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PROFILE: Environmental Impact Assessment Under the National Environmental Policy Act and the Protocol on Environmental Protection to the Antarctic Treaty.

/ Antarctica has been set aside by the international community for protection as a natural reserve and a place for scientific research. Through the Antarctic Treaty of 1961, the signing nations agreed to cooperate in protecting the antarctic environment, in conducting scientific studies, and in abstaining from the exercise of territorial claims. The 1991 signing of the Protocol on Environmental Protection to the Antarctic Treaty (Protocol) by representatives of the 26 nations comprising the Antarctic Treaty Consultative Parties (Parties) significantly strengthened environmental protection measures for the continent. The Protocol required ratification by each of the governments individually prior to official implementation. The US government ratified the Protocol by passage of the Antarctic Science, Tourism, and Conservation Act of 1997. Japan completed the process by ratifying the Protocol on December 15, 1997. US government actions undertaken in Antarctica are subject to the requirements of both the Protocol and the US National Environmental Policy Act (NEPA). There are differences in the scope and intent of the Protocol and NEPA; however, both require environmental impact assessment (EIA) as part of the planning process for proposed actions that have the potential for environmental impacts. In this paper we describe the two instruments and highlight key similarities and differences with particular attention to EIA. Through this comparison of the EIA requirements of NEPA and the Protocol, we show how the requirements of each can be used in concert to provide enhanced environmental protection for the antarctic environment. NEPA applies only to actions of the US government; therefore, because NEPA includes certain desirable attributes that have been refined and clarified through numerous court cases, and because the Protocol is just entering implementation internationally, some recommendations are made for strengthening the procedural requirements of the Protocol for activities undertaken by all Parties in Antarctica. The Protocol gives clear and strong guidance for protection of specific, valued antarctic environmental resources including intrinsic wilderness and aesthetic values, and the value of Antarctica as an area for scientific research. That guidance requires a higher standard of environmental protection for Antarctica than is required in other parts of the world. This paper shows that taken together NEPA and the Protocol call for closer examination of proposed actions and a more rigorous consideration of environmental impacts than either would alone. Three areas are identified where the EIA provisions of the Protocol could be strengthened to improve its effectiveness. First, the thresholds defined by the Protocol need to be clarified. Specifically, the meanings of the terms "minor" and "transitory" are not clear in the context of the Protocol. The use of "or" in the phrase "minor or transitory" further confuses the meaning. Second, cumulative impact assessment is called for by the Protocol but is not defined. A clear definition could reduce the chance that cumulative impacts would be given inadequate consideration. Finally, the public has limited opportunities to comment on or influence the preparation of initial or comprehensive environmental evaluations. Experience has shown that public input to environmental documents has a considerable influence on agency decision making and the quality of EIA that agencies perform.KEY WORDS: Environment; Impact assessment; Antarctica; NEPA; Protocol; Antarctic Treatyhttp://link.springer-ny.com/link/service/journals/00267/bibs/24n1p13.html

Journal Article↗

Enhancement of the signal-to-noise ratio in H2(15)O bolus PET activation images: a combined cold-bolus, switched protocol.

UNLABELLED: To increase the signal-to-noise ratio (S/N) of H2(15)O bolus PET activation images, we designed and tested a data acquisition protocol that alters the relative distribution of tracer in the uptake and washout phases of the input function. This protocol enhances the S/N gains obtained with conventional switched protocols by combining task switching and the use of a large bolus of blood free of tracer (cold bolus). The cold bolus is formed by sequestering blood in the lower limbs with a double cuff before tracer injection. METHODS: The effect of a combined cold-bolus, switched protocol on the signal from activation images was first simulated using a compartmental model of the uptake of H2(15)O into the brain. Then, the effectiveness of the protocol was investigated in 4 healthy volunteers performing a language task. Each volunteer underwent scanning 12 times: 3 activation/ baseline and 3 baseline/activation scans using the conventional switched protocol and 3 activation/baseline and 3 baseline/activation scans using the combined cold-bolus, switched protocol. The S/N changes introduced when using the cold bolus were analyzed by comparing, across protocols, the magnitude and statistical significance of the activation foci associated with the execution of the language task identified in the averaged subtracted images, and by comparing image noise levels. RESULTS: In the simulated datasets, the combined protocol yielded a substantial increase in the activation signals for scan durations greater than 60 s, in comparison with equivalent signals yielded by the switched protocol alone. In the PET experiments, activation foci obtained using the combined protocol had significantly higher t statistic values than did equivalent foci detected using the conventional switched protocol (mean improvement, 36%). Analysis of the S/N in the averaged subtracted images revealed that the improvements in statistical significance of the activation foci were caused by increases in the signal magnitudes and not by decreases in overall image noise. CONCLUSION: We designed a data acquisition protocol for H2(15)O bolus PET activation studies that combines the use of a tracer-free bolus with a switched protocol. Simulated and experimental data suggest that this combined protocol enhances the S/N gains obtained with a conventional switched protocol. Implementation of the combined protocol in H2(15)O bolus activation studies was easy.

