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Reproducibility of tilt-table test result in patients with malignant neurocardiogenic syncope.

The indication for permanent pacemaker remains controversial in malignant neurocardiogenic syncope. A highly reproducible prolonged pause during a repeat head-up tilt-table testing may identify a subgroup of neurally mediated syncope with a prominent and consistent cardioinhibitory component. Seven patients (3 females) with a mean age of 30 years (23-44 years) were diagnosed to have malignant neurocardiogenic -syncope; all are classified according to the Vasovagal Syncope International Study as 2B type, with observed sinus pauses ranged from 3 s to 26 s of which only 1 demonstrated a reproducible sinus pause. No recurrence of syncope was clinically observed in patients during the follow-up period. Of 6 patients treated non--pharmacologically, one required a beta-blocker and none required a permanent pacemaker. Prolonged asystole manifest during head-up tilt-table testing is a poorly reproducible phenomenon and permanent pacemaker implantation in malignant neurocardiogenic syncope should not be a first line therapy.

Adult↗

Reproducibility of brachial ultrasonography and flow-mediated dilatation (FMD) for assessing endothelial function.

BACKGROUND: High-resolution brachial artery ultrasonography is used to study vasodilator response induced by physiologic reactive hyperaemia. We examined the reproducibility of measuring flow-mediated dilatation (FMD) on two occasions. AIMS: To determine the degree of variability of this technique in our vascular laboratory for the design of clinical research studies. METHODS: Nineteen subjects were studied on two separate occasions using an Acuson 128 ultrasound device and a 7.0 MHz linear array transducer. Reactive hyperaemia was induced in the brachial artery by inflation and release of a blood pressure cuff. Nitrate-induced dilatation was assessed in 11 of the 19 subjects. Measurements were made by two observers blinded to subject details. RESULTS: The 11 subjects given sublingual GTN during the first ultrasound study had a mean nitrate-induced dilatation of 20.7% (sd 9.6). The mean vessel diameter of 3.78 mm (sd 0.7) at rest and 3.89 mm (sd 0.7) during reactive hyperaemia yielded a mean FMD of only 3.0% (sd 2.7). The mean difference in FMD within-observers was 0.13% (sd 2.07), between-observers 0.06% (sd 2.17) and between-studies was 0.57% (sd 6.83). CONCLUSIONS: The reproducibility of FMD measured by brachial artery ultrasound was poor and likely to render the measurements inaccurate for clinical research in our hands. Between-study variation contributed the largest proportion of total study variability. We suggest that investigators using this technique conduct their own careful reproducibility studies in order to avoid the misinterpretation of 'negative' studies.

Adult↗

Laser scanning as a tool for assessment of HIV-related facial lipoatrophy: evaluation of accuracy and reproducibility.

BACKGROUND: Facial lipoatrophy (LA) is a common complication of highly active antiretroviral therapy (HAART). Research into causes and treatment of facial LA is hindered by the lack of an objective measurement tool. OBJECTIVE: To evaluate the accuracy and reproducibility of three-dimensional laser scanning (LS) for estimating cheek volume changes. METHODS: Paired laser scans were performed and the images superimposed using commercial software. The volume difference between images was computed within a circle of radius 25 mm placed in a standardized position over the cheek area. Accuracy was tested by scanning before and after known volumes of plasticine (0.5--5 mL) were applied to the cheek area of a mannequin to simulate volume change. Reproducibility was tested by repeated scanning of the mannequin with and without 2 mL of plasticine, and repeated scanning of 10 healthy subjects over the course of 1 week. RESULTS: The mean difference between actual and estimated volume change was small across the range of volumes tested [mean difference 0.08 mL; 95% confidence interval (CI)-0.36 to 0.20 mL). The coefficient of variation for repeated measurements of 2-mL volume change was 5.8%. The intraclass correlation coefficient for scan-to-scan variability was 0.812 (95% CI 0.515--0.947) and for day-to-day variability it was 0.764 (95% CI 0.332--0.935). Conclusions LS is an accurate and reproducible method for estimating cheek volume changes. It may be useful as an objective tool for assessment of facial LA in clinical research studies.

Antiretroviral Therapy, Highly Active↗

The reproducibility of an enzyme-linked immunosorbent assay for detection of Chlamydia pneumoniae-specific antibodies.

