scholarly journals How to Design the Control Group in Randomized Controlled Trials of Acupuncture?

2012 ◽  
Vol 2012 ◽  
pp. 1-7 ◽  
Author(s):  
Jaung-Geng Lin ◽  
Chao-Hsun Chen ◽  
Yu-Che Huang ◽  
Yi-Hung Chen
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Control Group ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Based Medicine

In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.” We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field.

scholarly journals Breast Cancer Research to Support Evidence-Based Medicine in Nigeria: A Review of the Literature

2021 ◽  
pp. 384-390
Author(s):  
Omolara A. Fatiregun ◽  
Temiloluwa Oluokun ◽  
Nwamaka N. Lasebikan ◽  
Emmanuella Nwachukwu ◽  
Abiola A. Ibraheem ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Treatment Guidelines ◽  
Breast Cancer Research ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Based Medicine

PURPOSE Breast cancer is the most common malignancy in women worldwide. In Nigeria, it accounts for 22.7% of all new cancer cases among women. Evidence-based medicine (EBM) entails using the results from healthcare research to enhance the clinical decision-making process and develop evidence-based treatment guidelines. Level 1 and 2 studies, such as randomized controlled trials, meta-analyses, and systematic reviews of randomized controlled trials, yield more robust types of evidence. This study reviewed the levels of evidence of breast cancer publications in Nigeria. METHODS We conducted an electronic literature search of all studies published on breast cancer in Nigeria from January 1961 to August 2019. We reviewed all the articles found under the search term “Breast Cancer in Nigeria” on medical databases. RESULTS Our search identified 2,242 publications. One thousand two hundred fifty duplicates were removed, and 520 were excluded. A total of 472 articles were considered eligible for this review. Most of these articles were case series or reports (30.7%), qualitative studies (15.7%), followed by cross-sectional studies (13.3%), laboratory studies (12.9%), case-control studies (6.1%), case reports (7%), and cohort (5.7%). CONCLUSION Breast cancer research in Nigeria is yet to produce much evidence of the types considered to best support EBM. The scarcity of data hampers the implementation of EBM in Nigeria. Currently, most treatment guidelines are adapted from those developed in other countries, despite genetic differences among populations and different environmental influencing factors.

scholarly journals Evidence‐based medicine—When observational studies are better than randomized controlled trials

Nephrology ◽  
2020 ◽  
Vol 25 (10) ◽  
pp. 737-743
Author(s):  
Jizzo R. Bosdriesz ◽  
Vianda S. Stel ◽  
Merel van Diepen ◽  
Yvette Meuleman ◽  
Friedo W. Dekker ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Observational Studies ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Based Medicine ◽  
Better Than

Evidence-Based Medicine: Determining Quality of Randomized Controlled Trials

2014 ◽  
Vol 19 (4) ◽  
pp. 3-5
Author(s):  
Melissa Cheng
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Internal Validity ◽  
Cochrane Collaboration ◽  
Dropout Rate ◽  
Controlled Trials ◽  
Evidence Based ◽  
Double Blind ◽  
Randomized Controlled ◽  
Based Medicine

Abstract Evidence-based medicine is based on evidence gathered by randomized controlled trials (RCTs), which are considered the “gold standard” of research studies. Users of the medial literature must be able to read critically and evaluate RCTs. The present article uses the standards of the American College of Occupational and Environmental Medicine (ACOEM) practice guidelines in evaluating RCTs according to 11 criteria; these criteria follow those used by the Cochrane Collaboration in their evidence-based reviews. Well-written articles present their randomization schemes to create comparable groups, and studies must be controlled for co-interventions; in a double-blind trial, the co-interventions would be used equally in both groups, and treatment allocations should be concealed. Readers should ask if the study had acceptable compliance; that is, were patients doing what they were asked, and was the dropout rate acceptable (typically, less than 20%)? RCTs should be analyzed by an intention-to-treat analysis that includes all study subjects who were randomized, not just those who completed the study. Having high internal validity ensures a more accurate study that can be reproduced by others, so readers may ask if results are likely to be affected by observational bias, confounding, or chance variation. Readers can determine external validity by assessing study participants according to inclusion and exclusion criteria and baseline characteristics.

