Renata Cerutti

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

BackgroundThe 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.MethodsData 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.ResultsOverall, 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 Cronbachs 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).ConclusionThe 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.

Clinical trial on the efficacy of a new symbiotic formulation, Flortec, in patients with irritable bowel syndrome: a multicenter, randomized study.

Objectives Efficacy of symbiotics in patients with irritable bowel syndrome (IBS) remains unknown. Methods Patients were randomized to a prebiotic (n=135), or a symbiotic formulation containing Lactobacillus paracasei B21060 (Flortec, n=132). Primary efficacy was the responder rate for pain and global relief of symptoms in the overall population and in patients with predominant diarrhea (n=47). Post hoc time-trend analyses for changes within each treatment were carried out. Results Patients with absent/mild pain amounted to 54.7% in the symbiotic group and to 57.4% in the prebiotic group at treatment week 4, and to 53.9% and 53.4% at the end of treatment. Patients with amelioration of well-being were, respectively, 60.7% versus 61.7% at treatment week 4, and 63.3% versus 60.9% at the end of treatment. Within each treatment group, patients with absent/mild pain increased in the Flortec and the prebiotic group, but time trend analyses were significant only for Flortec (P=0.019). In IBS-predominant diarrhea, Flortec significantly reduced bowel movements, pain, and IBS scores. Conclusions To improve pain and well-being, Flortec is encouraging in patients with diarrhea predominant IBS. To establish its efficacy for the majority of IBS patients, Flortec has to be compared with an inert placebo in future work.

Prevalence of subclinical hypothyroidism in a population living in the Milan metropolitan area

Subclinical hypothyroidism is a condition characterized by increased levels of thyroid-stimulating hormone (TSH) associated with normal levels of free triiodothyronine (FT3) and free thyroxine (FT4). The exact prevalence of this condition in Italy is not known. The aim of this study was to assess the presence of subclinical hypothyroidism in 1001 subjects living in the Milan area (age 17–89) and apparently free from thyroid pathology. This sample which had applied to a large laboratory centre (Centro Diagnostico Italiano, Milano) for a routine check-up was seen from April to July 1996. A serum TSH assay was performed using a highly sensitive immunoenzymatic method, while an FT3 and FT4 assay was performed by means of a radioimmunologic method using commercial kits. The prevalence of subclinical hypothyroidism in the total population proved to be 4.7% (95% CI-Confidence Interval: 3.4–6.0). Sex stratification showed a prevalence of 6.1% in females and 3.4% in males. Prevalence in patients up to 65 was 4.2%. This value increased up to 8.0% in subjects over 65. By combining these variables, in females >65 prevalence increased to 11.3%. Overall, symptoms typical of overt hypothyroidism were found in 58.3% of patients suffering from subclinical hypothyroidism and in 39.9% of healthy subjects (p<0.02). The results of this study show that there is a significant presence (about 5%) of subclinical hypothyroidism in this population and that its frequency is more than doubled in women over 65. Early treatment might reduce the progression to overt hypothyroidism. The benefits of such a procedure were recently suggested by a decision making modelling approach applied to the Italian environment.

Visuospatial Planning and Problem Solving in Alzheimer’s Disease Patients: A Study with the Tower of London Test

Background: Executive dysfunction in Alzheimer’s disease (AD) has been recently recognized as an early and prominent clinical sign. The Tower of London (ToL), a task specifically devised to test executive functions of visuospatial planning and problem solving, has frequently been used in neuropsychological experiments, but rarely in the clinical ground. Methods: One hundred and sixty-one AD patients and 212 nondemented healthy controls were administered a simplified ToL version. Results: AD patients were significantly impaired (p < 0.0001) in all ToL scores and in the total execution time. The ‘accuracy’ score of ToL at a cut off of ≤29/36 yielded a sensitivity of 71.2% and a specificity of 76.4% (AUC 0.79) for the diagnosis of AD versus controls. Conclusions: Visuospatial planning and problem solving are significantly impaired in early dementia of the Alzheimer’s type. A successful sensitivity/specificity ratio, the independence of education and the simplicity of this version of ToL make it a useful executive functioning screening test for early AD.

