Dataset Information

Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.

ABSTRACT: To assess the pragmatism of published critical care randomized controlled trials self-described as pragmatic using a validated tool.

Data sources

Medical Literature Analysis and Retrieval Online database and PubMed interface from inception to November 1, 2021.

Study selection

We performed a systematic search of randomized controlled trials evaluating interventions for critically ill adults that self-identified as pragmatic in title or abstract.

Data extraction

Reviewers independently performed study selection and data extraction in duplicate; discrepancies were resolved by consensus. Pragmatism was assessed independently in duplicate by trained reviewers using the Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2), a validated tool designed to represent how explanatory/pragmatic a trial is on the pragmatic to explanatory continuum. Trials were scored in nine domains on a 5-point continuum (from 1 = very explanatory to 5 = very pragmatic). Discrepancies of greater than 2 points were adjudicated by consensus discussion.

Data synthesis

The search resulted in 284 studies; 56 met eligibility criteria. Forty-one of the trials had a discrepancy in at least one domain that required consensus discussion, most commonly in domains of eligibility and follow-up. Twelve studies (21.4%) were scored as "overall pragmatic," defined as score of greater than 4 in five domains provided the scores in the remaining domains were three. The overall PRECIS-2 score of self-identified pragmatic studies increased from 1995 to 2021 suggesting increasing pragmatism over time. Pragmatic trials were more likely to have a waiver of informed consent (p = 0.05).

Conclusions

The number and pragmatism of self-identified pragmatic trials have increased, particularly in the past decade. However, less than one-quarter of these trials that use the term pragmatic in title or abstract were retrospectively rated as pragmatic. Our results support the concept that trials are designed on a spectrum of pragmatic to explanatory. Advances in the design and reporting of critical care trials are needed to ensure their real-world applicability.

SUBMITTER: Palakshappa JA

PROVIDER: S-EPMC9312432 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.

Palakshappa Jessica A JA Gibbs Kevin W KW Lannan Margo T MT Cranford Anna R AR Taylor Stephanie P SP

Critical care explorations 20220722 7

To assess the pragmatism of published critical care randomized controlled trials self-described as pragmatic using a validated tool.<h4>Data sources</h4>Medical Literature Analysis and Retrieval Online database and PubMed interface from inception to November 1, 2021.<h4>Study selection</h4>We performed a systematic search of randomized controlled trials evaluating interventions for critically ill adults that self-identified as pragmatic in title or abstract.<h4>Data extraction</h4>Reviewers inde ...[more]

PMID: 35923590

Similar Datasets

Project description:BackgroundPragmatic clinical trials (PCTs) are designed to reflect how an investigational treatment would be applied in clinical practice. As such, unlike their explanatory counterparts, they measure therapeutic effectiveness and are capable of generating high-quality real-world evidence. However, the conduct of PCTs remains extremely rare. The scarcity of such studies has contributed to the emergence of the efficacy-effectiveness gap and has led to calls for launching more of them, including in the field of oncology. This analysis aimed to identify self-labelled pragmatic trials of antineoplastic interventions and to evaluate whether their use of this label was justified.MethodsWe searched PubMed® and Embase® for publications corresponding with studies that investigated antitumor therapies and that were tagged as pragmatic in their titles, abstracts and/or index terms. Subsequently, we consulted all available source documents for the included trials and extracted relevant information from them. The data collected were then used to appraise the degree of pragmatism displayed by the PCTs with the help of the validated PRECIS-2 tool.ResultsThe literature search returned 803 unique records, of which 46 were retained upon conclusion of the screening process. This ultimately resulted in the identification of 42 distinct trials that carried the 'pragmatic' label. These studies examined eight different categories of neoplasms and were mostly randomized, open-label, multicentric, single-country trials sponsored by non-commercial parties. On a scale of one (very explanatory) to five (very pragmatic), the median PCT had a PRECIS-2 score per domain of 3.13 (interquartile range: 2.57-3.53). The most and least pragmatic studies in the sample had a score of 4.44 and 1.57, respectively. Only a minority of trials were described in sufficient detail to allow them to be graded across all domains of the PRECIS-2 instrument. Many of the studies examined also had features that arguably precluded them from being pragmatic altogether, such as being monocentric or placebo-controlled in nature.ConclusionPCTs of antineoplastic treatments are generally no more pragmatic than they are explanatory.

Project description:IntroductionEvidence from randomized controlled trials (RCTs) is required to guide treatment of critically ill children, but the number of RCTs available is limited and the publications are often difficult to find. The objectives of this review were to systematically identify RCTs in pediatric critical care and describe their methods and reporting.MethodsWe searched MEDLINE, EMBASE, LILACS and CENTRAL (from inception to April 16, 2013) and reference lists of included RCTs and relevant systematic reviews. We included published RCTs administering any intervention to children in a pediatric ICU. We excluded trials conducted in neonatal ICUs, those enrolling exclusively preterm infants, and individual patient crossover trials. Pairs of reviewers independently screened studies for eligibility, assessed risk of bias, and abstracted data. Discrepancies were resolved by consensus.ResultsWe included 248 RCTs: 45 (18%) were multicentered and 14 (6%) were multinational. Trials most frequently enrolled both medical and surgical patients (43%) but postoperative cardiac surgery was the single largest population studied (19%). The most frequently evaluated types of intervention were medications (63%), devices (11%) and nutrition (8%). Laboratory or physiological measurements were the most frequent type of primary outcomes (18%). Half of these trials (50%) reported blinding. Of the 107 (43%) trials that reported an a priori sample size, 34 (32%) were stopped early. The median number of children randomized per trial was 49 and ranged from 6 to 4,947. The frequency of RCT publications increased at a mean rate of 0.7 RCTs per year (P<0.001) from 1 to 20 trials per year.ConclusionsThis scoping review identified the available RCTs in pediatric critical care and made them accessible to clinicians and researchers (http://epicc.mcmaster.ca). Most focused on medications and intermediate or surrogate outcomes, were single-centered and were conducted in North America and Western Europe. The results of this review underscore the need for trials with rigorous methodology, appropriate outcome measures, and improved quality of reporting to ensure that high quality evidence exists to support clinical decision-making in this vulnerable population.

