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At least 577 records · Page 32Linked to original sources

PubMed1992

Intravitreal antibiotics: accuracy of dilution by pharmacists, ophthalmologists, and ophthalmic assistants, using three protocols.

We compared the accuracy with which general ophthalmologists, pharmacy personnel, and ophthalmic assistants diluted intravitreal antibiotics, using a method of their own devising, a new protocol using an insulin syringe, and Duane's protocol. The insulin syringe method proved less accurate and more complex than Duane's protocol, but was better than not using a standardized protocol at all. With all methods, the pharmacy personnel produced the most accurate dilutions, with the least variability. The ophthalmologists' dilutions were much more variable both without a protocol and with the insulin syringe method, but they were acceptable with the Duane's protocol. The ophthalmic assistants produced unacceptable results with all methods. Since the decision to inject antibiotics is usually made under emergency conditions, when errors of dilution are more likely, whenever possible, pharmacy personnel should be entrusted with providing the dosage of medications to be injected intraocularly. If pharmacists are unavailable, ophthalmologists may reconstitute medications using a reliable and simple protocol such as Duane's.

Anti-Bacterial Agents↗

PubMedDate not supplied

A prospective, randomized clinical trial comparing two hyperbaric treatment protocols for carbon monoxide poisoning.

INTRODUCTION: The optimal hyperbaric oxygen (HBO2) treatment protocol for acute carbon monoxide (CO) poisoning is unknown. This is indicated by one study that found 18 different protocols to treat CO poisoning by North American multiplace hyperbaric facilities. A pilot study was conducted to evaluate the feasibility of randomizing patients to different protocols and to determine whether any large differences in clinical outcome were present between the two most common protocols. METHODS: Adult patients with accidental CO poisoning resulting in transient loss of consciousness, presentation to the emergency department within 12 hours, primary language English, high school education, and residence within 100 miles of the hyperbaric facility were recruited. Enrolled patients were randomized to one HBO2 treatment at 2.4 atmospheres absolute (atm abs) pressure with 90 minutes of 100% oxygen breathing vs. treatment by the US Air Force CO protocol (3.0 atm abs maximum pressure). A neurocognitive screening test was performed immediately after hyperbaric treatment and repeated 14-21 days later. RESULTS: From 1995 to 2002, 30 patients age 21 to 88 years were randomized, 18 to treatment at 2.4 atm abs and 12 to 3.0 atm abs. Average carboxyhemoglobin level for the population was 24.8 +/- 8.8% (mean +/- SD). Delay to hyperbaric treatment averaged 313 +/- 129 minutes. Neither variable was different between treatment groups. Six patients had abnormal neurocognitive testing immediately following hyperbaric treatment, 4 in the 2.4 atm abs group (22%) and 2 in the 3.0 atm abs group (17%) (P=0.71). One patient in each group demonstrated abnormality on delayed testing (p=0.75). One in each group did not return for follow-up. CONCLUSIONS: It is feasible to randomize CO-poisoned patients to different hyperbaric treatment protocols. Determination of differences in efficacy between treatment protocols will require a large multicenter trial with the use of detailed neurocognitive testing.

Adult↗

PubMedDate not supplied

A modified ultrarush insect venom immunotherapy protocol for children.

The prevalence of insect venom allergy in the European population is approximately 5%. Hymenoptera venom allergy is an important epidemiological problem. Ten to 40 deaths are reported annually in Germany. In contrast to conventional dose increase schedules lasting a minimum of 5 days, shorter protocols reduce the patient's stay in the hospital and provide an earlier protection toward stings. Clinical studies on ultrarush protocols have been published for adult patients, but very little data are currently available for children. Therefore, we investigated the safety and tolerability of a shortened insect venom immunotherapy (VIT) in children and adolescents. Forty-three children and adolescents (aged 4-18 years) with insect venom allergy were treated in this study. Five children were hyposensitized according to the ultrarush protocol with nine injections (as suggested by Brehler et al. (Safety of a two-day ultrarush insect VIT protocol in comparison with protocols of longer duration and involving a larger number of injections. J Allergy Clin Immunol 105:1231-1235,2000); 38 children received the modified ultrarush schedules with only eight subcutaneous injections. With both protocols the maintenance dose (100 microg) was achieved in 24 hours. Twenty-five patients (58.1%) showed no reaction after the injections. In 11 patients (25.6%), extensive erythema (>5 cm, maximum of 20 cm) was found at the injection site. Erythema and edema (>5 cm, maximum of 15 cm) were observed in seven patients (16.2%). The maintenance dose was well tolerated, with no systemic reaction in any patient. The modified ultrarush protocol for insect VIT used in this study showed very good tolerability and safety in children and adolescents. This dose regimen can increase compliance by shortening inpatient stay and reduces hospital costs.

