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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 distributes cleaned trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses that examine the effect of treatment across trials of different levels of pragmatism.
Background
Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the usage of the term "pragmatic" is not consistent and 프라그마틱 체험 its definition and assessment requires clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should aim to be as close as is possible to actual clinical practices that include recruiting participants, setting, designing, 프라그마틱 체험 delivery and implementation of interventions, determining and analysis outcomes, and primary analyses. This is a significant difference between explanatory trials, as described by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough manner.
The most pragmatic trials should not conceal participants or clinicians. This can result in bias in the estimations of the effect of treatment. The pragmatic trials also include patients from various health care settings to ensure that their results can be generalized to the real world.
Furthermore, pragmatic trials should focus on outcomes that are important to patients, like quality of life or functional recovery. This is particularly important when trials involve the use of invasive procedures or could have serious adverse effects. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The trial with a catheter, on the other hand utilized symptomatic catheter-related urinary tract infection as its primary outcome.
In addition to these features pragmatic trials should also reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally, pragmatic trials should seek to make their results as applicable to real-world clinical practice as possible by making sure that their primary method of analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).
Many RCTs which do not meet the criteria for pragmatism but have features that are in opposition to pragmatism, have been published in journals of varying types and incorrectly labeled as pragmatic. This can lead to misleading claims about pragmatism, and the use of the term should be made more uniform. The development of a PRECIS-2 tool that provides an objective and standardized evaluation of pragmatic aspects is a good start.
Methods
In a pragmatic research study it is the intention to inform policy or clinical decisions by demonstrating how an intervention could be integrated into routine treatment in real-world settings. This is distinct from explanation trials that test hypotheses regarding the causal-effect relationship in idealized 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 research can be a valuable source of information to make decisions in the healthcare context.
The PRECIS-2 tool assesses the degree of pragmatism in an RCT by scoring it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence and follow-up domains scored high scores, but the primary outcome and the method for missing data fell below the practical limit. This indicates that a trial can be designed with effective practical features, yet not damaging the quality.
However, it's difficult to determine how pragmatic a particular trial really is because the pragmatism score is not a binary attribute; some aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol changes during an experiment can alter its pragmatism score. Koppenaal and colleagues found that 36% of the 89 pragmatic studies were placebo-controlled or 프라그마틱 홈페이지 conducted prior to licensing. The majority of them were single-center. Therefore, they aren't very close to usual practice and can only be called pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.
A typical feature of pragmatic studies is that researchers try to make their findings more meaningful by analyzing subgroups within the trial. This can lead to unbalanced comparisons with a lower statistical power, thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome. This was a problem during the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates' differences at baseline.
Additionally, studies that are pragmatic may pose challenges to collection and interpretation safety data. This is because adverse events are typically reported by participants themselves and are prone to reporting errors, delays or coding errors. It is crucial to improve the accuracy and quality of outcomes in these trials.
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:
Increasing sensitivity to real-world issues, reducing study size and cost, and enabling the trial results to be more quickly implemented into clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. The right type of heterogeneity, for example, can help a study expand its findings to different patients or settings. However, the wrong type can reduce the assay sensitivity and, consequently, decrease the ability of a study to detect small treatment effects.
Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support a physiological hypothesis or clinical hypothesis, and pragmatic studies that guide the selection of appropriate treatments in the real-world clinical practice. Their framework included nine domains, each scored on a scale ranging from 1-5, with 1 being more informative and 5 indicating more pragmatic. The domains were recruitment setting, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.
The initial PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 developed an adaptation of the assessment, known as the Pragmascope, that was easier to use for systematic reviews. They discovered that pragmatic systematic reviews had higher average scores in the majority of domains, but lower scores in the primary analysis domain.
This difference in primary analysis domain can be explained by the way that most pragmatic trials approach data. Certain explanatory trials however, do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were merged.
It is important to remember that a pragmatic study does not mean a low-quality trial. In fact, there are increasing numbers of clinical trials which use the term 'pragmatic' either in their title or abstract (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in titles and 프라그마틱 무료체험 메타 abstracts could indicate a greater understanding of the importance of pragmatism however, it is not clear if this is evident in the content of the articles.
