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3. Confirmatory factor analysis of the Patient Assessment of Constipation-Symptoms (PAC-SYM) among patients with chronic constipation

Author

Neri L, Conway PM, Basilisco G, Altomare DF, Annese V, Badiali D, Bassotti G, Battaglia E, Bazzocchi G, Bellini M, Bendia E, Benini L, Biscaglia G, Biviano I, Bocchini R, Bonfrate L, Bonventre S, Bossa F, Brandimarte G, Cannizzaro R, Cicala M, Cipolletta L, Clara V, Cogliandro R, Comandini G, Corazziari E, Crotta S, CUOMO, ROSARIO, D'Alba L, De Giorgi F, Del Piano M, Di Fonzo M, Di Mario Francesco, Di Stefano M, D'Onofrio V, Efthymakis K, Fiore P, Fortuna M, Fries W, Gaetani E, Galeazzi F, Gasbarrini A, Geccherle' A, Giangregorio F, Girardi L, Grassini M, Groppo M, Guarnieri G, Iovino P, Lo Cascio M, Lolli R, Luzza F, Macarri G, Marino M, Miraglia S, Monastra S, Neri MC, Neri M, Noris RA, Orselli S, Passaretti S, Paviotti A, Pazzi P, Pilotto A, Portincasa P, Ranaldo N, Ravelli P, Rogai F, Sablich R, Savarino V, Spinzi G, Stanghellini V, Tammaro L, Torresan F, Usai Satta P, Valle C., Neri, L, Conway, Pm, Basilisco, G, Stanghellini, V, Neri, L., Conway, P., Basilisco, G., Bonventre, S, Altomare, Df, Annese, V, Badiali, D, Bassotti, G, Battaglia, E, Bazzocchi, G, Bellini, M, Bendia, E, Benini, L, Biscaglia, G, Biviano, I, Bocchini, R, Bonfrate, L, Bossa, F, Brandimarte, G, Cannizzaro, R, Cicala, M, Cipolletta, L, Clara, V, Cogliandro, R, Comandini, G, Corazziari, E, Crotta, S, Cuomo, Rosario, D'Alba, L, De Giorgi, F, Del Piano, M, Di Fonzo, M, Di Mario, Francesco, Di Stefano, M, D'Onofrio, V, Efthymakis, K, Fiore, P, Fortuna, M, Fries, W, Gaetani, E, Galeazzi, F, Gasbarrini, A, Geccherle', A, Giangregorio, F, Girardi, L, Grassini, M, Groppo, M, Guarnieri, G, Iovino, P, Lo Cascio, M, Lolli, R, Luzza, F, Macarri, G, Marino, M, Miraglia, S, Monastra, S, Neri, Mc, Neri, M, Noris, Ra, Orselli, S, Passaretti, S, Paviotti, A, Pazzi, P, Pilotto, A, Portincasa, P, Ranaldo, N, Ravelli, P, Rogai, F, Sablich, R, Savarino, V, Spinzi, G, Tammaro, L, Torresan, F, Usai Satta, P, and Valle, C.

Subjects
Adult, Male, medicine.medical_specialty, Abdominal pain, Constipation, Constipation severity, Chronic constipation, Chronic non-organic constipation, Quality of life, Chronic Disease, Female, Humans, Middle Aged, Patient Care, Quality of Life, Reproducibility of Results, Surveys and Questionnaires, Factor Analysis, Statistical, Public Health, Environmental and Occupational Health, Medicine (all), Reproducibility of Result, Internal medicine, medicine, Criterion validity, Surveys and Questionnaire, Settore MED/12 - Gastroenterologia, business.industry, Minimal clinically important difference, Environmental and Occupational Health, Settore MED/09 - MEDICINA INTERNA, Statistical, medicine.disease, Confirmatory factor analysis, Settore MED/18 - Chirurgia Generale, Physical therapy, Functional constipation, Public Health, medicine.symptom, business, Factor Analysis, Human
Abstract

Background and aim: PAC-SYM is widely adopted to asses constipation severity. However, it has been validated in a small sample, few items have been included based on expert opinion and not on empirical grounds, and its factor structure has never been replicated. We aimed at evaluating the psychometric properties of PAC-SYM in patients with chronic constipation. Methods: We enrolled 2,203 outpatients with chronic constipation in two waves. We used wave I sample to test the psychometric properties of the PAC-SYM and wave II sample to cross-validate its factor structure, to assess criterion validity, responsiveness to clinical change, and its minimal clinically important difference. Results: Only a minority of patients reported any rectal tearing (38 %). Deletion of such item leads to a 11-item version (M:PAC-SYM). The remaining items in the rectal domain were moderately correlated with the stool domain. Exploratory factor analysis and confirmatory factor analysis revealed a bifactor structure with two subscales (stool and abdominal symptoms) and a general severity factor. The M:PAC-SYM demonstrated excellent reliability, moderate correlation with SF-12 and treatment satisfaction (r = 0.28–0.45), discrimination across Rome III criteria for functional constipation and abdominal pain, and responsiveness to clinical change (β = −0.49; ω 2 = 0.25). M:PAC-SYM minimal clinically important difference was 0.24. Conclusion: Our analysis shows that the rectal domain may not represent a relevant cluster of symptoms for patients with chronic constipation. We developed a modified version of the PAC-SYM which might better represent symptom severity of most patients seeking care in gastroenterology referral centers