With use of an enzyme-linked immunosorbent assay (ELISA), Chlamydia pneumoniae immunoglobulins were detected in a consecutive series of patients' sera (n = 122 for IgA and IgG; n = 138 for IgM). When the ELISA tests were repeated, the percentage disagreements were 12%, 16% and 10% for C. pneumoniae IgA, IgG and IgM, respectively. The reproducibility of the ELISA, expressed as kappa values, for IgA, IgG and IgM was 0.73, 0.60 and 0.53, respectively (p < 0.001). It was concluded that the ELISA had good reproducibility for detecting C. pneumoniae IgA, and moderately good reproducibility for detecting C. pneumoniae IgG and IgM.

Aged↗

Fetal cardiac function and septal thickness in diabetic pregnancy: a controlled observational and reproducibility study.

OBJECTIVE: To determine the reproducibility of duplex Doppler waveform analysis and fetal cardiac interventricular septal thickness measurement and to compare these parameters in matched pregnancies with and without well-controlled maternal Type 1 diabetes at 18-20 weeks of gestation. DESIGN: A prospective blind twin cohort study and a blinded inter-observer and intra-observer agreement study. SETTING: A tertiary referral prenatal diagnostic unit within a university hospital. RESULTS: Good inter- and intra-observer agreement was found for the measurement of transvalvular peak flow velocities and the duration of ventricular ejection in the fetal heart. Inter-observer agreement for aortic flow acceleration rate was poor. M-mode measurement of interventricular septal thickness showed moderate reproducibility. The mean (SD) width of the interventricular septum in the fetuses of well controlled diabetic women was 2 1 mm (0.2 mm), and was significantly greater (P=0.01) when compared with the corresponding value in matched controls [1.9 mm (0.2 mm)]. No cardiac functional differences were evident. CONCLUSIONS: On-screen video analysis of Doppler cardiac flow waveforms and M-mode measurement of intraventricular septal thickness demonstrated good reproducibility. The fetuses of well controlled diabetic pregnancies demonstrated signs of altered cardiac morphology early in pregnancy, before any evident alterations in cardiac function.

Blood Flow Velocity↗

Reproducibility of blood pressure response to hydrochlorothiazide.

Few studies have investigated the reproducibility of responses to antihypertensive therapies. The purpose of this study was to assess the reproducibility of the blood pressure response to a thiazide diuretic, a preferred initial treatment for hypertension. Twenty-two subjects who underwent monotherapy with hydrochlorothiazide as part of a study to identify predictors of blood pressure response agreed to undergo the same protocol a second time, 26.6+/-11.8 (range, 4-52) months after their first participation. The mean systolic and diastolic blood pressure responses to hydrochlorothiazide did not differ significantly between the first and second participation (systolic response, -14.2+/-16.4 mm Hg vs. -16.0+/-16.5 mm Hg; diastolic response, -7.1+/-11.8 mm Hg vs. -6.6+/-8.6 mm Hg), and these responses were significantly correlated between the two trials (systolic response, r=0.61 and p<0.01; diastolic response, r=0.64 and p<0.01). However, both the direction and magnitude of responses for individual subjects varied considerably, with the limits of agreement between the first and second participations (i.e., 2 standard deviations above and below the mean difference between responses) ranging from 27.4 mm Hg to -23.8 mm Hg for systolic blood pressure response and from 17.4 mm Hg to -18.4 mm Hg for diastolic blood pressure response. These results show that the average systolic and diastolic blood pressure responses to hydrochlorothiazide for a group of subjects are reproducible; however, the responses for individual subjects are unpredictable.

Black or African American↗

Intraindividual reproducibility of postprandial and orthostatic blood pressure changes in older nursing-home patients: relationship with chronic use of cardiovascular medications.

