Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements

ObjectivesUnderpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes.MethodsWe conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS.ResultsWe secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure.ConclusionsStroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.     

The effect of aquatic physical therapy in patients with stroke: A systematic review and meta-analysis

ABSTRACT

Objective: The purpose of this study was to evaluate the literature reports of qualitative and quantitative results of physical therapy treatments in the alternative aquatic setting for individuals affected by strokes.

Method: PRISMA guidelines were used to carry out the systematic review and meta-analysis. Three bibliographic databases were searched: MEDLINE, PEDro, and the Cochrane Library. Papers included in the study were required to: (a) have a randomized controlled trial (RCT) design of research; and (b) be published in English; (c) be published during the last 10 years (2008–2018). Only randomized controlled trials were employed in the study. The quality of the clinical trials to be included was evaluated according to the Jadad scale. The internal validity was assessed according to the PEDro scale.

Results: Eleven RCTs were initially identified in the systematic review. Eight of these were involved in the meta-analysis comparing outcomes and follow-up. Eight studies received a Jadad score of three, indicating a high level of quality. The remaining three studies achieved a lower score which indicated lower qualitative level. Nearly all of the results of the quantitative analysis were statistically significant (P < 0,05) and most of them favored of the experimental group subject to aquatic treatment.

Conclusion: Aquatic physical therapy may be a valid means for the rehabilitation of people affected by stroke. The integration of this methodological approach with conventional physical therapy should be considered. However, more studies; a larger number of participants; and varying lengths of follow-up times are necessary.     

Effect of methylphenidate and/or levodopa coupled with physiotherapy on functional and motor recovery after stroke – a randomized,double‐blind,placebo‐controlled trial

Lokk J, Salman Roghani R, Delbari A. Effect of methylphenidate and/or levodopa coupled with physiotherapy on functional and motor recovery after stroke – a randomized, double‐blind, placebo‐controlled trial.
Acta Neurol Scand: 2011: 123: 266–273.
© 2010 John Wiley & Sons A/S. Objective – Amphetamine‐like drugs are reported to enhance motor recovery and activities of daily living (ADL) in stroke rehabilitation, but results from trials with humans are inconclusive. This study is aimed at investigating whether levodopa (LD) and/or methylphenidate (MPH) in combination with physiotherapy could improve functional motor recovery and ADL in patients with stroke. Material and methods – A randomized, double‐blind, placebo‐controlled trial with ischemic stroke patients randomly allocated to one of four treatment groups of either MPH, LD or MPH+LD or placebo combined with physiotherapy was performed. Motor function, ADL, and stroke severity were assessed by Fugl‐Meyer (FM), Barthel index (BI), and National Institute of Health Stroke Scale (NIHSS) at baseline, 15, 90, and 180 days respectively. Results – All participants showed recovery of motor function and ADL during treatment and at 6‐month follow‐up. There were slightly but significant differences in BI and NIHSS compared to placebo at the 6‐month follow‐up. Conclusion – Ischemic chronic stroke patients having MPH and/or LD in combination with physiotherapy showed a slight ADL and stroke severity improvement over time. Future studies should address the issue of the optimal therapeutic window and dosage of medications to identify those patients who would benefit most.     

Early filiform needle acupuncture for poststroke depression: a meta-analysis of 17 randomized controlled clinical trials

