Evidence map›Paper›PMID 30157890›Full record

Trial reportRadiation oncology (London, England)2018

International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study.

Georgia K B Halkett, Charles Adam Wigley, Samar M Aoun, Maurizio Portaluri, Francesco Tramacere, Lorenzo Livi, Beatrice Detti, Stefano Arcangeli, Jo-Asmund Lund, Are Kristensen and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IVMulticenter StudyValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiation oncology (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05880446 (PROstate CAncer Radiotherapy), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05880446 nacompletednot on this mapstarted 2023, after this paper: background citation

PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.

TypeinterventionalSponsorJules Bordet InstituteRan2023 to 2024Enrolled41ConditionsProstate Cancer, Radiotherapy Side Effect, Bowel Dysfunction, Quality of LifeArmsBowel symptoms & QoL assessment
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Georgia K B HalkettSchool of Nursing, Midwifery and Paramedicine, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia. g.halkett@curtin.edu.au.ORCID http://orcid.org/0000-0003-4065-4044
Charles Adam WigleyInstitute for Health Research, University of Notre Dame, Perth, Western Australia.
Samar M AounInstitute for Health Research, University of Notre Dame, Perth, Western Australia.
Maurizio PortaluriRadiation Oncology Dept. "A. Perrino" General Hospital, ASL Brindisi, Italy.
Francesco TramacereRadiation Oncology Dept. "A. Perrino" General Hospital, ASL Brindisi, Italy.
Lorenzo LiviUniversity of Florence, Florence, Italy.
Beatrice DettiUniversity of Florence, Florence, Italy.
Stefano ArcangeliSan Camillo and Forlanini Hospitals, Rome, Italy.
Jo-Asmund LundCancer Clinic, St. Olavs University Hospital, Trondheim, Norway.
Are KristensenCancer Clinic, St. Olavs University Hospital, Trondheim, Norway.
Nathalie McFaddenCentre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.
Arne GrunCharité - University Medicine, Berlin, Germany.
Sean BydderDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia.
Irina SackererDepartment of Radiation Oncology, Technical University of Munich, Munich, Germany.
Elfriede GreimelMedical University Graz, Graz, Austria.
Nigel SpryDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia.
EORTC Quality of Life Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy.

methodsPatients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module's scale structure was examined and validated using standard psychometric analysis techniques.

resultsThree items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3-0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities.

conclusionThe EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability.

trial registrationAustralian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224 .

Indexed as

Health Care SurveysQuality of LifeAdultAgedAged, 80 and overAustraliaCross-Cultural ComparisonFactor Analysis, StatisticalFemaleHumansMaleMiddle AgedProctitisPsychometricsRadiation InjuriesReproducibility of Results

Identifiers

PMID30157890
PMCPMC6116442

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.