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PubMed1988

Techniques to determine test protocol performance.

This paper considers the problem of determining the performance of test protocols, i.e., combinations of diagnostic tests. Two techniques are developed which provide quantitative measures of performance. First, protocol performance can be calculated from clinical data. This technique is simple and straightforward. The primary limitation is that the necessary clinical data may not be available. A second technique is developed to predict protocol performance based on (1) protocol design, (2) individual test performance, and (3) test correlation. This second technique is applied to two types of audiological protocols: those to determine retrocochlear site-of-lesion, and those to identify hearing loss in newborns. Both techniques provide information essential to the design and selection of test protocols. The ability to predict performance is extremely important because clinical studies to evaluate protocols can take years to complete, or may be impractical.

Audiology↗

PubMed2006

What is protocol-based care? A concept analysis.

AIM: To define protocol-based care to make this way of delivering health care amenable to theoretical and empirical studies. BACKGROUND: Although protocol-based care is associated with the evidence-based practice and standardization movements, it is an ill-defined and understood concept. METHOD: A multiphase concept analysis, inspired by an evolutionary view was used to clarify 'what is protocol-based care'. The inductive, five-phase process drew upon content analysis of policy documents and the literature, plus interviews with a purposive sample of 35 opinion leaders. RESULTS: The term was used interchangeably with protocols, pathways and guidelines in policy and guidance documents. A search of seven databases produced only 57 references to protocol-based care. The concept analysis revealed a continuum of scope and specificity and also distinguished specialist and generic applications of protocol-based care. CONCLUSIONS: Managers need to take cognizance of the significance and complexity of protocol-based care when introducing this way of working.

Clinical Protocols↗

PubMed2006

The effects of a treatment protocol for cardiac surgical patients with excessive blood loss on clinical outcomes.

BACKGROUND AND OBJECTIVES: Excessive blood loss (EBL) is a common complication of cardiac surgery that is associated with adverse events. The objective of this before/after study was to determine whether the implementation of a protocol for management of cardiac surgical patients with EBL was associated with improved clinical outcomes. MATERIALS AND METHODS: In November 2002, a protocol for prompt identification and aggressive management of cardiac surgical patients with EBL was implemented at our institution. The independent relationship between protocol implementation and adverse outcomes was measured by comparing the outcomes of patients who received > or = 4 RBC (red blood cell) units within 1 day of surgery and were operated on before protocol implementation (2000-02) with those operated on after protocol implementation (2003-05), using multivariable logistic regression analysis to control for the effects of confounders. The primary outcome was a composite of adverse events that included death, renal failure, stroke, and sepsis. Bootstrapping was used to confirm the validity of the results. RESULTS: Of the 11,314 patients who underwent surgery during the study period, 1875 (16.6%) received > or = 4 RBC units within 1 day of surgery, with 958 and 917 in the pre- and postprotocol periods, respectively. The composite adverse outcome occurred in 164 (17.1%) patients in the preprotocol period and 115 (12.5%) patients in the postprotocol period (P = 0.005). Protocol implementation was independently associated with reduced odds of the composite adverse outcome (odds ratio 0.67; 95% confidence interval 0.50, 0.91; P = 0.01). This estimate was stable in bootstrap sampling. CONCLUSION: Implementation of a protocol to manage EBL in cardiac surgery was independently associated with improved outcomes.

Aged↗

PubMed1992

Programmed electrical stimulation protocols: variations on a theme.