Adolescent↗

PubMed2006

Detection of sentinel lymph nodes in cervical cancer. A comparison of two protocols.

BACKGROUND: The aim of this study was lymphatic mapping to identify SLN in cervical cancer (CaCerv) with radioactive colloids, intraoperative detection with patent blue dye (PBD) and gamma probe (GP) and biopsy and comparison of two protocols. MATERIAL AND METHODS: In 54 patients with CaCerv before hysterectomy and lymph nodes dissection (LND) we performed preoperative lymphoscintigraphy utilizing 99mTc-colloid (Nanocoll, SentiScint or Nanocis), activity 40 MBq, on the operation day (30 women) or the day before operation (24 women). Gynaecologists injected 4 peritumoural injections of colloid into the cervix around the tumour. Scintigraphy followed 25-50 minutes (one-day protocol) or 12-19 hours (two-day protocol) after injection. Gynaecologists also injected 4 peritumoural injections of PBD into the cervix around the tumour. All women underwent SLN biopsy and LND (in average 35 lymph nodes were taken) and hysterectomy. SLNs (active and/or blue lymph nodes) were examined by a pathologist [histopathology and immunohistochemistry (IH) with detection of cytokeratine]. No SLN was examined without IH. RESULTS: The gynaecologists withdrew 123 SLNs (on average 2.27/1 patient) and in total 1898 lymph nodes (on average 35/1 patient). In 1 woman the tumour was inoperable. Two-day protocol, which involved scintigraphy, PBD and GP detected SLNs on both sides (45 SLNs) in 17 women (70.8%), SLNs on the one side (6 SLNs) in 3 patients (12.5%) and no SLNs were found in 4 women (16.7%). One-day protocol detected SLNs on both sides in 23 patients (74.1%)--63 SLNs, in 7 women on one side (25.9%)--9 SLNs. Metastases in SLNs (with or without metastases in other LN) were found in 21 patients (38.9%)--in 1 woman of stage FIGO IB1, in 1 woman of stage FIGO IB2, in 1 patient of stage FIGO IIIA and in all 18 patients of stage FIGO IIIB. False negative SLN detection was 0%. CONCLUSIONS: In SLN detection in patients with CaCerv, all 3 methods--scintigraphy, PBD and GP--should be used, and the success rate of SLN detection increases, although scintigraphy has lower significance than in SLN detection in malignant melanoma and breast cancer. One-day protocol had a better detection rate of SLN than two-day protocol. The method is promising but its results are not as unequivocal and optimistic as in breast cancer and malignant melanoma, and it is still experimental. Additional experience is necessary.

Adult↗

PubMed1987

Knowledge engineering for a clinical trial advice system: uncovering errors in protocol specification.

ONCOCIN is an expert system that provides advice to physicians who are treating cancer patients enrolled in clinical trials. The process of encoding oncology protocol knowledge for the system has revealed serious omissions and unintentional ambiguities in the protocol documents. We have also discovered that many protocols allow for significant latitude in treating patients and that even when protocol guidelines are explicit, physicians often choose to apply their own judgment on the assumption that the specifications are incomplete. Computer-based tools offer the possibility of insuring completeness and reproducibility in the definition of new protocols. One goal of our automated protocol authoring environment, called OPAL, is to help physicians develop protocols that are free of ambiguity and thus to assure better compliance and standardization of care.

