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Preoperative diagnostic protocol to predict candidates for unicompartmental arthroplasty.

Two hundred eight prosthetic knee arthroplasties were evaluated prospectively with a preoperative diagnostic protocol, the unicompartmental osteoarthrosis (UO) protocol. This is the first series of a preoperative diagnostic protocol able to predict localized osteoarthritic findings at surgery with reliability. The protocol was developed to accurately predict which osteoarthritic patients would be appropriate candidates for unicompartmental arthroplasties or high tibial osteotomy. The UO protocol reliability predicted which patients had isolated unicompartmental changes at surgery, allowing for the use of unicompartmental arthroplasties or high tibial osteotomy rather than tricompartmental prosthetic arthroplasty in 207 of 208 arthroplasties.

Arthroplasty↗

Receiver operating characteristic curve analysis of the performance of various radiographic protocols when screening dogs for pulmonary metastases.

Five radiographic protocols for detecting pulmonary metastases in dogs were compared by analyzing receiver operating characteristic curves for the protocols. Protocols compared were a right lateral view only, a left lateral view only, right lateral and dorsoventral views, both lateral views, and all 3 views. Three radiologists used each of the protocols to evaluate 99 sets of thoracic radiographs. Fifty-two sets of radiographs were from dogs confirmed histologically to have pulmonary metastases and 47 were from dogs proven at necropsy to be free of pulmonary metastases. Results of the 5 protocols were not statistically different. We concluded that a third view is not necessary when routinely screening dogs with cancer for pulmonary metastases and that the standard 2-view thoracic examination should be adequate. However, in individual cases, a third view may be the determining factor in establishing a radiographic diagnosis and should be obtained if any suspicious areas are seen.

Animals↗

Evaluation of a protocol on the care and management of a neurological patient with seizures.

In the hope of discovering a user friendly resource applicable to the Clinical practice of all nurses, staff at Vancouver General Hospital experiment with the use of nursing protocols. Last year nurses on the neurological unit proposed that effective management of seizure patients could be further facilitated when expected standards of care were properly developed, implemented, utilized and evaluated in the form of a nursing protocol. A two phase study was conducted attempting to compare those patients admitted to the unit one year prior to the use of the protocol, with those admitted for one year following its implementation. The results of this study will be presented in relation to the effectiveness of the protocol on patient outcomes. As well, the unit nurses' response to working with the protocol will be reviewed.

Clinical Protocols↗

Childhood non-Hodgkin's lymphoma--results of treatment with ALL high-risk protocol.

Between August 1984 and September 1990, 13 children with non-Hodgkin's lymphoma (NHL) were treated with ALL high-risk protocol (5 with TCLSG 842 regimen and 8 with TPOG 882B protocol) at Taichung Veterans General Hospital. Diagnosis of NHL was confirmed by histology. Nine had lymphoblastic lymphoma, three had histiocytic lymphoma and one had small non-cleaved cell lymphoma, according to the Rappaport classification. After thorough clinical evaluation eight children were NHL stage IV; four were stage III; and one was stage II. All these children had received chemotherapy as acute lymphocytic leukemia (ALL) high-risk protocol for a total of three years, including central nervous system (CNS) prophylaxis. Of the 13 patients, 9 (69.2%) gained complete remission. Over-all survival rate was 46.2%, with a median interval of 36 months. The complete remission rate and survival rate for the nine children with lymphoblastic lymphoma was better at 77.7% & 66.6% respectively. Within the nonresponsive group, two failed to remit because of early withdrawal from the protocol; the other two patients were refractory to treatment. Relapse was noted in one patient. As to the side effects, neutropenic fever was the most common problem encountered (9 occurrences in 13 patients). Other major complications included severe mucositis, massive GI bleeding, intracranial thrombosis induced by l-asparaginase and tumor lysis syndrome. Childhood NHL is often of diffuse types in pathology, and most affected children have advanced diseases at diagnosis. Choosing an optimal treatment protocol is important for good treatment results.

Adolescent↗

Fetal surgical protocols in Yucatan miniature swine.

