"Alcochoix+": controlled drinking within a structured programme - a cohort study in Switzerland.

AIMS OF THE STUDY: Controlled drinking as a therapy goal for problematic alcohol use is still a matter for debate, especially with regard to dependent drinkers. Furthermore, few structured controlled drinking programmes have been evaluated. The aim of this study was to observe the evolution of excessive and dependent drinkers in a French-language six-step controlled drinking programme called “Alcochoix+”. METHODS: This was a cohort study of patients in four centres in the French-speaking part of Switzerland who were enrolled between May 2010 and September 2011, and evaluated before and up to 1 year after completion of the programme, according to criteria such as drinking habits, evolution of the Alcohol Use Disorder Identification Test (AUDIT) score and quality of life indicators. We considered the patients who chose not to be followed up to have unchanged alcohol consumption. RESULTS: Recruitment was slow: 60 persons were enrolled, mostly middle-aged men, with excessive alcohol use / moderate alcohol dependence (median AUDIT score 20.5, median weekly alcohol consumption 350 g). Thirty-four participants (56.7%) completed the programme and their median weekly alcohol reduction was 160 g. The mean AUDIT score decreased to 14.1 points. Several aspects of quality of life improved. Changes were stable 1 year after the programme. Expressed satisfaction with the programme was high. CONCLUSIONS: This six-step structured controlled drinking programme designed for excessive drinkers also attracted moderately dependent drinkers. Those who had participated fully in the study significantly reduced their alcohol consumption, with a slight improvement in their quality of life. Future studies should identify the barriers to problem drinkers integrating controlled drinking programmes, and to underline the role of these programmes for moderately dependent drinkers.

Rationale and design of a multicentre, double-blind, prospective, randomized, European and Canadian study: evaluating patient outcomes and costs of managing adults with post-stroke focal spasticity.

OBJECTIVE: This report describes the design of a study aiming to provide evidence for the extended use of botulinum toxin A in focal post-stroke upper and lower limb spasticity and to evaluate the impact of incorporating botulinum toxin treatment into the rehabilitation of patients with spasticity. DESIGN: International, prospective, randomized, double-blind, placebo-controlled study with an open-label extension. METHODS: Approximately 300 adults with a stroke occurring ≥ 3 months before screening, presenting with symptoms and signs of an upper motor neuron syndrome and focal spasticity-related functional impairment, were randomized to botulinum toxin (BOTOX®, Allergan Inc.) + standard care or placebo + standard care. Study medication was administered at baseline and again at Week 12 if required, with follow-up to 52 weeks. The primary endpoint was the number of patients who achieved their investigator-rated principal active functional goal (as measured by Goal Attainment Scaling), at 10 weeks after the second injection (Weeks 22-34) or at the 24-week visit if no second injection was administered. Secondary endpoints included changes from baseline in level of goal achievement, health-related quality of life and resource utilization. CONCLUSION: Botulinum toxin A Economic Spasticity Trial (BEST) will provide information regarding clinical and cost-effectiveness of botulinum toxin + standard care vs standard care alone in patients with upper and/or lower limb post-stroke spasticity typically seen in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov number NCT-00549783.

Exploring the impact of changes in neurogenic urinary incontinence frequency and condition-specific quality of life on preference-based outcomes.

PURPOSE: Many trials do not measure quality-adjusted life years (QALYs). Therefore, decision analysts often map condition-specific outcomes to preference scores. We estimated the relationship between changes in preference scores and commonly reported condition-specific outcomes in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity. METHODS: In 59 patients recruited to a neurogenic UI trial, clinical outcomes (UI episodes), condition-specific quality of life (Incontinence Quality of Life Instrument (I-QOL)), and SF-6D preference scores were measured at enrollment and 24 weeks. We used multiple linear regression to estimate the impact on SF-6D scores of 50; 50-99 and 100% reductions in UI episodes and a 10-point improvement in I-QOL. RESULTS: By 24 weeks, mean (95% CI) daily UI episodes fell by 0.85 (0.04, 1.3) and mean I-QOL scores improved by 18 (12, 24). SF-6D scores increased by 0.03 (0.003, 0.058), due to improvements in role limitations. A > or = 50% reduction in UI episodes was achieved by 49% of patients and corresponded to a 0.09 (0.02, 0.16) SF-6D increase. A > or = 10-point increase in I-QOL was attained by 65% of patients and was associated with a 0.05 (-0.02, 0.12) SF-6D increase. CONCLUSIONS: These estimates provide preliminary data for decision analysts wishing to map neurogenic UI outcomes to preference scores.

Conjoint analysis of French and German parents' willingness to pay for meningococcal vaccine.

OBJECTIVE: To estimate the willingness of parents in France and Germany to pay for meningococcal conjugate vaccines for their teenage children. METHODS: A conjoint analysis survey was administered to parents who had received counselling on the nature and risks of meningococcal disease in young people. In each country, half were randomly assigned to view a video with graphical depictions of the effects of meningococcaemia. Subjects were then shown a series of 18 sets of three vaccine descriptions. Each description listed the price of a hypothetical vaccine (range 15-304 euro; 2001 values), the duration of protection, and the number of serogroups of the bacteria covered. The survey asked which vaccine they preferred and whether they would buy it. Conditional logit and generalised linear-random effects logit models assessed the effect of product attributes, personal background and video viewership on the probability of indicating a purchase. RESULTS: 92.6% of subjects would purchase at least one of the vaccines they encountered. Price elasticity ranged from -1.20 (France) to -2.48 (Germany). Exposure to graphical depictions of disease consequences negligibly increased the overall willingness to purchase vaccine in French participants, but lowered the overall willingness in German participants. CONCLUSION: In Germany and France, where there is still limited out-of-pocket health spending, the majority of sampled respondents stated that they would purchase meningococcal vaccines with their own money.