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PubMedDate not supplied

Evaluation of a 6-month chemotherapy protocol with no maintenance therapy for dogs with lymphoma.

The purpose of this study was to compare a maintenance-free chemotherapy protocol based on CHOP (H from hydroxydaunorubicin = doxorubicin, O from Oncovin = vincristine) to a similar protocol with a maintenance phase for the treatment of canine lymphoma. Fifty-three dogs with multicentric lymphoma were treated with a 6-month modified version of the University of Wisconsin (UW)-Madison chemotherapy protocol (UW-25). Disease-free interval (DFI) and survival were compared to a historical control group of 55 dogs treated with a similar protocol with a prolonged maintenance phase. Remission rate for the study dogs was 94.2% (complete remission = 92.3%, partial remission = 1.9%). DFI and survival between the 2 groups did not differ significantly, with median DFI and survival of the study dogs equal to 282 and 397 days compared to 220 and 303 days for the control dogs (P = .2835 and .3365, respectively). Univariate analysis identified substage b (P = .0087), German Shepherd breed (P = .0199), and body weight > 18 kg (P = .0016) as significant for worse survival. Longer survival was associated with thrombocytopenia (P = .0436). Multivariate analysis revealed that substage (P = .0388) and weight (P = .0125) retained significance for DFI, whereas substage (P = .0093), thrombocytopenia (P = .0150), and weight (P = 0 .0050) retained significance for survival. Overall, the protocol was well tolerated by the dogs, with 41.5% (22/53) requiring a treatment delay or dose modification, but only 9.4% (5/53) needing hospitalization. The 6-month chemotherapy protocol based on CHOP with no maintenance phase provides similar DFI and survival times when compared to a similar protocol with a prolonged maintenance phase.

Animals↗

PubMed2000

Helical CT protocols for the abdomen and pelvis: a survey.

OBJECTIVE: We surveyed members of the Society of Computed Body Tomography/Magnetic Resonance to evaluate current techniques used for helical CT in the abdomen and pelvis. MATERIALS AND METHODS: The survey was distributed to 70 members (36 institutions) of the Society of Computed Body Tomography/Magnetic Resonance. The survey included general questions related to abdominal and pelvic helical CT and also asked the members to write a protocol for 12 hypothetical requisitions. RESULTS: Thirty-two members (46%) responded, representing 28 institutions (78%). The number of protocols for helical CT of the abdomen and pelvis at each institution ranges from 2 to 35 (median, 11). IV contrast material is administered for 90% (median) of abdominal and pelvic CT examinations. Nonionic contrast material is used for 68% (median) of these examinations. IV contrast material is used by 100% of institutions for tumor staging protocols except for one institution that does not use IV contrast material for lymphoma staging. Fifty percent of the institutions obtain two- or three-phases of liver images for breast cancer staging. For all protocols, the average collimation and reconstruction interval is 7 mm except for renal (5 mm) and adrenal (4 mm) protocols. Rectal contrast material is administered most commonly for colon cancer staging (39% of institutions). CONCLUSION: There is a wide range in the number of protocols used for helical CT in the abdomen and pelvis among the responding institutions. Most protocols include use of nonionic IV contrast material injected at a rate of 3 ml/sec and a collimation of 7 mm.

Clinical Protocols↗

PubMed1993

Opiate detoxification protocols. A clinical manual.

The purpose of any opiate detoxification protocol is to minimize or eliminate the signs and symptoms associated with opiate withdrawal, thereby decreasing the chances of relapse to opiate dependence. In the last few years, because of the development of new medications such as clonidine, for the treatment of opiate withdrawal, a number of new protocols have been developed. Four different types of protocols are reviewed and outlined: methadone substitution/detoxification, codeine or other opiate substitution/detoxification, opiate of choice detoxification, and buprenorphine substitution/detoxification. In addition, six protocols utilizing clonidine are presented, including a protocol utilizing opiate antagonist precipitated withdrawal. Finally, two protocols that utilize naltrexone are outlined, and adjunct medications potentially useful in opiate detoxification are reviewed. Some suggestions for the treatment of drug-seeking behavior during detoxification and the advantages and disadvantages of the various protocols are summarized.

Administration, Cutaneous↗

PubMedDate not supplied

A computer-based flowcharting system for clinical protocols.

