Electronic Collection Of Patient-reported Outcomes Research Articles

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.

Feasibility and acceptability of implementing electronic patient reported outcomes (ePRO) collection in Zambia: Findings from a patient needs assessment.

12115 Background: Studies in high-income countries have shown that systematic, remote and electronic collection of patient-reported outcomes (ePROs) during chemotherapy, with provider intervention if symptoms worsen, is associated with fewer symptoms, better quality of life (QOL), and improved survival. It is unknown whether similar ePRO interventions, often using electronic medical record patient portals or mobile devices, can improve outcomes for cancer patients in low- and middle-income countries (LMICs). In sub-Saharan Africa (SSA), cervical cancer (CC) is the second most common cancer and most common cause of cancer deaths in women. As most patients are diagnosed with locally advanced disease, chemoradiotherapy is standard care; many have severe comorbidities such as HIV. Due to patients’ increased risk for high symptom burden, remote monitoring of ePROs during CC treatment may improve outcomes. We evaluated the feasibility and acceptability of ePRO collection in CC patients from SSA. Methods: Patients were recruited from a prospective cohort study of women with newly diagnosed CC at the Cancer Diseases Hospital in Lusaka, Zambia from June 2022 through January 2023. Patients completed an in-person interview regarding mobile technology usage comprising questions adapted from the 2019 Pew Report on Mobile Connectivity in Emerging Economies and the 2019 Global System for Mobile Communication Association Mobile Gender Gap Report. Questions were translated into 4 primary Zambian languages (Tonga, Nyanga, Lozi and Bemba). Results: Respondents’ (n = 100) mean age was 49.6 years (range, 29-75, SD 9.2), 55% were diagnosed with stage III-IV disease and 59% were HIV+. Most (70%) completed only primary school or no school, 29% reported not being able to read at all and 29% could read only parts of a sentence. Most personally owned a mobile phone (90%) and 8% reported using a phone that belonged to another person. Most used phones to make or receive calls (98%), for banking/mobile money (92%), and text messaging (67%). Of the 26% who owned a smartphone, only half connected to the internet by phone more than once weekly. Nearly all indicated willingness to use a phone to self-report CC-related symptoms if compensated for costs (98%), with 97% preferring to do so via a phone call and fewer via text message (43%) or mobile app (17%). Most (71%) were able to charge phones at home using electricity or solar power and 18% traveled more than 30 minutes to charge phones. Conclusions: Nearly all patients owned or had access to mobile phones and expressed willingness to self-report CC symptoms via phone. Findings support the feasibility and acceptability of ePRO collection and provide contextual data to guide implementation in LMICs, including consideration of telecommunications infrastructure and literacy, low internet use, and ePRO reporting preferences (i.e., calls vs text).

PCR219 Real-World Severe Symptom Trajectory in Multiple Myeloma Reported in Remote Symptom Monitoring with Electronic Patient-Reported Outcomes (ePRO)

Multiple Myeloma (MM) is associated with the high symptom burden. Systematic collection of electronic patient-reported outcomes (ePRO) for symptom monitoring in oncology practice improves survival, accelerates time to therapy, and manages resource utilization. As many patients with myeloma are treated with oral medications, with fewer clinic visits, ePROs present an opportunity to fill unmet needs for symptom monitoring for MM patients. This study aims to describe the severe symptom trajectory in MM population who utilized remote symptom monitoring with ePRO.

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study.

