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In Part IV of a series on the use of psychoactive drugs, the appropriate use of antianxiety agents is discussed. A step-wise approach which focuses on practical methods of managing anxiety is formulated. A framework is presented as a guide to clinicians treating anxiety symptoms in a variety of conditions.
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In light of the increasing demands being placed on cytapheresis donors and their occasional venous problems, it has become necessary to use 1-needle in addition to 2-needle separation techniques in thrombocytapheresis. We therefore compared five 1-needle and three 2-needle programs on four different cell separators and found that meanwhile both the platelet yields and the leukopenia (controlled by Nageotte chamber counting) of the products obtained with the 1-needle technique are equivalent to those obtained using the 2-needle technique, as long as the program is suitably adjusted.
OBJECTIVES: During the last decade, evidence-based medicine has given rise to an increasing number of medical practice guidelines and protocols. However, the work done on developing and distributing protocols outweighs the efforts on guaranteeing their quality. Indeed, anomalies like ambiguity and incompleteness are frequent in medical protocols. Recent efforts have tried to address the problem of protocol improvement, but they are not sufficient since they rely on informal processes and notations. Our objective is to improve the quality of medical protocols. APPROACH: The solution we suggest to the problem of quality improvement of protocols consists in the utilisation of formal methods. It requires the definition of an adequate protocol representation language, the development of techniques for the formal analysis of protocols described in that language and, more importantly, the evaluation of the feasibility of the approach based on the formalisation and verification of real-life medical protocols. For the first two aspects we rely on earlier work from the fields of knowledge representation and formal methods. The third aspect, i.e. the evaluation of the use of formal methods in the quality improvement of protocols, constitutes our main objective. The steps with which we have carried out this evaluation are the following: (1) take two real-life reference protocols which cover a wide variety of protocol characteristics; (2) formalise these reference protocols; (3) check the formalisation for the verification of interesting protocol properties; and (4) determine how many errors can be uncovered in this way. RESULTS: Our main results are: a consolidated formal language to model medical practice protocols; two protocols, each both modelled and formalised; a list of properties that medical protocols should satisfy; verification proofs for these protocols and properties; and perspectives of the potentials of this approach. Our results have been evaluated by a panel of medical experts, who judged that the problems we detected in the protocols with the help of formal methods were serious and should be avoided. CONCLUSIONS: We have succeeded in demonstrating the feasibility of formal methods for improving medical protocols.
BACKGROUND: Current guidelines for transthoracic direct-current cardioversion (DCCV) of atrial fibrillation (AF) recommend a step-up energy protocol. The aim of this study was to compare such a protocol with a protocol involving a high initial energy shock, anteroposterior paddle position and reversal of shock polarity, on cardioversion efficacy, total energy delivery, use of sedation and patient tolerability. METHODS: 261 patients (mean age 71+/-10 years, 62% male) referred for elective DCCV of persistent AF were enrolled. Patients were randomised to either protocol A: (1) 200 J anteroapical, (2) 360 J anteroapical, (3) 360 J anteroposterior; or protocol B: (1) 360 J anteroapical, (2) 360 J anteroposterior, and (3) 360 J posteroanterior. All procedures were performed under sedation with intravenous diazepam. RESULTS: Protocol B improved shock success rates (protocol A first shock success rate=42%, protocol B=68%, p<0.001; protocol A second shock success rate=72%, protocol B 86%, p=0.006; protocol A third shock success rate=83%, protocol B=92%, p=0.03) and required fewer shocks to achieve sinus rhythm (1.3+/-0.6) compared with protocol A (1.6+/-0.7, p<0.001). There were no differences in cumulative energy used (protocol A 473+/-286 J, protocol B 436+/-273 J, p=0.24) or sedation requirements (protocol A diazepam 22.1+/-9.0 mg, protocol B 21.7+/-8.9 mg, p=0.75). Both protocols were equally well tolerated by patients. CONCLUSION: High initial energy increased success rates and decreased the number of shocks but resulted in similar cumulative energy delivery, sedation use and patient tolerability compared with a conventional step-up protocol.
BACKGROUND: Severely malnourished children have high mortality rates. Death commonly occurs during the first 48 h after hospital admission, and has been attributed to faulty case-management. We developed a standardised protocol for acute-phase treatment of children with severe malnutrition and diarrhoea, with the aim of reducing mortality. METHODS: We compared severely malnourished children with diarrhoea aged 0-5 years managed by non-protocol conventional treatment, and those treated by our standardised protocol that included slow rehydration with an emphasis on oral rehydration. The standardised-protocol group included children admitted to the ICDDR,B Hospital, Dhaka between Jan 1, 1997, and June 30, 1997, while those admitted between Jan 1, 1996, and June 30, 1996, before the protocol was implemented, were the non-protocol group. FINDINGS: Characteristics on admission of children on standardised protocol (n=334) and non-protocol children (n=293) were similar except that more children on standardised protocol had oedema, acidosis, and Vibrio cholerae isolated from stools. 199 (59.9%) of children on standardised protocol were successfully rehydrated with oral rehydration solution, compared with 85 (29%) in the non-protocol group (p<0.0001). Use of expensive antibiotics was less frequent in children on standardised protocol than in the other group (p<0.0001). Children on standardised protocol had fewer episodes of hypoglycaemia than non-protocol children (15 vs 30, p=0.005). 49 (17%) of children on non-protocol treatment died, compared with 30 (9%) children on standardised protocol (odds ratio for mortality, 0.49, 95% CI 0.3-0.8, p=0.003). INTERPRETATION: Compared with non-protocol management, our standardised protocol resulted in fewer episodes of hypoglycaemia, less need for intravenous fluids, and a 47% reduction in mortality. This standardised protocol should be considered in all children with diarrhoea and severe malnutrition.
