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PubMed1998

The Bruce treadmill protocol: does walking or running during the fourth stage alter oxygen consumption values?

OBJECTIVE: To investigate heart rate (HR) and relative oxygen consumption (VO2) measures during two modes (walking or running stages four) of the Bruce treadmill protocol. PARTICIPANTS: Male volunteers (n = 27), ranging in age from 25 to 56 years (M = 39.1 +/- 10.7 yrs). EXPERIMENTAL DESIGN: S's performed to volitional fatigue on the two randomly assigned treadmill tests. MEASURES: HR and VO2 were taken each minute and at point of exhaustion. RESULTS: Dependent "t"-tests revealed a significantly (p < or = 0.05) difference between the protocols at 11 minutes (running = 46.7 +/- 3.9 > walking = 44.6 +/- 3.7 ml[kg.min-1]) and at 12 minutes (running = 49.3 +/- 4.1 > walking = 47.6 +/- 3.5 ml[kg.min-1]) on the VO2 values. A significant differences was noted on HR at 11 minutes (running = 158.1 +/- 13.5 > walking = 156.0 +/- 13.0 bpm) and at 12 minutes (running = 160.4 +/- 11.0 > walking = 157.8 +/- 11.4 bpm) between the protocols. The two-way ANOVA technique revealed no significant differences or interactions on VO2 or HR between younger (< 45 yrs) and older (> or = 45 yrs) subjects during either protocol. A one-way ANCOVA indicated no significant differences between taller and shorter subjects on VO2 during the fourth stage of the Bruce protocol. The correlations, between the two protocols, for HR were strong but were weaker and inconsistent for VO2. The repeated measures ANOVA indicated significant within subject variability between test administrations. CONCLUSIONS: When testing endurance trained males, modality, age and height are not factors in differences of VO2 values during the 4th stage of the Bruce treadmill test but learning effect could be.

Adult↗

PubMed1996

Induction toxicity of a modified Memorial Sloan-Kettering-New York II Protocol in children with relapsed acute lymphoblastic leukemia: a single institution study.

Although the chance of cure for children with acute lymphoblastic leukaemia (ALL) is high, their outlook with subsequent relapse is poor. Bone marrow transplantation may be an option for some, but the need for intensive reinduction chemotherapy regimens remains the best hope for effecting cure in the majority of relapsed children. The authors report the experience of using an intensive chemotherapy protocol (Memorial Sloan-Kettering-New York II Protocol, MSK-NY-II) in a series of relapsed children with ALL. Thirty children presenting to the Royal Alexandra Hospital for Children, Sydney, in their first relapse of ALL were treated according to a modification of the original MSK-NY-II protocol. Three children (10%) died during induction therapy, two from overwhelming Gram-negative sepsis, and one from intracerebral haemorrhage. Of 27 children completing induction, two children failed to enter remission; however, both had planned deviations from the protocol. Infectious complications were prominent with a total of 55 admissions for febrile neutropenic episodes. Eight children required the support of the intensive care unit for infectious complications. A total of 36 microbiological isolates were obtained from the patients during induction therapy. Ten bone marrow transplant procedures have been subsequently performed in these children, of whom five are alive and disease free at the time of writing. The MSK-NY-II protocol is an intensive regimen but with encouraging early remission rates in relapsed childhood ALL. Early sepsis in previously immunosuppressed children is an important cause of induction death.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1996

Evaluation of patients with advanced neuroblastoma surviving more than 5 years after initiation of an intensive Japanese protocol: a report from the Study Group of Japan for Treatment of Advanced Neuroblastoma.

In January 1985, a single protocol consisting of cyclophosphamide, vincristine, tetrahydropyranyl adriamycin, and cis-platinum for the treatment of advanced neuroblastoma was begun nationwide in Japan and was found to improve clinical results significantly in terms of 2- or 3-year survival rate. Between January 1985 and December 1988, 113 eligible patients (7 infants younger than 12 months of age with stage IVA disease and 106 patients aged 12 months or older with stage III or IV disease) were enrolled and followed up for 5 years or more after initiation of treatment, as of March 1994. In this study, the usefulness of the protocol for the treatment of advanced neuroblastoma was evaluated with survival rates in relation to age, tumor site, stage, and N-myc amplification for patients surviving more than 5 years after initiation of the protocol. Fifty of the 113 patients were alive 5 years or more after initiation of the treatment, 39 without any episodes of disease recurrence. Fourteen (70%) of 20 patients with stage III, 6 (50%) of 12 with stage IVB, and 24 (30%) of 81 with stage IVA disease were alive and disease-free 5 years after initiation of the protocol. Twenty (56%) of 36 patients without N-myc amplification were alive at 5 years after initiation of the protocol. Only one patient who was alive without evidence of the disease at 5 years had recurrence afterward.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1990

