Pragmatic Free Trial Meta
Pragmatic Free Trial Meta is a non-commercial, open data platform and infrastructure that supports research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2 allowing for multiple and diverse meta-epidemiological studies that examine the effects of treatment across trials with different levels of pragmatism and other design features.
Background
Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision making. The term "pragmatic",
프라그마틱 홈페이지 however, is used inconsistently and its definition and evaluation require further clarification. The purpose of pragmatic trials is to guide clinical practices and policy choices, rather than prove a physiological or clinical hypothesis. A pragmatic trial should try to be as close as possible to actual clinical practices that include recruitment of participants, setting, design, implementation and delivery of interventions, determining and analysis outcomes, and primary analyses. This is a major distinction between explanatory trials, as defined by Schwartz & Lellouch1 that are designed to test a hypothesis in a more thorough manner.
Trials that are truly practical should be careful not to blind patients or the clinicians as this could lead to distortions in estimates of the effect of treatment. Practical trials should also aim to enroll patients from a wide range of health care settings, to ensure that their findings can be applied to the real world.
Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like the quality of life and functional recovery. This is especially important when trials involve surgical procedures that are invasive or may have serious adverse impacts. The CRASH trial29, for example was focused on functional outcomes to evaluate a two-page case report with an electronic system for monitoring of patients admitted to hospitals with chronic heart failure, and the catheter trial28 focused on symptomatic catheter-associated urinary tract infections as its primary outcome.
In addition to these characteristics pragmatic trials should reduce the procedures for conducting trials and data collection requirements in order to reduce costs. Furthermore pragmatic trials should try to make their findings as relevant to actual clinical practice as is possible by making sure that their primary analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).
Despite these guidelines, many RCTs with features that defy pragmatism have been incorrectly self-labeled pragmatic and published in journals of all types. This can lead to false claims of pragmatism, and the usage of the term should be standardized. The creation of the PRECIS-2 tool, which offers an objective and standard assessment of pragmatic characteristics, is a good first step.
Methods
In a pragmatic study the goal is to inform clinical or policy decisions by demonstrating how the intervention can be incorporated into real-world routine care. This is different from explanatory trials that test hypotheses regarding the cause-effect relationship in idealised situations. In this way, pragmatic trials can have a lower internal validity than explanatory studies and be more susceptible to biases in their design, analysis, and conduct. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in healthcare.
The PRECIS-2 tool scores an RCT on 9 domains, with scores ranging from 1 to 5 (very pragmatist). In this study, the areas of recruitment, organization as well as flexibility in delivery flexibility in adherence, and follow-up received high scores. However, the principal outcome and the method for missing data was scored below the pragmatic limit. This suggests that a trial can be designed with effective practical features, but without compromising its quality.
It is hard to determine the amount of pragmatism that is present in a trial since pragmatism doesn't have a single characteristic. Certain aspects of a study can be more pragmatic than others. Furthermore, logistical or protocol modifications during the course of a trial can change its score in pragmatism. In addition 36% of 89 pragmatic trials identified by Koppenaal et al were placebo-controlled, or conducted prior to approval and a majority of them were single-center. Therefore, they aren't as common and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in these trials.
A typical feature of pragmatic research is that researchers try to make their findings more meaningful by studying subgroups within the trial. This can lead to unbalanced comparisons with a lower statistical power, increasing the chance of not or incorrectly detecting differences in the primary outcome. This was a problem in the meta-analysis of pragmatic trials due to the fact that secondary outcomes were not adjusted for covariates' differences at the baseline.
In addition the pragmatic trials may have challenges with respect to the collection and interpretation of safety data. This is due to the fact that adverse events are typically self-reported, and are prone to delays, errors or coding variations. It is therefore important to enhance the quality of outcomes for these trials, ideally by using national registries rather than relying on participants to report adverse events in the trial's own database.
Results
Although the definition of pragmatism doesn't require that clinical trials be 100% pragmatist there are benefits of including pragmatic elements in trials. These include:
Incorporating routine patients, the trial results can be translated more quickly into clinical practice. But pragmatic trials can have their disadvantages. The right type of heterogeneity for instance could allow a study to generalise its findings to many different patients or settings. However the wrong type of heterogeneity could reduce the assay sensitivity and, consequently, decrease the ability of a study to detect even minor effects of treatment.
A number of studies have attempted to categorize pragmatic trials, with various definitions and scoring systems. Schwartz and
프라그마틱 슈가러쉬 홈페이지 (
http://bbs.0817ch.com/) Lellouch1 created an approach to distinguish between explanatory trials that confirm the clinical or physiological hypothesis and pragmatic trials that inform the selection of appropriate therapies in the real-world clinical setting. Their framework included nine domains, each scoring on a scale of 1 to 5, with 1 indicating more lucid and 5 indicating more practical. The domains included recruitment, setting up, 무료슬롯
프라그마틱 슬롯 추천 (
https://Carpsmash20.werite.net/the-Most-effective-pragmatic-tricks-to-make-a-difference-in-your-life) delivery of intervention, flexible compliance and primary analysis.
The original PRECIS tool3 had similar domains and an assessment scale ranging from 1 to 5. Koppenaal et al10 developed an adaptation of this assessment, called the Pragmascope, that was easier to use for systematic reviews. They found that pragmatic reviews scored higher across all domains, however they 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 analyse their data in the intention to treat way however some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery,
프라그마틱 체험 and follow-up were merged.
It is crucial to keep in mind that a study that is pragmatic does not necessarily mean a low-quality study.