These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.

Validation of the EORTC QLQ-C30 quality of live questionnaire through combined qualitive and quantitative assessment of patient-observer agreement Groenvold, M.; Klee, M.C.; Sprangers, M.A.G.; Aaronson, N.K.

Summary The ECOG Scale of Performance Status (PS) is widely used to quantify the functional status of cancer patients, and is an important factor determining prognosis in a number of malignant conditions. The PS describes the status of symptoms and functions with respect to ambulatory status and need for care. PS 0 means normal activity, PS 1 means some symptoms, but still near fully ambulatory, PS 2 means less than 50%, and PS 3 means more than 50% of daytime in bed, while PS 4 means completely bedridden. An inter-observer variability study of PS assessment has been carried out to evaluate the non-chance agreement among three oncologists rating 100 consecutive cancer patients. Total unanimity was observed in 40 cases, unanimity between two observers in 53 cases, and total disagreement in seven cases. Kappa statistics reveal the ability of the observers compared to change alone and were used to evaluate non-chance agreement. Overall Kappa was 0.44, (95% confidence limits 0.38-0.51). The Kappa for PS 0 was 0.55 (0.44-0.67), while those for PS 1, 2, 3 and four were 0.48 (0.37-0.60), 0.31 (0.19-0.42), 0.43 (0.32-0.55), and 0.33 (0.33-0.45), respectively. If one observer allocated patients to PS 0-2, then another randomly selected observed placed the patients in the same category with a probability of 0.92. For patients with PS 3-4 the probability that the same category would be chosen was 0.82. Overall, the non-chance agreement between observers was only moderate, when all ECOG Performance Status groups were considered. However, agreement with regard to allocation of patients to PS 0-2 versus 3-4 was high. This is of interest because this cut-off is often used in clinical studies.

BACKGROUND Limited knowledge exists concerning the impact of radical hysterectomy (RH) alone on the sexual function of patients with early‐stage cervical carcinoma. The authors investigated the longitudinal course of self‐reported sexual function after RH. METHODS The current study was comprised of 173 patients with lymph node‐negative, early‐stage cervical carcinoma who had undergone RH and pelvic lymphadenectomy. They were assessed prospectively using a validated self‐assessment questionnaire 5 weeks and 3 months, 6 months, 12 months, 18 months, and 24 months after RH. Results were compared with an age‐matched control group from the general population. RESULTS Compared with control women, patients experienced severe orgasmic problems and uncomfortable sexual intercourse due to a reduced vaginal size during the first 6 months after RH, severe dyspareunia during the first 3 months, and sexual dissatisfaction during the 5 weeks after RH. A persistent lack of sexual interest and lubrication were reported throughout the first 2 years after RH. Long‐term lack of sexual interest and insufficient vaginal lubrication were confirmed by the patient's self‐reported changes 12 months after RH compared with before the cancer diagnosis and by a pre‐post comparison within patients. However, most of the patients who were sexually active before their cancer diagnosis were sexually active again 12 months after surgery (91%), although with a decrease in sexual frequency reported. CONCLUSIONS RH had a persistent and negative impact on patients' sexual interest and vaginal lubrication whereas the majority of other sexual and vaginal problems disappeared over time. Sexual and vaginal problems in the short‐term and long‐term after RH should be discussed with the patient before and after surgery. Cancer 2004;100:97–106. © 2003 American Cancer Society.