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Introduction: Thoracic surgery is a mainstay of therapy for lung cancer and other chronic pulmonary conditions, but recovery is often complicated. Digital health systems can facilitate remote postoperative symptom management yet obstacles persist in their routine clinical adoption. This study aimed to identify patient-perceived barriers and facilitators to using an electronic patient-reported outcome (ePRO) monitoring platform specially designed to detect complications from thoracic surgery postdischarge., Methods: Patients (n = 16) who underwent thoracic surgery and participated in an ePRO parent study completed semistructured interviews, which were analyzed using thematic content analysis and iterative team-based coding. Themes were mapped onto the three domains of the Capability, Opportunity, and Motivation Model of behavior framework to inform ePRO design and implementation improvements., Results: Analysis demonstrated seven dominant themes, including barriers (1. postoperative patient physical and mental health, 2. lack of access to email and poor internet connectivity, 3. lack of clarity on ePRO use in routine clinical care, and 4. symptom item redundancy) as well as facilitators (5. ease of the ePRO assessment completion, 6. engagement with the surgical care team on ePRO use, and 7. increased awareness of symptom experience through ePRO use). Suggested ePRO improvements included offering alternatives to web-based completion, tailoring symptom assessments to individual patients, and the need for patient education on ePROs for perioperative care., Conclusions: Addressable barriers and facilitators to implementation of ePRO symptom monitoring in the thoracic surgical patient population postdischarge have been identified. Future work will test the impact of design improvements on implementation outcomes of feasibility and acceptability., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: Patient reported outcome measures (PROMs) are increasingly used in oncology care, but pharmacists providing direct patient care have been overlooked. We engaged pharmacists and adults receiving oral oncolytics (chemotherapy medication taken by mouth) to develop a SmartForm© in the electronic health record (EHR) for PROM monitoring. Pharmacists verbally ask the patient side effect questions during routine telehealth encounters and enter responses in real time., Methods: Our development process was guided by the Knowledge to Action Framework. In phase 1 (Knowledge Inquiry), we prioritized side effects to assess in the EHR SmartForm© via interviews with patients and a Delphi panel with pharmacists. Adults receiving oral oncolytics for breast (n = 12), thoracic (n = 12), or hematological (n = 12) cancer were interviewed, with purposeful sampling for adults who were aged 65 + years or Black. Interviews were coded with content analysis. We conducted three Delphi rounds, with 11/19, 13/19, and 19/19 pharmacists, respectively. In phase 2 (Knowledge Synthesis), PROM items were selected and the EHR SmartForm© programmed. In phase 3 (Knowledge Tailoring), we conducted usability testing with pharmacists., Results: Pharmacists and patients were consistent in prioritizing side effects of oral oncolytics and 10 were retained. Patients advocated asking whether they can do their usual activities, while pharmacists added medication adherence. Usability testing yielded suggestions to simplify the SmartForm©., Conclusion: By presenting screenshots of our SmartForm©, our findings are useful to other healthcare systems looking for a PROM solution integrated in the EHR, with a reasonable pharmacist/clinician workload, and no requirement for patients to have internet access/comfort., (© 2024. The Author(s).)

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.

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., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Electronic patient-reported outcome (ePRO) systems can be used to engage patients in remote symptom monitoring to support postoperative care. We interviewed thoracic surgery patients with ePRO experience to identify factors that influenced use of ePROs to report their symptoms post-discharge., Method: This qualitative study used semi-structured telephone interviews with adults who underwent major thoracic surgery at an academic medical center in North Carolina. Individuals who enrolled in symptom monitoring, completed at least one ePRO survey, and were reachable by phone for the interview were included. The ePRO surveys assessed 10 symptoms, including validated Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures and thoracic surgery-specific questions. Surveys, offered via web-based and automated telephone options, were administered for four weeks post-discharge with alerts sent to clinicians for concerning symptoms. The interviews were guided by the Capability, Opportunity, Motivation model for behavior change (COM-B) and examined factors that influenced patients' completion of ePRO surveys post-discharge. Team members independently coded interviews and identified themes, informed by COM-B. We report descriptive statistics (demographics, number of surveys completed) and themes organized by COM-B components., Results: Of 28 patients invited, 25 (89%) completed interviews from July to October 2022. Participants were a median 58 years, 56% female, 80% White, and 56% had a history of malignancy. They completed 131/150 (87%) possible ePRO surveys. For capability, participants reported building ePROs into their routine and having the skills and knowledge, but lacking physical and emotional energy, to complete ePROs. For opportunity, participants identified the ease and convenience of accessing ePROs and providers' validation of ePROs. Motivators were perceived benefits of a deepening connection to their clinical team, improved symptom management for themselves and others, and self-reflection about their recovery. Factors limiting motivation included lack of clarity about the purpose of ePROs and a disconnect between symptom items and individual recovery experience., Conclusions: Patients described being motivated to complete ePROs when reinforced by clinicians and considered ePROs as valuable to their post-discharge experience. Future work should enhance ePRO patient education, improve provider alerts and communications about ePROs, and integrate options to capture patients' complex health journeys., (© 2024. The Author(s).)