Conclusions
As appreciation for the value of real-world evidence becomes increasingly commonplace and pragmatic trials have gained popularity in research. They are randomized clinical trials which compare real-world treatment options instead of experimental treatments under development. They include patients which are more closely resembling the patients who receive routine care, they employ comparators that are used in routine practice (e.g., 프라그마틱 무료체험 메타 existing drugs), and they depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research such as the biases associated with the use of volunteers and the lack of codes that vary in national registers.
Other advantages of pragmatic trials are the ability to use existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, pragmatic tests may have some limitations that limit their effectiveness and generalizability. For example, participation rates in some trials might be lower than anticipated due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g., industry trials). Practical trials are often restricted by the need to recruit participants in a timely manner. Additionally, some pragmatic trials lack controls to ensure that the observed differences aren't due to biases in trial conduct.
The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatic and that were published until 2022. They evaluated pragmatism using the PRECIS-2 tool, which consists of the domains eligibility criteria as well as recruitment, flexibility in adherence to interventions, and follow-up. They discovered that 14 of the trials scored as highly or pragmatic pragmatic (i.e., scoring 5 or higher) in one or more of these domains, and 프라그마틱 무료체험 메타 that the majority of them were single-center.
Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs, which include very specific criteria that are unlikely to be used in clinical practice, and they include populations from a wide variety of hospitals. According to the authors, may make pragmatic trials more useful and applicable in the daily clinical. However they do not guarantee that a trial is free of bias. The pragmatism principle is not a definite characteristic; a pragmatic test that does not possess all the characteristics of an explicative study can still produce valid and useful outcomes.
Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that facilitates research on pragmatic trials. It collects and distributes cleaned trial data, ratings and evaluations using PRECIS-2. This allows for diverse meta-epidemiological analyses that examine the effect of treatment across trials of different levels of pragmatism.
Background
Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the usage of the term "pragmatic" is not consistent and 프라그마틱 체험 its definition and assessment requires clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than confirm an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should aim to be as close as is possible to actual clinical practices that include recruiting participants, setting, designing, 프라그마틱 체험 delivery and implementation of interventions, determining and analysis outcomes, and primary analyses. This is a significant difference between explanatory trials, as described by Schwartz & Lellouch1 that are designed to test the hypothesis in a more thorough manner.
The most pragmatic trials should not conceal participants or clinicians. This can result in bias in the estimations of the effect of treatment. The pragmatic trials also include patients from various health care settings to ensure that their results can be generalized to the real world.
Furthermore, pragmatic trials should focus on outcomes that are important to patients, like quality of life or functional recovery. This is particularly important when trials involve the use of invasive procedures or could have serious adverse effects. The CRASH trial29 compared a 2 page report with an electronic monitoring system for hospitalized patients with chronic heart failure. The trial with a catheter, on the other hand utilized symptomatic catheter-related urinary tract infection as its primary outcome.
In addition to these features pragmatic trials should also reduce trial procedures and data-collection requirements to reduce costs and time commitments. Additionally, pragmatic trials should seek to make their results as applicable to real-world clinical practice as possible by making sure that their primary method of analysis is the intention-to-treat approach (as described in CONSORT extensions for pragmatic trials).
Many RCTs which do not meet the criteria for pragmatism but have features that are in opposition to pragmatism, have been published in journals of varying types and incorrectly labeled as pragmatic. This can lead to misleading claims about pragmatism, and the use of the term should be made more uniform. The development of a PRECIS-2 tool that provides an objective and standardized evaluation of pragmatic aspects is a good start.
Methods
In a pragmatic research study it is the intention to inform policy or clinical decisions by demonstrating how an intervention could be integrated into routine treatment in real-world settings. This is distinct from explanation trials that test hypotheses regarding the causal-effect relationship in idealized 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 research can be a valuable source of information to make decisions in the healthcare context.
The PRECIS-2 tool assesses the degree of pragmatism in an RCT by scoring it across 9 domains ranging from 1 (very explicative) to 5 (very pragmatic). In this study, the recruit-ment, organisation, flexibility: delivery, flexible adherence and follow-up domains scored high scores, but the primary outcome and the method for missing data fell below the practical limit. This indicates that a trial can be designed with effective practical features, yet not damaging the quality.
However, it's difficult to determine how pragmatic a particular trial really is because the pragmatism score is not a binary attribute; some aspects of a trial can be more pragmatic than others. Furthermore, logistical or protocol changes during an experiment can alter its pragmatism score. Koppenaal and colleagues found that 36% of the 89 pragmatic studies were placebo-controlled or 프라그마틱 홈페이지 conducted prior to licensing. The majority of them were single-center. Therefore, they aren't very close to usual practice and can only be called pragmatic in the event that their sponsors are supportive of the absence of blinding in these trials.
