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PubMed1998

Evaluation of the ECAT EXACT HR+ 3-D PET scanner in H2(15)O brain activation studies: dose fractionation strategies for rCBF and signal enhancing protocols.

We evaluated the performance of the ECAT EXACT HR+ 3-D whole-body positron emission tomography (PET) scanner when employed to measure brain function using H2(15)O bolus activation protocols that are completed in single same-day data acquisition sessions. Using vibrotactile and auditory stimuli as independent activation tasks, we studied the scanner performance under different imaging conditions in five healthy volunteers. Cerebral blood flow images were acquired from each volunteer using H2(15)O bolus injections of activity varying from 5-20 mCi. One-session dose-fractionation strategies were analyzed for rCBF, standard activity-concentration, switched, and cold-bolus/switched protocols. Performance characteristics. The scanner dead time grew linearly with injected dose from 10% to 25%. Random events varied from 30% to 50% of the detected events. Random and scattered events were corrected adequately at all doses. Estimated noise-effective-count curves plateau at about 10 mCi. One-session 12-injection bolus PET activation protocols. Using an acquisition protocol that accounts for the scanner performance and the practical aspects of imaging volunteers and neurological patients in a single same-day session, we assessed the correlation between the significance of activation foci and the dose/injection used. The one-session protocol employs 12 bolus injections/subject. We present evidence suggesting that when an rCBF protocol is used, image noise is reduced significantly when the activity injected increases from 5 to 10 mCi. Increasing the dose from 10 to 15 or 20 mCi yielded further but smaller reductions. Our observations also suggest that image noise will be strongly reduced if a 20-mCi dose/injection is used when data are collected using protocols that employ long acquisition times such as a switched or a cold-bolus/switched protocol.

Adult↗

PubMed2006

Pressure ulcer: Prevention protocols and prevalence.

AIMS AND OBJECTIVES: The aim of this paper is to analyse the protocols used in German hospitals and nursing homes for the prevention of pressure ulcers with regard to their contents and accordance with the national standard of the Deutsches Netzwerk für Qualitätsentwicklung in der Pflege (DNQP) and the European Pressure Ulcer Advisory Panel (EPUAP) and Royal College of Nursing (RCN) guidelines. Additionally, it is to show the relation between the existence and contents of the protocols of pressure ulcer prevention and pressure ulcer prevalence in the institutions. METHODS: On a fixed date trained nursing staff gathers data regarding the frequency of pressure ulcers during a prevalence survey. The existence of a pressure ulcer is established by physical examination after the risk assessment with the Braden-Scale. The patient's or resident's informed consent is a precondition for his or her participation in the survey. The protocols are available as hard copies on paper or electronic files. RESULTS: Only two out of the 21 protocols developed in-house are completely concurrent with the expert standard. The EPUAP and RCN guidelines include the aspect of training and further education that is missing in the in-house protocols and the DNQP expert standard. Evaluation of the data reveals that there is no relation between the availability of protocols and pressure ulcer prevalence. Neither is there any relation between the contents and pressure ulcer prevalence. The institutions currently developing protocols have the lowest prevalence rates. CONCLUSION: It is obvious that, while developing in-house protocols, the discussion about pressure ulcer prevention has led to a higher problem awareness in nurses and thus to an increased attentiveness in daily nursing practice which then results in improved outcomes. Two years after its publication, the expert standard is still not very well known, therefore this concentrated form of the most up-to-date knowledge is not available to all nursing staff as a basis for evidence-based practice. In addition, the sometimes outdated knowledge of nursing staff impedes the implementation of evidence-based practice guidelines. A systematic implementation strategy that assists guidelines being applied in practice is therefore required.

Aged↗

PubMed2006

Development of a protocol for capillary blood glucose testing in nursing home and rehabilitation settings.

