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PubMed1999

Comparison of Three Different Protocols for Dobutamine Stress Echocardiography: Does the Addition of Atropine Increase Complications, and Does It Improve Diagnostic Accuracy?

The addition of atropine during dobutamine stress echocardiography (DSE) is increasingly used for detecting coronary artery disease (CAD), but its safety and whether it has added diagnostic accuracy have not been well defined. The aim of this study was to retrospectively compare the complication rate and diagnostic accuracy of three different protocols in the same laboratory. DSE was performed in 1090 patients over a 5-year period. The protocol had included (1) 5' stages up to 30 µg/kg/min of dobutamine in the first 184 patients, (2) 3' stages up to 40 µg/kg/min in the next 274 patients, and (3) 3' stages up to 40 µg/kg/min with atropine, when required in the last 632 patients. A large number of patients (n = 938) underwent coronary angiography within 2 weeks, and 524 patients had a significant coronary stenosis (> 50%). In the whole group of 1090 patients, serious complications developed in 5 patients (one acute myocardial infarction, one sustained ventricular tachycardia, and three prolonged ischemia). Although the incidence was low, there were no detectable differences between protocols. Hypotension, which was defined as a >/= 20 mmHg decrease in systolic blood pressure from the baseline, was observed in 68 patients. Premature ventricular contraction was the most common arrhythmia. The complication rate was similar among three protocols. The diagnostic accuracy for detecting CAD was nearly the same among three protocols (30 µg, 86%; 40 µg, 84%; and 40 µg with atropine, 84%), but the prevalence of CAD was higher with the 30-µg protocol (65%) than the 40-µg protocol (55%) or 40-µg-with-atropine protocol (53%, P < 0.01). In 469 patients without a previous myocardial infarction, the prevalence of CAD was the same (38-42%). Sensitivity increased with more aggressive protocols (71%, 76%, and 84%). However, it was associated with the loss of specificity (92%, 92%, and 85%). Thus, the diagnostic accuracy was similar among groups (84%, 85%, and 84%). In conclusion, the addition of atropine during DSE does not increase the rate of complication compared with previous conservative protocols and shows the same diagnostic accuracy with a small increase in sensitivity at the cost of a small and matched decrease in specificity.

Journal Article↗

PubMed1988

Treadmill protocols for determination of maximum oxygen uptake in runners.

Four testing protocols were completed by each of 10 runners using a common speed for protocols 1 and 2 (P1 and P2), each runner's training pace for protocol 3 (P3) and a speed selected manually by the runner for protocol 4 (P4). Stages were increased by 2.5% grade every 2 min for each protocol except for P1, which had 1 min stages. There were no significant differences in maximum oxygen uptake (VO2 max) between protocols (P1, 65.0 +/- 5.6 ml.kg-1 min-1; P2, 64.5 +/- 5.3 ml.kg-1 min-1; P3, 66.2 +/- 3.9 ml.kg-1 min-1; P4, 64.7 +/- 5.8 ml.kg-1 min-1). Treadmill time was significantly less for P1 than for the other protocols. The rate of perceived exertion obtained at maximal exercise during P1 was less than that obtained during the other three protocols. Heart rate was significantly lower (P less than 0.05) at any level of submaximal VO2 during P3 than during the other protocols. We recommend a testing protocol using speeds approximating the runner's training pace and 1 min stages. This may result in lower perception of difficulty and HR throughout the test and shorter testing times.

Adult↗

PubMed1993

Changes in hormonal concentrations after different heavy-resistance exercise protocols in women.

Nine eumenorrheic women (age 24.11 +/- 4.28 yr) performed each of six randomly assigned heavy-resistance protocols (HREPs) on separate days during the early follicular phase of the menstrual cycle. The HREPs consisted of two series [series 1 (strength, S) and series 2 (hypertrophy, H)] of three protocols, each using identically ordered exercises controlled for load [5 vs. 10 repetitions maximum (RM)], rest period length (1 vs. 3 min), and total work (J) within each three-protocol series. Blood measures were determined pre-, mid- (after 4 of 8 exercises), and postexercise (0, 5, 15, 30, 60, 90, 120 min and 24 and 48 h). In series 1, a significant (P < 0.05) reduction in growth hormone (GH) was observed at 90 min postexercise for all three protocols. In series 2, the 10-RM protocol with 1-min rest periods (H10/1) produced significant increases above rest in GH concentrations at 0, 5, and 15 min postexercise, and the H10/1 and H5/1 protocols demonstrated significant reductions at 90 and 120 min postexercise. Cortisol demonstrated significant increases in response to the S10/3 protocol at 0 min, to the H10/1 protocol at midexercise and at 0 and 5 min postexercise, and to the H5/1 protocol at 5 and 15 min postexercise. No significant changes were observed in total insulin-like growth factor I, total testosterone, urea, or creatinine for any of the HREPs. Significant elevations in whole blood lactate and ammonia along with significant reductions in blood glucose were observed. Hormonal and metabolic blood variables measured in the early follicular phase of the menstrual cycle varied in response to different HREPs. The most dramatic increases above resting concentrations were observed with the H10/1 protocol, indicating that the more glycolytic HREPs may stimulate greater GH and cortisol increases.

