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Journal of Clinical Epidemiology Dec 2017The objective of this study was to identify and describe critical appraisal tools designed for assessing the quality of evidence (QoE) and/or strength of recommendations... (Review)
Review
Decision making about healthcare-related tests and diagnostic test strategies. Paper 3: a systematic review shows limitations in most tools designed to assess quality and develop recommendations.
OBJECTIVES
The objective of this study was to identify and describe critical appraisal tools designed for assessing the quality of evidence (QoE) and/or strength of recommendations (SoRs) related to health care-related tests and diagnostic strategies (HCTDSs).
STUDY DESIGN AND SETTING
We conducted a systematic review to identify tools applied in guidelines, methodological articles, and systematic reviews to assess HCTDS.
RESULTS
We screened 5,534 titles and abstracts, 1,004 full-text articles, and abstracted data from 330 references. We identified 29 tools and 14 modifications of existing tools for assessing QoE and SoR. Twenty-three out of 29 tools acknowledge the importance of assessing the QoE and SoR separately, but in 8, the SoR is based solely on QoE. When making decisions about the use of tests, patient values and preferences and impact on resource utilization were considered in 6 and 8 tools, respectively. There is also confusion about the terminology that describes the various factors that influence the QoE and SoR.
CONCLUSION
Although at least one approach includes all relevant criteria for assessing QoE and determining SoR, more detailed guidance about how to operationalize these assessments and make related judgments will be beneficial. There is a need for a better description of the framework for using evidence to make decisions and develop recommendations about HCTDS.
Topics: Decision Making; Diagnostic Tests, Routine; Evidence-Based Medicine; Female; Health Services; Humans; Male; Practice Guidelines as Topic; Quality of Health Care
PubMed: 28916490
DOI: 10.1016/j.jclinepi.2017.09.007 -
Expert Review of Molecular Diagnostics 2023This review presents an overview of field findings on sequence variation of histidine-rich proteins 2/3 (HRP2/3) for which reference types (1-24) have been identified,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review presents an overview of field findings on sequence variation of histidine-rich proteins 2/3 (HRP2/3) for which reference types (1-24) have been identified, and its critical impact on HRP2-based rapid diagnostic test (RDT) detection.
RESEARCH DESIGN AND METHODS
This systematic review and meta-analysis was registered with PROSPERO, CRD42022316027, and conducted as per the PRISMA guidelines, and the methodological quality of studies was assessed.
RESULTS
Of the 2184 records identified, 34 studies were included mostly from Africa (47.1%) and Asia (35.3%). The reference HRP2 types 1, 2, 3, 6, and 7 are invariably found at proportions ≥ 80-100% in all areas with the exception of The Americas where their proportion is very low. The proteins exhibited high diversity of variants/unknown types, especially for types 1, 2, 4, and 7. Eleven major HRP2 epitopes were found at pooled proportion > 90%. The existing models to predict RDT detection are greatly limited by the impact of factors such as low (very low) parasitemia, RDT brand, and HRP3 cross-reactivity. HRP2 length and presence/number of a given reference repeat type/variant did not seem to impact RDT detection.
CONCLUSIONS
HRP2/3 are highly polymorphic and current findings are insufficient, conflicting and not convincing enough to conclude on the role of HRP2/3 sequence polymorphism in HRP2-based RDT detection.
Topics: Humans; Plasmodium falciparum; Histidine; Malaria, Falciparum; Rapid Diagnostic Tests; Protozoan Proteins; Antigens, Protozoan; Malaria; Diagnostic Tests, Routine
PubMed: 37698448
DOI: 10.1080/14737159.2023.2255136 -
Evidence-based Medicine Apr 2014Poor reporting of diagnostic accuracy studies impedes an objective appraisal of the clinical performance of diagnostic tests. The Standards for Reporting of Diagnostic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Poor reporting of diagnostic accuracy studies impedes an objective appraisal of the clinical performance of diagnostic tests. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement, first published in 2003, aims to improve the reporting quality of such studies.
OBJECTIVE
To investigate to which extent published diagnostic accuracy studies adhere to the 25-item STARD checklist, whether the reporting quality has improved after STARD's launch and whether there are any factors associated with adherence.
