Who's really hypertensive? - Quality control issues in the assessment of blood pressure for randomized trials

The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study entry is essential to appropriately characterize hypertension in these elderly patients.

Evaluating Patient Education Materials about Radiation Therapy

Targeted treatment education for cancer patients has the potential to promote adjustment through assisting patients to participate in treatment decision making, comply with treatment regimens and cope more effectively with treatment side effects. A quasi-experimental longitudinal pre-test post-test and follow-up design was used to assess the effect of a patient education video about radiation therapy on patients' psychological distress, knowledge about radiation therapy, self-efficacy about coping with treatment and physical symptoms. Patients with head and neck (n = 26) and breast cancer (n = 66) were recruited into the study and allocated into control and intervention groups. No significant differences were found between the control and intervention groups on any of the outcome variables. However, patients in the intervention group reported high levels of satisfaction with the video and all reported that they would recommend the video to other patients preparing for radiation therapy. As well, 90% of patients in the intervention group reported that some or all of the information in the video was new to them. Education materials that have excellent face validity and that are well received by patients may fail to produce significant change using standard controlled study designs. Future research in this area may need to consider alternative paradigms for evaluating the helpfulness of such materials. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved.

Improving learning in undergraduate control engineering courses using context-based learning models

Control Engineering is an essential part of university electrical engineering education. Normally, a control course requires considerable mathematical as well as engineering knowledge and is consequently regarded as a difficult course by many undergraduate students. From the academic point of view, how to help the students to improve their learning of the control engineering knowledge is therefore an important task which requires careful planning and innovative teaching methods. Traditionally, the didactic teaching approach has been used to teach the students the concepts needed to solve control problems. This approach is commonly adopted in many mathematics intensive courses; however it generally lacks reflection from the students to improve their learning. This paper addresses the practice of action learning and context-based learning models in teaching university control courses. This context-based approach has been practised in teaching several control engineering courses in a university with promising results, particularly in view of student learning performances.

Hydraulic engineering in the 21st century: Where to?

For centuries, hydraulic engineers were at the forefront of science. The last forty years marked a change of perception in our society with a focus on environmental sustainability and management, particularly in developed countries. Herein, the writer illustrates his strong belief that the future of hydraulic engineering lies upon a combination of innovative engineering, research excellence and higher education of quality. This drive continues a long tradition established by eminent scholars like Arthur Thomas IPPEN, John Fisher KENNEDY and Hunter ROUSE.

Evaluation of an immunoassay (EMIT) for mycophenolic acid in plasma from renal transplant recipients compared with a high-performance liquid chromatography assay

Mycophenolic acid is an immunosuppressant administered as a bioavailable ester, mycophenolate mofetil. The pharmacokinetics of mycophenolic acid have been reported to be variable. Accurate measurement of concentrations of this drug could be important to adjust doses. The aim of this study was to compare the enzyme-multiplied immunoassay technique (EMIT [Dade Behring; San Jose, CA, U.S.A.]) for mycophenolic acid with a high-performance liquid chromatographic (HPLC) assay using samples collected from renal transplant recipients. The HPLC assay used solid phase extraction and a C18 stationary phase with ultraviolet (UV) detection (254 nm). The immunoassay required no manual sample preparation. Plasma samples (n = 102) from seven patients, collected at various times after a dose, were analyzed using both methods. Both assays fulfilled quality-control criteria. Higher concentrations were consistently measured in patient samples when using EMIT. The mean (+/- standard deviation [SD]) bias (EMIT-HPLC) was 1.88 +/- 0.86 mg/L. The differences in concentrations were higher in the middle of a dosage interval, suggesting that a metabolite might have been responsible for overestimation. Measurement of glucuronide concentrations by HPLC demonstrated only a weak correlation between assay differences and glucuronide concentrations. If the crossreacting substance is active, EMIT could provide a superior measure of immunosuppression; if inactive, further work is needed to improve antibody specificity. In conclusion, it was found that EMIT overestimates the concentration of mycophenolic acid in plasma samples from renal transplant recipients compared with HPLC analysis.

