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The Journal of Urology Feb 2022
Topics: Diagnostic Tests, Routine; Humans; Magnetic Resonance Imaging
PubMed: 34784726
DOI: 10.1097/JU.0000000000002324 -
Best Practice & Research. Clinical... Jun 2020Preoperative laboratory testing is often necessary and can be invaluable for diagnosis, assessment, and treatment. However, performing routine laboratory tests for... (Review)
Review
Preoperative laboratory testing is often necessary and can be invaluable for diagnosis, assessment, and treatment. However, performing routine laboratory tests for patients who are considered otherwise healthy is not usually beneficial and is costly. It is estimated that $18 billion (U.S.) is spent annually on preoperative testing, although how much is wasteful remains unknown. Ideally, a targeted and comprehensive patient history and physical exam should largely determine whether preprocedure laboratory studies should be obtained. Healthcare providers, primarily anesthesiologists, should remain cost-conscious when ordering specific laboratory or imaging tests prior to surgery based on available literature. We review the overall evidence and key points from the Choosing Wisely guidelines, the identification of potential wasteful practices, possible harms of testing, and key clinical findings associated with preoperative laboratory testing.
Topics: Cross-Sectional Studies; Diagnostic Tests, Routine; Humans; Practice Guidelines as Topic; Preoperative Care; Retrospective Studies; Societies, Medical
PubMed: 32711836
DOI: 10.1016/j.bpa.2020.04.006 -
European Journal of Endocrinology Feb 2021Diagnostic accuracy studies are fundamental for the assessment of diagnostic tests. Researchers need to understand the implications of their chosen design, opting for...
Diagnostic accuracy studies are fundamental for the assessment of diagnostic tests. Researchers need to understand the implications of their chosen design, opting for comparative designs where possible. Researchers should analyse test accuracy studies using the appropriate methods, acknowledging the uncertainty of results and avoiding overstating conclusions and ignoring the clinical situation which should inform the trade-off between sensitivity and specificity. Test accuracy studies should be reported with transparency using the STAndards for the Reporting of Diagnostic accuracy studies (STARD) checklist.
Topics: Checklist; Diagnostic Techniques, Endocrine; Diagnostic Tests, Routine; Humans; Random Allocation; Reference Values; Research Design; Sample Size; Sensitivity and Specificity
PubMed: 33410763
DOI: 10.1530/EJE-20-1239 -
Journal of Clinical Epidemiology Jan 2021New diagnostic tests to identify a well-established disease state must undergo a series of scientific studies from test construction to finally demonstrating a societal...
BACKGROUND AND OBJECTIVE
New diagnostic tests to identify a well-established disease state must undergo a series of scientific studies from test construction to finally demonstrating a societal impact. Traditionally, these studies are performed with substantial time gaps in between, resulting in a long time period from the initial idea to roll out in clinical practice including reimbursement. Seamless designs allowing us to combine a sequence of studies in one protocol may hence accelerate this process. Currently, a systematic investigation of the potential of seamless designs in diagnostic research is lacking.
METHODS
We identify major study types in diagnostic research and their basic characteristics with respect to the application of seamless designs. This information is used to identify major hurdles and opportunities for seamless designs.
RESULTS
The following major study types were identified: Variable construction studies, cut point finding studies, variable value studies, single-arm accuracy studies, comparative accuracy studies, change-in-management studies, observational discordant pair studies, randomized discordant pair studies, and randomized diagnostic studies. The following characteristics were identified: Type of recruitment (case-control vs. population-based), application of a reference standard, inclusion of a comparator, paired or unpaired application of a comparator, assessment of patient-relevant outcomes, and possibility for blinding of test results. Two basic hurdles could be identified: 1) Accuracy studies are hard to combine with postaccuracy studies in a seamless design for the following reasons. First, because the former are required to justify the latter and application of a reference test in outcome studies may be a threat to the integrity of the study. 2) Randomized diagnostic studies are probably best placed as singular studies at the end of the process, as all other questions should be clarified before performing such a study. However, otherwise there is a substantial potential for seamless designs. All steps from the construction to the comparison with the comparator can be combined in one protocol. This may include a switch from case-control to population-based recruitment as well as a switch from a single-arm study to a comparative accuracy study. In addition, change-in-management studies can be combined with an outcome study in discordant pairs.
