Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial

Girgis, Afaf; Durcinoska, Ivana; Arnold, Anthony; Descallar, Joseph; Kaadan, Nasreen; Koh, Eng‐Siew; Miller, Andrew; Ng, Wan; Carolan, Martin G; Della-Fiorentina, Stephen; Avery, Sandra; Delaney, Geoff P.

doi:10.2196/19685

Cited by 65 publications

(87 citation statements)

References 22 publications

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“…In these RCTs, clinical teams were alerted to patients reporting significant symptoms or a clinical deterioration. This enabled a real-time responsive service facilitating earlier intervention [2e4] and led to improvements in symptom control, a reduction in emergency department attendances and hospitalisation [2,3,5].…”

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confidence: 99%

The Routine Clinical Implementation of Electronic Patient-reported Outcome Measures (ePROMs) at The Christie NHS Foundation Trust

et al. 2021

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confidence: 99%

The Routine Clinical Implementation of Electronic Patient-reported Outcome Measures (ePROMs) at The Christie NHS Foundation Trust

et al. 2021

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“…37,38 The studies confirm better symptom control, reduced visits to emergency departments and even improved survival of patients with advanced cancers. 37,38 Those recent studies were performed in the USA, 36 Canada, 55 Australia 56 and France. 38 There is relatively limited experience of this approach in the UK, 57 particularly of investigating the integration of AE online reporting in electronic records and the addition of patient online self-reporting to the existing acute oncology patient care.…”

Section: The Need For Applied Health Researchmentioning

confidence: 99%

Electronic self-reporting of adverse events for patients undergoing cancer treatment: the eRAPID research programme including two RCTs

