Strategies to improve the implementation of workplace-based policies or practices targeting tobacco, alcohol, diet, physical activity and obesity.

BackgroundThe National Institutes of Health (NIH) Health Care Systems Research Collaboratory (NIH Collaboratory) seeks to produce generalizable knowledge about the conduct of pragmatic research in health systems. This analysis applied the PRECIS-2 pragmatic trial criteria to five NIH Collaboratory pragmatic trials to better understand 1) the pragmatic aspects of the design and implementation of treatments delivered in real world settings and 2) the usability of the PRECIS-2 criteria for assessing pragmatic features across studies and across time.Methods/DesignUsing the PRECIS-2 criteria, five pragmatic trials were each rated by eight raters. For each trial, we reviewed the original grant application and a required progress report written at the end of a 1-year planning period that included changes to the protocol or implementation approach. We calculated median scores and interrater reliability for each PRECIS domain and for the overall trial at both time points, as well as the differences in scores between the two time points. We also reviewed the rater comments associated with the scores.ResultsAll five trials were rated to be more pragmatic than explanatory, with comments indicating that raters generally perceived them to closely mirror routine clinical care across multiple domains. The PRECIS-2 domains for which the trials were, on average, rated as most pragmatic on the 1 to 5 scale at the conclusion of the planning period included primary analysis (mean = 4.7 (range = 4.5 to 4.9)), recruitment (4.3 (3.6 to 4.8)), eligibility (4.1 (3.4 to 4.8)), setting (4.1 (4.0 to 4.4)), follow-up (4.1 (3.4 to 4.9)), and primary outcome (4.1 (3.5 to 4.9)). On average, the less pragmatic domains were organization (3.3 (2.6 to 4.4)), flexibility of intervention delivery (3.5 (2.1-4.5)), and flexibility of intervention adherence (3.8 (2.8-4.5)). Interrater agreement was modest but statistically significant for four trials (Gwet’s AC1 statistic range 0.23 to 0.40) and the intraclass correlation coefficient ranged from 0.05 to 0.31. Rating challenges included assigning a single score for domains that may relate to both patients and care settings (that is, eligibility or recruitment) and determining to what extent aspects of complex research interventions differ from usual care.ConclusionsThese five trials in diverse healthcare settings were rated as highly pragmatic using the PRECIS-2 criteria. Applying the tool generated insightful discussion about real-world design decisions but also highlighted challenges using the tool. PRECIS-2 raters would benefit from additional guidance about how to rate the interwoven patient and practice-level considerations that arise in pragmatic trials.Trial registrationsClinicaltrials.gov trial registrations: NCT02019225, NCT01742065, NCT02015455, NCT02113592, NCT02063867.

Today, there are more than 16.9 million cancer survivors in the United States; this number is projected to grow to 22.2 million by 2030. While much progress has been made in understanding cancer survivors needs and in improving survivorship care since the seminal 2006 Institute of Medicine report From Cancer Patient to Cancer Survivor: Lost in Transition, there is a need to identify evidence gaps and research priorities pertaining to cancer survivorship. Thus, in April 2019, the National Cancer Institute convened grant-funded extramural cancer survivorship researchers, representatives of professional organizations, cancer survivors, and advocates for a one-day in-person meeting. At this meeting, and in a subsequent webinar aimed at soliciting input from the wider survivorship community, evidence gaps and ideas for next steps in the following six areas, identified from the 2006 Institute of Medicine report, were discussed: surveillance for recurrence and new cancers, management of long-term and late physical effects, management of long-term and late psychosocial effects, health promotion, care coordination, and financial hardship. Identified evidence gaps and next steps across the areas included the need to understand and address disparities among cancer survivors, to conduct longitudinal studies as well as longer-term (>5 years post-diagnosis) follow-up studies, to leverage existing data, and to incorporate implementation science strategies to translate findings into practice. Designing studies to address these broad evidence gaps, as well as those identified in each area, will expand our understanding of cancer survivors’ diverse needs, ultimately leading to the development and delivery of more comprehensive evidence-based quality care.

BackgroundThe National Cancer Institute (NCI) has supported implementation science for over a decade. We explore the application of implementation science across the cancer control continuum, including prevention, screening, treatment, and survivorship.MethodsWe reviewed funding trends of implementation science grants funded by the NCI between 2000 and 2012. We assessed study characteristics including cancer topic, position on the T2–T4 translational continuum, intended use of frameworks, study design, settings, methods, and replication and cost considerations.ResultsWe identified 67 NCI grant awards having an implementation science focus. R01 was the most common mechanism, and the total number of all awards increased from four in 2003 to 15 in 2012. Prevention grants were most frequent (49.3%) and cancer treatment least common (4.5%). Diffusion of Innovations and Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) were the most widely reported frameworks, but it is unclear how implementation science models informed planned study measures. Most grants (69%) included mixed methods, and half reported replication and cost considerations (49.3%).ConclusionsImplementation science in cancer research is active and diverse but could be enhanced by greater focus on measures development, assessment of how conceptual frameworks and their constructs lead to improved dissemination and implementation outcomes, and harmonization of measures that are valid, reliable, and practical across multiple settings.

The murine antimelanoma monoclonal antibody, 9.2.27, was administered intravenously to eight patients with metastatic malignant melanoma. Biopsies of metastatic nodules clearly demonstrate the selective localization of this antibody on the melanoma cell surface with a dose-response relationship to the quantity of administered antibody. The antibody infusions were clinically well tolerated and the pharmacokinetics of the antibody and the antiglobulin responses are described. This study indicates that murine monoclonal antibodies have potential as selective targeting agents in the design of future therapeutic trials using monoclonal antibodies or conjugates thereof in the treatment of cancer.