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A naturalistic comparison of two right unilateral electroconvulsive therapy dosing protocols: 2-3X seizure threshold versus fixed high-dose.

The aim of this study was to compare the outcomes associated with two differing right unilateral (RUL) electroconvulsive therapy (ECT) dosing protocols: 2-3X seizure threshold (2-3X ST) and fixed high dose (FHD) at 353 mC. A retrospective chart review was performed to compare patient outcomes during the implementation of two different dosing protocols: 2-3X ST from October 2000 to May 2001 and FHD from June 2001 to February 2002. A total of 56 patients received ECT under the 2-3X ST protocol, and 46 received ECT under the FHD protocol. In total, 13.6% of patients receiving ECT according to the 2-3X ST protocol received more than 12 ECT, whereas none of the FHD group received more than 12 ECT. The mean number of ECT per treatment course reduced significantly from 7.6 to 5.7 following the switch from the 2-3X ST protocol to the FHD protocol. There were no significant differences between the two groups in the incidence of adverse cognitive effects. ECT practitioners adhered to the 2-3X ST protocol for only 51.8% of ECT courses, with protocol adherence improving to 87% following introduction of the FHD protocol. Although this naturalistic retrospective chart survey had significant methodological limitations, it found that practitioners are more likely to correctly adhere to a fixed dose protocol, therefore, increasing its 'real world' effectiveness in comparison to titrated suprathreshold dosing techniques. The FHD protocol was associated with shorter courses of ECT than the 2-3X ST protocol, with no significant difference between the two protocols in clinically discernable adverse cognitive effects.

Adult↗

Physiological comparisons among three maximal treadmill exercise protocols in trained and untrained individuals.

The present investigation was undertaken to examine whether maximal oxygen uptake (VO2max) and anaerobic threshold (AT) measured during incremental treadmill exercise would be affected by the exercise protocol in trained and untrained individuals. Fifteen untrained men, 10 untrained women, and 12 trained individuals participated in this study. The Astrand, Bruce, and Costill/Fox protocols were selected for comparison. Each subject was tested using all three protocols and the three tests were conducted in a randomized counterbalanced order. During each test, oxygen uptake was measured every 30 s and the test was terminated according to the standard criteria. The VO2max was determined by averaging the two consecutive highest measurements, whereas AT was determined using ventilatory parameters following the V-slope technique. The Astrand, Bruce, and Costill/Fox protocols produced test durations of 9.8 (SEM 0.5), 12.4 (SEM 0.4), and 4.9 (SEM 0.3) min, respectively, in the untrained men, 9.0 (SEM 0.8), 11.0 (SEM 0.6), and 5.3 (SEM 0.6) min, respectively, in the untrained women, and 14.5 (SEM 0.5), 17.0 (SEM 0.5) and 10.4 (SEM 0.4) min, respectively, in the trained men. In the untrained men and women, no differences in VO2max were observed among the three different protocols, but AT was lower when using the Bruce compared to the Astrand protocol. In the trained men, VO2max and AT were lower when using the Bruce protocol than either the Astrand or Costill/Fox protocols. In conclusion, VO2max measured during treadmill exercise is not affected by the protocol of the test and using a running protocol of short duration (i.e. about 5 min) could be a time-efficient way of assessing VO2max in healthy untrained subjects. In trained subjects, however, a protocol consisting of running with small increments in gradient is effective in eliciting a higher VO2max. The lower AT associated with the Bruce protocol seen in both untrained and trained groups suggests this aerobic parameter is protocol dependent and this protocol dependency is not affected by training status.

Adult↗

Immunohistochemical double-staining of renal allograft tissue: critical assessment of three different protocols.

Quantitative analyses of renal allograft tissue using immunohistochemical double-staining could be a useful tool to extend the existing knowledge on renal allograft immunopathology. Due to technical reasons, this method has been only rarely applied in the past. The use of indirect immunohistochemistry for double-staining bears the risk of nonspecific cross reactions between the two staining sequences. To date, various procedures have been refined to avoid such cross reactions. Here we assessed the validity of three different protocols for indirect immunohistochemical double-staining on frozen sections of renal transplant biopsies ( n=12). Both colocalized antigens and antigens with a non-overlapping distribution were stained according to each of the three protocols. Differentiation between the two staining sequences was achieved by employing different colored substrates of alkaline phosphatase (protocol 1), different enzymes (peroxidase and alkaline phosphatase) together with the use of 3,3'-diaminobenzidine-tetrahydrochloride substrate in the first staining sequence (protocol 2), or primary antibodies from different species (protocol 3). Sensitivity and specificity of each protocol were determined by quantitative comparison with control single-stainings of adjacent sections. Sensitivity of the first staining sequence was about 100% with each of the three protocols investigated. In the second staining sequence, sensitivities of protocols 1 (50%) and 2 (54-66%) were much lower than of protocol 3 (100%). Specificity of the second staining sequence was only 44% with protocol 1 compared with 98% with protocol 2 and 100% with protocol 3. In conclusion, protocols 1 and 2 are not recommended for quantitative double-staining analyses. In contrast, protocol 3 provided maximum sensitivity and specificity, even for antigens that are colocalized on the same cell type. Thus, the use of primary antibodies from different species is by far the most reliable technique for quantitative double-staining analyses in renal allograft tissue.

