Pharmacological treatment for Tourette syndrome in children and adults: What is the quality of the evidence? A systematic review

2021 ◽  
Vol 35 (9) ◽  
pp. 1037-1061
Author(s):  
Frank MC Besag ◽  
Michael J Vasey ◽  
Kim SJ Lao ◽  
Uttom Chowdhury ◽  
Jeremy S Stern
Keyword(s):  
Tourette Syndrome ◽  
Neurodevelopmental Disorder ◽  
Poor Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Pharmacological Treatments ◽  
Quality Of Reporting ◽  
Involuntary Muscle ◽  
Tic Severity

Background: Tourette syndrome (TS) is a neurodevelopmental disorder characterised by involuntary muscle movements manifesting as motor and vocal tics. In the majority, tics are manageable without medication. Where tics cause discomfort or impair function, behavioural or pharmaceutical treatments may be considered. Aims: To provide a meticulous examination of the quality of evidence for the current pharmacological treatments for TS. Methods: PubMed and Google Scholar were searched to identify randomised, placebo-controlled trials (RCTs) of aripiprazole, risperidone, clonidine, guanfacine, haloperidol, pimozide, tiapride and sulpiride for the treatment of tics in children and adults with TS. Quality of reporting and risk of bias were assessed against the CONSORT checklist and Cochrane risk of bias criteria, respectively. Results: Seventeen RCTs were identified. Response rates reached 88.6% for aripiprazole, 68.9% for clonidine, 62.5% for risperidone and 19% for guanfacine. Statistically significant improvements were reported for all medications compared to placebo in at least one study and for at least one measure of tic severity. Most studies predated the CONSORT and Cochrane criteria and did not score highly when assessed on these measures. Conclusions: There are relatively few placebo-controlled trials of commonly prescribed medications. Studies are often of poor quality and short duration. There is evidence for the efficacy of each medication, but no drug is clearly superior. Clonidine and guanfacine are better tolerated than antipsychotics, but less effective. There is too little evidence to determine whether adults respond differently from children.

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.

Impact of National Cancer Institute's Common Toxicity Criteria and Common Terminology Criteria for Adverse Events on Quality of Treatment Related Harms Reporting: An Analysis of National Cancer Institute's Co-Operative Group Phase III Randomized Controlled Trials

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 673-673
Author(s):  
Rahul Mhaskar ◽  
Hesborn Wao ◽  
Tea Reljic ◽  
Ambuj Kumar ◽  
Benjamin Djulbegovic
Keyword(s):  
Poor Quality ◽  
Phase Iii ◽  
P Value ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Quality Of Treatment ◽  
Morbidity Data ◽  
Toxicity Criteria

