Arm ; Asian Continental Ancestry Group ; Bias (Epidemiology) ; Carboplatin ; Disease-Free Survival ; Doxorubicin ; Drug Therapy ; Follow-Up Studies ; Humans ; Maintenance Chemotherapy ; Ovarian Neoplasms ; Prognosis ; Quality of Life ; Recombination, Genetic ; Sample Size

bias of 0.005 (95% CI −0.011 to 0.021) with 95% limits of agreement of −0.16 to 0.17 between vFFR and FFR. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were 78.0%, 87.1%, 72.5%, 58.7%, and 92.6%, respectively, using the FFR cutoff of 0.80. They were 87.0%, 95.0%, 80.0%, 54.3%, and 98.5%, respectively, with the FFR cutoff of 0.75. The area under the receiver-operating characteristics curve of vFFR versus obstructive CTA stenosis was 0.88 versus 0.61 for the FFR cutoff of 0.80, respectively; it was 0.94 versus 0.62 for the FFR cutoff of 0.75.CONCLUSION: Our novel, fully automated, on-site vFFR technology showed excellent diagnostic performance for the detection of lesion-specific ischemia.]]>
Angiography ; Bias (Epidemiology) ; Constriction, Pathologic ; Coronary Angiography ; Fractional Flow Reserve, Myocardial ; Humans ; Ischemia ; Patient-Specific Modeling ; Sensitivity and Specificity

bias. In addition, there were no significant differences in intensive care unit (ICU) mortality, in-hospital mortality, 28-day mortality, or ICU length of stay between the groups.CONCLUSION: Discontinuing NE prior to AVP was associated with a lower incidence of hypotension in patients recovering from septic shock. However, our results should be interpreted with caution, due to the considerable between-study heterogeneity.]]>
Arginine Vasopressin ; Arginine ; Bias (Epidemiology) ; Consensus ; Hospital Mortality ; Humans ; Hypotension ; Incidence ; Intensive Care Units ; Length of Stay ; Mortality ; Norepinephrine ; Odds Ratio ; Population Characteristics ; Sepsis ; Shock, Septic ; Treatment Outcome ; Vasoconstrictor Agents

Cardiovascular disease (CVD) is considered a primary driver of global mortality and is estimated to be responsible for approximately 17.9 million deaths annually. Consequently, a substantial body of research related to CVD has developed, with an emphasis on identifying strategies for the prevention and effective treatment of CVD. In this review, we critically examine the existing CVD literature, and specifically highlight the contribution of Mendelian randomization analyses in CVD research. Throughout this review, we assess the extent to which research findings agree across a range of studies of differing design within a triangulation framework. If differing study designs are subject to non-overlapping sources of bias, consistent findings limit the extent to which results are merely an artefact of study design. Consequently, broad agreement across differing studies can be viewed as providing more robust causal evidence in contrast to limiting the scope of the review to a single specific study design. Utilising the triangulation approach, we highlight emerging patterns in research findings, and explore the potential of identified risk factors as targets for precision medicine and novel interventions.
Artifacts ; Bias (Epidemiology) ; Cardiovascular Diseases ; Mendelian Randomization Analysis ; Mortality ; Precision Medicine ; Random Allocation ; Risk Factors

Bias ; Coronavirus Infections ; epidemiology ; transmission ; Humans ; Pandemics ; Pneumonia, Viral ; epidemiology ; transmission ; Uncertainty

BACKGROUND AND PURPOSE: Tafamidis functions to delay the loss of function in transthyretin familial amyloid polyneuropathy (TTR-FAP), which is a rare inherited amyloidosis with progressive sensorimotor and autonomic polyneuropathy. This systematic literature review and meta-analysis evaluated the efficacy and safety of tafamidis in TTR-FAP patients, with the aim of improving the evidence-based medical evidence of this treatment option for TTP-FAP. METHODS: A systematic search of the English-language literature in five databases was performed through to May 31, 2018 by two reviewers who independently extracted data and assessed the risk of bias. We extracted efficacy and safety outcomes and performed a meta-analysis. Statistical tests were performed to check for heterogeneity and publication bias. RESULTS: The meta-analysis identified six relevant studies. The tafamidis group showed smaller changes from baseline in the Neuropathy Impairment Score–Lower Limbs [mean difference (MD)=−3.01, 95% confidence interval (CI)=−3.26 to −2.75, p < 0.001] and the Norfolk Quality of Life-Diabetic Neuropathy total quality of life score (MD=−6.67, 95% CI=−9.70 to −3.64, p < 0.001), and a higher modified body mass index (MD=72.45, 95% CI=69.41 to 75.49, p < 0.001), with no significant difference in total adverse events [odds ratio (OR)=0.69, 95% CI=0.35 to 1.35, p=0.27]. The incidence of adverse events did not differ between tafamidis and placebo treatment except for fatigue (OR=0.13, 95% CI=0.02 to 0.72, p=0.02) and hypesthesia (OR=0.16, 95% CI=0.03 to 0.92, p=0.04). CONCLUSIONS: This systematic review and meta-analysis has demonstrated that tafamidis delays neurologic progression and preserves a better nutritional status and the quality of life. The rates of adverse events did not differ between the patients in the tafamidis and placebo groups. Tafamidis might be a safer noninvasive option for patients with TTR-FAP.
Amyloid Neuropathies ; Amyloid Neuropathies, Familial* ; Amyloidosis ; Bias (Epidemiology) ; Body Mass Index ; Extremities ; Fatigue ; Humans ; Hypesthesia ; Incidence ; Nutritional Status ; Polyneuropathies ; Population Characteristics ; Prealbumin* ; Publication Bias ; Quality of Life