Clinical Trials as Topic↗

PubMed1996

Cardiorespiratory variables during a continuous ramp exercise protocol in normal young adults.

The purpose of the present study was to determine whether the cardiorespiratory variables measured during an exercise test with a continuously increasing workload (ramp) protocol are reproducible and to compare them to the values obtained with a step-wise incremental (James) protocol. Twenty normal adolescents and young adults performed two exercise tests on a cycle-ergometer, one with each protocol, and twelve of these subjects additionally performed a second identical ramp test. The results show that the cardiorespiratory variables measured during exercise with ramp protocol are reproducible and that peak values are not different from those obtained with step-wise incremental exercise protocol, except for a higher peak power. At intermediate equivalent workloads, there were significant correlations between cardiorespiratory variables measured in steady-state conditions with the incremental protocol and those obtained in non-steady-state conditions with the ramp protocol.

Adolescent↗

PubMed1996

The EON model of intervention protocols and guidelines.

We present a computational model of treatment protocols abstracted from implemented systems that we have developed previously. In our framework, a protocol is modeled as a hierarchical plan where high-level protocol steps are decomposed into descriptions of more specific actions. The clinical algorithms embodied in a protocol are represented by procedures that encode the sequencing, looping, and synchronization of protocol steps. The representation allows concurrent and optional protocol steps. We define the semantics of a procedure in terms of an execution model that specifies how the procedure should be interpreted. We show that the model can be applied to an asthma guideline different from the protocols for which the model was originally constructed.

Adult↗

PubMed1996

[Results of IVF and ET 1992-95 at the Gynecological-Obstetrical Clinic in Olomouc--comparison of stimulation protocols].

The authors compared three types of stimulation protocols used in their department in 1992-1995. In the standard protocol they evaluated the use of hMG and FSH with regard to the number of abolished cycles and the number of achieved pregnancies. They compared protocol No. 1 "standard: CC + G (FSH), protocol No. 2 "short": GnRH-a + hMG (FSH) and protocol No. 3 "long" GnRH-a + hMG (FSH). They evaluated the number of abolished cycles, the effectiveness of the protocols as regards the number of obtained oocytes, the number of performed embryo transfers, the number of clinical pregnancies/embryo transfers and the number of cryopreservations. The abortion rate in relation to the used protocol was also evaluated.

Embryo Transfer↗

PubMed1997

An evaluation of a chest pain diagnostic protocol to exclude acute cardiac ischemia in the emergency department.

BACKGROUND: Although accelerated diagnostic protocols are being increasingly used in emergency departments to diagnose acute cardiac ischemia, there have been no prospective evaluations of a chest pain diagnostic protocol with serial determinations of creatine kinase MB isoenzyme and mandatory exercise electrocardiography (ExECG). METHODS: Prospective cross-sectional study in which chest pain protocol results were compared with final (reference) diagnoses of acute cardiac ischemia (including acute myocardial infarction and unstable angina). Patients in need of hospital admission but at low probability (by a validated algorithm) for acute myocardial infarction were examined for exclusions: known coronary artery disease, cardiac complications, severe comorbidities, or inability to perform exercise testing. A 12-hour diagnostic protocol included serial measurements of creatine kinase MB, ECG, and clinical assessments followed by ExECG for those with negative initial serial testing. Reference diagnoses were established during hospitalization and diagnostic accuracy was assessed. RESULTS: The study group of 317 patients was 54% male and 65% black, and had a mean age of 46.6 years; 9.5% had a final diagnosis of acute cardiac ischemia. For this diagnosis, the protocol had a sensitivity of 90.0% (95% confidence interval, 72.3%-97.4%); specificity, 50.5% (95% confidence interval, 44.6%-56.4%); positive predictive value, 16.0%; and negative predictive value, 98.0%. Creatine kinase MB, serial ECGs, and ExECG each made a contribution to improved sensitivity and accuracy, whereas clinical reassessments were less discriminating, as indicated by protocol's receiver operating characteristic curve. CONCLUSIONS: A chest pain diagnostic protocol achieved high sensitivity and improved specificity over the standard emergency department workup. There were no adverse advents associated with early ExECG.

