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Biomedical subjects

G Apolone

Publications and source records attributed to G Apolone.

At least 19 recordsLinked to original sources
PubMed2006

Overweight and obesity in Italian adults 2004, and an overview of trends since 1983.

OBJECTIVE: Overweight has been increasing in several developed countries over the last few decades. No update information on the issue is available for Italy. DESIGN AND SETTING: We conducted a computer assisted personal in-house interview survey in March-April 2004, on a sample of 2932 Italian individuals (1407 men and 1525 women) aged 18 years or over, representative of the general adult Italian population. Information on weight and height was self-reported. RESULTS: Overall, 3.4% of the Italian adult population were underweight (< 18.5 kg/m2, 0.9% of men and 5.8% of women), 31.3% were overweight (25.0-29.9 kg/m2, 38.4% of men, 24.7% of women), and 8.2% were obese (> or = 30.0 kg/m2, 7.4% of men and 8.9% of women). Overweight or obesity was reported by 14.2% of subjects aged 18-24 years (20.6% of men and 7.6% of women). The highest proportions of overweight and obese subjects were in the 45-64 year age group for men (51.4% overweight, 10.0% obese) and in the > or = 65 year age group for women (38.8% overweight, 13.8% obese). Age- and sex-standardised prevalence of overweight or obesity was 36.0% for more educated subjects, and 54.0% for less educated ones. It was 32.3% in northern, 44.3% in central and 47.0% in southern Italy. Overweight increased from 1983 to the early 1990s, and levelled off thereafter. Prevalence of obesity remained around 8-9% across the last 20 years. CONCLUSIONS: Trends of overweight and obesity in Italy are more favourable than in several developed countries. Still, approximately 15 million of Italian adults are overweight and 4 million obese.

Adolescent↗
PubMed2005

Effects of new smoking regulations in Italy.

BACKGROUND: From 10 January 2005 the Italian government banned smoking in all indoor public places. We conducted a population-based survey to provide information on attitudes towards smoking regulation and to disentangle the impact of the smoking ban on tobacco consumption. PATIENTS AND METHODS: We considered data from a survey on smoking, based on 3114 subjects aged 15 or over, representative of the general adult Italian population in terms of age, sex, geographic area and socioeconomic status. RESULTS: Once smoke-free policies were introduced, support for them in the public opinion tended to increase. In Italy, smoke-free policies accounted for around 8% decrease in cigarette consumption in the short run. Moreover, tobacco bans were almost universally accepted, and the smoke-free legislation did not seem to unfavourably affect the business of restaurants or cafes. CONCLUSIONS: The results of our study on the first extensive smoking ban in a large country show the advantages of smoke-free legislations, which may have major public health implications.

Female↗
PubMed2005

Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures.

Despite important progress in understanding the molecular factors underlying the development of cancer and the improvement in response rates with new drugs, long-term survival is still disappointing for most common solid tumours. This might be because very little of the modest gain for patients is the result of the new compounds discovered and marketed recently. An assessment of the regulatory agencies' performance may suggest improvements. The present analysis summarizes and evaluates the type of studies and end points used by the EMEA to approve new anticancer drugs, and discusses the application of current regulations. This report is based on the information available on the EMEA web site. We identified current regulatory requirements for anticancer drugs promulgated by the agency and retrieved them in the relevant directory; information about empirical evidence supporting the approval of drugs for solid cancers through the centralised procedure were retrieved from the European Public Assessment Report (EPAR). We surveyed documents for drug applications and later extensions from January 1995, when EMEA was set up, to December 2004. We identified 14 anticancer drugs for 27 different indications (14 new applications and 13 extensions). Overall, 48 clinical studies were used as the basis for approval; randomised comparative (clinical) trial (RCT) and Response Rate were the study design and end points most frequently adopted (respectively, 25 out of 48 and 30 out of 48). In 13 cases, the EPAR explicitly reported differences between arms in terms of survival: the range was 0-3.7 months, and the mean and median differences were 1.5 and 1.2 months. The majority of studies (13 out of 27, 48%) involved the evaluation of complete and/or partial tumour responses, with regard to the end points supporting the 27 indications. Despite the recommendations of the current EMEA guidance documents, new anticancer agents are still often approved on the basis of small single arm trials that do not allow any assessment of an 'acceptable and extensively documented toxicity profile' and of end points such as response rate, time to progression or progression-free survival which at best can be considered indicators of anticancer activity and are not 'justified surrogate markers for clinical benefit'. Anticipating an earlier than ideal point along the drug approval path and the use of not fully validated surrogate end points in nonrandomised trials looks like a dangerous shortcut that might jeopardise consumers' health, leading to unsafe and ineffective drugs being marketed and prescribed. The present Note for Guidance for new anticancer agents needs revising. Drugs must be rapidly released for patients who need them but not be at the expense of adequate knowledge about the real benefit of the drugs.

