관련링크
Why Pragmatic Free Trial Meta Can Be More Risky Than You Thought |
작성일24-10-02 11:14 |
본문
Pragmatic Free Trial Meta
Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that examine the effects of treatment across trials that employ different levels of pragmatism as well as other design features.
Background
Pragmatic trials are increasingly recognized as providing real-world evidence for clinical decision-making. However, the use of the term "pragmatic" is inconsistent and its definition and evaluation requires clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should also try to be as similar to real-world clinical practice as possible, 프라그마틱 게임 including in the participation of participants, setting up and design of the intervention, its delivery and execution of the intervention, and the determination and analysis of the outcomes, and primary analyses. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough confirmation of an idea.
Truely pragmatic trials should not blind participants or clinicians. This can lead to a bias in the estimates of the effect of treatment. Practical trials also involve patients from different health care settings to ensure that the results can be generalized to the real world.
Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like quality of life and functional recovery. This is especially important for trials involving the use of invasive procedures or potentially serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The trial with a catheter, however was based on symptomatic catheter-related urinary tract infection as its primary outcome.
In addition to these characteristics pragmatic trials should reduce the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Additionally, pragmatic trials should aim to make their findings as relevant to real-world clinical practices as they can. This can be achieved by ensuring their primary analysis is based on an intention-to treat approach (as defined in CONSORT extensions).
Despite these criteria however, a large number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to misleading claims of pragmatism, and the use of the term should be made more uniform. The creation of the PRECIS-2 tool, which provides a standard objective assessment of pragmatic features, is a good first step.
Methods
In a pragmatic trial it is the intention to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. This differs from explanation trials that test hypotheses regarding the causal-effect relationship in idealized conditions. Consequently, pragmatic trials may have lower internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of information to make decisions in the context of healthcare.
The PRECIS-2 tool measures the degree of pragmatism within an RCT by scoring it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study the areas of recruitment, organisation and flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the main outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with good practical features, yet not damaging the quality.
It is difficult to determine the degree of pragmatism within a specific trial since pragmatism doesn't have a binary attribute. Some aspects of a research study can be more pragmatic than other. Additionally, logistical or protocol modifications during the course of an experiment can alter its score on pragmatism. Additionally 36% of 89 pragmatic trials identified by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing, and the majority were single-center. They are not in line with the norm, and can only be called pragmatic if the sponsors agree that such trials aren't blinded.
A common feature of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups within the trial. This can result in unbalanced analyses with lower statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a serious issue since the secondary outcomes weren't adjusted for variations in baseline covariates.
In addition practical trials can present challenges in the gathering and interpretation of safety data. It is because adverse events are typically self-reported and are susceptible to delays, errors or coding errors. It is important to improve the quality and accuracy of the outcomes in these trials.
Results
While the definition of pragmatism does not mean that trials must be 100% pragmatic, there are some advantages of including pragmatic elements in clinical trials. These include:
By including routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic trials can also have disadvantages. The right kind of heterogeneity, like, can help a study extend its findings to different settings or patients. However the wrong kind of heterogeneity can reduce the assay sensitivity, and therefore decrease the ability of a study to detect even minor effects of treatment.
A number of studies have attempted to categorize pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory trials that confirm a physiological or clinical hypothesis, and pragmatic trials that aid in the selection of appropriate treatments in clinical practice. Their framework included nine domains that were scored on a scale ranging from 1-5, with 1 indicating more explanatory and 5 indicating more practical. The domains were recruitment setting, setting, 프라그마틱 무료체험 intervention delivery with flexibility, follow-up and 무료 프라그마틱 primary analysis.
The initial 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 discovered that pragmatic systematic reviews had a higher average scores across all domains, but lower scores in the primary analysis domain.
This distinction in the primary analysis domains can be due to the way in which most pragmatic trials analyse data. Certain explanatory trials however do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery, and follow-up were merged.
It is crucial to keep in mind that a pragmatic study does not necessarily mean a low-quality study. In fact, there is increasing numbers of clinical trials that use the term "pragmatic" either in their abstracts or titles (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in titles and abstracts may suggest a greater awareness of the importance of pragmatism however, it is not clear if this is manifested in the content of the articles.
Conclusions
As the value of evidence from the real world becomes more widespread and pragmatic trials have gained momentum in research. They are randomized clinical trials which compare real-world treatment options rather than experimental treatments under development, they include patient populations that are more similar to the ones who are treated in routine care, they use comparisons that are commonplace in practice (e.g. existing medications) and depend on the self-reporting of participants about outcomes. This method has the potential to overcome the limitations of observational research that are prone to biases associated with reliance on volunteers and limited availability and the variability of coding in national registry systems.