Thirty-nine Yucatan miniature swine were used in three fetal surgical experimental protocols. They involved antiarrhythmic administration, pacemaker implantation, and in-utero diagnosis of ventricular septal defect by intraoperative echocardiography. Because of problems encountered with surgical protocols in the initial stages, modifications were made to prevent fetal hypothermia and intraoperative mortality. These modifications included environmental temperature support, staple surgical techniques to reduce operative time, and development of fetal catheters designed to facilitate cannulation of small vessels. Postoperative care protocols were intensive and included antibiotics, analgesics, and supportive care designed to reduce discomfort and prevent abortion and sepsis. Thirty-seven of 39 sows survived the surgical procedures; experiments were performed on 117 fetuses. Twenty-two fetuses died either intraoperatively or postoperatively because of complications related to the experimental protocols. Modification of surgical and postsurgical protocols for these projects demonstrates the feasibility of using miniature swine as a model for fetal surgery, when their use was appropriate for anatomic and physiologic reasons.

Animals↗

[The results of treatment by the Madrid Pediatric Oncology Group according to the BFM protocols in non-Hodgkin's B-cell lymphoma and acute B-cell lymphoblastic leukemia in pediatric patients].

The objective of this report is to present the results of the BFM group in the treatment of 41 children with non-Hodgkin's B cell lymphoma and acute B cell lymphoblastic leukemia according to the BFM 86 and 90 protocols. Forty-one children, between 2 and 16 years of age, were treated from November 1987 to October 1993. Of these, 25 were treated with the BFM 86 protocol (18 non-Hodgkin's B cell lymphomas and 7 acute B cell lymphoblastic leukemias) and the rest with the BFM 90 protocol (15 non-Hodgkin's B cell lymphomas and 1 acute B cell lymphoblastic leukemia). Complete remission was achieved in 97.5% of the patients. A relapse occurred in 12.5% of the cases. Currently, 80.4% remain in continuous complete remission and 17% have died. The 5 year actuarial survival rate of those treated with the BFM 86 and 90 protocols was 79% and 87%, respectively, and event free survival in the same period was 76% and 87%, respectively. There was no statistically significant difference in the results obtained with the two treatment protocols.

Adolescent↗

[The treatment results in children with malignant mesenchymal tumors according to the protocols of the International Society of Pediatric Oncology (SIOP)].

OBJECTIVE: To evaluate the SIOP protocols in the treatment of mesenchymal tumors. PATIENTS AND METHODS: We present the results obtained in 28 children diagnosed at a single pediatric hematology-oncology unit of having malignant mesenchymal tumors. These diagnoses were made between April 1981 and June 1994 and the children were treated following the consecutive SIOP protocols which have the objective of curing the disease with minimal sequelae. The first four patients with rhabdomyosarcoma were treated with MMT-SIOP 75, the next 9 children, also diagnosed with rhabdomyosarcoma, were treated with MMT-SIOP 84. During the same period of time, there was a case of synovial sarcoma treated only with surgical excision. The last 14 patients were included in the current protocol, initiated in 1989. Eleven of these patients had rhabdomyosarcoma and 3 synovial sarcoma. RESULTS: Overall survival and event-free survival at 5 years were 58% and 36%, respectively. Toxicity never was an important factor, although it was increasingly frequent and severe as protocols evolved. CONCLUSIONS: We conclude that our results are similar to those obtained in patients treated with SIOP protocols.

Adolescent↗

Introduction of a computerised protocol in clinical practice: is there anything to gain?

OBJECTIVES: To assess the potential benefit of a protocol for the diagnostic work-up and management of patients with obstructive jaundice, by comparing its recommendations with the policies actually followed in patients and to compare local expertise with diagnostic and therapeutic procedures with that described in published reports. DESIGN: A retrospective analysis of patients' records. SETTING: University hospital, The Netherlands. SUBJECTS: 49 consecutive patients who presented to the departments of internal medicine and surgery between June 1990 and June 1992 with serum alkaline phosphatase activities > 125 mumol/L, and serum bilirubin concentrations > 17 mumol/L. MAIN OUTCOME MEASURES: The proportions of diagnostic and therapeutic decisions that deviated from the recommendations, and the success rates of diagnostic and therapeutic procedures. RESULTS: In patients with bile duct stones the treatment strategies did not deviate from those recommended in the protocol. In patients with cancer 38 (30%) of the 128 diagnostic decisions and 4 (11%) of the 37 therapeutic decisions deviated from the protocol. Success rates of all diagnostic investigations were comparable with those reported, and success rates of endoscopic biliary drainage tended to be lower than those reported. CONCLUSIONS: The introduction of a protocol for the diagnostic work-up of patients with obstructive jaundice may reduce unnecessary investigations and diagnostic omissions by half. Because local expertise of some of the procedures seems to be significantly less than reported elsewhere it may be necessary to modify the protocol to better fit local circumstances.