Antineoplastic Agents↗
PubMed2005

Tobacco dependence in the general population in Italy.

BACKGROUND: Measures of tobacco dependence are mainly used in the clinical setting, but limited information is available on tobacco dependence on a population level. MATERIALS AND METHODS: To obtain estimates of tobacco dependence on a population level, a six-item Fagerstrom questionnaire was used in two surveys, conducted in 2002-2003 on a sample of 6773 individuals aged 15 years or over, representative of the Italian adult population. RESULTS: Overall, 27.1% of Italian adults described themselves as current cigarette smokers (32.2% of men, 22.4% of women). Of all smokers, 42.8% were classified as very low dependent, 28.6% as low dependent, 11.0% as intermediate, 13.8% as high and only 3.8% as very high dependent. The proportions of very low/low dependent were 67.4% in men and 76.8% in women. Those of high/very high dependent smokers were 21.4% in men and 12.5% in women, but only 2.8% at age 15-17 years and 8.4% at age 18-24 years. Only 23% of smokers, moreover, found it difficult to avoid smoking in places where smoking was forbidden. CONCLUSIONS: The observation that over two-thirds of smokers on a population level in Italy report low or very low dependence has useful implication for intervention on stopping smoking, particularly in the young, who appear to be low dependent. However, in this age group cessation rates were comparatively low.

Adolescent↗
PubMed2003

The QUOVADIS Study: features of obese Italian patients seeking treatment at specialist centers.

Obesity is a major risk factor for several chronic diseases, but the burden associated with it also extends to psychosocial areas and to perceived health status. In 1999 an observational study on health-related quality of life in obesity was planned. The study was entirely web-based. Case Report Forms and the individual items of 7 self-administered questionnaires were directly implemented on a general database via an extranet system from 25 Italian centers. By December 2001, after enrolment had stopped, the database included anthropometric, socioeconomic and clinical data of 1944 patients (78% females). Weight-cycling was reported in over 80% of cases, overeating in 60-65%, structured physical activity in only 13-15%. Several chronic illnesses were associated. Whereas the prevalence of diabetes and hypertension was related to the degree of obesity, hyperlipidemia and coronary heart disease did not increase further with increasing obesity. A disturbed psychological mood was twice more common in females. Concern for present health was the main reason for seeking treatment in both genders; concern for body appearance was more common in females. Male subjects were more frequently assigned to dietary counseling and physical exercise, whereas in females psychotherapy was more frequently considered. Various forms of behavioral approach were planned in approximately 50% of patients. Finally, very few patients were initially considered for pharmacological intervention or bariatric surgery. The study provides a comprehensive picture of Italian patients seeking treatment for obesity. Data on perceived health status, psychological well being, body image awareness, eating behavior disorders and psychopathological distress will provide clues to a comprehensive assessment of obesity, the effects of treatments and reasons for failure.

Adolescent↗
PubMed2002

Is EQ-5D a valid measure of HRQoL in patients with movement disorders? A comparison with SF-36 and FIM questionnaires.

