Collection Of Patient-reported Outcome Data Research Articles

A Prospective Observational Cohort Study for Newly Diagnosed Osteosarcoma Patients in the UK: ICONIC Study Initial Results.

There has been little change to the standard treatment for osteosarcoma (OS) over the last 25 years and there is an unmet need to identify new biomarkers and novel therapeutic approaches if outcomes are to improve. Furthermore, there is limited evidence on the impact of OS treatment on patient-reported outcomes (PROs). ICONIC (Improving Outcomes through Collaboration in Osteosarcoma; NCT04132895) is a prospective observational cohort study recruiting newly diagnosed OS patients across the United Kingdom (UK) with matched longitudinal collection of clinical, biological, and PRO data. During Stage 1, which assessed the feasibility of recruitment and data collection, 102 patients were recruited at 22 sites with representation from patient groups frequently excluded in OS studies, including patients over 50 years and those with less common primary sites. The feasibility of collecting clinical and biological samples, in addition to PRO data, has been established and there is ongoing analysis of these data as part of Stage 2. ICONIC will provide a unique, prospective cohort of newly diagnosed OS patients representative of the UK patient population, with fully annotated clinical outcomes linked to molecularly characterised biospecimens, allowing for comprehensive analyses to better understand biology and develop new biomarkers and novel therapeutic approaches.

Patient engagement in hematopoietic stem cell transplantation and cell therapy: a survey by the EBMT patient engagement task force & transplantation complications working party.

The EBMT (European Blood and Marrow Transplantation Society) aims to connect patients, the scientific community, and other stakeholders to improve hematopoietic stem cell transplantation and cellular therapy outcomes. We performed a cross-sectional online survey to understand the perceptions regarding Patient Reported Outcomes (PROs) and Patient Active Involvement in Research (PAIR) in over 800 stakeholders (n = 813). Patients (n = 278) and health care professionals (HCPs) (n = 351) were compared. We observed high openness for EBMT PRO collection (n = 680, 84.5% across stakeholders' groups; patients n = 256, 93.1% versus HCPs n = 273, 78.4% [p < 0.001]) and PAIR (n = 702, 87.3% across stakeholder groups; patients n = 256, 92.4% versus HCPs n = 296, 85.8% [p = 0.009]), with a significantly higher proportion of patients expressing interest compared to HCPs. Priority domains for PROs data-collection identified were the assessment of symptom experience, psychosocial and cognitive functioning. The most important issues for patients specifically were the data-collection of PROs reflecting cognitive function, the option of reporting data at home, the importance of identifying actionable targets to improve their recovery, and receiving feedback on their input when participating in research projects. Our multistakeholder approach suggests an added value to embracing patient engagement in the development of meaningful research and service design within the transplantation and cellular therapy community.

Current Trends and Outcomes in Cellular Therapy Activity in the United States, Including Prospective Patient-Reported Outcomes Data Collection in the Center for International Blood and Marrow Transplant Research Registry

The Center for International Blood and Marrow Transplant Research (CIBMTR) prepares an annual set of summary slides to summarize the trends in transplantation and cellular therapies. For the first time in the 2023 summary slides, the CIBMTR incorporated data for patients receiving chimeric antigen receptor T cell (CAR-T) infusions. In addition, data on patient-reported outcomes (PROs) are included. This report aims to update the annual trends in US hematopoietic cell transplantation (HCT) activity and incorporate data on the use of CAR-T therapies. A second aim is to present and describe the development, implementation, and current status of PRO data collection. In August 2020, the CIBMTR launched the Protocol for Collection of Patient-Reported Outcomes Data (CIBMTR PRO Protocol). The CIBMTR PRO Protocol operates under a centralized infrastructure to reduce the burden to centers. Specifically, PRO data are collected from a prospective convenience sample of adult HCT and CAR-T recipients who received treatment at contributing centers and consented for research. Data are merged and stored with the clinical data and used under the governance of the CIBMTR Research Database Protocol. Participants answer a series of surveys developed by the Patient Reported Outcomes Measurement Information System (PROMIS) focusing on physical, social and emotional, and other measures assessing financial well-being, occupational functioning, and social determinants of health. To complement traditionally measured clinical outcomes, the surveys are administered at the same time points at which clinical data are routinely collected. As of September 2023, PRO data have been collected from 993 patients across 25 different centers. With the goal of incorporating these important patient perspectives into standard clinical care, the CIBMTR has added the PRO data to Data Back to Centers (DBtC). Through expanding the data types represented in the registry, the CIBMTR aims to support holistic research accounting for the patients' perspective in improving patient outcomes. CIBMTR PRO data aim to provide a foundation for future large-scale, population-level evaluations to identify areas for improvement, emerging disparities in access and health outcomes (eg, by age, race, and ethnicity), and new therapies that may impact current treatment guidelines. Continuing to collect and grow the PRO data is critical for understanding these changes and identifying methods for improving patients' quality of life.

