SEARCH · PubMed Health

Results for “Protocol”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 775 records · Page 43Linked to original sources

PubMed1999

Immune tolerance protocols using low-dose factor VIII: a review of the literature.

Low-dose immune tolerance protocols use doses of factor VIII of less than 50 IU/kg/day to induce immune tolerance. Such protocols are chosen for a variety of reasons including cost, patient acceptability and ease of administration. Early published reports of low-dose protocols appeared in 1981, described small numbers of patients and moderate success. It was proposed that such protocols might modify inhibitor responses from high to low. Later reports are sparse and clinical success is again moderate. Useful treatment and expectation guidelines have emerged from experience with these protocols, and improvements for patients with inhibitors can be achieved. Consideration of immunological success, however, raises doubts about whether real immune tolerance is achieved with such protocols.

Factor VIII↗

PubMed2001

Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage.

BACKGROUND: Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. OBJECTIVE: The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. METHODS: We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. RESULTS: Fifty patients (mean age, 66 years; 76% white; 56% men) were treated by general neurologists (70%), stroke neurologists (24%), or emergency physicians (6%). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10% (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75% versus 10%, P:<0.001), symptomatic ICH (38% versus 5%, P:<0.02), and ICH attributable to rTPA, occurring within 36 hours (38% versus 2.4%, P:<0.01), respectively. CONCLUSIONS: NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.

Anticoagulants↗

PubMed2002

Patient and psychiatrist ratings of hypothetical schizophrenia research protocols: assessment of harm potential and factors influencing participation decisions.

OBJECTIVE: A central ethical issue in schizophrenia research is whether participants are able to provide informed consent, particularly for protocols entailing medication washouts or placebo treatments. Few data show how patients with schizophrenia and psychiatrists assess such scientific designs regarding potential harm, willingness to participate, and the relative influence of clinicians, family members, and financial incentives upon participation decisions. METHOD: In this preliminary study, structured interviews were conducted with schizophrenia patients (N=59), and parallel surveys were completed by attending and resident psychiatrists (N=70). Four hypothetical research protocols were rated. Patients were asked about their own views; psychiatrists provided both their personal views and predictions of patient views. RESULTS: Patients and psychiatrists both perceived substantially different levels of harm across the four protocols, identifying significantly greater harm for medication washouts or placebo treatments. Participants were less willing to enroll in protocols perceived as more harmful. Schizophrenia patients found enrollment decisions relatively easy. Patients and psychiatrists indicated that doctor recommendations, monetary incentives, and, to a lesser extent, family preferences had a mild influence on participation decisions. CONCLUSIONS: Given hypothetical protocols with variable design elements, schizophrenia patients and psychiatrists made meaningful and discerning harm assessments and participation decisions. These findings suggest that schizophrenia patients may have strengths in the research consent process that may not be fully recognized. The impact of outside influences upon research enrollment decisions remains uncertain. While psychiatrists were often accurate in predicting patient responses, data suggest the importance of clarifying views of individual patients regarding specific protocols.

Adult↗

PubMedDate not supplied

Comparison of methods used for the removal of DMSO following cryopreservation and the development of an automated protocol.

Current methods of islet isolation are limited, thus requiring islets to be pooled from multiple donors to provide sufficient islet mass to permit insulin independence following islet transplantation. Low temperature banking is one approach used to pool islet preparations. Recently, we developed a method for bulk cryopreservation of islets in a single freezer bag system that is less labor-intensive and more readily kept sterile. As a further improvement to this bulk cryopreservation protocol we examined islet survival following slow-step dilution or our standard sucrose dilution protocol. Known numbers of canine islets were cryopreserved in DMSO by slow cooling to -40 degrees C, storing at -196 degrees C, and rapid thawing. When islets were frozen and thawed in glass tubes the recovery of islets after 48 h of tissue culture was significantly higher when the DMSO was removed using either a slow step (71.7 +/- 2.7%) or a modified slow step (75.7 +/- 3.9%) protocol as compared with the standard sucrose dilution protocol (65.7 +/- 3.0%) (p < 0.05, unpaired t-test). Insulin secretion in vitro and in vivo graft function was similar between the experimental groups. Similarly, when islets were frozen then thawed in freezer bags, islet recovery following 48 h postcryopreservation tissue culture at 37 degrees C was 74.8 +/- 2.4% for slow-step dilution compared with 66.2 +/- 2.7% for the standard sucrose dilution group (p < 0.05, unpaired t-test). Islets thawed in the freezer bag using the modified slow-step dilution protocol showed equivalent functional viability during static incubation to nonfrozen controls. Bulk cryopreservation of isolated islets in single blood freezer bags is a practical alternative to cryopreservation in glass tubes. Development of an automated protocol for the slow stepwise removal of the cryoprotectant from islets in freezer bags will facilitate low temperature tissue banking of islets.

