Biomedical subjects
Giovanni Apolone
Publications and source records attributed to Giovanni Apolone.
Epilepsy and quality of life in adults: a review of instruments.
The aim of this report is to describe the state of the art of quality of life (QoL) instruments used for adults with epilepsy and to help those in the field to identify, select, and use the instruments most suitable for their purposes. We searched Medline and the Cochrane Database for articles in English, German, French, Spanish, Portuguese and Italian published by the end of 2002. Electronic retrieval was completed by hand-search. The final list included 203 articles reporting 205 studies. There were 62 validation studies and 143 clinical studies, including 7 population studies, 45 "pure" observational, 37 observational with aspects of validation and 54 experimental (38 randomized clinical trials and 16 non-randomized or non-controlled trials). Twenty-four generic and 21 specific QoL instruments were used. Eight were used in more than 10 studies, while 21 were used only once; 7/24 generic and 19/21 specific questionnaires were validated for epilepsy. The different domains considered in the 26 questionnaires specifically validated for epilepsy are listed. We classified questionnaires according to three aspects: validation, diffusion of use, and specificity of domains. Questionnaires covering all three aspects (WPSI, ESI-55, QOLIE-89, QOLIE-31, QOLIE-10, Liverpool Batteries) should be preferred when planning a QoL study in epilepsy. However, those covering only two aspects (SF-36, SEALS, EPSES, EOS, PESOS, QOLAS) could also be useful in selected situations or may become a first-choice instrument in the future, after more widespread use or complete validation. All the other instruments should at present be considered only for second choice.
A tax to prevent the epidemic of lung cancer.
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Health status, resource consumption, and costs of dysthymic patients in Italian primary care.
AIMS: To describe the health status, resource consumption and costs of patients with dysthymic disorder in the Italian primary care setting. METHODS: A total of 79 general practitioners (GPs) participated the study. Diagnosis was based on each GP's clinical assessment. At entry the Mini-International Neuropsychiatric Interview (MINI) was used as a supporting diagnostic aid. Health status was measured with the SF-36 questionnaire. Resource consumption and costs regarded the six months before enrolment. RESULTS: Out of 598 patients enrolled by GPs according to their clinical assessment, 503 fulfilled the MINI criteria and 95 did not. The latter had a better perception of their health than the former. Resource consumption was similar in the two groups; and the total per patient six-month costs did not differ significantly. CONCLUSIONS: The study confirms there may be a gap between standardised criteria for defining dysthymia and everyday clinical practice. All dysthymic patients diagnosed by GPs might be considered together from a health policy perspective.
Knowledge and opinions about clinical research. A cross-sectional survey in a sample of Italian citizens.
Large samples of the general population are exposed to the possibility of being enrolled in clinical trials on preventive strategies. Because little information is available on the general population, data were collected on what Italians know and how they feel about clinical research and factors that might help implement measures to improve participation in the main phases of clinical research were assessed. A random sample of 950 citizens representative of the Italian population was interviewed by ad hoc trained interviewers, using a standardized questionnaire with seven multiple-choice questions and two scenarios. Participants' knowledge and opinions about clinical research were in general limited, attitudes toward participation in clinical studies were unsatisfactory, and the results varied significantly according to sociodemographic and geographic variables. These results give a description of the people's level of knowledge and attitude about clinical research in Italy and also clarify the importance of factors that may be related to the study's principal variables. These findings might be useful in helping design and implement effective interventions to improve people's participation in the main phases of clinical research.
Health coverage in Italy.
Italy, as other developed European countries, has a national health service (NHS) that, in principle, offers universal health care and coverage to Italians and other legal (non-Italian) residents who have full access to health care. Although Italy has always spent less for health care than other European countries (Italy, in 2002, spent about 8% of its gross national product for health care, which is approximately half the level of spending in the U.S.), the government's lack of control over spending remained the most relevant problem. To enhance the capability to control and monitor the system, mainly in terms of expenditures and costs, from the late 1990s to the present, new health reforms were introduced. These reforms were in the context of a wider change involving other politics and administrative aspects, with a strong push to decentralize the decisions and the accountability at the regional level. Now, each region has an individual Health Regional Fund allocated for health care, along with the subsequent need to implement regional and individualized strategies to assure the governance of the cost and quality of care. The National Department of Health now is solely responsible to control and monitor the delivery of the essential level of care at the regional level, and they have maintained the governance of the drug policy. Although the changes synthesized above will require a long period to be fully implemented, a few negative effects have already occurred. Nevertheless, all citizens in Italy will have full access to any level of care, without any restrictions, for complex and costly procedures (as no explicit selection/adverse criteria were implemented), and the current policy on drugs does not imply any barriers for people (as essential drugs are directly and fully reimbursed by the NHS, with a small copayment being the only intervention that may be occasionally implemented when considered necessary).
