The Need for Randomized Controlled Trials in Podiatric Medical Research

2004 ◽  
Vol 94 (3) ◽  
pp. 221-228 ◽  
Author(s):  
Jill Porthouse ◽  
David J. Torgerson
Keyword(s):  
Health Care ◽  
Medical Research ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Cochrane Database ◽  
Key Features

The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research. (J Am Podiatr Med Assoc 94(3): 221–228, 2004)

scholarly journals Critical analysis of the drafting of physical therapy randomized controlled trials published in Portuguese

2016 ◽  
Vol 29 (2) ◽  
pp. 421-427
Author(s):  
Ercole da Cruz Rubini ◽  
Fabio Dutra Pereira ◽  
Renato Sobral Monteiro-Junior ◽  
Patricia Zaidan ◽  
Cintia Pereira de Souza ◽  
...  
Keyword(s):  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Critical Analysis ◽  
Physical Therapists ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Methodological Procedures

Abstract Introduction: randomized controlled trials are high quality studies. Many problems related to the drafting of these studies have been identified and consequently various national and international journals, in an attempt to improve this writing, have adopted the Consolidated Standards of Reporting Trials recommendations. Regarding the studies written specifically by physical therapists, until now, the quality of the drafting in Portuguese has been unknown. Aim: To critically analyze the drafting of RCTs in the area of physical therapy, published in Portuguese, in relation to the CONSORT recommendations. Materials and Methods: On 17th Oct, 2012, 548 RCTs in Portuguese were recovered from the MEDLINE and PEDro databases, which were divided among four evaluators who, after reading the abstracts, selected those related to physical therapy. Of these studies, 78 RCTs were related to physical therapy, which were divided among the four evaluators for the analysis of the drafting according to the CONSORT recommendations. The four evaluators who participated in this study previously obtained a median kappa above 70% when their analyses were compared to the analyses of the evaluator considered the gold standard due to having greater experience. Results: The quantity of items of the CONSORT recommendations according to year of publication was very small, corresponding to a mean of 43% of the items in the articles analyzed. Conclusion: The results make very clear the need to improve the quality of the drafting of the RCTs related to physical therapy in Portuguese and to include more rigorous methodological procedures, such as sample size, randomization and blinding. The dissemination and adoption of the CONSORT recommendations by physical therapy researchers would, without doubt, be a big step towards improving this quality.

scholarly journals Efficacy and Safety of Fuzi Formulae on the Treatment of Heart Failure as Complementary Therapy: A Systematic Review and Meta-Analysis of High-Quality Randomized Controlled Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-21
Author(s):  
Meng-Qi Yang ◽  
Yong-Mei Song ◽  
Huan-Yu Gao ◽  
Yi-Tao Xue
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
High Quality ◽  
Randomized Controlled ◽  
Link Type

Objective. Heart failure is a major public health problem worldwide nowadays. However, the morbidity, mortality, and awareness of heart failure are not satisfied as well as the status of current treatments. According to the standard treatment for chronic heart failure (CHFST), Fuzi (the seminal root of Aconitum carmichaelii Debx.) formulae are widely used as a complementary treatment for heart failure in clinical practice for a long time. We are aiming to assess the efficacy and safety of Fuzi formulae (FZF) on the treatment of heart failure according to high-quality randomized controlled trials (RCTs). Methods. RCTs in PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wanfang Database were searched from their inception until June 2019. In addition, the U.S. National Library of Medicine (clinicaltrials.gov) and the Chinese Clinical Trial Registry (http://www.chictr.org.cn) were also searched. We included RCTs that test the efficacy and safety of FZF for the treatment of heart failure, compared with placebo, CHFST, or placebo plus CHFST. The methodological quality of included studies were evaluated by the Cochrane Collaboration’s tool for assessing risk of bias. RCTs with Cochrane risk of bias (RoB) score ≥4 were included in the analysis. The meta-analysis was conducted through RevMan 5.2 software. The GRADE approach was used to assess the quality of the evidence. Results. Twelve RCTs with 1490 participants were identified. The studies investigated the efficacy and safety of FZF, such as FZF plus the CHFST vs placebo plus CHFST (n = 4), FZF plus CHFST vs CHFST (n = 6), FZF plus digoxin tablets (DT) plus CHFST vs placebo plus DT plus CHFST (n = 1), and FZF plus placebo plus CHFST vs placebo plus DT plus CHFST (n = 1). Meta-analysis indicated that FZF have additional benefits based on the CHFST in reducing plasma NT-proBNP level, MLHFQ scores, Lee’s heart failure scores (LHFs), and composite cardiac events (CCEs). Meanwhile, it also improved the efficacy on TCM symptoms (TCMs), NYHA functional classification (NYHAfc), 6MWD, and LVEF. Adverse events were reported in 6 out of 12 studies without significant statistical difference. However, after assessing the strength of evidence, it was found that only the quality of evidence for CCEs was high, and the others were either moderate or low or very low. So we could not draw confirmative conclusions on its additional benefits except CCEs. Further clinical trials should be well designed to avoid the issues that were identified in this study. Conclusion. The efficacy and additional benefits of FZF for CCEs were certain according to the high-quality evidence assessed through GRADE. However, the efficacy and additional benefits for the other outcomes were uncertain judging from current studies. In addition, the safety assessment has a great room for improvement. Thus, further research studies are needed to find more convincing proofs.

scholarly journals Comments on “Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals”

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rohan Kumar Ochani ◽  
Asim Shaikh ◽  
Naser Yamani
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Treatment Regimens ◽  
Randomized Controlled ◽  
Accurate Reporting

AbstractRandomized controlled trials are considered the gold standard in assessing treatment regimens, and since abstracts may be the only part of a paper that a physician reads, accurate reporting of data in abstracts is essential. The CONSORT checklist for abstracts was designed to standardize data reporting; however, for papers submitted to anesthesiology journals, the level of adherence to the CONSORT checklist for abstracts is unknown. Therefore, we commend Janackovic and Puljak for their efforts in determining the adherence of reports of trials in the highest-impact anesthesiology journals between 2014 and 2016. The results of their study are extremely important; however, we believe that that study had some methodological limitations, which we discuss in this manuscript.

scholarly journals A Qualitative Systematic Review of the Homeopathic Outcome Studies in Patients with HIV/AIDS

2021 ◽  
Vol 12 (42) ◽  
pp. 2-12
Author(s):  
Subhranil Saha ◽  
Malay Mundle ◽  
Shubhamoy Ghosh ◽  
Munmun Koley ◽  
Sk. Intaj Hossain
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Methodological Quality ◽  
Outcome Studies ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Hiv Aids

Background & Aim: Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine. The objective of this review is to test whether there is enough evidence of efficacy of homeopathy from conducted clinical trials in humans suffering from HIV/AIDS. Methods: The study design was criteria-based systematic review of cumulative research and assessment of the methodological quality of only 5 published clinical trials and one review article. Among the clinical outcome studies, 3 studies were of open-label, non-randomized, non-controlled format, 2 were randomized controlled trials and one was a set of replication study. The qualities of the trials were evaluated using a list of validated and pre-defined criteria of good methodology, and the outcomes of the trials were interpreted in relation to their quality. Main outcome measures were methodological qualities in terms of consideration of threats to external, internal, construct and statistical conclusion validity. Results: Trials were too few in number and were not of very high quality. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. The results of this review may be complicated by publication bias. Conclusions: At this moment, the evidences are not sufficient to draw definitive conclusions. So, further evaluation of homeopathy by well-performed controlled trials of high methodological quality is required.

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.

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