Operative Treatment of Ovarian Cancer and Borderline Tumors in Different Hospital Categories in Finland

Surgery is the cornerstone of ovarian cancer treatment and maximal cytoreduction is important. In the early 1980’s primary surgical treatment of ovarian cancer was performed in over 80 hospitals in Finland. The significance of the operative volume of the hospital, of the training of the surgeons and of centralization of surgical treatment has been widely discussed. The aim of the present study was to evaluate the outcome of surgical treatment of ovarian cancer in different hospital categories retrospectively and prospectively, and to analyze if any differences are reflected in survival. The retrospective study included 3851 ovarian cancer patients operated between 1983 and 1994 in Finland. The data was analyzed according to hospital category (university, central, and other) and by quartiles of the hospital operative volume. The results showed that patients operated in the highest operative volume hospitals had the best relative survival. When stratifying the analysis by the period of diagnosis (1983-1988 and 1989-1994), the university hospitals improved their performance the most. The prospective part of the thesis was initiated in 1999 and included 307 patients with invasive ovarian cancer and 65 patients with an ovarian borderline tumor. The baseline and 5-year surveys used a questionnaire that was filled in by the operating surgeons. For analysis of the 5-year followup data, the hospitals were divided into three categories (<10, 10-20, or >20 patients operated in 1999). The effect of the surgical volume was analyzed also as a continuous variable (1-47 operations per year). In university hospitals, pelvic lymphadenectomy was performed in 88 %, and para-aortic lymphadenectomy in 73 %, of the patients with stage I disease. The corresponding figures ranged from 11 % to 21 % in the other hospitals. For stage III ovarian cancer patients operated by gynecological oncologists, the estimated odds ratio for no macroscopic residual tumor was 3.0 times higher (95 % CI 1.2-7.5) than for those operated by general gynecologists. In the university and other hospitals 82% of the patients received platinum-based chemotherapy. Platinum + taxane combination was given to 63 % of the patients in the university and in 49 % in the other hospitals (p = 0.0763). Only a minority of the patients with tumors of borderline malignancy were staged according to recommendations, most often multiple peritoneal biopsies and omentectomy were neglected. FIGO stage, patient age, and residual tumor were independent prognostic factors of cancer-specific 5-year survival. A higher hospital operative volume was also a significant prognostic factor for better cancer-specific survival (p = 0.036) and disease-free survival (p = 0.048). In conclusion, ovarian cancer patients operated in high-volume university hospitals were more often optimally debulked and had a significantly better cancer-specific survival than patients operated in other hospitals. These results favor centralization of primary surgical treatment of ovarian cancer.

Foodstuffs and medicines as legal categories in the EU and China. Functional foods as a borderline case