A series of prospective protocols were designed to determine the yield ratio (true positives vs. false positives = nonclinical) in various patient groups using a variety of programmed electrical stimulation (PES) variables. First, a PES protocol was used in 772 patients. Single, double, and triple extrastimuli were delivered in sequence (leaving each successive extrastimulus just beyond its refractory period before moving to the next extrastimulus) during sinus rhythm and two ventricular paced rates at the RV apex, before moving to the outflow tract and repeating the sequence and then moving on to isoproterenol infusion with the PES sequence repeated at the apex. This protocol met NASPE standards for induction of VT in patients with coronary artery disease and a history of VT, while failing to induce monomorphic VT in any control patient. The best yield ratios combined with the greatest likelihood of inducing clinical tachycardia were achieved with sinus rhythm and three extrastimuli, and pacing at the lower rate and three extrastimuli. Pacing at the faster rate and triple extrastimuli was highly inductive of clinical arrhythmias, but had a low yield ratio due to induction of more nonclinical arrhythmias than other steps. The next protocol was performed in 61 patients with inducible ventricular tachycardia. In each case, the protocol described above was completed at the RV apex, even if tachycardia was also induced at an earlier point in the protocol. This allowed for more accurate yield ratios to be established for each step in the protocol, since each patient was exposed to each of these steps.(ABSTRACT TRUNCATED AT 250 WORDS)

Arrhythmias, Cardiac↗

PubMed1992

Audit of compliance with antenatal protocols.

OBJECTIVE: To assess the implementation of action protocols dictated by antenatal risk factors noted at the initial (booking) antenatal visit. DESIGN: Retrospective study of 2000 women delivered between 1 March 1990 and 29 March 1991. SETTING: Maternity department of a district general hospital supporting a multiethnic population in inner London. MAIN OUTCOME MEASURES: Comparison of clinical actions performed against those dictated by the department's protocols. Analysis according to clinical importance, gestation at booking, maternal age, parity, birth order, ethnic origin, and certainty of gestational age. RESULTS: Interobserver agreement between the two auditors was good (kappa statistic for risk factors detected, 0.78; for actions generated, 0.80). Of the 15,658 actions dictated by department protocols, 3673 (23.5%) were actually performed by the clinicians. The 63 combinations of risk factors and actions believed by consultants to be of particular clinical importance had an action rate of 28.3% compared with 18.6% for those considered less important (p < 0.001). Mothers who first visited the hospital antenatal clinic at or before 24 weeks' gestation had 25.2% of relevant protocols fulfilled (p < 0.001). Compliance was significantly improved in women aged 36 or over (32.4%), black women (24.9%), and cases of uncertain gestation (24.5%). Parity and birth order were not associated with an altered action rate. Ethnic origin deemed as "other" (than white, black, Asian, or oriental) or "unknown" was associated with poor compliance (19.3%). CONCLUSIONS: Compliance to a set of agreed protocols was poor even though a computer system was available and a protocol manual had been distributed. Protocols were more likely to be implemented in women who booked early and in some groups of women deemed at high risk including older mothers, black women, and those denoted as having uncertain gestational age.

Clinical Protocols↗

PubMedDate not supplied

EON: a component-based approach to automation of protocol-directed therapy.

Provision of automated support for planning protocol-directed therapy requires a computer program to take as input clinical data stored in an electronic patient-record system and to generate as output recommendations for therapeutic interventions and laboratory testing that are defined by applicable protocols. This paper presents a synthesis of research carried out at Stanford University to model the therapy-planning task and to demonstrate a component-based architecture for building protocol-based decision-support systems. We have constructed general-purpose software components that (1) interpret abstract protocol specifications to construct appropriate patient-specific treatment plans; (2) infer from time-stamped patient data higher-level, interval-based, abstract concepts; (3) perform time-oriented queries on a time-oriented patient database; and (4) allow acquisition and maintenance of protocol knowledge in a manner that facilitates efficient processing both by humans and by computers. We have implemented these components in a computer system known as EON. Each of the components has been developed, evaluated, and reported independently. We have evaluated the integration of the components as a composite architecture by implementing T-HELPER, a computer-based patient-record system that uses EON to offer advice regarding the management of patients who are following clinical trial protocols for AIDS or HIV infection. A test of the reuse of the software components in a different clinical domain demonstrated rapid development of a prototype application to support protocol-based care of patients who have breast cancer.

Algorithms↗

PubMed2001

A protocol for consultation of another physician in cases of euthanasia and assisted suicide.

