Determining the cut-off value for the Minimal Documentation System (MIDOS2) screening tool to initiate specialized palliative care based on patient's subjective need for palliative support and symptom burden in inpatients with advanced cancer.

PURPOSE: The Minimal Documentation System (MIDOS2) is recommended as a systematic screening tool for assessing symptom burden and patient needs in advanced cancer patients. Given the absence of an optimal weighting of individual symptoms and a corresponding cut-off value, this study aims to determine a threshold based on inpatient's subjective need for palliative support. Additionally, we investigate the correlation between symptom burden and subjective need for palliative support collected through a patient-reported outcome measure (PROM) with survival duration of less or more than one year. METHODS: Inpatients diagnosed with advanced solid cancer completed an electronic PROM, which included the MIDOS2 questionnaire among other tools. Differences in symptom burden were analysed between patients expressing subjective need for palliative support and those with survival of less or more than one year using ANOVA, Mann-Whitney-U Test, logistic regression, Pearson and Spearman correlation tests. Cut-off analyses were performed using a ROC curve. Youden-Index, sensitivity, and specificity measures were used as well. RESULTS: Between April 2020 and March 2021, 265 inpatients were included in the study. Using a ROC curve, the MIDOS2 analysis resulted in an Area under the curve (AUC) of 0.732, a corresponding cut-off value of eight points, a sensitivity of 76.36% and a specificity of 62.98% in assessing the subjective need for palliative support. The MIDOS2, with double weighting of the significant symptoms, showed a cut-off value of 14 points, achieving a sensitivity of 78.18% and a specificity of 72.38%. A total of 55 patients (20.8%) expressed a need for support from the palliative care team. This need was independent of the oncological tumour entity and increased among patients with a survival of less than one year. These patients reported significantly poorer physical (p < 0.001) or mental (p < 0.001) condition. Additionally, they reported higher intensities of pain (p = 0.002), depressive symptoms (p < 0.001), weakness (p < 0.001), anxiety (p < 0.001), and tiredness (p < 0.001). CONCLUSION: Using the established MIDOS2 cut-off value with an adjusted double weighting in our study, a large proportion of inpatients may be accurately referred to SPC based on their subjective need for palliative support. Additionally, subjective reports of poor general, mental, and physical condition, as well as pain, depressive symptoms, weakness, anxiety, and tiredness, increase the subjective need for palliative support, particularly in patients with a survival prognosis of less than one year.

Automation of ePROMs in radiation oncology and its impact on patient response and bias.

PURPOSE: This study evaluates the impact of integrating a novel, in-house developed electronic Patient-Reported Outcome Measures (ePROMs) tool with a commercial Oncology Information System (OIS) on patient response rates and potential biases in real-world data science applications. MATERIALS AND METHODS: We designed an ePROMs tool using the NodeJS web application framework, automatically sending e-mail questionnaires to patients based on their treatment schedules in the OIS. The tool is used across various treatment sites to collect PROMs data in a real-world setting. This research examined the effects of increasing automation levels on both recruitment and response rates, as well as potential biases across different patient cohorts. Automation was implemented in three escalating levels, from telephone reminders for missing reports to minimal intervention from study nurses. RESULTS: From August 2020 to December 2023, 1,944 patients participated in the PROMs study. Our findings indicate that automating the workflows substantially reduced the patient management workload. However, higher levels of automation led to lower response rates, particularly in collecting late-phase symptoms in breast and head-and-neck cancer cohorts. Additionally, email-based PROMs introduced an age bias when recruiting new patients for the ePROMs study. Nevertheless, age was not a significant predictor of early dropout or missing symptom reports among patients participating. Notably, increased automation was significantly correlated with lower response rates in breast (p = 0.026) and head-and-neck cancer patients (p < 0.001). CONCLUSION: Integrating ePROMs within the OIS can significantly reduce workload and personnel resources. However, this efficiency may compromise patient responses in certain groups. A balance must be achieved between workload, resource allocation, and the sensitivity needed to detect clinically significant effects. This may necessitate customized automation levels tailored to specific cancer groups, highlighting a fundamental trade-off between operational efficiency and data quality.

The advantages, disadvantages, threats, and opportunities of electronic patient-reported outcome systems in cancer: A systematic review.

