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.

scholarly journals A Systematic Review and Meta-Analysis of Immune-Related Adverse Events of Anti-PD-1 Drugs in Randomized Controlled Trials

2020 ◽  
Vol 19 ◽  
pp. 153303382096745
Author(s):  
Yukun Wang ◽  
Dejiu Kong ◽  
Chaokun Wang ◽  
Jing Chen ◽  
Jing Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Targeted Drugs ◽  
Randomized Controlled

Objective: We aimed to evaluate immune-related adverse events occurring in clinical trials of anti-programmed cell death 1 (PD-1) drugs, compared with control treatments, including chemotherapy, targeted drugs, or placebo. Further we compared the occurrence of immune -related events in patients treated with different anti-PD-1 drugs. Data Sources: Randomized controlled trial (RCT) data were sourced from PubMed, Embase, and the Cochrane Central Register of Controlled Trials combined with https://clinicaltrials.gov . Methods: Randomized controlled trial of anti-PD-1 drugs compared with control treatments published between January 1, 1970 and March 1,2019, were searched and data on trial patient characteristics, and adverse events extracted, reviewed, and subjected to meta-analysis. Results: Eighteen Randomized controlled trials were included in our study. The Randomized controlled trials compared nivolumab (n = 12), pembrolizumab (n = 6), with chemotherapy (n = 13), targeted drugs (n = 2), or placebo (n = 3). Compared with the control group, the risk of any immune-related adverse events in patients treated with anti-PD-1 drugs was increased (RR, 2.65; 95% confidence interval, 1.84–3.83; P < 0.00001). Of the immune-related adverse events, the risk rates of pneumonitis (risk ratio, 2.10; 95% CI, 0.85-5.18), colitis (2.96;1.62-5.38), hypophysitis(4.79;1.54-14.89), hypothyroidism(7.87;5.36-11.57), hyperthyroidism (7.03;4.35-11.34), rash (1.58;0.98-2.54), pruritus (2.28; 1.38-3.76), and hepatitis (9.31;2.18-39.85) were increased by anti-PD-1 drugs. Further, the risk of immune-related adverse events was similar for patients treated with pembrolizumab and nivolumab ( P = 0.14). Conclusions: In addition to previously reported organ-specific immune-related adverse events, we found that the risk of hyperthyroidism was also increased, in anit-PD-1-treated patients, relative to control treatments. The risk of total immune-related adverse events, was similar for pembrolizumab and nivolumab.

scholarly journals The effectiveness of preoperative individual information on reducing anxiety and pain after hysterectomy: A randomized controlled trial

2019 ◽  
Vol 10 (1) ◽  
pp. 67
Author(s):  
Hrønn Thorn ◽  
Lisbeth Uhrenfeldt
Keyword(s):  
Randomized Controlled Trial ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Anxiety Level ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Study Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Individual Information

Background and objective: Preoperative anxiety among gynecological patients is well-known and has a direct correlation with postoperative pain. By minimizing preoperative anxiety, the level of postoperative pain may decrease.  The purpose of this study was to evaluate the effect of preoperative structured information and dialogue on patients' anxiety and postoperative pain.Methods: A single-center non-blinded randomized controlled trial. Forty-six women scheduled for hysterectomy were allocated either to the study group or the control group.  The study group was given individual information at a preoperative consultation while the control group was given information at admittance. The main outcome was anxiety level and postoperative pain.Results: Forty participants (study group = 20; control group = 20) were analyzed. No statistically significant difference was found in anxiety level within the first 24 h postoperatively or in postoperative pain within four weeks between the groups.Conclusions: Preoperative individual information and dialogue did not result in significant effects in reducing anxiety level nor did it result in lower postoperative pain score.

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 A comparison of patient, intervention, comparison, outcome (PICO) to a new, alternative clinical question framework for search skills, search results, and self-efficacy: a randomized controlled trial

2020 ◽  
Vol 108 (2) ◽  
Author(s):  
Lorie A. Kloda ◽  
Jill T. Boruff ◽  
Alexandre Soares Cavalcante
Keyword(s):  
Randomized Controlled Trial ◽  
Information Literacy ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Clinical Question ◽  
Alternative Framework ◽  
Randomized Controlled ◽  
Clinical Questions ◽  
Experimental Group