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., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

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., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (© 2023. The Author(s).)

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.

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.

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.

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.

Competing Interests: Disclosure MDM reports honoraria from AstraZeneca, Boehringer Ingelheim, Janssen, Merck Sharp & Dohme (MSD), Novartis, Pfizer, Roche, Takeda for consultancy or participation to advisory boards and direct research funding from Tesaro/GlaxoSmithKline, institutional funding for work in clinical trials/contracted research from Beigene, Exelixis, MSD, Pfizer and Roche; EB reports institutional research funding from the United States National Cancer Institute and Patient-Centered Outcomes Research Institute (PCORI), payments for activities as an Associate Editor for the Journal of the American Medical Association (JAMA), and payments as a scientific advisor from the Research Triangle Institute, AstraZeneca, Carevive, Sivan, Navigating Cancer, Resilience and N-Power Medicine; FD has reported personal fees as an invited speaker from AstraZeneca, Bristol Myers Squibb (BMS), Chugai, Ipsen, Merck and Takeda; personal fees for advisory board membership of Roche; institutional fees for advisory board membership received from Sivan, institutional receiver was Hyperion and advisory board membership stopped 14 April 2020; member of Board of Directors for Kelindi (institutional receiver, Hyperion); institution (Hyperion) has participations and stocks in Kelindi (non-oncological software editor) and in the National Institut of e-Health; he has also reported non-remunerated activities as a member of ASCO; LJF reports honoraria from Genomic Health, Novartis, Eli Lilly, prIME a Medscape Oncology Company, Pfizer, Sobi, MSD, 3P Solution, Veracyte, Voluntis and AstraZeneca for consultancy/participation on advisory boards. Also, grant funding from Veracyte, Eli Lilly, Roche and BMS; PAG reports honoraria from InformedDNA as member of Scientific Advisory Board, Oxford University Press as Editor-in-Chief of the Journal of the National Cancer Institute, royalties from Up-to-date as section editor on Cancer Survivorship, institutional funding for work in clinical trials/contracted research from Blue Note Therapeutics, consultant for Grail and Blue Note Therapeutics and non-remunerated leadership roles for the Breast Cancer Research Foundation as member of Scientific Advisory Board; DH reports honoraria for consultancy and participation on the scientific advisory board of Carevive Systems, institutional funding for work on clinical trials from AstraZeneca and contracted research funding from the Leukemia and Lymphoma Society of Canada, contractual payment from York University, ON, Canada for course development and teaching; CK is a full-time employee of the German Cancer Society, a non-profit. He reports non-remunerated leadership roles for the non-profits German Association of Medical Sociology (board of directors, treasurer) and the German Network on Health Services Research (section chair, oncology section); FP reports honoraria from Bayer, Pierre Fabre, AstraZeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, institutional funding for work in clinical trials/contracted research from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GlaxoSmithKline, Merck, non-remunerated leadership roles for Associazione Italiana di Oncologia Medica – AIOM (future President); AMS reports honoraria from the Association of Community Cancer Centers, Pfizer, Genentech, Purchaser Business Group on Health, and Henry Ford Cancer Center, a financially compensated leadership role in Navigating Cancer (consultant in 2021 for less than 5000 USD), institutional funding for work in clinical trials/contracted research from Sivan Innovation and UroGen Pharma Ltd, and grant funding from PCORI, National Institutes of Health, Agency for Healthcare Research and Quality, Bladder Cancer Advocacy Network, Hematology/Oncology Pharmacy Association, Cancer and Aging Research Group; PS reports non-remunerated leadership roles with the Trans Tasman Radiation Oncology Group, Clinical Oncology Society of Australia and Head and Neck Cancer Australia; JFD reports honoraria from International Association for the Study of Lung Cancer (invited speaker), Fred Hutchinson Cancer Research Center (PCORI project), Genentech (advisory board), Pfizer (advisory board); financial compensation from International Association for the Study of Lung Cancer (independent consultant) and the United States government as a special employee and member of the Secretary's Advisory Committee for Human Research Protections (SACHRP); non-remunerated activities for LUNGevity (Scientific Advisory Board), National Cancer Institute (scientific panels); non-remunerated leadership roles for The ROS1ders (Vice President, Board Chair); and non-remunerated membership or affiliation with the International Association for the Study of Lung Cancer, American Society of Clinical Oncology, American Association for Cancer Research, Nuvalent, AnHeart Therapeutics and Turning Point Therapeutics; CIR reports honoraria from Kyowa Kirin, Molteni Pharma Spa, Mundipharma and Angelini Pharma for educational events and invited speaker; LW, LZ, KA and DS have declared no potential conflicts of interest.

