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

Patienten- versus arztberichtete Ergebnisse von Prostatakrebspatienten nach hypofraktionierter Radiotherapie innerhalb einer randomisierten kontrollierten Studie

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Abstract

Purpose

The 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.

Methods

Data 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.

Results

Data 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.

Conclusion

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

Zusammenfassung

Zielsetzung

Das Risiko des Entstehens von akuten Strahlentherapie(RT)-induzierten Nebenwirkungen erhöht sich bei hypofraktionierter Bestrahlung. Um behandlungsbedingte Nebenwirkungen aufzudecken, könnten von Patienten berichtete Ergebnisse (PRO) verlässlicher sein als die vom Arzt. Wir wollen daher die Übereinstimmungsrate zwischen Harnwegsnebenwirkungen und gastrointestinalen (GI) Nebenwirkungen und der Prävalenz der von Patienten und Ärzten berichteten Nebenwirkungen beurteilen.

Methoden

Verwendet wurden Daten aus einer randomisierten, kontrollierten Studie (RCT), in der zwei hypofraktionierte Bestrahlungsschemata verglichen wurden. Für die Beurteilung der PRO wurden Harnwegs- (Nykturie, Inkontinenz, häufiges Wasserlassen, Dysurie und Harndrang) und GI-Symptome (Verstopfung, Durchfall, Erbrechen, Übelkeit, Blähungen, Blutungen und Stuhlinkontinenz) anhand der QLQ-C30- und PR-25-Fragebögen der EORTC (European Organisation for Research and Treatment of Cancer) gemessen. Die gleichen Symptome wurden vom Arzt anhand des Common Terminology Criteria Adverse Events v4.0 bewertet. Die Ergebnisse wurden bei Baseline, Behandlungsende und nach Monat 1 und Monat 3 berichtet. PRO und vom Arzt berichtete Ergebnisse wurden in zwei Kategorien überführt (0 = keine Symptome, 1 = Symptome jeglicher Schwere) und mithilfe der Kappa(κ)-Statistik nach Cohen miteinander korreliert. Werte von weniger als 0,40 wurden als geringe Übereinstimmung angesehen. Außerdem wurde die Prävalenz der Symptome berechnet.

Ergebnisse

Verwendet wurden Daten von 160 Patienten. Der mittlere Cohen-κ-Wert betrug 0,31 (bei Werten zwischen 0,04 und 0,55) für Harnwegssymptome und 0,23 (bei Werten zwischen 0,04 und 0,47) für GI-Symptome. Mit Ausnahme von drei Symptomen bei Baseline waren alle patientenberichteten Symptome höher bewertet als die der Ärzte.

Schlussfolgerung

Zwischen den von Patienten und von Ärzten berichteten Symptomen besteht eine geringe Übereinstimmung, mit hohen Untererfassungsraten („underreporting“) durch die Ärzte.

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Funding

The present study was supported in part by a grant from Stichting tegen kanker, a nonprofit organization. The funders did not have access to the raw data and had no role in the study design, data collection, data analysis or interpretation, or writing of the report. V. Fonteyne is a post-doctorate clinical specialist funded by the Belgian Foundation against Cancer. R. Bultijnck was supported by a PhD fellowship of The Research Foundation—Flanders.

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Authors and Affiliations

  1. Department of Radiation Oncology and Experimental Cancer Research, Ghent University, Ghent, Belgium

    Elke Rammant M.Sc., Renée Bultijnck, Gert De Meerleer & Camille Sarrazyn

  2. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium

    Piet Ost, Martijn Swimberghe, Barbara Vanderstraeten & Valérie Fonteyne

  3. Department of Urology, Ghent University Hospital, Ghent, Belgium

    Nicolaas Lumen & Karel Decaestecker

  4. Department of Public Health, Ghent University, Ghent, Belgium

    Roos Colman

Authors
  1. Elke Rammant M.Sc.
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  2. Piet Ost
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Corresponding author

Correspondence to Elke Rammant M.Sc..

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Conflict of interest

E. Rammant, P. Ost, M. Swimberghe, B. Vanderstraeten, N. Lumen, K. Decaestecker, R. Bultijnck, G. De Meerleer, C. Sarrazyn, R. Colman, and V. Fonteyne declare that they have no competing interests.

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Rammant, E., Ost, P., Swimberghe, M. et al. Patient- versus physician-reported outcomes in prostate cancer patients receiving hypofractionated radiotherapy within a randomized controlled trial. Strahlenther Onkol 195, 393–401 (2019). https://doi.org/10.1007/s00066-018-1395-y

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  • DOI: https://doi.org/10.1007/s00066-018-1395-y

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