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At least 271 records · Page 15Linked to original sources
PubMed1997

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

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

Aged↗
PubMed1999

Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems.

Analysis of Variance↗
PubMed2004

Internet based clinical trial protocols -- as applied to a study of warfarin pharmacogenetics.

AIMS: To describe and evaluate the use of an Internet-based study protocol in a multicentre study of genetic risk factors in anticoagulant treatment. METHODS: A web-based study protocol, similar to existing anticoagulation medical record systems, was developed for entry of clinical data. It was also supplied with a separate interface for study monitoring. Measures were taken to assure the confidentiality of transferred data. In addition, software modifications were made to enable automated transfer of clinical data from an existing medical record system to the study database. RESULTS: The system has been in use since March 2002, and at present 39 centres have included 909 patients with a dropout rate of 2.8%. The need for education of participating clinicians has been satisfactorily provided for by means of written instructions and telephone support. CONCLUSIONS: Our study demonstrates the usability of Internet-based data acquisition techniques in a full-scale multicentre clinical trial. The main advantages of such a protocol are automated data validation and standardization, fast data transfer independent of geographical distance, user feedback, synchronization of protocol updates and automatic data formatting facilitating statistical analyses. Safety and accessibility are possibly cumbersome areas and should be addressed duly.

Adult↗
PubMed1997

Conscious sedation of pediatric oncology patients for painful procedures: development and implementation of a clinical practice protocol.

Pain during treatment procedures is often identified as the most distressing aspect of the entire cancer experience for a child with cancer. The use of conscious sedation may reduce this procedure-related pain and distress. A clinical practice protocol is necessary to maximize the efficacy and safety of conscious sedation use. In this article, the processes of developing and implementing a conscious sedation protocol for pediatric oncology patients undergoing painful procedures are presented. The protocol itself is included. A review of the literature on conscious sedation is presented, and implications for pediatric oncology nursing practice are discussed.

Adolescent↗
PubMed2006

Efficacy and safety of twice-daily pharmacokinetically enhanced amoxicillin/clavulanate (2000/125 mg) in the treatment of adults with community-acquired pneumonia in a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae.

OBJECTIVES: This randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily versus amoxicillin/clavulanate 875/125 mg three times daily, both given orally for 7 or 10 days, in the treatment of adults with community-acquired pneumonia in Spain, a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae. PATIENTS AND METHODS: Following 2:1 randomization, 566 patients (intent-to-treat population) received either amoxicillin/clavulanate 2000/125 mg (n = 374) or amoxicillin/clavulanate 875/125 mg (n = 192). RESULTS: Among the patients who did not deviate from the protocol (clinical per-protocol population), clinical success at day 21-28 post-therapy (test of cure; primary efficacy endpoint) was 92.4% (266/288) for amoxicillin/clavulanate 2000/125 mg and 91.2% (135/148) for amoxicillin/clavulanate 875/125 mg (treatment difference, 1.1; 95% confidence interval, -4.4, 6.6). Bacteriological success at test of cure in the bacteriology per-protocol population was 90.8% (79/87) with amoxicillin/clavulanate 2000/125 mg and 86.0% (43/50) with amoxicillin/clavulanate 875/125 mg (treatment difference 4.8; 95% confidence interval, -6.6, 16.2). At test of cure, amoxicillin/clavulanate 2000/125 mg was clinically and bacteriologically effective against 7/7 penicillin-resistant Streptococcus pneumoniae (MIC > or = 2 mg/L) isolates (including three amoxicillin non-susceptible strains) and amoxicillin/clavulanate 875/125 mg against 5/5 isolates (including one amoxicillin non-susceptible strain). CONCLUSIONS: Both treatment regimens were well tolerated. Amoxicillin/clavulanate 2000/125 mg was at least as effective clinically and as safe as amoxicillin/clavulanate 875/125 mg in the treatment of community-acquired pneumonia in adults in a country with a high prevalence of penicillin-resistant S. pneumoniae and has a more convenient twice daily posology.

Adult↗
PubMedDate not supplied

Left ventricular assist device weaning: hemodynamic response and relationship to stroke volume and rate reduction protocols.