OBJECTIVE: Consultation of another physician is an important method of review of the practice of euthanasia. For the project "support and consultation in euthanasia in Amsterdam" which is aimed at professionalising consultation, a protocol for consultation was developed to support the general practitioners who were going to work as consultants and to ensure uniformity. PARTICIPANTS: Ten experts (including general practitioners who were experienced in euthanasia and consultation, a psychiatrist, a social geriatrician, a professor in health law and a public prosecutor) and the general practitioners who were going to use the protocol. EVIDENCE: There is limited literature on consultation: discursive articles and empirical studies describing the practice of euthanasia. CONSENSUS: An initial draft on the basis of the literature was commented on by the experts and general practitioners in two rounds. Finally, the protocol was amended after it had been used during the training of consultants. CONCLUSIONS: The protocol differentiates between steps that are necessary in a consultation and steps that are recommended. Guidelines about four important aspects of consultation were given: independence, expertise, tasks and judgment of the consultant. In 97% of 109 consultations in which the protocol was used the consultant considered the protocol to be useful to a greater or lesser extent. Although this protocol was developed locally, it also employs universal principles. Therefore it can be of use in the development of consultation elsewhere.

Clinical Protocols↗

PubMed2003

A simple and reliable pretreatment protocol facilitates fluorescent in situ hybridisation on tissue microarrays of paraffin wax embedded tumour samples.

AIMS: To describe a robust pretreatment protocol for preparing paraffin wax embedded tissues on tissue microarrays for fluorescence in situ hybridisation (FISH). The newly developed pretreatment protocol described here was compared with the commonly used sodium thiocyanate based protocol and two different heating methods used in standard antigen unmasking protocols for immunohistochemistry (pressure cooking and microwaving in citrate acid buffer). METHODS: Dewaxed tissue sections were incubated in 10mM citric acid buffer at 80 degrees C for 30 minutes to two hours, followed by a short pepsin digestion (1-5 mg/ml). Pretreated tissues were co-denatured with DNA probes at 80 degrees C for 10 minutes, followed by hybridisation at 37 degrees C for 48-72 hours. RESULTS: The three protocols using citrate acid buffer produced FISH signals with superior signal to noise ratios compared with sodium thiocyanate pretreatment. Most importantly, the best tissue attachment was achieved using the newly developed pretreatment protocol: on tissue microarrays less than 1% of cores were lost. To date, a total of 30 probes have been successfully hybridised on to breast tissue and multi-tissue microarrays. CONCLUSION: This pretreatment protocol is easy, reproducible, and facilitates FISH on tissue microarrays, with potential for widespread application in cancer research.

Breast Neoplasms↗

PubMed1988

Undescended testis: comparison of two protocols of treatment with human chorionic gonadotropin. Effect on testicular descent and hormonal response.

A randomized study of two protocols of human chorionic gonadotropin (hCG) treatment was performed in 183 prepubertal boys between 7 months and 12 years of age: protocol I, in which the boys were given 7 injections of 1,500 IU every other day, and protocol II consisting of 4 injections of 100 IU/kg at 4- to 5-day intervals. In both protocols, by the end of the test, testosterone had risen significantly to values within the normal adult male range. However, the amplitude of the rise was slightly but significantly lower using protocol II (4.08 +/- 2.07 ng/ml) than protocol I (5.16 +/- 2.73 ng/ml). It would thus appear that repetition of the hCG injection at intervals of less than 4 days is unnecessary, and that a total stimulation period of 2-3 weeks is sufficient. Although not correlated with testosterone levels, the success rates for treatment were similar in both protocols and comparable to rates reported in the literature.

Adolescent↗

PubMed1999

Large scale implementation of a respiratory therapist-driven protocol for ventilator weaning.

