Increasing cancer drug prices are a challenge for patients and health systems in the USA and Europe. By contrast with the USA, national authorities in European countries often directly negotiate drug ...prices with manufacturers. The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) developed frameworks to evaluate the clinical value of cancer therapies: the ASCO-Value Framework (ASCO-VF) and the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). We aimed to assess the association between the clinical benefit of approved cancer drugs based on these frameworks and their drug prices in the USA and four European countries (England, Switzerland, Germany, and France).
For this cost–benefit analysis, we identified all new drugs with initial indications for adult cancers that were approved by the US Food and Drug Administration between Jan 1, 2009, and Dec 31, 2017, and by the European Medicines Agency up until Sept 1, 2019. For drugs indicated for solid tumours, we assessed clinical benefit using ASCO-VF and ESMO-MCBS. We compared monthly drug treatment costs between benefit levels using hierarchical linear regression models, and calculated Spearman's correlation coefficients between costs and benefit levels for individual countries.
Our cohort included 65 drugs: 47 (72%) drugs were approved for solid tumours and 18 (28%) were approved for haematological malignancies. The monthly drug treatment costs in the USA were a median of 2·31 times (IQR 1·79–3·17) as high as in the assessed European countries. There were no significant associations between monthly treatment costs for solid tumours and clinical benefit in all assessed countries, using the ESMO-MCBS (p=0·16 for the USA, p=0·98 for England, p=0·54 for Switzerland, p=0·52 for Germany, and p=0·40 for France), and for all assessed countries except France using ASCO-VF (p=0·56 for the USA, p=0·47 for England, p=0·26 for Switzerland, p=0·23 for Germany, and p=0·037 for France).
Cancer drugs with low or uncertain clinical benefit might be prioritised for price negotiations. Value frameworks could help identify therapies providing high clinical benefit that should be made rapidly available across countries.
Swiss Cancer Research Foundation (Krebsforschung Schweiz).
The coronavirus disease 2019 (COVID-19) pandemic has resulted in a strong negative impact on economic and social life worldwide. It has also negatively influenced people's general health and quality ...of life. The aim of the present study was to study the impact of social distancing on physical activity level, and the association between mood state (depression and anxiety level) or sex with actual physical activity levels, the change in physical activity caused by social distancing period, the adhesion level to social distancing, the adoption time of social distancing, family income and age.
A self-administered questionnaire with personal, quarantine, physical activity, and mood state disorders information's was answered by 2140 Brazilians of both sex who were recruited through online advertising.
The physical activity level adopted during the period of social distancing (3.5 ± 0.8) was lower than that the adopted prior to the pandemic period (2.9 ± 1.1, p < 0.001). Thirty percent of the participants presented symptoms of moderate/severe depression and 23.3% displayed moderate/severe anxiety symptoms. A greater presence of symptoms related to anxiety and depression were associated with low physical activity levels, low family monthly income, and younger age. A higher percentage of men who had no mood disorders was observed among those who were very active than among those less active.
The COVID-19 pandemic has a negative impact on physical activity. Those who reduced their level of physical activity had the highest levels of mood disorders. Therefore, physical activity programs should be encouraged, while respecting the necessary social distancing to prevent the spread of Severe Acute Respiratory Syndrome Coronavirus 2.
To describe the prevalence and determinants of potentially inappropriate medication (PIM) use and association with hospitalizations in an elderly managed care population in Switzerland.
Using health ...care claims data of four health insurers for a sample of managed care patients 65 years of age and older to compare persons on PIM with persons not on PIM. Beers' 2012 and PRISCUS criteria were used to determine the potential inappropriateness of prescribed medications. The sample included 16'490 elderly patients on PIM and 33'178 patients not on PIM in the time period of January 1, 2008 through December 31, 2012. Prevalence estimates are standardized to the population of Switzerland. Associations between PIM and hospitalizations were examined by multivariate Cox regression analyses controlling for possible confounding variables.
The estimated prevalence of PIM use in our managed care sample was 22.5%. Logistic regression analysis showed that number of different medications used in the previous year, total costs in the previous year and hospitalization in the previous year all significantly increased the likelihood of receiving PIM. Multiple Cox regression analysis revealed that those on cumulative levels of PIM use acted significantly as a factor related to greater hospitalization rates: the adjusted HR was 1.13 (95% CI 1.07-1.19) for 1 PIM, 1.27 (95% CI 1.19-1.35) for 2 PIM, 1.35 (95% CI 1.22-1.50) for 3 PIM, and 1.63 (95% CI 1.40-1.90) for more than 3 PIM compared to no PIM use.
