Clinical Relevance of Routine Monitoring of Patient-reported Outcomes <i>Versus</i> Clinician-reported Outcomes in Oncology

Fiteni, Frédéric; Cuenant, Alice; Favier, M; Cousin, Christelle; Houédé, Nadine

doi:10.21873/invivo.11433

Cited by 10 publications

(14 citation statements)

References 15 publications

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“…These numbers indicate that technology was a barrier when trying to recruit older/computer-naive patients to our RCT. This result is in line with Fiteni et al, who argue that patients who are computer-naive may be excluded from this kind of intervention [ 20 ]. These patients may also be the ones who would benefit the most from the intervention because they may be less likely to contact the hospital unscheduled.…”

Section: Discussionsupporting

confidence: 90%

“…If patients become engaged in the reporting of symptoms on a more frequent basis, there is a presumption that AEs are discovered at an earlier time-point, enabling relevant treatment to be initiated and thereby avoiding major complications [ 16 ]. Studies suggest that using patient-reported outcomes (PROs) may result in improved communication, early relapse detection, optimized symptom monitoring, improved survival, and better quality of life (QoL) [ 17 – 19 ], particularly by the use of electronic devices [ 20 ]. However, it has not been examined if PROs in relation to symptom management for melanoma patients treated with immunotherapy may lead to earlier detection of symptoms resulting in a reduction in the number of severe AEs.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

Tolstrup

Bastholt

Dieperink

et al. 2020

J Patient Rep Outcomes

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Background A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. Patients and methods Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. Results One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156). Conclusion It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. Trial registration Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

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Section: Discussionsupporting

confidence: 90%

Section: Introductionmentioning

confidence: 99%

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

Tolstrup

Bastholt

Dieperink

et al. 2020

J Patient Rep Outcomes

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“…For years, clinicians only focussed on traditional oncological outcomes, such as mortality and morbidity, in order to evaluate treatment effectiveness [ 2 ]. While survival and detection of recurrence are still the main pillars of cancer care follow-up, monitoring patient-centred outcomes, such as health-related quality of life (HRQoL), independence or fatigue, is now an accepted component of follow-up care [ 3 ]. This shift is also reflected in several oncological outcome sets of International Consortium of Health Outcomes Measurement (ICHOM) [ 4 – 6 ].…”

Section: Introductionmentioning

confidence: 99%

Patient outcomes, patient experiences and process indicators associated with the routine use of patient-reported outcome measures (PROMs) in cancer care: a systematic review

Graupner

Kimman

Mul

et al. 2020

Support Care Cancer

106

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Purpose In current cancer care, there is a growing debate about the value of using patient-reported outcome measures (PROMs) in daily clinical follow-up. A systematic review of the literature was conducted to assess the evidence of the effectiveness of the routine use of PROMs in daily cancer care in terms of patient outcomes, patient experiences and process indicators and to identify the effect of giving feedback about PROM findings to patients and/or health care professionals (HCPs). Methods A systematic search was performed. Studies were eligible for inclusion when they (1) used a PROM as an intervention, with or without feedback to patients and/or HCPs, compared with not using a PROM, and (2) used a PROM as an intervention with feedback to patients and/or HCPs, compared with using a PROM without giving feedback to patients and/or HCPs. Results After screening of 8341 references, 22 original studies met the inclusion criteria. Most studies found a positive effect on survival, symptoms, HRQoL and patient satisfaction. In general, using feedback to patient and/or HCPs about the PROM results led to better symptom control, HRQoL, patient satisfaction and patient-doctor communication. The majority of included studies had insufficient power to detect significant differences in the outcomes assessed. Conclusion This review shows that predominantly positive findings were found in the use of a PROM in daily cancer care. Additionally, more positive effects were seen when feedback is provided to patient and/or health care professionals, and it is thus highly recommended that this is always done.

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“…Novel therapies with new modes of activity, such as targeted agents and immunotherapy, are increasingly complex and have unknown toxicity profiles that require monitoring during trials. 1,2 In phase I trials (first-in-humans), the dose is gradually increased and safety, side effects, best dose, and timing are explored. 3 In phase II, early evaluation of efficacy is undertaken but safety and side effects are still explored.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff

et al. 2020

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Background/aims New classes of cancer drugs bring a range of unknown and undesirable adverse events. Adverse event monitoring is essential in phase I trials to assess toxicity and safety. In phase II, the focus is also on efficacy but robust data on adverse events continue to inform the safety and the adverse event profile. Standard, clinician-led monitoring has been shown to underestimate patients’ symptoms. Hence, patient-reported adverse event monitoring has been argued to complement and improve the information on adverse events in early phase clinical trials. With advances in information technology, real-time patient self-reported adverse events in trials are feasible. This study explored the experiences and procedures for reporting adverse events in early phase trials among patients, clinical staff, and trial staff, and their views on using an electronic patient-reported outcome adverse event system in this setting. Methods Qualitative interviews were conducted with patients, purposively sampled across ages, gender, and different phases of trials, and with clinical and trial-related staff involved in early phase trials (e.g. consultants, research nurses, hospital-based trial assistants/data managers, trial unit management staff). Interviews explored patient experiences and views on current adverse event reporting processes and electronic patient-reported outcome adverse event reporting. Framework analysis techniques were used to analyse the data. Results Interviewees were from two hospital trusts with early phase portfolios in England and a trial unit, and included sixteen patients, five consultants, four research nurses, five hospital-based trial staff, and two trial unit staff. Interviews identified three key themes (patient experiences, data flow, and views on electronic patient-reported outcome adverse event reporting). Stakeholders emphasised the intensity of trials for patients and the importance of extensive information provision within the uncertainty of early phase trial drugs. Regular face-to-face appointments for patients supplemented by telephone contact aimed to capture any adverse events. Delayed or under-reporting of mild- or low-severity symptoms was evident among patients. Hospital-based staff highlighted the challenges of current data collection including intense timescales, monitoring by trial sponsors, and high workload. Positive views on electronic patient-reported outcome adverse events highlighted that this could provide a more comprehensive and accurate view on the side effects of new drugs. Clinical staff emphasised patient safety and the need for clear responsibilities for monitoring. The need for careful decision-making about data flow and symptom attribution was highlighted; with trial unit staff emphasising the need for clinician review. Conclusion Technology advances mean it is timely to explore the benefits and challenges of electronic patient-reported outcome adverse event reporting. This is a complex area warranting further consideration within the trial community. We have developed an online patient self-reporting tool and a small pilot with early phase trial patients is underway.

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Clinical Relevance of Routine Monitoring of Patient-reported Outcomes Versus Clinician-reported Outcomes in Oncology

Cited by 10 publications

References 15 publications

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial

Patient outcomes, patient experiences and process indicators associated with the routine use of patient-reported outcome measures (PROMs) in cancer care: a systematic review

Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff

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