Pragmatic trials also have advantages, like the ability to leverage existing data sources and a greater chance of detecting significant differences than traditional trials. However, these tests could have some limitations that limit their effectiveness and generalizability. For example the participation rates in certain trials might be lower than expected 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 manner also limits the sample size and the impact of many pragmatic trials. Additionally certain pragmatic trials lack controls to ensure that the observed differences are not due to biases in trial conduct.
The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. The PRECIS-2 tool was used to determine the pragmatism of these trials. It covers areas like eligibility criteria as well as recruitment flexibility, adherence to intervention, and follow-up. They discovered that 14 of the trials scored pragmatic or 프라그마틱 사이트 추천 (site) highly practical (i.e. scoring 5 or more) in one or more of these domains and that the majority were single-center.
Trials with high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also have populations from many different hospitals. According to the authors, can make pragmatic trials more relevant and useful in everyday practice. However, they cannot guarantee that a trial will be free of bias. Moreover, the pragmatism of a trial is not a predetermined characteristic and a pragmatic trial that does not contain all the characteristics of a explanatory trial can yield valuable and reliable results.
Pragmatic Free Trial Meta is a non-commercial open data platform and infrastructure that supports research on pragmatic trials. It shares clean trial data and ratings using PRECIS-2, permitting multiple and varied meta-epidemiological studies that examine the effects of treatment across trials that employ different levels of pragmatism as well as other design features.
Background
Pragmatic trials are increasingly recognized as providing real-world evidence for clinical decision-making. However, the use of the term "pragmatic" is inconsistent and its definition and evaluation requires clarification. Pragmatic trials should be designed to inform policy and clinical practice decisions, rather than to prove an hypothesis that is based on a clinical or physiological basis. A pragmatic trial should also try to be as similar to real-world clinical practice as possible, 프라그마틱 게임 including in the participation of participants, setting up and design of the intervention, its delivery and execution of the intervention, and the determination and analysis of the outcomes, and primary analyses. This is a key distinction from explanation trials (as described by Schwartz and Lellouch1) that are intended to provide a more thorough confirmation of an idea.
Truely pragmatic trials should not blind participants or clinicians. This can lead to a bias in the estimates of the effect of treatment. Practical trials also involve patients from different health care settings to ensure that the results can be generalized to the real world.
Furthermore, trials that are pragmatic must be focused on outcomes that matter to patients, like quality of life and functional recovery. This is especially important for trials involving the use of invasive procedures or potentially serious adverse events. The CRASH trial29 compared a two-page report with an electronic monitoring system for hospitalized patients with chronic cardiac failure. The trial with a catheter, however was based on symptomatic catheter-related urinary tract infection as its primary outcome.
In addition to these characteristics pragmatic trials should reduce the procedures for conducting trials and requirements for data collection to cut down on costs and time commitments. Additionally, pragmatic trials should aim to make their findings as relevant to real-world clinical practices as they can. This can be achieved by ensuring their primary analysis is based on an intention-to treat approach (as defined in CONSORT extensions).
Despite these criteria however, a large number of RCTs with features that challenge the concept of pragmatism have been mislabeled as pragmatic and published in journals of all kinds. This can lead to misleading claims of pragmatism, and the use of the term should be made more uniform. The creation of the PRECIS-2 tool, which provides a standard objective assessment of pragmatic features, is a good first step.
Methods
In a pragmatic trial it is the intention to inform clinical or policy decisions by demonstrating how the intervention can be integrated into everyday routine care. This differs from explanation trials that test hypotheses regarding the causal-effect relationship in idealized conditions. Consequently, pragmatic trials may have lower internal validity than explanatory trials and might be more susceptible to bias in their design, conduct and analysis. Despite their limitations, pragmatic studies can be a valuable source of information to make decisions in the context of healthcare.
The PRECIS-2 tool measures the degree of pragmatism within an RCT by scoring it across 9 domains that range from 1 (very explicit) to 5 (very pragmatic). In this study the areas of recruitment, organisation and flexibility in delivery, flexible adherence, and follow-up were awarded high scores. However, the main outcome and method of missing data was scored below the pragmatic limit. This suggests that a trial can be designed with good practical features, yet not damaging the quality.