Animals↗

PubMed2002

Use of protocols and guidelines by telephone nurses.

Changes in health care delivery, specifically the addition of telephone advice, affect how nurses work and how patients perceive care. It is important to understand the resources available to these nurses, the process by which they provide care, and patient outcomes. This descriptive study describes one type of resource, the availability and use of protocols. It also describes relationships between protocols and the quality of the nursing process and patient outcomes. Two-hundred-three taped calls to 32 advice RNs and 156 patient follow-up calls were used to measure protocol usage, nursing process quality, and patient outcomes. Although protocols were available for 78.8% of the calls, nurses varied in their extent of use (63.9% not fully used). There was a negative relationship (r = -0.395, p < 0.000) between the availability of protocols and overall quality of the nursing process. Protocol availability and use did not affect patient outcomes.

Adult↗

PubMed1992

Effectiveness of a gentamicin dosing protocol based on postconceptional age: comparison to published neonatal guidelines.

OBJECTIVE: To evaluate the effectiveness of a gentamicin dosing protocol based on postconceptional age in producing therapeutic serum concentrations and to compare the protocol with commonly used gentamicin dosing guidelines. DESIGN: During the initial three months of this study infants were dosed according to physician discretion (group I). In the subsequent three-month period patients were dosed according to a postconceptional age dosing schedule (group II). SETTING: Infants were enrolled after being admitted to the Newborn Intensive Care Unit at the University of Miami/Jackson Memorial Medical Center. PATIENTS: Infants less than 37 weeks gestational age with normal renal function, not receiving indomethacin, and requiring gentamicin treatment were enrolled. Fifty-nine infants were enrolled into group I (median weight 1300 g [range 720-3300]), postconceptional age 29 weeks [26-37]); and 68 infants were enrolled into group II (weight 970 g [530-3000], postconceptional age 29 weeks [24-36]). INTERVENTION: Patients in group II were dosed according to the following protocol: postconceptional age less than 30 weeks, 3.0 mg/kg q24h, and postconceptional age 30-37 weeks, 2.5 mg/kg q18h. Peak and trough serum gentamicin concentrations were obtained in all study patients. Pharmacokinetic parameters were calculated from measured serum concentrations. Using the calculated pharmacokinetic data, peak and trough serum concentrations were simulated for five published neonatal dosing guidelines and the proposed postconceptional age protocol. MAIN OUTCOME MEASURES: The number of therapeutic serum gentamicin concentrations resulting from the dosing guidelines studied were compared. RESULTS: Measured trough concentrations differed significantly between the two groups with 35 percent of patients in group I and 90 percent of patients in group II having trough values less than 2 mg/L (p less than 0.001). There was no significant difference in measured peak concentrations between groups. Simulated trough concentrations were significantly different when postconceptional age dosing was compared with commonly used protocols (p less than 0.0001) with the highest percentage of concentrations less than 2 mg/L (89 percent) resulting from the proposed postconceptional age guidelines. CONCLUSIONS: These data suggest that the proposed postconceptional age protocol is reproducible and reliable in achieving therapeutic gentamicin serum concentrations in neonates.

Drug Administration Schedule↗

PubMed1997

Comparison of graded versus constant treadmill test protocols for quantifying intermittent claudication.

