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Biomedical subjects

Paola Mosconi

Publications and source records attributed to Paola Mosconi.

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

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

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

Health-related quality of life and need for IVF in 1000 Italian infertile couples.

BACKGROUND: A specific and still poorly investigated issue in the field of infertility is represented by the impact that the need for IVF techniques may have on health-related quality of life (HRQoL). METHODS: A total of 1000 consecutive couples (1000 women and 1000 men) were invited to complete the Health Survey Short Form (SF-36) questionnaire separately, prior to initiating their first IVF attempt in our unit. Patients were also invited to report about demographic and clinical characteristics. RESULTS: A total of 1936 (96.8%) agreed to participate. Male SF-36 scores were higher than those reported by women. Duration of infertility and previous IVF attempts significantly influenced HRQoL (P < 0.01). When scores were plotted in relation to the normative source of the Italian general population stratified by gender, corresponding age and geographical area, the subjective health profile did not significantly differ from the normative sample for both women and men. CONCLUSION: The need for IVF did not seem to markedly influence subjective health status. Conversely, duration of infertility and failure to achieve a pregnancy through IVF might have a negative impact.

Adult↗
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

Health-related quality of life in Italian patients with narcolepsy: the SF-36 health survey.

OBJECTIVE: To evaluate the psychometric performances of the 36-item short form (SF-36), a tool measuring health-related quality of life (HRQoL) in patients with narcolepsy or other sleep disorders, presenting excessive daytime sleepiness (EDS) as the main symptom. To compare the HRQoL of patients with narcolepsy with the Italian norm. To disclose the clinical predictors influencing the HRQoL. PATIENTS AND METHODS: One hundred and eight adults with narcolepsy, 115 with obstructive sleep apnea syndrome (OSAS) and 42 with idiopathic hypersomnia (IH) enrolled for a multicentric cross-section study employing self-administered questionnaires investigating the HRQoL (SF-36), EDS and cataplexy. A psychometric analysis and the standardized scoring of the 8 scales of the SF-36 were performed. The correlation between SF-36 scales and clinical features of narcolepsy was measured by a multiple linear regression analysis. RESULTS: SF-36 satisfied the recommended psychometric standards. Patients with narcolepsy had all domains except Bodily Pain lower than the Italian norm. Some of the variance of Physical Functioning (R(2) 0.07), Role functioning-Physical (R(2) 0.31), General Health (R(2) 0.15), Vitality (R(2) 0.10), Social Functioning (R(2) 0.21) and Role functioning-Emotional (R(2) 0.15) was explained both by EDS (inverse correlation) and disease duration (direct correlation). CONCLUSIONS: The SF-36 form is a reliable outcome measure for hypersomniac disorders. Narcolepsy seriously impacts patients' HRQoL in terms of physical and mental well-being and impairs physical and emotional functions, restricting social life. EDS is the main symptom determining this impairment. However, disease duration plays a role in counterbalancing this feature, probably by means of adaptation.

Activities of Daily Living↗
PubMed2004

Health-related quality of life associated with chronic conditions in eight countries: results from the International Quality of Life Assessment (IQOLA) Project.

CONTEXT: Few studies and no international comparisons have examined the impact of multiple chronic conditions on populations using a comprehensive health-related quality of life (HRQL) questionnaire. OBJECTIVE: The impact of common chronic conditions on HRQL among the general populations of eight countries was assessed. DESIGN: Cross-sectional mail and interview surveys were conducted. PARTICIPANTS AND SETTING: Sample representatives of the adult general population of eight countries (Denmark, France, Germany, Italy, Japan, The Netherlands, Norway and the United States) were evaluated. Sample sizes ranged from 2031 to 4084. MAIN OUTCOME MEASURES: Self-reported prevalence of chronic conditions (including allergies, arthritis, congestive heart failure, chronic lung disease, hypertension, diabetes, and ischemic heart disease), sociodemographic data and the SF-36 Health Survey were obtained. The SF-36 scale and summary scores were estimated for individuals with and without selected chronic conditions and compared across countries using multivariate linear regression analyses. Adjustments were made for age, gender, marital status, education and the mode of SF-36 administration. RESULTS: More than half (55.1%) of the pooled sample reported at least one chronic condition, and 30.2% had more than one. Hypertension, allergies and arthritis were the most frequently reported conditions. The effect of ischemic heart disease on many of the physical health scales was noteworthy, as was the impact of diabetes on general health, or arthritis on bodily pain scale scores. Arthritis, chronic lung disease and congestive heart failure were the conditions with a higher impact on SF-36 physical summary score, whereas for hypertension and allergies, HRQL impact was low (comparing with a typical person without chronic conditions, deviation scores were around -4 points for the first group and -1 for the second). Differences between chronic conditions in terms of their impact on SF-36 mental summary score were low (deviation scores ranged between -1 and -2). CONCLUSIONS: Arthritis has the highest HRQL impact in the general population of the countries studied due to the combination of a high deviation score on physical scales and a high frequency. Impact of chronic conditions on HRQL was similar roughly across countries, despite important variation in prevalence. The use of HRQL measures such as the SF-36 should be useful to better characterize the global burden of disease.

Adult↗
PubMed2003

Women's perception of the benefits of mammography screening: population-based survey in four countries.