It is difficult to determine the degree of pragmatism within a specific trial since pragmatism doesn't have a binary attribute. Some aspects of a research study can be more pragmatic than other. Additionally, logistical or protocol modifications during the course of an experiment can alter its score on pragmatism. Additionally 36% of 89 pragmatic trials identified by Koppenaal and colleagues were placebo-controlled or conducted prior to licensing, and the majority were single-center. They are not in line with the norm, and can only be called pragmatic if the sponsors agree that such trials aren't blinded.
A common feature of pragmatic studies is that researchers attempt to make their findings more meaningful by analyzing subgroups within the trial. This can result in unbalanced analyses with lower statistical power. This increases the chance of omitting or misinterpreting differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a serious issue since the secondary outcomes weren't adjusted for variations in baseline covariates.
In addition practical trials can present challenges in the gathering and interpretation of safety data. It is because adverse events are typically self-reported and are susceptible to delays, errors or coding errors. It is important to improve the quality and accuracy of the outcomes in these trials.
Results
While the definition of pragmatism does not mean that trials must be 100% pragmatic, there are some advantages of including pragmatic elements in clinical trials. These include:
By including routine patients, the results of trials can be more quickly translated into clinical practice. However, pragmatic trials can also have disadvantages. The right kind of heterogeneity, like, can help a study extend its findings to different settings or patients. However the wrong kind of heterogeneity can reduce the assay sensitivity, and therefore decrease the ability of a study to detect even minor effects of treatment.
A number of studies have attempted to categorize pragmatic trials using various definitions and scoring systems. Schwartz and Lellouch1 developed a framework to distinguish between explanatory trials that confirm a physiological or clinical hypothesis, and pragmatic trials that aid in the selection of appropriate treatments in clinical practice. Their framework included nine domains that were scored on a scale ranging from 1-5, with 1 indicating more explanatory and 5 indicating more practical. The domains were recruitment setting, setting, 프라그마틱 무료체험 intervention delivery with flexibility, follow-up and 무료 프라그마틱 primary analysis.
The initial 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 discovered that pragmatic systematic reviews had a higher average scores across all domains, but lower scores in the primary analysis domain.
This distinction in the primary analysis domains can be due to the way in which most pragmatic trials analyse data. Certain explanatory trials however do not. The overall score was lower for pragmatic systematic reviews when the domains on organisation, flexible delivery, and follow-up were merged.
It is crucial to keep in mind that a pragmatic study does not necessarily mean a low-quality study. In fact, there is increasing numbers of clinical trials that use the term "pragmatic" either in their abstracts or titles (as defined by MEDLINE but which is not precise nor sensitive). The use of these terms in titles and abstracts may suggest a greater awareness of the importance of pragmatism however, it is not clear if this is manifested in the content of the articles.
Conclusions
As the value of evidence from the real world becomes more widespread and pragmatic trials have gained momentum in research. They are randomized clinical trials which compare real-world treatment options rather than experimental treatments under development, they include patient populations that are more similar to the ones who are treated in routine care, they use comparisons that are commonplace in practice (e.g. existing medications) and depend on the self-reporting of participants about outcomes. This method has the potential to overcome the limitations of observational research that are prone to biases associated with reliance on volunteers and limited availability and the variability of coding in national registry systems.
Pragmatic trials also have advantages, like the ability to leverage existing data sources and a greater chance of detecting significant differences than traditional trials. However, these tests could have some limitations that limit their effectiveness and generalizability. For example the participation rates in certain trials might be lower than expected 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 manner also limits the sample size and the impact of many pragmatic trials. Additionally certain pragmatic trials lack controls to ensure that the observed differences are not due to biases in trial conduct.
The authors of the Pragmatic Free Trial Meta identified 48 RCTs that self-labeled themselves as pragmatic and were published up to 2022. The PRECIS-2 tool was used to determine the pragmatism of these trials. It covers areas like eligibility criteria as well as recruitment flexibility, adherence to intervention, and follow-up. They discovered that 14 of the trials scored pragmatic or 프라그마틱 사이트 추천 (site) highly practical (i.e. scoring 5 or more) in one or more of these domains and that the majority were single-center.
Trials with high pragmatism scores tend to have more criteria for eligibility than traditional RCTs. They also have populations from many different hospitals. According to the authors, can make pragmatic trials more relevant and useful in everyday practice. However, they cannot guarantee that a trial will be free of bias. Moreover, the pragmatism of a trial is not a predetermined characteristic and a pragmatic trial that does not contain all the characteristics of a explanatory trial can yield valuable and reliable results.
등록된 댓글이 없습니다.