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PubMed2000

Knowledge representation and tool support for critiquing clinical trial protocols.

The increasing complexities of clinical trials have led to increasing costs for investigators and organizations that author and administer those trials. The process of authoring a clinical trial protocol, the document that specifies the details of the study, is usually a manual task, and thus authors may introduce subtle errors in medical and procedural content. We have created a protocol inspection and critiquing tool (PICASSO) that evaluates the procedural aspects of a clinical trial protocol. To implement this tool, we developed a knowledge base for clinical trials that contains knowledge of the medical domain (diseases, drugs, lab tests, etc.) and of specific requirements for clinical trial protocols (eligibility criteria, patient treatments, and monitoring activities). We also developed a set of constraints, expressed in a formal language, that describe appropriate practices for authoring clinical trials. If a clinical trial designed with PICASSO violates any of these constraints, PICASSO generates a message to the user and a list of inconsistencies for each violated constraint. To test our methodology, we encoded portions of a hypothetical protocol and implemented designs consistent and inconsistent with known clinical trial practice. Our hope is that this methodology will be useful for standardizing new protocols and improving their quality.

Artificial Intelligence↗

PubMed2000

New protocol for immune tolerance induction in acquired hemophilia.

BACKGROUND AND OBJECTIVES: Immune tolerance induction (ITI) regimens with human factor VIII concentrates are rarely if ever implemented in adult patients with auto-inhibitors, in contrast to alloantibody suppression, which is used primarily in young children with congenital hemophilia. On the basis of some earlier experience with synchronization of plasma exchange therapy of various autoimmune disorders we have developed a new aggressive protocol for the treatment of patients with acquired factor VIII (FVIII) antibody. We have evaluated the outcome of 14 consecutive nonhemophilic FVIII inhibitor patients treated in a single center with our ITI protocol between 1992 and 1999, comparing them to 6 historical control patients, treated with traditional immunosuppression therapy (steroid +/- cyclophosphamide) between 1988 and 1992. DESIGN AND METHODS: Our ITI protocol consists of three weeks of treatment with 1) human FVIII concentrates (30 U/kg/day for the 1st week, 20 U/kg/day for the 2nd, and 15 U/kg/day for the 3rd week), plus 2) iv. cyclophosphamide (200mg/day to a total dose of 2-3 grams), plus 3) methylprednisolone (100 mg/day iv. for one week and than tapering down the dose gradually over the next two weeks). The treatment of acute bleeding episodes in the two groups was not different. High purity and ultra-high purity factor VIII concentrates were used for the ITI. We performed aPTT and mixing tests before and after two hours of incubation, Bethesda inhibitor assay, porcine FVIII cross-reactivity, FVIII:C before and after FVIII administration (recovery), three times a week. The sex ratio and mean age (64 years for the ITI group versus 57 years for the controls), the initial and peak inhibitor titers, and residual FVIII: C values at the diagnosis were similar in the two groups. RESULTS: Eradication of the inhibitor occurred in 13/14 patients in the ITI vs. 4/6 patients in the control group. The main difference between the two groups was in the time needed for the complete disappearance of the inhibitor (4.6 weeks for ITI vs. 28.3 weeks for controls). In the ITI group we have observed only two relapses during the relatively long follow-up period (26 months), and in both cases the same re-induction protocol was successful again. No bleeding-related mortality occurred in this group in contrast to that of 33% in the controls. Apart from the well-known adverse effects of glucocorticoid therapy, we have observed only one patient with transient cytopenia. We have not seen any adverse event which could be attributed to the use of FVIII concentrates. INTERPRETATION AND CONCLUSIONS: We conclude that the ITI protocol described here is highly effective for the treatment of acquired hemophilia, induces quick therapeutic responses and favorably influences the underlying autoimmune disorder. We suggest that our ITI protocol is suitable for the eradication of idiopathic and autoimmune-associated FVIII autoantibodies in patients presenting with severe bleeding.

Adult↗

PubMed2001

Comparison of a 6-hour and 9-hour protocol for evaluation of moderate-to-low risk chest pain patients in an emergency department diagnostic unit.

