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 shares cleaned trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological research studies to evaluate the effect of treatment on trials with different levels of pragmatism, as well as other design features.
Background
Pragmatic trials provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is a word that is often used in contradiction and its definition and evaluation require further clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, rather than to prove the validity of a clinical or physiological hypothesis. A pragmatic study should strive to be as close as is possible to the real-world clinical practice, including recruitment of participants, setting up, implementation and delivery of interventions, determining and analysis results, as well as primary analyses. This is a major distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough confirmation of a hypothesis.
Studies that are truly pragmatic should be careful not to blind patients or healthcare professionals in order to cause bias in the estimation of the effects of treatment. Pragmatic trials should also seek to recruit patients from a wide range of health care settings, to ensure that the results are generalizable to the real world.
Finally the focus of pragmatic trials should be on outcomes that are important to patients, like quality of life or functional recovery. This is particularly important in trials that require invasive procedures or have potentially serious adverse impacts. The CRASH trial29 compared a two-page report with an electronic monitoring system for
프라그마틱 무료 슬롯 무료체험 (
http://153.126.169.73/question2answer/index.php?qa=user&qa_1=oboetie2) patients in hospitals with chronic cardiac failure. The trial with a catheter, however was based on symptomatic catheter-related urinary tract infection as the primary outcome.
In addition to these aspects pragmatic trials should reduce trial procedures and data-collection requirements to cut costs and time commitments. Finally, pragmatic trials should seek to make their findings as relevant to actual clinical practice as possible by ensuring that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).
Despite these guidelines, a number of RCTs with features that defy the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all types. This could lead to misleading claims of pragmaticity and the usage of the term needs to be standardized. The creation of a PRECIS-2 tool that provides an objective, standardized evaluation of the pragmatic characteristics is a good start.
Methods
In a practical trial the goal is to inform policy or clinical decisions by demonstrating how the intervention can be integrated into everyday routine care. This is distinct from explanation trials, which test hypotheses about the causal-effect relationship in idealized settings. Consequently, pragmatic trials may be less reliable than explanatory trials and may be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of information for decision-making within the context of healthcare.
The PRECIS-2 tool measures the degree of pragmatism in an RCT by assessing it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study the domains of recruitment, organisation and flexibility in delivery, flexible adherence and
프라그마틱 무료체험 슬롯버프 무료체험 메타 (
jonpin.Com) follow-up were awarded high scores. However, the principal outcome and the method for missing data was scored below the pragmatic limit. This suggests that it is possible to design a trial with good pragmatic features without harming the quality of the results.
However, it is difficult to assess the degree of pragmatism a trial is, since the pragmatism score is not a binary characteristic; certain aspects of a study can be more pragmatic than others. A trial's pragmatism could be affected by modifications to the protocol or logistics during the trial. In addition 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted prior to approval and a majority of them were single-center. Thus, they are not very close to usual practice and can only be described as pragmatic if their sponsors are tolerant of the lack of blinding in these trials.
A common aspect of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups of the trial sample. This can lead to imbalanced analyses and less statistical power. This increases the possibility of omitting or ignoring differences in the primary outcomes. In the instance of the pragmatic trials that were included in this meta-analysis this was a significant problem because the secondary outcomes weren't adjusted for variations in baseline covariates.
In addition, pragmatic studies can pose difficulties in the collection and interpretation safety data. This is due to the fact that adverse events tend to be self-reported, and therefore are prone to delays, inaccuracies or coding differences. It is essential to improve the accuracy and quality of outcomes in these trials.
Results
Although the definition of pragmatism may not require that all trials be 100% pragmatic, there are benefits to including pragmatic components in clinical trials. These include:
Increased sensitivity to real-world issues which reduces study size and cost and allowing the study results to be faster translated into actual clinical practice (by including patients who are routinely treated). However, pragmatic trials may also have disadvantages. The right amount of heterogeneity, like could allow a study to extend its findings to different patients or settings. However the wrong type of heterogeneity could reduce the sensitivity of an assay and thus decrease the ability of a study to detect minor treatment effects.
Several studies have attempted to classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 developed an approach to distinguish between research studies that prove the clinical or physiological hypothesis as well as pragmatic trials that inform the selection of appropriate therapies in clinical practice. Their framework comprised nine domains, each scored on a scale of 1 to 5 with 1 indicating more explanatory and 5 suggesting more pragmatic. The domains covered recruitment and setting up, the delivery of intervention, flex compliance and primary analysis.
The original PRECIS tool3 was an adapted version of the PRECIS tool3 that was based on the same scale and domains. Koppenaal and colleagues10 developed an adaptation to this assessment called the Pragmascope that was easier to use in systematic reviews. They found that pragmatic reviews scored higher on average in most domains,
프라그마틱 슬롯 무료체험 but scored lower in the primary analysis domain.
The difference in the primary analysis domain could be due to the fact that the majority of pragmatic trials analyze their data in an intention to treat method however some explanation trials do not. The overall score for systematic reviews that were pragmatic was lower when the areas of organization, flexible delivery, and following-up were combined.