 weeks and at 1-year follow-up, conventional treatment plus scapular exercises program showed statistically and clinically significant differences in all functional outcomes assessed in patients with lateral elbow tendinopathy. [ABSTRACT FROM AUTHOR]

Abstract Background Obesity has been linked to arterial stiffness, while no consensus was reached on the association. We aimed to clarify the association of general and central obesity with arterial stiffness by combining observational studies and Mendelian randomization (MR) study. Methods Two cross-sectional studies were performed in UK Biobank and Fuqing Cohort, respectively. Two-sample MR study was conducted using summary data of GWASs from GIANT consortium and UK Biobank. General obesity and central obesity were measured using body mass index (BMI) and waist circumference (WC), respectively. Arterial stiffness was measured by arterial stiffness index (ASI) in UK Biobank or branchial-ankle pulse wave velocity (baPWV) in Fuqing Cohort. Results Two observational studies found a consistent positive association of BMI and WC with arterial stiffness when adjusting for age, sex, education, smoking, alcohol drinking, physical activity, and LDL cholesterol. However, when additionally adjusting for metabolic traits (i.e., systolic blood pressure, diastolic blood pressure, blood glucose, triglycerides, high-density lipoprotein cholesterol, and WC or BMI), the association with BMI changed to be inverse. As compared to the lowest quintile group, the adjusted ORs across groups of second to fifth quintile were 0.93, 0.90, 0.83, and 0.72 in UK Biobank and 0.88, 0.65, 0.63, and 0.50 in Fuqing Cohort. In contrast, the positive relationship with WC remained stable with the adjusted ORs of 1.23, 1.46, 1.60, and 1.56 in UK Biobank and 1.35, 1.44, 1.77, and 1.64 in Fuqing Cohort. MR analyses provided supportive evidence of the negative association with BMI (OR = 0.97, 95%CI = 0.94–1.00) and the positive association with WC (OR = 1.14, 95%CI = 1.08–1.20). Conclusions Observational and genetic analyses provide concordant results that central obesity is independently related to arterial stiffness, while the role of general obesity depends on metabolic status.

Background: Diabetic dyslipidemia poses a significant risk factor for cardiovascular complications in patients with diabetes mellitus. Empagliflozin and liraglutide are two commonly used medications in diabetes management, yet their comparative efficacy and safety in treating diabetic dyslipidemia remain under-explored. Aims and Objectives: This study aimed to assess the effectiveness and safety of Empagliflozin versus liraglutide in managing diabetic dyslipidemia. Materials and Methods: The study enrolled 100 participants with diabetes and dyslipidemia, divided equally into empagliflozin and liraglutide treatment groups. Baseline characteristics, including age, gender distribution, ethnicity, and duration of diabetes, were assessed and compared between the groups. Lipid profiles, encompassing total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides, were evaluated at baseline and after 6 months of treatment. Safety outcomes, such as the occurrence of mild gastrointestinal symptoms, hypoglycemia, and serious adverse events, were also monitored. Results: Both treatment groups exhibited comparable baseline characteristics. Following 6 months of treatment, both empagliflozin and liraglutide demonstrated significant improvements in lipid profiles. Reductions in total cholesterol, LDL cholesterol, and triglycerides, along with increases in HDL cholesterol, were observed in both groups. Moreover, there were no significant differences in the occurrence of adverse events between the two treatment groups, indicating similar safety profiles. Conclusion: This study provides evidence supporting the effectiveness and safety of empagliflozin and liraglutide in managing diabetic dyslipidemia. These findings highlight the potential of both medications as viable therapeutic options for patients with diabetes and dyslipidemia.

Abstract Background Numerous studies have been conducted to investigate the relationship between ABO and Rhesus (Rh) blood groups and various health outcomes. However, a comprehensive evaluation of the robustness of these associations is still lacking. Methods We searched PubMed, Web of Science, Embase, Scopus, Cochrane, and several regional databases from their inception until Feb 16, 2024, with the aim of identifying systematic reviews with meta-analyses of observational studies exploring associations between ABO and Rh blood groups and diverse health outcomes. For each association, we calculated the summary effect sizes, corresponding 95% confidence intervals, 95% prediction interval, heterogeneity, small-study effect, and evaluation of excess significance bias. The evidence was evaluated on a grading scale that ranged from convincing (Class I) to weak (Class IV). We assessed the certainty of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation criteria (GRADE). We also evaluated the methodological quality of included studies using the A Measurement Tool to Assess Systematic Reviews (AMSTAR). AMSTAR contains 11 items, which were scored as high (8–11), moderate (4–7), and low (0–3) quality. We have gotten the registration for protocol on the PROSPERO database (CRD42023409547). Results The current umbrella review included 51 systematic reviews with meta-analysis articles with 270 associations. We re-calculated each association and found only one convincing evidence (Class I) for an association between blood group B and type 2 diabetes mellitus risk compared with the non-B blood group. It had a summary odds ratio of 1.28 (95% confidence interval: 1.17, 1.40), was supported by 6870 cases with small heterogeneity (I 2 = 13%) and 95% prediction intervals excluding the null value, and without hints of small-study effects (P for Egger’s test > 0.10, but the largest study effect was not more conservative than the summary effect size) or excess of significance (P

Abstract Background Progressive supranuclear palsy (PSP) is a rare neurodegenerative brain disease with rapid progression and currently limited treatment options. A comprehensive understanding of disease progression, management, and healthcare resource utilization is limited, and further research is challenging due to the small population of patients. To address these challenges in conducting PSP research, individuals with PSP were recruited using a multichannel approach tailored specifically to the PSP community. We performed a retrospective observational study using data abstracted from participant medical records collected from multiple patient care centers. Results Seventy-two individuals with PSP were eligible for inclusion. On average, 144 medical documents per participant were collected from an average of 2.9 healthcare centers per participant, with a mean study period of 7.9 years. Among participants with a date of symptom onset documented in the medical records, the median time for the onset of the first fall was 2.0 years (IQR 3.2) before diagnosis, the median onset of unsteady gait or gait impairment was 1.2 years (IQR 1.8) before diagnosis, and the median onset of mobility problems was 0.8 years (IQR 1.8) before diagnosis. The most widely utilized healthcare resources, with at least 85% of participants using each of these resources at some point during the disease course, were medications (100%), imaging (99%), assistive devices (90%), supportive care (86%), and surgeries and procedures (85%). Conclusions This retrospective study adds to the current understanding of PSP symptoms, comorbidities, and healthcare resource utilization (HRU) across the disease journey. By involving individuals with PSP and their caregivers or legally authorized representatives in the research process, this study was unique in its approach to participant recruitment and enabled individuals to participate in research without the need for travel. We collected medical documents from multiple healthcare centers, allowing for broad data collection covering the entire disease journey. This approach to the collection of real-world data may be used to generate valuable insights into many aspects of disease progression and management in PSP and many other rare diseases.