OBJECTIVES: To develop an algorithm to standardize capillary blood glucose (CBG) testing in nursing home and rehabilitation patients. DESIGN: Descriptive study in which an interdisciplinary team from a nursing home, a rehabilitation center, and a diabetes mellitus care program developed and tested a protocol to standardize diabetes management parameters and CBG testing frequency. SETTING: Department of Veterans Affairs nursing home and rehabilitation unit. PARTICIPANTS: One hundred one patients admitted to the units during the 6-month study period who had orders for CBG testing. INTERVENTION: Use of a standardized CBG testing protocol. MEASUREMENTS: Use of management goal, use of CBG testing protocol, total CBG tests/month. RESULTS: One hundred one subjects received orders for CBG testing; 72 (72%) received orders for a management goal, and 69 (69%) received orders to use the CBG protocol. Of these 69 patients, 22 met their CBG goals and were advanced to less-frequent CBG testing using the protocol, and 15 did not meet their CBG goals and were not advanced. An additional 15 patients were advanced to less-frequent CBG testing but not using the protocol. In all, 54 of 69 patients (78%) were advanced or could have been advanced by protocol to less-frequent CBG testing. Total CBG testing per month did not change before, during, or after the study period. CONCLUSION: This protocol would be useful in long-term care facilities and in other congregate living settings where patients with diabetes mellitus have staff assisting with their diabetes management. Barriers to successful implementation are discussed.

Aged↗

PubMed2004

Effects of post-surgical cleansing protocols on early plaque control in periodontal and/or periimplant wound healing.

OBJECTIVE: The aim of this RCT was to evaluate early wound healing following specific post-surgical care protocols. MATERIAL AND METHODS: Following periodontal flap surgery, 60 patients were randomly assigned to follow one of two post-surgical protocols. Subjects smoking >20 cigarettes per day were excluded. Patients following the control protocol rinsed twice daily for 1 min with 0.1% of chlorhexidine (CHX) for 4 weeks. In addition to CHX rinsing, patients assigned to the test protocol applied CHX locally using a special very soft surgical toothbrush (Chirugia) from days 3 to 14, and a soft toothbrush (Ultrasuave) from days 14 to 28, twice daily. Baseline measurements included gingival crevicular fluid (GCF) flow rate, probing depth, probing attachment level, presence of bleeding on probing and full-mouth plaque score. Measurements were repeated at 1, 2 and 4 weeks after surgery. RESULTS: Both post-surgical protocols resulted in successful wound healing and optimal wound closure at 4 weeks. There were no statistical differences in the GCF flow rate between test and control protocols. There was a lower incidence of recession of > or =2 mm following the test protocol. CONCLUSION: The use of specific post-surgical cleansing protocols including the introduction of mechanical cleansing at day 3, using local application of CHX in addition to daily rinsing with CHX may be recommended.

Adult↗

PubMed2002

Comparison of high-energy photon and electron dosimetry for various dosimetry protocols.

The American Association of Physicists in Medicine Task Group 51 (TG-51) and the International Atomic Energy Agency (IAEA) published a new high-energy photon and electron dosimetry protocol, in 1999 and 2000, respectively. These protocols are based on the use of an ion chamber having an absorbed-dose to water calibration factor with a 60Co beam. These are different from the predecessors, the TG-21 and IAEA TRS-277 protocols, which require a 60Co exposure or air-kerma calibration factor. The purpose of this work is to present the dose comparison between various dosimetry protocols and the AAPM TG-51 protocol for clinical reference dosimetry of high-energy photon and electron beams. The absorbed-dose to water calculated according to the Japanese Association of Radiological Physics (JARP), International Atomic Energy Agency Technical Report Series No. 277 (IAEA TRS-277) and No. 398 (IAEA TRS-398) protocols is compared to that calculated using the TG-51 protocol. For various Farmer-type chambers in photon beams, TG-51 is found to predict 0.6-2.1% higher dose than JARP. Similarly, TG-51 is found to be higher by 0.7-1.7% than TRS-277. For electron beams TG-51 is higher than JARP by 1.5-3.8% and TRS-277 by 0.2-1.9%. The reasons for these differences are presented in terms of the cavity-gas calibration factor, Ngas, and a dose conversion factor, Fw, which converts the absorbed-dose to air in the chamber to the absorbed-dose to water. The ratio of cavity-gas calibration factors based on absorbed-dose to water calibration factors, N60Co(D,w), in TG-51 and cavity-gas calibration factors which are equivalent to absorbed-dose to air chamber factors, N(D,air), based on the IAEA TRS-381 protocol is 1.008 on average. However, the estimated uncertainty of the ratio between the two cavity-gas calibration factors is 0.9% (1 s.d.) and consequently, the observed difference of 0.8% is not significant. The absorbed-dose to water and exposure or air-kerma calibration factors are based on standards traceable to the National Institute of Standards and Technology (NIST). In contrast, the absorbed-dose to water determined with TRS-398 is in good agreement with TG-51 within about 0.5% for photon and electron beams.