Abstract PO3-10-10: Are we adequately integrating patient reported outcomes in breast cancer clinical trials?

Abstract Background: Integrating patient reported outcomes (PROs) in cancer care enhances clinical outcomes and creates a paradigm shift in providing patient-centered care. Several studies performed in the past 15 years have demonstrated that systematic monitoring of patients using PROs through surveys improve patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. There has been uncertainty over the type of PRO system to implement in cancer care, how to evaluate PRO in clinical trials, and how to compare this to the clinician common terminology criteria for adverse events (CTCAE). The PRO concept was first introduced in 1975 with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) survey. In May 2018, the National Cancer Institute established the PRO-CTCAE to be utilized for cancer patients to report and grade their treatment related adverse events, like that of clinician reported CTCAE. The goal of our study was to evaluate frequency of PRO incorporation in phase III breast cancer clinical trials. Methods: New England Journal of Medicine, Journal of Clinical Oncology, and Lancet were systematically searched to identify phase III breast cancer clinical trials published between January 2018 and June 2023. A total of 113 phase III studies were identified, 87 of which had reported protocols. Studies that did not demonstrate protocols on these search engines were not included in the review. Of these 87 clinical trials, 36 studies documented evaluation of PRO. These studies were segregated by year of publication. For each year, the number of total phase III breast cancer clinical trials that were published were compared to those that were published and evaluated PRO. A percentage was generated and allowed for a longitudinal trend to be analyzed over a 5-year period to assess if there was improved frequency of PRO integration into breast cancer clinical trials. Summary statistics were calculated using SAS 9.4. Results: 36 of 113 trials demonstrated PRO use and 26 utilized EORTC-QoL, 1 used PRO-CTCAE, and 9 used another measure of PRO assessment within their study protocol (such as FACT-B and PHQ-9. Additionally, in 2018, 33% of published breast cancer studies included PRO data. Since then, there have been fluctuations in breast cancer studies collecting PRO; 2019: 33%, 2020: 47%, 2021: 43%, 2022: 73%, and since the start of 2023: 9%. Conclusions: Our data suggests a trend towards improvement in frequency of PRO data collection in breast cancer clinical trials over the past 5 years, exemplified by the marked increase in 2022. There remains a need to incorporate PROs in clinical trials and routine care to improve patient experience and provide patient-centered care. Citation Format: Yadav Rina, Zhengyan Huang, Jessica Moss, Garima Gupta. Are we adequately integrating patient reported outcomes in breast cancer clinical trials? [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-10-10.

Gene Therapy in Hemophilia A: Achievements, Challenges, and Perspectives.