Objective: Electronic patient-reported outcome (ePRO) systems hold promise for revolutionizing communication between cancer patients and healthcare providers across various care settings. This systematic review explores the multifaceted landscape of ePROs in cancer care, encompassing their advantages, disadvantages, potential risks, and opportunities for improvement. Methods: In our systematic review, we conducted a rigorous search in Scopus, Web of Science, and PubMed, employing comprehensive medical subject heading terms for ePRO and cancer, with no date limitations up to 2024. Studies were critically appraised and thematically analyzed based on inclusion and exclusion criteria, including considerations of advantages, disadvantages, opportunities, and threats. Findings: Analyzing 85 articles revealed 69 themes categorized into four key areas. Advantages (n = 14) were dominated by themes like "improved quality of life and care." Disadvantages (n = 26) included "limited access and technical issues." Security concerns and lack of technical skills were prominent threats (n = 10). Opportunities (n = 19) highlighted advancements in symptom management and potential solutions for technical challenges. Conclusion: This review emphasizes the crucial role of continuous exploration, integration, and innovation in ePRO systems for optimizing patient outcomes in cancer care. Beyond traditional clinical settings, ePROs hold promise for applications in survivorship, palliative care, and remote monitoring. By addressing existing limitations and capitalizing on opportunities, ePROs can empower patients, enhance communication, and ultimately improve care delivery across the entire cancer care spectrum.

Patient adherence and response time in electronic patient-reported outcomes: insights from three longitudinal clinical trials.

PURPOSE: Patient-reported outcome measures (PROMs) are used to collect data on disease symptoms in support of clinical trial endpoints. Clinical studies can last a year or more, and the patients' adherence and response time to daily at-home questionnaires may vary significantly over time. The aim of this study was to understand patterns and changes in patients' completion of daily PROMs during longitudinal clinical studies. METHODS: Data were collected from 1342 patients randomized into three respiratory clinical trials (NCT03401229, NCT03347279, and NCT03406078). PROMs were completed by patients using electronic handheld devices that collected the starting and completion times. A Bayesian generalized linear mixed-effects model was used to identify unbiased coefficients associated with PROM adherence and response time using patient, site, and calendar features as covariates. RESULTS: Adherence decreased over time after randomization, and the rate of decrease was higher in younger patients. The 14-day pre-randomization adherence was correlated with adherence throughout the study. Patients were also more adherent during working days compared to non-working days. Oldest patients took twice as long to complete PROMs throughout the study; however, the response time for all patients decreased during the first month of the study regardless of age. Response time increased 7 days before and after the date of a scheduled clinic visit and when a patient-reported higher symptom burden. CONCLUSION: Detailed analyses of adherence and response time for daily PROMs in clinical trials can provide significant insights about trends of patient behavior in longitudinal clinical studies with high baseline adherence.

Predictive Criterion Validity of the Parsley Symptom Index Against the Patient-Reported Outcomes Measurement Information System-10 in a Chronic Disease Cohort: Retrospective Cohort Study.

BACKGROUND: Approximately 60% of US adults live with chronic disease, imposing a significant burden on patients and the health care system. With the rise of telehealth, patient-reported outcomes measures (PROMs) have emerged as pivotal tools for managing chronic disease. While numerous PROMs exist, few have been designed explicitly for telehealth settings. The Parsley Symptom Index (PSI) is an electronic patient-reported outcome measure (ePROM) developed specifically for telehealth environments. OBJECTIVE: Our aim is to determine whether the PSI predicts changes in the established Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) Global Health, a 10-question short form. METHODS: We conducted a retrospective cohort study using data from 367 unique patients, amassing 1170 observations between August 30, 2017, and January 30, 2023. Patients completed the PSI and the PROMIS-10 multiple times throughout the study period. Using univariate regression models, we assess the predictive criterion validity of the PSI against PROMIS-10 scores. RESULTS: This study revealed significant relationships between the PSI and PROMIS-10 physical and mental health scores through comprehensive univariate analyses, thus establishing support for the criterion validity of the PSI. These analyses highlighted the PSI's potential as an insightful tool for understanding and predicting both mental and physical health dimensions. CONCLUSIONS: Our findings emphasize the importance of the PSI in capturing the nuanced interactions between symptomatology and health outcomes. These insights reinforce the value of the PSI in clinical contexts and support its potential as a versatile tool in both research and practice.

