PMID- 34160732
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210729
IS  - 2509-8020 (Electronic)
IS  - 2509-8020 (Linking)
VI  - 5
IP  - 1
DP  - 2021 Jun 23
TI  - Development of patient-reported outcomes item set to evaluate acute treatment 
      toxicity to pelvic online magnetic resonance-guided radiotherapy.
PG  - 47
LID - 10.1186/s41687-021-00326-w [doi]
LID - 47
AB  - 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.
FAU - Moller, P K
AU  - Moller PK
AUID- ORCID: 0000-0002-0761-8028
AD  - Department of Oncology, Odense University Hospital, AgeCare, Academy of Geriatric 
      Cancer Research, Odense University Hospital, Odense, Denmark. 
      Pia.Krause.Moeller@rsyd.dk.
AD  - Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 
      Pia.Krause.Moeller@rsyd.dk.
FAU - Pappot, H
AU  - Pappot H
AD  - Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, 
      Copenhagen, Denmark.
AD  - Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
FAU - Bernchou, U
AU  - Bernchou U
AD  - Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
AD  - Laboratory of Radiation Physics, Odense University Hospital, Odense, Denmark.
FAU - Schytte, T
AU  - Schytte T
AD  - Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
AD  - Department of Oncology, Odense University Hospital, Odense, Denmark.
FAU - Dieperink, K B
AU  - Dieperink KB
AD  - Department of Oncology, Odense University Hospital, AgeCare, Academy of Geriatric 
      Cancer Research, Odense University Hospital, Odense, Denmark.
AD  - Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
LA  - eng
GR  - NNF18OC0052974/Novo Nordisk Fonden/
GR  - WP7/Academy of Geriatric Cancer Research (AgeCare)/
PT  - Journal Article
DEP - 20210623
PL  - Germany
TA  - J Patient Rep Outcomes
JT  - Journal of patient-reported outcomes
JID - 101722688
EIN - J Patient Rep Outcomes. 2021 Jul 27;5(1):62. PMID: 34313870
PMC - PMC8220120
OTO - NOTNLM
OT  - Acute toxicity
OT  - Cancer
OT  - Item selection
OT  - MR-linac
OT  - Online MRgRT
OT  - PRO
OT  - Patient-reported outcomes
OT  - Pelvic
OT  - Radiotherapy
COIS- The authors declare that they have no competing interests.
EDAT- 2021/06/24 06:00
MHDA- 2021/06/24 06:01
PMCR- 2021/06/23
CRDT- 2021/06/23 12:34
PHST- 2021/01/29 00:00 [received]
PHST- 2021/06/10 00:00 [accepted]
PHST- 2021/06/23 12:34 [entrez]
PHST- 2021/06/24 06:00 [pubmed]
PHST- 2021/06/24 06:01 [medline]
PHST- 2021/06/23 00:00 [pmc-release]
AID - 10.1186/s41687-021-00326-w [pii]
AID - 326 [pii]
AID - 10.1186/s41687-021-00326-w [doi]
PST - epublish
SO  - J Patient Rep Outcomes. 2021 Jun 23;5(1):47. doi: 10.1186/s41687-021-00326-w.