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PubMed1994

Measurement of low back mobility, isometric strength and isoinertial performance with isostation B-200 triaxial dynamometer: reproducibility of measurement and development of functional indices.

The reproducibility of measurements with the triaxial lumbar dynamometer Isostation B-200 was measured in 61 volunteers with or without low back problems. Both for the intra- and interrater measurements the reproducibility was good (r = 0.76-0.89) for lateral flexions and almost as good (r = 0.76-0.87) for the sum of all ranges of motion (SROM). The corresponding reproducibilities were excellent (r = 0.82-0.99) for the isometric strength and good (r = 0.60-0.90) for isoinertial flexion-extension repetition test parameters in the main (primary axis) direction. A number of parameters were combined into three functional indices: the reproducibility for "power" and "work" index was good (r = 0.76-0.94) in both intra- and interrater conditions, whereas for "movement" index it was somewhat weaker (r = 0.53-0.87). It is concluded that parameters: lateral flexions, SROM, isometric strength, and functional indices (power and work) are reproducible enough to use in further studies.

Adult↗

PubMed1993

Reproducibility of ambulatory and clinic blood pressure measurements in elderly hypertensive subjects.

OBJECTIVES: To compare the reproducibility of clinic and ambulatory blood pressure measurements in elderly hypertensive subjects. SUBJECTS: Twenty-two untreated elderly hypertensives, with a clinic systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 95 mmHg, and a mean age of 76 years (range 66-86). METHODS: Following three supine clinic blood pressure readings the subjects underwent 24-h non-invasive ambulatory blood pressure monitoring, measurements being taken at 20-min intervals from 0700 to 2200 h and at 30-min intervals from 2200 to 0700 h. Measurements were repeated during a further visit at a median interval of 10 weeks (range 1-10 months). RESULTS: Daytime ambulatory SBP levels were 20 mmHg (95% confidence interval 14-27 mmHg, P < 0.001) lower than clinic SBP, although DBP values were similar. The mean 24-h ambulatory SBP and DBP reproducibility [assessed by the standard deviation of differences (SDD) between visits] was significantly better than that for mean clinic blood pressure (SBP 6.3 versus 17.4 mmHg, P < 0.001; DBP 4.8 versus 7.0 mmHg, respectively, P < 0.05). With daytime defined as 1000-1959 h, the SDD between visits was 12.4 mmHg for SBP and 8.3 mmHg for DBP, but with daytime defined as 0700-2159 h, the SDD fell to 6.0 mmHg for SBP and 4.8 mmHg for DBP, values almost identical to those obtained with full 24-h blood pressure monitoring. There was no difference in night-time blood pressure reproducibility, whether night-time was defined as 2400-0559 h or 2200-0659 h. CONCLUSIONS: Both 24-h and daytime ambulatory blood pressure monitoring significantly improve the reproducibility of blood pressure measurements compared with clinic blood pressure readings in elderly hypertensive subjects. Increasing the number of daytime blood pressure readings by 50% (from 30 to 45) reduced the variability of blood pressure measurement by 50%. Twenty-four-hour ambulatory blood pressure monitoring is of value in obtaining reproducible blood pressure measurements in elderly hypertensive subjects. However, more than 30 readings are needed during a daytime recording to significantly reduce variability compared with repeated clinic measurements, although night-time variability is not significantly affected if the number of readings is reduced to 12 over a 6-h period.

Age Factors↗

PubMed1993

A test of reproducibility of blood pressure and heart rate variability using a controlled ambulatory procedure.

OBJECTIVE: To determine whether the previously reported poor reproducibility of blood pressure variability measured by ambulatory blood pressure monitoring (ABPM) is due to the uncontrolled nature of physical and mental activity during the monitoring period. DESIGN: ABPM was performed on two separate days during which subjects performed identical activities, accompanied by the experimenter. Thus, activity and posture were controlled, both within and between subjects. Two measures of variability were used: SD and the root-mean-square of successive differences (RMSSD). METHODS: Thirty-seven subjects participated. Each engaged in a series of activities, such as walking outdoors, editing and alphabetizing tasks, and eating lunch, while wearing an A & D 2420 ambulatory blood pressure monitor which took measurements at 5-min intervals. Measures of variability were computed within each session. RESULTS: Contrary to previous reports, reproducibility was moderately high for blood pressure, with significant correlations between SD and between RMSSD for systolic and diastolic blood pressure. Heart rate reproducibility was less good. CONCLUSIONS: Lack of standardization of activities from one occasion to another is a major reason for the poor reproducibility of blood pressure variability when measured using ABPM. Even when activities are standardized, however, the reproducibility of blood pressure variability is still only moderate and may limit the ability of researchers to detect associations between ABPM variability and other measures.