Adult↗

Optimized contrast-enhanced CT protocols for diagnostic whole-body 18F-FDG PET/CT: technical aspects of single-phase versus multiphase CT imaging.

UNLABELLED: The purpose of this study was to compare various PET/CT examination protocols that use contrast-enhanced single-phase or contrast-enhanced multiphase CT scans under different breathing conditions. METHODS: Sixty patients with different malignant tumors were randomized into 4 different PET/CT protocols. Single-phase protocols included an intravenous contrast-enhanced (Ultravist 370; iodine at 370 mg/mL) single-phase whole-body CT scan (90 mL at 1.8 mL/min; delay, 90 s) during shallow breathing (protocol A) or during normal expiration (NormExp; protocol B). Multiphase protocols included 2 separate CT scans in the arterial contrast enhancement phase (90 mL at 2.5-2.8 mL/min; bolus tracking; scan range, base of the skull to the kidneys) and the portal-venous contrast enhancement phase (delay, 90 s; scan range, base of the lungs to the proximal thighs) during shallow breathing (protocol C) or during NormExp (protocol D) followed by a low-dose CT scan during shallow breathing for attenuation correction and whole-body PET. Feasibility was assessed by comparing the misalignment of the upper abdominal organs quantitatively by means of the craniocaudal, lateral, and anterior-posterior differences on coregistered PET/CT images. For image quality, the occurrence of CT artifacts and mismatching of rigid body points were evaluated qualitatively. RESULTS: Misalignment was significantly lower for protocol B in almost all organs and represented the best coregistration quality. Surprisingly, protocol A showed significantly better alignment than the multiphase CT scans during NormExp. Misalignment values between the multiphase protocols were not significantly different, with a trend toward lower values for protocol D. The best CT image quality, with a significantly lower occurrence of artifacts, was found for protocols B and D (NormExp). The levels of mismatching of rigid body points because of patient movement in between the transmission and emission scans were similar for all protocols. CONCLUSION: Multiphase CT protocols presented a technical disadvantage represented by suboptimal image coregistration compared with single-phase protocols. Nevertheless, multiphase protocols are technically feasible and should be considered for patients who will benefit from a contrast-enhanced multiphase CT examination for diagnosis.

Artifacts↗

Whole body 16-row multislice CT in emergency room: effects of different protocols on scanning time, image quality and radiation exposure.

The objective of this study was to compare two different scanning protocols in patients suspected to have multiple trauma using multidetector 16-row computed tomography (CT) to better define scanning time, imaging quality and radiation exposure. Forty-six patients, between March 2004 and March 2005, with suspected multiple trauma (cerebral, spine, chest, abdominal and pelvis) were evaluated with two different protocols: Protocol "A" 26 patients; Protocol "B" 20 patients. Protocol A consists of a single-pass continuous whole-body acquisition (from vertex to pubic symphysis), whereas Protocol B of conventional segmented acquisition with scanning of body segments individually. Both protocols were performed using a multidetector 16-rows CT (Light-Speed 16, General Electric Medical System, Milwaukee, WI, USA) with the same technical factors. Radiation dose was evaluated in two ways: computer tomography dose index (CTDI) = dose measured in central and peripheral region of the subjects as a direct result of a CT section acquisition of T millimeters thick (independent from the two protocols) and dose length product (DLP) = total dose deposited over the length of the acquisition (dependent from the two protocols). Image quality was rated according to the following scores: 1, excellent; 2, good; 3, satisfactory; 4, moderate and 5, poor. The results were compared using Wilcoxon's test to identify significant difference in terms of image quality, scanning time, radiation exposure and presence of artifacts, assuming significance at a p value of <0.05. In the single-pass scanning, DLP was 2.671 mGy x cm and a total scan time of 35 s. In whole-body protocols, we have seen artifacts due to arm adduction in thorax and less image quality in brain. In the conventional segmented study, DLP was 3.217 mGy x cm and a total scan time of 65 s; this protocol offered less extraction capabilities of off-axial on focused images of the entire spine, aorta, facial bones or hip without rescanning. Protocol A revealed a significant decrease in scan time (35 vs 65 min, p < 0.05), time in the CT examination room (21.7 vs 31.6 min.; p < 0.05), and final image analysis (83.7 vs 102.9 min; p < 0.05) and radiation dose compared to protocol B (p < 0.05). No significant difference was found for patient transport time, image reconstruction time and imaging quality. Reconstruction and isotropic reformation of axial image acquired by whole-body, single-pass protocols due to entire spine evaluation, aortic and splanchnic CT angiography eliminate additional studies. The whole-body, single-pass protocols, compared with segmented acquisitions protocols, resulted in a reduced total radiation dose without relevant loss of diagnostic image information.

Adolescent↗

Deflazacort in Duchenne muscular dystrophy: a comparison of two different protocols.