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., Competing Interests: AMS has received unrelated consulting fees or speaking honoraria from Navigating Cancer, Association of Community Cancer Centers, Genentech, Pfizer, and Henry Ford Cancer Center. ALC has received unrelated consulting fees from Bayer. MMS has unrelated consulting fees from Amgen. She is also part owner of PALS, Inc. a digital health platform. No conflict of interest: MW, CMS, ER, JR, DMC, LN, SP, MC, MM, JRH.

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.

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.

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., (© 2022. The Author(s).)

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., (© Society of Behavioral Medicine 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose: Patient-reported outcome and experience measures (PROMs/PREMs) are well established in research for many health conditions, but barriers persist for implementing them in routine care. Implementation science (IS) offers a potential way forward, but its application has been limited for PROMs/PREMs., Methods: We compare similarities and differences for widely used IS frameworks and their applicability for implementing PROMs/PREMs through case studies. Three case studies implemented PROMs: (1) pain clinics in Canada; (2) oncology clinics in Australia; and (3) pediatric/adult clinics for chronic conditions in the Netherlands. The fourth case study is planning PREMs implementation in Canadian primary care clinics. We compare case studies on barriers, enablers, implementation strategies, and evaluation., Results: Case studies used IS frameworks to systematize barriers, to develop implementation strategies for clinics, and to evaluate implementation effectiveness. Across case studies, consistent PROM/PREM implementation barriers were technology, uncertainty about how or why to use PROMs/PREMs, and competing demands from established clinical workflows. Enabling factors in clinics were context specific. Implementation support strategies changed during pre-implementation, implementation, and post-implementation stages. Evaluation approaches were inconsistent across case studies, and thus, we present example evaluation metrics specific to PROMs/PREMs., Conclusion: Multilevel IS frameworks are necessary for PROM/PREM implementation given the complexity. In cross-study comparisons, barriers to PROM/PREM implementation were consistent across patient populations and care settings, but enablers were context specific, suggesting the need for tailored implementation strategies based on clinic resources. Theoretically guided studies are needed to clarify how, why, and in what circumstances IS principles lead to successful PROM/PREM integration and sustainability., (© 2020. The Author(s).)

Purpose: We evaluated the utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) for introducing patient-reported outcome measures (PROMs) into a medical oncology outpatient department. The i-PARIHS framework identifies four core constructs for implementation, including Facilitation, Innovation, Context and Recipients., Methods: A pilot study used the i-PARIHS framework to identify PROM implementation barriers and enablers to inform facilitation support strategies, such as training clinicians and staff, workflow support, technical support and audit and feedback. Pre- and post-implementation surveys were completed by 83 and 72 staff, respectively, (nurses, doctors and allied health), to assess perceived knowledge, enablers, barriers and utility of PROMs; and acceptability of the PROM intervention was also assessed post-implementation., Results: Important barriers included time constraints and previous experiences with technology. Enablers included good leadership support and a culture of learning. Facilitation strategies were used to overcome barriers identified in the i-PARIHS core domains. Compared to before the intervention, staff surveys showed improvement in perceived usefulness, perceived understanding and interpretation skills for PROMs. Staff perceptions about lack of time to use PROMs during visits remained a major perceived barrier post-implementation., Conclusion: The i-PARIHS framework was useful for guiding the implementation of PROMs in routine oncology care. The four core i-PARIHS constructs (Facilitation, Innovation, Context and Recipients) identified factors that directly impacted implementation, with Facilitation having a particularly important role to overcome these barriers. Oncology clinics and health systems considering implementing PROMs should consider having a dedicated Facilitator available during PROM implementation., (© 2020. The Author(s).)

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., (© 2021 Wiley Periodicals LLC.)