Adolescent↗

PubMed1996

Reproducibility of the response to short-term low salt intake in essential hypertension.

BACKGROUND: The reproducibility of the arterial pressure response to change in salt intake in essential hypertensives has been little investigated. OBJECTIVE: To study the reproducibility of the response to salt in 14 untreated patients with mild essential hypertension. METHODS: After a run-in phase (1 month), each patient ingested, in random order and with cross-over, 1 week of high salt intake (170 mmol/day) and 1 week of low salt intake (40 mmol/day). The identical experimental protocol was then repeated after an average interval of 3.4 months. Arterial pressure was measured (clinic arterial pressure and 24 h ambulatory monitoring) on the seventh day of each diet period. The reproducibility of the arterial pressure response was assessed in terms the intraclass correlation coefficient and the K statistics. RESULTS: There was a good compliance with the dietary prescription because the urinary Na excretion was on average very close to the prescribed intake both during the first and during the second salt intake period. Both clinic and 24 h arterial pressure fell significantly (P < 0.01) and to the same extent in the low-salt phases of the study. Clinic arterial pressure was consistently higher than 24 h ambulatory arterial pressure but the average changes induced by salt depletion were similar. The variability of 24 h ambulatory arterial pressure at constant salt intake was lower than that of clinic arterial pressure. However, the arterial pressure response to salt showed the same variability with the two methods. The reproducibility of the dichotomous classification of patients into salt-sensitive and -resistant was low both in terms of 24 h ambulatory and in terms of clinic blood pressure. CONCLUSION: Although on rechallenging the average arterial pressure response to salt remains unchanged in essential hypertensives, the individual responses are variable and the reproducibility of the dichotomous classification is unsatisfactory. The problem of dichotomizing patients into salt-sensitive and -resistant ones is only in very little part resolved by more precise arterial pressure estimates.

Adult↗

PubMed1999

Ambulatory blood pressure predicts end-organ damage only in subjects with reproducible recordings. HARVEST Study Investigators. Hypertension and Ambulatory Recording Venetia Study.

OBJECTIVE: To determine whether the prediction of target-organ damage varies according to the reproducibility of 24 h blood pressure. SETTING: Seventeen hypertension clinics in northeast Italy. MAIN OUTCOME MEASURES: Correlations of left ventricular mass index and albumin excretion rate with 24 h and office blood pressures in relation to tertiles of ambulatory blood pressure reproducibility. PATIENTS AND METHODS: In 716 consecutive, stage I, hypertensives enrolled in the Hypertension and Ambulatory Recording Venetia Study (HARVEST), ambulatory blood pressure monitoring was performed twice, 3 months apart In all subjects, the albumin excretion rate was measured by radioimmunoassay, and in 567, the left ventricular mass index was assessed by echocardiography. RESULTS: The subjects were divided into tertiles of ambulatory blood pressure consistency (between-monitoring differences, regardless of the sign). In the tertile of subjects with good reproducibility, correlation coefficients of systolic and diastolic ambulatory blood pressure with left ventricular mass and urinary albumin excretion were significant and higher than those of office blood pressure. In contrast, in the two tertiles with poorer reproducibility, the coefficients were barely or not significant for both pressures. The advantage of ambulatory blood pressure over office blood pressure in predicting target-organ damage was no longer present for systolic blood pressure differences greater than 3.8 mmHg and diastolic blood pressure differences greater than 3.1 mmHg. CONCLUSIONS: These data indicate that ambulatory blood pressure is a better predictor of left ventricular mass and urinary albumin excretion than office blood pressure, but only in subjects with good pressure reproducibility. Therefore, the assessment of hypertensive patients should be based on duplicate blood pressure monitorings. Recordings with 24 h systolic and diastolic blood pressure differences greater than 4 and 3 mmHg, respectively, should be considered with caution.

Adolescent↗

PubMed1999

Reproducibility of maximal exercise test data in the HERITAGE family study.