We compare the long-term benefits and side effects of deflazacort using two treatment protocols from Naples (N) and Toronto (T). Boys with Duchenne muscular dystrophy between the ages of 8 and 15 years and who had four or more years of deflazacort treatment were reviewed. Diagnostic criteria included males with proximal muscle weakness evident before 5 years, increased serum creatine kinase and genetic testing and/or a muscle biopsy consistent with Duchenne muscular dystrophy. Thirty-seven boys were treated with protocol-N using deflazacort at a dose of 0.6 mg/kg per day for the first 20 days of the month and no deflazacort for the remainder of the month. Boys with osteoporosis received daily vitamin D and calcium. Deflazacort treatment started between 4 and 8 years of age. Thirty-two were treated with protocol-T using deflazacort at a dose of 0.9 mg/kg per day, plus daily vitamin D and calcium. Treatment started between 6 and 8 years of age. All boys were monitored every 4-6 months. The results were compared with age-matched controls in the two groups (19 for protocol-N and 30 for protocol-T). For the boys treated with protocol-N, 97% were ambulatory at 9 years (control, 22%), 35% at 12 years (control, 0%), 25% at 15 years (control, 0%). For the 32 boys treated with protocol-T, 100% were ambulatory at 9 years (control, 48%), 83% at 12 years (control, 0%) and 77% at 15 years (control, 0%). No aids or leg braces were used for ambulation. In boys 13 years and older, a scoliosis of >20 degrees developed in 30% of the boys on protocol-N, 16% on protocol-T and 90% of controls. For protocol-N, no cataracts were observed while in protocol-T, 30% of boys had asymptomatic cataracts that required no treatment. Fractures occurred in 19% (control 16%) of boys on protocol-N and 16% (control, 20%) of boys on protocol-T. This report illustrates: (a) the importance of collaborative studies in developing treatment protocols in Duchenne muscular dystrophy and (b) the long-term beneficial effects of deflazacort treatment in both protocols. However, the protocol-T seems to be more effective and frequently is associated with asymptomatic cataracts.

Adolescent↗

Novel exercise protocol suitable for use on a treadmill or a bicycle ergometer.

Many exercise protocols are in use in clinical cardiology, but no single test is applicable to the wide range of patients' exercise capacity. A new protocol was devised that starts at a low workload and increases by 15% of the previous workload every minute. This is the first protocol to be based on exponential rather than linear increments in workload. The new protocol (standardised exponential exercise protocol, STEEP) is suitable for use on either a treadmill or a bicycle ergometer. This protocol was compared with standard protocols in 30 healthy male volunteers, each of whom performed four exercise tests: the STEEP treadmill and bicycle protocols, a modified Bruce treadmill protocol, and a 20 W/min bicycle protocol. During the two STEEP tests the subjects' oxygen consumption rose gradually and exponentially and there was close agreement between the bicycle and the treadmill protocols. A higher proportion of subjects completed the treadmill than the bicycle protocol. Submaximal heart rates were slightly higher during the bicycle test. The STEEP protocol took less time than the modified Bruce treadmill protocol, which tended to produce plateaux in oxygen consumption during the early stages. The 20 W/min bicycle protocol does not take account of subjects' body weight and consequently produced large intersubject variability in oxygen consumption. The STEEP protocol can be used on either a treadmill or a bicycle ergometer and it should be suitable for a wide range of patients.

Adult↗

Effects on baroreflex sensitivity measurements when different protocols are used to induce regular changes in beat-to-beat intervals and systolic pressure.

Baroreflex sensitivity is becoming an important clinical measurement. Nevertheless there is no recommend standard measurement protocol. This study assessed the ability of eight protocols to induce regular changes in cardiac beat-to-beat interval and systolic pressure (SP), and the effect each protocol had on baroreflex sensitivity (BRS). Twelve subjects had changes in cardiac beat-to-beat intervals and SP levels induced at 8 times a minute by following 8 different protocols, each for 3 min. These comprised breathing in a supine and standing posture, breathing through a resistance, breathing into a closed orifice (the breathing protocols), and performing handgrip exercises, being rocked, having legs raised and lowered, and being presented with mental arithmetic questions (the non-breathing protocols). Induction success of each protocol was determined by the percentage of cardiac beat-to-beat interval and SP level signals with a peak at 8 times per minute in their frequency spectra. The consistency of the induced changes was measured by a signal-to-noise ratio (SNR). BRS was calculated from the frequency spectra. The induction success was 85% for breathing and 31% for non-breathing protocols. The consistency of cardiac beat-to-beat interval changes was highest with supine breathing (SNR = 1.6 +/- 0.3) and resistance breathing (SNR = 1.5 +/- 0.5) protocols. The consistency of SP level changes was highest with resistance breathing (SNR = 1.0 +/- 0.3) and breathing into a closed orifice (SNR = 1.0 +/- 0.5) protocols. BRS values in the supine breathing protocol (24 +/- 10 ms mmHg(-1)) and the handgrip protocol (32 +/- 3 ms mmHg(-1)) were significantly greater (p < 0.05) than for standing breathing (11 +/- 5 ms mmHg(-1)), resistance breathing (17 +/- 8 ms mmHg(-1)) or breathing into a closed orifice (12 +/- 5 ms mmHg(-1)) protocols. Different protocols have different induction successes and degrees of effectiveness in inducing cardiac beat-to-beat and SP level changes. BRS is affected by the induction protocol used, highlighting the need for a standard measurement protocol.