Acceptance of Digital Health Technologies in Palliative Care Patients.

Background: Digital health technologies have potential to transform palliative care (PC) services. The global aging population poses unique challenges for PC, which digital health technologies may help overcome. Evaluation of attitudes and perceptions combined with quantification of prior use habits favor an understanding of psychological barriers to PC patient acceptance of digital health technologies including artificial intelligence (AI). Objectives: We aimed to evaluate the attitudes and perceptions of PC patients regarding a broad range of digital health technologies used in their routine monitoring and treatment and identify barriers to use. Methods: We used a 39-item questionnaire to evaluate acceptance and use of smartphone-based electronic patient report outcome measures, wearables, AI, data privacy, and virtual reality (VR) in 29 female and male PC inpatients. Results: A majority of patients indicated an interest in (69.0%) and positive attitude toward (75.9%) digital health technologies. Nearly all (93.1%) patients believe that digital health technologies will become more important in medicine in the future. Most patients would consider using their smartphone (79.3%) or wearable (69.0%) more often for their health. The most feasible technologies were smartphones, wearables, and VR. Barriers to acceptance included unfamiliarity, data security, errors in data interpretation, and loss of personal interaction through AI. Conclusion: In this patient survey, acceptance of new technologies in a PC patient population was high, encouraging its use also at the end-of-life.

Assessing Patient-Reported Outcomes in Routine Cancer Clinical Care Using Electronic Administration and Telehealth Technologies: Realist Synthesis of Potential Mechanisms for Improving Health Outcomes.

BACKGROUND: The routine measurement of patient-reported outcomes in cancer clinical care using electronic patient-reported outcome measures (ePROMs) is gaining momentum worldwide. However, a deep understanding of the mechanisms underpinning ePROM interventions that could inform their optimal design to improve health outcomes is needed. OBJECTIVE: This study aims to identify the implicit mechanisms that underpin the effectiveness of ePROM interventions and develop program theories about how and when ePROM interventions improve health outcomes. METHODS: A realist synthesis of the literature about ePROM interventions in cancer clinical care was performed. A conceptual framework of ePROM interventions was constructed to define the scope of the review and frame the initial program theories. Literature searches of Ovid MEDLINE, Ovid Embase, Scopus, and CINAHL, supplemented by citation tracking, were performed to identify relevant literature to develop, refine, and test program theories. Quality appraisal of relevant studies was performed using the Mixed Methods Appraisal Tool. RESULTS: Overall, 61 studies were included in the realist synthesis: 15 (25%) mixed methods studies, 9 (15%) qualitative studies, 13 (21%) descriptive studies, 21 (34%) randomized controlled trials, and 3 (5%) quasi-experimental studies. In total, 3 initial program theories were developed regarding the salient components of ePROM interventions-remote self-reporting, real-time feedback to clinicians, and clinician-patient telecommunication. The refined theories posit that remote self-reporting enables patients to recognize and report symptoms accurately and empowers them to communicate these to clinicians, real-time feedback prompts clinicians to manage symptoms proactively, and clinician-patient telephone interactions and e-interactions between clinic encounters improve symptom management by reshaping how clinicians and patients communicate. However, the intervention may not achieve the intended benefit if ePROMs become a reminder to patients of their illness and are not meaningful to them and when real-time feedback to clinicians lacks relevance and increases the workload. CONCLUSIONS: The key to improving health outcomes through ePROM interventions is enabling better symptom reporting and communication through remote symptom self-reporting, promoting proactive management of symptoms through real-time clinician feedback, and facilitating clinician-patient interactions. Patient engagement with self-reporting and clinician engagement in responding to feedback are vital and may reinforce each other in improving outcomes. Effective ePROM interventions might fundamentally alter how clinicians and patients interact between clinic encounters.

Study protocol for a randomized, controlled, multicentre, pragmatic trial with Rehabkompassen®-a digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke.

