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Biomedical subjects

Giovanni Apolone

Publications and source records attributed to Giovanni Apolone.

At least 19 recordsLinked to original sources
PubMed2006

Development and validation of the short version of the Psychological General Well-Being Index (PGWB-S).

BACKGROUND: The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed in US which produces a self-perceived evaluation of psychological well-being expressed by a summary score. The PGWBI has been validated and used in many countries on large samples of the general population and on specific patient groups. Recently a study was carried out in Italy to reduce the number of items of the original questionnaire, yielding the creation of a shorter validated version of the questionnaire (PGWB-S). The purpose of the present paper is to describe the methods adopted and to report and discuss the relevance of results. METHODS: Data for this study were collected from 4 different population samples: two general population samples a student and a patient sample. On the basis of the results of the first (development) sample population, six relevant items were identified statistically from the original questionnaire and grouped to assemble a new summary scale. Following the newly created 6-item questionnaire was administered in three independent population samples. Descriptive statistics, correlation coefficients, univariate and multivariate regression analyses were used to compare the performance of the long and short questionnaire, within and between population samples and across relevant subgroups. A further independent sample extracted by an ongoing cancer clinical trial served as final validation step. RESULTS: Overall, the questionnaires were administered to 1443 subjects. Six items were selected by a step-wise approach to explain 90% of the variance of the summary measure of the original questionnaire. Response rates reached 100%, while missing items were not observed. University students (n = 400) showed the highest mean value of the summary measure (75.3); while the patient sample (n = 28) had the lowest score (71.5). The correlation coefficients between the summary measures and the single items according to the different studies were satisfactory, reaching the highest estimates in the student sample. The internal consistency showed high values of the Cronbach's alpha coefficient (range 0.80-0.92) for all three study samples, coming close to the value of the coefficient established for the original questionnaire (0.94). A cross-validation in an independent sample of 755 cancer patients confirmed the item selection procedure and amount of variance explained by the new shorter questionnaire (ranging from 90. 2 to 95.1 %, across age and sex strata). CONCLUSION: The newly identified PGWB-S showed good acceptability and validity for the use in various settings in Italy. The translation of the PGWB-S into different languages, and its use in other linguistic settings will add evidence about its cross-cultural validity.

Adolescent↗
PubMed2006

Pain in cancer. An outcome research project to evaluate the epidemiology, the quality and the effects of pain treatment in cancer patients.

BACKGROUND: Management of pain related to advanced or metastatic cancer, although the availability of several pharmacological and non-pharmacological interventions and the existence of well-known guidelines and protocols, is often difficult and inadequate. Evidence of the relative effectiveness of current options for treating cancer pain from comparative randomized studies is scanty. METHODS: In the context of a wider project, a multicenter, open label, prospective Outcome Research study will be launched in Italy in 2006 to investigate the epidemiology of cancer pain and of its treatments, the quality of analgesic-drug therapy and the effectiveness of alternative analgesic strategies in a large, prospective, unselected cohort of cancer patients using the state-of-the art of patient-reported-outcomes. About 100 Italian centers will recruit 2500 patients with advanced/progressive/metastatic cancer with pain (related to the cancer disease) requiring analgesic treatments. Each center is expected to recruit 25 consecutive and eligible patients during the study inception period. Approximately two months will be allowed for subject recruitment and enrollment. Subject evaluation and follow-up will be for 3 months. The effect on outcomes of various therapeutic analgesic options administered by physicians, given the observational approach where patients are not assigned at random to different treatments, will be compared using the propensity score approach, allowing the adjustment for treatment selection bias. Later, after the launch of the observational study and on the basis of results, in specific subsamples of patients and in select centers of the network, a Randomized Controlled Trial will be carried out to formally compare the efficacy of alternative analgesic strategies, with particular emphasis on oral morphine (as comparator) and buprenorphine patch (as experimental arm). Results from the outcome (cohort) and experimental (Randomized Controlled Trial) studies will ensure both the external and internal validity.

Adult↗
PubMed2006

Construct validity of the Short Form-36 Health Survey and its relationship with BMI in obese outpatients.

