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Article: A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

Amato, Antonino / Aringhieri, Eugenio / Boccia, Stefania / Buccella, Filippo / Gorini, Barbara / Gramaglia, Donatella / Masetti, Riccardo / Rossi, Paolo / Pelicci, Pier Giuseppe

Annali dell'Istituto superiore di sanita

2017 Volume 53, Issue 2, Page(s) 104–107

Abstract: The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best ... ...

Abstract	The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.
Language	English
Publishing date	2017-04
Publishing country	Italy
Document type	Journal Article
ZDB-ID	950344-4
ISSN	0021-2571
ISSN	0021-2571
DOI	10.4415/ANN_17_02_05
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Article: Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study.

Sacchetti, Emilio / Galluzzo, Alessandro / Valsecchi, Paolo / Romeo, Fabio / Gorini, Barbara / Warrington, Lewis

Schizophrenia research

2009 Volume 110, Issue 1-3, Page(s) 80–89

Abstract: This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/ ... ...

Abstract	This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score >or=80, and CGI-S score >or=4. Patients were randomized to ziprasidone (80-160 mg/day, n=73) or clozapine (250-600 mg/day, n=74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (-25.0+/-22.0, 95% CI -30.2 to -19.8) and clozapine (-24.5+/-22.5, 95% CI -29.7 to -19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.
MeSH term(s)	Adult ; Analysis of Variance ; Antipsychotic Agents/therapeutic use ; Body Weight/drug effects ; Clozapine/therapeutic use ; Disease Progression ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Glucose/metabolism ; Humans ; Italy ; Lipids/blood ; Male ; Middle Aged ; Patient Compliance/statistics & numerical data ; Piperazines/therapeutic use ; Psychiatric Status Rating Scales ; Quality of Life ; Schizophrenia/blood ; Schizophrenia/drug therapy ; Schizophrenic Psychology ; Thiazoles/therapeutic use ; Young Adult
Chemical Substances	Antipsychotic Agents ; Lipids ; Piperazines ; Thiazoles ; ziprasidone (6UKA5VEJ6X) ; Glucose (IY9XDZ35W2) ; Clozapine (J60AR2IKIC)
Language	English
Publishing date	2009-05
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	639422-x
ISSN	1573-2509 ; 0920-9964
ISSN (online)	1573-2509
ISSN	0920-9964
DOI	10.1016/j.schres.2009.02.017
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Article ; Online: Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study.

Sacchetti, Emilio / Galluzzo, Alessandro / Valsecchi, Paolo / Romeo, Fabio / Gorini, Barbara / Warrington, Lewis

Schizophrenia research

2009 Volume 113, Issue 1, Page(s) 112–121

Abstract	This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS score >or= 80, and CGI-S score >or= 4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n = 74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (- 25.0 +/- 22.0, 95% CI - 30.2 to - 19.8) and clozapine (- 24.5 +/- 22.5, 95% CI - 29.7 to - 19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.
MeSH term(s)	Adult ; Analysis of Variance ; Antipsychotic Agents/therapeutic use ; Body Weight/drug effects ; Clozapine/therapeutic use ; Disease Progression ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Glucose/metabolism ; Humans ; Italy ; Lipids/blood ; Male ; Middle Aged ; Patient Compliance/statistics & numerical data ; Piperazines/therapeutic use ; Psychiatric Status Rating Scales ; Quality of Life ; Schizophrenia/blood ; Schizophrenia/drug therapy ; Schizophrenic Psychology ; Thiazoles/therapeutic use ; Young Adult
Chemical Substances	Antipsychotic Agents ; Lipids ; Piperazines ; Thiazoles ; ziprasidone (6UKA5VEJ6X) ; Glucose (IY9XDZ35W2) ; Clozapine (J60AR2IKIC)
Language	English
Publishing date	2009-05-20
Publishing country	Netherlands
Document type	Comparative Study ; Duplicate Publication ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	639422-x
ISSN	1573-2509 ; 0920-9964
ISSN (online)	1573-2509
ISSN	0920-9964
DOI	10.1016/j.schres.2009.05.002
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Article: Conformationally constrained analogues of endogenous tripeptide inhibitors of zinc metalloproteinases.

D'Alessio, S / Gallina, C / Gavuzzo, E / Giordano, C / Gorini, B / Mazza, F / Paglialunga Paradisi, M / Panini, G / Pochetti, G

European journal of medicinal chemistry

2001 Volume 36, Issue 1, Page(s) 43–53

Abstract: Two diastereomeric furan-2-carbonylamino-3-oxohexahydroindolizino[8,7-b]indole carboxylates, highly constrained analogues of endogenous pyroglutamyl tripeptide inhibitors of snake venom endopeptidases, have been prepared as potential inhibitors of ... ...

Abstract	Two diastereomeric furan-2-carbonylamino-3-oxohexahydroindolizino[8,7-b]indole carboxylates, highly constrained analogues of endogenous pyroglutamyl tripeptide inhibitors of snake venom endopeptidases, have been prepared as potential inhibitors of adamalysin II and matrix metalloproteinases. They proved to be inactive against adamalysin II and weak inhibitors of gelatinase A, gelatinase B, stromelysin 1 and human neutrophil collagenase. Evaluation of the mode of binding of the (2R,5S,11bR) isomer in the active site of adamalysin II suggests that the decrease of potency may be due to the reorientation of the acylamino chain in three of the heterocyclic nucleus, to a short contact at the entrance of the S'(1) hydrophobic cleft and to the loss of flexibility of the tetracyclic nucleus in the P'(1), P'(2) region of the inhibitor, which prevents optimal arrangement in the S'(1) specificity subsite.
MeSH term(s)	Animals ; Crystallization ; Humans ; Matrix Metalloproteinase Inhibitors ; Molecular Conformation ; Oligopeptides/chemical synthesis ; Snake Venoms/enzymology ; Zinc/chemistry
Chemical Substances	Matrix Metalloproteinase Inhibitors ; Oligopeptides ; Snake Venoms ; Zinc (J41CSQ7QDS)
Language	English
Publishing date	2001-02-14
Publishing country	France
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188597-2
ISSN	1768-3254 ; 0223-5234 ; 0009-4374
ISSN (online)	1768-3254
ISSN	0223-5234 ; 0009-4374
DOI	10.1016/s0223-5234(00)01192-2
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Article: Two crystal structures of human neutrophil collagenase, one complexed with a primed- and the other with an unprimed-side inhibitor: implications for drug design.

Gavuzzo, E / Pochetti, G / Mazza, F / Gallina, C / Gorini, B / D'Alessio, S / Pieper, M / Tschesche, H / Tucker, P A

Journal of medicinal chemistry

2000 Volume 43, Issue 18, Page(s) 3377–3385

Abstract: Two crystal structures of human neutrophil collagenase (HNC, MMP-8), one complexed with a primed- and the other with an unprimed-side inhibitor, were determined using synchrotron radiation at 100 K. Both inhibitors contain non-hydroxamate zinc-binding ... ...

Abstract	Two crystal structures of human neutrophil collagenase (HNC, MMP-8), one complexed with a primed- and the other with an unprimed-side inhibitor, were determined using synchrotron radiation at 100 K. Both inhibitors contain non-hydroxamate zinc-binding functions. The Pro-Leu-L-Trp(P)(OH)(2) occupies the unprimed region of the active site, furnishes new structural information regarding interaction between the catalytic zinc ion and the phosphonate group, and is the only example of occupation of the S(1) subsite of MMP-8 by the bulky tryptophan side chain. The (R)-2-(biphenyl-4-ylsulfonyl)-1,2,3, 4-tetrahydroisochinolin-3-carboxylic acid, a conformationally constrained D-Tic derivative, accommodates its biphenyl substituent into the deep primary specificity S(1)' subsite, inducing a widening of the entrance to this pocket; this modification of the protein, mainly consisting in a shift of the segment centered at Pro217, is observed for the first time in MMP-8 complexes. Cation-aromatic interactions can stabilize the formation of both complexes, and the beneficial effect of aromatic substituents in proximity of the catalytic zinc ion is discussed. The phosphonate group bound to either a primed- or unprimed-side inhibitor maintains the same relative position with respect to the catalytic zinc ion, suggesting that this binding function can be exploited for the design of combined inhibitors assembled to interact with both primed and unprimed regions of the active cleft.
MeSH term(s)	Catalytic Domain ; Crystallography, X-Ray ; Drug Design ; Humans ; Isoquinolines/chemistry ; Ligands ; Matrix Metalloproteinase 8/chemistry ; Matrix Metalloproteinase Inhibitors ; Models, Molecular ; Molecular Conformation ; Oligopeptides/chemistry ; Organophosphonates/chemistry ; Protease Inhibitors/chemistry ; Protein Binding ; Sulfones/chemistry ; Tetrahydroisoquinolines
Chemical Substances	2-(biphenyl-4-ylsulfonyl)-1,2,3,4-tetrahydroisoquinolin-3-carboxylic acid ; Isoquinolines ; Ligands ; Matrix Metalloproteinase Inhibitors ; Oligopeptides ; Organophosphonates ; Protease Inhibitors ; Sulfones ; Tetrahydroisoquinolines ; prolyl-leucyl-tryptophanphosphonic acid ; Matrix Metalloproteinase 8 (EC 3.4.24.34)
Language	English
Publishing date	2000-09-07
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	218133-2
ISSN	1520-4804 ; 0022-2623
ISSN (online)	1520-4804
ISSN	0022-2623
DOI	10.1021/jm9909589
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Article: A randomized double-blind comparison of ziprasidone vs. clozapine for cognition in patients with schizophrenia selected for resistance or intolerance to previous treatment.

Harvey, Philip D / Sacchetti, Emilio / Galluzzo, Alessandro / Romeo, Fabio / Gorini, Barbara / Bilder, Robert M / Loebel, Antony D

Schizophrenia research

2008 Volume 105, Issue 1-3, Page(s) 138–143

Abstract: Background: Recent data have suggested few differences in the cognitive effects of antipsychotic medications. However, assessment of such effects can be complex, due to a number of factors. Clozapine has previously shown greater clinical and lesser ... ...

Abstract	Background: Recent data have suggested few differences in the cognitive effects of antipsychotic medications. However, assessment of such effects can be complex, due to a number of factors. Clozapine has previously shown greater clinical and lesser cognitive benefits than other atypicals. This study compared the cognitive benefits of clozapine and ziprasidone in schizophrenia patients (n=130) with a history of either failure to respond to or intolerance of previous adequate antipsychotic treatments. Methods: Patients were randomized (double-blind) to either clozapine or ziprasidone in a single country (Italy), multi-site trial. The cognitive assessments examined episodic memory (RAVLT), executive functioning (Stroop test), and processing speed (Trail-making test (TMT) Parts A and B). Results: Analyses found statistically significant within-group improvements for ziprasidone in learning and delayed recall on the RAVLT and on TMT Parts A and B. Clozapine-treated patients improved on the RAVLT, but not on the TMT. A composite cognitive score improved from baseline in both groups, but the improvements were significantly larger in the ziprasidone group (p=.029). Implications: These results indicated that cognitive functioning improved following treatment with ziprasidone in patients with a history of either treatment resistance or intolerance, and that the effects are comparable or greater than those observed with clozapine. One interpretation of these findings is that clozapine treatment interferes with the performance benefits associated with practice.
MeSH term(s)	Adult ; Antipsychotic Agents/therapeutic use ; Clozapine/therapeutic use ; Cognition Disorders/diagnosis ; Cognition Disorders/drug therapy ; Cognition Disorders/psychology ; Double-Blind Method ; Drug Resistance ; Drug Tolerance ; Female ; Humans ; Italy ; Male ; Memory Disorders/diagnosis ; Memory Disorders/drug therapy ; Neuropsychological Tests/statistics & numerical data ; Piperazines/therapeutic use ; Placebos ; Schizophrenia/drug therapy ; Schizophrenic Psychology ; Thiazoles/therapeutic use ; Trail Making Test ; Treatment Outcome
Chemical Substances	Antipsychotic Agents ; Piperazines ; Placebos ; Thiazoles ; ziprasidone (6UKA5VEJ6X) ; Clozapine (J60AR2IKIC)
Language	English
Publishing date	2008-10
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	639422-x
ISSN	1573-2509 ; 0920-9964
ISSN (online)	1573-2509
ISSN	0920-9964
DOI	10.1016/j.schres.2007.11.014
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Article: Phosphonate inhibitors of adamalysin II and matrix metalloproteinases.

Gallina, C / Gavuzzo, E / Giordano, C / Gorini, B / Mazza, F / Paglialunga-Paradisi, M / Panini, G / Pochetti, G / Politi, V

Annals of the New York Academy of Sciences

1999 Volume 878, Page(s) 700–702

MeSH term(s)	Binding Sites ; Crotalid Venoms/antagonists & inhibitors ; Gelatinases/antagonists & inhibitors ; Matrix Metalloproteinase 2 ; Matrix Metalloproteinase 8 ; Matrix Metalloproteinase 9 ; Matrix Metalloproteinase Inhibitors ; Metalloendopeptidases/antagonists & inhibitors ; Organophosphonates/pharmacology ; Protease Inhibitors/pharmacology ; Structure-Activity Relationship ; Zinc/metabolism
Chemical Substances	Crotalid Venoms ; Matrix Metalloproteinase Inhibitors ; Organophosphonates ; Protease Inhibitors ; Gelatinases (EC 3.4.24.-) ; Metalloendopeptidases (EC 3.4.24.-) ; Matrix Metalloproteinase 2 (EC 3.4.24.24) ; Matrix Metalloproteinase 8 (EC 3.4.24.34) ; Matrix Metalloproteinase 9 (EC 3.4.24.35) ; Crotalus adamanteus proteinase II (EC 3.4.24.46) ; Zinc (J41CSQ7QDS)
Language	English
Publishing date	1999-06-30
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	211003-9
ISSN	1749-6632 ; 0077-8923
ISSN (online)	1749-6632
ISSN	0077-8923
DOI	10.1111/j.1749-6632.1999.tb07766.x
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Article: Helicobacter pylori: optimum diagnosis and test of cure.

Bazzoli, F / Zagari, R M / Pozzato, P / Fossi, S / Ricciardiello, L / De Luca, L / Nicolini, G / Berretti, D / Maltoni, S / Gorini, B / Martuzzi, C / Fuccio, L / Roda, E

Journal of chemotherapy (Florence, Italy)

1999 Volume 11, Issue 6, Page(s) 601–605

Abstract: The fact that about 50% of the world's population is infected with Helicobacter (H.) pylori and the important role that this bacterium plays in public health have been important incentives in the search for accurate diagnostic methods. A large number of ... ...

Abstract	The fact that about 50% of the world's population is infected with Helicobacter (H.) pylori and the important role that this bacterium plays in public health have been important incentives in the search for accurate diagnostic methods. A large number of invasive and non-invasive methods have been used to diagnose H. pylori infection. Each method has its advantages and disadvantages and each practitioner should choose the best diagnostic method according to the facilities available. Non-invasive tests for the diagnosis of H. pylori infection are largely used in clinical practice and in management of patients with gastroduodenal disease. Serology is the most widespread test but its use is not advised in the post-treatment follow-up. The Urea Breath Test is a simple, safe and highly accurate method ideal for evaluating the short-term follow-up of H. pylori eradication after therapy.
MeSH term(s)	Breath Tests/methods ; Carbon Radioisotopes ; Diagnosis, Differential ; Helicobacter Infections/diagnosis ; Helicobacter pylori ; Humans ; Public Health ; Serologic Tests ; Urea/analysis
Chemical Substances	Carbon Radioisotopes ; Urea (8W8T17847W)
Language	English
Publishing date	1999-12
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	1036294-0
ISSN	1973-9478 ; 1120-009X
ISSN (online)	1973-9478
ISSN	1120-009X
DOI	10.1179/joc.1999.11.6.601
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Article: Inhibition of adamalysin II and MMPs by phosphonate analogues of snake venom peptides.

D'Alessio, S / Gallina, C / Gavuzzo, E / Giordano, C / Gorini, B / Mazza, F / Paradisi, M P / Panini, G / Pochetti, G / Sella, A

Bioorganic & medicinal chemistry

1999 Volume 7, Issue 2, Page(s) 389–394

Abstract: Phosphonate analogues of the peptidomimetic N-(Furan-2-yl)carbonyl-Leu-Trp-OH were prepared with the goal of evaluating the effect of phosphonate for carboxylate replacement on binding with snake venom metalloproteinases and MMPs. N-(Furan-2-yl)carbonyl- ... ...

Abstract	Phosphonate analogues of the peptidomimetic N-(Furan-2-yl)carbonyl-Leu-Trp-OH were prepared with the goal of evaluating the effect of phosphonate for carboxylate replacement on binding with snake venom metalloproteinases and MMPs. N-(Furan-2-yl)carbonyl-Leu-L-Trp(P)-(OH)2 showed a 75-fold increase of the inhibiting activity against adamalysin II, a snake venom metalloproteinase structurally related to MMPs and TACE. Both the phosphonate and carboxylate peptidomimetics fit into the active site adopting a retrobinding mode and provide the structural base for a new class of metalloproteinases inhibitors.
MeSH term(s)	Inhibitory Concentration 50 ; Metalloendopeptidases/antagonists & inhibitors ; Models, Chemical ; Snake Venoms/pharmacology ; Spectrophotometry, Infrared ; Temperature
Chemical Substances	Snake Venoms ; Metalloendopeptidases (EC 3.4.24.-) ; Crotalus adamanteus proteinase II (EC 3.4.24.46)
Language	English
Publishing date	1999-04-15
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1161284-8
ISSN	1464-3391 ; 0968-0896
ISSN (online)	1464-3391
ISSN	0968-0896
DOI	10.1016/s0968-0896(98)00243-0
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Article: ASGE guidelines for the appropriate use of upper endoscopy: association with endoscopic findings.

Rossi, Angelo / Bersani, Gianluca / Ricci, Giorgio / Defabritiis, Giovanni / Pollino, Valeria / Suzzi, Alessandra / Gorini, Beatrice / Alvisi, Vittorio

Gastrointestinal endoscopy

2002 Volume 56, Issue 5, Page(s) 714–719

Abstract: Background: This prospective study examined the appropriate use of EGD in an open-access system with the American Society for Gastrointestinal Endoscopy (ASGE) guidelines and determined whether the ASGE guidelines were associated with relevant ... ...

Abstract	Background: This prospective study examined the appropriate use of EGD in an open-access system with the American Society for Gastrointestinal Endoscopy (ASGE) guidelines and determined whether the ASGE guidelines were associated with relevant endoscopic findings. Methods: In a cohort of 1777 consecutive patients referred for open-access EGD, the proportion of patients who underwent EGD for appropriate indications was prospectively assessed. The relationship between appropriateness and the presence of clinically relevant endoscopic diagnoses was assessed by calculating (1) the likelihood ratio, positive and negative, of the indications; and (2) the change in the probability of relevant endoscopic diagnoses in the presence of the ASGE criteria. Results: The rate for EGDs "generally not indicated" was 15.6%. Relevant endoscopic diagnoses were present in 47.4% of cases with ASGE indications versus 28.8% of patients without appropriate indications as defined by the ASGE criteria (OR: 2.23; 99% CI [1.55, 3.22]; p < 0.01). A similar difference was observed for erosive gastritis (OR: 1.86; 99% CI [1.17, 2.95]; p < 0.01), erosive esophagitis (OR: 1.48; 99% CI [0.87, 2.52]; p < 0.05), and Barrett's esophagus (OR: 9.76; 99% CI [0.72, 132]; p < 0.05). The pretest probability of finding a relevant endoscopic diagnosis was modified slightly when an ASGE indication(s) was present and decreased markedly when ASGE criteria were absent. Conclusions: The use of the ASGE guideline for appropriate indications for EGD can improve patient selection for the procedure. However, to avoid missed diagnoses of serious disease, use of the guidelines must be tailored to the specific clinical setting.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Dyspepsia/etiology ; Endoscopy, Digestive System ; Esophageal Diseases/diagnosis ; Female ; Gastroesophageal Reflux/diagnosis ; Guideline Adherence ; Humans ; Italy ; Male ; Middle Aged ; Practice Guidelines as Topic ; Prospective Studies ; Referral and Consultation ; Sensitivity and Specificity ; Stomach Diseases/complications ; Stomach Diseases/diagnosis
Language	English
Publishing date	2002-11
Publishing country	United States
Document type	Evaluation Studies ; Journal Article
ZDB-ID	391583-9
ISSN	1097-6779 ; 0016-5107
ISSN (online)	1097-6779
ISSN	0016-5107
DOI	10.1067/mge.2002.129222
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Zs.B 283: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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