Algorithms↗

PubMed1996

Can protocol-specified doses of chemotherapy and radiotherapy be used as a measure of treatment actually received? A CCG/NIH study on long-term survivors of acute lymphocytic leukemia.

In a cohort of 593 long-term survivors of acute lymphocytic leukemia identified through the Children's Cancer Group (CCG), treatment abstracts were obtained and compared to protocol information on radiation therapy and intravenous chemotherapy. This was done in order to evaluate the actual compliance to protocol-specified treatment, and assess if protocol-specified doses can be used in studies of late effects of treatment. The compliance to protocol-specified type of treatment ranged between 95.3% (intrathecal methotrexate) and 98.6% (adriamycin) for chemotherapy, and between 94.1% (cranial radiation) and 97.0% (extended field radiation) for radiation. Concordance with the protocol-specified chemotherapy dose (+/- 25%) was 57.5% for adriamycin, 91.3% for daunomycin, and 48.5% for cyclophosphamide. When concordance was low, most patients received doses that were lower than expected. Concordance with chemotherapy was significantly lower for high-dose regimens than for low-dose regimens. Concordance with protocol-specified radiation dose (+/- 10%) was 87.4% for cranial radiation, 87.8% for spinal radiation, and 85.7% for extended field radiation. Concordance with treatment did not differ by gender, relapse status, or age at diagnosis. In this cohort of leukemia survivors, the validity of type of treatment was greater than the validity of dosage. Great care should be used when drawing conclusions about effects of treatment dosage. Although costly and time consuming, it appears that chart reviews are the most appropriate way to collect information about dose-related effects of therapy.

Adolescent↗

PubMed1989

[Comparative study of 3 successive treatment protocols of osteogenic osteosarcoma in children, adolescents and young adults. Apropos of 100 cases].

Three therapeutic protocols were used successively for the treatment of osteogenic osteosarcoma since 1978. The first protocol associated initial surgery and 12 months of chemotherapy and was applied to 41 patients with good results in adults but poor results in children. A protocol introducing adjuvant chemotherapy based on the association of adriamycin-cisplatinum gave very disappointing results first in children and then in adults. The protocol based on HD MTX gave much more encouraging results: the long version (3 months preoperative chemotherapy) was effective in good responders but did not influence the course of poor responders. The shortened version of this protocol, derived from the T 10 Rosen protocol (1 month preoperative chemotherapy conservative surgery and appropriate peri- and postoperative chemotherapy) seems to transform the prognosis of osteosarcoma. Our current results indicate a complete primary remission rate of 89% at one year, and 83% at 33 months.

Adolescent↗

PubMed2000

Improved outcome in childhood B-cell lymphoma with the intensified French LMB protocol.

BACKGROUND: During the last 20 years, 120 children with B cell lymphoma were treated at the National Pediatric Hematology/Oncology Center of Israel. Until 1986, 63 patients received an institutional protocol (BMC), and thereafter 57 patients received a modified French LMB protocol. We report the results of a retrospective analysis comparing the results of these two protocols. PROCEDURE: Patient characteristics were similar in both groups except for stage of disease and lactate dehydrogenase (LDH) levels. Significantly more patients in the LMB group had higher stage disease, and the LDH levels also were higher (<600 microg/ml). RESULTS: Fifty-four of fifty-seven children on the modified LMB protocol are alive, disease-free, with an overall event-free survival of 94% (median follow-up of 73 months). Event-free survival for stages I, II, and III patients is 100%, and for stage IV 77%, whereas the overall event-free survival was 58% among 63 children treated previously, and for stage IV patients only 10%. Severe marrow suppression and neutropenic enterocolitis were the major complications of this intensive protocol. CONCLUSIONS: Intensive chemotherapy with a modified LMB protocol and modern supportive care result in a high cure rate of childhood B cell lymphoma even in patients with advanced disease.

Adolescent↗

PubMed2000

Estimating the parameters of aerobic function during exercise using an exponentially increasing work rate protocol.

