Tag: pubmed

BMC Med Imaging. 2022 Dec 24;22(1):226. doi: 10.1186/s12880-022-00952-w.

ABSTRACT

BACKGROUND: We aimed to determine the performance of ¹⁸ F-FAPI PET/CT used for preprocedural assessment of glioblastoma before radiotherapy.

METHODS: Twelve glioblastoma patients having undergone incomplete surgical resection or biopsy were examined with ¹⁸ F-FAPI PET/CT and MRI scanning before radiotherapy. All patients had confirmed tumor residues according to findings of histopathological and/or long-term clinical and radiological follow-ups. Lesion characterization data, including SUV_max and tumor-to-background ratio (TBR) on PET/CT were attained. PET/CT and MRI findings were compared in terms of number of lesions. The correlation between immunohistochemistry, molecular expression, and PET/CT parameters was also evaluated.

RESULTS: ¹⁸ F-FAPI PET/CT detected 16 FAPI-avid out of 23 lesions in 12 patients described on MRI. MRI was statistically different from ¹⁸ F-FAPI PET/CT for lesion detection according to the exact McNemar statistical test (P = 0.0156). The SUV_max and TBR of the glioblastomas was 7.08 ± 3.55 and 19.95 ± 13.22, respectively. The sensitivity and positive predictive value (PPV) of ¹⁸ F-FAPI PET were 69.6% and 100%, respectively. Neither the Ki-67 index nor the molecular expression was correlated with the FAPI-PET/CT parameters.

CONCLUSION: ¹⁸ F-FAPI PET/CT detects glioblastomas at a lower rate than MRI. However, the 100% PPV of the examination may make it useful for differentiating controversial lesions detected on MRI. The ¹⁸ F-FAPI-avid lesions are displayed more clearly probably due to a higher TBR. ¹⁸ F-FAPI PET/CT imaging might find application in glioblastoma biopsy and radiotherapy planning.

PMID:36566187 | DOI:10.1186/s12880-022-00952-w

BMC Musculoskelet Disord. 2022 Dec 24;23(1):1127. doi: 10.1186/s12891-022-06029-7.

ABSTRACT

BACKGROUND: Western Ontario shoulder instability index (WOSI) is a widely used disease-specific self-assessment measurement tool for patients with shoulder instability. The main aim of this study was to translate and cross culturally adapt the WOSI into Finnish language and to test its measurement properties.

METHODS: WOSI was translated in Finnish and adapted into an electronic user interface. 62 male patients with traumatic anteroinferior shoulder instability, programmed for stabilizing shoulder surgery, answered the questionnaire twice preoperatively (2 and 0 weeks), and twice postoperatively (3 and 12 months). Additional scoring tools, such as satisfaction to treatment outcome, subjective shoulder value (SSV), Oxford shoulder instability index (OSIS) and Constant score (CS), were used as comparators. The reliability, validity and responsiveness of WOSI were investigated through statistical analysis.

RESULTS: Preoperative test-retest results were available for 49 patients, and 54 patients were available at final follow up. The mean WOSI was 57.8 (SD 20.3), 70.4 (SD 18.9), and 85.9 (SD 15.5), at baseline, 3, and 12 months, respectively. There was a statistically significant mean improvement of 28.8 (SD 24.5) in WOSI between baseline and 12 months (p < 0.0001). The intraclass correlation coefficient for the preoperative WOSI was excellent 0.91. At 12 months WOSI had an excellent Pearson’s correlation coefficient both with SSV (0.69), OSIS (-0.81), and poor with CS (0.25) scores, confirming our a priori hypothesis. There were no detected floor nor ceiling effects for WOSI pre- or postoperatively. The calculated minimal detectable change was 9.2 and the estimated minimal clinically important difference 13.4 to 18.1.

CONCLUSION: Finnish version of WOSI is a reliable and valid tool for assessing health state and improvement after operative treatment of shoulder instability in young male patients.

PMID:36566181 | DOI:10.1186/s12891-022-06029-7

BMC Oral Health. 2022 Dec 24;22(1):637. doi: 10.1186/s12903-022-02641-0.

ABSTRACT

BACKGROUND: The aim of the current study was to investigate current dental practice in operative dentistry in Jordan, and the relationship between evidence-based dentistry in caries research and decision making in clinical practice in operative dentistry.

MATERIALS AND METHODS: This cross-sectional study was conducted through a survey of dentists in Jordan. The survey aimed to explore the degree of knowledge and practice of evidence-based dentistry in caries research the dentists possess regarding clinical decision making in operative dentistry. The sample size was composed of (5811) dentists whom registered in Jordan Dental Association database. Descriptive statistics were generated and Chi-square test was used to examine associations between the different variables and the significance level was set at P < 0.05.

