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A multisite study to examine the efficacy of the otoacoustic emission/automated auditory brainstem response newborn hearing screening protocol: results of visual reinforcement audiometry.

PURPOSE: This 3rd of 4 articles on a study of the efficacy of the 2-stage otoacoustic emission/automated auditory brainstem response (OAE/A-ABR) newborn hearing screening protocol describes (a) the behavioral audiometric protocol used to validate hearing status at 8-12 months of age, (b) the hearing status of the sample, and (c) the success of the visual reinforcement audiometry (VRA) protocol across 7 sites. METHOD: A total of 973 infants who failed OAE but passed A-ABR, in one or both ears, during newborn screening were tested with a VRA protocol, supplemented by tympanometry and OAE screening at age 8-12 months. RESULTS: VRA audiograms (1.0, 2.0, and 4.0 kHz) were obtained for 1,184 (82.7%) of the 1,432 study ears. Hearing loss was ruled out in another 100 ears by VRA in combination with OAE, for a total of 88.7% of the study sample. Permanent hearing loss was identified in 30 ears of 21 infants. Sites differed in their success with the VRA protocol. CONCLUSIONS: Continued monitoring of hearing beyond the newborn period is an important component of early detection of hearing loss. Using a structured protocol, VRA is an appropriate test method for most, but not all, infants. A battery of test procedures is often needed to adequately delineate hearing loss in infants. Examiner experience appears to be a factor in successful VRA.

Acoustic Impedance Tests↗

Comparison of two home care protocols for total joint replacement.

OBJECTIVES: To examine the effect of a more-efficient home care protocol to manage total joint replacement (TJR) patients after surgery. DESIGN: A randomized trial of two home care protocols for TJR management. SETTING: A hospital-affiliated home healthcare agency in a large midwestern city. PARTICIPANTS: Medicare-eligible individuals undergoing elective total hip or knee replacement surgery (N = 136). INTERVENTION: A home care protocol that included preoperative home visits by a nurse and a physical therapist and fewer postoperative visits (range of 9-12 visits) to the home than an existing protocol (range of 11-47 visits). MEASUREMENTS: Functional status, lower extremity functioning, health-related quality of life, satisfaction with care, and use and cost of healthcare services for 6 months postsurgery. RESULTS: There were no differences in functional status, health-related quality of life, or lower extremity functioning by group at 6 months. A marginally significant gain in satisfaction with access to care (P =.059) was found in the intervention group at 6 months. Home healthcare costs were 55% lower for the streamlined group (P <.001). Other costs did not differ significantly by group. CONCLUSION: TJR patients who received the more-efficient home care protocol experienced comparable outcomes to those who received the existing protocol. An abbreviated set of home care visits resulted in more-efficient delivery of care without compromising patient outcomes.

Aged↗

[Evaluation of different protocols for the leg cuff technique for measurement of dynamic cerebral autoregulation].

AIM: Aaslid's leg cuff method is a well validated technique to measure dynamic cerebral autoregulation. In the literature different protocols to choose cuff pressure have been described. The aim of this study is to find a technique as accurate as possible without un-necessary inconvenience for the patient. METHOD: The leg cuff test with bilateral cuffs was performed on 10 young healthy volunteers with three different protocols (cuff pressure at systolic level, doppler controlled and 30 mmHg above systolic level). For each examination the autoregulation index invented by Tiecks and Mahony was calculated. Statistical modelling of correlated data was done with Generalized Estimating Equations. RESULTS: The choice of the protocol influences the quality of the actual autoregulation test. The most reliable protocol is also the most inconvenient one for the patient. We found no systematic bias of the protocol on the autoregulation index, but the relation between induced blood pressure drop and resulting autoregulation index was close to statistical significance. CONCLUSION: For the leg cuff test with bilateral cuffs in awake patients we recommend to apply the protocol proposed by Tiecks. Additional report of the magnitude of induced blood pressure drop would be helpful to improve the results' comparability.

Blood Pressure↗

Effect of protocol on determination of velocity at VO2 max and on its time to exhaustion.

