Kava hepatotoxicity: comparative study of two structured quantitative methods for causality assessment

Background and objective: Ingestion of the medicinal herb kava has been associated with hepatotoxicity. We aimed to compare two different quantitative methods of causality assessment of patients with assumed hepatotoxicity by the herb. Methods: We assessed causality in 26 patients from Germany and Switzerland, using two structured quantitative analytical methods: the system of Maria and Victorino (MV) and that of the Council for International Organizations of Medical Sciences (CIOMS). In all 26 patients, regulatory ad hoc evaluation had suggested a causal relationship between liver disease and kava use. Results and discussion: Assessment with the MV scale resulted in no or low graded causality for kava in the 26 patients with liver disease. Causality was probable (n = 1), possible (n = 2), unlikely (n = 7), and excluded (n = 16). Causality for kava was more evident with the CIOMS scale: highly probable (n = 1), probable (n = 2), possible (n = 6), unlikely (n = 2) and excluded (n = 15). However, the results of both quantitative causality assessments are not supportive for most of the regulatory ad hoc causality assessments of the 26 patients. Conclusion: Grades of causality for suspected hepatotoxicity by kava were much lower when evaluated by structured quantitative causality assessment scales than by regulatory ad hoc judgements. The quantitative CIOMS scale is the preferable tool for causality assessment of spontaneous reports of hepatotoxcity involving kava.     

Enhancing predictive accuracy and reproducibility in clinical evaluation research

This paper introduces a special section of the current issue of the Journal of Evaluation in Clinical Practice that includes a set of 6 empirical articles showcasing a versatile, new machine‐learning statistical method, known as optimal data (or discriminant) analysis (ODA), specifically designed to produce statistical models that maximize predictive accuracy. As this set of papers clearly illustrates, ODA offers numerous important advantages over traditional statistical methods—advantages that enhance the validity and reproducibility of statistical conclusions in empirical research. This issue of the journal also includes a review of a recently published book that provides a comprehensive introduction to the logic, theory, and application of ODA in empirical research. It is argued that researchers have much to gain by using ODA to analyze their data.     

A descriptive study of the use of visual analogue scales and verbal rating scales for the assessment of postoperative pain in orthopedic patients

Visual analogue scales (VAS) and verbal rating scales (VRS) are widely used to assess pain. This paper presents a secondary analysis of a subsection of data collected as part of an evaluation of an intervention to improve nighttime pain. The aims were to describe the relationship between the VAS and VRS; to compare characteristics of the noncompliant groups in terms of age, gender, type of surgery, and analgesics; to explore the reasons for noncompletion of the VAS or VRS; and to determine the noncompliance rates with each assessment scale. Worst and average pain scores were obtained for the second postoperative night for 417 patients. Fifty-nine patients (14.2%) did not complete the VAS. In contrast, two patients did not complete the VRS (0.5%). The scores generated from the VAS and VRS correlated well, although the range of VAS scores corresponding to each VRS category was wide. We conclude that the VRS was more suitable for use in this clinical setting.     

Validation of pressure ulcer risk assessment scales: a critique

AIM: The aim of this paper is to present critical analysis of the validation methods of pressure ulcer risk assessment scales. BACKGROUND: The validation of pressure ulcer risk assessment scales remains a topic of considerable debate and uncertainty. The Braden scale and Norton scale are the most frequently used. Sensitivity and specificity are the recommended and most commonly used epidemiological tools to evaluate the validity of those risk assessment scales. DISCUSSION: The use of preventive measures influences both the sensitivity and specificity of the scales. Analysis of published studies on risk assessment scales reveals that, although some patients received preventive measures and others did not, this was not taken into account. Consequently, generalization of those results is not possible. Some possible alternative designs for studying the validity of risk assessment scales are discussed. CONCLUSIONS: Currently available risk assessment scales are of only limited value, and there use will result in many patients being falsely identified as at risk or not at risk. Sensitivity and specificity criteria are not the most appropriate tools to validate risk assessment scales. A risk assessment scale should be evaluated in combination with the preventive measures used.     

