Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial.

INTRODUCTION: Passive surveillance is recommended globally for the detection of adverse events following immunisation (AEFI) but this has significant challenges. Use of Mobile health for vaccine safety surveillance enables a consumer-centred approach to reporting. The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) a randomised control trial (RCT) sought to evaluate the efficacy and acceptability of SMS for AEFI surveillance. METHODS: Multi-centre RCT, participants were adult vaccinees or parents of children receiving any vaccine at a trial site. At enrolment randomisation occurred to one of two SMS groups or a control group. Prompts on days 2, 7 and 14 post-immunisation, were sent to the SMS group, to ascertain if a medical event following immunisation (MEFI) had occurred. No SMS's were sent to the control participants. Those in the SMS who notified an MEFI were pre-randomised to complete a computer assisted telephone interview or a web based report to determine if an AEFI had occurred whilst an AEFI in the controls was determined by a search for passive reports. The primary outcome was the AEFI detection rate in the SMS group compared to controls. RESULTS: We enrolled 6,338 participants, who were equally distributed across groups and who received 11,675 vaccines. The SMS group (4,225) received 12,675 surveillance prompts with 9.8% being non-compliant and not responding. In those that responded 90% indicated that no MEFI had been experienced and 184 had a verified AEFI. 6 control subjects had a reported AEFI. The AEFI detection rate was 13 fold greater in the SMS group when compared with controls (4.3 vs 0.3%). CONCLUSION: We have demonstrated that the STARSS methodology improves AEFI detection. Our findings should inform the wider use of SMS-based surveillance which is particularly relevant since establishing robust and novel pharmacovigilance systems is critical to monitoring novel vaccines which includes potential COVID vaccines.

Participant centred safety surveillance of health care workers receiving influenza vaccination.

Following the introduction of mandatory influenza vaccination for staff working in high risk clinical areas in 2018, we conducted active surveillance for adverse events following immunisation utilising an automated online survey to vaccine recipients at three and 42 days post immunisation. Most participants 2285 (92%) agreed to participate; 515 (32%) staff reported any symptom and eight (1.6%) sought medical attention. The odds of having a reaction decreased with age by approximately 2% per year. The system was acceptable to staff, and the data demonstrated rates of reported symptoms within expected rates for influenza vaccines from clinical trials. Rates of medical attendance were similar to previous surveillance. Participant centred real-time safety surveillance proved useful in this staff influenza vaccination context, providing reassurance with expected rates and profile of common adverse events following staff influenza vaccination.

Travel and non-travel associated rabies post exposure treatment in New South Wales residents, Australia, 2007-2011: a cross-sectional analysis.

BACKGROUND: Australian Bat Lyssavirus is endemic in Australian bats. More Australians are travelling to rabies (Lyssavirus 1) endemic countries. The nature and frequency of lyssavirus exposures and characteristics of New South Wales (NSW) residents exposed have not previously been described. METHOD: Access to free rabies post-exposure treatment (PET) can only be arranged through Public Health Units in NSW. Details of people receiving PET after potential exposures to rabies or ABLV from 1 January 2007 to 31 December 2011 were extracted from an NSW Ministry of Health web-based database and analysed to better understand lyssavirus exposure epidemiology. RESULTS: Of 1195 people receiving PET, 415 exposures were in Australia and 780 abroad; 78.3% occurring in Southeast Asia, mainly Indonesia (47.6%) where most were on the island of Bali (95.2%). PET use increased substantially for domestic and international exposures. In Australia, most bat exposures were to members of the public (76.0%), rather than to people who work with bats professionally or as volunteers, with 54.1% due to bat rescue attempts. Injuries abroad were mainly from monkeys (49.4%) and from dogs (35.8%). Only 4.0% of international travellers were vaccinated prior to their exposure. CONCLUSIONS: Increasing rates of PET in travelling and non-travelling Australians emphasise the need for more effective communication about appropriate animal avoidance and the measures required if exposed. Opportunities for increasing pre-exposure treatment amongst individuals likely to be exposed should be promoted.

Measurement of migration of soft tissue by modified Roentgen stereophotogrammetric analysis (RSA): validation of a new technique to monitor rotator cuff tears.