STUDY SELECTION
We performed a systematic review and searched MEDLINE, EMBASE and the Methodology Register of the Cochrane Library for studies that primarily aimed to examine the reporting quality of articles on diagnostic accuracy studies in humans by evaluating adherence to STARD. Study selection was performed in duplicate; data were extracted by one author and verified by the second author.
FINDINGS
We included 16 studies, analysing 1496 articles in total. Three studies investigated adherence in a general sample of diagnostic accuracy studies; the others did so in a specific field of research. The overall mean number of items reported varied from 9.1 to 14.3 between 13 evaluations that evaluated all 25 STARD items. Six studies quantitatively compared post-STARD with pre-STARD articles. Combining these results in a random-effects meta-analysis revealed a modest but significant increase in adherence after STARD's introduction (mean difference 1.41 items (95% CI 0.65 to 2.18)).
CONCLUSIONS
The reporting quality of diagnostic accuracy studies was consistently moderate, at least through halfway the 2000s. Our results suggest a small improvement in the years after the introduction of STARD. Adherence to STARD should be further promoted among researchers, editors and peer reviewers.
Topics: Checklist; Diagnostic Tests, Routine; Guideline Adherence; Humans; Practice Guidelines as Topic; Quality Control
PubMed: 24368333
DOI: 10.1136/eb-2013-101637 -
Journal of Orthopaedic Surgery and... Mar 2023The aim of this systematic review was to present the current evidence on the clinical use of single-photon emission computed tomography/computed tomography (SPECT/CT) in... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The aim of this systematic review was to present the current evidence on the clinical use of single-photon emission computed tomography/computed tomography (SPECT/CT) in the evaluation of noninfected painful knees after knee arthroplasty.
METHODS
Embase, PubMed, Google Scholar, Ovid, Scopus, Science Direct and the Cochrane Database of Systematic Reviews were searched from database inception to May 2022 following the PRISMA guidelines. As a primary outcome, we defined the role of SPECT/CT in the diagnostic approach to noninfected painful knee arthroplasty; as a secondary objective, we described the noninfection-related factors linked to painful knee arthroplasty. Pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio values and other indicators were calculated; receiver operating characteristic (ROC) curve analysis results and a summary of the areas under the curve (AUCs) from the included studies were reported. A Fagan plot, likelihood ratio plot and Deeks' funnel plot were generated and analysed. Methodological quality was assessed using the QUADAS-2 tool, and the certainty of evidence was assessed by the GRADE approach.
RESULTS
A total of 493 publications were identified, of which eight met the inclusion criteria, with a final pooled sample size of 308 patients. The pooled sensitivity and specificity of SPECT/CT in diagnosing the source of pain in painful knee prostheses were 0.86 (95% CI: 0.75-0.93) and 0.90 (95% CI: 0.79-0.96), respectively, with pooled +LR and -LR values of 8.9 (95% CI: 4.11-19.19) and 0.15 (95% CI: 0.09-0.28). The pooled diagnostic odds ratio was 57.35, and the area under the curve was 0.94. SPECT/CT highly accurately identified different sources of pain, such as loosening of the prosthetic components, patellofemoral overloading, instability, malalignment of the components and degeneration of the patellofemoral compartment. The confidence of the estimates was moderate according to the GRADE approach.
CONCLUSION
With demonstrated high sensitivity and specificity, as a diagnostic tool, SPECT/CT can identify the source of pain in painful knees after knee arthroplasty, particularly in cases of loosening, patellofemoral disorders and component malalignment (level of evidence III). These findings have significant clinical repercussions, such as in changing the initial diagnosis, identifying or excluding different causes of painful knee arthroplasties, guiding subsequent treatment and positively impacting the final clinical outcome. We moderately recommend the use of SPECT/CT for identifying the source of pain after knee arthroplasty according to the GRADE assessment. This review was preregistered in Prospero under code CRD42022320457.
Topics: Humans; Arthroplasty, Replacement, Knee; Single Photon Emission Computed Tomography Computed Tomography; Knee Joint; Pain; Sensitivity and Specificity; Diagnostic Tests, Routine
PubMed: 36945001
DOI: 10.1186/s13018-023-03687-8 -
The Lancet. Child & Adolescent Health May 2024Febrile infants presenting in the first 90 days of life are at higher risk of invasive and serious bacterial infections than older children. Modern clinical practice... (Meta-Analysis)
Meta-Analysis
Diagnostic test accuracy of procalcitonin and C-reactive protein for predicting invasive and serious bacterial infections in young febrile infants: a systematic review and meta-analysis.
