Dataset Information

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

ABSTRACT:

Background

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail.

Methodology/principal findings

We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028).

Conclusions/significance

The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

SUBMITTER: Thomson D

PROVIDER: S-EPMC2948021 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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Publications

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

Thomson Denise D Hartling Lisa L Cohen Eyal E Vandermeer Ben B Tjosvold Lisa L Klassen Terry P TP

PloS one 20100930 9

<h4>Background</h4>The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail.<h4>Methodology/principal findings</h4>We extracted descriptive data on ...[more]

PMID: 20927344

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Project description:BackgroundNine out of ten deaths from malaria occur in sub-Saharan Africa. Various control measures have achieved some progress in the control of the disease, but malaria is still a major public health problem in Africa. Randomized controlled trials (RCTs) are universally considered the best study type to rigorously assess whether an intervention is effective. The study reported here provides a descriptive analysis of RCTs reporting interventions for the prevention and treatment of malaria conducted in Africa, with the aim of providing detailed information on their main clinical and methodological characteristics, that could be used by researchers and policy makers to help plan future research.MethodsSystematic searches for malaria RCTs were conducted using electronic databases (Medline, Embase, the Cochrane Library), and an African geographic search filter to identify RCTs conducted in Africa was applied. Results were exported to the statistical package STATA 8 to obtain a random sample from the overall data set. Final analysis of trial characteristics was done in a double blinded fashion by two authors using a standardized data extraction form.ResultsA random sample of 92 confirmed RCTs (from a total of 943 reports obtained between 1948 and 2007) was prepared. Most trials investigated drug treatment in children with uncomplicated malaria. Few trials reported on treatment of severe malaria or on interventions in pregnant women. Most trials were of medium size (100-500 participants), individually randomized and based in a single centre. Reporting of trial quality was variable. Although three-quarter of trials provided information on participants' informed consent and ethics approval, more details are needed.ConclusionsThe majority of malaria RCT conducted in Africa report on drug treatment and prevention in children; there is need for more research done in pregnant women. Sources of funding, informed consent and trial quality were often poorly reported. Overall, clearer reporting of trials is needed.

Project description:BACKGROUND:Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published. Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging meta-analyses. We explored selection criteria used in trials of treatments for nsLBP. METHODS:A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, using a mixed-methods approach to analysis. Study inclusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category. RESULTS:We included 168 studies. Two inclusion themes (anatomical area, and symptoms and signs) were identified. Anatomical area was most reported as between costal margins and gluteal folds (n =?8, 5%), while low back pain (n =?150, 89%) with or without referred leg pain (n =?27, 16%) was the most reported symptom. Exclusion criteria comprised 21 themes. Previous or scheduled surgery (n =?84, 50%), pregnancy (n =?81, 48%), malignancy (n =?78, 46%), trauma (n =?63, 37%) and psychological conditions (n =?58, 34%) were the most common. Sub-themes of exclusion criteria mostly related to neurological signs and symptoms: nerve root compromise (n =?44, 26%), neurological signs (n =?34, 20%) or disc herniation (n =?30, 18%). Specific conditions that were most often exclusion criteria were spondylolisthesis (n =?35, 21%), spinal stenosis (n =?31, 18%) or osteoporosis (n =?27, 16%). CONCLUSION:RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria. Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses. We propose a template for reporting inclusion and exclusion criteria.

