Health Utilities in Gynecological Oncology and Mastology in Germany

Discussion

Health-economic evaluations have been growing in importance in recent years in healthcare systems throughout the world (3, 8, 9). The aim is to allow decisions to be made on the basis of an analysis and evaluation of requirements in the healthcare system, leading to the best possible results in terms of health-related quality of life. Since health utilities (scored states of health as a basis for calculating QALYs) have not so far been available for women with breast cancer or gynecological malignancies treated in Germany or other mainland European countries, data from English-speaking countries are usually used for decision-making models in oncology. However, since it is likely that different views regarding health and well-being prevail in different countries, it is necessary to have country-specific health utilities, based on data from women treated in Germany, in order to generate cost–benefit analyses. A comparative study on the evaluation of the state of health in the general population in six countries in Europe, using the EQ-5D questionnaire, concluded that the questionnaire is a suitable tool for collecting data to report states of health (10, 11). Particularly in relation to oncological diseases, research studies assume that individual evaluations, and thus the health utilities for the same state of health, may well differ considerably from country to country and between different cultures (11-14). In the present study, health utilities in patients in the fields of gynecological oncology and mastology, as well as in a healthy control group, were calculated using the German version of the EQ-5D questionnaire and with a VAS (6, 9, 11).

Particularly because it is a measurement tool that can be applied to any disease, the EQ-5D allows for comparison between different diseases, and this is extremely important for assessing the multi-dimensional benefit provided (3, 4, 6). However, this study shows that both participants with disease and healthy participants experienced few problems with regard to mobility, self-care, activity, pain/discomfort, or anxiety/depression. The proportion of patients with disease in the present group is well above the average proportion of patients with cancer in the general population. In relation to the subjective perception of symptoms, patients with carcinoma are, thus, receiving good treatment (15-17). At the same time, this of course raises the question of whether the EQ-5D is appropriate for the selected aspects used to evaluate states of health in patients with a gynecological carcinoma or breast carcinoma, or whether it is too non-specific for these diseases. Several studies have shown that assessments of quality of life differ markedly between respondents suffering from carcinoma and those without cancer (18, 19). In agreement with the findings of a report by Reeve et al. (20), patients with gynecological carcinomas are less affected by physical burdens due to their cancer and associated impairments of everyday life than patients with other cancer types. This may explain the slightly better results in comparison to other patients with cancer.

A diagnosis of cancer is a life-changing event associated with numerous effects on the patient and her social environment (21-23). VAS values fall by an average of 10.6 points after the diagnosis of a chronic disease (24). In the present study, the control group had higher median values than the patient group in both the VAS and also in the HI. The subjective current state of health in those with disease differed by a median of 20.00 for VAS and 0.1125 for HI from the data for healthy individuals. In addition, there were differences between the individual tumor entities both with regard to the patients' subjective assessment of their quality of life and also in the HI. After the healthy participants, patients with breast carcinoma had the highest median VAS values, followed by women with ovarian cancer. By contrast, however, lower HIs were seen for the patients with breast carcinoma.

Overall, the present study showed very high assessments of quality of life. Similar findings have also been reported in patients with carcinoma in other studies on quality of life (25). This may be due to the fact that many participants were already receiving follow-up care. Numerous studies have shown that quality of life in those with disease can indeed return to levels of healthy individuals (26, 27). Chan et al. noted that patients' status improves as early as six months after treatment for a gynecological carcinoma and is comparable with the state before treatment (26). Freedman et al. showed that psychological symptoms, in particular, greatly declined within 15 years after a first diagnosis of breast carcinoma, leading to a better evaluation of the state of health (25). An improvement in health for someone with disease thus leads to higher quality of life values than those seen in the constant state experienced by a healthy individual (6). In addition, high values may be due to the fact that some cancer patients tend to deny their history of cancer during the subsequent course (23, 25, 27).

