Pragmatic Free Trial Meta
Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes clean trial data, ratings, and evaluations using PRECIS-2. This allows for a variety of meta-epidemiological analyses to examine the effect of treatment across trials of various levels of pragmatism.
Background
Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision making. However, the usage of the term "pragmatic" is not consistent and its definition and evaluation requires clarification. Pragmatic trials are intended to inform clinical practices and policy decisions, not to prove a physiological or clinical hypothesis. A pragmatic study should try to be as similar to the real-world clinical environment as is possible, including its selection of participants, setting up and design, the delivery and execution of the intervention, and the determination and analysis of outcomes as well as primary analyses. This is a significant difference from explanatory trials (as described by Schwartz and Lellouch1) which are intended to provide a more thorough proof of the hypothesis.
Studies that are truly practical should not attempt to blind participants or healthcare professionals in order to result in bias in estimates of treatment effects. The trials that are pragmatic should also try to enroll patients from a variety of health care settings to ensure that the results are generalizable to the real world.
Finally, pragmatic trials must be focused on outcomes that matter to patients, such as the quality of life and functional recovery. This is particularly relevant when trials involve the use of invasive procedures or could have dangerous adverse consequences. The CRASH trial29 compared a two-page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The catheter trial28, however, used symptomatic catheter associated urinary tract infection as the primary outcome.
In addition to these aspects the pragmatic trial should also reduce the trial's procedures and data collection requirements in order to reduce costs. Additionally the aim of pragmatic trials is to make their findings as relevant to actual clinical practices as they can. This can be achieved by ensuring that their analysis is based on an intention-to treat approach (as described in CONSORT extensions).
Despite these criteria, a number of RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all kinds. This can result in misleading claims of pragmatism, and the use of the term needs to be standardized. The creation of a PRECIS-2 tool that can provide an objective and
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Methods
In a pragmatic trial the goal is to inform policy or clinical decisions by showing how an intervention could be implemented into routine care. This differs from explanation trials that test hypotheses about the cause-effect relationship in idealised situations. Therefore, pragmatic trials might be less reliable than explanatory trials and might be more susceptible to bias in their design, conduct, and analysis. Despite their limitations, pragmatic studies can provide valuable data for making decisions within the healthcare context.
The PRECIS-2 tool scores an RCT on 9 domains, ranging between 1 and 5 (very pragmatic). In this study, the recruitment, organization, flexibility in delivery and follow-up domains were awarded high scores, but the primary outcome and the method of missing data were not at the practical limit. This suggests that it is possible to design a trial using high-quality pragmatic features, without damaging the quality of its results.
It is difficult to determine the degree of pragmatism that is present in a trial because pragmatism does not have a single attribute. Certain aspects of a study can be more pragmatic than others. The pragmatism of a trial can be affected by changes to the protocol or logistics during the trial. Koppenaal and colleagues discovered that 36% of the 89 pragmatic studies were placebo-controlled or conducted prior to licensing. They also found that the majority were single-center. They are not close to the standard practice and are only called pragmatic if the sponsors agree that the trials aren't blinded.
Additionally, a typical feature of pragmatic trials is that the researchers try to make their results more meaningful by analysing subgroups of the trial sample. This can lead to unbalanced comparisons and lower statistical power, thereby increasing the chance of not or incorrectly detecting differences in the primary outcome. This was the case in the meta-analysis of pragmatic trials because secondary outcomes were not corrected for differences in covariates at baseline.
In addition the pragmatic trials may present challenges in the collection and interpretation of safety data. It is because adverse events are usually self-reported, and therefore are prone to delays, errors or coding differences. It is crucial to improve the accuracy and quality of outcomes in these trials.
Results
While the definition of pragmatism may not require that all clinical trials are 100% pragmatic, there are benefits when incorporating pragmatic components into trials. These include:
Increasing sensitivity to real-world issues which reduces study size and cost as well as allowing trial results to be faster translated into actual clinical practice (by including patients from routine care). But pragmatic trials can have disadvantages. The right amount of heterogeneity, for example, can help a study extend its findings to different patients or settings. However, the wrong type can reduce the sensitivity of an assay and thus decrease the ability of a study to detect even minor effects of treatment.
Numerous studies have attempted to classify pragmatic trials with various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that support a physiological hypothesis or clinical hypothesis, and pragmatic studies that inform the selection of appropriate therapies in the real-world clinical practice. Their framework included nine domains that were scored on a scale ranging from 1 to 5, with 1 indicating more explanatory and 5 suggesting more pragmatic. The domains included recruitment and setting up, the delivery of intervention, flexible adherence and primary analysis.
The initial PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et. al10 devised an adaptation of this assessment, called the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic reviews scored higher across all domains, however they scored lower in the primary analysis domain.
This distinction in the primary analysis domain could be explained by the fact that the majority of pragmatic trials analyze their data in an intention to treat manner however some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on the organization, flexibility of delivery and follow-up were merged.
It is important to remember that a pragmatic trial does not necessarily mean a poor
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please click the next internet page) quality trial, and indeed there is an increasing rate of clinical trials (as defined by MEDLINE search, but it is neither specific nor sensitive) that employ the term "pragmatic" in their abstract or title.