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At least 1,063 records · Page 59Linked to original sources

PubMed2005

Cleaning and sterilization protocol for reused cardiac electrophysiology catheters inactivates hepatitis and coxsackie viruses.

OBJECTIVE: To assess the efficacy of a standard cleaning and sterilization protocol employed during reuse of cardiac electrophysiology catheters on the infectivity of duck hepatitis B virus (DHBV; a surrogate for human hepatitis B virus), bovine viral diarrhea virus (BVDV; a surrogate for human hepatitis C virus), and human coxsackie type B3 virus (CB3). SETTING: Public health virology laboratory. METHODS: Studies were performed on the distal, electrode-containing segments of 120 electrophysiology catheters previously used in up to 10 clinical procedures. Catheter segments were immersed for 1 hour in blood infected with high titers of DHBV, BVDV, or CB3. After air drying for 2 hours, subgroups of 8 catheters were subjected to no treatment, washing in general-purpose detergent, washing in enzyme cleaner, sterilization in ethylene oxide, or the full protocol of sequential detergent-enzyme cleaner-ethylene oxide exposure. Presence of residual virus was assessed by nucleic acid detection and infectivity studies. RESULTS: DHBV nucleic acid was detected on catheters after individual steps and the full protocol, whereas BVDV and CB3 nucleic acids were detected after individual steps but not the full protocol. These findings were associated with the presence of infectious DHBV and CB3, but not BVDV, on catheters after washing in detergent or enzyme cleaner. However, ethylene oxide alone or the full protocol reduced infectivity of all three viruses to undetectable levels. CONCLUSION: These experimental studies provide strong evidence that appropriate cleaning and sterilization of reused electrophysiology catheters inactivates blood-borne viruses such as hepatitis B and C and coxsackie type B3.

Catheterization↗

PubMed1986

Performance of a urine-screening protocol.

The performance of a urinalysis protocol using screening Chemstrip-9 dipstick analysis with selective sediment microscopy and culture is reviewed. Sediment microscopy performed on urine samples positive for leukocyte esterase, nitrite, protein, or blood, or when specifically ordered (15% of urinalyses) was reduced by 57.1%. Protocol urine culture performed when more than 5 WBC/high-powered field (HPF), more than 10 bacteria/HPF, or yeasts were found on sediment microscopy or with a positive nitrite test was done for 9.8%. Urine culture was specifically ordered for another 13.6%. Percent significant bacteriuria (greater than or equal to 10(5) colony-forming units/mL) was higher for protocol-generated cultures (37.1%) versus ordered cultures (17.2%). For urinalyses with ordered cultures, the protocol would have detected 89.8% of cases with significant bacteriuria. The protocol has facilitated detection of significant bacteriuria with good acceptance by clinicians. Cost savings achieved by reduction of sediment microscopy was partly off-set by some increase in urine cultures performed.

Bacteriuria↗

PubMedDate not supplied

Electronic clinical trial protocol distribution via the World-Wide Web: a prototype for reducing costs and errors, improving accrual, and saving trees.

Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations.

Clinical Trials as Topic↗

PubMed1996

Fertilization and development of mouse oocytes cryopreserved using a theoretically optimized protocol.

Rational design of a cryopreservation protocol was demonstrated by using theoretical models of the cryopreservation process to develop an optimal freezing protocol for mouse oocytes. A coupled mechanistic model of the processes of freeze-induced cell dehydration and intracellular ice formation was developed, and cryomicroscopical measurements of intracellular ice formation kinetics were used to determine biophysical parameters required by the model, and to test model predictions of the freezing behaviour of mouse oocytes. A simple phenomenological model for oocyte damage resulting from exposure to concentrated electrolyte and cryoprotectant solutions during cryopreservation was obtained by defining a cost function equal to the duration of the freezing protocol. A two-step freezing protocol was theoretically optimized by using a sequential simplex algorithm to minimize the cost function, subject to the constraint that the predicted probability of intracellular ice formation remain below 5%, yielding a putative optimum at the cooling rate B = 0.59 degrees C/min, and plunge temperature Tp = -67 degrees C. By systematically varying B and Tp about these values in experiments with mouse oocytes cryopreserved in 1.5 M dimethyl sulphoxide, the maximal recovery of intact oocytes with a normal morphology (82%) was obtained for B = 0.5 degrees C/min and Tp = -80 degrees C. Further evaluation of the fertilizability and developmental capacity of oocytes cryopreserved using the optimized protocol yielded cleavage to the 2-cell stage in 65% of oocytes inseminated, and blastocyst formation in 50% of these 2-cell embryos.