Air↗

PubMed1998

Evaluation of two clinical protocols for the management of women with vaginal discharge in southern Thailand.

OBJECTIVES: (1) To compare the effectiveness of two clinical protocols for the management of vaginal discharge in the situations where no laboratory facilities are available but speculum examination is possible and where basic laboratory facilities are available. (2) To determine clinical and simple laboratory indicators for diagnosis of patients with vaginal discharge in the local setting. DESIGN: Alternate allocation of subjects to one of two management protocols. SUBJECTS: Women presenting to university gynaecology outpatients department with a complaint of vaginal discharge. METHODS: Subjects were alternately allocated management according to one of two protocols: one without (group A) and one with (group B) immediate access to results of basic laboratory tests. Full clinical assessment including speculum examination and microbiological assessment for infection with gonorrhoea, chlamydia, candida, trichomonas, and bacterial vaginosis was performed on all women. Follow up assessment of clinical and microbiological response was performed 1-2 weeks later. RESULTS: At initial assessment, both groups were similar in all respects except that more group B women had inflammation of the vulva. The prevalences of various conditions were: candidiasis 22%, bacterial vaginosis 38%, trichomoniasis 4%, chlamydia 4%, gonorrhoea 0.4%. There was no association between any demographic characteristic and diagnosis of cause of the discharge. Both protocols resulted in clinically and statistically significant improvements for women with candidiasis, bacterial vaginosis, and trichomoniasis. There were no clinically important differences in outcomes between the two protocols. The sensitivities and specificities of various indicators were: curd-like vaginal discharge for candidiasis, 72% and 100%; homogeneous vaginal discharge for bacterial vaginosis or trichomoniasis, 94% and 88%; absent or scanty lactobacilli for bacterial vaginosis, 99% and 68%; > 20% clue cells for bacterial vaginosis, 81% and 99%; visible endocervical mucopus for chlamydia or gonorrhoea, 36% and 86%; microscopic endocervical mucopus for chlamydia or gonorrhoea, 64% and 69%. CONCLUSIONS: Both protocols were equally effective in managing women with abnormal vaginal discharge. Simple clinical indicators for candidiasis, bacterial vaginosis, or trichomonas as in protocol A are sufficiently sensitive and specific for use in situations with no laboratory support. A modification to protocol A could increase detection of bacterial vaginosis at basic health service level. Further work is needed to identify appropriate indicators for infection with chlamydia or gonorrhoea.

Adult↗

PubMed2004

Implementing intensive insulin therapy: development and audit of the Bath insulin protocol.

