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Prediction of responders for outcome measures of locomotor Experience Applied Post Stroke trial.

ABSTRACT: The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-related outcomes and measures that captured disability, physical impairment, and quality of life. The most robust predictor was being closer at baseline to the primary outcome measure, which was the functional walking speed thresholds of 0.4 m/s (household walking) and 0.8 m/s (community walking). Regardless of baseline walking speed, a younger age and higher Berg Balance Scale score were relative predictors of responding, whether operationally defined by transitioning beyond each speed boundary or by a continuous change or a greater than median increase in walking speed. Of note, the cutoff values of 0.4 and 0.8 m/s had no particular significance compared with other walking speed changes despite their general use as descriptors of functional levels of walking. No evidence was found for any difference in predictors based on treatment group.

SUBMITTER: Dobkin BH

PROVIDER: S-EPMC4374620 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Prediction of responders for outcome measures of locomotor Experience Applied Post Stroke trial.

Dobkin Bruce H K BH Nadeau Stephen E SE Behrman Andrea L AL Wu Samuel S SS Rose Dorian K DK Bowden Mark M Studenski Stephanie S Lu Xiaomin X Duncan Pamela W PW

Journal of rehabilitation research and development 20140101 1

The Locomotor Experience Applied Post Stroke rehabilitation trial found equivalent walking outcomes for body weight-supported treadmill plus overground walking practice versus home-based exercise that did not emphasize walking. From this large database, we examined several clinically important questions that provide insights into recovery of walking that may affect future trial designs. Using logistic regression analyses, we examined predictors of response based on a variety of walking speed-rel ...[more]

PMID: 24805892

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Project description:BackgroundThere is growing interest in the use of routine patient-reported outcome measures (PROMs) to influence the care of individual patients with stroke. However, there are significant gaps in our understanding as to how PROMs influence post-stroke patient care and clinical practice. This is due to factors including the number of purported uses for PROMs and that PROMs are complex interventions, which attempt to stimulate varied actions or behaviours. Therefore, the objective of this realist synthesis is to offer theory-based explanations as to how PROMs influence post-stroke clinical practice and patient care.MethodsThis is a protocol for a realist synthesis, which involves three distinct phases: theory building (phase 1), theory testing and refinement (phase 2) and synthesis (phase 3). Phase 1 will develop initial rough programme theories (IRPTs), through literature searches (from January 2000 onwards) of MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Library and the grey literature. Only secondary sources will be included that contribute to the development of IRPTs. Only two IRPTs, prioritised by the stakeholder group, will be taken forward to be tested and refined during phase 2. Further novel searches will be employed in phase 2, utilising the same criteria as phase 1; however, phase 2 searches will not utilise grey literature searches, and only primary research studies that contribute to the refinement of programme theories under investigation will be included. Two independent reviewers will screen and select all returned results. The reviewers will code and annotate relevant sources, resulting in 'fragments' to be extracted and graded based on the richness of their contribution to explanation and causal insight. Further, these fragments will be organised into 'Context-Mechanism-Outcome' configurations. Phase 3 of the review will involve the synthesis of context-mechanism-outcome configurations to form middle-range theory-based explanations and developed logic models for stakeholders to understand how PROMs in post-stroke clinical practice and patient care work for whom, how and under what circumstances.DiscussionThe resulting realist synthesis will provide guidance on the implementation of PROMs within routine post-stroke clinical practice and patient care and act as a touchstone for further testing and refinement of PROMs programmes.Systematic review registrationPROSPERO CRD42020138649 .

Project description:BackgroundPersonalized medicine is the tailoring of treatment to the individual characteristics of patients. Once a treatment has been tested in a clinical trial and its effect overall quantified, it would be of great value to be able to use the baseline patients' characteristics to identify patients with larger/lower benefits from treatment, for a more personalized approach to therapy.MethodsWe show here a previously published statistical method, aimed at identifying patients' profiles associated to larger treatment benefits applied to three identical randomized clinical trials in multiple sclerosis, testing laquinimod vs placebo (ALLEGRO, BRAVO, and CONCERTO). We identified on the ALLEGRO patients' specific linear combinations of baseline variables, predicting heterogeneous response to treatment on disability progression. We choose the best score on the BRAVO, based on its ability to identify responders to treatment in this dataset. We finally got an external validation on the CONCERTO, testing on this new dataset the performance of the score in defining responders and non-responders.ResultsThe best response score defined on the ALLEGRO and the BRAVO was a linear combination of age, sex, previous relapses, brain volume, and MRI lesion activity. Splitting patients into responders and non-responders according to the score distribution, in the ALLEGRO, the hazard ratio (HR) for disability progression of laquinimod vs placebo was 0.38 for responders, HR = 1.31 for non-responders (interaction p = 0.0007). In the BRAVO, we had similar results: HR = 0.40 for responders and HR = 1.24 for non-responders (interaction p = 0.006). These findings were successfully replicated in the CONCERTO study, with HR = 0.44 for responders and HR=1.08 for non-responders (interaction p = 0.033).ConclusionsThis study demonstrates the possibility to refine and personalize the treatment effect estimated in randomized studies by using the baseline demographic and clinical characteristics of the included patients. The method can be applied to any randomized trial in any medical condition to create a treatment-specific score associated to different levels of response to the treatment tested in the trial. This is an easy and affordable method toward therapy personalization, indicating patient profiles related to a larger benefit from a specific drug, which may have implications for taking clinical decisions in everyday clinical practice.

