Pragmatic Free Trial Meta Pragmatic Free Trail Meta is an open data platform that enables 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 studies that examine the effects of treatment across trials with different levels of pragmatism and other design features. Background Pragmatic trials provide real-world evidence that can be used to make clinical decisions. The term "pragmatic", however, is used inconsistently and its definition and evaluation require clarification. The purpose of pragmatic trials is to inform clinical practice and policy decisions, not to confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic study should aim to be as similar to actual clinical practice as possible, including in the selection of participants, setting and design, the delivery and execution of the intervention, determination and analysis of outcomes and primary analyses. This is a major difference between explanation-based trials, as described by Schwartz & Lellouch1 which are designed to confirm a hypothesis in a more thorough way. Truly pragmatic trials should not conceal participants or clinicians. This could lead to a bias in the estimates of the effects of treatment. Practical trials also involve patients from various healthcare settings to ensure that their results can be generalized to the real world. Finally, pragmatic trials must be focused on outcomes that matter to patients, such as quality of life and functional recovery. This is especially important in trials that involve invasive procedures or those with potentially serious adverse events. The CRASH trial29, for example focused on the functional outcome 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 urinary tract infections caused by catheters as its primary outcome. In addition to these characteristics, pragmatic trials should minimize trial procedures and data-collection requirements to cut down on costs and time commitments. Finaly the aim of pragmatic trials is to make their findings as applicable to current clinical practices as they can. This can be accomplished by ensuring their primary analysis is based on an intention-to treat method (as described within CONSORT extensions). Despite these requirements however, a large number of RCTs with features that defy the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This could lead to false claims of pragmatism, and the usage of the term should be standardised. The development of the PRECIS-2 tool, which offers a standard objective assessment of pragmatic characteristics is a great first step. ?? ????? In a practical trial, the aim is to inform policy or clinical decisions by showing how an intervention could be integrated into everyday routine care. Explanatory trials test hypotheses regarding the cause-effect relationship within idealised settings. Therefore, pragmatic trials might have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can provide valuable information to make decisions in the healthcare context. The PRECIS-2 tool scores an RCT on 9 domains, ranging from 1 to 5 (very pragmatic). In this study, the domains of recruitment, organisation, flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the principal outcome and method of missing data was scored below the pragmatic limit. This suggests that it is possible to design a trial that has excellent pragmatic features without harming the quality of the outcomes. It is hard to determine the level of pragmatism in a particular trial because pragmatism does not have a single characteristic. Certain aspects of a study may 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. This means that they are not as common and can only be described as pragmatic if their sponsors are tolerant of the absence of blinding in these trials. Additionally, a typical feature of pragmatic trials is that researchers attempt to make their findings more valuable by studying subgroups of the sample. However, this often leads to unbalanced comparisons and lower statistical power, increasing the chance of not or misinterpreting the results of the primary outcome. In the case of the pragmatic trials included in this meta-analysis this was a serious issue because the secondary outcomes were not adjusted for the differences in the baseline covariates. In addition, pragmatic studies can pose difficulties in the gathering and interpretation of safety data. This is due to the fact that adverse events are usually self-reported and are prone to delays in reporting, inaccuracies or coding errors. It is therefore important to improve the quality of outcome ascertainment in these trials, and ideally by using national registries rather than relying on participants to report adverse events in the trial's database. Results While the definition of pragmatism does not require that clinical trials be 100% pragmatic there are benefits of including pragmatic elements in trials. These include: Increased sensitivity to real-world issues as well as reducing study size and cost, and enabling the trial results to be faster translated into actual clinical practice (by including patients from routine care). But pragmatic trials can be a challenge. For example, the right kind of heterogeneity can allow a study to generalize its findings to a variety of patients and settings; however, the wrong type of heterogeneity may reduce the assay's sensitivity and therefore reduce the power of a trial to detect small treatment effects. Many studies have attempted categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can discern between explanation-based studies that confirm the physiological hypothesis or clinical hypothesis and pragmatic studies that help inform the selection of appropriate therapies in clinical practice. The framework was comprised of nine domains that were evaluated on a scale of 1-5 which indicated that 1 was more informative and 5 being more pragmatic. The domains included recruitment setting, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis. The original PRECIS tool3 was based on a similar scale and domains. Koppenaal and colleagues10 created an adaptation of this assessment, known as the Pragmascope which was more user-friendly to use for systematic reviews. They found that pragmatic reviews scored higher in most domains, but scored lower in the primary analysis domain. The difference in the primary analysis domains could be explained by the way most pragmatic trials analyse data. Certain explanatory trials however don't. The overall score for systematic reviews that were pragmatic was lower when the areas of organization, flexible delivery, and following-up were combined. It is important to remember that a pragmatic study does not mean a low-quality trial. In fact, there is a growing number of clinical trials which use the term 'pragmatic' either in their title or abstract (as defined by MEDLINE however it is not precise nor sensitive). The use of these words in abstracts and titles could suggest a greater awareness of the importance of pragmatism but it is unclear whether this is reflected in the contents of the articles. Conclusions As the value of real-world evidence becomes increasingly widespread the pragmatic trial has gained popularity in research. They are clinical trials that are randomized that compare real-world care alternatives instead of experimental treatments in development, they include patient populations which are more closely resembling the ones who are treated in routine care, they use comparisons that are commonplace in practice (e.g. existing drugs) and rely on participant self-report of outcomes. This method could help overcome the limitations of observational research, such as the biases that arise from relying on volunteers, and the limited accessibility and coding flexibility in national registry systems. Pragmatic trials offer other advantages, including the ability to leverage existing data sources, and a greater chance of detecting significant differences than traditional trials. However, they may be prone to limitations that compromise their credibility and generalizability. The participation rates in certain trials may be lower than anticipated because of the healthy-volunteering effect, financial incentives, or competition from other research studies. The requirement to recruit participants in a timely manner also restricts the sample size and the impact of many pragmatic trials. Additionally some pragmatic trials do not have controls to ensure that the observed differences are not due to biases in the conduct of trials. The authors of the Pragmatic Free Trial Meta identified RCTs published up to 2022 that self-described as pragmatic. The PRECIS-2 tool was employed to assess the pragmatism of these trials. It includes domains such as eligibility criteria, recruitment flexibility, adherence to intervention, and follow-up. They discovered that 14 of the trials scored as highly or pragmatic sensible (i.e. scores of 5 or higher) in any one or more of these domains and that the majority of these were single-center. Trials with a high pragmatism rating tend to have higher eligibility criteria than traditional RCTs, which include very specific criteria that are not likely to be used in the clinical environment, and they contain patients from a broad range of hospitals. These characteristics, according to the authors, may make pragmatic trials more useful and applicable in the daily practice. However they do not guarantee that a trial will be free of bias. The pragmatism is not a fixed attribute; a pragmatic test that doesn't have all the characteristics of an explicative study could still yield valuable and valid results.
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