3种压疮危险评估量表在老年患者中应用的信效度研究

目的 比较和评价Norton、Braden和Waterlow 3种压疮危险评估量表在老年患者中应用的信效度.方法 选取某三级甲等医院老年患者271例,运用3种量表连续评估患者的压疮危险,以Cronbach's α系数、内容效度指数、因子分析、ROC曲线等方法评价和比较各量表的信效度.结果Norton、Braden、Watedow量表的内部一致性信度分别为0.71、0.79、0.32;内容效度指数分别为0.85、0.91、0.87;因子分析得到的方差累计贡献率分别为71.73%、70.34%、65.76%;灵敏度和特异度分别为(0.75、0.62)、(0.74、0.59)、(0.86、0.59).结论 Waterlow量表的内部一致性信度低,但预测能力最好;Braden量表的信效度均高,但预测能力偏低.     

两种跌倒评估量表在老年患者中的应用

目的探讨两种跌倒评估量表在老年患者中联合应用的可行性。方法使用Morse跌倒评估量表（Morse fall scale,MFS）和HendrichⅡ跌倒因素模型量表（hendfichⅡfall risk model,HFRM）,由2名护士操作,分别对60例老年患者进行评估。了解两种量表筛查高危跌倒人群情况。结果两名护士采用两种量表分别评估,Morse跌倒评估量表筛查的高危患者均多于HendrichⅡ跌倒因素模型量表,结果比较,均P＜0？05,差异具有统计学意义。结论 Morse跌倒评估量表和Hendrich II跌倒因素模型量表在临床中同时应用,弥补了各自的不足,从不同层面评估患者跌倒的危险性,预知高危因素,避免跌倒的发生。     

Pressure ulcers: validation of two risk assessment scales

Aims and objectives. To compare the predictive value of two pressure ulcer risk assessment scales (Braden and Norton) and of clinical judgement. To evaluate the impact of effective preventive measures on the predictive validity of the two risk assessment scales. Methods. Of the 1772 participating older patients, 314 were randomly selected and assigned to the ‘turning’ group; 1458 patients were assigned to the ‘non‐turning’ group. Using the Braden and the Norton scale the pressure ulcer risk was scored twice weekly during a four‐week period. Clinical assessment was monitored daily. The patients at risk in the ‘turning’ group (Braden score <17 or Norton score <12) were randomly assigned to a two‐hour turning schedule or to a four‐hour turning schedule in combination with a pressure‐reducing mattress. The ‘non‐turning’ group received preventive care based on the clinical judgement of the nurses. Results. The diagnostic accuracy was similar for both scales. If nurses act according to risk assessment scales, 80% of the patients would unnecessarily receive preventive measures. The use of effective preventive measures decreased the predictive value of the risk assessment scales. Nurses predicted pressure ulcer development less well than the Braden and the Norton scale. Only activity, sensory perception, skin condition and existence of old pressure ulcers were significant predictors of pressure ulcer lesions. Relevance to clinical practice. The effectiveness of the Norton and Braden scales is very low. Much needless work is done and expensive material is wrongly allocated. The use of effective preventive measures decreases the predictive value of the risk assessment scales. Although the performance of the risk assessment scales is poor, using a risk assessment tool seems to be a better alternative than relying on the clinical judgement of the nurses.     

Clinical scales for the assessment of spasticity,associated phenomena,and function: a systematic review of the literature

Purpose: To characterise clinical assessment methods for spasticity and/or its functional consequences in clinical patient populations at risk to suffer from spasticity. Method: Systematic literature search and manual-based two-step review process of psychometric properties of clinical assessment scales for spasticity and associated phenomena, as well as of functional scales with an association with spasticity. Reviewed psychometric properties included internal consistency, interrater, intrarater as well as retest reliability, construct validity, ecological validity, and responsiveness. Results: Until May 2003 electronic database searches established a reference pool of 4151 references of which 90 references contributed to the review objectives. An additional 20 references were identified by an informal reference search. Twenty-four clinical scales that assess spasticity and/or related phenomena as well as 10 scales for 'active function' and three scales for 'passive function' with an association with spasticity could be identified. Some evidence signals that a high interrater reliability of the Ashworth and modified Ashworth scales can be achieved, however not in all circumstances. For many scales, reliability data is, however, missing. This is especially true for test retest reliability. Information about construct validity can promote our understanding of what individual scales are likely to assess. Many scales have been able to document changes after therapeutic intervention. Conclusions: The collated evidence can guide our clinical decision about when to use which scale and can promote evidence-based assessment of spasticity and related clinical phenomena.     