The velocity associated with the achievement of VO2 max during an incremental treadmill test (v VO2 max) has been reported to be an indicator of performance in middle distance running events. Previous study has shown the reproducibility of the time to exhaustion (time limit: tlim) at v VO2 max performed by well-trained males in the same condition at one week of interval (Billat et al., 1994b). It is essential in studies involving tlim at v VO2 max that the v VO2 max be precisely determined, or else the measured tlim will be meaningless. The purpose of this study was to examine the influence of the stage duration and velocity incrementation on the velocity at VO2 max and, consequently, on the two times to exhaustion (tlim) associated with the two v VO2 max generated by the two protocols. v VO2 max was determined in 15 trained male endurance athletes as the lowest speed at which VO2 max was attained in speed-incremented 0%-slope treadmill tests. For one test, increments were 1.0 km.h-1 and stages were 2 min in duration; for the other test, increments were 0.5 km.h-1 and stages were 1 min in duration. Results of paired means t-tests revealed no difference in v VO2 max obtained using the two protocols. v VO2 max was 20.7 +/- 1.0 km.h-1 with the 1.0 km.h-1 x 2 min protocol and 20.8 +/- 0.9 km.h-1 with the 0.5 km.h-1 x 1 min protocol. In addition, VO2, VCO2, VE, VE/VO2 and respiratory exchange ratio at the submaximal intensities that were common to both protocols (e.g., 17.0 km.h-1, 18.0 km.h-1, 19.0 km.h-1, 20.0 km.h-1) did not differ. Times to exhaustion at the two v VO2 max demonstrated a high degree of inter-individual variability (coefficients of variation were 35% and 45%) but did not differ (345 +/- 120 s versus 373 +/- 169 s). These results demonstrated that small changes in protocol have no significant impact on the value of v VO2 max and in consequence on tlim v VO2 max.

Adult↗

Efficient otoacoustic emission protocols employed in a hospital-based neonatal screening program.

Within the context of a hospital-based newborn hearing screening program, we have studied the application of two OAE protocols (TEOAE and DPOAE) on a group of 250 well babies. The main goal of this study was to evaluate the performance of DPOAE protocol in a relatively large population sample. using a preset number of five tested frequencies, in comparison with a default TEOAE screening protocol. The data were collected on the second day of life and during spontaneous sleep. The TEOAE recordings were acquired with linear protocols using click stimuli of 70-75 dB SPL and were used as indicators of normal cochlear function. The cubic distortion product DPOAE responses were evoked by an asymmetrical 75-65 dB SPL protocol, with a frequency ratio of 1.22. Five frequencies (referring to F2) were tested at 1.5, 2.0, 3.0, 4.0 and 5.0 kHz. The data from the DPOAE responses show a similar pass rate (similarity = 0.98) to the linear TEOAE protocol. The data presented suggest that a DPOAE cochlear evaluation, at 5 pre-selected frequencies, has clinical potential.

Deafness↗

Ultra-rapid microwave-stimulated tissue processing with a modified protocol incorporating microwave fixation.

AIMS: To develop an ultra-rapid microwave (MW)-stimulated histoprocessing protocol that incorporates MW fixation and produces consistent, high quality sections. METHODS: A range of fresh autopsy tissues was divided into three groups composed of equal numbers of small and large tissue blocks. Group 1 tissues were fixed for 8 hours in 4% buffered formaldehyde and processed in a conventional tissue processor through a 15-hour cycle. Group 2 tissues were processed in a MW histoprocessor according to the manufacturer's recommended protocol of irradiation in a proprietary reagent before embedding in paraffin. Group 3 tissues were processed with our protocol that incorporated the addition of MW fixation in 4% buffered formaldehyde and MW irradiation in isopropyl alcohol after irradiation in the proprietary reagent. RESULTS: The manufacturer's protocol resulted in 'grey' and 'wet look' artefacts in large tissue blocks. These artefacts did not occur in our protocol which produced sections that were indistinguishable from those obtained with conventional 23-hour processing. Histochemical and immunohistochemical stains were also indistinguishable and the tissue blocks cut very smoothly. CONCLUSIONS: The incorporation of an additional step to ensure adequate tissue fixation and one to ensure optimal dehydration and clearing resulted in a MW histoprocessing protocol that produced consistent results for both large and small tissue blocks. Paraffin-impregnated blocks can be produced very rapidly from fresh small and large tissue blocks in 45 and 100 minutes, respectively.

