Engagement Among Diverse Patient Backgrounds in a Remote Symptom Monitoring Program.

PURPOSE: Previous randomized controlled trials have demonstrated benefit from remote symptom monitoring (RSM) with electronic patient-reported outcomes. However, the racial diversity of enrolled patients was low and did not reflect the real-world racial proportions for individuals with cancer. METHODS: This secondary, cross-sectional analysis evaluated engagement of patients with cancer in a RSM program. Patient-reported race was grouped as Black, Other, or White. Patient address was used to map patient residence to determine rurality using Rural-Urban Commuting Area Codes and neighborhood disadvantage using Area Deprivation Index. Key outcomes included (1) being approached for RSM enrollment, (2) declining enrollment, (3) adherence with RSM via continuous completion of symptom surveys, and (4) withdrawal from RSM participation. Risk ratios (RR) and 95% CI were estimated from modified Poisson models with robust SEs. RESULTS: Between May 2021 and May 2023, 883 patients were approached to participate, of which 56 (6%) declined RSM. Of those who enrolled in RSM, a total of 27% of patients were Black or African American and 67% were White. In adjusted models, all patient population subgroups of interest had similar likelihoods of being approached for RSM participation; however, Black or African American patients were more than 3× more likely to decline participation than White participants (RR, 3.09 [95% CI, 1.73 to 5.53]). Patients living in more disadvantaged neighborhoods were less likely to decline (RR, 0.49 [95% CI, 0.24 to 1.02]), but less likely to adhere to surveys (RR, 0.81 [95% CI, 0.68 to 0.97]). All patient populations had a similar likelihood of withdrawing. CONCLUSION: Black patients and individuals living in more disadvantaged neighborhoods are at risk for lower engagement in RSM. Further work is needed to identify and overcome barriers to equitable participation.

Emotional and functional well-being in long-term breast cancer survivorship.

PURPOSE: Emotional and functional well-being (EWB and FWB) are important components of mental health and quality of life. This study aims to evaluate long-term EWB and FWB in breast cancer (BC) survivors. METHODS: The Carolina Breast Cancer Study Phase 3 oversampled Black and younger (< 50 years in age) women so that they each represent approximately 50% of the study population and assessed participants' EWB and FWB with the Functional Assessment of Cancer Therapy-Breast (FACT-B) at 5- (baseline), 25-, and 84-months post diagnosis. Multinomial logit models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for associations between demographic and clinical characteristics and well-being change relative to baseline. RESULTS: Among 2,781 participants with BC, average EWB and FWB improved with time since diagnosis. Persistent FWB decrements were associated with Black race [OR 1.4 (95% CI 1.2-1.7) and 1.3 (95% CI 1.1-1.6), at 25-months and 84-months respectively], older age [OR 1.4 (95% CI 1.1-1.7) and 1.5 (95% CI 1.2-1.8), respectively], no chemotherapy, and recurrence [OR 2.9 (95% CI 1.8-4.8) and 3.1 (95% CI 2.1-4.6), respectively]. EWB decrements were associated with advanced stage and recurrence. Decrements in combined (FWB+EWB) well-being were associated with recurrence at both follow-up survey timepoints [ORs 4.7 (95% CI 2.7-8.0) and 4.3 (95% CI 2.8-6.6), respectively]. CONCLUSIONS: Long-term well-being varies by demographics and clinical features, with Black women and women with aggressive disease at greatest risk of long-term decrements.

Virtual quality improvement collaborative with primary care practices during COVID-19: a case study within a clinically integrated network.

INTRODUCTION: Quality improvement collaboratives (QICs) are a common approach to facilitate practice change and improve care delivery. Attention to QIC implementation processes and outcomes can inform best practices for designing and delivering collaborative content. In partnership with a clinically integrated network, we evaluated implementation outcomes for a virtual QIC with independent primary care practices delivered during COVID-19. METHODS: We conducted a longitudinal case study evaluation of a virtual QIC in which practices participated in bimonthly online meetings and monthly tailored QI coaching sessions from July 2020 to June 2021. Implementation outcomes included: (1) level of engagement (meeting attendance and poll questions), (2) QI capacity (assessments completed by QI coaches), (3) use of QI tools (plan-do-check-act (PDCA) cycles started and completed) and (4) participant perceptions of acceptability (interviews and surveys). RESULTS: Seven clinics from five primary care practices participated in the virtual QIC. Of the seven sites, five were community health centres, three were in rural counties and clinic size ranged from 1 to 7 physicians. For engagement, all practices had at least one member attend all online QIC meetings and most (9/11 (82%)) poll respondents reported meeting with their QI coach at least once per month. For QI capacity, practice-level scores showed improvements in foundational, intermediate and advanced QI work. For QI tools used, 26 PDCA cycles were initiated with 9 completed. Most (10/11 (91%)) survey respondents were satisfied with their virtual QIC experience. Twelve interviews revealed additional themes such as challenges in obtaining real-time data and working with multiple electronic medical record systems. DISCUSSION: A virtual QIC conducted with independent primary care practices during COVID-19 resulted in high participation and satisfaction. QI capacity and use of QI tools increased over 1 year. These implementation outcomes suggest that virtual QICs may be an attractive alternative to engage independent practices in QI work.

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Evaluating Nurses' Time to Response by Severity and Cancer Stage in a Remote Symptom Monitoring Program for Patients With Breast Cancer.

PURPOSE: Remote symptom monitoring (RSM) using electronic patient-reported outcomes enables patients with cancer to communicate symptoms between in-person visits. A better understanding of key RSM implementation outcomes is crucial to optimize efficiency and guide implementation efforts. This analysis evaluated the association between the severity of patient-reported symptom alerts and time to response by the health care team. METHODS: This secondary analysis included women with stage I-IV breast cancer who received care at a large academic medical center in the Southeastern United States (October 2020-September 2022). Symptom surveys with at least one severe symptom alert were categorized as severe. Response time was categorized as optimal if the alert was closed by a health care team member within 48 hours. Odds ratios (ORs), predicted probabilities, and 95% CIs were estimated using a patient-nested logistic regression model. RESULTS: Of 178 patients with breast cancer included in this analysis, 63% of patients identified as White and 85% of patients had a stage I-III or early-stage cancer. The median age at diagnosis was 55 years (IQR, 42-65). Of 1,087 surveys included, 36% reported at least one severe symptom alert and 77% had an optimal response time by the health care team. When compared with surveys that had no severe symptom alerts, surveys with at least one severe symptom alert had similar odds of having an optimal response time (OR, 0.97; 95% CI, 0.68 to 1.38). The results were similar when stratified by cancer stage. CONCLUSION: Response times to symptom alerts were similar for alerts with at least one severe symptom compared with alerts with no severe symptoms. This suggests that alert management is being incorporated into routine workflows and not prioritized based on disease or symptom alert severity.

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.

BACKGROUND: Cancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the "Patient Reported Outcomes-Informed Symptom Management System" (PRISMS) during post-ostomy creation care transition. METHODS: We conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data. RESULTS: We achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden. CONCLUSIONS: PRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects. TRIAL REGISTRATION: ClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020.

Institution-Specific Perinatal Emergency Checklists: Multicenter Report on Development, Implementation, and Sustainability.

OBJECTIVE: The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine endorse checklist use to improve obstetric care. However, there is limited research into development, implementation, and sustained use of perinatal emergency checklists to inform individual institutions. This study aimed to investigate the development and implementation of perinatal emergency checklists in diverse hospital settings in the United States. STUDY DESIGN: A qualitative study was conducted individually with clinicians from three health care systems. The participants developed and implemented institution-tailored perinatal emergency checklists. Interview transcriptions were coded using the Consolidated Framework for Implementation Research. RESULTS: The study sites included two health care systems and one individual hospital. Delivery volumes ranged from 3,500 to 48,000 deliveries a year. Interviews were conducted with all 10 participants approached. Checklists for 19 perinatal emergencies were developed at the three health care systems. Ten of the checklist topics were the same at all three institutions. Participants described the checklists as improving patient care during crises. The tools were viewed as opportunities to promote a shared mental model across clinical roles, to reduce redundancy and coordinate obstetric crisis management. Checklist were developed in small groups. Implementation was facilitated by those who developed the checklists. Participants agreed that simulation was essential for checklist refinement and effective use by response teams. Barriers to implementation included limited clinician availability. There was also an opportunity to strengthen integration of checklists workflow early in perinatal emergencies. Participants articulated that culture change took time, active practice, persistence, reinforcement, and process measurement. CONCLUSION: This study outlines processes to develop, implement, and sustain perinatal emergency checklists at three institutions. Participants agreed that multiple, parallel implementation tactics created the culture shift for integration. The overview and specific Consolidated Framework for Implementation Research components may be used to inform adaptation and sustainability for others considering implementing perinatal emergency checklists. KEY POINTS: · Perinatal emergency checklists reduce redundancy and coordinate obstetric crisis management.. · Perinatal emergency simulation is essential for checklist refinement and effective team use.. · Integrations of perinatal emergency checklists requires culture change and process measurement..

