Proposing phase I studies: patients', relatives', nurses' and specialists' perceptions.

PURPOSE: As of now the primary objective of studies on informed consent in phase I trials has been to assess patients' expectations and reasons for participation. We have previously shown that the quantity of information provided through a procedure of subsequent oral interviews with patients was adequate while the attention paid by the physician to the emotional needs and concerns of patients was not. We wanted therefore to assess and compare the perceptions of the information provided about the investigational study of patients, relatives, the research nurse and the investigator responsible for the phase I trial and the impact this information had on the patients' level of anxiety and depression. PATIENTS AND METHODS: The participation to a phase I study was proposed to patients through two subsequent interviews, the latter attended also by patients' relatives, the research nurse and the investigator coordinating the phase I trial. After the second interview, attendees were requested to complete a questionnaire assessing the principal reason for participating in the study and the informative, emotional and interactive dimension of the information. Patients were also requested to complete the Hospital Anxiety and Depression (HAD) scale before and after the second interview. RESULTS: The completed questionnaires of 31 of 42 patients were retrieved and analysed. The possibility to benefit from the study was indicated as the main reason for participating by 59% of the patients while it was judged to be the case in 78% and 86% of the patients by the nurse and the investigator, respectively. The information was judged to be clear and sufficient in almost all cases by all attendees, while the investigator judged that a lower percentage of patients felt at ease and could express their main worries during the interview, had been helped and were less worried after it than it was judged by the nurse and the relatives. Patients' state of anxiety and depression was not adversely affected by the information provided. CONCLUSIONS: Informing patients on the option of receiving an investigational treatment within a phase I study is feasible and can be done in a way felt appropriate by patients and relatives, nursing and medical professionals. Providing information in an appropriate manner does not increase patients' anxiety and depression. Divergence between the aims and interests of the investigators and patients might explain the difference in the evaluation of physician, a problem which could perhaps be partially overcome by the application of innovative phase I designs.

Clinical characteristics of adolescent headache.

We evaluate clinical characteristics of headache in a group of subjects > 12 years to assess the sensitivity and specificity of the IHS criteria. We consider whether age at onset may influence the clinical features. We used a semi-structured questionnaire to examine 136 patients consecutively referred to our division. We considered the following subdiagnoses: IHS 1.1, 1.2, 1.7, 2.1, 2.2, 2.3. Migrainous disorders were found to be more common than non-migrainous headaches. A definite diagnosis was established in 68.1% of the migrainous group and in 86.6% of the tension-type headache group. Unilateral location, severe intensity of pain, the presence of nausea, vomiting, phonophobia and photophobia were features which differed between migrainous and non-migrainous subjects. No difference was found regarding aggravation of the headache by physical activity. On the basis of the criterion duration of attacks < 2 hours, IHS 1.7 was found to differ significantly from other migraine types. With the exception of the presence of vomiting in migrainous patients, the age at onset was not found to be a factor influencing the characteristics of the headache. Diagnostic criteria for migraine were highly specific but poorly sensitive, and those for tension-type headaches highly sensitive but less specific. The sensitivity/specificity of the IHS criteria in adolescent migraine can be influenced by the heterogeneity of the clinical characteristics. In fact, the intensity, the location and the quality of pain were similar to those found in childhood migraine, while the concomitant symptoms were less frequent than in childhood and in adult migraine. Further studies are needed to define the degree of severity of the clinical features in adolescent headache and to address the question of the validity of the IHS criteria.

[Mortality in the Swiss and foreign immigrants in the Canton of Ticino]. / La mortalità negli svizzeri e negli stranieri immigrati nel Cantone Ticino.

The Canton Ticino is one of the Swiss cantons with the highest number of foreigners (mainly Italians): roughly 25% of the entire canton's population. The aim of this work, which is part of a wider study on the immigration problem in Switzerland, is to evaluate whether the immigrant population in the Canton Ticino presents differences in death rates, both in general and according to cause of death, with respect to the Swiss population. Crude and standardized death rates were calculated for autochthonals, Italians and other foreigners, using data on those deceased in the Canton during 1991 and 1994. Higher death-rates (both sexes and all age groups, except 0-19 years) were calculated for almost all causes of death, of the Swiss group with respect to Italians and other foreigners. The low death-rates found in the immigrants may be due, at least partially, to the "healthy emigrant" effect. This effect seems to be stronger than the effect of the often negative factors to which immigrants are exposed in the host country.