Adult↗

PubMed1995

Comparison of different protocols in plateletpheresis with the haemonetics MCS 3p blood cell separator with respect to parameters of product quality.

BACKGROUND: In thrombocytapheresis, intermittent flow cell separators produce platelet concentrates (PC) with a higher leucocyte contamination than continuous flow blood cell separators. The new discontinuous flow cell separator Haemonetics MCS 3p offers a low-leucocyte solution for PC. The quality of PC obtained by the MCS 3p was investigated in this study. DESIGN: Prospective study. SETTING: Haemapheresis Unit of a University Clinic. PATIENTS: Healthy blood donors from the haemapheresis unit. MATERIALS AND METHODS: Platelet (PLT) yield, separation efficiency and white blood cell (WBC) contamination were studied in three different protocols. Two protocols used a haemocalculator, which calculated the target volume based on the donor's physical characteristics and the desired PLT yield for the procedure. Protocol I used 3,000 ml as target process volume and protocol II 3.3 x 10(11) as desired PLT yield. Protocol III was used without haemocalculator. Glucose, lactate, lactate dehydrogenase (LDH), morphology score and pH value were analysed to investigate the quality of the PC. RESULTS: Platelet yield and separation efficiency were not statistically different in the three protocols. Leucocyte contamination was lowest in the protocol without haemocalculator (median: 3.15 x 10(6), range 0.4-20.8 x 10(6)). Glucose, lactate, LDH and pH were not statistically different in the three protocols. Morphology score was best in protocol III. CONCLUSIONS: PLT collection with the MCS 3p blood cell separator results in sufficient thrombocyte yields. Using the haemocalculator we were not able to achieve the desired platelet yield. For this reason, and because of the higher WBC contamination in protocol II we prefer PLT collection without the haemocalculator. The quality of the platelet concentrates was good with respect to the parameters glucose, lactate, LDH, morphology score and pH.

Adult↗

PubMedDate not supplied

Infusion protocol improves delivery of enteral tube feeding in the critical care unit.

BACKGROUND: Numerous factors may impede the delivery of enteral tube feedings (ETF) in the intensive care unit (ICU). We designed a prospective study to determine whether the use of an infusion protocol could improve the delivery of ETF in the ICU. METHODS: In a prior prospective study, we monitored all patients admitted to the medical intensive care unit (MICU) or cardiac care unit (CCU) who were made nil per os and placed on ETF (control group). We found that critically ill patients received only 52% of their goal calories, primarily due to physician underordering (66% of goal), frequent cessations of ETF (22% of the time), and slow advancement (14% at goal by 72 hours). Based on these findings, we developed an ETF protocol that incorporated standardized physician ordering and nursing procedures, rapid advancement, and limited ETF interruption. After extensive educational sessions, the ETF protocol was begun. Again, all patients admitted to the MICU or CCU who were made nil per os and placed on ETF were prospectively followed (protocol group). RESULTS: Thirty-one patients in the protocol group were followed during 312 days of ETF and compared with the control group (44 patients with 339 days of ETF). Despite efforts by the nutritional support team, the infusion protocol was used in only 18 patients (58%). The main reasons for noncompliance with the protocol were physician preference and system failure (ETF order sheet not placed in chart). When used, the infusion protocol improved physician ordering (control 66% of goal volume, noncompliant 68%, compliant 82%, p < .05); delivery of calories (control 52% of goal, noncompliant 55%, compliant 68%, p < .05); and advancement of ETF (control 14% at goal by 72 hours, noncompliant 31%, compliant 56%, p < .05). Although significant reduction in ETF cessation due to nursing care was noted, it represented only a fraction of the total time ETF were stopped. Cessation due to residual volumes, patient tolerance, and procedure continued to be a frequent occurrence and was often avoidable. CONCLUSIONS: An evidence-based infusion protocol improved the delivery of ETF in the ICU, primarily because of better physician ordering and more rapid advancement. The nursing staff rapidly assimilated these changes. However, physicians' reluctance to use the protocol limited its efficacy and will need continued educational efforts.

