Ethics of RCTs

2020 ◽  
pp. 280-292
Author(s):  
Michel Abramowicz ◽  
Ariane Szafarz
Keyword(s):  
Social Sciences ◽  
Randomized Controlled Trials ◽  
Development Economics ◽  
Medical Literature ◽  
Control Group ◽  
Controlled Trials ◽  
Clinical Investigator ◽  
Randomized Controlled ◽  
Ex Ante

Equipoise is defined by Freedman (1987: 141) as a “state of genuine uncertainty on the part of the clinical investigator regarding the comparative therapeutic merits of each arm in a trial.” This principle is grounded in the ethical motivation that any ex-ante preference for a given option would undermine the interests of those who are offered another. Randomized controlled trials (RCTs) in development economics disregard the equipoise requirement by typically disadvantaging the control group. This chapter investigates how the equipoise principle is formalized in the medical literature and discusses whether and how it should be taken into consideration by economists. It argues that equipoise is especially relevant when double (or even single) blindness is excluded and when the control group includes already vulnerable individuals. More generally, this chapter advocates for developing a vibrant ethics conversation on the design and fairness of RCTs in social sciences.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals Effects of Diet, Aerobic Exercise, or Both on Non-HDL-C in Adults: A Meta-Analysis of Randomized Controlled Trials

Cholesterol ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
George A. Kelley ◽  
Kristi S. Kelley
Keyword(s):  
Aerobic Exercise ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Density Lipoprotein ◽  
Control Group ◽  
Controlled Trials ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Effect Model

Purpose. To use the meta-analytic approach to examine the effects of diet (D), aerobic exercise (E), or both (DE) on non-high-density lipoprotein cholesterol (non-HDL-C) in adults. Methods. Randomized controlled trials in adults ≥18 years of age were included. A mixed-effect model was used to combine effect size (ES) results within each subgroup and to compare subgroups (Qb). Heterogeneity was examined using the Q and I2 statistics, and 95% confidence intervals (CI) were also calculated. Statistical significance was set at P≤0.05, while a trend for statistical significance was set between P>0.05, and ≤0.10. Results. A statistically significant exercise minus control group decrease in non-HDL-C was found for DE (7 ESs, 389 participants, x¯=-11.1 mg/dL, 95%  CI=−21.7 to −0.6, P=0.04, Q=2.4, P=0.88, I2=0%), a trend for the D group (7 ESs, 402 participants, x¯=−8.5 mg/dL, 95%  CI=−18.6 to 1.6, P=0.10, Q=0.76, P=0.99, I2=0%), and no change for the E group (7 ESs, 387 participants, x¯=3.0 mg/dL, 95%   CI=−7.1 to 13.1, P=0.56, Q=0.78, P=0.99, I2=0%). Overall, no statistically significant between-group differences were found (Qb=4.1, P=0.12). Conclusions. Diet combined with aerobic exercise may reduce non-HDL-C among adults in some settings.

scholarly journals The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han
Keyword(s):  
Virtual Reality ◽  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.

scholarly journals The efficacy and safety of antimuscarinics for the prevention or treatment of catheter-related bladder discomfort: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Zhongbao Zhou ◽  
Yuanshan Cui ◽  
Xiaoyi Zhang ◽  
Youyi Lu ◽  
Zhipeng Chen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Postoperative Nausea And Vomiting ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Facial Flushing ◽  
Blurred Vision ◽  
Randomized Controlled

