Real-world effectiveness and satisfaction with intravenous eptinezumab treatment in patients with chronic migraine: REVIEW, an observational, multi-site, US-based study.

BACKGROUND: Despite recent advancements in migraine treatment, some patients continue to endure significant disease burden. Due to the controlled nature of randomized trials in migraine prevention, many real-world patients with comorbidities or prior exposure to certain therapies are excluded. Capturing evidence of the effectiveness of treatment in real-world clinical settings can further shape treatment paradigms. The objective of this study was to develop a comprehensive understanding of both patients' and physicians' real-world experiences with eptinezumab for chronic migraine (CM). METHODS: REVIEW (Real-world EVidence and Insights into Experiences With eptinezumab) is an observational, multi-site (n = 4), US-based study designed to evaluate real-world experiences of patients treated with eptinezumab and their treating physicians. Patients were ≥ 18 years of age, with a diagnosis of CM, who had completed ≥ 2 consecutive eptinezumab infusion cycles (≥ 6 months of exposure). The study included a retrospective chart review, a patient survey, and a semi-structured physician interview that assessed patient and/or physician satisfaction with elements of daily living / well-being, migraine symptomology, and perspectives of the eptinezumab infusion experience. RESULTS: Of the 94 patients enrolled, 83% (78/94) were female, the mean age was 49.2 years, and the mean time since migraine diagnosis was 15.4 years. Before eptinezumab treatment, patients experienced a mean of 8 self-reported "good" days/month, which increased to 18 after treatment. Most patients took, on average, ≥ 10 days/month of prescription and/or over-the-counter medication (81% [75/93] and 66% [61/93], respectively) to treat migraine attacks before eptinezumab treatment, which dropped to 26% (24/93) and 23% (21/93) following eptinezumab treatment. Prior to receiving eptinezumab, 62% (58/93) of patients indicated being at least slightly concerned about infusions; after eptinezumab infusion, this dropped to 14% (13/93). These patient survey findings were consistent with physician responses. CONCLUSION: This real-world evidence study demonstrated high overall satisfaction with the effectiveness of eptinezumab treatment for CM among most patients and their physicians.

Use of [18F]Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography after Curative Treatment of Non-Small-Cell Lung Cancer Patients: A Nationwide Cohort Study.

[¹8F]Fluorodeoxyglucose positron emission tomography/computed tomography ([¹8F]FDG PET/CT) is a valuable imaging tool in the post-treatment management of non-small-cell lung cancer (NSCLC). This study aimed to investigate the trends in utilization and factors associated with the use of [¹8F]FDG PET/CT after curative-intent treatment. Data from 13,758 NSCLC patients diagnosed between 2007 and 2020 identified in the Danish Lung Cancer Registry, who underwent curative-intent treatment, were analyzed using multivariable regression. The results showed a significant increase in the use of [¹8F]FDG PET/CT scans, from 10.4 per 100 patients per year in 2007 to 39.6 in 2013, followed by a period of stability. Higher utilization rates were observed in patients who received radiotherapy (22% increase compared to surgical resection) and in patients with stage II-III disease (14% and 20% increase compared to stage I, respectively). Additionally, utilization was increased when other diagnostic procedures were performed, such as MRI, ultrasound, endoscopy, and biopsy. These findings highlight an increasing reliance on [¹8F]FDG PET/CT in post-treatment NSCLC, especially after radiotherapy and in patients with locally advanced disease, where treatment-induced radiographic changes and an increased risk of recurrence present a significant diagnostic challenge.

Clinical Outcome Assessment Instruments in Schizophrenia: A Scoping Literature Review with a Focus on the Potential of Patient-reported Outcomes.

Objective: The complexity inherent in the treatment of schizophrenia results in a multitude of outcome assessments being employed when conducting clinical trials. Subjective outcome assessments and minimal clinically important differences (MCIDs) to evaluate clinical meaningfulness have gained traction; however, the extent of application in evaluation of treatments for schizophrenia is unknown. A scoping review was conducted to assess the availability of published psychometric evaluations, including MCIDs, for clinical outcome assessments used to evaluate treatments for schizophrenia. Method of Research: Key databases (PubMed®, Embase®, APA PsycINFO®, International Society for Pharmacoeconomics and Outcomes Research) were searched for studies on schizophrenia published from 2010 to 2020. Secondary sources (ClinicalTrials.gov, PROLABELS™, FDA.gov) were also reviewed. Clinical outcome assessments were organized by type (patient-reported outcomes [PROs], clinician-reported outcomes [ClinROs], observer-reported outcomes [ObsROs]) and further classified by intended use (generic, mental health, schizophrenia). Reliability and internal consistency were evaluated using Cronbach's α. External validity was evaluated by intraclass correlation coefficient (ICC). Results: Across 140 studies, 66 clinical outcome assessments were identified. MCIDs were reported for eight of the 66 studies. Of these, two were PROs (generic) and six were ClinROs/ObsROs (three mental health-specific, three schizophrenia-specific). Reliability was good across generic, mental health-specific, and schizophrenia-specific categories, whereas external validity was strong mainly for schizophrenia-specific PROs. Overall, ClinROs/ObsROs that focused on mental health had good reliability and strong external validity. Conclusion: This review provides a comprehensive overview of the clinical outcome assessments used in schizophrenia research during the past ten years. Results highlight the heterogeneity of existing outcomes and a growing interest in PROs for schizophrenia.

