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Gepubliceerd in:

20-06-2020

Clinicians versus patients subjective adverse events assessment: based on patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Auteurs: Lei Liu, Tingting Suo, Yongqing Shen, Cuizhi Geng, Zhengchuan Song, Fengxia Liu, Jianxin Wang, Yanli Xie, Yanshou Zhang, Tiantian Tang, Lina Zhang, Weina Wang

Gepubliceerd in: Quality of Life Research | Uitgave 11/2020

Abstract

Purpose

Adverse events (AEs) assessment by clinicians is a standard practice in a clinical setting. However, studies have found clinicians tend to report fewer AEs, especially subjective AEs. We aimed to explore the difference of subjective AEs assessment between clinicians and patients based on PRO-CTCAE, and to discuss the necessity of incorporating patient into the evaluation of AEs.

Methods

Between April and July 2019, two different questionnaires with the same subjective AEs were given to patients and clinicians in the Day Chemotherapy ward of Breast Center in the Fourth Hospital of HeBei Medical University. Patients completed a Simplified Chinese version of PRO-CTCAE, including six common subjective AEs of chemotherapy: nausea, vomiting, diarrhea, fatigue, pain, and constipation. Clinicians completed the common terminology criteria for adverse events (CTCAE) with the same AEs. General information of enrolled patients and results from the questionnaires were collected and analyzed.

Results

384 paired questionnaires were collected. Clinicians reported less subjective AEs than patients, and the general agreement between patients and clinicians was poor. When considering the grade difference, we utilize weighted kappa coefficient to analysis, and agreement between patients and clinicians was poor (k < 0.4) regardless of the frequency, the severity and interfering with daily life of AEs, and the most discrepancies were within one point. Patients tended to grade severer than the clinician.

Conclusions

The results of this study showed that there were differences between clinicians and patients in subjective adverse events evaluation. Patient reporting of symptoms can be used as a supplementary method to incorporate the current approach to monitor subjective AEs, to improve the timeliness and accuracy of clinical evaluation of subjective AEs.

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Guy, R. C. (2014). International Conference on Harmonisation. Encyclopedia of Toxicology, 1070–1072.

Basch, E. (2010). The missing patient voice in drug-safety reporting. New England Journal of Medicine, 362(10), 865.CrossRefPubMed

Basch, E. (2014). New frontiers in patient-reported outcomes: Adverse event reporting, comparative effectiveness, and quality assessment. Annual Review of Medicine, 65(1), 307–317.CrossRefPubMed

Ebile, A. W., Ateudjieu, J., Yakum, M. N., Djuidje, M. N., & Watcho, P. (2015). Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: A documentary review of clinical trial protocols. BMC Medical Ethics, 16(1), 67.CrossRefPubMedPubMedCentral

Banerjee, A. K., Okun, S., Edwards, I. R., Wicks, P., Smith, M. Y., Mayall, S. J., et al. (2013). Patient-reported outcome measures in safety event reporting: PROSPER Consortium guidance. Drug Safe, 36(12), 1129–1149.CrossRef

Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Dueck, A. C., et al. (2014). Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). Journal of the National Cancer Institute, 106(9), dju244.CrossRefPubMedPubMedCentral

Landis, J. R., & Koch, G. G. (1977). The measurement of observer agreement for categorical data. Biometrics, 33(1), 189–196.CrossRef

Ríos, O. M., Gutiérrez, L. J., Talavera, J. O., Téllez-Rojo, M. M., Olivar López, V., Garduño Espinosa, J., et al. (2016). A comprehensive intervention for adverse drug reactions identification and reporting in a Pediatric Emergency Department. International Journal of Clinical Pharmacy, 38(1), 80–87.CrossRef

Zhang, S., Liang, F., & Tannock, I. (2016). Use and misuse of common terminology criteria for adverse events in cancer clinical trials. BMC Cancer, 16(1), 392.CrossRefPubMedPubMedCentral

10.

Basch, E., Abernethy, A. P., Mullins, C. D., Reeve, B. B., Smith, M. L., Coons, S. J., et al. (2012). Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. Journal of Clinical Oncology, 30(34), 4249–4255.CrossRefPubMed

11.

Storey, D. J., Waters, R. A., Hibberd, C. J., Rush, R. W., Cargill, A. T., Wall, L. R., et al. (2007). Clinically relevant fatigue in cancer outpatients: The Edinburgh Cancer Centre symptom study. Annals of Oncology, 18, 1861.CrossRefPubMed

12.

Wilson, A., Dowling, A., Abdolell, M., & Tannock, I. F. (2009). Perception of quality of life by patients, partners and treating physicians. Quality of Life Research, 9(9), 1041–1052.CrossRef

13.

Pakhomov, S., Jacobsen, S. J., Chute, C. G., & Roger, V. L. (2008). Agreement between patient-reported symptoms and their documentation in the medical record. American Journal of Managed Care, 14(8), 530–539.PubMed

14.

Atkinson, T. M., Ryan, S. J., Bennett, A. V., Stover, A. M., Saracino, R. M., Rogak, L. J., et al. (2016). The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): A systematic review. Supportive Care in Cancer, 24(8), 3669–3676.CrossRefPubMedPubMedCentral

15.

Chung, A. E., Shoenbill, K., Mitchell, S. A., Dueck, A. C., Schrag, D., Bruner, D. W., et al. (2019). Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Journal of the American Medical Informatics Association, 26(4), 276–285.CrossRefPubMedPubMedCentral

16.

Kawaguchi, T., Azuma, K., Sano, M., Kim, S., Kawahara, Y., Sano, Y., et al. (2017). The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): Psychometric validation and discordance between clinician and patient assessments of adverse events. Journal of Patient-Reported Outcomes, 2(1), 2.CrossRefPubMed

17.

Basch, E., Pugh, S. L., Dueck, A. C., Mitchell, S. A., Berk, L., Fogh, S., et al. (2017). Feasibility of patient reporting of symptomatic adverse events via the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. International Journal of Radiation Oncology Biology Physics, 98(2), 409–418.CrossRefPubMed

Titel: Clinicians versus patients subjective adverse events assessment: based on patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)
Auteurs: Lei Liu
Tingting Suo
Yongqing Shen
Cuizhi Geng
Zhengchuan Song
Fengxia Liu
Jianxin Wang
Yanli Xie
Yanshou Zhang
Tiantian Tang
Lina Zhang
Weina Wang
Publicatiedatum: 20-06-2020
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 11/2020
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-020-02558-7

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Abstract

Purpose

Methods

Results

Conclusions

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