In medicine, scientific and technological developments for investigation and treatment are proceeding at an ever increasing rate. Protocols for patient management are becoming ever more complicated. Rational design and scientific evaluation of protocols requires precise documentation. We propose a notation based on a series of simple flowcharts which describe procedures in increasing detail. Each step in a flowchart is justified by a reasoned argument, possibly including reference to published articles. General correctness requirements of a protocol include, for example, conformity with known indications and contraindications for investigations and treatments. These correctness requirements can be specified declaratively in mathematical logic and justified by reasoned argument. This makes the correspondence between a protocol and its scientific foundation even more explicit. Flowcharts of this nature are more easily created and modified using a personal computer. Furthermore, use of the computer enables a protocol to be checked automatically against its specification for more rapid identification of errors during development and maintenance of the protocol. We present the structured design of our flowcharting system in the 'Z' specification language, and we examine the practicality of our approach by means of a case study; the management of infertility. Our flowcharting system may also have application outside medicine where it is necessary to describe formal protocols for complex procedures.

Algorithms↗

PubMed1992

Factors that determine the cost and performance of early identification protocols.

In this paper, a simple model is used to examine the relation between important factors, such as prevalence of hearing loss, and protocol performance and cost. Protocol hit rate is determined primarily by the hit rate of the screening protocol and follow-up percentage, the percentage of infants who return for diagnostic testing. Many factors influence protocol cost. Not only does absolute cost change as certain model parameters are varied, but the relative cost of different protocols can change as well. The false alarm rate of the screening protocol and the follow-up percentage have the greatest impact on protocol cost.

Clinical Protocols↗

PubMed2004

[Short-term effect of treatment protocol utilizing levofloxacin, pasiniazide and M. Vaccae on multi- drug resistant pulmonary tuberculosis].

OBJECTIVE: To observe the effects of the protocol combining levofloxacin, pasiniazide, M. Vaccae (V+D+M protocol) in the treatment of multi-drug resistant pulmonary tuberculosis (MDR-TB). METHOD: Ninety-seven cases of MDR-TB randomized into V+D+M treatment protocol group (n=50) and control group (n=47) were observed for the negative sputum conversion rate, focal absorption, pulmonary cavity closure and improvement of immune function, after a 6-month treatment course. RESULTS: After the completion of the treatment course, the negative sputum conversion rate in V+D+M treatment protocol group was 84%, significantly higher than that in the control group (42%); the former group showed a focal absorption rate and pulmonary cavity closure rate of 83% and 66%, which were 33% and 26% respectively in the latter. In V+D+M treatment protocol group, T lymphocyte subgroups CD(3) and CD(4) were significantly elevated while CD(8) decreased after treatment, resulting in increased CD(4) to CD(8) ratio. The incidence of adverse effects resulting from the different treatment protocols in the two groups were comparable (30% vs 38%). CONCLUSION: V+D+M treatment protocol is effective for MDR-TB, which possesses the potential for application in clinical practice.

Adjuvants, Immunologic↗

PubMed2004

An ethnographic study of collaborative clinical trial protocol writing.

Clinical trial protocol documents play an important role in clinical research. However, clinical protocol writing remains a complex and relatively un-studied process. Protocols are often written by teams of people, yet little prior research has captured the problems or analyzed the collaboration support needs of protocol writers. Here we present the results of an initial ethnographic study into the clinical trial protocol writing processes at a representative cooperative clinical trial group funded by National Cancer Institute (NCI). We analyzed the collaborative nature of the writing process, identified common problems, derived information and communication support needs of collaborative clinical protocol writers, and provided recommendations to streamline the process. We believe that this paper contributes useful implications for the design of future collaborative clinical protocol writing tools.

Anthropology, Cultural↗

PubMed2004

A collaborative clinical trial protocol writing system.

Increasing complexity in medicine has caused clinical trial experts with disparate backgrounds from multiple organizations to collaborate when developing clinical trial protocols. Although many protocol-authoring tools provide computerbased decision support to assist in protocol writing, few of them provide sufficient collaboration support for a group of protocol writers. The iterative group writing activities among interdisciplinary clinical trial experts call for advanced tool support. Here we present a web-based protocol writing system with integrated support for collaborative reviewing and collaborative editing. The system uses a shared database to store threaded review comments and version information for electronic protocols. It also captures rich group event information to provide cross-activity awareness and to facilitate self-coordination within the collaborative writing team. We believe that our system can help streamline collaborative clinical trial protocol writing processes.

Clinical Protocols↗

PubMed2004

A review of perineal skin care protocols and skin barrier product use.