Background: With the growing use of dental implants, there is an urgent need to determine a prosthetic placement protocol by assessing implant stability and monitoring healing. Implant Stability Quotient (ISQ) values are produced using dental non-invasive devices through resonance frequency analysis, considered as indicators for measuring primary stability (i.e., at implant placement), monitoring biological stability (osseointegration), and prosthetic loading. A systematic and detailed comparison of ISQ measurement devices, for a given patient population, is lacking in the literature. This aspect is the subject of the present work, with the devices being two that are widely used in clinical practice (Osstell® and Osseo®100). The aim of this study was to evaluate the reliability of ISQ measurement using two standard devices most commonly used in clinical practice and to highlight any differences when comparing measurements at undefined time intervals. Methods: We enrolled 50 patients (16 males and 34 females) with a mean age of 55.4 years, who indicated dental implant placement and met the inclusion criteria. The sample was divided into two equal groups based on bone density: A (D1–D2 bone density) and B (D3–D4 bone density); each had 25 patients with 40 implants. ISQ was measured using two devices: Osstell® and Osseo 100®, at different time points (A: three and B: four follow-ups). Results: All enrolled patients completed the study without adverse events; all implants placed were successful, with no implant failure. In each of the study groups, ISQ values increased gradually with increasing follow-up time, and there was no significant difference between Osstell and Osseo 100 values at follow-up times except for the T1 follow-up in group A. Temporal comparisons for the two devices revealed significant differences in T0 vs. T2 in group A, whereas significant differences existed in T0 vs. T1, T2, and T3 in group B. Our findings indicated that the overall effect significantly depended on bone density rather than on the device used to measure ISQ. Conclusion: Regardless of the devices used, the ISQ measurement effectively monitors healing after implant insertion and allows prosthetic load to be modulated according to the ISQ value, especially when prosthetizing implants placed in fine trabecular bone (D4 or regenerated bone).

Background The incidence of non-alcoholic fatty liver disease (NAFLD) is increasing by years and has become a major public health problem. Serum osteocalcin (OCN), as a marker of bone formation, may increase the risk of NAFLD. Objective To conduct a Meta-analysis to quantitatively evaluate the association between imaging or biopsy-confirmed NAFLD and serum OCN levels. Methods English databases including Medline, Embase, Web of Science, Cochrane, and PROSPERO, as well as Chinese databases including CNKI, Wanfang Data, and VIP were searched for case-control studies, cross-sectional studies, and cohort studies on serum OCN and NAFLD. Two investigators screened the literature, extracted data and performed quality evaluation. Meta-analysis was performed using Stata 16.0 software. Results A total of 13 papers involving 11 772 participants were included. Meta-analysis showed that serum OCN levels were lower in patients with NAFLD than in those without NAFLD (SMD=-0.73, 95%CI=-1.20 to -0.27, P

Abstract Given the pleiotropic effects of statins beyond their lipid-lowering effects, there have been attempts to evaluate the role of statin therapy in IPF, but they have shown inconclusive results. Data from the National Health Insurance Service (NHIS) database of South Korea were used to investigate the effects of statin therapy on IPF. The IPF cohort consisted of a total of 10,568 patients who were newly diagnosed with IPF between 2010 and 2017. These patients were then matched in a 1:3 ratio to 31,704 subjects from a control cohort without IPF, with matching based on age and sex. A case–control study was performed to evaluate the association between statin use and the risk for IPF, and the multivariable analysis revealed that statin use was associated with a lower risk for IPF (adjusted OR 0.847, 95% CI 0.800–0.898). Using the IPF cohort, we also evaluated whether statin use at the time of diagnosis was associated with future clinical outcomes. The statin use at the time of IPF diagnosis was associated with improved overall survival (adjusted HR 0.779, 95% CI 0.709–0.856). Further prospective studies are needed to clarify the role of statin therapy in IPF.

ABSTRACT Objectives To analyze factors associated with delayed initiation of breast cancer treatment at an oncology referral center in Juiz de Fora, Minas Gerais state, between 2010 and 2019. Methods This was a cohort study using data from the Hospital-based Cancer Registry. The probability of not starting treatment within 60 days, in accordance with Brazilian law, was estimated using Kaplan-Meier, method and its association with the factors studied was assessed using the Cox model, presenting hazard ratios (HR) and respective 95% confidence intervals (95%CI). Results Among the 911 participants, the probability of delayed treatment initiation was 18.8% (95%CI 16.4;21.5). Those who underwent treatment at a health service other than the one where the cancer was diagnosed had a significantly higher risk (HR: 3.49; 95%CI 3.00;4.07). Conclusion Receiving a diagnosis and treatment at the same institution may help reduce waiting time to initiate cancer treatment.

Abstract Background Headache is a prevalent and debilitating symptom following traumatic brain injury (TBI). Large-scale, prospective cohort studies are needed to establish long-term headache prevalence and associated factors after TBI. This study aimed to assess the frequency and severity of headache after TBI and determine whether sociodemographic factors, injury severity characteristics, and pre- and post-injury comorbidities predicted changes in headache frequency and severity during the first 12 months after injury. Methods A large patient sample from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) prospective observational cohort study was used. Patients were stratified based on their clinical care pathway: admitted to an emergency room (ER), a ward (ADM) or an intensive care unit (ICU) in the acute phase. Headache was assessed using a single item from the Rivermead Post-Concussion Symptoms Questionnaire measured at baseline, 3, 6 and 12 months after injury. Mixed-effect logistic regression analyses were applied to investigate changes in headache frequency and associated predictors. Results A total of 2,291 patients responded to the headache item at baseline. At study enrolment, 59.3% of patients reported acute headache, with similar frequencies across all strata. Female patients and those aged up to 40 years reported a higher frequency of headache at baseline compared to males and older adults. The frequency of severe headache was highest in patients admitted to the ICU. The frequency of headache in the ER stratum decreased substantially from baseline to 3 months and remained from 3 to 6 months. Similar trajectory trends were observed in the ICU and ADM strata across 12 months. Younger age, more severe TBI, fatigue, neck pain and vision problems were among the predictors of more severe headache over time. More than 25% of patients experienced headache at 12 months after injury. Conclusions Headache is a common symptom after TBI, especially in female and younger patients. It typically decreases in the first 3 months before stabilising. However, more than a quarter of patients still experienced headache at 12 months after injury. Translational research is needed to advance the clinical decision-making process and improve targeted medical treatment for headache. Trial registration ClinicalTrials.gov NCT02210221.

Abstract Background About one-third of persons with migraine experience transient neurologic symptoms, referred to as aura. Despite its widespread prevalence, comprehensive clinical descriptions of migraine with aura remain sparse. Therefore, we aimed to provide an in-depth phenotypic analysis of aura symptoms and characteristics in a cross-sectional study of a large sample of adults diagnosed with migraine with aura. Methods Data were extracted from the baseline characteristics of participants in the Registry for Migraine (REFORM) study – a single-center, prospective, longitudinal cohort study. Participants were adults diagnosed with migraine aura, reporting ≥ 4 monthly migraine days in the preceding 3 months. Trained personnel conducted in-person semi-structured interviews, capturing details on the nature, duration, localization, and progression of individual aura symptoms. Results Of the 227 enrolled participants with migraine with aura, the mean age was 41.1 years, with a predominant female representation (n = 205 [90.3%]). Visual aura was present in 215 (94.7%) participants, somatosensory aura in 81 (35.7%), and speech and/or language aura in 31 (13.7%). A single type of aura was observed in 148 (65.2%) participants, whilst 79 (34.8%) reported multiple aura types. Most participants (n = 220 [96.9%]) described their aura symptoms as positive or gradually spreading. Headache in relation to aura was noted by 218 (96.0%) participants, with 177 (80.8%) stating that the onset of aura symptoms preceded the onset of headache. Conclusions This study offers a detailed clinical depiction of persons with migraine with aura, who were predominantly enrolled from a tertiary care unit. The findings highlight potential gaps in the available literature on migraine with aura and should bolster clinicians’ acumen in diagnosing migraine with aura in clinical settings.