Strides in advancements of care of persons with hemophilia include development of long-acting factor replacement therapies, novel substitution and hemostatic rebalancing agents, and most recently approved gene therapy. Several decades of preclinical and clinical trials have led to development of adeno-associated viral (AAV) vector-mediated gene transfer for endogenous production of factor VIII (FVIII) in hemophilia A (HA). Only one gene therapy product for HA (valoctocogene roxaparvovec) has been approved by regulatory authorities. Results of valoctocogene roxaparvovec trial show significant improvement in bleeding rates and use of factor replacement therapy; however, sustainability and duration of response show variability with overall decline in FVIII expression over time. Further challenges include untoward adverse effects involving liver toxicity requiring immunosuppression and development of neutralizing antibodies to AAV vector rendering future doses ineffective. Real-life applicability of gene therapy for HA will require appropriate patient screening, infrastructure setup, long-term monitoring including data collection of patient-reported outcomes and innovative payment schemes. This review article highlights the success and development of HA gene therapy trials, challenges including adverse outcomes and variability of response, and perspectives on approach to gene therapy including shared decision-making and need for future strategies to overcome the several unmet needs.

Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework

ABSTRACT Regulatory agencies are advancing the use of systematic approaches to collect patient experience data, including patient-reported outcomes (PROs), in cancer clinical trials to inform regulatory decision-making. Due in part to clinician under-reporting of symptomatic adverse events, there is a growing recognition that evaluation of cancer treatment tolerability should include the patient experience, both in terms of the overall side effect impact and symptomatic adverse events. Methodologies around implementation, analysis, and interpretation of “patient” reported tolerability are under development, and current approaches are largely descriptive. There is robust guidance for use of PROs as efficacy endpoints to compare cancer treatments, but it is unclear to what extent this can be relied-upon to develop tolerability endpoints. An important consideration when developing endpoints to compare tolerability between treatments is the linkage of trial design, objectives, and statistical analysis. Despite interest in and frequent collection of PRO data in oncology trials, heterogeneity in analyses and unclear PRO objectives mean that design, objectives, and analysis may not be aligned, posing substantial challenges for the interpretation of results. The recent ICH E9 (R1) estimand framework represents an opportunity to help address these challenges. Efforts to apply the estimand framework in the context of PROs have primarily focused on efficacy outcomes. In this paper, we discuss considerations for comparing the patient-reported tolerability of different treatments in an oncology trial context.

Acceptability, Perceptions, and Experiences Regarding Electronic Patient-Reported Outcomes After Laparoscopic Cholecystectomy: Protocol for a Mixed Methods Feasibility Study.

Patient-reported outcomes (PROs) can be defined as any report of a patient's health taken directly from the patient. Routine collection of PRO data has been shown to offer potential benefits to patient-doctor communication. Electronic forms of PRO measures (PROMs) could be more beneficial in comparison to traditional PROMs in obtaining PROs from patients. However, it is currently unclear whether the routine collection of electronic PRO data could result in better outcomes for patients undergoing laparoscopic cholecystectomy (LC). This study aims to explore the perspectives of patients and surgeons on the use of electronic PROMs. Based on prior research, technical skill and experience level of the surgeon, long-term quality of life, patient involvement in decision-making, communication skills of the surgeon, cleanliness of the ward environment, and standards of nursing care are identified to be the most important factors for the patients. This is a mixed methods prospective study that will collect both quantitative (survey) and qualitative (interview) data. The study has two components. The first involves the distribution of an electronic presurvey to patients who received elective LC within 48 hours of their surgery (n=80). This survey will explore the perspective of patients regarding the procedure, hospital experience, long-term outcomes, and the perceived value of using PROMs. These patients will then be followed up after 1 year and given another survey. The second component involves the distribution of the same survey and the completion of structured interviews with general surgeons (n=10). The survey will ascertain what PROs from the participants are most useful for the surgeons and the interviews will focus on how the surgeons view routine PRO collection. A convenience sampling approach will be used. Surveys will be distributed through Qualtrics and interviews will be completed on Microsoft Teams. Data collection began on February 14, 2023. As of February 12, 2024, 71 of 80 recruited patients have been given the presurvey. The follow-up with the patients and the general surgeon components of the study have not begun. The expected completion date of this study is in April 2025. Overall, this study will investigate the potential of electronic PRO collection to offer value for patients and general surgeons. This approach will ensure that patient care is investigated in a multifaceted way, offering patient-centric guidance to surgeons in their approach to care. DERR1-10.2196/57344.

The use of healthcare systems data for RCTs

BackgroundHealthcare systems data (HSD) has the potential to optimise the efficiency of randomised controlled trials (RCTs), by decreasing trial-specific data demands. Therefore, the use of HSD in trials is expected to increase. In 2019, it was estimated that 47% of NIHR-funded trials were planning to use HSD. We aim to understand the extent and nature of its current use and its evolution over time.MethodsWe identified a cohort of RCTs within the NIHR Journals Library that commenced after 2019 and were described as being in progress on 6 June 2022. Details on the source and use of HSD were extracted from eligible RCTs. The use of HSD was categorised according to whether it was used as the sole data source for outcomes and whether the outcomes were primary or secondary. HSD is often insufficient for patient-reported outcomes (PROs). We aimed to determine methods used by trialists for collecting PRO data alongside HSD.ResultsOf the 84 eligible studies, 52 (62%) planned to use HSD and 79 (94%) planned to collect PROs. The number of RCTs planning to use HSD for at least one outcome was 28 (54%) with 24 of these planning to use HSD as the sole data source for at least one outcome.The number of studies planning to use HSD for primary and secondary outcomes was 10 (20%) and 21 (40%) respectively. The sources of HSD were National Health Service (NHS) Digital (n = 37, 79%), patient registries (n = 7, 29%), primary care (n = 5, 21%), The Office for National Statistics (ONS) (n = 3, 13%) and other (n = 2, 8%).PROs were collected for 92% of the trials planning to use HSD. Methods for collection of PROs included in-person (n = 26, 54%), online (n = 22, 46%), postal (n = 18, 38%), phone (n = 14, 29%) and app (n = 2, 4%).ConclusionsHSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD.

The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial

BackgroundIncorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform.MethodsWe used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool—a short prompt for patients to provide information on treatment satisfaction and side effects—impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.ResultsCompared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005).ConclusionsPrompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment.Trial registrationThis trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).

Electronic Patient-Reported Outcome Data Collection Systems in Oncology Clinical Trials: A Survey of Clinical Research Professionals (an Alliance Study).

To describe clinical research professionals (CRPs)' experiences with electronic patient-reported outcome (ePRO) data collection systems in oncology clinical trials and identify correlates of CRPs' attitude toward technology. An online survey was conducted among 210 CRPs from 125 National Cancer Institute-funded research sites. Measures included CRPs' demographic characteristics, working years, employment locations, and previous experiences with various types of ePROs. Their attitude toward technology was measured by the Technology Attitude Scale-Adapted. The Wilcoxon signed-rank test was used to compare two subdomains of attitude (perceived usefulness [PU] and perceived ease of use [PEU]). Multiple linear regression was used to explore correlates of (1) overall attitude, (2) PU, and (3) PEU. The significance level was 5%. Participants' median age was 41 years (range, 21-67). Most were female (90%) and White (82%). More than half of the participants had previous experiences with web-based ePROs using patients' own devices (72%) or site-/sponsor-provided on-site devices (eg, kiosks or tablets; 64%). CRPs who were 60 years or older (β = -0.32, P < .05) or worked for 10-20 years (β = -0.11, P < .05) had relatively negative attitudes, controlling for other factors. Previous experiences with more ePRO types were associated with more positive attitudes (β = 0.08, P = .02). Similar correlates were found with PU but not with PEU. This study revealed that CRPs had various experiences with ePRO systems and attitudes toward technology. Age, working years, and previous experiences with ePROs were correlates of overall attitude toward technology and PU. These findings suggest necessary targeted training to facilitate ePRO use in oncology clinical trials by improving CRPs' awareness and attitude toward technology.

Veteran Perspectives on Phantom Limb Pain and Non-Drug Interventions.