[Mental disorder and the use of public psychiatric services in the foreign population in the Canton Ticino region]. / Disagio psichico e utilizzazione dei servizi psichiatrici pubblici nella popolazione straniera del Canton Ticino.

OBJECTIVE: To verify if the foreign population resident in the Canton Ticino, differs in the use of public psychiatric services and in the type of mental disorder presented, with respect to the Swiss population. DESIGN: Research completed on subjects Swiss and foreign, over 19 years old, and resident in the Canton Ticino, who during 1995 spent at least one day admitted at the psychiatric hospital or had at least one contact with the out-patient services. SETTING: Public psychiatric services of the Canton's sociopsychiatric organisation. MAIN OUTCOME MEASURES: For the Swiss, Italian and other non-Italian foreigners, the standardised annual rates of in- and outpatient prevalence and first admission and first outpatient contact were calculated, both totals and per diagnostic categories (ICD-10). RESULTS: The group of non-Italian foreigners presents higher total standardised annual rates of in-patient prevalence and first admission and above all, of first admission, with respect to the Swiss and Italian groups; furthermore, with respect to the other two groups it presents higher first admission rates for the schizophrenic syndromes (F2) in men and for mental disorders due to psychoactive substances (F1) in women. Whereas for first outpatient contacts the other foreigners present higher rates in neurotic syndromes (F4) in men, and affective syndromes (F3) in women. CONCLUSIONS: The results seem to confirm the presence of higher levels of mental disorder in non-Italian foreigners, above all for certain nationalities, with respect to Swiss and Italians. It is possible that the presence of a substantial offer of psychiatric services from the private sector may have caused an underestimation of the actual rate of mental disorder above all in the Swiss group and to a minor extent in that of the Italians.

Reasons for dissatisfaction: a survey of relatives of intensive care patients who died.

OBJECTIVE: To describe the reasons for eventual dissatisfaction among the families of patients who died in the intensive care unit (ICU), regarding both the assistance offered during the patient's stay in the hospital and the information received from the medical staff. DESIGN: Cross-sectional descriptive study, which was conducted after a survey using a questionnaire. SETTING: Interdisciplinary ICU (n = 8 beds) at San Giovanni Hospital in Bellinzona (CH). SUBJECTS: Three-hundred ninety families of patients who died in the ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A postal questionnaire (n = 43 questions) was sent to the families of 390 patients who died in the ICU during 8 yrs (1981 to 1989). The results referred to 123 replies: a) 82.6% of the respondents expressed no criticism of the patient's hospital stay; b) 90% considered the patient's treatment was adequate; c) 17% felt that the information received concerning diagnosis was insufficient or unclear; and d) 30% (particularly close relatives and those relatives who were informed of the death by telephone and not in person) expressed dissatisfaction regarding the information received on the cause of death. CONCLUSIONS: Our survey found that the relatives of patients who died were most dissatisfied with the care received according to: a) the type of death (e.g., sudden death vs. death preceded by a gradual deterioration in the patient's condition); and b) the manner in which the relatives were notified of the death (in person vs. by telephone). The personal characteristics of the people interviewed, such as gender and the closeness of their relationship to the deceased, also seem to have some bearing on the opinions expressed. A high percentage of respondents were satisfied with the treatment received by their dying relative and the information conveyed by caregivers. Nevertheless, the dissatisfaction expressed by some respondents indicates a need for improvement, especially in communicating information to the relatives of these patients.

Psychological distress and its correlates in secondary school students in Pavia, Italy.

Adolescence is a time of social as well as biological transition; nevertheless, there are very few epidemiological studies in this field in Italy. Therefore, we felt it would be useful to conduct a cross-sectional study on a sample of 1346 adolescents aged 14-19 years attending high schools in the Health Authority Area of Pavia (northern Italy) through a multi-dimensional approach, taking into consideration physical and psychological health, life habits, family environment and social life of teen-agers. We used a structured self-administered questionnaire consisting of 264 question items to achieve the study aim, which was to find the variables (among personal data, scholastic, family, relational characteristics and habits) correlated with psychological distress. The results showed that in this sample psychological distress (evaluated by GHQ-30) was significatively (p < 0.005) associated with female sex, problems with school friends and teachers, having at least one immigrant parent (from a region different from that of residence), little love for parents and poor parental psycho-physical health status, staying at home on the weekend, smoking and using psychoactive medicines.