Entry Criteria Research Articles

PET/CT/MRI in Clinical Trials of Alzheimer's Disease.

With the advent of PET imaging in 1976, 2-deoxy-2-[18F]fluoro-D-glucose (FDG)-PET became the preferred method for in vivo investigation of cerebral processes, including regional hypometabolism in Alzheimer's disease. With the emergence of amyloid-PET tracers, [11C]Pittsburgh Compound-B in 2004 and later [18F]florbetapir, [18F]florbetaben, and [18F]flumetamol, amyloid-PET has replaced FDG-PET in Alzheimer's disease anti-amyloid clinical trial treatments to ensure "amyloid positivity" as an entry criterion, and to measure treatment-related decline in cerebral amyloid deposits. MRI has been used to rule out other brain diseases and screen for 'amyloid-related imaging abnormalities' (ARIAs) of two kinds, ARIA-E and ARIA-H, characterized by edema and micro-hemorrhage, respectively, and, to a lesser extent, to measure changes in cerebral volumes. While early immunotherapy trials of Alzheimer's disease showed no clinical effects, newer monoclonal antibody trials reported decreases of 27% to 85% in the cerebral amyloid-PET signal, interpreted by the Food and Drug Administration as amyloid removal expected to result in a reduction in clinical decline. However, due to the lack of diagnostic specificity of amyloid-PET tracers, amyloid positivity cannot prevent the inclusion of non-Alzheimer's patients and even healthy subjects in these clinical trials. Moreover, the "decreasing amyloid accumulation" assessed by amyloid-PET imaging has questionable quantitative value in the presence of treatment-related brain damage (ARIAs). Therefore, future Alzheimer's clinical trials should disregard amyloid-PET imaging and focus instead on assessment of regional brain function by FDG-PET and MRI monitoring of ARIAs and brain volume loss in all trial patients.

The effect of acceptance and commitment therapy on work-related rumination and job fatigue of medical emergency and accident management center staff: an experimental study

BackgroundWorking in accident management centers and medical emergencies makes employees face psychological tensions and leads to a decrease in their work quality and endangering the lives of patients. Therefore, any solution to reduce their tension will be valuable. This study was conducted to investigate the effect of acceptance and commitment-based therapy (ACT) on work-related rumination and job fatigue among the employees of the Emergency and Medical Accident Management Center of Alborz Province, Iran.MethodsThis study is an experimental research with intervention and control groups conducted between January 16, 2019, and July 8, 2019. Sixty-four employees were selected based on the entry criteria and randomly assigned to two groups. People in the intervention group participated in 8 sessions of 2-hour therapy based on acceptance and commitment. Questionnaires for demographic information, work-related rumination, and occupational recovery/exhaustion were used to collect data. The intervention was conducted with univariate and multivariate covariance analysis.ResultsThe findings showed that the average job fatigue reached 16.78\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\:\\pm\\:$$\\end{document} 11.44 from 37.06 ± 16.70 in the pre-test with a decrease of 20.28 points. Also, the average of all rumination dimensions related to work decreased in the post-test. The findings showed that the effectiveness of treatment based on acceptance and commitment therapy was confirmed on job fatigue and all its components and all dimensions of work-related rumination (p < 0.05). The partial eta square index was greater than 0.14 in all cases and showed the significant effectiveness of the intervention on all components of work-related rumination and job fatigue.ConclusionTreatment based on acceptance and commitment reduced rumination and job fatigue. It is recommended to practice this intervention to improve personnel’s mental health and the quality of services provided to patients.Clinical trial numberNot applicable.

Is HLA-DQ typing useful in screening for celiac disease among Arabs with type 1 diabetes? A case-control study.