Animals↗

PubMed1992

In-vitro progesterone production of human granulosa--luteal cells: the impact of different stimulation protocols, poor ovarian response and polycystic ovarian syndrome.

Granulosa cells from 85 patients undergoing in-vitro fertilization were cultured to investigate the impact of different stimulation protocols on in-vitro steroid secretion. A luteinizing hormone-releasing hormone analogue (LHRHa) was used either in the long protocol (pituitary desensitization) or in the short, 'flare-up' regime. The steroidogenesis of granulosa cell cultures was investigated under basal conditions as well as after stimulation with luteinizing hormone (LH). The results were compared to the secretory capacity of cells obtained after treatment with gonadotrophins only. No correlation was found between the preovulatory oestradiol peak and subsequent in-vitro progesterone production. Granulosa-luteal cells from long protocol cycles exhibited lower progesterone production on day 2 after follicular aspiration. On days 3 and 4 there was no difference between the three stimulation protocols regarding either basal or stimulated progesterone secretion. Cells from poor responders produced significantly (P less than 0.05) less basal progesterone during culture but they responded sufficiently to an LH stimulus. Granulosa cells from polycystic ovaries showed the lowest basal progesterone secretion (P less than 0.01 versus control); however, a normal stimulated level was achieved by adding LH to the culture medium. It is concluded that long protocol LHRHa pretreatment affects the very early progesterone formation of granulosa-luteal cells. Based on these in-vitro results, both poor responders and patients with polycystic ovaries should be supported vigorously in the luteal phase.

Adult↗

PubMed1992

Pituitary gonadotrophin secretory capacity during the luteal phase in superovulation using GnRH-agonists and HMG in a desensitization or flare-up protocol.

Pituitary gonadotrophin reserve and basal gonadotrophin secretion were tested during the luteal phase in women superovulated with buserelin/human menopausal gonadotrophin (HMG) in a desensitization (n = 17) or flare-up protocol (n = 7). In the desensitization protocol the luteinizing hormone-releasing hormone (LHRH) stimulated serum LH and follicle stimulating hormone (FSH) concentrations remained impaired at least until day 14 after arrest of the agonist. In the flare-up protocol basal and stimulated LH secretion was still abnormal on days 14 and 15 after human chorionic gonadotrophin (HCG) injection. Normal basal serum FSH concentrations were measured at the end of the luteal phase in the flare-up protocol, but the response of FSH to LHRH injection was still subnormal. We conclude that gonadotrophin function remained impaired until the end of the luteal phase after desensitization and flare-up GnRH-agonist and HMG stimulation protocols. Corpus luteum stimulation with exogenous HCG or substitution therapy using natural progesterone are required to prevent the possible negative effects resulting from pituitary dysfunction after GnRH-agonist treatment.

Adult↗

PubMed2005

Perspectives on medical research involving men in schizophrenia and HIV-related protocols.

Ethical issues in research on serious physical and mental illnesses have received great attention, and yet little is known about how the perspectives of clinical research participants with different diagnoses may compare. We conducted a preliminary study to examine the attitudes of men enrolled in schizophrenia-related protocols and in HIV-related protocols regarding the importance of medical research, key aspects of research participation, and the acceptability of research involvement by various groups. A total of 33 men enrolled in schizophrenia protocols and 15 men enrolled in HIV-related protocols volunteered for our study. Respondents affirmed the importance of medical research and endorsed many positive things about participation. Autonomy and altruism were identified as motivators for research involvement. Participation by diverse groups was seen as acceptable. Respondents expressed comfort and little stress with the interview process. Men in different diagnostic groups largely saw the issues the same. Our findings thus suggest that people with schizophrenia and HIV/AIDS who are enrolled in protocols may share a number of core attitudes or beliefs related to ethical aspects of research participation. Further study is needed to explore how research involvement may influence perspectives and whether differences in views exist across people with diverse physical and mental illnesses.

Acquired Immunodeficiency Syndrome↗

PubMed2000

Treatment of bleeding episodes in patients with hemophilia and an inhibitor: comparison of two treatment protocols with recombinant activated factor VII.

Six hemophilia A patients with inhibitors were treated with a continuous infusion of recombinant activated factor VII (rFVIIa) for various bleeding episodes. Bleeding episodes (n = 101) were treated according to a 12 h regular dose protocol or a shortened (6 h) augmented dose protocol. Patient response to therapy was assessed by symptomatic improvement within predefined timeframes. Although patient number was limited, both protocols appeared similar with respect to the proportion of patients responding to therapy; however, the augmented dose protocol appeared to be superior to the regular dose protocol with shorter response time, shorter duration of therapy and possibly lower rFVIIa requirements. Further studies are needed to define the efficacy of rFVIIa augmented dose administered as continuous infusion in treating hemophilia patients with inhibitors during major bleeding episodes, trauma and surgery.

Adolescent↗

PubMed1990

Credentialing protocols used by internal medicine residency programs in New York State.

In the fall of 1988, the Association of Program Directors in Internal Medicine established a New York State (NYS) Task Force to assess the impact of the "Report of the New York State Ad Hoc Advisory Committee on Emergency Services--Supervision and Residents' Working Conditions." Fifty-eight of the 62 NYS internal medicine residencies were surveyed in 1989 and 21 provided copies of their credentialing protocols. Analysis of these protocols identified eight essentials of a viable credentialing protocol, including five present in a majority of the examined protocols. The study produced a master list of procedures with a corresponding range of certification criteria and confirmed most programs had undergone parallel development of remarkably similar protocols, suggesting that a uniform credentialing system was possible and warranted further study.

Credentialing↗

PubMed1997

Protocol-guided diuretic management: comparison of furosemide by continuous infusion and intermittent bolus.

OBJECTIVE: To evaluate the safety and relative effectiveness of two diuretic protocols in the intensive care unit (ICU). DESIGN: Prospective, randomized comparative study. PATIENTS: Thirty-three cardiac and medical ICU patients with pulmonary edema or fluid overload for which aggressive diuresis was intended. INTERVENTIONS: Enrolled patients were randomized to fluid management strategies combining fluid restriction and individually adjusted diuretic therapy by either continuous or bolus infusions of furosemide, titrated to achieve negative hourly fluid balance. MEASUREMENTS AND MAIN RESULTS: Cumulative intake minus output (primary endpoint); change in serum creatinine, and length of ICU and hospital stay (secondary endpoints). Diuresis by either protocol was feasible, safe, and effective. The main outcome measures were not significantly different for either group managed with a standardized protocol. CONCLUSIONS: Protocol-guided diuretic management, with individualized titration of dosage to defined physiologic endpoints can be readily and safely implemented in the ICU. Both continuous and bolus diuretic regimens appear equally effective in achieving negative fluid balance. Larger studies with a randomized control arm are needed before these protocols can be recommended as routine practice.

APACHE↗

PubMedDate not supplied

Formulating and evaluating audiological test protocols.

This paper is the last in a series about audiological tests and test protocols (test batteries) designed to differentiate cochlear from retrocochlear site-of-lesion. While the first two papers dealt with individual tests, this paper is concerned with the audiological test protocol. A conceptual framework is presented for formulating a test protocol, and techniques are discussed for evaluating protocol performance. Using clinical data, we evaluate the performance of the traditional audiological test battery and make recommendations for the clinical use of audiological test protocols.

Audiometry, Pure-Tone↗

PubMed1995

Magnetic resonance imaging protocol optimization for evaluation of hyaline cartilage in the distal interphalangeal joint of fingers.

RATIONALE AND OBJECTIVES: To identify a single magnetic resonance imaging (MRI) protocol that will provide optimal signal-to-noise ratio, resolution, and image contrast with minimal susceptibility artifacts and that will allow clear delineation and visualization of cartilage, fluid, bone, tendons, and ligaments within the distal interphalangeal (DIP) joint of the human hand. METHODS: A highly optimized 2.4 T MRI system was constructed from a 31-cm horizontal bore magnet, using a solenoid radiofrequency coil. This was used to study the DIP joints of 16 healthy, asymptomatic volunteers. RESULTS: A range of image contrast protocols were explored, including spin-echo T1 and T2, field echo, chemical shift suppression to give water only images, and magnetization transfer. Susceptibility variations were explored by changing the field strength from 0.6 to 2.4 T. A spin-echo protocol with TR = 1500 msec and TE = 30 msec can routinely produce images with resolution 0.075 x 0.150 for a slice thickness of 1 mm in 13 minutes. That protocol can visualize simultaneously compact and trabecular bone, two layers of cartilage, synovial fluid, and synovium within the joint, tendons and ligaments, and the volar plate. CONCLUSIONS: Although the contrast is not fully optimized for any one tissue, the spin echo protocol (TR = 1500, TE = 30) provides sagittal MR images, which clearly delineate the major structures of interest within the DIP joint, and which will be used in future studies to compare changes in the DIP joint because of aging or osteoarthritis. Experience gained by applying the above methods to a total of 16 healthy, asymptomatic volunteers has enabled a single sequence to be identified, which although not optimized for any one tissue, nevertheless visualized simultaneously and clearly delineated compact and trabecular bone, two layers of cartilage, synovial fluid, and synovium within the joint.

Adult↗

PubMed1996

Predicting functional capacity during treadmill testing independent of exercise protocol.

Clinically useful estimates of VO2max from treadmill tests (GXT) may be made using protocol-specific equations. In many cases, GXT may proceed more effectively if the clinician is free to adjust speed and grade independent of a specific protocol. We sought to determine whether VO2max could be predicted from the estimated steady-state VO2 of the terminal exercise stage. Seventy clinically stable individuals performed GXT with direct measurement of VO2. Exercise was incremented each minute to optimize clinical examination. Measured VO2max was compared to the estimated steady-state VO2 of the terminal stage based on ACSM equations. Equations for walking or running were used based on the patient's observed method of ambulation. The measured VO2max was always less than the ACSM estimate, with a regular relationship between measured and estimated VO2max. No handrail support: VO2max = 0.869.ACSM -0.07; R2 = 0.955, SEE = 4.8 ml.min-1.kg-1 (N = 30). With handrail support: VO2max = 0.694.ACSM + 3.33; R2 = 0.833, SEE = 4.4 ml.min-1.kg-1 (N = 40). The equations were cross-validated with 20 patients. The correlation between predicted and observed values was r = 0.98 and 0.97 without and with handrail support, respectively. The mean absolute prediction error (3.1 and 4.1 ml.min-1.kg-1) were similar to protocol-specific equations. We conclude that VO2max can be predicted independent of treadmill protocol with approximately the same error as protocol-specific equations.

Adult↗

PubMed1999

Development of a maximal testing protocol for the NordicTrack cross-country ski simulator.

