Background and Purpose-The modified Rankin Scale (mRS) is a popular primary stroke outcome measure, but its usefulness is limited by suboptimal reliability (inter-rater agreement). Methods-We developed and tested the reliability of a simplified mRS questionnaire (smRSq) in 50 patients after stroke seen in outpatient clinics. Randomly chosen paired raters administered the smRSq within 20 minutes of each other and the ratings were blinded until the end of this study. Results-Agreement among the raters was 78%, the statistic was 0.72 (95% CI, 0.58 -0.86), and the weighted w statistic taking into account the extent of disagreement was 0.82 (95% CI, 0.72-0.92). The average time to administer the smRSq was 1.67 minutes. Conclusions-The smRSq appears to have very good reliability that is similar to that of a structured interview mRS and is considerably less time-consuming. (Stroke. 2010;41:1048-1050.)Key Words: clinometrics Ⅲ modified Rankin Scale Ⅲ outcome assessment R eliability (consistency) of measurements is of paramount importance in scientific research. 1 The modified Rankin Scale (mRS) 2 is a popular primary outcome measure in acute stroke trials, but its usefulness is limited by suboptimal reliability (inter-rater agreement). There is considerable variability in the reported reliability of the mRS. 3 A structured interview mRS that takes Ϸ15 minutes to administer was developed to help improve the mRS reliability. 4 In a recent systematic review the overall agreement between mRS raters without a standardized rating approach was 71%, the kappa () statistic was 0.46 (95% CI, 0.41-0.51), and the weighted kappa ( w ) statistic, taking into account the extent of all disagreements, was 0.90 (95% CI, 0.86 -0.94). 3 Using the structured interview mRS, the overall agreement was Ϸ73%, was 0.62 (95% CI, 0.56 -0.69), and w was 0.87 (95% CI, 0.75-1.00). 3,5,6 Inter-rater agreement was significantly improved with the structured interview mRS among raters with varied professional backgrounds, 7 which simulates a multicenter clinical trial. In an effort to simplify, standardize, and increase further the reliability of the mRS, we developed a simplified mRS questionnaire (smRSq) and tested it among raters with varied professional experiences. Materials and MethodsFour stroke faculty members with a total of 63 years experience applying the traditional unstructured mRS jointly created the smRSq (Figure). Using the key issues distinguishing between consecutive mRS categories, we created relatively simple questions that could be answered "yes" or "no" by patients or caregivers with little or no explanation. The key mRS issues were having no residual symptoms (0), being able to resume all prestroke activities (Յ1), being able to live independently (Յ2), being able to walk without assistance (Յ3), and not requiring constant supervision (Յ4).We screened patients for this study consecutively in 4 weekly clinics staffed by the stroke specialists and in 2 weekly resident continuity clinics at the Medical College of Georgia. Eligibility f...
Results from this real-world assessment of the economic burden of migraine suggest that migraine imposes a substantial direct and indirect cost burden in the United States. Compared to matched nonmigraine patients, migraine patients were more likely to have work loss and longer periods of work loss, leading to significantly higher indirect costs. Migraine patients also had higher levels of healthcare utilization, despite the relatively stable prevalence of migraine and the available acute and preventive treatment options for migraine management.
BACKGROUND: A variety of biologic therapies are currently used for the treatment of inflammatory autoimmune diseases, including rheumatoid arthritis (RA), psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). These diseases require long-term treatment, and information regarding the use and costs of biologic therapies can be valuable in making treatment and formulary decisions for clinicians and payers.
Cisplatin was one of the first chemotherapeutic agents to exhibit broad efficacy in solid tumors and it remains among the most widely used agents in the treatment of cancer. Its introduction inspired great efforts to design similarly effective platinum agents that overcome the three main limitations of cisplatin: toxicity, tumor resistance and poor oral bioavailability. However, 40 years after the initial discovery of cisplatin, only two platinum agents have garnered US FDA approval: carboplatin and oxaliplatin. Although hundreds of promising agents were tested in clinical trials during the 1990s, only oxaliplatin made it past clinical development. For a brief period, the economic cost of these unsuccessful efforts retarded further efforts to develop new agents. However, two exciting platinum agents have been brought to Phase III trials: satraplatin in hormone-refractory prostate cancer and picoplatin in small-cell lung cancer. If successful, they may inspire a new effort to bring better-designed platinum agents to market. This article reviews the clinical development of platinum agents to date and speculates on the role of platinum agents in the near future.
Erenumab is predicted to reduce migraine-related direct and indirect costs, and increase QALYs compared to SC.
