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At least 181 records · Page 10Linked to original sources

PubMed1999

Basic research supported developments of chemotherapy in nonresectable isolated colorectal liver metastases to a protocol of hepatic artery infusion using mitoxantrone, 5-FU + folinic acid and mitomycin C.

OBJECTIVE: Since the developments in systemic chemotherapy of metastasized colorectal cancer have not resulted in substantial gains in survival times, we wished to improve the course of isolated nonresectable colorectal liver metastases (CPLM) by hepatic arterial infusion treatment. BACKGROUND: Patients (pts) with CRLM have a worse fate than those pts whose liver metastases could be resected. Systemic (i.v.) chemotherapy for CRLM/colorectal metastases does not improve survival to a relevant level (median survival time (med. surv.) after 5-Fluorouracil + Folinic Acid (5-FU + FA) i.v.: 6.4-14.3 months (m)). Hepatic artery infusion (HAI) with 5-Fluorode-oxyuridine (5-FUDR) has been demonstrated in a metaanalysis of randomized trials to be superior to i.v. treatment/palliative care (med. surv.: 15 vs. 10 m). The benefit of HAI with 5-FUDR, although recommended as treatment for CRLM, is severely compromised by the 5-FUDR induced hepatotoxicity, leading eventually to sclerosing cholangitis (SC)/liver scirrhosis. We have stepwise developed a protocol for HAI of CRLM, which is superior to HAI with 5-FUDR, and, most evidently, to systemic chemotherapy. PATIENTS/METHODS: Between 1982-1997, 222 CR (L) M patients were treated within subsequent protocols (Table). In protocol A, 68 CRLM pts received HAI with 5-FUDR (A1: nonrandomized pts; A2: randomized pts). In protocol B (randomized pts.), 46 pts received 5-FUDR i.a. (via HAI) + i.v. In protocol C, systemic chemotherapy with 5-FU + FA was conducted in 34 pts with metastasized colorectal cancers, including CRLM. In protocol D 5-FU + FA was delivered via HAI in 25 pts with CRLM. In protocol E, based on in vitro phase II studies and the results of protocol D, Mitoxantrone and Mitomycin C were added to 5-FU + FA (MFFM). Fifty (50) CRLM pts received HAI with MFFM. RESULTS: The response rates, med. surv. times, systemic toxicity and SC rates are shown in the table. HAI with MFFM produced objective responses in 66%, the med. surv. was 27.4 m, and no SC occurred. The ports surgically placed for HAI, e.g., in protocols D and E, functioned in 90%, 82%, and 76% 6, 9, and 11 m after start of the HAI. Quality of life in protocol E was high. Nine pts from protocols D + E with either partial (PR, 7 pts) or complete (CR, 2 pts) remissions received a secondary liver resection without hospital mortality, and 7/9 pts are living 2-58 m after liver resection, 2/9 pts died 11 and 22 m after resection. [table: see text] SUMMARY/CONCLUSIONS: Our learning curve to achieve optimal treatment of CRLM resulted in a protocol using HAI with MFFM. The results of this protocol (E) including the high remission rate, long median survival time, good port function, high quality of life, and, most interestingly, the possibility to downstage and resect primarily nonresectable metastases, seem to be superior to HAI with 5-FUDR of 5-FU + FA and to systemic chemotherapy with 5-FU + FA. This hypothesis is currently examined in a phase III study (HAI with MFFM vs. 5-FU + FA i.v.).

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1999

Intensive treatment of children with acute lymphoblastic leukemia according to ALL-BFM-86 without cranial radiotherapy: results of Dutch Childhood Leukemia Study Group Protocol ALL-7 (1988-1991).