Adolescent↗

PubMed2001

Outcomes in post-ICU mechanical ventilation: a therapist-implemented weaning protocol.

BACKGROUND: Therapist-implemented protocols have been used to extubate or wean patients in the ICU setting. Barlow Respiratory Hospital (BRH) functions as a center for weaning patients from prolonged mechanical ventilation (PMV) in the post-ICU setting of a long-term acute-care (LTAC) facility. A therapist-implemented patient-specific (TIPS) weaning protocol was developed at BRH to standardize weaning from PMV. STUDY DESIGN: Prospective cohort study with historical control. METHODS: A weaning protocol incorporating the procedures and pace of LTAC weaning was developed using available scientific evidence and expert consensus. After training of staff, collection and analysis of pilot data, and revisions and refinement of the protocol, the TIPS protocol was implemented hospital-wide. It was monitored for outcome, variance, and respiratory care practitioner (RCP) and physician compliance. RESULTS: Forty-six RCPs worked with eight pulmonologists treating 271 consecutive patients admitted for weaning from PMV during an 18-month period. Nineteen patients were excluded from weaning attempts by any method after initial physician evaluation. The remaining 252 patients (9,135 total ventilator days) were compared with a group of 238 patients treated by the same physicians in the 2 years before instituting protocol weaning. Median time to wean declined significantly from 29 days in historical control subjects to 17 days for TIPS protocol patients (p < 0.001). Outcomes (scored at discharge) were comparable for the two groups (TIPS group vs control group): weaned, 54.7% vs 58.4%; ventilator-dependent, 17.9% vs 10.9%; died, 27.4% vs 30.7% (p = 0.10). Variances incurred by physicians and RCPs were 324 and 136, respectively, for the 9,135 ventilator days. CONCLUSIONS: Patients weaned from PMV using a new therapist-implemented protocol at BRH, an LTAC facility specializing in weaning, had significantly shorter time to weaning than historical control subjects, with comparable outcomes. The weaning outcome data collected after the implementation of the TIPS protocol are in fact attributable to its use, as we found a high degree of compliance with the protocol.

Aged↗

PubMed2003

A comparison of two stretching protocols on hip range of motion: implications for total daily stretch duration.

It is theorized that the total stretch time in a day is more important than the actual single stretch duration time. The purpose of this study was to compare 2 stretching protocols, keeping total stretching time equivalent. The 2 protocols were a 10-second duration stretch and a 30-second duration stretch. Although the stretch durations differed, the total stretching time over the course of a day was held constant at 2 minutes for both protocols. Participants were randomly assigned a protocol to each of their legs: subjects stretched 1 leg with the 10-second protocol and the opposite leg with the 30-second protocol. The 10-second stretch was repeated 6 times for a total of 1 minute; the 30-second protocol was repeated 2 times for a total of 1 minute. Stretching was performed twice daily (a total of 2 minutes each day) for 6 weeks. All stretching was performed to the hamstring muscles. Hip flexion measurements were recorded at pretest, 3-weeks, and 6-weeks. Subjects demonstrated significant gains in range of motion for hip flexion over the course of 6 weeks, p = 0.000. No differences existed between the 2 protocols. Range of motion gains were equal between the 2 stretching protocols. The common denominator was total stretch time for a day. Regardless of the duration of a single stretch, the key to improvement was the total daily stretch time. These findings are important as they allow clinicians and individuals to customize stretching protocols to meet individual needs.

Adult↗

PubMed2002

Effect of exercise testing protocol on the relationship between minute ventilation and carbon dioxide production.