Perineal skin damage secondary to incontinence is painful, prevalent, and preventable. Skin care professionals consider regular application of skin protectants for patients with incontinence the standard of care for preventing perineal skin injury secondary to incontinence. Although protocols to improve care exist, the extent to which they are implemented and followed has not been documented. A study was conducted to ascertain the extent to which perineal skin care protocols are consistent with Wound, Ostomy and Continence Nurses Society Clinical Practice Guidelines and to estimate the level of compliance related to the use of protective perineal skin barriers. A convenience sample of 76 perineal skin care protocols was obtained from acute care (n = 55), long-term care (n = 9), and nondisclosed types of extended care facilities (n = 12). All protocol interventions were compared to the Wound, Ostomy and Continence Nurses guidelines. Healthcare Products Information Services data were used to obtain the total amount of skin protectants sold to US healthcare facilities in 2002. Skin protectant use was compared to previously published urinary and fecal (urofecal) incontinence prevalence data. All 76 protocols lacked one or more of the interventions considered important in perineal skin care. Although 75% of the protocols included the use of skin protectants, Healthcare Products Information Services data and urofecal prevalence data suggest underutilization of skin protectants; an estimated 10 cents per day versus an anticipated average cost of 23.5 cents per application is being spent. Further study is warranted and necessary to ensure the application of evidence-based protocols of care in practice.

Clinical Protocols↗

PubMedDate not supplied

Impact of the national protocol for malaria treatment on prescribing patterns in Gezira state, Sudan.

A cross-sectional study to assess the impact of the national protocol for malaria treatment was conducted in a town in Gezira state, central Sudan, in 2001. Most of the 165 doctors and medical assistants interviewed (80.0%) had not been trained in the protocol and many (57.5%) were still using their own protocols. Analysis of 410 prescriptions showed chloroquine was the most common antimalarial drug used (69.5% of prescriptions). Compared with a study before implementation of the protocol, more prescriptions met the protocol standards for correct chloroquine dose, whereas regimens for administration of intravenous quinine were still inadequate. The study showed a lack of continuous supervision, training and follow-up in the protocol guidelines and negative attitudes of hospital specialists towards the protocol.

Antimalarials↗

PubMed2006

Enabling protocol-based medical critiquing.

This paper investigates the combination of expert critiquing systems and formal medical protocols. Medical protocols might serve as a suitable basis for an expert critiquing system because of the ongoing acceptance of medical protocols and the rise of both evidence-based practice and evidence-based protocols. A prerequisite for a critiquing system based on medical protocols is the ability to match the actions a physician performs in practice to actions prescribed by a protocol. Previous research has shown that this is quite difficult, due to the fact that computerized systems are unable to handle deviations from a protocol, which are common in the medical domain. Our solution to this problem is based on extracting the intention underlying a physician's action and uses the intention as the basis for matching performed actions to prescribed actions. We propose an algorithm for the intention-based matching process and we evaluate the matching algorithm on 12 cases of hyperbilirubinemia in healthy term newborns.

Algorithms↗

PubMed1991

Modeling the cost and performance of early identification protocols.

This is the first in a series of three papers concerned with the early identification of hearing loss. In this paper, a simple model is presented that permits the calculation of the performance and cost of early identification protocols. In the second paper (Turner, in press), this model is used to compare four early identification protocols that differ in hearing screening strategies. The third paper (Turner, in press) examines the factors that influence the early identification protocol. The model described in this paper is sufficiently general to accommodate most early identification strategies including those that meet the goal of identification and habilitation by 6 months. The model measures protocol performance using hit rate, false alarm rate, and selected posterior probabilities. The model also calculates two measures of the financial cost. One measure reflects the cost of implementing the protocol; the other reflects the cost-effectiveness of the protocol. The parameters required by the model are also specified and are based on published clinical data. The model is provided to help audiologists design and select early identification protocols that are optimum for their particular clinical situation.

Clinical Protocols↗

PubMed1990

Effect of two oral care protocols on the incidence of stomatitis in hematology patients.

