scholarly journals Quality of Stroke Patient Information Applied in Randomized Controlled Trials—Literature Review

2020 ◽  
Vol 11 ◽  
Author(s):  
Anna C. Alegiani ◽  
Anne C. Rahn ◽  
Anke Steckelberg ◽  
Götz Thomalla ◽  
Christoph Heesen ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trials ◽  
Stroke Patient ◽  
Patient Information ◽  
Quality Criteria ◽  
Controlled Trials ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Information Materials

Background: Strokes have a huge impact on patients' quality of life. Although there are potentially effective secondary preventions and treatment options for stroke patients, adherence is mostly low. Low disease and treatment-related knowledge and, consequently, a lack of informed decision-making in stroke patients may contribute to this problem. However, stroke patient information did not seem to have relevant effects on patients' knowledge in randomized controlled trials. One contributing factor may be the lack of thoroughly developed patient information materials.Methods: We aimed to evaluate the quality of patient information materials for stroke patients by using randomized controlled trials, applying quality criteria for evidence-based patient information (EBPI). We conducted a literature search (MEDLINE, Embase, CINAHL, PsycINFO, and CENTRAL). To be included in the review, research had to be randomized controlled trials that provided stroke patient information, were published in English, and had knowledge assessed as the primary endpoint. Authors of primary studies were contacted and asked for information materials applied.Results: We screened 15,507 hits and identified 30 eligible studies. Information materials were available for only eight studies. Analyses revealed that all available materials had important shortcomings concerning EBPI quality criteria [concerning, for example, structural information (e.g., reporting conflicts of interest), content information (e.g., reporting sources of information), or comprehensive descriptions of treatment effects and side effects]. Frequently, treatment effects were reported only narratively without providing absolute numbers, values, or frequencies.Conclusion: Quality of materials differed, but none sufficiently fulfilled EBPI quality criteria. Unsatisfactory trial results concerning patient knowledge and patient involvement in decision-making may at least partially be explained by limitations of the provided materials. Future patient information should consider EBPI quality criteria.

scholarly journals The Effectiveness of Music Therapy on Hand Function in Patients With Stroke: A Systematic Review of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Wen-Hao Huang ◽  
Zu-Lin Dou ◽  
Hui-Min Jin ◽  
Ying Cui ◽  
Xin Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Music Therapy ◽  
Randomized Controlled Trials ◽  
Hand Function ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Stroke Patients ◽  
Positive Effects ◽  
Randomized Controlled

Objective: This study aims to evaluate the efficacy of music-supported therapy for stroke patients' hand function.Methods: The databases used included Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, PubMed, Embase, Music Index, and Google Scholar. Studies published between January 2010 and August 2020 were included. The searching key terms included “music-supported therapy,” “music therapy,” “hand function,” “hand dysfunction,” “stroke,” “ischemic,” and “hemorrhagic.” Randomized controlled trials or controlled trials involving adults who have hand function problems caused by stroke are included in this study. The methodological quality and risk of bias of the included studies were rated by two independent assessors under the guidance of Cochrane collaboration's risk of bias tool.Results: Twelve studies that met the inclusion criteria were included in this study. Totally, the data included 598 stroke patients (345 male, 253 female) with recruited time from 1.7 months to 3 years, and the mean age of the participants were 61.09 years old. Based on the Cochrane risk of bias tool, study quality ranged from three to seven out of seven points. Compared with the control group, outcomes including hand strength, range of joint motion, dexterity of hands, arm function, and quality of life were significantly superior with music-supported therapy. Five studies reported improved dexterity of hands, and one study reported the improvement of range of motion and strength of patients' hands, which supported the therapy has positive effects on patients' hand function and improving their quality of life after the therapy. The therapy ranged over a period of 4–8 weeks, with an average duration of 30 min/session and an average of three times per week.Conclusion: Based on the results, music-supported therapy could be a useful treatment for improving hand function and activities of daily living in patients with stroke, especially for patients within 6 months after stroke. However, the low certainty of evidence downgrades our confidence to practice in hospital. More and more randomized controlled trials and larger sample sizes are required for a deeper review.

scholarly journals Reporting quality of randomized, controlled trials evaluating immunotherapy in lung cancer

2021 ◽  
Author(s):  
Jun Du ◽  
Yundi Zhang ◽  
Yiting Dong ◽  
Jianchun Duan ◽  
Hua Bai ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

scholarly journals Head-to-head comparison of biological drugs for inflammatory bowel disease: from randomized controlled trials to real-world experience

2021 ◽  
Vol 14 ◽  
pp. 175628482110106
Author(s):  
Fabio Salvatore Macaluso ◽  
Marcello Maida ◽  
Mauro Grova ◽  
Federica Crispino ◽  
Giulia Teresi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Randomized Controlled Trials ◽  
Real World ◽  
Bowel Disease ◽  
Quality Data ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Therapeutic Algorithms ◽  
Inflammatory Bowel

During past years, the increasing knowledge of molecular mechanisms of inflammatory bowel disease (IBD) have led to the development of several targeted biological therapies. This great expansion of available medical options has prompted the need for comparative data between drugs. For years, given that most randomized controlled trials (RCTs) were performed only versus placebo, this demand has clashed with the absence of head-to-head trials comparing two or more treatments. The quality of evidence coming from real-world experience was low overall, so it was extremely difficult to clarify the correct positioning of the biologicals inside the therapeutic algorithms for IBD. Fortunately, times are changing: head-to-head comparative RCTs have been conducted or are ongoing, and the methodological quality of real-world studies is gradually increasing, mainly thanks to a higher rate of application of statistical methods capable of reducing the selection bias, such as the propensity score. In this evolving scenario, the increasing number of comparative RCTs is providing high-quality data for a correct drug positioning in IBD. In parallel, real-world observational studies are supporting the data coming from RCTs, and covering those comparisons not performed in the RCT setting. We believe that there is moderate evidence already available to support clinicians in the correct choice between different biologicals, and data will certainly be more robust in the near future.

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