In The Netherlands from July 1988 to October 1991, children (0 to 16 years of age) with de novo acute lymphoblastic leukemia (ALL) were treated according to protocol ALL-7 of the Dutch Childhood Leukemia Study Group (DCLSG). In this protocol, chemotherapy and treatment stratification were identical to the ALL-BFM-86 protocol (Reiter et al, Blood 84:3122, 1994), but cranial irradiation was restricted to patients with initial central nervous system (CNS) involvement. Patients were stratified into 3 risk groups, based on leukemia cell mass and response to initial treatment: standard-risk group (SRG), risk group (RG), and experimental group (EG). As in ALL-BFM-86, a randomized study on late intensification (protocol S) was performed in RG patients, and during the study (since October 1990), early reinduction treatment (protocol II) was introduced for SRG patients. Treatment duration for all patients was 18 months. Two hundred eighteen children entered the study: 74 SRG, 127 RG, and 17 EG patients. The overall complete remission (CR) rate was 98%. The 5-year event-free survival (EFS) for all DCLSG ALL-7 patients was 65. 3% (standard error [SE] 3.2%), which was significantly different from the 73% (SE 1%) 5-year EFS achieved in the ALL-BFM-86 study (P =.02, Z-test). However, restricting the analysis to SRG patients receiving protocol II with a total duration of treatment of 18 months, the 5-year EFS rates were 64.6% (SE 4.0%) and 67% (SE 4%), respectively, and no significant difference could be established (P =.67, Z-test). The 5-year EFS rates for SRG, RG, and EG patients were 63.5% (SE 5.6%), 66.6% (SE 4.2%), and 63.3% (SE 12.0%), respectively. SRG patients receiving protocol II fared better than patients not receiving protocol II (5-year EFS 76.7% [SE 7.7] and 54. 5% [SE 7.5], respectively). No difference in 5-year EFS was observed in RG patients randomized to receive or not to receive late intensification with protocol S. The overall CNS relapse rate at 5 years was 5.5%. The incidence rate at 5 years was 11.4% in SRG patients not receiving protocol II, whereas no CNS relapses occurred in SRG patients receiving protocol II. Six children died in first complete remission and 2 children developed a second malignancy (thyroid carcinoma and acute nonlymphoblastic leukemia). Systemic high-dose methotrexate (MTX) and intrathecal chemotherapy is a safe and effective method of CNS prophylaxis in the context of BFM-oriented treatment for all children with ALL, regardless of the risk group (with the possible exception of T-ALL patients with high white blood cell counts). The results of the DCLSG ALL-7 study confirm those of the ALL-BFM-86 study showing that early reinduction with protocol II is essential in the treatment of SRG patients and that late intensification with protocol S does not improve the prognosis for RG patients.

Adolescent↗

PubMed2004

Validation of a single-day maximal lactate steady state assessment protocol.

AIM: The classical maximal lactate steady state (MLSS) assessment protocol takes multiple days to measure thus necessitates athletes to return to a laboratory for several visits. The purpose of this study was to assess the validity and reliability of a new protocol (Palmer protocol), which proposes to measure MLSS in a single-day. METHODS: Nine endurance-trained males (age 21.1 +/- 1.6 years, VO2max of 63.2 +/- 3.2 ml x kg(-1) x min(-1)) performed the Palmer protocol and the classical MLSS assessment protocol. The classical MLSS protocol consisted of several constant-velocity runs of increasing intensity. The MLSS was defined as the highest velocity associated with an increase in blood lactate concentration ([La-]) = or < 1.0 mmol x L (-1) during the final 20 min of a 30 min run. Concurrent validity was assessed by calculating a Pearson product correlation coefficient between the running velocity at MLSS from the classical protocol and from the single-day Palmer protocol. Test-retest reliability was assessed by calculating a Pearson product correlation coefficient between the running velocities from 2 separate trials of the single-day Palmer protocol. RESULTS: The velocity at MLSS from the single-day Palmer protocol (236.4 +/- 27.8 m x min(-1)) produced a strong correlation of 0.97 (p<0.001) with the velocity at MLSS from the classical protocol (226.3 +/- 22.6 m x min(-1)). An equally strong correlation was calculated from test-retest reliability of the single-day Palmer protocol (r=0.97), (p<0.001). CONCLUSION: These results suggest that the single-day Palmer protocol is valid and reliable in the estimation of MLSS.

Acceleration↗

PubMed1993

Comparison of the Asymptomatic Cardiac Ischemia Pilot and modified Asymptomatic Cardiac Ischemia Pilot versus Bruce and Cornell exercise protocols.

