Purpose or Objective: Short-course radiotherapy (25 Gy in five fractions) was recently shown in a multi-national randomized phase III clinical trial to be non-inferior to a commonly used regimen (40 Gy in 15 fractions) in elderly and/or frail patients with glioblastoma multiforme, with no difference in overall survival (OS) and progression free survival (PFS).This study compared the cost-effectiveness of the two regimens. Material and Methods:The direct unit costs of imaging, radiotherapy (RT), and dexamethasone were collected in equitable US dollars (USD) from the five primary contributing countries to the trial, representing 88% of all patients accrued (n = 86) between 2010 and 2013.Effectiveness was measured by the restricted mean overall survival (RMOS) and progression free survival (RMPFS).Irwin's restricted mean method was used to calculate mean survival time in the presence of censoring, and life-years gained and PFS gained.The incremental cost-effectiveness ratio (ICER) was calculated as: Cost per life-year gained = (Difference in direct costs between short-course RT and commonly used RT) ÷ (Difference in life-years gained between short-course RT and commonly used RT).Indirect costs were also estimated for comparison.Results: There was no OS difference between the two studied populations.The median OSs for the short-course and commonly used RTs were 8.2 (6.1-10.3)and 7.7 (5.5-9.9)months, respectively.Median PFSs were also not different.The differences in the RMOS and the ICER, however, were +0.11 life-years and -USD 3307 per life-year gained, respectively.The differences in the RMPFS and the ICER were +0.02 PFS and -USD 19030, respectively.The negative ICER values indicated improvement in direct cost in addition to life-years gained with the short-course RT.Indirect cost comparison also identified improved survival-to-treatment time ratio and reduced cost for patients and care-givers with short-course RT. Conclusion:The direct cost account for ICER of -USD 3307 per life-year gained and -USD 19030 per PFS gained indicates that the short-course RT is less costly and more effective compared to the commonly used RT.Indirect cost is also improved with the short-course RT.
Background: It has been suggested that children and infants can develop multisystem inflammatory syndrome in children (MIS-C) in response to a SARS-CoV-2 infection and that Black children are overrepresented among cases. The aim of the current study was to quantify the association between Black, Asian, or other non-White genetic background and COVID-19-related MIS-C in children and infants. Methods: Eight different research groups contributed cases of MIS-C, potentially related to SARS-CoV-2 infection. Several sensitivity analyses were performed, including additional data available from the literature. Analyses were stratified by geographical region. Results: Seventy-three cases from nine distinct geographical regions were included in the primary analyses. In comparison to White children, the relative risk for developing MIS-C after SARS-CoV-2 infection was 15 [95% confidence interval (CI): 7.1 to 32] for Black children, 11 (CI: 2.2 to 57) for Asian, and 1.6 (CI: 0.58 to 4.2) for other ethnic background. Conclusion: Pediatricians should be aware of the fact that the risk of COVID-19-related MIS-C is severely increased in Black children.
The utilization rate of RT increased from 64.4% in 2011 to 70.3% in 2015. After BCS and mastectomy, 97.3% and 26.1% of the patients received RT, respectively. For patients undergoing BCS and mastectomy, lower age and ER + tumours were associated with higher RT utilisation rates. After mastectomy, also larger tumour sizes, lymph node involvement, grade-2 and 3 tumours and diagnosis in more recent years were associated with higher RT use.
Abstract: Evidence-based medicine has become associated with a preference for randomized trials. Randomization is a powerful tool against both known and unknown confounding. However, due to cost-induced constraints in size, randomized trials are seldom able to provide the subgroup analyses needed to gain much insight into effect modification. To apply results to an individual patient, effect modification needs to be considered. Results from randomized trials are therefore often difficult to apply in daily clinical practice. Confounding by indication, which randomization aims to prevent, is caused by more severely ill patients being less or more likely to be treated. Therefore, the prognostic indicators that physicians use to make treatment decisions become confounders. However, these same prognostic indicators are also effect modifiers. This is in fact exactly why they are relevant to decision-making. We use simple, fictive numerical examples to illustrate these concepts. Then we argue that if we would record all relevant variables, it would simultaneously solve the problem of confounding by indication and allow quantification of effect modification. It has previously been argued that it is practically more feasible to “simply” randomize treatment allocation, than to adequately correct for confounding by indication. We will argue that, in the current age of evidence-based medicine and highly regulated randomized trials, this balance has shifted. We therefore call for better observational clinical research. However, careless acceptance of results from poorly performed observational research can lead clinicians seriously astray. Therefore, a more interactive approach toward the medical literature might be needed, where more room is made for scientific discussion and interpretation of results, instead of one-way reporting. Keywords: treatment, personalized, effectiveness, effect modification, risk factors, confounding by indication
Microbial cure of chlamydia proctitis (lymphogranuloma venereum [LGV] and non-LGV) with doxycycline treatment was evaluated by chlamydia DNA and RNA persistence in anal swab specimens. In LGV proctitis, RNA persisted for up to 16 days. In non-LGV chlamydia proctitis, DNA was undetectable after 7 days. These findings support the Centers for Disease Control and Prevention's treatment recommendation of a 21-day doxycycline regimen for LGV proctitis and a 7-day regimen for non-LGV chlamydia proctitis. Delayed microbial cure of LGV proctitis should be considered in improved treatment regimens.
To investigate whether the Geriatric 8 (G8) score and the Timed Get Up and Go Test (TGUGT), together with clinical and demographic patient characteristics, are associated with survival and late toxicity after (chemo)radiation therapy, administered with curative intent in older patients with cancer.Four hundred and two patients aged ≥65 years (median age 72 years, range 65-96 years), diagnosed with either breast, non-small cell lung, prostate, head and neck, rectal or oesophageal cancer, and referred for curative (chemo)radiation therapy, took part in a multicentre prospective cohort study in eight radiotherapy centres in the Netherlands. The G8 and TGUGT scores were assessed before starting treatment. Other potential predictors and late toxicity were also recorded. Survival status and date of death, if applicable, were ascertained at the Dutch national death registry.After 2.5 years, the overall survival was 83%. Survival was 87% for patients with high G8 scores and 55% for patients with low G8 scores (Log-rank P value < 0.0001). Survival was 77% for patients with good TGUGT results and 50% for patients with poor TGUGT results (Log-rank P value < 0.001). In multivariable analysis, in addition to age and type of primary tumour, the association of the G8 score with overall survival remained, with a hazard ratio of 2.1 (95% confidence interval 1.2-3.8) for low versus high scores.G8 was associated with overall survival in older patients with cancer irradiated with curative intent. This association was independent of the predictive value of age and primary tumour.