Project description:OBJECTIVES:To analyse the completeness of reporting of blinding in randomised controlled trials (RCTs) of interventions in anaesthesiology, the actual blinding status of various persons associated with an RCT and trial authors' interpretation of blinding terminology related to RCTs. METHODS:This was a methodological study and a cross-sectional survey. We analysed reporting related to blinding in published RCTs of interventions published in seven highly cited anaesthesiology journals from 2014 to 2016 and registered protocols in ClinicalTrials.gov. We surveyed corresponding authors of included RCTs about their definitions of blinding. The primary outcome was the number of RCTs that explicitly described who was blinded in a trial. Secondary outcomes were definitions of blinding terminology in the trials; trial authors' interpretation of blinding terminology; discrepancies in the blinding description within registered protocols and between registered protocols and publications. RESULTS:Out of 622 analysed RCTs, 38% were not explicitly described as either open label or blinded studies and 10% did not report any information about blinding or lack of blinding. Only one manuscript fully reported the status of blinding for various individuals that may be involved with a trial. The most common descriptor was that a trial was double-blind. We found discrepant information regarding blinding in the majority of registered protocols. Even when there were no discrepancies in the registration, we found discrepancies in the reporting of blinding between the majority of registered protocols and published manuscripts. The survey of authors (40 responses from 231 eligible authors; 17% response rate) of analysed RCTs showed that they differed in how they defined different levels of blinding in trials. CONCLUSIONS:Reporting of the blinding status of key individuals involved in analysed anaesthesiology RCTs was insufficient. For reporting guidelines, peer reviewers and editors should insist on clear information on who was blinded in a trial instead of using the term 'double-blind' for different blinding practices.

Project description:BackgroundMost researchers in Uzbekistan prefer to publish their reports in journals of their home country. Moreover, the proportion of healthcare practitioners who prefer to use these national sources of information also remains high. However, the quality of publications from national journals, in post-Soviet countries, has not been systematically evaluated until now. The primary objective of this study was to evaluate the quality of randomized controlled trials' (RCTs) reports published in medical journals from Uzbekistan. We supposed that reports had at least minimal quality to contribute to the higher quality of healthcare.MethodsTo evaluate the quality of RCTs, we selected two journals from the list of national medical journals for which background information was provided. We decided to select articles from journals that had the highest subscription rate and were likely to have the highest impact on clinical decisions. The journals were Medical Journal of Uzbekistan and Paediatrics. Only issues published in 2007-2017 were considered for evaluation. Two evaluators independently scored RCTs and controlled clinical trials (CCTs) reported in the journals. The 5-point scale developed by Jadad et al. was used to evaluate the quality of reports. Consensus-based decision was made about the final score of each report.ResultsWe reviewed 1311 studies in the two journals and found 380 clinical trials reports for the final evaluation. Our main finding was that none of the reports received a final score of more than 1, with an absolute agreement between evaluators. A median score of the studied reports was equal to 0, predicting a very low quality of controlled trials reported in the national journals (Wilcoxon signed-rank test p = 1.0; 95% CI = 0-0).ConclusionsWe believe that quality of reports about controlled trials, in Uzbekistan, can be considered insufficient to contribute to the higher quality of care and patients' safety. In the worst case, such condition can cause serious damage to the public health and lead to ineffective use of resources in the country. Therefore, the better reporting and organization of RCTs and CCTs should become a main goal of all stakeholders interested in the effective and safe healthcare in the country.

Project description:Many randomized controlled trials (RCTs) are biased and difficult to reproduce due to methodological flaws and poor reporting. There is increasing attention for responsible research practices and implementation of reporting guidelines, but whether these efforts have improved the methodological quality of RCTs (e.g., lower risk of bias) is unknown. We, therefore, mapped risk-of-bias trends over time in RCT publications in relation to journal and author characteristics. Meta-information of 176,620 RCTs published between 1966 and 2018 was extracted. The risk-of-bias probability (random sequence generation, allocation concealment, blinding of patients/personnel, and blinding of outcome assessment) was assessed using a risk-of-bias machine learning tool. This tool was simultaneously validated using 63,327 human risk-of-bias assessments obtained from 17,394 RCTs evaluated in the Cochrane Database of Systematic Reviews (CDSR). Moreover, RCT registration and CONSORT Statement reporting were assessed using automated searches. Publication characteristics included the number of authors, journal impact factor (JIF), and medical discipline. The annual number of published RCTs substantially increased over 4 decades, accompanied by increases in authors (5.2 to 7.8) and institutions (2.9 to 4.8). The risk of bias remained present in most RCTs but decreased over time for allocation concealment (63% to 51%), random sequence generation (57% to 36%), and blinding of outcome assessment (58% to 52%). Trial registration (37% to 47%) and the use of the CONSORT Statement (1% to 20%) also rapidly increased. In journals with a higher impact factor (>10), the risk of bias was consistently lower with higher levels of RCT registration and the use of the CONSORT Statement. Automated risk-of-bias predictions had accuracies above 70% for allocation concealment (70.7%), random sequence generation (72.1%), and blinding of patients/personnel (79.8%), but not for blinding of outcome assessment (62.7%). In conclusion, the likelihood of bias in RCTs has generally decreased over the last decades. This optimistic trend may be driven by increased knowledge augmented by mandatory trial registration and more stringent reporting guidelines and journal requirements. Nevertheless, relatively high probabilities of bias remain, particularly in journals with lower impact factors. This emphasizes that further improvement of RCT registration, conduct, and reporting is still urgently needed.