Aged↗

Eighty-one percent event-free survival in advanced Burkitt's lymphoma/leukemia: no differences in outcome between pediatric and adult patients treated with the same intensive pediatric protocol.

BACKGROUND: Advanced Burkitt's lymphoma (BL) has an extremely poor prognosis in adults. With a previous protocol including CNS prophylaxis, 40% of our adult patients achieved CR and only 13% became long survivors. In 1988, following this poor experience, we adopted a very intensive pediatric-derived protocol. PATIENTS AND METHODS: Twenty-one consecutive patients, 8 adults (median age 35, stage III: 1; IV: 7; leukemias: 6) and 13 children (median age 10, state III: 8; IV: 5; leukemias: 4) were treated with the same protocol (POG 8617), based on alternate two-phase cycles with sequential high-dose CTX, VCR, ADM + CNS chemoprophylaxis (phase A) and HD MTX + HiDAC (phase B). Adults received 6 cycles, children 8; i.t. prophylaxis in phase B was omitted in adults. RESULTS: Twenty of 21 (95%) patients achieved CR (adults 100%, children 92%). Two patients died early; 2 relapsed at 4 and 9 months. With a median follow-up of 28 months (4-96), 17 patients (81%) are event free (adults 75%, children 85%). Severe infections affected 62% of adults and 15% of children. CONCLUSIONS: (1) The prognosis of adult advanced BL definitely improved with this intensive protocol. (2) There were no differences in outcome between adults and children. (3) Outcome of lymphoma and leukemia was similar. (4) Severe infections occurred frequently in adults. This intensive pediatric protocol requires a careful supportive therapy.

Adolescent↗

[Analysis and comparison of various quality protocols for radiotherapy linear accelerators].

The main parameters determining the quality of an electron beam produced by a linear accelerator for medical use were considered in this study, particularly: flatness, symmetry and uniformity. We analyzed and compared several protocols issued by national and international associations (such as the AAPM, IPSM, ICRU, NACP), the software protocol developed for the measurement system we used (Multidata) and the measurement instructions recommended by the accelerator manufacturer (Siemens). The above associations issue quality protocols to ensure system performances suitable for medical use, to increase patient safety and to improve the treatment outcome. Radiation therapy safety and improvement depend on correct dose measurements and dose distribution in the treated volume. Once the dose value per monitor unit ratio (Gy/M.U.) is determined, controls are necessary to be sure that the value does not change in time and that the dose distribution has the same effect in the whole treated volume. Our goal is to point out the differences and the affinities in the definition of the parameters, which change slightly in the different protocols, and to study the origin of the differences found when the experimental results were compared. Another important issue is represented by the frequency of quality controls, which are definitely different from the fast checks which are often performed. In conclusion, some suggestions are provided for the choice of the quality protocol to follow.

Clinical Protocols↗

Constructing a therapist-driven protocol. Spectrum of types and quality control.

Therapist-driven protocols for the implementation and delivery of respiratory care must be tailored to fit the needs of the individual institution. The method that is chosen for constructing a therapist-driven protocol depends on the type of protocol desired (disease-, symptom-, or treatment-based) and on whether a narrative or flow-diagram format is preferred. Because the goal of therapist-driven protocols is to provide a systematic method for determining appropriate respiratory care, quality control measures are necessary to ensure that desired outcomes are achieved. Quality control monitoring can be performed through the use of case-study exercises, verbal shift reports, and care-plan audits. Results of quality control monitoring techniques can be used to guide modification of protocols.

Clinical Protocols↗

Protocol violation in deep vein thrombosis prophylaxis.

This study aimed to determine how closely deep vein thrombosis (DVT) prophylactic policies are adhered to in routine general surgical practice, to identify reasons for policy violations and to assess the effects of policy modification. Eight adult patients, sixty of whom had undergone an operation, under the care of six general surgeons, each with their own written DVT protocol, were studied on one weekday. Thirty patients (50%) did not receive DVT prophylaxis according to the policy of the relevant consultant. Most violations occurred for unacceptable reasons, mainly starting low-dose subcutaneous heparin or using thromboembolic stockings postoperatively. However, 43% of protocol violations occurred for acceptable clinical reasons. Following the initial study, a uniform departmental DVT prophylaxis policy was introduced. Nursing and medical staff were thoroughly appraised of the new policy. In a repeat study of 75 patients 1 year later, there were 15 protocol violations among 58 patients who had undergone an operation (27%). However, there were no violations for acceptable reasons. The number of unacceptable protocol violations in the two studies was similar (24/60 and 17/56). The number of patients at moderate or high DVT risk who received no preoperative prophylaxis was the same in both studies (8/48 in both audits). DVT protocol violations are common in routine general surgical practice. Policy modification and unification results in fewer violations, but made little impact on the level of thromboprophylactic care.

