Reporting cardiovascular clinical trials

ESC CardioMed ◽  
2018 ◽  
pp. 3077-3079
Author(s):  
Muthiah Vaduganathan ◽  
Scott D. Solomon
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Critical Review ◽  
Consort Statement ◽  
Flow Diagram ◽  
Controlled Trials ◽  
High Quality ◽  
Standardized Reporting ◽  
Data Transparency ◽  
Key Aspects

Standardized reporting of cardiovascular randomized controlled trials (RCTs) is mandatory to maintain high-quality studies, facilitate critical review and evaluation, and promote data transparency, consistency, and reproducibility. The 25-item Consolidated Standards of Reporting Trials (CONSORT) Statement offers a clear and concise approach to reporting of contemporary RCTs that has been well accepted by the academic cardiovascular community. This chapter reviews the overall CONSORT checklist and flow diagram, and highlights key aspects with particular relevance to the conduct and reporting of contemporary cardiovascular RCTs.

Assessment of the content reporting for therapeutic exercise interventions among existing randomized controlled trials on knee osteoarthritis

2018 ◽  
Vol 32 (7) ◽  
pp. 980-984 ◽  
Author(s):  
Jennifer O’Neil ◽  
Daniel McEwen ◽  
Michael J Del Bel ◽  
Donguk Jo ◽  
Odette Thevenot ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Randomized Controlled Trials ◽  
Sports Medicine ◽  
Intraclass Correlation ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
High Quality ◽  
Exercise Interventions ◽  
Randomized Controlled ◽  
Standardized Reporting

Purpose/Rationale: Physical exercise interventions for the management of knee osteoarthritis are well known to be effective and accessible forms of rehabilitation and symptom management. However, without adequate reporting of these interventions, accurate replication and clinical use is negatively impacted. Objectives: The main objective of this article was to assess content reporting using The Consensus on Exercise Reporting Template list and 2016 American College of Sports Medicine guidelines among moderate- to high-quality exercise interventions randomized controlled trials (total score of ≥6/10 on the PEDro scale) involving individuals with knee osteoarthritis. Results: The Consensus on Exercise Reporting Template mean total score for all 47 included randomized controlled trials was 4.42 out of 19, demonstrating generally low quality of reporting. The Consensus on Exercise Reporting Template list and the 2016 American College of Sports Medicine guidelines scores were moderately correlated (based on 95% confidence interval, intraclass correlation coefficient = 0.508) for aerobic interventions only. Conclusion: The content analysis of exercise interventions in knee osteoarthritis demonstrated low scores for moderate- to high-quality trials. Improved standardized reporting is recommended to ensure knowledge transfer and replication of effective exercise programs for individuals with knee osteoarthritis.

scholarly journals Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

2018 ◽  
Vol 5 (1) ◽  
pp. 21
Author(s):  
Mahmood E. Elrggal ◽  
Morooj Al-Muwallad ◽  
Areej Al-Otaibi ◽  
Jomanah Alsiddik ◽  
Alaa Shahbar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Helicobacter Pylori ◽  
Randomized Controlled Trials ◽  
Consort Statement ◽  
Allocation Concealment ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects.<strong> </strong>Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in <em>Helicobacter pylori</em> associated infections by using the CONSORT 2010 checklist.</p><p class="abstract"><strong>Methods:</strong> All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on <em>Helicobacter pylori</em> associated infections were included in the review.</p><p class="abstract"><strong>Results:</strong> 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%).<strong> </strong>The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.</p><p><strong>Conclusions: </strong>The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.</p>

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 Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

The effect of almond intake on lipid profile: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Omid Asbaghi ◽  
Vihan Moodi ◽  
Amir Hadi ◽  
Elham Eslampour ◽  
Mina Shirinbakhshmasoleh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Lipid Profile ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled

A number of clinical trials have examined the effect of almond intake on the lipid profile in recent years; however, the results remain equivocal.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

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 A Review of Marital Intimacy-Enhancing Interventions among Married Individuals

2015 ◽  
Vol 8 (8) ◽  
pp. 74 ◽  
Author(s):  
Maryam Kardan-Souraki ◽  
Zeinab Hamzehgardeshi ◽  
Ismail Asadpour ◽  
Reza Ali Mohammadpour ◽  
Soghra Khani
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Main Concern ◽  
Care Providers ◽  
Marital Intimacy ◽  
Randomized Controlled ◽  
The Impact

<p><strong>BACKGROUND:</strong> Lack of intimacy is currently the main concern rather than main concern of the experts in psychology and counseling. It is considered as one of the most important causes for divorce and as such to improve marital intimacy a great number of interventions have been proposed in the literature. Intimacy training and counseling make the couples take effective and successful steps to increase marital intimacy. No study has reviewed the interventions promoting marital intimacy after marriage. Thus, this review study aimed to classify the articles investigating the impact of interventional programs on marital intimacy after marriage.</p><p><strong>SEARCH METHODS:</strong> In April 2015, we performed a general search in Google Scholar search engines, and then we did an advanced search the databases of Science Direct, ProQuest, SID, Magiran, Irandoc, Pubmed, Scopus, <a href="http://www.cochranelibrary.com/">Cochrane Library</a>, and Psych info; Cumulative Index to Nursing and Allied Health Literature (CINAHL). Also, lists of the references of the relevant articles were reviewed for additional citations. Using Medical Subject Headings (MESH) keywords: Intervention (Clinical Trials, Non-Randomized Controlled Trials, Randomized Controlled Trials, Education), intimacy, marital (Marriage) and selected related articles to the study objective were from 1995 to April 2015. Clinical trials that evaluated one or more behavioral interventions to improve marital intimacy were reviewed in the study.</p><p><strong>MAIN RESULTS:</strong> 39 trials met the inclusion criteria. Eleven interventions had follow-up, and 28 interventions lacked follow-up. The quality evidence for 22 interventions was low, for 15 interventions moderate, and for one intervention was considered high. Findings from studies were categorized in 11 categories as the intimacy promoting interventions in dimensions of emotional, psychological, physical, sexual, temporal, communicational, social and recreational, aesthetic, spiritual, intellectual intimacy, and total intimacy.</p><p><strong>AUTHORS’ CONCLUSIONS:</strong> Improving and promoting communication, problem solving, self-disclosure and empathic response skills and sexual education and counseling in the form of cognitive-behavioral techniques and based on religious and cultural context of each society, an effective step can be taken to enhance marital intimacy and strengthen family bonds and stability. Health care providers should consider which interventions are appropriate to the couple characteristics and their relationships.</p>

scholarly journals High-cited favorable studies for COVID-19 treatments ineffective in large trials

2022 ◽  
Author(s):  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Wide Dissemination ◽  
Highly Cited Articles ◽  
Highly Cited

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.

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