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Fundal height measurement. Part 2--Intra- and interexaminer reliability of three measurement techniques.

The intra- and interexaminer reliability of three fundal height measurement techniques (two tape measure and one caliper) was studied in a convenience sample of 60 pregnant women. The three measurements were obtained twice by two examiners. Four examiners with varying levels of clinical experience participated in the study; one examiner obtained measurements in all 60 cases and the other three examiners each obtained measurements in approximately one-third of the cases. Examiners were blinded to their own and to other examiners' measurements. The mean absolute differences between individual examiner's first and second measurements varied from 0.68 to 1.74 cm, the percentage of differences < or = 1.0 cm varied from 45% to 77.8%, and the maximal differences varied from 1.6 to 7.5 cm. The caliper technique consistently demonstrated the smallest mean absolute intraexaminer differences (0.68 to 1.39 cm) and the highest percentage of intraexaminer differences < or = 1.0 cm (55% to 77.8%). The differences between pairs of examiners' measurements were consistently greater than the differences between individual examiner's measurements: Mean absolute differences varied from 1.36 to 3.60 cm, the percentage of differences < or = 1.0 cm varied from 9.1% to 55.6%, and the maximal differences varied from 3.1 to 11.5 cm. Interexaminer differences were smallest for the tape "over-the-curve" measurements and the caliper measurements. These findings indicate that, to ensure maximal reliability, fundal height measurements should be obtained by the same clinician throughout pregnancy. Additionally, these findings indicate that calipers may be the most reliable method of obtaining fundal height measurements and that the accuracy of caliper measurements in identifying fetal growth disturbances and other pregnancy complications merits further investigation.

Anthropometry↗

Is a series of blood pressure measurements by the general practitioner or the patient a reliable alternative to ambulatory blood pressure measurement? A study in general practice with reference to short-term and long-term between-visit variability.

We studied the reproducibility of a series of blood pressure measurements by general practitioner (GP) and patient in comparison with that of ambulatory blood pressure measurement (ABPM), with reference to short-term and long-term between-visit variability using a prospective, comparative diagnostic study. The study group was 88 potentially hypertensive primary care patients (initial systolic blood pressure [SBP] between 160 and 200 mm Hg or with diastolic blood pressure [DBP] between 95 and 115 mm Hg). ABPMs were measured on 2 separate days (at a 6 month interval). Two series of measurements by the doctor (at 1 to 6 month intervals), and the patient (at a 1 week interval) were measured. Mean differences and standard deviations of mean differences (SDD) between two successive series of measurements, and between two ABPMs were computed. The Wilcoxon signed-ranks test was used to compare these standard deviations. Mean initial office-blood pressures were 161 (SBP) and 102 (DBP) mm Hg. Long-term between-visit variability (measurements by GP) was larger than short-term between-visit variability: SDDs were 16 v 11 mm Hg (SBP), and 10 v 8 mm Hg (DBP). The differences in average SBP and DBP between successive ABPMs and between successive series of office measurements by GP and home measurements by patient were not statistically significant. Mean differences between two series of measurements by GP and patient, and between two ABPMs, were 0 +/- 1 mm Hg. SDDs between successive ABPMs and series of measurements by GP and patient ranged from 8 to 11 mm Hg (SBP), and were 6 mm Hg (DBP). No statistically significant differences were found between the SDDs of the studied measurement procedures (SBP and DBP). In our study the reproducibility of ambulatory blood pressure measurement was not found to be better than that of a series of four duplicate measurements by GP or patient. Long-term (6 months interval) between-visit variability was larger than the short-term (1 week interval) between-visit variability.

Adult↗

The detection of gene-environment interaction for continuous traits: should we deal with measurement error by bigger studies or better measurement?