PURPOSE: The reproducibility of responses to maximal cycle ergometer testing was determined using data from the HERITAGE Family study at four Clinical Centers in the United States and Canada. METHODS: Reproducibility was determined from maximal exercise test data obtained a) on 2 d in a sample of 390 subjects (198 men and 192 women), b) across 4 d in an Intracenter Quality Control (ICQC) substudy with 55 subjects who were not part of the main study, and c) across 2 wk in a Traveling Crew Quality Control (TCQC) substudy with the same eight subjects who were tested at each of the four centers. Reproducibility was evaluated using technical errors, coefficients of variation (CV) for repeated measures, and intraclass correlation coefficients (ICC) for selected variables obtained on the main cohort, as well as on the ICQC and TCQC substudies. RESULTS: With the exception of systolic and diastolic blood pressures and respiratory exchange ratio, all the other variables (heart rate, ventilation, VO2, and VCO2) were highly reproducible, with CV below 10% and ICC over 0.86. These results were similar to those previously reported on the same subjects at a submaximal power output associated with 60% VO2max. Results were consistent for the main cohort, the ICQC sample, the TCQC sample, and across all four Clinical Centers. CONCLUSIONS: Day-to-day variations are small and reproducibility is high for maximal values of heart rate, ventilation, VO2 and VCO2 at each of the four Clinical Centers of the HERITAGE Family Study.

Adolescent↗

PubMed1990

Reproducibility and action levels for gamma camera uniformity.

Deciding on the action level for gamma camera non-uniformity is difficult because the reproducibilities of quality control measurements and service adjustments are usually unknown. This work evaluated the reproducibilities of integral uniformity (IU), differential uniformity (DU) and the corrected relative standard deviation (CRSD). The latter was calculated by removing from the relative standard deviation of the pixel counts the component due to statistical fluctuations. The reproducibility of each parameter was evaluated by analysing 10 intrinsic flood acquisitions with total counts of 2, 5, 10 and 30 million. All three parameters were less reproducible at the lower count densities, but as expected IU and DU also showed higher mean values. CRSD was consistent and highly reproducible, at all count densities. At 10 million counts CRSD had a coefficient of variation (COV) of 1.3% which was a five-fold improvement over the 6.6% and 6.1% found for IU and DU, respectively. The relative sensitivity of IU, DU and CRSD was compared in monthly measurements on 10 gamma cameras over one year. No significant difference in relative sensitivity was demonstrated: a change in camera performance produced about the same percentage change in each parameter. The precision with which service engineers adjust gamma cameras was also assessed by measuring the uniformity of 10 gamma cameras immediately after service adjustment at monthly intervals over one year. Finally, general action levels were defined for IU, DU and CRSD at 7%, 5% and 2.5% respectively.

Gamma Cameras↗

PubMed2004

Reproducibility of regional left ventricular wall thickening obtained by gating resting and redistribution 201Tl myocardial SPECT studies.

BACKGROUND: We have assessed the reproducibility of the estimates of regional left ventricular wall thickening between resting and redistribution Tl gated single photon emission computed tomography (SPECT) studies. METHODS: Thirty patients (28 males, two females) aged between 38 and 72 years (57.0 +/- 8.4 years) underwent resting and redistribution Tl gated SPECT. Perfusion was assessed semi-quantitatively using scores of 0-4. The assessment of wall thickening was performed both visually and by using automated software using scores of 0-3. The assessment of reproducibility was performed in 20 individual segments and 37 pairs of contiguous segments in each patient. RESULTS: In resting studies, mean global left ventricular ejection fraction (LVEF), end diastolic volume and end systolic volume were 34.2 +/- 11.7%, 180.5 +/- 70.6 ml and 123.3 +/- 60.0 ml, respectively. The corresponding values for the redistribution studies were 32.7 +/- 10.1%, 179.7 +/- 70.6 ml and 125.5 + 63.0 ml, respectively. There was good correlation between the resting and redistribution LVEFs (r=0.88), end diastolic volumes (r=0.90) and end systolic volumes (r=0.933). Reproducibility of visual wall thickening was 66% in individual segments and 82% in pairs of contiguous segments, and that of automated wall thickening was 48.0% in individual segments and 68% in pairs of contiguous segments. CONCLUSION: In conclusion, global left ventricular functional parameters obtained by resting Tl gated SPECT studies are highly reproducible in patients with impaired resting left ventricular function and large areas of scarred myocardium. Wall thickening and wall motion data are more reproducible in contiguous segments than in individual segments.