OBJECTIVE: To compare the 30-day outcomes of patients enrolled in a 6-hour and 9-hour emergency department (ED)-based chest pain centre (CPC) protocol. METHODS: All patients with the chief complaint of chest pain, who were older than 25 years, or with cocaine usage within 96 hours of initial presentation, were eligible for enrolment. Exclusion criteria included acute ST-segment elevation or depression >1 mm in 2 contiguous leads, history of coronary artery disease (CAD), haemodynamic instability or clinical syndromes consistent with unstable angina. Outcomes included ED disposition and cardiac events at 30 days (defined as acute myocardial infarction (AMI), percutaneous trans-luminal coronary angiography (PTCA), coronary artery bypass graft surgery (CABG),ventricular tachycardia or fibrillation (VT/VF) arrest, congestive heart failure (CHF) admission or cardiac-related death). The 9-hour protocol consisted of ST-segment monitoring,serial CK-MB draws at 0, 3,6 and 9 hours as well as a graded exercise test (GXT) prior to ED disposition. The 6-hour protocol eliminated the 9-hour serum marker determination, included cardiac Troponin-I (cTn-I) and allowed a GXT, 3 hours earlier. Follow-up was obtained by medical record review, phone contact, letter and also review of national and state death registries. RESULTS: The 9-hour protocol (October 1991-December 1997) included 2,133 patients and the 6-hour protocol (January 1998- August 1998) had 184 patients enrolled. The 6-hour protocol was not different from the 9-hour one in terms of percentage admissions (9-hour: 310, 14.5%; 6-hour: 33, 17.9%; p=0.213), Coronary Care Unit admission (9-hour: 59, 2.8%; 6-hour: 5, 2.7%; p=0.303) or 30-day cardiac events (9-hour: 38, 1.9%; 6-hour: 2, 1.3%; p=0.605). CONCLUSION: The 6-hour CPC strategy is an effective and safe evaluation method for patients at low to moderate risk for acute coronary syndromes.

Adult↗

PubMed1992

[A study of VMMC protocol (vindesine, mitoxantrone, mitomycin C) as a salvage chemotherapy in advanced breast cancers].

One hundred and three patients previously treated with chemotherapy including an anthracycline were entered in a VMMC protocol study: vindesine (Eldisine), mitoxantrone (Novantrone) and mitomycin C (Ametycine). Group A consisted of 41 women who received the protocol published by Belpomme: vindesine (2.5 mg/m2 day 1 and 8) and mitoxantrone (12 mg/m2/day) every 4 weeks, and mitomycin C (8 mg/m2) every 8 weeks. Group B consisted of 62 patients who were treated with a modified protocol: vindesine (2.5 mg/m2) and mitoxantrone (12 mg/m2) every 3 weeks on day 1, and mitomycin C (8 mg/m2) every 6 weeks. Tolerance was acceptable with 79% of patients complaining of weakness. There was a 66% incidence of gastro-intestinal toxicity, a 10.7%-incidence of neurotoxicity (reversible dysethesias), and a 5.8% incidence of cardiotoxicity. There was considerable hematotoxicity of grade 2, 3 and 4: neutropenia 16.6%, thrombocytopenia 7.7%, anemia 21.4%. There was a 19.2% overall objective response rate (CR and PR) (95% confidence interval: 12-30) (CR: 3.2%). The median duration of the response was 39 weeks. There was no significant difference in response rates whether or not the patients (19 cases) were undergoing simultaneous hormonal therapy and no difference according to the protocol used. Similarly, neither menopause nor a previous response to anthracyclines had any effect on the response rate. The 19.2% response in this protocol is similar to other breast cancer salvage chemotherapy protocols for patients who have failed to respond to anthracyclines (< 20%).

Adult↗

PubMedDate not supplied

[Therapeutic interchange between angiotensin II receptor blockers in institutionalized elderly patients. Implimenting a protocol].