BACKGROUND: The search for biologically relevant gene-environment interactions has been facilitated by technological advances in genotyping. The design of studies to detect interactions on continuous traits such as blood pressure and insulin sensitivity is attracting increasing attention. We have previously described power calculations for such studies, and this paper describes the extension of those calculations to take account of measurement error. METHODS: The model considered in this paper is a simple linear regression relating a continuous outcome to a continuously distributed exposure variable in which the ratio of slopes for each genotype is considered as the interaction parameter. The classical measurement error model is used to describe the uncertainty in measurement in the outcome and the exposure. The sample size to detect differing magnitudes of interaction with varying frequencies of the minor allele are calculated for a given main effect observed with error both in the exposure and the outcome. The sample size to detect a given interaction for a given minor allele frequency is calculated for differing degrees of measurement error in the assessment of the exposure and the outcome. RESULTS: The required sample size is dependent upon the magnitude of the interaction, the allele frequency and the strength of the association in those with the common allele. As an example, we take the situation in which the effect size in those with the common allele was a quarter of a standard deviation change in the outcome for a standard deviation change in the exposure. If a minor allele with a frequency of 20% leads to a doubling of that effect size, then the sample size is highly dependent upon the precision with which the exposure and outcome are measured. rho(Tx) and rho(Ty) are the correlation between the measured exposure and outcome, respectively and the true value. If poor measures of the exposure and outcome are used, (e.g. rho(Tx) = 0.3, rho(Ty) = 0.4), then a study size of 150 989 people would be required to detect the interaction with 95% power at a significance level of 10(-4). Such an interaction could be detected in study samples of under 10 000 people if more precise measurements of exposure and outcome were made (e.g. rho(Tx) = 0.7, rho(Ty) = 0.7), and possibly in samples of under 5000 if the precision of estimation were enhanced by taking repeated measurements. CONCLUSIONS: The formulae for calculating the sample size required to study the interaction between a continuous exposure and a genetic factor on a continuous outcome variable in the face of measurement error will be of considerable utility in designing studies with appropriate power. These calculations suggest that smaller studies with repeated and more precise measurement of the exposure and outcome will be as powerful as studies even 20 times bigger, which necessarily employ less precise measures because of their size. Even though the cost of genotyping is falling, the magnitude of the effect of measurement error on the power to detect interaction on continuous traits suggests that investment in studies with better measurement may be a more appropriate strategy than attempting to deal with error by increasing sample sizes.

Environmental Exposure↗

Quality of life measurement: bibliographic study of patient assessed health outcome measures.

OBJECTIVES: To assess the growth of quality of life measures and to examine the availability of measures across specialties. DESIGN: Systematic searches of electronic databases to identify developmental and evaluative work relating to health outcome measures assessed by patients. MAIN OUTCOME MEASURES: Types of measures: disease or population specific, dimension specific, generic, individualised, and utility. Specialties in which measures have been developed and evaluated. RESULTS: 3921 reports that described the development and evaluation of patient assessed measures met the inclusion criteria. Of those that were classifiable, 1819 (46%) were disease or population specific, 865 (22%) were generic, 690 (18%) were dimension specific, 409 (10%) were utility, and 62 (1%) were individualised measures. During 1990-9 the number of new reports of development and evaluation rose from 144 to 650 per year. Reports of disease specific measures rose exponentially. Over 30% of evaluations were in cancer, rheumatology and musculoskeletal disorders, and older people's health. The generic measures--SF-36, sickness impact profile, and Nottingham health profile--accounted for 612 (16%) reports. CONCLUSIONS: In some specialties there are numerous measures of quality of life and little standardisation. Primary research through the concurrent evaluation of measures and secondary research through structured reviews of measures are prerequisites for standardisation. Recommendations for the selection of patient assessed measures of health outcome are needed.

Health Status Indicators↗

Comparison of relative renal function measured with either 99mTc-DTPA or 99mTc-EC dynamic scintigraphies with that measured with 99mTc-DMSA static scintigraphy.