A new exercise protocol has been proposed, with respect to cardiopulmonary exercise testing, which starts at a low work rate (WR) and increases exponentially by a standard percentage of the previous work rate every minute: the test is termed STEEP (standardised exponential exercise protocol). The potential advantage of this protocol is that it can accommodate a wide range of subjects, since it allows a maximum to be attained with a relatively narrow variation of tolerance time, regardless of subjects exercise capacity. To date, only the VO2max has been compared with that from the current standard ramp protocol. The ramp, however, also allows other important parameters of aerobic function to be estimated: the anaerobic threshold (AT); the response time constant; and delta VO2/delta WR. The aim of this study was, therefore, to clarify whether these aerobic parameters can be readily discerned from the responses to the STEEP protocol both from a theoretical and practical viewpoint. As a result of theoretical considerations, we demonstrated that the VO2 time constant and delta VO2/delta WR may not both be estimated uniquely. As a practical expedient, a procedure was proposed for estimating the parameter analogues. The preliminary results for six subjects between the STEEP and ramp protocols showed consistent positive correlation for VO2max (r = 0.997) and AT-VO2 (r = 0.980), whereas the correlation for the VO2 time constant and delta VO2/delta WR were not significant. Further study is needed to clarify the reason(s) for the discrepancies both from a theoretical and practical viewpoint.

Clinical Protocols↗

PubMed2005

Detection of liver metastases under 2 cm: comparison of different acquisition protocols in four row multidetector-CT (MDCT).

This study compared different acquisition protocols performance to detect small liver metastases (<2 cm). Thirty consecutive patients with histologically proven hepatic metastases were explored by MDCT at the liver equilibrium phase by four successive acquisitions. We compared the following protocols (1-4): 5/30/1.5 (section thickness/table speed/pitch); 5/15/0.75; 5/11.25/0.75; and 2.5/15/1.5 with the same X-ray dose. The gold standard was based on patient radiological follow-up. Evolutive lesions were considered as true positive (TP). The described lesions, not found on the follow-up exams despite tumoral progression, were considered as false positive (FP). Stable lesions could not be considered as metastasis and were eliminated. One hundred and seventy-six lesions were detected: 61 TP and 91 FP. Twenty-four lesions were eliminated. The mean kappa values for protocols 1, 2, 3 and 4 were, respectively, 0.43, 0.68, 0.73 and 0.51 (0.61-0.80: substantial agreement) and the mean areas under the ROC curve were, respectively, 0.76, 0.87, 0.86 and 0.80. The results of protocols 2 and 3 were significantly superior to those of protocols 1 and 4. MDCT protocols using thin sections or an increased table speed are less efficient in detecting small metastases.

Adult↗

PubMed1992

Comparison of ischemic and physiologic responses during exercise tests in men using the standard and modified Bruce protocols.

The importance of low-level (warm-up) exercise for reducing exercise-induced myocardial ischemic symptoms in patients with coronary artery disease is well-recognized by clinicians. Whether altering the abruptness of exercise, such as that which occurs during different frequently used testing protocols, affects myocardial ischemic variables and maximal exercise capacity has not been resolved. This study seeks to determine the effects of altering the increment of work-rate change per exercise stage on both the ischemic threshold and maximal exercise capacity using 2 frequently used exercise testing protocols. Thirty-two patients with documented coronary artery disease and previously positive exercise tests (ischemic ST depression greater than or equal to 1.0 mm) performed symptom-limited exercise tests using both the standard and modified Bruce protocols in random order, 1 hour apart. Exercise electrocardiograms were analyzed to determine the ischemic threshold, defined as heart rate at onset of greater than or equal to 1.0 mm ischemic ST depression. Patients achieved a higher peak heart rate (124 +/- 19 vs 117 +/- 21 beats/min; p less than 0.0001), rate-pressure product (21.4 +/- 3.9 vs 19.8 +/- 4.1 beats/min x mm Hg x 10(3); p less than or equal to 0.0001) and oxygen consumption (VO2) (18.5 +/- 3.7 vs 16.5 +/- 4.4 ml/kg/min; p less than or equal to 0.001) with the standard than with the modified Bruce protocol. At matched submaximal exercise stages there were no differences in VO2, heart rate or oxygen pulse between protocols. Time to ischemic threshold was significantly reduced with the standard compared with the modified Bruce protocol (312 +/- 107 vs 607 +/- 221 seconds; p less than 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

PubMed1995

A no-touch technique protocol to diminish cerebrospinal fluid shunt infection.

