The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery

2004 ◽  
Vol 29 (6) ◽  
pp. 621-624 ◽  
Author(s):  
S. SAUERLAND ◽  
T. R. C. DAVIS
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Scientific Validity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Study Results ◽  
Methodological Aspects ◽  
Treat Analysis

To assure readers that study results are scientifically valid, the methods of a clinical trial should be described adequately. Since randomization, blinding, and intention-to-treat-analysis are major bias-reducing techniques, these aspects should be reported most accurately. The Consolidated standards of reporting trials (CONSORT) are recommendations to improve the reporting of trials. CONSORT requires that trial authors describe basic methodological aspects that readers need to appraise the strengths of report ed clinical trials. This article presents the CONSORT recommendations and explains some of their main aspects. From now on, the Journal of Hand Surgery will use CONSORT to assist authors of randomized controlled trials in improving the description of their studies. We believe that this decision increases the scientific validity of study reports and helps readers when critically appraising articles.

Quality of surgical randomized controlled trials in hand surgery: a systematic review

2018 ◽  
Vol 43 (8) ◽  
pp. 801-807 ◽  
Author(s):  
Chao Long ◽  
Heather E. desJardins-Park ◽  
Rita Popat ◽  
Paige M. Fox
Keyword(s):  
Randomized Controlled Trials ◽  
Hand Surgery ◽  
Controlled Trials ◽  
Jadad Score ◽  
Surgical Interventions ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Treat Analysis ◽  
Over Time

We assessed the quantity, quality and trends of randomized controlled trials comparing hand surgical interventions. Study characteristics were collected for 125 randomized controlled trials comparing hand surgical interventions. The Jadad scale (0–5), which assesses methodological quality of trials, was calculated. Logistic regressions were conducted to determine associations with the Jadad score. The studies were published between 1981 and 2015, with an increase over time, most often in Journal of Hand Surgery (European). Mean study size was 68 patients. Mean Jadad score was 2.1, without improvement over time. Thirty percent conducted a power analysis and 8% an intention-to-treat analysis. Studies conducted in the United Kingdom and with smaller sample sizes, power analysis and intention-to-treat analysis were associated with a higher Jadad score. The quantity of trials has increased over time while methodological quality has remained low, indicating a need to improve quality of trials in hand surgery literature.

scholarly journals Achieving effective patient and public involvement in international clinical trials in neurology

2019 ◽  
Vol 10 (3) ◽  
pp. 265-272 ◽  
Author(s):  
Emma C. Tallantyre ◽  
Nikos Evangelou ◽  
Clare Bale ◽  
Burhan Z. Chaudhry ◽  
Emma H. Gray ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Research Team ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Controlled Trials ◽  
Framework Analysis ◽  
Randomized Controlled ◽  
Structured Approach

There is a growing need for patient and public involvement (PPI) to inform the way that research is developed and performed. International randomized controlled trials are particularly likely to benefit from PPI, but guidance is lacking on how or when it should be incorporated. In this article, we describe the PPI process that occurred during the design and initiation of an international treatment clinical trial in MS. PPI was incorporated using a structured approach, aiming to minimize bias and achieve equivalence in study design, implementation, and interpretation. Methods included PPI representation within the study research team, and the use of focus groups, analyzed using thematic framework analysis. We report the outcomes of PPI and make recommendations on its use in other neurology clinical trials. By sharing our model for PPI, we aim to maximize effectiveness of future public involvement and to allow its effect to be better evaluated.

Abstract 13205: Underrepresentation of Women as Clinical Trialists in Heart Failure: A Systematic Review of Randomized Controlled Trials Published in High-impact Medical Journals

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Sera Whitelaw ◽  
Kristen Sullivan ◽  
Harriette G Van Spall
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Research Training ◽  
Senior Author ◽  
Controlled Trials ◽  
Medical Journals ◽  
Gender Distribution ◽  
Randomized Controlled

Introduction: Clinical trials change practice in cardiology but leading them typically requires advanced research training, mentorship, sponsorship, and networking. Women are underrepresented in cardiology and report challenges in obtaining mentorship and networking opportunities. Objective: To evaluate the gender distribution of first and senior authors in practice-changing clinical trials in heart failure (HF), and explore clinical trial characteristics associated with women as first authors. Methods: We searched MEDLINE, EMBASE and CINAHL databases for randomized controlled trials (RCTs) published January 2000 - May 2019. We included RCTs that recruited adults with HF with reduced ejection fraction that were published in medical journals with an impact factor of > 10. Two reviewers screened and extracted data independently. We determined the gender distribution of the authors, assessed temporal trends in authorship, and used logistic regression to identify characteristics associated with women in first authorship positions. Results: The search identified 10,596 unique studies, of which 317 met eligibility criteria. We found that 15.8%, 11.7%, and 10.7% of first, senior, and corresponding authors, respectively, were women. Multivariable analysis revealed that the first author was more likely to be a woman if the senior author of a clinical trial was a woman (odds ratio [OR] 2.17, 95% confidence interval [CI] 1.04-4.66, p=0.039), and if the trial was conducted at a single rather than multiple centers (OR 1.40, 95% CI 1.09-6.48, p=0.035). Source of funding (public or industry), type of intervention (health service, drug, device, or surgery), and region of trial coordination (Europe, North America, Central and South America, Asia, and Australia) were not associated with gender of first authors. The proportion of trials that included women as authors has decreased from 2000 to present. Conclusion: Women are under-represented as clinical trialists in HF. Adjusting for other trial characteristics, the first author of a clinical trial was more likely to be a woman if the senior author was a woman. Mentoring women as clinical trialists in the present era may be a strategic way to increase the gender diversity of clinical trialists in years to come.

PTSD Treatment Research: An Overview and Evaluation

2020 ◽  
Author(s):  
Paula P. Schnurr ◽  
Jessica L. Hamblen
Keyword(s):  
Clinical Trials ◽  
Treatment Outcome ◽  
Controlled Trials ◽  
Comorbid Conditions ◽  
Design Elements ◽  
Ptsd Treatment ◽  
Design Considerations ◽  
Randomized Controlled ◽  
Key Concepts ◽  
Treatment Research

This chapter provides an overview of key concepts in designing and evaluating clinical trials, with a focus on randomized controlled trials for PTSD. The first section discusses design elements and how they influence the conclusions that can be drawn from a study. Examples from the trauma literature are provided when available to illustrate concepts. The second section explores newer developments in PTSD treatment trials. Specifically, it discusses treatment and design considerations related to common comorbid conditions of PTSD, adapting treatments for low-resource environments and optimizing treatment outcome. The chapter’s goal is to improve the ability of both clinicians and researchers to critically review PTSD clinical trials.

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.

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