OBJECTIVE: The aim of this study was to compare the renal function measured with either 99mTc-DTPA or 99mTc-EC dynamic scintigraphies with that measured using 99mTc-DMSA static scintigraphy. METHODS: the values of relative renal function measured in 111 renal dynamic scintigraphies performed either with 99mTc-DTPA (55 studies) or with 99mTc-EC (56 studies) were compared with the relative function measured using 99mTc-DMSA static scintigraphy performed within a 1-month period. The comparisons were performed using Wilcoxon signed rank test. The number of 99mTc-DTPA and 99mTc-EC studies that presented relative renal function different by more than 5% from that measured with 99mTc-DMSA, using chi square test were also compared. RESULTS: the relative renal function measured with 99mTc-EC is not statistically different from that measured with 99mTc-DMSA (p = 0.97). The relative renal function measured with 99mTc-DTPA was statistically different from that measured using 99mTc-DMSA, but with a borderline statistical significance (p = 0.05). The number of studies with relative renal function different by more than 5% from that measured with 99mTc-DMSA is higher for the 99mTc-DTPA scintigraphy (p = 0.04) than for 99mTc-EC. CONCLUSION: the relative renal function measured with 99mTc-EC dynamic scintigraphy is comparable with that measured with 99mTc-DMSA static scintigraphy, while the relative renal function measured with 99mTc-DTPA dynamic scintigraphy presents a significant statistical difference from that measured with 99mTc-DMSA static scintigraphy.

Adolescent↗

Validation of the OMRON R3 blood pressure self-measuring device through simultaneous comparative invasive measurements according to protocol 58130 of the German Institute for Validation.

OBJECTIVES: To perform simultaneous invasive comparative measurements in order to validate the blood pressure self-measuring device OMRON R3 for use on the wrist, in accordance with protocol 58130 of the German Institute for Validation. METHODS: Five consecutive comparative blood pressure measurements were carried out for each of 15 patients (n = 75 measurements). The blood pressure was measured simultaneously non-invasively using the blood pressure self-measuring device OMRON R3 around the left wrist and at the same time invasively using a pigtail catheter situated in the aortic arch. The pressure curves were drawn continuously. The measuring arrangements, validation of the invasive-measurement unit and evaluation were all carried out in accordance with protocol 58130. RESULTS: The blood pressure self-measuring device OMRON R3 for use on the wrist satisfied the criteria of the European Standard prEn 1060-3. The OMRON systolic values were 2.2 +/- 3.9 mmHg higher and the diastolic values were 0.2 +/- 2.7 mmHg lower than the invasive ones. However, for higher blood pressure levels (> 150 mmHg), the device tested displayed an increasing tendency to underestimate the systolic blood pressure in one-third of the patients by 5-15 mmHg, compared with the invasive measurements. No faulty measurements occurred with the patient group examined. CONCLUSION: The blood pressure self-measuring device OMRON R3 for use on the wrist can be recommended for blood pressure self-measurement. When it is used correctly, it measures the blood pressure reliably and accurately.

Journal Article↗

Avoiding pitfalls in chronic disease quality measurement: a case for the next generation of technical quality measures.

The true utility of quality measurement lies in its ability to inspire quality improvement, with resultant enhancements in the processes and outcomes of care. Because quality measurement is expensive, it is difficult to justify using measures that are not likely to lead to important improvements in health. Many current measures of chronic disease technical quality, however, have one or more pitfalls that prevent them from motivating quality improvement reactions. These pitfalls include that: (1) measured processes of care lack strong links to outcomes; (2) actionable processes of care are not measured; (3) measures do not target those at highest risk; (4) measures do not allow for patient exceptions; and (5) intermediate outcome measures are not severity adjusted. To exemplify recent advancements and current pitfalls in chronic disease quality measurement, we examine the evolution of quality measures for diabetes mellitus and discuss the limitations of many currently used diabetes mellitus care measures. We then propose more clinically meaningful "tightly linked" measures that examine clinical processes directly linked to outcomes, target populations with specific diagnoses or intermediate disease outcomes that contribute to risk for poor downstream health outcomes, and explicitly incorporate exceptions. We believe that using more tightly linked measures in quality assessment will identify important quality of care problems and is more likely to produce improved outcomes for those with chronic diseases.

Chronic Disease↗

[Comparison of invasive blood pressure measurement in the aorta with indirect oscillometric blood pressure measurement at the wrist and forearm].