BACKGROUND
Febrile infants presenting in the first 90 days of life are at higher risk of invasive and serious bacterial infections than older children. Modern clinical practice guidelines, mostly using procalcitonin as a diagnostic biomarker, can identify infants who are at low risk and therefore suitable for tailored management. C-reactive protein, by comparison, is widely available, but whether C-reactive protein and procalcitonin have similar diagnostic accuracy is unclear. We aimed to compare the test accuracy of procalcitonin and C-reactive protein in the prediction of invasive or serious bacterial infections in febrile infants.
METHODS
For this systematic review and meta-analysis, we searched MEDLINE, EMBASE, Web of Science, and The Cochrane Library for diagnostic test accuracy studies up to June 19, 2023, using MeSH terms "procalcitonin", and "bacterial infection" or "fever" and keywords "invasive bacterial infection*" and "serious bacterial infection*", without language or date restrictions. Studies were selected by independent authors against eligibility criteria. Eligible studies included participants aged 90 days or younger presenting to hospital with a fever (≥38°C) or history of fever within the preceding 48 h. The primary index test was procalcitonin, and the secondary index test was C-reactive protein. Test kits had to be commercially available, and test samples had to be collected upon presentation to hospital. Invasive bacterial infection was defined as the presence of a bacterial pathogen in blood or cerebrospinal fluid, as detected by culture or quantitative PCR; authors' definitions of serious bacterial infection were used. Data were extracted from selected studies, and the detection of invasive or serious bacterial infections was analysed with two models for each biomarker. Diagnostic accuracy was determined against internationally recognised cutoff values (0·5 ng/mL for procalcitonin, 20 mg/L for C-reactive protein) and pooled to calculate partial area under the curve (pAUC) values for each biomarker. Optimum cutoff values were identified for each biomarker. This study is registered with PROSPERO, CRD42022293284.
FINDINGS
Of 734 studies derived from the literature search, 14 studies (n=7755) were included in the meta-analysis. For the detection of invasive bacterial infections, pAUC values were greater for procalcitonin (0·72, 95% CI 0·56-0·79) than C-reactive protein (0·28, 0·17-0·61; p=0·016). Optimal cutoffs for detecting invasive bacterial infections were 0·49 ng/mL for procalcitonin and 13·12 mg/L for C-reactive protein. For the detection of serious bacterial infections, procalcitonin and C-reactive protein had similar pAUC values (0·55, 0·44-0·69 vs 0·54, 0·40-0·61; p=0·92). For serious bacterial infections, the optimal cutoffs for procalcitonin and C-reactive protein were 0·17 ng/mL and 16·18 mg/L, respectively. Heterogeneity was low for studies investigating the test accuracy of procalcitonin in detecting invasive bacterial infection (I=23·5%), high for studies investigating procalcitonin for serious bacterial infection (I=75·5%), and moderate for studies investigating C-reactive protein for invasive bacterial infection (I=49·5%) and serious bacterial infection (I=28·3%). The absence of a single definition of serious bacterial infection across studies was the greatest source of interstudy variability and potential bias.
INTERPRETATION
Within a large cohort of febrile infants, a procalcitonin cutoff of 0·5 ng/mL had a superior pAUC value to a C-reactive protein cutoff of 20 mg/L for identifying invasive bacterial infections. In settings without access to procalcitonin, C-reactive protein should therefore be used cautiously for the identification of invasive bacterial infections, and a cutoff value below 20 mg/L should be considered. C-reactive protein and procalcitonin showed similar test accuracy for the identification of serious bacterial infection with internationally recognised cutoff values. This might reflect the challenges involved in confirming serious bacterial infection and the absence of a universally accepted definition of serious bacterial infection.
FUNDING
None.
Topics: Infant; Child; Humans; Adolescent; C-Reactive Protein; Procalcitonin; Fever; Biomarkers; Bacterial Infections; Diagnostic Tests, Routine
PubMed: 38499017
DOI: 10.1016/S2352-4642(24)00021-X -
Journal of Magnetic Resonance Imaging :... Jan 2021The detection of liver metastases is important for pancreatic cancer curative treatment eligibility. The data suggest that magnetic resonance imaging (MRI) is more... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The detection of liver metastases is important for pancreatic cancer curative treatment eligibility. The data suggest that magnetic resonance imaging (MRI) is more sensitive than computed tomography (CT) for the diagnosis of pancreatic cancer liver metastases. However, MRI is not currently recommended in multiple published guidelines.