BACKGROUND: The effect of exercise protocol on the slope of the relationship between minute ventilation and carbon dioxide production (deltaVE/deltaVCO2) has not fully been studied. METHODS: Twenty-five healthy volunteers performed two sessions of incremental bicycle exercise, one with a rapidly increasing staged (RIS: 25W every minute) protocol and another with a slowly increasing staged (SIS: 25W every 3 minutes) protocol to calculate the deltaVE/deltaVCO2. Six of the subjects also participated in sessions of steady state exercise (SSE) test various work rates. RESULTS: The deltaVE/deltaVCO2 was significantly lower when the RIS protocol was used than when the SIS protocol was used (23.3 +/- 2.3 vs. 24.9 +/- 1.8, p < 0.001). Data from the subjects who also underwent SSE sessions revealed that the deltaVE/deltaVCO2 from the SSE protocols was greater than that from the RIS protocol and identical with that from the SIS protocol (125.1 +/- 3.7. 20.6 +/- 1.7, and 24.0 +/- 2.7, respectively, p < 0.05), while arterial partial pressure of carbon dioxide during exercise was not different between the protocols (43.0 +/- 3.3. 39.9 +/- 2.1, and 40.8 +/- 2.6, respectively, n.s.). C ONCLUSIONS: Care must be taken in the interpretation of the values of deltaVE/deltaVCC2, as they are influenced by the difference in exercise protocol.

Adolescent↗

PubMed1992

Multidisciplinary protocol for determining aminoglycoside dosage.

A protocol for determining optimal dosages of aminoglycosides early in therapy is described, and the effectiveness of the protocol is evaluated. The protocol was developed jointly by physicians and pharmacists at a 550-bed hospital to ensure that surgical patients prescribed aminoglycosides were quickly and consistently put on a safe and effective course of therapy. Physicians select an aminoglycoside and calculate a loading dose and initial maintenance dosage by using a nomogram printed on an antimicrobial order form. Nurses are trained to administer and document aminoglycoside doses accurately and to draw blood samples at the correct times. Pharmacists order serum aminoglycoside concentration assays, analyze the results, and recommend changes in dosage when necessary. To evaluate the effectiveness of the dosing protocol, the records of surgical patients treated before and after the protocol was in place were reviewed. Compared with the control group, a higher percentage of patients treated under the protocol were receiving therapeutic, nontoxic dosages of aminoglycosides within 48 hours of the start of therapy. In addition, fewer serum drug concentration tests were ordered per patient under the protocol, and the percentage of concentration determinations useful for analysis was higher. The mean duration of aminoglycoside therapy was identical before and after the protocol was instituted, and nephrotoxic reactions tended to be less common among the protocol patients. An aminoglycoside dosing protocol requiring the cooperation of pharmacists, nurses, and physicians provides a consistent, safe, and effective means of managing aminoglycoside therapy for the hospitalized patient.

Adult↗

PubMedDate not supplied

The wash-in/washout protocol in stable xenon CT cerebral blood flow studies.

PURPOSE: We conducted a comparative study to optimize the scanning and inhalation protocols for xenon CT cerebral blood flow (CBF) examination (Xe CT), with the aim of improving the practical performance of Xe CT as a routine clinical examination. MATERIALS AND METHODS: Four different inhalation protocols, including 3-min, 6-min, and 8-min wash-in protocols, and a 3-min wash-in/5-min washout protocol, were compared in five healthy volunteers. Each subject underwent two serial Xe CT examinations with an interval of 30 min between the first one (wash-in) and the second one (wash-in/washout). A computer simulation was also performed to support the results of the clinical study. The rate of success was calculated from our experience of 110 clinical cases examined with the wash-in/washout protocol over the last 9 months. RESULTS: The mean CBF values with 6-min and 8-min wash-in protocols were 59.0 and 59.5 mL/100-g brain per min in the thalamus, and 19.5 and 19.0 mL/100-g brain per min in the frontal white matter, respectively. The mean CBF values with 3-min wash-in/5-min washout protocol were 60.0 mL/100-g brain per min in the thalamus and 18.5 mL/100-g brain per min in the frontal white matter, respectively. Computer simulation showed improved signal-to-noise ratio by employing the 3-min wash-in/5-min washout protocol instead of 8-min wash-in protocol for the same number of data points. The rate of success improved to 99.1% due to the significant decrease in head motion with the shorter period of inhalation. CONCLUSION: A wash-in/washout protocol is a useful alternative in Xe CT CBF measurement and more useful than the wash-in method for clinical purposes.

Administration, Inhalation↗

PubMed1988

A multiple muscle strength testing protocol.

