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PubMed1992

A noninvasive protocol for anterior temporal lobectomy.

We report the results of a protocol for choosing candidates for temporal lobectomy using a standard battery of objective tests without intracranial electrodes. We assigned each test a level of importance, and an algorithm was used to determine whether temporal lobectomy could be performed. Fifty-one patients (total pool, 103 patients) met protocol requirements and had an anterior temporal lobectomy with a mean follow-up of 39.4 months (range, 21 to 64 months), most remaining on anticonvulsant therapy. Eighty percent are seizure free, 12% have less than 3 seizures per year or only nocturnal seizures, and 8% have greater than 80% reduction in seizure frequency. One-third of patients who failed protocol criteria did not have temporal lobe seizures when studied with intracranial electrodes. We analyzed and modified the algorithm after comparing these patients with others who were poor candidates for temporal lobectomy. We conclude that this protocol is effective and recommend using such an objective algorithm.

Action Potentials↗

PubMed2004

Results of a prospective protocol of computed tomographic angiography in place of catheter angiography as the only diagnostic and pretreatment planning study for cerebral aneurysms by a combined neurovascular team.

OBJECTIVE: At many centers, patients undergo both computed tomographic angiography (CTA) and digital subtraction angiography (DSA). This practice negates most of the advantages of CTA, and it renders the risks and disadvantages of the two techniques additive. Previous reports in the literature have assessed the sensitivity and specificity of CTA compared with DSA; however, these investigations have not analyzed the clinical implications of a protocol that replaces DSA with CTA as the only diagnostic and pretreatment planning study for patients with cerebral aneurysms. METHODS: Since late 2001/early 2002, the combined neurovascular unit of the Massachusetts General Hospital has adopted a prospective protocol of CTA in place of DSA as the only diagnostic and pretreatment planning study for patients with cerebral aneurysms (ruptured and unruptured). We report the results obtained during the 12-month period from January 2002 to January 2003. RESULTS: During the study period, 223 patients with cerebral aneurysms underwent initial diagnostic evaluation for cerebral aneurysm by the combined neurovascular team of Massachusetts General Hospital. Of the 223 patients, 109 patients had confirmed subarachnoid hemorrhage (Group A) and 114 patients did not have SAH (Group B). All of these patients were included in the prospective CTA protocol. Cerebral aneurysm treatment was initiated on the basis of CTA alone in 93 Group A patients (86%), in 89 Group B patients (78%), and in 182 patients (82%) overall. Treatment consisted of surgical clipping in 152 patients (68%), endovascular coiling in 56 patients (25%), endovascular parent artery balloon occlusion in 4 patients (2%), and external carotid artery to internal carotid artery bypass and carotid artery surgical occlusion in 2 patients (1%). Nine patients (4%) did not undergo treatment. The cerebral aneurysm detection rate by CTA was 100% for the presenting aneurysm (ruptured aneurysm in Group A or symptomatic/presenting aneurysm in Group B) in both groups. The detection rate by CTA for total cerebral aneurysms, including incidental multiple aneurysms, was 95.3% in Group A, 98.3% in Group B, and 97% overall. The overall morbidity associated with DSA (pretreatment or as intraoperative or postoperative clip evaluation) was one patient (1.3%) with a minor nonneurological complication, one patient (1.3%) with a minor neurological complication, and no patients (0%) with a major neurological complication. CONCLUSION: We have demonstrated promising results with a prospective protocol of CTA in place of DSA as the only diagnostic and pretreatment planning study for patients with ruptured and unruptured cerebral aneurysms. It seems safe and effective to make decisions regarding treatment on the basis of CTA, without performing DSA, in the majority of patients with ruptured and unruptured cerebral aneurysms.

Adolescent↗

PubMed2006

Differences in sentinel lymph node pathology protocols lead to differences in surgical strategy in breast cancer patients.