The purpose of this study was to develop a technique to use Roentgen stereophotogrammetric analysis (RSA) to measure migration of soft-tissue structures after rotator cuff repair. RSA stereo films were obtained; images were analysed using a semi-automatic software program allowing 3D viewing of results. RSA imaging experiments were performed to validate the technique, using a glass phantom with implanted RSA beads and an animal model with steel sutures as RSA markers which were moved known distances. Repeated measurements allowed assessment of inter- and intra-observer variability at a maximum of 1.06 mm. RSA analysis of the phantom showed a variation up to 0.22 mm for static and 0.28 mm for dynamic studies. The ovine tissue specimen demonstrated that using steel sutures as RSA markers in soft tissue is feasible, although less accurate than when measuring bone motion. This novel application of RSA to measure soft tissue migration is practicable and can be extended to in vivo studies.

Measurement of laxity in the anterior cruciate ligament-deficient knee: a comparison of three different methods in vitro.

The aim of this study was to compare in-vitro measurements of anteroposterior laxity in the anterior cruciate ligament (ACL)-deficient knee using three different methods: an Instron materials-testing machine, then a KT-2000 arthrometer, and finally by Roentgen stereophotogrammetric analysis (RSA). Eight ACL-deficient human cadaver knees were used. Total displacement was measured between 90 N anterior and 90 N posterior tibiofemoral drawer forces at both 20 degrees and 90 degrees knee flexion. Laxity ranged from 11.5 to 27.6 mm at 20 degrees and from 8.7 to 23.9 mm at 90degrees. A statistically significant difference was not found between the mean RSA and KT-2000 measurements. However, the mean Instron measurements of laxity were significantly (3-4 mm) higher than both RSA and KT-2000 measurements. The clinical methods of RSA and the KT-2000 measurements agreed well but appeared to underestimate tibiofemoral anteroposterior laxity compared with the materials-testing machine. These findings may be helpful in the future comparison of different studies.

Kinematics of spinal motion during prolonged rowing.

Low back pain is a common problem in rowers of all levels. Few studies have looked at the relationship between rowing technique, the forces generated during the rowing stroke and the kinematics of spinal motion. Of particular concern with respect to spinal injury and damage are the effects of fatigue during long rowing sessions. A technique has been developed using an electromagnetic motion system and strain gauge instrumented load cell to measure spinal and pelvic motion and force generated at the handle during rowing on an exercise rowing ergometer. Using this technique 13 elite national and international oarsmen (mean age 22.43 +/- 1.5 y) from local top squad rowing teams were investigated. The test protocol consisted of a one hour rowing piece. During this session rowing stroke profiles were quantified in terms of lumbopelvic kinematics and stroke force profiles. These profiles were sampled at the start of the session and at quarterly intervals during the hour piece. From this data we were able to quantify the motion of the lumbar spine and pelvis during rowing and relate this to the stroke force profile. The stroke profiles over the one hour piece were then compared to examine the effects of prolonged rowing. This revealed marked increases in the amount of spinal motion during the hour piece. The relevance of this with regard to low back pain requires further investigation.

Movements of thoracic and abdominal compartments during ventilation at rest and during exercise.

The present investigation utilised simultaneous measurements of chest (Ch) and abdominal (Ab) circumferences and respiratory airflow to test the hypothesis that Ch circumferential expansion contributes proportionally little to tidal volume in the running Thoroughbred. During exercise, there were only small changes in Ch and Ab circumference and no increase with increasing tidal volume. At rest, walk and trot, the flow, Ch and Ab signals were in phase. However, during canter and gallop, the Ch and Ab changes were 180 degrees out of phase with each other and both were out of phase with airflow. In contrast to exercise, increase in ventilation at rest achieved by administration of lobeline resulted in a 4-6-fold increase in tidal volume; large excursions of the chest were always in phase with airflow. Furthermore, 3 horses showed an increase in chest circumference, demonstrating that chest stiffness per se does not preclude chest circumferential expansion. In conclusion, in the absence of significant increases in either Ch or Ab expansion during running, elongation of the thoracoabdominal segment may be the main determinant of tidal volume.

Spontaneous variability of left ventricular ejection fraction assessed with the Cardioscint.