Levels of evidence of articles in podiatric medical journals

2000 ◽  
Vol 90 (6) ◽  
pp. 300-302 ◽  
Author(s):  
MA Turlik ◽  
D Kushner
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Medical Profession ◽  
Controlled Trials ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Medical Journals ◽  
Levels Of Evidence ◽  
Randomized Controlled ◽  
Based Medicine

The authors reviewed 322 articles in podiatric medical journals to determine their level of evidence. Only 1% of the articles reviewed were randomized controlled trials. The authors concluded that if the podiatric medical profession wishes to become a participant in evidence-based medicine, greater emphasis must be placed on studies that assess hypotheses.

scholarly journals Observational studies and registers. Their quality and role in modern evidence-based medicine

2021 ◽  
Vol 20 (2) ◽  
Author(s):  
S. Yu. Martsevich ◽  
N. P. Kutishenko ◽  
Yu. V. Lukina ◽  
M. M. Lukyanov ◽  
O. M. Drapkina
Keyword(s):  
Side Effects ◽  
Randomized Controlled Trials ◽  
Therapeutic Effect ◽  
Evidence Based Medicine ◽  
Observational Studies ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Based Medicine

The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.

scholarly journals Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 2: Randomized Controlled Trials

2008 ◽  
Vol 6;11 (12;6) ◽  
pp. 717-773
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Evidence Based Medicine ◽  
Randomized Trials ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Hierarchy Of Evidence ◽  
Based Medicine

Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo-controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence for treatment alternatives. However, in practical clinical trials, interventions compared in the trial are clinically relevant alternatives, participants reflect the underlying affected population with the disease, participants come from a heterogeneous group of practice settings and geographic locations, and endpoints of the trial reflect a broad range of meaningful clinical outcomes. Key words: Randomized controlled trial (RCT), placebo-controlled trial, pragmatic controlled trial, randomization, allocation concealment, sample size, blinding, consolidated standards of reporting trials (CONSORT) statement, minimal clinically important change (MCIC), minimal clinical important difference (MCID)

Person-Centered Research: A novel approach to Randomized Controlled Trials

2018 ◽  
Vol 6 (2) ◽  
pp. 209
Author(s):  
Reza A Badian ◽  
Brendan McCormack ◽  
Vibeke Sundling
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
Centered Care ◽  
Based Medicine ◽  
Novel Design

Introduction: Integrating person-centered values with randomized controlled trials methodology is a novel idea. Person-centeredness is gaining steadily more prominence and attention in healthcare and health-related policy and research. Randomized controlled trials are considered as the gold standard in evidence-based medicine for evaluating the effects of treatment or determining the causal effect. A wide array of study designs is available, but there is a lack of designs with both strong person-centered principles and a strong position with respect to the level of evidence. In this paper we intend to introduce a novel design to fill such a gap.Aims and objectives: The aim of this paper is to introduce a novel study design where essential values of person-centered care (PCC) are integrated with randomized controlled trial (RCT) methodology into a novel study design termed a person-centered randomized controlled trial (PC-RCT).Methods: In this paper we discuss the importance and role of evidence in clinical research, levels of evidence, as well as the significance of study design in evidence-based medicine. Moreover, we discuss randomized controlled trials that are considered the gold standard to achieve high quality evidence. In this paper we will explain what the concept of person-centered care is and discuss the values associated with person-centeredness.The theoretical and methodological considerations that are relevant in applying this concept will be discussed before presenting how we intend to incorporate person-centered values into a randomized controlled trial in a novel study design that is both person-centered and randomized controlled (PC-RCT). Different aspects of this proposed novel study design will be discussed, including the theory and methods underlying this new proposed design, its novelty, different stages and practical steps involved in this proposed design. Challenges, drawbacks and possible solutions for addressing challenges of this novel design will be explored, focusing on the construct, dynamics, advantages, disadvantages and novelty of PC-RCT design.Conclusion: This paper presents how person-centered values and traditional randomised controlled trial principal values are integrated into one study design where the strengths of both concepts are merged into one. The proposed novel study design has stronger person-centered characteristics and is solid in its RCT features. This design ensures that participants have much more active participation in decision-making and gain more choice in their treatment. The proposed novel study design in this paper has clearly an important role to play in satisfying the need for a study design that can address both the need for rendering higher levels of evidence as well as simultaneously securing greater integration of person-centered values in the same study design.

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