Translation and initial validation of the Medication Adherence Report Scale (MARS) in Italian patients with Crohn's Disease

The MARS-5 (Medication Adherence Report Scale) was developed in English. The aim of this project was to analyse the MARS-5I (© Prof Rob Horne) psychometric properties and to identify whether its Italian translation is suitable for assessing medication adherence in Crohn Disease (CD) Italian patients. The MARS was translated and linguistically validated in Italian. The MARS-5I was used for evaluating medication adherence in the SOLE study, conducted in Italy on 552 subjects with CD. In order to un-bias the questionnaire results from the effects of treatment change and/or effectiveness, the analyses were performed on the 277 patients whose disease activity remained stable, selected among the 371 patients who maintained the same treatment between two consecutive visits. Internal consistency was high (Cronbach's alpha of 0.86). Pearson's correlation coefficient was 0.50 (p < 0.001) and 0.86 (p < 0.001- outliers removed), indicating satisfactory test-retest. MARS 5I scores were not correlated with Treatment Satisfaction Questionnaire for Medication but a small and statistically significant correlation was shown with physician-evaluated medication adherence, indicating convergent validity. MARS-5I, the Italian translation of the English MARS, showed satisfactory internal consistency and test-retest, and a low but statistically significant convergent validity. We confirmed the utility of this tool in patients with CD

Effect of baclofen on liquid and solid gastric emptying in rats Efeito do baclofen no esvaziamento gástrico de líquido e de sólidos em rato

CONTEXT: Gamma-aminobutyric acid (GABA) is a potent inhibitory neurotransmitter. There is evidence that GABA B receptors located in the dorsal complex and in afferent fibers of the vagus nerve participate in the control of gastrointestinal motility. OBJECTIVE: To assess the intracerebroventricularly (ICV) and intravenously (IV) effect of baclofen, a GABA B receptor agonist, on liquid and solid gastric emptying in rats. METHODS: Adult male Wistar rats weighing 250-300 g (n = 6-8 animals) were used. Gastric emptying of liquid test meals labeled with phenol red was evaluated by the determination of percent gastric retention (%GR) 10 and 15 min after orogastric administration of saline and 10% glucose meals, respectively. Baclofen was injected ICV (1 and 2 µg/animal) through a tube implanted into the lateral ventricle of the brain and was injected IV (1 and 2 mg/kg) into a tail vein. The gastric emptying of liquid was determined 10 or 30 min after ICV and IV baclofen administration, respectively. The gastric emptying of the solid meal was assessed by the determination of percent gastric retention 2 h after the beginning of the ingestion of the habitual ratio by the animal, consumed over a period of 30 min. Baclofen was administered ICV (1 and 2 µg/animal) or IV (1 and 2 mg/kg) immediately after the end of the ingestion of the solid meal. The control groups received vehicle (sterile saline solution) ICV or IV. RESULTS: The group of animals receiving baclofen ICV (2 mg/animal) presented a significantly lower (P<0.05, Tukey test) %GR (mean ± SEM) of the saline (18.1 ± 2.5%) compared to control (33.2 ± 2.2%). In the group receiving the drug IV, the gastric retention of the same test meal did not differ from control. ICV and IV administration of baclofen had no effect on the gastric emptying of the 10% glucose solution compared to control. ICV administration of 1 or 2 mg baclofen/animal significantly increased the gastric retention of the solid test meal (57.9 ± 6.5% and 66.6 ± 6.3%, respectively) compared to control (35.1 ± 4.4%). The same phenomenon was observed only with the IV dose of 2 mg/kg (71.9 ± 2.6%) compared to control (52.7 ± 2.8%). CONCLUSION: Baclofen administered: 1. ICV (2 µg/animal), but not IV, increased gastric emptying of a non-caloric isotonic liquid test meal (saline); 2. when administered ICV or IV, it had no effect of gastric emptying of a 10% glucose solution; 3) when administered ICV (1 and 2 mg/animal) and IV (2 mg/kg) it delayed the gastric emptying of the solid meal.<br>CONTEXTO: O ácido gama-aminobutírico (GABA) é um potente neurotransmissor inibitório. Há evidências que receptores GABA>B localizados no complexo dorsal do vago e em fibras aferentes do nervo vago participam no controle da motricidade gastrointestinal. OBJETIVO: Avaliar o efeito intracerebroventricular (ICV) e intravenoso (IV) do baclofen, um agonista para receptores GABA B, sobre o esvaziamento gástrico de líquidos e de sólidos em ratos. MÉTODOS: Foram utilizados ratos adultos Wistar, machos, de 250-300 g (n = 6-8 animais). O esvaziamento gástrico das refeições de prova líquidas, marcadas com fenol vermelho, foi avaliado através da determinação da % de retenção gástrica, 10 e 15 min após administração orogástrica das refeições salina e de glicose a 10%, respectivamente. As injeções ICV de baclofen (1 e 2 µg/animal) foram feitas através de uma sonda implantada no ventrículo lateral do cérebro e as injeções IV de baclofen (1 e 2 mg/kg) numa veia da cauda. O esvaziamento gástrico das refeições de prova líquidas foi determinado 10 ou 30 min após a administração de baclofen ICV ou IV, respectivamente. O esvaziamento gástrico da refeição sólida foi avaliado através da determinação da % de retenção gástrica 2 h após o início da ingestão da ração habitual do animal, ingerida durante 30 min. As administrações de baclofen ICV (1 e 2 µg/animal) e IV (1 e 2 mg/kg) foram feitas imediatamente após o término da ingestão da refeição sólida. Os grupos controles receberam ICV ou IV veículo (solução salina estéril). RESULTADOS: O grupo de animais que recebeu baclofen 2 mg/animal ICV apresentou retenção gástrica (média ± SEM) de salina (18.1 ± 2.5%) significantemente menor (P<0.05, teste de Tukey) em relação ao grupo controle (33.2 ± 2.2%). No grupo com administração IV da droga, a retenção gástrica da mesma refeição de prova não diferiu do seu controle. As administrações ICV e IV de baclofen não tiveram qualquer efeito no esvaziamento gástrico da solução de glicose a 10%, em relação aos seus controles. A administração ICV de 1 ou 2 µg/animal de baclofen aumentou significativamente as retenções gástricas da refeição de prova sólida (57.9 ± 6.5% e 66.6 ± 6.3%, respectivamente) em relação ao grupo controle (35.1 ± 4.4%). O mesmo fenômeno somente foi observado com a dose IV de 2 mg/kg (71.9 ± 2.6%) em relação ao grupo controle (52.7 ± 2.8%). CONCLUSÃO: O baclofen administrado: 1. ICV (2 µg/animal), mas não IV, aumentou o esvaziamento gástrico de uma refeição de prova líquida isotônica não-calórica (salina); 2. ICV ou IV, não teve efeito sobre o esvaziamento da solução de glicose a 10%; 3) ICV (1 e 2 µg/animal) e IV (2 mg/kg) retardou o esvaziamento gástrico da refeição sólida