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Do patient-reported outcome measures agree with clinical and photographic assessments of normal tissue effects after breast radiotherapy? The experience of the standardisation of breast radiotherapy (START) trials in early breast cancer

Do patient-reported outcome measures agree with clinical and photographic assessments of normal tissue effects after breast radiotherapy? The experience of the standardisation of breast radiotherapy (START) trials in early breast cancer
Do patient-reported outcome measures agree with clinical and photographic assessments of normal tissue effects after breast radiotherapy? The experience of the standardisation of breast radiotherapy (START) trials in early breast cancer
AIMS: In radiotherapy trials, normal tissue effects (NTE) are important end points and it is pertinent to ask whether patient-reported outcome measures (PROMs) could replace clinical and/or photographic assessments. Data from the Standardisation of Breast Radiotherapy (START) trials are examined.

MATERIALS AND METHODS: NTEs in the treated breast were recorded by (i) annual clinical assessments, (ii) photographs at 2 and 5 years, (iii) PROMs at 6 months, 1, 2 and 5 years after radiotherapy. Hazard ratios for the radiotherapy schedules were compared. Measures of agreement of assessments at 2 and 5 years tested concordance.

RESULTS: PROMs were available at 2 and/or 5 years for 1939 women, of whom 1870 had clinical and 1444 had photographic assessments. All methods were sensitive to the dose difference between schedules. Patients reported a higher prevalence for all NTE end points than clinicians or photographs (P < 0.001 for most NTEs). Concordance was generally poor; weighted kappa at 2 years ranged from 0.05 (telangiectasia) to 0.21 (shrinkage and oedema). The percentage agreement was lowest between PROMs and photographic assessments of change in breast appearance (38%).

CONCLUSIONS: All three methods produced similar conclusions for the comparison of trial schedules, despite low concordance between the methods on an individual patient basis. Careful consideration should be given to the different contributions of the measures of NTE in future radiotherapy trials.
breast radiotherapy, normal tissue effects, patient-reported outcomes
0936-6555
1-9
Haviland, J.S.
569aa43b-15bd-4e9d-b4a5-e68a84334cfe
Hopwood, P.
aed6184b-149a-4459-b68e-87a9e22241f0
Mills, L.
3021c899-cc3f-49d0-85e0-5243662dc803
Sydenham, M.
20bdbe66-b0f5-41df-9088-73bdb042211a
Bliss, J.M.
84e229a6-c019-47ef-92bb-0875b13f5c18
Yarnold, J.R.
0e51cc2f-3eb1-464f-bf61-d2ac2e86e958
Haviland, J.S.
569aa43b-15bd-4e9d-b4a5-e68a84334cfe
Hopwood, P.
aed6184b-149a-4459-b68e-87a9e22241f0
Mills, L.
3021c899-cc3f-49d0-85e0-5243662dc803
Sydenham, M.
20bdbe66-b0f5-41df-9088-73bdb042211a
Bliss, J.M.
84e229a6-c019-47ef-92bb-0875b13f5c18
Yarnold, J.R.
0e51cc2f-3eb1-464f-bf61-d2ac2e86e958

Haviland, J.S., Hopwood, P., Mills, L., Sydenham, M., Bliss, J.M. and Yarnold, J.R. (2016) Do patient-reported outcome measures agree with clinical and photographic assessments of normal tissue effects after breast radiotherapy? The experience of the standardisation of breast radiotherapy (START) trials in early breast cancer. Clinical Oncology, 1-9. (doi:10.1016/j.clon.2016.01.011). (PMID:26868286)

Record type: Article

Abstract

AIMS: In radiotherapy trials, normal tissue effects (NTE) are important end points and it is pertinent to ask whether patient-reported outcome measures (PROMs) could replace clinical and/or photographic assessments. Data from the Standardisation of Breast Radiotherapy (START) trials are examined.

MATERIALS AND METHODS: NTEs in the treated breast were recorded by (i) annual clinical assessments, (ii) photographs at 2 and 5 years, (iii) PROMs at 6 months, 1, 2 and 5 years after radiotherapy. Hazard ratios for the radiotherapy schedules were compared. Measures of agreement of assessments at 2 and 5 years tested concordance.

RESULTS: PROMs were available at 2 and/or 5 years for 1939 women, of whom 1870 had clinical and 1444 had photographic assessments. All methods were sensitive to the dose difference between schedules. Patients reported a higher prevalence for all NTE end points than clinicians or photographs (P < 0.001 for most NTEs). Concordance was generally poor; weighted kappa at 2 years ranged from 0.05 (telangiectasia) to 0.21 (shrinkage and oedema). The percentage agreement was lowest between PROMs and photographic assessments of change in breast appearance (38%).

CONCLUSIONS: All three methods produced similar conclusions for the comparison of trial schedules, despite low concordance between the methods on an individual patient basis. Careful consideration should be given to the different contributions of the measures of NTE in future radiotherapy trials.

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Accepted/In Press date: January 2016
e-pub ahead of print date: 8 February 2016
Keywords: breast radiotherapy, normal tissue effects, patient-reported outcomes
Organisations: Faculty of Health Sciences

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Local EPrints ID: 386894
URI: http://eprints.soton.ac.uk/id/eprint/386894
ISSN: 0936-6555
PURE UUID: 45911719-3a95-4724-a1a2-633018406622

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Date deposited: 05 Feb 2016 11:16
Last modified: 14 Mar 2024 22:39

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Contributors

Author: J.S. Haviland
Author: P. Hopwood
Author: L. Mills
Author: M. Sydenham
Author: J.M. Bliss
Author: J.R. Yarnold

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