Abstract Randomized controlled trials (RCTs) have traditionally been considered the gold standard for medical evidence. However, in light of emerging methodologies in data science, many experts question the role of RCTs. Within this context, experts in the USA and Canada came together to debate whether the primacy of RCTs as the gold standard for medical evidence, still holds in light of recent methodological advances in data science and in the era of big data. The purpose of this manuscript, aims to raise awareness of the pros and cons of RCTs and observational studies in order to help guide clinicians, researchers, students, and decision-makers in making informed decisions on the quality of medical evidence to support their work. In particular, new and underappreciated advantages and disadvantages of both designs are contrasted. Innovations taking place in both of these research methodologies, which can blur the lines between the two, are also discussed. Finally, practical guidance for clinicians and future directions in assessing the quality of evidence is offered.

Summary: Background: Despite numerous studies having evaluated the associations between human papillomavirus (HPV) infection and risk of specific cancers other than anogenital tract and oropharyngeal, the findings are inconsistent and the quality of evidence has not been systematically quantified. We aimed to summarise the existing evidence as well as to evaluate the strength and credibility of these associations. Methods: We conducted an umbrella review of systematic reviews and meta-analyses of observational studies. PubMed, EMBASE, and Web of Science were searched from inception to March 2024. Studies with systematic reviews and meta-analyses that examined associations between HPV or HPV-associated genotypes infection and specific cancers were eligible for this review. The quality of the methodology was evaluated using A Measurement Tool to Assess systematic Reviews (AMSTAR). The credibility of the evidence was assessed using GRADE. The protocol was preregistered with PROSPERO (CRD42023439070). Findings: The umbrella review identified 31 eligible studies reporting 87 associations with meta-analytic estimates, including 1191 individual studies with 336,195 participants. Of those, 29 (93.5%) studies were rated as over moderate quality by AMSTAR. Only one association indicating HPV-18 infection associated with an increased risk of breast cancer (odds ratio [OR] = 3.48, 95% confidence interval [CI] = 2.24–5.41) was graded as convincing evidence. There were five unique outcomes identified as highly suggestive evidence, including HPV infection increased the risk of oral squamous cell carcinoma (OR = 7.03, 95% CI = 3.87–12.76), oesophageal cancer (OR = 3.32, 95% CI = 2.54–4.34), oesophageal squamous cell carcinoma (OR = 2.69, 95% CI = 2.05–3.54), lung cancer (OR = 3.60, 95% CI = 2.59–5.01), and breast cancer (OR = 6.26, 95% CI = 4.35–9.00). According to GRADE, one association was classified as high, indicating that compared with the controls in normal tissues, HPV infection was associated with an increased risk of breast cancer. Interpretation: The umbrella review synthesised up-to-date observational evidence on HPV infection with the risk of breast cancer, oral squamous cell carcinoma, oesophageal cancer, oesophageal squamous cell carcinoma, and lung cancer. Further larger prospective cohort studies are needed to verify the associations, providing public health recommendations for prevention of disease. Funding: National Key Research and Development Program of China, Natural Science Foundation of China, Outstanding Scientific Fund of Shengjing Hospital of China Medical University, and 345 Talent Project of Shengjing Hospital of China Medical University.

Background The modern 24/7 society demands night shift work, which is a possible risk factor for chronic diseases. This study aimed to examine the associations of rotating night shift work duration with tooth loss and severe periodontitis. Methods This cross-sectional study used data from a self-administered questionnaire survey conducted among 3,044 permanent employees aged 20–64 years through a Japanese web research company in 2023. The duration of rotating night shift work was assessed using a question from the Nurses’ Health Study. Tooth loss was assessed based on self-reported remaining natural teeth count. Severe periodontitis was assessed using a validated screening questionnaire comprising four questions related to gum disease, loose tooth, bone loss, and bleeding gums. We employed linear regression models for tooth loss and Poisson regression models for severe periodontitis, adjusting for demographic, health and work-related variables and socioeconomic status. Results Among participants included, 10.9% worked in rotating night shifts for 1–5 years, while 11.0% worked in such shifts for ≥6 years. In fully adjusted models, rotating night shift work duration of 1–5 years was associated with tooth loss (beta −0.74, 95% confidence interval (CI) [−1.55 to 0.08]) and severe periodontitis (prevalence ratio 1.80, 95% CI [1.33–2.43]); however, the association with tooth loss was not statistically significant. Conclusions This study supports that employees who work short-term rotating night shifts may experience poor oral conditions. Further research is needed to determine whether long-term rotating night shift work is associated with deteriorated oral health.

Objectives: Patients with ankle fractures associated with diabetes experience more complications following standard open reduction–internal fixation (ORIF) than those without diabetes. Augmented fixation strategies, namely extended ORIF and hindfoot nails (HFNs), may offer better results and early weightbearing in this group. The aim of this study was to define the population of patients with diabetes undergoing primary fixation for ankle fractures. Secondarily, we aimed to assess the utilisation of standard and augmented strategies and the effect of these choices on surgical outcomes, including early post-operative weightbearing and surgical complications. Methods: A national multicentre retrospective cohort study was conducted between January and June 2019 in 56 centres (10 major trauma centres and 46 trauma units) in the United Kingdom; 1360 patients with specifically defined complex ankle fractures were enrolled. The patients’ demographics, fixation choices and surgical and functional outcomes were recorded. Statistical analysis was performed to compare high-risk patients with and without diabetes. Results: There were 316 patients in the diabetes cohort with a mean age of 63.9 yrs (vs. 49.3 yrs. in the non-diabetes cohort), and a greater frailty score > 4 (24% vs. 14% (non-diabetes cohort) (p < 0.03)); 7.5% had documented neuropathy. In the diabetes cohort, 79.7% underwent standard ORIF, 7.1% extended ORIF and 10.2% an HFN, compared to 87.7%, 3.0% and 10.3% in the non-diabetes cohort. Surgical wound complications after standard-ORIF were higher in the diabetes cohort (15.1% vs. 8.7%) (p < 0.02), but patients with diabetes who underwent augmented techniques showed little difference in surgical outcomes/complications compared to non-diabetes patients, even though early-weightbearing rates were greater than for standard-ORIF. Conclusions: Ankle fractures in diabetes occur in older, frailer patients, whilst lower-than-expected neuropathy rates suggest a need for improved assessment. Augmented surgical techniques may allow earlier weightbearing without increasing complications, in keeping with modern guidelines in ankle fracture management.

Abstract Background In the course of the SARS-CoV-2 pandemic, multiple vaccines were developed. Little was known about reactogenicity and safety in comparison to established vaccines, e.g. influenza, pneumococcus, or herpes zoster. Therefore, the present study aimed to compare self-reported side effects in persons vaccinated against SARS-CoV-2 with the incidence of side effects in persons receiving one of the established vaccines. Methods A longitudinal observational study was conducted over a total of 124 days using web-based surveys. Persons receiving either a vaccination against SARS-CoV-2 or one of the established vaccines (comparator group) were included. In the first questionnaire (short-term survey), 2 weeks after vaccination, mainly local and systemic complaints were evaluated. The long-term survey (42 days after vaccination) and follow-up survey (124 weeks after vaccination) focused on medical consultations for any reason. Multivariate analyses were conducted to determine the influence of the vaccine type (SARS-CoV-2 vs. comparator) and demographic factors. Results In total, data from 16,636 participants were included. Self-reported reactogenicity was lowest in the comparator group (53.2%) and highest in the ChAdOx1 group (85.3%). Local reactions were reported most frequently after mRNA-1273 (73.9%) and systemic reactions mainly after vector-based vaccines (79.8%). Almost all SARS-CoV-2 vaccines showed increased odds of reporting local or systemic reactions. Approximately equal proportions of participants reported medical consultations. None in the comparator group suspected a link to vaccination, while this was true for just over one in 10 in the mRNA-1273 group. The multivariate analysis showed that people with SARS-CoV-2 vaccination were not more likely to report medical consultations; patients who had received a regimen with at least one ChAdOx1 were even less likely to report medical consultations. Younger age, female gender and higher comorbidity were mostly associated with higher odds of medical consultations. Conclusion The rate of adverse reactions after established vaccinations was roughly comparable to previous studies. Two weeks after vaccination, participants in the SARS-CoV-2 vaccination group reported more local and systemic local reactions than participants in the comparator group. In the further course, however, there were no higher odds of medical consultations in either of the two groups. Thus, altogether, we assume comparable safety. Trial registration DRKS-ID DRKS00025881 and DRKS-ID DRKS00025373.

