Outcome measures used in clinical research evaluating pre-hospital blood component transfusion in traumatically injured bleeding patients

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Harriet Tucker ◽  
Pascale Avery ◽  
Karim Brohi ◽  
Ross Davenport ◽  
Joanne Griggs ◽  
...  
1995 ◽  
Vol 81 (2) ◽  
pp. 272-278
Author(s):  
Douglas G. Clayton ◽  
Adelaida M. Miro ◽  
David J. Kramer ◽  
Nathaniel Rodman ◽  
Stanley Wearden

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e047341
Author(s):  
Caroline Marra ◽  
William J Gordon ◽  
Ariel Dora Stern

ObjectivesIn an effort to mitigate COVID-19 related challenges for clinical research, the US Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of connected digital products (CDPs), tools that enable remote patient monitoring and telehealth consultation, in clinical trials both before and after the onset of the pandemic.DesignWe applied a comprehensive text search algorithm to clinical trial registry data to identify trials that use CDPs for remote monitoring or telehealth. We compared CDP use in the months before and after the issuance of FDA guidance facilitating virtual clinical trials.SettingAll trials registered on ClinicalTrials.gov with start dates from May 2019 through February 2021.Outcome measuresThe primary outcome measure was the overall percentage of CDP use in clinical trials started in the 10 months prior to the pandemic onset (May 2019–February 2020) compared with the 10 months following (May 2020–February 2021). Secondary outcome measures included CDP usage by trial type (interventional, observational), funder type (industry, non-industry) and diagnoses (COVID-19 or non-COVID-19 participants).ResultsCDP usage in clinical trials increased by only 1.65 percentage points, from 14.19% (n=23 473) of all trials initiated in the 10 months prior to the pandemic onset to 15.84% (n=26 009) of those started in the 10 months following (p<0.01). The increase occurred primarily in observational studies and non-industry funded trials and was driven entirely by CDP usage in trials for COVID-19.ConclusionsThese findings suggest that in the short-term, new options created by regulatory guidance to stimulate telehealth and remote monitoring were not widely incorporated into clinical research. In the months immediately following the pandemic onset, CDP adoption increased primarily in observational and non-industry funded studies where virtual protocols are likely medically necessary due to the participants’ COVID-19 diagnosis.


2010 ◽  
Vol 1 (1) ◽  
pp. 1 ◽  
Author(s):  
Pedro S. A. Wolf ◽  
W. Jake Jacobs

Animal behaviorists have made extensive use of GPS technology since 1991. In contrast, psychological research has made little use of the technology, even though the technology is relatively inexpensive, familiar, and widespread. Hence, its potential for pure and applied psychological research remains untapped. We describe three methods psychologists could apply to individual differences research, clinical research, or spatial use research. In the context of individual differences research, GPS technology permits us to test hypotheses predicting specific relations among patterns of spatial use and individual differences variables. In a clinical context, GPS technology provides outcome measures that may relate to the outcome of interventions designed to treat psychological disorders that, for example, may leave a person homebound (e.g. Agoraphobia, PTSD, TBI). Finally, GPS technology provides natural measures of spatial use. We, for example, used GPS technology to quantify traffic flow and exhibit use at the Arizona Sonora Desert Museum. Interested parties could easily extend this methodology some aspects of urban planning or business usage.  DOI:10.2458/azu_jmmss_v1i1_wolf


Surgery ◽  
2014 ◽  
Vol 156 (3) ◽  
pp. 564-569 ◽  
Author(s):  
Hunter B. Moore ◽  
Ernest E. Moore ◽  
Theresa L. Chin ◽  
Eduardo Gonzalez ◽  
Michael P. Chapman ◽  
...  

2007 ◽  
Vol 131 (5) ◽  
pp. 708-718 ◽  
Author(s):  
Anne F. Eder ◽  
Linda A. Chambers

Abstract Context.—Serious noninfectious complications are far more likely to occur than viral disease transmission from blood component transfusion. Objective.—To compile a comprehensive list of the noninfectious risks of transfusion, examples of published risk estimates, and summaries of recent information regarding cause, prevention, or management of noninfectious transfusion risks. Data Sources.—Information was obtained from peer-reviewed English-language medical journal publications since 1990. Conclusions.—Early complications, although potentially more serious, usually occur less frequently (&lt;1 in 1000 transfusions) than late complications, which often affect more than 1% of recipients. Areas of active investigation and discussion include acute hemolytic reactions, transfusion-related acute lung injury, red cell alloimmunization, platelet transfusion refractoriness, and transfusion immunosuppression. Continued effort toward research and education to promote recognition and prevention of noninfectious complications associated with blood components is warranted.


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