Abstract Abstract 673 Background: Informed decision making in health care requires balancing of information related to benefit and harms of treatments. However, it is shown that the amount of space dedicated for presenting information on harms in randomized trials is less than that used to list authors' names and affiliations. Poor or absent reporting of treatment-related harms can mislead decision makers at all levels (public, researchers, funding agencies). Several efforts have been made to improve the quality of data collection and reporting of treatment-related harms. In oncology, after recognizing that many cancer treatments are toxic, and not infrequently result in severe morbidity and even death, the National Cancer Institute's (NCI) lead the way to standardize terminology and data collection on treatment-related harms. The first standards for collection of harms data in cancer known as Common Toxicity Criteria (CTC) were developed in 1982 followed by three revisions. Here we investigate the impact of NCI CTC and NCI common terminology criteria for adverse events (CTCAE) on quality of reporting of treatment-related harms in a cohort of NCI cooperative group (NCI-COG) trials. Methods: We extracted data on elements addressing assessment of treatment-related harms from protocols and matching publications from all consecutive phase III NCI-COG randomized controlled trials (RCTs) for the years 1955 to 2006. RCTs reporting treatment-related mortality data as deaths per arm and treatment-related morbidity data as per patient per arm were categorized to have good quality. RCTs reporting treatment-related morbidity data in the aggregate method such as % of events per arm were categorized as intermediate quality while RCTs which did not report any treatment-related harms data were classified as poor quality. Results: We reviewed 429 RCTs enrolling 157,337 patients. Twenty seven percent (115/429) of RCTs had good quality of reporting of treatment-related harms while 63% (271/429) of RCTs were of intermediate quality. Only 10% (43/429) of RCTs had poor quality of reporting of treatment-related harms. Quality of treatment-related harms reporting did not improved with time. Nine percent (37/429) of RCTs were published before introduction of NCI CTC v1.0 while 66% (284/392) were published after NCI CTC v1.0 but before introduction of NCI v2.0 and 85% (92/108) of RCTs were published after NCI CTC v2.0 but before NCI CTCAE (figure). The quality of treatment-related harms reporting improved after introduction of NCI CTC v1.0 (p-value=0.002) while NCI CTC v2.0 (p-value= 0.78) and NCI CTACE (p-value=0.001) did not have positive impact on treatment-related harms reporting (figure). The NCI CTC/NCI CTCAE or similar standardized treatment-related harms assessment instrument was explicitly referred to in 55% (235/429) of protocols vs. 47% (203/429) of publications. Forty five percent (193/429) of protocols mentioned seriousness of treatment-related harms compared to 33% (142/429) of publications. Severity of treatment-related harms was mentioned in 63% (272/429) of protocols versus 71% (303/429) of publications. Conclusion: Quality of treatment-related harms reporting in NCI-COG RCTs did not improved with time. The introduction of NCI CTC initially did improve quality of treatment-related harms reporting. However, NCI CTC V2.0 and NCI CTCAE did not subsequently appear to impact reporting of quality of treatment-related harms in NCI-COG RCTs. Disclosures: No relevant conflicts of interest to declare.

Tools to assess the Risk of bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation

2021 ◽  
Author(s):  
Susan Armijo-Olivo ◽  
Michele Patrini ◽  
Ana Izabela S de Oliveira-Souza ◽  
Liz Dennett ◽  
Chiara Arienti ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Reporting Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals Methodological quality of systematic reviews on treatments for depression: a cross-sectional study

2017 ◽  
Vol 27 (6) ◽  
pp. 619-627 ◽  
Author(s):  
V. C. H. Chung ◽  
X. Y. Wu ◽  
Y. Feng ◽  
R. S. T. Ho ◽  
S. Y. S. Wong ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
A Priori ◽  
Cross Sectional Study ◽  
Risk Of Bias ◽  
Sectional Study ◽  
Pharmacological Treatments ◽  
Cross Sectional ◽  
Depression Treatments

Aims.Depression is one of the most common mental disorders and identifying effective treatment strategies is crucial for the control of depression. Well-conducted systematic reviews (SRs) and meta-analyses can provide the best evidence for supporting treatment decision-making. Nevertheless, the trustworthiness of conclusions can be limited by lack of methodological rigour. This study aims to assess the methodological quality of a representative sample of SRs on depression treatments.Methods.A cross-sectional study on the bibliographical and methodological characteristics of SRs published on depression treatments trials was conducted. Two electronic databases (the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects) were searched for potential SRs. SRs with at least one meta-analysis on the effects of depression treatments were considered eligible. The methodological quality of included SRs was assessed using the validated AMSTAR (Assessing the Methodological Quality of Systematic Reviews) tool. The associations between bibliographical characteristics and scoring on AMSTAR items were analysed using logistic regression analysis.Results.A total of 358 SRs were included and appraised. Over half of included SRs (n = 195) focused on non-pharmacological treatments and harms were reported in 45.5% (n = 163) of all studies. Studies varied in methods and reporting practices: only 112 (31.3%) took the risk of bias among primary studies into account when formulating conclusions; 245 (68.4%) did not fully declare conflict of interests; 93 (26.0%) reported an ‘a priori’ design and 104 (29.1%) provided lists of both included and excluded studies. Results from regression analyses showed: more recent publications were more likely to report ‘a priori’ designs [adjusted odds ratio (AOR) 1.31, 95% confidence interval (CI) 1.09–1.57], to describe study characteristics fully (AOR 1.16, 95% CI 1.06–1.28), and to assess presence of publication bias (AOR 1.13, 95% CI 1.06–1.19), but were less likely to list both included and excluded studies (AOR 0.86, 95% CI 0.81–0.92). SRs published in journals with higher impact factor (AOR 1.14, 95% CI 1.04–1.25), completed by more review authors (AOR 1.12, 95% CI 1.01–1.24) and SRs on non-pharmacological treatments (AOR 1.62, 95% CI 1.01–2.59) were associated with better performance in publication bias assessment.Conclusion.The methodological quality of included SRs is disappointing. Future SRs should strive to improve rigour by considering of risk of bias when formulating conclusions, reporting conflict of interests and authors should explicitly describe harms. SR authors should also use appropriate methods to combine the results, prevent language and publication biases, and ensure timely updates.

