UNASSIGNED: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study.
UNASSIGNED: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively.
UNASSIGNED: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p <.0001) faster than the pooled VRRs. Overall satisfaction (combined \"Very\" and \"Extremely\") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine.
UNASSIGNED: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine.
UNASSIGNED: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.

UNASSIGNED: Implantable cardioverter defibrillator (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) is underutilized in developing countries. The Improve SCA study has identified a subset of 1.5 primary prevention (1.5PP) patients with a higher risk of SCA and a significant mortality benefit from ICD therapy. From the perspective of China\'s healthcare system, we evaluated the cost-effectiveness of ICD therapy vs. no ICD therapy among 1.5PP patients with a view to informing clinical and policy decisions.
UNASSIGNED: A published Markov model was adjusted and verified to simulate the course of the disease and describe different health states of 1.5PP patients. The patient characteristics, mortality, utility and complication estimates were obtained from the Improve SCA study and other literature. Cost inputs were sourced from government tender prices, medical service prices and clinical experts\' surveys in 9 Chinese public hospitals. For both ICD and no ICD therapy, the total medical costs and quality-adjusted life-years (QALYs) were modelled over a lifetime horizon and the incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the model parameters. We used the willingness-to-pay (WTP) threshold recommended by China Guidelines for Pharmacoeconomic Evaluations, one to three times China\'s GDP per capita (CNY85,698-CNY257,094) in 2022 Chinese Yuan.
UNASSIGNED: The incremental cost effectiveness ratio (ICER) of ICD therapy compared to no ICD therapy is 139,652 CNY/QALY, which is about 1-2 times China\'s GDP per capita. The probability that ICD therapy is cost effective was 92.1%. Results from sensitivity analysis supported the findings of the base case.
UNASSIGNED: ICD therapy compared to no ICD therapy is cost-effective for the 1.5PP patients in China.

UNASSIGNED: This real-world retrospective database study quantified the costs of biomarker testing in a US population of patients with lung or thyroid cancers.
UNASSIGNED: The commercial claims IBM Marketscan database, a de-identified real-world dataset, was used to identify patients diagnosed with lung or thyroid cancer between 1/2015 and 12/2019. Eligible patients were 18 years or older with two or more lung or thyroid diagnosis codes. Patients were excluded who had evidence of prior cancer diagnoses. Subgroup analyses evaluated eligible patients with metastatic disease. Descriptive statistics were used to evaluate commercial insurance plan payer and patient out-of-pocket costs for diagnostic testing overall as well as by test procedure code and payer type. Costs were adjusted to 2020 US dollars.
UNASSIGNED: A total of 23,633 patients with lung cancer were eligible, 13,320 of whom had metastatic disease. There were 36,867 patients with thyroid cancer, 2,241 of whom had metastatic disease. Biomarker codes were observed among 68.4/75.8% (lung/metastatic lung) and 18.2/42.3% (thyroid/metastatic thyroid). Few patients had codes for comprehensive biomarker tests (5.2/6.7% lung/metastatic lung, 0.3/2.2% thyroid/metastatic thyroid) Among those with biomarker tests, the median per-patient total payer lifetime costs of all biomarker testing were $394/$462 (lung/metastatic lung) and $148/$232 (thyroid/metastatic thyroid). Total lifetime biomarker costs for payers ranged from a median of $128 (consumer-driven health plans) to $477 (preferred provider organizations). Median lifetime patient out-of-pocket costs were $0.00 for both tumor types and all payer types except for consumer-driven health plans ($12 for thyroid and $10 for metastatic lung).
UNASSIGNED: While comprehensive testing adds to the cost of biomarker testing, these data suggest the relatively low lifetime cost of biomarker testing for both payers and patients. Costs for biomarker testing should not be a limitation to access among these populations with commercial insurance plans in the US.
This real-world retrospective database study found that there is a relatively low lifetime total cost of biomarker testing for the care of patients with lung or thyroid cancers. While comprehensive testing adds to the cost of biomarker testing, these data suggest the relatively low lifetime cost of biomarker testing for both payers and patients. Payer costs for biomarker testing do not appear to be limitation to access among populations with commercial insurance plans in this study.