The Asymptomatic Cardiac Ischemia Pilot (ACIP) and modified ACIP treadmill exercise protocols were developed to test patients with coronary artery disease and to linearly increase work load between stages. The physiologic changes that occurred with ACIP and modified ACIP were compared to those with the Bruce and Cornell protocols in 28 normal subjects and 16 men with coronary artery disease. The exercise protocols were randomly assigned over 2 days, and gas exchange data were obtained continuously with each test. In normal subjects, the peak heart rate, systolic blood pressure, peak oxygen consumption rate (VO2) and minute ventilation were similar for the 4 protocols tested, with exercise time shortest for the Bruce protocol in comparison with the ACIP, modified ACIP and Cornell protocols (10.2 +/- 3.1 vs 13.4 +/- 4.9, 13.9 +/- 4.5, and 15.0 +/- 4.2 minutes, respectively; p < 0.001). The difference between predicted and observed VO2 was smallest for the ACIP protocol (37.0 +/- 11.0 vs 35.8 +/- 13.5 ml/kg/min) and greatest for the Bruce protocol (41.1 +/- 11.8 vs 36.7 +/- 15.0 ml/kg/min) in normal subjects, as well as in patients with coronary artery disease (ACIP protocol 26.9 +/- 7.1 vs 22.5 +/- 6.7, and Bruce protocol 29.1 +/- 7 vs 22.6 +/- 5.7 ml/kg/min, respectively). The ratio of VO2 to work rate, expressed as a slope, was similar in normal subjects for the 4 protocols tested. However, in patients with coronary artery disease, the slope was 0.84 and 0.83 for the ACIP and modified ACIP protocols, respectively, versus 0.61 and 0.71 for the Bruce and Cornell protocols, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2001

A protocol for the reduction of systematic patient setup errors with minimal portal imaging workload.

PURPOSE: To evaluate a new off-line patient setup correction protocol that minimizes the required number of portal images and perform a comparison with currently applied protocols. METHODS AND MATERIALS: We compared two types of off-line protocols: (a) the widely applied shrinking action level (SAL) protocol, in which the setup error, averaged over the measured treatment fractions, is compared with a threshold that decreases with the number of measurements, to decide if a correction is necessary; and (b) a new "no-action-level" (NAL) protocol, which simply calculates the mean setup error over a fixed number of fractions, and always corrects for it. The performance of the protocols was evaluated by applying them to (a) a database of measured setup errors from 600 prostate patients (with, on average, 10 imaged fractions/patient) and (b) Monte Carlo-generated setup error distributions for various values of the population systematic and random errors. RESULTS: The NAL protocol achieved a significantly higher accuracy than the SAL protocol for a similar workload in terms of image acquisition and analysis, as well as in setup corrections. The SAL protocol required approximately three times more images than the NAL protocol to obtain the same reduction of systematic errors. Application of the NAL protocol to measured setup errors confirmed its efficacy in systematic error reduction in a real patient population. CONCLUSION: The NAL protocol performed much more efficiently than the SAL protocol for both actually measured and simulated setup data. The resulting decrease in required portal images not only reduces workload, but also dose to healthy tissue, if dedicated large fields are required for portal imaging (double exposure).

Algorithms↗

PubMed2001

Value of the Bruce protocol to determine peak exercise oxygen consumption in patients evaluated for cardiac transplantation.

BACKGROUND: Peak exercise oxygen consumption (peak VO2) is an important discriminator of survival in patients with systolic heart failure and is used to select ambulatory patients for transplantation. The major trials assessing the relationship between peak VO2 and survival have used a variety of low-level exercise protocols. It is unknown how peak VO2 measured in this patient population by the more vigorous Bruce treadmill protocol compares with that obtained on less intense protocols. METHODS: We studied 15 patients (50 +/- 12 years old) with severe heart failure (left ventricular ejection fraction 23.5% +/- 8.6%). Patients randomly performed 3 exercise tests with the Bruce treadmill, modified Naughton treadmill, and modified bicycle protocols within 14 days. To determine the ability of this patient population to perform the Bruce protocol, we also retrospectively analyzed the ability of 84 patients to perform this test on their initial evaluations at our center. RESULTS: All patients reached the anaerobic threshold (AT) on all 3 protocols. The Bruce and modified Naughton treadmill protocols resulted in similar peak VO2 percent predicted peak VO2, and VO2 at AT values (17.7 +/- 3.8 mL/kg/min, 57.2% +/- 21.1% and 15.4 +/- 4.1 mL/kg/min vs 18.0 +/- 4.7 mL/kg/min, 58.1% +/- 22.5% and 15.6 +/- 4.4 mL/kg/min, respectively). Peak VO2 and VO2 at AT on both treadmill protocols were higher than those obtained with bicycle testing (15.3 +/- 3.1 and 11.8 +/- 3.0 mL/kg/min, P <.05). Exercise duration was shorter with the Bruce and bicycle protocols (6.2 +/- 2.2 and 6.7 +/- 2.4 minutes, respectively) compared with the modified Naughton protocol (9.7 +/- 4.3 minutes, both P <.005). In addition, 79 of the 84 patients (94%) evaluated were able to complete the Bruce protocol and reach AT. CONCLUSIONS: The Bruce protocol was more time efficient than the modified Naughton protocol and yielded similar peak VO2, percent predicted peak VO2, and VO2 at AT values. Bicycle exercise may underestimate peak VO2 values. The form of exercise should be considered when assessing peak VO2 criteria for transplant listing.