PURPOSE
To perform a comparative diagnostic test accuracy systematic review and meta-analysis comparing CT and MRI for pancreatic cancer liver metastases detection.
STUDY TYPE
Systematic review and meta-analysis.
DATA SOURCES
MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and multiple radiology society meeting archives were searched until November 2018. Comparative design studies reporting on liver CT and MRI accuracy for detection of pancreatic cancer liver metastases in the same cohort were included.
FIELD STRENGTH
1.5T or 3.0T.
ASSESSMENT
Demographic, methodologic, and diagnostic test accuracy data were extracted. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool.
STATISTICAL TESTS
Accuracy metrics were obtained using bivariate random-effects meta-analysis. The impact of different covariates on accuracy estimates was assessed using a meta-regression model. Covariates included modality, study design, tumor characteristics, risk of bias, and imaging protocols.
RESULTS
Fourteen studies including 987 patients with pancreatic cancer (205 with liver metastases) were included. Sensitivity for CT and MRI was 45% (confidence intervals [95% CI] 21-71%) and 83% (95% CI 74-88%), respectively. Specificity for CT and MRI was 94% (95% CI 84-98%) and 96% (95% CI 93-97%), respectively. The greater observed sensitivity of MRI was preserved in the meta-regression model (P = 0.01), while no difference in specificity was detected (P = 0.16). CT sensitivity was highest for triphasic and quadriphasic examinations compared to single phase or biphasic protocols (P = 0.03). Most studies were at high risk of bias.
DATA CONCLUSION
MRI is more sensitive than CT for pancreatic cancer liver metastases detection, accounting for confounding variables. Consideration of this finding in clinical practice guidelines is recommended.
LEVEL OF EVIDENCE
3 TECHNICAL EFFICACY STAGE: 3.
Topics: Diagnostic Tests, Routine; Humans; Liver Neoplasms; Magnetic Resonance Imaging; Pancreatic Neoplasms; Tomography, X-Ray Computed
PubMed: 31943576
DOI: 10.1002/jmri.27056 -
PloS One 2016There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme... (Meta-Analysis)
Meta-Analysis Review
There has been an increasing incidence of Lyme disease (LD) in Canada and the United States corresponding to the expanding range of the Ixodes tick vector and Lyme disease agent (Borrelia burgdorferi sensu stricto). There are many diagnostic tests for LD available in North America, all of which have some performance issues, and physicians are concerned about the appropriate use and interpretation of these tests. The objective of this systematic review is to summarize the North American evidence on the accuracy of diagnostic tests and test regimes at various stages of LD. Included in the review are 48 studies on diagnostic tests used in North America published since 1995. Thirteen studies examined a two-tier serological test protocol vs. clinical diagnosis, 24 studies examined single assays vs. clinical diagnosis, 9 studies examined single immunoblot vs. clinical diagnosis, 7 studies compared culture or PCR direct detection methods vs. clinical diagnosis, 22 studies compared two or more tests with each other and 8 studies compared a two-tiered serological test protocol to another test. Recent studies examining the sensitivity and specificity of various test protocols noted that the Immunetics® C6 B. burgdorferi ELISA™ and the two tier approach have superior specificity compared to proposed replacements, and the CDC recommended western blot algorithm has equivalent or superior specificity over other proposed test algorithms. There is a dramatic increase in test sensitivity with progression of B. burgdorferi infection from early to late LD. Direct detection methods, culture and PCR of tissue or blood samples were not as sensitive or timely compared to serological testing. It was also noted that there are a large number of both commercial (n = 42) and in-house developed tests used by private laboratories which have not been evaluated in the primary literature.
Topics: Antibodies, Bacterial; Borrelia burgdorferi; DNA, Bacterial; Databases, Factual; Diagnostic Tests, Routine; Enzyme-Linked Immunosorbent Assay; Humans; Lyme Disease; Polymerase Chain Reaction; Reproducibility of Results; Sensitivity and Specificity; Serologic Tests
PubMed: 28002488
DOI: 10.1371/journal.pone.0168613 -
Injury Aug 2022Prioritising patients in mass casualty incidents (MCI) can be extremely difficult. Therefore, triage systems are important in every emergency medical service. This study... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prioritising patients in mass casualty incidents (MCI) can be extremely difficult. Therefore, triage systems are important in every emergency medical service. This study reviews the accuracy of primary triage systems for MCI in trauma register studies.
