What should be defined as good outcome in stroke trials; a modified Rankin score of 0–1 or 0–2?

Weisscher, Nadine; Vermeulen, M.; Roos, Y. B. W. E. M.; Haan, Rob J. de

doi:10.1007/s00415-008-0796-8

Cited by 123 publications

(105 citation statements)

References 30 publications

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“…A variety of exploratory outcome measures will be evaluated including global measures of functional disability measured by the modified Rankin scale,36 quality of life measured by PDQ‐3937 and NeuroQOL,38 the change in the ambulatory capacity (sum of 5 UPDRS items: falling, freezing, walking, gait, postural stability)39, and cognitive function as measured by MOCA 24. Finally, we will model the trajectory of UPDRS change before and after initiation of ST (D in Fig.…”

Section: Methodsmentioning

confidence: 99%

A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY‐PD III)

Biglan

Oakes

Lang

et al. 2017

Ann Clin Transl Neurol

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ObjectiveTo describe the rationale for a novel study design and baseline characteristics of a disease‐modifying trial of isradipine 10 mg daily in early Parkinson disease (PD).Methods STEADY‐PDIII is a 36‐month, Phase 3, parallel group, placebo‐controlled study of the efficacy of isradipine 10 mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I‐III score in the practically defined ON state. Secondary outcome measures include clinically meaningful measures of disability progression in early PD: (1) Time to initiation and utilization of dopaminergic therapy; (2) Time to onset of motor complications; (3) Change in nonmotor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function, and pharmacokinetic analysis. Rationale for the current design and alternative design approaches are discussed.ResultsThe entire cohort of 336 participants was enrolled at 55 Parkinson Study Group sites in North America. The percentage of male participants were 68.5% with a mean age of 61.9 years (sd 9.0), mean Hoehn and Yahr stage of 1.7 (sd 0.5), mean UPDRS total of 23.1 (sd 8.6), and MoCA of 28.1 (sd 1.4).Interpretation STEADY‐PD III has a novel and innovative design allowing for the determination of longer duration benefits on clinically relevant outcomes in a relatively small cohort on top of the benefit derived from symptomatic therapy. Baseline characteristics are similar to those in previously enrolled de novo PD trials. This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits.

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Section: Methodsmentioning

confidence: 99%

A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY‐PD III)

Biglan

Oakes

Lang

et al. 2017

Ann Clin Transl Neurol

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“…Short term outcome was evaluated for the surviving patients after one month from ICH onset using modified Rankin scale 19 which estimates the patient disability with a score ranging from 0 to 6 patients with a score of 0-2 had a favorable outcome. Those with a score of more than 2 considered unfavorable outcome .…”

Section: Patients and Methods:-mentioning

confidence: 99%

Prognostic Significance of Serum Calcium Level in a Sample of Egyptian Patients With Intracerebral Hemorrhage.

Sarhan.¹,

Shehta²,

Ramadan³

et al. 2017

IJAR

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“…All adults who sustained a first mild stroke defined as a score >8.5/11.5 on the Canadian Neurological Scale 18 (where a higher score indicates mild or no deficit) or a modified Rankin Score 19 between 0 and 2 on admission and who were discharged home within 3 weeks of the index event were invited to participate. Other inclusion criteria included telephone access, ability to understand basic instructions and express basic needs, and ability to communicate in English or French.…”

Section: Participantsmentioning

confidence: 99%

The YOU CALL–WE CALL Randomized Clinical Trial

Rochette

Korner‐Bitensky

Bishop

et al. 2013

Circ: Cardiovascular Quality and Outcomes

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Background-Comparison of a multimodal intervention WE CALL (study initiated phone support/information provision) versus a passive intervention YOU CALL (participant can contact a resource person) in individuals with first mild stroke. Methods and Results-This study is a single-blinded randomized clinical trial. Primary outcome includes unplanned use of health services (participant diaries) for adverse events and quality of life (Euroquol-5D, Quality of Life Index). Secondary outcomes include planned use of health services (diaries), mood (Beck Depression Inventory II), and participation (Assessment of Life Habits [LIFE-H]). Blind assessments were done at baseline, 6, and 12 months. A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time, with a significance level of 0.01. We enrolled 186 patients (WE=92; YOU=94) with a mean age of 62.5±12.5 years, and 42.5% were women. No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures (effect sizes ranged from 0.25 to 0.7). The only significant change for both groups from 6 months to 1 year (n=139) was in the social domains of the LIFE-H (increment in score, 0.4/9±1.3 [95% confidence interval, 0.1-0.7]; effect size, 0.3). Qualitatively, the WE CALL intervention was perceived as reassuring, increased insight, and problem solving while decreasing anxiety. Only 6 of 94 (6.4%) YOU CALL participants availed themselves of the intervention. Conclusions-Although the 2 groups improved equally over time, WE CALL intervention was perceived as helpful, whereas YOU CALL intervention was not used. Clinical Trial Registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN95662526.(Circ Cardiovasc Qual Outcomes. 2013;6:674-679.)

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What should be defined as good outcome in stroke trials; a modified Rankin score of 0–1 or 0–2?

Cited by 123 publications

References 30 publications

A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY‐PD III)

A novel design of a Phase III trial of isradipine in early Parkinson disease (STEADY‐PD III)

Prognostic Significance of Serum Calcium Level in a Sample of Egyptian Patients With Intracerebral Hemorrhage.

The YOU CALL–WE CALL Randomized Clinical Trial

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