A miniature, non-imaging caesium iodide nuclear probe optically coupled to a photodiode (the 'Cardioscint') has been developed which, in conjunction with a modified personal computer, is capable of continuous on-line monitoring of left ventricular function and ST-segment level at the bedside. The purpose of this study was to assess the variability in ejection fraction over periods of time and to compare this variability with that of equilibrium gamma camera radionuclide ventriculography. Ten normal volunteers (nine male) of mean (S.D.) age 49 (10) years underwent semisupine radionuclide ventriculography using both gamma camera and Cardioscint in randomized order. The gamma camera recorded four consecutive acquisitions (mean of 7.2 min each) and the Cardioscint, using a 20 s acquisition time, recorded left ventricular function over 35 min per subject. The mean ejection fraction of the group by gamma camera was 52 (7)% and by Cardioscint was 54 (5)%. When the variability in ejection fraction by gamma camera was compared with the Cardioscint averaged over corresponding time periods (i.e. an average of 7.2 min), the mean coefficient of variation of the camera was 5.0% versus 2.9% for the probe system. Individual 20-s probe acquisitions over the total study duration (reflecting the short-term variability of the system) had a coefficient of variation of 5.1%. Thus the Cardioscint provides a stable continuous recording of ejection fraction. These volunteer data provide a basis for interpretation of data acquired in the clinical situation.

Clinical validation of a miniature nuclear probe system for continuous on-line monitoring of cardiac function and ST-segment.

A new, miniature cesium iodide/photodiode nuclear probe (the "Cardioscint") has been developed for continuous on-line measurement of left ventricular function and the ST-segment. Ejection fraction (EF) measurements in 77 patients were compared with gated equilibrium radionuclide ventriculograms. The probe was positioned over the left ventricle by first using a blind positioning algorithm and then by using the gamma camera. Background was measured both manually and automatically. There was good correlation between probe (positioned blind) and gamma camera EF with both manual (r = 0.80, n = 65) and automatic (r = 0.78, n = 66) backgrounds. Use of the gamma camera did not significantly alter the results. Correlation between the probe stroke counts and thermodilution-derived stroke index during atrial pacing in six subjects was also satisfactory (r = 0.69, n = 102). Thus, the Cardioscint is able to provide a reliable estimate of EF and can track rapid changes in cardiac volumes.

Effects of chronic congestive heart failure secondary to coronary artery disease on the circadian rhythm of blood pressure and heart rate.

In 20 subjects with chronic congestive heart failure due to coronary artery disease, the 24-hour variability of ambulatory intraarterial blood pressure (BP) was studied using an improved Oxford Medilog system, and correlated with left ventricular function at rest. The mean radionuclide ejection fraction was 27% (range 10 to 42), the mean pulmonary arterial wedge pressure was 18 mm Hg (5 to 37) and the mean cardiac index was 2.8 liters/min/m2 (2 to 3.8). The 24-hour systolic BP and heart rate (HR) variability indexes were less than those of 22 normal volunteers (p less than 0.05) and were strongly correlated (p less than 0.05) with ejection fraction at rest and pulmonary arterial wedge pressure. Stepwise regression showed that a combination of the mean nocturnal HR and the standard deviation of the hourly mean systolic BP values accounted for 67% of the variability in ejection fraction between patients. Similarly, 73% of the variation in pulmonary wedge pressure was explained by combining the 24-hour mean HR and the mean nocturnal HR.

The ST segment of the ambulatory electrocardiogram in a normal population.

The behaviour of the ST segment in everyday life was studied by ambulatory electrocardiography in 111 normal volunteers. Fifteen were excluded because of abnormal exercise responses (10 subjects) and significant postural ST segment shifts (five subjects). This left 62 men and 34 women, mean (SD) age 40.5 (12.6) years (range 20-67 years). Ambulatory monitoring of leads CM5 and CC5 for 24 hours was followed by a maximal treadmill exercise test. The tapes of the ambulatory monitoring were analysed by a computer aided system. The computer printed trend plots of the ST segment (measured both at the J point and at J + 60 ms) to detect episodes of ST segment elevation and depression, which were confirmed by visual analysis of real time printouts. Twelve subjects showed "ischaemic" ST segment depression and nine subjects showed ST segment elevation. Eight people with ambulatory ST segment changes were studied during exercise by radionuclide ventriculography and thallium-201 imaging scans. Although seven of the eight thallium studies were normal, radionuclide ventriculography showed functional impairment in five cases. Seven of the 10 subjects with abnormal exercise tests were similarly investigated and their results followed the same pattern, with normal thallium images in six and functional impairment in four. Ambulatory electrocardiography was repeated in 20 people after a median of 20 days. The ST segment changes were reproducible. ST segment changes of an apparently ischaemic nature occur even in a carefully defined normal population but they do not necessarily represent latent clinically significant coronary artery disease. This indicates that ST segment changes seen in patients with known obstructive coronary artery disease should be interpreted with caution.