Adult↗

PubMed1996

Reproducibility of a questionnaire for assessment of physical load during work and leisure time. Stockholm MUSIC I Study Group. MUSculoskeletal Intervention Center.

A self-administered questionnaire on physical load in lifetime occupational work, in present job, and in present leisure activities was tested for reproducibility with the test-retest method in 126 male and 217 female workers from 30 occupations. The questionnaire contained 92 questions and nine different response scales. The results indicated that questions concerning physical activity retrospectively and in the present job, vibrations in the present job, working postures involving the whole body, and questions concerning specific leisure activities (eg ball games, skiing, etc) seem to offer sufficient reproducibility to be worth testing for validity, at least at a 5-point ordinal level. Questions concerning working postures involving parts of the body, including awkward postures, and questions concerning manual materials handling seem to offer too poor reproducibility to be used in studies in which the aim is to quantify duration in proportions of a typical working day and frequencies in times per hour. Questions concerning level of physical activity and exertion in domestic work seem to offer too poor reproducibility to be used at a 5-point ordinal level. Gender, age, and musculoskeletal complaints did not influence the reproducibility to any great extent.

Adolescent↗

PubMed2004

Macular and retinal nerve fiber layer thickness measurement reproducibility using optical coherence tomography (OCT-3).

PURPOSE: To assess the reproducibility of retinal nerve fiber layer thickness and macular thickness measurements using OCT-3. METHODS: Randomly chosen eyes of healthy individuals were scanned following pupillary dilation by two trained operators (RGO, RV) using OCT-3 (software version A1.1, Carl Zeiss Meditec, Inc., Dublin, CA), three times on separate days within a one-month period. Fast and regular macula (128 A-scans), and fast and regular RNFL (256 A-scans) scanning protocols were performed. Intra- and interoperator measurement reproducibility was evaluated. RESULTS: Ten eyes of 10 subjects (6 females, 4 males) were enrolled. Mean age was 32 +/- 11.2 years (range, 21 to 52 years). Intraoperator reproducibility was high for both macular and RNFL thickness measurements. Mean coefficients of variation (CV) for mean total RNFL thickness measurements ranged from 6.9 +/- 6.4% to 8.0 +/- 3.5% for operators 1 and 2 in fast and regular RNFL protocols. Mean CV for mean macular thickness measurements ranged from 4.7 +/- 2.6% to 6.4 +/- 5.5% for operator 1 and 2 in fast and regular macula protocols. There was no difference in mean total RNFL and mean foveal thickness measurements performed on different days (P > 0.05 for all measurements in all protocols, for operators 1 and 2, ANOVA). Interoperator reproducibility was high for both macular and RNFL thickness measurements (P > 0.05 for all measurements in all protocols, paired t test). CONCLUSION: OCT-3 RNFL and macular thickness measurements are reproducible in normal eyes. These results should be validated in ocular hypertensive and glaucomatous eyes.

Adult↗

PubMed2001

Reproducibility of ambulatory blood pressure measurements in essential hypertension.

BACKGROUND: Data on the reproducibility of serial measurements of ambulatory blood pressure in hypertensive patients are lacking. The purpose of this study was to examine (1) the reproducibility of four consecutive ambulatory blood pressure measurements, and (2) the reproducibility of nocturnal falls in blood pressure in hypertensive patients. METHODS: Twenty patients with mild to moderate essential hypertension underwent four separate ambulatory blood pressure monitorings, on the same day of the week, at 30-day intervals. Antihypertensive therapy was discontinued for 2 weeks before each recording. Comparing the mean values of blood pressure over 24h, as well as diurnal, nocturnal and hourly periods, among the four recordings determined the reproducibility of blood pressure measurements. A day/night difference in mean systolic and in mean diastolic blood pressure defined the nocturnal fall in blood pressure. RESULTS: No significant differences were observed in either hourly, 24-h, diurnal or nocturnal systolic blood pressure, diastolic blood pressure and heart rate, or in the nocturnal fall in systolic and diastolic blood pressure among the four recordings. CONCLUSIONS: Hourly systolic blood pressure, diastolic blood pressure, heart rate, and nocturnal fall in blood pressure were reproducible in four ambulatory blood pressure monitorings recorded over 4 months. These findings suggest that ambulatory blood pressure monitoring is a reliable tool to monitor blood pressure changes.

