BackgroundEnhancing rehabilitation methods for patients with stroke is essential, particularly during the transition from inpatient to outpatient care. Digital applications are being developed to provide telerehabilitation programs. The existing virtual blended care platform Blended Clinic (Blended Clinic AI GmbH) offers app-based training for patients after a stroke and comprises 3 main components, including training, coaching, and monitoring. ObjectiveThis study assesses the usability and user experience of the novel Swiss Tele-Assisted Rehabilitation and Training (START) program within the Blended Clinic platform in patients after stroke and therapists. MethodsThe START program was developed within 3 workshops and an online survey. It contains 10 6-week exercise programs tailored to the levels of the modified Rankin Scale (mRS), 5 infographics, and 5 podcasts. Eight patients after stroke and 10 therapists took part in a single-center usability study. All participants were introduced to the Blended Clinic app and subsequently used it independently. The Blended Clinic platform, including the START program, was evaluated by both user groups based on the System Usability Scale (SUS) and the Mobile App Rating Scale (MARS-G). Additionally, feedback was collected, observations were documented, and program adherence metrics were calculated. ResultsThe mean SUS scores were 87.2 (SD 10.8) for 8 patients and 83.3 (SD 11.3) for 10 therapists. The MARS-G scores were 3.9 (SD 0.5) for patients and 4.1 (SD 0.4) for therapists for categories A-D. User experience was rated 4.1 (SD 0.5) for patients, while device usability was 3.8 (SD 0.8) for patients and 4.2 (SD 0.5) for therapists. Adherence to the training schedule varied among patients (16.7%-80% of the planned sessions) and was rather low for many of the patients. ConclusionsThe START program, delivered via the Blended Clinic platform, was considered user-friendly and received good usability ratings from patients with stroke and therapists. Recommendations to enhance compliance are provided.
OBJECTIVES:Network meta-analysis (NMA) with individual participant data can estimate how treatment effects change with patient characteristics. Yet cost-effectiveness analyses typically use population-average effects. We introduce a framework that incorporates NMA-derived heterogeneous treatment effects into cost-effectiveness analysis using a risk-modeling approach. METHODS:We first derived a baseline risk score for each patient using a prognostic model. This risk score was then used as an effect modifier in a network meta-regression to estimate risk-specific treatment effects. These effects were incorporated into the cost-effectiveness model to estimate the incremental cost-effectiveness ratios and net monetary benefits as functions of the baseline risk score. We demonstrated the approach using data from observational and randomized studies in relapsing-remitting multiple sclerosis, comparing dimethyl fumarate, glatiramer acetate, and placebo. RESULTS:Risk-dependent treatment effects from the prediction-NMR framework led to substantial variation in cost-effectiveness across the baseline risk distribution. When these treatment effects were incorporated into the cost-effectiveness model, incremental cost-effectiveness ratios increased steadily across baseline risk quintiles, from 48 811 Swiss Francs [CHF] (US $62 034) /QALY in the lowest-risk group to 212 870 CHF (US $270 536)/QALY in the highest. Dimethyl fumarate has a higher net monetary benefit up to a baseline risk of 55%, after which glatiramer acetate becomes the preferred option. CONCLUSIONS:Our findings show that integrating baseline risk modeling with NMA and cost-effectiveness analysis provides more informative decision-making than relying on average effects. Treatment value can vary substantially across the risk spectrum, indicating that optimal therapy selection is strongly dependent on individual patient risk.