Randomised controlled trial of health assessments for older Australian veterans and war widows

Objective: To assess the effect of home-based health assessments for older Australians on health-related quality of life, hospital and nursing home admissions, and death. Design: Randomised controlled trial of the effect of health assessments over 3 years. Participants and setting: 1569 community-living veterans and war widows receiving full benefits from the Department of Veterans' Affairs and aged 70 years or over were randomly selected in 1997 from 10 regions of New South Wales and Queensland and randomly allocated to receive either usual care (n = 627) or health assessments (n = 942). Intervention: Annual or 6-monthly home-based health assessments by health professionals, with telephone follow-up, and written report to a nominated general practitioner. Main outcome measures: Differences in health-related quality of life, admission to hospital and nursing home, and death over 3 years of follow-up. Results: 3-year follow-up interviews were conducted for 1031 participants. Intervention-group participants who remained in the study reported higher quality of life than control-group participants (difference in Physical Component Summary score, 0.90; 95% CI, 0.05-1.76; difference in Mental Component Summary score, 1.36; 95% CI, 0.40-2.32). There was no significant difference in the probability of hospital admission or death between intervention and control groups over the study period. Significantly more participants in the intervention group were admitted to nursing homes compared with the control group (30 v 7; P < 0.01). Conclusions: Health assessments for older people may have small positive effects on quality of life for those who remain resident in the community, but do not prevent deaths. Assessments may increase the probability of nursing-home placement.

A Test of Performance of Breast MRI Interpretation in a Multicentre Screening Study

Objectives: The aim of this study was to assess the consistency and performance of radiologists interpreting breast magnetic resonance imaging (MRI) examinations. Materials and Methods: Two test sets of eight cases comprising cancers, benign disease, technical problems and parenchymal enhancement were prepared from two manufacturers' equipment (X and Y) and reported by 15 radiologists using the recording form and scoring system of the UK MRI breast screening study [(MAgnetic Resonance Imaging in Breast Screening (MARIBS)]. Variations in assessments of morphology, kinetic scores and diagnosis were measured by assessing intraobserver and interobserver variability and agreement. The sensitivity and specificity of reporting performances was determined using receiver operating characteristic (ROC) curve analysis. Results: Intraobserver variation was seen in 13 (27.7%) of 47 of the radiologists' conclusions (four technical and seven pathological differences). Substantial interobserver variation was observed in the scores recorded for morphology, pattern of enhancement, quantification of enhancement and washout pattern. The overall sensitivity of breast MRI was high [88.6%, 95% confidence interval (CI) 77.4-94.7%], combined with a specificity of 69.2% (95% CI 60.5-76.7%). The sensitivities were similar for the two test sets (P=.3), but the specificity was significantly higher for the Manufacturer X dataset (P

Assessing the quality of risk factor survey data: lessons from the WHO MONICA Project

Background and purpose Survey data quality is a combination of the representativeness of the sample, the accuracy and precision of measurements, data processing and management with several subcomponents in each. The purpose of this paper is to show how, in the final risk factor surveys of the WHO MONICA Project, information on data quality were obtained, quantified, and used in the analysis. Methods and results In the WHO MONICA (Multinational MONItoring of trends and determinants in CArdiovascular disease) Project, the information about the data quality components was documented in retrospective quality assessment reports. On the basis of the documented information and the survey data, the quality of each data component was assessed and summarized using quality scores. The quality scores were used in sensitivity testing of the results both by excluding populations with low quality scores and by weighting the data by its quality scores. Conclusions Detailed documentation of all survey procedures with standardized protocols, training, and quality control are steps towards optimizing data quality. Quantifying data quality is a further step. Methods used in the WHO MONICA Project could be adopted to improve quality in other health surveys.

Compositional analysis of teas from Australian supermarkets

Caffeine, total amino acids, water extract and moisture content are considered to be quality indicators for leaf teas and teabags. These analyses were examined in 20 leaf teas and 36 teabags sampled from Australian supermarkets. About 70% of the analysed samples showed a moisture content higher than Vie maximum accepted level, 6.5%, for tea storage and marketing by the tea industries and traders. Water appropriate extract of 15 samples out of 36 teabags was lower than that of the teas without teabags, which indicates that the quality of the paper used for teabags needs to be evaluated. Moreover, one of the black leaf tea samples was found to have a water extract below the lower limit of international standards. Four green and black teas of the same brand, claimed to contain less than 3% caffeine, were found to have 3-4%, the same as the other samples analysed in this study. The mean total contents of amino acids were 2.50% and 1.76% in black leaf teas and the teabags, respectively, whereas they were 3.44% and 2.28% in green leaf teas and the teabags, respectively. Furthermore, the weights of 28 teabags out of 36 samples were found to lie outside of the proposed +/- 2% variation accepted by the tea industries and traders, and 4 samples showed even larger variation, 10% being out of the proposed weights. This investigation also showed that the solubility of caffeine and water extract was affected by the permeability of teabags, whereas total amino acids were very variable. These results suggest that an efficient and practical quality control system for both imported and Australian-made teas in the Australian supermarkets should be developed, implemented and enforced. Chemical analysis should be a part of the system for establishing an objective assessment for the quality control. (c) 2004 Elsevier Ltd. All rights reserved.