Antigens, CD↗

Synchronization of estrus and fertility in zebu beef heifers treated with three estrus synchronization protocols.

The effects on estrus and fertility of 3 estrus synchronization protocols were studied in Brahman beef heifers. In Treatment 1 (PGF protocol; n=234), heifers received 7.5 mg, i.m. prostianol on Day 0 and were inseminated after observed estrus until Day 5. Treatment 2 (10-d NOR protocol; n = 220) consisted of norgestomet (NOR; 3 mg, s.c. implant and 3 mg, i.m.) and estradiol valerate (5 mg, i.m.) treatment on Day -10, NOR implant removal and 400 IU, i.m. PMSG on Day 0, and AI after observed estrus through to Day 5. Treatment 3 (14-d NOR+PGF protocol; n = 168) constituted a NOR implant (3 mg, sc) on Day -14, NOR implant removal on Day 0, PGF on Day 16, and AI after observed estrus through to Day 21. All heifers were examined for return to estrus at the next cycle and inseminated after observed estrus. The heifers were then exposed to bulls for at least 21 d. During the period of estrus observation (5 d) after treatment, those heifers treated with the PGF protocol had a lower (P<0.01) rate of estrual response (58%) than heifers treated with the 10-d NOR (87%) or 14-d NOR+PGF (88%) protocol. Heifers treated with the 10-d NOR protocol displayed estrus earlier and had a closer synchrony of estrus than heifers treated with either the PGF or the 14-d NOR+PGF protocol. Heifers treated with the 14-d NOR+PGF protocol had higher (P<0.05) conception and calving rates (51 and 46%) to AI at the induced estrus than heifers treated with the PGF (45 and 27%) or the 10-d NOR (38 and 33%) protocol. Calving rate to 2 rounds of AI was greater (P<0.05) for heifers treated with the 14-d NOR-PGF (50%) protocol than heifers treated with the 10-d NOR (38%) but not the PGF (43%) protocol. Breeding season calving rates were similar among the 3 protocols. The results show that the 14-d NOR+PGF estrus synchronization protocol induced a high incidence of estrus with comparatively high fertility in Brahman heifers.

Animal Husbandry↗

Automated blood component collection with the MCS 3p cell separator: evaluation of three protocols for buffy coat-poor and white cell-reduced packed red cells and plasma.

BACKGROUND: Automated collection of blood components with a cell separator (MCS 3p, Haemonetics), was performed according to three protocols. STUDY DESIGN AND METHODS: The first protocol provided 2 units of fresh-frozen plasma (FFP); and one buffy coat-poor red cell (RBC) concentrate in additive solution. The second protocol included an additional in-line filtration of the RBC in a closed system after storage at 4 degrees C for 24 hours. In the third protocol, an additional platelet concentrate (PC) was recovered from the buffy coat. Cell counts and biochemical characterization of the RBCs (n = 20 each) were determined on Days 0, 1, 14, 28, and 49. RESULTS: The RBC volume was 336 +/- 9 mL (first protocol), 337 +/- 7 mL (second protocol) and 293 +/- 12 mL (third protocol) with a hematocrit of 59 +/- 2, 53 +/- 3, and 61 +/- 5, percent respectively. On Day 49, hemolysis was 0.24 +/- 0.1 percent (first protocol), 0.33 +/- 0.32 percent (second protocol), and 0.38 +/- 0.1 percent (third protocol). The filtered RBC concentrate met the international standards for white cell-reduced RBCs. Filtration resulted in a clinically irrelevant increase of hemolysis. The in vitro RBC values (lactate dehydrogenase, 2-hydroxybutyrate dehydrogenase, hemolysis, potassium, 2,3 DPG, ATP) were at least equal to those in RBCs collected by conventional whole-blood donation. There is a trend toward extended preservation of 2,3 DPG in RBCs collected by apheresis. Two units of FFP could be collected with each donation (first protocol: 420 +/- 55 mL, 5.4 +/- 7 WBCs/microL, 6.5 +/- 5 x 10(3) platelets/microL; second protocol: 440 +/- 33 mL, 3 +/- 5.2 WBCs/microL, 32 +/- 12 x 10(3) platelets/microL; third protocol: 398 +/- 32 mL, 5 +/- 12 WBCs/microL; 3.4 +/- 3.5 x 10(3) platelets/microL). PCs prepared from the buffy coat collected by the third protocol contained 90 +/- 30 x 10(9) platelets in 88 +/- 14 mL of plasma. In vitro test results in these PCs were superior to those in PCs collected by conventional whole-blood donation. The procedure was well tolerated by all donors. No adverse reactions appeared. CONCLUSION: Erythroplasmapheresis with the MCS 3p cell separator is a useful alternative to conventional whole-blood donation and separation.

