Paola Mosconi | Mario Negri Institute for Pharmacological Research. Milan, IT (original) (raw)

Papers by Paola Mosconi

Health Expectations, 2007

Statistics in Medicine, 1998

One of the main issues to be considered in conducting clinical trials concerns the presence of mi... more One of the main issues to be considered in conducting clinical trials concerns the presence of missing data. This aspect is particularly relevant in oncology longitudinal studies, characterized by a long follow-up, and especially in quality of life studies where there is still little knowledge about patients' characteristics that predict loss of data. Since the middle of the 1980s the GIVIO (Interdisciplinary Group for Cancer Care Evaluation) co-operative group has been involved in conducting quality of life assessment studies, also focusing on the development of some strategies aimed at the minimization of missing data. In this paper we report on the results of two trials, which are now completed, concerning the quality of life assessment in a sample of breast and colon cancer patients. In order to cope with the problem of missing data, in both the trials the strategy of follow-up mailing was adopted, which proved to be an effective way to increase the response rate by nearly 50 per cent at each time point.

Epilepsy Research, 2005

The aim of this report is to describe the state of the art of quality of life (QoL) instruments u... more 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 &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;pure&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; 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.

European Journal of Epidemiology, 1991

Risk factors for pneumonia were analysed in a large population of critically ill patients, collec... more Risk factors for pneumonia were analysed in a large population of critically ill patients, collected in two prospective multicentre “pneumonia studies” in Italy. Twenty-three intensive care units were involved and the study time was 150 unit months. Only patients without previous pulmonary infection, with intensive care unit stay ≥ 48 hours and no rapidly irreversible illness at admission were included. The incidence of pneumonia in the 1475 selected patients was 15% (220 cases). 239 patients died in ICU; the mortality rate was significantly higher in patients developing pneumonia (p Multivariate analysis of seven risk factors for pneumonia showed a significantly higher risk in patients with neuromuscular disease (OR = 3.8, p Rapid recognition of at-risk patients seems clinically important and may improve awareness programs and preventive approaches.

Head and Neck-journal for The Sciences and Specialties of The Head and Neck, 2000

ABSTRACT Interest in measuring health-related quality of life has increased together with the awa... more ABSTRACT 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. 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. 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. 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.

Journal of Neurology Neurosurgery and Psychiatry, 1999

Breast Cancer Research and Treatment, 1999

Although the psychosocial concomitants of early-stage breast cancer have been well-documented, th... more Although the psychosocial concomitants of early-stage breast cancer have been well-documented, the relationship between cancer recurrence and quality of life remains less clear. We conducted a prospective, longitudinal study in order to clarify the relationship between recurrent cancer and quality of life, and to determine predictors of quality of life following recurrence. Sixty-nine women with recurrent breast cancer completed questionnaires assessing multiple components of quality of life at three time points: prior to recurrence, immediately after the diagnosis of recurrence, and at follow-up 6 months later. Perceptions of overall quality of life, general health status, emotional, social, and physical functioning were poorer immediately following the diagnosis of recurrence than they had been prior to recurrence. These women also evidenced significant improvement in several domains of quality of life between initial recurrence and follow-up; nonetheless, most areas of quality of life were impaired compared to pre-recurrence. Self-reported physical symptoms were a strong predictor of post-recurrence ratings of overall quality of life. These data suggest that the recurrence of breast cancer is associated with significant changes in quality of life. Quality of life did not progressively deteriorate, however, attesting to the resilience of women coping with this major stressor. These data shed light on issues of potential importance to patients managing this serious illness and may have implications for health-care professionals working with this population.

Health and Quality of Life Outcomes, 2006

Background The PGWBI is a 22-item health-related Quality of Life (HRQoL) questionnaire developed ... more 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.