A quick test (QT) protocol was developed to allow for the rapid testing of multiple muscle groups in order to profile body strength. Maximum muscle strength was also obtained using a standard test (ST) protocol. The ST protocol consisted of three five-second trials with a one-minute rest between trials and no more than four muscle groups tested per day. The QT protocol allowed only a five-second rest between trials. Thirteen subjects were evaluated using both protocols. Subjects were positioned either sitting or supine, depending on the muscle groups being evaluated. Stabilization was provided to minimize substitution patterns. Measurements were obtained using a load cell and a computerized recording system. Using the QT protocol and testing 13 muscle groups in one session vs five sessions with the ST protocol resulted in an average reduction of 4% in strength values for the QT protocol. The results suggest that the clinical use of the QT protocol may not significantly reduce the accuracy of repeated measurements even though values obtained may be slightly lower than those obtained using the ST protocol.

Adult↗

PubMed1993

Application of DNA analysis in a population-screening program for neonatal diagnosis of cystic fibrosis (CF): comparison of screening protocols.

We compare two protocols for newborn screening for cystic fibrosis (CF). The first uses the immunoreactive trypsinogen (IRT) assay with a cutoff of > or = 180 ng/ml and a sweat test to identify CF patients. The second uses the IRT assay with a 100 ng/ml cutoff in conjunction with direct analysis for the delta F508 CF transmembrane conductance regulator (CFTR) mutation in a two-tiered (i.e., IRT/DNA) protocol, followed by a sweat test. We screened 220,865 newborns from Wisconsin for CF, using the IRT protocol identifying 369 infants with an elevated IRT, of whom 46 were found to have CF. Another 7 CF patients were identified who had a false-negative IRT level. The CF incidence in the white population was 1 in 3,431 (carrier incidence of 1 in 30). The IRT protocol had a sensitivity of 87% and a positive predictive value of 12.5%. We subsequently used the IRT/DNA protocol to screen 21,258 infants. Of 518 infants with an IRT level > or = 100 ng/ml, 24 carried at least one copy of the delta F508 CFTR mutation, and 4 of these infants were found to have CF, yielding a positive predictive value for this protocol of 16.7%. Direct comparison of the positive predictive value of the two protocols is not valid, because of the different populations screened. However, had the IRT protocol been used on the IRT/DNA cohort, 50 infants, including the 4 with CF, would have received sweat tests, yielding a positive predictive value of 8%. Because of the small sample size, this positive predictive value is not significantly different from that obtained for the IRT/DNA test. However, from a practical point of view the IRT/DNA approach does decrease considerably the number of sweat tests that must be undertaken. The number of false positives for the IRT protocol (46 in 21,258) is increased significantly compared with that for the IRT/DNA approach (20 in 21,258; P < .001). The incidence of delta F508 carriers detected in cohorts with an elevated IRT level was increased compared with the incidence in the general population. The direct costs for the IRT/DNA approach (100 ng/ml) were $11,374 per CF patient detected, compared with $10,187 per CF patient detected for the IRT protocol. Therefore, we conclude that the IRT/DNA approach to CF newborn screening decreases the number of false-positive subjects contacted, without a significant increase in cost.

Analysis of Variance↗

PubMed1996

Influence of the exercise protocol on hemodynamic, gas exchange, and neurohumoral responses to exercise in heart transplant recipients.

BACKGROUND: A gradual accommodation to increasing exercise loads has been recommended for exercise testing in denervated posttransplantation heart recipients. However, how the exercise protocol influence the hemodynamic, gas exchange, and hormonal response to exercise in this not been studied. METHODS: Nine heart transplant recipients tests incremental maximal bicycle ergometry tests in random order. Exercise stages of 1 and 3 minute durations were compared with matched work rate increments ranging between 30 and 40 W. Expiratory gas was measured continuously and arterial blood was sampled at each of the matched work rates. RESULTS: Total exercise duration was 6.4 +/- and 15.3 +/- 0.7 minutes for the 1-minute and 3-minute protocols, respectively. Maximal workload was significantly higher during the 1-minute versus the 3-minute protocol (238 +/- 9 versus 200 +/- 11 W, p < 0.001), but maximal oxygen uptake was not significantly different (25.5 +/- 1.1 versus 26.5 +/- 1.2 ml. min-1.kg-1). Hemodynamic, metabolic, and some hormonal parameters showed marked differences between the two protocols, with significantly higher responses observed during the 3-minute protocol for heart rate, ventilation, lactate, atrial natriuretic factor, and growth hormone. Catecholamine (epinephrine and norepinephrine) and insulin responses did not differ between the two tests. If expressed as a relative exercise intensity (percentage of maximal oxygen uptake) no differences in hormonal responses were observed between the two protocols, except for growth hormone response which remained higher during the 3-minute protocol. CONCLUSIONS: Although maximal oxygen uptake was independent of the exercise protocol in these heart transplant recipients, the exercise protocol has a major influence on the hormonal and metabolic response. The delayed response observed for oxygen uptake and hormonal responses suggests a significant physiologic lag time during the more rapidly incremental protocol. These differences should be taken into account when exercise is used as a method to evaluate the heart transplant recipient.