Objective To understand treatment preferences of people with migraine and the relative importance of improvements in efficacy and avoiding adverse events (AEs), such as cognition problems or weight gain. Background Current preventive migraine medicines are associated with poor adherence and tolerability. There is an unmet need for effective migraine‐specific preventive treatments with fewer AEs. Methods In a web‐based discrete‐choice experiment survey, respondents who self‐reported having ≥6 migraine days/month were offered choices between pairs of hypothetical preventive migraine medicines. Six attributes, each with 3 levels, defined the medicines: reduction in headache days per month (10%, 25%, or 50%), frequency of limitations with physical activities (none, 1‐category improvement, or 2‐category improvement), cognition problems (no problems, thinking problems, or memory problems), weight gain (none, 5% body weight gain, or 10% body weight gain), how the medicine is taken (daily oral pill, once‐monthly injection, or twice‐monthly injection), and monthly out‐of‐pocket cost ($5, $60, or $175). The attributes and levels were informed by clinician input, the clinical literature, and 2 focus groups. An experimental design was used to create the pairs of hypothetical medicines for the discrete‐choice experiment questions. Random‐parameters logit was used to estimate the relative importance of the medicine attributes, and the results were used to predict the percentage of respondents who would select one medicine profile over another and to calculate willingness to pay for changes in attribute levels. Results The sample included 300 respondents; 72% indicated that migraines make physical activities difficult all or most of the time, and 81% had taken a prescription medicine to prevent migraine in the last 6 months. Respondents reported having, on average, approximately 16 headache days per month. Among noncost attributes, respondents valued a change from a 10% reduction in migraine days to a 50% reduction more highly than avoiding the worst levels of AEs, but were willing to trade off efficacy for less‐severe AEs. Avoiding memory problems was more important than avoiding thinking problems. Avoiding a 10% weight gain was more important than avoiding thinking and memory problems. Respondents preferred a once‐monthly injection or daily pill to twice‐monthly injection. Respondents, on average, were willing to pay $84 (95% confidence interval [CI], $64‐$103) per month to avoid a 10% weight gain, $59 (95% CI, $42‐$76) per month to avoid memory problems, $35 (95% CI, $20‐$51) per month to avoid a 5% weight gain, and $32 (95% CI, $18‐$46) per month to avoid thinking problems. Conclusions A preventive migraine medicine with improved efficacy and AE profile and a favorable mode of administration would be valuable to migraine sufferers. Patients may be willing to trade off efficacy for better AE profiles. Clinicians should work with patients to select treatments that meet each patient’s needs.
Background and objectives: RCVS (Reversible Cerebral Vasoconstrictive Syndrome) is a condition associated with vasoactive agents that alter endothelial function. There is growing evidence that endothelial inflammation contributes to cerebrovascular disease in patients with coronavirus disease 2019 . In our study, we describe the clinical features, risk factors, and outcomes of RCVS in a multicenter case series of patients with COVID-19. Materials and methods: Multicenter retrospective case series. We collected clinical characteristics, imaging, and outcomes of patients with RCVS and COVID-19 identified at each participating site. Results: Ten patients were identified, 7 women, ages 21 À 62 years. Risk factors included use of vasoconstrictive agents in 7 and history of migraine in 2. Presenting symptoms included thunderclap headache in 5 patients with recurrent headaches in 4. Eight were hypertensive on arrival to the hospital. Symptoms of COVID-19 included fever in 2, respiratory symptoms in 8, and gastrointestinal symptoms in 1. One patient did not have systemic COVID-19 symptoms. MRI showed subarachnoid hemorrhage in 3 cases, intraparenchymal hemorrhage in 2, acute ischemic stroke in 4, FLAIR hyperintensities in 2, and no abnormalities in 1 case. Neurovascular imaging showed focal segment irregularity and narrowing concerning for vasospasm of the left MCA in 4 cases and diffuse, multifocal narrowing of the intracranial vasculature in 6 cases. Outcomes varied, with 2 deaths, 2 remaining in the ICU, and 6
BACKGROUND: Migraine imposes substantial economic burden on patients and the health care system. Approximately 18% of women and 6% of men suffer from migraine in the United States. This is a heterogeneous group, and little data are available to evaluate factors associated with migraine costs. OBJECTIVE: To evaluate characteristics associated with high costs among commercially insured patients with migraine. METHODS: This retrospective analysis identified patients with migraine in the Truven Health MarketScan Research Databases between January 2008 and June 2013. Patients were required to have 12 months continuous enrollment before and after migraine diagnoses and/or migraine-specific medications (index date). Patients with costs greater than the top 25th percentile of all-cause costs during the 12-month post-index period were classified into the upper quartile (UQ) cohort. Multiple logistic regression was used to evaluate demographic and clinical factors associated with being in the UQ cohort, and generalized linear models were used to estimate the incremental costs by select factors after controlling for other covariates.RESULTS: In the total population, 857,073 patients (mean [SD] age: 43.2 [12.5] years), were included, with 83.2% females. Average post-index annual all-cause costs were $13,045 (SD = $25,328) with the top 25th percentile of costs at $14,120. Overall, 44.4% and 54.8% of patients had ≥ 1 pre-index claim for opioids and triptans, respectively. Patients with ≥ 2 migraine-related emergency room visits were twice as likely to be in the UQ cohort (OR = 2.13, 95% CI = 2.02-2.25; P < 0.05
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