We prospectively investigated the large-scale implementation of a respiratory-therapist-driven protocol (TDP) that included 117 respiratory care practitioners (RCPs) managing 1,067 patients with respiratory failure over 9,048 patient days of mechanical ventilation. During a 12-mo period, we reintroduced a previously validated protocol that included a daily screen (DS) coupled with spontaneous breathing trials (SBTs) and physician prompt, as a TDP without daily input from a physician or "weaning team." With graded, staged educational interventions at 2-mo intervals, RCPs had a 97% completion rate and a 95% correct interpretation rate for the DS. The frequency with which patients who passed the DS underwent SBTs increased throughout the implementation process (p < 0.001). As the year progressed, RCPs more often considered SBTs once patients had passed a DS (p < 0.001), and physicians ordered more SBTs (46 versus 65%, p = 0.004). Overall, SBTs were ordered more often on the medicine than on the surgical services (81 versus 63%, p = 0.001), likely reflecting medical intensivists' prior use of this protocol. Important barriers to protocol compliance were identified through a questionnaire (89 respondents, 76%), and included: Physician unfamiliarity with the protocol, RCP inconsistency in seeking an order for an SBT from the physician, specific reasons cited by the physician for not advancing the patient to a SBT, and lack of stationary unit assignments by RCPs performing the protocol. We conclude that implementation of a validated weaning strategy is feasible as a TDP without daily supervision from a weaning physician or team. RCPs can appropriately perform and interpret DS data more than 95% of the time, but significant barriers to SBTs exist. Through a staged implementation process, using periodic reinforcement of all participants in ventilator management, improved compliance with this large-scale weaning protocol can be achieved.

Clinical Protocols↗

PubMedDate not supplied

Implementation and evaluation of a standardized herpes simplex virus prophylaxis protocol on a leukemia/bone marrow transplant unit.

OBJECTIVE: To assess the impact of a standardized acyclovir prophylaxis protocol for the prevention of herpes simplex virus (HSV) infection and disease in bone marrow transplant and leukemic patients. DESIGN: Two-phase, open sequential study involving prospective patient monitoring and retrospective health record review. SETTING: Tertiary care teaching hospital. PATIENTS: Fifty-seven patients (35 preprotocol, 22 postprotocol) who received acyclovir for HSV prophylaxis during an 18-month study period. INTERVENTIONS: An acyclovir HSV prophylaxis protocol was developed and implemented. Under this protocol, all HSV immunoglobulin G-seropositive hematology patients received an acyclovir regimen of 125 mg/m2 i.v. q6h or 600 mg p.o. q6h (if tolerated) from day -5 to day 30. Regimens not matching protocol were modified by pharmacists in conjunction with the prescriber. All treatment courses were followed daily by pharmacists to modify dosage according to renal function and assess appropriateness of the i.v. route. Tablets, capsules, or suspensions were promoted if the patient was considered tolerant of the oral route. MAIN OUTCOME PARAMETERS: Outcome parameters included (1) incidence of parenteral, oral, or combined therapy; (2) total prophylactic acyclovir dose per patient; (3) mean prophylactic acyclovir daily dose; (4) mean duration of acyclovir prophylaxis; and (5) HSV reactivation rate. RESULTS: Following implementation of the protocol, the mean total i.v. acyclovir dose per patient decreased from 20.1 g (range 3.6-109.5) to 11.7 g (range 1.0-43.0; p = 0.1162). The mean cumulative oral dose increased from 12.1 g (range 0.4-70.0) to 33.1 g (range 2.4-93.6; p = 0.0007). Mean duration of therapy increased from 27.6 to 33.5 days (p = 0.23). The mean duration of oral therapy increased from 10.5 days (+/- SD 10.9) to 17.2 days (+/- SD 12.1) (p = 0.034). The appropriateness of use of the i.v. dosage form increased from 53 to 88 percent of treatment days (p = 0.013). No difference in HSV reactivation rate was observed when comparing patients prior to and following protocol implementation. A drug acquisition savings of $1112.00 (CDN) per patient was realized. CONCLUSIONS: The implementation of a standardized HSV acyclovir prophylaxis protocol has resulted in significant drug acquisition cost savings without an apparent negative impact on patient outcome.

