Background The Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention. The trial is being conducted by SWOG through the National Cancer Institute Community Oncology Research Program in 45 clinics. The ESAG includes ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist. This manuscript describes the ESAG’s role and impact on the trial. Methods During early trial development, the research team assembled the ESAG to inform plans for each phase of the trial. ESAG members provide feedback and engage in problem solving to improve trial implementation. Each year, members participate in one in-person meeting, web conferences and targeted email discussion. Additionally, they complete a survey that assesses their satisfaction with communication and collaboration. The research team collected and reviewed stakeholder input from 2014 to 2018 for impact on the trial. Results The ESAG has informed trial design, implementation and dissemination planning. The group advised the trial’s endpoints, regimen list and development of cohort and usual care arms. Based on ESAG input, the research team enhanced patient surveys and added pharmacy-related questions to the component application to assess order entry systems. ESAG patient partners collaborated with the research team to develop a patient brochure and study summary for clinic staff. In addition to identifying recruitment strategies and patient-oriented platforms for publicly sharing results, ESAG members participated as co-authors on this manuscript and a conference poster presentation highlighting stakeholder influence on the trial. The annual satisfaction survey results suggest that ESAG members were satisfied with the methods, frequency and target areas of their engagement in the trial during project years 1–3. Conclusions Diverse stakeholder engagement has been essential in optimizing the design, implementation and planned dissemination of the TrACER Study. The lessons described in the manuscript may assist others to effectively partner with stakeholders on clinical research.

This qualitative study investigates clinician-identified barriers and facilitators to colonoscopy completion among patients in a safety net health care system who receive abnormal fecal immunochemical test (FIT) results.

Journal of Patient-Centered Research and Reviews (JPCRR) is an open access, peer-reviewed medical journal focused on disseminating scholarly works devoted to improving patient-centered care practices, health outcomes, and the patient experience. Purpose Patient-reported outcomes (PROs) are frequently used in clinical care to monitor treatment response. However, most guidelines on PRO use treat all patients the same. This study tested the feasibility and validity of a method for determining individually meaningful change in PRO measures. Methods Participants (n=398) completed 12 pain and distress questions to define individually meaningful change. This mixed-methods study used both quantitative and qualitative analyses, including descriptive statistics, inferential statistics, and content analysis. Results Two-thirds (67%) of the sample reported at least one medical condition, including depression and back pain. Most participants (70%-90%) were able to answer the questions as intended. Participants varied widely in the amount of change they considered meaningful (coefficients of variation: 40%-99%). Higher symptom levels were associated with larger amounts of change considered meaningful and with greater likelihood of answering questions as intended. Participants reported a variety of reasons for why they considered an amount of change in pain or distress meaningful. The hypothetical nature of the questions and the need to reference previous questions was found to be confusing. Conclusions Asking patients to define an individual level for meaningful change on PROs was feasible and valid. Having patients define their own goals on PROs for treatment of pain or distress could make treatment more patient-centered.

ImportanceColony-stimulating factors are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia. Research suggests that 55% to 95% of colony-stimulating factor prescribing is inconsistent with national guidelines.ObjectiveTo examine whether a guideline-based standing order for primary prophylactic colony-stimulating factors improves use and reduces the incidence of febrile neutropenia.Design, Setting, and ParticipantsThis cluster randomized clinical trial, the Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER), involved 32 community oncology clinics in the US. Participants were adult patients with breast, colorectal, or non–small cell lung cancer initiating cancer therapy and enrolled between January 2016 and April 2020. Data analysis was performed from July to October 2021.InterventionsSites were randomized 3:1 to implementation of a guideline-based primary prophylactic colony-stimulating factor standing order system or usual care. Automated orders were added for high-risk regimens, and an alert not to prescribe was included for low-risk regimens. Risk was based on National Comprehensive Cancer Network guidelines.Main Outcomes and MeasuresThe primary outcome was to find an increase in colony-stimulating factor use among high-risk patients from 40% to 75%, a reduction in use among low-risk patients from 17% to 7%, and a 50% reduction in febrile neutropenia rates in the intervention group. Mixed model logistic regression adjusted for correlation of outcomes within a clinic.ResultsA total of 2946 patients (median [IQR] age, 59.0 [50.0-67.0] years; 2233 women [77.0%]; 2292 White [79.1%]) were enrolled; 2287 were randomized to the intervention, and 659 were randomized to usual care. Colony-stimulating factor use for patients receiving high-risk regimens was high and not significantly different between groups (847 of 950 patients [89.2%] in the intervention group vs 296 of 309 patients [95.8%] in the usual care group). Among high-risk patients, febrile neutropenia rates for the intervention (58 of 947 patients [6.1%]) and usual care (13 of 308 patients [4.2%]) groups were not significantly different. The febrile neutropenia rate for patients receiving high-risk regimens not receiving colony-stimulating factors was 14.9% (17 of 114 patients). Among the 585 patients receiving low-risk regimens, colony-stimulating factor use was low and did not differ between groups (29 of 457 patients [6.3%] in the intervention group vs 7 of 128 patients [5.5%] in the usual care group). Febrile neutropenia rates did not differ between usual care (1 of 127 patients [0.8%]) and the intervention (7 of 452 patients [1.5%]) groups.Conclusions and RelevanceIn this cluster randomized clinical trial, implementation of a guideline-informed standing order did not affect colony-stimulating factor use or febrile neutropenia rates in high-risk and low-risk patients. Overall, use was generally appropriate for the level of risk. Standing order interventions do not appear to be necessary or effective in the setting of prophylactic colony-stimulating factor prescribing.Trial RegistrationClinicalTrials.gov Identifier: NCT02728596

IntroductionTransportation is a common barrier to colonoscopy completion for colorectal cancer (CRC) screening. The study aims to identify the barriers, facilitators, and process recommendations to implement a rideshare non-emergency medical transportation (NEMT) intervention following colonoscopy completion within a safety-net healthcare setting.MethodsWe used informal stakeholder engagement, story boards—a novel user-centered design technique, listening sessions and the nominal group technique to identify the barriers, facilitators, and process to implementing a rideshare NEMT program following colonoscopy completion in a large safety-net healthcare system.ResultsBarriers to implementing a rideshare NEMT intervention for colonoscopy completion included: inability to expand an existing NEMT program beyond Medicaid patients and lack of patient chaperones with rideshare NEMT programs. Facilitators included: commercially available rideshare NEMT platforms that were lower cost and had shorter wait times than the alternative of taxis. Operationalizing and implementing a rideshare NEMT intervention in our healthcare system required the following steps: 1) identifying key stakeholders, 2) engaging stakeholder groups in discussion to identify barriers and solutions, 3) obtaining institutional sign-off, 4) developing a process for reviewing and selecting a rideshare NEMT program, 5) executing contracts, 6) developing a standard operating procedure and 7) training clinic staff to use the rideshare platform.DiscussionRideshare NEMT after procedural sedation is administered may improve colonoscopy completion rates and provide one solution to inadequate CRC screening. If successful, our rideshare model could be broadly applicable to other safety-net health systems, populations with high social needs, and settings where procedural sedation is administered.