The data on the usefulness of DQ-typing in screening for celiac disease (CD) among type 1 diabetic (T1D) patients came from the West. We conducted this study among T1D patients to: (1) determine the frequency of DQ-genotypes, (2) assess the risk associated with human leukocyte antigen (HLA)-DQ genotypes, and (3) identify the cost-effective screening strategy. HLA-DQ genotyping was performed on 67 T1D patients with CD (cases) (mean age 15 years) and 224 T1D patients without CD (controls) (mean age 18.29 years) (2021-2023). The entry criterion for the control group was duration of T1D ≥5 years and negative annual celiac serology assay. On comparison of the cases versus controls, T1D patients carrying homozygous DQ2.5 genotype (30% vs. 13.8%) or DR3-DQ2.5 haplotype (81.3% vs. 65.7%) showed significantly "higher risk" (odds ratio [OR] = 2.64, p = 0.002; OR = 2.3, p = 0.008, respectively) to develop CD. Only 4% do not harbor any of the CD-at risk genotypes (DQ2.5, DQ8, or DQ2.2) and none developed CD. Heterozygous DQ8 was associated with a significantly lower risk of developing CD with OR of 0.123 (1.5% in cases vs. 10.3% in controls, p = 0.022). Only 4% of Saudi patients with T1D carry DQ-genotypes at no risk to develop CD, which supports the European guidelines that recommend celiac serology test as the most cost-effective screening method. We identified the risk gradient associated with DQ-genotypes to develop CD in our population which could help in counseling patients for the risk to develop CD and planning follow-up serology tests.

How much is too much: A case study of local self-government units in Slovakia using absolute variability to determine the importance of financial criteria in MCDM analysis.

The performance evaluation of local self-government entities is very difficult, as their primary goal is not to make a profit, but to provide services to their residents that will contribute to an increase in their quality of life. In this context, it is necessary to evaluate their activity from the point of view of several available criteria, for which it is possible to find relevant and recognized sources. The presented research works with five criteria, identified by the Institute for Economic and Social Reforms, and aims to quantify the agreement of the results of the assessment of the financial health of territorial self-government entities in 2020 using the TOPSIS technique with a gradually decreasing number of criteria. For this purpose, a total of 26 combinations of criteria are created, with the number of 5, 4, 3 and 2 used criteria, the importance of which is determined based on their absolute variability using the standard deviation method. The results obtained in this way are interpreted using a wide range of mathematical and statistical methods including the Kolmogorov-Smirnov test, Levene test, Jaccard index and others. As a result, the multi-criteria evaluation of territorial self-government subjects (in our case, district cities) proved to be highly applicable. However, the result itself is largely determined by the structure and number of entry criteria. Based on the performed analyses, we can see that significant differences result from their reduction. Each such reduction has an impact on the overall results, but it is possible to find combinations that defy this conclusion.

Incremental eligibility criteria for the BMT CTN 1507 haploidentical trial for children with sickle cell disease

AbstractThe Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 1507 leadership and the data safety monitoring board (DSMB) established incremental entry criteria for children aged 5 to 14.99 years with sickle cell disease (SCD) enrolling in a phase 2 trial of HLA-haploidentical hematopoietic stem cell transplantation. First, the enrollment was limited to overt stroke in the first 10 participants (stage 4). Subsequently, the DSMB reviewed the interim results and expanded the eligibility to include children with silent cerebral infarcts or abnormal transcranial Doppler velocities with magnetic resonance angiography–defined cerebral vasculopathy (stage 3). A third cohort was enrolled after the DSMB reviewed the clinical outcomes in these cumulative initial enrollments (n = 18). Additions to the entry criteria included nonneurologic morbidities (stage 2). Eligibility criteria included the following: (1) life-threatening acute chest syndrome requiring exchange transfusion; (2) right heart catheterization confirmed pulmonary hypertension; (3) persistent systemic hypertension despite maximum medical therapy; (4) acute pain despite maximum medical therapy in the absence of psychosocial factors and unmanaged asthma after adjudication; or (5) 2 major priapism episodes in 12 months or 3 in 24 months. Children with SCD who did not meet the criteria for stages 4, 3, and 2 were not eligible. To our knowledge, for the first time, we introduce a staged strategy for eligibility in a curative therapy trial for children with SCD concordant with 45 Code of Federal Regulations § 46.405(b). The research governance–mandated eligibility strategy used within the BMT CTN 1507 phase 2 study may apply to future pediatric SCD curative therapy trials. This trial was registered at www.ClinicalTrials.gov as #NCT032635590.