Abstract Objectives To evaluate how peri-implant hard and soft tissue height (BH, MH) alter after final prostheses placement related to labial hard and soft tissue thickness (BW, MW). Materials and methods Forty-five platform-switched implants were classified into four groups according to BW and MW: type 1 (thick BW and thick MW), type 2 (thick BW and thin MW), type 3 (thin BW and thick MW), type 4 (thin BW and thin MW). Tissue resorption was evaluated on cone-beam CT images taken at final prostheses placement, at 1-year follow-up, and at 2-year follow-up. Kruskal–Wallis test and post hoc Mann–Whitney test were applied; significance was set to 0.05. Results BH resorption was 0.13 ± 0.12 mm in type 1, 0.26 ± 0.17 mm in type 2, 0.09 ± 0.09 mm in type 3, 0.94 ± 0.19 mm in type 4. Differences between type 1 and 4, type 2 and 4, and type 3 and 4 were statistically significant (p

Abstract Background Since the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens. Methods In an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related. Results Data of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 − ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 − mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens. Conclusions Our analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation. Trial registration DRKS DRKS00025881 ( https://drks.de/search/de/trial/DRKS00025373 ). Registered on 14 October 2021. DRKS DRKS00025373 ( https://drks.de/search/de/trial/DRKS00025881 ). Registered on 21 May 2021. Registered retrospectively.

Background Human mpox is a viral disease caused by an Orthopoxvirus, human mpox virus (hMPXV), typically causing fever and a rash. Mpox has historically been endemic to parts of Central and West Africa, with small numbers of imported cases reported elsewhere, but starting May 2022 an unprecedented global outbreak caused by clade IIb hMPXV was reported outside traditionally endemic countries. This prompted the initiation of MOSAIC, a cohort study implemented in Europe and Asia that aims to describe clinical and virologic outcomes of PCR-confirmed hMPXV disease, including those who receive antiviral therapy. The focus of this article, however, is on describing the study protocol itself with implementation process and operational challenges. Methods MOSAIC recruits participants of any age with laboratory-confirmed mpox disease who provide informed consent. Participants enrol in the cohort for a total of six months. Blood, lesion and throat samples are collected at several timepoints from the day of diagnosis or the first day of treatment (Day 1) until Day 28 for PCR detection of hMPXV. Clinical data are collected by clinicians and participants (via a self-completion questionnaire) for six months to characterize the signs and symptoms associated with the illness, as well as short- and more long-term outcomes. Discussion The design and prompt implementation of clinical research response is key in addressing emerging outbreaks. MOSAIC began enrolment within two months of the start of the international mpox epidemic. Enrolment has been stopped and the last follow-up visits are expected in January 2024. ICTRP registration EU CT number: 2022-501132-42-00 (22/06/2022)

Background In observational studies, how the magnitude of potential selection bias in a sensitivity analysis can be quantified is rarely discussed. The purpose of this study was to develop a sensitivity analysis strategy by using the bias-correction index (BCI) approach for quantifying the influence and direction of selection bias. Methods We used a BCI, a function of selection probabilities conditional on outcome and covariates, with different selection bias scenarios in a logistic regression setting. A bias-correction sensitivity plot was illustrated to analyze the associations between proctoscopy examination and sociodemographic variables obtained using the data from the Taiwan National Health Interview Survey (NHIS) and of a subset of individuals who consented to having their health insurance data further linked. Results We included 15,247 people aged ≥20 years, and 87.74% of whom signed the informed consent. When the entire sample was considered, smokers were less likely to undergo proctoscopic examination (odds ratio (OR): 0.69, 95% CI [0.57–0.84]), than nonsmokers were. When the data of only the people who provided consent were considered, the OR was 0.76 (95% CI [0.62–0.94]). The bias-correction sensitivity plot indicated varying ORs under different degrees of selection bias. Conclusions When data are only available in a subsample of a population, a bias-correction sensitivity plot can be used to easily visualize varying ORs under different selection bias scenarios. The similar strategy can be applied to models other than logistic regression if an appropriate BCI is derived.

Background Human mpox is a viral disease caused by an Orthopoxvirus, human mpox virus (hMPXV), typically causing fever and a rash. Mpox has historically been endemic to parts of Central and West Africa, with small numbers of imported cases reported elsewhere, but starting May 2022 an unprecedented global outbreak caused by clade IIb hMPXV was reported outside traditionally endemic countries. This prompted the initiation of MOSAIC, a cohort study implemented in Europe and Asia that aims to describe clinical and virologic outcomes of PCR-confirmed hMPXV disease, including those who receive antiviral therapy. The study is ongoing. Methods MOSAIC recruits participants of any age with laboratory-confirmed mpox disease who provide informed consent. Participants enrol in the cohort for a total of six months. Blood, lesion and throat samples are collected at several timepoints from the day of diagnosis or the first day of treatment (Day 1) until Day 28 for PCR detection of hMPXV. Clinical data are collected by clinicians and participants (via a self-completion questionnaire) for six months to characterize the signs and symptoms associated with the illness, as well as short- and more long-term outcomes. Discussion The design and prompt implementation of clinical research response is key in addressing emerging outbreaks. MOSAIC began enrolment within two months of the start of the international mpox epidemic. While the number of cases is now low, the study remains open for inclusion. ICTRP registration EU CT number: 2022-501132-42-00 (22/06/2022)

Background Bronchopulmonary dysplasia (BPD) is the most common severe lung disease in premature infants, which is the damage to immature lung caused by multiple factors. Identifying risk factors of BPD is important for developing prevention strategies. The risk factors of BPD are still controversial, and there are few systematic reviews. Objective To systematically analyze the risk factors for BPD in preterm infants. Methods This study searched CNKI, Wanfang Data, CBM, VIP, PubMed, Embase, Web of Science and Cochrane Library for studies evaluating risk factors of BPD from inception to October 2021. We used RevMan 5.3 software to perform meta-analysis. Results We included 23 studies of 33 508 BPD premature infants. The overall NOS scores of included studies were relatively high. The results of meta-analysis showed that mother with chorioamnionitis〔OR=1.46, 95%CI (1.18, 1.80) , P=0.000 6〕, gestational hypertension〔OR=1.26, 95%CI (1.15, 1.37) , P7 days〔OR=7.99, 95%CI (4.47, 14.29) , P0.05) . Conclusion Current evidence showed that mother with chorioamnionitis, gestational hypertension, preterm rupture of membranes and preterm infants with SGA, delivery room intubation, 5 min Apgar score 7 days, administration of pulmonary surfactant, steroids, RDS, PDA, sepsis, NEC were risk factors for BPD in preterm infants. High birth weight and large gestational age were protective factors for BPD in preterm infants. Clinicians should identify and address the relevant risk factors of BPD, thus preventing the BPD in premature infants.