We assessed the descriptive part of the EQ-5D system in rehabilitation patients with validity severe moving disorders and compared it with the FIM and the SF-36 Health Survey in a sample of 60 patients. We analyzed the EQ-5D convergent validity and the correlations between EQ-5D scores and a clinical variables. The internal validity of the EQ-5D instrument proved good. Moreover, the EQ-5D discriminated symptom severity as scored by the FIM and the SF-36 correspondent subscales. We analyzed the sensitivity of the EQ-5D only with respect to the ability of patients to move with or without a wheelchair. Most patients considered "moving a wheelchair" as a good way of "getting about." This investigation can be considered a pilot study on the performance of the EQ-5D in a group of pathologies involving various degrees of movement disorders. The findings show possible problems of misinterpretation in the levels of the mobility dimension.

Journal Article↗
PubMed2002

Does a drug do better when it is new?

BACKGROUND: When assessing a new, promising therapeutic approach, a clinician's perception of a drug's effectiveness may be shaped by different kinds of phenomena, and among them, a favorable attitude towards new treatments, and as a result a tendency to overestimate their efficacy (wish bias). MATERIALS AND METHODS: A retrospective study of published randomized clinical trials of doxorubicin-based chemotherapy for advanced breast cancer was carried out. Global (complete plus partial) response rate over time with allowance for type of drug regimen (mono- or polychemotherapy) and prior adjuvant therapies was assessed in the doxorubicin-containing arm using multivariate logistic regression analysis. RESULTS: Twenty-nine studies published from 1975 to 1999 were retrieved for a total of 2234 women with advanced breast cancer enrolled in the doxorubicin-containing arms. There was a significant decrease in response rate to doxorubicin as first-line treatment over time that resisted adjustment for important differences in therapeutic management [odds ratio for global response = 0.89, 95% confidence interval (CI) 0.81 to 0.99]. CONCLUSIONS: Although only one drug (doxorubicin) in one clinical context (advanced breast cancer) has been analyzed, our findings support the use of double blind methodology whenever possible when assessing subjective endpoints and encourage further studies aimed at defining the clinical relevance of a wish bias in medicine.

Antineoplastic Agents↗
PubMed2002

Knowledge and opinion on prostate and prevalence of self-reported BPH and prostate-related events. A cross-sectional survey in Italy.

Benign prostatic hyperplasia (BPH) is a very common condition in ageing men and causes considerable morbidity. Although great strides have been made recently, important issues remain under-researched and poorly understood. We have conducted a survey on a representative sample of Italian males to investigate the knowledge and opinion on prostate, to estimate the self-reported prevalence and intensity of BPH and LUTS (low urinary tract symptoms) and to evaluate the performance of the International Prostate Symptom Score (I-PSS) in a population-based sample. Trained interviewers administered a standardized questionnaire to a representative random sample of 671 Italian men aged 50 years and over, between May and June 2000. Univariate and multivariate statistical techniques were used to estimate the prevalence of relevant events, and the associations with selected variables. Only half of responders were able to identify the reason for prostate enlargement, less than one-third recently had spoken with a doctor, and only 8.6% had had a rectal examination. Further, 13.7% (95% confidence interval (CI) 11.1-16.3%) had ever been told they had BPH, with less than half of them receiving surgery for BPH. About 19% reported moderate-severe I-PSS. Both self-reported BPH and severe-moderate LUTS increased significantly with age ( -value <0.01). As to the I-PSS performance, we documented in a community-based sample that it is reliable and valid. Results of the multivariate analysis suggest that, in addition to age, a person's knowledge that they have BPH and a poor perception of health status are the main variables associated with the probability of moderate-severe LUTS. In conclusion, this community-based survey documents that Italian males have a poor knowledge and perception of prostate-related conditions and do not adequately care about them and, thus, do not seek medical attention. These facts notwithstanding, urological conditions such as BPH are common and may largely affect an individual's life. Our findings might help in the design and implementation of effective interventions to improve people's knowledge and understanding of prostate and change their attitudes towards medical care.

Adult↗
PubMed2001

Factors associated with poor health-related quality of life of patients with cirrhosis.