The Relationship Between Metabolic Syndrome with Physical Activity and Eating Habits: The Result of the Tabari Cohort Study

Background: Metabolic syndrome (MetS) is a group of metabolic issues that increase the risk of type 2 diabetes and heart disease. Objectives: To reduce deaths from type 2 diabetes and heart disease, this study was conducted to determine the relationship between metabolic syndrome, physical activity, and eating habits in participants of the Tabari cohort study. Methods: In this descriptive cross-sectional study, data from the Tabari cohort in an urban and mountain area in Sari, Mazandaran, was utilized from June 2015 to November 2017. Background information of participants was documented, and their eating habits were assessed using a food habit questionnaire. Additionally, the physical activity levels of the participants were recorded. All individuals were assessed for metabolic syndrome according to the third Adult Treatment Panel (ATP III) guidelines. The gathered data was then inputted into SPSS V.23 software for analysis. Qualitative variables, such as demographic and epidemiological data, were compared between the two groups using the chi-square test, while quantitative variables were compared using an independent t-test. Results: A total of 10,255 adults between the ages of 35 and 70 participated in this study, and after applying entry and exit criteria, 9,976 people, including 4,083 with metabolic syndrome and 5,893 healthy individuals, were included in the final analysis. There was no significant difference in the average Body Mass Index (BMI) between individuals with metabolic syndrome (30.6 ± 4.5 kg/m²) and healthy individuals (26.8 ± 4.4 kg/m²). However, individuals with metabolic syndrome exhibited significantly higher values for height, weight, waist circumference, abdominal circumference, and wrist circumference compared to the control group (P = 0.001). The average Metabolic Equivalent of Task (MET) for the entire population was 43.03 ± 9.27, with a median of 40.68 (range: Twenty-four-one hundred three) hours/day. A greater percentage of individuals with metabolic syndrome (57.0%) and healthy individuals (45.2%) had MET values below the average (P = 0.001). Regarding energy intake, individuals with metabolic syndrome consumed an average of 2189.74 ± 721.90 calories, while healthy individuals consumed 2354.92 ± 4.04 calories, showing a significant difference (P = 0.006). Moreover, healthy individuals demonstrated significantly higher consumption of added salt in food, fried foods, fried potatoes, fried onions, fried vegetables, and various types of cooking oils compared to those with metabolic syndrome (P = 0.001). Conclusions: Based on the results of the Tabari cohort study, the prevalence of metabolic syndrome in Mazandaran was 41.10%, highlighting the need for prevention and screening programs. In this study, individuals with metabolic syndrome consumed fewer fried foods, trans fats, and daily calories compared to the healthy group. Considering that this study is cross-sectional and utilized data from the Tabari cohort, it is assumed that the difference is due to dietary compliance and lifestyle changes in patients with metabolic syndrome. It is recommended that prospective studies be designed to evaluate the causes of differences in metabolic syndrome components between the two groups.

Legislative developments in personal insolvency in China’s mainland: A comparative analysis of regional practices in China’s mainland, Hong Kong, and Taiwan Region

AbstractWith the ongoing implementation of personal insolvency practices in China’s mainland, the realization of a nationwide personal insolvency system in China’s mainland no longer appears distant. In the design of specific personal insolvency schemes, key elements to consider are establishing entry criteria, assessing the integrity of debtors, determining the duration of the discharge examination period, setting the length of the blocking period for subsequent insolvencies. Additionally, the availability of a simplified procedure for personal insolvency should also be considered. By analysing 12 official documents from regional practices in China's mainland and comparing them with corresponding regulations in Taiwan Region ("Taiwan") and Hong Kong, we can draw valuable experiences and identify shortcomings. This effort aims to lay the foundation for a unified personal insolvency system in the future of China’s mainland.