Clinical scales for the assessment of spasticity, associated phenomena, and function: a systematic review of the literature

Purpose: To characterise clinical assessment methods for spasticity and/or its functional consequences in clinical patient populations at risk to suffer from spasticity. Method: Systematic literature search and manual-based two-step review process of psychometric properties of clinical assessment scales for spasticity and associated phenomena, as well as of functional scales with an association with spasticity. Reviewed psychometric properties included internal consistency, interrater, intrarater as well as retest reliability, construct validity, ecological validity, and responsiveness. Results: Until May 2003 electronic database searches established a reference pool of 4151 references of which 90 references contributed to the review objectives. An additional 20 references were identified by an informal reference search. Twenty-four clinical scales that assess spasticity and/or related phenomena as well as 10 scales for 'active function' and three scales for 'passive function' with an association with spasticity could be identified. Some evidence signals that a high interrater reliability of the Ashworth and modified Ashworth scales can be achieved, however not in all circumstances. For many scales, reliability data is, however, missing. This is especially true for test retest reliability. Information about construct validity can promote our understanding of what individual scales are likely to assess. Many scales have been able to document changes after therapeutic intervention. Conclusions: The collated evidence can guide our clinical decision about when to use which scale and can promote evidence-based assessment of spasticity and related clinical phenomena.     

Accuracy assessment of prediction in patient outcomes

In order to provide effective health care to patients, clinicians must rely on their ability to accurately diagnose disease and to prognosticate the outcomes. Prognostic studies have received considerable attention in health science and medicine in relation to patient outcomes. However, little effort has been spent on evaluating prognostic accuracy. The purpose of this paper is to present a comprehensive review of the methods for assessing prognostic accuracy in patient outcome prediction. The strengths and limitations of these approaches are critically appraised. We argue that we need to consider incorporating accuracy assessment for predicting patient outcomes both in clinical practice and in research.     

Intraobserver and interobserver reproducibility of 3-dimensional power Doppler vascular indices in assessment of solid and cystic-solid adnexal masses.

OBJECTIVE: The purpose of this study was to assess the intraobserver and interobserver reproducibility of 3-dimensional (3D) power Doppler angiography-derived vascular indices in evaluation of vascularized solid and cystic-solid adnexal masses. METHODS: Stored 3D power Doppler angiographic volume data from 12 consecutive women with a diagnosis of a complex adnexal mass (6 cystic-solid and 6 solid) evaluated and treated at our institution were retrieved from our database for analysis. Two examiners performed the calculations blinded to each other. Calculations were performed offline in a computer using Virtual Organ Computer-Aided Analysis software (plane A, 9 degrees rotation step) to assess volume and vascularization (vascularization index, flow index, and vascularization-flow index) from solid areas within the tumor. In all cases, a definitive histologic diagnosis was obtained. Intraobserver and interobserver reproducibility was assessed by calculating the intraclass and interclass correlation coefficients for each index. RESULTS: All tumors proved to be malignant after surgical removal. Intraobserver reproducibility for both examiners and interobserver reproducibility were high for all indices (interclass correlation coefficient > 0.95). CONCLUSIONS: Three-dimensional power Doppler angiography is a reproducible technique for offline assessment of stored 3D volume data of vascularized adnexal masses.     

