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Screen-positive rates and agreement among six family history screening protocols for breast/ovarian cancer in a population-based cohort of 21- to 55-year-old women.

PURPOSE: Mutations in the BRCA1 and BRCA2 genes are responsible for approximately 2% of breast cancers by age 70 years. Professional and governmental groups recommend using family history protocols as an initial step in identifying women and families for mutation testing. We assess screen-positive rates and levels of agreement between these protocols. METHODS: We applied six family history screening protocols to a population-based cohort of 321 women, age 21 to 55 years, who reported their personal and family history of breast and ovarian cancer. RESULTS: The proportion of women and families identified as candidates for mutation testing ranged from 4.4% to 7.8%, depending on the protocol. The protocols had low or fair agreement (kappa <0.75 for 14 of 15 comparisons), but all identified six women (1.9%, 95% confidence interval 0.7%-4.0%) as screen positive. When the effect of missing ages of cancer onset was modeled, these rates increased (range 6.5%-11.5%), and nine women (2.8%) were screen positive by all protocols. CONCLUSION: Given limitations of family history as a screening test for hereditary cancer related to BRCA1/2 mutations, 1% to 2% of women in the general population should initially be identified for mutation testing. One way to achieve this would be to require that multiple screening protocols agree.

Adult↗

Pregnancy rate after timed artificial insemination in early post-partum dairy cows after Ovsynch or specific synchronization protocols.

The present study was designed to compare the reproductive performance of pre-synchronized post-partum dairy cows subjected, either to the Ovsynch protocol without screening for ovarian status (control group), or to a specific oestrous synchronization protocol applied according to their ovarian status, as determined by transrectal ultrasound (experimental group). The study was conducted on 428 lactating dairy cows. Cows in the Ovsynch group (n = 205) were synchronized and time inseminated after receiving the Ovsynch protocol treatment. Cows in the specific synchronization (Ssynch) group (n = 223) were weekly subjected to transrectal ultrasound exams for 4 weeks, or until AI or starting treatment, and divided into four subgroups according to their ovarian status: (i). corpus luteum (CL) subgroup (n = 130), cows with a CL; (ii). natural oestrus (NE) subgroup (n = 58), cows showing NE; (iii). anovulatory follicles (AF) subgroup (n = 26), cows considered to have AF; and (iv). ovarian cysts (OC) subgroup (n = 9), cows with OC. Cows in the Ssynch group were synchronized and time inseminated following a specific oestrous synchronization protocol, or inseminated at NE. Logistic regression analysis was carried out for the dependent variables ovulation and pregnancy rates to first and to second AI (second AI: first AI + return AI). Cows subjected to Ssynch were 2.1 times more likely to become pregnant at first and at second AI compared with those synchronized using the Ovsynch protocol (P < 0.0001). Our results show that the response of post-partum pre-synchronized cows to a specific oestrous synchronization protocol applied according to their ovarian status is more effective than the response to the Ovsynch protocol applied without taking into account the ovarian status of the animals.

Animals↗

Effects of a shared protocol between urologists and general practitioners on referral patterns and initial diagnostic management of men with lower urinary tract symptoms in Italy: the Prostate Destination study.

OBJECTIVE: To assess whether adopting a shared protocol between urologists and general practitioners (GPs) might change diagnostic procedures and referral patterns in the management of men with lower urinary tract symptoms (LUTS). SUBJECTS AND METHODS: Forty-five urological centres and 263 GPs in Italy participated in this prospective study. Procedures adopted by GPs for evaluating five consecutive patients (aged > or = 50 years) were compared before (phase 1) and after (phase 2) implementation of the shared protocol. An evidence-based diagnostic algorithm was developed and approved by participating urologists and presented to local GPs at a training session. Protocol modifications were allowed after discussion with GPs. Direct costs of diagnostic procedures carried out before and after implementing the protocol were calculated from the perspective of the national health service. RESULTS: In all, 903 patients were evaluable in phase 1 and 856 in phase 2. Implementation of the protocol did not change referral patterns, with about half the patients being managed entirely by GPs. The use of a digital rectal examination by GPs increased from 32% to 41%, use of transrectal and suprapubic ultrasonography decreased from 33% to 23% and 53% to 44%, respectively, (all P < 0.001) and use of the International Prostate Symptom Score increased from 4.5% to 23.1% (P < 0.001). Overall, protocol-recommended tests were used more frequently, while those not recommended decreased after implementing the protocol. However, overuse of the tests not recommended (i.e. urine culture and free/total prostate specific antigen ratio) remained high. The mean cost per patient of diagnostic procedures ordered by GPs decreased from Euros 71.82 to Euros 61.93, with Euros 9.9 saved for each patient. CONCLUSION: Our intervention failed to decrease the percentage of cases of LUTS being referred to specialists, but was moderately effective in inducing changes in the diagnostic management by GPs that were indicative of increased compliance with best-practice principles, and produced cost savings of 13.8%.

Aged↗

Comparison of 1- and 2-day protocols for myocardial SPECT: a Monte Carlo study.

BACKGROUND: Myocardial perfusion single-photon emission computed tomography (SPECT) is carried out by combining a rest and a stress study that are performed either on one day or two separate days. A problem when performing the two studies on 1 day is that the residual activity from the first study contributes to the activity measured in the second study. AIM: Our aim was to identify and evaluate trends in the quantification parameters of myocardial perfusion images as a function of separation time between rest and stress. METHODS: A digital phantom was used for the generation of heart images and a Monte Carlo-based scintillation camera program was used to simulate SPECT projection images. In our simulations, the rest images were normal and the stress images included lesions of different types and localization. Two programs for quantification of myocardial perfusion images were used to assess the different images in an automated and objective way. RESULTS: The summed difference scores observed with the 2-day protocol were 3 +/- 1 (mean +/- SD) higher for AutoQUANT and 2 +/- 1 higher for 4D-MSPECT compared with those observed with the 1-day protocol. The extent values were 2% points higher for the 2-day protocol compared with the 1-day protocol for both programs. CONCLUSIONS: There are differences in the quantitative assessment of perfusion defects depending on the type of protocol used. The contribution of residual activity is larger when a 1-day protocol is used compared with the 2-day protocol. The differences, although small, are of a magnitude that results in a clear shift in quantification parameters.

Coronary Artery Disease↗

Criterion-based validity of an intracarotid amobarbital recognition-memory protocol.

PURPOSE: We tested whether the behavioral components of an Intracarotid Amobarbital Protocol (IAP) had criterion validity. It was hypothesized that a recognition-memory test designed for intracarotid injections and used to predict the risk of global amnesia before an elective temporal lobectomy should also identify persons who are severely amnesic due to other neurologic causes. Divergent validity predicts that speech tasks would be unaffected by amnesia. Test-retest reliability also was measured. METHODS: Fifteen persons with severe amnesia were administered four alternate forms of a yes/no recognition-memory protocol and a speech protocol. No drug injection occurred. Standardized neuropsychological tests were used to divide the amnesic group into those with Global Amnesia (i.e., retain no ongoing memories), Severe Amnesia (i.e., memory impaired), and Amnesia Plus (severe amnesia plus other neuropsychologic deficits). RESULTS: Two persons with Global Amnesia obtained scores at or below chance (i.e., failed) on the memory protocol. Unexpectedly, 12 of 13 severely amnesic persons obtained near-perfect memory scores. Amnesia had no impact on the speech protocol. Pass/Fail outcomes were highly correlated across all four sets. CONCLUSIONS: A four-item IAP memory protocol showed good reliability and criterion validity in identifying the rare condition of Global Amnesia, but it was insensitive to other disabling, severe amnesic disorders. This IAP memory protocol might have validity in predicting a postsurgical Global Amnesic disorder, but it did not identify and therefore could not predict other more common severe amnesic disorders.

Adolescent↗

The "low intensity treadmill exercise" protocol for appropriate rate adaptive programming of minute ventilation controlled pacemakers.