INTRODUCTION:Levodopa did not enhance early motor recovery at 3 months after stroke in the Enhancement of Stroke Rehabilitation with Levodopa (ESTREL) trial. However, whether levodopa modifies the time course of recovery, leading to a delayed benefit remains unclear. Here, we examined levodopa's effects on the trajectories of motor recovery up to 6 months after stroke. PATIENTS AND METHODS:The ESTREL trial, a double-blind, randomised controlled clinical trial, compared a 39-day regimen of levodopa/carbidopa (100 mg/25 mg, 3×/day) to placebo alongside standardised task-oriented training. We longitudinally analysed Fugl-Meyer Motor Assessment (FMA) total scores (primary outcome), mRS and NIHSS (secondary outcomes) at baseline (0-7 days post stroke), 5 weeks, 3 and 6 months using linear mixed-effects models including timepoint, treatment allocation and their interaction. RESULTS:In total, 576 of 610 (94%) participants (median age 73 years; 40% female) were analysed. FMA scores improved over time in both groups (P < .001), with no overall levodopa effect across visits (estimate 0.65 points, 95% CI, -3.3 to 4.6; P = .75). There was no indication that levodopa modified the recovery trajectory (χ2 = 0.52, df = 3, P = .91), and estimated levodopa-placebo differences in FMA changes across visit intervals were small, ranging from -0.7 to +0.8 points, with confidence intervals crossing zero. Secondary outcomes showed similar longitudinal improvement, without evidence of a treatment effect. CONCLUSION:In this post hoc analysis of ESTREL participants with repeated FMA assessments, motor impairment improved from the first days after stroke up to 6 months. Levodopa added to task-oriented inpatient rehabilitation did not improve motor recovery or alter its trajectory over this period. CLINICAL TRIAL REGISTRATION:NCT03735901, available at ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT03735901?cond=NCT03735901&rank=1.
INTRODUCTION:Post-stroke depression (PSD) frequently occurs after acute stroke and negatively affects rehabilitation. Dopamine has beneficial effects on motivation and emotional stability. In stroke patients, low dopamine levels are linked to PSD. This study investigated whether levodopa treatment during in-hospital rehabilitation impacts PSD compared to placebo. PATIENTS AND METHODS:ESTREL-Depression was a pre-planned analysis of the multicenter, randomized, double-blind, placebo-controlled ESTREL trial. Participants with an acute ischemic or hemorrhagic stroke were randomly assigned to receive either levodopa/carbidopa (100/25 mg) or placebo three times daily for 39 days. All ESTREL participants with (1) information about the presence or absence of depression at three months and (2) who took at least 80% of the study medication were eligible for the study. Participants with a history of depression were excluded. For the primary outcome, the presence of PSD was defined as having a T-score of ≥55 in the Patient-Reported Outcomes Measurement Information System short-form depression-4a 3 months after randomization. Binary logistic regression was performed to assess the effect of levodopa on PSD. RESULTS:The study included 407 ESTREL participants (median age 72, 60% male), 209 receiving levodopa, and 198 receiving placebo. At 3 months, the frequency and odds of PSD did not differ between the levodopa group (26%) and the placebo group (28%) (OR = 0.93, 95% CI, 0.60-1.43). CONCLUSION:In the ESTREL-Depression study, treatment with levodopa had no impact on the occurrence of PSD. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov: NCT03735901 (https://clinicaltrials.gov/study/NCT03735901).
IntroductionPersistent Postural-Perceptual Dizziness (PPPD) is a chronic functional vestibular disorder exacerbated by posture, movement, or visual stimuli. Widely used dizziness questionnaires lack specificity for PPPD symptoms. The Niigata PPPD Questionnaire (NPQ) and its German-translated and revised version (NPQ-R), including two additional subscales, were developed to address this gap. Its internal consistency, convergent validity, and test–retest reliability were found to be satisfactory. The aim of the present study was to examine the NPQ-R’s structure using confirmatory factor analysis (CFA) and Rasch item analysis.Materials and methodsWe analysed data from 265 (135 female) patients (50.2 ± 16.8 years, dizziness duration 46.3 ± 76.6 months) who completed the NPQ-R. CFA was conducted using the robust maximum likelihood estimator in R (lavaan), and Rasch item analysis was performed for each subscale separately.ResultsCFA revealed moderate-to-high covariances between the five latent variables (range: 0.59–0.97), with all items except one demonstrating significant standardised loadings. Rasch analysis indicated acceptable item fit for most items. Person separation reliability ranged from 0.63 to 0.75 across subscales. Item 2 (Visual Stimulation) exhibited misfit.DiscussionThe NPQ-R demonstrates promising psychometric properties. While the Rasch analyses support reliability and internal coherence, the CFA results suggest that the overall five-factor model may require refinement. Conceptual clarity and wording of specific items should be re-examined. However, the NPQ-R remains suitable for PPPD assessment and severity determination in clinical and research contexts, while theoretical and empirical refinement of its factor structure is recommended.