Adenosine Triphosphate↗

Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation.

OBJECTIVE: To compare a practice of protocol-directed sedation during mechanical ventilation implemented by nurses with traditional non-protocol-directed sedation administration. DESIGN: Randomized, controlled clinical trial. SETTING: Medical intensive care unit (19 beds) in an urban teaching hospital. PATIENTS: Patients requiring mechanical ventilation (n = 321). INTERVENTIONS: Patients were randomly assigned to receive either protocol-directed sedation (n = 162) or non-protocol-directed sedation (n = 159). MEASUREMENTS AND MAIN RESULTS: The median duration of mechanical ventilation was 55.9 hrs (95% confidence interval, 41.0-90.0 hrs) for patients managed with protocol-directed sedation and 117.0 hrs (95% confidence interval, 96.0-155.6 hrs) for patients receiving non-protocol-directed sedation. Kaplan-Meier analysis demonstrated that patients in the protocol-directed sedation group had statistically shorter durations of mechanical ventilation than patients in the non-protocol-directed sedation group (chi-square = 7.00, p = .008, log rank test; chi-square = 8.54, p = .004, Wilcoxon's test; chi-square = 9.18, p = .003, -2 log test). Lengths of stay in the intensive care unit (5.7+/-5.9 days vs. 7.5+/-6.5 days; p = .013) and hospital (14.0+/-17.3 days vs. 19.9+/-24.2 days; p < .001) were also significantly shorter among patients in the protocol-directed sedation group. Among the 132 patients (41.1%) receiving continuous intravenous sedation, those in the protocol-directed sedation group (n = 66) had a significantly shorter duration of continuous intravenous sedation than those in the non-protocol-directed sedation group (n = 66) (3.5+/-4.0 days vs. 5.6+/-6.4 days; p = .003). Patients in the protocol-directed sedation group also had a significantly lower tracheostomy rate compared with patients in the non-protocol-directed sedation group (10 of 162 patients [6.2%] vs. 21 of 159 patients [13.2%], p = .038). CONCLUSIONS: The use of protocol-directed sedation can reduce the duration of mechanical ventilation, the intensive care unit and hospital lengths of stay, and the need for tracheostomy among critically ill patients with acute respiratory failure.

Algorithms↗

Hemodynamic changes, plasma catecholamine responses, and echocardiographically detected contractile reserve during two different dobutamine-infusion protocols.

We studied hemodynamic changes, catecholamine responses, and the occurrence of improved wall thickening by echocardiography during two different dobutamine-infusion protocols. Forty-three patients were studied by using a stepwise incremental dobutamine dose-infusion protocol (10-40 microg/kg/min, 3-min intervals); a subgroup of 11 patients also underwent a continuous dobutamine-infusion protocol (10 microg/kg/min for 12 min) in random order. No patient used beta-blockers. At 3-min intervals, blood pressure, heart rate, and plasma concentrations of dobutamine, epinephrine, and norepinephrine were measured. The echocardiographic improvement of wall thickening was analyzed only in paired protocols by visual assessment in left ventricular regions with normal wall motion at rest. The mean heart rate increased in the continuous and stepwise protocols from 73 to 99 and 74 to 132 beats/min. There was no significant change in blood pressure response between the two protocols. The mean plasma dobutamine concentrations during the continuous and stepwise protocols at 0, 3, 6, 9, and 12 min were 0/0; 31/38; 80/203; 106/448; and 120/692 ng/ml, respectively. In each patient, a response curve was constructed for the plasma dobutamine concentration versus heart rate. The heart rate increment and dobutamine concentration at which wall thickening was detected were similar with both protocols (14 +/- 5 vs. 12 +/- 7 beats/min) and (80 +/- 40 vs. 92 +/- 48 ng/ml; mean +/- SD). Wall thickening was noted in two of 11 patients between 0 and 3 min and 11 of 11 patients between 3 and 6 min in both protocols. Catecholamine responses during the continuous and stepwise protocols were epinephrine, 23 versus 28/28 versus 36, and norepinephrine 301 versus 323/347 versus 519. Only norepinephrine plasma concentrations increased significantly during the stepwise protocol. A 6-min dobutamine infusion was sufficient during both protocols to reach an adequate plasma dobutamine concentration, which induced a detectable increase of wall thickening in all patients. There is a significant differences between the two protocols with regard to the plasma catecholamine changes, so some of the hemodynamic effects during the stepwise dobutamine-infusion protocol may be mediated through release of endogenous catecholamines.

Adrenergic beta-Agonists↗

Comparison of outcomes and direct cost between minimal stimulation and conventional protocols on ovarian stimulation in in vitro fertilization.