Purpose: In the USA, many of the nearly 90,000 adolescents and young adults (AYAs) diagnosed with cancer each year do not receive services to address the full scope of needs they experience during and after cancer treatment. To facilitate a systematic and patient-centered approach to delivering services to address the unmet needs of AYAs with cancer, we developed the AYA Needs Assessment & Service Bridge (NA-SB)., Methods: To develop NA-SB, we leveraged user-centered design, an iterative process for intervention development based on prospective user (i.e., provider and AYA) engagement. Specifically, we conducted usability testing and concept mapping to refine an existing tool-the Cancer Needs Questionnaire-Young People-to promote its usability and usefulness in routine cancer practice., Results: Our user-centered design process yielded a need assessment which assesses AYAs' physical, psychosocial, and practical needs. Importantly, needs in the assessment are grouped by services expected to address them, creating an intuitive and actionable link between needs and services., Conclusion: NA-SB has the potential to improve care coordination at the individual level by allowing cancer care programs to tailor service delivery and resource provision to the individual needs of AYAs they serve.

Performance measurement is the process of collecting, analyzing, and reporting standardized measures of clinical performance that can be compared across practices to evaluate how well care was provided. We conducted a systematic review to identify stakeholder perceptions of key symptoms and health domains to test as patient-reported performance measures in oncology. Stakeholders included cancer patients, caregivers, clinicians, and healthcare administrators. Standard review methodology was used, consistent with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). MEDLINE/PubMed, EMBASE, and the Cochrane Library were searched to identify relevant studies through August 2020. Four coders independently reviewed entries and conflicts were resolved by a fifth coder. Efficacy and effectiveness studies, and studies focused exclusively on patient experiences of care (e.g., communication skills of providers) were excluded. Searches generated 1813 articles and 1779 were coded as not relevant, leaving 34 international articles for extraction. Patients, caregivers, clinicians, and healthcare administrators prioritize psychosocial care (e.g., distress) and symptom management for patient-reported performance measures. Patients and caregivers also perceive that maintaining physical function and daily activities are critical. Clinicians and administrators perceive control of specific symptoms to be critical (gastrointestinal symptoms, pain, poor sleep). Results were used to inform testing at six US cancer centers.

The AIDS Clinical Trials Group (ACTG) A5345 study included an intensively monitored antiretroviral pause (IMAP), during which a cohort of participants temporarily stopped antiretroviral treatment during chronic HIV infection. We surveyed participant perceptions and understanding of A5345 using a cross-sectional sociobehavioral questionnaire. Participants completed the baseline questionnaire either before or after initiating the study's IMAP. Questionnaire responses were linked to existing demographic data. Quantitative responses were analyzed overall and stratified by IMAP status. Open-ended responses were analyzed using conventional content analysis. Thirty-two participants completed the baseline sociobehavioral questionnaire. Half ( n  = 16) completed it before (i.e., pre-IMAP initiation group) and half ( n  = 16) after IMAP initiation (i.e., post-IMAP initiation group). Eight pre-IMAP initiation respondents (50%) and 11 post-IMAP respondents (69%) responded "yes" when asked if they perceived any direct benefits from participating in A5345. Perceived societal-level benefits included furthering HIV cure-related research and helping the HIV community. Perceived personal-level benefits included the opportunity to learn about the body's response to IMAP and financial compensation. The majority of respondents-13 from each group (81% of each)-reported risks from participation, for example, viral load becoming detectable. A5345 participants perceived both societal- and personal-level benefits of study participation. While the majority of survey respondents perceived participatory risks, nearly one in five did not. Key messages pertaining to study-related risks and benefits may need to be clarified or reiterated periodically throughout follow-up in HIV cure-related studies with IMAPs. Clinical Trail Registration Number: NCT03001128.

Purpose: Performance status (PS) is assessed during cancer treatment to determine clinical trial eligibility, appropriateness for treatment, and need for supportive care. There is rising interest for patients to report this information directly. We determined whether clinician- and patient-reported PS were equally associated with mortality and service utilization in patients with cancer., Methods: A secondary analysis was conducted using data from an radiotherapy plus chemotherapy in which 441 patients with advanced cancer and clinicians reported PS using the Eastern Cooperative Oncology Group scale. Simple kappa statistics measured agreement between clinician-reported performance status (cPS) and patient-reported performance status (pPS). Associations of cPS and pPS with emergency department (ED) and hospital visits and overall survival were evaluated via Cox regression, competing risk regression, and Fisher's exact tests., Results: cPS and pPS correlated weakly (kappa = 0.27). Both pPS and cPS were associated with survival, ED visits, and hospitalizations, but only cPS remained associated after adjustment (survival: HR, 1.75; P < .0001). The first available cPS predicted mortality more strongly than the first available pPS (HR for death, comparing PS ≥ 1 v 0: 2.05 for cPS and 1.41 for pPS). When pPS questionnaires were repeated over time and averaged, associations with outcomes were stronger as measured by AIC model fit. Both pPS and cPS were associated with EQ-5D subcomponents (eg, 75%-77% with no usual activity deficits for PS 0, v 42%-51% for PS ≥ 1)., Conclusion: Both clinician-reported PS and patient-reported PS provide useful information and can be considered for clinical trials and routine care.