BACKGROUND: Stroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients' rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease disability is largely lacking in current stroke care. The overall purpose of this study is to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen®, among persons discharged from acute care settings after a stroke. METHODS: This multicentre, parallel, open-label, two-arm pragmatic randomized controlled trial with an allocation ratio of 1:1 will be conducted in Sweden. A total of 1106 adult stroke patients will have follow-up visits in usual care settings at 3 and 12 months after stroke onset. At the 3-month follow-up, participants will have a usual outpatient visit without (control group, n = 553) or with (intervention group, n = 553) the Rehabkompassen® tool. All participants will receive the intervention at the 12-month follow-up visit. Feedback from the end-users (patient and health care practitioners) will be collected after the visits. The primary outcomes will be the patients' independence and social participation at the 12-month visits. Secondary outcomes will include end-users' satisfaction, barriers and facilitators for adopting the instrument, other stroke impacts, health-related quality of life and the cost-effectiveness of the instrument, calculated by incremental cost per quality-adjusted life year (QALY). DISCUSSION: The outcomes of this trial will inform clinical practice and health care policy on the role of the Rehabkompassen® digital follow-up tool in the post-acute continuum of care after stroke. TRIAL REGISTRATION: ClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023.

Are All Societies Ready for Digital Tools? Feasibility Study on the Use of Mobile Application in Polish Early Breast Cancer Patients Treated with Perioperative Chemotherapy.

BACKGROUND: The population of individuals affected by breast cancer is growing, and with advances in cancer treatment implemented into usual care, there is an urgent need to improve the recognition, monitoring and treatment of therapy-induced adverse effects. This study aims to explore the use of an in-app electronic questionnaire to assess and monitor chemotherapy-related symptoms in early breast cancer patients treated with perioperative chemotherapy. METHOD: Between December 2019 and June 2021, 72 female study participants used the mobile app Centrum Chorób Piersi UCK and completed an in-app questionnaire about the 14 most common chemotherapy-related symptoms. Replies including symptoms with a critical value triggered automatic email alerts to the nursing team. RESULTS: Acceptance of the study was higher among younger women and patients originating from rural areas, while possible digital exclusion among patients >60 years was observed during the enrolment process. A total of 55 participants completed the electronic questionnaire at least once and generated 553 responses with 1808 specific problems reported. Fatigue (n = 428) was the most common problem, and fever (n = 5) the least reported problem. A total of 21 participants triggered alerts with responses containing symptoms with critical value assessment (n = 89). Significant negative correlation was observed between the number of responses and time from the first chemotherapy administration; however, the number of responses was not determined by any sociodemographic or medical factors. Significant positive correlations were identified between the number of communicated problems and participants' age. The usage of our electronic symptom assessment questionnaire decreased substantially after the period of active encouragement during the study enrolment. CONCLUSIONS: Not all societies are ready for innovative eHealth solutions. Patients' age should be carefully considered when app-based interventions are introduced to usual cancer care. Additional support is suggested for older patients to improve their awareness and participation in eHealth interventions. More research involving older participants is needed to explore and address their particular needs and perspectives on eHealth solutions.

Digital solution in the follow-up of early breast cancer a randomized study.

BACKGROUND: After primary treatment, patients with early breast cancer (EBC) are followed-up for at least 5 years. At the Helsinki University Hospital (HUS) surveillance includes appointments at 1, 3 and 5 years, and between pre-planned visits a phone call service operated by a nurse practitioner for counseling about symptoms related to side-effects or potential recurrence. In 2015 HUS launched a digital solution for cancer patients. This study was designed to find out patient preference, Health related (HR) quality of life (QOL) and satisfaction with a digital solution compared to a phone call service during the first year of follow-up. MATERIAL AND METHODS: Patients with EBC were randomized at the final visit of radiotherapy to surveillance by phone calls or by the digital Noona solution during the first year outside pre-planned visits. After six months the groups were crossed over to the other arm. Primary endpoint was patient preference for either follow-up method among those who had contacted the study nurse at least once by both phone service and digital solution. RESULTS: Out of the 765 patients randomized, 142 had contacted the hospital with both methods and were eligible for inclusion in the analyses of the present study. Out of the 142 patients, 56 preferred phone calls, 43 the digital solution while 43 considered both modalities equal. Preference for the digital solution was higher among patients aged 65 or less. There were no differences in HR QoL or overall satisfaction between the modalities. However, the patients rated the timeliness of response better while using the digital solution. CONCLUSION: Of the patients 30% preferred the digital solution, 40% phone calls while 30% found them equal as the primary follow-up method for EBC during the first year outside pre-planned visits. There is a need to include also digital solutions in surveillance of EBC. CLINICALTRIALS.GOV IDENTIFIER: NCT04980989.