OBJECTIVES: Although postprandial and orthostatic hypotension are commonly observed in nursing home residents, their reproducibility, relationship to each other, and association with chronic use of cardiovascular medications are poorly understood. DESIGN: We examined blood pressure (BP) and heart rate (HR) before and after postural change, and before and after a 419-kcal meal in 22 nursing home residents (mean age 89 +/- 5 (SD) years), each on two occasions, to determine reproducibility changes. These studies were repeated in 17 residents, with and without previous administration of cardiovascular medications, in random order. SETTING: Hebrew Rehabilitation Center for the Aged, an academic long-term care facility. RESULTS: Systolic BP declined an average (+/- SE) of 16 +/- 4 mm Hg and 12 +/- 4 mm Hg during the first and second meal studies, respectively. Mean intra-class correlation of postprandial systolic BP values during the two studies was 0.88 (95% CI 0.85-0.97). Systolic BP increased significantly during the first posture test to a maximum of 8 +/- 6 mm Hg at 6 minutes. There was no significant difference over time in postural systolic BP between the two tests. Repeated postural studies showed a mean intra-class correlation of 0.72 (95% CI 0.62-0.92) for changes in systolic BP. Cardiovascular medications had no additional effect on postprandial or orthostatic BP and HR changes. During the first studies, 10 subjects had postprandial hypotension, and three subjects had orthostatic hypotension, but only two of 22 subjects had both. CONCLUSIONS: Patterns of systolic BP response to meals or postural change are reproducible. BP responses to meals and postural change seem to be unaffected by potentially hypotensive medications in chronic users. Postprandial hypotension is distinct from orthostatic hypotension, occurring more commonly than orthostatic hypotension and infrequently together in the same patients.

Aged↗

Reproducibility of transesophageal pacing in patients with Wolff-Parkinson-White syndrome.

The purpose of this study was to assess, in patients with ventricular preexcitation, the time dependent physiological variation of antegrade conduction properties in the AV node and in accessory pathways (Aps) as a function of autonomic tone variation induced by posture and physical effort, using noninvasive transesophageal atrial pacing. In 74 WPW patients (mean age 21.31 +/- 9.46 yrs), AV node and Kent antegrade effective refractory periods (at pacing cycle lengths 600, 400, and 320 ms), Wenckebach point, shortest preexcited RR intervals during sustained atrial fibrillation (AF) or atrial pacing, as well as the inducibility of AV reentry tachycardia (AVRT) and AF/flutter (AFL) were assessed. All measurements were carried out at rest, in supine and upright positions, and during effort. A second study was carried out approximately 3 months after the first study. The coefficient of variation (CVs) and reproducibility (CRs) were calculated. For each parameter, the differences between the mean of the two studies were not statistically significant. The CVs and CRs ranged between 0.4% and 4% and between 2 and 28 ms, respectively. AF was induced in 40 (54%) of 74 patients at the first study and in 30 (40.5%) of 74 patients at the second study. AVRT was induced in 33 (45%) of 74 patients at the first study and in 38 (51.3%) of 74 patients at the second study. The reproducibility was 45% for AF/AFL and 65% for reentry tachycardia. Transesophageal atrial pacing is a reliable method for noninvasive reproducible evaluation of antegrade electrophysiological properties of both the AV node and APs in WPW patients. However, the effect of autonomic balance variation has to be taken into account and precisely defined because it may significantly affect the inducibility of supraventricular arrhythmias and the estimation of the absolute values of the vulnerable parameters.

Adult↗

Reproducibility of electrophysiological measurements in cardiac transplant recipients.

The clinical usefulness of certain electrophysiological measurements, particularly those of sinus node function, is limited by variation in autonomic tone resulting in poor reproducibility. The denervated transplanted heart is not susceptible to direct autonomic control and, therefore, electrophysiological measurements may be more reproducible in this group. To our knowledge, this hypothesis has not previously been systematically evaluated. Ten adult recipients underwent serial electrophysiological studies between 10-18 days after cardiac transplantation. Five studies were performed at 2-hour intervals during a single day, between 9:00 a.m. and 5:00 p.m. Spontaneous cycle length (SCL) was recorded. Sinus node recovery time (SNRT), sinoatrial conduction time (SACT), and atrioventricular (AV) Wenckebach cycle length were measured using standard techniques. The effective refractory periods of the complete AV conducting system (AVERP), atrium (AERP), and ventricle (VERP) were measured. Corrected maximal SNRT was normal in all subjects. Mean coefficients of variation (Cv) for SCL, corrected maximal SNRT, and SACT were 2.8%, 7.4%, and 3.5%, respectively. AVERP was less than AERP in seven subjects, limiting further analysis. The mean Cv for AV Wenckebach cycle length was 2.1%. The mean coefficients of variation for AERP were 3.6% and 3.7%, and for VERP 3% and 3.3%, at 600- and 400-ms drive cycle lengths, respectively. Previous studies report much greater variation in innervated subjects particularly of indices of sinus node function. Thus, the reproducibility of electrophysiological measurements of sinus and AV node function in the transplanted heart is better than in normal subjects. This may have important implications for the reliability of electrophysiological testing in transplant recipients.