A typical feature of pragmatic studies is that researchers try to make their findings more meaningful by analyzing subgroups within the trial. This can lead to unbalanced comparisons with a lower statistical power, thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome. This was a problem during the meta-analysis of pragmatic trials because secondary outcomes were not adjusted for covariates' differences at baseline.
Additionally, studies that are pragmatic may pose challenges to collection and interpretation safety data. This is because adverse events are typically reported by participants themselves and are prone to reporting errors, delays or coding errors. It is crucial to improve the accuracy and quality of outcomes in these trials.
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:
Increasing sensitivity to real-world issues, reducing study size and cost, and enabling the trial results to be more quickly implemented into clinical practice (by including routine patients). However, pragmatic trials may have disadvantages. The right type of heterogeneity, for example, can help a study expand its findings to different patients or settings. However, the wrong type can reduce the assay sensitivity and, consequently, decrease the ability of a study to detect small treatment effects.
Many studies have attempted classify pragmatic trials using different definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support a physiological hypothesis or clinical hypothesis, and pragmatic studies that guide the selection of appropriate treatments in the real-world clinical practice. Their framework included nine domains, each scored on a scale ranging from 1-5, with 1 being more informative and 5 indicating more pragmatic. The domains were recruitment setting, setting, intervention delivery and follow-up, as well as flexible adherence and primary analysis.
The initial PRECIS tool3 included similar domains and a scale of 1 to 5. Koppenaal et al10 developed an adaptation of the assessment, known as the Pragmascope, that was easier to use for systematic reviews. They discovered that pragmatic systematic reviews had higher average scores in the majority of domains, but lower scores in the primary analysis domain.
This difference in primary analysis domain can be explained by the way that most pragmatic trials approach data. Certain explanatory trials however, do not. The overall score was lower for pragmatic systematic reviews when the domains of the organization, flexibility of delivery and follow-up were merged.
It is important to remember that a pragmatic study does not mean a low-quality trial. In fact, there are increasing numbers of clinical trials which use the term 'pragmatic' either in their title or abstract (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in titles and 프라그마틱 무료체험 메타 abstracts could indicate a greater understanding of the importance of pragmatism however, it is not clear if this is evident in the content of the articles.
Conclusions
As appreciation for the value of real-world evidence becomes increasingly commonplace and pragmatic trials have gained popularity in research. They are randomized clinical trials which compare real-world treatment options instead of experimental treatments under development. They include patients which are more closely resembling the patients who receive routine care, they employ comparators that are used in routine practice (e.g., 프라그마틱 무료체험 메타 existing drugs), and they depend on participants' self-reports of outcomes. This approach can overcome the limitations of observational research such as the biases associated with the use of volunteers and the lack of codes that vary in national registers.
Other advantages of pragmatic trials are the ability to use existing data sources, as well as a higher probability of detecting significant changes than traditional trials. However, pragmatic tests may have some limitations that limit their effectiveness and generalizability. For example, participation rates in some trials might be lower than anticipated due to the healthy-volunteer effect and financial incentives or competition for participants from other research studies (e.g., industry trials). Practical trials are often restricted by the need to recruit participants in a timely manner. Additionally, some pragmatic trials lack controls to ensure that the observed differences aren't due to biases in trial conduct.
The authors of the Pragmatic Free Trial Meta identified 48 RCTs self-labeled as pragmatic and that were published until 2022. They evaluated pragmatism using the PRECIS-2 tool, which consists of the domains eligibility criteria as well as recruitment, flexibility in adherence to interventions, and follow-up. They discovered that 14 of the trials scored as highly or pragmatic pragmatic (i.e., scoring 5 or higher) in one or more of these domains, and 프라그마틱 무료체험 메타 that the majority of them were single-center.
Trials that have a high pragmatism score tend to have broader eligibility criteria than traditional RCTs, which include very specific criteria that are unlikely to be used in clinical practice, and they include populations from a wide variety of hospitals. According to the authors, may make pragmatic trials more useful and applicable in the daily clinical. However they do not guarantee that a trial is free of bias. The pragmatism principle is not a definite characteristic; a pragmatic test that does not possess all the characteristics of an explicative study can still produce valid and useful outcomes.
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