Changes in hepatitis B vaccine perception in response to the COVID-19 pandemic: Development of the Shift in vaccine confidence (SVC) survey tool.

The COVID-19 pandemic has disrupted access to, adherence to, and perceptions of routine vaccinations. We developed the Shift in Vaccine Confidence (SVC) survey tool to assess the impact of the pandemic on routine vaccinations, with a focus on the HBV vaccine, in Kinshasa, Democratic Republic of Congo (DRC). This study describes the content validation steps we conducted to ensure the survey tool is meaningful to measure changes in vaccine confidence to regular immunization (HBV vaccine) due to the pandemic. Three rounds of stakeholder feedback from a DRC-based study team, content and measurement experts, and study participants allowed us to produce a measure with improved readability and clarity.

Oncology Providers' and Professionals' Experiences With Suicide Risk Screening Among Patients With Head and Neck Cancer: A Qualitative Study.

PURPOSE: There has been limited study of the implementation of suicide risk screening for patients with head and neck cancer (HNC) as a part of routine care. To address this gap, this study assessed oncology providers' and professionals' perspectives about barriers and facilitators of implementing a suicide risk screening among patients with HNC. MATERIALS AND METHODS: All patients with HNC with an in-person visit completed a suicide risk screening on an electronic tablet. Patients reporting passive death wish were then screened for active suicidal ideation and referred for appropriate intervention. Interviews were conducted with 25 oncology providers and professionals who played a key role in implementation including nurses, medical assistants, patient access representatives, advanced practice providers, physicians, social workers, and informatics staff. The interview guide was based on the Consolidated Framework for Implementation Research. Interviews were transcribed and analyzed for themes. RESULTS: Participants identified multilevel implementation barriers, such as intervention level (eg, patient difficulty with using a tablet), process level (eg, limited nursing engagement), organizational level (eg, limited clinic Wi-Fi connectivity), and individual level (eg, low clinician self-efficacy for interpreting and acting upon patient-reported outcome scores). Participants noted facilitators, such as effective care coordination across nursing and social work staff and the opportunity for patients to be screened multiple times. Participants recommended strengthening patient and clinician education and providing patients with other modalities for data entry (eg, desktop computer in the waiting room). CONCLUSION: Participants identified important intervention modifications that may be needed to optimize suicide risk screening in cancer care settings.

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

The Key Driver Implementation Scale (KDIS) for practice facilitators: Psychometric testing in the "Southeastern collaboration to improve blood pressure control" trial.

BACKGROUND: Practice facilitators (PFs) provide tailored support to primary care practices to improve the quality of care delivery. Often used by PFs, the "Key Driver Implementation Scale" (KDIS) measures the degree to which a practice implements quality improvement activities from the Chronic Care Model, but the scale's psychometric properties have not been investigated. We examined construct validity, reliability, floor and ceiling effects, and a longitudinal trend test of the KDIS items in the Southeastern Collaboration to Improve Blood Pressure Control trial. METHODS: The KDIS items assess a practice's progress toward implementing: a clinical information system (using their own data to drive change); standardized care processes; optimized team care; patient self-management support; and leadership support. We assessed construct validity and estimated reliability with a multilevel confirmatory factor analysis (CFA). A trend test examined whether the KDIS items increased over time and estimated the expected number of months needed to move a practice to the highest response options. RESULTS: PFs completed monthly KDIS ratings over 12 months for 32 primary care practices, yielding a total of 384 observations. Data was fitted to a unidimensional CFA model; however, parameter fit was modest and could be improved. Reliability was 0.70. Practices started scoring at the highest levels beginning in month 5, indicating low variability. The KDIS items did show an upward trend over 12 months (all p < .001), indicating that practices were increasingly implementing key activities. The expected time to move a practice to the highest response category was 9.1 months for standardized care processes, 10.2 for clinical information system, 12.6 for self-management support, 13.1 for leadership, and 14.3 months for optimized team care. CONCLUSIONS: The KDIS items showed acceptable reliability, but work is needed in larger sample sizes to determine if two or more groups of implementation activities are being measured rather than one.