Modern wearable devices provide objective and continuous activity data that could be leveraged to enhance cancer care. We prospectively studied the feasibility of monitoring physical activity using a commercial wearable device and collecting electronic patient-reported outcomes (ePROs) during radiotherapy (RT) for head and neck cancer (HNC). Patients planned for a course of external beam RT with curative intent for HNC were instructed to use a commercial fitness tracker throughout the RT course. During weekly clinic visits, physician-scored adverse events were recorded during using Common Terminology Criteria for Adverse Events version 4.0, and patients completed ePRO surveys using a clinic tablet or computer. Feasibility of activity monitoring was defined as collection of step data for at least 80% of the RT course for at least 80% of patients. Exploratory analyses described associations between step counts, ePROs, and clinical events. Twenty-nine patients with HNC were enrolled and had analyzable data. Overall, step data were recorded on 70% of the days during patients' RT courses, and there were only 11 patients (38%) for whom step data were collected on at least 80% of days during RT. Mixed effects linear regression models demonstrated declines in daily step counts and worsening of most PROs during RT. Cox proportional hazards models revealed a potential association between high daily step counts and both reduced risk of feeding tube placement (hazard ratio [HR], 0.87 per 1,000 steps, P < .001) and reduced risk of hospitalization (HR, 0.60 per 1,000 steps, P < .001). We did not achieve our feasibility end point, suggesting that rigorous workflows are required to achieve continuous activity monitoring during RT. Although limited by a modest sample size, our findings are consistent with previous reports indicating that wearable device data can help identify patients who are at risk for unplanned hospitalization.

Predictors for response to electronic patient-reported outcomes in routine care in patients with rheumatoid arthritis: a retrospective cohort study

Routine collection of electronic patient-reported outcomes (ePROs) can improve clinical care. However, a low response rate may counteract the benefits. To optimize adoption, the aim of this study was to investigate which patient factors and/or timing of the invitation predicted response to ePROs sent prior to consultations in patients with rheumatoid arthritis. We performed a retrospective database study with clinical data collected as part of usual care from the electronic medical records at Reade Amsterdam. The dataset comprised the email invitations to complete the ePRO sent prior to consultation. Multiple patient factors and factors defining the timing of the invitation were investigated if they predicted response to the ePRO through a multivariable logistic generalized estimating equation analysis. In total, 17.070 ePRO invitations were sent to 3194 patients (mean age 60 (SD 14), 74% female), of which 40% was completed. Patients between 55 and 73 years (OR 1.39, 95%CI 1.09–1.77) and with higher social economic status (SES) (OR 1.51, 95%CI 1.22–1.88) had significantly higher odds for completing the ePRO, while patients living in an urban area had lower odds (OR 0.69, 95% CI 0.62–0.76). In year 4 after implementation, the OR was increased to 3.69 (95% CI 2.91–4.90). The implementation of ePROs in daily clinical practice needs improvement since 40% of the ePROs sent prior to consultations were completed. Patients that had higher odds to report the next ePRO were between the age of 55–73, had a higher socio-economic status, and were residents in a rural area. The adoption of reporting the PRO increased over time, but the timing of the prompt did not predict response. Additional research is needed to understand ePRO completion, especially for patients with lower socio-economic status.

Real-World Evidence of Collecting Quality of Life (QoL) and Symptoms Perception Using the HM-PRO© Tool As a Patient-Reported Outcome Measure (PROM) in Patients with Lymphoma While Receiving Intravenous Chemotherapy