Project description:IntroductionTraditional methods for obtaining outcomes for patients after acute stroke are resource-intensive. This study aimed to examine the feasibility, reliability, cost, and acceptability of collecting outcomes after acute stroke with a short message service (SMS)-text messaging program.MethodsPatients were enrolled in an SMS-text messaging program at acute stroke hospitalization discharge. Participants were prompted to complete assessments including the modified Rankin scale (mRS) and Patient-Reported Outcomes Measurement (PROM) Information System Global-10 at 30, 60, and 90 days postdischarge via SMS-text. Agreement and cost of SMS-text data collection were compared to those obtained from traditional follow-up methods (via phone or in the clinic). Participant satisfaction was surveyed upon program conclusion.ResultsOf the 350 patients who agreed to receive SMS texts, 40.5% responded to one or more assessments. Assessment responders were more likely to have English listed as their preferred language (p = 0.009), have a shorter length of hospital stay (p = 0.01), lower NIH stroke scale upon admission (p < 0.001), and be discharged home (p < 0.001) as compared to nonresponders. Weighted Cohen's kappa revealed that the agreement between SMS texting and traditional methods was almost perfect for dichotomized (good vs. poor) (κ = 0.8) and ordinal levels of the mRS score (κ = 0.8). Polychoric correlations revealed a significant association for PROM scores ( ρ = 0.4, p < 0.01 and ρ = 0.4, p < 0.01). A cost equation showed that gathering outcomes via SMS texting would be less costly than phone follow-up for cohorts with more than 181 patients. Nearly all participants (91%) found the program acceptable and not burdensome (94%), and most (53%) felt it was helpful. Poststroke outcome data collection via SMS texting is feasible, reliable, low-cost, and acceptable. Reliability was higher for functional outcomes as compared to PROMs.ConclusionsWhile further validation is required, our findings suggest that SMS texting is a feasible method for gathering outcomes after stroke at scale to evaluate the efficacy of acute stroke treatments.

Project description:BackgroundCigarette smoking is a known risk factor for cardiovascular disease, including ischemic stroke. The literature regarding the rate of persistent smoking after acute ischemic stroke and its effect on subsequent cardiovascular events is scarce. With this study, we aimed to report the rate of persistent smoking after ischemic stroke and the association between smoking status and major cardiovascular outcomes.MethodsThis is a post-hoc analysis of the SPS3 trial (Secondary Prevention of Small Subcortical Strokes). Patients were divided into 4 groups based on smoking status at trial enrollment: (1) never smokers, (2) former smokers, (3) smokers who quit at 3 months, and (4) persistent smokers. The primary outcome is a major adverse cardiovascular events composite of stroke (ischemic and hemorrhagic), myocardial infarction, and mortality. Outcomes were adjudicated after month 3 of enrollment until an outcome event or the end of study follow-up.ResultsA total of 2874 patients were included in the study. Of the total cohort, 570 patients (20%) were smokers at enrollment, of whom 408 (71.5%) patients continued to smoke and 162 (28.4%) quit smoking by 3 months. The major adverse cardiovascular events outcome occurred in 18.4%, 12.4%, 16.2%, and 14.4%, respectively, in persistent smokers, smokers who quit, prior smokers, and never smokers. In a model adjusted for age, sex, race, ethnicity, education, employment status, history of hypertension, diabetes, hyperlipidemia, myocardial infarction, and intensive blood pressure randomization arm, the risk of major adverse cardiovascular events, and death were higher in the persistent smokers compared with never smokers (HR for major adverse cardiovascular events: 1.56 [95% CI, 1.16-2.09]; HR for death: 2.0 [95% CI, 2.18-3.12]). The risk of stroke, and MI did not differ according to smoking status Conclusions: Compared with never smoking, persistent smoking after acute ischemic stroke was associated with an increased risk of cardiovascular events and death.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT00059306.

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Prediction of responders for outcome measures of locomotor Experience Applied Post Stroke trial.

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Prediction of responders for outcome measures of locomotor Experience Applied Post Stroke trial.

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