Dexamethasone used as an antiemetic in chemotherapy protocols inhibits natural cytotoxic (NC) cell activity.

Because dexamethasone is often included as an antiemetic in chemotherapy protocols that involve cisplatin and because cisplatin has been shown to increase the in vitro lysis of tumor cells by natural cytotoxic (NC) effector cells, we determined the NC activity of 27 patients who received dexamethasone in conjunction with seven different cisplatin-based chemotherapy protocols. The results of this analysis showed that the NC activity of patients who received cisplatin-based chemotherapy protocols that included dexamethasone was reduced significantly 24 hours after treatment compared with before treatment (P less than 0.001). The addition of dexamethasone (at a concentration equivalent to the plasma level of patients treated with dexamethasone) to the in vitro assay of NC activity caused a significant decrease in NC activity compared with when dexamethasone was not added (P less than 0.001). There was no cumulative effect of dexamethasone in that the reduction of NC activity by dexamethasone was not significantly different in patients who had been treated previously at least four times and in patients who were treated for the first time. When dexamethasone was not included in the chemotherapy protocol the NC activity of 19 patients was not reduced 24 hours after treatment. These results indicate that dexamethasone causes a significant reduction in NC activity. Although the tumor surveillance role of human NC cells in vivo has not been established, the effect of dexamethasone on NC cells suggests that additional research of the effect of dexamethasone in cisplatin-based chemotherapy protocols is warranted.

Adult↗

PubMed2003

Lymphoblastic lymphoma of childhood and the LSA2-L2 protocol: the 30-year experience at Memorial-Sloan-Kettering Cancer Center.

BACKGROUND: Until the 1970s, diffuse lymphoblastic lymphoma (DLBL) was considered incurable. With intensive multidrug regimens, the majority of patients can now be cured. In the current study, the authors present what to their knowledge is the longest follow-up presented to date (median, 20 years for survivors) of the largest group of DLBL patients treated with a single protocol at a single institution. METHODS: Between 1971-1990, a total of 95 consecutive patients (age < 21 years) with DLBL were treated with the LSA(2)-L(2) protocol at the Memorial Sloan-Kettering Cancer Center (MSKCC). Patients with Stage I-II disease were treated for 2 years. In 1980, the protocol was modified and patients with Stage III and IV disease were treated for 3 years. In addition, before the modification, patients with Stage IV disease received a cumulative dose of 15,600 mg/m(2) of cyclophosphamide for 3 years; after 1980, these patients received the same dosage as the other patients (i.e., 8400 mg/m(2) for 2 years). Radiation therapy initially was administered to all patients with bulky disease in the primary tumor site. Until 1977, the dose of radiation was 20-55 grays (Gy); from 1977 to 1989, the dose was 20 Gy. After the fifth year of completion of treatment, all patients were evaluated comprehensively every 2 years. RESULTS: The overall survival (OS) of the patients was 79% with a median follow-up of 20 years. The overall event-free survival (EFS) was 75% (71 of 95 patients). Seventeen patients developed a disease recurrence and 15 died of disease. The OS and EFS rates for patients with Stages I-II disease (n = 8) were 87% and 87%, respectively, and the OS and EFS rates for patients with Stage III disease (n = 41) were 90% and 85%, respectively. The OS and EFS for patients with Stage IVA disease (with bone marrow [BM] involvement of < 25%) (n = 19) were 79% and 73%, respectively, whereas the OS and EFS for patients with Stage IVB disease (BM involvement of > 25%) (n = 27) were 74% and 70%. Of the 29 patients with Stage IV disease who were treated with the original protocol, 7 died of disease (1 of 8 patients with Stage IVA disease and 6 of 21 patients with Stage IVB disease). Of the 17 patients with Stage IV disease who were treated with the modified protocol, 3 died of disease (2 of 11 patients with Stage IVA disease and 1 of 6 patients with Stage IVB disease). Six patients developed secondary malignancies, four of whom died. CONCLUSIONS: Long-term EFS can be achieved in the majority of patients with widely disseminated pediatric DLBL. Chemotherapy alone appears to be sufficient prophylaxis against disease recurrence in the central nervous system. No disease-related or treatment-related deaths were reported to occur > 4.5 years after diagnosis in the current study.

