Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology

PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL). METHODS: Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored. RESULTS: Of 520 patients, 249 consented (47.9%)—mean age was 62 years, 51% were male, and 70% were married—and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff. CONCLUSION: Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting

Overcoming barriers to integrating patient-reported outcomes in clinical practice and electronic health records

There is burgeoning interest in integrating electronic patient-reported outcomes (PROs) into the workflow of routine cancer care. In general, this involves offering patients an interface for self-reporting their symptoms, distress, physical functioning, and other clinically oriented information through online or telephone systems, with this information conveyed to clinicians through real-time alerts and longitudinal graphic reports

Patient-Reported Outcomes for Tolerability Assessment in Phase i Cancer Clinical Trials

Patient-reported outcomes (PROs) have historically been used in clinical trials to assess symptoms or quality of life in pivotal (late phase) or postmarketing trials. More recently, interest has risen to use PROs to elicit information about symptomatic adverse events directly from patients, for example, nausea or peripheral sensory neuropathy associated with investigational treatments

Origin of pyroxenites in the oceanic mantle and their implications on the reactive percolation of depleted melts

Pyroxenites are diffuse in fertile mantle peridotites and considered an important component in the mantle source of oceanic basalts. They are rarely documented in abyssal and ophiolitic peridotites representing residual mantle after melt generation, and few studies defining their origin are to date available. We present a field-based microstructural and geochemical investigation of the pyroxenite layers associated with depleted peridotites from the Mt. Maggiore ophiolitic body (Corsica, France). Field and petrographic evidence indicate that pyroxenite formation preceded the melt\u2013rock interaction history that affected this mantle sector during Jurassic exhumation, namely (1) spinel-facies reactive porous flow leading to partial dissolution of the pyroxenites, and (2) plagioclase-facies melt impregnation leading to [plagioclase + orthopyroxene] interstitial crystallization. Pyroxenes show major element compositions similar to abyssal pyroxenites from slow-spreading ridges, indicative of magmatic segregation at pressures higher than 7 kbar. Both the parental melts of pyroxenites and the melts involved in the subsequent percolation were characterized by Na2O-poor, LREE-depleted compositions, consistent with unaggregated melt increments. This implies that they represent the continuous evolution of similarly depleted melts leading to different processes (pyroxenite segregation and later melt\u2013rock interaction) during their upward migration. To support the genetic relation and the continuity between the formation of pyroxenites and the subsequent melt\u2013rock interaction history, we modeled all the documented processes in sequence, i.e.: (1) formation of single-melt increments after 6% mantle decompressional fractional melting; (2) high-pressure segregation of pyroxenites; (3) spinel-facies reactive porous flow, (4) plagioclase-facies melt impregnation. The early fractionation of pyroxenites leads to a decrease in pyroxene saturation that is necessary for the subsequent reactive porous flow process, without any significant change in the melt REE composition

Symptom Monitoring in Pediatric Oncology Using Patient-Reported Outcomes: Why, How, and Where Next

Symptom monitoring using patient-reported outcomes (PROs) is not common in pediatric oncology, despite interest from stakeholders—including patients, families, clinicians, and regulatory organizations—and proven clinical benefit in adult oncology. This article examines the foundational data for patient-reported symptom reporting in this population and posits the next investigative steps toward the implementation of patient-reported symptom monitoring in the care and research of pediatric oncology patients. The reasoning behind, and feasibility of, monitoring symptoms in pediatric oncology patients using PRO measures are discussed, as well as specific tools that have been developed to track symptoms in this population, including innovative electronic self-reporting platforms built to engage children in the symptom reporting process. Aspects of engaging both patients and clinicians in the symptom self-report process are reviewed, as are the experiences of “early adopters” of this process in pediatric oncology and across pediatrics. It is clear that there are key issues that remain regarding the use of PROs for symptom monitoring, including selection of specific outcomes to monitor, how to resolve discrepant reports, and determination of benefit. The next steps for investigation of these issues are discussed. Unanswered questions notwithstanding, work should continue to make patient-reported symptom monitoring an established, evidence-based part of routine and research practice in pediatric oncology

Surrogate End Points and Patient-Reported Outcomes for Novel Oncology Drugs Approved between 2011 and 2017

The US Food and Drug Administration (FDA) may approve drugs based on surrogate end points that reasonably predict that a drug provides clinical benefit. If approved via the accelerated approval pathway, the FDA may require postmarketing studies to confirm the perceived clinical benefit. Assessment of patient-reported outcomes (PROs), defined as any report on a patient’s health that comes directly from the patient, can also play a key role in understanding benefits and tolerability of oncology drugs. We sought to examine the use of surrogate end points for overall survival (OS) in new oncology drug approvals, to evaluate the use of PROs in trials supporting approvals, and to determine whether oncology drugs initially approved without evidence of OS or PRO benefits demonstrated improvements in either measure postapproval