Efforts to improve cancer care primarily come from two fields: improvement science and implementation science. The two fields have developed independently, yet they have potential for synergy. Leveraging that synergy to enhance alignment could both reduce duplication and, more importantly, enhance the potential of both fields to improve care. To better understand potential for alignment, we examined 20 highly cited cancer-related improvement science and implementation science studies published in the past 5 years, characterizing and comparing their objectives, methods, and approaches to practice change. We categorized studies as improvement science or implementation science based on authors' descriptions when possible; otherwise, we categorized studies as improvement science if they evaluated efforts to improve the quality, value, or safety of care, or implementation science if they evaluated efforts to promote the implementation of evidence-based interventions into practice. All implementation studies (10/10) and most improvement science studies (6/10) sought to improve uptake of evidence-based interventions. Improvement science and implementation science studies employed similar approaches to change practice. For example, training was employed in 8/10 implementation science studies and 4/10 improvement science studies. However, improvement science and implementation science studies used different terminology to describe similar concepts and emphasized different methodological aspects in reporting. Only 4/20 studies (2 from each category) described using a formal theory or conceptual framework to guide program development. Most studies were multi-site (10/10 implementation science and 6/10 improvement science) and a minority (2 from each category) used a randomized design. Based on our review, cancer-related improvement science and implementation science studies use different terminology and emphasize different methodological aspects in reporting but share similarities in purpose, scope, and methods, and are at similar levels of scientific development. The fields are well-positioned for alignment. We propose that next steps include harmonizing language and cross-fertilizing methods of program development and evaluation.

Purpose: There is increasing interest in implementing digital systems for remote monitoring of patients' symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems., Methods: PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians., Results: Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often., Conclusion: These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

Background: Use of electronic patient-reported outcomes (ePROs) in routine cancer care can help identify troublesome symptoms and facilitate discussions between patients and clinicians and has been shown to improve patient satisfaction, quality of life, and survival., Methods: Eighty patients with stage IV non-hematologic malignancies on chemotherapy participated. Patient-Reported Symptom Monitoring (PRSM) surveys were sent every 14 days via the Epic MyChart system over a 12-week period. Surveys were offered via phone or paper if patients failed to complete the automated MyChart survey by day 16. Severe symptoms or concerning symptom trends were automatically highlighted in reports for clinic staff. Patients reporting severe symptoms were routed to oncology nursing triage for standard symptom care management., Results: Two hundred seventy-one surveys were sent during the 12-week study period. One hundred eighty-three surveys (66%) were completed, with 68% completed electronically via MyChart, 25% by paper, and 7% by phone call from a research coordinator. At least one severe symptom was reported on 36% of all surveys. However, most severe symptoms did not result in urgent triage follow-up because they were already being addressed and/or patients felt they were manageable. Patients and clinicians generally said the ePRO was efficient and helpful for addressing distressing symptoms and would use it in routine oncology care., Conclusion: ePROs can be integrated into the electronic health record using the Epic MyChart system. Patients and clinicians gave positive feedback on the system. Monitoring symptoms in real time may soon become part of standard oncology practice and requires seamless methods for collection.

Purpose: Patients undergoing a hematopoietic stem cell transplantation (HCT) have varied symptoms during their hospitalization. This study examined whether daily symptom reporting (with electronic patient-reported outcomes [PROs]) in an inpatient bone marrow transplant clinic reduced symptom burden on post-transplant days +7, +10, and +14., Methods: A prospective, single-institution 1:1 pilot randomized, two-arm study recruited HCT patients. HCT inpatients (N = 76) reported daily on 16 common symptoms using the PRO version of the Common Terminology for Adverse Events (PRO-CTCAE). Fisher's exact test was used to examine differences in the proportion of patients reporting individual symptoms. Multivariable linear regression modeling was used to examine group differences in peak symptom burden, while controlling for symptom burden at baseline, age, comorbidity, and transplantation type (autologous or allogeneic)., Results: HCT patients receiving the PRO intervention also experienced lower peak symptom burden (average of 16 symptoms) at days +7, +10, and +14 (10.4 vs 14.5, p = 0.03)., Conclusions: Daily use of electronic symptom reporting to nurses in an inpatient bone marrow transplant clinic reduced peak symptom burden and improved individual symptoms during the 2 weeks post-transplant. A multi-site trial is warranted to demonstrate the generalizability, efficacy, and value of this intervention., Trial Registration: ClinicalTrials.gov identifier: NCT02574897.