Healthcare Costs in the Year Before and After Alzheimer's Disease Diagnosis: A Danish Register-Based Matched Cohort Study.

BACKGROUND: Alzheimer's disease (AD) carries a significant economic burden, with costs peaking around the time of diagnosis. However, the cost of diagnosis, including the time leading up to it, has not been studied thoroughly. Furthermore, regionalized healthcare structure could result in differences in the pre-diagnostic costs for people with suspected AD. OBJECTIVE: This study set out to estimate the excess healthcare costs before and after AD diagnosis compared to a matched non-AD population and to investigate regional variation in AD healthcare costs in Denmark. METHODS: We used a register-based cohort of 25,523 matched pairs of new cases of AD and non-AD controls. The healthcare costs included costs on medication, and inpatient-, outpatient-, and primary care visits. Generalized estimating equations were employed to estimate the excess healthcare cost attributable to diagnosing AD, and the variation in costs across regions. RESULTS: Mean excess costs attributable to AD were € 3,284 and € 6,173 in the year before and after diagnosis, respectively. Regional differences in healthcare costs were identified in both the AD and control groups and were more pronounced in patients with AD (PwAD). CONCLUSION: PwAD incur higher healthcare costs across all cost categories in the year before and after diagnosis. Regional differences in healthcare utilization by PwAD may reveal potential variation in access to healthcare. These findings suggest that a more standardized and targeted diagnostic process may help reduce costs and variation in access to healthcare.

The impact of patient-controlled hospital admissions among patients with severe mental disorders on health care cost: A nationwide register-based cohort study using quasi-experimental design.

To assess whether patient-controlled admissions (PCA) to psychiatric hospital wards have an effect on total health care costs in the short term and longer term compared with patients receiving treatment as usual (TAU). Based on Danish register data and using coarsened exact matching, patients who signed a contract for PCA during 2013-2016 were matched on observables with a control group of TAU patients identified from psychiatric registers. As primary outcome patients' expenditure was explored in 6-monthly intervals over the first 12 months, and as secondary outcome over the 12-24 month period after index month. To control for unobservable selection a quasi-experimental difference-in-difference design was applied on the matched population using the principle of intention to treat. 414 PCA patients (out of 423 available) were successfully matched with 7181 never exposed TAU patients (out of 67,331 available). Total healthcare costs for PCA patients were €8887 (95% CI 708-17,067) higher per month than unexposed TAU patients in the first six months after index. Monthly psychiatric costs were €8922 (95% CI 708-17,067) higher for PCA patients than for TAU patients. These differences persisted, in the next three six-monthly periods, albeit were not statistically significant, in the second six-monthly period after index. In conclusion, driven by the psychiatric costs, implementing PCA increased the total healthcare costs in the short term compared with TAU. More research of the impact on health care costs in a broader and long-term perspective is still needed.

A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial.

OBJECTIVE: Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe/high-impact cLBP. Such programs are expensive, not easily accessible, and have limited effect; therefore, new cost-effective strategies are warranted. Cognitive functional therapy (CFT) has shown promising results but has not been compared with an interdisciplinary pain management approach. The primary aim of this randomized controlled trial is to investigate if a pathway starting with CFT including psychologist support (CFT+) with the option of additional usual care (if needed) is superior in improving disability and more cost-effective at 12 months compared with an interdisciplinary pain management pathway (usual care). METHODS: This pragmatic, 2-arm, parallel-group randomized controlled trial will randomly allocate patients (n = 176) aged 18 to 75 years referred to an interdisciplinary pain center due to severe cLBP to 1 of 2 groups (1:1 ratio). Participants randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed), and participants randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual's situation, needs, and resources. The primary outcome is the proportion of participants with an 8-point improvement in the Oswestry Disability Index score at 12 months. Exploratory outcomes are change in Oswestry Disability Index scores over time and an economic analysis of quality-adjusted life years using the 3-level version of the EuroQol EQ-5D. IMPACT: The study evaluates the cost-effectiveness of CFT+ with the option of additional usual care (if needed) for individuals with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.

Long term resource consequences of a nationwide introduction of robotic surgery for women with early stage endometrial cancer.

OBJECTIVE: The majority of cost-studies related to robotic surgery has a short follow-up and primarily report the costs from the index surgery. The aim of this study was to evaluate the long-term resource consequences of introducing robotic surgery for early stage endometrial cancer in Denmark. METHODS: The study included all women with early stage endometrial cancer who underwent robotic, laparoscopic and open access surgery from January 2008 to June 2015. Data was linked from national databases to determine resource consumption and costs from hospital treatments, outpatient contacts, primary health care sector visits, labor market affiliation and prescription of medication. Each patient was observed in a period of 12 months before- and after surgery. The key exposure variable was women who were exposed to robotic surgery compared to those who were not. RESULTS: A total of 4133 women underwent surgery for early stage endometrial cancer. The study found additional costs of $7309 (95% confidence interval [CI] 2100-11,620, P = 0.001) per patient in the group exposed to robotic surgery including long-term costs post-surgery compared to the non-exposed group (non-robotic group). When controlling for time trends, the introduction of robotic surgery did not reduce the number of bed days (mean diff -0.42, 95% CI -3.03-2.19, P = 0.752). CONCLUSIONS: The introduction of robotic surgery for early stage endometrial cancer did not generate any long-term cost savings. The additional costs of robotic surgery were primarily driven by the index surgery. Any reduction in bed days could be explained by time trends.