RESULTS: 4000 responses were collected from the web-survey, response rate (68.83%). Nearly half of the surveyed dentists focus on the chief complaint of their patients (n = 2032, 50.8%) rather than doing full mouth assessment. Nearly two-thirds of dentists (n = 2608, 65.2%) treat lesions confined to enamel with operative treatment. Half of dentists use operative treatment when asked about the routine management of radiographically detected proximal caries confined to enamel. When treating incipient lesions, the majority (n = 3220, 80.5%) use preventive treatment. Three-quarters of dentists (n = 2992, 74.8%) treat deep dentinal caries by removing just the soft infected carious dentin, and treated old failed restorations with replacement.

CONCLUSION: In operative dentistry, the evidence-based research is not implemented clinically. To optimize relationship between evidence-based dentistry and clinical decision-making, dental curriculum has to be updated and modified constantly.

PMID:36566180 | DOI:10.1186/s12903-022-02641-0

Respir Res. 2022 Dec 24;23(1):375. doi: 10.1186/s12931-022-02278-1.

ABSTRACT

We recently reported in the phase 3 PANAMO trial that selectively blocking complement 5a (C5a) with vilobelimab led to improved survival in critically ill COVID-19 patients. C5a is an important contributor to the innate immune system and can also activate the coagulation system. High C5a levels have been reported in severely ill COVID-19 patients and correlate with disease severity and mortality. Previously, we assessed the potential benefit and safety of vilobelimab in severe COVID-19 patients. In the current substudy of the phase 2 PANAMO trial, we aim to explore the effects of vilobelimab on various biomarkers of inflammation and coagulation. Between March 31 and April 24, 2020, 17 patients with severe COVID-19 pneumonia were enrolled in an exploratory, open-label, randomised phase 2 trial. Blood markers of complement, endothelial activation, epithelial barrier disruption, inflammation, neutrophil activation, neutrophil extracellular trap (NET) formation and coagulopathy were measured using enzyme-linked immunosorbent assay (ELISA) or utilizing the Luminex platform. During the first 15 days after inclusion, change in biomarker concentrations between the two groups were modelled with linear mixed-effects models with spatial splines and compared. Eight patients were randomized to vilobelimab treatment plus best supportive care (BSC) and nine patients were randomized to BSC only. A significant decrease over time was seen in the vilobelimab plus BSC group for C5a compared to the BSC only group (p < 0.001). ADAMTS13 levels decreased over time in the BSC only group compared to the vilobelimab plus BSC group (p < 0.01) and interleukin-8 (IL-8) levels were statistically more suppressed in the vilobelimab plus BSC group compared to the BSC group (p = 0.03). Our preliminary results show that C5a inhibition decreases the inflammatory response and hypercoagulability, which likely explains the beneficial effect of vilobelimab in severe COVID-19 patients. Validation of these results in a larger sample size is warranted.

PMID:36566174 | DOI:10.1186/s12931-022-02278-1

Vaccine. 2022 Dec 22:S0264-410X(22)01531-6. doi: 10.1016/j.vaccine.2022.12.017. Online ahead of print.

ABSTRACT

Despite the widespread effectiveness of pneumococcal conjugate vaccines on the overall incidence of invasive pneumococcal disease, the global epidemiological landscape continues to be transformed by residual disease from non-vaccine serotypes, thus highlighting the need for vaccines with expanded disease coverage. To address these needs, we have developed V116,an investigational 21-valent non-adjuvanted pneumococcal conjugate vaccine (PCV),containingpneumococcal polysaccharides (PnPs) 3, 6A, 7F, 8, 9N, 10A, 11A,12F, 15A, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B, anda de-O-acetylated 15B(deOAc15B) individually conjugated to the nontoxic diphtheria toxoid CRM197 carrier protein. Preclinical studies evaluated the immunogenicity of V116 inadult monkeys, rabbits, and mice. Following one dose, V116 was found to be immunogenic in preclinical animal species and induced functional antibodies for all serotypes included in the vaccine, in addition to cross-reactive functional antibodies to serotypes 6C and 15B. In these preclinical animal studies, the increased valency of V116 did not result in serotype-specific antibody suppression when compared to lower valent vaccines V114 or PCV13. In addition, when compared with naïve controls, splenocytes from V116 to immunized animals demonstrated significant induction of CRM197-specific T cells in both IFN-γ and IL-4 ELISPOT assays, as well as Th1 and Th2 cytokine induction through in vitro stimulation assays, thus suggesting the ability of V116 to engage T cell dependent immune response pathways to aid in development of memory B cells. V116 also demonstrated significant protection in mice from intratracheal challenge with serotype 24F, a novel serotype not contained in any currently licensed vaccine.