Purpose: Patient-reported outcome measures (PROMs) that assess how patients feel and function have potential for evaluating quality of care. Stakeholder recommendations for PRO-based performance measures (PMs) were elicited, and feasibility testing was conducted at six cancer centers., Methods: Interviews were conducted with 124 stakeholders to determine priority symptoms and risk adjustment variables for PRO-PMs and perceived acceptability. Stakeholders included patients and advocates, caregivers, clinicians, administrators, and thought leaders. Feasibility testing was conducted in six cancer centers. Patients completed PROMs at home 5-15 days into a chemotherapy cycle. Feasibility was operationalized as ≥ 75% completed PROMs and ≥ 75% patient acceptability., Results: Stakeholder priority PRO-PMs for systemic therapy were GI symptoms (diarrhea, constipation, nausea, vomiting), depression/anxiety, pain, insomnia, fatigue, dyspnea, physical function, and neuropathy. Recommended risk adjusters included demographics, insurance type, cancer type, comorbidities, emetic risk, and difficulty paying bills. In feasibility testing, 653 patients enrolled (approximately 110 per site), and 607 (93%) completed PROMs, which indicated high feasibility for home collection. The majority of patients (470 of 607; 77%) completed PROMs without a reminder call, and 137 (23%) of 607 completed them after a reminder call. Most patients (72%) completed PROMs through web, 17% paper, or 2% interactive voice response (automated call that verbally asked patient questions). For acceptability, > 95% of patients found PROM items to be easy to understand and complete., Conclusion: Clinicians, patients, and other stakeholders agree that PMs that are based on how patients feel and function would be an important addition to quality measurement. This study also shows that PRO-PMs can be feasibly captured at home during systemic therapy and are acceptable to patients. PRO-PMs may add value to the portfolio of PMs as oncology transitions from fee-for-service payment models to performance-based care that emphasizes outcome measures.

Background: This paper is part of a series comparing different psychometric approaches to evaluate patient-reported outcome (PRO) measures using the same items and dataset. We provide an overview and example application to demonstrate 1) using item response theory (IRT) to identify poor and well performing items; 2) testing if items perform differently based on demographic characteristics (differential item functioning, DIF); and 3) balancing IRT and content validity considerations to select items for short forms., Methods: Model fit, local dependence, and DIF were examined for 51 items initially considered for the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Depression item bank. Samejima's graded response model was used to examine how well each item measured severity levels of depression and how well it distinguished between individuals with high and low levels of depression. Two short forms were constructed based on psychometric properties and consensus discussions with instrument developers, including psychometricians and content experts. Calibrations presented here are for didactic purposes and are not intended to replace official PROMIS parameters or to be used for research., Results: Of the 51 depression items, 14 exhibited local dependence, 3 exhibited DIF for gender, and 9 exhibited misfit, and these items were removed from consideration for short forms. Short form 1 prioritized content, and thus items were chosen to meet DSM-V criteria rather than being discarded for lower discrimination parameters. Short form 2 prioritized well performing items, and thus fewer DSM-V criteria were satisfied. Short forms 1-2 performed similarly for model fit statistics, but short form 2 provided greater item precision., Conclusions: IRT is a family of flexible models providing item- and scale-level information, making it a powerful tool for scale construction and refinement. Strengths of IRT models include placing respondents and items on the same metric, testing DIF across demographic or clinical subgroups, and facilitating creation of targeted short forms. Limitations include large sample sizes to obtain stable item parameters, and necessary familiarity with measurement methods to interpret results. Combining psychometric data with stakeholder input (including people with lived experiences of the health condition and clinicians) is highly recommended for scale development and evaluation.