Background: Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by SARS CoV-2 that emerged in Wuhan, China, and has rapidly spread worldwide. The mortality rate of critically ill COVID-19 patients is high. The objective of the study was to assess the COVID-19 disease severity and outcome among COVID-19 positive patients admitted before and after vaccination. Methodology: A prospective observational study conducted among all patients aged more than 18 years were included in the study. The patients who were positive before vaccination and received at least one dose of vaccine and positive after receiving two doses of vaccination included in the study. Disease severity was assessed in terms of high-resolution computed tomography (HRCT) score, intensive care unit (ICU) admission, SpO2 maintained, oxygen, plasma exchange, steroids received and on mechanical ventilation, and outcome was assessed on prognosis and stabilized/discharged to home. Results: A total of 172 were participated in the study with 101 (58.7%) males and 71 (41.3) females, respectively. Amongst them, 92 were affected before vaccination and 80 were affected before vaccination. The patients admitted in the ICU were 56 (32.6%) and 116 (67.4%) were not admitted in the ICU; among the patient admitted in ICU 42 (45.7%) before vaccination, and 14 (17.5%) were after vaccination, and difference was statistically significant with P- value 10 litres given and mechanical ventilation were positively associated with the vaccine received and disease severity with P- value

Introduction: In about 30% of cases, renal cell carcinoma (RCC) is detected initially in the metastatic stage (mRCC). The mainstay of mRCC treatment is anti-angiogenesis targeted therapy and immunotherapy which both have significantly prolonged progression-free survival and overall survival in patients with mRCC. Aim: The aim of this study was to examine the association between the time interval from diagnosis of mRCC to the start of systemic therapy with the radiologically assessed best treatment response after 12 months of therapy. Material and methods: This observational study included 85 patients diagnosed initially in the metastatic stage of RCC. All patients received single-agent systemic targeted therapy sunitinib. The minimum follow-up period was 12 months. The radiologic assessment was performed after every 3 months, and the RECIST criteria were used to evaluate the best treatment response. Results: The mean time interval from mRCC diagnosis to the start of systemic targeted therapy was 3.5 ± 2.5 months, with a median of 2 months. No statistically significant association was observed between the best radiologically assessed treatment response after 12 months of therapy and the time interval from diagnosis of mRCC to the start of systemic targeted therapy (p = 0.7). Moreover, no statistically significant association was found between the best radiologically assessed treatment response after 12 months of therapy and a total number of metastatic sites at baseline. Conclusion: No association was observed between the best radiologically assessed treatment response after 12 months of systemic targeted therapy, neither with the time interval from mRCC diagnosis to the start of systemic targeted therapy nor with the total number of metastatic sites in patients who were initially diagnosed with mRCC and received sunitinib in first-line setting.

Background Hidradenocarcinoma is a rare malignancy of sweat gland differentiation. Published literature has reported that hidradenocarcinoma has a high recurrence and metastasis rate, and the prognosis is extremely poor. However, the sample sizes included in these studies are insufficient, and therefore, the findings are doubtful. Materials and methods Clinicopathological characteristics and survival data of 289 hidradenocarcinoma patients were extracted from the SEER database (covering 18 registries, 2000–2018) released in July 2021. The distribution of clinicopathological characteristics was compared using the Pearson chi-square test. Overall survival (OS) and cancer-specific survival (CSS) were analysed using the log-rank test and univariate analysis. Results The primary site of hidradenocarcinoma in 121 patients was located in the head and neck, accounting for 41.9%, and the others were located in the trunk and limbs. For hidradenocarcinoma, the mean OS and CSS were 164 months and 165.9 months, respectively; the 10-year OS rate and CSS rate were 60.2% and 90.5%, respectively. Survival analysis showed that the primary site, sex, age, race, histologic grade, stage, and surgery are not associated with hidradenocarcinoma patients’ OS or CSS. For head and neck hidradenocarcinoma or trunk and limbs hidradenocarcinoma, sex, age, race, histologic grade, AJCC stage, and primary site surgery are still not related to prognosis. Tumour size is correlated with patients’ OS rather than CSS. Conclusions Hidradenocarcinoma is a malignant tumour with a good prognosis, which is different from previous views. Tumour size is inversely proportional to patients’ overall survival time affecting the OS and CSS of patients. Improving health awareness, initial histological examination and timely surgery are the keys to improving the prognosis.

Ribavirin has been used widely to treat Lassa fever in West Africa since the 1980s. However, few studies have systematically appraised the evidence for its use. We conducted a systematic review of published and unpublished literature retrieved from electronic databases and gray literature from inception to March 8, 2022. We identified 13 studies of the comparative effectiveness of ribavirin versus no ribavirin treatment on mortality outcomes, including unpublished data from a study in Sierra Leone provided through a US Freedom of Information Act request. Although ribavirin was associated with decreased mortality rates, results of these studies were at critical or serious risk for bias when appraised using the ROBINS-I tool. Important risks for bias related to lack of control for confounders, immortal time bias, and missing outcome data. Robust evidence supporting the use of ribavirin in Lassa fever is lacking. Well-conducted clinical trials to elucidate the effectiveness of ribavirin for Lassa fever are needed.

Abstract Background Miridesap depletes circulating serum amyloid P (SAP) and dezamizumab (anti-SAP monoclonal antibody) targets SAP on amyloid deposits, triggering amyloid removal. In a phase 1, first-in-human study (FIHS), progressive amyloid removal was observed in some patients after ≤ 3 cycles of miridesap/dezamizumab. Methods This observational, non-interventional study in patients who received miridesap/dezamizumab during the FIHS (planned follow-up: 5 years) evaluated response to treatment based on routine assessments of disease status and key organ function. In a post hoc analysis, patients responding to treatment in the FIHS during follow-up were identified as responders and further categorized as sustained or declining responders. Results In the FIHS, 17/23 patients were treatment responders. Of these patients, seven (immunoglobulin light chain [AL], n = 6; serum amyloid A, n = 1) were considered sustained responders and ten (fibrinogen-a alpha chain [AFib], n = 5; AL, n = 4; apolipoprotein A-I, n = 1) were considered declining responders. We primarily present responder patient-level data for functional, cardiac, laboratory and imaging assessments conducted during the follow-up period, with non-responder data presented as supplementary. Conclusion No further development of miridesap/dezamizumab is planned in amyloidosis. However, long-term follow-up of these patients may provide insight into whether active removal of amyloid deposits has an impact on disease progression. Trial registration ClinicalTrials.gov, NCT01777243. Registered 28 January 2013, https://clinicaltrials.gov/ct2/show/study/NCT01777243 .

In 2021, over 50% of U.S. adults drank alcohol in the past month with over 25% reporting binge drinking, an increase over previous years. Alcohol use is associated with increased risk of accidents, poor birth outcomes, cancer, chronic diseases, and mortality. During the COVID-19 pandemic alcohol consumption and alcohol-related deaths increased. National organizations recommend screening for unhealthy alcohol use in general health care settings as a prevention strategy.This observational study examined alcohol screening rates in primary care practices in Boston, MA in the context of the COVID-19 pandemic, from July 2019 through May 2022. Screening rates were mapped, by month, to the number of COVID-19 cases. Alcohol screening dropped substantially during the first COVID-19 surge but steadily increased to baseline between the second and third surges. This decline was likely due to competing pandemic-related priorities (e.g., testing, urgent care) and the transition to telemedicine. While some health screening cannot be completed virtually, screening for alcohol is possible. Innovative workflow strategies (e.g., pre-visit screening via patient portals, support staff screening using virtual rooming processes) should be considered to avoid future interruptions of screening for unhealthy alcohol use in primary care.