OBJECTIVE: To assess the effectiveness of a therapeutic interchange protocol for angiotensin II receptor blockers (ARB's) in the maintenance of blood pressure levels for institutionalized elderly patients diagnosed with hypertension. METHODS: A new protocol was discussed by the Pharmacy and Therapeutics Committee, and its implementation by the Pharmacy Department was authorized. The protocol specifies equivalent doses between drugs and the patients' clinical follow-up. Criteria used in the assessment includes: need to change dosage for an ARB included in the Pharmacotherapeutic Guide, and blood pressure changes after drug interchange. RESULTS: In the absence of hepatic insufficiency, the protocol may replace the standard doses of any drugs within this group with losartan 50 mg daily. If needed, the dose of losartan may be increased to 100 mg daily divided into two doses. Eighteen patients, which represent 10% of all interchange operations carried out by the Pharmacy Department, were included in this study. Blood pressures both before and after the interchange process show no major differences between them. Only two patients required an increase in the dose of losartan. CONCLUSION: The implementation of a therapeutic interchange protocol as agreed upon by the Pharmacy and Therapeutics Committee allows the clinical follow-up of patients and therefore facilitates an evaluation of the process. This ARB interchange protocol, as suggested for the institutionalized elderly population setting, has proven effective in maintaining anti-hypertensive activity.

Aged↗

PubMed1992

A change in flushing protocols of central venous catheters.

Oncology nurses working with hematology patients at the Tom Baker Cancer Centre questioned the need for twice daily flushings of central venous catheters. The nurses speculated that weekly flushings would be more convenient for patients, maintain patency, reduce risk of infections, and save the costs of supplies and nursing time. In 1986, the nurses, in collaboration with physicians, introduced a weekly flushing protocol for outpatients attending the clinic. The staff noted that no difference in rates of infection or patency appeared to result from this change in protocol. In an effort to provide empirical data in support of this fundamental shift in nursing protocols, the nurses initiated a study to examine infection rates and patency related to weekly flushing procedures. The study involved 82 patients with 89 catheter insertions. Overall infection rates were 19.1% or 0.15 per 100 catheter days. These rates were 0.25 per 100 catheter days for patients undergoing bone marrow transplant (BMT) and 0.07 per 100 catheter days in patients not undergoing BMT. Reduced patency occurred in only 13.5% of catheters studied, requiring a change in flushing protocol. When compared with published complication rates, these findings support the use of a weekly flushing protocol. As a result, staff and patients continue to use the weekly flushing protocol with greater confidence.

Adult↗

PubMed2006

Improving adherence to a mechanical ventilation weaning protocol for critically ill adults: outcomes after an implementation program.

BACKGROUND: Despite multiple reminders, education sessions, and multidisciplinary team involvement, adherence to an evidence-based mechanical ventilation weaning protocol had been less than 1% in a general systems intensive care unit since implementation. OBJECTIVE: To assess the effectiveness of using an implementation program, the Model for Accelerating Improvement, to improve adherence and clinical outcomes after restarting a mechanical ventilation weaning protocol in an adult general systems intensive care unit. METHODS: A prospective comparative design, before and after implementation of the Model for Accelerating Improvement, was used with a consecutive sample of 129 patients and 112 multidisciplinary team members. Clinical outcomes were rate of unsuccessful extubations, rate of ventilator-associated pneumonia, and duration of mechanical ventilation; practice outcomes were staff's understanding of the mechanical ventilation weaning protocol, perceptions of the practice safety climate, and adherence to the weaning protocol. RESULTS: After the intervention, the rate of unsuccessful extubations decreased, and staff's understanding of and adherence to the weaning protocol increased significantly. The rate of ventilator-associated pneumonia, duration of mechanical ventilation, and staff's perceptions of the practice safety climate did not change significantly. CONCLUSION: Implementing the Model for Accelerating Improvement improved understanding of and adherence to protocol-directed weaning and reduced the rate of unsuccessful extubations.

Adolescent↗

PubMed1991

Combination therapy of M2-protocol and interferon-alpha as remission induction in refractory multiple myeloma.

A successful induction of remission in two patients with resistant multiple myeloma using a new combination therapy of modified M-2 protocol and interferon-alpha (IFN-alpha) is described. The first case was a 32-year-old man with K type urinary Bence-Jones protein who became resistant after treatment with melphalan and prednisone (MP protocol). IFN-alpha alone had a marginal response. The modified M-2 protocol proved insufficient. Therefore, IFN-alpha was administered in the interval of M-2 protocol. This combination therapy showed remarkable responses. The second case was a 59-year-old woman with advanced IgA myeloma who was treated with M-2 protocol and became resistant. IFN-alpha alone resulted in a slight response. After addition of IFN-alpha to the modified M-2 protocol, a rapid reduction in the level of serum IgA was found and clinical symptoms including bone pain, anaemia and so on were dramatically improved. No infection and/or intolerable side effects were observed in either case. This combination treatment appears worthy to try in cases of resistant or relapsing myeloma patients.

