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Concept: Validation

199

We aimed to derive and validate a clinical decision rule (CDR) for suspected cardiac chest pain in the emergency department (ED). Incorporating information available at the time of first presentation, this CDR would effectively risk-stratify patients and immediately identify: (A) patients for whom hospitalisation may be safely avoided; and (B) high-risk patients, facilitating judicious use of resources.

Concepts: Myocardial infarction, Hospital, Heart, Validation, Avicenna, Decision theory, Acute coronary syndrome, Chest pain

174

BACKGROUND: Despite considerable global investigation over several decades, the roles of vitamin D in health and disease development remains convoluted. One recognised issue is the difficulty of accurately measuring the active forms of vitamin D. Advances made include some new methods addressing the potential interference by excluding epimers and isobars. However, there is no evidence that epimers are without function. Therefore, the aim of this study was to develop and validate, for the first time, a new assay to simultaneously measure levels of 6 forms of vitamin D along with two epimers. The assay was applied to multilevel certified reference material calibrators and 25 pooled human sera samples obtained from the Vitamin D External Quality Assessment Scheme (DEQAS) to demonstrate its efficiency. RESULTS: The assay is capable of simultaneously measuring 8 vitamin D analogues over the calibration ranges and LODs (in nmol/L) of: 1alpha25(OH)2D2 [0.015-1; 0.01], 1alpha25(OH)2D3 [0.1-100; 0.01], 25OHD3 [0.5-100, 0.025], 3-epi-25OHD3 [0.1-100, 0.05], 25OHD2 [0.5-100, 0.025], 3-epi-25OHD2 [0.1-100, 0.05], vitamin D3 [0.5-100, 0.05] and vitamin D2 [0.5-100, 0.05], using stanozolol-d3 as internal standard. Certified reference material calibrators and external quality control samples (DEQAS) were analysed to meet the standards outlined by National Institute of Standards and Technology (NIST). Validation steps included recovery and both precision and accuracy under inter- and intra-day variation limit of detection, and analysis of each analyte over a linear range. All validation parameters were in line with acceptable Food and Drug Administration (FDA) guidelines and the standards of the National Institute of Standards and Technology (NIST). All eight analogues were quantified with the 25OHD levels being commensurate with DEQAS data. CONCLUSIONS: This report details the application of a new LC-MS/MS based assay for the efficient analysis of eight analogues of vitamin D over a range of samples, which is a significant advance over the existing methods. Simultaneous measure of 8 vitamin D analogues does not compromise the analytical capability of the assay to quantify the commonly used biomarker (25OHD) for vitamin D status. The results demonstrate the feasibility of applying the assay in research and clinical practice that i) excludes misleading measures owing to epimers and isobars and ii) is able to quantify the excluded component to facilitate further in vivo investigation into the roles of ubiquitous epimers.

Concepts: Vitamin D, Mass spectrometry, Measurement, Validation, Analytical chemistry, Standard, Calibration, Certified reference materials

153

A small number of nomograms have been previously developed to predict the individual survival of patients who undergo curative resection for gastric cancer. However, all were derived from single high-volume centers. The aim of this study was to develop and validate a nomogram for gastric cancer patients using a multicenter database.

Concepts: Validation, Stomach, Nomogram

124

The identification and evaluation of activities capable of dislodging calyceal renal calculi require a patient surrogate or validated functional pyelocalyceal renal model.

Concepts: Validation

30

We previously derived the Ottawa Subarachnoid Hemorrhage Rule to identify subarachnoid hemorrhage (SAH) in patients with acute headache. Our objective was to validate the rule in a new cohort of consecutive patients who visited an emergency department.

Concepts: Hospital, Validation, Subarachnoid hemorrhage, Verification and validation

29

A growing body of evidence is documenting the significant role of cognitive factors in influencing gambling behaviors. Although measures of cognitive biases have been developed, further validation of these scales is needed among non-Western samples. The 21-item Gamblers' Belief Questionnaire was originally developed and validated by Steenbergh et al. (in Psychol. Addict. Behav., 16: 143-149, 2002). The scale then has been widely used in the gambling research of the West. The present study was designed to examine and validate the Chinese version of Gamblers' Belief Questionnaire (GBQ-C) using 258 Chinese participants. Confirmatory factor analyses indicated the 2-factor model provided a good fit to the data as evidenced by various model fit indices (CFI = .91, RMSEA = .08 and SRMR = .05). Additional evidence for the validity of the GBQ-C was provided by significant correlations with other relevant measures (range .40-.75). In sum, the present study provides support for the GBQ-C as a valuable tool for assessing gambling cognitions among Chinese samples.