Journal of Clinical Epidemiology, 1998

American Journal of Public Health, 1991

The influence of Italian physicians' attitudes, beliefs, and personal characteristics on ... more The influence of Italian physicians' attitudes, beliefs, and personal characteristics on medical decision making is examined in the case of surgical treatment of early breast cancer. Responses to a mail survey of 657 physicians from different specialties were analyzed comparing doctors recommending a radical procedure (9%) to those preferring a conservative procedure for younger patients only (25%), and those considering conservative surgery the treatment of choice regardless of patients' age (66%). The findings suggest that the likelihood of physicians' preferring a conservative procedure is influenced by their specialty and the extent to which they feel that a patient should have a role in the treatment decision more than by differences in the beliefs of treatment outcomes. Only preferences of the small group indicating radical surgery as the sole admissible treatment can be accounted for by ignorance or distrust of results of recent trials. These findings suggest that other than scientific factors guide many doctors in their decision making; they may help to explain why the diffusion of research results into clinical practice is often disappointingly slow.

Haematologica-the Hematology Journal, 2009

Critical Care Medicine, 1989

In a randomized multicenter clinical trial on antibiotic prophylaxis, 1,319 patients in 23 ICUs w... more In a randomized multicenter clinical trial on antibiotic prophylaxis, 1,319 patients in 23 ICUs were enrolled over a 4-month period. The end-point of the study was the prevention of early onset pneumonia (EOP), defined as acquired pneumonia diagnosed within 4 days of ICU admission; this accounted for greater than 50% of overall pneumonia. Patients eligible for the study were divided into three groups which received either cefoxitin (2 g iv for three doses/8 h), penicillin G (2 million U iv for four doses/6 h), or no antibiotic (control group). In the overall population, the incidence of EOP was 6.1% in the prophylaxis recipients vs. 7.2% in the control group (a 15.3% reduction). No statistically different rates of pneumonia or death were found among the groups. Patients with impaired reflexes on admission or prolonged ventilatory support were noted to have a lower incidence of EOP and an improved outcome when treated with cefoxitin.

Breast Cancer Research and Treatment, 2004

Background. Since most advanced cancers are still incurable, oncologic clinical research pays con... more 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.

Pharmacoepidemiology and Drug Safety, 1992

A post-marketing surveillance case-control study was set up and applied in an Italian hospital ne... more A post-marketing surveillance case-control study was set up and applied in an Italian hospital network to quantify the risk of upper gastrointestinal bleeding (UGB) and exposure to non-steroidal anti-inflammatory drugs (NSAIDs). During the period of study 441 cases of UGB and 1323 controls were recruited. The odds ratios associated with NSAIDs use were estimated for intake occurring over two different periods of time prior to hospital admission (i.e. during the preceding week and month). A strong association emerged for aspirin intake, both in the week (ORMLR = 11.2; 95% CI 7.8–16.9) and in the month (ORMLR = 6.9; 95% CI 4.6–10.2) preceding hospital admission. A significant increase in the risk of UGB and use of diclofenac, naproxen and ibuprofen, and indomethacin was also found in the two exposure periods considered, while for piroxicam a significant association was only apparent in the analysis of 1-month exposure. As expected, paracetamol and pyrazolone derivatives were not associated with UGB. This pilot experience has shown the feasibility of setting up a multicentre post-marketing surveillance programme and of establishing a network for drug monitoring within the Italian National Health Service, capable of providing a thorough evaluation of the benefit/risk profile of drugs.

Intensive Care Medicine, 1987

A prospective multicenter study concerning the incidence, onset time, risk factors and mortality ... more A prospective multicenter study concerning the incidence, onset time, risk factors and mortality of pneumonia was carried out by the Intensive Care Units Collaborative Group for Infection Control in Lombardy, Northern Italy. Out of 1304 patients admitted over 3 months in 16 intensive care units (ICUs), 441 met the criteria for the protocol (no previous pulmonary infection or irreversible terminal illness, ICU stay>48 h). The incidence of acquired pneumonia was 21.3% (94/441), with 54.2% of cases diagnosed within 4 days of admission (early onset pneumonia). Impairment of airway reflexes on admission and more than 24h respiratory assistance were shown as significant risk ractors (RR) for early onset pneumonia (respectively RR=12.4, with 95% confidence interval (CI)=5.3–28.9 and RR=3.3, with 95% CI=1.8–5.9). A suggested pathogenetic mechanism is aspiration of oropharyngeal contents at the onset of acute illness, due to depression of protective reflexes with delayed clearance of bacterial contamination. No protection was offered by routinely applied prophylactic antibiotic therapy.