BACKGROUND: Internationally, there is no consensus on the pathology protocol to be used to examine the sentinel lymph node (SN). At present, therefore, various hospitals use different SN pathology protocols of which the effect has not been fully elucidated. We hypothesized that differences between hospitals in SN pathology protocols affect subsequent surgical treatment strategies. METHODS: Patients from four hospitals (A-D) were prospectively registered when they underwent an SN biopsy. In hospitals A, B, and C, three levels of the SN were examined pathologically, whereas in hospital D, at least seven additional levels were examined. In the absence of apparent metastases with hematoxylin and eosin examination, immunohistochemical examination was performed in all four hospitals. RESULTS: In total, 541 eligible patients were included. In hospital D, more patients were diagnosed with a positive SN (P < .001) as compared with hospitals A, B, and C, mainly because of increased detection of isolated tumor cells. This led to more completion axillary lymph node dissections in hospital D (66.3% of patients (P < .0001), compared with 29.0% in hospitals A, B, and C combined). Positive non-SNs were detected in 13.9% of patients in hospital D, compared with 9.7% in hospitals A, B, and C (P = .70). That is, in 52.4% of patients in hospital D, a negative completion axillary lymph node dissection was performed, compared with 19.3% of patients in hospitals A, B, and C combined. CONCLUSIONS: Differences in SN pathology protocols between hospitals do have a substantial effect on SN findings and subsequent surgical treatment strategies. Whether ultrastaging and, thus, additional surgery can offer better survival remains to be determined.

Adult↗

PubMed2001

A protocol-based evaluation of medical image digitizers.

Medical film digitizers play an important transitory role as digital-to-analogue bridges in radiology. Their use requires performance evaluation to assure medical image quality. A complete quality control protocol is presented, based on a set of test objects adaptable to the specification of various digitizers. The protocol includes parameters such as uniformity, input-output response, noise, geometric distortion, spatial resolution, low contrast discrimination, film slippage and light leakage, as well as associated measurement methods. The applicability of the protocol is demonstrated with two types of medical film digitizers; a charge-coupled device (CCD) digitizer and a laser digitizer. The potential value of the protocol is also discussed.

Analog-Digital Conversion↗

PubMed2003

Protocol for retrieval and analysis of breast implants.

The Center for Implant Retrieval and Analysis has been established at Washington University's Division of Plastic and Reconstructive Surgery for the purpose of studying implantable devices retrieved after surgery or autopsy and assessing their condition after implantation. Since the early 1990s, significant experience has been gained in testing and analyzing silicone gel breast implants and, to a lesser extent, saline-filled devices. However, there has been no systematic method reported for collecting and evaluating these implants in a way that would permit different laboratories to compare their data. This article offers the plastic and reconstructive surgery community a standardized protocol for analyzing explanted silicone gel and saline-filled breast implants. The protocol gives surgeons a clearly defined approach for removing, handling, documenting, and shipping explanted breast implants. At the same time, biomaterials researchers can use the protocol to acquire implant data with reliable and reproducible methods. Because the study of saline implants has lagged behind the study of silicone gel implants, the article concludes with a demonstration of how this protocol can be applied to obtain mechanical properties data and use scanning electron microscopy to illuminate failure mechanisms of saline devices, including three explants removed after 20+ years in vivo.

Breast Implants↗

PubMedDate not supplied

Treatment of dogs with lymphoma using a 12-week, maintenance-free combination chemotherapy protocol.

BACKGROUND: Treatment of lymphoma in dogs by long-term chemotherapy has favorable results. However, the efficacy of short-term, maintenance-free treatment protocols on remission and survival times in dogs has not been determined. HYPOTHESIS: That treatment using a 12-week chemotherapy protocol would be associated with satisfactory treatment outcome in dogs with lymphoma. ANIMALS: 77 dogs with histologically or cytologically confirmed diagnosis of lymphoma. METHODS: Prospective clinical trial in which dogs were treated with a 12-week chemotherapy protocol consisting of L-asparaginase, vincristine, cyclophosphamide, doxorubicin, and prednisolone. RESULTS: Complete remission rate was 76.3%. Multivariate logistic regression analysis revealed that clinical substage (P = .006) and immunophenotype (P = .003) had a significant influence on the likelihood of a dog achieving complete remission. Median duration of first complete remission was 243 days (range 19-1,191 days). The 6-month, 1-year, and 2-year remission rates were 68%, 28%, and 16%, respectively. In the multivariate analysis of patient variables, immunophenotype (P = .022) revealed a significant influence on first remission duration. Toxicosis was mild with the exception of 1 treatment-associated death. CONCLUSIONS AND CLINICAL IMPORTANCE: In this group of dogs the 12-week maintenance-free chemotherapy protocol was well tolerated and had satisfactory results.

Animals↗

PubMed2006

A computer protocol to evaluate subjects with chest pain in the emergency department: a multicenter study.