Concepts: Psychology, Critical thinking, Validation, Cognition, Factor analysis, Cognitive bias, Anecdotal evidence

28

The determination of factor VIII (FVIII) potency in FVIII concentrates can be performed using both manual and automated methods. This work aimed to validate the use of the chromogenic kit Coamatic(®) FVIII (Chromogenix) on the automated ACL(®) Elite PRO analyzer for evaluating the potency of FVIII in commercial preparations in pharmaceutical analytical laboratories. After setting the activation and reading times to 2 min and 3 min, respectively, the validation parameters, according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q2 (R1), were as follows: linearity, expressed by the adjusted model: log (Absorbance) = 1.848 + 0.777∙log (Concentration), with r(2)  = 0.998; accuracy was verified (P-value = 0.6959); and the coefficient of variation for repeatability and intermediate precision was ≤6.5%. The Coamatic(®) FVIII kit method has been adapted to the ACL Elite PRO analyzer with improved performance compared with a manual microplate method.

Concepts: Pharmacology, Validation, Psychometrics, Performance, Pharmaceutical drug, Factor VIII, Verification, Verification and validation

28

Study design:Cross-sectional validation study.Objectives:To develop and validate a self-report version of the Spinal Cord Independence Measure (SCIM III).Setting:Two SCI rehabilitation facilities in Switzerland.Methods:SCIM III comprises 19 questions on daily tasks with a total score between 0 and 100 and subscales for ‘self-care’, ‘respiration & sphincter management’ and ‘mobility’. A self-report version (SCIM-SR) was developed by expert discussions and pretests in individuals with spinal cord injury (SCI) using a German translation. A convenience sample of 99 inpatients with SCI was recruited. SCIM-SR data were analyzed together with SCIM III data obtained from attending health professionals.Results:High correlations between SCIM III and SCIM-SR were observed. Pearson’s r for the total score was 0.87 (95% confidence interval (CI) 0.82-0.91), for the subscales self-care 0.87 (0.81-0.91); respiration & sphincter management 0.81 (0.73-0.87); and mobility 0.87 (0.82-0.91). Intraclass correlations were: total score 0.90 (95% CI 0.85-0.93); self-care 0.86 (0.79-0.90); respiration & sphincter management 0.80 (0.71-0.86); and mobility 0.83 (0.76-0.89). Bland-Altman plots showed that patients rated their functioning higher than professionals, in particular for mobility. The mean difference between SCIM-SR and SCIM III for the total score was 5.14 (point estimate 95% CI 2.95-7.34), self-care 0.89 (0.19-1.59), respiration & sphincter management 1.05 (0.18-2.28 ) and mobility 3.49 (2.44-4.54). Particularly patients readmitted because of pressure sores rated their independence higher than attending professionals.Conclusion:Our results support the criterion validity of SCIM-SR. The self-report version may facilitate long-term evaluations of independence in persons with SCI in their home situation.

Concepts: Statistics, Validation, Criterion validity, Pearson product-moment correlation coefficient, Spinal cord injury, Statistical inference, The Criterion, Interval estimation

28

BACKGROUND: Community violence is a substantial problem for the NHS. Information sharing of emergency department data with community safety partnerships (CSP) has been associated with substantial reductions in assault attendances in emergency departments supported by academic institutions. We sought to validate these findings in a setting not supported by a public health or academic structure. METHODS: We instituted anonymous data sharing with the police to reduce community violence, and increased involvement with the local CSP. We measured the effectiveness of this approach with routinely collected data at the emergency department and the police. We used police data from 2009, and emergency department data from 2000. RESULTS: Initially, the number of assault patients requiring emergency department treatment rose after we initiated data sharing. After improving the data flows, the number of assault patients fell back to the predata-sharing level. There was no change in the number of hospital admissions during the study period. There were decreases in the numbers of violent crimes against the person, with and without injury, recorded by the police. CONCLUSIONS: We have successfully implemented data sharing in our institution without the support of an academic institution. This has been associated with reductions in violent crime, but it is not clear whether this association is causal.

Concepts: Domestic violence, Hospital, Validation, Crime, Violent crime, Violence, Institution, Academic elitism

27

The original Manchester Acute Coronary Syndromes model (MACS) ‘rules in’ and ‘rules out’ acute coronary syndromes (ACS) using high sensitivity cardiac troponin T (hs-cTnT) and heart-type fatty acid binding protein (H-FABP) measured at admission. The latter is not always available. We aimed to refine and validate MACS as Troponin-only Manchester Acute Coronary Syndromes (T-MACS), cutting down the biomarkers to just hs-cTnT.

Concepts: Nutrition, Blood, Myocardial infarction, Validation, Biochemistry, Troponin, Hydrolysis