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The Reasons Pragmatic Free Trial Meta Is More Risky Than You Think |
작성일24-10-29 04:10 |
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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 research studies to evaluate the effect of treatment on trials that have different levels of pragmatism as well as other design features.
Background
Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the use of the term "pragmatic" is not consistent and its definition as well as assessment requires further clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, not to confirm an hypothesis that is based on a clinical or physiological basis. 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 distinction between explanation-based trials, as described by Schwartz & Lellouch1, which are designed to confirm the hypothesis in a more thorough manner.
Studies that are truly practical should avoid attempting to blind participants or healthcare professionals, as this may result in bias in estimates of the effect of treatment. Pragmatic trials should also seek to enroll patients from a wide range of health care settings to ensure that their findings can be applied to the real world.
Additionally, pragmatic trials should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is particularly important in trials that require invasive procedures or have potentially harmful adverse effects. The CRASH trial29, for instance was 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. In addition, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.
In addition to these features, pragmatic trials should minimize the trial's procedures and data collection requirements in order to reduce costs. Finaly, pragmatic trials should aim to make their findings as applicable to current clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on an intention-to treat approach (as described within CONSORT extensions).
Despite these criteria, many RCTs with features that challenge the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all types. This can lead to misleading claims of pragmatism and the term's use should be standardized. The development of a PRECIS-2 tool that offers a standardized objective assessment of pragmatic features 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 care in real-world settings. This is different from explanatory trials that test hypotheses about the causal-effect relationship in idealized settings. Therefore, pragmatic trials could have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in healthcare.
The PRECIS-2 tool measures the degree of pragmatism in an RCT by assessing it across 9 domains ranging from 1 (very explicit) to 5 (very pragmatic). In this study the areas of recruitment, organization and flexibility in delivery, flexible adherence and follow-up were awarded high scores. However, the main outcome and the method of missing data was scored below the pragmatic limit. This indicates that a trial can be designed with good practical features, but without damaging the quality.
It is hard to determine the degree of pragmatism in a particular trial since pragmatism doesn't have a single characteristic. Some aspects of a study may be more pragmatic than others. Additionally, logistical or protocol modifications made during a trial can change its pragmatism score. Additionally 36% of 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or 프라그마틱 사이트 conducted before approval and a majority of them were single-center. Therefore, they aren't quite as typical and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.
Another common aspect of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the sample. This can lead to unbalanced analyses with less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a significant problem because the secondary outcomes were not adjusted to account for the differences in baseline covariates.
In addition, pragmatic studies can pose difficulties in the gathering and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and 프라그마틱 무료 슬롯 (Bookmarkassist.com) are prone to reporting delays, inaccuracies, or coding variations. It is important to improve the accuracy and quality of the results in these trials.
Results
While the definition of pragmatism doesn't require that all clinical trials be 100% pragmatic there are benefits when incorporating pragmatic components into trials. These include:
Increased sensitivity to real-world issues which reduces study size and cost, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including patients who are routinely treated). However, 프라그마틱 정품 확인법 프라그마틱 정품 사이트 (visit the up coming internet page) pragmatic studies can also have drawbacks. For instance, the right type of heterogeneity could help the trial to apply its findings to a variety of patients and settings; however the wrong type of heterogeneity can reduce assay sensitiveness and consequently lessen the ability of a study to detect even minor effects of treatment.
Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support a physiological or clinical hypothesis, and pragmatic studies that help inform the choice for appropriate therapies in real world clinical practice. The framework was comprised of nine domains assessed on a scale of 1-5 with 1 being more informative and 5 being more pragmatic. The domains covered recruitment of intervention, setting up, delivery of intervention, flex adhering to the program and primary analysis.
The original PRECIS tool3 was built on the same scale and domains. Koppenaal et al10 developed an adaptation of this assessment, called the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic systematic reviews had higher average scores across all domains but lower scores in the primary analysis domain.
This distinction in the primary analysis domain could be due to the fact that most pragmatic trials analyse their data in an intention to treat method, whereas some explanatory trials do not. The overall score for pragmatic systematic reviews was lower when the domains of organisation, flexible delivery and follow-up were merged.
It is important to remember that a pragmatic trial doesn't necessarily mean a low-quality trial, and in fact there is an increasing number of clinical trials (as defined by MEDLINE search, but this is neither specific nor sensitive) which use the word "pragmatic" in their abstract or title. These terms may indicate that there is a greater understanding of pragmatism in abstracts and titles, however it's not clear whether this is evident in content.