BACKGROUND: Cerebrospinal fluid (CSF) shunts become infected primarily by bacterial organisms indigenous to the patient's skin flora, but bacteria from the operating room environment, hospital, or no obvious source may also infect a shunt. To decrease the incidence of shunt infection, a no-touch technique protocol was developed and utilized in a prospective manner. METHODS: A before-after trial analysis was performed to compare the infection rates between patients who had CSF shunts placed using the no-touch technique protocol versus patients who had surgery without the protocol. Patients were stratified by age, etiology of hydrocephalus, type of shunt surgery, and presence of a contaminated skin wound, namely, tracheostomy, gastrostomy-jejunostomy, colostomy, or halo. The differences in infection rates were analyzed with the Fisher exact test with midpoint value correction, and standard statistical methods were used to calculate the 90% confidence interval odds ratio and number to treat. RESULTS: The no-touch technique protocol resulted in a clinically significant threefold decrease in shunt infection rate from 9.1% to 2.9% (p = 0.058 at 0.10 level, odds ratio 0.305, confidence interval 0.084-1.11), and a near threefold decrease in the infection rate per patient from 11.3% to 3.9% (p = 0.032 at 0.10 level, odds ratio 0.243, confidence interval 0.065-0.906). CONCLUSIONS: The no-touch technique protocol as described herein is a useful method to decrease shunt infection. A larger prospective, randomized, multicenter clinical trial is encouraged to stringently assess the efficacy of the protocol.

Adolescent↗

PubMedDate not supplied

Protocols used by UK general practitioners, what is expected of them and what solutions are provided.

A postal survey on attitudes to the use of clinical protocols by Family Health Service Authorities and general practitioners in the United Kingdom showed that some FHSAs had a relatively optimistic view of the implementation of protocols by GPs. Forty-two percent of the 61 FHSAs who responded stated that they had no policy for helping primary care introduce protocols in the key areas of the management or referral of asthma, diabetes, hypertension and ischaemic heart disease. The general practitioners identified these areas but there was a feeling of resentment by some of the respondents as they felt the electronic protocols were not in general user friendly. It was felt that the main General practitioner computer suppliers are capable of meeting the protocol needs of an increasingly computerised primary health care service for the future. The changes to the UK primary health scene are discussed in relation to protocol implementation by general practitioners.

Clinical Protocols↗

PubMed1996

Effects of a supportive protocol processing system (ProtoVIEW) on clinical behaviour of residents in the accident and emergency department.

A randomized two period crossover trial was performed at the Accident and Emergency (A & E) department of the University Hospital in Nijmegen (The Netherlands). We assessed what the impact was of (mandatory) consultation of a protocol for the management of isolated traumas on treatment decisions of residents. All eight surgical residents who regularly worked in the A & E department participated in the trial. All patients who entered the A & E department between October 13, 1992 and June 9, 1993, of age 16 years or older with an isolated fracture without concomitant lesions were admitted to the study. During the experimental periods, the management protocol was available on computer (using ProtoVIEW) and during the control periods on paper. Main measurements were treatment adjustments made by residents (after consulting different information sources), and their opinion about ProtoVIEW as an information source assessed by means of a questionnaire. When protocol consultation was mandatory, residents changed their treatments almost four times more often towards the protocol than during the control periods (P = 0.01 Chi-square test). Most residents found ProtoVIEW easy to use, liked it as a useful training source while half of them said they would use the system in daily clinical practice. We conclude that mandatory protocol consultation using ProtoVIEW influenced protocol adherence positively.

Attitude↗