Adolescent↗

PubMed2006

Improved outcome in the treatment of pediatric multifocal Langerhans cell histiocytosis: Results from the Japan Langerhans Cell Histiocytosis Study Group-96 protocol study.

BACKGROUND: The treatment outcome of multifocal childhood Langerhans cell histiocytosis (LCH) has not been satisfactory and has resulted in poor therapeutic responses with high mortality and a high incidence of reactivation with late sequelae. To overcome these issues, the Japan LCH Study Group-96 (JLSG-96) protocol was conducted prospectively from 1996 to 2001 in Japan. METHODS: Newly diagnosed children with multifocal LCH were classified into 2 groups: a single-system multisite (SS-m) group and a multisystem (MS) group. All patients initially were treated on Protocol A, which consisted of 6 weeks of induction therapy with combined cytosine arabinoside, vincristine (VCR), and prednisolone (PSL) followed by 6 months of maintenance therapy. Patients who had a poor response to the induction of Protocol A were switched to a salvage regimen (Protocol B), which consisted of an intensive combination of doxorubicin, cyclophosphamide, VCR, and PSL. RESULTS: In total, 91 patients were treated, including 32 patients in the SS-m group and 59 patients in the MS group. At the median 5-year follow-up, 96.9% of patients in the SS-m group and 78.0% of patients in the MS group had good response status. Diabetes insipidus developed in 3.1% of patients in the SS-m group and in 8.9% of patients in the MS group. The overall survival rate at 5 years for the SS-m and MS groups was 100% and 94.4% +/- 3.2%, respectively. CONCLUSIONS: The JLSG-96 protocol attained very low mortality for pediatric patients with multifocal LCH.

Adolescent↗

PubMed1990

Optimization of survey protocols for MRI.

A method for evaluating the sensitivity of MRI protocols to changes in an arbitrary number of tissue parameters over a broad range of parameter values is presented. This analysis is useful for choosing an optimal basis set of images for either a "survey" protocol or tissue segmentation algorithms. A survey protocol is required when searching for a lesion of unknown type or location. Segmentation requires unique signal signatures for tissues that may cover a broad range of tissue parameter values. Data acquisition is modeled as a mapping of a domain of tissue parameter values into a signal manifold in a signal strength space defined by the MRI protocol. The efficacy of the protocol is evaluated by investigating the characteristics of the signal manifold. A figure of merit which maximizes the probability of discriminating each point in the domain of tissue parameters from all others is developed.

Clinical Protocols↗

PubMed1987

Increasing the rate of identification of battered women in an emergency department: use of a nursing protocol.

In recognition of the increasing problem of family violence, the authors developed and tested an interview protocol focused on female victims of family violence. The purpose of the protocol was to increase nurses' identification of battered women receiving care in the emergency department. Using a time-series design, data were collected from patient records during four months prior to introduction of the protocol. These data were compared to comparable post-protocol data. There was a significant increase in nursing staff identification of female domestic violence victims following introduction of the protocol.

Clinical Protocols↗

PubMed2006

Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat.