Published
2014

5. Bloating is associated with worse quality of life, treatment satisfaction, and treatment responsiveness among patients with constipation-predominant irritable bowel syndrome and functional constipation

Author

Neri, L., Iovino, P., Altomare, D. F., Annese, V., Badiali, D., Basilisco, G., Bassotti, G., Battaglia, E., Bazzocchi, G., Bellini, M., Bendia, E., Benini, L., Biscaglia, G., Biviano, I., Bocchini, R., Bonventre, S., Bossa, F., Brandimarte, G., Cannizzaro, R., Cicala, M., Cipolletta, L., Clara, V., Cogliandro, R., Comandini, G., Corazziari, E., Crotta, S., Cuomo, R., D'Alba, L., De Giorgi, F., Del Piano, M., Di Fonzo, M., Di Mario, F., Di Stefano, M., D'Onofrio, V., Efthymakis, K., Fiore, P., Fortuna, M., Fries, W., Gaetani, Eleonora, Galeazzi, F., Gasbarrini, Antonio, Geccherle, A., Giangregorio, F., Girardi, L., Grassini, M., Groppo, M., Guarnieri, G., Lo Cascio, M., Lolli, R., Luzza, F., Macarri, G., Marino, M., Miraglia, S., Monastra, S., Neri, M. C., Neri, M., Noris, R. A., Orselli, S., Passaretti, S., Paviotti, A., Pazzi, P., Pilotto, A., Portincasa, P., Ranaldo, N., Ravelli, P., Rogai, F., Sablich, R., Savarino, V., Spinzi, G., Stanghellini, V., Tammaro, L., Torresan, F., Usai Satta, P., Valle C., Claudio, Gaetani E. (ORCID:0000-0002-7808-1491), Gasbarrini A. (ORCID:0000-0002-7278-4823), Neri, L., Iovino, P., Altomare, D. F., Annese, V., Badiali, D., Basilisco, G., Bassotti, G., Battaglia, E., Bazzocchi, G., Bellini, M., Bendia, E., Benini, L., Biscaglia, G., Biviano, I., Bocchini, R., Bonventre, S., Bossa, F., Brandimarte, G., Cannizzaro, R., Cicala, M., Cipolletta, L., Clara, V., Cogliandro, R., Comandini, G., Corazziari, E., Crotta, S., Cuomo, R., D'Alba, L., De Giorgi, F., Del Piano, M., Di Fonzo, M., Di Mario, F., Di Stefano, M., D'Onofrio, V., Efthymakis, K., Fiore, P., Fortuna, M., Fries, W., Gaetani, Eleonora, Galeazzi, F., Gasbarrini, Antonio, Geccherle, A., Giangregorio, F., Girardi, L., Grassini, M., Groppo, M., Guarnieri, G., Lo Cascio, M., Lolli, R., Luzza, F., Macarri, G., Marino, M., Miraglia, S., Monastra, S., Neri, M. C., Neri, M., Noris, R. A., Orselli, S., Passaretti, S., Paviotti, A., Pazzi, P., Pilotto, A., Portincasa, P., Ranaldo, N., Ravelli, P., Rogai, F., Sablich, R., Savarino, V., Spinzi, G., Stanghellini, V., Tammaro, L., Torresan, F., Usai Satta, P., Valle C., Claudio, Gaetani E. (ORCID:0000-0002-7808-1491), and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

Background: The management of bloating is unclear and its relationship with patients' well-being and treatment satisfaction independent of other abdominal symptoms is uncharacterized. We evaluated the association of bloating with patient-reported outcomes. Methods: Thirty-nine centers for functional gastrointestinal disorders joined the laxative inadequate relief survey. We enrolled 2203 consecutive outpatients with functional constipation (FC) or constipation-predominant irritable bowel syndrome (IBS-C) in two cross-sectional waves. Both wave 1 and 2 included the SF-12, the patient assessment of constipation-symptoms (PAC-SYM), and the treatment satisfaction questionnaire for medication (TSQM-2). Wave 2 only included a global rating of change (GRC) scale to assess patients' assessment of efficacy concerning treatment switches occurred in the 3 months prior to the interview. Bloating in the abdomen was defined on the basis of PAC-SYM item 3. Key Results: The average age was 50.1 years (SD, 16.7) and 82.1% of patients were women. The prevalence of bloating was 91.6% (n = 1970). Bloating was associated with SF-12 Physical Composite Score (p < 0.01), SF-12 Mental Composite Score (p < 0.01), GRC (p < 0.01), Satisfaction with treatment effectiveness (p < 0.01), convenience of administration (p < 0.01), and side effects (p < 0.01) after adjustment for possible confounders. Conclusions & Inferences: Our data suggest that patients regard bloating as a key element in assessing clinical changes and treatments' efficacy as this symptom exerts a strong influence on patient-reported outcomes independent of possible confounders and other symptoms of constipation. Our data provide the rationale to investigate the efficacy and tolerability of new treatments specifically addressing this important, yet disregarded, patients' complain.

Published
2016

9. Increased arterial stiffness in nonalcoholic fatty liver disease: the Cardio-GOOSE study

Author

Paolo Salvi, Davide Agnoletti, Paolo Pazzi, Giulia Comandini, Elena Magnani, Raffaele Ruffini, Antonino Praticò, Gabriele Pagliarani, Athanase Benetos, Claudio Borghi, Salvi P, Ruffini R, Agnoletti D, Magnani E, Pagliarani G, Comandini G, Praticò A, Borghi C, Benetos A, and Pazzi P.

Subjects
Adult, Male, medicine.medical_specialty, Physiology, Population, Gastroenterology, Cohort Studies, Diabetes mellitus, Internal medicine, Nonalcoholic fatty liver disease, Internal Medicine, Medicine, Humans, education, Pulse wave velocity, Aged, Ultrasonography, Metabolic Syndrome, education.field_of_study, business.industry, nutritional and metabolic diseases, Middle Aged, medicine.disease, Atherosclerosis, digestive system diseases, Elasticity, Fatty Liver, Femoral Artery, Endocrinology, Carotid Arteries, Intima-media thickness, Pulsatile Flow, cardiovascular system, Arterial stiffness, Female, Metabolic syndrome, Cardiology and Cardiovascular Medicine, business, Tunica Intima, Tunica Media, Dyslipidemia, Blood Flow Velocity
Abstract

OBJECTIVE Nonalcoholic fatty liver disease (NAFLD) is a very frequent disease in Western countries. NAFLD shares with metabolic syndrome the same etiologic factors, such as obesity, diabetes, and dyslipidemia, which are also major cardiovascular risk factors. Cardio-GOOSE (Cardio-Gambettola ObservatOry liver Steatosis Estimation) is a population-based cohort study finalized to evaluate the relationship between NAFLD, subclinical vascular damage, and arterial stiffness. METHODS The study population consisted of 220 participants (123 women), aged between 30 and 70 years, who participated in the GOOSE study. Arterial stiffness was determined by measuring the carotid-femoral pulse wave velocity (PWV) by means of the PulsePen device. Preclinical atherosclerosis was detected by carotid intima-media thickness (IMT) measurement. RESULTS NAFLD was associated with metabolic syndrome in 48% of cases. IMT values were strongly related to metabolic syndrome factors. No significant differences in IMT were found between controls and patients with isolated NAFLD (0.77 +/- 0.15 mm versus 0.76 +/- 0.14 mm). Conversely, in patients with NAFLD associated with metabolic syndrome, IMT values were significantly higher than in patients with NAFLD alone (0.85 +/- 0.16 mm, P < 0.005). PWV values were significantly lower in controls compared to patients with isolated NAFLD (7.40 +/- 1.47 versus 7.98 +/- 1.51 m/s, P < 0.05) as well as patients with both NAFLD and metabolic syndrome (8.29 +/- 2.2 m/s, P < 0.001). The prevalence in NAFLD was increased in patients with the highest PWV values, and persisted after adjustment for factors determining metabolic syndrome (P < 0.05). CONCLUSIONS This study has shown a possible independent role of NAFLD in determining arterial stiffness.

Published
2010

10. Acoustic transmission loss in Hilbert fractal metamaterials.

Author

Comandini G, Ouisse M, Ting VP, and Scarpa F

Abstract

Acoustic metamaterials are increasingly being considered as a viable technology for sound insulation. Fractal patterns constitute a potentially groundbreaking architecture for acoustic metamaterials. We describe in this work the behaviour of the transmission loss of Hilbert fractal metamaterials used for sound control purposes. The transmission loss of 3D printed metamaterials with Hilbert fractal patterns related to configurations from the zeroth to the fourth order is investigated here using impedance tube tests and Finite Element models. We evaluate, in particular, the impact of the equivalent porosity and the relative size of the cavity of the fractal pattern versus the overall dimensions of the metamaterial unit. We also provide an analytical formulation that relates the acoustic cavity resonances in the fractal patterns and the frequencies associated with the maxima of the transmission losses, providing opportunities to tune the sound insulation properties through control of the fractal architecture., (© 2023. The Author(s).)

Published
2023
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