Research-based oral care protocols for the control and treatment of stomatitis secondary to cytotoxic therapy are scarce in the nursing literature. The purpose of this pilot study was to determine the efficacy of two different oral care protocols in decreasing the incidence of stomatitis in patients with hematologic malignancies receiving chemotherapy and radiation therapy. It was hypothesized that patients with hematologic malignancies using oral care protocol A would have a lower incidence of treatment-induced stomatitis than patients using oral care protocol B. Eighteen subjects with hematologic malignancies treated with high doses of chemotherapy alone or in combination with radiation therapy were randomly assigned to one of two specific oral care protocols. Protocols differed in the type of lip lubricant, toothette, and mouthwash used. The Oral Assessment Guide (21) was used to assess oral status five times a week for the duration of each subject's hospitalization. A t test for independent samples was used to determine if the difference in the condition of the oral cavity was related to the different oral care treatments. A statistically significant difference was not found between the mean oral assessment scores of the two groups. A trend emerged, however, of a lower incidence of stomatitis in the subjects using the experimental oral care protocol. A serendipitous finding was that reinforcement of oral care instructions and nursing assessments of the oral cavity seemed to promote patient compliance with the oral care regime. A supplementary analysis revealed a statistically significant (r = -0.7177) negative correlation between the degree of stomatitis and the peripheral white blood cell count.

Adult↗

PubMed1989

[Results of the treatment of Hodgkin's disease: the importance of establishing and executing a protocol].

A retrospective analysis was performed on 32 patients seen at Keio University Hospital and its affiliated hospitals from 1976 to 1987. Twenty-two patients were treated with our protocol, and the other 10 were not for several reasons. In this study, we compared the results of the treatment of these two groups. There were 20 males and 12 females. Age ranged from 13 to 72 years with a median value of 36 years. Histologically, six had lymphocytic predominance, 12 nodular sclerosis, 14 mixed cellularity. In the protocol group, seven were clinical stage I, 12 were CS II, two were CS III, and one was CS IV. Nine patients in the protocol group underwent staging laparotomy, and four CS II patients were upstaged to PS III. In the non-protocol group, five were CS I, four were CS II, one was CS III. According to the protocol, staging laparotomy was done excepting CS III.IV patients and some of CS I patients. In case of CS I without laparotomy, pathological stage(PS) I.II, or PS III1 with minimal splenic involvement, they were treated with radiation only. The rest of the patients were treated with chemotherapy and booster irradiation. Ten-year survival and 10-year relapse-free survival were 100%, 75%, respectively in the protocol group. In the non-protocol group, they were 31% and 32%, respectively. When picking up 17 patients treated by the authors through the whole process, 10-year survival and 10-year relapse-free survival were 100%, 92%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1986

[Acute lymphoblastic leukemia in children. Long survivals obtained with protocols C2-72 and D-74 (1972-1977)].

Between 1972-1977, 92 patients with acute lymphoblastic leukemia, between 0 and 14 years of age, were treated with C2-72 and D-74 protocols. Induction treatment consisted of prednisolone (PRED)-vincristine (VCR) with the addition of daunorubicin (prot. C2-72) or asparaginase (prot. D-74). In both protocols, preventive therapy on the CNS consisted of cranial irradiation (24 Gy) and 5 doses of methotrexate i.t. (MTX). For the maintenance phase in protocol C2-72, three combinations: mercaptopurine (MP)-MTX, MP-Ara.C and MTX-cyclophosphamide, were sequentially administered for 3 years, with reinductions of PRED-VCR every three months. In protocol D-74, only MP-MTX was used for 3 years; the random half of the patients also received "reinductions". In protocol C2-72, BCG was administered by scarifications for 2 years to patients in remission after 36 months; in D-74, the random-half patients received BCG and irradiated allogeneic blasts for one year. The other half of the patients received no other treatment. The overall disease-free survival rate is 45.6% with a duration of between 84 and 156 months. Only one death occurred after 7 years. In protocol C2-72, 9 of 26 initial patients (34.6%) and in protocol D-74, 33 of 66 initial patients (50%) are still alive, off treatment and with no sign of disease. Ten patients (10.8%) died in continuous remission of infection (8) or toxic encephalopathy (2); five deaths were caused by "Pn. carinii". The incidence of meningeal relapse was 11% and isolated testicular relapse in males 15.7%; moreover, in 6 of the 22 boys in remission, programmed testicular biopsy showed interstitial leukemic infiltrates. Analysis of initial risk factors permitted the establishment of a risk index (r.i.): in cases with a r.i. below 3 (76% of cases) the survival rate was 53%; in the group with a higher r.i. (24%), it was 22%. Further conclusions of this study were: the lack of effectivity of "reinductions" and immunotherapy and proof of a higher rate of relapses in males mainly owing to isolated testicular relapse.

