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.

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.