Poor quality of dietary assessment in randomised controlled trials of nutritional interventions for type 2 diabetes may impact outcome conclusions: a systematic review and meta-analysis

Nutrition ◽  
2021 ◽  
pp. 111498
Author(s):  
Tian Wang ◽  
George Siopis ◽  
Hiu Yee Wong ◽  
Margaret Allman-Farinelli
Keyword(s):  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Dietary Assessment ◽  
Poor Quality ◽  
Controlled Trials ◽  
Nutritional Interventions ◽  
Randomised Controlled ◽  
Impact Outcome

scholarly journals Ivermectin for the prevention of COVID-19: addressing potential bias and medical fraud

2021 ◽  
Author(s):  
Andrew Hill ◽  
Manya Mirchandani ◽  
Leah Ellis ◽  
Victoria Pilkington
Keyword(s):  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Group Analysis ◽  
Poor Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Quality Of Data ◽  
Randomised Controlled ◽  
Post Hoc

Abstract Background Ivermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials. Objectives To conduct a meta-analysis with randomised controlled trials of ivermectin for the prevention of COVID-19, while controlling for the quality of data. Methods We conducted a sub-group analysis based on the quality of randomised controlled trials evaluating ivermectin for the prevention of COVID-19. Quality was assessed using the Cochrane Risk of Bias measures (RoB 2) and additional checks on raw data, where possible. Results Four studies were included in the meta-analysis. One was rated as being potentially fraudulent, two as having a high risk of bias and one as having some concerns for bias. Ivermectin did not have a significant effect on preventing RT-PCR confirmed COVID-19 infection. Ivermectin had a significant effect on preventing symptomatic COVID-19 infection in one trial with some concerns of bias, but this result was based on post-hoc analysis of a multi-arm study. Conclusions This meta-analysis demonstrates that the currently available randomised trials evaluating ivermectin for the prevention of COVID-19 are insufficient and of poor quality.

scholarly journals Poor Quality of Dietary Assessment in Randomised Controlled Trials of Nutritional Interventions for Type 2 Diabetes May Impact Outcome Conclusions: A Systematic Review

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 64-64
Author(s):  
Tian Wang ◽  
George Siopis ◽  
Hiu Yee Wong ◽  
Margaret Allman-Farinelli
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Dietary Assessment ◽  
Poor Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Nutritional Interventions ◽  
Randomized Controlled

Abstract Objectives Diet is critical in diabetes management and new nutritional interventions are continuously being tested in randomized controlled trials. However, to make meaningful conclusions about the efficacy of dietary treatments, it is critical to be certain that the participants adhered to the dietary intervention and the dietary changes are valid. The objective of this meta-analysis was to assess the quality of dietary assessment and whether it might impact on study metabolic outcomes. Methods Four databases, MEDLINE, EMBASE, CINAHL and CENTRAL, were searched, from inception until September 2019 for randomized controlled trials of nutritional interventions in people with non-insulin-dependent type 2 diabetes. Trials that measured nutritional intakes in methods and HbA1c as an outcome were included. Investigators assessed risk of bias and quality of the dietary measurements using the Cochrane Risk of Bias Assessment Tool 2.0 and a redeveloped EURICA tool, respectively. The study was conducted in accordance with the Preferred Reporting in Systematic Reviews and Meta-analyses. PROSPERO registration number: CRD42019146471. Results Of 2552 records retrieved, 23 studies met the inclusion criteria. Nineteen studies aimed to achieve a reduction in HbA1c, and four studies aimed to maintain HbA1c while improving other metabolic/nutritional outcomes. Two studies were rated as ‘good’, six as ‘medium’, and 15 as ‘poor’ in the quality assessment of the dietary measurement tool. The majority of studies were rated as high risk of bias. Of those studies with medium or high diet quality assessment, six of eight achieved the desired outcome whereas only four of the 15 other studies achieved the desired clinical outcome for HbA1c. Conclusions The poor quality of dietary assessment in clinical trials manipulating dietary intakes casts uncertainty on the legitimacy of causal mechanisms attributed to dietary interventions. Attention to the validity and reliability of dietary assessment methods is warranted. Funding Sources No funding support for conducting this review was received.

Acupuncture for Amnestic Mild Cognitive Impairment: A Meta-Analysis of Randomised Controlled Trials

2016 ◽  
Vol 34 (5) ◽  
pp. 342-348 ◽  
Author(s):  
Min Deng ◽  
Xu-Feng Wang
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Scientific Journal ◽  
Adjunctive Treatment ◽  
Controlled Trials ◽  
Randomised Controlled

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.

Treating depression with physical activity in adolescents and young adults: a systematic review and meta-analysis of randomised controlled trials

2017 ◽  
Vol 48 (7) ◽  
pp. 1068-1083 ◽  
Author(s):  
A. P. Bailey ◽  
S. E. Hetrick ◽  
S. Rosenbaum ◽  
R. Purcell ◽  
A. G. Parker
Keyword(s):  
Physical Activity ◽  
Young Adults ◽  
Treatment Effect ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Adolescents And Young Adults ◽  
Controlled Trials ◽  
Randomised Controlled

AbstractWe aimed to establish the treatment effect of physical activity for depression in young people through meta-analysis. Four databases were searched to September 2016 for randomised controlled trials of physical activity interventions for adolescents and young adults, 12–25 years, experiencing a diagnosis or threshold symptoms of depression. Random-effects meta-analysis was used to estimate the standardised mean difference (SMD) between physical activity and control conditions. Subgroup analysis and meta-regression investigated potential treatment effect modifiers. Acceptability was estimated using dropout. Trials were assessed against risk of bias domains and overall quality of evidence was assessed using GRADE criteria. Seventeen trials were eligible and 16 provided data from 771 participants showing a large effect of physical activity on depression symptoms compared to controls (SMD = −0.82, 95% CI = −1.02 to −0.61, p < 0.05, I2 = 38%). The effect remained robust in trials with clinical samples (k = 5, SMD = −0.72, 95% CI = −1.15 to −0.30), and in trials using attention/activity placebo controls (k = 7, SMD = −0.82, 95% CI = −1.05 to −0.59). Dropout was 11% across physical activity arms and equivalent in controls (k = 12, RD = −0.01, 95% CI = −0.04 to 0.03, p = 0.70). However, the quality of RCT-level evidence contributing to the primary analysis was downgraded two levels to LOW (trial-level risk of bias, suspected publication bias), suggesting uncertainty in the size of effect and caution in its interpretation. While physical activity appears to be a promising and acceptable intervention for adolescents and young adults experiencing depression, robust clinical effectiveness trials that minimise risk of bias are required to increase confidence in the current finding. The specific intervention characteristics required to improve depression remain unclear, however best candidates given current evidence may include, but are not limited to, supervised, aerobic-based activity of moderate-to-vigorous intensity, engaged in multiple times per week over eight or more weeks. Further research is needed. (Registration: PROSPERO-CRD 42015024388).

Sign in / Sign up

Export Citation Format

Share Document