The Importance of High-Quality Evidence of the Long-Term Impact of Nonfatal Events Used in Randomized Controlled Trials: A Case Study of Prasugrel

2011 ◽  
Vol 90 (1) ◽  
pp. 27-29 ◽  
Author(s):  
C Y Lu ◽  
J Karnon ◽  
M J Sorich
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Long Term Impact ◽  
Quality Evidence

scholarly journals TRADE-OFFS BETWEEN EPISTEMIC AND MORAL VALUES IN EVIDENCE-BASED POLICY

2018 ◽  
Vol 35 (1) ◽  
pp. 49-78 ◽  
Author(s):  
Donal Khosrowi
Keyword(s):  
Controlled Trials ◽  
Evidence Based ◽  
Epistemic Values ◽  
High Quality ◽  
Political Values ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Evidence Based Policy ◽  
Trade Offs ◽  
Quality Evidence

Abstract:Proponents of evidence-based policy (EBP) call for public policy to be informed by high-quality evidence from randomized controlled trials. This methodological preference aims to promote several epistemic values, e.g. rigour, unbiasedness, precision, and the ability to obtain causal conclusions. I argue that there is a trade-off between these epistemic values and several non-epistemic, moral and political values. This is because the evidence afforded by standard EBP methods is differentially useful for pursuing different moral and political values. I expand on how this challenges ideals of value-freedom and -neutrality in EBP, and offer suggestions for how EBP methodology might be revised.

scholarly journals Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach

2019 ◽  
Vol 29 (5) ◽  
pp. 672-679 ◽  
Author(s):  
Leila Rooshenas ◽  
Sangeetha Paramasivan ◽  
Marcus Jepson ◽  
Jenny L. Donovan
Keyword(s):  
Qualitative Research ◽  
Comparative Effectiveness ◽  
Quantitative Data ◽  
Randomized Trials ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Health Care Interventions ◽  
High Quality Evidence ◽  
Quality Evidence

Randomized controlled trials (RCTs) can provide high quality evidence about the comparative effectiveness of health care interventions, but many RCTs struggle with or fail to complete recruitment. RCTs are built on the principles of the experimental method, but their planning, conduct, and interpretation can depend on complex social, behavioral, and cultural factors that may be best understood through qualitative research. Most qualitative studies undertaken alongside RCTs involve interviews that produce data that are used in a supportive or supplicatory role, but there is potential for qualitative research to be more influential. In this article, we describe the research methods underpinning the “QuinteT” (Qualitative Research Integrated Within Trials) approach to understand and address RCT recruitment difficulties. The QuinteT Recruitment Intervention (QRI) brings together multiple qualitative strategies and quantitative data and uses triangulation to understand recruitment issues rapidly. These nuanced understandings are used to inform the implementation of collaborative actions to improve recruitment.

Effects of targeted hydration on risk of major adverse renal and cardiac events: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Z Guo ◽  
L Lei ◽  
J Liu ◽  
F Song ◽  
Y He ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Contrast Agents ◽  
Randomized Controlled Trials ◽  
Pulmonary Edema ◽  
Controlled Trials ◽  
Cardiac Events ◽  
High Quality ◽  
Randomized Controlled ◽  
Long Term Mortality

Abstract Background Inconsistent results have been published that have evaluated the preventive effect of targeted hydration in major adverse renal and cardiac events among patients exposed to contrast agents. Methods Online databases were searched up to October, 2019, for randomized controlled trials (RCTs). The primary outcome was the incidence of contrast-induced acute kidney injury (CI-AKI), and the secondary outcomes were all-cause in-hospital mortality, all-cause long-term mortality, requirement for dialysis, acute pulmonary edema and stroke/transient ischemic attack (TIA). Results 9 high quality trials were identified including 2424 patients. Overall, compared with general hydration, targeted hydration significantly reduced the incidence of CI-AKI by 58% (RR 0.42; 95% CI: 0.33–0.54, p<0.01), the requirement for dialysis by 68% (RR 0.32, 95% CI: 0.17–0.62, p<0.01) and the all-cause long-term mortality by 55% (RR 0.45; 95% CI: 0.26–0.76, p<0.01). The effect on all-cause in-hospital mortality was not statistically significant. The effect on acute pulmonary edema and stroke/TIA also showed no difference between two groups (RR: 0.54, 95% CI: 0.28–1.03, p=0.18; RR: 0.61, 95% CI: 0.14–2.61, p=0.49, respectively). Trial sequential analysis confirmed that an additional 3900 study participants would need to be recruited to demonstrate a statistically significant improvement for all-cause in-hospital mortality. Conclusions Targeted hydration likely reduces the incidence of CI-AKI, dialysis and all-cause long-term mortality in patients exposed to contrast agents. However, further independent high-quality RCTs should elucidate the effectiveness and safety of this prophylactic strategy in interventional cardiology. Funding Acknowledgement Type of funding source: None