OBJECTIVE: Chest pain is a frequent cause of medical admission to the emergency department and the main differential diagnosis is between coronary and non-coronary chest pain. We elaborated a computer protocol for the management of patients with chest pain. METHODS: The computer protocol was made of three sections according to clinical, electrocardiographic and biochemical data. Each section was coded by a letter indicating the probability of coronary chest pain for each section. The combination of the three letters formed a score string used to assign patients to four subgroups of overall probability of coronary chest pain (low, medium-low, medium-high, and high). Low-probability patients were discharged from the emergency department, whereas high-probability patients were admitted to the coronary care unit. The medium-probability patients underwent further evaluation by means of a stress test and were re-classified as having a final low probability (negative test) or high probability (positive test). RESULTS: We evaluated 472 patients (mean age 64 years, range 18-97 years; 47% female). The incidence of coronary events in patients with low, medium-low, medium-high and high overall probability was 1.9, 12.8,13.5 and 68.0%, respectively (P < 0.05). The positive and negative predictive values of the protocol were 64.7 and 97.1%, respectively. CONCLUSIONS: Our computer protocol represents a reliable method for the management of patients with chest pain and a non-diagnostic electrocardiogram.

Adolescent↗

PubMed2006

[Methodological thoughts about research of standardized clinical protocols of traditional Chinese medicine].

The treatment of traditional Chinese medicine (TCM) has been proved effective in clinical practice for thousands of years. To standardize the clinical protocols of TCM is absolutely necessary for enhancing the research quality of TCM and expanding the international influence of TCM. The standardization research on clinical protocols of TCM should be based on the basic theory of TCM and in the light of good clinical practice (GCP) principles. The clinical criteria for both diagnosis and efficacy evaluation of disease are also needed. To include all symptoms, tongue manifestations and pulse presentations into case report form, and to compare the differences in these clinical parameters between effective and non-effective cases by multivariate analysis may be helpful to find more specific indications for therapeutic protocol of TCM. Furthermore, It is suggested that two or more clinical trials on one therapeutic protocol are needed to identify its accurate indications.

Clinical Protocols↗

PubMedDate not supplied

Protocol-driven vs. physician-driven electrolyte replacement in adult critically ill patients.

BACKGROUND: The intensive care unit is a dynamic environment, where high numbers of patients cared for by health care workers of different experiences and backgrounds might result in great variability in patient care. Protocol-driven interventions may facilitate timely and uniform care of common problems, like electrolyte disturbances. We prospectively compared protocol-driven (PRD) vs. physician-driven (PHD) electrolyte replacement in adult critically ill patients. PATIENTS AND METHODS: In the first month of the two-month study, potassium, magnesium, and phosphate levels were checked by a physician before ordering replacement (PHD replacement period). Over the second month, ICU nurses proceeded with replacement according to the protocol (PRD replacement period). We collected demographic data, admission diagnosis, number of potassium, magnesium, and phosphate levels done per day, number of low levels per day, number of replacements per day, time between availability of results to ordering replacement, time to starting replacement, post-replacement levels, serum creatinine, replacement dose, arrhythmias and replacement route. RESULTS: During the PHD replacement period, 43 patients meeting the inclusion criteria were admitted to the ICU, while 44 were admitted during the PRD month. The mean time (minutes) from identifying results to replacement of potassium, phosphate and magnesium was significantly longer with PHD replacement compared with PRD replacement (161, 187, and 189 minutes vs. 19, 26, and 19 minutes) (P<0.0001). The number of replacements needed and not given was also significantly lower in the PRD replacement period compared with the PHD replacement period (2, 4, and 0 compared with 9, 6 and 0) (P<0.05). No patients had high post-replacement serum concentrations of potassium, phosphate or magnesium. CONCLUSIONS: This study shows that a protocol-driven replacement strategy for potassium, magnesium and phosphate is more efficient and as safe as a physician-driven replacement strategy.

Adolescent↗

PubMed2000

Protocols for the examination of tumors of diverse sites: introduction. Cancer committee of the College of American Pathologists.

This issue of the Archives includes previously unpublished protocols for the examination of specimens removed from patients with cancer of diverse sites. We provide a historical context for the development of these protocols and describe the process of development and approval. General information about the structure and content of the protocols is also provided. Cancer protocol development is an important step in the process of standardized cancer reporting. The value of such standardized reporting is discussed.

Clinical Protocols↗

PubMed2007

Application of a combined protocol for rational request and utilization of antibody assays improves clinical diagnostic efficacy in autoimmune rheumatic disease.

CONTEXT: Because of a marked increase in the number of requests for antinuclear antibodies, anti-extractable nuclear antigen antibodies, and anti-double-stranded DNA antibodies for the diagnosis of autoimmune rheumatic disease, guidelines have been proposed for their appropriate use. OBJECTIVE: To evaluate in terms of clinical efficacy and cost-benefit ratio the outcome of applying a protocol for the diagnosis of autoimmune rheumatic disease. DESIGN: A diagnostic protocol for the rational utilization of second-level tests (anti-extractable nuclear antigen antibodies and anti-double-stranded DNA antibodies) was applied at Hospital Polyclinic beginning January 2004. The appropriateness of 685 consecutive requests received at the clinical pathology laboratory from January to June 2004 was assessed. Patients who underwent these laboratory tests were followed up for 12 months after blood sample drawing. RESULTS: Introduction of the protocol led to a significant reduction in the number of second-level tests prescribed (27.9% vs 49.5% for anti-extractable nuclear antigen antibodies; 27.5% vs 56.6% for anti-double-stranded DNA antibodies). After the period of observation, none of the 163 patients who had negative results on the first-level test and were asymptomatic, for whom second-level tests had not therefore been performed, were found to have autoimmune rheumatic disease. In 90.5% (77/85) of patients positive for the second-level tests, clinical confirmation of autoimmune rheumatic disease was obtained. CONCLUSIONS: Not only did application of the diagnostic protocol reduce the number of second-level tests performed but it also increased their specificity. Our data thus indicate that the use of shared guidelines by clinical and laboratory specialists yields satisfactory results.

Antibodies, Anti-Idiotypic↗

PubMedDate not supplied

The research agenda for protocol-based care.

BACKGROUND: Protocol-based care is increasingly being used to deliver collaborative, integrated and improved patient-centred care, based on the best available evidence. This article provides an overview of key issues arising from protocol-based care literature to illustrate the research agenda for this important care delivery approach. CONCLUSION: Protocols provide great potential to deliver best practice. However, questions remain about the benefits of protocol-based care.

Clinical Protocols↗

PubMed1998

Web-based resources for clinical protocol management.

The data monitoring regulatory procedures, and administrative tasks associated with protocol management have become increasingly complex. Relational database technology and Internet-based connectivity offer resources to improve the quality and efficiency of protocol operations. At Fox Chase Cancer Center, we have developed a suite of database applications for protocol management and tracking of patient accrual. All data transactions and reporting occur through a graphical web browser interface using standard Internet technology. Security and confidentiality have been addressed through encryption, user authentication, address restriction, and database authority. Database management has been tightly integrated with protocol operations to avoid duplication of resources and effort. Data query functions also extend to other institutional resources, such as tumor registry and the hospital clinical laboratory, to further reduce the need for redundant data storage. Newer components, such as chemotherapy orders and toxicity reporting, have been incorporated in a modular fashion. Although custom software development can be expensive and time-consuming, it offers the best opportunity for successful integration with existing resources, staff, and procedures, as well as collaboration with other institutions.

Clinical Protocols↗

PubMed1993

Development of a methylprednisolone protocol for use in acute spinal cord injuries.

Acute spinal cord injury is a serious medical condition that results in 10,000 new cases of paralysis each year. Initial physical damage to the spinal cord is followed by chemical damage, resulting in cell death and scar tissue formation. Methylprednisolone therapy has proven effective in suppressing the chemical damage, particularly when started within 8 hours of injury. A protocol developed by the Pharmacy Department at Methodist Medical Center in Dallas, Texas, is described. This protocol facilitates accurate, efficient preparation and administration of this emergency therapy. The protocol takes advantage of the pharmacist's unique expertise to lessen the risk of calculation errors and mistakes in preparation, by providing a tailored drug admixture for administration at a fixed flow rate. The protocol and a sample of the pharmacy work sheet are presented.

Clinical Protocols↗

PubMed1995

Weaning from mechanical ventilation: physician-directed vs a respiratory-therapist-directed protocol.