Introduction: Patient-reported outcome (PRO) measures used during cancer care delivery improve communication about symptoms between patients and clinicians and reduce service utilization for uncontrolled symptoms. However, uptake of PROs in routine cancer care has been slow. In this paper, we describe stakeholder engagement activities used to overcome barriers to implementing PROs. Implementation occurred in 2 study settings: PROs completed in the waiting room and reviewed during clinical visits to guide symptom management for multiple myeloma (visit-based PROs); and weekly PROs completed by cancer patients between chemotherapy visits to monitor symptoms at home (remote PROs)., Methods: PRO implementation steps across studies included: (1) clinician and patient input on key symptoms, PRO measures, and identifying which PRO responses are clinically concerning to better target nursing actions; (2) developing PRO-based clinical decision support (CDS) for responding to concerning PROs; (3) training clinicians and clinical research assistants to interpret PROs and use software; and (4) describing implementation impact (frequency of concerning PRO responses and nursing actions)., Discussion: Clinician and patient input was critical for identifying key symptoms, PRO measures, and clinically concerning response options. For the visit-based PRO observational study, all symptom scores appeared on a clinician dashboard, and those rated ≥1 by patients (on a 0-4 or 0-10 scale) had PRO-based CDS available for access. For the 2 remote PROs trials, stakeholders recommended that the 2 "worst" response options (eg, PRO responses of "often"/"always" or "severe"/"very severe") would trigger an automated email alert to a nurse along with PRO-based CDS. In each study, PRO-based CDS was tailored based on clinician input. Across studies, the most common nursing response to concerning PROs was counseling patients on (or providing care plans for) self-management of symptoms. In the trials, the percentage of weekly remote PROs generating an alert to a nurse ranged from 13% at an academic center to 36% in community oncology practices., Key Points: Across 3 prospective studies, PROs implemented into cancer care enabled tailored care based on issues identified on PROs. Stakeholder engagement was critical for successful implementation. This paper assists in addressing important PRO implementation challenges by describing a stakeholder-driven approach.

Background: Many state Medicaid programs are implementing pharmacist-led medication management programs to improve outcomes for high-risk beneficiaries. There are a limited number of studies examining implementation of these programs, making it difficult to assess why program outcomes might vary across organizations. To address this, we tested the applicability of the organizational theory of innovation implementation effectiveness to examine implementation of a community pharmacy Medicaid medication management program., Methods: We used a hurdle regression model to examine whether organizational determinants, such as implementation climate and innovation-values fit, were associated with effective implementation. We defined effective implementation in two ways: implementation versus non-implementation and program reach (i.e., the proportion of the target population that received the intervention). Data sources included an implementation survey administered to participating community pharmacies and administrative data., Results: The findings suggest that implementation climate is positively and significantly associated with implementation versus non-implementation (AME = 2.65, p < 0.001) and with program reach (AME = 5.05, p = 0.001). Similarly, the results suggest that innovation-values fit is positively and significantly associated with implementation (AME = 2.17, p = 0.037) and program reach (AME = 11.79, p < 0.001). Some structural characteristics, such as having a clinical pharmacist on staff, were significant predictors of implementation and program reach whereas other characteristics, such as pharmacy type or prescription volume, were not., Conclusions: Our study supported the use of the organizational theory of innovation implementation effectiveness to identify organizational determinants that are associated with effective implementation (e.g., implementation climate and innovation-values fit). Unlike broader environmental factors or structural characteristics (e.g., pharmacy type), implementation climate and innovation-values fit are modifiable factors and can be targeted through intervention-a finding that is important for community pharmacy practice. Additional research is needed to determine what implementation strategies can be used by community pharmacy leaders and practitioners to develop a positive implementation climate and innovation-values fit for medication management programs.

Purpose of Review: The American Society of Clinical Oncology (ASCO) palliative care recommendations have been updated into a full guideline. Symptom questionnaires-completed and reviewed with patients during care delivery-are poised to play a large role in this guideline because they provide a more comprehensive understanding of symptoms. This article provides an overview of the guideline and describes how symptom questionnaires can be used to satisfy the guideline., Recent Findings: Standardized symptom questionnaires can be used for three purposes in care delivery: symptom management, referral to specialty palliative and supportive care, and to assess high-quality care. Challenges include necessary changes to clinic workflow to collect patient responses and respond to electronic alerts for worsening symptoms. Symptom questionnaires administered as part of routine care delivery are highly informative and worth the time to enhance symptom management in routine care, to increase referrals, and to standardize performance metrics.

Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function., (© The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently, there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings., Methods: A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5658 articles retrieved, 28 studies met the inclusion criteria., Results: Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies (n = 21)., Conclusions: The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

Purpose: This study evaluates the prevalence and factors associated with major depressive disorder (MDD) in a population of cancer survivors and the impact of co-occurring MDD and urinary incontinence (UI) on health-related quality of life (HRQOL)., Methods: The prevalence of MDD risk among cancer survivors (breast, prostate, bladder, colorectal, lung, and endometrial/uterine cancers) and those without cancer was estimated using the Surveillance, Epidemiology and End Results Program-Medicare Health Outcomes Survey (SEER-MHOS) linked database (n = 9,282 with cancer/n = 289,744 without cancer). Risk for MDD was measured using three items from the Diagnostic Interview Schedule, and HRQOL was measured by the SF-36. UI was defined as self-reported leakage of urine causing a problem in previous 6 months. Factors associated with MDD were investigated using logistic regression, and the impact of co-occurring MDD and UI on HRQOL scores was determined using linear regression., Results: The prevalence of MDD risk ranged from 19.2 % for prostate to 34.1 % for lung. Lung cancer diagnosis was associated with risk of MDD. Being ≥5 years from diagnosis was associated with decreased risk of MDD (prevalence odds ratio (POR) = 0.82, 95 % confidence interval (95 % CI) 0.71, 0.95). The coexistence of both UI and MDD was associated with a decrease across HRQOL subscales; including 40 points on role-emotional (RE) score., Conclusions: Cancer survivors reporting co-occurrence of UI and MDD experienced significant decrements in HRQOL., Implications of Cancer Survivors: Understanding the combined effect of UI and MDD may help clinicians to better recognize and alleviate their effects on cancer survivors' HRQOL.

Background: Health care providers have little population-based evidence about health-related quality of life (HRQOL) changes, from the pre- to postdiagnosis period, and treatment-related recovery time for women aged 65 years and older diagnosed with breast cancer., Methods: Older women with and without breast cancer completed self-reports of HRQOL at baseline and 2 years later as part of annual Medicare Health Outcomes Surveys (MHOS). MHOS was linked to Surveillance, Epidemiology, and End Results registries, which were used to categorize women with breast cancer by treatment type (breast-conserving surgery, breast-conserving surgery plus radiation, mastectomy) and time since diagnosis at follow-up. Each cancer case diagnosed in 1998 through 2007 (N = 542) was matched to 5 women without cancer (N = 2710) using propensity score matching. Analysis of covariance models examined changes in HRQOL, adjusting for demographics and initial functioning., Results: Older women within 6 months of diagnosis had greater declines than women without cancer in SF-36 Physical (-5.8 vs -1.8) and Mental (-3.6 vs -0.7) Component Summary scores, General Health (-12.3 vs -4.6), Vitality (-11.0 vs -2.2), Bodily Pain (-8.5 vs -2.1), Social Functioning (-15.1 vs -3.3), Role-Physical (-26.5 vs -3.9), and Role-Emotional (-13.1 vs -3.1) scores (all P < .05). By approximately 1 year, women with and without breast cancer had similar HRQOL. Comparable declines in Physical Component Summary and Role-Physical occurred across treatment types., Conclusions: Women aged 65 years and older diagnosed with breast cancer should be counseled that survivors within 6 months of diagnosis are vulnerable to HRQOL declines, compared to women without breast cancer, but that decrements generally wane after 12 months., (© 2014 American Cancer Society.)

Purpose: To empirically determine clinically meaningful cut-scores on the 0-10 response scale of the revised Piper Fatigue Scale (PFS-R) and its shorter version (PFS-12). Breast cancer survivors were classified (i.e., none, mild, moderate, or severe fatigue) based on the cut-scores, and relationships between these cut-scores and decrements in health-related quality of life (HRQOL) were examined., Methods: A total of 857 breast cancer survivors, stages in situ-IIIa, from the Health, Eating, Activity, and Lifestyle (HEAL) Study were eligible. Survivors completed the PFS-R, SF-36, and a sexual health scale approximately 3 years after diagnosis. Multivariate analysis of covariance was used to examine five fatigue severity cut-score models, controlling for demographics, clinical characteristics, comorbidity, and antidepressant use. Multivariate regression was used to examine HRQOL decrements by cut-score category., Results: Analyses supported two similar fatigue severity cut-score models for the PFS-R and PFS-12: Model A.) none (0), mild (1-3), moderate (4-6), and severe (7-10); and Model D.) none (0), mild (1-2), moderate (3-5), and severe (6-10). For every threshold increase in fatigue severity, clinically meaningful decrements in physical, mental, and sexual health scores were observed, supporting construct validity of the fatigue cut-scores., Conclusion: Standardized fatigue cut-scores may enhance interpretability and comparability across studies and populations and guide treating planning.