Project description:BackgroundThe recent focus on the critical setting, especially with the COVID-19 pandemic, has highlighted the need for minimizing contact-based care and increasing robotic use. Robotics is a rising field in the context of health care, and we sought to evaluate the use of robots in critical care settings.ObjectiveAlthough robotic presence is prevalent in the surgical setting, its role in critical care has not been well established. We aimed to examine the uses and limitations of robots for patients who are critically ill.MethodsThis systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. MEDLINE, Embase, IEEE Xplore, and ACM Library were searched from their inception to December 23, 2021. Included studies involved patients requiring critical care, both in intensive care units or high-dependency units, or settings that required critical care procedures (eg, intubation and cardiopulmonary resuscitation). Randomized trials and observational studies were included.ResultsA total of 33 studies were included. The greatest application of robots in the intensive care unit was in the field of telepresence, whereby robots proved advantageous in providing a reduced response time, earlier intervention, and lower mortality rates. Challenges of telepresence included regulatory and financial barriers. In therapy and stroke rehabilitation, robots achieved superior clinical outcomes safely. Robotic use in patient evaluation and assessment was mainly through ultrasound evaluation, obtaining satisfactory to superior results with the added benefits of remote assessment, time savings, and increased efficiency. Robots in drug dispensing and delivery increased efficiency and generated cost savings. All the robots had technological limitations and hidden costs.ConclusionsOverall, our results show that robotic use in critical care settings is a beneficial, effective, and well-received intervention that delivers significant benefits to patients, staff, and hospitals. Looking ahead, it is necessary to form strong ethical and legislative frameworks and overcome various regulatory and financial barriers.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42021234162; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=234162.

Project description:BackgroundRemote self-administered visual acuity (VA) tests have the potential to allow patients and non-specialists to assess vision without eye health professional input. Validation in pragmatic trials is necessary to demonstrate the accuracy and reliability of tests in relevant settings to justify deployment. Here, published pragmatic trials of these tests were synthesised to summarise the effectiveness of available options and appraise the quality of their supporting evidence.MethodsA systematic review was undertaken in accordance with a preregistered protocol (CRD42022385045). The Cochrane Library, Embase, MEDLINE, and Scopus were searched. Screening was conducted according to the following criteria: (1) English language; (2) primary research article; (3) visual acuity test conducted out of eye clinic; (4) no clinical administration of remote test; (5) accuracy or reliability of remote test analysed. There were no restrictions on trial participants. Quality assessment was conducted with QUADAS-2.ResultsOf 1227 identified reports, 10 studies were ultimately included. One study was at high risk of bias and two studies exhibited concerning features of bias; all studies were applicable. Three trials-of DigiVis, iSight Professional, and Peek Acuity-from two studies suggested that accuracy of the remote tests is comparable to clinical assessment. All other trials exhibited inferior accuracy, including conflicting results from a pooled study of iSight Professional and Peek Acuity. Two studies evaluated test-retest agreement-one trial provided evidence that DigiVis is as reliable as clinical assessment. The three most accurate tests required access to digital devices. Reporting was inconsistent and often incomplete, particularly with regards to describing methods and conducting statistical analysis.ConclusionsRemote self-administered VA tests appear promising, but further pragmatic trials are indicated to justify deployment in carefully defined contexts to facilitate patient or non-specialist led assessment. Deployment could augment teleophthalmology, non-specialist eye assessment, pre-consultation triage, and autonomous long-term monitoring of vision.

Project description:BackgroundPragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision.MethodsMEDLINE, Embase, CINAHL and PsycINFO were searched from inception to January 2022. Articles and book chapters that discussed how to identify or develop usual care comparators were included. Experts in the field were also contacted. Reference lists and forward citation searches of included articles were screened. Data were analysed using a narrative synthesis approach.ResultsOne thousand nine hundred thirty records were identified, 1611 titles and abstracts screened, 112 full texts screened, and 16 articles included in the review. Results indicated that the content of a usual care comparator should be informed by the aims of the trial, existing care practices, clinical guidelines, and characteristics of the target population. Its content should also be driven by the trial's requirements to protect participants, inform practice, and be methodologically robust, efficient, feasible and acceptable to stakeholders. When deciding the content of usual care, researchers will need to gather information about these drivers, balance tensions that might occur when responding to different trial objectives, and decide how usual care will be described and monitored in the trial.DiscussionWhen deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial's design phase.Trial registrationPROSPERO CRD42022307324.

Dataset Information

Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.

Data sources

Study selection

Data extraction

Data synthesis

Conclusions

Publications

Systematic Review of the "Pragmatism" of Pragmatic Critical Care Trials.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets