scholarly journals Lessons Learned in Participant Recruitment and Retention: The EXCITE Trial

2006 ◽  
Vol 86 (11) ◽  
pp. 1520-1533 ◽  
Author(s):  
Sarah Blanton ◽  
David M Morris ◽  
Michelle G Prettyman ◽  
Karen McCulloch ◽  
Susan Redmond ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Research Process ◽  
Lessons Learned ◽  
Evidence Based ◽  
Ethical Aspects ◽  
Recruitment Process ◽  
Participant Recruitment ◽  
Integral Role

Abstract Participant recruitment is considered the most difficult aspect of the research process. Despite the integral role of recruitment in randomized clinical trials, publication of data defining the recruitment effort is not routine in rehabilitation initiatives. The recruitment process for the Extremity Constraint-Induced Therapy Evaluation (EXCITE) trial illustrates obstacles to and strategies for participant accrual and retention that are inherent in rehabilitation clinical trials. The purpose of this article is to increase awareness of the multiple facets of recruitment necessary for successful clinical trials, thus supporting the continued development of evidence-based practice in physical therapy. The Recruitment Index is presented as a variable to measure recruitment efficacy. In addition, ethical aspects of recruitment are explored, including informed consent and the concept of therapeutic misconception.

scholarly journals Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin Kasenda ◽  
Junhao Liu ◽  
Yu Jiang ◽  
Byron Gajewski ◽  
Cen Wu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Collaborative Study ◽  
Healthcare Intervention ◽  
Recruitment Process ◽  
Participant Recruitment ◽  
Promising Tool ◽  
Level Information ◽  
Recruitment Patterns ◽  
Enhance Efficiency

Abstract Background Poor recruitment of patients is the predominant reason for early termination of randomized clinical trials (RCTs). Systematic empirical investigations and validation studies of existing recruitment models, however, are lacking. We aim to provide evidence-based guidance on how to predict and monitor recruitment of patients into RCTs. Our specific objectives are the following: (1) to establish a large sample of RCTs (target n = 300) with individual patient recruitment data from a large variety of RCTs, (2) to investigate participant recruitment patterns and study site recruitment patterns and their association with the overall recruitment process, (3) to investigate the validity of a freely available recruitment model, and (4) to develop a user-friendly tool to assist trial investigators in the planning and monitoring of the recruitment process. Methods Eligible RCTs need to have completed the recruitment process, used a parallel group design, and investigated any healthcare intervention where participants had the free choice to participate. To establish the planned sample of RCTs, we will use our contacts to national and international RCT networks, clinical trial units, and individual trial investigators. From included RCTs, we will collect patient-level information (date of randomization), site-level information (date of trial site activation), and trial-level information (target sample size). We will examine recruitment patterns using recruitment trajectories and stratifications by RCT characteristics. We will investigate associations of early recruitment patterns with overall recruitment by correlation and multivariable regression. To examine the validity of a freely available Bayesian prediction model, we will compare model predictions to collected empirical data of included RCTs. Finally, we will user-test any promising tool using qualitative methods for further tool improvement. Discussion This research will contribute to a better understanding of participant recruitment to RCTs, which could enhance efficiency and reduce the waste of resources in clinical research with a comprehensive, concerted, international effort.

scholarly journals Evidence-based review of the role of reoperation in the management of malignant glioma

1998 ◽  
Vol 4 (6) ◽  
pp. E13 ◽  
Author(s):  
Clifford B. Soults ◽  
Greg S. Canute ◽  
Timothy C. Ryken
Keyword(s):  
Clinical Trials ◽  
Malignant Glioma ◽  
Randomized Clinical Trials ◽  
Case Series ◽  
Class Ii ◽  
Current Status ◽  
Evidence Based ◽  
Class Iii ◽  
Key Words Glioblastoma

Using an evidence-based approach to available clinical studies, the authors examined the role of reoperation in the management of malignant glioma. A review of 1270 Medline-referenced articles spanning the period from 1966 through March 1998 was undertaken using the key words “glioblastoma” and “astrocytoma.” Using an evidence-based four-tiered grading system, the authors found only 14 articles that met their inclusion criteria. Of these, 11 were graded as Class III (retrospective case series) and three as Class II (prospective nonrandomized studies). There were no Class I reports (randomized clinical trials), and all Class IV reports (opinion reports) were excluded. The authors of 10 Class III and one Class II articles supported the role of reoperation in increasing survival time or quality of life in selected patients; however, the results of multivariate analysis in two Class II and one Class III article did not support prolonged survival. The authors conclude that there was insufficient evidence to support either a standard or a guideline for reoperation in malignant glioma given the current status of the literature. Selection bias was a major factor in these studies. With continued interest in clinical trials for recurrent malignant glioma, the role of reoperation needs to be addressed in case-controlled or randomized fashion to establish either standards or guidelines on this commonly debated issue.

scholarly journals Lessons Learnt from Evidence-Based Approach of Using Chinese Herbal Medicines in Liver Cancer

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Zhan Zheng ◽  
William Chi-Shing Cho ◽  
Ling Xu ◽  
Juyong Wang ◽  
Daniel Man-Yuen Sze
Keyword(s):  
Clinical Trials ◽  
Liver Cancer ◽  
Randomized Clinical Trials ◽  
Herbal Medicines ◽  
Therapeutic Benefit ◽  
Lessons Learned ◽  
Syndrome Differentiation ◽  
Evidence Based ◽  
Chinese Herbal ◽  
Tcm Syndrome

This paper is a systematic review of evidence-based studies of the effectiveness of Chinese herbal medicine (CHM) in the treatment of liver cancer. After a detailed analysis of the literature, five animal studies and four human clinical trials met the criteria for inclusion. Analysis revealed that results of the clinical trials, whilst encouraging, need to be interpreted with caution as problems with study designs may lead to apparent benefits being attributable to various forms of bias. However, as each of the CHM agents used in these studies appeared to be potentially beneficial, further well-designed and controlled randomized clinical trials are warranted. The second part of this review focused on the lessons learned from the relationships between Traditional Chinese Medicine (TCM) theory, TCM Syndrome Differentiation, and modern scientific understanding of mechanisms of action of CHM agents. The understanding of TCM Syndrome Differentiation may allow identification of different patterns of disharmony and may provide important guidance to the prescription of CHM. Furthermore, quality control using both biological and chemical fingerprinting of CHM is important to ensure batch-to-batch consistency to deliver sustained therapeutic benefit. Also, careful assessment of herb-drug interactions is paramount for safety and integrative use of western chemotherapeutic and CHM agents.

scholarly journals Evidence-based approaches to comparing the effectiveness of modern cardiology interventions: trends, bias and prospects

2020 ◽  
Vol 25 (8) ◽  
pp. 4037
Author(s):  
S. R. Gilyarevsky ◽  
Yu. N. Belenkov
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Drug Use ◽  
Propensity Score ◽  
Observational Studies ◽  
Large Scale ◽  
Randomized Clinical Trials ◽  
Evidence Based ◽  
Improved Methods

The article discusses the limitations of the evidence from observational studies. Modern approaches to reducing bias in observational studies are discussed in detail, in particular, propensity score matching, which has become popular in recent years. The main differences between randomized and observational studies are discussed. Arguments against the observational studies and improved methods of analysis to compare the treatments’ effectiveness in clinical practice are presented. The role of observational studies as a source of evidence is discussed. The article points out the validity of performing large-scale prospective observational studies to assess the effects of postmarketing drug use in clinical practice, as well as to obtain data on drug use in patients that differ from those in randomized clinical trials.

scholarly journals COVID-19: Role of Nutrition and Supplementation

Nutrients ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 976
Author(s):  
Fiorenzo Moscatelli ◽  
Francesco Sessa ◽  
Anna Valenzano ◽  
Rita Polito ◽  
Vincenzo Monda ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Viral Infections ◽  
Overweight And Obesity ◽  
Shortness Of Breath ◽  
Nutritional Interventions ◽  
The World ◽  
Diet Regimen ◽  
Specific Diet