The objective of rate adaptive pacemakers that measure minute ventilation by transthoracic impedance is to simulate the physiological relationship of the sensed signal to the sinus node response during exercise, thus achieving an appropriate matching of heart rate with patient effort. The purpose of this study was to determine the physiological relationship between heart rate and minute ventilation (HR/VE) during peak exercise testing in order to develop a database for appropriate rate adaptive slope programming of minute ventilation controlled pacemakers. Due to several clinical limitations of peak exercise testing, it was additionally determined whether the 35-watt "low intensity treadmill exercise" (LITE) protocol can be used as a substitute for peak exercise test using the "ramping incremental treadmill exercise" (RITE) protocol in order to assess the correct HR/VE slope below the anaerobic threshold. The stress tests were performed on a treadmill with the collection of breath-by-breath gas exchange. Linear regression analysis was used to determine the HR/VE slope below and above the anaerobic threshold and during the early, dynamic phase of low intensity exercise with the RITE and LITE protocols, respectively. The results of this testing in 41 healthy subjects demonstrated that the HR/VE relationship throughout treadmill exercise using the RITE protocol was not linear but curvilinear in nature, with a steeper HR/VE slope of 1.54 +/- 0.51 below versus 1.15 +/- 0.37 above the anaerobic threshold (P < 0.005). The HR/VE slope determined during the early, dynamic phase of the LITE protocol (1.58 +/- 0.88) did not differ from the HR/VE slope from rest to anaerobic threshold obtained using the peak exercise RITE test (1.54 +/- 0.51; P = 0.79). Rate adaptive pacing should simulate the curvilinear relationship between heart rate and minute ventilation from rest to peak exercise. The HR/VE slope determined during the early, dynamic phase of low intensity exercise represents the HR/VE slope derived from the RITE protocol below the anaerobic threshold. According to the peak exercise database, the slope above anaerobic threshold can easily be calculated as a percentage of the slope below the anaerobic threshold. The LITE protocol can, therefore, be effectively performed as a substitute for peak exercise stress tests to determine the correct pacemaker rate response factor in order to obtain a physiological heart rate to minute ventilation relationship for the appropriate matching of paced heart rate with patient effort.

Anaerobic Threshold↗

Update of AAPM Task Group No. 43 Report: A revised AAPM protocol for brachytherapy dose calculations.

Since publication of the American Association of Physicists in Medicine (AAPM) Task Group No. 43 Report in 1995 (TG-43), both the utilization of permanent source implantation and the number of low-energy interstitial brachytherapy source models commercially available have dramatically increased. In addition, the National Institute of Standards and Technology has introduced a new primary standard of air-kerma strength, and the brachytherapy dosimetry literature has grown substantially, documenting both improved dosimetry methodologies and dosimetric characterization of particular source models. In response to these advances, the AAPM Low-energy Interstitial Brachytherapy Dosimetry subcommittee (LIBD) herein presents an update of the TG-43 protocol for calculation of dose-rate distributions around photon-emitting brachytherapy sources. The updated protocol (TG-43U1) includes (a) a revised definition of air-kerma strength; (b) elimination of apparent activity for specification of source strength; (c) elimination of the anisotropy constant in favor of the distance-dependent one-dimensional anisotropy function; (d) guidance on extrapolating tabulated TG-43 parameters to longer and shorter distances; and (e) correction for minor inconsistencies and omissions in the original protocol and its implementation. Among the corrections are consistent guidelines for use of point- and line-source geometry functions. In addition, this report recommends a unified approach to comparing reference dose distributions derived from different investigators to develop a single critically evaluated consensus dataset as well as guidelines for performing and describing future theoretical and experimental single-source dosimetry studies. Finally, the report includes consensus datasets, in the form of dose-rate constants, radial dose functions, and one-dimensional (1D) and two-dimensional (2D) anisotropy functions, for all low-energy brachytherapy source models that met the AAPM dosimetric prerequisites [Med. Phys. 25, 2269 (1998)] as of July 15, 2001. These include the following 125I sources: Amersham Health models 6702 and 6711, Best Medical model 2301, North American Scientific Inc. (NASI) model MED3631-A/M, Bebig/Theragenics model I25.S06, and the Imagyn Medical Technologies Inc. isostar model IS-12501. The 103Pd sources included are the Theragenics Corporation model 200 and NASI model MED3633. The AAPM recommends that the revised dose-calculation protocol and revised source-specific dose-rate distributions be adopted by all end users for clinical treatment planning of low energy brachytherapy interstitial sources. Depending upon the dose-calculation protocol and parameters currently used by individual physicists, adoption of this protocol may result in changes to patient dose calculations. These changes should be carefully evaluated and reviewed with the radiation oncologist preceding implementation of the current protocol.