Aged↗

PubMed2005

Reproducible assessment of radiolucent lines in total knee arthroplasty.

The Knee Society Total Knee Arthroplasty Radiographic Evaluation and Scoring System was introduced to encourage uniform reporting of radiographic outcome. However, the method for evaluation of radiolucent lines has been shown to be unreliable. Because it has been shown that reducing the complexity of classification systems increases reliability and reproducibility, we questioned whether a simplification of the Radiographic Evaluation and Scoring System would improve reliability and reproducibility. A new system for assessment of radiolucent lines was introduced, and the interobserver reliability and intraobserver reproducibility were studied in 100 patients with 120 total knee replacements. For the new system the mean kappa intraobserver reproducibility coefficient was 0.71 (range, 0.62-0.85) for the femoral component, 0.86 (range, 0.80-0.96) for the tibial component, and 0.58 (range, 0.46-0.75) for the patella prosthesis. The mean interobserver reliability coefficient among three observers was 0.61 (range, 0.45-0.72) for the femoral component, 0.82 (range, 0.73-0.88) for the tibial component, and 0.58 (range, 0.43-0.72) for the patella prosthesis. The new system for assessment of radiolucent lines increased reliability and reproducibility and should supplement the Knee Society's Radiographic Evaluation and Scoring System.

Aged↗

PubMed2005

Intra-observer reproducibility and interobserver reliability of the radiographic parameters in the Spinal Deformity Study Group's AIS Radiographic Measurement Manual.

STUDY DESIGN: Retrospective cross-sectional assessment of the reproducibility and reliability of radiographic parameters. OBJECTIVE: To measure the intra-examiner and interexaminer reproducibility and reliability of salient radiographic features. SUMMARY OF BACKGROUND DATA: The management and treatment of adolescent idiopathic scoliosis (AIS) depends on accurate and reproducible radiographic measurements of the deformity. METHODS: Ten sets of radiographs were randomly selected from a sample of patients with AIS, with initial curves between 20 degrees and 45 degrees. Fourteen measures of the deformity were measured from posteroanterior and lateral radiographs by 2 examiners, and were repeated 5 times at intervals of 3-5 days. Intra-examiner and interexaminer differences were examined. The parameters include measures of curve size, spinal imbalance, sagittal kyphosis and alignment, maximum apical vertebral rotation, T1 tilt, spondylolysis/spondylolisthesis, and skeletal age. RESULTS: Intra-examiner reproducibility was generally excellent for parameters measured from the posteroanterior radiographs but only fair to good for parameters from the lateral radiographs, in which some landmarks were not clearly visible. Of the 13 parameters observed, 7 had excellent interobserver reliability. CONCLUSIONS: The measurements from the lateral radiograph were less reproducible and reliable and, thus, may not add value to the assessment of AIS. Taking additional measures encourages a systematic and comprehensive assessment of spinal radiographs.

Adolescent↗

PubMed2006

Quantitative assessment of patellar cartilage volume and thickness at 3.0 tesla comparing a 3D-fast low angle shot versus a 3D-true fast imaging with steady-state precession sequence for reproducibility.