Ultrasound assessment of the rotator cuff cable: comparison between young and elderly asymptomatic volunteers and interobserver reproducibility

Our aim was to characterize rotator cable ultrasound appearance in shoulders of different-aged asymptomatic volunteers, also estimating interobserver reproducibility. We studied 83 shoulders in 42 young volunteers (mean age 26 ± 7.0 years, range 21-35 years) and 66 shoulders in 36 elderly volunteers (65-81 years, 73 ± 4.9 years), noting rotator cable visibility and its minimum thickness and width. Interobserver reproducibility was tested in elderly volunteers by two blinded observers. χ², U Mann-Whitney, t-test, Bland-Altman, and κ statistics were used. Rotator cable was less frequently detected in younger than elderly volunteers (25/83 vs. 36/66 shoulders; p = 0.002). Young subjects had thicker (1.5 ± 0.2 mm, range 1.3-1.8 mm vs. 1.1 ± 0.1 mm, 0.9-1.3 mm; p < 0.001) and wider rotator cable (5.8 ± 0.7 mm, 4.5-7.1 mm vs. 4.0 ± 1.2 mm, 2.5-7.1 mm; p < 0.001) than elderly volunteers. Thickness and width reproducibility index were 89% and 94%, respectively; κ = 0.87. Ultrasound demonstrated different rotator cable consistency in younger and elderly asymptomatic patients, with high interobserver reproducibility.     

Assessment of drug-induced liver injury in clinical practice

Currently, pharmaceutical preparations are serious contributors to liver disease, with hepatotoxicity ranking as the most frequent cause for acute liver failure and post-marketing regulatory decisions. The diagnostic approach of drug-induced liver injury (DILI) is still rudimentary and inaccurate because of the lack of reliable markers for use in general clinical practice. To incriminate any given drug in an episode of liver dysfunction is a step-by-step process that requires a high degree of suspicion, compatible chronology, awareness of the drug's hepatotoxic potential, the exclusion of alternative causes of liver damage, and the ability to detect the presence of subtle data that favour a toxic aetiology. Clinical and laboratory data may also be assessed with algorithms or clinical scales, which may add consistency to the clinical judgment by translating the suspicion into a quantitative score. The CIOMS/RUCAM instrument is considered at present the best method for assessing causality in DILI, although it could be improved through the use of large database of bona fide DILI cases for validation criteria.     

老年人疼痛强度评估量表的选择

目的:调查老年人使用4种常用疼痛强度评估量表的情况,为选择合适的老年疼痛评估工具提供依据.方法:广州市两家老人院的61例65岁以上老年人参加了研究.用随机顺序排列的直观模拟量表(VAS)、数字评定量表(NRS)、词语描述量表(VDS)和修订版面部表情疼痛量表(FPS-R),对老年人的回忆性疼痛进行评估.结果:受试对象中男性17例,女性44例,平均年龄81.7岁,54例(88.5%) 认知正常,7例(11.5%)有一定程度的认知受损.4种量表疼痛评分间的Spearman相关系数为0.84～0.94.老年人能够用至少一种量表来主诉疼痛强度.FPS-R是错误率最低而首选率最高的量表.结论:4种量表均可用于评估老年人的疼痛,但FPS-R是最佳量表.将FPS-R、VDS和NRS 3种量表合并,制成简易疼痛评估尺,适合老年人认知功能且实用的疼痛评估方法.     

Exploring the efficacy and safety of polyene phosphatidylcholine for treatment of drug-induced liver injury using the Roussel Uclaf causality assessment method: a propensity score matching comparison

Objective In China, polyene phosphatidylcholine (PPC) is widely used to treat alanine aminotransferase (ALT) elevation associated with various liver diseases. Here, we assessed the efficacy and safety of PPC in treating drug-induced liver injury (DILI).Methods Data from a multicenter retrospective cohort study (DILI-R) were analyzed to compare PPC and magnesium isoglycyrrhizinate (MgIG) for treatment of DILI. We used the Roussel Uclaf causality assessment method (RUCAM) to evaluate patients with DILI. Patients with RUCAM scores ≥6 were included in the study, while those with RUCAM scores <6 were further evaluated by a panel of hepatologists. The primary outcome was the proportion of patients with ALT normalization at discharge. Propensity score matching was used to identify 183 matched pairs of patients (366 patients in total) from 25,927 patients with DILI.Results Among the DILI patients, 64 of 183 (34.97%) achieved normal ALT levels after treatment in both the PPC and the MgIG groups.Conclusion There were no significant differences in safety biomarkers including serum creatinine, blood urea nitrogen, white blood cells, platelets, hemoglobin, and albumin between patients treated with PPC or MgIG. The safety and efficacy of these two agents for treatment of DILI were comparable.     