Phantom limb pain (PLP) commonly occurs post-amputation and can negatively affect the daily functioning of persons with amputation. Best practices for medication and non-drug management remain unclear. To better understand the PLP experience and patients' familiarity with treatments, phone interviews were conducted at the Minneapolis Veterans Affairs Regional Amputation Center in Veterans with amputations. Fifty Veteran participants (average age 66, 96% male) with lower limb amputation were recruited for phone-based data collection of patient-reported outcomes (ie, demographics using the Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) and pain experience using the Phantom Phenomena Questionnaire) to characterize the population and a semi-structured interview. Notes taken during interviews were analyzed using the Krueger and Casey constant comparison analysis method. Participants had an average of 15 years since amputation, and 80% reported PLP as identified with the Phantom Phenomena Questionnaire. Investigators identified several core themes from the qualitative interviews including 1) high variability in the experience of PLP, 2) acceptance and resilience, and 3) PLP treatment perceptions. The majority of participants reported trying common non-drug treatments with none endorsed consistently as highly effective. More research is needed to inform identification and implementation of clinical best practices for non-drug interventions for PLP and understand the factors that influence engagement in non-drug interventions. The participants in this study were largely male, so these results may not be generalizable to females.

Patient-Reported Outcomes Collection at an Urban HIV Clinic Associated With a Historically Black Medical College in the Southern United States: Qualitative Interview Study Among Patients With HIV.

Black Americans, particularly in the southern United States, are disproportionately affected by the US HIV epidemic. Patient-reported outcome (PRO) data collection can improve patient outcomes and provide oft-overlooked data on mental health, substance use, and patient adherence to antiretroviral therapy. We piloted the use of an electronic tablet to collect PRO data on social and behavioral determinants of health among people with HIV at the Meharry Community Wellness Center, an HIV clinic affiliated with a Historically Black Medical College in Nashville, Tennessee. Our primary objective was to better understand patients' experiences and comfort with using an electronic PRO tool through patient interviews. We enrolled 100 people with HIV in care at the Meharry Community Wellness Center consecutively to completely validate PRO tools using the Research Electronic Data Capture platform on a hand-held tablet. Using a purposive sampling strategy, we enrolled 20 of the 100 participants in an in-depth interview (IDI). Interview guide development was grounded in the cognitive-behavioral model, in which thoughts, feelings, and behaviors are interrelated. IDIs were audio recorded, transcribed, deidentified, and formatted for coding. A hierarchical coding system was developed and refined using an inductive-deductive approach. Among the 100 people with HIV enrolled, the median age was 50 (IQR 42-54) years; 89% (n=89) were Black, 60% (n=60) were male, and 82% (n=82) were living below 100% of the federal poverty level in 2016. Five major interview themes emerged: overall experience, question content, sensitive topics, clinic visit impact, and future recommendations. IDI participants felt that the tablet was easy to use and that the question content was meaningful. Question content related to trauma, sexual and drug use behaviors, mental health, stigma, and discrimination elicited uncomfortable or distressing feelings in some participants. Patients expressed a strong desire to be truthful, and most would complete these surveys without compensation at future visits if offered. The use of an electronic tablet to complete PRO data collection was well received by this cohort of vulnerable persons in HIV care in the southern United States. Despite some discomfort related to question content, our cohort overwhelmingly believed this was a meaningful part of their medical experience and expressed a high desire for truthfulness. Future research will focus on scaling up the implementation and evaluation of PRO data collection in a contextually appropriate manner while obtaining input from providers and staff to ensure that the collected data are both applicable and actionable.

PATIENT REPORTED OUTCOME MEASURES AND PATIENT ENGAGEMENT IN HEART FAILURE CLINICAL TRIALS: MULTI-STAKEHOLDER PERSPECTIVES.

