Fatigue in spinocerebellar ataxia: Patient self-assessment of an early and disabling symptom

Objective: To identify the prevalence and severity of fatigue and predicting factors for severe fatigue in autosomal dominant spinocerebellar ataxia (SCA). Methods: We studied a cross-section of 123 patients with SCA. Six functional scales were used in a self-assessment: the Fatigue Severity Scale (FSS); the Beck Depression Inventory (BDI); the Rotterdam Handicap Scale (RHS); the Short Form-36 health survey, distinguishing a norm-based physical and mental component score (Nb-PCS and Nb-MCS); the Pittsburgh Sleep Quality Index (PSQI); and the Epworth Sleepiness Scale (ESS). A subset of 58 patients wa

Study protocol for a non-inferiority trial of a blended smoking cessation treatment versus face-to-face treatment (LiveSmokefree-Study)

Background: Smoking cessation can significantly reduce the risk of developing smoking-related diseases. Several face-to-face and web-based treatments have shown to be effective. Blending of web-based and face-to-face treatment is expected to improve smoking cessation treatment. The primary objective of this study is to compare the prolonged abstinence rate of the blended smoking cessation treatment with the face-to-face treatment. Secondary objectives are to assess the benefits of blended treatment in terms of cost effectiveness and patient satisfaction, and to identify mechanisms underlying successful smoking cessation. Methods/Design: This study will be a single-center randomized controlled non-inferiority-trial with parallel group design. Patients (n = 344) will be randomly assigned to either the blended or the face-to-face group. Both treatments will consist of ten sessions with equal content held within 6 months. In the blended treatment five out of ten sessions will be delivered online. The treatments will cover the majority of behavior change techniques that are evidence-based within smoking cessation counseling. All face-to-face sessions in both treatments will take place at the outpatient smoking cessation clinic of a hospital. The primary outcome parameter will be biochemically validated prolonged abstinence at 15 months from the start of the smoking cessation treatment. Discussion: This RCT will be the first study to examine the effectiveness of a blended smoking cessation treatment. It will also be the first study to explore patient satisfaction, adherence, cost-effectiveness, and the clinically relevant influencing factors of a blended smoking cessation treatment. The findings of this RCT are expected to substantially strengthen the base of evidence available to inform the development and delivery of smoking cessation treatment

Adherence to blended or face-to-face smoking cessation treatment and predictors of adherence: randomized controlled trial

BACKGROUND: Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity. OBJECTIVE: The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment. METHODS: We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics. RESULTS: We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R2=0.049; face-to-face R2=0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R2=0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R2=0.164). CONCLUSIONS: This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research. TRIAL REGISTRATION: Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113

Veiligheid en verdraagbaarheid van verneveling van amoxicilline + clavulaanzuur bij stabiele coPD-patienten

OBJECTIVE: To study the safety and tolerability of nebulized amoxicillin + clavulanic acid in patients with stable COPD. Acute exacerbations in COPD are often treated with antibiotics. Previous studies showed ineffective amoxicillin concentrations in sputum in two thirds of the patients treated with systemic amoxicillin + clavulanic acid. Local administration, theoretically providing higher concentrations, has not been described before. DESIGN: Prospective observational intervention study. METHODS: Nine subjects received ascending doses amoxicillin + clavulanic acid, ranging from 50 + 10 mg up to 300 + 60 mg. Plasma and expectorated sputum samples were assayed for amoxicillin content. Safety was evaluated by spirometry before and after nebulization. Tolerability was evaluated by questionnaire. RESULTS: Spirometry showed no clinically relevant reduction in FEV1 after nebulization with amoxicillin + clavulanic acid. In 34 nebulizations only 3 mild adverse events occurred. The sputum amoxicillin quantification showed levels well above MIC90, while no effective levels were found in plasma. CONCLUSION: Inhalation of nebulized amoxicillin + clavulanic acid is safe and well tolerated. Nebulized amoxicillin + clavulanic acid produces sputum concentrations well above MIC with low systemic exposure