At the end of 2019, a new coronavirus (COVID-19) appeared on the world scene, which mainly affects the respiratory system, causing pneumonia and multi-organ failure, and, although it starts with common symptoms such as shortness of breath and fever, in about 2–3% of cases it leads to death. Unfortunately, to date, no specific treatments have been found for the cure of this virus and, therefore, it is advisable to implement all possible strategies in order to prevent infection. In this context, it is important to better define the role of all behaviors, in particular nutrition, in order to establish whether these can both prevent infection and improve the outcome of the disease in patients with COVID-19. In the literature, it is widely shown that states of malnutrition, overweight, and obesity negatively affect the immune system, leading to viral infections, and several studies have shown that nutritional interventions can act as immunostimulators, helping to prevent viral infections. Even if several measures, such as the assumption of a specific diet regimen, the use of dietary supplements, and other similar interventions, are promising for the prevention, management, and recovery of COVID-19 patients, it is important to highlight that strong data from randomized clinical trials are needed to support any such assumption. Considering this particular scenario, we present a literature review addressing several important aspects related to diet and SARS-CoV-2 infection, in order to highlight the importance of diet and supplementation in prevention and management of, as well as recovery from COVID-19.

Radiotherapy research activity and radiographer involvement in the UK

2009 ◽  
Vol 8 (2) ◽  
pp. 105-110 ◽  
Author(s):  
Julie Davies ◽  
Christine Rawlings
Keyword(s):  
Clinical Trials ◽  
New Technologies ◽  
Research Process ◽  
Standards Of Care ◽  
Service Development ◽  
Evidence Based ◽  
Research Activity ◽  
Local Initiatives ◽  
The Uk ◽  
Further Development

AbstractIn the UK, radiotherapy research is being conducted at national and international levels which include multi-centre clinical trials. Local initiatives and trials are also ongoing where work is being performed to develop techniques or protocols for new technologies and service development. Active participation within these studies is now leading to a culture change with radiographers (radiation therapists) becoming an integral part of the research process. There are currently 70 radiographers in the UK participating in research. This accounts for 2.5% of the UK profession. With the extension of role diversification, research radiographers are undertaking many new roles; however, there is still scope for further development. The therapists’ role in working within this research environment is to ensure improved standards of care focussed on evidence-based practice.

The Case of Pandemic Flu Vaccines: Some Lessons Learned

2010 ◽  
Vol 1 (4) ◽  
pp. 427-431
Author(s):  
Francisco Bombillar
Keyword(s):  
Clinical Trials ◽  
Marketing Authorisation ◽  
Drug Approval ◽  
Case Law ◽  
Lessons Learned ◽  
Regulatory Agencies ◽  
Pandemic Flu ◽  
The Individual

This section updates readers on the latest developments in pharmaceutical law, giving information on legislation and case law on various matters (such as clinical and pre-clinical trials, drug approval and marketing authorisation, the role of regulatory agencies) and providing analysis on how and to what extent they might affect health and security of the individual as well as in industry.

Interventions for Students with Autism and Asperger’s Syndrome

2017 ◽  
Author(s):  
Michelle S. Ballan ◽  
Molly Burke Freyer ◽  
Lauren Powledge
Keyword(s):  
Video Modeling ◽  
The United States ◽  
Autism Spectrum ◽  
Attention Training ◽  
Evidence Based ◽  
Activity Schedules ◽  
Training Video ◽  
Integral Role ◽  
Students With Autism

Evidence-based interventions for students with autism spectrum disorder (ASD) are explored, and trends and changes in the diagnosis of ASD in the United States are examined. Evidence-based interventions in various settings and modalities are discussed, with detailed descriptions of several effective evidence-based interventions including joint attention training, video modeling, story-based interventions, and activity schedules. The integral role of social workers in the lives of children with ASD in multiple settings, particularly the classroom, is emphasized. Social work must be vigilant to keep pace with the ever-changing field of autism, with its frequent improvements in understanding, diagnosis, and treatment.

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