PURPOSE: The purpose of this study was to develop a valid VO2max testing protocol for the NordicTrack (NT) cross-country ski simulator. METHODS: To be considered a valid protocol, it was felt that the maximal values obtained from the cross-country skiing (XC) test should be similar to those obtained from a maximal graded treadmill (TM) test. During pilot testing, cadence (strides x min(-1), arm resistance, leg resistance, and grade were individually manipulated to study the effect on measured VO2. A protocol for the NT was developed from the findings of the pilot study, and the results were compared with a TM VO2max test utilizing the Bruce protocol. Thirteen male and 15 female volunteers (aged 22-49 yr) served as subjects and completed both tests in random order. The maximal physiological responses from the XC and TM max tests were compared using paired t-tests. RESULTS: There were no significant (P>0.05) differences in maximal VO2 (42.5 vs. 42.6 mL x kg(-1) x min(-1); 3.27 vs. 3.31 L x min(-1)), heart rates (HR; 185 vs. 185 bpm), or ratings of perceived exertion (RPE; 19.0 vs. 19.1) for the XC and TM tests. There were significant (P<0.05) differences for maximal VE (124.5 vs. 118.6 L x min(-1)) and respiratory exchange ratio (RER; 1.15 vs. 1.21) between the XC and TM tests, respectively. CONCLUSIONS: It was concluded that the testing protocol developed for the NT XC simulator is valid and can be expected to elicit similar maximal values when compared with TM testing.

Adult↗

PubMed2000

Validity of the modified back-saver sit-and-reach test: a comparison with other protocols.

PURPOSE: Studies have shown that the classical sit-and-reach (CSR) test, the modified sit-and-reach (MSR), and the newly developed back-saver sit-and-reach (BS) test have poor criterion-related validity in estimating low-back flexibility but yielded moderate criterion-related validity in hamstring flexibility. The V sit-and-reach (VSR) test was found to be practical but the validity has not been established. The purpose of this study was to propose a modified back-saver sit-and-reach (MBS) test, which incorporated all advantages of the various protocols, and to compare the criterion-related validity and reliability of all these tests. METHODS: 158 college students (F = 96, and M = 62; age = 20.77 +/- 2.51) performed CSR, VSR, BS (left and right leg), and MBS (left and right leg) tests in a randomized order. Scores from each test were then correlated with the criterion measures. RESULTS: For all sit-reach tests, intraclass reliability (single trial) was very high (r = 0.89-0.98). MBS yielded significant and highest r with low-back and hamstring criterion for men (r = 0.47-0.67) and women (r = 0.23-0.54). The low-back and right hamstring validity of MBS for men were significantly (P < 0.01) higher than those from BS and CSR, whereas no differences in criterion-related validity were found between the MBS and other protocols in women. The ratings of perceived comfort among the sit-and-reach protocols were significantly different (P < 0.001) from each other. The rating for MBS was observed the most comfortable test as compared with other protocols. CONCLUSION: The MBS test is not only a reliable test for hamstring and low-back flexibility, it is also a more practical with improved validity for hamstring and low-back flexibility in men than previous protocols.

Adolescent↗

PubMed2000

A study of stiffness protocol as exemplified by testing of a burst fracture model in sagittal plane.

STUDY DESIGN: An in vitro biomechanical study of lumbar spine segments. OBJECTIVE: To study the characteristics of the stiffness test protocol. SUMMARY OF BACKGROUND DATA: In an in vitro study using a flexibility protocol, forces are applied and motions are measured; no center of rotation needs to be specified. In a study using a stiffness protocol, the forces are measured and the motions are applied. This does require the center of rotation to be specified. Many biomechanical studies of the spine are available, but there is lack of clarity concerning which of these two test protocols is appropriate to achieve a certain study goal. METHODS: Five-vertebrae lumbar spine specimens with burst fractures in the middle vertebrae (L1) were used. Specially designed apparatus applied flexion and extension rotations around five centers of rotations located on anteroposterior line through the middle of L1. Maximum moment of 4 Nm was applied. RESULTS: The authors found load-displacement curves, ranges of motion, and neutral zones obtained at the five centers of rotations to be markedly different. The center of rotation located at the posterior longitudinal ligament produced large range of motion and neutral zones in comparison to the centers of rotation located at the anterior longitudinal ligament and the spinous process tip (P<0.01). CONCLUSIONS: The stiffness protocol requires that a center of rotation be specified. Shown here is the significant variability in the load-displacement curves, depending on the choice of the location of the center of rotation. Certain center of rotation locations may block the natural motions of the spine and may result in tissue damage.

Adult↗

PubMed2000

Protocol renal allograft biopsies and the design of clinical trials aimed to prevent or treat chronic allograft nephropathy.