Adolescent↗

Outcomes in abdominal hysterectomy patients with benign disease. Use of physician-developed clinical protocols.

OBJECTIVE: To develop a clinical protocol for standardizing preoperative and postoperative care in abdominal hysterectomy patients with benign disease while maintaining quality and increasing efficiency. STUDY DESIGN: Protocol and nonprotocol groups of patients were compared with respect to key quality and efficiency outcomes in a non-randomized study. Patient group outcomes were compared using descriptive, Student's t, chi 2 and log-rank statistics. Statistical tests were performed at a .05 level of significance. RESULTS: Results from two separate protocol study periods conducted in 1996 and 1997 are reported. In both study periods statistical analyses and graphic presentations illustrate that protocol implementation improved quality of care by increasing the percentage of patients receiving appropriate antibiotic prophylaxis; maintained quality as monitored through 30-day readmission rates and a postdischarge patient survey; and improved efficiency, as evidenced by shorter times to incision and length of hospital stay. CONCLUSION: At Toledo Hospital, the clinical practice protocol directed at abdominal hysterectomy patients has been an effective tool in efforts to improve quality and efficiency in patient care.

Clinical Protocols↗

[The effect of a rational and consensual protocol for the use of ceftriaxone in a general hospital].

In hospitals in Spain there has been a large increase in the use of wide spectrum antibiotics. The objective of this study was to evaluate the influence of a rational, consensual protocol on the use of ceftriaxone. An observational and prospective study was carried out using information provided by the Servicio de Farmacia on the in-hospital prescriptions for ceftriaxone. The study included two groups as follows: a control group (October-December 1995) not taking into account the protocols for antibiotic treatment; and a study group in the same months in 1996 with the consensual protocols taken into account. The criteria for the type of patient, infection, evolution and antibiotic treatment were evaluated according to the criteria in the international literature on this type of study. The initial characteristics of both groups of patients were similar. Following the use of the protocol there was a significantly associated reduction in use (48 cases in the study group vs. 57 cases in the control group), an increase in the appropriate use (31. 57% in the control group vs. 75% in the study group), an increase in the cure rate (70.17% in the control group vs. 91.7% in the study group) and a decrease in hospital stay of 7.53 days (22.59 days in the control group vs. 15.06 in the study group), producing a savings per cured patient of 617.142 pesetas. It was concluded that the consensual protocol and its proper application make for a highly interesting approach given that it allowed for better quality use of ceftriaxone with greater cost-effectiveness.

Bacterial Infections↗

Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams.

CONTEXT: With the success of zidovudine chemoprophylaxis for prevention of perinatal transmission of the human immunodeficiency virus (HIV), an increasing number of HIV-exposed but uninfected children will have in utero exposure to zidovudine and other antiretroviral drugs. OBJECTIVE: To evaluate the long-term effects of in utero exposure to zidovudine vs placebo among a randomized cohort of uninfected children. DESIGN: Prospective cohort study based on data collected during Pediatric AIDS Clinical Trials Group Protocol 076, a perinatal zidovudine HIV prevention trial, and Protocol 219, a long-term observational protocol. SETTING: Pediatric research clinics in the United States. PATIENTS: Two hundred thirty-four uninfected children born to 230 HIV-infected women enrolled in Protocol 076 and followed up through February 28, 1997, in Protocol 219 (122 in the zidovudine group and 112 in the placebo group). MAIN OUTCOME MEASURES: Physical growth measurements, immunologic parameters, cognitive/developmental function, occurrence of neoplasms, and mortality data assessed every 6 months for children younger than 24 months and yearly thereafter or as clinically indicated. Baseline echocardiogram and funduscopic evaluations were collected before 36 months of age. RESULTS: Median age of children at time of last follow-up visit was 4.2 years (range, 3.2-5.6 years). There were no significant differences between children exposed to zidovudine and those who received placebo in terms of sequential data on lymphocyte subsets; weight, height, and head circumference z scores; and cognitive/developmental function. No deaths or malignancies occurred. Two children (both exposed to zidovudine) are being followed up for abnormal, unexplained ophthalmic findings. One child exposed to zidovudine had a mild cardiomyopathy on echocardiogram at the age of 48 months; the child is clinically asymptomatic. CONCLUSIONS: No adverse effects were observed in HIV-uninfected children with in utero and neonatal exposure to zidovudine followed up for as long as 5.6 years. Continued prospective evaluations of children born to HIV-infected women who are exposed to antiretroviral or immunotherapeutic agents are critical to assess the long-term safety of interventions that prevent perinatal HIV transmission.