Adult↗

PubMed1994

Comparison of submaximal exercise responses using the Bruce vs modified Bruce protocols.

The purpose of this study was to determine whether the parameters commonly used to evaluate a training effect can be compared when serial tests are performed using different protocols. Thirty-two patients with stable coronary artery disease performed both the standard and modified Bruce protocols in a random order, 1 h apart. Physiologic variables at matched exercise stage I including heart rate (99 +/- 12 vs 101 +/- 14 bpm), rate-pressure product (15 +/- 3 vs 15 +/- 3 bpm x mmHg x 10(3)), and VO2 (13.5 +/- 2.1 vs 13.0 +/- 3.0 ml.kg-1 x min-1) were not significantly different for exercise tests performed using the standard vs modified Bruce protocols respectively. Similarly, these parameters were also nearly identical at matched exercise stage II. However, peak VO2 was significantly higher using the standard vs modified Bruce protocol, although the difference was small. Therefore, these data indicate that a difference in the heart rate response at matched submaximal workrates on tests using these two protocols before and after a training program is most likely due to a training effect. Conversely, improvements in peak VO2 using the standard vs modified Bruce are at least in part due to inherent differences in responses between these two protocols.

Blood Pressure↗

PubMed1994

Physician-guided treatment compared with a heparin protocol for deep vein thrombosis.

BACKGROUND: Effective heparin therapy, defined by therapeutic prolongation of the activated partial thromboplastin time (APTT), decreases the risk of recurrent venous thromboembolism. Achieving therapeutic prolongation of the APTT within 24 hours of the start of heparin therapy has proved difficult. We hypothesized that a protocol that delivered high initial heparin infusions to patients without identifiable risk for bleeding complications would decrease the time to achieve a therapeutic anticoagulant effect without increasing the incidence of major bleeding complications. METHODS: To test this hypothesis, we studied concurrent patient cohorts. We defined a therapeutic anticoagulant effect (APTT > 55 seconds) to be an APTT more than 1.5 times the upper limit of normal. Twenty patients with acute symptomatic deep vein thrombosis received a 5000-U heparin bolus, followed by 1680 U/h (low risk to bleed) or 1240 U/h (high risk to bleed), adjusted by protocol-directed response to APTT results. Forty-eight patients with deep vein thrombosis were treated by their physicians. The Kaplan-Meier method was used to examine the proportion of patients who achieved an APTT greater than 55 seconds as a function of time. RESULTS: The two study cohorts did not differ with respect to age, weight, or risk factors for venous thromboembolism. Analysis of Kaplan-Meier curves showed that the heparin protocol decreased the time to achieve a therapeutic anticoagulant effect (P = .025). Ten (91%) of 11 patients (95% confidence interval, 59% to 100%) without risks to bleed who were treated by the heparin protocol and 29 (60%) of 48 patients (95% confidence interval, 45% to 74%) not treated by the protocol had an initial therapeutic APTT (P = .006). CONCLUSION: A protocol that delivers higher initial heparin infusions to patients without identifiable risks for bleeding decreases the time needed to achieve therapeutic prolongation of APTT, when compared with nonprotocol physician management.

Aged↗

PubMed1997

Diagnosis of ectopic pregnancy--why we need a protocol.

