“…The limitations of this study are as follows: (1) This study will not assess the risk of bias and reporting quality. Two previous studies reported the risk of bias and reporting quality of included trials with the results of PRECIS-2 assessments 18 19. However, since this study will evaluate the methodological features of trials in terms of pragmatism rather than reporting the clinical effect of interventions or quality of trials, assessing the risk of bias and reporting quality would be non-essential.…”
Section: Discussionmentioning
confidence: 99%
“…(2) Search terms that could mean pragmatic intention are not included in this study. Previously, two studies assessed ‘self-labelled’ or ‘self-declared’ pragmatic trials, and used additional search terms including ‘practical’, ‘comparative effectiveness’ or ‘naturalistic’16 19; however, this study will include trials self-declared as ‘pragmatic’ and other terms will not be included in the search strategy.…”
IntroductionThe pragmatic design has received much attention in the field of acupuncture clinical trials because of insufficient information about the specific effects of acupuncture. However, pragmatism in pragmatic acupuncture trials has not been comprehensively investigated. The PRECIS-2 tool was developed and has been gradually used to design pragmatic trials; therefore, we will apply the PRECIS-2 tool to investigate the pragmatism of pragmatic acupuncture trials in this study.Methods and analysisIn this systematic review, self-declared ‘pragmatic’ randomised clinical trials (RCTs) or protocols of self-declared ‘pragmatic’ RCTs investigating acupuncture will be searched and included to be reviewed. MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov for registered trials will be electronically searched from inception to March 2022. Protocols of published RCTs or secondary analysis of RCTs will be excluded. Additionally, no language restriction will be applied. Two authors will independently extract descriptive information and assess the pragmatism of pragmatic acupuncture trials using nine domains of the PRECIS-2 tool and one additional domain—control. Descriptive statistics will be reported for each domain and the overall score, and a one-sample t-test will be used to statistically analyse whether the score is greater than 3 (equally pragmatic and explanatory). The wheel diagrams of the nine domains of the PRECIS-2 tool will be used to demonstrate the pragmatism of the included studies.Ethics and disseminationEthical approval is not warranted as this study will obtain data from previously reported articles. The results will be disseminated through peer-reviewed journals and conferences.PROSPERO registration numberCRD42021236975.
“…The limitations of this study are as follows: (1) This study will not assess the risk of bias and reporting quality. Two previous studies reported the risk of bias and reporting quality of included trials with the results of PRECIS-2 assessments 18 19. However, since this study will evaluate the methodological features of trials in terms of pragmatism rather than reporting the clinical effect of interventions or quality of trials, assessing the risk of bias and reporting quality would be non-essential.…”
Section: Discussionmentioning
confidence: 99%
“…(2) Search terms that could mean pragmatic intention are not included in this study. Previously, two studies assessed ‘self-labelled’ or ‘self-declared’ pragmatic trials, and used additional search terms including ‘practical’, ‘comparative effectiveness’ or ‘naturalistic’16 19; however, this study will include trials self-declared as ‘pragmatic’ and other terms will not be included in the search strategy.…”
IntroductionThe pragmatic design has received much attention in the field of acupuncture clinical trials because of insufficient information about the specific effects of acupuncture. However, pragmatism in pragmatic acupuncture trials has not been comprehensively investigated. The PRECIS-2 tool was developed and has been gradually used to design pragmatic trials; therefore, we will apply the PRECIS-2 tool to investigate the pragmatism of pragmatic acupuncture trials in this study.Methods and analysisIn this systematic review, self-declared ‘pragmatic’ randomised clinical trials (RCTs) or protocols of self-declared ‘pragmatic’ RCTs investigating acupuncture will be searched and included to be reviewed. MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov for registered trials will be electronically searched from inception to March 2022. Protocols of published RCTs or secondary analysis of RCTs will be excluded. Additionally, no language restriction will be applied. Two authors will independently extract descriptive information and assess the pragmatism of pragmatic acupuncture trials using nine domains of the PRECIS-2 tool and one additional domain—control. Descriptive statistics will be reported for each domain and the overall score, and a one-sample t-test will be used to statistically analyse whether the score is greater than 3 (equally pragmatic and explanatory). The wheel diagrams of the nine domains of the PRECIS-2 tool will be used to demonstrate the pragmatism of the included studies.Ethics and disseminationEthical approval is not warranted as this study will obtain data from previously reported articles. The results will be disseminated through peer-reviewed journals and conferences.PROSPERO registration numberCRD42021236975.