Acceptance of physical activity monitoring in cancer patients during radiotherapy, the GIROfit phase 2 pilot trial.

Background: In radiotherapy the timely identification of patients needing intervention and supportive care due to side effects is an important task especially in the outpatient setting. Activity trackers as an increasingly used lifestyle device may enable physicians to monitor patient's physical activity (PA) and to intervene early during the course of radiotherapy. Objective: The primary aim of this trial was to assess patient acceptance of PA monitoring in an outpatient setting and to correlate changes in PA with toxicity and changes in quality of life. Methods: Patients undergoing radio(chemo-)therapy with a curative intent were eligible to participate in this prospective pilot phase II trial. Patients were instructed to wear a commercially available activity tracker during the course of radiotherapy and four weeks afterwards. Quality of life (QoL) and fatigue was scored using the Functional assessment of Chronic Illness Therapy questionnaire. A linear regression was performed to determine baseline activity and changes in step counts during radiotherapy. Results: We included 23 patients in this trial. Two withdrew consent before the start of treatment, two patients were excluded after prophylactic feeding tube placement and prolonged recovery. Compliance in the remaining 19 patients was high, with availability of step-counts on 92% of the days. Baseline step counts were 6274 for breast cancer patients and 3621 for patients with other entities. Decreasing activity during radiotherapy coincided with the development of side effects and declines in quality of life. Conclusions: Activity trackers as tool to monitor PA during and after radiotherapy were accepted by a majority of the patients included in the current trial. Observed changes in PA correlated with patient reported side effects and QoL in some of the patients.

A narrative review of current evidence supporting the implementation of electronic patient-reported outcome measures in the management of chronic diseases.

An application of telemedicine of growing interest and relevance is the use of personal computers and mobile devices to collect patient-reported outcomes (PROs). PROs are self-reports of patients' health status without interpretation by anyone else. The tools developed to assess PROs are known as patient-reported outcomes measures (PROMs). The technological innovations that have led to an increased ownership of electronic devices have also facilitated the development of electronic PROMs (ePROMs). ePROMs are a conduit for telemedicine in the care of patients with chronic diseases. Various studies have demonstrated that the use of ePROMs in routine clinical practice is both acceptable and feasible with patients increasingly expressing a preference for an electronic mode of administration. There is increasing evidence that the use of electronic patient-reported outcome (ePROMs) could have significant impacts on outcomes valued by patients, healthcare providers and researchers. Whilst the development and implementation of these systems may be initially costly and resource-intensive, patient preferences and existing evidence to support their implementation suggests the need for continued research prioritisation in this area. This narrative review summarises and discusses evidence of the impact of ePROMs on clinical parameters and outcomes relevant to chronic diseases. We also explore recently published literature regarding issues that may influence the robust implementation of ePROMs for routine clinical practice.

Does scrolling affect measurement equivalence of electronic patient-reported outcome measures (ePROM)? Results of a quantitative equivalence study.

BACKGROUND: Scrolling is a perceived barrier in the use of bring your own device (BYOD) to capture electronic patient reported outcomes (ePROs). This study explored the impact of scrolling on the measurement equivalence of electronic patient-reported outcome measures (ePROMs) in the presence and absence of scrolling. METHODS: Adult participants with a chronic condition involving daily pain completed ePROMs on four devices with different scrolling properties: a large provisioned device not requiring scrolling; two provisioned devices requiring scrolling - one with a "smart-scrolling" feature that disabled the "next" button until all information was viewed, and a second without this feature; and BYOD with smart-scrolling. The ePROMs included were the SF-12, EQ-5D-5L, and three pain measures: a visual analogue scale, a numeric response scale and a Likert scale. Participants completed English or Spanish versions according to their first language. Associations between ePROM scores were assessed using intraclass correlation coefficients (ICCs), with lower bound of 95% confidence interval (CI) > 0.7 indicating comparability. RESULTS: One hundred fifteen English- or Spanish-speaking participants (21-75y) completed all four administrations. High associations between scrolling and non-scrolling were observed (ICCs: 0.71-0.96). The equivalence threshold was met for all but one SF-12 domain score (bodily pain; lower 95% CI: 0.65) and two EQ-5D-5L item scores (pain/discomfort, usual activities; lower 95% CI: 0.64/0.67). Age, language, and device size produced insignificant differences in scores. CONCLUSIONS: The measurement properties of PROMs are preserved even in the presence of scrolling on a handheld device. Further studies that assess scrolling impact over long-term, repeated use are recommended.

