Alternative monotherapy or add-on therapy in patients with epilepsy whose seizures do not respond to the first monotherapy: an Italian multicenter prospective observational study.

A prospective multicenter observational study was undertaken on children and adults with epilepsy in whom first monotherapy failed, to assess indications and effects of alternative monotherapy vs. polytherapy. Patients were followed until 12-month remission, drug withdrawal, or up to 18months. Monotherapy and polytherapy were compared for patients' baseline features, indication, retention time, remission, adverse events (AE), quality of life, and direct and indirect costs. Included were 157 men and 174 women, aged 2-86years. Of the patients, 72.2% were switched to alternative monotherapy. Baseline treatment was changed for lack of efficacy (73.9%) or adverse events (26.1%). Two hundred forty-three completed the study (remission: 175; 72.0%). Retention time, hospital admissions, days off-work and off-school, and quality of life did not differ between the two treatment groups. Patients were followed for 365.3person-years. Three hundred eighty-three incident AEs were reported by 46.4% of patients in monotherapy and 40.2% in polytherapy (serious AEs: 9.6% vs. 8.7%, mostly nondrug-related).

Screening of related donors and peripheral blood stem cell collection practices at different Italian apheresis centres.

BACKGROUND: Recommendations on eligibility criteria for donation of haematopoietic stem cells, management of collection of the cells and follow-up mainly concern unrelated donors. The aim of this study was to analyse the screening of related donors and collection practices at different Italian apheresis centres. MATERIALS AND METHODS: A questionnaire regarding eligibility criteria for related haematopoietic stem cell donors, their peripheral blood collections and early follow-up was sent to several apheresis units. Data from the full charts of 500 candidates, screened between May 2005 and December 2009, were retrospectively evaluated. RESULTS: The donors' records, eligibility criteria, collections and follow-up are managed differently in each centre. Of the 500 evaluable candidates (51.2% male, 49.8% female; median age 47 years, range 13-77), 26.4% underwent thorough screening according to Italian Bone Marrow Donor Registry standards, while local protocols were applied to 73.6%; 91 candidates (18.2%) proved ineligible for donation. In the end, 352 donors (53.4% male, 46.6% female; median age 45 years, range 16-76) underwent 508 leukaphereses. Central venous catheters were used in 8.0% of donors, mainly in one centre. Unsuitable pre-apheresis peripheral blood parameters were reported in 38.7% of the aphereses. Leukapheresis-related adverse events were recorded in 23.0% of the procedures, with a drop-out rate of 0.2% for severe events. No donation-related fatalities occurred. The CD34+ cell yield was <2×10(6)/kg of recipient's body weight from 1.1% of donors ≥70 years old. DISCUSSION: More uniformity in donor screening procedures, management of peripheral blood collection and follow-up should be planned at a national level to maximise the safety of related donors.

Anterior craniofacial resection for malignant paranasal tumors: a monoinstitutional experience of 366 cases.

BACKGROUND: The purpose of this study was to evaluate the results of a mono-institutional series of patients treated with anterior craniofacial resection for malignant paranasal sinus tumors. METHODS: We analyzed all patients with malignant paranasal sinus tumors treated with anterior craniofacial resection at our institution between 1987 and 2007. All tumors were classified according to both the American Joint Committee on Cancer (AJCC)-2002 and the Istituto Nazionale Tumori (INT) classifications. RESULTS: The sample included 366 patients. There was intraorbital spread in 108 cases. The skull base was eroded in 127 patients, with dura or brain involvement in 93 patients. The 10-year disease-specific survival was 53.1%. Histologic subtype, INT stage, surgical margins, and postsurgical radiotherapy were significant, independent predictors for both local relapse and disease-specific survival (DSS). The AJCC-2002 classification was not significant when tested in place of INT stage. CONCLUSION: Our data indicated that craniofacial resection and postsurgical radiotherapy remain the primary option for malignant tumors involving the anterior skull base.

Class III nerve-sparing radical hysterectomy versus standard class III radical hysterectomy: an observational study.

BACKGROUND: The purpose of this observational study was to evaluate disease-free survival, overall survival, local recurrence rate, and morbidities in patients submitted to class III nerve-sparing radical hysterectomy (NSRH) compared with standard radical hysterectomy (RH) in cervical cancer (CC). This was a comparative study in the context of multimodal therapies. MATERIALS AND METHODS: We investigated patients with CC admitted to the National Cancer Institute of Milan between January 4, 2001, and September 29, 2009, treated with NSRH. We compared patients operated with RH between March 20, 1980, and December 28, 1995. A total of 496 patients were enrolled. The median follow-up was 93 months (42 and 159 months for the NSRH and RH groups, respectively). RESULTS: The overall number of relapses was 30 out of 185 and 60 out of 311 for NSRH and RH, respectively. Five-year disease-free survival estimate was 78.9% (95% confidence interval [CI] 72.0-85.7) in NSRH and 79.8% (95% CI 75.3-84.3) in RH (P=0.519). Five-year overall survival estimate was 90.8% (95% CI 85.9-95.6) in NSRH and 84.1% (95% CI 8.0-88.3) in RH (P=0.192). Rates of postoperative serious complications were 9.7% and 19.6% for NSRH and RH, respectively (P=0.004). Positive pelvic lymph node and vagina status were significant (P<0.01) independent predictors by multivariable analyses. CONCLUSIONS: The oncologic results were comparable between NSRH and conventional class III RH in the context of two multimodal treatments. Bladder function and postoperative complications rate are improved by nerve-sparing technique. The nerve-sparing technique should be considered in all CC patients addressed to surgery because it improves functional outcome and preserves radicality without compromising overall survival.

Inter-rater agreement in the assessment of response to motor and cognitive rehabilitation of children and adolescents with epilepsy.

INTRODUCTION: To assess inter-rater agreement among child neurologists and psychiatrists on evaluation of response to physical and cognitive rehabilitation of children and adolescents with epilepsy. MATERIALS AND METHODS: Five child neurologists/psychiatrists ("raters") were invited to draw 2-3 short case reports among those most commonly seen. 14 case histories were presented and raters used a structured questionnaire to report changes after selected rehabilitation programs. Response was coded as "Yes", "No", or "Uncertain" in different functional domains (Motor, Social, Alimentary, Communication, Personal Autonomy). Inter-rater agreement was measured using the kappa statistic. Raters where then asked to discuss any reason for disagreement. The test was repeated with different cases (16 case histories) adding a sixth rater, who had participated to the discussion. RESULTS: Even with this small number of cases, the agreement mostly ranged from poor to good in the first test (worse for Social, Personal Autonomy and Communication). Training improved agreement in almost all domains. There were no frank outliers. The agreement was lower with a specific approach (i.e. grouping "Uncertain" to "No") than with sensitive approach (i.e. grouping "Uncertain" to "Yes"). DISCUSSION: The interpretation of patients' response to physical and cognitive rehabilitation tends to vary among Italian child neurologists/psychiatrists depending on measures and training procedures. Discussion and training improves agreement, although this is only a pilot study conducted using a non standardized questionnaire.

Response to rehabilitation of children and adolescents with epilepsy.

One hundred fifty-six children and adolescents with epilepsy from six Italian rehabilitation units were retrospectively enrolled to define the proportion of patients with epileptogenic developmental disorders who benefit from comprehensive rehabilitation programs and to identify factors predicting treatment response. The rehabilitation programs were classified as neuromotor, psychomotor, and speech and language. For each program, the response was coded as present or absent according to the caring physician's judgment. Selected demographic and clinical variables were correlated to treatment response. Neuromotor rehabilitation was performed in 86 cases (55%), psychomotor rehabilitation in 54 cases (34%), and speech and language rehabilitation in 40 cases (26%). Response rates were 58, 74, and 90%, respectively. Independent negative predictors of treatment response included severity of functional impairment (odds ratio=0.02, 95% confidence interval=0.01-0.14) and daily seizures (odds ratio=0.22, 95% confidence interval=0.08-0.58).

Development and validation of the Italian version of the Spinal Cord Independence Measure III.

PURPOSE: To provide a translation and cultural adaptation of the Spinal Cord Independence Measure version III scale for Italy (i-SCIM3) and to validate this version of the scale. METHOD: i-SCIM3 was developed involving a forward-backward translation and administered to patients with spinal cord lesions (SCL) admitted to two centers. Two raters for each center evaluated patients at admission and discharge. Psychometric testing included reliability by internal consistency (Cronbach's alpha) and test-retest reliability. The validity of i-SCIM3 was assessed by comparing it with the Italian version of Functional Independence Measure (FIM). RESULTS: One hundred three adult patients with SCL (84 males) with a mean age of 50.33+/-15.35 years were recruited. Seventy-four patients were paraplegic and 29 patients were tetraplegic. The median time elapsed between the two evaluations was 77.5 days (interquartile range, 53-144 days). Internal consistency, inter-rater reliability, and test-retest reliability were satisfactory overall, showing values higher than 0.90. The validity of i-SCIM3 was confirmed by the close correlation with FIM results both at admission and discharge (r=0.91, p<0.01). The sensitivity to change of i-SCIM3 was similar to that of FIM. CONCLUSION: i-SCIM3 was found to be a consistent, reliable, and valid scale for use in the clinical setting. It is the first validated scale in Italian for patients with SCL.