Adult↗

PubMed1993

Comparison of treadmill exercise testing protocols for wheelchair users.

The reduced early mortality and the increased life span of persons with spinal cord injury (SCI) and other chronically disabling conditions which result in loss of use of the legs places them at increased risk of coronary heart disease, diabetes, and hypertension. Exercise testing in this population is becoming more common, but there is a need for assessment of protocols in order to determine the best method to elicit a maximal response in a reasonable time without endangering the patient. Three wheelchair treadmill protocols were compared in seven men with paraplegia aged 21-44 years (five SCI, two post-polio). Subjects repeated each protocol to estimate reliability. Protocol G consisted of increasing treadmill grade at a constant speed (4.8 km.h-1); in protocol S, the speed was increased at a constant grade (0%), and in protocol C, speed and grade were increased. Two-minute stages were used in all protocols. Peak oxygen uptake [VO2max; mean (SD): 23.6 (5.8) ml.kg-1 x min-1; 1.66 (0.37) l.min-1], VCO2 production [1.98 (0.46) l.min-1], ventilation volume [83.0 (25.6) l.min-1], respiratory exchange ratio [1.2 (0.12)], and heart rate [173 (18)] were determined. Over all trials none of the variables was significantly different among the three protocols, but all were highest in C and lowest in S. Reliability coefficients for absolute and relative VO2max ranged from 0.76 and 0.81 in G to 0.95 and 0.98 in C (all P < 0.05). These data suggest that an incremental treadmill test similar to the C protocol may be the optimal method to use when evaluating the exercise capacity of wheelchair users.

Adult↗

PubMed2005

A randomised prospective comparison of three protocols for head-up tilt testing and carotid sinus massage.

INTRODUCTION: Head-up tilt testing is an important tool in the diagnosis of syncope. Several different protocols are in use. This study aimed to compare three different protocols in an unselected population of patients with recurrent unexplained syncope and to assess long-term outcome using conventional tilt-directed management or implantable loop recorder (Reveal Plus)-directed management, allowing evaluation of the sensitivity and specificity of the technique. METHODS: Patients with recurrent unexplained syncope were randomized to one of three tilt protocols: Drug-free--70 degree tilt, 45 min, CSM at 5 and 45 min. GTN--70 degree tilt, 35 min, CSM at 5 min, 400 microg of glyceryl trinitrate spray administered sublingually at 20 min. Adenosine--70 degree tilt, 5 min, CSM when blood pressure is stable in upright position, adenosine bonus at 150 microg/kg after CSM. Tilts were terminated at the onset of syncope, when systolic BP reached 60 mm Hg, or in the presence of prolonged hypotension (> 3 min systolic BP < 80 mm Hg). Appropriate therapies were commenced according to the result of the tilt test. All patients without a definite indication for immediate cardiac pacing (asystolic tilt) were randomized to conventional management or ILR implantation. Recurrent syncopal events were compared to tilt outcome, allowing estimation of sensitivity and specificity. RESULTS: Of 214 patients, aged 68+/-18 years, 55% were female, with a median of three previous syncopes. 13 patients received pacemakers due to asystolic syncope during tilt testing. The proportion of VASIS classification diagnoses was similar with each protocol; however more positive diagnoses resulted from the GTN protocol (p=0.0013). 47% of patients achieved a diagnosis with tilt testing. We were able to correlate a subsequent spontaneous syncope to tilt result in 36 patients (18%). Heart rate during a spontaneous event was similar to that obtained during tilt testing (+/- 10%) in 55% of cases. Sensitivities for combined protocols, adenosine, GTN, and drug-free protocols were 50%, 50%, 100%, and 21%, respectively. Specificities were 85%, 100%, 75%, and 71%, respectively. CONCLUSIONS: A high diagnosis rate for unexplained syncope can be achieved with tilt testing. The GTN protocol resulted in significantly more diagnoses than the other compared protocols with good sensitivity and adequate specificity. Sensitivity of the drug-free tilt test was lower than drug-augmented tilt testing.