7742 Clinical Outcomes of Thyroid Cancer Patients Enrolled in a Comprehensive Thyroid Cancer Survivorship Program

Abstract Disclosure: M.A. Ruiz Santillan: None. J.L. Rollins: None. S. Lee-Kim: None. M.I. Hu: None. S.I. Sherman: None. J. Varghese: None. N.L. Busaidy: None. M. Cabanillas: None. R. Dadu: None. P.C. Iyer: None. A.K. Ying: None. S.G. Waguespack: None. J.K. Devin: None. C. Jimenez: None. R. Vassilopoulou-Sellin: None. R.F. Gagel: None. M. Zafereo: None. P.H. Graham: None. N.D. Perrier: None. E. Grubbs: None. S.B. Fisher: None. M.A. Habra: None. Background Thyroid cancer, being the most common endocrine malignancy with excellent prognosis, is an ideal model for cancer survivorship. The Thyroid Cancer Survivorship clinic (TCSC) was established to provide oncologic, functional, behavioral follow-up, and age-appropriate cancer screening. Entry criteria into TCSC were developed using expert opinion as formalized consensus guidelines for thyroid cancer survivorship care do not exist. Patients may transition at 1, 3, or 5 years after initial diagnosis depending on original histology and stage, lack of definitive biochemical (thyroglobulin or Calcitonin/CEA), and/or structural evidence of disease. It is run by nurse practitioners with physician supervision. The impact of the transition criteria from acute care to survivorship has not been evaluated. To fill this knowledge gap, we analyzed data from TCSC to assess important clinical outcomes including return to active care, disease recurrence, and overall survival. Methods A single-institution, retrospective review was conducted to identify patients with differentiated (DTC) and medullary (MTC) thyroid cancer enrolled in our TCSC. We particularly assessed patients who were referred from TCSC back to active care because of suspected recurrence, which was defined as either biochemical and/or structural and based on abnormal biochemical markers and/or imaging. Results Between 2009-2023, 2887 patients were transitioned from active care to the TCSC out of whom 246 (8%) patients returned to active care for: the evaluation of endocrine disorders in 84 pts (2.9%), scheduling factors 74 pts (2.6%), and suspected recurrence in 88 pts (3%) (83 with DTC and 5 with MTC). Recurrence was suspected based on abnormal biochemical markers in 40/88, imaging in 34/88, or both in 14/88. Of the patients with suspected recurrence there were 66 females and 22 males with a median age at the time of initial diagnosis of 44 (range: 18-76) years. The median follow-up time from diagnosis to the last visit to our institution was 14 (range: 5-55) years and the median follow-up from transition to the TCSC to the last visit was 8 (range: 1-14) years. At the time of entering TCSC, 21/88 (24%) had biochemical indeterminate disease, while 38 (43%) had indeterminate imaging findings on neck ultrasound. DTC patients returned to active care after a median of 5 (range: 0.26-13) years and MTC patients returned after a median of 2 years (range: 0.81-11). At the last follow-up visit, 42/88 (48%) patients were alive with no evidence of disease, 41/88 (47%) were alive with residual disease and 5/88 (5%) died (3 of thyroid cancer, 1 of breast and 1 of genitourinary malignancy complications). Conclusions The retention rate is high in TCSC, with a small percentage transitioning back to active care. Only 3% of patients transitioned back to active care for suspected recurrences, with half occurring more than 5 years after entering survivorship. Presentation: 6/3/2024

Chronic Kidney Disease Predisposes to Acute Congestive Heart Failure, Cardiogenic Shock, and Mortality in Patients Undergoing Percutaneous Coronary Intervention

The relations between degrees of chronic kidney disease (CKD) and congestive heart failure (CHF) events after percutaneous coronary intervention (PCI) are not well characterized. We sought to determine the relation between different stages of CKD and acute CHF events, including HF and cardiogenic shock (CS), and the impact of CKD stages on all-cause mortality after PCI. Patients who underwent PCI from 2009 to 2017 were identified from our institution's National Cardiovascular Disease Registry CathPCI Database. Patients were stratified by CKD stage 1 (estimated glomerular filtration rate [eGFR] ≥90 ml/min/1.73 m2), 2 (60 to 89), 3a (45 to 59), 3b (30 to 44), 4 (16 to 29), 5 (≤15), and current dialysis. The primary end point was composite HF events defined as acute HF or CS within 30 days after PCI, or in-hospital mortality, stratified by CKD and analyzed by multivariable regression after screening with univariate analysis (p <0.05 entry criteria). Patients with CKD stage 3a or worse had more composite HF events, with an increase in all components, compared with patients with CKD stages 1 to 2 (p <0.0001 for all comparisons). After multivariable adjustment, CKD stages 3a to 5 remained independent predictors of composite HF or in-hospital mortality events. eGFR remained a strong predictor of acute HF events after multivariable adjustment, with a model including eGFR and baseline and procedural characteristics achieving excellent discriminatory ability with area under the curve 0.92. In conclusion, baseline eGFR is a strong, independent predictor of acute HF events after PCI. CKD stages 3a to 5 independently predict HF events including HF decompensation and CS and are predictors of in-hospital mortality after PCI. Patients with baseline CKD may benefit from targeted interventions to limit acute HF events after PCI.