Validation of a Mobile Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form: An Observational Randomized Crossover Trial.

BACKGROUND: The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) questionnaire is an effective tool for evaluating shoulder joint function. The development and usage of a mobile version of the ASES questionnaire has the potential to save time, money, and effort. OBJECTIVE: The aim of this study is to assess the equivalence between the paper and mobile versions of the ASES questionnaire and their acceptability among patients. METHODS: The paper and mobile versions of the ASES questionnaire were used to evaluate the shoulder joint function of 50 patients with shoulder pain. This study included patients from the shoulder clinic of Sun Yat-sen Memorial Hospital. The intraclass correlation coefficient (ICC) and Bland-Altman method were used to evaluate the agreement (reliability) of the scores obtained by the two methods (paper versus mobile). RESULTS: Of the 50 patients recruited from March 2018 to May 2019, 46 (92%) completed the study. There was a high agreement between the paper and mobile versions of the ASES questionnaire (ICC=0.979, 95% CI 0.943-0.987; P<.001). The mean difference between the scores of the mobile and paper versions was 1.0, and only 1/46 (2%) had a difference greater than the minimal clinically important difference of 12 points. About 75% of patients preferred the mobile version to the paper version. CONCLUSIONS: Our study shows that the mobile version of the ASES questionnaire is comparable to the paper version, and has a higher patient preference. This could prove to be a useful tool for epidemiological studies and patient follow-up over longer periods of time.

Key methodological considerations for usability testing of electronic patient-reported outcome (ePRO) systems.

INTRODUCTION: Recent advances in information technology and improved access to the internet have led to a rapid increase in the adoption and ownership of electronic devices such as touch screen smartphones and tablet computers. This has also led to a renewed interest in the field of digital health also referred to as telehealth or electronic health (eHealth). There is now a drive to collect these PROs electronically using ePRO systems. METHOD: However, the user interfaces of ePRO systems need to be adequately assessed to ensure they are not only fit for purpose but also acceptable to patients who are the end users. Usability testing is a technique that involves the testing of systems, products or websites with participants drawn from the target population. Usability testing can assist ePRO developers in the evaluation of ePRO user interface. The complexity of ePRO systems; stage of development; metrics to measure; and the use of scenarios, moderators and appropriate sample sizes are key methodological issues to consider when planning usability tests. CONCLUSION: The findings from usability testing may facilitate the improvement of ePRO systems making them more usable and acceptable to end users. This may in turn improve the adoption of ePRO systems post-implementation. This article highlights the key methodological issues to consider and address when planning usability testing of ePRO systems.

Validation of the Electronic Version of the International Index of Erectile Function (IIEF-5 and IIEF-15): A Crossover Study.