The prevalence of PIM in managed care health plans are widely found but seem to be much lower than rates of non-managed care plans. Furthermore, our study revealed a significant association with adverse outcomes in terms of hospitalizations. These findings stress the need for further development of interventions to decrease drug-related problems and manage patients with multiple chronic conditions.
This study aimed to identify variations in weekly training load, training monotony, and training strain across a 10-week period (during both, pre- and in-season phases); and to analyze the ...dose-response relationships between training markers and maximal aerobic speed (MAS), maximal oxygen uptake, and isokinetic strength. Twenty-seven professional soccer players (24.9±3.5 years old) were monitored across the 10-week period using global positioning system units. Players were also tested for maximal aerobic speed, maximal oxygen uptake, and isokinetic strength before and after 10 weeks of training. Large positive correlations were found between sum of training load and extension peak torque in the right lower limb (r = 0.57, 90%CI0.15;0.82) and the ratio agonist/antagonist in the right lower limb (r = 0.51, 0.06;0.78). It was observed that loading measures fluctuated across the period of the study and that the load was meaningfully associated with changes in the fitness status of players. However, those magnitudes of correlations were small-to-large, suggesting that variations in fitness level cannot be exclusively explained by the accumulated load and loading profile.
The high cost of cancer medicines is a public health challenge. Policy makers in the US and Europe are debating reforms to drug pricing that would cover both the prices of new medicines when entering ...the market and price increases after they are launched.
To assess launch prices, postlaunch price changes, and clinical benefit of cancer drugs in the US compared with 3 European countries (England, Germany, and Switzerland).
This economic evaluation identified all new drugs that were approved for use in the US, England, Germany, and Switzerland with initial indications for treatment of adult solid tumor and hematologic cancers. Analysis included drugs approved by the US Food and Drug Administration between January 1, 2009, and December 31, 2019, and by the European Medicines Agency and Swissmedic until December 31, 2019. Prices were adjusted for currency and inflation. Clinical benefit of drugs indicated for solid tumors was assessed using the American Society of Clinical Oncology Value Framework and European Society for Medical Oncology Magnitude of Clinical Benefit Scale. Using Spearman rank correlation coefficients, correlations between clinical benefit and launch prices and postlaunch price changes for each country were evaluated.
Launch prices, postlaunch price changes, and clinical benefit of cancer drugs.
The cohort included 65 drugs: 47 (72%) approved for solid tumors and 18 (28%) for hematologic cancers. In all countries, the lowest median monthly treatment costs at launch were greater in 2018-2019 vs 2009-2010: $14 580 vs $5790 in the US, $5888 vs $4289 in Germany, $6593 vs $5784 in Switzerland, and $6867 vs $3939 in England. Between 2009 and 2019, 48 of 65 (74%) cancer drugs had price increases in the US that were greater than inflation. Only 1 of 62 (2%) drugs in England, 0 of 60 drugs in Germany, and 7 of 56 drugs (13%) in Switzerland had a median price increase greater than inflation. There were no associations between launch prices or postlaunch price changes and clinical benefit in any assessed country.
During this economic evaluation study period, launch prices of cancer drugs were substantially higher in the US than in the assessed similar high-income European countries, a gap that increased in the years after approval. Cancer drug prices frequently increased faster than inflation in the US but decreased on inflation-adjusted terms in Europe. Price changes were not associated with clinical benefit in any country.
Vitamin B12 is often used to improve cognitive function, depressive symptoms, and fatigue. In most cases, such complaints are not associated with overt vitamin B12 deficiency or advanced neurological ...disorders and the effectiveness of vitamin B12 supplementation in such cases is uncertain. The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) is to assess the effects of vitamin B12 alone (B12 alone), in addition to vitamin B12 and folic acid with or without vitamin B6 (B complex) on cognitive function, depressive symptoms, and idiopathic fatigue in patients without advanced neurological disorders or overt vitamin B12 deficiency. Medline, Embase, PsycInfo, Cochrane Library, and Scopus were searched. A total of 16 RCTs with 6276 participants were included. Regarding cognitive function outcomes, we found no evidence for an effect of B12 alone or B complex supplementation on any subdomain of cognitive function outcomes. Further, meta-regression showed no significant associations of treatment effects with any of the potential predictors. We also found no overall effect of vitamin supplementation on measures of depression. Further, only one study reported effects on idiopathic fatigue, and therefore, no analysis was possible. Vitamin B12 supplementation is likely ineffective for improving cognitive function and depressive symptoms in patients without advanced neurological disorders.