Adult↗

PubMed2000

New York State universal newborn hearing screening demonstration project: effects of screening protocol on inpatient outcome measures.

OBJECTIVE: To examine differences among various test protocols on the fail rate at hospital discharge for infants in the well-baby nursery (WBN) and neonatal intensive care unit (NICU) who received hearing screening through a universal newborn hearing screening demonstration project. DESIGN: The outcomes of several screening protocols were examined. Two technologies were used: transient evoked otoacoustic emissions (TEOAEs) alone or in combination with the auditory brain stem response (ABR). The performance of test protocols in both nurseries within eight hospitals was examined over a 2- to 3-yr period. In the WBN, six hospitals used a screening protocol of TEOAE technology first followed by an ABR (automated or conventional) technology screening for newborns who referred on TEOAE screening. Two hospitals used TEOAE only in the WBN. Seven hospitals used screening protocols in the NICU that used a combination of TEOAE and ABR technologies (TEOAE technology administered first or second, before or after TEOAE, or TEOAE and ABR tests on all infants). Only one hospital used TEOAE technology exclusively for hearing screening. RESULTS: Significant differences among screening protocols were found across hospitals in the first, second, and third years of the program. The combination of TEOAE technology and ABR technology (a two-technology screening protocol) resulted in a significantly lower fail rate at hospital discharge than the use of a single-technology (TEOAE). Fail rates at discharge were twice as high using the one-technology protocol versus two-technology protocol, even when the best outcomes from program year 3 were considered exclusively. Results of two-technology versus one-technology protocols were similar in the NICU. Use of a second technology for screening TEOAE fails significantly reduced every hospital that used the protocol's fail rate at discharge. CONCLUSIONS: A two-technology screening protocol resulted in significantly lower fail rates at hospital discharge in both the WBN and NICU nurseries than use of a single-technology (TEOAE) hearing screening protocol.

Evoked Potentials, Auditory, Brain Stem↗

PubMed2001

Individually adapted examination protocols for reduction of radiation exposure in chest CT.

RATIONALE AND OBJECTIVES: To develop a simple directive for the reduction of radiation exposure without loss of diagnostic information in routine chest CT examinations. METHODS: Two hundred fifty adult patients (164 male, 86 female) were entered into a prospective trial. All examinations were performed with a multislice CT technique (Somatom Volume Zoom, Siemens). Four groups of 50 patients each were scanned with patient-related specific parameters: individual mA-s values were derived from the estimated body weight: kilograms + 10, +/- 0, - 10, and - 20 mAs. The results were compared with those of 50 patients who were examined by a standard chest protocol by using the parameters 120 mAs and 140 kV. All other parameters including the tube voltage were kept constant. Subjective image quality was rated on a three-point scale: 1 = excellent, 2 = fair, 3 = nondiagnostic. In addition, objective criteria based on signal-to-noise measurements were assessed by using a region-of-interest methodology. RESULTS: Image quality was sufficient in all cases. Mean subjective gradings of image quality, based on soft-tissue window settings, were 1.1 for the 120-mAs protocol, 1.1 for the (body weight [kg] + 10) mAs protocol, 1.1 for the (body weight [kg] +/- 0) mAs protocol, 1.3 for the (body weight [kg] - 10) mAs protocol, and 1.2 for the (body weight [kg] - 20) mAs protocol. Objective criteria based on noise measurements showed mean +/- standard deviation values of 5.7 +/- 0.8 Hounsfield units (HU) for the 120-mAs protocol. For the reduced-dose protocols, values were calculated as 7.6 +/- 1.2 HU (group + 10), 7.9 +/- 1.3 HU (group +/- 0), 8.7 +/- 1.2 HU (group - 10), and finally 9.1 +/- 1.3 HU (group - 20). The best correlation for an entire subgroup was achieved with the - 10 protocol (body weight [kg] - 10) mAs, with nearly constant noise related to body weight in all patients. CONCLUSIONS: By deriving mAs values from body weight estimation, an individually adapted protocol for chest CT can be recommended and easily employed in a clinical setting. With an adaptation of the tube current-time product based on the estimated body weight of the patient - 10 (body weight [kg] - 10 mAs), a well-balanced examination without significant loss of information, even in soft-tissue window settings, can be performed with this particular scanner. For this adapted mAs protocol, a mean reduction of radiation exposure of 45% was achievable, compared with the standard protocol. A maximum decrease per case down to 31 mAs was obtained, without relevant loss of image quality. Therefore, for other types of CT scanners, analogous protocols may be adapted.