Artifacts↗

Protocols for college health nurses: alive and well in the 1990s.

This article seeks to assist college health nurses in developing appropriate protocols for patient care. In addition, the authors outline factors influencing protocol content, design, and development and describe steps in creating individualized protocols by practice setting. To provide college health nurses with a basic understanding of protocols, the authors offer definitions and examples of appropriate and inappropriate use, and show how protocols can influence the delivery of patient care. Although protocols may provide college health nurses with directives for managing specific health problems, they require a sophisticated level of judgment and skill in their implementation.

Female↗

A protocol for assessment of risk in wheelchair driving within a healthcare facility.

PURPOSE: The purpose of this article is to describe how a skilled nursing facility with significant wheelchair traffic developed a protocol for the multidisciplinary assessment and intervention management of patients whose wheelchair use represents a risk to self and others. This article describes the procedure and two case studies illustrating the utility of the protocol. METHOD: Staff of the facility developed a protocol for responding to sentinel events related to patients hurting themselves and others while using a wheelchair or observed using the wheelchair in an unsafe manner. The goal of the protocol is to determine the cause of the event, identify the necessary multidisciplinary interventions, and the evaluation of the effectiveness of the interventions. RESULTS: Case study analysis of the interventions indicated that a multidisciplinary evaluation and treatment plan leads to treatment interventions that suit the patient's medical condition while affording the patient the greatest amount of independence. CONCLUSION: Many patients who live in a long-term skilled nursing facility must use either a manual or a power wheelchair for mobility. For these patients, the wheelchair may represent one of the last forms of independence they enjoy. The implementation of the protocol helped staff respond to important changes to the patient's condition and prepare a coordinated intervention. The patients found the protocol to be a helpful component of their treatment.

Accidents↗

A modified protocol for quantitative fit testing using the PortaCount.

A modified quantitative fit testing method has been developed for testing half masks using the TSI PortaCount respirator fit tester. This approach focuses on shortening the time for each exercise during fit testing; however, the shortened protocol is applied only to the very good-fitting masks. For marginal-fitting masks, the testing is carried out according to the full Occupational Safety and Health Administration (OSHA) respiratory protection standard (29CFR1910.134).(1) The shortened protocol (currently not approved by OSHA) still uses all the exercises required by the OSHA standard but for a shorter time (30 seconds [s] for each exercise instead of the usual 60 s). How good the fit has to be to qualify for a shortened exercise is determined by the statistical analysis of a large data set containing pass and fail fit-test data. The statistical analysis involves calculating the sensitivity and specificity of the pass and failed fit tests on half masks. From this analysis, a multiplication factor (K) to the OSHA pass/fail criterion was developed. For a respirator to undergo the shortened protocol, the fit factor obtained during any exercise must be K times the OSHA pass/fail criterion of 100 for half masks. Hence, this approach is more conservative than fit testing protocols that involve shortened exercises regardless of the fit. Nevertheless, this approach still saves time without compromising the accuracy of the fit test expressed in terms of sensitivity and specificity. For the existing data, 85 percent of the fit tests would have been performed according to the faster test protocol while only 15 percent of the tests would have been tested according to the full-length OSHA test protocol.

Decision Trees↗

Determination of absorbed dose to water in reference conditions for radiotherapy kilovoltage x-rays between 10 and 300 kV: a comparison of the data in the IAEA, IPEMB, DIN and NCS dosimetry protocols.