The standard method for quantifying the symptoms of intermittent claudication is by using treadmill walking distance. It has recently been suggested that a graded exercise test is much more reproducible than a constant load exercise test. Graded protocols have also been claimed to abolish the placebo effect that has been reported with the constant load test. The reproducibility of absolute claudication distance (ACD) and initial claudication distance (ICD) using a constant load was compared to the graded load treadmill protocol. Fourteen patients (mean age 66 years) with varying severity of stable intermittent claudication were tested using a constant load (3.2 km/h, 10% gradient) and a graded load (3.2 km/h, 0% gradient increasing by 3.5% every 3 min). Patients were tested twice using each protocol in a random sequence, with a minimum 2 day interval between visits. Intra-class correlation coefficient (R) with a constant load protocol for ICD and ACD was R = 0.68, R = 0.93, respectively. With a graded protocol R = 0.84 for ICD and R = 0.98 for ACD. Relative coefficient of repeatability for ICD and ACD during constant load tests were 1.47 and 1.90 respectively and with a graded load test were 1.69 and 1.52 respectively. It was concluded that the graded load test was more reproducible than the constant load test but only by a small margin, whilst ACD was much more reproducible than ICD using either protocol.

Aged↗

PubMed2005

The impact of the Family Communication Coordinator (FCC) Protocol on the role stress of hospital chaplains.

The Family Communication Coordinator (FCC) Protocol was implemented to provide early family intervention and to facilitate effective communications during potential organ donation cases. Previous studies found the Protocol associated with improved donor outcome measures and with reduced role stress for ICU nurses caring for potential donors. The present study examines the impact of the Protocol on the perceived role stress of hospital chaplains serving as FCCs. All hospital chaplains serving as FCCs at an academic teaching hospital were surveyed. Their perceptions of job dimensions, role stress, job satisfaction, and commitment were measured; interviews and secondary data supplemented the surveys. The findings demonstrate that the FCC Protocol is associated with improved role stress, specifically role ambiguity and role conflict, among hospital chaplains serving as FCCs. Additionally, the findings suggest that satisfaction with the Protocol may be associated with experience with the Protocol.

Chaplaincy Service, Hospital↗

PubMed1992

Detection protocols for biotinylated probes: optimization using multistep techniques.

Recent studies using biotinylated in situ hybridization (ISH) have utilized a wide range of detection protocols for the biotinylated hybrids, leading to conflicting reports in the literature regarding sensitivity. In this study we compared 11 different detection protocols for biotinylated ISH using a measles virus-specific RNA probe on formalin-fixed, paraffin-embedded central nervous system tissue infected with measles virus. Maximum sensitivity was achieved with five-step detection protocols incorporating the use of a monoclonal antibody to biotin. Single-step detection protocols were found to be insensitive, as shown by their failure to detect viral nucleic acid in infected white-matter cells. Only by increasing the number of steps in the detection protocols were these infected cells demonstrable. Unless pre-hybridization, hybridization, and detection protocols are optimized, the results obtained in pathogenicity studies using ISH could be misinterpreted, leading to false conclusions about nucleic acid distribution. This also applies to the ever-increasing use of ISH for diagnostic purposes.

Antibodies, Monoclonal↗

PubMed2006

A preliminary protocol for multi-professional centers for the determination of signs and symptoms of temporomandibular disorders.

The objective of the present study was to test a protocol for the quantification of the frequency and severity of signs and symptoms of temporomandibular disorders (TMD) according to patient perception during two phases of investigation. The protocol was developed based on the signs and symptoms most frequently reported in the literature and on the circumstances in which they produce discomfort. Eighty-four patients diagnosed with TMD by functional examination of the masticatory system responded to the protocol questions and indicated the severity of signs and symptoms using an eleven point numerical scale (Phase 1). Forty-two patients were fitted with an occlusal splint (treated group) and the remaining participants did not use a splint (control group). The protocol questions were asked after 50 days of treatment (Phase 2). Based on the results of nonparametric statistical analysis, the incidence of signs and symptoms was high in Phase 1 and significant, with no difference between the groups, whereas the treated and control groups differed in Phase 2. A comparison between Phases 1 and 2 showed that only the treated group presented a reduction in the severity of signs and symptoms. The study showed that using this protocol, it is possible to define the frequency and severity of symptoms as well as the effect of the treatment. The advantage of this protocol is that it would complement the data obtained using clinical examination with information provided by the patient in a measurable manner.