Adult↗

Radioguided surgery of parathyroid adenomas and recurrent thyroid cancer using the "low sestamibi dose" protocol.

PURPOSE: The aim of this study was to establish the clinical efficacy of the "low sestamibi dose" (LSD) protocol to perform thyroid and parathyroid radioguided surgery in a large series of patients homogeneously studied and operated on by the same surgeon. The LSD protocol was initially developed in our center to cure primary hyperparathyroid (PHPT) patients with a high likelihood of a solitary parathyroid adenoma (PA) by minimally invasive radioguided surgery (MIRS). Since then, the same protocol has been applied to differentiated thyroid cancer (DTC) patients with 131I-negative, but sestamibi-positive, locoregional recurrent disease in order to obtain radical radioguided extirpation of tumoral lesions at reoperation. STUDY DESIGN: We reviewed the clinical charts of 453 consecutive patients referred at the surgical department at Padova University (Padova, Italy) to investigate a PHPT or a DTC recurrence: 336 patients (74.2%) met the inclusion criteria for radioguided surgery, and these patients were analyzed for the aim of this study. There were 298 patients affected by PHPT with a high likelihood of a solitary sestamibipositive PA and 38 DTC patients affected by 131I-negative, but sestamibi-positive, locoregional recurrence. All patients underwent a preoperative imaging work-up, including sestamibi scintigraphy (doubletracer subtraction scan in PHPT patients and single-tracer, wash-out scan in DTC patients) and high-resolution neck ultrasonography (US). The LSD protocol we developed consists of the intravenous injection of a very low (1 mCi) sestamibi dose in the operating theater just 10 minutes before commencing intervention for the purpose of radioguided surgery only. At variance with the traditional "high (20-25 mCi) sestamibi dose (HSD)" protocol in which imaging and radioguided surgery are obtained in the same day, in the LSD protocol, imaging and radioguided surgery are performed in different days. The LSD protocol allows some advantages over the HSD protocol: (1) more time for acquiring and interpreting preoperative imaging (planar scintigraphy, single-photon emission computed tomography [SPECT], US); (2) an accurate selection of patients to whom MIRS is offered, especially in countries where the prevalence of nodular goiter with sestamibi-avid thyroid nodules (exclusion criteria for MIRS) is relatively high, as in mid-south-European countries; (3) it facilitates the work planning in the operating theater (bilateral neck exploration requires an operating time of at least double to that of MIRS); and (4) the radiation exposure dose to operating theater personnel is very low-substantially negligible, using the LSD protocol: This aspect assumes great importance in countries where radioproteximetric rules are stringent, as in Europe. RESULTS: PHPT patients. MIRS was successfully performed by a 1.5-2-cm skin incision in 287 of 298 PHPT patients (96.3%) in whom such an approach was scheduled on the basis of preoperative imaging, including 41 of 57 patients (71.9%) who had previously received thyroid or unsuccessful parathyroid surgery in another center. No case of major intraoperative complication was recorded. No case of persistent or recurrent PHPT was observed during postsurgical follow-up. DTC patients. A total of 79 metastatic lesions were intraoperatively detected by the gamma probe and successfully removed (68 of them had been correctly visualized at preoperative sestamibi scintigraphy). During subsequent follow-up, 18 patients (72%) were considered disease-free, whereas 7 had persistent disease (increased serum thyroglobulin levels). The radiation exposure dose to the surgeon using the LSD protocol was 1.2 uSi/hour, that is, 20-30-fold lower than that delivered with the HSD protocol used for PHPT patients and with the 131I protocol used for DTC patients with recurrence. CONCLUSIONS: On the basis of our data, it can be concluded that the LSD protocol is a safe and effective protocol to perform in both MIRS in PHPT patients and radioguided reoperation in DTC patients with 131I-negative recurrence. Furthermore, from a radioproteximetric point of view, in comparison with other radioguided protocols used for the same purposes, the LSD protocol minimizes the radiation-exposure dose to the surgeon and operating theater personnel.

Adenoma↗

Comparison of European and North American malignant hyperthermia diagnostic protocol outcomes for use in genetic studies.

