The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings

The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review

The process of assessing patient symptoms and functionality using patient-reported outcomes (PROs) and functional performance status (FPS) is an essential aspect of patient-centered oncology research and care. However, PRO and FPS measures are often employed separately or inconsistently combined. Thus, the purpose of this study was to conduct a systematic review of the level of association between PRO and FPS measures to determine their differential or combined utility

Caratterizzazione archeometrica preliminare di materiali ceramici provenienti dal territorio di Mondragone (Caserta).

This paper presents the results of a preliminary archaeometric study on 14 potsherds collected in three sites of Mondragone territory (Caserta, Southern Italy), where two surface surveys campaign were carried out in 2007 and 2008. More than 700 fragments of artifacts (flint, pottery, daub and bricks) were found in the 18 sites identified in the studied area, being the potsherds the most represented archaeological materials. Petrographic analysis under optical microscopy and mineralogical characterization by X-ray powder diffraction were carried out in order to identify homogenous groups, to define the provenance of the raw materials and possible importation cases by comparison with the natural resources available in the region, as well as to constrain the production technology, with particular reference to the paste preparation and the firing process. Five main petrographic groups were defined, the features of which showed strong compatibility with clayey and silty-clayey alluvial deposits of Mondragone territory, suggesting a local production of the studied pottery. Mineral assemblages constrained the firing temperature in the interval 750-950\ub0C, at variable redox conditions defined on the basis of the paste colour, suggesting the use of pit firing or kilns with firing chamber directly in contact with the firebox. The comparison with other productions of the area reveals differences in terms of superficial treatments with respect to more recent pottery and strong technological analogies with other contexts in the Campania region, even attributed to different prehistoric and historic periods

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

PURPOSE: Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. METHODS: A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5,658 articles retrieved, 28 studies met inclusion criteria. RESULTS: Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had large variation across the majority of studies (n = 21). CONCLUSIONS: The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs