Persistence on therapy and propensity matched outcome comparison of two subcutaneous interferon beta 1a dosages for multiple sclerosis

To compare treatment persistence between two dosages of interferon β-1a in a large observational multiple sclerosis registry and assess disease outcomes of first line MS treatment at these dosages using propensity scoring to adjust for baseline imbalance in disease characteristics. Treatment discontinuations were evaluated in all patients within the MSBase registry who commenced interferon β-1a SC thrice weekly (n = 4678). Furthermore, we assessed 2-year clinical outcomes in 1220 patients treated with interferon β-1a in either dosage (22 µg or 44 µg) as their first disease modifying agent, matched on propensity score calculated from pre-treatment demographic and clinical variables. A subgroup analysis was performed on 456 matched patients who also had baseline MRI variables recorded. Overall, 4054 treatment discontinuations were recorded in 3059 patients. The patients receiving the lower interferon dosage were more likely to discontinue treatment than those with the higher dosage (25% vs. 20% annual probability of discontinuation, respectively). This was seen in discontinuations with reasons recorded as “lack of efficacy” (3.3% vs. 1.7%), “scheduled stop” (2.2% vs. 1.3%) or without the reason recorded (16.7% vs. 13.3% annual discontinuation rate, 22 µg vs. 44 µg dosage, respectively). Propensity score was determined by treating centre and disability (score without MRI parameters) or centre, sex and number of contrast-enhancing lesions (score including MRI parameters). No differences in clinical outcomes at two years (relapse rate, time relapse-free and disability) were observed between the matched patients treated with either of the interferon dosages. Treatment discontinuations were more common in interferon β-1a 22 µg SC thrice weekly. However, 2-year clinical outcomes did not differ between patients receiving the different dosages, thus replicating in a registry dataset derived from “real-world” database the results of the pivotal randomised trial. Propensity score matching effectively minimised baseline covariate imbalance between two directly compared sub-populations from a large observational registry

The Italian multiple sclerosis register

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups

The Italian multiple sclerosis register

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups

Alta specializzazione e centri di riferimento: la regionalizzazione della chirurgia dell'esofago

La societ\ue0 aperta in cui viviamo oggi gode di livelli di libert\ue0 mai prima raggiunti, l\u2019individuo \ue8 preminente sul collettivo, ogni principio etico, morale su cui si sono strutturate le societ\ue0, gli stati, in particolare quelli del mondo occidentale, sono stati e possono essere oggetto oggi di revisione filosofica e sociologica. Tale lavoro di revisione si traduce in cambiamenti dell\u2019uomo e delle aggregazioni che gi uomini attuano per vivere. La fiducia nella techn\ue8, sembra avere sostituito nella maggioranza le credenze che nei millenni hanno alleviato l\u2019angoscia insita nell\u2019uomo sin dalla prima presa di coscienza. Forse nel mondo della salute di oggi , da queste trasformazioni profonde derivano da un lato la richiesta imperativa della pi\uf9 avanzata tecnologia per la difesa del s\ue9 corporale e intellettuale, la diffusa convinzione della ineluttabilit\ue0 del risultato positivo di ogni atto medico, dall\u2019altro le azioni legali versus medici ed ospedali e la cosiddetta medicina difensiva anch\u2019essa basata sulla tecnologia, ad evitare l\u2019accusa di omissione. In questo contesto culturale, riduzione delle risorse e distribuzione delle stesse secondo le regole della organizzazione aziendale della Sanit\ue0, offerta continua di nuove tecnologie diagnostiche e terapeutiche, innovative quanto costose, richiesta da parte della societ\ue0 di elevati livelli di assistenza, costituiscono gli elementi principali di una equazione di non semplice soluzione E\u2019 comune percezione di Societ\ue0 Scientifiche, dei singoli medici e delle associazioni che li rappresentano e delle persone attente alle trasformazioni degli organi posti a presidio della salute, per esperienza diretta o per sensibilit\ue0 personale, che non infrequentemente la cura dei pazienti affetti da patologie complesse quali quelle oggetto di questo lavoro, siano influenzate dai fattori sopra menzionati. Il paziente affetto da patologia esofagea candidato alla terapia chirurgica \ue8 archetipo del paziente complesso. La complessit\ue0 \ue8 data anche dal fatto che le malattie dell\u2019esofago, neoplastiche e non, sono nella grande maggioranza classificabili come rare (il \u201cProgramma d\u2019azione comunitario sulle malattie rare 1999 2003\u201ddell\u2019Unione Europea, definisce \u201crara\u201d una malattia che colpisce non pi\uf9 di 5 pazienti su 10.000 abitanti). La costituzione di centri di riferimento per la chirurgia esofagea, eventualmente su base regionale, sembra rappresentare la soluzione atta a conseguire il miglioramento della cura a fronte dell\u2019utilizzo ottimale delle risorse impiegate. Sussistono peraltro posizioni e pareri diverse sulle soluzioni organizzative, sui parametri di valutazione del risultato di strutture e di processi di struttura, sugli effetti, della creazione di centri di riferimento sul delicato tessuto del servizio sanitario di una nazione. Nell\u2019ambito della Universit\ue0 di Bologna e del Servizio Sanitario Regionale dell\u2019Emilia-Romagna \ue8 attivo da trenta anni il \u201c centro per lo studio e la terapia delle malattie dell\u2019 esofago \u201c , gruppo interdisciplinare che ha conseguito nel tempo non trascurabili risultati clinici e scientifici. Scopo del presente lavoro \ue8 di fare il punto sugli orientamenti attuali in ordine alla organizzazione della chirurgia esofagea

Survey on chest drainage systems adopted in Europe.

The aim of this survey, promoted by the European Society of Thoracic Surgeons, was to acquire information and advice from 'the field' in order to promote development of technology for thoracic surgery and to provide information for future guidelines on chest drainage. Society members were offered a questionnaire on the European Society of Thoracic Surgeons website (November 2006) composed of seven sections comprehending 21 detailed items. The questionnaire was completed by 120 centres, 100% performed lung surgery, 91.6% mediastinal surgery, 54.1% oesophageal surgery, 10% cardiothoracic surgery. The PVC straight drain (mean 55.9%) and silicon drain (mean 38.4%), water-valve/water suction disposable chest drainage collection system (mean 43.4%), one bottle (mean 24.8%), and two bottles with suction control (mean 18.2%), were the most frequently used. After pneumonectomy 51.2% used a balanced drainage system, 9% periodical thoracocentesis, 39.8% others. In 57.5-92% drainage suction was stopped 4 postoperative days. In 17.6-60.7% drains were removed 4 postoperative days. The survey demonstrates a trend toward the use of updated technical devices, high consideration of the costs, and clinical practice based on personal preferences

Long term results of the thoracoscopic Collis-Laparoscopic Nissen for the treatment of severe GERD with acquired short esophagus.

Long term results of the thoracoscopic Collis-Laparoscopic Nissen for the treatment of severe GERD with acquired short esophagus.Background: Purpose of this study is to present the long term results of the thoracoscopic Collis laparoscopic Nissen performed for the treatment of severe GERD associated with short esophagus. Methods: GERD patients were assessed before surgery with interview based on semi-quantitative scales for grading of symptoms, esophagitis from 0 (no symptoms and esophagitis) to 3 (severe symptoms and esophagitis), global evaluation (excellent, good, fair, insuffi cient), endoscopy hysthology, barium swallow, manometry; after surgery every year, alternating interview and tests (same questionnaires as above) except routine manometry, according to a protocol. Intraoperatively the length of the addominal esophagus after maximal mediastinal mobilization of the esophagus was measured with a validated technique; true short esophagus was diagnosed when the submerged segment was 1.5 cm. After surgery, result in patients receiving medical therapy or with recurrent hernia, although asymptomatic, was classifi ed as insuffi cient. Results: From 1996 to 2011, 299 minimally invasive procedures for GERD were performed. In 62/299 (20.7 %) short esophagus was assessed. The left thoracoscopic Collis gastroplasty was associated with 1 Toupet and 1 Dor (motility disorders), with the Nissen fl oppy fundusplication in 60 patients (24 women, 36 men, mean age 55.2 13.7 years, range 20 - 77). 5 procedures were converted at the beginning of the experience. Mortality was 1.7% (1/60), morbidity 11.7% (7/60). The mean follow-up was 58.6 32.1 months (range 12–108). Discussion: With the thoracoscopic Collis-laparoscopic Nissen in patients affected by severe GERD and true short esophagus , satisfactory long-term results were achieved in 93.4% of cases. Disclosure: All authors have declared no confl icts of interest

Laparoscopic/Thoracoscopic surgery for complex non axial hiatus hernia.

Background: In order to demonstrate the feasibility and the corner stones of the minimally invasive surgical technique for the treatment of paraoesophageal and massive incarcerated hiatus hernia we show the case of a 66 years old woman with 20 years history of GORD symptoms, dyspnoea with orthopnea, erosive oesophagitis and recurrent sideropenic anaemia. Barium swallow shows a paraoesophageal hiatus hernia. We present a second case of a 56 years old man complaining severe GORD symptoms since 6 years with painful dysphagia, erosive oesophagitis. Barium swallow shows a non-reducible 10 cm diameter massive incarcerated hiatus hernia. Methods: The steps of the surgical procedure are: 1) complete resection of the hernia sac and fat pad with preservation of the vagus nerves, 2) localization of the position of the GO junction with respect to the apex of the hiatus with a combined endoscopic\u2013laparoscopic procedure, 3) measurement of the length of the esophageal submerged segment, 4) isolation of the mediastinal oesophagus, 5) Collis gastroplasty in case of short oesophagus , 6) hiatus alloplasty, 7) Nissen floppy fundusplication. Results: After maximal oesophageal mobilization , in the first patient the GO junction was placed 2,5 cm below the hiatus and a standard fundusplication was performed , in the second case the GO junction was placed across the hiatus and a combined laparoscopic-left thoracoscopic Collis gastroplasty was necessary. Conclusions: The minimally invasive approach for complex hiatus hernias appears feasible. 15 patients (mean age 65.8 \ub1 11.7 years) underwent laparoscopic Nissen and 14 (mean age 66.5 \ub1 11.7 years) thoraco-laparoscopic Collis-Nissen. Median follow up was 21 months (r. 6-58) with 1 mortality in each group (pulmonary embolus and Collis fistula). Results were excellent and good in 93%, and fair or poor in 7%

Prevalence of gastro-esophageal reflux disease.

Prevalence of gastro-esophageal reflux disease