scholarly journals Assessing the impact of retraction on the citation of randomized controlled trial reports: an interrupted time-series analysis

2018 ◽  
Vol 24 (1) ◽  
pp. 44-51 ◽  
Author(s):  
Andrew Mott ◽  
Caroline Fairhurst ◽  
David Torgerson
Keyword(s):  
Time Series ◽  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Interrupted Time Series ◽  
Controlled Trials ◽  
Interrupted Time Series Analysis ◽  
Randomized Controlled ◽  
Before And After ◽  
The Impact

Objectives To assess the impact of retraction on the citation of randomized controlled trials. Methods We used an interrupted time-series with matched controls. PubMed, CINHAL, Google and the Retraction Watch Database were searched. We identified retracted publications reporting the results of randomized controlled trials involving human participants with two years of available data before and after retraction. We obtained monthly citation counts across all articles for the 24 months before and after retraction, from Web of Science. We used a Poisson segmented regression to detect changes in the level and trend of citation following retraction. We also undertook a matched control analysis of unretracted randomized controlled trials and a sensitivity analysis to account for cases of large-scale, well-advertised fraud. Results We identified 387 retracted randomized controlled trial reports, of which 218 (56.3%) were included in the interrupted time-series analysis. A reduction of 22.9% (95% CI 4.0% to 38.2%, p = 0.02) was observed in the number of citations in the month after retraction, and a further reduction of 1.9% (95% CI 0.4% to 3.5%, p = 0.02) per month in the following 24 months, relative to the expected trend. There was no evidence of a statistically significant reduction among the matched controls. Authors with a large number of retractions saw a 48.2% reduction at the time of retraction (95% CI 17.7% to 67.3%, p = 0.01). Other cases had a more gradual reduction with no change at the time of retraction and a 1.8% reduction per month in the following 24 months (95% CI 0.2% to 3.4%, p = 0.03). Conclusions Retractions of randomized controlled trial reports can be effective in reducing citations. Other factors, such as the scale of the retractions and media attention, may play a role in the effectiveness of the reduction.

scholarly journals Does pregabalin effectively and safely relieve postoperative pain in patients undergoing pulmonary resections?

2019 ◽  
Vol 29 (4) ◽  
pp. 555-560 ◽  
Author(s):  
Shuangjiang Li ◽  
Wenbiao Zhang ◽  
Shan Cheng ◽  
Yongjiang Li
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Control Group ◽  
Controlled Trials ◽  
Clinical Question ◽  
Randomized Controlled ◽  
Study Type

Summary A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether pregabalin could effectively and safely reduce postoperative pain in patients undergoing pulmonary resections. Altogether 23 papers were found using the reported search, of which 6 randomized controlled trials represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Five of 6 randomized controlled trials demonstrated that the application of oral pregabalin during the perioperative period could effectively reduce postoperative pain after pulmonary resections without compromising patients’ safety. One randomized controlled trial reported no difference in the postoperative pain levels between the pregabalin group and the control group. The rates of adverse effects were generally found to be decreased in patients who received pregabalin compared to the patients who received routine analgesia, although 2 studies reported significantly higher incidences of mild drowsiness and dizziness among the pregabalin-treated patients. Currently available evidence supports that the perioperative administration of pregabalin can effectively and safely relieve postoperative pain for patients undergoing pulmonary resections.

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 Tutorial para planejamento e execução de ensaios clínicos randomizados

2019 ◽  
Vol 76 ◽  
pp. 1
Author(s):  
Olavo Barbosa de Oliveira-Neto ◽  
Raul Ribeiro de Andrade ◽  
Isabelle Oliveira Santos ◽  
Luciano Timbó Barbosa ◽  
Célio Fernando De Sousa-Rodrigues ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Publication Type ◽  
Randomized Controlled ◽  
Mesh Terms

Objetivo: O objetivo do presente estudo foi apresentar um tutorial para planejamento e execução de ensaios clínicos randomizados. Materiais e métodos: Uma busca foi realizada na base de dados digital MEDLINE via PubMed. A seguinte estratégia de busca foi utilizada: "randomized controlled trial"[Publication Type] OR "randomized controlled trials as topic"[MeSH Terms] OR "randomized controlled trial"[All Fields]. Uma busca manual também foi realizada. Resultados: O presente tutorial apresenta e discute os seguintes tópicos de grande importância para estudos de ensaios clínicos randomizados: importância de ensaios clínicos randomizados, itens metodológicos (pergunta da pesquisa, registro do protocolo, critérios de elegibilidade, variáveis de interesse, coleta e análise dos dados, risco de viés), e qualidade metodológica. Os ensaios clínicos randomizados possuem o menor risco de viés para avaliar intervenções na área da saúde. Conclusões: O tutorial oferece uma descrição concisa e prática de importantes itens de ensaios clínicos randomizados, os quais podem ser utilizados por clínicos e pesquisadores para melhor entender, planejar e executar esse tipo de estudo

scholarly journals Comments on “Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals”

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Rohan Kumar Ochani ◽  
Asim Shaikh ◽  
Naser Yamani
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trial ◽  
Reporting Quality ◽  
Controlled Trials ◽  
Treatment Regimens ◽  
Randomized Controlled ◽  
Accurate Reporting

AbstractRandomized controlled trials are considered the gold standard in assessing treatment regimens, and since abstracts may be the only part of a paper that a physician reads, accurate reporting of data in abstracts is essential. The CONSORT checklist for abstracts was designed to standardize data reporting; however, for papers submitted to anesthesiology journals, the level of adherence to the CONSORT checklist for abstracts is unknown. Therefore, we commend Janackovic and Puljak for their efforts in determining the adherence of reports of trials in the highest-impact anesthesiology journals between 2014 and 2016. The results of their study are extremely important; however, we believe that that study had some methodological limitations, which we discuss in this manuscript.

Beyond Randomized Controlled Trials

2012 ◽  
Vol 17 (1) ◽  
pp. 72-75 ◽  
Author(s):  
Isaac Golden
Keyword(s):  
Alternative Medicine ◽  
Randomized Controlled Trials ◽  
Complementary And Alternative Medicine ◽  
Controlled Trial ◽  
Pharmaceutical Research ◽  
Controlled Trials ◽  
Medicine Research ◽  
Randomized Controlled ◽  
The Impact ◽  
Complementary And Alternative

Complementary and alternative medicine is criticized by some as lacking evidence to support the effectiveness of its methods and medicines. Such critics typically point to mixed results from using randomized controlled trials to test complementary and alternative medicine. Randomized controlled trials have been held to be the “gold standard” in pharmaceutical research, but a growing body of evidence in orthodox journals has identified their limitations. Here, 5 fundamental flaws in the randomized controlled trial–based model are discussed as well as the impact on its relevance for testing complementary and alternative medicine therapies. A better way to evaluate complementary and alternative medicine therapies is also proposed. A 7-item checklist is suggested to quantify the strength of an area of complementary and alternative medicine research.

Sign in / Sign up

Export Citation Format

Share Document