Abstract Objectives This meta-analysis aimed to evaluate the efficacy and safety of antimuscarinics for the prevention or treatment of catheter related bladder discomfort (CRBD). Methods The MEDLINE, EMBASE, and Cochrane Controlled Trials Register (from 1987 to July 2021) were used to search randomized controlled trials. The PRISMA checklists were followed. RevMan5.4.0 was used for statistical analysis. Results Eleven studies involving 1165 patients were involved in the analysis. The study reported that the incidence of CRBD observed in the antimuscarinics group was significantly lower than that of the control group at 0-, 1-, 2-, and 6-h after drug therapy (P = 0.001, P < 0.0001, P = 0.0005, and P = 0.001, respectively). For side effects, there were not statistical differences between the antimuscarinics group and the control group, mainly including dry mouth (risk ratio (RR) = 1.31, 95% confidence interval (CI) = 0.95 to 1.80, P = 0.09), postoperative nausea and vomiting (RR = 1.02, 95% CI = 0.55 to 1.90, P = 0.87), facial flushing (RR = 1.06, 95% CI = 0.43 to 2.61, P = 0.90), and blurred vision (RR = 0.95, 95% CI = 0.35 to 2.58, P = 0.91). Besides, rescue analgesics were required less in the antimuscarinics group than in the control group (RR = 0.51, 95% CI = 0.32 to 0.80, P = 0.003). Conclusions Compared with the control group, the antimuscarinics group had a significant improvement on CRBD, the patients were well tolerated and the use rate of rescue analgesics was low.

scholarly journals CADRES COMPETENCE IN COMMUNITY-BASED MANAGEMENT OF CHILD ILLNESS IN BANYUMAS DISTRICT, CENTRAL JAVA, INDONESIA

2018 ◽  
Vol 4 (5) ◽  
pp. 492-501
Author(s):  
Umi Solikhah ◽  
Hari Kusnanto ◽  
Fitri Haryanti ◽  
Yayi Suryo Prabandari
Keyword(s):  
Randomized Controlled Trials ◽  
Health Center ◽  
Health Workers ◽  
Intervention Group ◽  
T Test ◽  
Control Group ◽  
P Value ◽  
Controlled Trials ◽  
Child Illness ◽  
Randomized Controlled

Background: One of the efforts in the health sector for programs to reduce infant and under-five mortality and morbidity rates is by the competence-based integrated management childhood illness (CB-IMCI) program. However, the program has been poorly implemented by health workers at the health center. Thus, the involvement of cadres is needed and their competency remains important to be improved.Objective: To quantitatively analyze cadre knowledge and competencies in the CB-IMCI program, and its relationship with the implementation of CB-IMCI, as well as to qualitatively explore and analyze the responses of cadres, health workers, and the community to the addition of cadre roles to the management of sick children.Methods: This was a mixed methods study with randomized controlled trials and qualitative method. For randomized controlled trials, 100 cadres were selected, which 50 randomly assigned in the intervention and control group. And for quantitative methods, informants included 10 cadres, 4 health workers, and 20 mothers. Paired t-test and independent t-test were employed for quantitative analysis, and triangulation was used for qualitative analysis.Results: The improvement of knowledge in the intervention group was better (I=14.42/C=4.44/p-value 0.00). The intervention group was more competent in the management of child illness (p-value 0.00). In addition, the cadres have additional competencies assisted by health workers to confidently detect cases earlier, and health center services reach a wider coverage in the community.Conclusion: The addition of cadres roles and competencies in the management of child illness in the community can be implemented in Banyumas Regency. It is suggested that the implementation of this program should be followed up in other health centers by the health department of Indonesia.

scholarly journals Impact of Ketamine on Pain Management in Cesarean Section: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 2;23 (4;2) ◽  
pp. 135-148
Author(s):  
Zifeng Xu
Keyword(s):  
Cesarean Section ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Control Effect ◽  
Randomized Controlled ◽  
Time Required ◽  
The Cochrane Library