OBJECTIVES: We sought to compare patellar cartilage volume and thickness measurement between 3D-FLASH and 3D-True fast imaging with steady-state precession (FISP) image data at 3.0 T. MATERIALS AND METHODS: One knee each of 6 healthy adults was examined by axial magnetic resonance imaging (MRI) performed with a 3D-fast flow angle shot (FLASH) water-excitation sequence and a 3D-TrueFISP water-excitation sequence (spatial resolution 0.31 x 0.31 x 1.5 mm3). Patellar cartilage volume and mean/maximum thickness were calculated. Intraindividual/average reproducibility and interindividual variability were determined from 3 consecutive data sets acquired for each volunteer and sequence. RESULTS: Patellar cartilage volume and thickness as well as reproducibility was slightly but not significantly lower for the 3D-TrueFISP data than for the 3D-FLASH data (volume: 3.4-6.3 mL (3D-FLASH)/3.1-6.0 mL (3D-TrueFISP), average reproducibility 1.8% (3D-FLASH)/4.4% (3D-TrueFISP); mean thickness: 2.1-2.8 mm (3D-FLASH)/1.9-2.6 mm (3D-TrueFISP), average reproducibility 2.8% (3D-FLASH)/3.8% (3D-TrueFISP); maximum thickness: 4.7-6.6 mm (3D-FLASH)/4.5-6.2 mm (3D-TrueFISP), average reproducibility 2.6% (3D-FLASH)/4.1% (3D-TrueFISP)). Interindividual variability was comparable for both sequence techniques. CONCLUSION: At 3.0 T, the 3D-FLASH sequence showed tendency to be slightly superior to the 3D-TrueFISP sequence considering robust and valid assessment of quantitative cartilage parameters in young healthy adults, although there was found no significant statistical difference between both imaging techniques. However, in patients suffering from osteoarthritis (OA), the 3D-TrueFISP sequence might prove advantageous for monitoring of disease progression and evaluation of therapy success, particularly because the substantially higher signal to noise ratio/contrast to noise ratio values might allow for higher spatial resolution and hence for improvement of the accuracy of segmentation process especially at the articular surface.

Adult↗

PubMed2006

Assessing the temporal reproducibility of human esophageal motor-evoked potentials to transcranial magnetic stimulation.

BACKGROUND: Although the electrophysiological properties and reproducibility of somatic limb motor evoked potentials (MEPs) to transcranial magnetic stimulation (TMS) are well characterized, little is known about the reproducibility of MEPs for viscerosomatic structures such as the esophagus. AIM: To determine the temporal reproducibility of esophageal MEPs to TMS. METHODS: MEPs to TMS were recorded from the proximal esophagus, using a swallowed catheter housing a pair of electrodes, in eight healthy subjects at five stimulus intensities (SI) (motor threshold [MT] to 20% above MT). For each SI, 20 consecutive TMS stimuli at 5-second intervals were delivered over a single scalp site (dominant hemisphere at site exhibiting MT at lowest SI) and repeated 40 and 80 minutes thereafter. MEP amplitudes and latencies were measured, and means were sequentially calculated for each SI and then log-transformed. The repeatability coefficients (RC) for the three time points were calculated across each set of 20 stimuli and presented as an exponential ratio. RESULTS: Best RC (amplitude/latency) were achieved at 120% SI relative to MT, being 1.8/1.2 (optimal = 1.0). For lower intensities of 115%, 110%, 105%, and 100% SI, the RC were 2.1/1.2, 2.1/1.1, 2.4/1.2, and 2.6/1.4, respectively. For all SI, the greatest reductions in RC occurred over the first 10 stimuli, with little additional gain beyond this number. CONCLUSIONS: Latencies of esophageal MEP to TMS across intensities are highly reproducible, whereas amplitudes are more stimulus intensity-dependent, being most reliable and reproducible at the highest stimulus strengths. SIGNIFICANCE: Using careful parameters, TMS can be used reliably in future studies of viscerosomatic structures, although the size of the response variability needs to be taken into account when assessing changes in cortico-fugal activity.

Adult↗

PubMed2005

Reproducibility of forearm vasodilator response to intra-arterial infusion of calcitonin gene-related peptide assessed by venous occlusion plethysmography.

AIMS: To assess the reproducibility of the forearm blood flow (FBF) response to intra-arterial infusion of calcitonin-gene related peptide (CGRP), measured by venous occlusion plethysmography. In addition, to compare different ways of expressing the FBF response and perform sample size calculations. METHODS: On two separate visits, CGRP (10 ng min(-1) dl(-1) forearm) was infused for 45 min into the brachial artery of six healthy subjects. Reproducibility was assessed by calculating mean difference, repeatability coefficient, within-subject coefficient of variation (WCV) and intraclass correlation coefficient. RESULTS: CGRP increased FBF from 2.8 +/- 0.4 and 3.2 +/- 0.7 (at baseline) to 15.4 +/- 1.4 and 15.2 +/- 1.5 ml min(-1) dl(-1) forearm (at 45 min) on visits 1 and 2, respectively (P < 0.0001 for both visits). Mean difference in FBF at 45 min between both visits was 0.3 ml min(-1) dl(-1) forearm (repeatability coefficient: 4.1 ml min(-1) dl(-1) forearm). This FBF response appeared to be more reproducible when expressed as absolute FBF in the infused arm (WCV 11%) compared with absolute FBF-ratio between both arms (WCV 37%), percentage change from baseline in FBF in the infused arm (WCV 29%) and percentage change from baseline in FBF-ratio (WCV 40%). When expressed as absolute FBF, a sample size of five (95% confidence interval: 2-12) subjects gives 90% power at a type I error probability of 0.05 to detect a 25% shift in FBF response. CONCLUSIONS: Intra-arterial infusion of CGRP results in a forearm vasodilator response which is reproducible between days. This response is most reproducible when expressed as absolute FBF. The presented methodology provides a suitable pharmacodynamic model to assess the in vivo activity of CGRP-receptor antagonists in a small number of subjects.

