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Pragmatic Free Trial Meta
Pragmatic Free Trail Meta is an open data platform that allows research into 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 research studies to compare treatment effects estimates across trials that employ different levels of pragmatism, as well as other design features.
Background
Pragmatic trials are increasingly acknowledged as providing evidence from the real world for clinical decision making. However, the use of the term "pragmatic" is not consistent and its definition as well as assessment requires clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, not to confirm the validity of a clinical or physiological hypothesis. A pragmatic trial should also strive to be as close to real-world clinical practice as possible, such as the participation of participants, setting and design of the intervention, its delivery and implementation of the intervention, as well as the determination and analysis of outcomes and primary analyses. This is a major difference from explanatory trials (as described by Schwartz and Lellouch1), which are intended to provide a more complete confirmation of the hypothesis.
Trials that are truly practical should not attempt to blind participants or healthcare professionals as this could lead to distortions in estimates of treatment effects. The trials that are pragmatic should also try to recruit patients from a wide range of health care settings to ensure that their findings can be compared to the real world.
Finally, pragmatic trials must be focused on outcomes that matter to patients, like quality of life and functional recovery. This is particularly relevant for trials involving the use of invasive procedures or potential for serious adverse events. The CRASH trial29 compared a 2 page report with an electronic monitoring system for patients in hospitals suffering from chronic cardiac failure. The catheter trial28, on the other hand utilized symptomatic catheter-related urinary tract infections as its primary outcome.
In addition to these aspects, pragmatic trials should minimize the trial procedures and data collection requirements to reduce costs. Finaly the aim of pragmatic trials is to make their results as applicable to current clinical practices as they can. This can be achieved by ensuring that their analysis is based on the intention to treat approach (as described in CONSORT extensions).
Despite these guidelines, a number of 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 needs to be standardized. The development of the PRECIS-2 tool, which provides an objective standard for assessing practical features is a good initial step.
Methods
In a practical study, the goal is to inform clinical or policy decisions by demonstrating how an intervention could be integrated into routine care in real-world situations. This is different from explanatory trials, which test hypotheses about the cause-effect relationship in idealised conditions. In this way, pragmatic trials could have lower internal validity than explanation studies and are more susceptible to biases in their design, analysis, and conduct. Despite their limitations, pragmatic studies can provide valuable data for making decisions within the context of healthcare.
The PRECIS-2 tool assesses the degree of pragmatism within an RCT by scoring it across 9 domains ranging from 1 (very explanatory) to 5 (very pragmatic). In this study, the areas of recruitment, organisation and flexibility in delivery, flexibility in adherence, and follow-up received high scores. However, the primary outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial could be designed with well-thought-out pragmatic features, without harming the quality of the trial.
It is, however, difficult to assess how pragmatic a particular trial really is because pragmatism is not a binary characteristic; certain aspects of a trial may be more pragmatic than others. The pragmatism of a trial can be affected by changes to the protocol or the logistics during the trial. Koppenaal and colleagues found that 36% of 89 pragmatic studies were placebo-controlled, or conducted prior to licensing. Most were also single-center. This means that they are not quite as typical and can only be described as pragmatic when their sponsors are accepting of the absence of blinding in these trials.
Additionally, a typical feature of pragmatic trials is that the researchers attempt to make their findings more meaningful by analysing subgroups of the trial sample. This can lead to imbalanced analyses and lower statistical power. This increases the risk of omitting or misinterpreting differences in the primary outcomes. In the instance of the pragmatic trials included in this meta-analysis, this was a significant problem because the secondary outcomes were not adjusted to account for the differences in the baseline covariates.
Furthermore the pragmatic trials may have challenges with respect to the gathering and interpretation of safety data. This is due to the fact that adverse events tend to be self-reported, and are prone to delays, inaccuracies or coding differences. Therefore, it is crucial to improve the quality of outcome ascertainment in these trials, ideally by using national registries rather than relying on participants to report adverse events on the trial's own database.
Results
While the definition of pragmatism does not require that all trials are 100 100% pragmatic, there are benefits to including pragmatic components in clinical trials. These include:
By including routine patients, the results of trials can be translated more quickly into clinical practice. However, pragmatic trials can also have disadvantages. The right type of heterogeneity for instance could allow a study to expand its findings to different settings or patients. However, the wrong type can reduce the assay sensitivity and, consequently, reduce a trial's power to detect small treatment effects.
Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework for distinguishing between explanation-based trials that support a clinical or physiological hypothesis as well as pragmatic trials that inform the choice of appropriate therapies in the real-world clinical setting. The framework consisted of nine domains scored on a 1-5 scale, with 1 being more explanatory while 5 was more practical. 프라그마틱 체험 included recruitment, setting up, delivery of intervention, flex adhering to the program and primary analysis.
The original PRECIS tool3 featured similar domains and scales from 1 to 5. Koppenaal et al10 devised an adaptation of this assessment, dubbed the Pragmascope which was more user-friendly to use in systematic reviews. They found that pragmatic systematic reviews had a higher average score in most domains, with lower scores in the primary analysis domain.
This difference in the primary analysis domain could be explained by the fact that most pragmatic trials process their data in an intention to treat method while some explanation trials do not. The overall score was lower for pragmatic systematic reviews when the domains on the organization, flexibility of delivery and follow-up were combined.
It is important to remember that a study that is pragmatic does not necessarily mean a low-quality study. In fact, there are a growing number of clinical trials that use the term "pragmatic" either in their title or abstract (as defined by MEDLINE but which is neither precise nor sensitive). These terms may signal an increased understanding of pragmatism in titles and abstracts, but it isn't clear whether this is evident in the content.
Conclusions
As the importance of real-world evidence becomes increasingly popular, pragmatic trials have gained popularity in research. They are clinical trials that are randomized which compare real-world treatment options instead of experimental treatments in development, they involve patient populations that more closely mirror the ones who are treated in routine care, they use comparators which exist in routine practice (e.g., existing drugs), and they rely on participant self-report of outcomes. This approach could help overcome limitations of observational studies, such as the biases associated with reliance on volunteers and limited accessibility and coding flexibility in national registry systems.
Other advantages of pragmatic trials are the possibility of using existing data sources, and a higher probability of detecting significant changes than traditional trials. However, pragmatic trials may be prone to limitations that compromise their credibility and generalizability. For instance the rates of participation in some trials could be lower than anticipated due to the healthy-volunteer influence and incentives to pay or compete for participants from other research studies (e.g., industry trials). The need to recruit individuals in a timely fashion also reduces the size of the sample and impact of many pragmatic trials. Certain pragmatic trials lack controls to ensure that observed differences aren't caused by biases in the trial.
The authors of the Pragmatic Free Trial Meta identified RCTs published from 2022 to 2022 that self-described as pragmatic. The PRECIS-2 tool was used to assess the degree of pragmatism. It includes areas like eligibility criteria and flexibility in recruitment, adherence to intervention, and follow-up. They discovered that 14 of the trials scored highly or pragmatic practical (i.e. scores of 5 or more) in one or more of these domains, and that the majority of them were single-center.
Trials with a high pragmatism rating tend to have more expansive eligibility criteria than traditional RCTs that have specific criteria that aren't likely to be used in the clinical environment, and they contain patients from a broad range of hospitals. The authors claim that these characteristics can help make pragmatic trials more effective and applicable to everyday clinical practice, however they don't necessarily mean that a pragmatic trial is free from bias. Furthermore, the pragmatism of trials is not a predetermined characteristic and a pragmatic trial that doesn't have all the characteristics of an explanatory trial may yield valuable and reliable results.