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프라그마틱 체험 is a noncommercial open data platform and infrastructure that supports research on pragmatic trials It is a platform that collects and shares clean trial data and ratings using PRECIS2 permitting multiple and varied metaepidemiological studies that examine the effects of treatment across trials with different levels of pragmatism as well as other design features Background Pragmatic trials are becoming more widely recognized as providing realworld evidence for clinical decision making However the use of the term pragmatic is not consistent and its definition and assessment requires further clarification Pragmatic trials should be designed to inform policy and clinical practice decisions not to confirm an hypothesis that is based on a clinical or physiological basis A pragmatic study should try to be as similar to actual clinical practice as possible including in its recruitment of participants setting up and design as well as the implementation of the intervention as well as the determination and analysis of outcomes and primary analysis This is a major distinction from explanation trials as described by Schwartz and Lellouch1 which are intended to provide a more thorough confirmation of an idea Studies that are truly pragmatic must not attempt to blind participants or clinicians as this may result in bias in estimates of the effects of treatment Practical trials should also aim to recruit patients from a variety of health care settings to ensure that the results can be compared to the real world Finally pragmatic trials should focus on outcomes that are vital to patients like quality of life or functional recovery This is particularly relevant in trials that involve invasive procedures or those with potential for dangerous adverse events The CRASH trial29 for example was focused on functional outcomes to evaluate a twopage case report with an electronic system for the monitoring of patients admitted to hospitals with chronic heart failure and the catheter trial28 utilized urinary tract infections caused by catheters as the primary outcome In addition to these characteristics pragmatic trials should minimize trial procedures and datacollection requirements to cut down on costs and time commitments Additionally these trials should strive to make their findings as applicable to current clinical practices as they can This can be achieved by ensuring their primary analysis is based on the intentionto treat method as defined in CONSORT extensions Many RCTs which do not meet the criteria for pragmatism but have features that are contrary to pragmatism have been published in journals of varying types and incorrectly labeled as pragmatic This can lead to misleading claims of pragmatism and the use of the term should be standardised The creation of the PRECIS2 tool which offers an objective and standard assessment of pragmatic features is a good initial step Methods In a practical trial it is the intention to inform clinical or policy decisions by demonstrating how an intervention would be incorporated into realworld routine care Explanatory trials test hypotheses about the causeeffect relationship within idealised settings In this way pragmatic trials could have a lower internal validity than studies that explain and are more susceptible to biases in their design analysis conduct and design Despite their limitations pragmatic studies can provide valuable information for decisionmaking within the context of healthcare The PRECIS2 tool assesses the degree of pragmatism within an RCT by assessing it across 9 domains ranging from 1 very explicative to 5 very pragmatic In this study the recruitment organization flexibility in delivery flexible adherence and followup domains were awarded high scores however the primary outcome and the method of missing data fell below the pragmatic limit This suggests that it is possible to design a trial that has highquality pragmatic features without harming the quality of the outcomes It is hard to determine the amount of pragmatism in a particular study because pragmatism is not a have a single attribute Certain aspects of a study can be more pragmatic than other The pragmatism of a trial can be affected by modifications to the protocol or the logistics during the trial In addition 36 of the 89 pragmatic trials identified by Koppenaal and colleagues were placebocontrolled or conducted prior to licensing and the majority were singlecenter They are not close to the usual practice and are only called pragmatic if their sponsors agree that these trials arent blinded A typical feature of pragmatic studies is that researchers try to make their findings more relevant by studying subgroups within the trial However this often leads to unbalanced comparisons and lower statistical power thereby increasing the likelihood of missing or misinterpreting differences in the primary outcome In the case of the pragmatic trials included in this metaanalysis this was a serious issue because the secondary outcomes were not adjusted to account for variations in the baseline covariates Additionally studies that are pragmatic can present challenges in the collection and interpretation safety data This is due to the fact that adverse events are usually selfreported and are susceptible to reporting delays inaccuracies or coding variations It is therefore important to improve the quality of outcomes assessment in these trials ideally by using national registry databases instead of relying on participants to report adverse events in the trials database Results While the definition of pragmatism doesnt require that clinical trials be 100 pragmatist There are advantages of including pragmatic elements in trials These include By including routine patients the results of the trial can be more quickly translated into clinical practice However pragmatic studies can also have disadvantages For instance the appropriate kind of heterogeneity can allow a trial to generalise its results to many different patients and settings however the wrong type of heterogeneity may reduce the assays sensitivity and therefore decrease the ability of a study to detect small treatment effects A variety of studies have attempted to categorize pragmatic trials using various definitions and scoring methods Schwartz and Lellouch1 created a framework to distinguish between explanatory trials that confirm the clinical or physiological hypothesis and pragmatic trials that inform the selection of appropriate treatments in the realworld clinical setting Their framework comprised nine domains that were scored on a scale of 15 with 1 indicating more explanatory and 5 indicating more pragmatic The domains included recruitment and setting up the delivery of intervention flex compliance and primary analysis The original PRECIS tool3 was built on the same scale and domains Koppenaal and colleagues10 developed an adaptation to this assessment dubbed the Pragmascope that was easier to use in systematic reviews Highly recommended Website found that pragmatic systematic reviews had a higher average scores across all domains but lower scores in the primary analysis domain This difference in primary analysis domains could be explained by the way most pragmatic trials analyse data Certain explanatory trials however dont The overall score for pragmatic systematic reviews was lower when the domains of organisation flexible delivery and followingup were combined It is crucial to keep in mind that a study that is pragmatic does not mean a lowquality trial In fact there are increasing numbers of clinical trials that use the term pragmatic either in their title or abstract as defined by MEDLINE but that is neither precise nor sensitive The use of these words in abstracts and titles may suggest a greater awareness of the importance of pragmatism however it is not clear if this is reflected in the content of the articles Conclusions As appreciation for the value of realworld evidence becomes increasingly commonplace the pragmatic trial has gained momentum in research They are randomized clinical trials that evaluate realworld alternatives to care rather than experimental treatments under development they have patients which are more closely resembling the patients who receive routine care they use comparators that are used in routine practice eg existing drugs and depend on participants selfreports of outcomes This method can help overcome the limitations of observational studies which include the biases that arise from relying on volunteers and the limited availability and coding variability in national registries Pragmatic trials have other advantages such as the ability to use existing data sources and a greater probability of detecting meaningful differences from traditional trials However pragmatic tests may have some limitations that limit their reliability and generalizability For example participation rates in some trials may be lower than anticipated due to the healthyvolunteer effect and financial incentives or competition for participants from other research studies eg industry trials A lot of pragmatic trials are limited by the need to enroll participants quickly Additionally some pragmatic trials lack controls to ensure that the observed differences arent due to biases in trial conduct The authors of the Pragmatic Free Trial Meta identified 48 RCTs selflabeled as pragmatist and published up to 2022 They assessed pragmatism by using the PRECIS2 tool that includes the eligibility criteria for domains and recruitment criteria as well as flexibility in adherence to intervention and followup They discovered 14 trials scored highly pragmatic or pragmatic ie scoring 5 or more in at least one of these domains Trials with a high pragmatism rating tend to have broader eligibility criteria than traditional RCTs which include very specific criteria that are not likely to be present in the clinical setting and comprise patients from a wide range of hospitals According to the authors could make pragmatic trials more relevant and relevant to everyday clinical However they do not guarantee that a trial is free of bias The pragmatism principle is not a fixed attribute the test that does not possess all the characteristics of an explanatory study could still yield valid and useful outcomes