A multidisciplinary project to improve the quality of cancer pain management in Italy: background, methods, and preliminary results.
Pain afflicts most cancer patients, mainly in the advanced and metastatic phases of the disease. Despite the existence of several guidelines for cancer pain management that are based on the recommendations by the World Health Organization and the availability of effective treatments for 70% to 90% of cases, undertreatment is well documented and can involve up to 40% of patients. Undertreatment is usually attributed to an incorrect use of opioids for reasons often conceptualized in terms of barriers related to healthcare provider, patient, family, institution, and society. In Italy, opioid consumption rates are among the lowest in Europe despite some of recent efforts to improve the analgesic prescription and utilization. In the context of a wide project coordinated by the Mario Negri Institute, a non-for-profit private foundation located in Milan, Italy, 4 activities were launched: (1) a critical appraisal of information available on the Web, with the preparation and publication of a meta-site to facilitate the use of selected resources; (2) an evaluation of prescriptions of analgesic drugs in a cohort of cancer patients using a large administrative database; (3) a nationwide outcome research study to assess the epidemiology, quality, and effectiveness of different analgesic strategies; and (4) a multimodal, community-based intervention based on information, education, and training programs to change the knowledge, opinions, and attitude toward cancer pain treatment. Activities started in 2005. Some results and outputs are already available; others will be ready by the end of 2007.
Quality of life in breast and colon cancer long-term survivors: an assessment with the EORTC QLQ-C30 and SF-36 questionnaires.
AIMS AND BACKGROUND: Although the long-term survival of cancer patients has risen during the last decades, little is known about their quality of life. Assessment of the long-term effect of disease and treatments on subjective qualitative aspects of life that are related to health may be important for identifying specific long-term sequelae of cancer and treatments. In order to better understand the outcomes on a long-term survivor population, a sample of breast and colon cancer patients was evaluated using state-of-the-art health-related quality of life (HRQoL) approaches and instruments PATIENTS AND METHODS: EORTC OLQ-C30 and SF-36 HS questionnaires were mailed to a sample of subjects with a diagnosis of breast or colon cancer recruited in two randomized clinical trials with a median follow-up of 65 and 100 months, respectively. Data obtained with the SF-36 HS questionnaire were compared with data from a representative sample of the Italian population, whereas the EORTC QLQ-C30 data were evaluated across relevant subgroups. RESULTS: Out of 2208 subjects, 1772 were randomized to receive the different types of questionnaires and 921 answered (52%). According to the findings, if no serious comorbidity or relapse appeared, long-term cancer survivors reported having a substantially satisfying HRQoL, not much different from (age and sex) comparable controls. The most intriguing findings were those obtained from breast cancer patients. They reported a somewhat higher level than comparable Italian women of limitations in activities, when describing their role, as due to physical problems. In addition, breast cancer patients also reported lower scores (worse health perception) in two EORTC scales describing activities of daily living than colon cancer patients. When data were plotted according to the type of medical therapy, hormone therapy versus chemotherapy, a higher HRQoL was reported by the former than the latter group. CONCLUSIONS: Our study supports the hypotheses that the impact of cancer on quality of life over a period of time is not necessarily devastating in survivors. As regards the impact of different medical strategies, although our data are consistent with other research supporting the hypotheses that hormone therapy does not cause a decrease in long-term quality of life, differences we observed between hormone and chemotherapy might be caused by the action of confounds we were not able to control for or by the distortion introduced by the design of the present study.
Smoking in Italy, 2002.