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly used to measure patient's perspective of functional well-being, disease burden, treatment effectiveness, and clinical decision making. Electronic versions are increasingly feasible because of smartphone and tablet usage. However, validation of these electronic PROMs (ePROMs) is warranted for justified implementation. The International Index of Erectile Function (IIEF) 5 and 15 are widely used PROMs in urology to measure erectile dysfunction. Measurement reliability and validity testing of the IIEF ePROMs are essential before clinical application. OBJECTIVE: The aim of this study was to assess reliability and validity of an ePROM version of both IIEF-5 and 15. METHODS: This study included 179 patients from our urology outpatient clinic. It also had a randomized crossover design-participants completed either a paper and electronic IIEF-5 or 15 or twice completed an electronic version-with a 5-day delay. Internal consistency was assessed using Cronbach alpha and Spearman-Brown coefficient, test-retest reliability using the intraclass correlation coefficient (ICC), and convergent validity using the Pearson and Spearman correlation coefficient. RESULTS: A total of 122 participants completed the study. Internal consistency was excellent for the electronic IIEF-5 (ICC 0.902) and good to excellent for the domains of the IIEF-15 (ICC 0.962-0.834). Test-retest reliability was excellent for the IIEF-5 (ICC 0.924) and good to excellent for the domains of the IIEF-15 (ICC 0.950-0.778). Convergent validity was excellent for the IIEF-5 and IIEF-15, with a correlation of r=0.923 and r=0.951, respectively. CONCLUSIONS: We successfully introduced patient-acceptable ePROM versions of the IIEF-5 and IIEF-15. This study's results demonstrate that the ePROM versions of the IIEF-5 and IIEF-15 can be reliably implemented, as outcomes are reliable and in accordance with findings of the paper version. TRIAL REGISTRATION: ClinicalTrials.gov NCT03222388; https://clinicaltrials.gov/ct2/show/NCT03222388.

Patient and Clinician Perspectives on Electronic Patient-Reported Outcome Measures in the Management of Advanced CKD: A Qualitative Study.

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) can substantially affect patients' health-related quality of life. Electronic patient-reported outcome measures (ePROMs) may capture symptoms and health-related quality of life and assist in the management of CKD. This study explored patient and clinician views on the use of a renal ePROM system. STUDY DESIGN: Qualitative study. SETTING & PARTICIPANTS: 12 patients with stage 4 or 5 CKD (non-dialysis dependent); 22 clinicians (6 CKD community nurses, 1 clinical psychologist, 10 nephrologists, 3 specialist registrars, and 2 renal surgeons) in the United Kingdom. ANALYTICAL APPROACH: Semi-structured interviews and focus group discussion during which patients received paper versions of the Kidney Disease Quality of Life-36 and the Integrated Patient Outcome Scale-Renal to exemplify the type of content that could be included in an ePROM. Thematic analysis of interview transcripts. RESULTS: 4 themes were identified: (1) general opinions of PROMs, (2) potential benefits and applications of an ePROM system, (3) practical considerations for the implementation of ePROMs, and (4) concerns, barriers, and facilitators. Patients were willing to complete ePROMs on a regular basis as part of their care despite clinician concerns about patient burden. Patients assessed the questionnaires favorably. Clinicians suggested that the extent of adoption of renal ePROM systems in routine clinical settings should be based on evidence of significant impact on patient outcomes. Clinicians were concerned that an ePROM system may raise patient expectations to unrealistic levels and expose clinicians to the risk for litigation. Patients and clinicians identified potential benefits and highlighted issues and concerns that need to be addressed to ensure the successful implementation of the renal ePROM system. LIMITATIONS: Transferability of the findings may be limited because only English-speaking participants were recruited to the study. CONCLUSIONS: A renal ePROM system may play a supportive role in the routine clinical management of patients with advanced CKD if the concerns of clinicians and patients can be sufficiently addressed.

Development and usability testing of an electronic patient-reported outcome measure (ePROM) system for patients with advanced chronic kidney disease.

BACKGROUND: Chronic kidney disease (CKD) is a long-term medical condition associated with symptoms which may negatively impact on patients' health-related quality of life (HRQOL). Patient-reported outcome (PRO) measures or questionnaires may be used to capture symptoms/HRQOL experienced by patients with advanced CKD. METHOD: Two PRO questionnaires were electronically adapted and incorporated in an electronic system developed at University Hospitals Birmingham NHS Foundation Trust (UHB), Birmingham. Usability testing was conducted with patients with advanced CKD. Qualitative methodology was used to elicit participants' views. RESULTS: Participants had a mean age of 64.3 years (range: 36-87 years). All owned electronic devices and had access to the internet. The mean time required to complete the two electronic questionnaires was 15.9 min (range = 8-34 min). Patients who had difficulties with the system were those who had the least experience of using the internet and electronic devices. The average usability and satisfaction score was 4.6 (5-point scale). CONCLUSIONS: Our study suggests that individuals with advanced CKD may find the Renal ePROM system acceptable and easy to use. The use of the Renal ePROM may complement clinician-reported outcomes and assist with the management of patients with advanced CKD.