Air↗

Multicenter evaluation of a modified protocol for the RAPIDEC staph system for direct identification of Staphylococcus aureus in blood cultures.

A modified protocol for the RAPIDEC Staph system (bioMérieux, Marcy-l'Etoile, France) for direct identification of Staphylococcus aureus in blood cultures was evaluated in a multicenter study. A total of 129 blood cultures (BACTEC 9000 Blood Culture System; Becton Dickinson Diagnostic Instrument Systems, Sparks, Md.) containing gram-positive cocci in clusters were analyzed by conventional methods and by RAPIDEC Staph in accordance with the manufacturer's protocol and in accordance with a modified protocol. The sensitivity, specificity, and positive and negative predictive values obtained with the manufacturer's protocol were 90.5, 97.7, 95. 0, and 95.5%, respectively, and those obtained with the modified protocol were 100, 96.6, 93.3, and 100%, respectively. The modified protocol for the RAPIDEC Staph is easier to perform than the manufacturer's protocol and is very reliable.

Bacteremia↗

Harmonization of pulsed-field gel electrophoresis protocols for epidemiological typing of strains of methicillin-resistant Staphylococcus aureus: a single approach developed by consensus in 10 European laboratories and its application for tracing the spread of related strains.

Pulsed-fieldgel electrophoresis (PFGE) is the most common genotypic method used in reference and clinical laboratories for typing methicillin-resistant Staphylococcus aureus (MRSA). Many different protocols have been developed in laboratories that have extensive experience with the technique and have established national databases. However, the comparabilities of the different European PFGE protocols for MRSA and of the various national MRSA clones themselves had not been addressed until now. This multinational European Union (EU) project has established for the first time a European database of representative epidemic MRSA (EMRSA) strains and has compared them by using a new "harmonized" PFGE protocol developed by a consensus approach that has demonstrated sufficient reproducibility to allow the successful comparison of pulsed-field gels between laboratories and the tracking of strains around the EU. In-house protocols from 10 laboratories in eight European countries were compared by each center with a "gold standard" or initial harmonized protocol in which many of the parameters had been standardized. The group found that it was not important to standardize some elements of the protocol, such as the type of agarose, DNA block preparation, and plug digestion. Other elements were shown to be critical, namely, a standard gel volume and concentration of agarose, the DNA concentration in the plug, the ionic strength and volume of running buffer used, the running temperature, the voltage, and the switching times of electrophoresis. A new harmonized protocol was agreed on, further modified in a pilot study in two laboratories, and finally tested by all others. Seven laboratories' gels were found to be of sufficiently good quality to allow comparison of the strains by using a computer software program, while two gels could not be analyzed because of inadequate destaining and DNA overloading. Good-quality gels and inclusion of an internal quality control strain are essential before attempting intercenter PFGE comparisons. A number of clonally related strains have been shown to be present in multiple countries throughout Europe. The well-known Iberian clone has been demonstrated in Belgium, Finland, France, Germany, and Spain (and from the wider HARMONY collection in Portugal, Slovenia, and Sweden). Strains from the United Kingdom (EMRSA-15 and -16) have been identified in several othercountries, and other clonally related strains have also been identified. This highlights the need for closer international collaboration to monitor the spread of current epidemic strains as well as the emergence of new ones.

Bacterial Typing Techniques↗

Establishment of a protocol to test fatigue of the trunk muscles.

BACKGROUND: Muscle fatigue has high relevance in human performance yet little research has evaluated how it should be assessed. OBJECTIVE: To perform a pilot study to identify suitable methods of generating and assessing fatigue of the trunk flexor and extensor muscles. METHODS: Sixteen university rugby players (mean (SEM) age 21.9 (0.2) years) were recruited and subjected to four protocols (A, B, C, D), separated by a week to allow recovery, with peak torque being recorded during each test: A, isokinetic measurements before and after fatigue, with a 10 repetition isokinetic fatigue period; B, isokinetic measurements before and after fatigue with a 45 second isometric fatigue period; C, isometric measurements before and after fatigue with a 10 repetition isokinetic fatigue period; D, isometric measurements before and after fatigue with a 45 second isometric fatigue period. All were conducted during flexion and extension of the trunk on the Cybex Norm Isokinetic Dynamometer trunk flexion-extension unit. RESULTS: All subjects completed all four protocols. Fatigue induction appeared more effective in flexion than extension. Significant differences in mean peak torque before and after fatigue were seen in protocols A, B, and D in flexion and only in protocol D for extension. In flexion, protocol D produced the greatest fatigue, peak torque being 16.2% less after than before fatigue, suggesting greatest sensitivity. CONCLUSIONS: Protocol D, which incorporates isometric testing and fatigue protocols, appears to be able to produce fatigue most effectively, and therefore may provide the most valid assessment of fatigue in the trunk flexor and extensor muscles.

