There are several grading systems for recording radiotherapy toxicity, In 1995 the radiotherapy community published the late effects in normal tissues - subjective, objective, management and analytic (LENT SOMA) scales in an attempt to unify and improve the reporting of radiotherapy toxicity. The US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) were developed in 1982 to improve reporting of adverse drug events in chemotherapy trials. Version 2 was published in 1999 to improve the completeness, accuracy, and precision of the CTC, and to standardise reporting across groups and therapeutic modalities. Subsequently named the Common Terminology Criteria for Adverse Events (CTCAE), version 3 incorporated LENT items to enable collection of late toxicity data and improve applicability for radiotherapy. Although multiple scoring systems continue to be used in radiotherapy studies, there is increasing recognition and use of CTCAE (current version 4). An important aspect of CTCAEv3/4 is the inclusion of both physician and patient reported outcomes.
The relationship between radiotherapy side-effects and quality-of-life
Patient reported outcomes of toxicity and health-related quality-of-life are different. Although quality-of-life researchers try to reflect the impact of cancer treatment toxicity using patient-reported quality-of-life tools, quality-of-life is a subjective measure, significantly modulated by a person’s ability to adapt to adversity. Quality-of-life and toxicity are correlated in some studies, but against expectation they are not in others. Quality-of-life tools have diverse domains including social support and spirituality. The domains are not specific for radiotherapy. The side-effect endpoints that are most important for radiotherapy are those that are specific for radiotherapy and show a radiation dose response, such as change in breast appearance, rectal bleeding and pneumonitis. While assessment of quality-of-life may be complementary to side-effect reporting (assessed by patients or clinicians), it is not a substitute .
Development of questionnaires for collecting CTCAE patient reported outcomes following radiotherapy
Questionnaires were developed by Dr Susan Davidson at The Christie, Manchester to assist with the collection of patient reported toxicity data for radiotherapy patients. The questionnaires were first developed to facilitate the collection of LENT items for patients with gynaecological or prostate cancer. The questionnaires were updated to collect CTCAE data for patients with gynaecological/female pelvis, prostate/male pelvis or head and neck cancer. The questionnaires underwent extensive validation to check for reliability, compliance and acceptability. These questionnaires are available via the following website: http://www.christie.nhs.uk/the-foundation-trust/treatments-and-clinical-services/clinical-oncology-scoring-treatment-effects/ctcaelent-soma-questionnaires.aspx
The female pelvis questionnaire was translated into Portuguese, Afrikaans, Hinde and Marathi for use in an IAEA trial.
Further development of the questionnaires for the REQUITE study
The previously developed and well validated prostate/male pelvis questionnaire was used. A questionnaire for use in lung cancer patients had been developed but not validated. The lung questionnaires were revised via consultation with REQUITE investigators. Both questionnaires were translated into multiple languages as required for the REQUITE observational study. The following procedures were followed:
- Two native speakers (French, Flemish, Spanish, Dutch, German, Italian, American) translated the English questionnaires independently
- Translations were merged into a single forward translation by a third person and any discrepancies resolved via discussion (no disagreements were identified during this process that would have required used of alternative wording for resolution by backward translation)
- Two native English speakers independently back translated the questionnaires into English and a single back translated version was sent to the REQUITE Project Manager for review
- Differences were itemised and resolved via discussion
- Questionnaires were tested in 10-15 patients in each country and patients asked to complete a short questionnaire asking whether any questions were confusing or embarrassing
Farnell DJ, et al, West CM, Davidson SE. Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy. Radiother Oncol 2010;97:136-42.
Davidson SE, Burns M, Routledge J, West CM, Swindell R, Logue JP, Wylie J, Slevin NJ, Cowan RA, Magee B, Harris MA. Short report: a morbidity scoring system for Clinical Oncology practice: questionnaires produced from the LENT SOMA scoring system. Clin Oncol (R Coll Radiol) 2002;14:68-9
Routledge JA, Burns MP, Swindell R, Khoo VS, West CM, Davidson SE. Evaluation of the LENT-SOMA scales for the prospective assessment of treatment morbidity in cervical carcinoma. Int J Radiat Oncol Biol Phys 2003;56:502-10.
Livsey JE, Routledge J, Burns M, Swindell R, Davidson SE, Cowan RA, Logue JP, Wylie JP. Scoring of treatment-related late effects in prostate cancer. Radiother Oncol 2002;65:109-21.
Barraclough LH, Routledge JA, Farnell DJ, Burns MP, Swindell R, Livsey JE, Davidson SE. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer. Radiother Oncol 2012;103:327-32.
Farnell DJ, Routledge J, Hannon R, Logue JP, Cowan RA, Wylie JP, Barraclough LH, Livsey JE, Swindell R, Davidson SE. Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. Eur J Cancer 2010;46:534-40.
Ho KF, Farnell DJ, Routledge JA, Burns MP, Sykes AJ, Slevin NJ, Davidson SE. Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy. Eur J Cancer 2009;45:1992-8.
Trotti A, Bentzen S. The need for adverse effects reporting standards in oncology clinical trials.J Clin Oncol 2004;22:19-22.