Functional Disability in Early Alzheimer’s Disease – A Validation Study of the Italian Version of the Disability Assessment for Dementia Scale

Aim: To determine the applicability and psychometric properties of the Italian version of the Disability Assessment of Dementia scale (DAD-I) in a community-residing population with early-stage Alzheimer’s disease (AD). Methods: The DAD-I was administered to the primary caregivers of 159 patients (mean age ± SD 77.1 ± 5.2) with mild AD (mean Mini Mental State Examination, MMSE, ± SD 23.1 ± 2.2). Results: The DAD-I showed excellent internal consistency reliability (Cronbach’s α = 0.92) and good construct validity. The DAD-I score was not significantly associated with gender, education and presumed duration of the illness, and had a low negative correlation with age. The DAD-I score correlated moderately with the traditional Instrumental Activities of Daily Living and Activities of Daily Living scales, respectively, with r = 0.53 and r = 0.54 (p < 0.0001). Relatively low, but statistically significant correlations (r ranging between 0.21 and 0.31) with the MMSE were also found. Conclusion: The DAD-I was found to be a reliable and valid instrument to assess functional disability in community-dwelling Italian subjects with early-stage AD.

Tower of London test: a comparison between conventional statistic approach and modelling based on artificial neural network in differentiating fronto-temporal dementia from Alzheimer's disease.

The early differentiation of Alzheimer’s disease (AD) from frontotemporal dementia (FTD) may be difficult. The Tower of London (ToL), thought to assess executive functions such as planning and visuo-spatial working memory, could help in this purpose. Twentytwo Dementia Centers consecutively recruited patients with early FTD or AD. ToL performances of these groups were analyzed using both the conventional statistical approaches and the Artificial Neural Networks (ANNs) modelling. Ninety-four non aphasic FTD and 160 AD patients were recruited. ToL Accuracy Score (AS) significantly (p < 0.05) The use of hidden information contained in the different items of ToL and the non linear processing of the data through ANNs allows a high discrimination between FTD and AD in individual patients. However, the discriminant validity of AS checked by ROC curve analysis, yielded no significant results in terms of sensitivity and specificity (AUC 0.63). The performances of the 12 Success Subscores (SS) together with age, gender and schooling years were entered into advanced ANNs developed by Semeion Institute. The best ANNs were selected and submitted to ROC curves. The nonlinear model was able to discriminate FTD from AD with an average AUC for 7 independent trials of 0.82. The use of hidden information contained in the different items of ToL and the non linear processing of the data through ANNs allows a high discrimination between FTD and AD in individual patients.

Clinical Trial on the Efficacy of a New Symbiotic Formulation, Flortec, in Patients With Acute Diarrhea: A Multicenter, Randomized Study in Primary Care

Objectives Few randomized studies have been carried out on adult patients affected by acute diarrhea especially in primary care, which is the natural context for this kind of disorder. Lactobacillus paracasei B 21060 is a novel strain of lactobacillus, which has been shown to be effective in relieving symptoms associated with diarrhea of irritable bowel syndrome subtype and in shortening diarrhea duration. In this study, we compared the therapeutic efficacy, safety, and tolerability of a new symbiotic formulation, Flortec, containing L. paracasei B-21060, with lactobacillus GG (FlorVis GG) in the treatment of acute presumed infectious diarrhea. Methods Fourteen general practitioners working in the Perugia health authority district carried out a randomized controlled, parallel-group, open trial in 174 adult patients suffering from acute diarrhea (87 enrolled in the Flortec group and 87 in the FlorVis group). Both the products were administered according to their standard recommended dosage. The main efficacy criterion was the duration of diarrhea after beginning treatment. Treatment duration was 10 days. Enrolled patients kept a careful track of their symptoms noting them in a personal diary for 12 days. Results The 2 groups resulted to be homogeneous at baseline with regard to prognostic variables. The mean duration of diarrhea from the start of treatment in the Flortec group was 4.24 (2.73 SD) days versus 5.09 (3.72 SD) days in the FlorVis group (P=0.09). Clinical success rates in terms of absence of abdominal pain and absence of diarrhea (defined as <2 bowel movements of watery or loose stool consistency) recorded at different time-points were statistically superior in the Flortec group (Kaplan–Meyer P=0.05 for both the symptoms). The physician judged that overall efficacy was good or very good in 91.8% of the patients in the Flortec group. The corresponding value in the FlorVis group was 83.7% (P=0.003). The 2 treatments showed a very good tolerability profile, with negligible and similar adverse event rates and similar concomitant medication usage rates. Conclusions Oral therapy with Flortec proved to be more effective than FlorVis GG in the treatment of acute diarrhea in adults treated at a primary care setting.

Pharmacokinetics of anorectal nifedipine and lidocaine (lignocaine) ointment following haemorrhoidectomy: An open-label, single-dose, phase IV clinical study

AbstractObjectives: This study aimed to assess whether topical anorectal application of an ointment containing nifedipine (0.3% w/w) and lidocaine (lignocaine) [1.5% w/w] to patients undergoing Milligan-Morgan haemorrhoidectomy achieves pharmacologically relevant serum concentrations of the active ingredients and has any haemodynamic effects or adverse effects. Methods: A single dose of 3 g of study ointment was circumferentially applied inside the anus to 24 patients (17 males and 7 females) aged 23–71 years (mean ± SD: 42.9 ± 4.9 years) during postoperative dressing after Milligan-Morgan haemorrhoidectomy from March 2007 to January 2008. Blood samples for the determination of nifedipine and lidocaine serum concentrations were drawn before surgery and at 20, 40, 60, 90, 120, 240, 360, 480 and 720 minutes after application. Serum concentrations of nifedipine and lidocaine were determined by a high-performance liquid chromatography method in order to calculate pharmacokinetic parameters. Patients’ BP, heart rate and ECG readings were monitored during the study. Results: Chromatographic signals of nifedipine were sporadically observed in only five patients (20.8%), consistent with therapeutically negligible concentrations and insufficient to permit calculation of any pharmacokinetic parameters. The serum concentrations of nifedipine in these five patients ranged from 5.9 to 18.8 ng/mL. Lidocaine concentrations were detectable in all patients. The means ± SD and medians of pharmacokinetic parameters for lidocaine were as follows: maximum serum concentration (Cmax) 245.1±370.8 ng/mL, 73.6 ng/mL; time to reach Cmax (tmax) 69.2±78.3 minutes, 40 minutes; area under the serum concentration-time curve from 0 to 6 hours (AUC6) 756.5±1254.1 ng·h/mL, 238.2 ng·h/mL. Only three patients had maximum serum concentrations above 1000 ng/mL (1037.8, 1044.75 and 1364.1 ng/mL). These outlier concentrations were four to five times lower than the threshold of CNS lidocaine toxicity (5000–6000 ng/mL). No serious local or systemic adverse events were observed throughout the study, and no subjects developed arrhythmias or significant ECG changes. Neither BP nor mean heart rate varied significantly after application of a single dose. Conclusions: This study demonstrates that single-dose topical application of an ointment containing nifedipine (0.3% w/w) and lidocaine (1.5% w/w) to patients undergoing Milligan-Morgan haemorrhoidectomy is safe to use. Following application onto damaged anorectal mucosa, nifedipine and lidocaine are absorbed into the bloodstream in small quantities that do not have any major implications for the safety of the product. Further studies are required to evaluate nifedipine and lidocaine concentrations in serum using a multiple-dose regimen.

Approfondimenti su differenze di genere nell’influsso della cultura sul benessere psicologico

Come mostrano i precedenti capitoli di questo volume, che riflettono a loro volta una folta letteratura [1–6], la partecipazione culturale avrebbe ricadute positive molto importanti sul benessere e la percezione dello stato di salute. Il presente approfondimento risponde all’esigenza di valutare questa relazione anche su sottogruppi di popolazione nelle loro segmentazioni tipiche, fra cui la piu suggestiva e quella di genere. Lo studio ambientato nel 2009 nella citta di Milano, descritto al capitolo 16, si e prestato particolarmente all’approfondimento di questa tematica, grazie alle tradizioni civili e culturali della citta. Il focus di questo capitolo e quello di valutare la ricaduta sul benessere di genere delle attivita di tempo libero, in particolare di quelle culturali, cogliendone le evidenze empiriche e offrendo alcune spiegazioni sulle differenze tra genere maschile e femminile.