Adult↗

Breathing strategy in master athletes and untrained elderly subjects according to the incremental protocol.

To analyze the influence of step-duration protocol (1 vs. 3 min) on breathing strategy according to the physical fitness of healthy elderly subjects, this study compared the ventilatory responses and exercise tidal flow-volume loops (ETFVL) at the first and second ventilatory thresholds (VT(1) and VT(2)). Nineteen master athletes (mean age (+/- SD), 63.1 +/- 3.2 y; (.)VO(2)(max), 41.5 mL x (min x kg)(-1)) and 8 untrained elderly subjects (age, 65.5 +/- 2.3 y; (.)VO(2)(max), 25.8 mL x (min x kg)(-1)) performed 2 exhaustive exercise tests on a cycle ergometer. In untrained subjects, at VT(1) and VT(2), no significant difference was measured in ventilatory responses and ETFVL between protocols. Master athletes, at VT(2), presented a significantly higher (.)VCO(2) (P < 0.01), ventilation ((.)VE; P < 0.01), breathing frequency (f(b); P < 0.05), tidal volume relative to inspiratory capatcity (V(t)/IC) (P < 0.01),V(t) relative to forced vital capacity (V(t)/FVC; P < 0.05), and lower inspiratory reserve volume relative to FVC (IRV/FVC; P < 0.01) during the 1 min protocol than during the 3 min protocol. Master athletes, at maximal exercise, expressed significantly higher (.)VCO(2) (P < 0.01) and dyspnea (P < 0.05) with the shorter protocol. We concluded that, in untrained subjects, neither incremental exercise test had an impact on respiratory responses during exercise. Nevertheless, in master athletes, breathing strategy seems to be protocol dependent. The short test induced higher mechanical ventilatory constraints and dyspneic feeling than the long protocol, which could be explained by a higher (.)VE itself linked to a greater (.)VCO(2) and a higher blood lactate concentration.

Aged↗

Development of a hockey-specific, skate-treadmill VO2 max protocol.

The purpose of this study was to investigate a protocol for the determination of VO2 max utilizing a motor-driven skate treadmill (ST). On separate days, 6 male hockey players completed a ST and a cycle ergometer (BK) VO2 max protocol. The results showed no significant difference between the ST and BK protocols for relative (60.4 +/- 5.09 vs. 59.0 +/- 8.31 ml.kg-1.min-1) and absolute VO2 max values (4.51 +/- 0.50 vs. 4.39 +/- 0.59 L.min-1), respectively. Significantly higher HR max was recorded during the ST protocol (202.3 +/- 4.27 vs. 200.7 +/- 4.55 b.min-1) (p < 0.05). Peak VE and VT were nonsignificant between the two conditions. However, peak f was higher for the ST protocol (63.0 +/- 7.56 vs. 60.2 +/- 7.76 breath.min-1) (p < 0.05). Although the physiological response to both protocols was similar, the ST protocol replicates a hockey stride, which may provide more applicable information for the development of training programs.

Adolescent↗

Radiation dose is reduced with a single-pass whole-body multi-detector row CT trauma protocol compared with a conventional segmented method: initial experience.

Radiation dose data were collected from a calibrated multi-detector row computed tomographic (CT) scanner during trauma CT. One protocol (used with 10 case subjects) involved a single-pass continuous whole-body acquisition from cranial vertex to symphysis pubis, while the other, conventional protocol (used with 10 control subjects) involved scouting and scanning body segments (head, cervical spine, chest, abdomen, and pelvis) individually. Technical factors were kept constant within each body segment for the single-pass and the segmented protocols. Statistics included univariate analysis, two-tailed t testing to evaluate statistical significance of the summary statistic, and power and subject population contingency tables. The mean dose length product (DLP) with the single-pass protocol was 17% lower than the sum of the DLPs of each of the individual body segment scans (P <.001). Analysis of power and subject population by using a difference in mean of 500 mGy. cm and an alpha of.05 revealed a (1-beta) of higher than 0.90 for a sample of 10 patients. Thus, a whole-body single-pass trauma protocol, compared with a typical segmented acquisition protocol matched for imaging technique, resulted in reduced total radiation dose. The reduction in radiation dose is thought to represent a reduction in redundant imaging at overlap zones between body segments scanned in the segmental protocol but not in the continuous acquisition.

