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Future Microbiology 2015Despite enormous progress, tuberculosis (TB) is still a major global health problem. Poor patients' adherence to the current treatment leads to the emergence of... (Review)
Review
Despite enormous progress, tuberculosis (TB) is still a major global health problem. Poor patients' adherence to the current treatment leads to the emergence of multidrug resistant (MDR) and extensively drug resistant (XDR) strains. While increased numbers of MDR-TB cases can be ascribed to difficulties in treating TB-HIV coinfected patients, many studies demonstrated that the emergence of drug-resistant TB is clearly linked to misdiagnosis and mismanagement of drug-susceptible TB. Therefore, rapid detection and proper treatment are needed globally to both cure TB patients and prevent wide spreading of the disease. This paper provides a survey of the major strategies that have been explored for overcoming drug resistance in TB.
Topics: Antitubercular Agents; Diagnostic Tests, Routine; Drug Resistance, Bacterial; Drug Therapy; Humans; Medication Adherence; Mycobacterium; Tuberculosis
PubMed: 26516679
DOI: 10.2217/fmb.15.76 -
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 -
Malaria Journal Mar 2016Symptoms caused by bacterial, viral and malarial infections usually overlap and aetiologic diagnosis is difficult. Patient management in low-resource countries with... (Review)
Review
Symptoms caused by bacterial, viral and malarial infections usually overlap and aetiologic diagnosis is difficult. Patient management in low-resource countries with limited laboratory services has been based predominantly on clinical evaluation and syndromic approaches. However, such clinical assessment has limited accuracy both for identifying the likely aetiological cause and for the early recognition of patients who will progress to serious or fatal disease. Plasma-detectable biomarkers that rapidly and accurately diagnose severe infectious diseases could reduce morbidity and decrease the unnecessary use of usually scarce therapeutic drugs. The discovery of microRNAs (miRNAs) has opened exciting new avenues to identify blood biomarkers of organ-specific injury. This review assesses current knowledge on the relationship between malaria disease and miRNAs, and evaluates how future research might lead to the use of these small molecules for identifying patients with severe malaria disease and facilitate treatment decisions.
Topics: Diagnostic Tests, Routine; Host-Pathogen Interactions; Humans; Malaria; MicroRNAs; Molecular Diagnostic Techniques
PubMed: 26979504
DOI: 10.1186/s12936-016-1222-9 -
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 -
Journal of Clinical Epidemiology Dec 2017In this first of a series of five articles, we provide an overview of how and why healthcare-related tests and diagnostic strategies are currently applied. We also... (Review)
Review
OBJECTIVES
In this first of a series of five articles, we provide an overview of how and why healthcare-related tests and diagnostic strategies are currently applied. We also describe how our findings can be integrated with existing frameworks for making decisions that guide the use of healthcare-related tests and diagnostic strategies.
STUDY DESIGN AND SETTING
We searched MEDLINE, references of identified articles, chapters in relevant textbooks, and identified articles citing classic literature on this topic.
RESULTS
We provide updated frameworks for the potential roles and applications of tests with suggested definitions and practical examples. We also discuss study designs that are commonly used to assess tests' performance and the effects of tests on people's health. These designs include diagnostic randomized controlled trials and retrospective validation. We describe the utility of these and other currently suggested designs, which questions they can answer and which ones they cannot. In addition, we summarize the challenges unique to decision-making resulting from the use of tests.
CONCLUSION
This overview highlights current challenges in the application of tests in decision-making in healthcare, provides clarifications, and informs the proposed solutions.
Topics: Clinical Decision-Making; Delivery of Health Care; Diagnostic Tests, Routine; Female; Health Services; Humans; Male; Practice Guidelines as Topic; Quality Control
PubMed: 28916488
DOI: 10.1016/j.jclinepi.2017.09.003 -
Journal of Clinical Microbiology Oct 2017
Topics: Bias; Datasets as Topic; Diagnostic Tests, Routine; Predictive Value of Tests; Reference Standards
PubMed: 28947507
DOI: 10.1128/JCM.00969-17 -
Preventive Veterinary Medicine May 2018A systematic review was conducted to identify studies with data for statistical meta-analyses of sensitivity (Se) and specificity (Sp) of ante-mortem and post-mortem... (Review)
Review
A systematic review was conducted to identify studies with data for statistical meta-analyses of sensitivity (Se) and specificity (Sp) of ante-mortem and post-mortem diagnostic tests for bovine tuberculosis (bTB) in cattle. Members of a working group (WG) developed and tested search criteria and developed a standardised two-stage review process, to identify primary studies with numerator and denominator data for test performance and an agreed range of covariate data. No limits were applied to year, language, region or type of test in initial searches of electronic databases. In stage 1, titles and available abstracts were reviewed. References that complied with stage 1 selection criteria were reviewed in entirety and agreed data were extracted from references that complied with stage 2 selection criteria. At stage 1, 9782 references were reviewed and 261 (2.6%) passed through to stage 2 where 215 English language references were each randomly allocated to two of 18 WG reviewers and 46 references in other languages were allocated to native speakers. Agreement regarding eligibility between reviewers of the same reference at stage 2 was moderate (Kappa statistic = 0.51) and a resolution procedure was conducted. Only 119 references (published 1934-2009) were identified with eligible performance estimates for one or more of 14 different diagnostic test types; despite a comprehensive search strategy and the global impact of bTB. Searches of electronic databases for diagnostic test performance data were found to be nonspecific with regard to identifying references with diagnostic test Se or Sp data. Guidelines for the content of abstracts to research papers reporting diagnostic test performance are presented. The results of meta-analyses of the sensitivity and specificity of the tests, and of an evaluation of the methodological quality of the source references, are presented in accompanying papers (Nuñez-Garcia et al., 2017; Downs et al., 2017).
Topics: Animals; Autopsy; Cattle; Diagnostic Tests, Routine; Sensitivity and Specificity; Tuberculosis, Bovine
PubMed: 29395122
DOI: 10.1016/j.prevetmed.2017.11.004 -
Computational and Mathematical Methods... 2019Diagnostic tests are approaches used in clinical practice to identify with high accuracy the disease of a particular patient and thus to provide early and proper... (Review)
Review
Diagnostic tests are approaches used in clinical practice to identify with high accuracy the disease of a particular patient and thus to provide early and proper treatment. Reporting high-quality results of diagnostic tests, for both basic and advanced methods, is solely the responsibility of the authors. Despite the existence of recommendation and standards regarding the content or format of statistical aspects, the quality of what and how the statistic is reported when a diagnostic test is assessed varied from excellent to very poor. This article briefly reviews the steps in the evaluation of a diagnostic test from the anatomy, to the role in clinical practice, and to the statistical methods used to show their performances. The statistical approaches are linked with the phase, clinical question, and objective and are accompanied by examples. More details are provided for phase I and II studies while the statistical treatment of phase III and IV is just briefly presented. Several free online resources useful in the calculation of some statistics are also given.
Topics: Clinical Laboratory Techniques; Cohort Studies; Cost-Benefit Analysis; Cross-Sectional Studies; Diagnostic Errors; Diagnostic Tests, Routine; False Positive Reactions; Humans; Internet; ROC Curve; Reference Values; Reproducibility of Results; Research Design; Statistics as Topic
PubMed: 31275427
DOI: 10.1155/2019/1891569