Epidemiologic Methods↗

PubMed2006

The Virtual Insect Brain protocol: creating and comparing standardized neuroanatomy.

BACKGROUND: In the fly Drosophila melanogaster, new genetic, physiological, molecular and behavioral techniques for the functional analysis of the brain are rapidly accumulating. These diverse investigations on the function of the insect brain use gene expression patterns that can be visualized and provide the means for manipulating groups of neurons as a common ground. To take advantage of these patterns one needs to know their typical anatomy. RESULTS: This paper describes the Virtual Insect Brain (VIB) protocol, a script suite for the quantitative assessment, comparison, and presentation of neuroanatomical data. It is based on the 3D-reconstruction and visualization software Amira, version 3.x (Mercury Inc.) 1. Besides its backbone, a standardization procedure which aligns individual 3D images (series of virtual sections obtained by confocal microscopy) to a common coordinate system and computes average intensities for each voxel (volume pixel) the VIB protocol provides an elaborate data management system for data administration. The VIB protocol facilitates direct comparison of gene expression patterns and describes their interindividual variability. It provides volumetry of brain regions and helps to characterize the phenotypes of brain structure mutants. Using the VIB protocol does not require any programming skills since all operations are carried out at an intuitively usable graphical user interface. Although the VIB protocol has been developed for the standardization of Drosophila neuroanatomy, the program structure can be used for the standardization of other 3D structures as well. CONCLUSION: Standardizing brains and gene expression patterns is a new approach to biological shape and its variability. The VIB protocol provides a first set of tools supporting this endeavor in Drosophila. The script suite is freely available at http://www.neurofly.de2.

Animals↗

PubMed2004

Is eligibility for a chemotherapy protocol a good prognostic factor for invasive bladder cancer after radical cystectomy?

PURPOSE: To assess whether eligibility to an adjuvant chemotherapy protocol in itself represents a good prognostic factor after radical cystectomy for bladder cancer. PATIENTS AND METHODS: Between April 1984 and May 1989, our institution entered 35 patients with invasive bladder cancer into the Swiss Group for Clinical and Epidemiological Cancer Research (SAKK) study 09/84. They were randomly assigned to either observation or three postoperative courses of cisplatin monotherapy after cystectomy. This study had a negative result. The outcome of these 35 patients (protocol group) was compared with an age- and tumor-stage-matched cohort (matched group; n = 35) who also underwent cystectomy during the same period, but were not entered into the SAKK study, as well as the remaining 57 patients treated during the study period for the same indication (remaining group). RESULTS: Median overall survival decreased from 76.3 months in the protocol group to 52.1 months in the matched group and to 20.3 months in the remaining group. The respective times of median recurrence-free survival were 67.2, 16.0, and 9.4 months. Tumor progression occurred in 46% of the protocol group compared with 69% in the matched group and 65% in the remaining group (P < .05). Cancer-related death was noted in 40% of the protocol group, 57% in the matched group, and 56% in the remaining group. CONCLUSION: These data suggest that being willing and fit enough for a chemotherapy protocol is a good prognostic factor for invasive bladder cancer. This eligibility bias emphasizes the need for prospective, randomized trials, and indicates that single-group studies using historical or matched controls have to be interpreted with caution.

Aged↗

PubMed2006

The OECD program to validate the rat Hershberger bioassay to screen compounds for in vivo androgen and antiandrogen responses. Phase 1: use of a potent agonist and a potent antagonist to test the standardized protocol.