OBJECTIVE: To investigate the construct validity of the Short Form-36 (SF-36) Health Survey questionnaire in obese patients. RESEARCH METHODS AND PROCEDURES: Our series consisted of 1735 obese patients (age, 44.7 +/- 11.0 years; 1346 women) consecutively enrolled in the QUOVADIS study, an observational multicenter study of obese treatment-seeking outpatients. The construct validity of the SF-36 was assessed by main component analysis. Age-, gender-, and education-adjusted general linear models were used to investigate the relationship between BMI and SF-36 domains or factors identified by main component analysis. RESULTS: BMI was significantly associated with poor health-related quality of life in all eight SF-36 domains, and the strongest association was observed with physical activity. Main components analysis generated a six-factor solution explaining 59% of the observed variance. BMI was strongly associated with factors based on the loading of items regarding the physical activity domain and factors based on role-physical and role-emotional items or general health and bodily pain items. In contrast, mental health-, vitality-, and social functioning-based factors were not related to BMI. DISCUSSION: In obese treatment-seeking outpatients, the clustering of SF-36 items in main components is not significantly different from the domain-based approach generally used, thus confirming the robustness of such a generic questionnaire in this specific condition. However, the peculiar clustering of some SF-36 items and their relationship with BMI suggest that the health-related quality of life profile of subjects belonging to that population may be better described with alternative aggregations of the SF-36 items or with disease-tailored questionnaires.

Adult↗
PubMed2006

Prevalence of smoking and attitude towards smoking regulation in Italy, 2004.

AIMS AND BACKGROUND: To update trends in smoking prevalence in Italy to 2004, and describe the attitudes towards forthcoming regulation of smoking. METHODS: Population-based face-to-face survey conducted in March-April 2004 on a sample of 3050 individuals (1509 men and 1541 women) aged 15 or over, representative of the general adult Italian population in terms of age, sex, geographic area, habitat, education and working status. RESULTS: Overall, 26.2% of the Italians aged 15 or over described themselves as current cigarette smokers (30.0% of men, 22.5% of women); 19.1% of men and 11.2% of women smoked 15 or more cigarettes per day. Ex-smokers were 17.9% (24.8% of men, 11.2% of women). The difference in smoking prevalence between men and women was greater in the elderly. More educated men, and those residing in northern Italy were less frequently current smokers. Conversely, women with a low level of education (19%) were less frequently current smokers than those with higher education (24%). More than 85% of Italian adult population were in favour of restrictions of smoking in public places, such as cafes and restaurants, and to ban smoking in workplaces. CONCLUSIONS: Self-reported smoking prevalence is decreasing in men but not in females. There is widespread support for smoking restriction in public areas.

Adolescent↗
PubMed2006

Oncologists' opinions about research ethics committees in Italy: an update, 2004.

While there is general consensus about the basic features of ethical research, the explosion of information from technology, genetics and clinical research, and the desire to accelerate the translation of preliminary findings into clinical research and practice have created space for conflicts between the aims of research, medical ethics and human rights. Research ethics committees (RECs) play a crucial role. In 2004, a short standardized questionnaire was sent to 110 Italian oncologists. The questionnaire explored aspects of the interaction between oncologists and RECs, including reports on personal experience with RECs, and the oncologists' opinions and level of satisfaction with important functions of RECs, such as bureaucratic, ethics, scientific, and educational and training aspects. The findings are compared with those from the previous surveys. Eighty-three out of the 91 oncologists returned the questionnaire. Responders were working in 67 hospitals (60 RECs). The level of satisfaction with REC activities was high for ethical and scientific aspects (87 and 80% were satisfied or very satisfied, respectively); somewhat lower for bureaucratic and secretarial aspects (61%); and much lower for educational and formation activities (33%). Comparison with other surveys does not show any important difference. The main findings of this survey are the stable figures concerning oncologists' opinions and the low ratings given to education and training aspects. This latter finding clearly identifies the need for educational activities, and the possibility of using this approach to foster interactions between RECs and researchers.

Attitude of Health Personnel↗
PubMed2005

Channels of cigarette distribution, price and tobacco consumption in Italy.

BACKGROUND: Limited information is available on the role of smuggling and of perceived influence of cigarette price on tobacco consumption in Italy. To elucidate the issues, we included specific questions in a survey on smoking in Italy. METHODS: Between March and April 2004, we conducted a survey on 3050 individuals aged 15 or over, representative of the general adult Italian population. The questionnaire included the estimate of the role of various channels of cigarette distribution and information on the self-reported perception of influence of prices on cigarette consumption in the young. RESULTS: Among current smokers, 85.6% bought cigarettes from tobacco shops, 7.5% from vending machines, and 6.9% from other channels of distribution, including smuggling, and internet (plus offered cigarettes). Overall, 35.9% of ever smokers (37.9% of males and 32.8% of females) reported that the prices had an intermediate to high influence on cigarette consumption in the young. Younger and less educated smokers were not more prone to report an influence of prices. CONCLUSIONS: These data indicate that in Italy smuggling now covers a limited proportion of cigarette sales, while cigarette prices have a substantial influence on tobacco consumption in the young.

