Evidence map›Paper›PMID 30406289›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2019

Patient- versus physician-reported outcomes in prostate cancer patients receiving hypofractionated radiotherapy within a randomized controlled trial.

Elke Rammant, Piet Ost, Martijn Swimberghe, Barbara Vanderstraeten, Nicolaas Lumen, Karel Decaestecker, Renée Bultijnck, Gert De Meerleer, Camille Sarrazyn, Roos Colman and 1 more

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  16. Patient-Reported Outcome Measures in Liver and Gastrointestinal Cancer Randomized Controlled Trials.International journal of environmental research and public health · 2023
    Review
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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

11 authors.

Elke RammantDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium. elke.rammant@uzgent.be.ORCID http://orcid.org/0000-0001-6130-2502
Piet OstDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium.
Martijn SwimbergheDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium.
Barbara VanderstraetenDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium.
Nicolaas LumenDepartment of Urology, Ghent University Hospital, Ghent, Belgium.
Karel DecaesteckerDepartment of Urology, Ghent University Hospital, Ghent, Belgium.
Renée BultijnckDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium.
Gert De MeerleerDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium.
Camille SarrazynDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium.
Roos ColmanDepartment of Public Health, Ghent University, Ghent, Belgium.
Valérie FonteyneDepartment of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe risk of developing acute radiotherapy(RT)-induced side effects may increase with hypofractionated RT. To detect treatment-related side effects, patient-reported outcomes (PROs) might be more reliable than physician-reported outcomes. Therefore, we tried to evaluate the rate of agreement between urinary and gastrointestinal (GI) side effects and the prevalence of side effects reported by patients and by physicians.

methodsData from a randomized controlled trial (RCT) comparing two hypofractionated RT schedules were used. Urinary (nocturia, incontinence, frequency, dysuria, and urgency) and GI (obstruction, diarrhea, vomiting, nausea, bloating, hemorragia, and incontinence) symptoms measured by the EORTC QLQ-C30 and PR-25 were used for PROs. The same symptoms were scored by the physician using the Common Terminology Criteria Adverse Events v4.0. Outcomes were reported at baseline, end of treatment, month 1, and month 3. PROs and physician-reported outcomes were converted in two categories (0 = no symptoms; 1 = symptoms of any severity) and were correlated using the kappa (κ) correlation statistics. Values below 0.40 were considered low agreement. In addition, the prevalence of symptoms was calculated.

resultsData from 160 patients were used. The mean value for Cohen's κ was 0.31 (ranging between 0.04 and 0.55) and 0.23 (ranging between 0.04 and 0.47) for urinary and GI symptoms, respectively. Except for three symptoms at baseline, all symptoms reported by patients were higher than those reported by physicians.

conclusionThere is low agreement between symptoms reported by patients and physicians, with high rates of underreporting by the physician.

Indexed as

Attitude of Health PersonnelPatient SatisfactionRadiation Dose HypofractionationAgedGastrointestinal TractHumansMaleMiddle AgedPrevalenceProspective StudiesProstatic NeoplasmsQuality of LifeRadiation InjuriesReproducibility of ResultsRiskTreatment OutcomePatient-reported outcomesProstate cancerQuality of lifeRadiotherapyUrinary and gastrointestinal toxicity

Identifiers

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Registered trials

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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.