Objective: In educating students in the health professions about evidence-based practice, instructors and librarians typically use the patient, intervention, comparison, outcome (PICO) framework for asking clinical questions. A recent study proposed an alternative framework for the rehabilitation professions. The present study investigated the effectiveness of teaching the alternative framework in an educational setting.Methods: A randomized controlled trial was conducted with students in occupational therapy (OT) and physical therapy (PT) to determine if the alternative framework for asking clinical questions was effective for identifying information needs and searching the literature. Participants were randomly allocated to a control or experimental group to receive ninety minutes of information literacy instruction from a librarian about formulating clinical questions and searching the literature using MEDLINE. The control group received instruction that included the PICO question framework, and the experimental group received instruction that included the alternative framework.Results: There were no significant differences in search performance or search skills (strategy and clinical question formulation) between the two groups. Both the control and experimental groups demonstrated a modest but significant increase in information literacy self-efficacy after the instruction; however, there was no difference between the two groups.Conclusion: When taught in an information literacy session, the new, alternative framework is as effective as PICO when assessing OT and PT students’ searching skills. Librarian-led workshops using either question formulation framework led to an increase in information literacy self-efficacy post-instruction.

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 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 Effect of posterior quadratus lumborum blockade on the quality of recovery after major gynaecological laparoscopic surgery: A randomized controlled trial

2019 ◽  
Vol 47 (2) ◽  
pp. 146-151 ◽  
Author(s):  
Hiroko Fujimoto ◽  
Tomoya Irie ◽  
Takahiro Mihara ◽  
Yusuke Mizuno ◽  
Takeshi Nomura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Surgery ◽  
Postoperative Pain ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Quadratus Lumborum

Bilateral quadratus lumborum blockade (QLB) using ultrasound guidance has been introduced as an abdominal truncal block to improve postoperative analgesia and quality of recovery (QoR) after abdominal surgery, but efficacy remains controversial. The primary aim of this study was to evaluate the efficacy of posterior QLB on the postoperative QoR, and secondarily to evaluate postoperative pain after gynaecological laparoscopic surgery (LS). This study was a single-centre randomized controlled trial. QLB group patients underwent bilateral posterior quadratus lumborum injections with 25–30 mL of 0.25% levobupivacaine after induction of general anaesthesia; the control group underwent no block. Both groups were administered fentanyl-based intravenous patient-controlled analgesia postoperatively. The postoperative QoR was measured using the Quality of Recovery 40 (QoR-40) questionnaire score; postoperative pain was evaluated using the visual analogue scale (VAS) and the cumulative postoperative fentanyl dose. Thirty-one and 29 patients were randomised to the QLB and control groups, respectively. The intraoperative remifentanil dosage was significantly less in the QLB group. The median (interquartile range) for the QoR-40 score was not different between the groups: 154 (133–168) in the QLB group and 158 (144–172) in the control group. There were no statistically significant differences in secondary outcome variables. Single-shot QLB did not improve the QoR or postoperative pain in patients managed by multimodal analgesia after gynaecological LS.

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.

scholarly journals Does candidate for plate fixation selection improve the functional outcome after midshaft clavicle fracture? A systematic review of 1348 patients

2018 ◽  
Vol 11 (1) ◽  
pp. 9-16 ◽  
Author(s):  
M Vautrin ◽  
G Kaminski ◽  
B Barimani ◽  
J Elmers ◽  
V Philippe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Randomized Controlled Trials ◽  
Functional Outcome ◽  
Surgical Management ◽  
Controlled Trial ◽  
Clavicle Fracture ◽  
Controlled Trials ◽  
Union Rate ◽  
Non Union ◽  
Randomized Controlled

Introduction The hypothesis of this study was that patient selection for midshaft clavicle fracture (open reduction internal fixation with plate versus conservative) would give better functional outcome than random treatment allocation. Methods We performed a systematic literature search for primary studies providing functional score and non-union rate after conservative or surgical management of midshaft clavicle fractures. Six randomized controlled trial and 19 non-randomized controlled trial studies encompassing a total of 1348 patients were included. Results Patients treated with surgical management were found to have statistically superior Constant scores in non-randomized controlled trials than in randomized controlled trials (94.76 ± 6.4 versus 92.49 ± 6.2; p < 0.0001). For conservative treatment, randomized controlled trials were found to have significantly better functional outcome. The prevalence of non-union (6.1%) did not show significant statistical difference between non-randomized controlled trial and randomized controlled trial studies. The functional outcome after surgical management was significantly higher than after conservative management in both randomized controlled trial and non-randomized controlled trial groups. The non-union rate after surgery (1.1% for both non-randomized controlled trial and randomized controlled trial) was significantly lower than following conservative treatment (9.9% non-randomized controlled trial versus 15.1% randomized controlled trial). Discussion This review shows that patient selection for surgery may influence functional outcome after midshaft clavicle fracture. Our results also confirm that plate fixation provides better functional outcome and lower non-union rate.

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