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Consensus on the Definition and Assessment of External Validity of Randomized Controlled Trials: A Delphi Study
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Andres Jung; Tobias Braun; Susan Armijo-Olivo; Dimitris Challoumas; Kerstin Luedtke – Research Synthesis Methods, 2024
External validity is an important parameter that needs to be considered for decision making in health research, but no widely accepted measurement tool for the assessment of external validity of randomized controlled trials (RCTs) exists. One of the most limiting factors for creating such a tool is probably the substantial heterogeneity and lack…
Descriptors: Randomized Controlled Trials, Validity, Delphi Technique, Definitions
Frequency of Use and Adequacy of Cochrane Risk of Bias Tool 2 in Non-Cochrane Systematic Reviews Published in 2020: Meta-Research Study
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Andrija Babic; Ognjen Barcot; Tomislav Viskovic; Frano Šaric; Aleksandar Kirkovski; Ivana Barun; Zvonimir Križanac; Roshan Arjun Ananda; Yuli Viviana Fuentes Barreiro; Narges Malih; Daiana Anne-Marie Dimcea; Josipa Ordulj; Ishanka Weerasekara; Matteo Spezia; Marija Franka Žuljevic; Jelena Šuto; Luca Tancredi; Andela Pijuk; Susanna Sammali; Veronica Iascone; Thilo Groote; Tina Poklepovic Pericic; Livia Puljak – Research Synthesis Methods, 2024
Risk of bias (RoB) assessment is essential to the systematic review methodology. The new version of the Cochrane RoB tool for randomized trials (RoB 2) was published in 2019 to address limitations identified since the first version of the tool was published in 2008 and to increase the reliability of assessments. This study analyzed the frequency…
Descriptors: Risk, Bias, Use Studies, Meta Analysis
Data Extraction for Evidence Synthesis Using a Large Language Model: A Proof-of-Concept Study
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Gerald Gartlehner; Leila Kahwati; Rainer Hilscher; Ian Thomas; Shannon Kugley; Karen Crotty; Meera Viswanathan; Barbara Nussbaumer-Streit; Graham Booth; Nathaniel Erskine; Amanda Konet; Robert Chew – Research Synthesis Methods, 2024
Data extraction is a crucial, yet labor-intensive and error-prone part of evidence synthesis. To date, efforts to harness machine learning for enhancing efficiency of the data extraction process have fallen short of achieving sufficient accuracy and usability. With the release of large language models (LLMs), new possibilities have emerged to…
Descriptors: Data Collection, Evidence, Synthesis, Language Processing
Accuracy and Precision of Fixed and Random Effects in Meta-Analyses of Randomized Control Trials for Continuous Outcomes
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Timo Gnambs; Ulrich Schroeders – Research Synthesis Methods, 2024
Meta-analyses of treatment effects in randomized control trials are often faced with the problem of missing information required to calculate effect sizes and their sampling variances. Particularly, correlations between pre- and posttest scores are frequently not available. As an ad-hoc solution, researchers impute a constant value for the missing…
Descriptors: Accuracy, Meta Analysis, Randomized Controlled Trials, Effect Size
Development of the Individual Participant Data Integrity Tool for Assessing the Integrity of Randomised Trials Using Individual Participant Data
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Kylie E. Hunter; Mason Aberoumand; Sol Libesman; James X. Sotiropoulos; Jonathan G. Williams; Wentao Li; Jannik Aagerup; Ben W. Mol; Rui Wang; Angie Barba; Nipun Shrestha; Angela C. Webster; Anna Lene Seidler – Research Synthesis Methods, 2024
Increasing integrity concerns in medical research have prompted the development of tools to detect untrustworthy studies. Existing tools primarily assess published aggregate data (AD), though scrutiny of individual participant data (IPD) is often required to detect trustworthiness issues. Thus, we developed the IPD Integrity Tool for detecting…
Descriptors: Integrity, Randomized Controlled Trials, Data Use, Individual Characteristics
A Search of Only Four Key Databases Would Identify Most Randomized Controlled Trials of Acupuncture: A Meta-Epidemiological Study
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Guo, Qiong; Cheng, Yifan; Zhang, Chenyang; Yang, Huifang; Chen, Xia; Wang, Xinyi; Yang, Liu; Feng, Kun; Long, Youlin; Shao, Zilun; Wang, Yutian; Lin, Yifei; Liao, Ga; Huang, Jin; Du, Liang – Research Synthesis Methods, 2022
Little research has been conducted to assess which specific databases should be searched when performing a systematic review (SR) on acupuncture. The current study aimed to identify key databases and the optimal database combination to retrieve randomized controlled trials (RCTs) on acupuncture for inclusion in SRs. A systematic search for SRs in…
Descriptors: Databases, Randomized Controlled Trials, Medical Services, Literature Reviews
Identifying and Managing Problematic Trials: A Research Integrity Assessment Tool for Randomized Controlled Trials in Evidence Synthesis
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Weibel, Stephanie; Popp, Maria; Reis, Stefanie; Skoetz, Nicole; Garner, Paul; Sydenham, Emma – Research Synthesis Methods, 2023
Evidence synthesis findings depend on the assumption that the included studies follow good clinical practice and results are not fabricated or false. Studies which are problematic due to scientific misconduct, poor research practice, or honest error may distort evidence synthesis findings. Authors of evidence synthesis need transparent mechanisms…