Conclusions
In recent years, pragmatic trials have been gaining popularity in research as the value of real-world evidence is becoming increasingly acknowledged. They are randomized studies that compare real-world treatment options with new treatments that are being developed. They include patient populations more closely resembling those treated in regular care. This method is able to overcome the limitations of observational research such as the biases associated with the reliance on volunteers and the lack of the coding differences in national registry.
Pragmatic trials also have advantages, like the ability to use existing data sources and a greater likelihood of detecting meaningful differences from traditional trials. However, they may still have limitations which undermine their validity 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. Practical trials are often restricted by the need to enroll participants quickly. Additionally some pragmatic trials don't have 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 pragmatist and published up to 2022. They evaluated pragmatism using the PRECIS-2 tool, which includes the eligibility criteria for domains and recruitment criteria, as well as flexibility in adherence to intervention and follow-up. They discovered that 14 of the trials scored highly or pragmatic pragmatic (i.e. scores of 5 or 프라그마틱 무료 슬롯 more) in any one or more of these domains, and that the majority of these were single-center.
Trials with a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs that have specific criteria that are unlikely to be present in clinical practice, and they comprise patients from a wide variety of hospitals. These characteristics, according to the authors, may make pragmatic trials more relevant and useful in the daily clinical. However they do not ensure that a study is free of bias. Furthermore, the pragmatism of a trial is not a predetermined characteristic; a pragmatic trial that doesn't contain all the characteristics of a explanatory trial may yield reliable and relevant 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 research studies to evaluate the effect of treatment on trials that have different levels of pragmatism as well as other design features.
Background
Pragmatic trials provide evidence from the real world that can be used to make clinical decisions. However, the use of the term "pragmatic" is not consistent and its definition as well as assessment requires further clarification. Pragmatic trials should be designed to guide clinical practice and policy decisions, not to confirm an hypothesis that is based on a clinical or physiological basis. 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 distinction between explanation-based trials, as described by Schwartz & Lellouch1, which are designed to confirm the hypothesis in a more thorough manner.
Studies that are truly practical should avoid attempting to blind participants or healthcare professionals, as this may result in bias in estimates of the effect of treatment. Pragmatic trials should also seek to enroll patients from a wide range of health care settings to ensure that their findings can be applied to the real world.
Additionally, pragmatic trials should focus on outcomes that are crucial to patients, such as quality of life or functional recovery. This is particularly important in trials that require invasive procedures or have potentially harmful adverse effects. The CRASH trial29, for instance was 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. In addition, the catheter trial28 utilized symptomatic catheter-associated urinary tract infections as the primary outcome.
In addition to these features, pragmatic trials should minimize the trial's procedures and data collection requirements in order to reduce costs. Finaly, pragmatic trials should aim to make their findings as applicable to current clinical practice as is possible. This can be accomplished by ensuring their primary analysis is based on an intention-to treat approach (as described within CONSORT extensions).
Despite these criteria, many RCTs with features that challenge the notion of pragmatism were incorrectly labeled pragmatic and published in journals of all types. This can lead to misleading claims of pragmatism and the term's use should be standardized. The development of a PRECIS-2 tool that offers a standardized objective assessment of pragmatic features 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 care in real-world settings. This is different from explanatory trials that test hypotheses about the causal-effect relationship in idealized settings. Therefore, pragmatic trials could have less internal validity than explanatory trials and might be more susceptible to bias in their design, conduct, and analysis. Despite these limitations, pragmatic trials can contribute valuable information to decision-making in healthcare.
The PRECIS-2 tool measures the degree of pragmatism in an RCT by assessing it across 9 domains ranging from 1 (very explicit) to 5 (very pragmatic). In this study the areas of recruitment, organization and flexibility in delivery, flexible adherence and follow-up were awarded high scores. However, the main outcome and the method of missing data was scored below the pragmatic limit. This indicates that a trial can be designed with good practical features, but without damaging the quality.
It is hard to determine the degree of pragmatism in a particular trial since pragmatism doesn't have a single characteristic. Some aspects of a study may be more pragmatic than others. Additionally, logistical or protocol modifications made during a trial can change its pragmatism score. Additionally 36% of 89 pragmatic trials discovered by Koppenaal and colleagues were placebo-controlled or 프라그마틱 사이트 conducted before approval and a majority of them were single-center. Therefore, they aren't quite as typical and can only be called pragmatic in the event that their sponsors are supportive of the lack of blinding in such trials.