OBJECTIVE: To audit the management after instituting a screening programme for ectopic pregnancy in an institution with a protocol utilising ultrasound examination and serial human chorionic gonadotropin (hCG) and to examine the risk of missed diagnosis with deviation from the protocol. MATERIAL AND METHOD: A retrospective analysis of the management of 145 symptomatic patients in early pregnancies without intrauterine gestational sacs from ultrasound examinations, during the period April to June 1994 in Kandang Kerbau Hospital. Patients underwent serial hCG tests over 48 hours with or without repeat ultrasound scans before definitive treatment unless clinical indications for emergency surgery was necessary. RESULTS: There were 35 ectopic pregnancies (24%), 16 were viable intrauterine pregnancies (11%), 87 were non-viable pregnancies (60%) and 7 were of unknown outcome. There were much practice deviations from the protocol. Forty-four percent (64 cases) of the management decisions were made based on the initial clinical and ultrasound findings, and another 14% (21 cases) after a repeat assessment within the next day by either a repeat scan or serial serum hCG over one day. Among them, two of the 29 operated for suspected ectopic pregnancy were not ectopic (7%) and two of the 56 thought not to be ectopic, turned out to be ectopic (4%) (p < 10(-8)). Six percent (8 cases) defaulted after the initial assessments and one of them was found to be ectopic subsequently. Thirty percent (43 cases) adhered to the protocol. They had serial serum hCG done over two days. Seven of them requiring further repeats of serial serum hCG before management decisions were made. Four patients who were operated on were confirmed ectopic and 39 patients not operated on were not ectopic. Three percent (5 cases) were managed by serial hCG over 3 to 5 days and another 3% (4 cases) by repeating scan over one to two weeks without serial hCG. None of these was ectopic. The percentage change of hCG levels over two days gave indications of the likely diagnosis. CONCLUSION: Adhering to a protocol utilising the principle of ultrasound scan, serial hCGs and selective repeat ultrasound scans are highly recommended for the diagnosis of ectopic pregnancy. Any deviation from protocol is dangerous, with a 4% risk of missing an ectopic and a 7% risk of unnecessary operation for suspected ectopic pregnancy.

Algorithms↗

PubMed1995

The role of protocols and professional judgement in emergency medical dispatching.

The task of evaluating incoming calls to Emergency Medical Services (EMS) systems in order to determine the most appropriate response is performed in many different ways in current EMS systems. At one end of the spectrum, the process is entirely dependent on the judgement of professionals, while at the other end protocols specify the exact questions to be asked and corresponding decisions. This case study describes the experience of the Montreal EMS system, Urgences santé, where professional telephone evaluation performed by nurses since 1981 was replaced by a protocolized system in 1992. During the professional era, there were many attempts to formalize the nurses' decision-making process. These first revealed that professional judgement tended to override decision-support tools that did not allow a flexible processing of the information spontaneously provided by callers. Second, the choice of a single protocol for each call was unnatural for professionals who could spontaneously integrate multiple aspects of a problem in parallel. Third, when protocols were used by professionals, it was a posteriori in order to document their decisions rather than actually support them. Fourth, the use of Artificial Intelligence (AI) methods in order to formalize professional judgement revealed its great complexity, which was confirmed by cognitive analyses of the nurses' decision-making processes. In particular, decisions of not sending EMS resources seemed to be the most difficult. These unsuccessful attempts at formalizing professional judgement led to an evaluation of its performance in terms of results, i.e. to which extent actual decisions minimized errors (both false positives and false negatives) and decision times. A random sample of 1006 calls was collected and the ideal decision was determined by concensus of experts for each call based on the patient's clinical condition. This theoretical decision was considered as a goal standard to which actual decisions were compared. Data analysis revealed that sensitivity of telephone triage (i.e. decision to send EMS resources or not) was almost perfect and specificity was 0.55. The necessary compromise between sensitivity and specificity varied with the types of decisions. Decision times were related to the urgency of the situations, more urgent calls being processed more rapidly. These results were interpreted as representing sophisticated optimization processes in professional judgement. The professional system was replaced by a non-professional protocolized system in 1992. This new system has not yet been formally evaluated in terms of results, but many sources of evidence suggest that it was accompanied by a deterioration of performance. Many contextual factors influence the organization of telephone assessment in EMS systems. This case study suggests that professional judgement may be most useful in contexts where the demand for EMS services often exceeds the availability of resources. On the other hand, protocolized systems may be more appropriate in the absence of such constraints, and where the litigation context prohibits the occurrence of any false negative.

Artificial Intelligence↗

PubMedDate not supplied

The need for a center-tailored treatment protocol for peritonitis.