Humans↗

Hepatic helical CT: contrast material injection protocol.

PURPOSE: To develop and compare contrast material injection protocols suitable for hepatic helical computed tomography (CT). MATERIALS AND METHODS: Monophasic and biphasic helical CT were performed with contrast material with an iodine load of 50 g at 3 mL/sec for 60 seconds or at 5 mL/sec for 10 seconds and 2 mL/sec for 65 seconds, respectively. In 58 men and 51 women, aged 22-77 years, aortic and hepatic enhancement curves were constructed from a cluster acquisition with a slip-ring scanner operating in a nonhelical mode. RESULTS: The monophasic protocol produced a higher peak aortic enhancement (180 HU +/- 47 [+/- 1 standard deviation]) than the biphasic protocol (150 HU +/- 24). Peak hepatic enhancement (63-64 HU +/- 15) was equivalent. Calculated equilibrium time for the monophasic protocol was 95.1 seconds and for the biphasic protocol was 101.4 seconds. The contrast enhancement index differed only marginally between the two protocols (P < .4). CONCLUSION: Monophasic and biphasic protocols produced equivalent results when tailored for the shorter temporal window of a rapid-sequence helical acquisition.

Adult↗

The impact of implementing an enteral tube feeding protocol on caloric and protein delivery in intensive care unit patients.

BACKGROUND: The purpose of this study was to determine the effect of an enteral tube feeding protocol on caloric and protein delivery to intensive care unit (ICU) patients. METHODS: This prospective study consisted of 2 phases: before and after the implementation on an enteral-feeding protocol. The following data were collected: demographics, Acute Physiology and Chronic Health Evaluation II score and Simplified Acute Physiology Score II, caloric and protein requirements, the location of the feeding tube tip, and prokinetic agents use. The primary endpoint was caloric and protein intake as a percentage of the requirement. Secondary endpoints were gastric residuals >150 mL, vomiting episodes, ICU and hospital lengths of stay, mechanical ventilation duration, and ICU and hospital mortality. RESULTS: There were no significant differences between the control (n = 100) and protocol groups (n = 103) in baseline characteristics. The protocol was associated with significant improvement in the 7-day average of caloric intake/requirement (53.9 +/- 2.3% vs 64.5 +/- 2.2%, p = .001) and protein intake/requirement (56.7 +/- 2.6% vs 67.4% +/- 2.7%, p = .005). Caloric and protein intake improved whether the patient was receiving prokinetic agent or not. There was a trend toward lower gastric residual volumes and vomiting episodes in the protocol group. Patients receiving gastric feeding showed significant improvement in caloric intake to levels comparable to patients with postpyloric feeding. CONCLUSIONS: Enteral tube feeding protocol is effective in improving feeding delivery in ICU patients independent of prokinetic agent use. Protocol for enteral tube feeding should be considered in the management of ICU patients, given the positive impact of this nonpharmacologic, non-interventional tool.

Journal Article↗

The efficacy of an enteral access protocol for feeding trauma patients.