BACKGROUND: Screening programmes are often actively promoted to achieve high coverage, which may result in unrealistic expectations. We examined women's understanding of the likely benefits of mammography screening. METHODS: Telephone survey of random samples of the female population aged > or =15 years in the US, UK, Italy, and Switzerland using three closed questions on the expected benefits of mammography screening. RESULTS: A total of 5964 women were contacted and 4140 women (69%) participated. Misconceptions were widespread: a majority of women believed that screening prevents or reduces the risk of contracting breast cancer (68%), that screening at least halves breast cancer mortality (62%), and that 10 years of regular screening will prevent 10 or more breast cancer deaths per 1000 women (75%). In multivariate analysis higher number of correct answers was positively associated with higher educational status (odds ratio [OR] = 1.44, 95% CI: 1.25, 1.66) and negatively with having had a mammography in the last 2 years (OR = 0.86, 95% CI: 0.73, 1.01). Compared with US women (reference group) and Swiss women (OR = 0.98, 95% CI: 0.82, 1.18) respondents in Italy (OR = 0.61, 95% CI: 0.50, 0.74) and the UK (OR = 0.73, 95% CI: 0.60, 0.88) gave fewer correct answers. CONCLUSION: In the US and three European countries a high proportion of women overestimated the benefits that can be expected from screening mammography. This finding raises doubts on informed consent procedures within breast cancer screening programmes.

Adolescent↗
PubMed2002

Cyproterone acetate versus a continuous monophasic oral contraceptive in the treatment of recurrent pelvic pain after conservative surgery for symptomatic endometriosis.

OBJECTIVE: To evaluate the efficacy and safety of cyproterone acetate versus an oral contraceptive in the treatment of endometriosis-associated recurrent pelvic pain. DESIGN: Randomized controlled trial. SETTING: Academic center. PATIENT(S): Ninety women with recurrent moderate or severe pelvic pain after conservative surgery for symptomatic endometriosis. INTERVENTION(S): Six months of continuous treatment with oral cyproterone acetate, 12.5 mg/d, or an oral contraceptive containing ethinyl estradiol, 0.02 mg, and desogestrel, 0.15 mg. MAIN OUTCOME MEASURE(S): Degree of satisfaction with therapy. RESULT(S): Six patients in the cyproterone acetate arm and nine in the oral contraceptive arm withdrew because of side effects (n = 9), treatment inefficacy (n = 4), or loss to follow-up (n = 2). At 6 months, dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain scores were substantially reduced, and significant improvements were observed in health-related quality-of-life, psychiatric profile, and sexual satisfaction; no major between-group differences were seen. Subjective and metabolic side effects were limited. According to an intention-to-treat analysis, 33 of 45 (73%) of patients in the cyproterone acetate group and 30 of 45 (67%) in the oral contraceptive group were satisfied with the treatment received. CONCLUSIONS: Both cyproterone acetate and a continuous monophasic oral contraceptive were effective, safe, and inexpensive therapy for recurrent pain after conservative surgery for endometriosis.

Adult↗
PubMed2002

Consumer health information: the role of breast cancer associations.

BACKGROUND: Providing information for patients is currently a growth need for health professionals, medical journals, and consumer associations. Despite several patients or consumers associations being active in Italy, scarce evidence is available on the volume and type of activities carried out. A national survey was carried out to investigate the volume and the nature of phone requests for information addressed to associations belonging to the Italian Forum of EUROPA DONNA, an European movement active in 28 countries, working to raise public awareness of breast cancer. METHODS: A structured questionnaire was sent to all EUROPA DONNA breast cancer associations to be filled in by the persons in charge for delivering the telephone information. RESULTS: Of the 87 breast cancer associations contacted, 41 (47%) participated to the survey, completing a total of 2383 questionnaires for 4251 kinds of information. Most of the people who called were women and about 57% were breast cancer patients. A wide range of information were required: 29% on prevention, 22% on practical problems of daily life, 23% on services actually offered by breast cancer associations, 10% on psychological counselling, and finally 14% for advice on primary therapy and follow-up. In more than one-third of phone calls, people were looking for opinion from women who personally experienced a breast cancer. CONCLUSION: This survey shows that breast cancer associations receive daily requests of information and convey a wide range of information. The findings underline the need to create meaningful partnership between health professionals and patient's associations in the complex field of information and communication.

Breast Neoplasms↗
PubMed1999

Italian forum of Europa Donna: a survey of breast cancer associations.

Europa Donna is the first European woman's movement against breast cancer. It is a coalition of breast cancer associations and individual women and is active in 20 nations. Europa Donna is not intended to replace existing organizations. Rather, it provides a focus for the exchange of information and experiences between members and serves as a moving force for combined action. It promotes public awareness of breast cancer, advances in research and good clinical practice. In Italy there are more than 200 active breast cancer associations. The Italian forum of Europa Donna was formed in 1996. Between June and September 1996 a postal survey was conducted to research the characteristics and activities of the various breast cancer associations in Italy in order to help, inform and promote future initiatives of the Italian forum of Europa Donna. A total of 213 breast cancer associations were sent a postal questionnaire. Ninety-five of them (44.6%) participated in the survey. The results show that the breast cancer associations in Italy vary markedly in terms of their structure and organization. The associations perceive a variety of deficiencies in the prevention, diagnosis and treatment of breast cancer within the Italian National Health Service and they offer a wide range of services themselves. Their views of the relevance of the 10 goals of Europa Donna vary. In this paper, we discuss the implications of the low rate of participation in the survey and the heterogeneity of the breast cancer associations' structures, activities and views for the future activities of the Italian forum of Europa Donna.

Journal Article↗
PubMedDate not supplied

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.

Databases as Topic↗
PubMedDate not supplied

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.

Adolescent↗