Adolescent↗

PubMed1995

Small noncleaved cell lymphoma and leukemia in adults. A retrospective study of 65 adults treated with the LMB pediatric protocols.

In France, more than 80% of children with Burkitt's lymphoma or Burkitt's leukemia (ALL3) are now cured with the LMB (B-cell non-Hodgkin's lymphoma and B-ALL) protocols of the Société Française d'Oncologie Pédiatrique, but so far, poor results have been obtained in the few adult studies available. We have analyzed the experience with LMB protocols in adult patients. This retrospective study involved 65 adult patients with small noncleaved cell lymphoma or ALL3 treated with the LMB protocols. They were 17 to 65 years old and not previously treated. Human immunodeficiency virus-infected patients were excluded. The diagnoses were made between September 1984 and August 1991. According to the Murphy classification, 12 patients (18%) had stage I or II disease, 25 (38%), stage III disease; 4 (6%), stage IV disease; and 24 (37%), ALL3 (> or = 25% blasts). According to the Ann Arbor classification, 9 patients had stage I disease; 8 patients, stage II; 5 patients, stage III; 21 patients, stage IV disease; and 22 patients, ALL (> or = 30% blasts). Twelve patients had central nervous system (CNS) involvement before treatment. Thirty-nine patients were treated according to the LMB 84 protocol scheme; 14 according to the LMB 86 protocol, and 12 patients received the LMB 84 induction courses followed by the LMB 86 consolidation courses. Three patients underwent bone marrow transplantation (BMT) while in second complete remission (CR) and 3 others had refractory disease. There were some protocol violations caused by empirical medical decisions: local irradiation was performed in 4 patients, 2 patients received prophylactic radiation to the brain that was not specified in the protocol, 13 patients underwent BMT in first CR, and methotrexate doses were modified in 10 patients. Fifty-eight patients (89%) achieved a CR. There were four (6%) primary induction treatment failures, and three (4%) early treatment-related deaths. Eight patients relapsed between 2 and 30 months after CR (median, 4.7 months). Forty-seven patients are alive in CR (45 first CR, 2 second CR) with a median follow-up of 57 months (24 to 93 months). There were five toxicity-related deaths among patients in CR including four BMT-related deaths and five deaths caused by refractory relapses. One patient died in CR at 62 months of rectal cancer. The 3-year overall survival rate is 74% (SE = 5). According to the stages in the Murphy classification, the 3-year survival rates are stages I and II, 100%; stage III, 80% (SE = 7); and stage IV and ALL, 57% (SE = 8). Seven of 12 patients with initial CNS disease are alive with a median survival of 56 months.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

PubMed1993

Protocol management of adult respiratory distress syndrome.

Protocol control of severely ill ICU patients seems feasible. A satisfactory computer infrastructure makes protocol control practical. A reported four-fold survival rate increase associated with protocol control of ventilatory management of adult respiratory distress syndrome patients suggests that it is not harmful. Protocol control represents a medical decision-support approach for standardizing therapy. Computerized protocols might provide a solution to the nonuniformity of care in clinical ICU practice and investigation. My colleagues and I can envision a multicenter consortium of hospitals equipped to carry out computerized protocol-controlled care. Such a consortium could rapidly complete large, randomized, clinical trials under computerized protocol control. This arrangement could provide much more definitive results than are currently possible. Interpretation of outcomes research results should thereby be made easier and conclusions should be more credible and more likely to contribute to medical policy formulation.

Adult↗

PubMed1993

[Comparison of ovulation induction protocols for in vitro fertilization].

In a retrospective study we evaluated 4 controlled ovarian hyperstimulation (COH) protocols for in vitro fertilization (IVF) treatment. Treatment cycles 4 through 8 were analyzed in patients, who in 3 previous attempts reached the stage of embryo transfer (ET) but did not conceive. The 426 recorded cycles included all indications for IVF, but not the male factor. The age range was 25-46 years. Patients underwent from 4 cycles (169 women) to 8 cycles (27 women). The COH protocols used included established combinations of menotropins, clomiphene citrate/hMG, and short and long protocols of GnRH analogs followed by hMG. There were no statistically significant differences in patient age, etiology and duration of infertility, or distribution of the various COH protocols among the groups of patients. No single protocol was significantly superior to any other when the pregnancy rate per cycle was assessed. The results did not justify changing a COH protocol which had lead to ET but not to pregnancy, for another protocol.

Adolescent↗