OBJECTIVE: Despite many improvements in connectology, peritonitis continues to be a major burden in peritoneal dialysis. Because of the high variety in causative organisms and of the differences in their sensitivity patterns, surveillance of the epidemiology of peritonitis and the appropriate adaptation of the therapy are necessary. This study was performed to evaluate the influence of the nature of causative bacteria on the effectiveness of empirical treatment protocols. Based on this information, a new empiric treatment protocol was proposed. SETTING: Peritoneal dialysis program of a university hospital. DESIGN: All episodes of peritonitis at the University Hospital Gent between 1 January 1994 and 31 December 1996 were analyzed retrospectively. Results of microbiological cultures, microscopic evaluation of dialysate, and clinical course were noted. RESULTS: During 1240 patient-months at risk, 50 episodes of peritonitis with identifiable responsible bacteria were observed. Gram-positive organisms were cultured in 34 episodes, and gram-negative organisms were found in 16 episodes. No responsible organism could be identified in 25 additional cases. Resistance to methicillin was registered in 33% of the cultures with staphylococci. There was no resistance to vancomycin. A new empirical treatment protocol was proposed, using a single dose of vancomycin and gentamicin intraperitoneally the first day, followed by oral treatment with ciprofloxacin. With this protocol, a 96% coverage rate is obtained, as opposed to a 78% coverage by using the Ad Hoc Advisory Committee protocol (p < 0.01). CONCLUSION: Individual centers should continue to monitor the epidemiology of peritoneal dialysis-related peritonitis and the epidemiology of the causative organisms and their sensitivity patterns in order to adapt general guidelines into a center-tailored empirical treatment protocol.

Anti-Bacterial Agents↗

PubMed1998

Outcome of patients with traumatic brain injury managed on a standardised head injury protocol.

A standardised protocol in the management of severe head injury in our hospital enables pre-determined critical care-paths and consistent treatment regimes to be instituted. In Singapore there has been no previously reported data on the outcome of severely head injured patients. Over a 6-month period, 48 consecutive patients who were enrolled in our severe head injury protocol were prospectively studied. In addition to demographic and outcome data, physiologic measurements obtained from a computerised patient information system (Carevue Hewlett-Packard 9000) were analysed to determine the mean cerebral perfusion pressure (CPP) and intracranial pressure (ICP) achieved throughout the protocol period. Median Glasgow Coma Score for all patients on admission to the protocol was 6 (range 4 to 8). The mean age was 34.46 +/- 15.03 years with a male to female ratio of 43:5. The average duration of treatment on the protocol was 110.73 hours. Initial ICP measured was 25.5 +/- 19.68 mmHg. Outcome was measured at 6 months post-injury using the Glasgow Outcome Score. Favourable outcome (GOS 4-5) was seen in 29 of 48 patients (60.4%) while 12 out of 48 (25%) had an unfavourable outcome. There was a mortality of 14.6% (7 of 48 patients). Patients who survived had a higher mean CPP (P = 0.00005), a lower initial ICP and a mean ICP (P = 0.007 and 0.0009). The use of a protocol with standardised treatment goals in the management of traumatic brain injury allows for the optimal use of limited resources and provides consistency in treatment. Good outcome is related to early aggressive resuscitation to prevent hypotension and hypoxia, prompt evacuation of surgical mass lesions and the maintenance of an adequate cerebral perfusion pressure. Our results are comparable with that reported in other established neurotrauma systems.

Accidents↗

PubMed1998

[Violations of chemotherapy protocols for ovarian cancer--reasons and consequences].

In times when colony-stimulating factors were not available, delays of treatment or dose reductions were necessary, to assure that chemotherapy could be safely administered. In a retrospective analysis the effects of chemotherapy protocol violations on the survival of patients with ovarian cancer was evaluated. The serial courses of leukocyte counts were often the determinants for a protocol adequate chemotherapy in contrary to the thrombocytes but the serial platelet counts had no influence on protocol violations. Only time-related protocol violations have been found in 7.6% of the cases. There seems to be no apparent influence on patients' survival. However, accomplishment of treatment schedules, which may be regarded as a reaction towards unsatisfactory tumour response, at the initial visit alone or in combination with time-related protocol violations as well as tumour stage, course of tumour markers (CA 125) had a strong impact on survival while higher dosage levels produces only a trend towards improved survival. The use of growth factors will probably reduce the percentage of protocol violations caused by neutropenia, but it is questionable if it will reduce mortality due to tumour progression.