A comparison of four of the most commonly used dosimetry protocols for the determination of absorbed dose to water in therapeutic kilovoltage x-rays using an ionization chamber (IAEA TRS-277, IPEMB, DIN and NCS) has been carried out. Owing to the different energy ranges and HVLs recommended by each protocol, backscatter factors, water-to-air mass energy absorption coefficient ratios and perturbation correction factors have been recast to a common quality range that all protocols satisfy individually to make a comparison possible. The results of the comparison show that in the sometimes reduced quality range originally included by the different protocols, determinations of absorbed dose to water at all beam qualities agree to within +/-1.0% with that obtained using the second edition of the IAEA TRS-277 code of practice (1997). The extrapolation of data to a common beam quality range practically preserves the agreement for all the protocols except for that issued by the NCS at the extremes of the range, where differences of up to 1.8% and 1.4% have been found for low and medium energies respectively. In all cases the DIN protocol yields very good agreement with TRS-277.

Models, Theoretical↗

Standardization of pulsed-field gel electrophoresis protocols for the subtyping of Escherichia coli O157:H7, Salmonella, and Shigella for PulseNet.

Standardized rapid pulsed-field gel electrophoresis (PFGE) protocols for the subtyping of Escherichia coli O157:H7, Salmonella serotypes, and Shigella species are described. These protocols are used by laboratories in PulseNet, a network of state and local health departments, and other public health laboratories that perform real-time PFGE subtyping of these bacterial foodborne pathogens for surveillance and outbreak investigations. Development and standardization of these protocols consisted of a thorough optimization of reagents and reaction conditions to ensure that the protocols yielded consistent results and high-quality PFGE pattern data in all the PulseNet participating laboratories. These rapid PFGE protocols are based on the original 3-4-day standardized procedure developed at Centers for Disease Control and Prevention that was validated in 1996 and 1997 by eight independent laboratories. By using these rapid standardized PFGE protocols, PulseNet laboratories are able to subtype foodborne pathogens in approximately 24 h, allowing for the early detection of foodborne disease case clusters and often aiding in the identification of the source responsible for the infections.

Cluster Analysis↗

Evaluation of gentamicin pharmacokinetics and dosing protocols in 195 neonates.

Gentamicin pharmacokinetics and dosing protocols in neonates were studied. Demographic and pharmacokinetic data on 202 neonates treated with gentamicin at a 500-bed medical center were collected over a three-year period. Administered doses, gentamicin concentration measurements, and recorded times were used to calculate each patient's clearance, volume of distribution, elimination rate constant, and half-life. The performance of 15 dosing protocols, including 6 previously published ones and 9 developed on the basis of the study, was evaluated using the pharmacokinetic data. Of the 202 patients, 195 were included in the analysis. The mean +/- S.D. clearance, volume of distribution, elimination rate constant, and half-life were 0.047 +/- 0.015 L/hr/kg, 0.45 +/- 0.11 L/kg, 0.107 +/- 0.032 L/hr, and 7.19 +/- 2.64 hours, respectively. Weight, urine output, gestational age, and postconceptional age (PCA) had the highest correlation with the pharmacokinetic values. Blood urea nitrogen concentration (BUN) and Apgar score were poor predictors of the pharmacokinetic values. There were no significant differences among patient subsets based on race and BUN, but subset analysis based on PCA did indicate significant differences. In simulations, the protocols based on the study patients tended to perform better than the literature protocols, with all but three achieving therapeutic goals in 75% or more of the neonates. Of the published protocols, Murphy and Carter's produced the greatest percentage of neonates with peaks from 5 to 10 mg/L and troughs of <2 mg/L. The devised protocols tended to perform poorly in producing troughs between 1 and 2 mg/L, yet performed comparatively well in providing therapeutic peaks from 5 to 10 mg/L.

Body Weight↗

Ploidy and karyotype of hepatocytes isolated from enzyme-altered foci in two different protocols of multistage hepatocarcinogenesis in the rat.