BACKGROUND & AIMS: Increasing interest is being given to health-related quality of life in chronic diseases. In cirrhosis, both physical functioning and mental well-being may be altered, but no study has investigated factors associated with a poor perceived health status. METHODS: We measured quality of life by Short Form-36 and Nottingham Health Profile questionnaires in 544 patients with cirrhosis. Data were compared with age- and gender-adjusted values of 2 random samples of the Italian population (more than 2000 subjects). Factors associated with poor perceived health status were identified by logistic regression. RESULTS: All domains of health-related quality of life, except pain, were altered in cirrhosis (by 9%-42%), mainly in younger patients. There were minor differences in relation to gender, whereas etiology had no effects. Severity of disease (Child-Pugh score) and, above all, muscle cramps were the factors most closely associated with poor health status perception. Self-rating of disease progression was associated with ascites and pruritus, whereas previous variceal sclerotherapy and the use of disaccharides had a protective effect. Most areas of daily life were affected by perceived health problems; this was mainly true for paid employment and sex life in men and home life and social life in women. CONCLUSIONS: Quality of life is variably impaired in cirrhosis, also in uncomplicated patients. Non-life-threatening symptoms, such as muscle cramps, are of major concern. These data are the basis for longitudinal studies measuring the effects of therapy and procedures on patient-derived health outcomes.

Aged↗
PubMed2001

Subjective health status assessment: evaluation of the Italian version of the SF-12 Health Survey. Results from the MiOS Project.

BACKGROUND: SF-12 is a generic short form health survey, developed in the USA from the original SF-36. It produces two summary measures evaluating physical and mental self-perceived health that are interchangeable with those from the SF-36. SF-12 has been successfully tested in nine Western European countries on large samples of the general population, where it has proved its brevity, comprehensiveness, reliability, validity and cross-cultural applicability. The present analysis directly assesses the SF-12 for the first time in various Italian settings, including the general population and specific patient groups. METHODS: Data for this report were collected from five different samples; in four of them the SF-12 was used as a 'stand-alone' instrument, while in the other one (used as the reference) it was embedded in the SF-36. Descriptive statistics, Spearman's correlation coefficients, confirmatory factor analysis, ordinal uni- and multi-variate least squares regression model and covariance analysis were used to evaluate the summary measures in each sample, and across relevant subgroups. Studies were ordered according to the expected deviance, from the 'normal' health status of the reference group to the sample with the expected highest level of illness. RESULTS: Overall, more than 11,000 subjects were evaluated. Response rates ranged from 63 to 100%, while missing items accounted only for 0.2-8.2% of all items. Uni- and multi-variate analyses showed a positive association between both physical component summary (PCS) and mental component summary (MCS) scores and their respective items in all examined samples. MCS scores were fairly similar across all samples, with the only exception being patients recently discharged from hospital, whose subjective mental health perception was higher than expected and the highest of all (52.2). Finally, we found a substantial impact of ageing on physical health perception, while the MCS was shown to be less sensitive to the age effect. CONCLUSIONS: This analysis shows that the SF-12 has good validity, while some issues related to its most appropriate mode of administration and target groups might require further attention.

Adolescent↗
PubMed2001

Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval.

Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: (i) identify diseases or drugs for which formal HR-QOL assessment is recommended; (ii) identify measures and methods recommended; and (iii) evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts.

Drug Approval↗
PubMed2000

The performance of SF-36 health survey in patients with laryngeal cancer. Head and Neck Cancer Italian Working Group.