The aim of this study was to test associations between accumulated external load and changes in body composition, isokinetic strength, and aerobic capacity of soccer players. Twenty-three ...professional soccer players (age: 24.7 ± 2.8 years; height: 179.2 ± 6.3; experience: 9.7 ± 2.1 years) participated in this study. This pre-post study design was performed during 10 weeks from July to August of 2017 (4 weeks of pre-season and 6 weeks during the early season). Players were monitored daily by GPS technology and were assessed before and after a 10-week period in terms of body mass (BM), fat mass, lean mass, isokinetic strength at 60°/s, VO
, and HR
. Large-to-very large positive correlations were found between the sum of sprinting distance and % differences of BM 0.70, (-0.09;0.95), HR
0.51, (-0.37;0.91), agonist (quadriceps)/antagonist (hamstrings) left ratio 0.84, (0.27;0.97) and agonist/antagonist right ratio 0.92, (0.58;0.99). Large positive correlations were found between the acceleration sum and % differences of VO
0.58, (-0.29;0.92), quadriceps left peak torque 0.66, (-0.16;0.94), hamstrings left peak torque 0.68, (-0.13;0.94) and hamstrings right peak torque 0.62, (-0.22;0.93). Sprinting load was largely and positively associated with changes in knee strength asymmetries. Acceleration sum was largely and positively correlated with variations at VO
and peak torques at hamstrings. In addition, dose-response relationships using external load variables were identified in professional soccer players.
There currently exists no comprehensive and up-to date overview on the financial impact of the different adverse events covered by the Patient Safety Indicators (PSIs) from the Agency for Healthcare ...Research and Quality. We conducted a retrospective case-control study using propensity score matching on a national administrative data set of 1 million inpatients in Switzerland to compare excess costs associated with 16 different adverse events both individually and on a nationally aggregated level. After matching 8,986 cases with adverse events across the investigated PSIs to 26,931 controls, we used regression analyses to determine the excess costs associated with the adverse events and to control for other cost-related influences. The average excess costs associated with the PSI-related adverse events ranged from CHF 1,211 (PSI 18, obstetric trauma with instrument) to CHF 137,967 (PSI 10, postoperative acute kidney injuries) with an average of CHF 27,409 across all PSIs. In addition, adverse events were associated with 7.8-day longer stays, 2.5 times more early readmissions (within 18 days), and 4.1 times higher mortality rates on average. At a national level, the PSIs were associated with CHF 347 million higher inpatient costs in 2019, which corresponds to about 2.2% of the annual inpatient costs in Switzerland. By comparing the excess costs of different PSIs on a nationally aggregated level, we offer a financial perspective on the implications of in-hospital adverse events and provide recommendations for policymakers regarding specific investments in patient safety to reduce costs and suffering.
Health effects of vegetarian and vegan diets are well known. However, data is sparse in terms of their appropriateness for the special nutritional demands of endurance runners. Therefore, the aim of ...this study was to investigate the health status of vegetarian (VER) and vegan endurance runners (VGR) and compare it to omnivorous endurance runners (OR). A total of 245 female and male recreational runners completed an online survey. Health status was assessed by measuring health-related indicators (body weight, mental health, chronic diseases, and hypersensitivity reactions, medication intake) and health-related behavior (smoking habits, supplement intake, food choice, healthcare utilization). Data analysis was performed by using non-parametric ANOVA and MANOVA. There were 109 OR, 45 VER and 91 VGR. Significant differences (
< 0.05) were determined for the following findings: (i) body weight for VER and VGR was less than for OR, (ii) VGR had highest
scores, and (iii) VGR reported the lowest prevalences of allergies. There was no association (
> 0.05) between diet and mental health, medication intake, smoking habits, supplement intake, and healthcare utilization. These findings support the notion that adhering to vegetarian kinds of diet, in particular to a vegan diet, is associated with a good health status and, thus, at least an equal alternative to an omnivorous diet for endurance runners.
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