Oncological diseases affect the quality of life not only during, but also after treatment. Treatment is always associated with numerous physical and psychological side-effects, the extent of which may vary depending on the type of therapy administered (28). In the present study, the greatest impairments of quality of life were particularly observed in patients who were currently undergoing surgical therapy. A severely-negative effect of current surgery was clearly noted in patients with primary disease (VAS_{Surgery&Primary situation}=67.00). This is attributable to severe psychological and also physical impairment for these patients. By contrast, Chan et al. observed the highest quality of life in patients presenting for surgical treatment (26). The lowest values were seen in various studies in patients receiving chemotherapy (breast cancer: HI_Chemotherapy=0.50; HI_Radiotherapy=0.83) (26, 29). This was explained by severe impairment due to symptoms such as hair loss and neuropathy (26). In addition, chemotherapy often follows surgery, possibly creating a cumulative burden.

Marked impairment was also evident in patients who were attending the hospital for diagnostic procedures and who had received information about recurrence or metastasis shortly before completing the questionnaire, or who were waiting for the results of examinations regarding further disease spread. Severe psychological burdens are present in such cases. The highest quality of life was reported by those who were receiving antibody therapy or bisphosphonate infusions at the time of the study – explicable by the low physical burden these treatment measures involve. This was not clearly evident in the HIs, but it can be seen that the HI declines above all due to the impaired mobility associated with surgical therapy.

Disease can be associated with numerous life changes, which can also have effects on psychological function (21, 23, 26, 27, 30-32). It is, therefore, important to take the effects of psychological assistance into account, in addition to medical and technological considerations. Depression is a frequent type of comorbidity in patients with cancer. Problems associated with the aspect of anxiety/depression are greater among those affected. According to a study in the Czech Republic, approximately 61% of patients with metastatic breast cancer suffer from depression (33). The authors noted that the patients' quality of life was thereby markedly reduced (VAS=59.2). In the group included in the present survey, patients with metastatic breast cancer also had a lower score, at 70.00, than healthy individuals. Psychosocial and social symptoms can reduce the evaluation of the state of health (20, 27). As there is known to be a high incidence of psychological problems due to oncological diseases, there is a clear need for attention to be given to the psychological condition of patients with cancer (and to include this in cost–benefit analyses) (23, 26, 33). Psychological impairment due to diagnosis and treatment and the associated side-effects are often greater than limitations of physical function (34). Regarding the influence of psychological counseling, self-help groups and similar services on the patients' assessment of their state of health, the results of the sub-analysis of this study are surprising. The uptake of additional services such as psychological counseling, participation in self-help groups, or the offer of relaxation therapy to support oncological treatment was relatively low in the present group. Most affected patients never used any such services at any time, but achieved better state of health on the VAS and in the HIs in comparison with those who did make use these options (e.g. psychological counseling: VAS_Never=75.25, HI_Never=0.9990; VAS_Regular=64.75, HI_Regular=0.8870). Even lower evaluations were measured for participants who did not have access to psychological counseling (VAS_{Not offered}=51.00). Assistance in one's personal surroundings and support from one's family and partner are important aspects in coping with disease. It is, therefore, conceivable that a lack of assistance and an additional failure to offer psycho-oncological support might lead to considerable deterioration in the affected patients' situation (31).

Clear effects and significant differences in the influence of socio-cultural factors on quality of life were evident in the present study both with regard to the values obtained for the VAS and also in the HIs. The main sources for comparison with other healthcare systems are from the USA. For patients with breast cancer in all tumor stages, Schleinitz et al. observed the greatest impairment of quality of life in association with chemotherapy, followed by hormone therapy and radiotherapy (29). In the present group in Germany, by contrast, radiotherapy was associated with the poorest quality of life on the VAS (VAS_Radiotherapy=55.50, HI_Radiotherapy=0.8870).

One limitation of the present study is that the patient group mainly consisted of patients with breast carcinoma, so that the effects of this disease on the results may be predominant. With regard to the other tumor entities, the validity of the results for quality of life may be limited due to the smaller numbers of cases.

The results of the present study represent a major contribution to the establishment of health utilities for patients in gynecological oncology and mastology in Germany. As the results differ from those of other countries in International comparisons, it must be noted that resource allocation decisions should not generally be based on International data, as there are substantial differences between countries in the affected groups. German health utilities are thus now available for the first time for future cost–benefit value models. Detailed data of all treatments for the different carcinoma entities not shown here can be requested from the authors for further cost-benefit analyses in the German healthcare system.