BACKGROUND: Halothane and caffeine diagnostic protocols and an experimental ryanodine test from the North American Malignant Hyperthermia (MH) Group (NAMHG) and the European MH Group (EMHG) have not been compared in the same persons until now. METHODS: The outcomes of the NAMHG and EMHG halothane and caffeine contracture tests were compared in 84 persons referred for diagnostic testing. In addition, the authors assessed the experimental ryanodine protocol in 50 of these persons. RESULTS: Although the NAMHG and EMHG halothane protocols are slightly different methodologically, each yielded outcomes in close (84-100%) agreement with diagnoses made by the other protocol. Excluding 23 persons judged to be equivocal (marginally positive responders) by the EMHG protocol resulted in fewer persons classified as normal and MH susceptible (42 and 19, respectively) than those classified by the NAMHG protocol (48 and 34, respectively). For the 61 persons not excluded as equivocal, the diagnoses were identical by both protocols, with the exception of one person who was diagnosed as MH susceptible by the NAMHG protocol and as "normal" by the EMHG protocol. The NAMHG protocol produced only two equivocal diagnoses. Therefore, a normal or MH diagnosis by the NAMHG protocol was frequently associated with an equivocal diagnosis by the EMHG protocol. The time to 0.2-g contracture after the addition of 1 microM ryanodine completely separated populations, which was in agreement with the EMHG protocol and, except for one person, with the NAMHG protocol. CONCLUSIONS: Overall, the NAMHG and EMHG protocols and the experimental ryanodine test yielded similar diagnoses. The EMHG protocol reduced the number of marginal responders in the final analysis, which may make the remaining diagnoses slightly more accurate for use in genetic studies.

Caffeine↗

Contrast enhancement for whole-body screening using multidetector row helical CT: comparison between uniphasic and biphasic injection protocols.

OBJECTIVE: To investigate which is more suitable for whole-body screening with multidetector row CT (MDCT) during one breathhold, a uniphasic or biphasic injection protocol for contrast material. SUBJECTS AND METHODS: Sixty patients received a volume of 1.7 mL x weight (kg) with iopamidol 300 mg iodine/mL. The patients were randomized into two injection protocols: A) a fixed injection rate of 2.0 mL/sec with a 70 sec delay, B) administration of 80% of the contrast material in 40 sec, then administration of the remaining 20% in 20 sec with an 80 sec delay. A helical scan from the apex of the lung to the base of the pelvic cavity was performed during one breathhold. CT attenuation values of the thoracic aorta, pulmonary artery, abdominal aorta, portal vein, superior vena cava (SVC), suprarenal and infrarenal inferior vena cava (IVC), liver, and pancreas were measured. Two radiologists visually assessed the degree enhancement of the IVC. In addition, the two radiologists visually assessed artifacts caused by contrast material in the subclavian vein and SVC using a four-point scale. RESULTS: Enhancement of the SVC in protocol A was significantly better than that in protocol B (p=0.04). Enhancement of the infrarenal IVC and liver in protocol B was significantly better than that in protocol A (p<0.01, p<0.01). Renal enhancement in protocol B was significantly better than that in protocol A (p=0.02). In all patients with both protocols A and B, enhancement of the suprarenal IVC was visually graded as acceptable or good. In all patients with protocol B, enhancement of the infrarenal IVC was graded as acceptable or good. In only 2/3 of patients with protocol A, enhancement of the infrarenal IVC was graded as acceptable or good. There was no significant difference in artifacts in the subclavian vein between the two protocols (p=0.77). Artifacts in the SVC in protocol B were significantly fewer than those in protocol A (p<0.01). CONCLUSION: Protocol B was more suitable for whole-body screening than protocol A, because of better enhancement of the liver and infrarenal IVC and fewer artifacts in the SVC.

Artifacts↗

Gonadotropin releasing hormone agonist protocols for pituitary desensitization in in vitro fertilization and gamete intrafallopian transfer cycles.

BACKGROUND: Gonadotropin releasing hormone agonists (GnRHa) are used in assisted reproduction cycles to reversibly block pituitary function and prevent a luteinizing hormone surge. In the short and ultrashort protocols of GnRHa administration, injection of gonadotropins is commenced a few days after the start of GnRHa. In the long protocols (with GnRHa started either in the midluteal phase or in the early follicular phase) gonadotropin administration is delayed until pituitary desensitization has been achieved, usually 2-3 weeks. OBJECTIVES: To conduct a systematic overview of available data comparing short or ultrashort and long GnRHa protocols for pituitary desensitization in in vitro fertilization (IVF) and gamete intra-fallopian transfer (GIFT) treatment cycles. SEARCH STRATEGY: Search strategies included on-line searching of the MEDLINE and EMBASE data bases and the Cochrane Menstrual Disorders and Subfertility Group's Specialised Register from 1982 to 1998, and hand searching of bibliographies of relevant publications and reviews, and abstracts of scientific meetings. SELECTION CRITERIA: Randomized trials of short or ultrashort versus long (follicular or luteal phase start) GnRHa protocols in IVF or GIFT treatment cycles. DATA COLLECTION AND ANALYSIS: Data were extracted into 2 x 2 tables. For the primary outcome, clinical pregnancy per cycle started, the overall common odds ratio (OR) and the risk difference with 95% confidence interval (CI) were calculated after verifying the presence of homogeneity of treatment effect across all trials. The following subgroup comparisons were performed: ultrashort versus long protocols, short versus long protocols and, within each of these comparisons, subgroups of studies which used the long protocol with follicular phase start or the long protocol with luteal phase start. Secondary outcomes considered were clinical pregnancy per oocyte retrieval and per embryo transfer, spontaneous abortion, ongoing/delivered pregnancy per cycle started, number of ampoules of gonadotropin used, number of oocytes retrieved, and fertilization rate. MAIN RESULTS: Twenty-six trials met the inclusion criteria. The common OR for clinical pregnancy per cycle started was 1.32 (95% CI, 1.10 - 1.57) in favour of the long GnRHa protocol. The studies were subgrouped, depending on whether, in the long protocol, the GnRHa was commenced in the follicular phase (8 trials) or luteal phase (16 trials). The respective ORs were 1.54 (95% CI, 1.11 - 2. 13) and 1.21 (95% CI, 0.98 - 1.51). After excluding the four trials using the ultrashort protocol, the OR for long versus short protocols (22 trials) was 1.27 (95% CI, 1.04 - 1.56). A comparison of long versus ultrashort protocols (4 trials) produced an OR of 1. 47 (95% CI, 1.02 - 2.12). REVIEWER'S CONCLUSIONS: On the basis of clinical pregnancy rate per cycle started, this meta-analysis demonstrates the superiority of the long protocol over the short and ultrashort protocols for GnRHa use in IVF and GIFT cycles.