Background: Immune-checkpoint inhibitors (ICIs) are effective against various cancers; however, immune-related adverse events (irAEs) have been reported and the timing and risk factors are unknown. Therefore, we examined the incidence and timing of irAE occurrence. Methods: Patients who received ICIs at our hospital between 1 April 2016 and 31 March 2020 were enrolled. Patients were classified into an irAE group or non-irAE group. In addition, we examined the onset time and symptoms of irAEs for each ICI type. Results: A total of 80 patients received ICIs, of which 27 (33.8%) developed irAEs. The incidence of irAEs was 35.3% for nivolumab, 35.5% for pembrolizumab, and 28.6% for atezolizumab. The incidence of pneumonitis was 12.5%, 8.8% for dermatologic adverse events, and 6.3% for thyroid dysfunction. The earliest case of onset was after the 1st course, and the latest cases occurred after the 66th course. By the sixth course, 69% of the irAEs occurred. The positive rates for anti-thyroid peroxidase and anti-thyroglobulin antibodies were higher in the irAE group compared to the non-irAE group. Conclusions: Our findings suggest a high probability of irAEs occurring early in ICI treatment, with a diverse range of symptoms. This underscores the need for vigilant monitoring and tailored patient management during the initial courses of ICI therapy.

From the initial COVID-19 outbreak, Italy was the first Western country to be seriously affected by the pandemic. Understanding vaccine hesitancy can help efforts to achieve broad vaccination coverage. The objectives of this research were to determine the extent of vaccine hesitancy in Italy and to understand the characteristics of those segments of the population with some hesitancy. Between January and February 2021, 41,473 subjects answered the second questionnaire delivered in phase II of the web-based EPICOVID19 survey. Among the included adult volunteers living in Italy, 4653 (11.2%) reported having previously received at least one dose of the COVID-19 vaccine. In the sample of 36,820 respondents, all not vaccinated (age 51.1 ± 13.5; 59.7% female; 63.6% high level of education), the comparison between hesitant and inclined participants was accompanied by percentages and odds ratios. A total of 2449 individuals were hesitant (6.7% of the unvaccinated ones). Hesitancy was higher among women (OR = 1.48; 95%CI: 1.36–1.62); it was highest in the 50–59 and 40–49 age groups and among those with a lower educational level. A higher level of education was associated with a lower proportion of hesitancy (5.54%) compared with 9.44% among respondents with a low level of education (OR = 0.56; 95%CI: 0.46–0.68). Hesitancy was most common in subjects who did not report fear of infection (12.4%, OR = 4.0; 95%CI: 3.46–4.61). The results can guide the design of tailored information and communication campaigns through considering objective and subjective characteristics.

Abstract Background Lymphatic malformations (LMs) represent a potentially life-threatening, rare disease of the lymphatic system characterized by development of abnormal vessels, outpouchings, or cysts filled with lymphatic fluid. There are three morphologic types of LMs based on the size of the individual cysts: macrocystic (typically > 2 cm), microcystic (generally

Aim. To study the efficacy and safety of exogenous phosphocreatine (EF) in patients with chronic heart failure (CHF). Materials and methods. The all-Russian prospective observational study BYHEART included 842 patients who were treated with EF. Before and after the course of EF therapy, the following studies were conducted: a questionnaire on the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and a clinical condition assessment scale (SHOCK), transthoracic echocardiography with an assessment of the left ventricular ejection fraction, a 6-minute walk test, determination of the level of pro-natriuretic N-terminal peptide (NT-proBNP), glomerular filtration rate. All patients before the course of EF received long-term optimal drug therapy of CHF. Results. Statistical analysis was carried out in the general group of patients (n=842), as well as in groups of patients A (n=418, the course of treatment of EF is less than 20 g /course) and group B (n=424, the course of treatment of EF is greater than or equal to 20 g/course). The results obtained demonstrate a positive effect of the use of the course of therapy of EF in patients with CHF on the quality of life (QOL), reverse left ventricular remodeling, functional class of CHF, as well as the concentration of NT-pro-BNP, especially in the group of patients who received more than 20 grams of the medication. Conclusion. The use of EF is a promising pharmacological method of treatment in addition to optimal drug therapy in patients with CHF.

Epidemiological studies typically examine the causal effect of exposure on a health outcome. Standardization is one of the most straightforward methods for estimating causal estimands. However, compared to inverse probability weighting, there is a lack of user-centric explanations for implementing standardization to estimate causal estimands. This paper explains the standardization method using basic R functions only and how it is linked to the R package stdReg, which can be used to implement the same procedure. We provide a step-by-step tutorial for estimating causal risk differences, causal risk ratios, and causal odds ratios based on standardization. We also discuss how to carry out subgroup analysis in detail.

Background: Prescription analysis is the simplest method to observe the current treatment practice in any health-care setting. Biopharmaceuticals are a class of drugs that hold great promise in treating diseases. In recent years, there has been an increase in their consumption. The present analysis was carried out to obtain data on the prescribing patterns and the prevalence of the use of biologics in two departments of a tertiary care hospital through a cross-sectional study. Methodology: The study was conducted as an observational study in the departments of rheumatology and endocrinology of a tertiary care hospital in western India. Data were collected from the prescription notebooks or medical case sheets of patients on treatment in the outpatient departments (OPDs) or wards by the rheumatologists or endocrinologists of the hospital. The World Health Organization core drug use indicators for drug prescription analysis were calculated. Results: A total of 4684 drugs had been prescribed in the 874 patient encounters analyzed with the average number of drugs per prescription being 5.36. While 13.3% of prescriptions in the rheumatology department contained a biologic, more than 55% of prescriptions in the endocrinology department contained a biologic. The commonly used biologics were infliximab and etanercept in the rheumatology department and insulin analogs in the endocrinology department. Conclusion: The use of eight types of biologics in rheumatoid arthritis patients in this study is an indicator of active monitoring of the disease and early intervention. The present study has brought out the rational use of biologics such as infliximab and etanercept in rheumatology and insulin analogs in the endocrinology departments of the hospital.

Recent evidence suggests an association between hypertension and periodontitis, although the pathways and implications underlying both chronic conditions are still poorly understood. Therefore, the aim of this study was to evaluate the relationship between hypertension and periodontitis through an observational clinical study using periodontal, physical, and biochemical analyses in hypertensive and non-hypertensive individuals with periodontitis. A total of one hundred patients were divided into two groups. The first group was hypertensive patients with periodontitis. The second group was non-hypertensive patients with periodontitis. Periodontal parameters of probing depth, bleeding on probing, and clinical attachment level were evaluated. The systolic, diastolic, mean, and differential blood pressure were measured in the physical examination. In addition, body mass index and waist–hip ratio were verified. Biochemical tests for glycated hemoglobin, fasting blood glucose, estimated blood glucose, total cholesterol, high-density lipoprotein, creatinine, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, and C-reactive protein were evaluated. The data were submitted for statistical analysis (α = 0.05%). The results of this study demonstrated that patients with cardiovascular disease did not present with worse periodontal clinical parameters in the conditions studied. However, it is important to bear in mind that this cross-sectional study has some inherent limitations to its design; therefore, to study the relationship between hypertension and periodontitis further, an interventional randomized clinical trial should be conducted.

(1) Background: The assessment and application of registered nurses’ professional skills are essential to providing quality and safe care. Self-efficacy can positively affect the professional competence of registered nurses. This study analysed professional competence and its association with self-efficacy among registered nurses. (2) Methods: A cross-sectional observational study was conducted. The sampling was conventional. The data collection took place through the Albanian version of the Nurse Professional Competence Scale Short Form (A-NPCS-SF), which was used to assess their professional skills, and the Albanian version of the Nursing Profession Self-Efficacy Scale (A-NPSES), which was used to assess their self-efficacy. The study was based on a convenience sample of 985 registered nurses from the 12 Albanian provinces. (3) Results: The Cronbach alpha value for the A-NPCS-SF scale was 0.947, while for the A-NPSES scale, it was 0.875, proving both scales to be reliable. Self-efficacy does not play an essential role in the development of the professional competence of registered nurses since our survey found only one dimension correlates with these two elements. (4) Conclusions: The results of our analysis have instead highlighted the importance of a close relationship between job satisfaction and the development of professional skills.

