Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer

McCloskey, P.; Stones, Nicola; Bayman, N.; Burt, Paul A; Chittalia, A.; Harris, Maggie A; Lee, Lip W; Pemberton, L.; Sheikh, Hamid Y; Swindell, Ric; Faivre-Finn, Corinne

doi:10.1016/j.radonc.2014.07.008

Cited by 29 publications

(31 citation statements)

References 32 publications

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“…Seven such studies reported this as a general finding, with agreement statistics ranging from κ = 0.00 to r = 0.74 [14, 24, 27, 32, 34, 35]. Regardless of how pain was self-reported by patients (i.e., EuroQol EQ-5D or EORTC QLQ-C30), four independent studies reported moderate agreement between PRO and CTCAE ratings ( r range = 0.33–0.37; κ range = 0.16–0.29) [16, 17, 20, 26].…”

Section: Resultsmentioning

confidence: 84%

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Atkinson

Ryan

Bennett

et al. 2016

Support Care Cancer

287

177

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Purpose Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. Methods A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5,658 articles retrieved, 28 studies met inclusion criteria. Results Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had large variation across the majority of studies (n = 21). Conclusions The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

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Section: Resultsmentioning

confidence: 84%

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Atkinson

Ryan

Bennett

et al. 2016

Support Care Cancer

287

177

View full text Add to dashboard Cite

show abstract

“…The aim of health services is to increase health gain for patients in terms of both healthcare professional assessments of the presence, and severity, of a disease, and patient self-assessments of health. It is well known that these two assessments are not always consistent [1][2][3]. Therefore, outcomes within health services need to include both these dimensions; that is, clinical observations, laboratory measures and other examinations need to be combined with patients' own assessments of their perceived physical, mental and social well-being and functional ability.…”

Section: Patient-reported Outcomes and Outcome Measuresmentioning

confidence: 99%

Patient‐reported outcomes in the Swedish National Quality Registers

2015

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Patient-reported outcomes (PROs) are important in the healthcare system to gain understanding of patients' views on the effects of a treatment. There is an abundance of available patient-reported outcome measures (PROMs), both disease specific and generic. In the Swedish healthcare system, the national quality registers are obliged to incorporate PROs for certification at a high level. A review of the latest annual applications for funding (n = 108) shows that at present, 93 national quality registers include some form of PROM or patient-reported experience measure (PREM). Half of the registers include some type of generic measure, more than half include disease/symptom-specific measures, and around 40% include PREMs. Several different measures and combinations of measures are used, the most common of which are the EQ-5D, followed by the SF-36/RAND-36. About one-fifth of the registers report examples of how patient-reported data are used for local quality improvement. These examples include enhancing shared decision-making in clinical encounters (most common), as a basis for care plans, clinical decision aids and treatment guidelines, to improve the precision of indications for surgery (patient and healthcare professional assessments may differ), to monitor complications after the patient has left hospital and to improve patient information. In addition, funding applications reveal that most registers plan to extend their array of PROMs and PREMs in future, and to increase their use of patient-reported data as a basis for quality improvement.

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“…A lung questionnaire [18] was revised via consultation with REQUITE investigators. The previously developed and validated male pelvis questionnaire was used.…”

Section: Further Development Of Patient-reported Toxicity Questionnaimentioning

confidence: 99%

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

et al. 2014

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The worldwide number of cancer survivors within 5 years of diagnosis was estimated to be about 28.7 million in 2008 [1]. Many must cope with the long-term effects of treatment, which can affect health-related quality of life [2,3]. These issues need to be addressed in a systematic manner in order to enhance the participation of cancer survivors in society and reduce healthcare costs. Sideeffects and quality of life in long-term survivors after radiotherapy are not well researched and the data are rarely collected in a systematic manner in routine follow-up. Also, studies investigating side-effects can be difficult to compare because of the use of different toxicity reporting systems and a lack of pretreatment data, which is important to ensure that side-effects are related to radiotherapy rather than other underlying health problems [4]. Predictive models of radiotherapy toxicity require cross-centre validation for widespread clinical implementation [5]. Genetics is important, but no biomarker has been validated for clinical use. Predictive model research has the potential to not only improve quality of life, but also to increase survival, for example by using isotoxic strategies [6], and to decrease healthcare costs with a more rational use of expensive medical technology such as proton therapy [7]. The REQUITE ProjectREQUITE is funded by the European Union through its Seventh Framework Programme. The objectives of the project are to: (i) carry out a multicentre, cohort study collecting blood samples, epidemiology and treatment data, longitudinal side-effect and quality of life data (before and after treatment, years 1 and 2); (ii) produce a centralised database and biobank of DNA for 5300 patients; (iii) validate published biomarkers of radiosensitivity; (iv) validate clinical predictors of radiotherapy toxicity and incorporate biomarker data; (v) design interventional trials to reduce long-term side-effects; (vi) provide a resource for dissemination and exploitation to the radiotherapy community. The project focuses on cancers of the breast, lung and prostate.

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Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer

Cited by 29 publications

References 32 publications

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

Patient‐reported outcomes in the Swedish National Quality Registers

The REQUITE Project: Validating Predictive Models and Biomarkers of Radiotherapy Toxicity to Reduce Side-effects and Improve Quality of Life in Cancer Survivors

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