Indirectly measured blood pressure at the wrist or upper arm was compared with directly measured values in the aortic arch during routinely performed diagnostic cardiac catheterization in 100 patients (31-80 years, mean 59.3 years, 60% males). The noninvasive measurements were carried out by oscillometric devices, NAiS Blood Pressure Watch for measurements at the wrist, and Hestia OZ80 at the upper arm. Systolic blood pressure measured at the wrist was 4.3 +/- 14.1 mm Hg, and the diastolic value 6.0 +/- 8.9 mm Hg higher than when measured at the aortic arch; the difference was significant in both cases. Correlation coefficients were 0.85 for systolic and 0.71 for diastolic blood pressure. In 16% of the patients the systolic blood pressure at the wrist differed more than +/- 20 mm Hg. The diastolic blood pressure at the wrist measured more than +/- 20 mm Hg higher than in the aorta in 5% of the patients. At the upper arm mean systolic values were not different to the aorta. The diastolic pressure was 9.3 +/- 9.8 mm Hg higher in the aorta than at the upper arm. To verify the accuracy of values measured with the NAiS Blood Pressure Watch compared with the standard technique at the upper arm, sequential measurements were made at wrist and ipsilateral upper arm in the same group of 100 patients. The systolic blood pressure at the left wrist was 3.4 +/- 13.3 mm Hg higher and the diastolic pressure 3.8 +/- 9.5 mm Hg lower than at the upper arm. Only 53% of systolic values lay within a range of +/- 10 mm Hg. The correspondence between wrist and upper arm values was better for diastolic blood pressure, the values differing by less than +/- 10 mm Hg in two-thirds of patients. Self-measurement of arterial blood pressure with an oscillometric device at the wrist can be recommended only in individual cases with a difference of simultaneously measured values at the upper arm of less than +/- 10 mm Hg for systolic and diastolic blood pressures. The standard method for indirectly measuring arterial blood pressure remains the measurement at the upper arm site, which nevertheless showed a systolic pseudohypertension (deviation of more than 10 mm Hg) in comparison to the invasively measured values in 15% of our selected patients and a diastolic pseudohypertension (deviation of more than 15 mm Hg) in 23% of the patients.

Adult↗

Connecting stuttering management and measurement: V. Deduction and induction in the development of stuttering treatment outcome measures and stuttering treatments.

BACKGROUND: The development of evidence-based practice, which is increasingly popular in stuttering treatment, is closely linked to the development of outcome measures. AIMS: Two approaches to the development of stuttering treatment outcome measures are outlined. The first is the deductive, top-down approach, where the development of specific outcome measures is guided by a priori general conceptualizations of the nature of the disorder. A competing approach to the development of stuttering treatment outcome measures is outlined. This is the inductive, or bottom up approach. This approach uses Baer's (1988, 1990) notion of specific complaints of clients as the starting point to develop inductive statements for use as general guidance for developing treatment outcome measures. MAIN CONTRIBUTION: It is argued that the deductive approach to development of outcome measures has limitations. It is overly prescriptive, generating numerous and increasingly complex outcome measures that are potentially confusing for clinicians. Further, it is arbitrary and fragile, being linked to conceptualizations and theories about stuttering, which, by necessity, are limited themselves. Further, the development of numerous outcome measures is not compatible with the conduct of randomized controlled trials, which allow a maximum of two primary outcome measures. In contrast, the inductive approach to the development of outcome measures has in its favour that it is empirically driven rather than arbitrary, and that it facilitates a yoking of the development of clinical outcomes and the clinical methods to attain those outcomes. The approach is unlikely to lead to the development of fruitless treatment methods. Further, the approach is parsimonious to the extent that it is likely to produce few guiding generalities for treatment outcome assessment -- perhaps as few as two in the case of adults and one in the case of preschoolers. This is well suited to the use of the randomized controlled trial as a source of evidence for treatment efficacy. CONCLUSIONS: One inductive statement that can be used to guide the development of outcome measures is that the ill effects of stuttered speech could be troubling for those who seek clinical help. The other is that those who seek clinical help are likely to experience speech-related anxiety. Together, these sources of information provide sound guidance for the development of outcome measures relating to stuttered speech and speech-related anxiety, and guidance for the development of treatments to offset those ill effects of the condition. Until another outcome measure can be derived from inductive processes, those treatment developments should serve all the needs of those who stutter and the clinicians who provide those needs.