scholarly journals Therapeutic Evidence of Human Mesenchymal Stem Cell Transplantation for Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Baocheng Xie ◽  
Minyi Chen ◽  
Runkai Hu ◽  
Weichao Han ◽  
Shaobo Ding
Keyword(s):  
Cerebral Palsy ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Meta Analysis ◽  
Human Mesenchymal Stem Cell ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Quality Evidence

Cerebral palsy (CP) is a kind of movement and posture disorder syndrome in early childhood. In recent years, human mesenchymal stem cell (hMSC) transplantation has become a promising therapeutic strategy for CP. However, clinical evidence is still limited and controversial about clinical efficacy of hMSC therapy for CP. Our aim is to evaluate the efficacy and safety of hMSC transplantation for children with CP using a meta-analysis of randomized controlled trials (RCTs). We conducted a systematic literature search including Embase, PubMed, ClinicalTrials.gov, Cochrane Controlled Trials Register databases, Chinese Clinical Trial Registry, and Web of Science from building database to February 2020. We used Cochrane bias risk assessment for the included studies. The result of pooled analysis showed that hMSC therapy significantly increased gross motor function measure (GMFM) scores (standardized mean difference SMD=1.10, 95%CI=0.66‐1.53, P<0.00001, high-quality evidence) and comprehensive function assessment (CFA) (SMD=1.30, 95%CI=0.71‐1.90, P<0.0001, high-quality evidence) in children with CP, compared with the control group. In the subgroup analysis, the results showed that hMSC therapy significantly increased GMFM scores of 3, 6, and 12 months and CFA of 3, 6, and 12 months. Adverse event (AE) of upper respiratory infection, diarrhea, and constipation was not statistically significant between the two groups. This meta-analysis synthesized the primary outcomes and suggested that hMSC therapy is beneficial, effective, and safe in improving GMFM scores and CFA scores in children with CP. In addition, subgroup analysis showed that hMSC therapy has a lasting positive benefit for CP in 3, 6, and 12 months.

scholarly journals Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review

2019 ◽  
Vol 10 (6) ◽  
pp. 775-783
Author(s):  
Amit Jain ◽  
Majd Marrache ◽  
Andrew Harris ◽  
Varun Puvanesarajah ◽  
Brian J. Neuman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Structural Allograft ◽  
Patient Reported ◽  
Spine Degeneration ◽  
Quality Evidence

Study Design: Systematic literature review. Objective: Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. Methods: Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. Results: Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. Conclusion: Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. Level of Evidence: II.

scholarly journals EXPRESS: The benefit of exercise-based rehabilitation programmes in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
pp. 204589402110078
Author(s):  
Lu Yan ◽  
Wence Shi ◽  
Zhi-hong Liu ◽  
Qin Luo ◽  
Zhihui Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Randomized Controlled Trials ◽  
Exercise Capacity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean ◽  
Quality Evidence

Background: Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension (PH), and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with PH. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with PH through a meta-analysis of randomized controlled trials. Methods: We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials (RCTs) comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I ² statistic to estimate the degree of heterogeneity. Results: Nine RCTs are included, however, only seven RCTs were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension (PAH). The study duration ranged from 3 to15 weeks. The mean six-minute walk distance after exercise training was 51.94 metres higher than control (27.65 to 76.23 metres, n=234, 7 RCTs, low quality evidence), the mean peak oxygen uptake  was 2.96 ml/kg/minute higher (2.49 to 3.43 ml/kg/minute, n=179, 4 RCTs, low-quality evidence) than in the control group . Concluded: Our finding suggest that an exercise-based training program positively influences exercise capacity in patients with PH.

scholarly journals Nutrition in infancy and long-term risk of obesity: evidence from 2 randomized controlled trials

2010 ◽  
Vol 92 (5) ◽  
pp. 1133-1144 ◽  
Author(s):  
Atul Singhal ◽  
Kathy Kennedy ◽  
Julie Lanigan ◽  
Mary Fewtrell ◽  
Tim J Cole ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled
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