The effect of knee position on torque output during inversion and eversion movements at the ankle.

The purpose of this study was to compare the effect of knee position on the magnitude of torque generated during the isokinetic movements of inversion and eversion at the ankle. Mean peak torque values at 30 and 120 degrees /sec were collected from 12 subjects, ages 21-31, from two test positions. The knee was stabilized in 10 degrees of flexion for the first test position and 70 degrees for the second. Additionally, mean peak amplitude of hamstring motor unit action potentials was compared between the two test positions to demonstrate differences in hamstring activity. At both speeds, mean peak torque values of the inversion-eversion movements, as well as mean peak amplitude of hamstring motor unit action potentials, was significantly lower in 10 degrees compared to 70 degrees of knee flexion (p < 0.01). It was concluded that isokinetic testing at the ankle with the knee in a close packed position, near full extension, provides a more valid representation of isolated muscular performance than testing with the knee in a loose packed position of midrange flexion.J Orthop Sports Phys Ther 1988;10(5):177-183.

Mechanisms of arrhythmias accompanying ST-segment depression on ambulatory monitoring in stable angina pectoris.

To investigate the mechanisms of ischemic arrhythmias during daily life, 32 patients with stable angina pectoris and documented ischemic episodes were studied by 24-hour ambulatory electrocardiographic monitoring. The severity of arrhythmias observed at or before peak ST-segment depression (early arrhythmias) and arrhythmias presenting during or after resolution of the ST-segment changes (late arrhythmias) was graded according to a modified Lown classification. Eleven patients (34%) had ischemic arrhythmias and had a greater number of ischemic episodes (6.0 +/- 5.4 vs 2.3 +/- 1.5, p less than 0.001) than patients without ischemic arrhythmias. Ischemic episodes accompanied by arrhythmias had a greater ST-segment depression (2.8 +/- 1.6 mm vs 1.9 +/- 0.6 mm, p less than 0.001), and duration (18.2 +/- 14.8 minutes vs 5.7 +/- 2.6 minutes, p less than 0.001) than those without arrhythmias. Ventricular tachycardia was observed in 3 patients during the early phase of ischemia and in 2 during or after recovery. Early but not late ventricular tachycardias were preceded by prodromal ventricular ectopic activity. Late arrhythmias were more frequent and severe than early arrhythmias, with an increased incidence of R-on-T ectopic complexes. In patients with stable angina, potentially life-threatening arrhythmias are closely associated with severe repetitive episodes of ischemia, and different mechanisms produce early and late arrhythmias. Prevention or reduction of the severity of ischemic episodes occurring during daily life in patients with stable angina may be more effective than prophylactic antiarrhythmic therapy.

Ambulatory heart rate and ST-segment depression during painful and silent myocardial ischemia in chronic stable angina pectoris.

The relation between heart rate and ischemic ST-segment depression was studied in 70 patients with documented obstructive coronary artery disease (CAD) and reproducible effort angina. Symptom-limited treadmill exercise testing was performed before and after a 2-week placebo period and 24-hour FM ambulatory electrocardiographic monitoring at the end of the placebo period. The means (+/- standard deviation) of the basal and placebo values for exercise time, heart rate and maximal ST-segment depression were: 6.4 +/- 2.6 minutes vs 6.9 +/- 2.8 minutes (difference not significant [NS]), 125 +/- 17 beats/min vs 125 +/- 19 beats/min (NS) and 2.3 +/- 0.8 mm vs 2.1 +/- 0.8 (NS), respectively. Ambulatory monitoring revealed 205 episodes of significant ST-segment depression (J + 80 ms; 49 episodes with more than 1 mm, 83 with more than 2 mm, 39 with more than 3 mm and 34 with more than 4 mm). Of all episodes of ST-segment depression, 130 (64%) were asymptomatic. The episodes lasted for 3 to 110 minutes. The maximal 24-hour ambulatory heart rate and ST-segment depression during ischemic episodes were expressed as a percentage of those seen during exercise-induced ischemia. When all ambulatory ischemic episodes (both symptomatic and asymptomatic) were compared with exercise-induced ischemic changes in the individual patient, there was little difference in heart rate (91 +/- 15% vs 90 +/- 18%, NS) but there was a greater magnitude of ST-segment depression (122 +/- 57% vs 104 +/- 52%, p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Effect of hyperoxia on substrate utilization during intense submaximal exercise.