Anxiety↗

Reliability of lumbar dynamometry measurements in patients with chronic low back pain with test-retest measurements on different days.

Lumbar dynamometry is a potentially useful method for assessing the state of trunk muscles in low back pain (LBP) patients. The purpose of this study was to assess the reliability of lumbar dynamometry measurements in chronic LBP patients by conducting test-retest measurements on different days. Thirty-one men and 14 women with chronic LBP participated in this study. The experiments consisted of three sets of lumbar dynamometry measurements (Isostation B200) carried out on three different days with a 2- to 3-day interval. A standard protocol was administered to all subjects, consisting of a range-of-motion measurement about each axis, a 5 s maximum isometric trial about each axis and five dynamic repetitions about each axis against a resistance set at 25% and at 50% of the maximum isometric torque. Correlation coefficients and regression analysis were used to detect possible learning effects. One-way anova and regression analysis were used to assess the reliability of the measurements. High coefficients were found for the correlation between the first and second lumbar dynamometry measurements. Regression analysis showed that the differences between those measurements were not significant. This means that there was no learning effect operating between the first and second lumbar dynamometry measurements. One-way anova showed a reliability higher than 0.90 for the torque and velocity parameters. Reliability for the range-of-motion parameters was somewhat lower: between 0.76 and 0.94. Regression analysis showed no significant differences between the second and third measurements for the torque and velocity parameters. For range-of-motion parameters significant differences were found. From this study it can be concluded that the Isostation B200 provides reliable measures of torque and velocity parameters, but measures of the range-of-motion parameters are unreliable. No learning effect operates between the first and second lumbar dynamometry measurements, which means that a single measurement, with prior warming up and practice, is sufficient to assess the performance of the LBP patient.

Adult↗

Measurement of vertebral body heights: ex vivo comparisons between morphometric X-ray absorptiometry, morphometric radiography and direct measurements.

Morphometric X-ray absorptiometry (MXA) offers some potential advantages over spinal radiography for the quantitative evaluation of vertebral fractures in individuals with spinal osteoporosis. This ex vivo study examined the accuracy of MXA and quantitative morphometry (QM) for the evaluation of vertebral height, in relation to direct measurements from cadaveric vertebral columns. Spinal radiographs and MXA scans were obtained from nine cadaveric vertebral columns (mean age at death 64 years). Anterior, middle and posterior vertebral body heights of all segments from T4 to L4 were measured interactively using MXA software and QM (from the spinal radiographs), and compared with direct measurements derived using digital callipers following cadaveric dissection. Coefficients of variation for repeat QM and MXA scan analysis were less than 2%. The QM and MXA measurements were both strongly correlated (r(2) = 0.99) with the direct measurements, with accuracy errors of between 2.6% and 4.3%, and 4.5% and 4.8%, for QM and MXA respectively. At the three measurement sites, analysis of measurement differences showed that QM tended to overestimate the true height and MXA tended towards under-estimation. The mean difference between the direct measurements and QM measurements ranged from 2.7% to 8.7%, and the mean difference between direct and MXA measurements ranged from -2. 9% to 4.1%. There was strong linear association between the MXA and QM measurements (r(2) = 0.99) with mean differences at the three measurement sites ranging from -4.1% to -5.9%. Under the optimal (ex vivo) scanning conditions used in this study, MXA is comparable to spinal radiography for the assessment of vertebral height. Further studies are required to determine the conditions under which satisfactory MXA image resolution and measurement accuracy can be achieved in a clinical population.

Absorptiometry, Photon↗

Study of low bladder volume measurement using 3-dimensional ultrasound scanning device: improvement in measurement accuracy through training when bladder volume is 150 ml or less.