First-principles calculation on the transport properties of molecular wires between Au clusters under equilibrium

Based on the matrix Green's function method combined with hybrid tight-binding / density functional theory, we calculate the conductances of a series of gold-dithiol molecule-gold junctions including benzenedithiol (BDT), benzenedimethanethiol (BDMT), hexanedithiol (HDT), octanedithiol (ODT) and decanedithiol (DDT). An atomically-contacted extended molecule model is used in our calculation. As an important procedure, we determine the position of the Fermi level by the energy reference according to the results from ultraviolet photoelectron spectroscopy (UPS) experiments. After considering the experimental uncertainty in UPS measurement, the calculated results of molecular conductances near the Fermi level qualitatively agree with the experimental values measured by Tao et. al. [{\it Science} 301, 1221 (2003); {\it J. Am. Chem. Soc.} 125, 16164 (2003); {\it Nano. Lett.} 4, 267 (2004).]Comment: 12 pages,8 figure

Assessing bowel preparation quality using the mean number of adenomas per colonoscopy

Introduction: The quality of the bowel preparation directly influences colonoscopy effectiveness. Quality indicators are widely employed to monitor operator performance and to gauge colonoscopy effectiveness. Some have suggested that the enumeration of the mean number of adenomas per colonoscopy (MNA) may be a more useful measure of bowel preparation quality, but evidence of the utility of this metric is limited. The relationship between bowel preparation quality and MNA was assessed. Methods: Records of adult patients, aged 50–74 years, who had undergone a screening colonoscopy in a 6 month period at a hospital-based endoscopy suite in New York City were examined. Excluded were those who were symptomatic or having a colonoscopy for surveillance. Patient and procedural characteristics and clinical findings were abstracted from the endoscopy database. Bowel preparation quality was recorded as excellent, good, fair and poor. Histology and size of polyps removed were gathered from pathology reports. MNA was calculated and incident rate ratios assessing the relationship between bowel preparation quality, MNA, and covariates was calculated using Poisson regression. Results: A total of 2422 colonoscopies were identified; 815 (33.6%) were screening colonoscopies among average risk individuals, 50–74 years; 203 (24.9%) had ≥1 adenomas; and 666 (81.7%) had excellent/good preparation quality. Overall MNA was 0.34 [standard deviation (SD) 0.68] and MNA was greater among those >60 years [incident rate ratio (IRR) 1.89, 95% confidence interval (CI) 1.48–2.42), males (IRR 1.60, 95%CI 1.26–2.04) and those with good bowel preparation (IRR 2.54, 95%CI 1.04–6.16). Among those with ≥1 adenomas, MNA was 1.48 (SD 1.05) for excellent and 1.00 (SD 0.00) for poor quality preparation (p = 0.55). Conclusions: We found that MNA is sensitive to changes in bowel preparation with higher MNA among those with good bowel preparation compared with those with poor preparation. Our evidence suggests MNA was particularly sensitive when restricted to only those in whom adenomas were seen

ASCO's quality care symposium and the evolving science of value-based care

Since 2012, ASCO has sponsored its annual Quality Care Symposium. In developing this symposium, ASCO recognized the emerging importance of quality improvement and measurement in clinical practice and the value to the oncology community of a forum for sharing ideas and experiences. Moreover, it was recognized that there is a science of quality measurement based in the collection and systematic analysis of data that could empower practices to substantiate and continuously improve their initiatives and patient care

Electronic patient self-assessment and management (SAM): a novel framework for cancer survivorship

<p>Abstract</p> <p>Background</p> <p>We propose a novel framework for management of cancer survivorship: electronic patient Self-Assessment and Management (SAM). SAM is a framework for transfer of information to and from patients in such a way as to increase both the patient's and the health care provider's understanding of the patient's progress, and to help ensure that patient care follows best practice.</p> <p>Methods</p> <p>Patients who participate in the SAM system are contacted by email at regular intervals and asked to complete validated questionnaires online. Patient responses on these questionnaires are then analyzed in order to provide patients with real-time, online information about their progress and to provide them with tailored and standardized medical advice. Patient-level data from the questionnaires are ported in real time to the patient's health care provider to be uploaded to clinic notes. An initial version of SAM has been developed at Memorial Sloan-Kettering Cancer Center (MSKCC) and the University of California, San Francisco (UCSF) for aiding the clinical management of patients after surgery for prostate cancer.</p> <p>Results</p> <p>Pilot testing at MSKCC and UCSF suggests that implementation of SAM systems are feasible, with no major problems with compliance (> 70% response rate) or security.</p> <p>Conclusion</p> <p>SAM is a conceptually simple framework for passing information to and from patients in such a way as to increase both the patient's and the health care provider's understanding of the patient's progress, and to help ensure that patient care follows best practice.</p