UNASSIGNED: The PULsE-AI trial sought to determine the effectiveness of a screening strategy that included a machine learning risk prediction algorithm in conjunction with diagnostic testing for identification of undiagnosed atrial fibrillation (AF) in primary care. This study aimed to evaluate the cost-effectiveness of implementing the screening strategy in a real-world setting.
UNASSIGNED: Data from the PULsE-AI trial - a prospective, randomized, controlled trial conducted across six general practices in England from June 2019 to February 2021 - were used to inform a cost-effectiveness analysis that included a hybrid screening decision tree and Markov AF disease progression model. Model outcomes were reported at both individual- and population-level (estimated UK population ≥30 years of age at high-risk of undiagnosed AF) and included number of patients screened, number of AF cases identified, mean total and incremental costs (screening, events, treatment), quality-adjusted-life-years (QALYs), and incremental cost-effectiveness ratio (ICER).
UNASSIGNED: The screening strategy was estimated to result in 45,493 new diagnoses of AF across the high-risk population in the UK (3.3 million), and an estimated additional 14,004 lifetime diagnoses compared with routine care only. Per-patient costs for high-risk individuals who underwent the screening strategy were estimated at £1,985 (vs £1,888 for individuals receiving routine care only). At a population-level, the screening strategy was associated with a cost increase of approximately £322 million and an increase of 81,000 QALYs. The screening strategy demonstrated cost-effectiveness versus routine care only at an accepted ICER threshold of £20,000 per QALY-gained, with an ICER of £3,994/QALY.
UNASSIGNED: Compared with routine care only, it is cost-effective to target individuals at high risk of undiagnosed AF, through an AF risk prediction algorithm, who should then undergo diagnostic testing. This AF risk prediction algorithm can reduce the number of patients needed to be screened to identify undiagnosed AF, thus alleviating primary care burden.

OBJECTIVE: The aim of this study was to capture and measure the impact of caregiving for an adult with uncontrolled drug-resistant focal-onset seizures (FOS) on the caregivers\' quality of life (QoL), and to quantify the costs of productivity losses associated with providing informal care in this patient population.
METHODS: An online survey, which included the EQ-5D-5L, CarerQol-7D and the Work Productivity and Activity Impairment: Specific-Health Problem (WPAI:SHP) questionnaires, was administered to caregivers of individuals with uncontrolled drug-resistant FOS in the United Kingdom (UK), France, Spain, Germany, Italy, and Sweden.
RESULTS: The study included 345 caregivers. Most were males, aged between 25 and 34 years old whose caring responsibilities took between 15 and 24 h per week. The caregivers\' mean EQ-5D-5L score was 0.6, with 95% confidence intervals (CI) of [0.58, 0.63], whilst the mean CarerQol-7D score was 72.61 [70.46, 74.76]. Caregivers\' mental health was the most substantially affected aspect of their QoL. In addition, most caregivers reported deriving some or a lot of fulfilment out of their caregiving tasks. The WPAI:SHP showed that the mean percentage of work impairment due to caregiving responsibilities was 63%, [59.75, 66.26]. The mean annualised costs of productivity losses per caregiver were estimated at €14,872 [€11,908; €17,888].
CONCLUSIONS: One limitation consisted in the use of an online survey instead of a face-to-face interview. However, the medical terms were clearly explained, and examples were provided to help participants to give accurate responses. Another limitation was that the respondents self-reported as caregivers. Efforts were made to mitigate this weakness by using screener questions.
CONCLUSIONS: This study found that providing informal care for people with uncontrolled drug-resistant FOS had a negative impact on caregivers\' QoL, with mental health being affected the most. However, caregivers found their role fulfilling and had support with their caring tasks.