Background: The pain control effect of ketamine versus control in women during cesarean operation is not well determined. Objectives: The present meta-analysis aimed to evaluate the clinical efficacy of ketamine versus control in cesarean section anesthesia for reducing the postoperative pain and analgesia. Study Design: We used meta-analysis to address this concern. Setting: Meta-analysis-based study. Methods: The databases PubMed, Embase, and the Cochrane Library were systematically searched to identify the relevant randomized controlled trials (RCTs) of ketamine versus control in controlling pain after cesarean section from inception to August 2018. Based on the Cochrane Handbook, the combined analysis was performed using Revman 5.3 software. Results: A total of 20 RCTs with 1,737 patients who underwent cesarean section were included. Meta-analysis showed that the pain score in the ketamine group was less than that of the control group (mean difference [MD], –1.10; 95% confidence interval [CI], –1.61, –0.59; P < 0.0001). Application of ketamine during cesarean section also resulted in decreased consumption of morphine when compared with the control group (MD, –6.11 mg; 95% CI, –9.93, –2.29; P = 0.002). In addition, the first time required for analgesia was significantly longer in the ketamine group than that of the control group (MD, 72.48 minutes; 95% CI, 50.85, 94.11; P < 0.00001). Limitations: Limited patients were included with moderate strength. Conclusions: Ketamine supplementation during cesarean section reduces pain and morphine consumption and prolongs the postoperative analgesia. Key words: Ketamine, cesarean section, randomized controlled trials, meta-analysis

scholarly journals Meta-Analysis of the Clinical Value of Danshen Injection and Huangqi Injection in Liver Cirrhosis

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Changtai Zhu ◽  
Hao Cao ◽  
Xifa Zhou ◽  
Chunlei Dong ◽  
Judong Luo ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Biomedical Literature ◽  
Control Group ◽  
Controlled Trials ◽  
Serum Total Bilirubin ◽  
Clinical Value ◽  
Randomized Controlled ◽  
Danshen Injection

Objective. To evaluate the clinical value of Danshen injection and Huangqi injection for the treatment of liver cirrhosis.Methods. The Chinese Biomedical Literature Database (CBM), Chinese Scientific Journals Full-Text Database (VIP), Wanfang Database, China National Knowledge Infrastructure (CNKI), PubMed, and EMBASE database were searched to collect the literatures about the randomized controlled trials involving the treatment of liver cirrhosis with Danshen injection combined with Huangqi injection, and the data analyses were performed using RevMan 4.2 software.Results. A total of 11 studies involving 1086 patients (trials group: 554 cases, control group: 532 cases) were included in this study. Compared with those in control group, the meta-analysis showed-that the total effectiveness rate and the level of serum albumin increased, while serum total bilirubin, alanine transmninase, type III procollagen, hyaluronic acid, laminin, and type-IV collagen decreased in trials group. The Jadad score ranged from 1 to 2 and the funnel plot analysis suggests that publication bias may occur.Conclusions. Danshen injection combined with Huangqi injection may promote the curative efficacy of liver cirrhosis, which is a promising novel treatment approach. The exact outcome needs to perform rigorously designed, multicenter, and large randomized controlled trials.

scholarly journals Effects of ACEIs and ARBs on the Residual Renal Function in Peritoneal Dialysis Patients: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Lei Ding ◽  
Jingjuan Yang ◽  
Lizhu Li ◽  
Yi Yang
Keyword(s):  
Renal Function ◽  
Peritoneal Dialysis ◽  
Randomized Controlled Trials ◽  
Active Control ◽  
Meta Analysis ◽  
Residual Renal Function ◽  
Control Group ◽  
Controlled Trials ◽  
Active Control Group ◽  
Randomized Controlled

Background. In peritoneal dialysis (PD) patients, whether angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) could protect residual renal function is still controversial. To assess the effects of ACEIs and ARBs on the residual renal function and cardiovascular (CV) events in peritoneal dialysis patients, we performed a meta-analysis of randomized controlled trials. Materials and Methods. We searched PubMed, EMBASE, the Cochrane Library, the CNKI database, and the Wanfang database for relevant articles from database inception to November 30, 2019. Randomized controlled trials were included. The primary outcome was the decline in the residual renal function (RRF). Results. Thirteen trials with 625 participants were included in the meta-analysis. The average residual GFR declined by 1.79 ml/min per 1.73 m2 in the ACEI/ARB group versus 1.44 ml/min per 1.73 m2 in the placebo or active control group at 3 mo. The average residual GFR declined by 2.02 versus 2.06, 2.16 versus 2.72, and -0.04 versus 2.74 ml/min per 1.73 m2 in the placebo or active control group at 6 months (mo), 12 mo, and 24 mo, respectively. The decline in residual GFR showed a significant difference between the ACEI/ARB group and the placebo or active control group at 12 mo (MD=−0.64 ml/min per 1.73 m2; 95% CI: -0.97~-0.32; I2=44%; P<0.0001). No significant difference was observed in Kt/V, urinary protein excretion, weekly creatinine clearance, CV events, or serum potassium levels. Conclusions. In the present study, we found that the use of ACEIs and ARBs, especially long-term treatment, decreased the decline of RRF in patients on PD. ACEIs and ARBs do not cause an additional risk of side effects.

