How Can We Evaluate the Electronic Patient-Reported Outcome Appropriately?

Shojima, Hikaru; Shimomura, Akihiko; Kadowaki, M; Kawamura, Yukino; Shimizu, Chikako

doi:10.1200/jco.21.00482

Cited by 3 publications

(4 citation statements)

References 5 publications

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“…In addition, the questionnaire to monitor symptoms was specifically designed for melanoma patients receiving CPI(s) [ 21 ], precisely assessing the toxicities they may experience as recommended by Kluetz et al [ 35 ]. Shojima et al [ 36 ] also argue that AEs vary across treatment regimens, making it difficult to evaluate them. In our study, all patients had melanoma and were treated with drugs with the same toxicity profile, substantial strengths in studying AEs among patients with cancer.…”

Section: Discussionmentioning

confidence: 99%

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

Tolstrup

Pappot

Bastholt

et al. 2022

J Patient Rep Outcomes

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Introduction In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. Methods The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. Results There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. Conclusion Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients’ HRQoL. Trial registration: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registeredhttps://clinicaltrials.gov/.

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Section: Discussionmentioning

confidence: 99%

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

Tolstrup

Pappot

Bastholt

et al. 2022

J Patient Rep Outcomes

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“…Data management is a tremendous challenge, but the advent of digital transformation may lead to the disruption of current practices and will revolutionize healthcare in the decade to come. There is still an ongoing debate on whether PROMs are being assessed on paper versus electronically; although, it has been shown that the latter far exceeds the potential disadvantages, and manual analysis of paper PROMs is not affordable anymore given the current overall labor shortage [ 9 , 54 , 55 , 56 ].…”

Section: Interoperable Digital Platform: Data Assessment and Analysismentioning

confidence: 99%

The Sarcoma-Specific Instrument to Longitudinally Assess Health-Related Outcomes of the Routine Care Cycle

et al. 2023

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Patient-based health related quality of life (HRQoL) measurements are associated with an improvement in quality of care and outcomes. For a complex disease such as sarcoma, there is no disease-specific questionnaire available which covers all clinically relevant dimensions. Herein, we report on the development of an electronically implemented, sarcoma-specific instrument to assess health-related outcomes, which encompasses a combination of generic questionnaires tailored to the respective disease and treatment status covering the entire longitudinal care cycle. An interoperable digital platform was designed to provide a node between patients and physicians and to integrate the sarcoma-specific HRQoL instrument with patient and physician-based quality indicators to allow longitudinal structured real-world-time data evidence analytics. This approach enables the prediction modeling of disease, and by attributing cost tags to quality indicators, treatment effectiveness for a given disease will be directly correlated with financial expenses, which may ultimately lead to a more sustainable healthcare system.

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“…Shojima et al 1 have provided comments and questions on our recent publication, 2 where we demonstrated that an electronic patient-reported outcome–based intervention, called eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (online patient reporting of disease- and treatment-related symptoms during chemotherapy, supplemented by an immediate severity-tailored patient advice) improved patient physical well-being early during the course of treatment (6 and 12 weeks) in a mixed population of 508 patients with cancer. The impact was in patients treated with curative intent (two thirds of the sample) and in those experiencing mild to moderate symptoms.…”

mentioning

confidence: 99%

“…Shojima et al 1 expressed concerns over the variability of the patient population (early and metastatic disease; breast, colorectal, and gynecologic cancers; types and duration of chemotherapy; and duration of adverse events beyond 18 weeks of the trial). These are valid points and have been considered carefully during the design of eRAPID intervention and the randomized trial.…”

mentioning

confidence: 99%

Reply to H. Shojima et al

Absolom

Warrington

Hudson

et al. 2021

JCO

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Shojima et al 1 have provided comments and questions on our recent publication, 2 where we demonstrated that an electronic patient-reported outcome-based intervention, called eRAPID electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (online patient reporting of disease-and treatment-related symptoms during chemotherapy, supplemented by an immediate severity-tailored patient advice) improved patient physical well-being early during the course of treatment (6 and 12 weeks) in a mixed population of 508 patients with cancer. The impact was in patients treated with curative intent (two thirds of the sample) and in those experiencing mild to moderate symptoms. Patients also reported better selfefficacy in symptom management.

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How Can We Evaluate the Electronic Patient-Reported Outcome Appropriately?

Cited by 3 publications

References 5 publications

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

Impact of patient-reported outcomes on symptom monitoring during treatment with checkpoint inhibitors: health-related quality of life among melanoma patients in a randomized controlled trial

The Sarcoma-Specific Instrument to Longitudinally Assess Health-Related Outcomes of the Routine Care Cycle

Reply to H. Shojima et al

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