OBJECTIVE: To evaluate the effectiveness and safety of filiform needle acupuncture for poststroke depression, and to compare acupuncture with the therapeutic efficacy of antidepressant drugs. DATA RETRIEVAL: We retrieved data from the Chinese National Knowledge Infrastructure(1979–2012), Wanfang(1980–2012), VIP(1989–2012), Chinese Biomedical Literature(1975–2012), PubMed(1966–2012), Ovid Lww(–2012), and Cochrane Library(–2012) Database using the internet. SELECTION CRITERIA: Randomized controlled trials on filiform needle acupuncture versus antidepressant drugs for treatment of poststroke depression were included. Moreover, the included articles scored at least 4 points on the Jadad scale. Exclusion criteria: other acupuncture therapies as treatment group, not stroke-induced depression patients, score 4 points, non-randomized controlled trials, or animal trials. MAIN OUTCOME MEASURES: These were the Hamilton Depression Scale scores, clinical effective rate, Self-Rating Depression Scale scores, Side Effect Rating Scale scores, and incidence of adverse reaction and events. RESULTS: A total of 17 randomized controlled clinical trials were included. Meta-analysis results displayed that after 4 weeks of treatment, clinical effective rate was better in patients treated with filiform needle acupuncture than those treated with simple antidepressant drugs [relative risk = 1.11, 95% confidence interval(CI): 1.03–1.21, P = 0.01]. At 6 weeks, clinical effective rate was similar between filiform needle acupuncture and antidepressant drug groups. At 2 weeks after filiform needle acupuncture, Hamilton Depression Scale(17 items) scores were lower than in the antidepressant drug group(mean difference =-2.34, 95%CI:-3.46 to-1.22, P 0.000,1). At 4 weeks, Hamilton Depression Scale(24 items) scores were similar between filiform needle acupuncture and antidepressant drug groups. Self-Rating Depression Scale scores were lower in filiform needle acupuncture group than in the antidepressant drug group. Side Effect Rating Scale was used in only two articles, and no meta-analysis was conducted. Safety evaluation of the 17 articles showed that gastrointestinal tract reactions such as nausea and vomiting were very common in the antidepressant drug group. Incidence of adverse reaction and events was very low in the filiform needle acupuncture group. CONCLUSION: Early filiform needle acupuncture for poststroke depression can perfectly control depression. Filiform needle acupuncture is safe and reliable. Therapeutic effects of filiform needle acupuncture were better than those of antidepressant drugs.     

单纯疱疹病毒性脑炎治疗措施的临床证据评价

目的评价不同治疗方案对单纯疱疹病毒性脑炎的作用及不良反应,以为循证制定最佳治疗方案。方法以脑炎、病毒性脑炎、单纯疱疹病毒、抗病毒治疗、肾上腺皮质激素、治疗等词组作为检索词,分别检索MEDLINE、Cochrane图书馆、万方数据知识服务平台学术期刊库和中国知网中国期刊全文数据库,并辅以手工检索,获取临床指南、系统评价、随机对照试验、临床对照试验及病例观察研究的相关文献,采用Jadad量表对文献质量进行评价。结果经筛选共纳入与单纯疱疹病毒性脑炎治疗有关的临床指南2篇、系统评价2篇、随机对照试验2篇、临床对照试验2篇、病例观察研究3篇;其中9篇被评为高质量文献（3篇Jadad量表评分为4分、5篇评分为5分、1篇评分为7分）,2篇为低质量文献（评分为3分）。对各种治疗方法的疗效及安全性评价显示：（1）抗病毒药物为单纯疱疹病毒性脑炎的首选治疗方法。（2）若病情不能缓解,应在充分评价肾上腺皮质激素利弊后考虑激素类药物治疗。（3）肾上腺皮质激素疗效欠佳者可考虑加用免疫治疗药物以缓解症状。（4）外科手术治疗不作为推荐治疗方法,唯有在颅内压过高的情况下方考虑施行手术减压。结论借助循证医学评价方法可为单纯疱疹病毒性脑炎患者的治疗提供最佳临床证据。     