PURPOSE: Using a Bladder Scan BVI6100 portable 3-dimensional ultrasound scanning device we examined measured values of bladder volume, especially focusing on volumes of 150 ml or less. MATERIALS AND METHODS: A total of 89 men and 71 women were enrolled in the study. We performed a comparison study between the measured value (the average of 3 bladder volume measurements after a trial in male and female modes) using the BVI6100 and the actual measured value determined by urethral catheterization in each patient. We examined factors that could increase the error rate and measuring techniques to decrease measurement errors. We also reviewed the training effects of measurement for a year. RESULTS: Actual measured values in all patients correlated well with the average value of 3 measurements after a trial of BVI6100 in male mode. The correlation coefficient was 0.941 (0.967 after a year), the mean +/- SD error rate was -2.0% +/- 22.0% (-2.0% +/- 13.8% after a year) and the average variation coefficient was 12.4 (7.6 after a year). It was found that measurement results using the BVI6100 were influenced by patient factors, including extracted edges between the bladder wall and urine, thickened bladder wall, irregular bladder wall, flattened bladder, mistaking the prostate for the bladder in male mode, mistaking the bladder for the uterus in female mode, etc, and examiner factors, including changes in the angle between the BVI6100 and the abdominal wall, compatibility between the abdominal wall and the ultrasound probe, controlling deflection while using the probe, etc. It was also found that measurement accuracy could be improved regarding patient and examiner factors by choosing appropriate patients and performing concise measurement procedures (training effects). CONCLUSIONS: When appropriate patients are chosen and proper measurement is performed, the BVI6100 provides significantly higher accuracy for determining lower bladder volume compared with existing abdominal ultrasound methods.

Aged↗

Reliability of measuring iliac crest level in the standing and sitting position using a new measurement device.

BACKGROUND: To date, the reliability studies of iliac crest (IC) level used nominal scales and presented conflicting results. To perform the IC level measurement, we propose the use of a measurement device that is composed of an inclinometer mounted on a crest level tester that measures IC level in degrees. OBJECTIVES: To determine the interrater reliability of measuring iliac crest level in the standing and sitting position using an experimental device and to assess the precision of the measurements taken with the experimental device. METHOD: Forty individuals (mean age 40 +/- 12 years) referred to physical therapy for treatment of low back pain (LBP) participated in the study (16 male participants). Six examiners performed the measurements. Three of the 6 examiners performed the measurements on each individual. Each examiner independently performed the measurement of IC level in standing and in sitting using the measurement device. RESULTS: Intraclass correlation coefficients, [formula (1,1)] for measurement of IC level in standing and sitting, were 0.80 (95% CI = 0.7-0.9) and 0.73 (95% CI = 0.6-0.8), respectively. Standard errors of measurement for IC level in standing and sitting were 0.91 and 0.86 degrees, respectively. CONCLUSION: The use of a measurement device resulted in good reliability of IC level measurement in degrees in standing and moderate reliability of IC level in sitting position. This finding is relevant to plan future studies that will investigate if changes in IC level may be associated with outcomes of pain and function in patients with low back or pelvic dysfunctions.

Adult↗

Effects of velocity distribution, diameter measurement and velocity tracing on the accuracy of cardiac output measurement by pulsed Doppler echocardiography in the aortic annulus of pigs.

UNLABELLED: The accuracy of cardiac output measurement by pulsed Doppler echocardiography can be affected by several factors, such as the velocity distribution, the measurement of diameter and the method of tracing the pulsed Doppler flow spectrum. This experimental study was designed to find the most accurate way of measuring cardiac output in consideration of all these factors. In 10 open-chest normal piglets (24 +/- 1 kg), the velocity distribution in the aortic annulus was evaluated using Doppler colour flow mapping. Cardiac output was measured by pulsed Doppler echocardiography in the aortic annulus by a number of different ways and compared to the simultaneous result of the thermodilution method. All measurements were made at baseline, after intravenous injection of esmolol and during infusion of dobutamine. RESULTS: (1) the velocity distribution in the aortic annulus in the piglets was just slightly skewed during all three haemodynamic situations; (2) The in vivo measurements of the diameter of the aortic annulus varied throughout the ejection period, but the average of the three largest diameter measurements was almost identical with the diameter measured in vitro (18.5 +/- 0.3 mm vs. 18.6 +/- 0.2 mm; p = NS); (3) Tracing the maximal velocity of the pulsed Doppler flow spectrum produced a cardiac output that was 18%-21% higher than that measured by the thermodilution method, while tracing the brightest part (modal velocity) of the pulsed Doppler flow spectrum yielded a cardiac output very close to the thermodilution measurement. CONCLUSION: The velocity distribution in the aortic annulus in the piglet has little effect on cardiac output measurement by pulsed Doppler. Using the maximal measurable diameter of the aortic annulus and tracing the brightest part of the pulsed Doppler flow spectrum yielded the cardiac output closest to that measured by the thermodilution method.