AIM: To determine whether minimal stimulation with clomiphene and gonadotropin provides outcomes and direct costs comparable with those of a conventional GnRHa-gonadotropin stimulation protocol for infertile patients undergoing in vitro fertilization. METHODS: A non-randomized clinical trial was conducted from 1 July 1996 to 31 March 2003 at the Infertility and Assisted Reproductive Unit, Ramathibodi Hospital, Faculty of Medicine, Mahidol University, Thailand. A total of 192 patients were recruited of whom 96 cases underwent ovarian stimulated cycles with minimal stimulation protocol, and 96 controls underwent ovarian stimulated cycles with GnRHa-gonadotropin protocol, with cases and controls matched for age and infertility cause. RESULTS: The median patient age was 35 years. Endometriosis was the most frequent infertility cause (28.1%). The conventional GnRHa-gonadotropin protocol could give more oocyte numbers than the minimal stimulation protocol (7.3 +/- 4.9 vs 4.5 +/- 3.3 oocytes). The fertilization rate and cleavage rate were similar (73.4 +/- 31.9 and 84.9 +/- 32.6 in minimal stimulation protocol, 69.3 +/- 29.6 and 88.4 +/- 28.0 in GnRHa-gonadotropin protocol, respectively). The pregnancy rate per oocyte retrieval cycle in the GnRHa-gonadotropin protocol was similar to the minimal stimulation protocol. (13.1%vs 13.0%, P = 1.000). However, the cost per pregnancy of minimal stimulation protocol was less than that of GnRHa-gonadotropin protocol. (6021.95 US dollars for minimal stimulation protocol per pregnancy, 10,785.65 US dollars for GnRHa-gonadotropin protocol per pregnancy, P < 0.000). CONCLUSION: Minimal stimulation was less effective than conventional GnRHa-gonadotropin on the ovarian stimulation. However, the total costs of minimal stimulation were cheaper than the conventional GnRHa-gonadotropin protocol. The decreased costs of minimal stimulation justifies further evaluation of its role in the treatment of infertility in selected cases.

Adult↗

Prospective comparison of a conventional and an accelerated protocol for programmed ventricular stimulation in patients with coronary artery disease.

BACKGROUND: This study compared the sensitivity, specificity, and efficiency of a "conventional" and "accelerated" programmed stimulation protocol in 293 patients with coronary artery disease who had a history of sustained or nonsustained monomorphic ventricular tachycardia (VT). METHODS AND RESULTS: In the conventional protocol, one and two extrastimuli were introduced during sinus rhythm and during basic drive trains at cycle lengths of 600 and 400 msec at the right ventricular apex and then at the outflow tract or septum. In the accelerated protocol, one, two, and then three extrastimuli were introduced at each of three basic drive train cycle lengths (350, 400, and 600 msec) at the right ventricular apex; the procedure was repeated at a second right ventricular site. Six hundred thirty-four electrophysiological tests were performed using one of these two protocols either in the baseline state (293 tests) or during drug testing (341 tests). The yield of sustained, monomorphic VT was 89% with the conventional protocol and 92% with the accelerated protocol during baseline tests in patients who had a history of sustained VT (p = 0.05); 20% and 34%, respectively, during baseline tests in patients with a history of nonsustained VT (p = 0.06); and 70% and 77%, respectively, during drug testing (p = 0.2). To induce sustained, monomorphic VT, 10.1 +/- 5.0 (mean +/- SD) protocol steps and 14.4 +/- 8.7 minutes were required with the conventional protocol, compared with 4.0 +/- 3.7 steps and 5.6 +/- 6.1 minutes with the accelerated protocol (p less than 0.001 for each comparison). Among the tests in which sustained, monomorphic VT was induced, sustained polymorphic VT or ventricular fibrillation was induced more often with the conventional protocol (3.6%) than with the accelerated protocol (0.9%, p = 0.05). CONCLUSIONS: The efficiency of programmed stimulation can be improved by the early use of a basic drive train cycle length of 350 msec and three extrastimuli. Compared with a conventional stimulation protocol, the accelerated protocol used in this study reduces the number of protocol steps and duration of time required to induce monomorphic VT by an average of more than 50% and improves the specificity of programmed stimulation without impairing the yield of monomorphic VT.

Cardiac Pacing, Artificial↗

[Improved detection of fill-in using sublingual nitroglycerin in technetium-99m tetrofosmin exercise/rest single photon emission computed tomography one day protocol for old myocardial infarction].

This study assessed the effect of sublingual nitroglycerin administered before rest imaging in the technetium-99m (99mTc) tetrofosmin exercise and rest same day protocols to determine whether the use of nitroglycerin improved the detection of fill-in the rest single photon emission computed tomography (SPECT) images 3 hours after peak exercise. Twenty-one patients with old myocardial infarction underwent repeated 99mTc-tetrofosmin exercise/rest same day protocols with and without the administration of sublingual nitroglycerin (0.3 mg) 5 min before the second injection of 99mTc-tetrofosmin for rest SPECT imaging. Twelve of these patients also underwent ordinary exercise/redistribution 201T1 SPECT imaging. The control study protocol images showed decreased uptake of 99mTc-tetrofosmin on exercise in 157 of 420 segments and the presence of fill-in at rest in 58 segments. Images obtained with administration of nitroglycerin showed decreased uptake of 99mTc-tetrofosmin on exercise in 163 of 420 segments and fill-in in 74 segments at rest. The frequency of fill-in was greater in the nitroglycerin protocol than in the control protocol (p < 0.05). The segments were scored as different grades according to 99mTc-tetrofosmin uptake between 2 protocols. Fill-in was only present or more remarkable in 31 segments in the nitroglycerin protocol than in the control protocol. Fill-in was only present or more remarkable in 10 segments in the control protocol than in the nitroglycerin protocol. In the nitroglycerin protocol, the mean defect score of the exercise images, calculated from the bull's eye image automatically, was higher than that of the rest images (121 +/- 40 vs 94 +/- 53, p < 0.01). The mean severity score of the exercise images, also calculated from the bull's eye image automatically, was likewise higher than that of the rest images (691 +/- 382 vs 524 +/- 431, p < 0.01), whereas the mean severity score of the stress images and rest images in the control protocol was not significantly different. Moreover, the mean defect score and severity score of the rest images from the nitroglycerin protocol were significantly lower than those obtained from the control protocol (p < 0.05). Sublingual nitroglycerin administration before the injection of 99mTc-tetrofosmin at the rest study in the one day exercise/rest studies enhanced fill-in, so may enhance the detection of viable myocardium, allowing more informed decisions regarding cardiac revascularization in patients with chronic coronary artery disease.

Administration, Sublingual↗

[A prospective, randomized controlled study comparing the effects of gonadotropin-releasing hormone agonist long and short protocols for in vitro fertilization].

OBJECTIVE: To compare the effects of gonadotropin-releasing hormone agonist (GnRH-a) long and short protocols as part of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment. METHODS: One hundred and nine infertile couples accepted a prospective, randomized comparative study for IVF or ICSI treatment were divided into GnRH-a long protocol group (55 cases) and GnRH-a short protocol group (54 cases). GnRH-a long protocol group: GnRH-a was taken by nasal spray 0.9 mg/day starting on day 21 of the previous menstrual cycle. Once the patient was down regulated, gonadotropin (Gn) injection was started. GnRH-a short protocol group: GnRH-a was taken by nasal spray 0.45 mg/day starting on day 2 of the menstrual cycle, and Gn was started on the same day. Two groups had human chorionic gonadotrophin (hCG) administered when the leading follicle was at least 18 mm in diameter. Oocytes were retrieved 36 hours after hCG administration guided by transvaginal ultrasounography. IVF/ICSI were performed as routine. RESULTS: Serum follicle stimulating hormone and luteinizing hormone (LH) levels on the day of starting Gn were lower in the long protocol group comparing with the short protocol group [(4.4 +/- 1.2) IU/L Vs (6.3 +/- 1.7) IU/L, (2.7 +/- 1.5) IU/L Vs (4.4 +/- 2.8) IU/L, P < 0.01 respectively]. The levels of serum estradiol (E2), LH and E2 per oocyte on the day of hCG injection were lower in the long protocol group comparing with the short protocol group [(7,119 +/- 3,584) pmol/L Vs (9,523 +/- 3,587) pmol/L, (1.0 +/- 1.0) IU/L Vs (4.0 +/- 3.4) IU/L, (610 +/- 315) pmol/L Vs (935 +/- 450) pmol/L, P < 0.01 respectively]. Patients treated with short protocol were stimulated for a shorter period, required fewer Gn ampoules than the long protocol group [(10.1 +/- 1.5) d Vs (11.1 +/- 1.2) d, (23.4 +/- 8.7) Amps Vs (28.0 +/- 8.6) Amps, P < 0.01 respectly]. There are no statistically differences between the two groups in the numbers of oocytes retrieved, metaphase of second meiosis oocytes, fertilized oocytes, cleaved embryos, high quality embryos and pregnancy rates. CONCLUSIONS: The GnRH-a long and short protocols have equal effects on controlled ovarian hyperstimulation for in vitro fertilization. Patients who received GnRH-a short protocol required fewer ampoules of gonadotrpins and shorter period of treatment than those who received the GnRH-a long protocol.

Adult↗

Effects of three sedative protocols on glomerular filtration rate in clinically normal dogs.