单纯疱疹病毒性脑炎治疗措施的临床证据评价

目的评价不同治疗方案对单纯疱疹病毒性脑炎的作用及不良反应,以为循证制定最佳治疗方案。方法以脑炎、病毒性脑炎、单纯疱疹病毒、抗病毒治疗、肾上腺皮质激素、治疗等词组作为检索词,分别检索MEDLINE、Cochrane图书馆、万方数据知识服务平台学术期刊库和中国知网中国期刊全文数据库,并辅以手工检索,获取临床指南、系统评价、随机对照试验、临床对照试验及病例观察研究的相关文献,采用Jadad量表对文献质量进行评价。结果经筛选共纳入与单纯疱疹病毒性脑炎治疗有关的临床指南2篇、系统评价2篇、随机对照试验2篇、临床对照试验2篇、病例观察研究3篇;其中9篇被评为高质量文献(3篇Jadad量表评分为4分、5篇评分为5分、1篇评分为7分),2篇为低质量文献(评分为3分)。对各种治疗方法的疗效及安全性评价显示:(1)抗病毒药物为单纯疱疹病毒性脑炎的首选治疗方法。(2)若病情不能缓解,应在充分评价肾上腺皮质激素利弊后考虑激素类药物治疗。(3)肾上腺皮质激素疗效欠佳者可考虑加用免疫治疗药物以缓解症状。(4)外科手术治疗不作为推荐治疗方法,唯有在颅内压过高的情况下方考虑施行手术减压。结论借助循证医学评价方法可为单纯疱疹病毒性脑炎患者的治疗提供最佳临床证据。     

Effectiveness of acupuncture for Parkinson's disease: A systematic review

The objective of this review is to assess the clinical evidence for or against acupuncture as a treatment for Parkinson's disease (PD). We searched the literature using 17 databases from their inception to September 2007 (searched again 3rd January 2008), without language restrictions. We included all randomized clinical trials (RCTs) regardless of their design. Methodological quality was assessed using the Jadad score. Eleven RCTs met all inclusion criteria. Three RCTs assessed the effectiveness of acupuncture on Unified Parkinson's Disease Rating Scale (UPDRS) compared with placebo acupuncture. A meta‐analysis of these studies showed no significant effect (n = 96, WMD, 5.7; 95% CI ?2.8 to 14.2, P = 0.19, heterogeneity: tau² = 0, χ² = 0.97, P = 0.62, I² = 0%). Another six RCTs compared acupuncture plus conventional drugs on improvement of symptoms of PD with drugs only. A meta‐analysis of two of these studies suggested a positive effect of scalp acupuncture (n = 106, RR, 1.46, 95% CI = 1.15 to 1.87, P = 0.002; heterogeneity: tau² = 0.00, χ² = 1.14, P = 0.29, I² = 12%). Two further RCTs tested acupuncture versus no treatment. The meta‐analysis of these studies also suggested beneficial effects of acupuncture. The results of the latter two types of RCTs fail to adequately control for nonspecific effects. In conclusion, the evidence for the effectiveness of acupuncture for treating PD is not convincing. The number and quality of trials as well as their total sample size are too low to draw any firm conclusion. Further rigorous trials are warranted. © 2008 Movement Disorder Society     

肌萎缩侧索硬化症治疗措施的临床证据评价

目的 评价不同治疗方案对肌萎缩侧索硬化症的作用及药物不良反应,以为循证制定最佳治疗方案.方法 以肌萎缩侧索硬化症、利鲁唑、加巴喷丁、拉莫三嗪、神经营养因子、抗氧化和氧自由基清除药、基凶治疗、神经十细胞治疗、治疗等词组作为检索词,分别检索MEDLINE、Cochrane图书馆、万方数据知识服务平台学术期刊库和中国知网中国期刊全文数据库,按照相应的纳入标准和排除标准,获取临床指南.系统评价、随机对照临床试验、临床对照试验、回顾性病例分析及病例观察研究的相关文献.并采用Jadad量表对文献质量进行评价,判断研究结论的真实性和可靠性.同时手工榆索有关会议资料和中英文原著、教科书,并与该研究领域从事此方面研究的学者联系,以便对在线检索不到全文者直接Email联系以获取全文.结果 经筛选纳入与肌萎缩侧索硬化症治疗相关的系统评价4篇、随机对照临床试验18篇、临床对照试验11篇、病例观察研究6篇.其中27篇为高质量文献(Jadad量表评价:11篇4分、13篇5分、3篇7分),12篇为低质量文献(评分3分).对各种治疗方法或药物疗效及安全性进行评价显示:利鲁唑为目前唯一被美幽食晶与药晶管理局批准应用于临床的药物,缺乏其他更有效的治疗药物;利鲁唑无效时口r采用多药联合方案及对症治疗.结论 借助循证医学评价方法可为肌萎缩侧索硬化症患者的治疗提供最佳临床证据.