Otorhinolaryngology

2016 ◽  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trials ◽  
General Practitioners ◽  
Individual Patient Data ◽  
Controlled Trials ◽  
Evidence Based ◽  
Randomized Controlled ◽  
The Past ◽  
Meta Analyses ◽  
Based Medicine

Conditions of the ear, nose, or throat (ENT) are common diagnoses in primary care and are a frequent indication for referral to secondary care. They have a major impact on health and health-care resources, and it is therefore important that the management of ENT conditions is based upon the best available evidence. Such evidence should come from methodologically sound research in patients representative of those seen in everyday practice. Over the past decades, general practitioners and ENT surgeons have embraced the principles of evidence-based medicine, actively contributing to randomized controlled trials in this field. Consequently, management of ENT conditions is shifting from experience-based to evidence-based. The randomized controlled trials and individual patient data meta-analyses presented in this chapter have been instrumental in the development of clinical guidelines that allow general practitioners and ENT surgeons to make evidence-based shared decisions for the management of some of the commonest ENT conditions.

scholarly journals A guide to do randomized controlled trials in the field of otolaryngology

2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Groups ◽  
Controlled Trials ◽  
Main Body ◽  
Main Research ◽  
Randomized Controlled ◽  
New Treatment ◽  
Meta Analyses ◽  
Based Medicine

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.

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.

Plastic and reconstructive surgery

2016 ◽  
Keyword(s):  
Randomized Controlled Trials ◽  
Plastic Surgery ◽  
Reconstructive Surgery ◽  
Controlled Trials ◽  
Evidence Based ◽  
Trial And Error ◽  
Plastic And Reconstructive Surgery ◽  
Randomized Controlled ◽  
The Past ◽  
Evidence Based Surgery

In plastic and reconstructive surgery, innovation and creativity have been foremost, with science and evidence following. Unlike for a number of other specialties, the advances in plastic surgery have largely come from imagination, innovations, and trial and error, rather than from scientific trials. Somewhat more than for the rest of surgery, in plastics (where the art and craft of each particular surgeon counts immeasurably), randomized controlled trials of techniques have failed to be generated in the past, due to the difficulty of objectively assessing the success of surgery with an aesthetic-based nature. Consequently, evidence-based study of plastic surgery is a relatively new and developing field. This chapter focuses on the growing importance of evidence-based surgery in this specialty, showing that scientific trials are now being performed with increasing frequency.

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.

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.

Conditional copula models for correlated survival endpoints: Individual patient data meta-analysis of randomized controlled trials

2021 ◽  
pp. 096228022110463
Author(s):  
Takeshi Emura ◽  
Casimir Ledoux Sofeu ◽  
Virginie Rondeau
Keyword(s):  
Randomized Controlled Trials ◽  
Individual Patient Data ◽  
Controlled Trials ◽  
Kendall’S Tau ◽  
Kendall's Tau ◽  
Randomized Controlled ◽  
Conditional Copula ◽  
Survival Endpoints ◽  
Definition Of ◽  
Meta Analyses

Correlations among survival endpoints are important for exploring surrogate endpoints of the true endpoint. With a valid surrogate endpoint tightly correlated with the true endpoint, the efficacy of a new drug/treatment can be measurable on it. However, the existing methods for measuring correlation between two endpoints impose an invalid assumption: correlation structure is constant across different treatment arms. In this article, we reconsider the definition of Kendall's concordance measure (tau) in the context of individual patient data meta-analyses of randomized controlled trials. According to our new definition of Kendall's tau, its value depends on the treatment arms. We then suggest extending the existing copula (and frailty) models so that their Kendall's tau can vary across treatment arms. Our newly proposed model, a joint frailty-conditional copula model, is the implementation of the new definition of Kendall's tau in meta-analyses. In order to facilitate our approach, we develop an original R function condCox.reg(.) and make it available in the R package joint.Cox ( https://CRAN.R-project.org/package=joint.Cox ). We apply the proposed method to a gastric cancer dataset (3288 patients in 14 randomized trials from the GASTRIC group). This data analysis concludes that Kendall's tau has different values between the surgical treatment arm and the adjuvant chemotherapy arm ( p-value<0.001), whereas disease-free survival remains a valid surrogate at individual level for overall survival in these trials.

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