UNASSIGNED: This study aimed to estimate the association of patiromer exposure vs. no potassium (K+) binder (NoKb) exposure with healthcare utilization and expenditures among a cohort of Medicare Advantage patients with hyperkalemia (HK).
UNASSIGNED: Using Optum\'s Clinformatics Data Mart (study period 2016-2019), the authors assessed propensity score-matched patients (1:1) with a serum K+ concentration ≥5.0 mmol/L and an HK diagnosis that were exposed to patiromer or NoKb on baseline characteristics. The following outcomes were compared: (1) inpatient/emergency department (ED) encounters, (2) inpatient costs greater than or equal to mean Medicare Advantage inpatient cost (i.e. $14,900), and (3) the relative healthcare spending rate. Logistic regression and zero-inflated negative binomial regression were used to analyze the outcomes.
UNASSIGNED: The study cohort included 1,539 patiromer and NoKb matched pairs. Baseline characteristics were (patiromer/NoKb): age 74/75 years; female 42/40%; serum K+ 5.6/5.6 mmol/L; eGFR rate 36/36 mL/min/1.73 m2; low-income subsidy 42/41%, chronic kidney disease 96/96%; end-stage renal disease 12/12%; and congestive heart failure 37/36%. A total of 253 matched pairs (506 patients) remained uncensored and were analyzed at 6 months. Inpatient/ED encounters were observed for 25% (patiromer) and 37% (NoKb) (odds ratio [OR] 0.58, 95% confidence interval [CI]: 0.38-0.89). The relative odds of having inpatient costs ≥$14,900 were ∼50% less for patients exposed to patiromer vs. NoKb (OR [95% CI]: 0.47 [0.25-0.89]). The relative total healthcare spending rate (including inpatient, outpatient, ED, and pharmacy costs) was 19% less for patients exposed to patiromer vs. NoKb (spending rate ratio [95% CI]: 0.81 [0.67-0.98]).
UNASSIGNED: Among Medicare Advantage patients with HK, patiromer exposure (vs. NoKb) was associated with statistically significant reductions in the proportion with inpatient/ED encounters, inpatient costs ≥$14,900, and lower total healthcare spending. Further research, with larger sample size, is warranted to fully validate these findings.

BACKGROUND: Helicobacter pylori are gram-negative spiral shaped bacteria, with sheathed flagella. H. pylori infection is one of the most common chronic infections in humans. Infection is usually acquired during childhood, and becomes a lifelong infection in most people unless treated. The aim of this study was to evaluate serum levels of oxidative stress indices in children with H. pylori infection.
METHODS: The present study was carried out on 60 children infected with H. pylori including 28 males, 32 females with their age ranging from 7-10 years and mean age value of 8.5 ± 1.65 ( Group I). This study included also 60 children as a control group including 26 males, 34 females with their age ranging from 7-11 and mean age value of 8.99 ± 1.63 (Group II). For all children in groups I the following were done: Diagnosis of H. pylori infection through H. pylori stool antigen testing using enzyme immunoassay kit and gastric antrum mucosal biopsies which were tested for urease activity using Campylobacter like organism test (CLO test). Measurements of serum oxidative stress markers including Superoxide dismutase (SOD), Malondialdhyde, Glutathione, Catalase and Nitric oxide were done in patients and controls.
RESULTS: Serum nitric oxide and reduced glutathione were significantly lower in patients compared to controls while serum MDA, Serum catalase and Serum SOD were significantly higher in patients compared to controls (nitric oxide was 91.111 ±6.366 in patients versus 107.211±2.121 in controls with p value of 0.001, reduced glutathione in patients was 2.457± 0.081 versus 2.889±0.491 in controls with p value of 0.001, serum MDA in patients was 140.22±5.18 versus 116.22±2.98 in controls with p value of 0.001, catalase was 401.645± 4.344 versus 278.221±71.712 in controls with p value of 0.001 and SOD in patients was 16.936±9.145 versus 5.578±0.231 in controls with p value of 0.001).
CONCLUSIONS: H. pylori infection is associated with oxidative stress with significantly lower serum nitric oxide and reduced glutathione and significantly higher serum MDA, catalase and SOD in patients compared to controls.
CONCLUSIONS: Antioxidants may be beneficial adjuvant treatment in H. pylori infection as H. pylori infection is associated with oxidative stress.