Anti-HIV Agents↗

Facilitated detection of oncogene mutations from exfoliated tissue material by a PNA-mediated 'enriched PCR' protocol.

An 'enriched polymerase chain reaction (PCR)' protocol has been established for the sensitive detection of oncogene mutations in body fluid samples from cancer patients. This two-step protocol combines an allele-specific PCR clamping step followed by a PCR-RFLP (restriction fragment length polymorphism) confirmatory step. The method thus resembles a nested PCR technique starting directly from genomic DNA material and, in no more than 54 PCR cycles, allows the sensitive detection of one mutant allele in 10(3) normal alleles. This protocol was tested on bronchial cytology samples and sputum taken from lung cancer patients and point mutations could be detected both in codon 12 of K-ras and in three codons (248, 249, and 273) of the p53 gene. Comparing this protocol with a different 'enriched PCR' method based on repetitive PCR-RFLP steps, a high concordance was noted between the two methods. Although the present protocol seems to be less sensitive by approximately one order of magnitude, it is much easier to perform and thus could be applied to the rapid but sensitive detection of allelic subfractions in a population of cells derived from exfoliative material.

Bronchoalveolar Lavage Fluid↗

Interim review of the Transnational Case-control Study of Oral Contraceptives and Health: approved protocol revisions through September 1995.

UNLABELLED: The protocol of the Transnational Study on Oral Contraceptives has been published at the outset of the study in order to ensure the correct performance of the study and to ensure the study's scientific integrity. Potential revisions and additions to this protocol had been announced in the prior publication. This article focuses on those points of protocol which have been resolved as practical experience was gathered as well as additional modifications required by practical and scientific considerations. The major alterations are based on exposure prevalences in controls and on power calculations. The low (1.8%) exposure to gestodene among German controls led to the discontinuation of the German component and to the accelerated accession in additional countries. THE CASE: control ratio was altered to 3:1 for purposes of economy based on power calculations. Numerous minor points, most addressed in the prior protocol, have been resolved. It is found that these modifications of the study protocol do not impair the study's conduct, its scientific integrity, nor its capability of providing answers to the study question.

Journal Article↗

Young adults 16-21 years of age at diagnosis entered on Childrens Cancer Group acute lymphoblastic leukemia and acute myeloblastic leukemia protocols. Results of treatment.

BACKGROUND: Scant data are available on event-free survival (EFS) for young adults with leukemia who were 16-21 years of age at diagnosis. In acute lymphoblastic leukemia (ALL), it is well recognized that children have a better EFS compared with adults, whereas for acute myelocytic leukemia (AML), EFS results seem to be similar. To determine the appropriate treatment for young adults with leukemia, outcome data are essential. METHODS: Young adults entered on the Childrens Cancer Group (CCG) 100 series ALL protocols and the CCG 213 AML protocol were analyzed for EFS and survival. Prognostic factors for EFS also were determined. RESULTS: The actuarial EFS for 143 young adults with ALL treated on the CCG 100 series ALL protocols was 64 +/- 4% at 4 years and 59 +/- 4% at 6 years. The major adverse prognostic feature was leukocyte counts greater than 50,000/microliters. The actuarial EFS for 79 young adults with AML entered on CCG 213 was 32.2 +/- 5.3% at 2 years and 28.6 +/- 5.3% at 3 years. CONCLUSIONS: Young adults with ALL treated on CCG protocols have a 6-year EFS of approximately 60%. This is similar to the EFS for patients 10-15+ years of age at diagnosis treated on the same protocols and better than EFS results reported from most adult trials. Young adults with AML had a slightly inferior outcome compared with younger children.

Adolescent↗