INTRODUCTION: Electronic collection of patient-reported outcomes (PROM) is becoming widespread in healthcare to objectively measure and collect the patient's subjective experience during their illness. The implementation in routine cancer care during treatment remains to be seen. More specifically, little is known about the use and success of electronic reporting during active cancer treatment in frail and older patients. HM-PRO© is a validated PROM tool developed by the European Hematology Association Specialized Working Group of QoL in patients with hematologic malignancies. OBJECTIVES: The primary end point was to analyze the adverse effects reported by patients when receiving intravenous chemotherapy treatment and its impact on the quality of life of patients over time through the HM-PRO© questionnaire. METHODS: Of the 200 patients included in the health outcomes assessment program, 90 patients with a diagnosis of lymphoma and with at least two completed questionnaires were collected during the period 2020-2022. The scores and answers to the HM-PRO© questionnaires were also gathered. HM-PRO© questionnaires were submitted electronically through the hospital patient portal prior to the start of treatment and subsequently at 3, 6, 12 months and 1 year after starting chemotherapy. The questionnaires included questions about eating habits, social life, mental health and personal emotional situation, physical condition and symptoms derived from the lymphoma itself and/or chemotherapy. The statistical analysis was performed using a generalized model with patient analysis of the time variable including the necessary confounding variables for each quality variable. Temporal autocorrelation with the AR1 function has been considered. RESULTS: Demographic data are shown in Table 1. Age at diagnosis did not influence any parameter except for physical status where we found significant differences (p=0.002, rho=0.1095), probably in relation to greater frailty in older patients. However, the side effects of treatment, and the symptoms associated with the disease were tolerated similarly regardless of age. In terms of gender differences, men were less affected in their eating & drinking habits. Men show a tendency to remain with less symptomatic burden during treatment. The involvements of the social and emotional spheres were similar in both sexes Symptoms related to the disease or treatment improved after 6 months (p<0.02) from the onset of chemotherapy. Physical condition improved significantly after one year (p=0.03) regardless of the lymphoma' stage and the comorbidities. The nutritional status of patients also improved after 12 months and was influenced by the stage of lymphoma, with better scores among patients with localized disease (p=0.02). At the social level, patients experienced a significant improvement after 6 months, especially those with localized stages and a lower score on the CIRS (Cumulative Illness Rating Scale) scale. This does not occur in the emotional sphere where it takes more than 12 months to observe a significant improvement (p=0.03). This was probably because mental health and psychological sequelae were more complex to deal with in the short term (Figure 1). CONCLUSIONS: Intravenous chemotherapy is not free of adverse events and may affect patients in very different ways; it is important to compile these side effects in order to help healthcare workers to provide a more individualized care. Older patients suffer a greater deterioration of their physical condition but their other spheres are no more affected than in the rest of the population. Geriatric assessment is fundamental and age alone should not be the only limiting factor in treating our patients. If we take into account the stage of the lymphoma, it significantly affects the social aspect and the eating habits of the patients. On the other hand, a higher score on the CIRS scale only correlates with a worse score on the social well-being. This indicates that a comprehensive approach to all spheres of the patient's life must turn now into a reality. The self-perception of symptoms due to lymphoma as well as the chemotherapy-related toxicity impact negatively in the quality of life of patients in a relevant way during the first year after diagnosis, improving significantly afterwards to their baseline situation. Intensive treatment does not indefinitely affect the quality of life of hematologic patients. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Reliability and Validity of Electronic Patient-Reported Outcomes Using the Smartphone App AllerSearch for Hay Fever: Prospective Observational Study.

BackgroundHay fever is a highly prevalent, heterogenous, and multifactorial disease. Patients may benefit from longitudinal assessments using mobile health (mHealth) principles. We have previously attempted to establish an effective mHealth platform for patients with hay fever through AllerSearch, our in-house smartphone app that assesses electronic patient-reported outcomes through a questionnaire on hay fever and provides evidence-based advice. To be used by the public, an investigation on its reliability and validity is necessary.ObjectiveThe aim of this paper is to assess the reliability and validity of subjective symptom data on hay fever collected through our app, AllerSearch.MethodsThis study used a prospective observational design. The participants were patients aged ≥20 years recruited from a single university hospital between June 2, 2021, and January 26, 2022. We excluded patients who could not use smartphones as well as those with incomplete data records and outlier data. All participants answered the Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire (JACQLQ), first in the paper-and-pencil format and subsequently on AllerSearch on the same day. The JACQLQ comprises the following three domains: Domain I, with 9 items on ocular or nasal symptoms; Domain II, with 17 items on daily activity and psychological well-being; and Domain III, with 3 items on overall condition by face score. The concordance rate of each domain between the 2 platforms was calculated. The internal consistency of Domains I and II of the 2 platforms was assessed using Cronbach alpha coefficients, the concurrent validity of Domains I and II was assessed by calculating Pearson correlation coefficients, and the mean differences between the 2 platforms were assessed using Bland-Altman analysis.ResultsIn total, 22 participants were recruited; the data of 20 (91%) participants were analyzed. The average age was 65.4 (SD 12.8) years, and 80% (16/20) of the participants were women. The concordance rate of Domains I, II, and III between the paper-based and app-based JACQLQ was 0.78, 0.85, and 0.90, respectively. The internal consistency of Domains I and II between the 2 platforms was satisfactory (Cronbach alpha of .964 and .919, respectively). Pearson correlation analysis yielded a significant positive correlation between Domains I and II across the 2 platforms (r=0.920 and r=0.968, respectively). The mean difference in Domains I and II between the 2 platforms was 3.35 units (95% limits of agreement: –6.51 to 13.2).ConclusionsOur findings indicate that AllerSearch is a valid and reliable tool for the collection of electronic patient-reported outcomes to assess hay fever, contributing to the advantages of the mHealth platform.

