I) Introduction

VASA ◽  
2003 ◽  
Vol 32 (Supplement 63) ◽  
pp. 3-6
Keyword(s):  
Randomized Controlled Trials ◽  
Current Practice ◽  
Compression Therapy ◽  
Controlled Trials ◽  
Clinical Effects ◽  
Randomized Controlled ◽  
Venous Diseases ◽  
Based Medicine ◽  
Near Future ◽  
Venous Disorders

Background. The use of compression therapy is mainly based on tradition and experience. Randomized controlled trials demonstrating clinical effects in different indications are rare or non-existing. A clear proof of effectiveness for different compression devices endorsed by evidence based medicine will be a prerequisite for reimbursement by health budgets in the near future. Against this background a group of experts has discussed and approved the following position document under the auspices of the International Union of Phlebology. Indications for compression therapy in phlebology and lymphology are mainly: 1. Chronic venous disorders (CEAP C0-C6 ) (1) 2. Acute venous diseases 3. Lymphoedema. The following 3 questions are discussed for every single indication: ¥ What is done? (Current practice and rationale) ¥ What do we know? (Level of recommendation based on present knowledge) ¥ What do we need to know? (Proposals for randomized controlled trials on compression therapy)

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.

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 Comparing Several Treatments with Antibiotics for CommunityAcquired Pneumonia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Fusheng Bai ◽  
Xinming Li
Keyword(s):  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Clinical Effects ◽  
Cure Rate ◽  
Ceftaroline Fosamil ◽  
Randomized Controlled

Background: We aimed to review relevant randomized controlled trials to assess the relative clinical effects of antibiotic treatment of patients with community-acquired pneumonia (CAP). Methods: In this meta-analysis, we identified relevant studies from PubMed, Cochrane, and Embase using appropriate keywords. Key pertinent sources in the literature were also reviewed and all articles published through Oct 2019 were considered for inclusion. For each study, we assessed the risk ratios (RRs) or mean difference combined with the 95% confidence interval (CI) to assess and synthesize outcomes. Results: Overall, 36 studies were consistent with the meta-analysis, involving 17,076 patients. There was no significant difference in the mortality after subgroup analysis: individualized treatment vs. standard treatment; β-lactams plus macrolides vs. β-lactam and/or fluoroquinolone; ceftaroline fosamil vs. ceftriaxone; combination therapy vs. monotherapy or high-dose vs. low-dose. The drug-related adverse event incidence was significantly higher in the ceftriaxone group than in the other drug groups (P<0.05) and also higher in the tigecyline group than in the levofloxacin group (P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the test-of-cure (TOC) visit in the clinically evaluable population, modified intent-to-treat efficacy (MITTE) population, microbiologically evaluable (ME) population and the microbiological MITTE (mMITTE) population (all P<0.05). Compared with ceftriaxone, ceftaroline fosamil significantly increased the clinical cure rate at the TOC visit in the mMITTE population of Gram positiveStreptococcus pneumoniae (P<0.05) and multidrug-resistant S. pneumoniae (P<0.05). Conclusion: There was a limited number of included studies in the subgroup analysis, but it will still be necessary to conduct more high-quality randomized controlled trials to confirm the clinical efficacy of different antibiotics used to treat CAP.

VP90 Uniform Assessment Methods To Assess New Genomic Tests

2017 ◽  
Vol 33 (S1) ◽  
pp. 190-191
Author(s):  
Fueloep Scheibler ◽  
Daniel Fleer ◽  
Konstanze Angelescu ◽  
Lina Rodenhäuser ◽  
Martina Markes ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
New Technologies ◽  
Attrition Rate ◽  
Benefit Assessment ◽  
Controlled Trials ◽  
Final Report ◽  
Inclusion Criteria ◽  
International Consensus ◽  
Randomized Controlled ◽  
Near Future

INTRODUCTION:With the possibility to analyze gene expression a plethora of new genomic tests are surging into the medical market. The assessment of these new technologies in Health Technology Assessment (HTA) reports is challenging and we need international consensus on uniform criteria to support HTA, but also to establish clear and standardized requirements for clinical studies.METHODS:The German Institute for Quality and Efficiency in Health Care (IQWiG) has been commissioned to assess the benefits and harms of biomarkers to predict which women would benefit from chemotherapy treatment after surgery of primary breast cancer. The final report was published in October, 2016 (1).RESULTS:Only eight studies complied with the inclusion criteria of the systematic review. No prognostic study fulfilled the inclusion criteria. Only two randomized controlled trials (RCTs) delivered information utilizable for benefit assessment. Based mainly on 5-year results from the MINDACT trial, the report concluded that there currently is not enough information to support a positive decision on biomarkers in this specific indication. Ongoing randomized controlled trials like TailorX, PlanB, RxPONDER, ADAPT or OPTIMA are expected to provide some additional evidence in the near future. After publication of the IQWiG report an extensive debate on several methodological characteristics of this report was fuelled. In addition, some other HTA agencies, such as the National Institute for Health and Care Excellence (NICE) made slightly different conclusions.CONCLUSIONS:The presentation will give a résumé of the main arguments and focus on differences between the IQWiG report and other HTA reports. Questions, like the required study type, study characteristics (for example, attrition rate, follow up, outcomes), data quality, cut-offs or patient preferences in diagnostic information will be provided. The aim of the presentation and discussion is to get a step forward in defining key characteristics and elements of benefit assessment and primary studies for these new technologies. A consensus among HTA reviewers in these approaches seems to be essential in the near future.

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
Sign in / Sign up

Export Citation Format

Share Document