For superiority trials, the intent-to-treat population (ITT) is considered the primary analysis population because it tends to avoid the over-optimistic estimates of efficacy that results from a per-protocol (PP) population. However, the roles of the ITT population and PP population in non-inferiority studies are not clearly defined as in superiority trials. In this paper, a simulation study is conducted to systematically investigate the impact of different types of missingness and protocol violations on the conservatism or anticonservatism of analyses based on the ITT and the PP population in non-inferiority trials. We find that conservatism or anticonservatism of the PP or ITT analysis depends on many factors, including the type of protocol deviation and missingness, the treatment trajectory (for longitudinal study) and the method of handling missing data in ITT population. The requirement that non-inferiority be shown for both PP and ITT populations does not necessarily guarantee the validity of a non-inferiority conclusion and a sufficiently powered PP analysis is not necessarily powered for ITT analysis. It is important to assess the potential types and rates of protocol deviation and missingness that might occur in a non-inferiority trial and to obtain some prior knowledge regarding the treatment trajectory of the test treatment versus the active control at the design stage so that a proper analysis plan and appropriate power estimation can be carried out. In general, for the types of protocol violations and missingness considered, we find that hybrid ITT/PP analysis, which excludes non-compliant patients as in the PP analysis and properly addresses the impact of non-trivial missing data as in the MLE-based ITT analysis, is more promising by way of providing reliable non-inferiority tests.

Analysis of Variance↗

PubMed1989

Compliance of physicians and patients with a consensus protocol for treatment of advanced breast cancer.

In a multicenter study we used a consensus protocol including more than five subsequent therapeutic steps for treatment of patients with advanced breast cancer. A total of 335 evaluable patients from 27 participating hospitals were allocated to a low- or high-risk group, receiving different therapies during the initial phase of treatment. About half of these patients were treated without protocol violations (compliers). The protocol non-compliers were divided into three groups: those receiving more intensive therapy than recommended, those with similarly intensive, and those with less intensive therapy. The reasons for protocol violations were analysed. The intensity of the therapy given actually was correlated with the survival of subgroups. Median survival times were significantly longer in 208 low-risk than in 127 high-risk patients (P less than 0.0001), marginally longer in 165 compliers than in 170 non-compliers (P less than 0.04), significantly longer in low-risk compliers than in low-risk non-compliers (P = 0.002), and significantly shorter in high-risk compliers than in high-risk non-compliers (P = 0.007). Survival of all subgroups of low-risk non-compliers was the same regardless of the actual therapies given. The survival of high-risk patients who received less intensive therapy was significantly longer than that of high-risk compliers (P = 0.015). After six cycles of successful chemotherapy there was no difference, either in time to progression or in survival, between patients who had received either maintenance therapy or no therapy. We postulate that the groups of low-risk and high-risk patients comprised patients with different prognoses. Among low-risk patients, survival of the subgroup with poor prognosis (low-risk non-compliers) was not influenced by therapy. Among high-risk patients, a subgroup with poor prognosis may have been overtreated by using standard chemotherapies as recommended in our consensus protocol.

Breast Neoplasms↗

PubMed2006

Outcome of scorpion sting envenomation after a protocol guided therapy.

OBJECTIVE: Scorpion sting (SS) envenomation is a life threatening emergency in children, though not so severe in adults. Attempt to develop protocol using prazosin and dobutamine and few other drugs to treat SS. METHODS: Children aged 0-13 years with a history of scorpion sting were studied. Clinical features, complications, drug therapy and outcome of the cases for the period 1992-97(N = 186) was collected by the authors and also from the medical records department (RETROSPECTIVE GROUP). Cases treated during 1997-2000 (N = 198) as per the protocol were recorded as PROSPECTIVE GROUP. All the cases were observed for at least for 24 hours. Cases coming within 4 hours of a sting were given a dose of Prazosin (30 mic.gm/Kg/dose) and were observed. Those who came after 4 hours & were asymptomatic received only symptomatic treatment. Cases with signs of envenomation received Prazosin every 6 hourly till recovery. Cases having acute pulmonary edema (APE) were treated with dobutamine and sodium nitroprusside drip. Complicated cases were monitored in PICU as per the protocol. RESULT: Complications associated with excessive parasympathetic and sympathetic stimulation were observed. Myocarditis was observed due to the toxin and excessive catecholamine, which complicated in left ventricular failure (LVF) and APE. Nearly half of the children with acute myocarditis developed APE. Death was mainly due to myocarditis and APE, with or without encephalopathy. Mortality was high in children who received steroid and antihistaminics outside and who came late (> 4 hours). CONCLUSION: Complication rate remained almost same in both the groups. There was a significant reduction in overall mortality (P = < 0.0155) and in deaths associated with APE (P = < 0.0001) after the protocol guided therapy. There was also a reduction in mortality in encephalopathy group though not statistically significant. This treatment protocol and aggressive management of APE reduced the mortality due to SS significantly.