Clinical evidence of myocardial recovery in a small cohort of patients supported with a left ventricular assist device (LVAD) has been reported. Development of an optimal LVAD weaning protocol is needed for these patients to sustain recovery after device explant. In this study, we tested the hypothesis that LVAD stroke volume reduction produces a steady-state mechanical reloading of left ventricular (LV) pressures and volumes compared with LVAD rate reduction that results in transient mechanical reloading of the heart due to beat-to-beat variation in LV pressures and volumes. The relationship of LVAD flow to LVAD stroke volume and systolic interval over a range of LVAD rates (60, 80, 100, 120, and 140 bpm) was validated in a mock circulatory flow loop. In six acute experiments, calves were implanted with a pneumatic paracorporeal LVAD (PVAD, Thoratec, Pleasanton, CA). The PVAD was operated asynchronously in the auto volume mode (full decompression) for 30 minutes to establish a baseline control condition. The calf hearts were then mechanically reloaded by LVAD rate reduction (80, 60, and 40 bpm) or LVAD stroke volume reduction (100, 120, and 140 bpm) protocols consisting of 30 minutes of support at each LVAD beat rate. The order of weaning protocols was randomized with a 30-minute recovery period (LVAD volume mode to fully decompress heart allowing it to rest) between protocols to enable return to baseline control state. Aortic pressure and flow, LV pressure and volume, pulmonary artery flow, and LVAD flow waveforms were recorded for each test condition. The LVAD stroke volume reduction protocol produced steady-state mechanical reloading compared with VAD rate reduction that resulted in transient LV mechanical reloading. This distinction is due to differences in their temporal relationships between LVAD and LV filling and emptying cycles. The acute hemodynamic benefit of LVAD stroke volume reduction was greater reduction in LV end-diastolic pressure and increase in LV segmental shortening than LVAD rate reduction. The long-term effects of steady-state and transient LV mechanical reloading on myocardial structure and function toward achieving sustained myocardial recovery warrant further investigation.

Animals↗
PubMed1998

Research fundamentals: III. elements of a research protocol for clinical trials.

A clinical trial is a powerful technique for evaluating the effectiveness of an experimental intervention. The initial stages of planning a clinical trial involve choosing and refining a research question, selecting a study design, and deciding on appropriate statistical tests and sample sizes. The success of the study depends upon how well these issues are thought out in advance, and how they can be put into practice. The protocol is the written document that allows the investigator to communicate details of how the research question will be answered. In the following article, the basic components of the research protocol are described. Issues related to quality control, data entry, and pilot testing are discussed. This is the third in a series of research fundamental concept papers, written by members of the SAEM Research Committee.

Clinical Protocols↗
PubMed2001

Safety of a clinical surveillance protocol with 3- and 6-week warfarin prophylaxis after total joint arthroplasty.

The charts of 1869 patients were reviewed for the occurrence of deep venous thrombosis (DVT) and pulmonary embolism after total hip or knee arthroplasty. Prophylaxis consisted of 3 (group 1; n=1235) or 6 (group 2; n=634) weeks low-dose warfarin, pneumatic compression boots worn by patients in the hospital, mobilization on the first postoperative day, and a clinical surveillance protocol. Venous ultrasound or ventilation/perfusion lung scintigraphy (V/Q) was performed only if patients became symptomatic. patients. Twenty-three (1.8%) patients were positive for DVT. Ventilation/perfusion lung scintigraphy was performed on 25 patients, and 5 (0.4%) patients were positive for pulmonary embolism. In group 2, 117 patients were evaluated for DVT, and 19 (3%) patients had positive results determined by ultrasound. Twenty-five patients were evaluated with V/Q and only 1 (0.16%) patient was positive for pulmonary embolism. No patient developed a fatal pulmonary embolism or postphlebitic syndrome. This prophylaxis protocol is an efficient and cost-effective method for the prevention of significant events after surgery.

Aged↗
PubMed2000

Ramp exercise protocols for clinical and cardiopulmonary exercise testing.

Historically, the protocol used for exercise testing has been based on tradition, convenience or both. In the 1990s, a considerable amount of research has focused on the effect of the exercise protocol on test performance, including exercise tolerance, diagnostic accuracy, gas exchange patterns and the accuracy with which oxygen uptake (VO2) is predicted from the work rate. Studies have suggested that protocols which contain large and/or unequal increments in work cause a disruption in the normal linear relation between VO2 and work rate, leading to an overprediction of metabolic equivalents. Other studies have demonstrated that such protocols can mask the salutary effects of an intervention, and some have suggested that the protocol design can influence the diagnostic performance of the test. Guidelines published by major organisations have therefore suggested that the protocol be individualised based on the patient being tested and the purpose of the test. The ramp approach to exercise testing has recently been advocated because it facilitates recommendations made in these guidelines. This article reviews these issues and discusses the evolution of ramp testing which has occurred in the 1990s.

Energy Metabolism↗
PubMedDate not supplied

The impact of a normoglycemic management protocol on clinical outcomes in the trauma intensive care unit.

BACKGROUND: The purpose of this study was to determine if protocol-driven normoglycemic management in trauma patients affected glucose control, ventilator-associated pneumonia, surgical-site infection, and inpatient mortality. METHODS: A prospective, consecutive-series, historically controlled study design evaluated protocol-driven normoglycemic management among trauma patients at Vanderbilt University Medical Center. Those mechanically ventilated > or =24 hours and > or =15 years of age were included. A glycemic-control protocol required insulin infusion therapy for glucose >110 mg/dL. Control patients included those who met criteria, were admitted the year preceding protocol implementation, and had hyperglycemia treated at the physician's discretion. RESULTS: Eight hundred eighteen patients met study criteria; 383 were managed without protocol; 435 underwent protocol. The protocol group had lower glucose levels 7 of 14 days measured. After admission, both groups had mean daily glucose levels <150 mg/dL. No difference in pneumonia (31.6% vs 34.5%; p = .413), surgical infection (5.0% vs 5.7%; p = .645) or mortality (12.3% vs 13.1%; p = .722) occurred between groups. If one episode of blood glucose level was > or =150 mg/dL (n = 638; 78.0%), outcomes were worse: higher daily glucose levels for 14 days after admission (p < .001), pneumonia rates (35.9% vs 23.3%; p = .002), and mortality (14.6% vs 6.1%; p = .002). One or more days of glucose > or =150 mg/dL had a 2- to 3-fold increase in the odds of death. Protocol use in these patients was not associated with outcome improvement. CONCLUSIONS: Protocol-driven management decreased glucose levels 7 of 14 days after admission without outcome change. One or more glucose levels > or =150 mg/dL were associated with worse outcome.