Adult↗

PubMed2005

Barostat testing of rectal sensation and compliance in humans: comparison of results across two centres and overall reproducibility.

We assessed reproducibility of measurements of rectal compliance and sensation in health in studies conducted at two centres. We estimated samples size necessary to show clinically meaningful changes in future studies. We performed rectal barostat tests three times (day 1, day 1 after 4 h and 14-17 days later) in 34 healthy participants. We measured compliance and pressure thresholds for first sensation, urgency, discomfort and pain using ascending method of limits and symptom ratings for gas, urgency, discomfort and pain during four phasic distensions (12, 24, 36 and 48 mmHg) in random order. Results obtained at the two centres differed minimally. Reproducibility of sensory end points varies with type of sensation, pressure level and method of distension. Pressure threshold for pain and sensory ratings for non-painful sensations at 36 and 48 mmHg distension were most reproducible in the two centres. Sample size calculations suggested that crossover design is preferable in therapeutic trials: for each dose of medication tested, a sample of 21 should be sufficient to demonstrate 30% changes in all sensory thresholds and almost all sensory ratings. We conclude that reproducibility varies with sensation type, pressure level and distension method, but in a two-centre study, differences in observed results of sensation are minimal and pressure threshold for pain and sensory ratings at 36-48 mmHg of distension are reproducible.

Adult↗

PubMed1996

Comparative reproducibility of defibrillation threshold and upper limit of vulnerability.

The upper limit of vulnerability (ULV) is the strength at or above which VF is not induced when a stimulus is delivered during the vulnerable phase of the cardiac cycle. Previous studies have demonstrated a statistically significant correlation between the ULV and the defibrillation threshold (DFT) in groups of patients. However, the correlation between ULV and DFT may not be close in individual patients. This imperfect correlation may be due to physiological factors or to limitations of the measurement methods. The reproducibility of either DFT or ULV has not been studied critically. The purpose of this study was to compare the reproducibility of clinically applicable methods for determination of DFT and ULV. We prospectively studied 25 patients with a transvenous implantable cardioverter defibrillator (Medtronic 7219D) at postoperative electrophysiological study. DFT was defined as the lowest energy that defibrillated after 10 seconds of VF. The ULV was defined as the lowest energy that did not induce VF with three shocks at 0, 20, and 40 ms before the peak of the T wave in ventricular paced rhythm at a cycle length of 500 ms. Both the DFT and the ULV were determined twice for biphasic pulses using a three-step, midpoint protocol. There was no significant difference between the two determinations of DFT (10.1 +/- 5.9 J vs 10.4 +/- 5.8 J), the two determinations of ULV (13.4 +/- 6.8 J vs 13.8 +/- 6.6) or the DFT-ULV Pearson correlation coefficients for each determination (0.84, P < 0.001 vs 0.75, P < 0.001). To analyze reproducibility, Lin concordance coefficients for second determination versus first determination were constructed for both ULV and DFT. This coefficient is similar to the Pearson correlation coefficient, but measures closeness to the line of identity rather than the line of regression. The Lin concordance coefficient for ULV was higher than that for DFT (0.93, 95% CI 0.85-0.97 vs 0.64, 95% CI 0.33-0.82; P < 0.01). For paired comparison of defibrillation efficacy under different experimental conditions, the sample sizes required to detect differences of 2 J, 3 J, and 4 J (80% power, P < 0.05) were 52, 24, and 15 for DFT versus 15, 8, and 6 for ULV. We conclude that a simple, clinically applicable method for determination of ULV is more reproducible than the single point DFT. Measured correlations between the ULV and single point are limited by the reproducibility of the DFT measurement.

Defibrillators, Implantable↗