Atrioventricular Node↗

Long-term reproducibility of ventricular tachycardia induction with electrophysiological testing in patients with coronary heart disease and depressed left ventricular ejection fraction.

The Multicenter Automatic Defibrillator Implantation Trial (MADIT) has recently confirmed the role of programmed ventricular stimulation (PVS) to identify the high risk patients of sudden death after myocardial infarction and to prevent this risk. The purpose of this study was to evaluate the long-term reproducibility of PVS in these patients. Thirty patients with coronary heart disease without spontaneous documented sustained ventricular tachycardia (VT) underwent two programmed stimulations in the absence of antiarrhythmic drug treatment between 2 and 6 years (mean 4 years). No patient had a myocardial infarction or intervening cardiac surgery during this period. The protocol of study was similar using up to three extrastimuli in two sites of the right ventricle, delivered in sinus rhythm and driven rhythm (600 ms, 400 ms, respectively). On the first PVS, 17 patients had inducible sustained VT (group I). Thirteen patients did not have inducible VT (group II). On the second PVS all group I patients but one had inducible VT, but the cycle length was significantly modified in 11. In group II, five patients had inducible VT and in the other patients the PVS remained negative. In conclusion, in patients with coronary heart disease, but without documented VT, the long-term reproducibility of PVS was excellent in those with inducible VT (94%); the patients remain at risk of VT and a prophylactic implantable cardioverter defibrillator could be considered. In patients with initially negative study, reproducibility of PVS was lower (61.5%), probably because of the progressive remodeling after myocardial infarction. Therefore, the occurrence of new symptoms in patients with previously negative study requires a second programmed ventricular stimulation.

Adult↗

Reproducibility and simplification of 13C-octanoic acid breath test for gastric emptying of solids.

OBJECTIVE: The accuracy of the 13C-octanoic acid breath test is enhanced by breath sampling over 6 h rather than 4 h, but this increases the cost of the test. Our aim was to validate a less costly but accurate sequence of breath sampling for measuring gastric emptying of solids. METHODS: We performed the 13C-octanoic acid breath test and tested its reproducibility relative to simultaneous scintigraphy in 30 healthy volunteers. RESULTS: There was a significant but weak correlation between t1/2 measured by the two tests (rs = 0.54, p < 0.005), but not between the duration of the lag phase. The differences in the t1/2 measurements between the tests were different between subjects but were highly reproducible within subjects. Within- and between-subject variations of measurements of gastric emptying with the 13C-octanoic acid breath test were not significantly different from the variations observed with scintigraphy. A subset of 11 breath samples collected over 6 h (24 samples) predicted (r2 > 0.95) the variables characterizing the cumulative appearance of 13CO2 in breath; these samples were at 35, 50, 95, 110, 140, 155, 215, 245, 260, 290, and 335 min. The accuracy of this subset of sampling times was confirmed in a separate set of breath test samples over 6 h from the same 30 subjects. CONCLUSIONS: The 13C-octanoic acid breath test for gastric emptying of solids is as reproducible as scintigraphy. A subset of 11 sampling times provides sufficient information to characterize the whole breath-test curve, but the sampling period should be extended to 6 h after dosing.

Adolescent↗

Reproducibility of attachment level measurements with two models of the Florida Probe.