Implementing Electronic Patient-Reported Outcomes for Patients With New Oral Chemotherapy Prescriptions at an Academic Site and a Community Site.

Oral chemotherapy challenges providers' abilities to safely monitor patients' symptoms, adherence, and financial toxicity. COVID-19 has increased the urgency of caring for patients remotely. Collection of electronic patient-reported outcomes (ePROs) has demonstrated efficacy for patients on intravenous chemotherapy, but limited data support their use in oral chemotherapy. We undertook a pilot project to assess the feasibility of implementing an ePRO system for patients starting oral chemotherapy at our cancer center, which includes both an academic site and a community site. Patients initiating oral chemotherapy were asked to participate. A five-question tool was built in REDCap. Concerning responses triggered outreach within one business day. The primary outcome was time to first symptom assessment. For comparison, we used a historical cohort of patients who had been prescribed oral chemotherapies by providers in the same disease groups at the cancer center. Twenty-five of 62 (40%) patients completed ePRO assessments. Fifty historical charts were reviewed. Time to first symptom assessment was 7 days (IQR, 4-14 days) in the historical group compared with 3 days (IQR, 2-4 days) in the ePRO group. Time to clinical action was 14 days (7-35 days) in the historical group compared with 8 days (4-19 days) in the ePRO group. No statistically significant differences were detected in 30-day emergency department visit or hospitalization (12% for both groups) or 90-day emergency department visit or hospitalization rates (historical 28% and ePRO 20%). An ePRO tool monitoring patient concerns about adherence, cost, and toxicities for patients with new oral chemotherapy regimens is feasible and improves time to symptom assessment. Further investigation is needed to improve patient engagement with ePROs and evaluate the long-term impacts for patients on oral chemotherapy.

Feasibility and acceptability of electronic administration of patient reported outcomes using mHealth platform in emergency department patients with non-medical opioid use

BackgroundThe emergency department (ED) offers an important opportunity to identify patients with opioid use disorder (OUD) and initiate treatment. However, post-ED follow-up is challenging, and novel approaches to enhance care transitions are urgently needed. Outcomes following ED visits have traditionally focused on overdose, treatment engagement, and mortality with an absence of patient reported outcomes (PROs), for example patient ability to schedule follow-up OUD treatment appointments or pick up a prescription medication, that may better inform evaluation of treatment pathways and near-term outcomes after acute events. In the context of increasing novel secure mobile health (mHealth) platforms, we explored the feasibility and acceptability of electronically collecting PROs from ED patients with non-medical opioid use to enhance care in the ED and transitions of care.MethodsED patients with non-medical opioid use or opioid overdose who endorsed willingness and ability to complete electronic surveys after discharge were enrolled from a tertiary, urban academic ED. Participants were enrolled in an mHealth platform, shared electronic health records with researchers, and completed electronic surveys of PROs at baseline, three- and thirty-days post discharge from the hospital, including questions about ability to schedule a follow-up appointment, pick up a prescription medication and overdose risk behaviors. Primary outcomes were measures of feasibility and acceptability of electronic PRO collection among ED patients with non-medical opioid use.ResultsAmong 1,808 patients assessed for eligibility between June-December 2019, 101 of 130 (78%) eligible adult patients consented to participate. Ninety-six (95%) of 101 patients completed registration in the mHealth platform, and 77/96 (80%) were successful in sharing their electronic health data. Completion rates for the baseline, three-day and thirty-day surveys were 97% (93/96), 49% (47/96) and 42% (40/96). Implementation challenges included short engagement window during ED visit, limited access to smartphones/computers, insufficient battery life of participant phone to access email and password, forgotten emails and passwords, multi-step verification processes for account set-up, and complaints about hospital care, most of which were effectively addressed by study personnel.ConclusionsED patients with OUD were willing to share electronic health information and PROs, although implementation challenges were common, and more than half of participants were lost-to-follow-up after hospital discharge at 30 days. Efforts to streamline communication and remove barriers to engagement are needed to improve the collection of PROs and pathways of care in ED patients with OUD.Clinical Trial Registration ClinicalTrials.gov (NCT03985163). Date of Registration: June 10, 2019, Retrospectively registered (First enrollment June 8, 2019). https://clinicaltrials.gov/ct2/show/record/NCT03985163