BACKGROUND: MBT carry poor prognosis and more than 80% of MBT recur locally within 2 cm of the resection margin because of inadequate surgical removal. A number of techniques have been implemented in recent years to improve surgical removal of MBT with variable success. We examined two methods commonly used to resect MBT to establish which one offered the best chances of gross total removal; MRI guided technology and ALA-induced fluorescence.
METHODS: Twenty consecutive patients diagnosed with MBT were included in this study. They were given 20mg ALA per kg body weight 3h before anaesthesia orally mixed in water. Surgery was planned using preoperative enhanced MPR age images. Surgery was executed using the Stealth Station image guidance system and ALA-induced fluorescence microsurgical techniques. During surgery the intensity of fluorescence was graded into red, pink or blue. The intensity of fluorescence was also measured using pulsed 405 nm laser and a compact spectrometer using a touch probe directly placed on the tissue. The extent of tumour invasion was assessed intraoperatively using standard white light, blue light and spectroscopic measurements. Postoperative enhanced MRI was used to assess the extent of resection and the volume of residual tumour was measured.
RESULTS: There were six newly diagnosed GBM, eight recurrent GBM, one oligodendroglioma (ODG) and five metastases (MET). On enhanced MRI, the mean diameter of new GBM, recurrent GBM, ODG and MET was 2.3 cm, 2.3 cm, 1.5 cm, and 2.3 cm respectively. Under the blue light, the mean diameter of new GBM, recurrent GBM, ODG and MET was 2.9 cm, 3 cm, 1.5 cm and 2.3 cm respectively. The results of quantitative measurements of fluorescence ratios revealed that red fluorescence corresponded to 5.9-11.6 (solid tumour on histology), and pink fluorescence measured 0.8-1.9 (infiltrating edge of tumour on histology). When we compared the maximum tumour diameter of GBM we found on average it was 10mm wider on spectroscopy compared to standard white light microscopy and 6mm wider than what the enhanced MRI demonstrated.
CONCLUSIONS: Fluorescence technology revealed that GBMs are wider than the enhanced MRI had demonstrated, while MET enhanced MRI was similar in size to fluorescence. Furthermore, solid tumour can be identified intraoperatively and can be measured using fluorescence and spectroscopy techniques and it can be removed safely. Infiltrating tumour can also be identified intraoperatively using this technology and can be removed in non-eloquent areas to maximise surgical resection.

Lymphoid tissues are of intense interest for studies of the pathogenesis of human immunodeficiency virus (HIV) in humans and simian immunodeficiency virus (SIV) in macaques but are relatively difficult to sample non-invasively. Fine needle aspiration (FNA) cytology, conventionally a diagnostic procedure for lymphadenopathy, can be used for longitudinal study of tissue cell subsets during HIV/SIV infection. In this study, we serially sampled lymph node (LN) FNA from pigtail macaques and studied cell subsets in the aspect of absolute count, frequency, and functionality by flow cytometry. The median recovered lymphocyte count from FNA samples was 2.01×10(5) (3.0×10(3) to 2.25×10(6), n=38) and median CD4+ T cell subset recovered was 5.94×10(4) (277 to 6.17×10(5), n=38). Although we observed a relatively large variation in the frequencies of cell subsets of FNA samples taken from different time points, the cell subset composition of FNA samples, in particular T cell and CD4+ T cell frequencies, was broadly comparable to whole excised LNs (n=6) and distinct from peripheral blood. A subset of CD4+ T cells that is located almost exclusively in secondary lymphoid tissues, T follicular helper (TFH) cells, was readily identifiable in LN FNAs and the TFH cell frequencies were strongly correlated with B cell frequencies. In vitro functionality of FNA lymphocytes was demonstrated using polyclonal SEB stimulation, resulting in a median 6% of responding CD4+ T cells, comparable to circulating CD4+ T lymphocytes. We conclude that serial sampling of macaque LNs using FNA is a potentially useful method to study the immunopathogenesis of SIV infection and may be extended to HIV infection.