Aged↗

PubMed2006

Surgical challenges associated with intensive treatment protocols for high-risk neuroblastoma.

BACKGROUND: High-risk neuroblastoma (NB; age, >1 year; INSS stage 4) is associated with a poor outcome. At our institution, the current dose-intensive high-risk Children's Oncology Group protocol for advanced NB appears to have a higher surgical complication rate as compared with previous protocols. METHODS: All stage 4 patients (n = 51) entered in high-risk protocols between 1995 and 2005 were analyzed. Patients in the current high-risk protocol, Children's Oncology Group A3973 (n = 22), were compared with those in the 2 previous protocols, CCG 3891 and POG 9341 (n = 29). RESULTS: Patients were comparable in their mean age and tumor markers, including Shimada histology, MYCN amplification, 1p deletion, tumor origin, and extent of metastasis. However, transfusion requirement (86% vs 45%; P = .0019), postoperative infection rate (32% vs 3%; P = .02), and other postoperative issues including nutritional support (45% vs 3%; P = .0001) were significantly higher with the current protocol. No perioperative mortality was noted in either group, and the extent of resectability and margins were similar. Importantly, with the current protocol, the survival rate was higher (P = .0022) and the recurrence rate was significantly lower (P = .0003). CONCLUSIONS: Despite higher surgical morbidity associated with the current high-risk protocol (2.59 vs 0.86 complications/person; P < .01), the recurrence rate is lower and interim survival rate is improved for patients with high-risk NB. Therefore, the higher surgical complication rates associated with the current high-risk protocol are acceptable.

Child, Preschool↗

PubMed1996

Experience in the use of the NIOSH diffusive sampler evaluation protocol.

Diffusive sampler operation may be affected by a large number of factors. Interactions between the factors may also be important. A protocol for determining sampler performance has been developed by the National Institute for Occupational Safety and Health (NIOSH) that addresses sampler precision and accuracy when these factors vary within the ranges normally encountered in the field. However, it is costly, time-consuming, and often unnecessary to apply all of the tests to each sampler for every possible chemical hazard. A sampler shown to sample a specific vapor accurately may be assumed to require fewer tests to assure equal performance with related chemicals. The criteria used to define the reduced tests depends somewhat on sampler design, and the justification for applying the criteria must depend on information gained from validating a large selection of related chemicals using the full protocol. Thus, the full protocol remains the standard of reference for the lower validation level. Based on these considerations a "bilevel validation" approach was developed for the SKC 575 series diffusive sampler. Application of the bilevel approach to the NIOSH protocol is described, and the results are related to the full NIOSH protocol and also to a European validation protocol. The European protocol recognizes the validity of reduced tests for homologue validation. The conclusions are that (1) it is feasible to validate a sampler for a large number of organic vapors using the NIOSH protocol and that this number can be substantially increased by use of a bilevel approach, saving time and resources, and (2) samplers validated to either the NIOSH or European protocol should be accepted as meeting the requirements of the other.

Air Pollutants, Occupational↗

PubMed1998

Genetic protocols review by Institutional Review Boards at National Cancer Institute-designated cancer centers.

Absent a clear and enforceable national policy on cancer genetic testing and genetic research, the responsibility may currently be on institutional review boards to regulate those activities at their institutions through protocol approval or disapproval. The survey reported here was carried out to gain information on National Cancer Institute-designated cancer center policies governing institutional review board review of genetic protocols and the preparedness of institutional review boards to review genetic protocols. Thirty-five responses (63% response rate) were received, of which 30 were evaluable. Twenty-four responders reported that they believed that there is a need for research that may lead to improved review of genetic research and genetic testing protocols. Only 14 responders felt adequately informed of current and developing issues and legislation relative to genetic testing and research. Seven responders reported that their cancer centers require an institutional review board-approved protocol for genetic testing activities. Five responders reported that their cancer centers have a formal written policy that guides institutional review board review of genetic testing protocols. About half of the responders reported that their cancer centers have no formal written policy that guides institutional review board review of genetic research protocols. Only three responders reported that institutional review board members receive formal training to prepare them to evaluate all of the issues associated with genetic protocols. We conclude that greater effort needs to be made to establish uniform policy governing cancer genetic testing and genetic research and greater effort should be made to prepare institutional review boards formally for the review of genetic-related protocols.

Cancer Care Facilities↗