The Organisation for Economic Cooperation and Development (OECD) has completed phase 1 of the Hershberger validation intended to identify in vivo activity of suspected androgens and antiandrogens. Seventeen laboratories from 7 countries participated in phase 1, and results were collated and evaluated by the OECD with the support of an international committee of experts. Five androgen-responsive tissues (ventral prostate, paired seminal vesicles and coagulating glands, levator ani and bulbocavernosus muscles, glans penis, and paired Cowper's or bulbourethral glands) were evaluated. The standardized protocols used selected doses of a reference androgen, testosterone propionate (TP), and an antiandrogen, flutamide (FLU). All laboratories successfully detected TP-stimulated increases in androgen-responsive tissue weight and decreases in TP-stimulated tissue weights when FLU was co-administered. The standardized protocols performed well under a variety of conditions (e.g., strain, diet, housing protocol, bedding). There was good agreement among laboratories with regard to the TP doses inducing significant increases in tissue weights and the FLU doses decreasing TP-stimulated tissue weights. Several additional procedures (e.g., weighing of the dorsolateral prostate and fixation of tissues before weighing) and serum component measurements (e.g., luteinizing hormone) were also included by some laboratories to assess their potential utility. The results indicated that the OECD Hershberger protocol was robust, reproducible, and transferable across laboratories. Based on this phase 1 validation study, the protocols have been refined, and the next phase of the OECD validation program will test the protocol with selected doses of weak androgen agonists, androgen antagonists, a 5alpha-reductase inhibitor, and chemicals having no androgenic activity.

Androgen Antagonists↗

PubMed1975

Prediction of maximal oxygen consumption. Comparison of the Bruce and Balke treadmill protocols.

This study investigated the hypothesis that an individual's maximal oxygen consumption can be realistically predicted by the maximal time achieved in the Balke or Bruce treadmill protocols. The range of maximal oxygen consumption that can be expected for healthy individuals of any given age and activity was also evaluated. The maximal oxygen consumptions achieved by 79 men exercised using the Balke protocol and 77 men using the Bruce protocol were linearly regressed by a least-squares fit technique on maximal treadmill time and on age with activity status classified. Statistical analysis demonstrated an inadequate relationship for predicting maximal oxygen consumption from maximal treadmill time using either protocol. Also, maximal oxygen consumption correlated poorly with age even though activity status was considered. These findings make the nomogram for predicting an individual's functional aerobic impairment a clinical technique of questionable value. Since maximal oxygen consumption can only be grossly estimated from the maximal time performed in the Bruce or Balke protocols, there is no necessity to use them in preference to other clinically acceptable protocols.

Adult↗

PubMed2003

A protocol to estimate the release of anthropogenic hydrocarbons from contaminated soils.

An operational protocol, appropriate for a tier 1 or tier 2 type relative risk evaluation of a site that has polycyclic aromatic hydrocarbon (PAH) or petroleum hydrocarbon impacted soils, was developed to estimate the fraction of anthropogenic hydrophobic hydrocarbons that will be released rapidly from such soils. The development of this protocol used over 400 datasets from 40 different field samples to establish and verify the operational protocol. The datasets resulted from four-month kinetic desorption studies of these field samples. Based on the chemicals evaluated, the protocol has greatest application to two, three, and four ring-PAH and to diesel range aliphatic hydrocarbons. The protocol is a simple batch desorption analysis that uses established methods and is conducted for 7 d. The protocol results were verified with specific correlation relationships (r2 = 0.81 to 0.96) to estimate the rapidly releasing fraction (F value) that is obtained in a full, four-month chemical release evaluation.

Biological Availability↗

PubMed2000

Comparison of 5 protocols based on their abilities to use data extracted from digitized clinical radiographs to discriminate between patients with gingivitis and periodontitis.