OBJECTIVE: To determine the effects of 3 sedative protocols (butorphanol and diazepam [BD] IV; acepromazine and butorphanol [AB] IV; diazepam and ketamine [DK] IV) on glomerular filtration rate (GFR) as measured by 99mTc DTPA nuclear scintigraphy and to compare them with GFR measured without sedation. Cardiovascular, respiratory, and sedative effects of each protocol also were measured. ANIMALS: 12 adult male Walker Hounds. PROCEDURE: Systolic, diastolic, and mean arterial blood pressures and heart and respiratory rates were measured before, during, and after scintigraphic measurement of GFR. RESULTS: Difference in GFR was not significant between any of the sedative regimens and the control. The DK protocol caused significant increases in systolic, diastolic, and mean arterial blood pressure; compared with the AB and BD protocols, it caused significant increases in heart rate versus all protocols, and was associated with the lowest mean GFR (2.80 ml/min/kg of body weight). The AB protocol caused significant decreases in systolic, diastolic, and mean arterial blood pressures, compared with DK and the nonsedation protocols. Mean GFR for the BD protocol was 2.94 ml/min/kg, and was 3.13 ml/min/kg for the AB and the nonsedation protocols. The AB protocol provided the best sedation with minimal additional restraint required. The BD and nonsedation protocols often were associated with substantial dog movement. The DK protocol induced inadequate duration of immobilization (< 10 minutes) in some dogs and excitement in others. CONCLUSION: GFR measurements obtained with any of the sedative protocols were not significantly different, compared with measurements in awake dogs. The AB protocol provides the best sedative effects and was associated with GFR values identical to those in awake dogs. Systemic hypotension caused by acepromazine did not decrease GFR in clinically normal dogs.

Acepromazine↗

Comparison of three radiotherapy treatment planning protocols of definitive external-beam radiation for localized prostate cancer.

BACKGROUND: Three radiotherapy treatment planning (RTTP) protocols for definitive external-beam radiation for localized prostate cancer, designed and clinically applied at Kyoto University, were compared. METHODS: Treatment plans were created according to three different RTTP protocols (old three-dimensional conformal radiotherapy [3D-CRT], new 3D-CRT, and intensity-modulated radiotherapy [IMRT]) on computed tomography (CT) data sets of five patients with localized prostate cancer. The dynamic-arc conformal technique was used in the 3D-CRT protocols. Differences in dose distribution were evaluated and compared based on dose-volume histogram (DVH) analyses. RESULTS: The coverage of the clinical target volume (= prostate alone) was comparable among the three RTTP protocols. However, the average values for the percent volume that received at least 95% of the prescription dose (V95), the percent of the prescription dose covering 95% of the volume (D95), and the conformity index of the planning target volume (PTV) were 99%, 97%, and 0.88 for the IMRT; 93.9%, 94.5%, and 0.76 for the new 3D-CRT; and 59.6%, 82.9%, and 0.6 for the old 3D-CRT protocol, respectively. Inhomogeneity of doses to the PTV was larger with the IMRT protocol than with the new 3D-CRT protocol. Doses to both the rectal wall and bladder wall were almost comparable with the new 3D-CRT and IMRT protocols, but were lower with the old 3D-CRT protocol, due to the lowest prescription dose and incomplete dose coverage of the PTV. CONCLUSION: The old 3D-CRT protocol could not achieve the goals for the PTV set in the IMRT protocol. The new 3D-CRT and IMRT protocols were generally comparable in terms of both the PTV coverage and normal tissue-sparing, although the IMRT protocol achieved the most conformal dose distribution to the PTV, in return for a larger, but acceptable, dose inhomogeneity.

Clinical Protocols↗

An evaluation of five protocols for surgical handwashing in relation to skin condition and microbial counts.

Five protocols for surgical handwashing (scrubbing) were evaluated for their efficiency of removal of micro-organisms and their drying effect on the skin. The scrubbing protocols tested were: (1) an initial scrub of 5 min and consecutive scrubs of 3.5 min with chlorhexidine gluconate 4% (CHG-5); (2) an initial scrub of 3 min and consecutive scrubs of 2.5 min with chlorhexidine gluconate 4% (CHG-3); (3) an initial scrub of 3 min and consecutive scrubs of 2.5 min with povidone iodine 5% and triclosan 1% (PI-3); (4) an initial scrub of 2 min with chlorhexidine gluconate 4% followed by a 30 s application of isopropanol 70% and chlorhexidine gluconate 0.5%, and a 30 s application of isopropanol 70% and chlorhexidine gluconate 0.5% for consecutive scrubs (IPA); and (5) an initial scrub of 2 min with chlorhexidine gluconate 4% followed by a 30 s application of ethanol 70% and chlorhexidine gluconate 0.5%, and a 30 s application of ethanol 70% and chlorhexidine gluconate 0.5% for consecutive scrubs (EA). A convenience sample of 23 operating theatre nurses completed each scrub protocol for one week in a randomized order. A week of normal work activities intervened between each protocol. Subjects were assessed before commencing and after completing the week of each protocol to determine changes in the microbial counts and skin condition of the hands. Specimens for microbial analysis were collected before, immediately after and 2 h after an initial scrub, and 2 h after a consecutive scrub. The CHG-5, CHG-3 and PI-3 protocols, which used detergent-based antiseptics only, were compared with protocols incorporating an alcohol-based antiseptic (IPA and EA). The protocols incorporating alcohol-based antiseptics and the CHG-5 protocol were generally associated with the lowest post-scrub numbers of colony forming units (cfu). No difference between the CHG-5 protocol and the alcohol-based antiseptics was found at the beginning of the test week, but after exclusive use of the respective protocols for a week, the alcohol-based antiseptics were associated with significantly lower cfu numbers in two out of the three post-scrub samples (P = 0.003, P = 0.035). Although virtually no statistically significant differences in skin condition were found, many subjects reported the alcohol-based antiseptic protocols to be less drying on the skin. The findings of this study support the proposition that a scrub protocol using alcohol-based antiseptics is as effective and no more damaging to skin than more time-consuming, conventional methods using detergent-based antiseptics.