Clinical assessment of the progression of periodontitis is based on the measurement of periodontal probing attachment levels over time. In calculating these changes, duplicate measurements from fixed reference points, including cemento-enamel junctions and acrylic stents, have been used to assist in detecting progressive disease. The Florida Probe has been previously shown to improve the reproducibility of these measurements when used with an acrylic stent. The objective of the present study was to evaluate the reproducibility of 2 models of the Florida Probe, the original stent model and the modified disk model, in measuring attachment level. The disk probe differs from the stent probe in that it uses the occlusal surface of the tooth as a static reference point in calculating changes in attachment level measurements. In 10 subjects, sites were probed 2 x by 2 examiners using both types of probe. Standard deviations and intra- and inter-examiner correlations were calculated. These results demonstrate that the new disk probe yields reproducible measurements similar to the stent probe and is therefore suitable for use in longitudinal clinical studies.

Equipment Design↗

Accuracy and reproducibility of two manual periodontal probes. An in vitro study.

BACKGROUND: Periodontal probe is the standard instrument for assessment of probing pocket depth and clinical attachment level. However, probing measurements have inherent measurement errors from a wide range of sources, such as instrument, patient, examiner and disease status. AIM: The purpose of the present study was to create an in vitro model simulating gingival sulcus/pocket and investigate the accuracy and reproducibility of two different manual probes. METHODS: Thirty-three aluminium blocks with dimensions of 2 x 2 cm and thickness ranging from 2.00 to 10.00 mm were constructed. Holes with a diameter of 1.00 mm were made in the blocks through the whole thickness. These 33 aluminium blocks were then carefully stuck together so that the probing faces would be on the same level. A plastic material, which shows deformation with forces >45 g was placed at the base of the blocks. Two conventional manual probes (Williams and WHO probes) were used in the present study. Seventeen periodontists were selected to perform duplicate measurements on the blocks over two visits using both of the probes. The intra- and inter-examiner percentage accuracy (with regard to 0.25 mm) and reproducibility for each of the duplicate measurements was calculated and analysed using repeated measure analysis of variance (ANOVA) (three factor experiments with repeated measure on two factors; probe and probing session). RESULTS: ANOVA showed statistically significant differences between the examiners (p=0.000) and between the two readings of each probe (p=0.002), while the differences between the two probes were not statistically significant (p=0.098). The overall percentage of accuracy was higher with WHO probe compared with Williams probe. Kappa analysis revealed better reproducibility percentages for WHO probe in comparison with Williams probe. CONCLUSIONS: This in vitro study, using a metal construction and a plastic material with a deformation coefficient similar to that of gingival pocket, may be suggested as a good model to test intra- and inter-examiner differences in periodontal probing. Our findings emphasise the importance of inter-examiner calibration for probing, particularly in longitudinal studies.

Adult↗

Classification, reproducibility and prevalence of root proximity in periodontal patients.

AIM: The primary aim of this study is to define and classify root proximity. The secondary aim is to examine the reproducibility of the measurement tools, to study the prevalence per inter-dental area and to examine whether the distance from the cemento-enamel junction (CEJ) to the bone crest (BC) differs between sites with root proximity and their contra-lateral sites without root proximity. MATERIAL AND METHODS: In order to indicate the location of root proximity, a modification of the Shei ruler was developed, dividing the roots into three equal parts. A radiographic template was used to measure the distance between the roots, in this way determining the severity of the root proximity. The reproducibility of the measurement tool was tested, the prevalence was calculated and the distances CEJ-BC for root proximity sites and contra-lateral sites were recorded. RESULTS: A two-digit classification was obtained dividing the root into three locations [apical (A), between (B) and coronal (C)], with each location having the possibility of three different severities of root proximity. The described modification of the Shei ruler and the measurement tool for the severities can be considered as reproducible measurement tools. Root proximity was most prevalent in maxillary molars and between central and lateral incisors in the maxilla and mandible. There was no difference in CEJ-BC distance between the root proximity sites and their contra-lateral sites. CONCLUSION: We can conclude that a two-digit classification for root proximity was established. Root proximity in untreated periodontal patients has no influence on the distance CEJ-BC. However, the location of root proximity becomes important from the moment that periodontal disease has been established at that site. The severity of root proximity is important for choosing treatment options. There is a striking similarity between bone loss patterns and tooth loss and the location of inter-dental spaces where root proximity is most prevalent.

Adolescent↗

Comparison of intra-examiner reproducibility in scoring caries in primary teeth of two scoring systems used to monitor caries progression.

