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- Philp, Ian, et al.
(author)
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Development of a Poststroke Checklist to Standardize Follow-up Care for Stroke Survivors
- 2013
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In: Journal of Stroke & Cerebrovascular Diseases. - : Elsevier BV. - 1532-8511 .- 1052-3057. ; 22:7, s. 173-180
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Journal article (peer-reviewed)abstract
- Background: Long-term care for stroke survivors is fragmented and lacks an evidence-based, easy-to-use tool to identify persistent long-term problems among stroke survivors and streamline referral for treatment. We sought to develop a poststroke checklist (PSC) to help health care professionals identify poststroke problems amenable to treatment and subsequent referral. Methods: An instrument development team, supported by measurement experts, international stroke experts, and poststroke care stakeholders, was created to develop a long-term PSC. A list of long-term poststroke problem areas was generated by an international, multidisciplinary group of stroke experts, the Global Stroke Community Advisory Panel. Using Delphi methods, a consensus was reached on which problem areas on the list were most important and relevant to include in a PSC. The instrument development team concurrently created the actual checklist, which provided example language about how to ask about poststroke problem areas and linked patient responses to a specific referral process. Results: Eleven long-term poststroke problem areas were rated highly and consistently among stroke experts participating in the Delphi process (n = 12): secondary prevention, activities of daily living, mobility, spasticity, pain, incontinence, communication, mood, cognition, life after stroke, and relationship with caregiver. These problem areas were included in the long-term PSC. Conclusions: The PSC was developed to be a brief and easy-to-use tool, intended to facilitate a standardized approach for health care providers to identify long-term problems in stroke survivors and to facilitate appropriate referrals for treatment.
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2. |
- Ruilope, LM, et al.
(author)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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In: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Journal article (peer-reviewed)abstract
- <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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3. |
- Ward, Anthony B., et al.
(author)
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Evaluation of the Post Stroke Checklist: a pilot study in the United Kingdom and Singapore
- 2014
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In: International Journal of Stroke. - : SAGE Publications. - 1747-4949 .- 1747-4930. ; 9, s. 76-84
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Journal article (peer-reviewed)abstract
- Background There is currently no standardized process for long-term follow-up care. As a result, management of post-stroke care varies greatly, and the needs of stroke survivors are not fully addressed. The Post Stroke Checklist was developed by the Global Stroke Community Advisory Panel as a means of standardizing long-term stroke care. Since its development, the Post Stroke Checklist has gained international recognition from various stroke networks and is endorsed by the World Stroke Organization to support improved stroke survivor follow-up and care. Aims The aim of this study was to evaluate the feasibility and usefulness of the Post Stroke Checklist in clinical practice and assess its relevance to stroke survivors in pilot studies in the United Kingdom and Singapore. Methods The Post Stroke Checklist was administered to stroke survivors in the United Kingdom (n = 42) and Singapore (n = 100) by clinicians. To assess the feasibility of the Post Stroke Checklist in clinical practice, an independent researcher observed the assessment and made notes relating to the patient-clinician interaction and their interpretations of the Post Stroke Checklist items. Patient and clinician satisfaction with the Post Stroke Checklist was assessed by three questions, responded to on a 0-10 numerical rating scale. Clinicians also completed a Pragmatic Face and Content Validity test to evaluate their overall impressions of the Post Stroke Checklist. In the United Kingdom, a subset of patients (n = 14) took part in a concept elicitation interview prior to being administered the Post Stroke Checklist, followed by a cognitive debriefing interview to assess relevance and comprehension of the Post Stroke Checklist. Results The Post Stroke Checklist identified frequently reported problems for stroke survivors including cognition (reported by 47.2% of patients), mood (43.7%), and life after stroke (38%). An average of 3.2 problems per patient was identified across both countries (range 0-10). An average of 5 and 2.6 problems per patient were identified in the United Kingdom and Singapore, respectively. The average time taken to administer the Post Stroke Checklist was 17 mins (standard deviation 7.5) in Singapore and 13 mins (standard deviation 7.6) in the United Kingdom. Satisfaction ratings were high for patients (8.6/10) and clinicians (7.7/10), and clinician feedback via the Pragmatic Face and Content Validity test indicated that the Post Stroke Checklist is 'useful', 'informative', and 'exhaustive'. All concepts measured by the Post Stroke Checklist were spontaneously discussed by patients during the concept elicitation interviews, suggesting that the Post Stroke Checklist is relevant to stroke survivors. Cognitive debriefing data indicated that the items were generally well understood and relevant to stroke. Minor revisions were made to the Post Stroke Checklist based on patient feedback. Conclusions The findings suggest that the Post Stroke Checklist is a feasible and useful measure for identifying long term stroke care needs in a clinical practice setting. Pilot testing indicated that the Post Stroke Checklist is able to identify a wide range of unmet needs, and patient and clinician feedback indicated a high level of satisfaction with the Post Stroke Checklist assessment. The items were generally well understood and considered relevant to stroke survivors, indicating the Post Stroke Checklist is a feasible, useful, and relevant measure of poststroke care.
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4. |
- Wissel, Joerg, et al.
(author)
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OnabotulinumtoxinA Improves Pain in Patients With Post-Stroke Spasticity: Findings From a Randomized, Double-Blind, Placebo-Controlled Trial
- 2016
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In: Journal of Pain and Symptom Management. - : ELSEVIER SCIENCE INC. - 0885-3924 .- 1873-6513. ; 52:1, s. 17-26
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Journal article (peer-reviewed)abstract
- Context. Patients with post-stroke spasticity (PSS) commonly experience pain in affected limbs, which may impact quality of life. Objectives. To assess onabotulinumtoxinA for pain in patients with PSS from the BOTOX (R) Economic Spasticity Trial, a multicenter, randomized, double-blind, placebo-controlled trial. Methods. Patients with PSS (N = 273) were randomized to 22- to 34-week double-blind treatment with onabotulinumtoxinA + standard care (SC) or placebo injection + SC and were eligible to receive open-label onabotulinumtoxinA up to 52 weeks. Assessments included change from baseline on the 11-point pain numeric rating scale, proportion of patients with baseline pain amp;gt;= 4 achieving amp;gt;= 30% and amp;gt;= 50% improvement in pain, and pain interference with work at Week 12, end of double-blind treatment, and Week 52. Results. At baseline, most patients (74.3%) experienced pain and 47.4% had pain amp;gt;= 4 (pain subgroup). Mean pain reduction from baseline at Week 12 was significantly greater with onabotulinumtoxinA + SC (-0.77, 95% CI -1.14 to -0.40) than placebo + SC (-0.13, 95% CI -0.51 to 0.24; P amp;lt; 0.05). Higher proportions of patients in the pain subgroup achieved amp;gt;= 30% and amp;gt;= 50% reductions in pain at Week 12 with onabotulinumtoxinA + SC (53.7% and 37.0%, respectively) compared with placebo (28.8% and 18.6%, respectively; P amp;lt; 0.05). Reductions in pain were sustained through Week 52. Compared with placebo + SC, onabotulinumtoxinA consistently reduced pain interference with work. Conclusion. This is the first randomized, placebo-controlled trial demonstrating statistically significant and clinically meaningful reductions in pain and pain interference with work with onabotulinumtoxinA in patients with PSS. (C) 2016 The Authors. Published by Elsevier Inc. on behalf of American Academy of Hospice and Palliative Medicine. This is an open access article under the CC BY-NC-ND license.
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