BACKGROUND: Proper enteral access to deliver specialized nutrition support in critically injured patients can be difficult, time consuming, and costly. We designed a protocol with interdisciplinary input to facilitate early enteral access in our trauma patients. Our primary objective was to determine if the protocol improved our ability to obtain small-bowel access in patients within 48 hours of their admission to the surgical intensive care unit (SICU). Secondary objectives were to examine the efficacy of the protocol by evaluating parenteral nutrition (PN) use, adequacy of enteral caloric delivery, and clinical outcomes including pneumonia and sepsis rates, SICU length of stay (LOS), hospital LOS, and mortality before and after its implementation. METHODS: The medical records of 51 trauma patients admitted to the SICU, who met inclusion criteria, were reviewed retrospectively and divided into 2 groups. Patients in group 1 were admitted before protocol implementation (1997-1998, n = 17). Patients in group 2 were admitted after protocol implementation (1998-2000, n = 34). RESULTS: Small-bowel access was achieved earlier in group 2 compared with group 1 [2.2 +/- 2 days vs 5.4 +/- 8 days, respectively (p = .04)]. PN was used less frequently in group 2 at 41.2% (14/34) as opposed to 64.7% (11/17) in group 1 (p = .05). There was a reduction in the number of days to reach caloric goal from 4.9 days in group 1 to 3.9 days in group 2 (n.s.). Clinical outcomes were similar in both groups. CONCLUSIONS: The use of a protocol was effective in the achievement of prompt small bowel access. The number of days to reach caloric goal decreased after protocol implementation, but not to a statistically significant degree. However, we were able to detect a significant reduction in the use of PN.

Adult↗

The EpiDerm test protocol for the upcoming ECVAM validation study on in vitro skin irritation tests--an assessment of the performance of the optimised test.

During the past decade, several validation studies have been conducted on in vitro methods for discriminating between skin irritating and non-irritating chemicals. The reconstructed human skin models, EpiDerm and EPISKIN, provided the most promising results. Based on experience of the similar performance of the two skin models, it was suggested that a common test protocol and prediction model should be developed for the prediction of skin irritation potential with the two models. When the EPISKIN protocol was applied with the EpiDerm model, an acceptable specificity (80%) was achieved, whereas the sensitivity (60%) was low. In 2003, the EPISKIN protocol was further refined by extending the post-incubation period following exposure to test chemicals. This extension and additional technical improvements to the EpiDerm protocol were evaluated with 19 chemicals from the prevalidation study. With the new test design, high sensitivity (80%) and specificity (78%) were obtained. The statistical probability for correct classifications was high, so the test was considered to be ready for formal validation. However, since test optimisation had been conducted with the same test chemicals as were used in the ECVAM prevalidation study, it was decided that the optimisation of the protocol had to be verified with a new set of chemicals. Thus, in the current study, 26 additional chemicals (10 rabbit irritants and 16 non-irritants), which had previously been selected and tested by LOREAL with EPISKIN, were evaluated in three independent experiments with EpiDerm. With this unbalanced testing set, a specificity of 94%, and a sensitivity of 60% were obtained, while the positive and negative predictivity and accuracy remained almost unchanged (around 80%) in comparison to the in vivo rabbit data. Overall, 45 chemicals (20 irritants and 25 non-irritants) were tested according to the final protocol. The resulting high positive (82%) and negative predictive values (79%) confirmed the reliability (accuracy of 80%) of the improved test protocol of the EpiDerm model.

Animal Testing Alternatives↗

Using simulation for training and to change protocol during the outbreak of severe acute respiratory syndrome.

INTRODUCTION: During the 2003 severe acute respiratory syndrome (SARS) crisis, we proposed and tested a new protocol for cardiac arrest in a patient with SARS. The protocol was rapidly and effectively instituted by teamwork training using high-fidelity simulation. METHODS: Phase 1 was a curriculum design of a SARS-specific cardiac arrest protocol in three steps: planning the new protocol, repeated simulations of this protocol in a classroom, and a subsequent simulation of a cardiac arrest on a hospital ward. Phase 2 was the training of 275 healthcare workers (HCWs) using the new protocol. Training involved a seminar, practice in wearing the mandatory personal protection system (PPS), and cardiac arrest simulations with subsequent debriefing. RESULTS: Simulation provided insights that had not been considered in earlier phases of development. For example, a single person can don a PPS worn for the SARS patient in 1 1/2 minutes. However, when multiple members of a cardiac arrest team were dressing simultaneously, the time to don the PPS increased to between 3 1/2 and 5 1/2 minutes. Errors in infection control as well as in medical management of advanced cardiac life support (ACLS) were corrected. CONCLUSION: During the SARS crisis, real-time use of a high-fidelity simulator allowed the training of 275 HCWs in 2 weeks, with debriefing and error management. HCWs were required to manage the SARS cardiac arrest wearing unfamiliar equipment and following a modified ACLS protocol. The insight gained from this experience will be valuable for future infectious disease challenges in critical care.

Canada↗