Six trained males [mean maximal O2 uptake (VO2max) = 66 ml X kg-1 X min-1] performed 30 min of cycling (mean = 76.8% VO2max) during normoxia (21.35 +/- 0.16% O2) and hyperoxia (61.34 +/- 1.0% O2). Values for VO2, CO2 output (VCO2), minute ventilation (VE), respiratory exchange ratio (RER), venous lactate, glycerol, free fatty acids, glucose, and alanine were obtained before, during, and after the exercise bout to investigate the possibility that a substrate shift is responsible for the previously observed enhanced performance and decreased RER during exercise with hyperoxia. VO2, free fatty acids, glucose, and alanine values were not significantly different in hyperoxia compared with normoxia. VCO2, RER, VE, and glycerol and lactate levels were all lower during hyperoxia. These results are interpreted to support the possibility of a substrate shift during hyperoxia.

An evaluation of the Avionics Pressurometer III 1978 at home and in hospital.

The Avionics Pressurometer III is the only noninvasive indirect ambulatory blood pressure system which provides 24-h blood pressure measurements, but it has been subjected to limited evaluation. We report a critical evaluation comparing it to simultaneous intra-arterial blood pressures both at home and at hospital as well as during standardized exercise. Comparisons with simultaneous indirect methods were also made. Twenty-two hypertensives undergoing intra-arterial ambulatory blood pressure monitoring wore the two recorders for one day. The mean difference (standard deviation SD) for intra-arterial blood pressure--Avionics blood pressure was 2 (SD 8.6)/-14 (SD 10.3) mmHg at home and -3 (SD 15.4)/-11 (SD 12.3) mmHg at hospital. At the end of exercise the figures for the same comparison were -7 (SD 16)/0 (SD 15.6) mmHg. In general the agreement between intra-arterial and Avionics pressurometer recordings was closer for systolic than for diastolic blood pressures but there was wide variation for individuals as shown by the standard deviations about the mean difference. We did not use the recorder at night as patients complained that the noise kept them awake and so night-time blood pressures were not attainable. We do not think the recorder performed satisfactorily during physical exertion, and in view of its expense, this recorder is of limited potential value in supplying accurate information.

Ambulatory blood pressure and assessment of pacemaker function.

Ten patients in sinus rhythm with ventricular demand (VVI) pacemakers implanted for the sick sinus syndrome underwent 24 hour ambulatory blood pressure and electrocardiographic recording by a modified version of the Oxford system. Five patients had symptoms of dizziness or presyncope at the time of study and five were symptom free. The onset of pacing was associated with a fall in arterial blood pressure in both groups which was larger in the patients with symptoms, and in these patients the blood pressure recovery consequent on baroreflex activation was delayed by up to fifteen beats. In three of the patients with symptoms the original pacemaker was replaced by an atrioventricular pacing (DVI) device. This abolished symptoms and the initial fall and delayed recovery of blood pressure. Thus it appears that the development of symptoms of hypotension after the onset of ventricular pacing is determined by the rate of the baroreflex response. These symptoms and the haemodynamic consequences may be alleviated by dual chamber pacing.

An evaluation of self-recorded blood pressure during drug trials.

To our knowledge, there have been no published comparisons of different techniques for measuring blood pressure during clinical trials. We undertook a comparison during clinical trials with verapamil and prazosin. During an open trial of verapamil we compared the treatment-induced blood pressure reductions as measured by clinic, intra-arterial, and self-recorded methods. The mean reduction in blood pressure was 38 +/- 13.6/20 +/- 10.1 mm Hg for clinic blood pressure, 24 +/- 17.9/16 +/- 7.3 mm Hg for self-recorded blood pressure, and 23 +/- 12.3/19 +/- 10.1 mm Hg for mean daytime intra-arterial blood pressure. During prazosin treatment the mean reduction in blood pressure was 28 +/- 21.5/18 +/- 8.5 mm Hg for clinic blood pressure, 21 +/- 20.5/6 +/- 13.7 mm Hg for self-recorded blood pressure, and 18 +/- 19.2/5 +/- 9.6 mm Hg for mean daytime intra-arterial blood pressure. There was little agreement between methods within individual patients and for group comparisons of intra-arterial or clinic methods. There was, however, good agreement between intra-arterial and self-recorded methods. This study suggests that self-recorded blood pressure recording is suitable for monitoring efficacy of antihypertensive agents in a group of patients, although caution must be exercised when interpreting the effects of therapy when measured by indirect methods in an individual patient.