Another common aspect of pragmatic trials is that the researchers attempt to make their findings more relevant by analyzing subgroups of the sample. This can lead to unbalanced analyses with less statistical power. This increases the chance of omitting or ignoring differences in the primary outcomes. In the case of the pragmatic studies included in this meta-analysis this was a significant problem because the secondary outcomes were not adjusted to account for the differences in baseline covariates.
In addition, pragmatic studies can pose difficulties in the gathering and interpretation of safety data. This is because adverse events are generally reported by the participants themselves and 프라그마틱 무료 슬롯 (Bookmarkassist.com) are prone to reporting delays, inaccuracies, or coding variations. It is important to improve the accuracy and quality of the results in these trials.
Results
While the definition of pragmatism doesn't require that all clinical trials be 100% pragmatic there are benefits when incorporating pragmatic components into trials. These include:
Increased sensitivity to real-world issues which reduces study size and cost, and enabling the trial results to be more quickly transferred into real-world clinical practice (by including patients who are routinely treated). However, 프라그마틱 정품 확인법 프라그마틱 정품 사이트 (visit the up coming internet page) pragmatic studies can also have drawbacks. For instance, the right type of heterogeneity could help the trial to apply its findings to a variety of patients and settings; however the wrong type of heterogeneity can reduce assay sensitiveness and consequently lessen the ability of a study to detect even minor effects of treatment.
Several studies have attempted to categorize pragmatic trials using various definitions and scoring methods. Schwartz and Lellouch1 have developed a framework that can differentiate between explanation studies that support a physiological or clinical hypothesis, and pragmatic studies that help inform the choice for appropriate therapies in real world clinical practice. The framework was comprised of nine domains assessed on a scale of 1-5 with 1 being more informative and 5 being more pragmatic. The domains covered recruitment of intervention, setting up, delivery of intervention, flex adhering to the program and primary analysis.
The original PRECIS tool3 was built on the same scale and domains. Koppenaal et al10 developed an adaptation of this assessment, called the Pragmascope that was simpler to use for systematic reviews. They discovered that pragmatic systematic reviews had higher average scores across all domains but lower scores in the primary analysis domain.
This distinction in the primary analysis domain could be due to the fact that most pragmatic trials analyse their data in an intention to treat method, whereas some explanatory trials do not. The overall score for pragmatic systematic reviews was lower when the domains of organisation, flexible delivery and follow-up were merged.
It is important to remember that a pragmatic trial doesn't necessarily mean a low-quality trial, and in fact there is an increasing number of clinical trials (as defined by MEDLINE search, but this is neither specific nor sensitive) which use the word "pragmatic" in their abstract or title. These terms may indicate that there is a greater understanding of pragmatism in abstracts and titles, however it's not clear whether this is evident in content.
Conclusions
In recent years, pragmatic trials have been gaining popularity in research as the value of real-world evidence is becoming increasingly acknowledged. They are randomized studies that compare real-world treatment options with new treatments that are being developed. They include patient populations more closely resembling those treated in regular care. This method is able to overcome the limitations of observational research such as the biases associated with the reliance on volunteers and the lack of the coding differences in national registry.
Pragmatic trials also have advantages, like the ability to use existing data sources and a greater likelihood of detecting meaningful differences from traditional trials. However, they may still have limitations which undermine their validity 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. Practical trials are often restricted by the need to enroll participants quickly. Additionally some pragmatic trials don't have 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 pragmatist and published up to 2022. They evaluated pragmatism using the PRECIS-2 tool, which includes the eligibility criteria for domains and recruitment criteria, as well as flexibility in adherence to intervention and follow-up. They discovered that 14 of the trials scored highly or pragmatic pragmatic (i.e. scores of 5 or 프라그마틱 무료 슬롯 more) in any one or more of these domains, and that the majority of these were single-center.
Trials with a high pragmatism score tend to have more expansive eligibility criteria than traditional RCTs that have specific criteria that are unlikely to be present in clinical practice, and they comprise patients from a wide variety of hospitals. These characteristics, according to the authors, may make pragmatic trials more relevant and useful in the daily clinical. However they do not ensure that a study is free of bias. Furthermore, the pragmatism of a trial is not a predetermined characteristic; a pragmatic trial that doesn't contain all the characteristics of a explanatory trial may yield reliable and relevant results.
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