(1) Background: As the worldwide aging population is growing, there is a need to embrace the role of physical activity in the anxiety of older people. Objectives: To analyze anxiety in older people practitioners and non-practitioners of physical activity; (2) Methods: ample composed of 690 older people of both genders, unselected volunteers, residing in Brazil, present (as participants or observers) in selected street races in the state of Rio de Janeiro, Brazil, between 30 October 2019, and 12 March 2020. An instrument composed of the sociodemographic questionnaire and questions from the Beck Anxiety Inventory, BAI, and the Physical Activity Inventory for older people, Baecke-Old. Design: Ex-post-facto observational analytical descriptive research; (3) Results: The average age of the sample was in the range of 65 to 69y, 74% female, 94% completed high school, 69% living with the family, 84% practicing physical activity. Anxiety levels were 26% (without), 35% (mild), 21% (moderate), and 18% (severe). The comparison of anxiety showed a difference between the groups of active and sedentary elderly. Logistic regression analysis considering anxiety (yes or no; dichotomous variable) and physical activity (yes or no; dichotomous variable) and Odds Ratio were performed to identify possible influences of the independent variables PA, gender, marital status, and education on anxiety. Only physical activity was associated with anxiety. (4) Conclusions: The sample data of this research point to the conclusion that physical activity influences anxiety levels with 98% certainty, and it is suggested that it be enriched in the future with different studies with different designs. The older people practitioners of physical activity with a high level of education presented as 26% without, 35% mild, 21% moderate, and 18% severe anxiety. More active individuals are less likely to develop anxiety.

Abstract Background In this prospective, multicenter, non-comparative observational study, the effectiveness and safety of the triple single-pill combination (SPC) of olmesartan/amlodipine/hydrochlorothiazide (OM/AML/HCTZ) were evaluated in a real clinical practice setting in Korean patients with essential hypertension. Methods A total of 3752 patients were enrolled and followed for 12 months after administration of OM/AML/HCTZ. Primary endpoint was change from baseline to month 6 in the mean systolic blood pressure (SBP). Secondary endpoints included changes from baseline in the mean SBP at month 3, 9, 12 and the mean diastolic blood pressure (DBP) at month 3, 6, 9, 12; changes in the mean SBP/DBP according to age and underlying risk factors; and blood pressure control rate (%) at different time points. Adherence to and satisfaction with OM/AML/HCTZ treatment among patients and physicians were assessed by medication possession ratio (MPR) and numeric rating scale, respectively, as exploratory endpoints. Safety was evaluated by the incidence and severity of adverse events (AEs) as well as the discontinuation rate due to AEs. Results OM/AML/HCTZ administration led to significant reductions in the mean SBP/DBP by 11.5/6.6, 12.3/7.0, 12.3/7.2, and 12.8/7.4 mmHg from baseline to month 3, 6, 9 and 12, respectively (P

ABSTRACT Introduction and objectives: After the positive pre-clinical and clinical results with Angiolite, a cobalt-chromium sirolimus-eluting stent, we decided to analyze its performance in a non-selected, real-world population: the RANGO registry. Methods: We conducted an observational, prospective, multicenter registry of patients with different clinical indications. All consecutive patients treated with percutaneous coronary intervention with, at least, 1 Angiolite stent and who gave their informed consent were included. The registry primary endpoint was the occurrence of target lesion failure (TLF) at 6, 12, and 24 months defined as cardiovascular death, myocardial infarction (MI) related to target vessel, and clinically driven target lesion revascularization. The secondary endpoints were the individual components of the primary endpoint, major adverse cardiovascular events (MACE: all-cause mortality, any MI, or any revascularization), and stent thrombosis. We describe the 2-year clinical results of the RANGO study in the entire population, in those who only received Angiolite stents, and in 2 predefined subgroups: diabetics and patients with small-vessels (≤ 2.5mm). Results: 646 patients (426 of them only received Angiolite stents) with a high-risk profile were recruited: prevalence of previous MI (18.4%), previous coronary revascularization (23.4%), clinical presentation as ST-segment elevation MI (23.1%), and multivessel disease (47.8%). At the 2-year follow-up, the rates of TLF, MACE, and stent thrombosis were 3.4%, 9.6%, and 0.9%, respectively. Similar results were observed among patients treated with Angiolite stents only: TLF, 3.1%; MACE, 8.0%; thrombosis, 0.7%. The rates were not significantly different for the diabetic (TLF, 3.0%; MACE, 14.1%; thrombosis, 1.0%), and small-vessel subgroups (TLF, 4.3%; MACE, 12.1%; thrombosis, 0%). Conclusions: In conclusion, the results of this observational registry on the use of Angiolite in a real-world population, including a high-risk population, corroborate the excellent results observed in previous studies, up to a 2-year follow-up. An extended 5-year follow-up is planned to discard the occurrence of late events.

Abstract Background The BNT162b2 mRNA vaccine has been shown to be effective at preventing serious COVID-19 events in clinical trials. There is less evidence on effectiveness in real-world settings, especially for older people. Here, we aimed to estimate vaccine effectiveness in the context of the rapid NHS mass-vaccination programme in England, exploiting age-based vaccination eligibility thresholds to minimise and correct for selection bias. Methods We studied 170,226 individuals between the ages of 80 and 83 years from community settings outside care homes who received one dose of BNT162b2 mRNA between the 15 and 20 December 2020 and were scheduled a second dose 21 days later. We matched these vaccine recipients to slightly younger (aged 76–79 years) persons not yet eligible to receive the vaccine on gender, area of residence, area deprivation, health status, living arrangements, acute illness, and history of seasonal flu vaccination. We compared their rates of COVID-19 positivity and hospitalisation in the subsequent 45 days. We adjusted for the increasing concentration of COVID-19 positivity in the control population caused by the requirement to have no COVID-19 symptoms prior to vaccination. Results Emergency hospital admissions were 51.0% (95% confidence interval 19.9 to 69.5%) lower and positive COVID-19 tests were 55.2% (40.8 to 66.8%) lower for vaccinated individuals compared to matched controls 21 to 27 days after first vaccination. Emergency admissions were 75.6% (52.8 to 87.6%) lower, and positive COVID-19 tests were 70.1% (55.1 to 80.1%) lower 35 to 41 days after first vaccination when 79% of participants had received a second dose within 26 days of their first dose. Conclusions Receipt of the BNT162b2 mRNA vaccine is effective at reducing COVID-19 hospitalisations and infections. The nationwide vaccination of older adults in England with the BNT162b2 mRNA vaccine reduced the burden of COVID-19.