From Bioink to Tissue: Exploring Chitosan-Agarose Composite in the Context of Printability and Cellular Behaviour

This study presents an innovative method for producing thermosensitive bioink from chitosan hydrogels saturated with carbon dioxide and agarose. It focuses on a detailed characterisation of their physicochemical properties and potential applications in biomedicine and tissue engineering. The ORO test approved the rapid regeneration of the three-dimensional structure of chitosan–agarose composites in a unidirectional bench press simulation test. The diffusion of dyes through the chitosan–agarose hydrogel membranes strongly depended on the share of both polymers in the composite and the molecular weight of the dyes. Glucose, as a nutrient marker, also diffused through all membranes regardless of composition. Biocompatibility assessment using MTT tests on 46BR.1N fibroblasts and HaCaT keratinocytes confirmed the safety of the bioink. The regenerative potential of the bioink was confirmed by efficient cell migration, especially HaCaT. Long-term viability studies showed that chitosan–agarose scaffolds, unlike the agarose ones, support cell proliferation and survival, especially 14 days after bioink extrusion. Experiments in a skin wound model in mice confirmed the biocompatibility of the tested dressing and the beneficial action of chitosan on healing. Studies on vessel formation in chicken embryos highlight the potential of the chitosan–agarose composition to enhance proangiogenic effects. This composition meets all entry criteria and possesses excellent biological properties.

Optimizing water-fertilizer integration with drip irrigation management to improve crop yield, water, and nitrogen use efficiency: A meta-analysis study

So far, many studies have examined the effects of drip irrigation and water-fertilizer integration on crop yield indices, nutrient use efficiency (NUE), and water use efficiency (WUE). However, they are carried out under different conditions. Due to the scattered research results and the lack of general conclusions from published results, it is necessary to use meta-analysis as a structured method to draw a conclusion. Therefore, a meta-analysis was conducted to quantitatively evaluate the effects of water–fertilizer integration with drip irrigation (WFIDI) on nitrogen use efficiency (NUE), water use efficiency (WUE), and crop yield to explore the most suitable application strategy of WFIDI, further discussion of its impact mechanism. A total of 352 studies in the Chinese region were included, of which 84 studies met the entry criteria for the meta-analysis, and 779 pairs of data were finally obtained. The meta-analysis results showed that WFIDI improved NUE (31.3 %), WUE (34.5 %) and crop yield (12.5 %) by changing soil physical and chemical properties (SOC increased by 36.4 %, TN increased by 9.3 %, and ETC decreased by 11.5 %). In order to screen the key influencing factors and determine the applicable conditions, PCA and win-win analysis were carried out. The results showed that WFIDI was suitable for food crops and fruit trees in medium-textured soils. It is recommended to use subsurface drip irrigation with a lower flow rate (≤1Lh−1) and nitrogen fertilizer (10–25 % lower than the traditional nitrogen application rate of farmers). This study provides inspiration for efficient and economical agricultural water management.

Emulations of Oncology Trials Using Real-World Data: A Systematic Literature Review.

By evaluating published emulations of oncology RCTs studies in which both the active and comparator groups are sourced from RWD and target trial results are available for benchmarking, this systematic review aims to gain insight into factors related to emulation performance. Thirteen oncology emulation studies using various types of RWD were identified through an online database search of PubMed through 2022. Based on the ROBINS-I tool, most studies (N=8) had a serious risk of overall bias driven by risk of bias from confounding. Approximately half of the studies (N=6) fully proxied the RCT entry criteria. Of 11 RWD studies that provided sufficient detail to quantify emulation performance, the emulation HR estimate fell within the 95% CI of the trial estimate in 9 of the studies. There were no clear trends between risk of bias or degree to which the entry criteria were proxied and emulation performance. Findings may have been influenced by publication bias and researcher degrees of freedom, as only one emulation study pre-registered its protocol. Tools for comprehensively characterizing factors that affect emulation performance, including the real-world clinical context as it relates to the RCT research question, are needed to evaluate the feasibility of a RCT emulation.

