Pragmatic Free Trial Meta
Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It is a platform that collects and shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that examine the effects of treatment across trials with different levels of pragmatism, as well as other design features.
Background
Pragmatic studies provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however,
프라그마틱 플레이 is not used in a consistent manner and its definition and measurement require further clarification. The purpose of pragmatic trials is to inform clinical practices and policy decisions rather than confirm a physiological hypothesis or clinical hypothesis. A pragmatic trial should try to be as close as it is to real-world clinical practices, including recruiting participants, setting, designing, delivery and execution of interventions, determining and analysis outcomes, and primary analyses. This is a major difference between explanatory trials, as defined by Schwartz and Lellouch1 that are designed to prove a hypothesis in a more thorough manner.
The trials that are truly practical should avoid attempting to blind participants or the clinicians in order to result in bias in estimates of the effect of treatment. The trials that are pragmatic should also try to attract patients from a wide range of health care settings, to ensure that the results can be applied to the real world.
Additionally studies that are pragmatic should focus on outcomes that are crucial to patients,
프라그마틱 체험 such as quality of life or functional recovery. This is particularly important for trials that involve the use of invasive procedures or could have harmful adverse impacts. The CRASH trial29, for example, focused on functional outcomes to evaluate a two-page case report with an electronic system to monitor the health of patients admitted to hospitals with chronic heart failure. Similarly, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.
In addition to these features the pragmatic trial should also reduce the trial's procedures and
프라그마틱 data collection requirements in order to reduce costs. Furthermore pragmatic trials should try to make their results as applicable to clinical practice as possible by making sure that their primary method of analysis is based on the intention-to-treat method (as described in CONSORT extensions for pragmatic trials).
Despite these criteria, a number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all types. This can result in misleading claims of pragmaticity, and the use of the term must be standardized. The development of a PRECIS-2 tool that offers an objective and
프라그마틱 슬롯 팁 standardized assessment of pragmatic features is a good start.
Methods
In a practical study the aim is to inform policy or clinical decisions by demonstrating how an intervention can be integrated into routine care in real-world contexts. Explanatory trials test hypotheses concerning the cause-effect relationship within idealised conditions. Therefore, pragmatic trials could 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 data for making decisions within the healthcare context.
The PRECIS-2 tool evaluates an RCT on 9 domains, ranging between 1 and 5 (very pragmatic). In this study, the domains of recruitment, organisation, flexibility in delivery, flexible adherence and follow-up scored high. However, the primary outcome and the method for missing data were scored below the practical limit. This suggests that it is possible to design a trial that has excellent pragmatic features without compromising the quality of its results.
It is hard to determine the amount of pragmatism that is present in a trial since pragmatism doesn't possess a specific characteristic. Some aspects of a study can be more pragmatic than other. A trial's pragmatism can be affected by modifications to the protocol or the logistics during the trial. Additionally 36% of the 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or conducted before licensing and most were single-center. They aren't in line with the usual practice, and can only be considered pragmatic if their sponsors accept that the trials are not blinded.
A common aspect of pragmatic studies is that researchers attempt to make their findings more relevant by studying subgroups of the trial sample. However, this often leads to unbalanced comparisons with a lower statistical power, which increases the risk of either not detecting or misinterpreting the results of the primary outcome. In the case of the pragmatic trials included in this meta-analysis this was a major issue because the secondary outcomes weren't adjusted for differences in baseline covariates.
Furthermore, pragmatic studies can pose difficulties in the gathering and interpretation of safety data. It is because adverse events are usually self-reported, and are prone to delays, errors or coding differences. Therefore, it is crucial to improve the quality of outcome ascertainment in these trials, ideally by using national registry databases instead of relying on participants to report adverse events in a trial's own database.
Results
Although the definition of pragmatism may not require that all clinical trials be 100% pragmatist, there are benefits of including pragmatic elements in trials. These include:
Enhancing sensitivity to issues in the real world which reduces study size and cost, and enabling the trial results to be faster transferred into real-world clinical practice (by including patients from routine care). However, pragmatic trials may have disadvantages. The right amount of heterogeneity, for example, can help a study extend its findings to different settings or patients. 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.
Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 developed a framework to distinguish between explanatory studies that prove a physiological hypothesis or
프라그마틱 무료체험 메타 clinical hypothesis, and pragmatic studies that guide the selection of appropriate treatments in clinical practice. Their framework comprised nine domains, each scored on a scale ranging from 1 to 5 with 1 indicating more lucid and 5 indicating more practical. The domains included recruitment of intervention, setting up, delivery of intervention, flexible compliance and primary analysis.
The initial PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 developed an adaptation of this assessment, dubbed the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic reviews scored higher in all domains, but scored lower in the primary analysis domain.
The difference in the main analysis domain could be due to the fact that the majority of pragmatic trials analyze their data in an intention to treat manner while some explanation trials do not. The overall score was lower for systematic reviews that were pragmatic when the domains on organisation, flexible delivery, and follow-up were merged.