Validation and the first results of clinical use of an EORTC QLQ PRT-23 module to assess quality of life in patients with radiation-induced rectitis

Objective: to make the language adaptation and testing of an EORTC QLQ PRT-23 module, a method to assess quality of life, which has been elaborated in conjunction with the European organization for research and treatment of cancer quality of life questionnaire group (EORTC QLQ group), in clinical practice.
Subjects and methods. An initiative study of the language adaptation of the EORTC QLQ PRT-23 module was completed. The elaborated questionnaire was tested in clinical practice. The criteria for including patients (n = 176) in the study were successful radical antitumor therapy; at least three months’ duration of small pelvic radiotherapy (RT); clinical Stage 0–IV according to the Radiation Therapy Oncology Group (RTOG) and EORTC; and endoscopically verified signs of developed radiation-induced rectitis (Stages 0–IV after M.S. Bardychev); no recurrence of the underlying disease throughout the follow-up; patient compliance; availability of a patient to be followed. Results. The range of performed RT in the patients included in the study protocol was as follows: 61 (34.6 %) patients had a total focal dose of RT, which was not higher than the tolerance values for the rectal mucosa (from 60 to 70 Gy); 115 (65.4 %) patients had a radiation dose range of 70 to 80 Gy. At least 3 months passed from the completion of the given RT to the study inclusion. 
With the EORTC QLQ PRT-23 module, the differences between RTOG/EORTC 0 and RTOG/EORTC II–IV groups were as follows: p0–II < 0.02, p0–III < 0.0001, and p0–IV < 0.0006. When the EORTC QLQ С-30 and QLQ PRT-23 in RTOG/EORTC III group (n = 7) and the RTOG/EORTC 0 group, this was p0–III < 0.002.
Assessment of the QLQ С-30 and QLQ PRT-23 modules and comparison of patients with RTOG/EORTC Stages I, II, and IV and those with RTOG/EORTC stage 0 revealed no statistically significant group difference: p0–I < 0.81, p0–II < 0.07, and p0–IV < 0.07, respectively. 
The use of the QLQ PRT-23 module only yielded significantly different results between the patients without chronic radiation-induced rectitis (Stage 0) and those with the endoscopic manifestations of Stages III and IV radiation-induced rectitis (p0–III < 0.0006; p0–IV < 0.0004). The values of the EORTC QLQ С-30 and QLQ PRT-23 questionnaires were statistically significantly different in the patients with endoscopically verified radiation-induced rectitis and in those without this condition (p0–I < 0.03; p0–II < 0.02; p0–III < 0.0016; p0–IV < 0.00009). 
Conclusion. The EORTC QLQ С-30 and QLQ PRT-23 questionnaires may be used in the patients with chronic radiation-induced rectitis for assessment of the quality-of-life index, for determination of the integral values over time (before, during, and after treatment), for informed involvement of a patient during treatment, for estimation of patient satisfaction with the therapy performed. The EORTC QLQ С-30 questionnaire supplemented by the QLQ PRT-23 module is a subjective method. Our study provided support for the fact that the QLQ С-30 and QLQ PRT-23 questionnaires for staging chronic radiation-induced rectitis must be used in combination with any third questionnaire. 

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