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A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis

OBJECTIVES: The clinical assessment of radioiodine-induced sialadenitis is relied on the observer-defined toxicity grading model. However, this model has significant limitations, the major one being the lack of systematic assessment based on objective criteria. The main aim of this study was the dev...

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Autores principales: Christou, Andri, Papastavrou, Evridiki, Merkouris, Anastasios, Charalambous, Andreas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8414619/
https://www.ncbi.nlm.nih.gov/pubmed/34484788
http://dx.doi.org/10.1177/20503121211042211
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author Christou, Andri
Papastavrou, Evridiki
Merkouris, Anastasios
Charalambous, Andreas
author_facet Christou, Andri
Papastavrou, Evridiki
Merkouris, Anastasios
Charalambous, Andreas
author_sort Christou, Andri
collection PubMed
description OBJECTIVES: The clinical assessment of radioiodine-induced sialadenitis is relied on the observer-defined toxicity grading model. However, this model has significant limitations, the major one being the lack of systematic assessment based on objective criteria. The main aim of this study was the development and testing of an assessment tool which could examine the severity of post-irradiation sialadenitis. METHODS: The development of the Sialadenitis Assessment Tool proceeded through three phases. The first and second phases included a literature review and the development of the tool which derived from the review, respectively. The third phase involved a pilot testing of the Assessment Tool to a sample of 34 patients undergoing I(131) therapy. The assessment was carried out by two independent healthcare professionals, pre- and post-radioiodine therapy. The results of the assessment tool were compared with other scales, including the DIRIX and EORTC H&N35. RESULTS: According to the Cohen’s kappa test, the Sialadenitis Assessment Tool is a reliable tool for the assessment of sialadenitis (Cohen’s κ = 1). The concurrent and internal validity tests showed a tendency of association with most variables (p < 0.001) in the DIRIX and EORTC QLQ-HN35 scales. CONCLUSION: Preliminary evidence show that Sialadenitis Assessment Tool is a valid and reliable tool to assess radioiodine-induced sialadenitis in patients undergoing I(131) therapy post-thyroidectomy.
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spelling pubmed-84146192021-09-04 A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis Christou, Andri Papastavrou, Evridiki Merkouris, Anastasios Charalambous, Andreas SAGE Open Med Original Research Article OBJECTIVES: The clinical assessment of radioiodine-induced sialadenitis is relied on the observer-defined toxicity grading model. However, this model has significant limitations, the major one being the lack of systematic assessment based on objective criteria. The main aim of this study was the development and testing of an assessment tool which could examine the severity of post-irradiation sialadenitis. METHODS: The development of the Sialadenitis Assessment Tool proceeded through three phases. The first and second phases included a literature review and the development of the tool which derived from the review, respectively. The third phase involved a pilot testing of the Assessment Tool to a sample of 34 patients undergoing I(131) therapy. The assessment was carried out by two independent healthcare professionals, pre- and post-radioiodine therapy. The results of the assessment tool were compared with other scales, including the DIRIX and EORTC H&N35. RESULTS: According to the Cohen’s kappa test, the Sialadenitis Assessment Tool is a reliable tool for the assessment of sialadenitis (Cohen’s κ = 1). The concurrent and internal validity tests showed a tendency of association with most variables (p < 0.001) in the DIRIX and EORTC QLQ-HN35 scales. CONCLUSION: Preliminary evidence show that Sialadenitis Assessment Tool is a valid and reliable tool to assess radioiodine-induced sialadenitis in patients undergoing I(131) therapy post-thyroidectomy. SAGE Publications 2021-09-01 /pmc/articles/PMC8414619/ /pubmed/34484788 http://dx.doi.org/10.1177/20503121211042211 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research Article
Christou, Andri
Papastavrou, Evridiki
Merkouris, Anastasios
Charalambous, Andreas
A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title_full A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title_fullStr A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title_full_unstemmed A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title_short A pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
title_sort pretest–posttest pilot study for the development and preliminary validation of a tool for the clinical assessment of radioiodine induced sialadenitis
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8414619/
https://www.ncbi.nlm.nih.gov/pubmed/34484788
http://dx.doi.org/10.1177/20503121211042211
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