AIMS AND BACKGROUND: To update estimates of smoking prevalence in Italy to the year 2002. METHODS: Population-based, face-to-face survey conducted by the DOXA (the Italian Branch of the Gallup International Association) in March-April 2002 on 3,238 individuals aged 15 or over, representative of the whole Italian population. RESULTS: Overall, 26.6% of Italian adults were current cigarette smokers (31.1% of men, 22.3% of women); 19.9% of men and 10.4% of women smoked 15 or more cigarettes per day. Ex-smokers were 15.2% (21.9% of men, 9.0% of women). There was no appreciable difference with reference to geographic area or education in men, but more educated women were more frequently smokers (28%). Compared to 2001, reported smoking prevalence declined by 3.7% in men and 1.3% in women, and the fall was evident in various age groups, including the youngest one (15-24 years). However, part of the fall is likely due to increased underreporting, since these survey figures are appreciably underestimated as compared to sale data. Among ex-smokers, 84% had stopped without support. Among smokers, 37% had tried at least once to stop. Using the Fagerström questionnaire, 69.5% of smokers were classified as low or very low dependent, whereas only 20.0% of smokers were classified as high or very high dependent. Women, younger and elderly, as well as more educated smokers of both sexes tended to be less dependent. CONCLUSIONS: Self-reported smoking prevalence tends to decline in Italy, although the overall figure (26.6% of Italian adults) remains considerably higher than the USA and several Western European countries.
Ethics committees in Italy: a survey on a sample of oncologists.
AIMS AND BACKGROUND: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. METHODS AND STUDY DESIGN: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. RESULTS: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. CONCLUSIONS: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.
Smoking in Italy 2003, with a focus on the young.
AIMS AND BACKGROUND: To update trends in smoking prevalence in Italy to 2003, with specific focus on the young. METHODS: A population-based, face-to-face survey conducted in February-April 2003 on 3,535 individuals aged 15 or over, representative of the whole Italian adult population, plus an over sampling of 426 subjects aged 15 to 24 years. RESULTS: Overall, 27.6% of Italians described themselves as current cigarette smokers (33.2% men, 22.5% women); 20.1% of men and 8.0% of women smoked 15 or more cigarettes per day. Ex-smokers were 16.6% (22.5% men, 11.2% women). No appreciable difference with reference to geographic area was observed. Less educated men, but more educated women, were more frequently smokers. As compared to previous years, no noticeable change was observed in overall smoking prevalence. However, an appreciable decline was observed in the young (15 to 24 years), from 37.6% in 2001 to 32.6% in 2003 for men, and from 30.4% to 20.7% for women. Among current smokers, 40.6% had tried at least once to stop. Of these, only 6.8% had used some pharmacological and 1.8% some psychological support. CONCLUSIONS: Overall self-reported smoking prevalence had not appreciably changed over the last few years. However, prevalence of smoking appears to have declined in the young. Compared to legal sale data, tobacco consumption is substantially under reported.
Smoking in Italian women and men, 2001.
AIMS AND BACKGROUND: To analyze and update smoking prevalence and trends in Italy to 2001. METHODS AND STUDY DESIGN: Population-based household survey conducted by the DOXA (The Italian Branch of the Gallup International Association) in 2001 on a total of 3,296 individuals aged 15 or over, representative of the whole Italian population. RESULTS: Overall, 28.9% of the Italian population (34.8% of males, 23.6% of females) were current cigarette smokers, and a further 0.2% (0.4% of males) were cigar or pipe smokers; 14.6% (19.9% of males, 8.7% of females) smoked 15 or more cigarettes per day. Ex-smokers were 16.6% (25.5% of males, 8.4% of females). In males the smoking prevalence steadily declined, from 65.0% in 1957 to 34.8% in 2001, but the fall was comparatively limited during the last decade. In females, the smoking prevalence was below 10% in the 1950s and 1960s, peaked at 25.9% in 1990, and declined to 23.6% in 2001. The mean number of cigarettes smoked per day, however, tended to increase, reaching 16.4 in 2001 (18.8 for males, 12.2 for females). Moreover, compared with legal sales data these figures appear underestimated by 25% to 35%. The difference in smoking prevalence between males and females tended to increase with age. Among males the smoking prevalence was lower in the North, while it was similar among females in various areas of the country. CONCLUSION: For the first time since the 1950s the overall smoking prevalence in Italian adults fell below 30%, but the figure is now higher than in most Western countries. Also for females the smoking prevalence in Italy is now higher than in the USA. This reflects the absence of any comprehensive policy and legislation against smoking in Italy.