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Building the Story of Scientific Evidence for Digital Therapeutics: Trials, Meta-Analysis, and Real-World Data
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Derek Richards, Angel Enrique, Jorge Palacios, Nora Eilert
Moving beyond the individual trial as described above are studies based on the pooling or synthesis of research findings across multiple studies, so-called systematic reviews. Systematic reviews aim to identify all studies pertaining to a specific topic or answer a particular research question by systematically searching published and sometimes unpublished literature. The studies are then selected based on pre-defined eligibility criteria that have to be explicit and reproducible, and then the outcomes of these studies are synthesized systematically. Having identified all studies meeting pre-defined criteria, statistical methods are then used to combine results across those studies. These methods are commonly referred to as meta-analysis (Cuijpers, 2016). Thus, meta-analyses are a specific type of systematic review, but they also integrate the findings of the included studies to estimate the magnitude of the effects. Meta-analyses may either be based on aggregate data (i.e., data provided as mean scores at a study-level for each study) or on individual participant data (i.e., individual data points for each participant within each included study), with the latter being termed Individual Participant Data Meta-Analysis (IPD-MA) (Debray et al., 2015).
Publication Bias in Meta-Analysis
Published in Ding-Geng (Din) Chen, Karl E. Peace, Applied Meta-Analysis with R and Stata, 2021
In planning a systematic review, it is customary for researchers to develop inclusion criteria to guide the types of studies that are included. In perfect hypothetical situations, researchers may be able to locate all reviews that meet their criteria. However, in reality, this is not always possible. Moreover, not including some studies may result in loss of information when the missing studies are a random subset of all relevant studies. This loss of data may impact inferential results, including wider confidence intervals, and less powerful tests, but should have no systematic impact on the effect size. However, if the missing studies are not missing at random, or are otherwise preferentially not included, then the sample of chosen studies will be biased. In the literature, the concern is that studies with a relatively large or statistically significant effect size for a specific question are more likely to be published than studies with smaller or negative effect sizes. This bias in the published literature will be carried over to a meta-analysis using that literature.
Critical appraisal of systematic reviews
Published in O. Ajetunmobi, Making Sense of Critical Appraisal, 2021
A systematic review is a scientific evaluation of several studies that have been conducted on a specific clinical question. By pooling together the results from several studies, the evidence drawn from systematic reviews can be very powerful and influential indeed. Unsurprisingly therefore, systematic reviews are regarded as a gold standard source of research evidence, even more so than individual randomized clinical trials.
Lutetium-177 PSMA for the treatment of metastatic castrate resistant prostate cancer: a systematic review
Published in Expert Review of Anticancer Therapy, 2023
Kanchi Patell, Matthew Kurian, Jorge A. Garcia, Prateek Mendiratta, Pedro C. Barata, Angela Y. Jia, Daniel E. Spratt, Jason R. Brown
This systematic review yielded a total of 10,418 articles. Of these, 8772 were duplicates and were removed, resulting in 1646 articles. After screening for exclusions, 100 records remained and were reviewed for our study, of which 40 were unique retrospective or prospective studies (Figure 1). Our review includes 16 retrospective studies, 3 real-world studies, 9 phase I/II trials, and 1 phase III clinical trial as well as 11 clinical trials that are currently enrolling. Per the ROBIS tool, a low risk of bias for all domains was evident. This means that our systematic review followed a clear and well-defined protocol, searched for relevant studies in a comprehensive and unbiased manner, assessed the quality of included studies appropriately, and synthesized the findings in a transparent and objective way.
Lateral Violence and Microaggressions in the LGBTQ+ Community: A Scoping Review
Published in Journal of Homosexuality, 2023
Duy Tran, Corrinne T Sullivan, Lucy Nicholas
Having established the lack of literature using the concept of lateral violence in discussing the LGBTQ+ community, a scoping review was carried out to identify the extant literature on the use of ingroup microaggressions. Scoping reviews are a category of literature review which, as the name implies, focuses on assessing the extent of existing and relevant literature on topics of interest (Colquhoun et al., 2014). In doing so, scoping reviews also highlight what gaps exist within current research on the topic (Arksey & O’Malley, 2005). There are a few key differences between a systematic review and a scoping review. Generally, a systematic review is designed with a specific question in mind, and thus aims to find a small number of quality-assessed studies that can be synthesized to answer the said question (Arksey & O’Malley, 2005). On the other hand, a scoping review typically concerns itself with more general areas of interest, and consequently is less concerned with answering specific questions or evaluating the quality of studies when looking for literature (Arksey & O’Malley, 2005). While a scoping review can be completed in a relatively short amount of time compared to a systematic review, it is in no way a “quick” or “easy” option (Arksey & O’Malley, 2005). Conducting a scoping review requires a high level of academic rigor, analytic skills, and transparency to ensure its quality and reliability (Munn et al., 2018).
International expert group collaboration for developing an adverse outcome pathway for radiation induced leukemia
Published in International Journal of Radiation Biology, 2022
Dmitry Klokov, Kimberly Applegate, Christophe Badie, Dag Anders Brede, Fieke Dekkers, Melis Karabulutoglu, Yevgeniya Le, Eric Andreas Rutten, Katalin Lumniczky, Maria Gomolka
Although a hypothetical draft AOP to IR-induced leukemia has been generated, using the existing expertise and skills of the members of the leukemia working group, as well as a preliminary narrative literature screen, further work must focus on generation of weight of evidence for each of the KEs and their KERs. It is not uncommon that this subsequent review and literature analysis is done in a narrative manner. Alternatively, a systematic review offers a number of advantages. The most obvious is the avoidance of reviewer bias by following a defined protocol with a question/hypothesis statement and a set of inclusion and exclusion criteria that are based on the question being addressed. Additionally, the workflow is transparent and reproducible, and results in a data extraction stage. Lastly, the systematic review is often capable of identifying studies that are suitable for meta-analysis, thus making quantitative evaluations possible. The systematic review approach has been increasingly used for reviews in biomedical literature, and many of its benefits are immediately applicable to the literature review for development of AOPs. It is not surprising then that the research community involved in the advancing the area of radiation AOPs turned their attention to systematic review of literature as a valuable approach in the development of AOPs (Kozbenko et al. 2022).