Female↗

Prostate biopsy protocols: 3D visualization-based evaluation and clinical correlation.

OBJECTIVES: Systematic needle core biopsy is commonly used for the diagnosis of prostate cancer by urologists worldwide. As accurate and early diagnosis will result in more and better options for treatment, it is critical that the best possible protocols for biopsy be used clinically. In this study, we develop three-dimensional (3D) modeling and simulation technologies to evaluate most of the biopsy protocols in current clinical use, and correlate the results with those from clinical cases. MATERIALS AND METHODS: Using deformable modeling techniques, 3D computerized prostate surface models were reconstructed from step-sectioned, whole-mounted radical prostatectomy specimens with localized prostate cancer. A 3D computer simulation system was developed to accurately depict the anatomy of the prostate and all individual tumor foci. A user-friendly interface was developed in the system so that a physician can easily and interactively use it for prostate needle core biopsy. A total of 281 prostate models were reconstructed, and 18 biopsies were performed by a urologist on each model to determine the detection rates of seven different biopsy protocols. Clinical biopsies from 35 patient cases were also reviewed and correlated with the simulation results. RESULTS: The most commonly used sextant biopsy had only a 71.5% detection rate, while rates for the 10-pattern and 12-pattern protocols were much higher (96.4% and 97.2%, respectively). Even the lateral 4-pattern protocol performed better than the sextant protocol, with a detection rate of 89.3%. The lateral sextant biopsy protocol (using sites similar to, but more lateral than, those in the sextant protocol) achieved a rate of 92.5%. Although the rate of the 14-pattern biopsy was a little higher (97.5%), it used four more biopsies to achieve this increase, which, according to McNemar's test, is not statistically significant when compared to results with the 10-pattern protocol. The 5-region protocol, which uses 12 biopsies, had a detection rate of 89.7%. Transition zone and seminal vesicle biopsies did not result in a significantly increased detection rate when added to the patterns above. The clinical correlation also confirmed that the 10-pattern protocol was significantly superior to the traditional sextant biopsy pattern. CONCLUSIONS: The 10-pattern biopsy protocol was the most optimized among all the protocols evaluated. This protocol supplemented the sextant biopsy protocol with four more lateral biopsies in the mid and apical sites on both sides.

Biopsy, Needle↗

Efficacy of post operative adjuvant therapy with human interferon beta, MCNU and radiation (IMR) for malignant glioma: comparison among three protocols.

In order to develop ultimate adjuvant therapy for malignant gliomas, we analysed 77 patients with malignant gliomas (29 anaplastic astrocytomas (AAs) and 48 glioblastoma multiformes (GMs)) treated by three protocols of IMR therapy (human interferon-beta (HuIFN-beta), MCNU and radiation). In protocol 1 (n = 45: AA = 13, GM = 32), 1 x 10(6) IU of HuIFN-beta was administrated intravenously once a day for 7 days. On day 2, MCNU was administrated at a dose of 2 mg/kg b.w. intravenously and from day 3, radiation was started in five weekly fractions of 2 Gy for 6 weeks. Total dose was 60 Gy. Protocol 2 (n = 19: AA = 11, GM = 8) was comparable with protocol 1 except HuIFN-beta was administrated twice a day at a dose of 1 x 10(6) IU each. Protocol 3 (n = 13: AA = 5, GM = 8) differed from protocol 2 only in a high dose-hyperfractionated radiation which was given twice a day at a dose of 1.5 Gy each and for a total dose of 66 Gy. Antitumor effects were evaluated by survival and response rate determined by decrease of tumor size. Significant improvement was obtained in patients with AAs by protocol 2 and 3. Response rates of patients with AAs and GMs were 46.2% and 50% in protocol 1, 63.6% and 50% in protocol 2, and 80% and 50% in protocol 3, respectively. One and two year survival rates in AAs were 46.4% and 34.8% in protocol 1, both 75% in protocol 2, and both 100% in protocol 3. Survival rates in GMs were not different among them. Except of radiation necrosis, which was observed in 38.5% of the patients under protocol 3, there was no significant difference in the adverse effects among the three protocols. In the present study, the efficacy of IMR therapy for patients with malignant gliomas, especially for AAs, was cofirmed. We conclude that twice a day administrations of HuIFN-beta in combination with a high dose-hyperfractionated radiation provide increased efficacy in IMR therapy.