Descriptors: Identification, Randomized Controlled Trials, Integrity, Evaluation Methods
Commercial Funding and Estimated Intervention Effects in Randomized Clinical Trials: Systematic Review of Meta-Epidemiological Studies
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Nejstgaard, Camilla Hansen; Laursen, David Ruben Teindl; Lundh, Andreas; Hróbjartsson, Asbjørn – Research Synthesis Methods, 2023
We investigated to which degree commercial funding is associated with estimated intervention effects in randomized trials. We included meta-epidemiological studies with published data on the association between commercial funding and results or conclusions of randomized trials. We searched five databases and other sources. We selected one result…
Descriptors: Private Financial Support, Intervention, Randomized Controlled Trials, Literature Reviews
Comparison of Statistical Methods for Integrating Real-World Evidence in a Rare Events Meta-Analysis of Randomized Controlled Trials
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Yao, Minghong; Wang, Yuning; Ren, Yan; Jia, Yulong; Zou, Kang; Li, Ling; Sun, Xin – Research Synthesis Methods, 2023
Rare events meta-analyses of randomized controlled trials (RCTs) are often underpowered because the outcomes are infrequent. Real-world evidence (RWE) from non-randomized studies may provide valuable complementary evidence about the effects of rare events, and there is growing interest in including such evidence in the decision-making process.…
Descriptors: Evidence, Meta Analysis, Randomized Controlled Trials, Decision Making
Combining Endpoint and Change Data Did Not Affect the Summary Standardised Mean Difference in Pairwise and Network Meta-Analyses: An Empirical Study in Depression
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Edoardo G. Ostinelli; Orestis Efthimiou; Yan Luo; Clara Miguel; Eirini Karyotaki; Pim Cuijpers; Toshi A. Furukawa; Georgia Salanti; Andrea Cipriani – Research Synthesis Methods, 2024
When studies use different scales to measure continuous outcomes, standardised mean differences (SMD) are required to meta-analyse the data. However, outcomes are often reported as endpoint or change from baseline scores. Combining corresponding SMDs can be problematic and available guidance advises against this practice. We aimed to examine the…
Descriptors: Network Analysis, Meta Analysis, Depression (Psychology), Regression (Statistics)
From Registration to Publication: A Study on Dutch Academic Randomized Controlled Trials
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Huiskens, Joost; Kool, Boudewijn R. J.; Bakker, Jean-Michel; Bruns, Emma R. J.; de Jonge, Stijn W.; Olthof, Pim B.; van Rosmalen, Belle V.; van Gulik, Thomas M.; Hooft, Lotty; Punt, Cornelis J. A. – Research Synthesis Methods, 2020
Introduction: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch…
Descriptors: Randomized Controlled Trials, Databases, Foreign Countries, Medical Research
A Comparison of Methods for Enriching Network Meta-Analyses in the Absence of Individual Patient Data
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Proctor, Tanja; Zimmermann, Samuel; Seide, Svenja; Kieser, Meinhard – Research Synthesis Methods, 2022
During drug development, a biomarker is sometimes identified as separating a patient population into those with more and those with less benefit from evaluated treatments. Consequently, later studies might be targeted, while earlier ones are performed in mixed patient populations. This poses a challenge in evidence synthesis, especially if only…
Descriptors: Comparative Analysis, Meta Analysis, Patients, Medical Research
Reverse-Bayes Methods for Evidence Assessment and Research Synthesis
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Held, Leonhard; Matthews, Robert; Ott, Manuela; Pawel, Samuel – Research Synthesis Methods, 2022
It is now widely accepted that the standard inferential toolkit used by the scientific research community--null-hypothesis significance testing (NHST)--is not fit for purpose. Yet despite the threat posed to the scientific enterprise, there is no agreement concerning alternative approaches for evidence assessment. This lack of consensus reflects…
Descriptors: Bayesian Statistics, Statistical Inference, Hypothesis Testing, Credibility
Multivariate Network Meta-Analysis of Survival Function Parameters
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Cope, Shannon; Chan, Keith; Jansen, Jeroen P. – Research Synthesis Methods, 2020
Background: Network meta-analysis (NMA) of survival data with a multidimensional treatment effect has been introduced as an alternative to NMA based on the proportional hazards assumption. However, these flexible models have some limitations, such as the use of an approximate likelihood based on discrete hazards, rather than a likelihood for…
Descriptors: Multivariate Analysis, Meta Analysis, Network Analysis, Models
Statistical Approaches to Adjusting Weights for Dependent Arms in Network Meta-Analysis
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Su, Yu-Xuan; Tu, Yu-Kang – Research Synthesis Methods, 2018
Network meta-analysis compares multiple treatments in terms of their efficacy and harm by including evidence from randomized controlled trials. Most clinical trials use parallel design, where patients are randomly allocated to different treatments and receive only 1 treatment. However, some trials use within person designs such as split-body,…
Descriptors: Network Analysis, Meta Analysis, Randomized Controlled Trials, Research Design
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