Patient Reported Outcome Measure (PROM) Collection Rates When Part of Routine Clinical Workflow in an Academic Radiation Oncology Department

Patient reported outcome measures (PROMs) are tools, usually questionnaires, that measure patient reported outcomes (PROs), directly recording a patient's health status and symptoms without interpretation by clinicians. Use of PROs can improve patient survival, quality of life, and financial toxicity. The goal of this study was to assess the collection rate of PROs in our academic radiation oncology department since implementing an electronic PROs collection system as a part of routine clinical care in 2016. Our hypothesis was that we could collect PROs from a significant proportion of our patients using digital tools without significantly changing our clinical workflows.Patients were assigned cancer-specific PROMs by their clinicians, and could submit answers by using a tablet provided in clinic or by using our electronic health record (EHR)-associated patient portal on a computer or mobile device (tablet or phone). We analyzed the collection rate of PROs from adult patients who received care in our department between March 2016 and March 2020. A Chi-squared test was used to compare groups.In total, we requested 216,842 PROMs from 22,471 patients (43% male, 57% female) from 176,904 visits. We received 127,686 PROMs from 77,689 encounters (43.9%) where patients were assigned at least one questionnaire. Among the collected PROMs (where at least one question was answered), 72% were answered completely. The number of collected PROMs increased over time, and the completely answered rate also increased over time. Patients who were more likely to answer PROMs were female, white, married or had a civil union or life partner, lived in-state, spoke English, had completed fewer years of schooling, and had a work status of full time or not retired or disabled. Most surveys were collected using a tablet in clinic (94%) from patients with breast (33%), genitourinary (19%), or thoracic (14%) malignancies during on treatment visits (54%). All P-values for described patterns were < 0.001.PROs can be collected with relatively high rates from all patients in an academic radiation oncology department, though variations exist. This suggests that more radiation oncology clinics should try to incorporate PROs into routine patient care if they have sufficient resources. Implementation strategies should be shared among institutions, especially if they share EHR vendors.

The Effects of a Pandemic on Patient Engagement in a Patient-Reported Outcome Platform at Orthopaedic Sports Medicine Centers (106)

The Effects of a Pandemic on Patient Engagement in a Patient-Reported Outcome Platform at Orthopaedic Sports Medicine Centers (106)