Adrenergic beta-Antagonists↗

The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure.

BACKGROUND: Empathy is a key aspect of the clinical encounter but there is a lack of patient-assessed measures suitable for general clinical settings. OBJECTIVES: Our aim was to develop a consultation process measure based on a broad definition of empathy, which is meaningful to patients irrespective of their socio-economic background. METHODS: Qualitative and quantitative approaches were used to develop and validate the new measure, which we have called the consultation and relational empathy (CARE) measure. Concurrent validity was assessed by correlational analysis against other validated measures in a series of three pilot studies in general practice (in areas of high or low socio-economic deprivation). Face and content validity was investigated by 43 interviews with patients from both types of areas, and by feedback from GPs and expert researchers in the field. RESULTS: The initial version of the new measure (pilot 1; high deprivation practice) correlated strongly (r = 0.85) with the Reynolds empathy measure (RES) and the Barrett-Lennard empathy subscale (BLESS) (r = 0.63), but had a highly skewed distribution (skew -1.879, kurtosis 3.563). Statistical analysis, and feedback from the 20 patients interviewed, the GPs and the expert researchers, led to a number of modifications. The revised, second version of the CARE measure, tested in an area of low deprivation (pilot 2) also correlated strongly with the established empathy measures (r = 0.84 versus RES and r = 0.77 versus BLESS) but had a less skewed distribution (skew -0.634, kurtosis -0.067). Internal reliability of the revised version was high (Cronbach's alpha 0.92). Patient feedback at interview (n = 13) led to only minor modification. The final version of the CARE measure, tested in pilot 3 (high deprivation practice) confirmed the validation with the other empathy measures (r = 0.85 versus RES and r = 0.84 versus BLESS) and the face validity (feedback from 10 patients). CONCLUSIONS: These preliminary results support the validity and reliability of the CARE measure as a tool for measuring patients' perceptions of relational empathy in the consultation.

Adult↗

Summary measures of quality of diabetes care: comparison of continuous weighted performance measurement and dichotomous thresholds.

BACKGROUND: The Institute of Medicine has suggested that related individual measures of quality be combined into summary measures. Averages of adherence on dichotomous measures for intermediate outcomes have shortcomings because control of individual risk factors differs in their health benefit. Therefore, a common metric is necessary to weight measures appropriately. OBJECTIVE: Compare health care system performance using continuous measures weighted based on quality adjusted life years saved (QALYsS) versus dichotomous threshold measures. RESEARCH DESIGN: Retrospective cross-sectional analysis of 2000-01 chart abstraction data of diabetic patients from 141 Veterans Health Administration medical centers. Outcome variables included correlation of individual level and facility level adherence to and rankings by continuous weighted individual and summary dichotomous measures for glycemic control (<8% A1c), blood pressure (<140/80 mm/Hg), and low-density lipoprotein-cholesterol (LDL-C) <130 mg/dl. RESULTS: The 141 facilities had a range of 163-740 (mean 263) subjects. The population (n = 37 142) was largely male (86.1%) and older (mean age 65.9 years, SD +/-11.4 years), with mean overall A1c of 7.58%, systolic blood pressure of 137.2 mm/Hg, and LDL-C 104.8 mg/dl. There was excellent correlation between QALYsS and dichotomous outcomes for A1c (r = 0.86), blood pressure (r = 0.94), LDL-C (r = 0.95), and the summary measure (r = 0.92), but poor correlation among the risk factors (r = 0.19-0.36). There was considerable difference in rankings between the dichotomous and the continuous weighted measures; only 46% of facilities remained within the same or within 1 decile. CONCLUSION: Continuous weighted measures for the major risk factors for diabetes-related complications have high correlation with dichotomous measures. We propose that a continuous QALYs-weighted summary measure could function as a global measure for the quality of diabetes care.