Adult↗

PubMed1999

Measurement of maximal oxygen uptake from two different laboratory protocols in runners and squash players.

PURPOSE: The aims of the study were to assess whether different test protocols used to elicit maximal oxygen uptake values (VO2max) attain similar results, whether different VO2max protocols were preferable for different athletic groups, and to assess whether the noninvasive criteria used to indicate the attainment of VO2max are achieved similarly in different VO2max testing protocols. METHODS: This study evaluated the attainment of either VO2max or peak VO2 (VO2peak) during two treadmill VO2max protocols: a progressive speed protocol (PSP) and a progressive incline protocol (PIP). Ten runners and 10 squash players were studied to assess whether achievement of VO2max criteria was either sport-specific or protocol-specific, or both. RESULTS: There were no significant differences in the VO2peak values reached in either PSP or PIP protocol (64.4 +/- 5.9 vs 66.5 +/- 6.0 mLO2 x kg(-1) x min(-1)). But HRmax (196 +/- 5 vs 189 +/- 5 beats x min(-1); PSP vs PIP; P < 0.01) and RER (1.14 +/- 0.05 vs 1.07 +/- 0.04; PSP vs PIP; P < 0.01) were significantly higher during the PSP test. Fifty percent of the subjects reached a plateau in either test, and of these subjects, 90% satisfied the three noninvasive criteria for VO2max in the PSP group, compared with 10% in the PIP group. CONCLUSIONS: The indirect criteria used to assess the attainment of VO2max may be limited, as the VO2peak values were higher in the PIP protocol compared with the PSP protocol, although not significantly different, whereas the HR and RER values were significantly lower in the PIP than PSP protocol. Furthermore, only 50% of subjects demonstrated the plateau phenomenon in oxygen uptake with either protocol. It may be concluded that the measured physiological variables coinciding with VO2peak may differ when different protocols are used to elicit VO2max.

Adult↗

PubMedDate not supplied

Comparison of IAEA 1987 and AAPM 1983 protocols for dosimetry calibration of radiotherapy beams.

The IAEA 1987 protocol is an international protocol which has made a number of improvements over the AAPM 1983 protocol for calibration of high-energy photon and electron beams. We present a detailed numerical comparison between the two protocols by calculating (i) Ngas and ND for PTW (PMMA wall), Capintec (air-equivalent plastic wall) and NEL (graphite wall) Farmer type ionization chambers for 60Co gamma rays; (ii) dose-to-water with chamber in water irradiated by 4- or 25-MV x rays; (iii) dose-to-water with chamber in water, PMMA, and polystyrene phantoms irradiated by 5- and 10-MeV electrons; and (iv) dose-to-water with chamber in water irradiated by 20-MeV electrons. For photons, the IAEA protocol gives results which are in good agreement with the AAPM protocol; on average the IAEA results are 0.6% smaller than the AAPM results while discrepancies between the two are in the range of -0.4% to -1.2%. For 10-MeV electrons also, the IAEA protocol gives results which are in excellent agreement with the AAPM protocol; on average the IAEA results are 0.3% smaller than the AAPM results while discrepancies between the two are in the range of -1.0% to +0.5%. In contrast to the above, for 5-MeV electrons, the IAEA protocols give results smaller than the AAPM protocol by 2.0% on average with discrepancies between protocols ranging from -4.1% to -0.7% depending upon the ionization chamber and phantom material used. For 5-MeV electrons, the discrepancies are particularly large for polystyrene phantom; the average discrepancies being -1.4%, -1.1%, and -3.6% for water, PMMA, and polystyrene, respectively. If data for 5-MeV electrons with polystyrene phantom are excluded, then the overall agreement between the two protocols for photons and electrons is within the range of -1.9% to +0.5%. Principal reasons for the observed discrepancies are (i) IAEA uses the correct expression for ND resulting in up to +0.8% correction; (ii) IAEA uses the most recent stopping power ratio for graphite-to-air resulting in up to +0.5% correction; (iii) IAEA uses a correction of up to +0.8% for the central electrode which AAPM ignores; (iv) the present estimates of the percent depth doses which arise from the differences in measurement depths in the two protocols; and (v) IAEA uses measured values of the fluence correction factor while AAPM uses a theoretical estimate resulting in corrections of up to -2.2%.

Calibration↗

PubMed1999

Comparison of 4 computed tomographic imaging protocols for lateral tibial plateau fractures.

OBJECTIVE: Many computed tomographic (CT) imaging protocols are used for pretreatment assessment of tibial plateau fractures. This study compares the diagnostic capabilities of 4 CT protocols. METHODS: Lateral tibial plateau fractures were induced in 19 knee specimens and CT scans were obtained with the following protocols: 1) 3-mm collimation, axial acquisition, 2) 3-mm collimation, helical acquisition, 3) mixed-increment collimation, axial acquisition, and 4) 3-mm collimation, helical acquisition with 50% overlap reconstruction of raw data. Two-dimensional coronal and sagittal reformations and 3-dimensional surface reconstruction images were analyzed for maximum fragment depression, peripheral fragment displacement, fracture pattern classification and quality of image. Specimen dissection established maximal articular surface depression, fragment displacement and actual fracture pattern. RESULTS: None of the 2-dimensional reformations from the 4 protocols proved statistically superior for determining maximal fracture depression, fragment displacement, or fracture classification. There was a trend toward more accurate fracture classification with the mixed-increment axial protocol and the overlap protocol than either of the 3-mm protocols, but this was not statistically significant. All protocols were statistically equivalent in predicting fracture pattern classification using 3-dimensional images. However, the 3-dimensional images were of significantly higher quality when obtained with either the mixed-increment axial protocol or the overlap protocol. CONCLUSIONS: There were no statistically significant differences in the objective assessment of tibial plateau fractures among the 4 different protocols. The 3-dimensional images derived from the mixed-increment axial protocol and the 3-mm helical protocol with 50% overlap reconstruction were of superior quality.

Cadaver↗

PubMed2003

Antibiotic prophylaxis for external ventricular drains in neurosurgical patients: an audit of compliance with a clinical management protocol.

OBJECTIVE: To examine the clinical impact of a management protocol for external ventricular drains (EVD). PATIENTS AND METHODS: All patients with EVDs over a six-month period were reviewed retrospectively. Data concerning the indications for EVD placement, antibiotics and cerebrospinal fluid (CSF) analyses were collected. A restrictive antibiotic protocol (e.g. intravenous cephalothin 1g 6-hourly for 24 hours, unless other antibiotics were prescribed for a documented pre-existing infection) was introduced for all patients requiring placement of an EVD during the following six months and all patients were observed prospectively. Daily CSF samples were collected under sterile conditions and examined for organisms, cells, glucose and protein and sent for microbiological culture. External ventricular drains were removed after five days and replaced if further monitoring or CSF drainage was required. Adherence to the protocol and the incidence of ventriculitis was determined. RESULTS: Twelve patients with EVDs were identified during the 6 month pre-protocol period and 15 patients with EVDs were identified during the 6 month post-protocol period. There was no significant difference between the total (72 vs 88 days) and mean (6 vs 5.9 days) drain placement times between the two groups. There was no significant difference between the mean numbers of CSF samples in the two groups. CSF aspirates were not analysed in 35/72 samples (49%) in the pre-protocol group compared with 45/88 (51%) samples in the post-protocol group. Positive CSF Gram-stains were found in 3/12 (25%) patients in the pre-protocol group and in 0/15(0%) in the post-protocol group. Positive CSF cultures decreased significantly in the post-protocol group (17 vs 5, p = 0.0009). Prophylactic antibiotics were prescribed in 5/12 (42%) patients in the pre-protocol group compared with 12/15 (80%) patients in the post-protocol group. CONCLUSIONS: The protocol was associated with a statistically significant improvement in compliance with antibiotic prescription and reduction in the incidence of positive CSF cultures.

Journal Article↗

PubMed1998

Signal-enhancing switched protocols to study higher-order cognitive tasks with PET.

UNLABELLED: We tested the effectiveness of a switched protocol when it is used to detect signals that result from the study of a higher-order cognitive task with PET. Using language tasks that have been studied extensively in our laboratories, we compared the signal-to-noise ratio (S/N) and statistical significance of the activation signals detected in PET images of regional cerebral blood flow (rCBF), obtained using a standard activation protocol, and of activity concentration, obtained using a switched protocol. METHODS: Four volunteers were studied with PET while they were performing synonym-generation and word-repetition tasks (activation and baseline tasks, respectively). Each volunteer had three activation/baseline and three baseline/ activation scans. Data for each scan were collected in two frames (60 and 120 sec long). During the first 60 sec, data were collected using a standard activation protocol. Subjects then switched tasks, and acquisition continued for 120 sec. Two images were obtained from each scan: an rCBF image using the first frame and an activity-concentration image using both frames. Images were transformed into Talairach space, subtracted and averaged within and across subjects. Parametric t-statistic images were generated for each protocol, and the magnitude and significance of the activation signals yielded by the two acquisition methods were compared. RESULTS: All the activation foci detected using measurements of rCBF were detected when the switched protocol was used; this protocol, in addition, yielded better S/N values. The cognitive component introduced by task-switching in switched protocols did not yield extra statistically significant foci. In single subjects, the average improvement in the signal significance from regions of activation, at a 95% confidence level, was between 6% and 25%. When scans were averaged across subjects, the switched protocol yielded improvements in signal statistical significance of up to 38%. CONCLUSION: We present evidence suggesting that switched protocols can be used to study higher-order cognitive tasks and that they yield activation foci with S/N values that are greater than those of equivalent foci detected using an rCBF protocol. Switched protocols appear to be easy to apply to the testing of higher-order cognitive functions. However, the extra cognitive requirement of switching tasks during data acquisition may be a limiting factor when switched protocols are used to study memory processes.

Adult↗

PubMed2001

Evaluation of image quality and dose in renal colic: comparison of different spiral-CT protocols.

The aim of this study was to test different technical spiral-CT parameters to obtain optimal image quality with reduced X-ray dose. Images were acquired with a spiral-CT system Philips Tomoscan AVE1, using 250 mA, 120 kV, and 1-s rotational time. Three protocols were tested: protocol A with 5-mm thickness, pitch 1.6, slice reconstruction every 2.5 mm; protocol B with 3-mm thickness, pitch 1.6, slice reconstruction every 1.5 mm; and protocol C with 3-mm thickness, pitch 2, slice reconstruction every 1.5 mm. Two phantoms were employed to evaluate the image quality. Axial images were acquired, then sagittal and coronal images were reconstructed. Finally, the absorbed X-ray dose for each protocol was measured. Regarding image quality, 5-mm-thick images (protocol A) showed greater spatial resolution and lower noise compared with 3-mm-thick images (protocols B and C) on the axial plane; 3-mm reconstructed sagittal and coronal images (protocols B and C) showed an improved image quality compared with 5-mm reformatted images (protocol A). Concerning X-ray dose, the mean dose was: protocol A 19.6 +/- 0.8 mGy; protocol B 14.4 +/- 0.6 mGy; protocol C 12.5 +/- 1.0 mGy. Our study supports the use of thin slices (3 mm) combined with pitch of 1.6 or 2 in renal colic for X-ray dose reduction to the patient and good image quality.

Clinical Protocols↗

PubMed2005

A comparison of the 1-step, 2-step, and 3-step protocols for obtaining barefoot plantar pressure data in the diabetic neuropathic foot.

BACKGROUND: Barefoot plantar pressure measurements are routinely used in the risk evaluation for ulceration in diabetic patients with neuropathy. The aim was to compare three step-protocols commonly used for pressure assessment in these patients. METHODS: Dynamic barefoot plantar pressures were measured in 14 diabetic neuropathic patients (vibration perception threshold >35 V) contacting a pressure platform on the first, second or third step after gait initiation. Ten repeated trials per step-protocol were collected. The 3-step protocol was regarded the reference protocol. Peak pressure, pressure-time integral and contact time were calculated for each of six anatomical foot regions. Intraclass correlation coefficients (ICC) were calculated to assess reliability in each protocol. FINDINGS: Regional peak pressures and pressure-time integrals were not significantly different between protocols. Contact time was significantly different in the heel region between the 1-step and 3-step protocol only (P<0.05). Intraclass correlation coefficients for the maximum 10 repeated trials were high (>0.87) and similar between protocols. Reliable estimates (ICC>0.85) of peak pressure were achieved with three repeated trials in the 2-step protocol, and four in the other two; for pressure-time integral these numbers were 7 (1-step), 4 (2-step), and 5 trials (3-step). INTERPRETATION: Barefoot plantar pressures in the diabetic neuropathic foot can be assessed in a reproducible manner with any of the step-protocols used. For this purpose, the 1-step and 2-step protocols prove to be valid methods. A 2-step protocol requires the least amount of repeated trials for obtaining reliable pressure data and may be recommended for assessment of these patients.

Biomechanical Phenomena↗

PubMed1995

Comparison of ambulance dispatch protocols for nontraumatic abdominal pain.