1-Propanol↗

Toxicity, supportive care and costs of two chemotherapy protocols for treatment of childhood ALL in Russia: BFM 90m and MB 91.

Since the late 1980s, polychemotherapy protocols for the treatment of childhood acute lymphoblastic leukaemia (ALL) derived from Western European and American regimens have been introduced in Russian paediatric oncology centres. Whereas treatment results were significantly improved compared with the results of former non-standard treatment strategies, the substantial toxicity of these protocols required a high standard of supportive care, and the high costs of treatment became a major problem. In 1991, a new protocol was developed with the aim of reducing toxicity and costs without affecting efficacy of the treatment. Since 1991, a single-centre study comparing the new Russian Protocol, Moscow-Berlin 91 (MB), with a modified version of the protocol ALL BFM 90 (BFM) of the Berlin-Frankfurt-Münster group was performed in Moscow to evaluate possible advantages of the new protocol under Russian conditions. The aim of the present analysis was to compare toxicity, need of supportive care and expense of both regimens (BFM, 25 pts; MB, 32 pts). Hepatotoxicity (liver enzymes), nephrotoxicity (creatinine), duration of neutropenia, and platelet transfusions were similar in both protocols. The median erythrocyte transfusion level was greater in the BFM (1000 ml/m2) than the MB patients (505 ml/m2, P < 0.01), as was the length of intravenous (i.v.) antibiotic therapy (22 days BFM versus 9 days MB, P < 0.01), treatment delays (39 days BFM versus 21 days MB, P < 0.001), and duration of in-patient treatment (47 days BFM versus 18 days MB, P < 0.001). Side-effects of the MB protocol occurred mainly during induction therapy. Total costs (mean cost/person/m2 body surface) of treatment including supportive care were 1.73-fold higher for the BFM protocol than MB, whereas costs of cytostatic drugs were comparable in both groups. In Russia both protocols were feasible. During consolidation therapy tolerance to treatment was better in MB 91 compared with BFM 90m, whereas toxicity during induction therapy was similar in both protocols. With respect to costs and side-effects, the MB 91 protocol appears to be an alternative to established protocols for countries with limited financial and clinical resources.

Antineoplastic Combined Chemotherapy Protocols↗

Predicting adverse outcomes in a diagnosis-based protocol system for rapid sequence intubation.

Our ED at Louisiana State University developed a unique approach to airway management by having four diagnosis-based protocols for rapid sequence intubation (RSI). This study examines protocol use and outcome from RSI in an academic ED. The study objective was to identify variables that are predictive of adverse outcomes in patients requiring RSI. This was a 4-year prospective, observational, data-gathering study of all intubations in an academic ED setting with >250,000 patient visits per year. Four protocols were established for 1) children <10 years of age, 2) adults with increased intracranial pressure, 3) adults with chronic obstructive pulmonary disease/asthma, and 4) other adults not fitting B or C. A special continuing quality improvement (CQI) committee was established to examine each case of RSI. Prospective data were collected, including age, race, gender, protocol, diagnostic group, intubation indication, and preintubation oxygen saturation. Diagnostic group was categorized as medical, blunt trauma, or penetrating trauma. Adverse outcome was defined as any case with hemodynamic changes, those requiring surgical or bronchoscopic intervention, and those requiring more than three attempts at intubation. Data were analyzed using univariate analysis, logistic regression, and a binomial regression tree analysis with SPSS 9.0 (Chicago, IL) and Answer Tree (SPSS). A total of 1,320 consecutive intubated patients were included. Protocol A was used in 4%, B in 43%, C in 15%, and D in 38%. Significant differences in number of cases with adverse outcome were based on protocol (P =.03) and final diagnosis (P <.03). Protocol C was less likely to be associated with adverse outcome than protocol D (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.1-0.7). Penetrating trauma was more likely to be associated with adverse outcome (OR = 1.8, 95%, CI = 1.1-3.2) than blunt trauma. A regression tree analysis yielded the following, all cases using protocol A or C or medical cases using B had an adverse event in 11 of 458 (2.4%), whereas nonmedical cases using protocols B or D and medical cases using D had adverse outcomes in 73 of 862 cases (8.5%). The decision rules lead to a better classification of cases with adverse outcomes (2.4 vs 8.5%, of = 6.1%, 95% CI = 3.7-8.4). Adult trauma patients who fit the protocols B or D or adult medical patients who fit protocol B were at higher risk for adverse outcomes with RSI. This could alert the physician to a population at higher risk for adverse outcomes. Variables available in a diagnosis-based protocol RSI system can be used to predict adverse outcome among patients requiring RSI.