BACKGROUND: Interest in measuring health-related quality of life has increased together with the awareness that such humanistic outcomes require valid and reliable measures. Among the several generic questionnaires, the Short Form 36 Items Health Survey (SF-36) is recognized for its comprehensiveness, brevity, and high standards of reliability and validity. It has been translated and validated in several languages. METHODS: In the framework of a larger, prospective, multicenter study aimed to produce and validate an Italian questionnaire tailored to laryngeal cancer patients, the SF-36 was administered to a sample of well-characterized cases. It was, therefore, possible to test its characteristics in terms of patients' acceptance, psychometric, and clinical validity. RESULTS: Overall, findings show that in this sample of 165 consecutive patients with laryngeal cancer at various stage of disease, the SF-36 performance was very good. The patients' acceptance was satisfactory: all patients completed the questionnaire. All the questionnaire scales met the standards suggested in terms of grouping and scaling assumptions. The internal reliability coefficients actually replicate the satisfactory findings reported for the original SF-36. In terms of capability of the questionnaire scales to discriminate between groups expected to differ in a given health concept in relation to clinical variables, the results were also good. CONCLUSIONS: This study showed that SF-36 was well accepted by patients and was able to detect the impact of different treatment approaches on health- related quality of life. It is likely that the sensitivity and the precision of the SF-36 can be further improved by integrating brief questionnaire modules specific for laryngeal clinical issues.

Adaptation, Psychological↗
PubMed2000

Functional status in patients with spinal cord injury: a new standardized measurement scale. Gruppo Interdisciplinare Valutazione Interventi Riabilitativi.

OBJECTIVE: To report on the validation process of a new functional assessment scale (Valutazione Funzionale Mielolesi [VFM]) for patients with spinal cord injury (SCI). DESIGN: Prospective study testing for the VFM in a sample of patients with SCI to evaluate the scale characteristics in terms of psychometric and clinical validity. SETTING: Eight SCI units located in northern Italy. PATIENTS: One hundred patients were recruited and followed up for 18 months. Seventy-seven subjects were men, subjects' mean age was 37 years, 67 were paraplegic, and for 81 their SCI was of traumatic etiology. MAIN OUTCOME MEASURES: VFM's characteristics are described using estimates of construct and criterion validity (estimates of the strength and direction of associations between different VFM tasks and between VFM and other medical and nonmedical variables). The Barthel index was used as concurrent and independent measure. RESULTS: VFM met all psychometric criteria usually recommended and, at least in the current sample, was found to be strongly correlated with independent clinical variables (diagnosis and lesion level) and with the Barthel index. Moreover, most of the domains were able to document large and significant changes over time. CONCLUSIONS: VFM is a reliable and valid tool that can be used confidently in the rehabilitation setting for patients with SCI to screen for functional problems and monitor changes in patients' functional status and impact of rehabilitation.

Activities of Daily Living↗
PubMed2000

Health-related quality of life in asymptomatic patients with HIV. Evaluation of the SF-36 health survey in Italian patients.

OBJECTIVE: To investigate the psychometric performance and clinical validity of the 36-Item Short Form (SF-36) health survey when completed by asymptomatic HIV-positive Italian patients and to compare their health profile with a representative sample of 2031 Italian citizens (the Italian norm). PATIENTS AND METHODS: This was an observational, multicentre, cross-sectional survey. Microbiologists throughout Italy recruited asymptomatic HIV-positive individuals who were aged at least 18 years and aware of their infection. Investigators collected demographic, social, clinical and treatment data. Patients, classified into 2 clinical categories (A1 and A2) according to explicit pre-defined criteria, completed the SF-36 health survey in the context of a medical visit. RESULTS: Between April and July 1996, 46 microbiologists recruited 214 patients (201 evaluable). No inconsistent responses were observed in 96% of the sample. The usually recommended psychometric standards were satisfied, and the internal consistency reliability indices were always greater than 0.70. Weak to moderate associations were found between SF-36 health survey scores and physicians' estimates of patients' physical performance, while no significant associations were found with CD4+ counts. On average, HIV-positive patients reported lower scores than the Italian norm, and patients in category A2 showed lower scores than patients in A1. These differences were more relevant in scales describing role limitations, general health perception, and psychological well-being. CONCLUSION: Our study showed that the SF-36 health survey maintained its psychometric properties in a sample of Italian asymptomatic HIV-positive patients and produced data that showed its validity and robustness in such a setting.

Adolescent↗