STUDY OBJECTIVE: To compare rates of undertriage and overtriage of six ambulance dispatch protocols for the presenting complaint of nontraumatic abdominal pain, and to identify the optimal protocol. DESIGN: Retrospective prehospital and emergency department chart review to classify patients' conditions as "emergency" or "nonemergency." Utility analysis was used to identify the preferred protocol and monetary cost-effectiveness analysis to identify the least expensive protocol. SETTING: County emergency medical services (EMS) system with five receiving hospitals serving a mainly urban population of approximately 350,000. PARTICIPANTS: Records of 902 patients who called 911 for nontraumatic abdominal pain were reviewed; patients not transported were excluded. Twenty-seven county EMS medical directors completed questionnaires. RESULTS: Six ambulance dispatch protocols for nontraumatic abdominal pain were developed: indiscriminate-dispatch, four selective protocols, and no-dispatch. A dichotomous classification system was derived prospectively from the prehospital and medical records of patients who had activated the EMS system before the study period to define "emergency" and "nonemergency" conditions associated with nontraumatic abdominal pain. Emergency criteria identified patients with conditions requiring medical treatment within 1 hour. Reviewers determined, for each patient, whether an ambulance would have been dispatched by each of the protocols. Undertriage and overtriage rates were calculated for each protocol. County EMS medical directors assigned utility values to four potential outcomes of ambulance dispatch by the direct scaling method. The outcomes comprised correct and incorrect decisions to dispatch ambulances to patients with and without emergencies. The protocols were compared by decision analysis. A cost analysis was also performed, using an estimated marginal cost per transport of $302. Sensitivity analysis demonstrated the effect of varying the cost of an undertriage error and the cost per response. Of the 788 patients included in the study, 7.8% had conditions defined as emergencies. The four selective ambulance dispatch protocols had overtriage rates ranging from 10% to 51% and undertriage rates of 4% to 7%. None of the protocols was proven superior on the basis of the medical directors' assignment of utility values. The marginal cost of dispatching advanced life support ambulances to all patients with this complaint was $3,838 per emergency. CONCLUSION: The majority of patients with nontraumatic abdominal pain who requested ambulance transport during the study period did not have conditions that were classified as emergencies. In the study model, if an undertriage error costs more than $3,674, indiscriminate ambulance dispatch is the least expensive protocol, and if an undertriage error costs less than $3,674, no ambulance dispatch is the least expensive strategy.

Abdominal Pain↗

PubMed1997

Problems and promises of the protocol.

Creating protocols (or guidelines, standards) for medical work is becoming big business. The pros and cons of protocols have been reiterated many times: advocates argue that protocols may enhance the quality of care, reduce unwanted variations in practice, and may help to render medical practice more scientific. Critics, on the contrary, argue that protocols will lead to cookbook medicine, to de-skilling, and to a reduced quality of care. In the continuing reiteration of these claims, they have more and more become removed from the actual practices of medical work and of the creation and use of protocols. Building on empirical research of these practices, this paper attempts to revitalise the debate. Four problems of the protocol are discussed: the protocol reinforces the tendency to perceive and describe medical action as an individual, formally rational process; the protocol contributes to the widespread illusion of the single answer; the protocol contributes to the loss of importance of information and interventions which are difficult to explicate and/or to quantify; and the protocol will lead to an increasing bureaucratisation and regulation of health care practices. Judicious use of protocols has several promises, which are discussed subsequently: explicating a scheme of actions creates a forum for discussion, and delegating parts of the decision-making process to a protocol may lead to personnel acquiring new competences.

Clinical Competence↗

PubMed2003

A practical approach to evidence-based medicine: lessons learned from developing ventilator management protocols.

Development of robust clinical protocols is a time-consuming process that requires allocation of sufficient time and resources. As outlined for the mechanical-ventilation protocol, the goals of the protocol must be clear before embarking on this journey. Critical appraisal of existing evidence is an essential first step to developing a draft protocol. The inclusion of a multidisciplinary team of clinicians, including nurses and respiratory therapists, is required to refine the logic and to ensure protocol acceptance. Extensive bedside testing of the protocol across the spectrum of patients in which it will be applied is essential for ensuring that the protocol works as intended. An effective, ongoing training program must be implemented to ensure protocol success. The final protocol should be carefully monitored in 50 to 100 patients to ensure that clinicians are complying with the protocol rules and that adverse events related to the protocol are not occurring. Finally, protocols must be tended to and updated when new evidence becomes available.

Clinical Protocols↗