BACKGROUND: This study was undertaken to compare 5 digital analytic protocols for their abilities to extract data from digital clinical radiographs and discriminate between patients with gingivitis and periodontitis. METHODS: Five digital-image analysis protocols were compared for their abilities to discriminate between two groups of 24 patients each. One group was diagnosed with healthy gingiva (or gingivitis) and the second with periodontitis. These groups were previously evaluated in published studies that used fractal and morphologic analyses. Pre-existing clinical radiographs for each patient were digitized and regions of interest (ROIs) were placed on interdental bone in mandibular posterior quadrants. The 5 protocols used were: 1) MGB: a median filtration to remove high-frequency noise, a Gaussian filtration to remove low-frequency noise, binarization of the resulting image, and quantification of the black pixels; 2) MGBS: the same protocol as MGB except for a skeletonization of the binary image and a quantification of the skeleton's pixels; 3) GBS: Gaussian filtration, binarization (thresholding on the mean pixel value) of the resulting image, skeletonization, and quantification of the pixels of the skeleton; 4) NS: normalization, skeletonization, and quantification of the skeleton's pixels; and 5) S: a variation of NS, except normalization was not used. The resulting values for the 2 patient groups were compared with Mann-Whitney U tests and effect likelihood-ratio test. RESULTS: For digitized radiographs, the mean gray-scale value (+/- standard deviation) for gingivitis patients was 183.22 +/- 18.53 and for periodontitis patients 181.26 +/- 17.20. Mann-Whitney U tests resulted in the following P values for these protocols: MGBS <0.01; S <0.01; GBS <0.01; NS <0.01; and MGB <0.83. Effect likelihood-ratio tests indicated that only MGBS and S significantly contributed to models containing the other factors. CONCLUSIONS: Small variations to protocols affected the strength of the discrimination between the gingivitis and periodontitis groups. While there is potential for morphologic analysis to be used to discriminate between patients with gingivitis and periodontitis, a robust technique was not identified.

Adult↗

PubMed2000

Ramp exercise protocols for clinical and cardiopulmonary exercise testing.

Historically, the protocol used for exercise testing has been based on tradition, convenience or both. In the 1990s, a considerable amount of research has focused on the effect of the exercise protocol on test performance, including exercise tolerance, diagnostic accuracy, gas exchange patterns and the accuracy with which oxygen uptake (VO2) is predicted from the work rate. Studies have suggested that protocols which contain large and/or unequal increments in work cause a disruption in the normal linear relation between VO2 and work rate, leading to an overprediction of metabolic equivalents. Other studies have demonstrated that such protocols can mask the salutary effects of an intervention, and some have suggested that the protocol design can influence the diagnostic performance of the test. Guidelines published by major organisations have therefore suggested that the protocol be individualised based on the patient being tested and the purpose of the test. The ramp approach to exercise testing has recently been advocated because it facilitates recommendations made in these guidelines. This article reviews these issues and discusses the evolution of ramp testing which has occurred in the 1990s.

Energy Metabolism↗

PubMed2000

Reliability of two 2,400-m time-trial protocols for assessing performance of Standardbred racehorses.

OBJECTIVE: To evaluate the reliability of 2 time-trial protocols, 1 that involved use of a pacemaker and 1 that did not, for assessing performance of Standardbred racehorses. ANIMALS: 3- to 7-year-old Standardbred maiden pacers. PROCEDURE: 11 Standardbred pacers were used to determine the reliability of a time-trial protocol that involved use of a galloping pacemaker. All tests were performed by a single driver. Horses were paced for an initial 1,600 m then raced and timed for the final 800 m. They were retested 9 days later. Twenty-two horses were used to determine the reliability of a time-trial protocol that did not involve use of a pacemaker. All tests were performed by a second driver. Horses were paced for the first 1,200 m then raced and timed for the final 1,200 m. They were retested 3 and 8 days later. RESULTS: Reliability of performance time, expressed as the coefficient of variation (ie, the typical percentage variation in a horse's time between trials), was similar for the 2 protocols (1.0% and 1.3%, respectively). CONCLUSIONS: The small variations in performance times for the 2 time-trial protocols were similar to those of the best comparable laboratory and field tests of human and equine performance. Both protocols would be suitable for investigating factors affecting performance of Standardbred racehorses.

Analysis of Variance↗