A large multinational clinical trial has found that giving healthcare providers access to European Organisation for Research and Treatment of Cancer (EORTC) patient-reported outcome (PRO) data signifi...

STORQ (Standards for Transparent reporting of Oral Health-Related Quality of life studies) is a reporting guideline in development, registered with the EQUATOR Network, for studies that measure oral h...

A study has shown that, for people living with advanced cancer, a weekly remote check-in with the care team can have a significant impact on outcomes.

One important way that pharma companies can deliver true patient advocacy is by bringing cross-functional experience to the table.

Background: Immune checkpoint inhibitors are widely used in oncology but can cause immune-related adverse events (irAEs), which may be severe or life-threatening if not detected early. Electronic patient-reported outcome (ePRO) symptom monitoring systems may facilitate timely recognition and management of irAEs. #usability testing is a critical stage in ePRO system development, yet no published examples of formal #usability and acceptance testing exist. Objective: This study aims to assess the #usability and acceptance of a co-designed ePRO symptom monitoring prototype for irAEs embedded within the Epic electronic medical record. Methods: Testing was conducted at an Australian quaternary #Cancer center. Eligible participants were patients who had received or were receiving immune checkpoint inhibitors, their caregivers, or clinicians (oncologists and nurse specialists). Participants completed baseline digital literacy assessments (16-item Mobile Device Proficiency Questionnaire [MDPQ-16] and 12-item Computer Proficiency Questionnaire [CPQ-12]) before a structured testing session. Each session involved role-specific tasks using the patient-facing Health Hub or the clinician-facing Epic electronic medical record. #usability was assessed using the System #usability Scale (SUS). Acceptance was assessed using a customized Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. Semistructured interviews were used to capture qualitative feedback. Results: A total of 30 participants (7 patients, 3 caregivers, 10 oncologists, and 10 nurse specialists) completed 10 testing sessions. Median MDPQ-16 and CPQ-12 scores were higher for clinicians compared to patients and caregivers. Median SUS scores indicated high #usability—patients and caregivers: 77.5% (IQR 70.0%‐86.3%), oncologists: 82.5% (IQR 80.0%‐90.0%), and nurse specialists: 80.0% (IQR 75.6%‐94.4%). Median UTAUT scores demonstrated strong user acceptance—patients or caregivers: 4.27 (IQR 4.09‐4.58), oncologists: 4.33 (IQR 4‐4.63), and nurse specialists: 4.23 (IQR 3.87‐4.57). Health Hub #usability themes highlighted overall ease of navigation and efficiency of reporting, but a need for clearer survey navigation, simplification of the actions page, and improved organization of trend graphs. For clinicians, themes included efficient side effect capture and intuitive system design, but a need to improve navigation to results, optimize data display, and facilitate team-based alert management. Health Hub acceptance themes highlighted patient empowerment to self-manage, enhanced patient-clinician communication, and reinforcement of existing care. However, concerns were raised about digital equity for vulnerable groups. Clinicians reported that the system streamlined side effect management between visits, aligned with existing Epic workflows, and could be tailored to personal preferences. Concerns remained regarding additional workload and medico-legal responsibilities associated with real-time alerts. Conclusions: The ePRO prototype demonstrated high levels of #usability and acceptance across patients, caregivers, and clinicians. Limitations around navigation and data visualization, alongside equity and workload concerns, will guide refinements prior to implementation. These findings emphasize the value of rigorous formative #usability and acceptance testing to optimize ePRO systems prior to deployment in routine #Cancer care.

Background: The Michigan Oncology Quality Consortium developed a rapid patient-reported outcome measure (RapidPRO) focused on oral anti#Cancer agents (OAAs). We piloted this measure in 6 oncology practices to determine its usefulness in representing the symptom experience and medication adherence among individuals taking OAAs. It is common in oncology for #Cancer-specific approaches to be used. We sought to use 1 instrument for all OAAs as a means to simplify future implementation in practice. Objective: This study aimed to describe the use of RapidPRO in practice and quantify clinical metrics in RapidPRO for symptom burden, confidence to manage symptoms, confidence to know when to seek care, and OAA medication adherence. Methods: This observational study was conducted across 6 practices from July 2016 to December 2018. RapidPRO assesses symptoms, patient confidence, and medication adherence with respect to OAAs. Results: There were 2252 RapidPROs completed by 695 patients. Among individuals completing at least 2 RapidPROs, the median number of days between them was 28 (IQR 14-42). Of the 2252 completed RapidPROs, 1213 (53.9%) reported at least one moderate or severe symptom, and 28% (485/1705) reported medication nonadherence. Most bothersome symptoms (MBSs; n=1045) were reported in 35.1% (790/2252) of the RapidPROs, and 46.5% (323/695) of all patients reported an MBS. In exploratory analyses, RapidPROs that reported a moderate or severe symptom or lower confidence to manage symptoms were more likely to be nonadherent to OAA therapy. The most common reason for medication nonadherence was “experienced side effects.” Conclusions: These results show that most RapidPROs reported at least one moderate or severe symptom and 28% (485/1705) reported medication nonadherence. As well, RapidPRO was able to capture most patients’ MBSs. By implementing RapidPRO, practices can identify patients who experience symptoms, as well as those who report medication nonadherence.