Intensive insulin therapy to control blood glucose has been found to reduce mortality among critically ill patients in a surgical intensive care unit, though a simple prescriptive insulin infusion protocol to achieve this has not been published previously. This study documents the development and routine use of a simple prescriptive intravenous insulin infusion protocol for critically ill patients and compares the results with previous practice. During development the protocol was optimized and practical issues of implementation addressed. The optimized protocol was then used for all ICU admissions, and a prospectively defined retrospective chart audit performed for the first month of use. Results were compared with a similar time period the previous year. In September 2002, 27 admissions were started on the protocol. Blood glucose for the time on the protocol had a median value of 6.2 (IQR 5.9-7.1) mmol/l compared with 9.2 (IQR 8.1-10.2) mmol/l for those on insulin in 2001. Blood glucose for the whole ICU stay for those on the protocol in 2002 had a median value of 6.6 (IQR 6.0-7.4) mmol/l compared with 8.6 (IQR 8.0-9.4) mmol/l in 2001. Blood glucose for all ICU patients in 2002 had a median value of 6.5 (IQR 6.0-7.3) mmol/l compared with 7.2 (IQR 6.3-8.3) mmol/l in 2001. Three blood glucose recordings were less than 2.2 mmol/l in September 2002. This study provides initial effectiveness and safety data for the Bath Insulin Protocol Further audits in a larger patient population are now needed.

Blood Glucose↗

PubMed2004

Unintended consequences: the impact of protocol change on critical care nurses' perceptions of stress.

CONTEXT: The Family Communication Coordinator protocol was implemented to facilitate effective communications during potential organ donation cases. Previous research records its effectiveness relative to donor outcome measures. By redefining and clarifying role responsibilities, the protocol may be associated with reduced job stress for those caring for potential donors. OBJECTIVES: To determine the relationship of the Family Communication Coordinator protocol on the role stress of critical care nurses. To examine role stress in terms of role ambiguity, role conflict, and role overload within the context of potential organ donation cases. DESIGN: Retrospective nonexperimental descriptive design. SETTING: Critical care units of an academic teaching hospital. PARTICIPANTS: Nineteen critical care nurses with experience before and after implementation of the Family Communication Coordinator protocol. MAIN OUTCOME MEASURES: Job dimensions, role stress, job satisfaction, and commitment, measured using surveys. These data were supplemented with interviews and hospital records. RESULTS: The findings demonstrate that the Family Communication Coordinator protocol is associated with reduced role stress. More specifically, the nurses perceived significant reductions in role ambiguity and role conflict, and some reduction in role overload. The findings highlight high satisfaction with the protocol, as well as improved job satisfaction, and professional and organizational commitment. CONCLUSIONS: The results suggest that reduced role stress among critical care nurses is associated with implementation of a protocol already associated with improved organ donation outcomes. The findings suggest positive outcomes also may impact other staff, multidisciplinary functions, and the organization. Similar protocols may be appropriate in other end-of-life situations to reduce uncertainty and stress among critical care professionals.

Attitude of Health Personnel↗

PubMed2005

The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study.

BACKGROUND: Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. METHODS: Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. RESULTS: Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14-17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25-53) and 37 (95% CI: 27-46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. CONCLUSION: The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees.

Clinical Protocols↗

PubMed2006

Assessing health systems for type 1 diabetes in sub-Saharan Africa: developing a 'Rapid Assessment Protocol for Insulin Access'.

BACKGROUND: In order to improve the health of people with Type 1 diabetes in developing countries, a clear analysis of the constraints to insulin access and diabetes care is needed. We developed a Rapid Assessment Protocol for Insulin Access, comprising a series of questionnaires as well as a protocol for the gathering of other data through site visits, discussions, and document reviews. METHODS: The Rapid Assessment Protocol for Insulin Access draws on the principles of Rapid Assessment Protocols which have been developed and implemented in several different areas. This protocol was adapted through a thorough literature review on diabetes, chronic condition management and medicine supply in developing countries. A visit to three countries in sub-Saharan Africa and meetings with different experts in the field of diabetes helped refine the questionnaires. Following the development of the questionnaires these were tested with various people familiar with diabetes and/or healthcare in developing countries. The Protocol was piloted in Mozambique then refined and had two further iterations in Zambia and Mali. Translations of questionnaires were made into local languages when necessary, with back translation to ensure precision. RESULTS: In each country the protocol was implemented in 3 areas--the capital city, a large urban centre and a predominantly rural area and their respective surroundings. Interviews were carried out by local teams trained on how to use the tool. Data was then collected and entered into a database for analysis. CONCLUSION: The Rapid Assessment Protocol for Insulin Access was developed to provide a situational analysis of Type 1 diabetes, in order to make recommendations to the national Ministries of Health and Diabetes Associations. It provided valuable information on patients' access to insulin, syringes, monitoring and care. It was thus able to sketch a picture of the health care system with regards to its ability to care for people with diabetes. In all countries where this tool was used the involvement of local stakeholders resulted in the process acting as a catalyst in bringing diabetes to the attention of the health authorities.