The investigation was designed to compare the reproducibility of scoring systems proposed by Pitts (1), and Murray & Majid (2), when used to monitor caries progression in primary teeth. A sub-sample of the posterior bitewing radiographs of 301, 5-yr-old children from a Duraphat clinical trial were re-examined. The difference in the reproducibility of the two methods was not significant (P greater than 0.05). The concern regarding the effect on reproducibility of using scoring systems with subdivisions of enamel when measuring caries progression in primary teeth appears to be unfounded.

Bias↗

Visual assessment of human skin irritation: a sensitive and reproducible tool.

Human volunteer studies of skin irritation have been carried out for decades, both for research and for safety evaluation purposes. For the majority of this time, and consequently for the majority of the studies, assessment of the skin reactions has been made visually. Typical endpoints include erythema, oedema, dryness and scaling, some or all of which would be rated on a simple scale, eg 0, +/-, +, ++, + + +. Such approaches can be criticized as subjective, of poor reproducibility, lacking in sensitivity and highly variable between observers and/or institutions. In consequence, instrumental methods of assessment have been strongly promoted and do indeed offer several advantages, not least their objectivity. However, it is possible to use the human eye, which is a very sensitive tool, to make detailed, accurate and reproducible descriptions of skin irritation reactions. To achieve this, it is necessary to give prolonged and thorough training to each observer. In this paper, 3 examples of human volunteer studies, in which different pairs of trained observers independently carried out double blinded scoring of the irritation reactions, are reported. The grading patterns produced were almost identical; statistical analysis showed that properly trained observers are in fact able to reliably measure a grade of erythema to within +/- 1 on a 10 point scale; 97.6% of scores were within 2 grade points on this scale. These results provide evidence that visual scoring can be sensitive, reliable and reproducible within a testing institution.

Dermatitis, Irritant↗

Reproducibility studies on arteriolar hyaline thickening scoring in calcineurin inhibitor-treated renal allograft recipients.

Arteriolar hyaline thickening (AH) is the most characteristic lesion of chronic calcineurin inhibitor nephrotoxicity. This study was performed to compare the inter-observer reproducibility of AH scoring using Banff criteria and a newly proposed criterion. Forty-five nonprotocol post-transplant biopsies from 38 patients immunosuppressed with tacrolimus or cyclosporine A (CsA) were included. The severity of AH was blindly scored by three observers. According to the new criteria, AH is graded based on circular vs. noncircular involvement and the number of arterioles involved. The kappa statistics were used to assess the inter-observer reproducibility. Twenty-seven (60%) biopsies showed AH. The AH grades by both criteria were correlated with serum creatinine at biopsy and inversely correlated with estimated glomerular filtration rate (GFR) (p < 0.05). The recent AH criteria improved the mean pairwise agreement (79.4% vs. 68%) and the overall kappa value (0.67 vs. 0.52) (p = 0.02) compared to Banff criteria. The mean inter-slide variation using Banff and the new criterion were 23% and 27.6%, respectively (p > 0.05). The new AH criterion results in better inter-observer reproducibility, and is clinically validated against serum creatinine and estimated GFR. There is substantial intra-biopsy variation, therefore, evaluation of more than one section is crucial to determine severity of arteriolar damage more accurately.

Adolescent↗

Histological evaluation of prostatic cancer. (II): Reproducibility of a histological grading system.

The aim of this study was to evaluate the reproducibility, expressed by kappa coefficients, of the histological grading system of prostatic cancer as proposed by Schroeder, Hop, Blom and Mostofi in 1985. This grading system has five prognostic groups based on combinations of growth pattern, mitoses and nuclear anaplasia. All histological slides from 85 cases of prostatic carcinoma were blindly evaluated on two independent occasions by each of four pathologists. The overall INTER-observer agreement and mean INTRA-observer agreement regarding "prognostic group" were 0.55 and 0.69 respectively, whereas the kappa coefficients were 0.38 and 0.57 respectively. An acceptable level of INTER-observer reproducibility of prognostic group I (kappa = 0.70), of the parameter "growth pattern" (kappa = 0.60) and of "slight nuclear anaplasia" (kappa = 0.62) was found. A low overall kappa coefficient of "mitoses" and "nuclear anaplasia" was found. Based on the well reproducible parameters a simplified grading system is proposed.

Anaplasia↗