Motor sensory physiotherapy intervention in premature infants in neonatal intensive care unit (NICU)

Purpose: The purpose of this study is to explore the importance of implementing a customized motor sensory physiotherapy program by recording data about the total days spent and weight gain of preterm infants in Neonatal Intensive Care Unit. Methods: Randomized clinical trial of a sample of thirty (30) preterm infants split in two 15-member groups, one intervention group and one control group. An adapted program of motor sensory physiotherapy techniques, while in NICU, was implemented to the intervention group while nothing was implemented to the control group. Both groups met the same entry criteria. The same protocol of motor sensory physiotherapy was applied in the intervention group during the whole period of the study. Results: Data show that customized motor sensory physiotherapy while in NICU improves weight gain and reduces total days of stay. Discussion: Even though adapted motor sensory physiotherapy intervention has a positive impact on the development and outcome of preterm infants in NICU, more research is required on the physiotherapy techniques by studying a larger sample size in NICU.

Classification Criteria for Axial Disease in Youth with Juvenile Spondyloarthritis.

To develop and validate classification criteria for axial disease in youth with juvenile spondyloarthritis (SpA; AxJSpA). This international initiative consisted of four phases: 1) Item generation; 2) Item reduction; 3) Criteria development; and 4) Validation of the AxJSpA criteria by an independent team of experts in an internationally representative Validation cohort. These criteria are intended to be used on youth with a physician diagnosis of juvenile SpA and for whom axial disease is suspected. Item generation consisted of a systematic literature review and a free-listing exercise using input from international physicians and collectively resulted in 108 items. After the item reduction exercise and expert panel input, 37 items remained for further consideration. The final AxJSpA criteria domains included: imaging: active inflammation, imaging: structural lesions, pain chronicity, pain pattern, pain location, stiffness, and genetics. The most heavily weighted domains were active inflammation and structural lesions on imaging. Imaging typical of sacroiliitis was deemed necessary, but not sufficient, to classify a youth with AxJSpA. The threshold for classification of AxJSpA was a score of ≥55 (out of 100). When tested in the validation data set, the final criteria had a specificity of 97.5% (95% CI: 91.4-99.7), sensitivity of 64.3% (95% CI: 54.9-73.1) and Area Under the Receiver Operating Characteristic (AUROC) curve of 0.81 (95% CI: 0.76-0.86). The new AxJSpA classification criteria require an entry criterion, physician diagnosis of juvenile SpA, and include seven weighted domains. The AxJSpA classification criteria are validated and designed to identify participants for research studies.

Difficult-to-treat axial spondyloarthritis patients

Objectives: This study aimed to formulate D2T (difficult to treat) criteria for axial spondyloarthritis (AxSpA) patients and identify the prevalence of D2T patients and their characteristics. Patients and methods: The cross-sectional study was conducted with 166 AxSpA patients (93 males, 73 females; mean age: 47.1±12.9 years; range, 19 to 78 years) between February 2023 and March 2023. The criteria were based on patients treated according to the European Alliance of Associations for Rheumatology (EULAR) recommendations for AxSpA. Entry criteria were treatment failure to ≥2 biological/targeted synthetic disease-modifying antirheumatic drugs with two different mechanisms of action or ≥3 biological/targeted synthetic disease-modifying antirheumatic drugs. Potential preliminary factors for D2T criteria were analyzed, and the characteristics of the subjects matching D2T criteria were compared with those of others. Results: One hundred forty-two ankylosing spondylitis patients and 24 nonradiographic AxSpA patients were included in the study. The rate of fulfilling the D2T criteria was 22.9% (n=38) among AxsPA patients treated with biological agents. The potential D2T criteria were met by 23.2% of ankylosing spondylitis and 20.8% of nonradiographic AxSpA patients. Baseline characteristics, such as sex, age, diagnosis age, occupation, and education, of D2T patients were not statistically different from other patients. The prevalence of fibromyalgia was higher in D2T patients (p&lt;0.001). Disease activity indices and acute phase response indicators were higher and quality of life was worse in D2T patients. Conclusion: There was a considerable amount of AxSpA patients fulfilling the D2T criteria despite new and effective treatment agents.