Adult↗
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↗
PubMed2002

Study of coronary flow reserve with intravenous use of microbubbles (contrast echocardiography) and adenosine: protocol for clinical application in patients suspected of having coronary heart disease.

OBJECTIVE: To test the feasibility, safety and accuracy of the adenosine protocol in the study of myocardial perfusion with microbubbles contrast echocardiography. METHODS: 81 pts (64 male, 60+11 years) were submitted to contrast echocardiography with PESDA (sonicated solution of albumin 20%-1ml, dextrose 5%-12ml and deca-fluorobutane gas-8ml) to study the myocardial perfusion at rest and after bolus injection of adenosine (6 to 18mg) and to coronary angiography within 1 month each other. For each patient 3 left ventricle perfusion beds were considered (total of 243 territories). 208 territories were analyzed and 35 territories were excluded. PESDA was continuously infused (1-2ml/min), titrated for best myocardial contrast. Triggered (1:1) second harmonic imaging was used. RESULTS: Coronary angiography showed 70 flow limiting (> 75%) lesions and 138 no flow limiting lesions. At rest an obvious myocardium contrast enhancement was seen in at least 1 segment of a territory in all patients. After adenosine injection an unquestionable further increase in myocardial contrast was observed in 136 territories (99%) related to no flow limiting lesions, lasting < 10 s, and a myocardial perfusion defect was detected in 68 territories (97%) related to flow limiting lesions. It was observed only 4 false results. There were no serious complications. CONCLUSION: Myocardial perfusion study with PESDA and adenosine protocol is a practical, safe and accurate method to analyze the coronary flow reserve.

Adenosine↗
PubMed1997

From hospital information system components to the medical record and clinical guidelines & protocols.

This paper introduces an ongoing project towards the development of a new generation HIS, aiming at the integration of clinical and administrative information within a common framework. Its design incorporates explicit knowledge about domain objects and professional activities to be processed by the system together with related knowledge management services and act management services. The paper presents the conceptual model of the proposed HIS architecture, that supports a rich and fully integrated patient data model, enabling the implementation of a dynamic electronic patient record tightly coupled with computerised guideline knowledge bases.

Clinical Protocols↗
PubMed1976

Case finding of unrelated disease in the orthopedic clinic.

Protocols for detecting hypertension and pelvic disease were established in the orthopedic outpatient department. A significant percentage (hypertension, 20%; pelvic disease, 10%) of the patients were found to have undiagnosed pathologic conditions. The cost to the orthopedist of such case finding was minimal in terms of time and money. Methods of securing adequate follow-up are discussed.

Adult↗
PubMed2001

Nurse-led weaning from mechanical ventilation: where's the evidence?

BACKGROUND: Several authors have suggested clinical protocols as a means of shortening ventilation time and the important role of the nurse in reducing ventilation time has also been highlighted. Despite the many references in the literature to reducing weaning times using clinical protocols, it is not clear whether nurse-led weaning strategies hasten weaning from mechanical ventilation compared with physician-led care. OBJECTIVE: to systematically review the published literature to answer the question: Does nurse-led weaning from mechanical ventilation reduce duration of ventilation compared with doctor-led care? DATA SOURCES: MEDLINE, CINHAL, EMBASE, Cochrane Library, Best Evidence, hand search, expert opinion, controlled trials register. STUDY SELECTION: randomized controlled trials (RCTs) and cohort studies where nurses or respiratory therapists lead the weaning from mechanical ventilation; duration of ventilation must be stated. DATA EXTRACTION: performed by the author, who extracted data on statistical significance of the difference in duration of ventilation between control and trial groups, complication rates (such as reintubation) and mortality. DATA SYNTHESIS: statistical synthesis was not attempted but narrative synthesis was performed. RESULTS: only 1 randomized controlled trial and 2 cohort studies were found where nurses or respiratory therapists led weaning using a protocol. Two studies showed reduction in ventilation time without additional complications; the third study had the weakest evidence, because it was retrospective, and showed no difference between control and treatment groups. CONCLUSIONS: There is limited evidence suggesting that nurse-led weaning may reduce ventilation time; however, it is not clear whether it was the nurse-led aspect or the clinical protocol that produced the effect.

Clinical Protocols↗