METHODS
We registered a protocol at PROSPERO ID: CRD42018115438. We searched MEDLINE, EMBASE, Central, Web of Science, Scopus, Clinical Trials, Google Scholar, and reference lists for eligible studies. We included studies that both examined a primary triage system for MCI in trauma registers and provided sensitivity and specificity for critically injured vs non-critically injured as results. We excluded studies that used paediatric, chemical, biological, radiological or nuclear MCIs populations or triage systems. Finally, we calculated intra-study relative sensitivity, specificity and diagnostic odds ratio for each triage system.
RESULTS
Triage Sieve (TS) significantly underperformed in relative diagnostic odds ratio (DOR) when compared to START and CareFlight (CF) (START vs TS: 19.85 vs 13.23 (p<0.0001)│CF vs TS: 23.72 vs 12.83 (p<0.0001)). There was no significant difference in DOR between TS and Military Sieve (MS) (p<0.710). Compared to START, MS and CF TS had significantly higher relative specificity (START vs TS: 93.6% vs 96.1% (p=0.047)│CF vs TS: 96% vs 95.3% (p=0.0006)│MS vs TS: 94% vs 88.3% (p=0.0002)) and lower relative sensitivity (START vs TS: 57.8% vs 34.8% (p<0.0001)│CF vs TS: 53.9% vs 34.7% (p<0.0001)│MS vs TS: 51.9% vs 35.2% p<0.0001)). CF had significantly better relative DOR than START (CF vs START: 23.56 vs 27.79 (p=0.043)). MS had significantly better relative sensitivity than CF and START (MS vs CF: 49.5% vs 38.7% (p<0.0001)│MS vs START: 49.4% vs 43.9% (p=0.01)). In contrast, CF had significantly better relative specificity than MS (MS vs CF: 91.3% vs 93.3% (p<0.0001)). The remaining comparisons did not yield any significant differences.
CONCLUSION
As the included studies were at risk of bias and had heterogenic characteristics, our results should be interpreted with caution. Nonetheless, our results point towards inferior accuracy of Triage Sieve compared to START and CareFlight, and less firmly point towards superior accuracy of Military Sieve compared to START, CareFlight and Triage Sieve.
Topics: Child; Diagnostic Tests, Routine; Emergency Medical Services; Humans; Mass Casualty Incidents; Sensitivity and Specificity; Triage
PubMed: 35660101
DOI: 10.1016/j.injury.2022.05.006 -
Korean Journal of Radiology 2015In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available... (Meta-Analysis)
Meta-Analysis Review
In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods.
Topics: Databases, Factual; Diagnostic Tests, Routine; Humans; ROC Curve; Research
PubMed: 26576106
DOI: 10.3348/kjr.2015.16.6.1175 -
Clinical Nursing Research May 2021Delirium is a reversible impairment of metabolism in the human brain. Early detection is important, and an effective screening tool for nurses is crucial. The Delirium... (Meta-Analysis)
Meta-Analysis
Delirium is a reversible impairment of metabolism in the human brain. Early detection is important, and an effective screening tool for nurses is crucial. The Delirium Observation Screening (DOS) scale is one such screening tool; however, its diagnostic test accuracy has not yet been thoroughly examined. This study, therefore, aimed to evaluate the accuracy of the scale through a systematic review and meta-analysis. In July 2019, a search was conducted in the MEDLINE, CINAHL, Embase, and PsycARTICLES databases, and following a review against pre-defined eligibility criteria, eight studies were finally included. The quality assessment tool of diagnostic accuracy studies was applied to each study and a hierarchical regression model was used to calculate the pooled estimates of sensitivity (90%; 76%-97%, CI 95%) and specificity (92%; 88%-94%, CI 95%). The findings indicated a high diagnostic test accuracy for the DOS scale.
Topics: Delirium; Diagnostic Tests, Routine; Humans; Mass Screening; Sensitivity and Specificity
PubMed: 33174438
DOI: 10.1177/1054773820961234