Adjuvants, Immunologic↗

Comparison in the same patient of two programmed ventricular stimulation protocols to induce ventricular tachycardia.

In 24 consecutive patients with documented ventricular tachycardia (VT) (22 patients) or fibrillation (VF) (2 patients), results of 2 programmed ventricular stimulation protocols to initiate VT/VF were prospectively studied. Seventeen patients had VT/VF after a healed myocardial infarction (MI) and 7 patients had idiopathic VT. In both protocols (designated 1 and 2), the right ventricular (RV) apex was paced at 100 beats/min, using a maximum of 2 ventricular premature complexes (VPCs) given at twice diastolic threshold. This protocol had a sensitivity of 25%. In protocol 1, the pacing site was changed to the RV outflow tract and the previous steps were repeated; in protocol 2, the pacing rate was increased to 120 and 140 beats/min at the RV apex, also using a maximum of 2 VPCs. The next step in protocol 1 consisted of increase of current strength to 20 mA and repeating previous steps at the RV apex and RV outflow tract, with a maximum of 2 VPCs; in the next step in protocol 2, three VPCs were used during sinus rhythm and pacing was performed at rates of 100, 120 and 140 beats/min. In protocol 1, therefore, only stimulation site and current strength were changed, while in protocol 2 only pacing rate and number of VPCs were modified. Protocol 1 had a sensitivity of 54% and protocol 2 a sensitivity of 83%. The sensitivity of protocol 2 was statistically higher than that of protocol 1 (p less than 0.05). In the group of patients with VT after MI, the sensitivity was 66% for protocol 1 and 93% for protocol 2.(ABSTRACT TRUNCATED AT 250 WORDS)

Cardiac Pacing, Artificial↗

Evaluation of current and novel protocols for disinfection of airplane passenger footwear under simulated conditions.

Aerobic bacterial culture was used to compare the effectiveness of the current USDA footwear disinfection protocol for airplane passengers contacting livestock to a novel protocol. The current protocol consists of brushing and dipping shoe soles in 1% Virkon S. The number of bacteria was not different between shoes treated with the current protocol and untreated shoes. No shoes met the standard for disinfection after the current disinfection protocol was completed. The novel protocol consisted of brushing shoe soles, wiping soles with a cotton towel soaked in 1% Virkon S, and drying soles with paper towels. The number of bacteria was less (P<0.0001) on treated shoes compared to control shoes. Eighteen of 20 shoes (90%) cleaned using the novel protocol met the standard for disinfection. Direct comparison of the current and novel protocols found that the number of bacteria cultured was less (P<0.0001) after implementing the novel protocol compared to implementing the current protocol. Again, no shoes treated using the current protocol met the standard for disinfection after the current protocol was completed. Sixteen and 17 of 20 shoes (80--85%), respectively, met the standard for disinfection after the novel protocol was completed. Under conditions of this study, current US airport footwear disinfection protocols were inadequate to disinfect footwear when using aerobic bacteria as a marker for disinfection. We recommend implementation of the novel footwear disinfectant protocol for select passengers from international flights.

Animal Diseases↗

Simplified dispatch-assisted CPR instructions outperform standard protocol.

OBJECTIVE: Dispatch-assisted chest compressions only CPR (CC-CPR) has gained widespread acceptance, and recent research suggests that increasing the proportion of compression time during CPR may increase survival from out-of-hospital cardiac arrest. We created a simplified CC-CPR protocol to reduce time to start chest compressions and to increase the proportion of time spent delivering chest compressions. This simplified protocol was compared to a published protocol, Medical Priority Dispatch System (MPDS) Version 11.2, recommended by the National Academies of Emergency Dispatch. METHODS: Subjects were randomized to the MPDS v11.2 protocol or a simplified protocol. Data was recorded from a Laerdal Resusci Anne Skillreporter manikin. A simulated emergency medical dispatcher, contacted by cell phone, delivered standardized instructions for both protocols. Outcomes included chest compression rate, depth, hand position, full release, overall proportion of compressions without error, time to start of CPR and total hands-off chest time. Proportions were analyzed by Wilcoxon's Rank Sum tests and time variables with Welch ANOVA and Wilcoxon's Rank Sum test. All tests used a two-sided alpha-level of 0.05. RESULTS: One hundred and seventeen subjects were randomized prospectively, 58 to the standard protocol and 59 to the simplified protocol. The average age of subjects in both groups was 25 years old. For both groups, the compression rate was equivalent (104 simplified versus 94 MPDS, p = 0.13), as was the proportion with total release (1.0 simplified versus 1.0 MPDS, p = 0.09). The proportion to the correct depth was greater in the simplified protocol (0.31 versus 0.03, p < 0.01), as was the proportion of compressions done without error (0.05 versus 0.0, p = 0.16). Time to start of chest compressions and total hands-off chest time were better in the simplified protocol (start time 60.9s versus 78.6s, p < 0.0001; hands-off chest time 69 s versus 95 s, p < 0.0001). The proportion with correct hand position, however, was worse in the simplified protocol (0.35 versus 0.84, p < 0.01). CONCLUSIONS: The simplified protocol was as good as, or better than the MPDS v11.2 protocol in every aspect studied except hand position, and the simplified protocol resulted in significant time savings. The protocol may need modification to ensure correct hand position. Time savings and improved quality of CPR achieved by the new set of instructions could be important in strengthening critical links in the cardiac chain of survival.