Antineoplastic Agents↗

PubMed1999

Five-step protocol for carotid endarterectomy in the managed health care era.

BACKGROUND: We developed a protocol combining 5 cost-effective strategies to determine whether elective carotid endarterectomy (CEA) could be performed safely without adversely affecting well-established low morbidity and mortality rates and with significant hospital cost savings. METHODS: Between April 1, 1995, and December 31, 1996, 109 of 141 patients were prospectively enrolled as candidates into a 5-step CEA protocol: (1) duplex ultrasonography (DU) performed at an accredited vascular laboratory as the sole diagnostic carotid preoperative study, (2) admission the day of operation, (3) cervical block anesthesia to eliminate intraoperative electroencephalogram monitoring, (4) transfer from the recovery room after a 4-hour observation period to the vascular ward, and (5) discharge the first postoperative morning. The other 32 patients were excluded from analysis; 16 patients were treated by vascular surgeons not participating in the protocol, 9 were treated concomitantly for other medical problems, and 7 were admitted emergently. RESULTS: One patient died of carotid hemorrhage the first postoperative morning, and one had an intraoperative embolic stroke for a combined mortality-stroke rate of 1.8% (2 of 109). Of the 109 patients, 70% (76) underwent operation using DU as the sole diagnostic study, 95% (104) were admitted the day of operation, 76% (83) had cervical block anesthesia, 59% (64) were transferred to the floor the day of operation, and 83% (90) were discharged the morning after operation. None of the 109 patients were adversely affected by these 5 cost-saving strategies except potentially the patient who bled the first postoperative morning. The predicted charges of a patient treated with a perioperative protocol that many vascular surgeons currently use (preoperative arteriography, general anesthesia with intraoperative electroencephalogram monitoring, overnight intensive care unit stay, discharge on postoperative day 2) was $16,073 compared with $10,437 for a patient who completed all 5 steps of the protocol detailed above. CONCLUSIONS: On the basis of these results documenting significant cost savings and acceptably low morbidity and mortality rates, this 5-step protocol may be considered the standard for performing CEA in this era of cost containment. These results may be compared with endovascular intervention, which has recently been proposed as a less expensive technique to treat carotid disease.

Aged↗

PubMed2001

The amblyopia treatment study visual acuity testing protocol.

OBJECTIVE: To evaluate the reliability of a new visual acuity testing protocol for children using isolated surrounded HOTV optotypes. METHODS: After initial pilot testing and modification, the protocol was evaluated using the Baylor-Video Acuity Tester (BVAT) to present isolated surrounded HOTV optotypes. At 6 sites, the protocol was evaluated for testability in 178 children aged 2 to 7 years and for reliability in a subset of 88 children. Twenty-eight percent of the 178 children were classified as having amblyopia. RESULTS: Using the modified protocol, testability ranged from 24% in 2-year-olds to 96% in 5- to 7-year-olds. Test-retest reliability was high (r = 0.82), with 93% of retest scores within 0.1 logMAR unit of the initial test score. The 95% confidence interval for an acuity score was calculated to be the score +/-0.125 logMAR unit. For a change between 2 acuity scores, the 95% confidence interval was the difference +/-0.18 logMAR unit. CONCLUSIONS: The visual acuity protocol had a high level of testability in 3- to 7-year-olds and excellent test-retest reliability. The protocol has been incorporated into the multicenter Amblyopia Treatment Study and has wide potential application for standardizing visual acuity testing in children.

Amblyopia↗

PubMed1979

A protocol for the air caloric test and a comparison with a standard water caloric test.

This communication describes the development of a protocol for the air caloric stimulus for vestibular testing. The protocol is based on matching the peak responses of air and water caloric stimuli and minimizing subject discomfort. Air stimulus temperatures of 30 and 44 degrees C are used, and these appear to minimize subject complaints of pain with the test. Composite data are presented from 16 normal subjects who were tested with the protocol. A comparison is made with their responses to a standard water protocol. Test-retest data for both air and water protocols are also presented, and these data indicate similar day-to-day variation in the two methods. On the basis of the work presented, it is concluded that the air protocol produces responses equivalent to that of standard water calorics in a group of normal subjects. Neither test was found, in the present experiments, to be particularly sensitive.

Air↗