Acyclovir↗

PubMed1983

Treatment of acute lymphoblastic leukemia in adults: results of the L-10 and L-10M protocols.

Two successive protocols (L-10 and L-10M) employing multidrug induction therapy with vincristine, prednisone, and doxorubicin (Adriamycin) plus an intensive consolidation phase and maintenance program have led to a significant improvement in the prognosis of adult acute lymphoblastic leukemia (ALL). The complete remission (CR) rates for the 34 patients entered on the L-10 protocol and the 38 patients entered on the L-10M protocol were 85% and 84%, respectively. The median duration of remission has not yet been reached for either the L-10 (median follow-up, 5.5 years; range, 3.5-7.5 years) or the L-10M protocol (median follow-up, 2.5 years; range, 1-3.5 years). The median survival time has not yet been reached for the L-10M protocol. Central nervous system prophylaxis with intrathecal methotrexate alone was effective in preventing central nervous system relapse. An analysis of possible prognostic factors indicated that patients less than 25 years of age had a higher CR rate than older patients (p = 0.02). Patients with an initial leukocyte count below 15,000/microL experienced longer remissions than patients with a leukocyte count above 15,000/microL (p = 0.008), and patients who achieved CR within the first month of therapy were in remission longer than those requiring a longer time to achieve CR (p = 0.04). Patients with T cell ALL did not have a poorer prognosis than other patients treated on these protocols. The L-10 and L-10M protocols were well tolerated with minimal morbidity.

Adolescent↗

PubMed2003

Disseminated neuroblastoma in children older than one year at diagnosis: comparable results with three consecutive high-dose protocols adopted by the Italian Co-Operative Group for Neuroblastoma.

PURPOSE: To compare the outcomes associated with modifications in three consecutive protocols employed by the Italian Co-Operative Group for Neuroblastoma (ICGNB) in disseminated neuroblastoma. PATIENTS AND METHODS: Between January 1985 and November 1997, a total of 359 children aged 1 to 15 years with newly diagnosed stage 4 neuroblastoma were enrolled in three consecutive protocols. Compared with ICGNB-85, the ICGNB-89 protocol contained two more chemotherapy cycles, and some drugs were given at greater doses, whereas in the ICGNB-92 protocol, the induction phase included a chelating agent, and individual cycles contained four drugs instead of two. RESULTS: A total of 330 of 359 evaluable children were included in this analysis; 106 children were treated with ICGNB-85, 65 children were treated with ICGNB-89, and 159 children were treated with ICGNB-92 protocols. Radical resection of primary tumor was carried out in 59.4%, 50.8%, and 57.9% of the patients, respectively. Major tumor response after induction therapy was achieved in 66.7%, 69.2%, and 68.6% of the patients, respectively. A total of 218 of 232 patients received consolidation therapy consisting of conventional chemotherapy in 65 patients and of high-dose chemotherapy in 153 patients. Disease recurrence or progression occurred in 82.1%, 69.2%, and 74.8% of the patients, respectively. Therapy-related deaths occurred in 1.9%, 12.3%, and 6.9% of the patients, respectively. Five-year overall survival (OS) for the three studies was 26%, 23%, and 28%, and event-free survival (EFS) was 19%, 17%, and 17%, respectively. CONCLUSION: The therapeutic modifications adopted in the ICGNB-89 and ICGNB-92 protocols were not associated with a significant improvement in response rate or in the 5-year OS and EFS as compared with the ICGNB-85 protocol. Attempts at intensifying chemotherapy were associated with greater toxicity.

Adolescent↗

PubMed1994

Effect of a stroke protocol on hospital costs of stroke patients.