Adolescent↗

Pharmacy-managed protocol for warfarin use in orthopedic surgery patients.

A pharmacy-managed protocol for warfarin use in orthopedic surgery patients was studied. In 1990 a protocol designed to accommodate either protocol- or physician-determined dosing of warfarin for orthopedic antithrombotic prophylaxis (OAP) was implemented at a community hospital. A "protocol" group consisting of patients treated entirely under the protocol-determined dosing option was prospectively identified over a two-year period. A "physician" group consisting of patients treated by physicians in the 10 months immediately preceding implementation of the protocol was also identified. The ability of the protocol to achieve laboratory-test and clinical goals was assessed by comparing the two groups. The proportion of patients who received OAP increased from 89% for the physician group to 98% for the protocol group. Mean prothrombin times (PTs) were significantly higher in the protocol group only on postoperative day 2; 66% of all PTs beyond post-operative day 1 in the protocol group were within the targeted range, which reflected an International Normalized Ratio of 1.6-3.2. The frequencies of clinically apparent postoperative thrombotic events and bleeding episodes were low in each group and comparable to literature values. Analysis of protocol-group patients with PTs of > 20 seconds indicated that lower weight, female sex, and blood loss during surgery were associated with an elevated PT. The protocol was revised to provide for a lower initial warfarin dose in elderly women. A pharmacy-managed protocol for dosing warfarin achieved therapeutic goals and promoted nearly universal use of OAP in patients undergoing high-risk orthopedic surgery.

Blood Coagulation Tests↗

Individualization of the biopsy protocol according to the prostate gland volume for prostate cancer detection.

PURPOSE: In this study we assessed the relative yield of 10 core biopsy, and the whole range of alternative 8 and 6 core biopsy protocols over that of the classic sextant biopsy protocol. We determined the optimum number of cores per biopsy according to prostate volume in patients who experienced prostate biopsy for the first time. MATERIALS AND METHODS: A total of 503 men with the indications of abnormal digital rectal examination and/or serum prostate specific antigen greater than 2.5 ng/ml were included in the study. All patients underwent a 10 core biopsy protocol with an additional 1 core from each suspicious area detected by transrectal ultrasound. Prostate volume was divided into quartiles, namely 14.9 to 35, 35.1 to 50, 50.1 to 65 and 65.1 to 150 cc. The optimum number of biopsy cores was determined in patients with different prostate volumes. RESULTS: Median age was 63 years and prostate specific antigen was 7.4 ng/ml in the whole group. Of 503 patients 159 (31.6%) were positive for prostate cancer. Cancer detection rates decreased significantly from 49.6% to 20.8% as prostate volume increased in preset quartiles. Lesion biopsies revealed the lowest unique cancer detection rates for all prostate volume quartiles (0% to 3%). There was an obvious positive trend in cancer detection rates in favor of the 10 core biopsy protocol over sextant biopsies in all patient groups. Classic sextant biopsy protocol proved to be inadequate for all prostate volumes. Among sextant biopsy protocols laterally placed cores including the apex, lateral mid gland and lateral base had the best cancer detection rates (81% to 95%). The 8 core biopsy scheme consisting of the apex, mid gland, lateral mid gland and lateral base resulted in an only 1% lower detection rate (97%) than the 10 core biopsy protocol in the lowest quartile. The yield of the 10 core biopsy protocol in patients with a prostate volume of between 35.1 and 150 cc outscored that of the optimal 8 core biopsy scheme including the apex, base, lateral mid gland and lateral base with 3% to 8% differences in the cancer detection rate. CONCLUSIONS: The 10 core biopsy protocol must be used in all group of patients except patients with a prostate volume of 14.9 to 35 cc. In patients with a prostate volume of 14.9 to 35 cc the 8 core biopsy protocol consisting of the apex, mid gland, lateral mid gland and lateral base can be used since it revealed results similar to those of the 10 core biopsy protocol. The classic sextant biopsy protocol seemed inadequate for all prostate volumes. Patients with a larger prostate had lower cancer detection rates. Transrectal ultrasound directed lesion biopsies may be omitted when using 10 core biopsy protocols since the yield of these biopsies was less than 2%.

Adult↗