The use of PRO in adverse event identification during cancer therapy – choosing the right questions to ask

Nissen, Aase; Bager, Louise; Pappot, Helle

doi:10.1080/0284186x.2018.1560496

Cited by 17 publications

(11 citation statements)

References 8 publications

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“…1 ). Methods used in the item selection process were inspired by systematic item selection as previously used [ 27 , 30 , 34 – 36 ]. A parallel mixed-methods approach was used to validate the content of the pelvic item set in phase 2 [ 37 ].…”

Section: Methodsmentioning

confidence: 99%

“…To capture the patient perspectives related to online MRgRT, it is important to ensure the right questions are asked. Questions reflecting relevant expected symptoms that are meaningful to the patients [ 26 , 27 ]. A systematic selection of symptomatic AEs tailors the PRO questionnaire to the right purpose, population and treatment [ 28 ].…”

Section: Introductionmentioning

confidence: 99%

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Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Møller

Pappot

Bernchou

et al. 2021

J Patient Rep Outcomes

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Background A new technology in cancer treatment, the MR-linac, provides online magnetic resonance-guided radiotherapy (MRgRT) that combines real-time visualization of the tumor and surrounding tissue with radiation therapy to deliver treatment more accurately. Online MRgRT makes it possible to minimize treatment volume, potentially reducing acute treatment toxicity. Patient-reported outcomes (PRO) add the patient perspective to evaluating treatment toxicity related to new technology. The objective of this mixed-methods study was to develop and explore the content validity of a set of PRO items to evaluate acute pelvic toxicity to radiotherapy including online MRgRT. Methods A literature review and chart audit were conducted to identify symptomatic adverse events (AEs) to be selected from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) library and European Organisation for Research and Treatment of Cancer (EORTC) item library. To validate the content, the item set was applied in a prospective pilot cohort of patients referred for primary pelvic RT with curative intent. Patients reported symptoms weekly during RT (4–8 weeks) and the subsequent 4 weeks. Follow-up reports were collected at 8, 12, and 24 weeks after RT. To ensure symptom coverage clinician-reported toxicity and individual patient interviews were conducted. The symptomatic AEs were included in the final item set if ≥20% of patients reported them. Results Eighteen acute symptomatic AEs were selected for the initial item set. Forty patients (32 prostate cancer, 8 cervical cancer) were included in the pilot study. Patients with prostate cancer and those with cervical cancer both reported all 18 acute AEs. However, vomiting was not reported by > 20% of patients thus excluded from the item set. Adding a few diagnosis-specific AEs to the final item set was required for both prostate and cervical cancer patients. Conclusions A PRO item set for patients with pelvic cancer treated with radiotherapy with a curative intent was developed and content validity explored. In the pilot study, the item set captured the most common acute symptomatic AEs for patients with prostate and cervical cancer related to pelvic RT including online MRgRT. Further validation of the content in broader disease sites would be needed in future studies.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Møller

Pappot

Bernchou

et al. 2021

J Patient Rep Outcomes

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“…The International Society of Quality of life (ISOQOL) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) PRO extension have provided key elements for the planning of PRO studies while the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoint Data (SISAQOL) Consortium has suggested international standards for analysis of QoL and PRO data in clinical trials which may assure that the impact of PRO in such studies is better aligned and not lost [9]. We have previously demonstrated, how questionnaires developed to cover the same diagnosis and treatment situation may differ, leaving the risk of losing the potential of PROs [11] and have along with others suggested a systematic approach to following these guidelines in the question of item selection [12][13][14][15]. These studies therefore highlight the need to adhere to the proposed guidelines to ensure systematic use of the patient's voice through PRO data.…”

Section: Editorialmentioning

confidence: 99%

Expectations to Patient-Reported Outcome (PRO) in Oncology – PRO for a purpose, when and how?

Pappot

Taarnhøj

2020

Acta Oncologica

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“…Regarding the use of the PRO-CTCAEä items to declare symptomatic adverse events, FDA recommends selecting a set of the most important symptomatic AEs that are expected to occur [17]. However, research on methods to select appropriate symptom-related PROs is still limited [18,19].…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study

Lopes

Colomer‐Lahiguera

Alfonso³

et al. 2021

European Journal of Cancer

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The use of PRO in adverse event identification during cancer therapy – choosing the right questions to ask

Cited by 17 publications

References 8 publications

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Development of patient-reported outcomes item set to evaluate acute treatment toxicity to pelvic online magnetic resonance-guided radiotherapy

Expectations to Patient-Reported Outcome (PRO) in Oncology – PRO for a purpose, when and how?

Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study

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