Content Validity of Anatomic Site-Specific Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Sets for Assessment of Acute Symptomatic Toxicities in Radiation Oncology

Purpose: To improve assessment of symptomatic toxicity in cancer clinical trials and complement clinician-based toxicity reporting, the US National Cancer Institute developed a measurement system called the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The objective of this study was to examine the content validity of PRO-CTCAE in patients undergoing radiation therapy and to establish anatomic site-specific item sets for implementation in cancer research. Methods and Materials: Patients receiving radiation to the brain, head and neck, breast, thorax, abdomen, or pelvis were recruited during the final week of radiation. Participants described side effects qualitatively and completed anatomic site-specific checklists indicating the presence or absence of symptomatic toxicities drawn from the PRO-CTCAE library. Items endorsed by ≥20% of participants were selected for inclusion. Symptomatic toxicities described qualitatively were content analyzed and summarized. Symptomatic toxicities not reflected in the PRO-CTCAE item library were tabulated. Results: We conducted 389 interviews of patients receiving radiation to the brain (n = 46), head and neck (n = 69), breast (n = 134), thorax (n = 30), abdomen (n = 27), female pelvis (n = 36), or male pelvis (n = 47). Median age was 62 years; 62% were female. The 53 solicited PRO-CTCAE symptoms reflected all reported radiation-induced toxicities with the exception of phlegm/mucus production and mouth/throat pain with swallowing in patients receiving head and neck radiation, eye dryness/irritation in patients undergoing brain radiation, and obstructive urinary symptoms in men receiving pelvic radiation. The PRO-CTCAE items “skin burns” and “pain” require greater specificity to adequately reflect toxicities experienced during radiation. Conclusions: PRO-CTCAE demonstrates strong content validity as a measure of symptomatic toxicities in patients receiving radiation. These results provide empirical support for the definition of site-specific PRO-CTCAE item sets to assess the symptomatic toxicities of radiation therapy. The site-specific PRO-CTCAE item sets developed herein are currently being deployed in our department via an electronic platform to capture treatment-related toxicity

Personalized estimation of one-year mortality risk after elective hip or knee arthroplasty for osteoarthritis

Aims To develop and validate patient-centred algorithms that estimate individual risk of death over the first year after elective joint arthroplasty surgery for osteoarthritis. Methods A total of 763,213 hip and knee joint arthroplasty episodes recorded in the National Joint Registry for England and Wales (NJR) and 105,407 episodes from the Norwegian Arthroplasty Register were used to model individual mortality risk over the first year after surgery using flexible parametric survival regression. Results The one-year mortality rates in the NJR were 10.8 and 8.9 per 1,000 patient-years after hip and knee arthroplasty, respectively. The Norwegian mortality rates were 9.1 and 6.0 per 1,000 patient-years, respectively. The strongest predictors of death in the final models were age, sex, body mass index, and American Society of Anesthesiologists grade. Exposure variables related to the intervention, with the exception of knee arthroplasty type, did not add discrimination over patient factors alone. Discrimination was good in both cohorts, with c-indices above 0.76 for the hip and above 0.70 for the knee. Time-dependent Brier scores indicated appropriate estimation of the mortality rate (≤ 0.01, all models). Conclusion Simple demographic and clinical information may be used to calculate an individualized estimation for one-year mortality risk after hip or knee arthroplasty (https://jointcalc.shef.ac.uk). These models may be used to provide patients with an estimate of the risk of mortality after joint arthroplasty

A comparison of flare forecasting methods. II. Benchmarks, metrics and performance results for operational solar flare forecasting systems

YesSolar flares are extremely energetic phenomena in our Solar System. Their impulsive, often drastic radiative increases, in particular at short wavelengths, bring immediate impacts that motivate solar physics and space weather research to understand solar flares to the point of being able to forecast them. As data and algorithms improve dramatically, questions must be asked concerning how well the forecasting performs; crucially, we must ask how to rigorously measure performance in order to critically gauge any improvements. Building upon earlier-developed methodology (Barnes et al. 2016, Paper I), international representatives of regional warning centers and research facilities assembled in 2017 at the Institute for Space-Earth Environmental Research, Nagoya University, Japan to – for the first time – directly compare the performance of operational solar flare forecasting methods. Multiple quantitative evaluation metrics are employed, with focus and discussion on evaluation methodologies given the restrictions of operational forecasting. Numerous methods performed consistently above the “no skill” level, although which method scored top marks is decisively a function of flare event definition and the metric used; there was no single winner. Following in this paper series we ask why the performances differ by examining implementation details (Leka et al. 2019, Paper III), and then we present a novel analysis method to evaluate temporal patterns of forecasting errors in (Park et al. 2019, Paper IV). With these works, this team presents a well-defined and robust methodology for evaluating solar flare forecasting methods in both research and operational frameworks, and today’s performance benchmarks against which improvements and new methods may be compared

Social identification moderates cognitive health and well-being following story- and song-based reminiscence

Objectives: Reminiscence is a popular intervention for seniors, but, with mixed evidence supporting its efficacy, questions have been raised about the mechanisms underlying improvement. The present paper addresses this question by investigating the degree to which health effects depend on the development of a shared sense of group identification. This is examined in the context of traditional story-based reminiscence as well as novel forms of song-based reminiscence.Method: As the focus of a manualized intervention, 40 participants were randomly assigned to secular song (n = 13), religious song (n = 13), or standard story reminiscence (n = 14) groups. These were run over six weeks with cognitive performance, anxiety, and life satisfaction measured before and after the intervention. Measures of group fit were included to examine whether social identification contributed to outcomes.Results: No evidence of change emerged over time as a function of intervention form alone, but analysis of identification data revealed significant interactions with the type of reminiscence group. Specifically, initial fit with the story reminiscence group was associated with enhanced cognitive outcomes and greater life satisfaction, while fit with the religious song reminiscence group was associated with greater life satisfaction and less anxiety.Conclusion: These findings show that group identification is a key moderator through which reminiscence promotes health outcomes. Implications for theory and practice highlight an inherent limitation in randomized controlled trials insofar as they may compromise participants group identification