Quality and Risk of Bias in Panax ginseng Randomized Controlled Trials: A Review

2013 ◽  
Vol 41 (02) ◽  
pp. 231-252 ◽  
Author(s):  
Johannah L. Shergis ◽  
Anthony L. Zhang ◽  
Wenyu Zhou ◽  
Charlie C. Xue
Keyword(s):  
Randomized Controlled Trials ◽  
Panax Ginseng ◽  
Methodological Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Publication Date ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Clinical Benefits

Panax ginseng is one of the most frequently used herbs in the world. Numerous trials have evaluated its clinical benefits. However, the quality of these studies has not been comprehensively and systematically assessed. We reviewed randomized controlled trials (RCTs) of Panax ginseng to evaluate their quality and risk of bias. We searched four English databases, without publication date restriction. Two reviewers extracted details about the studies' methodological quality, guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist and its extension for herbal interventions. Risk of bias was determined using the Cochrane Risk of Bias tool. Of 475 potentially relevant studies, 58 met our inclusion criteria. In these 58 studies, 48.3% of the suggested CONSORT checklist items and 35.9% of the extended herbal items were reported. The quality of RCTs published after the CONSORT checklist improved. Until 1995 (before CONSORT) (n = 4), 32.8% of the items were reported in studies. From 1996–2006 (CONSORT published and revised) (n = 30), 46.1% were reported, and from 2007 (n = 24), 53.5% were reported (p = 0.005). After the CONSORT extension for herbal interventions was published in 2006, RCT quality also improved, although not significantly. Until 2005 (n = 34), 35.2% of the extended herbal items were reported in studies; and from 2006 onwards (n = 24), 37.3% were reported (p = 0.64). Most studies classified risk of bias as "unclear". Overall, the quality of Panax ginseng RCT methodology has improved since the CONSORT checklist was introduced. However, more can be done to improve the methodological quality of, and reporting in, RCTs.

Improved quality of reporting safety data of medication in paediatric randomised controlled trials

2021 ◽  
pp. archdischild-2020-321197
Author(s):  
Taco Jan Prins ◽  
Corine Rollema ◽  
Eric van Roon ◽  
Tjalling de Vries
Keyword(s):  
Adverse Events ◽  
Randomised Controlled Trials ◽  
Safety Data ◽  
Drug Event ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Event Reporting ◽  
The Past ◽  
Randomised Controlled

ObjectiveEvaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017–2018 compared with our earlier study.DesignLiterature search with a systemic appraisal of adverse drug event reporting.Main outcome measuresQuality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient.ResultsWe reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05).ConclusionsReporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

Quality of reporting in randomized controlled trials of therapeutic cardiovascular medical devices

Surgery ◽  
2019 ◽  
Vol 165 (5) ◽  
pp. 965-969 ◽  
Author(s):  
Wenwen Chen ◽  
Jiajie Yu ◽  
Longhao Zhang ◽  
Guanyue Su ◽  
Wen Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Devices ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled
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