CONCLUSION
There is a potential for seamless designs in diagnostic research. It is wise to have the whole sequence of necessary studies in mind and to plan a full programme than rather individual studies one by one.
Topics: Comparative Effectiveness Research; Data Accuracy; Diagnostic Tests, Routine; Humans; Patient Selection; Randomized Controlled Trials as Topic; Reference Standards; Research Design; Treatment Outcome
PubMed: 32991994
DOI: 10.1016/j.jclinepi.2020.09.019 -
Acta Paediatrica (Oslo, Norway : 1992) Jun 2022
Topics: Asthma; Child; Diagnostic Tests, Routine; Humans
PubMed: 35146796
DOI: 10.1111/apa.16278 -
Expert Review of Molecular Diagnostics Dec 2020: Preterm birth (PTB) is common, occurring in over 10% of all live births globally, and is increasing worldwide. The limitations of traditional biomarkers of PTB, such...
: Preterm birth (PTB) is common, occurring in over 10% of all live births globally, and is increasing worldwide. The limitations of traditional biomarkers of PTB, such as fetal fibronectin (fFN) and phosphorylated insulin-like growth factor-binding protein-1 (phIGFBP-1) have been well demonstrated in the literature. Therefore, augmenting clinical assessment with newer biomarkers, such as placental alpha macroglobulin-1 (PAMG-1); PartoSure, has the potential to improve disease monitoring and the best interventions. : The present expert opinion evaluates the utility and limitations of PAMG-1; PartoSure as a biomarker for PTB in light of the current literature. : Although fFN, phIGFBP-1 and PAMG-1; PartoSure test had similar negative predictive value (NPV) and negative likelihood ratio (LR-), the PAMG-1; PartoSure test had the highest specificity, positive predictive value (PPV), and positive likelihood ratio (LR+) across all at-risk pregnant women. Although findings of this review may be encouraging, the PartoSure test should not be interpreted as absolute evidence for prediction of PTB. The PartoSure test result should always be used in conjunction with information available from the clinical evaluation of the pregnant woman and other diagnostic procedures such as cervical examination, assessment of uterine activity, and evaluation of other risk factors.
Topics: Biomarkers; Diagnostic Tests, Routine; Female; Humans; Infant, Newborn; Insulin-Like Growth Factor Binding Protein 1; Pregnancy; Premature Birth; Reproducibility of Results; Sensitivity and Specificity
PubMed: 33175636
DOI: 10.1080/14737159.2020.1848549 -
Critical Care Medicine Jan 2022
Topics: Coronavirus; Coronavirus Infections; Diagnostic Tests, Routine; Humans; Judgment
PubMed: 34407038
DOI: 10.1097/CCM.0000000000005248 -
Critical Care (London, England) Nov 2019
Topics: Anti-Bacterial Agents; Diagnostic Tests, Routine; Humans; Infections; Practice Patterns, Physicians'; Sepsis
PubMed: 31783896
DOI: 10.1186/s13054-019-2675-3 -
JAMA Jun 2023
Topics: Diagnostic Tests, Routine; Clinical Trials as Topic; Diagnostic Techniques and Procedures; Treatment Outcome
PubMed: 37338887
DOI: 10.1001/jama.2023.8972 -
Journal of Clinical Microbiology Jul 2020In this commentary, we provide a broad overview of how the rapidly evolving coronavirus disease 2019 (COVID-19) diagnostic landscape has impacted clinical care during... (Review)
Review
In this commentary, we provide a broad overview of how the rapidly evolving coronavirus disease 2019 (COVID-19) diagnostic landscape has impacted clinical care during the COVID-19 pandemic. We review aspects of both molecular and serologic testing and discuss the logistical challenges faced with each. We also highlight the progress that has been made in the development and implementation of these assays as well as the need for ongoing improvement in diagnostic testing capabilities.
Topics: Betacoronavirus; COVID-19; COVID-19 Testing; Clinical Laboratory Techniques; Coronavirus Infections; Diagnostic Tests, Routine; Humans; Pandemics; Pneumonia, Viral; SARS-CoV-2
PubMed: 32703894
DOI: 10.1128/JCM.01287-20