Background: Providing patients with information about their health and treatment options is an important part of the shared decision-making process, which can lead to care that best reflects patient needs, values, and preferences. Patient-reported outcomes (PROs) are regularly collected in clinical contexts and can be embedded in decision aids as patient-reported measures of health status. One example of a PRO-based decision aid is the Arthritis care through Shared Knowledge (A.S.K.) report, which provides patients with individual PRO data for decision-making about osteoarthritis care. Given that using data in decision-making is unfamiliar to many patients, support may be required to ensure these aids are utilized as intended. Objective: This paper describes how A.S.K coaching, a group education session, was designed to ensure patients understood the A.S.K. report, including their PRO scores, and how to use the information to inform clinical consultations. We present (a) quantitative evaluation results associated with attendance and self-assessment of learning and (b) qualitative evaluation results on motivation to attend, acceptability of the session format, and achievement of session goals. Methods: The virtual, one-hour session was designed and refined collaboratively with clinical experts and patient advisers. Patients in one arm of a pragmatic cluster-randomized trial evaluating the A.S.K. report were then invited to attend coaching. To understand the profile of attendees, sociodemographic and clinical data were compared with all participants invited to coaching (N=1545) and a patient-reported assessment of self-efficacy was collected on a subset (N=178). Additionally, a post-session survey was used to self-assess learning. Qualitative data were synthesized from semi-structured post-coaching interviews, paired pre-/post-coaching interviews, and free-text responses to a post-session survey. A qualitative descriptive approach was used for analysis. Results: Compared to non-attendees, patients reporting higher education, greater health literacy, Medicare insurance, and lower self-efficacy for managing treatments were more likely to attend A.S.K. coaching when invited. Participants’ self-assessment of learning showed improved understanding of current and projected symptoms and where to find additional osteoarthritis information. Qualitatively, patients reported attending to gain information that could benefit their treatment or to aid in research. The virtual, group format was generally described as acceptable, and the session goals related to report understanding, patient empowerment, appointment preparation, and additional resources were met. Suggestions for improvement, such as providing more opportunities for group interaction, were also provided. Conclusions: Results highlight the value of coaching as an intervention to help patients understand and use novel health information, including PRO symptom assessments, for decision-making. Given that it was well liked by patients, promoted greater understanding of the decision aid, and increased feelings of empowerment in preparing for a clinical consultation, A.S.K. Coaching appears to be a promising intervention to support patients in making decisions using a PRO-based decision aid.

Background: Advances in antiretroviral therapy have transformed HIV into a manageable chronic condition, allowing people living with HIV (PLWH) to live longer. However, with aging, PLWH face increased risks of lifestyle-related diseases and unaddressed psychosocial issues, including stigma, discrimination, and mental health concerns. Patient-reported outcomes (PROs) are essential tools in person-centered care and have demonstrated clinical utility in oncology and rheumatology, yet remain underutilized in infectious disease settings. Recently, the European AIDS Clinical Society has recommended electronic PRO (ePRO) systems to support HIV care. Objective: This study aimed to evaluate the #feasibility and clinical utility of a smartphone-based ePRO system specifically developed for PLWH in Japan. Methods: A retrospective study was conducted among PLWH who attended the HIV outpatient clinic at Teikyo University Hospital between July and September 2022. Participants who consented to use the ePRO system installed a smartphone application and completed the HIV Symptom Index prior to their clinic visit. Physicians reviewed the responses during consultations. Following the visits, patients completed a #usability survey addressing clarity, response time, satisfaction, communication quality, and intention for future use. Medical records were reviewed to determine whether any new symptoms, findings, or medical actions had been added that had not been documented in the previous two years. Results: A total of 27 PLWH (median age 46 years, 100% male) used the ePRO app, and 25 (93%) completed the post-use questionnaire. Of these, 19 (76%) completed the symptom index within 5 minutes, while one participant took more than 15 minutes. Regarding #usability, 76% reported being satisfied or very satisfied, and 76% found the system useful in improving communication with their provider. Additionally, 76% expressed willingness to use the system again, while five indicated interest only if improvements were made. Medical record analysis revealed that 17 patients (63%) had new clinical information documented, including mental health symptoms (n=7), skin problems (n=7), and new diagnoses or treatment changes in 6 cases. Over 40% of patients reported issues such as anxiety, insomnia, dermatologic symptoms, or concerns related to body image. Conclusions: This pilot study demonstrated that a smartphone-based ePRO system for PLWH is feasible and well accepted in real-world clinical practice. It facilitated early detection of psychosocial and physical issues that may otherwise be overlooked in routine care and improved patient–provider communication. The findings support the integration of ePRO systems into HIV care and underscore the need for further refinement of the app and prospective studies to assess long-term impact on patient outcomes and quality of care.

Background: Fatigue is a prevalent and debilitating symptom in many chronic conditions, including immune-mediated inflammatory diseases (IMIDs) and neurodegenerative diseases (NDDs). Fatigue often fluctuates significantly within and between days, yet traditional patient-reported outcomes (PROs) typically rely on recall periods of a week or more, potentially missing these short-term variations. The development of digital tools, such as electronic diaries (eDiaries), offers a unique opportunity to collect granular, real-time data. However, the #feasibility, adherence, and comparability of eDiary-based assessments to established PROs require further investigation. Objective: This study aimed to evaluate the #feasibility and acceptability of using a high-frequency eDiary to capture intra-day variability in fatigue and to compare eDiary data with scores obtained from the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), a validated weekly recall PRO. Methods: Data were collected from 159 participants enrolled in the IDEA-FAST #feasibility Study; a four-week prospective observational study conducted at four European centres. Participants included individuals with NDDs (n=39), IMIDs (n=78), and healthy volunteers (HVs; n=42). Participants used an eDiary to report their physical and mental fatigue levels up to four times daily on a 7-point Likert scale (0 = low, 6 = high). Adherence was calculated as the proportion of completed eDiary entries relative to the total expected entries. Correlations between averaged eDiary scores and weekly FACIT-F scores were analysed. Results: Adherence to the eDiary protocol was 62% overall, varying by cohort, with the highest adherence (93%) observed in the primary Sjögren’s syndrome (PSS) cohort and the lowest adherence in Parkinson’s disease (PD) (43%) and Huntington’s Disease (HD) (44%) cohorts. The average adherence was 44% in the NDD cohorts and 74% in IMID cohorts. Fatigue levels showed clear diurnal variation, with significantly higher fatigue reported in the evening compared to the morning (p

Background: Traditionally, treatment outcomes of service users with a substance use disorder (SUD) are measured using objective and provider-reported indicators. In recent years, there has been a shift toward incorporating patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) to capture service users’ perspectives on treatment outcomes and experiences. Objective: The OMER-BE (Outcome Measurement and Evaluation as a Routine Practice in Alcohol and Other Drug Services in Belgium) study evaluates the acceptability and #feasibility of PROMs and PREMs in different SUD treatment services, using the recently developed International Consortium for Health Outcomes Measurement Standard Set for Addictions. This paper presents the design and baseline characteristics of the study, indicators of attrition at 45-day follow-up, and the #feasibility of the implementation of PROMs and PREMs in residential and outpatient services. Methods: A convenience sample of 189 treatment-seeking individuals with SUD from different inpatient (therapeutic communities and psychiatric centers) and outpatient treatment services was followed for six months. Sociodemographic characteristics; clinical factors; and PROMs including recovery strengths, quality of life, and global health were assessed at baseline and within 3 weeks after starting treatment. Additionally, PROMs and PREMs were measured 45, 90, and 180 days later. Comparisons were made between treatment modalities, and indicators of attrition at the 45-day follow-up were assessed using ANOVA and chi-square tests. Results: Baseline differences were observed between the three treatment modalities regarding education, SUD treatment history, primary substance, and Attention-Deficit/Hyperactivity Disorder Self-Report scores. Overall, patients in psychiatric treatment centers had a higher education level and less polysubstance use, while outpatients had fewer previous SUD treatments but received relatively more often opioid agonist treatment. Inpatients reported more attention-deficit/hyperactivity disorder symptoms and higher SUD severity than outpatients. Additionally, recovery strength scores were significantly lower in the outpatient group compared to the other groups, particularly in the subdomains of “Substance Use,” “Self-care,” and “Outlook on Life.” At the 45-day follow-up assessment, the attrition rate was 36.6%. Comparisons between participants who completed the 45-day follow-up and those who dropped out revealed that completers were significantly older, had a higher level of education, were more likely to live alone, and were more likely to have a mother born in Belgium. They also had higher average scores on the “Material Resources” domain of the Substance Use Recovery Evaluator, which includes questions about stable housing, a steady income, and effective financial management. Conclusions: Evaluating PROMs and PREMs appears to be feasible in a diverse group of treatment-seeking patients with SUD in Belgium. However, challenges remain for structural implementation in practice, especially in outpatient services. Routine monitoring of PROMs and PREMs has the potential to empower patients, service providers, and policy makers by providing a comprehensive understanding of service users’ needs and treatment effectiveness.