Project description:BackgroundThere is an unresolved debate about the reliability of the interpretation of P value. Some investigators have suggested that an alternative Bayesian method is preferred in conducting health research. As randomized-controlled trials (RCTs) are important in generating research evidence, we decided to investigate the extent, if any, the inferential statistical framework in published RCTs in child health research have changed over 10 years. We aim to examine the change in P value and Bayesian analysis in RCTs in child health research papers published from 2007 to 2017.MethodsWe will search the Cochrane Central Register of Controlled Trials (Wiley) to identify relevant citations. We will leverage a pre-existing sample of child health RCTs published in 2007 (n=300) used in our previous study of reporting quality of pediatric RCTs. Using the same strategy and study selection methods, we will identify a comparable random sample of child health RCTs published in 2017 (n=300). Eligible studies will include RCTs in health research among individuals aged 21 years and below. One reviewer will select studies for inclusion and extract the data and another reviewer will verify these. Disagreements will be resolved by a discussion between reviewers or by involving another reviewer. We will perform a descriptive analysis of 2007 and 2017 samples and analyze the results using both the frequentist and Bayesian methods. We will present specific characteristics of the clinical trials from 2007 and 2017 in tabular and graphical forms. We will report the difference in the proportion of P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. Clustering around P values of significance, if observed, will be reported.DiscussionThis review will present the difference in the proportion of trials that reported on P value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. The implications for future clinical research will be discussed and this research work will be published in a peer-reviewed journal. This review has the potential to help inform the need for a change in the methodological approach from the null hypothesis significance test to Bayesian methods.Systematic review registrationOpen Science Framework https://osf.io/aj2df.

Project description:ObjectivesDue to the rapid spread of COVID-19 worldwide, many countries have designed clinical trials to find efficient treatments. We aimed to critically report the characteristics of all the registered and published randomized clinical trials (RCTs) conducted on COVID-19, and summarize the evaluation of potential therapies developed in various regions.Evidence acquisitionWe comprehensively searched PubMed, Cochrane Library, Web of Science, Scopus, and Clinicaltrial.gov databases to retrieve all the relevant studies up to July 19, 2021, in conformity with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart. We included all English-language published/registered RCTs on COVID-19, and excluded non-RCT, in-vitro/in-vivo, editorials, and review studies. Two reviewers independently evaluated all the records, and then analyzed by using SPSS 17.ResultsWithin 3018 included studies, 2801 (92.8%) and 217 (7.2%) were registered or published RCTs consisting of about 600 synthetic drugs. Herbal medicines have been studied in 23 trials (10.6%) among the published RCTs and in 357 registered RCTs (12.7%). Hydroxychloroquine 23 (10.6%) and convalescent plasma 194 (6.9%) alone or in combination with other agents were the most frequently used interventions in published and registered RCTs, respectively. Most published RCTs have been conducted in Western Pacific Region (WPRO) (50 trials, 23.0%) including 45 trials from China. Also, a greater proportion of registered RCTs have been conducted in the Region of the Americas (PAHO) (885 trials, 31.6%) including 596 RCTs from the United States (U.S). Globally, 283 registered trials have been conducted to assess new developed vaccines for COVID or previously established for other disorders.ConclusionThe present study highlighted the wide range of potential therapeutic agents in published and registered COVID-19 clinical trials across a wide range of regions. However, it is urgently required to global coordination in order to conduct more well-designed trials and progress in discovering safe and effective treatments.

Dataset Information

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

Background

Methodology/principal findings

Conclusions/significance

Publications

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

Similar Datasets

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