Africa South of the Sahara↗

PubMed2000

Long-term experience with an accelerated protocol for diagnosis of chest pain.

CONTEXT: More than 6 million patients present annually with chest pain suggestive of acute coronary syndrome. Rapid and accurate diagnosis is essential for best clinical outcomes, for optimal management of hospital resources, and for minimizing medicolegal exposure. OBJECTIVE: To evaluate the clinical and cost outcomes of an accelerated protocol for chest pain triage in a community-based hospital of moderate size. METHODS: One hundred successive patients with chest pain were diagnosed according to the Traditional Chest Pain Protocol, which included testing of serial blood samples for creatine kinase (CK)-MB and total CK. These patients were also subjected to the Accelerated Chest Pain Protocol under evaluation, which included testing at shortened intervals for myoglobin and cardiac troponin I in addition to CK and CK-MB. Diagnostic sensitivity and specificity were compared versus the final assigned diagnosis. The Accelerated Chest Pain Protocol was implemented for routine use. Follow-up evaluations were conducted at 1 month (test group A, N = 180) and 22 months (test group B, N = 180). Costs for diagnosis and treatment of the 2 test groups were compared with those for the control group. RESULTS: The 2 protocols had equivalent specificity values (99%). The sensitivity of the Accelerated Chest Pain Protocol was higher than that of the Traditional Chest Pain Protocol (95% vs 58%). Cost savings of 29% and a reduction in length of stay of 33% were achieved in test group B versus the control group. CONCLUSIONS: The Accelerated Chest Pain Protocol improved the accuracy and timeliness of diagnosis of acute coronary syndrome while reducing costs.

Aged↗

PubMed2003

Collaborative practice: development, implementation, and evaluation of a weaning protocol for patients receiving mechanical ventilation.

BACKGROUND: Use of protocols to reduce weaning time for patients receiving mechanical ventilation helps reduce cost and length of stay. However, implementation of this type of protocol is not easy and requires a consistent collaborative effort. OBJECTIVE: To provide a systematic approach to the weaning process by developing, implementing, and evaluating a protocol for weaning patients from mechanical ventilation in a medical respiratory intensive care unit. METHODS: The weaning protocol used was a modification of a protocol developed by Ely et al. Modifications included a more aggressive approach in proceeding to the spontaneous breathing trial, inclusion of the Richmond Agitation-Sedation Scale, and documentation of the production of secretions. RESULTS: Implementation of the protocol significantly reduced the duration of mechanical ventilation as measured by 8-hour shifts and ventilator days. Although length of stay in the intensive care unit was not significantly reduced (P = .29), a continuing downward trend occurred, from a mean of 8.6 days before the protocol was implemented to 7.9 days during the last 6 months of data collection (P = .07). CONCLUSIONS: The need to provide efficient care requires the collaboration of all disciplines involved in providing patients' care. The weaning protocol introduced in this study demonstrates the benefits of using a collaborative team to identify best practices and implement them in a practice setting.

Clinical Protocols↗

PubMed2005

[Analysis of therapeutic effectiveness of Nanfang ALL 99 protocol in childhood acute lymphoblastic leukemia patients].