Aged↗

Reproducibility of plantar pressure measurements in patients with chronic arthritis: a comparison of one-step, two-step, and three-step protocols and an estimate of the number of measurements required.

BACKGROUND: Plantar pressure measurement may be a helpful evaluation tool in patients with foot complaints. Determination of dynamic pressure distribution under the foot may give information regarding gait, progress of disorders, and the effect of treatment. However, for these measurements to have clinical application, reproducibility, consistency, and accuracy must be ascertained. We compared the reproducibility of measurements among one-step, two-step, and three-step protocols for data collection in patients with arthritis. In addition, the number of measurements needed for a consistent average was determined for the protocol that was found to be the most reproducible. METHODS: Twenty patients with foot complaints secondary to arthritis participated in the study. Each patient was tested with a pressure platform system using two of the three testing protocols. Reproducibility of contact time and maximal peak pressure were assessed. Intraclass Correlation Coefficients (ICC) were calculated for measurement results among protocols. In stage two of the study, the number of measurements needed for a consistent average was determined by calculating the first three measurements, the first five measurements, and then all seven measurements for both feet. ICC of three, five, and seven measurements were compared. The two-step protocol (13 patients), which was found in stage one of the study to be the most reproducible, was used for this determination. RESULTS: Reproducibility was found to be reasonable or good for all three measurement protocols. The mean values of contact time for the one-step protocol were found to be higher than the mean values of contact time for the two-step or three-step protocols in both feet. The differences between the one-step and three-step protocols were statistically significant for the left foot only. The mean peak pressure did not show statistically-significant differences among the three protocols. The one-step and three-step protocols were not used for stage two of the study. Using the two-step protocol, three measurements were found to be sufficient for obtaining a consistent average. CONCLUSIONS: The results of our study indicated that the one-step, two-step, and three-step protocols of collecting plantar pressure measurements in patients with foot complaints secondary to chronic arthritis were all similar. However, the use of the two-step protocol is recommended over the one-step and three-step protocols; the one-step protocol produced a longer stance phase that did not resemble normal walking and when comparing the two-step and three-step protocols, the two-step protocol was less time consuming and less strenuous for patients with painful feet.

Adolescent↗

Validation of the Omron F3 blood pressure measuring device for use in the finger through simultaneous invasive comparative measurements according to the German Institute for Validation (DIN) 58130 protocol.

OBJECTIVES AND DESIGN: Simultaneous invasive comparative measurements in order to validate the blood pressure measuring device Omron F3 for use in the finger, in accordance with the German Institute for Validation (DIN) 58130 protocol. METHODS: A total of five consecutive simultaneous blood pressure comparative measurements were carried out in each of 15 patients (n = 75). Blood pressure was measured in the left index finger using the blood pressure measuring device Omron F3, and at the same time invasively using a pigtail catheter situated in the aortic arch. The measuring arrangements, validation of the unit of invasive measurement and evaluation were all carried out in accordance with the DIN 58130 protocol. RESULTS: The blood pressure measuring device Omron F3 for use in the finger fulfils the criteria of the European Standard prEn 1060-3. Systolic blood pressure decreased by 2.9+/- 6.6 mmHg and diastolic blood pressure decreased by 2.6+/- 5.9 mmHg. CONCLUSION: The blood pressure measuring device Omron F3 measures blood pressure reliably and accurately if used correctly in appropriate patients. Before using the device for the first time, comparative blood pressure measurements in the upper arm, using the standard auscultatory blood pressure measurement technique according to Riva-Rocci and Korotkoff, should be carried out, in order to check the accuracy of measurement.

Adult↗