PMID:36566163 | DOI:10.1016/j.vaccine.2022.12.017

J Am Pharm Assoc (2003). 2022 Nov 12:S1544-3191(22)00367-3. doi: 10.1016/j.japh.2022.10.022. Online ahead of print.

ABSTRACT

PURPOSE: Accurately describing pharmacy productivity in the ambulatory oncology infusion setting is important to ensure appropriate labor utilization. The purpose of this study was to develop a productivity model utilizing weighted medication complexity and prospective schedule data to determine if predicted productivity corresponds to actual productivity across 6 ambulatory oncology infusion sites.

METHODS: This study was a 2-part analysis. Part 1 was to modify the historic productivity model from dispense code weighting to individual medication complexity weighting. Medication-specific relative value units were determined by analyzing 12 months of historic timestamp data from the electronic health record and gravimetric technology software. The productivity model containing updated relative value units was compared to the historic model to determine if the difference in total calculated full-time equivalents (FTEs) was within 2.0 FTEs. Part 2 applied prospective infusion schedule data to the updated model to determine if predicted productivity corresponded to actual productivity (within 2.0 FTEs) for pharmacy infusion services.

RESULTS: The mean difference in total calculated FTEs for infusion during the study period was 2.46 (standard deviation = 1.87) and was within the range of 2.0 FTEs (P = 0.54), indicating that the updated model was not statistically different from the historic model. The mean difference in total calculated FTEs between the predictive and actual productivity model for infusion was 18.28 (standard deviation = 1.00) and was out of the range of 2.0 FTEs (P < 0.001), indicating that predicted productivity was statistically different from the actual productivity.

CONCLUSION: Medication complexity weighting can be used to provide a comprehensive assessment of workload and productivity across pharmacy infusion services. The methodology used to assess predictive productivity should be explored further.

PMID:36566159 | DOI:10.1016/j.japh.2022.10.022

J Am Heart Assoc. 2022 Dec 24:e027652. doi: 10.1161/JAHA.122.027652. Online ahead of print.

ABSTRACT

Background Outcomes and treatment effects of therapy may vary according to the cause of heart failure (HF). Methods and Results In this post hoc analysis of the EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction) trial, the effect of empagliflozin on cardiovascular and renal outcomes was assessed according to the cause of HF. The cause of HF was investigator reported and stratified as ischemic or nonischemic. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% CIs. Of the 3730 patients enrolled, 1929 (51.7%) had ischemic cause. In the placebo arm, patients with ischemic cause of HF did not have a significantly higher risk of cardiovascular mortality (HR, 1.21 [95% CI, 0.90-1.63]) and hospitalization for HF (HR, 0.90 [95% CI, 0.72-1.12]) compared with nonischemic cause. Empagliflozin compared with placebo significantly reduced the risk of cardiovascular death or hospitalization for HF in patients with ischemic and nonischemic cause (HR, 0.82 [95% CI, 0.68-0.99] for ischemic and HR, 0.67 [95% CI, 0.55-0.82] for nonischemic cause; P interaction=0.15). The benefit of empagliflozin on HF hospitalization, the renal composite end point, estimated glomerular filtration slope changes, and health status scores were also consistent in both groups without treatment by cause modification. Conclusions Empagliflozin offers cardiovascular and renal benefits in patients with heart failure with reduced ejection fraction regardless of the cause of HF. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.

PMID:36565199 | DOI:10.1161/JAHA.122.027652

J Am Heart Assoc. 2022 Dec 24:e028144. doi: 10.1161/JAHA.122.028144. Online ahead of print.

ABSTRACT

Background Transcatheter aortic valve replacement (TAVR)/intervention has become the standard of care for treatment of severe aortic stenosis across the spectrum of risk. There are socioeconomic disparities in access to TAVR. The impact of these disparities on postprocedural outcomes remains unknown. Our objective was to examine the association between neighborhood-level social deprivation and post-TAVR mortality and hospital readmission. Methods and Results We conducted a population-based retrospective cohort study of all 4145 patients in Ontario, Canada, who received TAVR from April 1, 2017, to March 31, 2020. Our co-primary outcomes were 1-year postprocedure mortality and 1-year postprocedure readmission. Using Cox proportional hazards models for mortality and cause-specific competing risk hazard models for readmission, we evaluated the relationship between neighborhood-level measures of residential instability, material deprivation, and concentration of racial and ethnic groups with post-TAVR outcomes. After multivariable adjustment, we found a statistically significant relationship between residential instability and postprocedural 1-year mortality, ranging from a hazard ratio of 1.64 to a hazard ratio of 2.05. There was a significant association between the highest degree of residential instability and 1-year readmission (hazard ratio, 1.23 [95% CI, 1.01-1.49]). There was no association between material deprivation and concentration of racial and ethnic groups with post-TAVR outcomes. Conclusions Residential instability was associated with increased risk for post-TAVR mortality, and the highest quintile of residential instability was associated with increased post-TAVR readmission. To reduce health disparities and promote an equitable health care system, further research and policy interventions will be required to identify and support economically and socially minoritized patients undergoing TAVR.