Inter- and intra-observer reproducibility of quantitative renographic parameters of differential function and renal drainage in children

Abstract

Purpose. To evaluate inter- and intra-observer reproducibility of renographic quantitative parameters of input and output in children. Methods. 100 children with unilateral or bilateral uropathy were selected, aiming to cover the entire range of ages, overall glomerular filtration rate (GFR), differential renal function (DRF) and quality of drainage. Renograms were acquired and processed according to the EANM guidelines, using a non-commercial software. Following parameters were tested: DRF using integral and Patlak methods, normalized residual activity (NORA) and output efficiency (OE) at 20 min and on the late post-erect post-micturition acquisition. Three observers from the same department and one from Santiago (Chile) processed independently the 100 renograms using the same renal software. Two observers reprocessed the 100 renograms again two months later in order to evaluate the intra-observer reproducibility. Results and conclusion. No significant difference was observed between the four observers, whatever the considered parameter of input function or output. For left DRF (Integral and Patlak methods), 95% of the individual differences were between ?5% and +5 %. They were between ?0.5 and +0.5 units for both NORA 20 and NORA PM, and between ?10% and +10% for OE 20 and OE PM. Inter-and intra- observer reproducibility were comparable. Outliers tended to be more frequent for Patlak than for Integral. Very low GFR (< 20 mL/min/1.73 m²), very young age (first days of life), huge megaureters, NORA values higher than 2.0, OE values below 60% and bladder in the renal background area (ectopic kidney) were the main characteristics of extreme differences.     

Pressure ulcer risk assessment in critical care: Interrater reliability and validity studies of the Braden and Waterlow scales and subjective ratings in two intensive care units

Background

The application of standardized pressure ulcer risk assessment scales is recommended in clinical practice.

Objectives

The aims of this study were to compare the interrater reliabilities of the Braden and Waterlow scores and subjective pressure ulcer risk assessment and to determine the construct validity of these three assessment approaches.

Design

Observational.

Settings

Two intensive care units of a large University Hospital in Germany.

Participants

21 and 24 patients were assessed by 53 nurses. Patients’ mean age was 69.7 (SD 8.3) and 67.2 (SD 11.3).

Methods

Two interrater reliability studies were conducted. Samples of patients were assessed independently by a sample of three nurses. A 10-cm visual analogue scale was applied to measure subjective pressure ulcer risk rating. Intraclass correlation coefficients (ICC) and standard errors of measurement (SEM) were used to determine interrater reliability and agreement of the item and sum scores. Pearson product moment correlation coefficients (r) were used to indicate the degree and direction of the relationships between the measures.

Results

The interrater reliability for the subjective pressure ulcer risk assessment was ICC(1,1) = 0.51 (95% CI 0.26-0.74) and 0.71 (95% CI 0.53-0.85). Interrater reliability of Braden scale sum scores was ICC(1,1) = 0.72 (95% CI 0.52-0.87) and 0.84 (95% CI 0.72-0.92) and for Waterlow scale sum scores ICC(1,1) = 0.36 (95% CI 0.09-0.63) and 0.51 (95% CI 0.27-0.72). The absolute degree of correlation between the measures ranged from 0.51 to 0.77.

Conclusions

Interrater reliability coefficients indicate a high degree of measurement error inherent in the scores. Compared to subjective risk assessment and the Waterlow scale scores the Braden scale performed best. However, measurement error is too high to draw valid inferences for individuals. Less than 26-59% of variances in scores of one scale were determined by scores of another scale indicating that all three instruments only partly measured the same construct. The use of the Braden-, Waterlow- and Visual Analogue scales for measuring pressure ulcer risk of intensive care unit patients is not recommended.