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial.

Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Design, Setting, and Participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. Interventions: In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. Main Outcomes and Measures: The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. Results: Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006). Conclusions and Relevance: In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival. Trial Registration: ClinicalTrials.gov Identifier: NCT03249090.

Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Nonmuscle-Invasive Bladder Cancer.

PURPOSE: Optima II ("OPTimized Instillation of Mitomycin for Bladder Cancer Treatment," clinicaltrials.gov: NCT03558503) was a phase 2b trial evaluating a nonsurgical alternative as a primary treatment for nonmuscle-invasive bladder cancer (NMIBC). Patients received 6 weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel. This is the first study to report on patient-reported side effects of UGN-102. MATERIALS AND METHODS: Sixty-three patients enrolled in Optima II from 20 sites. Of these 63 patients, 44 were in the cohort completing a quarterly patient-reported outcome measure assessing side effects. Changes in side effects were evaluated using the Wilcoxon signed-rank test. Associations of 3-month outcomes with demographic and clinical characteristics were examined with regression, controlling for baseline values. Ten of 44 patients (23%) were interviewed after the trial to understand tolerability for future patients making treatment decisions. Transcripts were double-coded using standard methods. RESULTS: In the patient-reported outcome measure cohort (44), 61% were men, 57% aged 65+ years and 89% were non-Hispanic White. UGN-102 did not cause decrements in patient-reported urinary symptoms, bloating/flatulence or malaise at the primary endpoint of 3 months. Sexual function mildly worsened. Future health worries improved. Demographics were not correlated with changes. Clinically, sexual function was correlated with new NMIBC and bloating/flatulence was associated with transurethral resection of bladder tumor within 12 months. In interviews, patients appreciated a nonsurgical alternative, would recommend the gel to other patients and would choose the gel over surgery. CONCLUSIONS: A nonsurgical, chemoablative gel (UGN-102) used as a primary treatment for NMIBC offers a more patient-centered therapeutic approach than standard treatments.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance. Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Ethnography and user-centered design to inform context-driven implementation.

Despite pervasive findings pointing to its inextricable role in intervention implementation, context remains poorly understood in implementation science. Existing approaches for describing context (e.g., surveys, interviews) may be narrow in scope or superficial in their elicitation of contextual data. Thus, in-depth and multilevel approaches are needed to meaningfully describe the contexts into which interventions will be implemented. Moreover, many studies assess context without subsequently using contextual information to enhance implementation. To be useful for improving implementation, though, methods are needed to apply contextual information during implementation. In the case example presented in this paper, we embedded an ethnographic assessment of context within a user-centered design approach to describe implementation context and apply that information to promote implementation. We developed a patient-reported outcome measure-based clinical intervention to assess and address the pervasive unmet needs of young adults with cancer: the Needs Assessment & Service Bridge (NA-SB). In this paper, we describe the user-centered design process that we used to anticipate context modifications needed to deliver NA-SB and implementation strategies needed to facilitate its implementation. Our ethnographic contextual inquiry yielded a rich understanding of local implementation context and contextual variation across potential scale-up contexts. Other methods from user-centered design (i.e., translation tables and a design team prototyping workshop) allowed us to translate that information into specifications for NA-SB delivery and a plan for implementation. Embedding ethnographic methods within a user-centered design approach can help us to tailor interventions and implementation strategies to their contexts of use to promote implementation.

The field of implementation science studies how to better integrate research evidence into practice. To accomplish this integration, it is important to understand the contexts into which interventions are being implemented. For example, implementation may be influenced by contextual factors such as patient/provider beliefs about an intervention, budget constraints, leadership buy-in, an organization's readiness to change, and many others. Understanding these factors upfront can allow us to adapt interventions to better suit context (e.g., tailoring intervention content to patients' needs), change context to make it more ready for implementation (e.g., changing provider workflow to accommodate an intervention), and anticipate strategies that may be needed to implement an intervention (e.g., delivering training on the intervention to providers). To do this, the field of implementation science is in need of methods for assessing context and using that information to improve implementation. In this paper, we present several methods, including ethnography and methods from user-centered design, for using context to inform implementation efforts.

Electronic patient-reported outcomes monitoring during lung cancer chemotherapy: A nested cohort within the PRO-TECT pragmatic trial (AFT-39).

OBJECTIVES: Patients with lung cancer have high symptom burden and diminished quality of life. Electronic patient-reported outcome (PRO) platforms deliver repeated longitudinal surveys via web or telephone to patients and alert clinicians about concerning symptoms. This study aims to determine feasibility of electronic PRO monitoring in lung cancer patients receiving treatment in community settings. METHODS: Adults receiving treatment for advanced or metastatic lung cancer at 26 community sites were invited to participate in a prospective trial of weekly electronic PRO symptom monitoring for 12 months (NCT03249090). Surveys assessing patients' satisfaction with the electronic PRO system were administered at 3 months. Descriptive statistics were generated for demographics, survey completion rates, symptom occurrence, and provider PRO alert management approaches. Pairwise relationships between symptom items were evaluated using intra-individual repeated-measures correlation coefficients. RESULTS: Lung cancer patients (n = 118) participating in electronic PROs were older (mean 64.4 vs 61.9 years, p = 0.03), had worse performance status (p = 0.002), more comorbidities (p = 0.02), and less technology experience than patients with other cancers. Of delivered weekly PRO surveys over 12 months, 91% were completed. Nearly all (97%) patients reported concerning (i.e., severe or worsening) symptoms during participation, with 33% of surveys including concerning symptoms. Pain was the most frequent and longest lasting symptom and was associated with reduced activity level. More than half of alerts to clinicians for concerning symptoms led to intervention. The majority (87%) would recommend using electronic PRO monitoring to other lung cancer patients. CONCLUSIONS: Remote longitudinal weekly monitoring of patients with lung cancer using validated electronic PRO surveys was feasible in a multicenter, community-based pragmatic study. A high symptom burden specific to lung cancer was detected and clinician outreach in response to alerts was frequent, suggesting electronic PROs may be a beneficial strategy for identifying actionable symptoms and allow opportunities to optimize well-being in this population.

Pediatric lymphoma patients in Malawi present with poor health-related quality of life at diagnosis and improve throughout treatment and follow-up across all Pediatric PROMIS-25 domains.

BACKGROUND: Patient-reportedoutcomes (PROs) that assess health-related quality of life (HRQoL) are increasingly important components of cancer care and research that are infrequently used in sub-Saharan Africa (SSA). METHODS: We administered the Chichewa Pediatric Patient-Reported Outcome Measurement Information System Pediatric (PROMIS)-25 at diagnosis, active treatment, and follow-up among pediatric lymphoma patients in Lilongwe, Malawi. Mean scores were calculated for the six PROMIS-25 HRQoL domains (Mobility, Anxiety, Depressive Symptoms, Fatigue, Peer Relationships, Pain Interference). Differences in HRQoL throughout treatment were compared using the minimally important difference (MID) and an ANOVA analysis. Kaplan-Meier survival estimates and Cox hazard ratios for mortality are reported. RESULTS: Seventy-five children completed PROMIS-25 surveys at diagnosis, 35 (47%) during active treatment, and 24 (32%) at follow-up. The majority of patients died (n = 37, 49%) or were lost to follow-up (n = 6, 8%). Most (n = 51, 68%) were male, median age was 10 (interquartile range [IQR] 8-12), 48/73 (66%) presented with advanced stage III/IV, 61 (81%) were diagnosed with Burkitt lymphoma and 14 (19%) Hodgkin lymphoma. At diagnosis, HRQoL was poor across all domains, except for Peer Relationships. Improvements in HRQoL during active treatment and follow-up exceeded the MID. On exploratory analysis, fair-poor PROMIS Mobility <40 and severe Pain Intensity = 10 at diagnosis were associated with increased mortality risk and worse survival, but were not statistically significant. CONCLUSIONS: Pediatric lymphoma patients in Malawi present with poor HRQoL that improves throughout treatment and survivorship. Baseline PROMIS scores may provide important prognostic information. PROs offer an opportunity to include patient voices and prioritize holistic patient-centered care in low-resource settings.