The ploidy and karyotypes of hepatocytes isolated from the livers of rats subjected to the protocols of Peraino et al. and of Solt and Farber were determined by the examination of such cells in primary culture. A study of 100 or more metaphases from each of five rats on each protocol revealed that 75-80% of gamma-glutamyltranspeptidase-positive (GGT+) hepatocytes isolated from livers of rats in either protocol were diploid, whereas only 23-33% of GGT- cells were diploid. Fifty percent or more of the karyotypes of hepatocytes from livers of rats receiving the Solt-Farber protocol exhibited one or more chromosomal breaks, whereas hepatocytes from livers of rats subjected to the Peraino protocol showed no increase in chromosomal breakage over that in normal controls. These studies demonstrate that the majority of GGT+ cells from altered hepatic foci are diploid and that the greater toxicity of the Solt-Farber protocol over that of Peraino is correlated with marked chromosomal breakage of GGT+ hepatocytes.

Animals↗

A comparative randomized multicentric study comparing the step-up versus step-down protocol in polycystic ovary syndrome.

BACKGROUND: The aim of the study was to evaluate follicular development and ovulation comparing the low-dose step-up and the step-down protocols, in women with clomiphene citrate (CC)-resistant polycystic ovaries. METHODS: Eighty-three women were randomized, and treated with recombinant (r) FSH (Puregon) using either the step-up (n=44) or step-down (n=39) protocol. They were followed up for three cycles unless pregnancy occurred. RESULTS: Monofollicular development occurred in 68.2% of the 85 cycles in the step-up group, as compared with 32% of the 72 cycles in the step-down group (P<0.0001). Hyperstimulation was statistically less frequent using the step-up procedure (4.7 versus 36%, P<0.0001). Both protocols used the same number of FSH units per cycle (951+/-586 versus 967+/-458 in step-up and step-down respectively, P=not significant). However, the duration of ovarian stimulation was statistically different (15.2+/-7.0 days in step-up versus 9.7+/-3.1 in step-down, P<0.001). Ovulation was observed in 70.3% of the cycles using the step-up procedure as compared with 51.3% using the step-down procedure (P<0.01). The cumulative rate of clinical gestations during the study did not differ between the two groups (38.6% in the step-up versus 30.8% in the step-down procedure). CONCLUSIONS: The step-up protocol using rFSH (Puregon), is more efficient in obtaining a monofollicular development and ovulation than the step-down protocol, in women with CC-resistant polycystic ovaries. Although the duration of stimulation is longer, the rate of ovarian hyperstimulation is much lower using the step-up protocol.

Adult↗

Treatment of catheter-related bacteraemia with an antibiotic lock protocol: effect of bacterial pathogen.

BACKGROUND: The standard therapy of dialysis catheter-related bacteraemia involves both systemic antibiotics and catheter replacement. We reported recently that instillation of an antibiotic lock (highly concentrated antibiotic solution) into the catheter lumen after dialysis sessions, in conjunction with systemic antibiotics, can successfully treat many episodes of catheter-related bacteraemia without requiring catheter removal. The present study evaluated whether the likelihood of achieving a cure with this protocol depends on the type of pathogen. METHODS: This was a historically controlled interventional study of an antibiotic lock protocol for the treatment of catheter-related bacteraemia. We analysed prospectively the likelihood of clinical cure (fever resolution and negative surveillance cultures) with an antibiotic lock protocol among patients with dialysis catheter-related bacteraemia. In addition, infection-free catheter survival was evaluated for up to 150 days, and compared with that observed among patients managed with routine catheter replacement. RESULTS: Overall, the antibiotic lock protocol was successful in 33 of 47 infected patients (70%) with catheter-related bacteraemia. The likelihood of a clinical cure was 87% for Gram-negative infections, 75% for Staphylococcus epidermidis infections, and only 40% for Staphylococcus aureus infections (P = 0.04). The median infection-free catheter survival with the antibiotic lock protocol was longer than that observed among patients with routine catheter replacement (154 vs 71 days, P = 0.02). CONCLUSIONS: The clinical success of an antibiotic lock protocol in eradicating catheter-related bacteraemia while salvaging the catheter is highly dependent on the bacterial pathogen. Thus, the overall success rate in an individual dialysis programme will depend on the relative frequencies of different bacterial pathogens.