scholarly journals Massage Therapy in Children with Asthma: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Ji Wu ◽  
Xi-Wen Yang ◽  
Ming Zhang
Keyword(s):  
Treatment Group ◽  
Pulmonary Function ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Plasma Concentrations ◽  
Massage Therapy ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Children With Asthma

Objective. To systematically evaluate the efficacy of massage, a traditional treatment method of traditional Chinese medicine on children with asthma. Methods. Literatures from 5 databases using the date ranging from 1 January, 1990, to 13 December, 2016, were reviewed, which were all randomized controlled trials evaluating the efficacy on children with asthma and effect on lung function mainly by massage therapy. Results. 14 researches with 1299 patients were included in the meta-analysis. Compared with control group, a better efficacy was found in treatment group, which focused on massage therapy. Compared with control group, there was remarkable increase on FEV1 as well as PEF in treatment group. Conclusion. All studies have shown that massage therapy has a significantly positive effect on children with asthma, improves the pulmonary function parameters of large airway, reduces the plasma concentrations of PAF and prostaglandin, and increases the levels of PAF-AH and DP1; therefore, it greatly improves pulmonary function. However, the limited research designs of included studies lead to high risk of bias. More randomized controlled trials with better methodological quality are needed to further confirm the effectiveness of massage.

Effect of bovine lactoferrin on prevention of late-onset sepsis in infants <1500g: a pooled analysis of individual patient data from two randomized controlled trials.

2020 ◽  
Author(s):  
Theresa J. Ochoa ◽  
Sebastian Loli ◽  
Karina Mendoza ◽  
Cesar Carcamo ◽  
Sicilia Bellomo ◽  
...  
Keyword(s):  
Birth Weight ◽  
Human Milk ◽  
Randomized Controlled Trials ◽  
Late Onset ◽  
Milk Intake ◽  
Control Group ◽  
Controlled Trials ◽  
Bovine Lactoferrin ◽  
Randomized Controlled ◽  
Late Onset Sepsis

We previously conducted two randomized controlled trials of bovine lactoferrin (bLF) for prevention of late-onset sepsis (LOS) in infants with a birth weight <2500g (Study 1) and <2000g (Study 2). The aim of this study was to determine the effect of bLF on prevention of culture-proven or probable LOS in infants with a birth weight <1500g from both studies, and to determine the bLF effect depending on human milk intake. Both trial designs had similar inclusion and exclusion criteria, same bLF dose (200mg/kg/day) and same control (maltodextrin). We fitted multivariate Cox regression models to estimate the effect of bLF on the risk of development of the composite outcome, adjusting for covariates. We included 335 neonates with a mean birth weight of 1162g ±244g; 27.5% were <1000g. There were 33 first episodes of LOS in the bLF group and 48 in the control group (19.5% vs 28.9%). bLF had a protective effect on the risk of development LOS, Hazard Ratio (HR) 0.64 (%95CI: 0.41-0.99,p=0.048); particularly among infants <1000g, HR 0.46 (%95CI: 0.22-0.96,p=0.039) and among infants with low human milk intake, HR 0.40 (%95CI: 0.19-0.84,p=0.015). bLF supplementation protects against LOS in infants <1500g, especially among infants not receiving human milk.

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