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study

BackgroundDigital monitoring of treatment-related symptoms and self-reported patient outcomes is important for the quality of care among cancer patients. As mobile devices are ubiquitous nowadays, the collection of electronic patient-reported outcomes (ePROs) is gaining momentum. So far, data are lacking on the modalities that contribute to the quantity and quality of ePROs.ObjectiveThe objective of our study was to compare the utilization of two versions of a subsequently employed mobile app for electronic monitoring of PROs and to test our hypothesis that a shared review of symptoms in patient-physician collaboration has an impact on the number of data entries.MethodsThe Consilium Care app engages cancer patients to standardize reporting of well-being and treatment-related symptoms in outpatient settings. For descriptive comparison of the utilization of two slightly different app versions, data were obtained from an early breast cancer trial (version 1 of the app, n=86) and an ongoing study including patients with advanced disease (version 2 of the app, n=106). In both app versions, patients and doctors were allowed to share the information from data entries during consultations. Version 2 of the app, however, randomly selected symptoms that required a detailed and shared regular patient-doctor review in order to focus on the collection and appropriate interpretation regarding awareness and guidance for severity grading. The numbers and types of symptom entries, satisfaction with both app versions, and patients’ perceived effects during consultations were included for analysis.ResultsSymptom severity grading was performed according to the Common Terminology Criteria for Adverse Events (CTCAE) using a horizontal slider and was indicated in descriptive terminology in both apps, while a graphical display facilitated the illustration of symptom history charts. In total, 192 patients electronically reported 11,437 data entries on well-being and 33,380 data entries on individual symptoms. Overall, 628 (of 872 intended) requested patient-doctor symptom reviews were performed in version 2 of the app. Both the amount of data entries per patient and day for well-being (version 1 vs version 2: 0.3 vs 1.0; P<.001) and symptoms (version 1 vs version 2: 1.3 vs 1.9; P=.04) appeared significantly increased in version 2 of the app. Overall satisfaction with both app versions was high, although version 2 of the app was perceived to be more helpful in general.ConclusionsVersion 2 of the app showed much better results than version 1 of the app. A request for collaborative patient-doctor symptom review is likely to affect the number of digital symptom data entries. This app shows high potential to improve the patient-doctor experience.Trial RegistrationClinicalTrials.gov NCT02004496; https://clinicaltrials.gov/ct2/show/NCT02004496 and ClinicalTrials.gov NCT03578731; https://clinicaltrials.gov/ct2/show/NCT03578731

Electronic collection of patient-reported outcomes following discharge after surgery: systematic review.

BackgroundLittle is known about the electronic collection and clinical feedback of patient-reported outcomes (ePROs) following surgical discharge. This systematic review summarized the evidence on the collection and uses of electronic systems to collect PROs after discharge from hospital after surgery.MethodSystematic searches of MEDLINE, Embase, PsycINFO, CINAHL and Cochrane Central were undertaken from database inception to July 2019 using terms for ‘patient reported outcomes’, ‘electronic’, ‘surgery’ and ‘at home’. Primary research of all study designs was included if they used electronic systems to collect PRO data in adults after hospital discharge following surgery. Data were collected on the settings, patient groups and specialties, ePRO systems (including features and functions), PRO data collected, and integration with health records.ResultsFourteen studies were included from 9474 records, including two RCTs and six orthopaedic surgery studies. Most studies (9 of 14) used commercial ePRO systems. Six reported types of electronic device were used: tablets or other portable devices (3 studies), smartphones (2), combination of smartphones, tablets, portable devices and computers (1). Systems had limited features and functions such as real-time clinical feedback (6 studies) and messaging service for patients with care teams (3). No study described ePRO system integration with electronic health records to support clinical feedback.ConclusionThere is limited reporting of ePRO systems in the surgical literature, and ePRO systems lack integration with hospital clinical systems. Future research should describe the ePRO system and ePRO questionnaires used, and challenges encountered during the study, to support efficient upscaling of ePRO systems using tried and tested approaches.

Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer.

Head and neck (H&N) cancer patients experience significant acute side effects from treatment. This study evaluates prospectively collected patient-reported outcomes (PROs) in H&N patients undergoing radiotherapy (RT) to assess feasibility of electronically collecting PROs and to objectively document symptom acuity and trajectory during RT. H&N patients undergoing radical RT at our multicentre institution completed a 12-item partial survey of the Vanderbilt Head & Neck Symptom Survey 2.0 prior to RT and weekly on RT. Between October 2016 and October 2018, 318 of 333 patients completed a baseline survey and at least one weekly survey. The average number of weekly questionnaires completed was 5 (range 1-8). The mean maximum symptom scores were highest for dysgeusia (5.8/10), pain (5.4/10), mucositis (4.8/10), weight loss due to swallowing (4.5/10) and mucus causing choking/gagging (4.3/10). On multivariate analysis, female gender, sinonasal, nasopharynx and oropharynx primaries were associated with a greater risk of moderate-severe pain (p < 0.05). Sinonasal, nasopharynx, oral cavity, oropharynx and thyroid primaries were associated with a greater risk of moderate-severe mucositis during radiation (p < 0.0001). Salivary gland, sinonasal, nasopharynx and oropharynx primaries and higher radiation dose were associated with a greater risk of moderate-severe dysgeusia (all p < 0.05). Electronic PRO collection during H&N cancer RT is feasible. H&N cancer patients experience significant symptoms during RT, and the most severe symptoms reported were dysgeusia, pain and mucositis. Oropharynx cancer patients reported the highest symptom scores during RT.

Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation.

BackgroundPatient-reported outcomes (PROs) can be of great value for both research and chronic disease management. We developed a new module of the ANRS CO3 Aquitaine cohort study’s Web-based data capture and visualization solution (APPEGE 2.0) for the collection of electronic PROs among people living with HIV cared for in Nouvelle Aquitaine, France.ObjectiveThis study aimed to evaluate the usability of 2 successively developed prototypes of ARPEGE 2.0’s electronic PROs module before launching a pilot study, owing to the novelty of the proposed data collection method for our setting and specific characteristics of the target population.MethodsA total of 2 sequential rounds of empirical, task-based usability evaluations were conducted, involving 8 research staff and then 7 people living with HIV. Evaluators provided written feedback during round 1 and oral feedback during round 2. Evaluators who completed the full set of tasks responded to the System Usability Scale (SUS). We assessed changes in SUS scores between rounds and concluded usability testing when SUS scores reached a ceiling effect, defining good usability a priori as a usability score of 70.ResultsInsights were generated regarding the visibility of system status and the match between the system and the real world that improved the module’s usability. Research staff evaluators reported mean SUS scores of 65 (SD 18.87) and patient evaluators reported mean SUS scores of 85 (SD 5.4; P=.032).ConclusionsSoftware modifications, informed by successive rounds of usability testing, resulted in sufficient gains in usability to undertake piloting. Insights generated during evaluations prompted us to find the appropriate balance between optimal security and ease of use.Trial RegistrationClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202International Registered Report Identifier (IRRID)RR2-10.2196/10.2196/resprot.9439

Patient-reported outcomes in cancer care - hearing the patient voice at greater volume.

Recording of patient-reported outcomes (PROs) enables direct measurement of the experiences of patients with cancer. In the past decade, the use of PROs has become a prominent topic in health-care innovation; this trend highlights the role of the patient experience as a key measure of health-care quality. Historically, PROs were used solely in the context of research studies, but a growing body of literature supports the feasibility of electronic collection of PROs, yielding reliable data that are sometimes of better quality than clinician-reported data. The incorporation of electronic PRO (ePRO) assessments into standard health-care settings seems to improve the quality of care delivered to patients with cancer. Such efforts, however, have not been widely adopted, owing to the difficulties of integrating PRO-data collection into clinical workflows and electronic medical-record systems. The collection of ePRO data is expected to enhance the quality of care received by patients with cancer; however, for this approach to become routine practice, uniquely trained people, and appropriate policies and analytical solutions need to be implemented. In this Review, we discuss considerations regarding measurements of PROs, implementation challenges, as well as evidence of outcome improvements associated with the use of PROs, focusing on the centrality of PROs as part of 'big-data' initiatives in learning health-care systems.

From PRO screening to improved wellness: A nurse-led intervention.