Anti-Bacterial Agents↗

A comparison of the Naughton and modified Bruce treadmill exercise protocols in their ability to detect ischaemic abnormalities six weeks after myocardial infarction.

Symptom-limited Naughton and modified Bruce treadmill exercise protocols were compared in 20 patients to assess their ability in detecting additional ischaemic abnormalities six weeks after myocardial infarction. Eleven patients had a result indicating reversible myocardial ischaemia on both tests while the other nine had no ischaemic abnormality during either of the two protocols. The only significant difference between the two protocols was the longer exercise duration resulting from the Naughton protocol (17.3 +/- 5.0 vs. 14.8 +/- 2.8 mins, P less than 0.01). The mean maximum heart rates, rate-pressure products and achieved workloads did not differ significantly. We conclude that even though the Naughton protocol resulted in a significantly longer mean maximum exercise duration, the protocols were equally effective in detecting additional ischaemic abnormalities six weeks after myocardial infarction.

Aged↗

Differential effects of gonadotrophin-releasing hormone agonists administered as desensitizing or flare protocols on hormonal function in the luteal phase of hyperstimulated cycles.

The incorporation of gonadotrophin-releasing hormone agonist (GnRHa) in in-vitro fertilization (IVF) stimulation protocols has led to doubt about the quality of the subsequent luteal phase. The effects of two GnRHa stimulation protocols on luteal phase concentrations of oestradiol (E2), progesterone (P), luteinizing hormone (LH) and follicle stimulating hormone (FSH) were compared with the standard clomiphene stimulation regimen. Subjects receiving clomiphene with human menopausal gonadotrophin (HMG, n = 377) showed essentially similar luteal phase P concentrations to those receiving leuprolide acetate/HMG as a desensitization protocol. Subjects receiving concomitant leuprolide and HMG from day 2 to utilize the flare effect of the GnRHa exhibited significantly lower P levels in the luteal phase compared to clomiphene/HMG and leuprolide desensitization protocols despite the addition of HCG support. This occurred despite equivalent E2 concentrations at the time of ovulation and identical numbers of oocytes recovered. LH concentrations in non-conception cycles were suppressed for at least 14 days in the luteal phase in both GnRHa protocols compared to clomiphene stimulation. Differences were less obvious in cycles where conception occurred suggesting that implantation may proceed more favourably when the luteal endocrinology was optimal. It is concluded that flare methods of GnRHa hyperstimulation are associated with significantly different luteal phases compared with clomiphene or desensitization protocols. It is proposed that the use of the flare type of stimulation may significantly influence the response of the granulosa cells to LH or HCG via gonadotrophin receptors or through altered post-receptor function.

Chorionic Gonadotropin↗

Prospective randomized study of D-Trp6-LHRH versus buserelin in long desensitization protocols for medically assisted conception cycles.

In a prospective, controlled, randomized study where two different agonists were used, we compared three different long desensitization protocols for induction of multiple follicular growth in medically assisted conception cycles. In protocol A, 30 patients were injected with buserelin twice a day for 15 days prior to ovarian stimulation until human chorionic gonadotrophin (HCG) administration. In protocol B, 30 patients were injected with a single dose of long acting Triptorelin (3.75 mg) 15 days before the ovarian stimulation onset. In protocol C, 30 patients were injected with the long acting Triptorelin 4 weeks before ovarian stimulation followed by daily administration of 0.1 mg of the same agonist until HCG injection. There was no difference in the ovarian response to exogenous gonadotrophin stimulation, except for the presence of premature luteinization in two patients in group B. A significantly higher number of mature oocytes was collected from patients with protocol A; however, the fertilization and cleavage rate demonstrated no significant difference among the three groups of patients. The ongoing pregnancy rate and the implantation rate per treatment cycle were very similar in the three study groups. When the convenience, cost and side-effects for the patient are being considered, protocol B should be selected as the first choice when the agonist is utilized for the purpose of inducing pituitary desensitization before and during ovarian stimulation.

Adult↗