BACKGROUND: The minimum sample size to perform a clinical trial aimed to modify the natural history of chronic allograft nephropathy (CAN) is very large. Since the presence of chronic tubulointerstitial damage in renal protocol biopsy specimens is an independent predictor of late outcome, we evaluated whether protocol biopsies could facilitate the design of trials aimed to prevent or treat CAN. METHODS: Two hundred eighty-two protocol biopsy specimens were obtained 3 months after transplantation in 280 patients with serum creatinine levels <300 micromol/L, proteinuria <1000 mg/day, and stable function. The specimens were evaluated according to the Banff criteria. RESULTS: Graft survival depended on the presence of CAN and renal transplant vasculopathy (RTV). Thus, biopsy specimens were classified as: (a) no CAN (n=174); (b) CAN without RTV (n=87); and (c) CAN with RTV (n=21). Graft survival at 10 years was 95%, 82%, and 41%, respectively (P=0.001). Total serum cholesterol before transplantation was 4.5+/-1.1, 4.6+/-1.1, and 5.3+/-1.6 mmol/L, respectively (P=0.009) and it was the only predictor of RTV. Power analysis (beta=20%, alpha=5%) was done to evaluate whether protocol biopsies can facilitate the design of clinical trials aimed either to prevent or treat CAN. We showed that the most feasible approach would be to use the presence of CAN as the primary efficacy end point in a prevention trial. To demonstrate a 50% reduction in the incidence of CAN at 3 months, 570 patients would be required. CONCLUSIONS: Protocol biopsies may allow a reduction of sample size and especially the time of follow-up in a trial aimed to prevent CAN.

Biopsy↗

PubMed2001

Promising early outcomes with a novel, complete steroid avoidance immunosuppression protocol in pediatric renal transplantation.

BACKGROUND: Corticosteroids have been a cornerstone of immunosuppression for four decades despite their adverse side effects. Past attempts at steroid withdrawal in pediatric renal transplantation have had little success. This study tests the hypothesis that a complete steroid-free immunosuppressive protocol avoids steroid dependency for suppression of the immune response with its accompanying risk of acute rejection on steroid withdrawal. METHODS: An open labeled prospective study of complete steroid avoidance immunosuppressive protocol was undertaken in 10 unsensitized pediatric recipients (ages 5-21 years; mean 14.4 years) of first renal allografts. Steroids were substituted with extended daclizumab use, in combination with tacrolimus and mycophenolate mofetil. Protocol biopsies were performed in the steroid-free group at 0, 1, 3, 6, and 12 months posttransplantation. Clinical outcomes were compared to a steroid-based group of 37 matched historical controls. RESULTS: Graft and patient survival was 100% in both groups. Clinical acute rejection was absent in the steroid-free group at a mean follow-up time of 9 months (range 3-13.7 months). Protocol biopsies in the steroid-free group (includes 10 patients at 3 months, 7 at 6 months, and 4 at 12 months) revealed only two instances of mild (Banff 1A) subclinical rejection (reversed by only a nominal increase in immunosuppression) and no chronic rejection. At 6 months the steroid-free group had no hypertension requiring treatment (P=0.003), no hypercholesterolemia (P=0.007), and essentially no body disfigurement (P=0.0001). Serum creatinines, Schwartz GFR, and mean delta height Z scores trended better in the steroid-free group. In the steroid-free group, one patient had cytomegalovirus disease at 1 month and three had easily treated herpes simplex stomatitis, but with no significant increase in bacterial infections or rehospitalizations over the steroid-based group. The steroid-free group was more anemic early posttransplantation (P=0.004), suggesting an early role of steroids in erythrogenesis; erythropoietin use normalized hematocrits by 6 months. CONCLUSIONS: Complete steroid-free immunosuppression is efficacious and safe in this selected group of children with no early clinical acute rejection episodes. This protocol avoids the morbid side effects of steroids without increasing infection, and may play a future critical role in avoiding noncompliance, although optimizing renal function and growth.

Adolescent↗