Clinical studies can be conducted to gather real world evidence (RWE) not available from randomized controlled trials, providing new information and knowledge. Although the concept of RWE emerged relatively recently, numerous clinical studies are utilizing it. However, many researchers are engaging in trial and error that may not overcome the various biases that occur in electronic medical record (EMR)-based RWE studies. While RWE can reflect the real world, there are still limitations to its acceptance. There are many hurdles in using RWE and solutions must be explored. Results based on RWE may be overestimated and it can be difficult to derive good quality results. This paper discusses data quality management, direct chart review, sample size, study design, and the interpretation of EMR-based RWE. More specifically, this paper shares the experience of the various hurdles that occur when conducting RWE studies and discusses the easy-to-false errors. RWE is still in the developmental stage and numerous aspects of RWE use remain unclear. Nonetheless, despite its many limitations, increasing use of RWE is still anticipated. This will require continued experience and effort in using RWE, as well as upgrading RWE research through the accumulation of information on such experiences and efforts.
Bias (Epidemiology) ; Cohort Studies ; Data Accuracy ; Electronic Health Records ; Sample Size

OBJECTIVE: To assess the accuracy and potential bias of computed tomography (CT) ventricular volumetry using semiautomatic three-dimensional (3D) threshold-based segmentation in repaired tetralogy of Fallot, and to compare them to those of two-dimensional (2D) magnetic resonance imaging (MRI). MATERIALS AND METHODS: This retrospective study evaluated 32 patients with repaired tetralogy of Fallot who had undergone both cardiac CT and MRI within 3 years. For ventricular volumetry, semiautomatic 3D threshold-based segmentation was used in CT, while a manual simplified contouring 2D method was used in MRI. The indexed ventricular volumes were compared between CT and MRI. The indexed ventricular stroke volumes were compared with the indexed arterial stroke volumes measured using phase-contrast MRI. The mean differences and degrees of agreement in the indexed ventricular and stroke volumes were evaluated using Bland-Altman analysis. RESULTS: The indexed end-systolic (ES) volumes showed no significant difference between CT and MRI (p > 0.05), while the indexed end-diastolic (ED) volumes were significantly larger on CT than on MRI (93.6 ± 17.5 mL/m² vs. 87.3 ± 15.5 mL/m² for the left ventricle [p < 0.001] and 177.2 ± 39.5 mL/m² vs. 161.7 ± 33.1 mL/m² for the right ventricle [p < 0.001], respectively). The mean differences between CT and MRI were smaller for the indexed ES volumes (2.0–2.5 mL/m²) than for the indexed ED volumes (6.3–15.5 mL/m²). CT overestimated the stroke volumes by 14–16%. With phase-contrast MRI as a reference, CT (7.2–14.3 mL/m²) showed greater mean differences in the indexed stroke volumes than did MRI (0.8–3.3 mL/m²; p < 0.005). CONCLUSION: Compared to 2D MRI, CT ventricular volumetry using semiautomatic 3D threshold-based segmentation provides comparable ES volumes, but overestimates the ED and stroke volumes in patients with repaired tetralogy of Fallot.
Bias (Epidemiology) ; Heart Defects, Congenital ; Heart Ventricles ; Humans ; Magnetic Resonance Imaging* ; Methods ; Retrospective Studies ; Stroke Volume ; Tetralogy of Fallot*

A third of men with type 2 diabetes (T2DM) have hypogonadotrophic hypogonadism (HH) and associated increased risk of cardiovascular and all-cause mortality. Men with HH are at increased risk of developing incident T2DM. We conducted MEDLINE, EMBASE, and COCHRANE reviews on T2DM, HH, testosterone deficiency, cardiovascular and all-cause mortality from May 2005 to October 2017, yielding 1,714 articles, 52 clinical trials and 32 randomized controlled trials (RCT). Studies with testosterone therapy suggest significant benefits in sexual function, quality of life, glycaemic control, anaemia, bone density, fat, and lean muscle mass. Meta-analyses of RCT, rather than providing clarification, have further confused the issue by including under-powered studies of inadequate duration, multiple regimes, some discontinued, and inbuilt bias in terms of studies included or excluded from analysis.
Bias (Epidemiology) ; Bone Density ; Cardiovascular Diseases ; Diabetes Mellitus, Type 2 ; Humans ; Hypogonadism ; Male ; Mortality ; Quality of Life ; Testosterone*

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
Bias (Epidemiology) ; Creatinine* ; Delivery of Health Care ; Diagnosis ; Indicators and Reagents ; Kidney Diseases ; Methods ; Quality Control ; Risk Assessment