Adolescent↗
PubMed2005

How Italian health consumers feel about clinical research: a questionnaire survey.

BACKGROUND: Because little information is available about the public's awareness of and attitudes toward clinical research, we planned a survey on a convenience sample of health consumers. METHODS: A cross-sectional national survey was carried out using a questionnaire with seven multiple choice questions and two scenarios. A convenience sample of 2000 individuals aged 18 years and older was interviewed in nine out of 21 Italian regions. RESULTS: Sixty-nine per cent reported they were aware of the existence of clinical research and 45% were aware of ethics committees; 29% and 49% indicated they would agree to participate in a prevention study or therapeutic randomized clinical trial, respectively. These percentages decreased when we asked about giving permission for a younger relative. Participants' awareness, opinions and attitudes varied significantly according to socio-demographic and geographical variables. People who were aware of clinical research tended to have a more open attitude toward participation [preventive study: odds ratio (OR) 1.6, 95% confidence interval (CI) 1.3-2.0, P = 0.001; therapeutic study: OR 1.3, 95% CI 1.1-1.6, P = 0.003), even after adjustment for confounding factors. A comparison with an independent and random sample of Italian citizens documented a difference in relevant case-mix factors and a different profile in terms of awareness, opinion and attitudes, which held after statistical adjustment. CONCLUSIONS: Health consumers are generally not very aware of clinical research, and their attitudes towards participation seem to be related to the level of awareness. A few variables, such as age, sex, schooling and area of residence, are related to the study questions. These findings may help with the implementation of educational interventions, and underline the need to create meaningful partnerships between health professionals and consumer associations.

Adolescent↗
PubMed2005

Influenza vaccine in healthy children: a meta-analysis.

We conducted a meta-analysis of 13 randomised clinical trials evaluating the efficacy of influenza vaccine in healthy children. Against culture-confirmed influenza the overall efficacy was 74% (95% confidence interval, CI, 57%-84%), 65% for inactivated and 80% for live-attenuated vaccine. Corresponding figures were 59% (95% CI 43%-71%), 63% and 54% for serologically-confirmed influenza, and 33% (95% CI 29%-36%), 33% and 34% for clinical illness. Influenza vaccine is effective in preventing laboratory-confirmed and clinical influenza in healthy children, with no clear difference between inactivated and live-attenuated vaccine. Data on infants and younger children were too scanty to allow separate assessment.

Adolescent↗
PubMed2005

Impact of a major thermoelectric plant on self-perceived health status.

BACKGROUND: Measuring self-perceived health status and risk perception according to environmental factors remains a major open issue with important health policy implications. METHODS: To measure self-perceived health status in an area where a major thermoelectric plant has been active since 1994, in October 2001, we conducted a two sample survey using the SF-12 Health Survey. The study sample (2001 individuals) representative of the population living in the plant area (Montalto di Castro, Central Italy) was compared with a random sample of the general Italian population (1928 individuals). Mean values were adjusted for age, sex and education. RESULTS: SF-12 summary scales means are comparable in both samples: 50.2 (SE: 0.3) versus 49.9 (SE: 0.3) for the physical score, and 47.7 (SE: 0.4) versus 48.7 (SE: 0.4) for the mental score for Montalto di Castro area and Italian sample respectively. CONCLUSION: People living near a major thermoelectric plant have a subjective health status comparable to that reported by the general Italian population.

Adolescent↗
PubMed2004

Quality of life in randomized trials of cytotoxic or hormonal treatment of advanced breast cancer. Is there added value?

BACKGROUND: Since most advanced cancers are still incurable, oncologic clinical research pays considerable attention to palliation, increasingly valuing subjective measures of outcome such as quality of life (QoL). We reviewed randomised clinical trials (RCT) of cytotoxic or hormonal treatments in advanced breast cancer (ABC), published before December 2003, to evaluate the methodological quality of QoL assessment and assess its added value (over classical clinical endpoints (CCE), i.e. survival, response, time to progression, toxicity) in the choice of the best treatment option. METHODS: RCTs were classified according to treatment characteristics and the CCEs. A descriptive analysis was based on the methodological aspects of QoL assessment and the clinical value of QoL findings was judged by counting the frequency of reporting in the study abstracts and the assessment of QoL combined with CCEs. RESULTS: We retrieved 33 eligible RCTs (10,791 patients); only 20 reported the number of patients considered in QoL principal analysis and only 69% of randomized patients were included in such analyses. A total of 17 different QoL questionnaires were used, 11 only once. QoL assessment lasted from less than 12 weeks to progression, and timing of questionnaires from 2 to 12 weeks. Compliance rates were 85.7% for baseline forms and 67% for overall assessment, but this information was available for only 18 and 20 trials, respectively. Wide variability emerged in analysis strategies and statistical approaches. QoL findings were reported in 12 study abstracts (37% of patients). Eight studies reported a significant difference in QoL scores but since QoL data often failed to parallel the clinical findings (e.g. better QoL scores were reported in two of 17 trials with better CCEs and in six of 20 with significant differences in toxicity profiles), the QoL added value was difficult to ascertain and, on the whole, only moderate. CONCLUSION: In ABC trials, QoL assessment added relatively little value to CCEs in helping select the best treatment option, apparently largely because of sub-optimal methodological standards.

Antineoplastic Agents, Hormonal↗
PubMed2004

The metabolic syndrome in treatment-seeking obese persons.

Obesity is a major risk factor for several metabolic diseases, frequently clustering to form the metabolic syndrome, carrying a high risk of cardiovascular mortality. We aimed to assess the prevalence of the metabolic syndrome in treatment-seeking obese subjects and the potential protective effect of physical activity. A cross-sectional analysis of data from a large Italian database of treatment-seeking obese subjects was performed. The metabolic syndrome was defined according to the criteria provisionally set by the National Cholesterol Education Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, based on waist circumference, fasting glucose, triglyceride (TG) and high-density lipoprotein-cholesterol (HDL-C) levels, and arterial pressure. Data were available in 1,889 Caucasian subjects, 78% females, from 25 obesity centers. Minimum criteria for the metabolic syndrome were fulfilled in 53% of cases. The prevalence increased with age and obesity class and was negatively associated with participation in a structured program of physical activity (odds ratio, 0.76; 0.58 to 0.99; P =.041), after correction for age, sex, and body mass. The prevalence of cardiovascular disease was higher in subjects with the metabolic syndrome. A subset of 12.8% of cases had no metabolic abnormalities. They had a lower prevalence of abdominal obesity and cardiovascular disease. Isolated obesity was significantly associated with physical activity (odds ratio, 1.86; 1.33 to 2.60; P =.0003). Multiple metabolic disorders are present in most obese patients, and their prevalence is lower in physically active subjects. It is time to move towards a more integrated approach and to reconsider resource allocation to improve lifestyle changes for large-scale control of obesity.

Adult↗
PubMed2003

Clinical and outcome research in oncology. The need for integration.

Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of specific knowledge, methods, instruments and resources and upon their appropriate integration in the mainstream of clinical research. In the USA specific interdisciplinary projects have been launched by the NCI. In Europe there is a lack of such initiatives. The correct placement of OR in the anti-cancer drug development process will guarantee the highest possible standard of validity and reliability of OR at European level and better integration of both translational and outcome research in the mainstream of clinical research into anti-cancer drugs, thus speeding up the introduction of the results of patient-oriented translational clinical research into clinical practice.

Antineoplastic Agents↗
PubMed2003

Laparoscopic uterosacral ligament resection for dysmenorrhea associated with endometriosis: results of a randomized, controlled trial.

OBJECTIVE: To evaluate the efficacy of laparoscopic resection of the uterosacral ligaments in women with endometriosis and predominantly midline dysmenorrhea. DESIGN: Randomized controlled trial. SETTING: Two academic departments. One hundred eighty patients undergoing operative laparoscopy as first-line therapy for stage I to IV symptomatic endometriosis. INTERVENTION(S): Operative laparoscopy including uterosacral ligament resection or conservative surgery alone. MAIN OUTCOME MEASURE(S): Proportion of women with recurrence of moderate or severe dysmenorrhea 1 year after surgery. RESULT(S): No complications occurred. Among the patients who were evaluable 1 year after operative laparoscopy, 23 of 78 (29%) women who had uterosacral ligament resection and 21 of 78 (27%) women who had conservative surgery only reported recurrent dysmenorrhea. The corresponding numbers of patients at 3 years were 21 of 59 (36%) women and 18 of 57 (32%) women, respectively. Time to recurrence was similar in the two groups. Pain was substantially reduced, and patients in both groups experienced similar and significant improvements in health-related quality of life, psychiatric profile, and sexual satisfaction. Overall, 68 of 90 (75%) patients in the uterosacral ligament resection group and 67 of 90 (74%) patients in the conservative surgery group were satisfied at 1 year. CONCLUSION(S): Addition of uterosacral ligament resection to conservative laparoscopic surgery for endometriosis did not reduce the medium- or long-term frequency and severity of recurrence of dysmenorrhea.

Adult↗