There are many consequences of heart failure (HF), including symptoms, impaired health-related quality of life (HRQoL), and physical and social limitations (functional status). These have a substantial impact on patients' lives, yet are not routinely captured in clinical trials. Patient-reported outcomes (PROs) can quantify patients' experiences of their disease and its treatment. Steps can be taken to improve the use of PROs in HF trials, in regulatory and payer decisions, and in patient care. Importantly, PRO measures (PROMs) must be developed with involvement of patients, family members, and caregivers from diverse demographic groups and communities. PRO data collection should become more routine not only in clinical trials but also in clinical practice. This may be facilitated by the use of digital tools and interdisciplinary patient advocacy efforts. There is a need for standardisation, not only of the PROM instruments, but also in procedures for analysis, interpretation and reporting PRO data. More work needs to be done to determine the degree of change that is important to patients and that which is associated with increased risks of clinical events. This "minimal clinically important difference (MCID)" requires further research to determine thresholds for different PROMs, to assess consistency across trial populations, and to define standards for improvement that warrant regulatory and reimbursement approvals. PROs are a vital part of patient care and drug development, and more work should be done to ensure that these measures are both reflective of the patient experience and that they are more widely employed.

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online

The Official Journal of ATTD Advanced Technologies &amp; Treatments for Diabetes Conference 22‐25 February 2023 I Berlin &amp; Online

RWD10 Measuring Patient Satisfaction From Patient Reported Outcomes (PRO) Application Embedded in the Hospital's Treatment Pathway in Finland

Patient Reported Outcomes (PROs) are valuable in monitoring patients’ real-time wellbeing, but the data collection is only viable if patients feel satisfied to actively answer the digital PRO questionnaires. Patient satisfaction on the applications’ technical solution is evident to the response rate of this appreciated real-world data (RWD). It can be especially challenging to use digital solutions embedded in the hospital’s treatment pathway, when they require strong authentication, pin codes and patients ID. The important patient privacy aspect can lead to possible challenges in the collection of PRO data from less digitally capable patients. The objective of this study was to understand how satisfied the patients are with the current solution.

Longitudinal Collection of Patient-Reported Outcomes and Activity Data during CAR-T Therapy: Feasibility, Acceptability, and Data Visualization.

Simple SummaryPatients treated with chimeric antigen receptor T-cell therapy (CAR-T) are at risk for severe toxicities post-treatment. Patient-reported outcomes and activity data from fitness trackers could be helpful for monitoring patients after CAR-T. The aim of this pilot study was to test the feasibility and acceptability of having patients complete surveys on a rigorous schedule and wear a Fitbit tracker continuously, from before their CAR-T infusion through 90-days post-infusion. In a sample of 12 patients with hematologic malignancies, we demonstrated feasibility and acceptability, with high rates of behavioral adherence to the study procedures. These findings suggest that large-scale data collection efforts using these procedures will be successful. In turn, patient-reported outcomes and activity data could be used to identify predictors of severe CAR-T-related toxicities.Background: Clinicians must closely monitor patients for toxicities after chimeric antigen receptor T-cell therapy (CAR-T). Patient-reported outcomes (PROs) (e.g., toxicities, quality of life) and activity data (e.g., steps, sleep) may complement clinicians’ observations. This study tested the feasibility and acceptability of collecting PROs and activity data from patients with hematologic malignancies during CAR-T and explored preliminary data patterns. Methods: Participants wore a Fitbit tracker and completed PROs at several timepoints through 90-days post-infusion. Feasibility was assessed with a priori benchmarks for recruitment (≥50%), retention (≥70%), PRO completion (≥70%), and days wearing the Fitbit (≥50%). Acceptability was assessed with participant satisfaction (a priori benchmark > 2 on a 0–4 scale). Results: Participants (N = 12) were M = 66 years old (SD = 7). Rates of recruitment (68%), retention (83%), PRO completion (85%), and days wearing the Fitbit (85%) indicated feasibility. Satisfaction with completing the PROs (M = 3.2, SD = 0.5) and wearing the Fitbit (M = 2.9, SD = 0.5) indicated acceptability. Preliminary data patterns suggested that participants with better treatment response (vs. progressive disease) had a higher toxicity burden. Conclusions: Longitudinal PRO and activity data collection was feasible and acceptable. Data collected on a larger scale may be used to specify risk prediction models to identify predictors of severe CAR-T-related toxicities and inform early interventions.