OBJECTIVE: To determine the impact of a protocol on hospitalization costs for patients admitted with stroke. DESIGN AND SETTING: Nonrandomized control trial in an urban community hospital with 376 beds. PATIENTS: All patients admitted with a diagnosis-related group code of 014 (cerebrovascular disease) were included (N = 390). Patients with subdural hematoma (N = 2) or subarachnoid hemorrhage (N = 2) were excluded. INTERVENTION: A protocol for treatment of acute stroke was developed that included a critical path for nursing care, an algorithm for emergency department care, and suggested admission orders for physicians. MAIN OUTCOME MEASURES: The hospital information system computer database was searched for hospitalization charges, length of stay, tests performed, and treatments provided. RESULTS: Patients treated with the protocol had lower charges compared with historical (p = 0.026) and concurrent (p = 0.02) control groups. Lower charges were accounted for by a decreased length of stay in the protocol group compared with historical (p = 0.001) and concurrent (p = 0.13) controls. Tests and treatments provided were similar except that carotid Doppler studies and deep venous thrombosis prophylaxis were more frequently done in those treated with the protocol (p = 0.001 for carotid Doppler and p = 0.026 for deep venous thrombosis prophylaxis). There were no differences in outcome measures such as death or discharge disposition. Medical complications were similar in all groups. CONCLUSIONS: There were significant savings in hospitalization cost for patients with acute stroke after introduction of a treatment protocol. These savings were almost entirely related to decreased length of stay. The protocol led to modest differences in tests ordered and treatments provided.

Acute Disease↗

PubMed2007

Rapid desensitization protocols for patients with cardiovascular disease and aspirin hypersensitivity in an era of dual antiplatelet therapy.

OBJECTIVE: To review the available protocols for rapid desensitization of patients with aspirin hypersensitivity and apply the data for use in patients with cardiovascular disease who would benefit from the dual antiplatelet therapy. DATA SOURCES: A literature search was conducted via MEDLINE from 1966 to December 2006. Main search terms included: aspirin sensitivity, aspirin allergy, aspirin desensitization, aspirin-induced asthma, aspirin therapy, and aspirin intolerance syndrome. STUDY SELECTION AND DATA EXTRACTION: Articles describing rapid aspirin desensitization protocols were selected for review. Literature pertaining to aspirin hypersensitivity, drug desensitization, and the use of aspirin and dual antiplatelet therapy was also examined. Three rapid desensitization protocols were identified and evaluated. DATA SYNTHESIS: While landmark studies demonstrated that dual antiplatelet therapy with aspirin and clopidogrel significantly reduces mortality and morbidity in acute coronary syndromes and coronary stenting, patients with aspirin hypersensitivity are frequently managed with clopidogrel alone with no supporting data. Approximately 10% of the population experiences hypersensitivity to aspirin, which can manifest as asthma exacerbations, rhinorrhea, angioedema, urticaria, and anaphylaxis. The hypersensitivity reaction is mediated through aspirin-directed antibodies or by excessive leukotriene production. The desensitization process involved depletion of these mediators, as well as down-regulation of leukotriene receptors. Two groups of investigators developed rapid protocols to desensitize patients with aspirin hypersensitivity safely and effectively. The rapid protocol developed by Wong provides benefits over other protocols with its low starting dose and completion in less than 3 hours, low incidence of adverse effects, and high success rate in aspirin desensitization. CONCLUSIONS: The Wong protocol is an attractive option for the rapid desensitization of patients requiring dual antiplatelet therapy with aspirin and clopidogrel in the perimyocardial infarction period.

Aspirin↗

PubMed1992

A successful computerized protocol for clinical management of pressure control inverse ratio ventilation in ARDS patients.