Adult↗

Detection of coronary calcification with electron-beam computed tomography: evaluation of interexamination reproducibility and comparison of three image-acquisition protocols.

The purpose of this investigation was to determine the variability of electron-beam computed tomography (EBCT) measurement of coronary calcification by using two commonly employed image-acquisition protocols and to compare this variability with that of a new image-acquisition protocol. We performed three EBCT scans within 15 minutes on each of 324 consecutive high-risk, asymptomatic subjects participating in an ongoing epidemiologic research investigation. Subjects were divided into three groups: group 1 (n = 175) received two scans with a standard 20-slice, 3 mm slice thickness image-acquisition protocol and a third scan with the new 20-slice, 6 mm slice thickness protocol; group 2 (n = 77) received two scans with a new 6 mm slice thickness image-acquisition protocol and a third scan with a standard 20-slice, 3 mm slice thickness protocol; group 3 (n = 72) received two scans with a 30-slice, 3 mm slice thickness image-acquisition protocol and a third scan with a 20-slice, 6 mm slice thickness protocol. Calcium score, calcium mass estimate, and calcium volume estimate were determined for each scan. We compared retest variability of calcium measurements for each of the three image-acquisition protocols. The variability of the new 6 mm slice thickness protocol was significantly lower than that of either the 20-slice 3 mm slice thickness protocol (p = 0.009) or the 30-slice 3 mm slice thickness protocol (p = 0.02) for measurement of calcium score, mass, or volume. Retest reproducibility for all three image-acquisition protocols was low; however, the 20-slice 6 mm slice thickness protocol gave reproducibility superior to either of the 3 mm slice thickness protocols. Variability of absolute indices increased, and variability of relative indices decreased as the value of these indices increased. EBCT is not sufficiently reproducible to allow serial quantitation of coronary calcium in individual patients over relatively short periods (< 2 years).

Aged↗

The limited protocol MRI in diagnosis of lumbar disc herniation.

OBJECTIVE: To assess agreement in detection of lumbar disc herniation (LDH) between limited and full protocol MRI. MATERIAL AND METHOD: 123 patients who requested lumbar MRI for diagnosis of disc herniation were assessed The full protocol MRI composed of sagittal T1-wi, sagittal T2-wi and axial T2-wi was performed on each patient. The sagittal T2-wi was selected as the limited protocol MRI. The limited and full protocols MRI of each patient were separately interpreted by three neuroradiologists to assess disc herniation and nerve root compression. The consensus results of limited and full protocol were compared. The diagnostic performance of each protocol was analyzed using surgery as the gold standard. RESULTS: There were 62 females and 61 males enrolled into the study between the age of 21-60 years old (means = 42.91 years). The duration of pain was 1-204 months (mean = 31.20 months). The degree of severity was mild in 23.58%, moderate 45.52% and severe 30.89% of cases. Thirty-three cases were operated on. For detection of LDH, the limited protocol gave the same interpretation results as the full protocol (0 = 1.04, 95%CI = 0.94, 1.14 with accepted range of 0.95-1.05). In nerve root compression, the limited protocol was not accurate as the full protocol (0 = 0.75, 95%CI = 0.87, 0.63). The sensitivity, specificity, accuracy, PPV, NPV, and LR+ in the surgical group of limited protocol in diagnosis of LDH were 82.61%, 80%, 81.82%, 90.48%, 60.67%, 4.13 and in nerve root compression were 54.84%, 100%, 57.58%, 100%, 12.5% respectively. The same statistics of full protocol MRI in diagnosis of LDH were 82.61%, 70.80%, 78.79%, 86.36%, 63.64%, 2.75 and of nerve root compression were 80.65%, 100%, 81.82%, 100%, 25% respectively. The sensitivity and specificity in diagnosis of LDH were not different in both protocols but the sensitivity of nerve root compression was statistically significant different (p < 0.013, 95%CI = -0.33, -0.25). CONCLUSION: The authors concluded that limited protocol MRI may replace full protocol MRI in diagnosis of LDH but not in nerve root compression.

Adult↗