Feasibility study on collecting patient-reported outcomes from breast cancer patients using the LINE-ePRO system.

Due to the increasing complexity of cancer treatment, ensuring safety and maintaining the quality of life during treatment are important issues. Patient‐reported outcomes (PROs) in oncology are essential for assessing patient symptoms. A feasibility study was undertaken on breast cancer patients by building a PRO data collection system based on LINE, one of the most popular social network service applications in Japan. In this study, one or more predefined PRO questions for each breast cancer patient's clinical situation were sent to the patient’s LINE application daily. The patient selected a predefined answer by tapping the screen, but no free‐text answers were allowed. Seventy‐three patients were enrolled. The median observation period was 435 days (84‐656 days), and the total number of PROs collected was 16,417, with a mean of 224.9 reports per patient. Patients on adjuvant endocrine therapy were notified of 2.5 questions per week, and the median number of responses per week and response rate were 2.387 (1.687‐11.627) and 95.5%, respectively. Analyzing the results by age group, the number of responses from those aged 60 and above was equal to or higher than that of the younger age group. It was also possible to track each patient’s PROs accurately. These results suggested that the design of the system, based on an application used daily, instead of using specifically prepared applications for collecting electronic PROs, was the reason for the favorable acceptance from patients and the satisfactory response rate from all age groups, including the elderly.

High Incidence of Combined and Posterior Labral Tears in Military Patients With Operative Shoulder Instability

Background: Anterior shoulder instability is the pattern most commonly reported in the civilian population, but military servicemembers may represent a unique population. At 1.7 per 1000 person-years, servicemembers not only have a higher incidence of instability events compared with civilians (reported rate of 0.2-0.8), but the distribution of labral tears in the military may differ significantly as well. Hypothesis: The incidence of combined and posterior labral tears in the military population will be greater than numbers previously reported. Study Design: Cross-sectional study; Level of evidence, 3. Methods: The Wounded, Ill, and Injured Registry, a Department of Defense patient reported outcomes data collection platform that includes all military branches, was queried retrospectively for all patients who had undergone a primary arthroscopic or open shoulder stabilization procedure (Current Procedural Terminology codes 29806, 23455, 23462) between October 2016 and January 2019. Demographic information was obtained through intake forms completed by patients at the time of enrollment into the Military Orthopaedics Tracking Injuries and Outcomes Network. Tear location was determined arthroscopically and labeled as anterior, inferior, posterior, superior, or any combination thereof. Chi-square analysis was used to compare the percentage of patients with isolated anterior, isolated posterior, isolated inferior, or combined labral tears in the current study cohort with those in a previously reported cohort of patients with operative shoulder instability at a single military treatment facility. Results: A total of 311 patients were included who had undergone primary shoulder stabilization during the study period. Of these patients, 94 (30.2%) had isolated anterior tears, 76 (24.4%) had isolated posterior tears, and 136 (43.7%) had combined tears. We observed a higher percentage of combined tears in our data set than in a data set from a single military treatment facility (χ2(2) = 48.2; P < .00001). Chi-square analysis demonstrated that significantly more female patients had an isolated anterior labral tear (51.2%) compared with male patients (27.1%; χ2(2) = 9.4; P = .009). Conclusion: The incidence of combined and posterior labral tears in the military population is greater than numbers previously reported in both military and civilian populations.

Testing Digital Methods of Patient-Reported Outcomes Data Collection: Prospective Cluster Randomized Trial to Test SMS Text Messaging and Mobile Surveys