PMID:36565194 | DOI:10.1161/JAHA.122.028144

J Am Heart Assoc. 2022 Dec 24:e027790. doi: 10.1161/JAHA.122.027790. Online ahead of print.

ABSTRACT

Background Peripheral artery disease is endemic in our globally aging population, with >200 million affected worldwide. Graft/stent thrombosis after revascularization is common and frequently results in amputation, major adverse cardiovascular events, and cardiovascular mortality. Optimizing medications to decrease thrombosis is of paramount importance; however, limited guidance exists on how to use and monitor antithrombotic therapy in this heterogeneous population. Thromboelastography with platelet mapping (TEG-PM) provides comprehensive coagulation metrics and may be integral to the next stage of patient-centered thrombophrophylaxis. This prospective study aimed to determine if TEG-PM could predict subacute graft/stent thrombosis following lower extremity revascularization, and if objective cut point values could be established to identify those high-risk patients. Methods and Results We conducted a single-center prospective observational study of patients undergoing lower extremity revascularization. Patients were followed up for the composite end point postoperative graft/stent thrombosis at 1 year. TEG-PM analysis of the time point before thrombosis in the event group was compared with the last postoperative visit in the nonevent group. Cox proportional hazards analysis examined the association of TEG-PM metrics to thrombosis. Cut point analysis explored the predictive capacity of TEG-PM metrics for those at high risk. A total of 162 patients were analyzed, of whom 30 (18.5%) experienced graft/stent thrombosis. Patients with thrombosis had significantly greater platelet aggregation (79.7±15.7 versus 58.5±26.4) and lower platelet inhibition (20.7±15.6% versus 41.1±26.6%) (all P<0.01). Cox proportional hazards analysis revealed that for every 1% increase in platelet aggregation, the hazard of experiencing an event during the study period increased by 5% (hazard ratio, 1.05 [95% CI, 1.02-1.07]; P<0.01). An optimal cut point of >70.8% platelet aggregation and/or <29.2% platelet inhibition identifies those at high risk of thrombosis with 87% sensitivity and 70% to 71% specificity. Conclusions Among patients undergoing lower extremity revascularization, increased platelet reactivity was predictive of subacute postoperative graft/stent thrombosis. On the basis of the cut points of >70.8% platelet aggregation and <29.2% platelet inhibition, consideration of an alternative or augmented antithrombotic regimen for high-risk patients may decrease the risk of postoperative thrombotic events.

PMID:36565191 | DOI:10.1161/JAHA.122.027790

J Am Heart Assoc. 2022 Dec 24:e026578. doi: 10.1161/JAHA.122.026578. Online ahead of print.

ABSTRACT

Background Salt restriction may lower blood pressure variability (BPV), but previous studies have shown inconsistent results. Therefore, we investigated in an observational study and intervention trial whether urinary sodium excretion and salt intake are associated with 24-hour BPV. Methods and Results We used data from the cross-sectional population-based Maastricht Study (n=2652; 60±8 years; 52% men) and from a randomized crossover trial (n=40; 49±11 years; 33% men). In the observational study, we measured 24-hour urinary sodium excretion and 24-hour BPV and performed linear regression adjusted for age, sex, mean blood pressure, lifestyle, and cardiovascular risk factors. In the intervention study, participants adhered to a 7-day low- and high-salt diet (50 and 250 mmol NaCl/24 h) with a washout period of 14 days, 24-hour BPV was measured during each diet. We used linear mixed models adjusted for order of diet, mean blood pressure, and body mass index. In the observational study, 24-hour urinary sodium excretion was not associated with 24-hour systolic or diastolic BPV (β, per 1 g/24 h urinary sodium excretion: 0.05 mm Hg [95% CI, -0.02 to 0.11] and 0.04 mm Hg [95% CI, -0.01 to 0.09], respectively). In the intervention trial, mean difference in 24-hour systolic and diastolic BPV between the low- and high-salt diet was not statistically significantly different (0.62 mm Hg [95% CI, -0.10 to 1.35] and 0.04 mm Hg [95% CI, -0.54 to 0.63], respectively). Conclusions Urinary sodium excretion and salt intake are not independently associated with 24-hour BPV. These findings suggest that salt restriction is not an effective strategy to lower BPV in the White general population. Registration URL: https://clinicaltrials.gov/ct2/show/NCT02068781.

PMID:36565181 | DOI:10.1161/JAHA.122.026578