72 Background: Emotional and physical distress in cancer patients is underreported and undertreated. In effort to address this, the Quality Oncology Practice Initiative (QOPI) requires patients to be screened for emotional well-being and pain by their second oncology visit. This project details one cancer center’s quality improvement initiative to: (1) utilize patient reported outcomes (PRO) screening to identify patient distress, (2) develop adaptive nurse-led algorithms to assess and intervene for unmet needs. Methods: In June 2015, we launched electronic collection of PROs using the Patient Reported Outcome Measurement Instrument System (PROMIS) global screen. Screening is completed via EMR patient portal prior to first return visit and 30-day intervals thereafter. A nurse-led algorithm categorizing distress was developed with evidence-based clinical pathways for care. Pathways optimize primary palliative care and referrals to specialist palliative services when appropriate. In August 2015, we will randomize four nurse navigators in gynecologic oncology to test the algorithm and make adaptations for scaling cancer center wide. We will assess the percent of patients screening positive for distress and the rate of primary palliative care interventions (e.g., symptom management and psychosocial support). We will also assess rate of referral to specialist palliative teams. Finally, we will interview a subset of patients to compare self-reported need, clinical management of needs, and whether needs were managed to the patient’s satisfaction. Results: We expect to report on adoption and adaptation of the algorithm for disease-specific groups. We will also report rates of primary palliative care interventions, referrals to specialist palliative care and PROs. Conclusions: Standard screening using PROs and clinical care pathways may foster early identification and management of patient’s psychosocial and physical needs. Support for oncology nurses to lead assessment and connect patients with resources is an opportunity to incorporate primary palliative care into oncology practice. The use of structured, adaptive, novel algorithms is a promising approach to meet patient needs and improve access to supportive resources.

The role of technical advances in the adoption and integration of patient-reported outcomes in clinical care.

Patient-reported outcomes (PROs) are gaining recognition as key measures for improving the quality of patient care in clinical care settings. Three factors have made the implementation of PROs in clinical care more feasible: increased use of modern measurement methods in PRO design and validation, rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations. As electronic PRO collection and reporting capabilities have improved, the challenges of collecting PRO data have changed. To update information on PRO adoption considerations in clinical care, highlighting electronic and technical advances with respect to measure selection, clinical workflow, data infrastructure, and outcomes reporting. Five practical case studies across diverse health care settings and patient populations are used to explore how implementation barriers were addressed to promote the successful integration of PRO collection into the clinical workflow. The case studies address selecting and reporting of relevant content, workflow integration, previsit screening, effective evaluation, and electronic health record integration. These case studies exemplify elements of well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. They also highlight emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems.

Strategies to use tablet computers for collection of electronic patient-reported outcomes.

BackgroundMobile devices are increasingly being used for data collection in research. However, many researchers do not have experience in collecting data electronically. Hence, the purpose of this short report was to identify issues that emerged in a study that incorporated electronic capture of patient-reported outcomes in clinical settings, and strategies used to address the issues.FindingsThe issues pertaining to electronic patient-reported outcome data collection were captured qualitatively during a study on use of electronic patient-reported outcomes in two home dialysis units. Fifty-six patients completed three surveys on tablet computers, including the Kidney Disease Quality of Life-36, the Edmonton Symptom Assessment Scale, and a satisfaction measure. Issues that arose throughout the research process were recorded during ethics reviews, implementation process, and data collection. Four core issues emerged including logistics of technology, security, institutional and financial support, and electronic design.ConclusionsAlthough use of mobile devices for data collection has many benefits, it also poses new challenges for researchers. Advance consideration of possible issues that emerge in the process, and strategies that can help address these issues, may prevent disruption and enhance validity of findings.

The rationale for collecting patient-reported symptoms during routine chemotherapy.

Patient-reported outcomes (PROs) such as symptoms and functional status are commonly measured in clinical trials. There is increasing interest to integrate PROs into routine clinical practice, for example during chemotherapy or postoperatively. There are several rationales for this. First, patient self-reporting improves patient-clinic communication, symptom detection, and symptom control. Second, patient-reported data may be used for quality assessment. Third, aggregated patient-reported data can be informative in comparative-effectiveness research (CER). Of particular interest is an approach that employs electronic collection of PROs with interfaces to the electronic health record (EHR) and clinician alerts for concerning symptoms. Multiple systems have been developed in oncology with these characteristics. Barriers to implementation exist, such as cost, logistics, EHR interfacing, data representation, and data interpretation, but have been largely overcome. Missing data remain a concern, but backup data collection strategies can bring self-report compliance rates up to about 85% in unselected routine care patients with advanced cancers. Overall, including patient self-reporting in routine care enhances quality of care and patient satisfaction, and is expected to become more common in the future. American Society for Clinical Oncology (ASCO) has several ongoing initiatives to develop standards and clinical practice tools in this area.