Comparative long-term outcomes of vitrectomy combined with anterior chamber intraocular lens to intra-scleral haptic fixation of posterior chamber intraocular lens

PurposeTo evaluate the long-term clinical outcomes in patients with combined pars plana vitrectomy (PPV) with anterior chamber intraocular lens (ACIOL) to intrascleral haptic fixation (ISHF) using the Agarwal technique with fibrin glue to secure the scleral flap of a posterior chamber intraocular lens.MethodsRetrospective, consecutive, single-center, comparative case series. 83 eyes were studied. Patients with < 8 months of follow-up were excluded. Detailed pre-, intra-, and post-operative complications were analyzed using mixed model univariate analysis and t-test. Pre- and post-operative best corrected visual acuity (BCVA) was analyzed.ResultsTwenty-five subjects met entry criteria. Mean age at time of surgery was 70.4 ± 17.7 years in the ACIOL group (n = 12) and 54.6 ± 21.1 years in the ISHF group (n = 13; p = 0.03). Mean follow-up was 38.2 months. Incidence of corneal decompensation was similar in the ACIOL and ISHF lens group (p = 0.93). There was no difference in the BCVA mean change or cystoid macular edema (CME) at the final visit between the groups (p = 0.47; p = 0.08), but there was a trend toward increased CME in the ACIOL group.ConclusionsPPV with concomitant placement of either ACIOL or ISHF lens result in improvement in BCVA. Both procedures are well tolerated and result in favorable outcomes with long-term follow-up though varying patient populations do not allow precise comparison between the two groups.

Evaluation of university and training standards in clinical perfusion, an European-wide survey.

Adequate theoretical and practical training of prospective clinical perfusionists is essential for maintaining clinical standards and ensuring patient safety during cardiac surgery procedures. Perfusion schools play a crucial role in establishing and maintaining higher education and training standards in clinical perfusion. The aim of this study is to obtain a comprehensive overview of European training standards in clinical perfusion in 2023. For this study, 53 perfusion schools in Europe were found and contacted, of which 30 (56.6%) responded, giving a sample size of n = 30, which were then included in the data analysis. The quantitative data of the survey are analysed using descriptive methods. The university and training standards in clinical perfusion in Europe vary in many respects. Starting with the entry criterion for studies (most frequently a required bachelor's degree 36.7% or 2nd most common an university entrance qualification 30%), the duration [from <12 months (13.3%) up to 36 months (13.3%)] and regarding the content of the teaching in clinical perfusion [<30 European Credit Transfer System (ECTS) (33.3%) and more than 180 ECTS (6.7%)]. The mean value for teaching in clinical perfusion content is 62.63 ECTS credits. The obtained results show important differences between countries and schools. As such, they form a valuable database for future discussions establishing a common European curriculum and training standards for perfusionists. For the generalizability of the results, further evaluations and larger samples are needed.

Comparing the hemodynamic changes, bleeding, and surgeon’s satisfaction during rhinoplasty surgery by use of two drugs, labetalol and dexmedetomidine added to anesthetic technique: a randomized clinical trial

Background: Rhinoplasty is a common surgery in the world. Bleeding is a common concern during rhinoplasty. Hemodynamic stability and quality of view of the surgical field help to achieve the best results. The aim was to compare the effect of two drugs, dexmedetomidine and labetalol, on the amount of bleeding and satisfaction with rhinoplasty surgery. Methods: A cross-sectional descriptive study includes candidates for rhinoplasty surgery, referring to Moradi Hospital in Rafsanjan. Twenty patients were assigned to each group (dexmedetomidine and labetalol) based on the entry and exit criteria. Systolic and diastolic blood pressures and mean arterial pressure were measured before, 20 minutes after complete anesthesia, and the start of rhinoplasty surgery. All patients were operated by the same surgeon using the same technique. The surgeon’s level of satisfaction indicated with the field of vision is given as follows: good, moderate, and poor. Results: The study was performed on 40 subjects in two groups (n = 20), of which 14 (35 %) were male and 26 (65 %) were female. The results presented statistically significant differences in mean osteotomy systolic blood pressure (P = 0.018), osteotomy diastolic blood pressure (P = 0.015), mean osteotomy arterial pressure (P = 0.002), after 20 minutes heart rate (P &lt; 0.001), and osteotomy heart rate (P = 0.001) between two groups. Furthermore, significant differences were observed regarding systolic blood pressure (P = 0.015), mean arterial pressure (P = 0.03), and heart rate (P &lt; 0.001) after controlling for the effect of the group. Conclusions: The labetalol is the preferred option for controlling hypotension that provides better surgical field visibility compared to dexmedetomidine in rhinoplasty surgery.