OBJECTIVE: With more precise diagnostic criteria and risk classifications, more effective therapy administered in clinical trials, and better supportive care, the outcome of children with acute lymphoblastic leukemia (ALL) has been improved dramatically. Today, approximately 80% of children treated for this disease in developed countries enjoy long-term event free survival (EFS) and in most instances, would be cured. In this study, treatment outcome of 82 childhood ALL patients in the hospital were analyzed, and ways for how to improve the EFS rate in childhood ALL were explored. METHODS: Eighty-two patients with ALL were enrolled into the Nanfang ALL 99 protocol which derived from German BFM ALL 95 and Hong Kong-Singapore acute lymphoblastic leukemia 97 (HK-SG ALL 97). Dexamethasone instead of hydrocortisone was used for triple intrathecal therapy. Standard at risk patients who had been irregularly treated in other hospitals for short periods of time were classified as at intermediate risk. When ANC was > or = 1.0 x 10(9)/L and platelet > or = 100 x 10(9)/L, chemotherapy was started. Life table method was used to estimate survival rate and statistical analysis was done by using software SPSS for Windows. RESULTS: From March 1999 to September 2003, 82 childhood ALL patients were treated with the Nanfang ALL 99 protocol and 78 (95.1%) patients attained complete remission (CR) in a median time of 33 days. Out of 82 patients, 13 patients dropped out of the the Nanfang ALL 99 protocol because of financial difficulty or other reasons. Sixty nine patients were consecutively treated with the Nanfang ALL 99 protocol. The overall EFS rate at 2 years, 3 years and 5 years were 91.3%, 85.9% and 75.2%, respectively, with a median observation duration of 34 months. Three patients died of complications (4.3%). The disease relapsed in 6 patients and they died finally. CONCLUSION: The outcome of patients treated with the Nanfang ALL 99 protocol was favorable, and the mortality rate of this chemotherapeutic protocol was low. This protocol was well tolerated by Chinese patients and therefore the protocol is worthy of application in China.

Adolescent↗

PubMed1988

[Therapy of advanced neuroblastoma by the protocol of the Welfare Ministry used by the Sawaguchi Group].

Five patients with advanced neuroblastoma were treated with the protocol of the Welfare Ministry used by the Sawaguchi group. This protocol consists of cyclophosphamide (CPM), vincristine (VCR), 4'-O-tetrahydropyranyladriamycin (THP-ADM) and cisplatinum (CDDP). Two patients treated with this protocol as the first therapy obtained partial remission. Two patients who had obtained complete remission before the treatment with this protocol remained in complete remission after the treatment. One patient who had shown poor response to the therapy given before treatment with this protocol also showed poor response to the protocol. The most significant side effect with this protocol was myelosuppression, the severity of which was closely related to the dose of THP-ADM. Damage to the liver, kidney and heart was not very significant. We advocate that patients with advanced neuroblastoma can obtain complete remission with the aid of surgery and radiotherapy, etc., if they are treated with the present protocol as the first therapy.

Adrenal Gland Neoplasms↗

PubMedDate not supplied

[Treatment of aggressive non-Hodgkin's lymphoma with the ProMACE- CytaBOM protocol].