Velikova

Absolom

Hewison

et al. 2022

Programme Grants Appl Res

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Background Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events. Objectives The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. better adverse event control, improved patient safety and experiences)? Will eRAPID be cost-effective? Design Five mixed-methods work packages were conducted, incorporating co-design with patients and health-care professionals: work package 1 – development and implementation of the electronic platform across hospital centres; work package 2 – development of patient-reported adverse event items and advice (systematic and scoping reviews, patient interviews, Delphi exercise); work package 3 – mapping health-care professionals and care pathways; work package 4 – feasibility pilot studies to assess patient and clinician acceptability; and work package 5 – a single-centre randomised controlled trial of systemic treatment with a full health economic assessment. Setting The setting was three UK cancer centres (in Leeds, Manchester and Bristol). Participants The intervention was developed and evaluated with patients and clinicians. The systemic randomised controlled trial included 508 participants who were starting treatment for breast, colorectal or gynaecological cancer and 55 health-care professionals. The radiotherapy feasibility pilot recruited 167 patients undergoing treatment for pelvic cancers. The surgical feasibility pilot included 40 gastrointestinal cancer patients. Intervention eRAPID is an online system that allows patients to complete adverse event/symptom reports from home or hospital. The system provides immediate severity-graded advice based on clinical algorithms to guide self-management or hospital contact. Adverse event data are transferred to electronic patient records for review by clinical teams. Patients complete an online symptom report every week and whenever they experience symptoms. Main outcome measures In systemic treatment, the primary outcome was Functional Assessment of Cancer Therapy – General, Physical Well-Being score assessed at 6, 12 and 18 weeks (primary end point). Secondary outcomes included cost-effectiveness assessed through the comparison of health-care costs and quality-adjusted life-years. Patient self-efficacy was measured (using the Self-Efficacy for Managing Chronic Diseases 6-item Scale). The radiotherapy pilot studied feasibility (recruitment and attrition rates) and selection of outcome measures. The surgical pilot examined symptom report completeness, system actions, barriers to using eRAPID and technical performance. Results eRAPID was successfully developed and introduced across the treatments and centres. The systemic randomised controlled trial found no statistically significant effect of eRAPID on the primary end point at 18 weeks. There was a significant effect at 6 weeks (adjusted difference least square means 1.08, 95% confidence interval 0.12 to 2.05; p = 0.028) and 12 weeks (adjusted difference least square means 1.01, 95% confidence interval 0.05 to 1.98; p = 0.0395). No between-arm differences were found for admissions or calls/visits to acute oncology or chemotherapy delivery. Health economic analyses over 18 weeks indicated no statistically significant difference between the cost of the eRAPID information technology system and the cost of usual care (£12.28, 95% confidence interval –£1240.91 to £1167.69; p > 0.05). Mean differences were small, with eRAPID having a 55% probability of being cost-effective at the National Institute for Health and Care Excellence-recommended cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained. Patient self-efficacy was greater in the intervention arm (0.48, 95% confidence interval 0.13 to 0.83; p = 0.0073). Qualitative interviews indicated that many participants found eRAPID useful for support and guidance. Patient adherence to adverse-event symptom reporting was good (median compliance 72.2%). In the radiotherapy pilot, high levels of consent (73.2%) and low attrition rates (10%) were observed. Patient quality-of-life outcomes indicated a potential intervention benefit in chemoradiotherapy arms. In the surgical pilot, 40 out of 91 approached patients (44%) consented. Symptom report completion rates were high. Across the studies, clinician intervention engagement was varied. Both patient and staff feedback on the value of eRAPID was positive. Limitations The randomised controlled trial methodology led to small numbers of patients simultaneously using the intervention, thus reducing overall clinician exposure to and engagement with eRAPID. Furthermore, staff saw patients across both arms, introducing a contamination bias and potentially reducing the intervention effect. The health economic results were limited by numbers of missing data (e.g. for use of resources and EuroQol-5 Dimensions). Conclusions This research provides evidence that online symptom monitoring with inbuilt patient advice is acceptable to patients and clinical teams. Evidence of patient benefit was found, particularly during the early phases of treatment and in relation to self-efficacy. The findings will help improve the intervention and guide future trial designs. Future work Definitive trials in radiotherapy and surgical settings are suggested. Future research during systemic treatments could study self-report online interventions to replace elements of traditional follow-up care in the curative setting. Further research during modern targeted treatments (e.g. immunotherapy and small-molecule oral therapy) and in metastatic disease is recommended. Trial registration The systemic randomised controlled trial is registered as ISRCTN88520246. The radiotherapy trial is registered as ClinicalTrials.gov NCT02747264. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 1. See the NIHR Journals Library website for further project information.

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“…Recently, it has become possible to implement ePRO, a system that allows patients to report their symptoms electronically in real‐time using their smartphones or tablet devices. The usefulness of the ePRO system has been reported in several clinical studies that prospectively collected PRO data from patients with solid tumors 2‐6 . In addition, ePRO was found to be equally reliable as a tool for assessing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire‐C30 (EORTC QLQ‐C30) and Functional Assessment of Cancer Therapy‐Breast (FACT‐B), which are frequently used QOL in breast cancer clinical trials 7,8 .…”

Section: Introductionmentioning

confidence: 99%

“…The usefulness of the ePRO system has been reported in several clinical studies that prospectively collected PRO data from patients with solid tumors. [2][3][4][5][6] In addition, ePRO was found to be equally reliable as a tool for assessing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and Functional Assessment of Cancer Therapy-Breast (FACT-B), which are frequently used QOL in breast cancer clinical trials. 7,8 However, it is necessary to be proficient in operating ePRO-specific applications, which may be difficult, especially for the elderly who are not accustomed to handling digital devices.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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

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Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial

Cited by 65 publications

References 22 publications

The Routine Clinical Implementation of Electronic Patient-reported Outcome Measures (ePROMs) at The Christie NHS Foundation Trust

The Routine Clinical Implementation of Electronic Patient-reported Outcome Measures (ePROMs) at The Christie NHS Foundation Trust

Electronic self-reporting of adverse events for patients undergoing cancer treatment: the eRAPID research programme including two RCTs

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

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