Investigation on pharmaceutical care barriers perceived by clinical pharmacists in secondary and tertiary hospitals in China

ObjectiveThis study aimed to understand the current status of pharmaceutical care barriers perceived by clinical pharmacists in secondary and tertiary hospitals in China, and to provide a reference for further improving the quality of pharmaceutical care and perfecting the construction of pharmaceutical care system in China. MethodsThe PCBS-CH scale (Pharmaceutical Care Barriers Scale in Chinese Hospitals) was used to measure the perceived pharmaceutical care barriers of clinical pharmacists, and descriptive statistical analysis was used to identify the main barriers faced by clinical pharmacists. The different barriers perceived by clinical pharmacists with various characteristics was investigated by subgroup analysis. ResultsA total of 1266 clinical pharmacists from 31 provinces were finally included. The results revealed that the main barriers faced by clinical pharmacists in the process of implementing pharmaceutical care included lack of additional staffing, lack of time for pharmaceutical care provision and continuing education, and lack of an electronic information system and prescription evaluation system for pharmaceutical care. Subgroup analysis found that clinical pharmacists who are without training (P < 0.001), worked in tertiary hospitals (P = 0.036), and had other training certificates (P < 0.001) perceived higher pharmaceutical care barriers. ConclusionClinical pharmacists in secondary and tertiary hospitals in China have a low perception of overall pharmaceutical care barriers, but still face some important barriers. In order to promote the development of pharmaceutical care in China, the quality of clinical pharmacists should be improved, strict entry criteria should be established, clear responsibilities should be defined, the rights of female clinical pharmacists should be protected, and hospital facilities should be upgraded.

Mean of Daily Versus Single Week Recall-Based Pain Quality Assessments in Neuropathic Pain Trials: Implications for Assay Sensitivity

Patients with neuropathic pain often present with variable pain and nonpainful sensory qualities that could serve as outcomes in randomized clinical trials (RCTs). This study aimed to investigate the within-participant variability in the severity of these sensory qualities and whether the means of 7 daily pain quality assessments provide better assay sensitivity (ie, more sensitivity to treatment effects) than single-week recall-based assessments. This secondary analysis used data from an RCT of transcutaneous electrical nerve stimulation for chemotherapy-induced peripheral neuropathy (N = 142). Participants rated the severity of painful and nonpainful sensory qualities using 0 to 10 numeric rating scales daily for 1 week (24-hour recall) and 1 time at the end of each week (week recall) at trial baseline and endpoint (after 6 weeks of treatment). For pain quality assay sensitivity analyses, the 2 types of measures were used to 1) define the study sample (ie, how many participants met minimum baseline pain quality severity) and 2) calculate the observed effect sizes (ie, between-group differences in mean pain qualities) using analysis of covariances. The projected sample sizes required to detect the observed effect sizes in future clinical trials for hot/burning pain and cramping were substantially smaller using the daily mean outcome compared with week recall (ie, hot/burning pain: 153 vs 388, cramping: 121 vs 349), and only marginally larger for sharp/shooting pain (22 participants) with the daily mean outcome. Compared with single-week recall-based assessments of pain qualities, the mean of daily assessments may improve RCT assay sensitivity when used to define entry criteria and assess outcomes. PerspectiveThis study suggests that means of daily pain quality assessments may improve assay sensitivity when used to define entry criteria and assess outcomes in clinical trials. This work may inform design of future clinical trials evaluating the intensity of different pain qualities.