INTRODUCTION: The Working Formulation Classification (for clinical use) divides non-Hodgkin's lymphoma (NHL), according to the nature of the disease and response to therapy into the low, medium and high risk lymphomas. Although these subgroups include different pathohistological types of NHL, they are considered sufficiently homogenous for joint therapy planning [1]. The first generation protocol (CHOP) managed to achieve complete remission (CR) in 50-55% of patients with 30-35% of survival rate [2]. A large four-branch comparative study of SWOG group compared CHOP as the first generation protocol with the third generation protocols ProMACE CytaBOM, m-BACOD and MCOD-D. The results have shown a similar CR and survival rates, so that CHOP is considered a gold standard for the treatment of aggressive NHL [6]. In the light of individual reports stating a high CR rate in the treatment of aggressive NHL by ProMACE CytaBOM [3-5] we present our experience and observations related to the use of this protocol. METHOD: Over the period from 1991 through May 1996 at the Department of Lymphoproliferative Diseases, Institute of Haematology, Clinical Centre of Serbia in Belgrade, we treated 25 patients with pathohistologic evidence of medium to high risk lymphomas, where cases of lymphoblast lymphoma and Burkit's lymphoma were excluded. The median follow-up was 27 months (maximum 63 months). RESULTS: Four of 25 patients were > 60 years. Three of these died. Pathohistological analysis revealed that of 20 cases of medium risk aggressive lymphoma five had diffuse, small cleaved cells, 7 had diffuse mixed and 8 diffuse centroblast cells. Although diffuse NHL with small cleaved cells is classified into clinically indolent lymphomas, two of five patients were in the fourth clinical stage, and three of five patients had a large tumorous mass. In the high risk group five patients had immunoblast lymphoma. Karnofsky index was high in 20/25. According to Ann Arbor criteria 19/25 patients were in IVCS and 7/25 had a large tumour mass. Most patients had clinical symptoms (21/25). Extranodal localization was confirmed in 19 patients. Bone marrow and hepatic infiltrations were most common: 9 and 6 patients, respectively. Eleven patients had a single extranodal localization, while 8 had 2 or more. The median follow-up was 27 months (maximum 63 months), and 21/25 (84%) patients responded to therapy (CR + PR). Complete remission was achieved in 14 patients (56%), and PR in 7 (28%) patients. In the CR group two died, and relapse developed in one after 28 months. In 11 cases CR is maintained. The average duration of CR was 16 months (3-38 months), and PR was maintained for 6 months (20 months in one case). The average survival was 24.5 months (range 3-53). DISCUSSION: The fact that a half of adult patients with disseminated aggressive NHL can be cured with combined chemotherapy is the major oncological achievement in the last 20 years. The protocol combines 4-8 drugs, and the joint report of the SFOG group for lymphoma in over 1200 patients with lymphoma has shown that the second and third generation protocols are not more effective than the standard CHOP or CHOPBleom protocols [6]. The optimum therapeutic protocol in the treatment of aggressive lymphoma is still unpredictable due to the fact that it is inadequate to compare the results of individual institutions with the results of collaborative groups; there is also a significant difference in the prognostic factors in different research groups; there is no sufficient complete and published results that suggest the lower CR than the original reports (which may be related to the evaluation of tumour and remission). There are not sufficient data on the incidence of secondary carcinoma and leukaemia [1]. The decision on the therapy should be based on two lines of information: those related to each particular patient (age, associated diseases) and those related to the tumour (large mass, immunophenotyping, cytoge

Adult↗

PubMed1998

Reliability between two observers using a protocol for diagnosing essential tremor.

Protocols with demonstrated reliability have been established for the diagnosis of numerous movement disorders. whereas in the essential tremor (ET) literature, there is no discussion about the reliability of diagnostic protocols. Lack of knowledge of the reliability of diagnostic protocols in ET limits the use of these protocols because reliability is an essential requirement for scientific quality in data management. The objective of this study was to determine the reliability of a protocol for diagnosing ET. The protocol consists of a Tremor Interview, a videotaped Tremor Examination, and a diagnostic algorithm. Eighty-three subjects with ET, identified in a community-based health study in Washington Heights-Inwood, New York, were matched with 83 control subjects from the same community. These subjects and their relatives are being recruited to participate in the Washington Heights-Inwood Genetic Study of ET. Two hundred twenty-six subjects have been evaluated to date (35 ET cases, 40 controls, 151 relatives). All 226 underwent an 84-item Tremor Interview and 26-item videotaped Tremor Examination. Diagnoses (normal, possible ET, probable ET, definite ET) were independently assigned by two blinded neurologists specializing in movement disorders. The kappa statistic, k, was used to determine diagnostic agreement between these two neurologists. The concordance rate between two raters using diagnostic categories definite ET, probable ET. possible ET, and normal was 80%; kw = 0.84 (near perfect to perfect agreement). The concordance rate between two raters using two diagnostic categories (definite ET and normal) was 100%; k = 1.00 (perfect agreement). There was high correlation between the two raters' total tremor scores (r = 0.89, p < 0.00001). This diagnostic protocol is highly reliable. Research in ET would greatly benefit from diagnostic protocols with demonstrated reliability.