“…Of note, the PRECIS-2 tool was developed to help investigators to match their design choices to their intended degree of pragmatism before conducting the trial. Whether the PRECIS-2 is a reliable tool to retrospectively rate the pragmatism of study designs is unknown, although such analysis has been performed 10 , 11 . Fig.…”
Section: The Explanatory–pragmatic Continuummentioning
The majority of cardiovascular randomized controlled trials (RCTs) test interventions in selected patient populations under explicitly protocol-defined settings. Although these ‘explanatory’ trial designs optimize conditions to test the efficacy and safety of an intervention, they limit the generalizability of trial findings in broader clinical settings. The concept of ‘pragmatism’ in RCTs addresses this concern by providing counterbalance to the more idealized situation underpinning explanatory RCTs and optimizing effectiveness over efficacy. The central tenets of pragmatism in RCTs are to test interventions in routine clinical settings, with patients who are representative of broad clinical practice, and to reduce the burden on investigators and participants by minimizing the number of trial visits and the intensity of trial-based testing. Pragmatic evaluation of interventions is particularly important in cardiovascular diseases, where the risk of death among patients has remained fairly stable over the past few decades despite the development of new therapeutic interventions. Pragmatic RCTs can help to reveal the ‘real-world’ effectiveness of therapeutic interventions and elucidate barriers to their implementation. In this Review, we discuss the attributes of pragmatism in RCT design, conduct and interpretation as well as the general need for increased pragmatism in cardiovascular RCTs. We also summarize current challenges and potential solutions to the implementation of pragmatism in RCTs and highlight selected ongoing and completed cardiovascular RCTs with pragmatic trial designs.
“…2 Pragmatic RCT may provide a more realworld picture of comparative effectiveness due to more liberal inclusion criteria but also have short follow-up time, at least under full randomisation. 3 While comparative effectiveness should be assessed also in observational studies and registers, the interpretation of the results is hampered by the limitations of observational studies, 4 and in particular two potential limitations. The first limitation is related to confounding.…”
Section: Introductionmentioning
confidence: 99%
“…However, clinical trials have restrictive inclusion criteria and usually short follow-up, and thus do not provide a full picture of clinical responses for the broader patient population seen in clinical practice, especially for chronic diseases 2. Pragmatic RCT may provide a more real-world picture of comparative effectiveness due to more liberal inclusion criteria but also have short follow-up time, at least under full randomisation 3…”
BackgroundComparing treatment effectiveness over time in observational settings is hampered by several major threats, among them confounding and attrition bias.ObjectivesTo develop European Alliance of Associations for Rheumatology (EULAR) points to consider (PtC) when analysing and reporting comparative effectiveness research using observational data in rheumatology.MethodsThe PtC were developed using a three-step process according to the EULAR Standard Operating Procedures. Based on a systematic review of methods currently used in comparative effectiveness studies, the PtC were formulated through two in-person meetings of a multidisciplinary task force and a two-round online Delphi, using expert opinion and a simulation study. Finally, feedback from a larger audience was used to refine the PtC. Mean levels of agreement among the task force were calculated.ResultsThree overarching principles and 10 PtC were formulated, addressing, in particular, potential biases relating to attrition or confounding by indication. Building on Strengthening the Reporting of Observational Studies in Epidemiology guidelines, these PtC insist on the definition of the baseline for analysis and treatment effectiveness. They also focus on the reasons for stopping treatment as an important consideration when assessing effectiveness. Finally, the PtC recommend providing key information on missingness patterns.ConclusionTo improve the reliability of an increasing number of real-world comparative effectiveness studies in rheumatology, special attention is required to reduce potential biases. Adherence to clear recommendations for the analysis and reporting of observational comparative effectiveness studies will improve the trustworthiness of their results.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