BackgroundHealth care delivery continues to evolve, with an effort being made to create patient-centered care models using patient-reported outcomes (PROs) data. Collecting PROs has remained challenging and an expanding landscape of digital health offers a variety of methods to engage patients.ObjectiveThe aim of this study is to prospectively investigate two common methods of remote PRO data collection. The study sought to compare response and engagement rates for bidirectional SMS text messaging and mobile surveys following orthopedic surgery.MethodsThe study was a prospective, block randomized trial of adults undergoing elective orthopedic procedures over 6 weeks. The primary objective was to determine if the method of digital patient engagement would impact response and completion rates. The primary outcome was response rate and total completion of PRO questionnaires.ResultsA total of 127 participants were block randomized into receiving a mobile survey (n=63) delivered as a hyperlink or responding to the same questions through an automated bidirectional SMS text messaging system (n=64). Gender, age, number of comorbidities, and opioid prescriptions were similar across messaging arms. Patients receiving the mobile survey were more likely to have had a knee-related surgery (n=50, 83.3% vs n=40, 62.5%; P=.02) but less likely to have had an invasive procedure (n=26, 41.3% vs n=39, 60.9%; P=.03). Overall engagement over the immediate postoperative period was similar. Prolonged engagement for patients taking opioids past postoperative day 4 was higher in the mobile survey arm at day 7 (18/19, 94.7% vs 9/16, 56.3%). Patients with more invasive procedures showed a trend toward being responsive at day 4 as compared to not responding (n=41, 59.4% vs n=24, 41.4%; P=.05).ConclusionsAs mobile patient engagement becomes more common in health care, testing the various options to engage patients to gather data is crucial to inform future care and research. We found that bidirectional SMS text messaging and mobile surveys were comparable in response and engagement rates; however, mobile surveys may trend toward higher response rates over longer periods of time.Trial RegistrationClinicalTrials.gov NCT03532256; https://clinicaltrials.gov/ct2/show/NCT03532256

Preparing for the spread of patient-reported outcome (PRO) data collection from primary care to community pharmacy: a mixed-methods study

BackgroundMedication non-adherence is a significant public health problem. Patient-reported outcomes (PROs) offer a rich data source to facilitate resolution of medication non-adherence. PatientToc™ is an electronic PRO data collection software originally implemented at primary care practices in California, United States (US). Currently, the use of standardized PRO data collection systems in US community pharmacies is limited. Thus, we are conducting a two-phase evaluation of the spread and scale of PatientToc™ to US Midwestern community pharmacies. This report focuses on the first phase of the evaluation. The objective of this phase was to prepare for implementation of PatientToc™ in community pharmacies by conducting a pre-implementation developmental formative evaluation to (1) identify potential barriers, facilitators, and actionable recommendations to PatientToc™ implementation and (2) create a draft implementation toolkit.MethodsData collection consisted of demographics, observations, audio-recorded contextual inquiries, and semi-structured interviews with staff (e.g., primary care providers, pharmacists, pharmacy technicians) and patients during 1-day site visits to a purposive sample of (1) primary care practices currently using PatientToc™ and (2) community pharmacies in Indiana, Wisconsin, and Minnesota interested in the future use of PatientToc™. Post-visit site observation debriefs were also audio-recorded. Verbatim transcripts of all recordings were coded using deductive/inductive approaches and intra-/inter-site summaries were produced identifying potential barriers, facilitators, and actionable recommendations mapped to the Consolidated Framework for Implementation Research constructs. A stakeholder advisory panel engaged in an Evidence-Based Quality Improvement (EBQI) implementation process. This included “member checking” and prioritizing findings, and feedback on the adapted PatientToc™ application, implementation strategies, and accompanying toolkit for community pharmacy implementation.ResultsTwo primary care practices, nine pharmacies, and 89 individuals participated. Eight major themes (four barriers and four facilitators) and 14 recommendations were identified. Throughout the four EBQI sessions, the panel (1) confirmed findings; (2) designated high priority recommendations: (a) explain PatientToc™ and its benefits clearly and simply to patients, (b) ensure patients can complete questionnaires within 10 min, and (c) provide hands-on training/resources for pharmacy teams; and (3) provided feedback on the adapted PatientToc™ application and finalized toolkit items for initial community pharmacy implementation.ConclusionsAdoption of electronically captured PROs in community pharmacies is warranted. The implementation strategies systematically developed in this study can serve as a model for implementation of technology-driven health information patient care services, in the understudied context of community pharmacies.