Adolescent↗

PubMed1994

Evaluation of reduced protocols for carcinogenicity testing of chemicals: report of a joint EPA/NIEHS workshop.

The current U.S. Environmental Protection Agency (EPA) and other national/international guidelines specify the use of two species and two sexes rodents (usually the rat and the mouse) for carcinogenicity testing of chemicals. In view of the enormous number of chemicals to be tested, the high cost of testing, and the large number of animals used in the present protocol, many academic, industrial, and government authorities are examining the possibility of using a reduced protocol (less than two species and two sexes of rodents) for carcinogenicity testing of chemicals. The use of a reduced protocol offers many advantages as well as some disadvantages. To pursue further the potential implications and impacts of using a reduced protocol for carcinogenicity testing on the processes of hazard identification and risk assessment, a workshop entitled "Evaluation of Reduced Protocols for Carcinogenicity Testing of Chemicals" was held at the Embassy Suites Hotel in Alexandria, Virginia on September 22 and 23, 1992. It was cosponsored by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and the National Toxicology Program of the National Institutes of Environmental Health Sciences (NTP/NIEHS) and attended by more than 60 participants from government, industry, academia, and the general public. The Expert Consensus Panel and most of the participants supported the use of reduced protocols in carcinogenicity testing. However, it was recognized that reduced protocols may not be appropriate for the testing of all chemicals and that additional analyses/data may be needed for selection of the most appropriate reduced protocol for certain chemicals/chemical classes.

Animals↗

PubMed1991

Biological assays for irritant, tumor-initiating and -promoting activities. III. Computer-assisted management and validation of biodata generated by standardized initiation/promotion protocols in skin of mice.

The initiation/promotion standard protocol 28 (protocol 28), developed and used previously as an experimental model to verify the cancerogenic process of initiation/promotion in mouse skin, was revised in three aspects: (a) statistically it was shown sufficient to use, per promoter dose group, 16 colony-outbred female NMRI mice: (b) by weekly individual records of tumor response (and health status) of each mouse in a dose group, cumulative tumor incidences (and mean and extreme body weights) are determined; from these data the collective records (tumor response, health status), the only data accessible from protocol 28, may be generated in addition; (c) the details of dose groups and all data on tumor response and health status are processed by computer using the program package PAPILLOM. The latter was developed specifically for this purpose, is written in the programming language APL and designed for easy handling by staff of animal laboratories. The program package calculates, from the individual records per promoter dose group, cumulative tumor incidences (and survival data) with confidence limits for any one exposure time, and the package may be linked to programs for statistical validations. In addition, from the collective records it calculates the tumor rates, tumor yields and survival rates for any one exposure time. These data, obtained by either of the standard protocols (16 or 28), are fully comparable. For pure compounds they may be used to calculate semiquantitative tumor-promoting potencies. These values for more than 80 polyfunctional diterpenes of the tigliane, ingenane and daphnane type, scattered in or calculated from previous papers, together with their irritancies, were compiled. Within recent years, computer-assisted standard protocol 16 has been used to handle and evaluate about 1000 promoter dose groups. Protocol 16 allows one to extract and utilize more and better toxicological information on tumor response and health status from any one dose group, utilizing significantly fewer experimental animals than required by protocol 28. Thus, the computer-assisted standard protocol 16 optimizes the utility of the experimental model of mouse skin for the amount, quality and management of experimental data as well as for the requirements of animal protection.

Animals↗