Maintaining over time clinical performance targets on anaemia correction in unselected population on chronic dialysis at 20 Italian centres. Data from a retrospective study for a clinical audit.

BACKGROUND: The Italian and European Best Practice Guidelines (EBPG) recommend a target haemoglobin value greater than 11 g/dl in most patients with Chronic Kidney Diseases. However, it is still difficult to maintain these values at a steady rate. Thus, the main aim of the study was to evaluate, throughout 2005, how many patients steadily maintained the performance targets related to anaemia treatment. METHODS: The survey was conducted on 3283 patients on haemodialysis (HD) and peritoneal dialysis (PD) at 20 Italian dialysis centres. 540 patients were randomly selected; each centre provided a statistically significant sample proportional to its total number of patients. Maintenance of the following target levels was assessed over time: Haemoglobin (HB) 11-12 gr/dl; Iron: 60-160 mcg/dl; Ferritin: 30-400 mcg/l; Transferrin: 200-360 mg/dl; Transferrin saturation percentage (TSAT %):> 25 <50; Dialysis doses (KT/V): >1.2 <2.0 for non-diabetic HD patients; >1.5 <2.2 for diabetic HD patients; DP: >1.8 <2.5.Outcome included:1- Percentage of target maintenance for each parameter.2- Erythropoietin dose in relation to dialysis techniques, presence of cancer or myeloma, diabetic status, Vitamin B therapy.3- Erythropoietin dose (International Units/kg/week) (IU/kg/wk) depending on: haemoglobin values, hospitalization of more than 3 days. RESULTS: Mean age was 65.1; mean haemoglobin concentration over the whole population was 11.3 gr/dl (Standard Deviation (SD): 0.91). The clinical performance targets were maintained over time as follows: HB: 4.3% (Mean 11.43 gr/dl) (SD: 0.42); Ferritin: 71.1% (Mean: 250.23 mcg/L (SD:104.07); Iron: 95.0% (Mean 59.79 mcg/dl)(SD:16.76); Transferrin: 44.8% (Mean 216.83 mg/dl) (SD: 19,50); TSAT %: in 8.4% (Mean: 34.33% (SD: 6.56); HD KT/V: 61.0% (Mean:1.46) (SD: 0.7); PD KT/V:31.4% (Mean: 2.10) (SD: 0.02). The average weekly dose of Erythropoietin (IU/Kg/Wk) was significantly lower for the peritoneal dialysis technique; the higher haemoglobin values, the lower the Erythropoietin dose (IU/Kg/Wk). CONCLUSION: A very low percentage of patients maintained haemoglobin target values over time. We need to identify precise criteria to evaluate the stability over time of clinical performance targets proposed by the guidelines.

Hypogonadism, diabetes mellitus, hypothyroidism, hypoparathyroidism: incidence and prevalence related to iron overload and chelation therapy in patients with thalassaemia major followed from 1980 to 2007 in the Ferrara Centre.

273 patients with thalassaemia major followed from diagnosis in the Ferrara Centre were divided into 3 cohorts (C) according to the year of birth (C1=1954-1964, 85 patients; C2=1965-1974, 129 patients; C3=1975-2001, 59 patients) in order to study the trends of endocrine complications. Menarche occurred in 52 out of 112 patients (46%), without significant differences among the 3 groups, at the mean age of 13.9+/-1.4 years. Sixty-five percent of these patients had secondary amenorrhoea at the mean age of 18.8+/-3.7 years. In males complete pubertal development occurred in 48% of patients (C1:31%, C2: 44%, C3: 63%, p<0.05) followed by secondary hypogonadism in 24% of patients above 21 years of age. Primary (80%) and central 20%) hypothyroidism were diagnosed in 31% of patients (C1: 55%, C2: 31.5%, C3: 13.4%, p<0.05), diabetes mellitus (DM) in 17% of patients (C1: 28.6%, C2: 17.2%, C3: 3.4%, p<0.05), and hypoparathyroidism in 10.6% of cases (C1: 18.7%, C2: 10.1%, C3: 3.4%, p<0.05). No difference was found in patient mean age of diagnosis of hypothyroidism, DM or hypoparathyroidism (20.4+/-8.2 years, 19+/-5 yrs and 18.5+/-5.8 yrs respectively) but in all three groups age at diagnosis significantly increased over time (hypothyroidism and DM: p<0.001; hypoparathyroidism: p<0.01). Over time the prevalence of hypothyroidism, diabetes mellitus and hypoparathyroidism increased to 24.4%, 14.7%, and 6.7%, respectively, at the time of the study. Incidences peaked in the early 1980's, and declined in the following years (primary hypothyroidism from 6.5% in 1981 to 0.9% in 2007, p<0.01; DM from 3.9% in 1986 to 0.8% in 2007, p<0.05; hypoparathyroidism 2.4% in 1984 to 0% in 2007, p<0.01) and correlated with the decrease in annual mean serum ferritin levels in all patients (p<0.001). The main risk factors associated with endocrine complications were high serum ferritin levels, poor compliance with desferioxamine (DFO) therapy, early onset of transfusion therapy (only for hypogonadism) and splenectomy (only for hypothyroidism). Serum ferritin levels of approximately 2000 ng/ml were found to correlate with hypogonadism, and 3000 ng/ml for hypothyroidism, hypoparathyroidism and DM. The incidences of hypothyroidism, DM and hypoparathyroidism were not significantly different in 18 patients on long term treatment with deferiprone (DPO) compared with 64 patients continuously treated with DFO, from 1995 to 2007. In conclusion, our longitudinal study shows that in the last 30 years in the Ferrara Centre the incidences of hypothyroidism, diabetes mellitus, and hypoparathyroidism declined, and pubertal development in males with thalassemia major improved in patients, on DFO treatment, born after 1976. The efficacy of alternative chelation regimes with deferiprone or deferasirox to monotherapy with desferioxamine remains to be established.

Mild subclinical hypothyroidism in thalassaemia major: prevalence, multigated radionuclide test, clinical and laboratory long-term follow-up study.

From 1990 to 1991, the Pediatric and Adolescent Endocrine Outpatient Clinic of Arcispedale S. Anna admitted 97 thalassaemia major (TM) patients for endocrine evaluation. Their mean age was 14.2+/-5.7 years (range 5-28 years). Sixty-eight (70%) had normal thyroid function and twenty-one (21.6%) were discharged with a diagnosis of hypothyroidism of different degrees of severity. Thirteen patients out of 21 (61.9%) were females. Twelve patients (57.1%) fulfilled the criteria for subclinical hypothyroidism (SH). Their mean age was 15.7+/-3.5 years (range 9-22 years). A positive direct correlation was observed between the following variables: TSH and serum ferritin, TG and basal TSH, basal TSH and peak levels after TRH stimulation test. In 6 out of 12 TM patients (50%) with SH type a, the basal ejection fraction assessed by MUGA scan was normal; 1 TM patient (8.3%) showed mild abnormality and 5 TM patients (41.6%) showed severe abnormalities. A normal response during exercise (increase in LVEF greater than 5 percentage units) occurred in 10 patients (83.3%). Global or segmental left ventricular dysfunction at rest and during exercise were found in 8 patients (66.6%) and 10 patients (83.3%), respectively. These cardiac abnormalities were more common in TM patients with severe iron overload and poor compliance to DFX treatment (group A: serum ferritin above 2500 ng/ml) compared to TM patients with mild-moderate iron overload (group B: serum ferritin below 2500 ng/ml). In the control group of TM patients (group C) with normal thyroid function the assessment of MUGA scan was normal in all subjects at rest and after exercise. Global or segmental left ventricular dysfunction was observed only during exercise in 50% of TM patients with normal thyroid function (group C). Our patients with SH exhibited three different thyroid function patterns during follow-up: a. 3 (25%) of 12 studied TM patients showed a normalization of serum TSH levels b. 2 patients (16.6%) showed intermittent elevation of serum TSH with normal serum FT4 concentrations c. 3 patients (25%) had a persistent mild elevation of serum TSH concentration (from 6.3 to 7.6 microU/ml) with serum FT4 concentrations within the normal range. Two TM patients (16.6%) were treated with L-thyroxine. The reason for starting therapy was an abnormality of basal LVEF in the presence of mild iron overload (serum ferritin levels 665 ng/ml and 523 ng/ml). One TM patient with persistent SH type a developed a papillary carcinoma, and another, a multinodular goiter. The serum ferritin levels at diagnosis were 4739 ng/ml and 744 ng/ml,respectively. The thyroid function in TM patients from group C remained normal during the follow-up period. Two patients (Group A: patients no. 1 and 2) with severe iron overload and poor compliance to chelation therapy died during the follow-up, due to heart failure and arrhythmia. The time intervals between the first abnormal LVEF value and the development of symptomatic heart failure were 3.8 and 4.3 years. An improvement of LVEF was observed in three TM patients from group A after 24 months of intensive subcutaneous chelation therapy with DFX, and in two patients from Group B after 12-14 months of L-thyroxine replacement therapy in association with regular iron chelation therapy. In those two TM patients the basal LVEF increased from 37% to 45% and from 45% to 49%. In conclusion, although the findings are limited to a small group of TM patients with SH type a, our results show a high prevalence of primary hypothyroidism with the predominance of its mildest form, its stable course over years in most patients, and the presence of cardiac involvement in patients with severe-moderate iron overload. Regular iron chelation therapy should be advised for these patients to prevent thyroid dysfunction and the development of clinically significant myocardial dysfunction. In addition, therapy with L-thyroxine should be considered in iron overloaded TM patients with SH and a poor response to chelation therapy and in patients with SH and mild iron overload.

Methylenetetrahydrofolate reductase C677T and A1298C gene variants in adult non-Hodgkin's lymphoma patients: association with toxicity and survival.

BACKGROUND AND OBJECTIVES: Common methylenetetrahydrofolate reductase gene variants (MTHFR C677T and A1298C) have been described to have opposite effects on cancer patients. They may reduce cancer susceptibility and increase drug-related toxicity when folate antagonists (e.g. methotrexate) are utilized. We analyzed 110 patients with high-grade non-Hodgkin's lymphoma (NHL), 68 of whom were eligible for a chemotherapy combination containing methotrexate (MACOP-B) and 42 for chemotherapy without methotrexate (CHOP). DESIGN AND METHODS: Patients were genotyped by polymerase chain reaction and stratified by MTHFR variants. These data were related to the toxicity (WHO grade GO-4) that the patients suffered and their survival. Overall 64 cases (58.2%) developed some form of toxicity and 23 (20.9%) had grade 3/4 toxicity. RESULTS: When considering toxicity of any grade (grade 1-4), the 677TT genotype was significantly over-represented among cases with mucositis (OR=4.85; 95% CI, 1.47-15.97; p=0.009) and those with hepatic toxicity (OR=3.43; 95% CI, 0.99-11.86; p=0.052). Sub-analyses in the group treated with MACOP-B showed a slight increase in the risk of developing mucositis (OR=5.22; 95% CI, 1.20-27.27; p=0.03), and a strong increase in the risk of hepatic toxicity (OR=7.08; 95% CI, 1.38-36.2; p=0.019) and thrombocytopenia (OR=7.69, 95% CI 1.0-58.94; p=0.05). Interestingly, compared to the risk of developing toxicity of any grade, the risk of developing severe (grade 3/4) mucositis was almost doubled in the whole group of cases with 677TT (OR=8.13; 95% CI 1.61-41.04; p=0.011) and dramatically increased in the MACOP-B-treated cases with this gene variant (OR=24.6; 95% CI 2.49-87.41; p=0.001). There were significant results for 1298CC cases exclusively for mucositis (any grade, OR=5.33; 95% CI, 1.25-22.70; p=0.023 and OR=9.15; 95% CI, 1.14-73.41; p=0.037; for the whole group and the MACOP-B-treated group, respectively). Similarly, the risk of 1298CC patients developing severe mucositis increased (OR=9.24; 95% CI, 1.47-58.0; p=0.017 and OR=11.53; 0.93-143.18; p=0.057; in the whole group and in the MACOP-B-treated group, respectively). Event-free survival analysis revealed a lower probability of event-free survival at 5 years for 677T-carriers (log-ranks, p=0.05 and p=0.07 in the whole group and in the MACOP-B-treated group, respectively). More significant results were obtained when 1298CC cases were excluded from the reference group (log-ranks, p=0.03 and p=0.04, respectively). No significant associations were found in the CHOP-treated group. INTERPRETATION AND CONCLUSIONS: Our data suggest that MTHFR gene variants play a critical role in NHL outcome, possibly by interfering with the action of methotrexate with significant effects on toxicity and survival. Genotyping of folate pathway gene variants might be useful to enable reduction of chemotherapy toxicity and/or to improve survival by indicating when dose adjustments or alternative treatments are necessary.

Unsedated ultrathin upper endoscopy is better than conventional endoscopy in routine outpatient gastroenterology practice: a randomized trial.

AIM: to compare the feasibility and patients' tolerance of esophagogastroduodenoscopy (EGD) using a thin endoscope with those of conventional oral EGD and to determine the optimal route of introduction of small-caliber endoscopes. METHODS: One hundred and sixty outpatients referred for diagnostic EGD were randomly allocated to 3 groups: conventional (C)-EGD (9.8 mm in diameter), transnasal (TN)-EGD and transoral (TO)-EGD (5.9 mm in diameter). Pre-EGD anxiety was measured using a 100-mm visual analogue scale (VAS). After EGD, patients and endoscopists completed a questionnaire on the pain, nausea, choking, overall discomfort, and quality of the examination either using VAS or answering some questions. The duration of EGD was timed. Blood oxygen saturation (SaO2) and heart rate (HR) were monitored during EGD. RESULTS: Twenty-one patients refused to participate in the study. The 3 groups were well-matched for age, gender, experience with EGD, and anxiety. EGD was completed in 91.1% (41/45), 97.5% (40/41), and 96.2% (51/53) of cases in TN-EGD, TO-EGD, and C-EGD groups, respectively. TN-EGD lasted longer (3.11 +/- 1.60 min) than TO-EGD (2.25 +/- 1.45 min) and C-EGD (2.49 +/- 1.64 min) (P<0.05). The overall tolerance was higher (P<0.05) and the overall discomfort was lower (P<0.05) in TN-EGD group than in C-EGD group. EGD was tolerated "better than expected" in 73.2% of patients in TN-EGD group and 55% and 39.2% of patients in TO-EGD and C-EGD groups, respectively (P<0.05). Endoscopy was tolerated "worst than expected" in 4.9% of patients in TN-EGD group and 17.5% and 23.5% of patients in TO-EGD and C-EGD groups, respectively (P<0.05). TN-EGD caused mild epistaxis in one case. The ability to insufflate air, wash the lens, and suction of the thin endoscope were lower than those of conventional instrument (P<0.001). All biopsies performed were adequate for histological assessment. CONCLUSION: Diagnostic TN-EGD is better tolerated than C-EGD. Narrow-diameter endoscope has a level of diagnostic accuracy comparable to that of conventional gastroscope, even though some technical characteristics of these instruments should be improved. Transnasal EGD with narrow-diameter endoscope should be proposed to all patients undergoing diagnostic EGD.

Diagnostic accuracy of a rapid fecal test to confirm H pylori eradication after therapy: prospective comparison with a laboratory stool test.

AIM: To investigate the clinical performances of rapid stool test (ImmunoCard STAT HpSA, Meridian Diagnostic Inc.) in the evaluation of eradication therapy of H pylori and to compare it with a well-known and validated laboratory stool test (Amplified IDEA Hp StAR, Dako). METHODS: Stool samples of 122 patients were evaluated after eradication therapy of H pylori. H pylori status was assessed by 13C-urea breath test (UBT). Stool specimens were tested using either the rapid immunoassay kit or the laboratory immunoassay kit. RESULTS: Forty-three patients were infected and 79 non-infected. Sensitivity and specificity of ImmunoCard STAT and Hp StAR were 58.14% and 76.4%, and 97.47% and 98.73%, respectively (P > 0.05). Overall agreement between the two tests was 92.6% (113 of 122 cases). CONCLUSION: ImmunoCard STAT seems to have rather low performances, and it cannot be regarded as a reliable tool in the post-treatment setting. Also Hp StAR cannot be recommended to confirm H pylori eradication after treatment.

Factors predictive of patient satisfaction with anesthesia.

BACKGROUND: In this multicenter prospective study, we identified factors associated with satisfaction with anesthesia in patients staying in hospital at least 24 h after surgery. METHODS: The study was performed in six centers. Inpatients aged more than 18 yr, who underwent a wide range of common surgical procedures, were asked to answer a 10-item instrument to measure patient satisfaction with anesthesia (mean score range, 0-10) and some specific questions, and to rate their perceived health (score, 0-10). Anesthesia staff members were invited to self-compile a Maslach Burnout Inventory. RESULTS: The satisfaction evaluation questionnaire was returned by 1290 patients (mean age, 61 +/- 16 yr; males, 54.4%). The mean global satisfaction score was 8.7 (95% CI: 8.7-8.8), being <9 in 632 (49%) and > or =9 in 658 (51%) patients. The Maslach Burnout Inventory was returned by 55 anesthesiologists and 68 nurses. Multivariate regression identified five variables as significant predictors of a mean global satisfaction of >/=9: 1) having been treated in a service with perioperative nurses specifically dedicated only to anesthesia; 2) having been treated where anesthesia information leaflets were provided preoperatively; 3) having received more than two anesthesiologist visits after surgery; 4) having a perceived health score >8.5; and 5) being older that 70 yr. No relationship was found between staff burnout and patient satisfaction. CONCLUSIONS: Inpatient satisfaction can be improved by an organization in which surgical suite nurses are dedicated only to anesthesia, a written anesthesia information leaflet is given during the preoperative visit and postoperative visits are enhanced.

A family-based education program for obesity: a three-year study.

BACKGROUND: The epidemic of obesity is increasing in all countries. However, the number of controlled studies focusing on childhood obesity, with a long follow-up is still limited. Even though Behavioral Therapy shows some efficacy, it requires a prolonged teamwork that is not always available in public health settings. In addition, Behavioral Therapy is not always accepted. We describe a new intensive and sustainable family-based, Therapeutic Education program for childhood obesity. METHODS: Controlled clinical study: a family-based Therapeutic Education program without dietetic prescription involving overweight and obese children/adolescents, without evident psychological troubles, and their families. The program consisted of three clinical and therapeutic education sessions, carried out by a single physician. Further sessions were carried out every six months in the first year and then every year. STUDY POPULATION: 190 overweight children, 85 treated with a therapeutic education program (45 males and 40 females, mean age of 10.43 +/- 3) with an average BMI% of 154.72 +/- 19.6% and 105 matched children, treated with traditional dietary approach.Children's Body Mass Index (BMI) % and BMI Standard Deviation Score measured at baseline and after a three year-follow-up, were compared. Statistical tests: ANOVA-RM (repeated measures) controlled for distribution by Kolmogorov-Smirnov, Bartlett's test or correspondent non-parametric procedures, X2 tests or Fisher's exact test and simple linear regression. RESULTS: After a follow-up of 2.7 +/- 1.1 years, 72.9% of the children who followed the Therapeutic Education Program obtained a BMI% reduction, compared to 42.8% of children who followed the traditional dietary treatment. Weight reduction was good in moderately obese children and in the severely obese. In addition, a smaller proportion of children treated with therapeutic education had negative results (BMI increase of >10%) compared to those treated with dietary approach (11.8% vs. 25.7%); finally, periodic phone calls reduced the drop-out rate in the therapeutic education group. CONCLUSION: These results indicate the efficacy and sustainability of the Therapeutic Education program, that was completely carried out by a single pediatrician; in addition, it met with an elevated participant acceptance, suggesting a convenient therapeutic solution for skilled pediatricians and selected obese children, when Behavioral Therapy is not available or teamwork is poor.

Common gene polymorphisms in the metabolic folate and methylation pathway and the risk of acute lymphoblastic leukemia and non-Hodgkin's lymphoma in adults.

Folate and methionine metabolism is involved in DNA synthesis and methylation processes. Polymorphisms in the genes of folate metabolism enzymes have been associated with some forms of cancer. In a case-control study, we evaluated whether four common polymorphisms in methylenetetrahydrofolate reductase (MTHFR C677T and A1298C), methionine synthase (MS A2756G), and methionine synthase reductase (MTRR A66G) genes may have a role in altering susceptibility to adult acute lymphoblastic leukemia (ALL) and non-Hodgkin's lymphoma (NHL). We analyzed DNA of 120 adult ALL, 200 NHL, and 257 healthy control subjects. Individual carrying the MTHFR 677TT genotype showed a 3.6-fold decreased ALL risk [odds ratio (OR) 0.28, 95% confidence interval (95% CI) 0.12-0.72] than wild-types. Similarly, MS 2756GG individuals showed a 5.0-fold decreased ALL risk (OR 0.20, 95% CI 0.02-1.45) than wild-types. In combined results, subjects with the MTHFR 677CT/TT and MS 2756AG/GG genotypes revealed a 3.6-fold ALL risk reduction (OR 0.28, 95% CI 0.14-0.58) and those with the MTHFR 677TT and MTRR 66AG genotypes revealed a 4.2-fold ALL risk reduction (OR 0.24, 95% CI 0.06-0.81). Finally, those with the MS 2756AG/GG and MTRR 66AG/GG genotypes revealed a 2.2-fold ALL risk reduction (OR 0.45, 95% CI 0.10-0.85). Single analysis for NHL did not show any significant difference for all the polymorphisms investigated, but in the low-grade NHL subgroup, we found a 2.0-fold risk reduction for the MTRR 66GG homozygous genotype (OR 0.50, 95% CI 0.25-0.99), which was higher (OR 0.37, 95% CI 0.14-0.85) when analyzed in combination with MS 2756AA genotype. These data are in accordance with the hypothesis that polymorphisms in the genes for folate and methionine metabolism might play a greater role in the occurrence of ALL than NHL by influencing DNA synthesis and/or DNA methylation.

Upper gastrointestinal endoscopy: are preparatory interventions or conscious sedation effective? A randomized trial.

AIM: The fears and concerns are associated with gastroscopy (EGD) decrease patient compliance. Conscious sedation (CS) and non-pharmacological interventions have been proposed to reduce anxiety and allow better execution of EGD. The aim of this study was to assess whether CS, supplementary information with a videotape, or presence of a relative during the examination could improve the tolerance to EGD. METHODS: Two hundred and twenty-six outpatients (pts), scheduled for a first-time non-emergency EGD were randomly assigned to 4 groups: Co-group (62 pts): throat anaesthesia only; Mi-group (52 pts): CS with i.v. midazolam; Re-group (58 pts): presence of a relative throughout the procedure; Vi-group (54 pts): additional information with a videotape. Anxiety was measured using the "Spielberger State and Trait Anxiety Scales". The patients assessed the overall discomfort during the procedure on an 100-mm visual analogue scale, and their tolerance to EGD answering a questionnaire. The endoscopist evaluated the technical difficulty of the examination and the tolerance of the patients on an 100-mm visual analogue scale and answering a questionnaire. RESULTS: Pre-endoscopy anxiety levels were higher in the Mi-group than in the other groups (P<0.001). On the basis of the patients' evaluation, EGD was well tolerated by 80.7% of patients in Mi-group, 43.5% in Co-group, 58.6% in Re-group, and 50% in Vi-group (P<0.01). The discomfort caused by EGD, evaluated by either the endoscopist or the patients, was lower in Mi-group than in the other groups. The discomfort was correlated with "age" (P<0.001) and "groups of patients" (P<0.05) in the patients' evaluation, and with "gender" (females tolerated better than males, P<0.001) and "groups of patients" (P<0.05) in the endoscopist's evaluation. CONCLUSION: Conscious sedation can improve the tolerance to EGD. Male gender and young age are predictive factors of bad tolerance to the procedure.

Diabetes mellitus and impaired glucose tolerance in thalassaemia major: incidence, prevalence, risk factors and survival in patients followed in the Ferrara Center.

Two hundred and seventy-three patients with thalassaemia major (TM) were followed in the Ferrara Thalassaemia Centre over a thirty-year period. Forty-two patients had insulin dependent diabetes mellitus (IDDM). The first case was diagnosed in 1973. The incidence of IDDM peaked in 1986 (3.9%), and it was 0.7% at the time of the study (March 1998). The prevalence of IDDM increased progressively over time, reaching 14.2% in 1998. Mean age at diagnosis of IDDM was 18.2 -/+ 3.6 years and this also rose significantly during the study period (p<0.01). Hypogonadism was present in 91% of patients with IDDM, hypothyroidism in 68%, hypoparathyroidism in 21%, and cardiopathy in 69%, all significantly more prevalent than in patients without IDDM. These complications appeared with the same frequency before and after the diagnosis of IDDM. Survival of patients with and without IDDM was similar and no difference in the primary cause of death was found between the two groups. Main risk factors associated with IDDM were poor compliance with desferioxamine (DFO) treatment (p<0.05%), advanced age at the start of intensive chelation therapy (p<0.001), liver cirrhosis or severe fibrosis (p<0.0001, odds ratio 9.5, CI 95% 2.8-32.6). Prevalence of impaired glucose tolerance (IGT) was highest in 1981, 1984, and 1985 when the incidence of IDDM was increasing; in 1995 the prevalence of IGT in patients aged 16-20 years was lower in comparison with that observed in 1975 (17% vs. 59%, p<0.01). Risk factors associated with IGT were: male sex (p<0.05), poor compliance with DFO therapy (p<0.05) and liver iron concentration 4 times above the normal value. In conclusion, our longitudinal study confirms that the incidence of IDDM and prevalence of IGT have been decreasing over the course of the last decade, appearing at a more advanced age, although some differences have not reached statistical significance. Iron overload and liver disease were the main associated risk factors, while positive family history for diabetes did not influence glucose metabolism in our patients.

[Assessment of anxiety levels in patients during diagnostic endoscopy]. / Valutazione dei livelli di ansia in pazienti sottoposti ad endoscopia diagnostica.

Patients with increased pre-endoscopic anxiety take advantage of the use of conscious sedation. However, the habit of using premedication varies according to the type of endoscopic examination. Aims of this study were: to evaluate whether different endoscopic procedures may have different effects on patient anxiety; and whether anxiety affects patient tolerance. 163 consecutive outpatients undergoing endoscopy (75 gastroscopy, 51 colonoscopy and 37 bronchoscopy) were interviewed to evaluate pre-endoscopy anxiety, by using the Spielberger State-Trait Anxiety Inventory. After endoscopy, endoscopists rated patient cooperation on a 10-cm visual analogue scale. Females had state and trait anxiety levels higher than males (50.49 +/- 1.37 vs 45.07 +/- 1.20, p < 0.01; and 44.46 +/- 1.06 vs 38.48 +/- 1.01, p < 0.01). Anxiety levels were not related with the type of endoscopic procedure. A direct relationship was observed between state and trait anxiety (p < 0.001). Patient cooperation to endoscopy was inversely related with both trait (p < 0.05) and state anxiety (p < 0.01). In conclusion, gastroscopy, colonoscopy and bronchoscopy seem to induce similar pre-endoscopy anxiety levels. Therefore, the different frequency in the use of intravenous sedation between bronchial and gastrointestinal endoscopy does not seem justified.

Post-Anaesthetic Discharge Scoring System to assess patient recovery and discharge after colonoscopy.

AIM: To investigate whether discharge scoring criteria are as safe as clinical criteria for discharge decision and allow for earlier discharge. METHODS: About 220 consecutive outpatients undergoing colonoscopy under sedation with Meperidine plus Midazolam were enrolled and assigned to 2 groups: in Control-group (110 subjects) discharge decision was based on the clinical assessment; in PADSS-group (110 subjects) discharge decision was based on the modified Post-Anaesthetic Discharge Scoring System (PADSS). Measurements of the PADDS score were taken every 20 min after colonoscopy, and patients were discharged after two consecutive PADSS scores ≥ 9. The investigator called each patient 24-48 h after discharge to administer a standardized questionnaire, to detect any delayed complications. Patients in which cecal intubation was not performed and those who were not found at follow-up phone call were excluded from the study. RESULTS: Thirteen patients (7 in Control-group and 6 in PADSS-group) were excluded from the study. Recovery from sedation was faster in PADSS-group than in Control-group (58.75 ± 18.67 min vs 95.14 ± 10.85 min, respectively; P < 0.001). Recovery time resulted shorter than 60 min in 39 patients of PADSS-group (37.5%), and in no patient of Control-group (P < 0.001). At follow-up phone call, no patient declared any hospital re-admission because of problems related to colonoscopy and/or sedation. Mild delayed post-discharge symptoms occurred in 57 patients in Control-group (55.3%) and in 32 in PADSS-group (30.7%). The most common symptoms were drowsiness, weakness, abdominal distension, and headache. Only 3 subjects needed to take some drugs because of post-discharge symptoms. CONCLUSION: The Post-Anaesthetic Discharge Scoring System is as safe as the clinical assessment and allows for an earlier patient discharge after colonoscopy performed under sedation.

The management of pain from collapse of osteoporotic vertebrae with continuous intrathecal morphine infusion.

Objectives. Vertebral fractures are the most common consequences of severe osteoporosis. The chronic pain from collapse of osteoporotic vertebrae affects quality of life (QoL) and autonomy of patients. The management of pain with oral or transdermal opiates can cause severe side-effects. Continuous intrathecal administration of morphine through an implantable pump might represent an alternative therapy to conventional oral or transdermal administration of opioids and has some advantages and disadvantages for pain relief and improvement in QoL when compared to conventional opioid delivery. It is our objective to report our experience using intrathecal delivery of analgesics in a population of patients with refractory pain due to vertebral fractures. Materials and Methods. In 24 patients, refractory to conventional delivery of opioids, we used intrathecal analgesic therapy. To test for efficacy and improvement in QoL, we administered the visual analog scale (VAS) for pain and the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Before patients were selected for pump implantation, an intraspinal drug delivery trial was performed to monitor side-effects and responses to intrathecal therapy. Results. Significant pain relief was obtained in all implanted patients. Using the QUALEFFO, we observed significant improvement of all variables such as QDL (quality of daily life), DW (domestic work), ambulation, and PHS (perception of health status), before and after one year after pump implantation. With intrathecal morphine infusion, none of the 24 patients required additional systemic analgesic medication. The mean morphine dose during the spinal trial was 11.28 mg/day, 7.92 mg/day at pump implantation, and 16.32 mg/day at one-year follow-up. Conclusions. Our results show that intrathecal administration of morphine efficiently relieves the symptoms of pain and improves QoL. Continuous intrathecal administration of morphine appears to be an alternative therapy to conventional analgesic drug delivery and has advantages in those patients who have severe side-effects with systemic administration of analgesics.