UNLABELLED: To speed weaning and free physicians for other duties, we changed from a physician-directed to a respiratory therapist (RT)-directed protocol for weaning cardiac surgery patients from mechanical ventilation. METHODS: Eligible patients were identified by physicians after which RTs initiated and directed an intermittent mandatory ventilation weaning in accordance with a written weaning protocol. Eligibility criteria for entry into the weaning protocol (Phase 1) were expanded at the end of 4 months to include more complicated and unstable patients to be weaned by the RT-directed protocol (Phase 2). Total ventilation time and the duration of weaning were recorded for all patients during both phases and during the 2-months prior to implementing RT-directed weaning (control period). All patients were physician weaned during the control period. RESULTS: No complications were associated with the introduction of RT-directed weaning. The percentage of all cardiac surgery patients weaned by the RTs increased progressively from 41 to 90% over the 7-month study period. When compared to a similar group of physician-weaned patients in the control period, the RT-weaned patients in Phase 1 and Phase 2 of the study had a significantly shorter median total ventilation time (18.6 vs 16.8 hours [p = 0.02, chi 2.95,1] for Phase 1 and 19.7 vs 17.8 hours [p = 0.04] for Phase 2). CONCLUSIONS: We have demonstrated that respiratory therapists can safely and efficiently wean cardiac surgery patients from mechanical ventilation.

Aged↗

PubMed1998

Documentation on track with protocols.

To make sure nurses and other disciplines teaching patients were following teaching standards (and to improve documentation), one hospital created teaching protocols for several top diagnoses. As a result, its documentation jumped from 58% to 92%. The hospital took the following steps to ensure the success of the protocols: Existing protocol committees wrote teaching protocols. Clinical educators conducted staff in-services. Guidelines for implementation were created.

Case Management↗

PubMed1999

[Results of a prospective protocol for the treatment of adult Hodgkin's disease].

To report the results of an adapted protocol of treatment of Hodgkin disease in Tunisian patients. 70 patients (47 males and 23 females, sex-ratio = 2.04) with a mean age of 38.5 years (15 to 75) are enrolled in a therapeutic protocol to the prognostic factors and based on chemotherapy with MOPP/ABV or hybrid associated to radiotherapy. We perform an evaluation of response to chemotherapy after the 4th cycle, after the 6th cycle and then at the end of the protocol. Our population is characterized by the frequency of young patients(34% between 30 and 40 years), histologic types 2 and 3 (45 and 48%) and advanced disease with 60% of stages III and IV. After the 4th cycle, 32 patients(45%) are in complete response and 31(44%) in partial response, while 6 patients(9%) progress under chemotherapy. After 6 cycles, we observe 44 in complete response(72%) including 46% of the bad responders after 4 cycles. At the end of the protocol and on the 58 evaluable patients, 50 remain in complete response(86%). We observe 5 deaths occurred in 3 progressing patients and in 2 patients by infection after chemotherapy. 5-year actuarial and disease-free survival is 60% and 56% and median survival is 83 months. In the univariate analysis, response to chemotherapy represent the unic significant prognostic factor.

Adolescent↗

PubMedDate not supplied

[Protocol for preoperative chest X-rays in elective surgery].

BACKGROUND: To evaluate the effects of a protocol designed to optimize the use of preoperative chest X-rays (CXRs) in the evaluation of patients undergoing anesthesia for elective surgery. DESIGN: Observational prospective study. SETTING: General 350 bedded hospital, with main surgical branches. METHODS: a) PROTOCOL: routine CXRs can be avoided in patients aged less than 60 years, nonsmokers, without acute-chronic respiratory, cardiovascular symptoms, free from neoplastic diseases, not candidates to major vascular, abdominal or thoracic surgery, not treated with immunosuppressive therapy, nor immigrants from areas of endemic TB. b) All out patient subjects admitted to anesthesiology service for evaluation prior to elective surgery. RESULTS: Out of 5198 patients, 3795 were enrolled in the protocol; in 152 cases, preoperative CXRs were performed, 3456 patients (57.2% ASA 1; 42% ASA 2; 0.8% ASA 3) underwent surgery without CXRs. Thirty-four percent of patients had general anesthesia, 54.5% regional anesthesia, 20.6% regional-peripheral anesthesia with/without MAC. No critical events nor major complications were observed in the perioperative period in these subjects. Preoperative CXRs (performed in 152 cases) yelded useful informations with effect on the clinical management in 20 instances. CONCLUSIONS: In a context of adequate preoperative anesthesiologic evaluation, this protocol proved to be effective in reducing the number of routine preoperative CXRs in patients undergoing elective surgery. This resulted in a substantial reduction of radiation exposure both to the subject and to the general population, and costs saving, without evident negative side-effects.

Adolescent↗