The thesis discusses the regulation of foodstuffs and medicines, and particularly the regulation of functional foods. Legal systems investigated are the EU and China. Both are members of the WTO and Codex Alimentarius, which binds European and Chinese rules together. The study uses three Chinese berries as case examples of how product development faces regulation in practice. The berries have traditional uses as herbal medicines. Europe and China have similar nutrition problems to be resolved, such as obesity, cardiovascular disease, and diabetes. The three berries might be suitable raw materials for functional foods. Consumer products with health-enhancing functions, such as lowering blood pressure, might legally be classifi ed either as foodstuffs or medicines. The classifi cation will depend on functions and presentation of the product. In our opinion, food and medicine regulation should come closer together so the classifi cation issue would no longer be an issue. Safety of both foodstuffs and medicines is strictly regulated. With medicines, safety is a more relative concept, where benefi ts of the product are compared to side-effects in thorough scientifi c tests and trials. Foods, on the other hand, are not allowed to have side-effects. Hygiene rules and rules on the use of chemicals apply. In China, food safety is currently at focus as China has had several severe food scandals. Newly developed foods are called novel foods, and are specifi cally regulated. The current European novel food regulation from 1997 treats traditional third country products as novel. The Chinese regulation of 2007 also defi nes novel foods as something unfamiliar to a Chinese consumer. The concepts of novel food thus serve a protectionist purpose. As regards marketing, foods are allowed to bear health claims, whereas medicines bear medicinal claims. The separation is legally strict: foods are not to be presented as having medicinal functions. European nutrition and health claim regulation exists since 2006. China also has its regulation on health foods, listing the permitted claims and how to substantiate them. Health claims are allowed only on health foods. The European rules on medicines include separate categories for herbal medicines, traditional herbal medicines, and homeopathic medicines, where there are differing requirements for scientifi c substantiation. The scientifi c and political grounds for the separate categories provoke criticism. At surface, the Chinese legal system seems similar to the European one. To facilitate trade, China has enacted modern laws. Laws are needed as the country moves from planned economy to market economy: ‘rule of law’ needs to replace ‘rule of man’. Instead of being citizens, Chinese people long were subordinates to the Emperor. Confucius himself advised to avoid confl ict. Still, Chinese people do not and cannot always trust the legal system, as laws are enforced in an inconsistent manner, and courts are weak. In China, there have been problems with confl icting national and local laws. In Europe, the competence of the EU vs. the competence of the Member States is still not resolved, even though the European Commission often states that free trade requires harmonisation. Food and medicine regulation is created by international organisations, food and medicine control agencies, standards agencies, companies and their organisations. Regulation can be divided in ‘hard law’ and ‘soft law’. One might claim that hard law is in crisis, as soft law is gaining importance. If law is out of fashion, regulation certainly isn’t. In the future, ‘law’ might mean a process where rules and incentives are created by states, NGOs, companies, consumers, and other stakeholders. ‘Law’ might thus refer to a constant negotiation between public and private actors. Legal principles such as transparency, equal treatment, and the right to be heard would still be important.

“IF ONLY I COULD�? ~ “THERE IS ALWAYS A LOOPHOLE"? Hope and hopelessness experienced by the severely depressive and nondepressive

The aim of this research was to structure a conceptual model of hope and hopelessness based on dictionary definitions, and to verify this model on the basis of the experiences of the severely depressive and non-depressive elderly. This research has produced a substantive theory of hope and hopelessness which is based on the experiences of the depressive and non-depressive elderly, and on the concept analysis of hope and hopelessness based on English dictionary definitions. The patients who participated in the research were 65 years old and older men and women (n=22) who had been admitted to a psychiatric hospital because of major depression, and another group: the non-depressive elderly (n=21), who were recruited from the pensioners’ clubs. The data were collected in interviews using the Clinical Assessment Tool, developed by Farran, Salloway and Clark (1990) and Farran, Wilken and Popovich (1992), and it produced 553 pages of written text, which were analysed using the ATLAS/ti programme. ATLAS/ti is a tool for analysing qualitative data and is based on Grounded Theory. The medical and nursing records of the depressive elderly completed source triangulation. The concept analysis of hope and hopelessness was made on the basis of the definitions of English dictionaries (n=103), using semantic analysis and the ATLAS/ti programme. The most important hope-promoting factors were human relations, health and managing in everyday living. Autonomy, self-determination and feeling of security were highly appreciated among the elderly. Hopelessness, on the other hand, was most often associated with the same factors: human relations, health and everyday living. Especially, losses of significant others were experienced as strongly hope-diminishing. Old age had brought freedom from duties concerning others, but now, when you finally had an opportunity to enjoy yourself, you could not accomplish anything; you were clasped in the arms of total inability, depression had come. The most obvious difference in the life course of the depressive and nondepressive elderly was the abundance of traumatic experiences in the childhood and youth of the depressive elderly. The continuous circulation of fearful thoughts was almost touchable, and suicidality was described in connection with these thoughts. You were afraid to be awake and also to go to sleep. Managing day by day was the goal. The research produced the Basic Social Process (BSP) of hope: achieving - maintaining - losing, which expresses a continuous balancing between Being without and Being with. The importance of the object of hope was combined with the amount of hope and disappointment. The process of approaching defined the realisation of hope and the process of withdrawal that of losing. Joy and security versus grief and insecurity defined the Being with and Being without. Two core categories were found. The first one “If only I could�? reflects lack of energy, lack of knowledge, lack of courage and lack of ability. The other one “There is always a loophole�? reflects deliberate tracing of possibilities and the belief in finding solutions, and managing.