Adolescent↗

PubMed2006

Lymphoscintigraphy and radioguided sentinel node biopsy in oral cavity squamous cell carcinoma: same day protocol.

The routine use of a sentinel node biopsy (SNB) protocol in oral cavity squamous cell carcinomas (SCC) has been challenged on the basis of the elevated number of sentinel nodes (SNs) detected (>2.5) and on the multiply neck level involvement reported in several studies. These data limit the practical application of the protocol, because in such cases, it seems easier and safer to perform a selective neck dissection. The aim of our study is to perform radioguided surgery 1-3 h after lymphoscintigraphy (same day protocol) to detect the lymph nodes closest to the tumour site. In our study, 12 patients affected by cT1-2 N0 SCC of the oral cavity were submitted to a same day protocol of a lymphoscintigraphic examination (1-3 h before surgery) and a radioguided SNB. We used a hand-held gamma probe and performed an elective neck dissection on all patients. The SNs were found in all cases with 83% localised in the ipsilateral neck in only levels I-II. The mean number of SN detected was 2.1, with a mean pathological size of 13.8 mm measured on pathological specimen. Metastases were found in 5/12 cases (41.6%), on levels I, II and III and all were identified by step serial sectioning and routine H&E staining. This study confirms the accuracy of SNB in predicting the presence of occult metastases. This protocol is designed to detect SNs, which are almost always on neck level I and II, thereby limiting the number of nodes examined and the extension of the surgical approach.

Carcinoma, Squamous Cell↗

PubMed1995

Consultation behaviour of residents supported with a protocol processing system (ProtoVIEW) at the emergency ward.

We evaluated the consultation behaviour of residents using a protocol processing system in routine clinical practice. A total of 125 consecutive patients, of age 16 years or older with an isolated fracture without concomitant lesions, were treated with computer support between 13 October 1992 and 9 June 1993. All eight surgical residents who worked at the emergency ward of the University Hospital in Nijmegen, The Netherlands participated. The mean consultancy time, method of information retrieval, number of correct protocols found, number of windows retrieved and attitude towards ProtoVIEW as a useful information source were estimated. Main results are: a mean consultancy time of 1.5 min per case, residents browsed through the protocol information more often than using keyword search. The correct protocols were found in 98% of the cases while on average a minimum number of text-browse windows was retrieved. Residents were positive about the way protocols were presented and about the information supplied by ProtoVIEW. From this study we may conclude that ProtoVIEW consultation is hardly time consuming, and easy to use. Since keyword search was hardly used, expanding the number of synonyms may stimulate searching by keyword more often.

Adolescent↗

PubMedDate not supplied

Protocols for clinical care.

This paper describes the work of the DILEMMA project to provide protocol-based decision support in a variety of clinical domains. We give an outline of the generic protocol model that DILEMMA has produced, and the protocol task manager (PTM) software developed to assist protocol use in routine clinical practice. We summarise the validation of the model carried out to date, and take a quick look at the place of protocols in the wider context of clinical decision support.

Clinical Protocols↗

PubMed1993

Expediting the early hospital care of the adult patient with nontraumatic chest pain: impact of a modified ED triage protocol.

A prospective study that compared a traditional emergency department (ED) triage protocol with an expedited protocol was conducted to determine if minimizing the subjectivity of nursing triage would result in more efficient management of adult patients presenting with nontraumatic chest pain. The traditional protocol triaged 382 patients into 1 of 5 categories of acuity. The expedited study group (418 patients) were triaged as usual but subsequently were treated as if they were triage category 1 or 2 (medical evaluation within 15 minutes of arrival). Traditional triage led to 40% of acute myocardial infarction (AMI) patients being triaged into inappropriately low-acuity categories. The expedited protocol resulted in significant improvement in the following intervals: ED arrival to triage, triage to cubicle, ED arrival to cubicle, ED arrival to electrocardiogram (ECG) ordered, ED arrival to ECG available, ED arrival to physician evaluation, and ED arrival to decision to thrombolyse. Study patients with non-AMI cardiac chest pain and AMI cardiac chest pain were evaluated by a physician an average of 12 minutes and 8 minutes after ED arrival, respectively. Delays in interdepartmental processes, such as ECG-technician responsiveness, thrombolysis protocol fulfillment and thrombolytic agent delivery, negated benefits derived from improvements in internal processes. Effective coordination of the numerous processes involved in the initial ED management of adult patients with nontraumatic chest pain is required to make thrombolytic therapy for AMI within 30 minutes of patient arrival a routinely achievable goal.

