Evaluating Health-Related Quality of Life in Cancer Clinical Trials: The National Cancer Institute of Canada Clinical Trials Group Experience

AbstractIntroductionThe National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) Quality of Life (QOL) Committee was initiated in 1986.PurposeThe purpose of this review is to describe the evolution of the Committee's work and to highlight key developments such as the formulation of a policy regarding health-related quality-of-life (HRQOL) assessment, the provision of guidelines to ensure completion of HRQOL data within the protocol requirements, the rationale behind the choice of HRQOL instruments, the timing of assessments and the development of data analytic methods. These developments are illustrated with examples from CTG studies.RecommendationsThere is a lack of concordance between conventional toxicity data and HRQOL data and comparative studies designed to elucidate these differences are to be encouraged. Also, more studies are required to compare different analytic strategies and to determine how much missing data is acceptable, particularly in oncology studies where attrition is inevitable

Measurement and Evaluation for Prognostics and Health Management (PHM) for Manufacturing Operations – Summary of an Interactive Workshop Highlighting PHM Trends

Personnel from the National Institute of Standards and Technology (NIST) organized and led a Measurement and Evaluation for Prognostics and Health Management for Manufacturing Operations (ME4PHM) workshop at the 2019 Annual Conference of the Prognostics and Health Management Society held on September 23rd, 2019 in Scottsdale, Arizona. This event featured panel presentations and discussions from industry, government, and academic participants who are focused in advancing monitoring, diagnostic, and prognostic (collectively known as prognostic and health management (PHM)) capabilities within manufacturing operations. The participants represented a diverse cross-section of technology developers, integrators, end-users/manufacturers (from small to large), and researchers. These contributors discussed 1) what works well, 2) common challenges that need to be addressed, 3) where the community’s priorities should be focused, and 4) how PHM technological adoption can be sped in a cost-effective manner. This report summarizes the workshop and offers lessons learned regarding the current state of PHM. Based upon the discussions, recommended next steps to advance this technological domain are also presented

Rethinking Maintenance Terminology for an Industry 4.0 Future

Sensors and mathematical models have been used since the 1990’s to assess the health of systems and diagnose anomalous behavior. The advent of the Internet of Things (IoT) increases the range of assets on which data can be collected cost effectively. Cloud-computing and the wider availability of data and models are democratizing the implementation of prognostic health (PHM) technologies. Together, these advancements and other Industry 4.0 developments are creating a paradigm shift in how maintenance work is planned and executed. In this new future, maintenance will be initiated once a potential failure has been detected (using PHM) and thus completed before a functional failure has occurred. Thus corrective work is required since corrective work is defined as “work done to restore the function of an asset after failure or when failure is imminent.” Many metrics for measuring the effectiveness of maintenance work management are grounded in a negative perspective of corrective work and do not clearly capture work arising from condition monitoring and predictive modeling investments. In this paper, we use case studies to demonstrate the need to rethink maintenance terminology. The outcomes of this work include 1) definitions to be used for consistent evaluation of work management performance in an Industry 4.0 future and 2) recommendations to improve detection of work related to PHM activities

A Data-Driven Framework for Team Formation for Maintenance Tasks

Even as maintenance evolves with new technologies, it is still a heavily human-driven domain; multiple steps in the maintenance workflow still require human expertise and intervention. Various maintenance activities require multiple maintainers, all with different skill sets and expertise, and from various positions and levels within the organization. Responding to maintenance requests, training exercises, or executing larger maintenance projects all can require maintenance teams. Having the correct assortment of individuals both in terms of skills and management experience can help improve the efficiency of these maintenance tasks. This paper presents a workflow for creating teams of maintainers by adapting accepted practices from the human-computer interaction (HCI) community. These steps provide a low-cost solution to help account for the needs of maintainers and their management, while matching skills of the maintainers with the needs of the activity

Radiation Oncology Workforce Recruitment Survey of 2000-2010 Graduates: Is There Need for Better Physician Resource Planning?

Purpose of the Study: To survey employment and training characteristics of Canadian radiation oncology training program graduates and foreign medical graduates with Canadian radiation oncology post-graduate education or specialist certification. Methods: A 38-question, web-based survey was distributed to radiation oncologists who completed specialty training between 2000-2010. Results: Out of 256 radiation oncologists contacted, 148 completed the survey (58% response rate). Thirty-two respondents (22%) were foreign MD graduates. One-hundred and fifteen respondents (78%) undertook fellowship training after residency. Many Canadian MD graduates (77%) and foreign MD graduates (34%) had staff positions in Canada, while 11% of all respondents had staff positions outside Canada, and 21% did not have a commitment for staff employment. Of the 31 respondents without a staff position, 22 graduated from Canadian residency training in 2009 or 2010, and 21 had completed medical school training in Canada. Conclusions: The majority of respondents were successful in securing staff positions in Canada. A sizeable proportion extended training with fellowships. New graduates may have more difficulty in finding Canadian staff positions in radiation oncology in the near future. Implications for specialty training programs and for an improved national strategy for physician resource planning are discussed

Patient-reported outcome (PRO) assessment in clinical trials : a systematic review of guidance for trial protocol writers

BACKGROUND: Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. METHODS AND FINDINGS: We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. CONCLUSIONS: PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care