Aspiration pneumonia (AP) is the leading cause of death among the elderly in Japan. The factors associated with the survival of elderly patients with AP are investigated in this retrospective observational study. Patients with AP over the age of 60 who were assessed for swallowing function in our hospital between April 2015 and March 2016 were eligible. Data on patients' body mass index (BMI), food consistency, and Karnofsky performance status were collected from medical records in hospital and again after recovery. Following hospital discharge, eligible patients were sent questionnaires containing information about their physical conditions, such as body weight and the Japanese version of the functional independence measure. Respondents were divided into two groups: those who died and those who survived, and the factors associated with patient mortality were investigated. There were 19 responses from 50 eligible patients, and seven patients died. The participants' average age was 81 years (SD 9.32). There were ten male participants (52.6%, p=1.00), and there were no significant differences in the mortality and survival groups. The most significant finding was that BMI was significantly lower in the patients who died (p=0.037, Cohen’s d=1.10). Fisher's exact tests clearly demonstrated that patients with a BMI

Abstract Background Osmophobia, is common among primary headaches, with prevalence of migraine. The study aimed to evaluate prevalence and clinical characteristics of patients with osmophobia in a cohort of primary headache patients selected at a tertiary headache center. The second aim was to verify the possible predicting role of osmophobia in preventive treatment response in a sub cohort of migraine patients. Methods This was an observational retrospective cohort study based on data collected in a tertiary headache center. We selected patients aged 18–65 years, diagnosed as migraine without aura (MO), migraine with aura (MA) or Chronic Migraine (CM), Tension-Type Headache (TTH); and Cluster Headache (CH). We also selected a sub-cohort of migraine patients who were prescribed preventive treatment, according to Italian Guidelines, visited after 3 months follow up. Patients were considered osmophobic, if reported this symptom in at least the 20% of headache episodes. Other considered variables were: headache frequeny, the migraine disability assessment (MIDAS), Allodynia Symptom Checklist, Self-rating Depression scale, Self-rating Anxiety scale, Pain intensity evaluated by Numerical Rating Scale-NRS- form 0 to 10. Results The 37,9% of patients reported osmophobia (444 patients with osmophobia, 726 without osmophobia). Osmophobia prevailed in patients with the different migraine subtypes, and was absent in patients with episodic tension type headache and cluster headache (chi square 68.7 DF 7 p

ABSTRACT BACKGROUND: The relationship between spirituality and health has been the object of growing discussion. There is a lack of data on spiritual needs assessments in Brazil. OBJECTIVE: This study aimed to assess the spiritual needs of patients admitted to a public tertiary hospital and perform a comparative analysis between patients with and without indications for palliative care. DESIGN AND SETTING: A cross-sectional observational study included patients hospitalized between August and December 2020 in Hospital do Servidor Publico Municipal, Sao Paulo, Brazil. METHODS: The included patients answered a questionnaire consisting of sociodemographic data, the Duke religiosity scale, and the Spiritual Needs Assessment for Patients (SNAP) tool for a spiritual needs assessment. The World Health Organization Palliative Needs tool (NECPAL) was used to evaluate the indications for palliative care. The level of significance adopted was 5%. RESULTS: A total of 66 patients were included in this study. Most participants (97%) declared themselves as belonging to a religion. The group without indication for palliative care by the NECPAL showed greater spiritual (P = 0.043) and psychosocial needs (P = 0.004). No statistically significant difference was observed in the religious needs domain (P = 0.176). There were no statistically significant differences in the Duke scale scores between the two groups. CONCLUSION: Spiritual, psychosocial, and religious needs are prevalent among hospitalized patients, and multidisciplinary teams must consider these needs in their management approach. In addition, this study suggests that psychosocial and spiritual needs can be even higher in patients who do not receive palliative care.

Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies (DMTs) could decrease the antibody response against COVID-19 vaccines, we carried out this retrospective study with the aim to evaluate the safety of these vaccines in terms of AEFI occurrence and the antibody response after MS patients had received the third dose. Two hundred and ten patients (64.8% female; mean age: 46 years) received the third dose of the mRNA-based COVID-19 vaccine and were included in the study. Third doses were administered from October 2021 to January 2022. The majority of patients (n = 193) were diagnosed with RRMS and EDSS values were ≤3.0 in 72.4% of them. DMTs most commonly used by included patients were interferon Beta 1-a, dimethyl fumarate, natalizumab and fingolimod. Overall, 160 patients (68.8% female) experienced 294 AEFIs, of which about 90% were classified as short-term, while 9.2% were classified as long-term. The most commonly reported following the booster dose were pain at the injection site, flu-like symptoms, headache, fever and fatigue. Regarding the immune response, consistently with literature data, we found that patients receiving ocrelizumab and fingolimod had lower IgG titer than patients receiving other DMTs.

With the mass vaccination program for COVID-19 mRNA vaccines, there has been sufficient real-world study (RWS) on the topic to summarize their safety in the total population and in immunocompromised (IC) patients who were excluded from phase 3 clinical trials. We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 mRNA vaccines, with a total of 5,132,799 subjects from 122 articles. In the case of the total population vaccinated with first, second, and third doses, the pooled incidence of any adverse events (AEs) was 62.20%, 70.39%, and 58.60%; that of any local AEs was 52.03%, 47.99%, and 65.00%; that of any systemic AEs was 29.07%, 47.86%, and 32.71%. Among the immunocompromised patients, the pooled odds ratio of any AEs, any local AEs, and systemic AEs were slightly lower than or similar to those of the healthy controls at 0.60 (95% CI: 0.33–1.11), 0.19 (95% CI: 0.10–0.37), and 0.36 (95% CI: 0.25–0.54), with pooled incidences of 51.95%, 38.82%, and 31.00%, respectively. The spectrum of AEs associated with the vaccines was broad, but most AEs were transient, self-limiting, and mild to moderate. Moreover, younger adults, women, and people with prior SARS-CoV-2 infection were more likely to experience AEs.

Primary care services can play an important role in addressing health inequalities and challenges of population ageing. The aim of this study is to investigate whether the availability of local primary care services can support satisfaction with health services and self-rated health in older people. This study was based on a population-based cohort study, Understanding Society: the UK Household Longitudinal Study, focusing on people aged ≥ 50 at Wave 3 (2011–2013; N = 14498) and Wave 6 (2014–2016; N = 13025) in England. Locations of primary care services, including general practitioner (GP) practices and other community health services, were identified from National Health Service Digital and linked to residential areas of the study participants. Multilevel Poisson regression modelling was used to investigate the associations between the availability of local primary care services, satisfaction with health services and self-rated health adjusting for sociodemographic factors, deprivation and urban/rural settings. Participants who had more GP practices in local areas were less likely to report dissatisfaction with health services in Wave 3 (IRR: 0.67; 95% CI: 0.52, 0.85) and Wave 6 (IRR: 0.74; 95% CI: 0.59, 0.92). No associations with self-rated health were found in both waves. These associations were similar across deprivation levels and urban/rural settings. The results suggest that increasing availability of local primary care services may improve satisfaction but not health in older people. To optimise the supportive role of primary care services in healthy ageing, future research should identify complex needs of health and social care in older people and their experience of using the services.

TeenCovidLife is part of Generation Scotland’s CovidLife projects, a set of longitudinal observational studies designed to assess the psychosocial and health impacts of the COVID-19 pandemic. TeenCovidLife focused on how adolescents in Scotland were coping during the pandemic. As of September 2021, Generation Scotland had conducted three TeenCovidLife surveys. Participants from previous surveys were invited to participate in the next, meaning the age ranges shifted over time. TeenCovidLife Survey 1 consists of data from 5,543 young people age 12 to 17, collected from 22 May to 5 July 2020, during the first school closures period in Scotland. TeenCovidLife Survey 2 consists of data from 2,245 young people aged 12 to 18, collected from 18 August to 14 October 2020, when the initial lockdown measures were beginning to ease, and schools reopened in Scotland. TeenCovidLife Survey 3 consists of data from 597 young people age 12 to 19, collected from 12 May to 27 June 2021, a year after the first survey, after the schools returned following the second lockdown in 2021. A total of 316 participants took part in all three surveys. TeenCovidLife collected data on general health and well-being, as well as topics specific to COVID-19, such as adherence to COVID-19 health guidance, feelings about school closures, and the impact of exam cancellations. Limited work has examined the impact of the COVID-19 pandemic on young people. TeenCovidLife provides relevant and timely data to assess the impact of the pandemic on young people in Scotland. The dataset is available under authorised access from Generation Scotland; see the Generation Scotland website for more information.