Adult↗

PubMed1992

Treatment of poor prognosis Burkitt's lymphoma in adults with the Société Française d'Oncologie Pédiatrique LMB Protocol--a study of the Federation Nationale des Centres de Lutte Contre le Cancer (FNLCC).

14 adult patients between 16 and 50 years old with small non-cleaved cell lymphoma (Burkitt's lymphoma) were prospectively treated from 1982 to 1990 with the LMB protocols of the Société Française d'Oncologie Pédiatrique (SFOP). No HIV-positive patients were included. All patients had extensive disease with bad prognosis factors, i.e. 10 patients had Murphy stage III and 4 had stage IV with bone marrow involvement. The LMB protocols were characterised by high-dose fractionated cyclophosphamide, high-dose methotrexate (HD-MTX), and cytosine arabinoside. No local or central nervous system irradiation was used. Treatment duration ranged from 5 (LMB 84) to 12 (LMB 81) months. There were no therapy-related deaths. All patients achieved complete remission (CR). 6 patients relapsed between 2 and 30 months following CR. 8 of the 14 patients (57%) are still alive and disease-free after treatment by LMB protocol alone. 2 patients were salvaged with bone marrow transplantation after relapse and a total of 10 out of 14 patients (71%) are disease-free at the time of this report. Our results showed the high curability of advanced Burkitt's lymphoma using a paediatric protocol, even in adult patients. The LMB protocol may be applied to adult patients but requires intensive care during the induction period.

Adolescent↗

PubMed2004

Dropout rates for intent-to-treat and per protocol analyses.

PURPOSE: To describe dropout rates for the intent-to-treat and per protocol analyses from prospective clinical trials. METHODS: Review of prospective multi-center parallel studies of 100 patients or more from 1996 onwards. RESULTS: We identified 33 articles (70 treatment arms) that fit the criteria for this study. No statistical differences in dropout rates were observed among drug classes for either the intent-to-treat (P =.075) or per protocol analyses (P =.40). A difference was observed in the percent dropout rate for the intent-to-treat analyses decreasing with the length of the study (P <.0001). This finding was not observed by the number of study visits (P =.44). However, a statistically greater percent dropout rate was observed for the per protocol analyses increasing with the length of the study (P =.034) and number of study visits (P =.01). No statistical differences were observed or with increasing sample size of the study for either the intent-to-treat or per protocol analyses (P >.05). CONCLUSIONS: Known discontinuation rates for per protocol and intent-to-treat analyses may help in planning sample sizes for future clinical trials.

Antihypertensive Agents↗

PubMed2004

Blood saving protocol in elective total knee arthroplasty.

BACKGROUND: To eliminate the need for allogeneic blood transfusion in patients undergoing elective total knee arthroplasty, we established and tried a protocol of combined methods, which is characterized by effectiveness, ease in application, and safety. It is based on perioperative administration of human recombinant erythropoietin plus iron and folic acid, mild acute normovolemic hemodilution, meticulous surgical technique, postoperative blood salvage through a closed-wound drainage system, and lower transfusion triggers. DATA SOURCES: Sixty-one patients entered the protocol, and the results were retrospectively compared with the ones obtained from 58 consecutive patients who were operated on in the past before the use of any blood saving technique. CONCLUSIONS: Only 5 patients of those who entered the protocol finally needed allogeneic blood transfusion, receiving a total number of 7 units, which is remarkable when compared with the 50 patients before the application of the protocol who required 111 units. Consequently, the utilization of allogeneic blood was reduced by 94%, a statistically quite significant result (P <0,001). We believe the protocol should be included in orthopedic surgeons' alternatives for blood saving in elective total knee arthroplasty.

Aged↗