We have developed a computerized protocol that provides a systematic approach for management of pressure control-inverse ratio ventilation (PCIRV). The protocols were used for 1,466 h in ten around-the-clock PCIRV evaluations on seven patients with severe adult respiratory distress syndrome (ARDS). Patient therapy was controlled by protocol 95 percent of the time (1,396 of 1,466 h) and 90 percent of the protocol instructions (1,937 of 2,158) were followed by the clinical staff. Of the 221 protocol instructions, 88 (39 percent) not followed were due to invalid PEEPi measurements. Compared with preceding values during CPPV, the expired minute ventilation was reduced by 27 percent during PCIRV while maintaining a pH that was not clinically different (mean difference in pH = 0.02). There was no difference in the PaO2, PEEPi, or the FIO2 between PCIRV and CPPV. The PEEP setting was reduced by 33 percent from 9 +/- 0.05 to 6 +/- 0.6 and the I:E ratio increased from 0.64 +/- 0.04 to 2.3 +/- 0.10. Peak airway pressure was reduced by 24 percent (from 59 +/- 1.5 to 45 +/- 0.6) and mean airway pressure increased by 27 percent (from 22 +/- 0.8 to 28 +/- 0.6) in PCIRV. Right atrial and pulmonary artery pressures were higher and cardiac output lower in PCIRV but blood pressure was unchanged. The success of this protocol has demonstrated the feasibility of using PEEPi as a primary control variable for oxygenation. This computerized PCIRV protocol should make the future use of PCIRV less mystifying, simpler, and more systematic.

Adult↗

PubMed2001

Mechanical ventilator weaning protocols driven by nonphysician health-care professionals: evidence-based clinical practice guidelines.

Health-care professionals (HCPs) can provide protocol-based care that has a measurable impact on critically ill patients beyond their liberation from mechanical ventilation (MV). Randomized controlled trials have demonstrated that protocols for liberating patients from MV driven by nonphysician HCPs can reduce the duration of MV. The structure and features of protocols should be adapted from published protocols to incorporate patient-specific needs, clinician preferences, and institutional resources. As a general approach, shortly after patients demonstrate that their condition has been stabilized on the ventilator, a spontaneous breathing trial (SBT) is safe to perform and is indicated. Ventilator management strategies for patients who fail a trial of spontaneous breathing include the following: (1) consideration of all remediable factors (such as electrolyte derangements, bronchospasm, malnutrition, patient positioning, and excess secretions) to enhance the prospects of successful liberation from MV; (2) use of a comfortable, safe, and well-monitored mode of MV (such as pressure support ventilation); and (3) repeating a trial of spontaneous breathing on the following day. For patients who pass the SBT, the decision to extubate must be guided by clinical judgment and objective data to minimize the risk of unnecessary reintubations and self-extubations. Protocols should not represent rigid rules but, rather, guides to patient care. Moreover, the protocols may evolve over time as clinical and institutional experience with them increases. Useful protocols aim to safely and efficiently liberate patients from MV, reducing unnecessary or harmful variations in approach.

Clinical Protocols↗

PubMedDate not supplied

Evaluation of a high-dose chemotherapy protocol with no maintenance therapy for dogs with lymphoma.

The purpose of this study was to evaluate the efficacy and toxicity of an intensified dose protocol with no maintenance phase for the treatment of canine lymphoma. Forty-nine dogs all weighing more than 15 kg were entered. Dogs were staged and treated with a modified version of the University of Wisconsin (UW)-Madison protocol for lymphoma. Modifications included increased dosages of cyclophosphamide (250 mg/m2 compared to 200 mg/m2) and doxorubicin (37.5 mg/m2 compared to 30 mg/m2), with no crossover to chlorambucil or methotrexate. After 25 weeks on protocol (17 treatments), therapy was discontinued and dogs were monitored for relapse on a monthly basis. Disease-free interval (DFI) and overall survival were compared to 55 historical controls treated with the UW-Madison protocol. The 2 groups were comparable with respect to age, sex, breed, stage, presence of hypercalcemia, and CD3 status; a trend toward more substage b dogs was present in the high-dose group (P = .076). When comparing response rate, DFI, death due to disease, and death due to treatment-related toxicity, more dogs were dead due to toxicity (P < .001; odds ratio = 8.8) in the high-dose group. Overall survival between the high-dose and control groups did not differ significantly (P = .55) at 270 and 318 days, respectively. The intensified dose protocol is an option for owners who are willing to risk higher toxicity for a shorter protocol with no statistical difference in survival from the UW-Madison protocol.

Animals↗