OBJECTIVE: The Fourth International Workshop on Gestational Diabetes recently suggested that two techniques, a 2-tiered protocol and a 1-tiered protocol, to screen for gestational diabetes mellitus are acceptable alternatives. This study was undertaken to compare the direct costs and patient time expenditures associated with implementing both techniques. STUDY DESIGN: A MEDLINE search was undertaken to determine the prevalence of positive and negative screening results. Direct costs of testing were estimated by determining the range of supply costs from manufacturers' catalogs and the labor costs by estimating the time required to perform each procedure and multiplying by the appropriate range of wages; these costs were then multiplied by the appropriate range of the number of procedures required to implement both protocols, and the totals were summed. Patient time expended was estimated by assigning test times of 1, 2, and 3 hours for the 50-g screening glucose challenge test, the 75-g oral glucose tolerance test, and the 100-g oral glucose tolerance test, respectively. If additional visits were required, 2 travel-time units were assigned each time a patient underwent a procedure. These units were multiplied by the range of patients undergoing various tests to implement the alternative protocols. RESULTS: We identified low and high direct costs, test times, and travel units per patient screened by the 1- and 2-tiered testing protocols. Low and high direct costs were $3.46 and $7.88, respectively, for the 2-tiered protocol and $5.64 and $10.88, respectively, for the 1-tiered protocol (relative ratios, 1.63 for low direct costs in each protocol and 1.38 for high direct costs in each protocol). Low and high test times were 1.4 and 1.5 hours, respectively, for the 2-tiered protocol and 2.0 and 2.0 hours, respectively, for the 1-tiered protocol (relative ratios, 1.47 for low test times in each protocol and 1.32 for high test times in each protocol). Low and high travel units for the 2-tiered protocol were 0.2 and 0.3, respectively, when the glucose challenge test was given at the prenatal visit, and 2.2 and 2.3, respectively, when the test was not given at that time. Low and high travel units for the 1-tiered protocol were 8.3 and 5.8, respectively, when the glucose challenge test was given at the prenatal visit, and 0.89 and 0.85, respectively, when the test was not given at that time. CONCLUSIONS: The 2-tiered protocol appears to be associated with lower direct implementation costs and less patient time expenditure than the 1-tiered scheme. The 1-tiered protocol is associated with slightly less travel time, but this is unlikely to offset the test time advantage of the 2-tiered protocol. Until further data regarding the relative clinical utility of the 2 protocols become available, these factors may be important for clinicians in deciding which screening format to follow.
Four exercise test protocols (Bruce, Balke, Ellestad and Steep) were compared in 16 patients with proven coronary artery disease in demonstrating the anti-anginal effects of sublingual glyceryl trinitrate in a randomization double-blind trial. Glyceryl trinitrate significantly improved the time, heart rate and rate pressure product to peak exercise, onset of angina and 1 mm ST segment depression in all four protocols (P < 0.05) (except rate pressure product to angina in the Balke protocol). The increase in exercise time was greatest for the Balke protocol at peak exercise (188.1 +/- 187.1) (mean +/- SD in s), at onset of angina (251.9 +/- 247.1) and at 1 mm ST depression (233.6 +/- 243.8), followed by the Steep and Bruce protocols, and was lowest for the Ellestad protocol 41.9 +/- 42.4, 96.5 +/- 65.8, 82.6 +/- 74.0, respectively. Increase in time to peak exercise with glyceryl trinitrate was significantly greater for the Balke protocol in comparison with the other three protocols and for the Bruce and Steep protocols when compared to the Ellestad protocol. Time to 1 mm ST depression with treatment was significantly greater on the Balke and Bruce protocols than the Ellestad protocol, and to onset of angina for the Balke compared to other three protocols. There were no significant differences between the Bruce and Steep protocols for any of the endpoints. The magnitude of treatment effect in the different protocols was accompanied by correspondingly greater inter-patient variability such that no protocol was more, or less, sensitive than another in detecting treatment effect. Changes in heart rate and rate pressure product with treatment were generally similar between the different protocols. In conclusion, a protocol with small and frequent increments (Balke), although able to show greater increase in exercise duration with glyceryl trinitrate than more aggressive protocols, is no more sensitive at detecting treatment effect.
BACKGROUND: Plantar pressure measurement may be a helpful evaluation tool in patients with foot complaints. Determination of dynamic pressure distribution under the foot may give information regarding gait, progress of disorders, and the effect of treatment. However, for these measurements to have clinical application, reproducibility, consistency, and accuracy must be ascertained. We compared the reproducibility of measurements among one-step, two-step, and three-step protocols for data collection in patients with arthritis. In addition, the number of measurements needed for a consistent average was determined for the protocol that was found to be the most reproducible. METHODS: Twenty patients with foot complaints secondary to arthritis participated in the study. Each patient was tested with a pressure platform system using two of the three testing protocols. Reproducibility of contact time and maximal peak pressure were assessed. Intraclass Correlation Coefficients (ICC) were calculated for measurement results among protocols. In stage two of the study, the number of measurements needed for a consistent average was determined by calculating the first three measurements, the first five measurements, and then all seven measurements for both feet. ICC of three, five, and seven measurements were compared. The two-step protocol (13 patients), which was found in stage one of the study to be the most reproducible, was used for this determination. RESULTS: Reproducibility was found to be reasonable or good for all three measurement protocols. The mean values of contact time for the one-step protocol were found to be higher than the mean values of contact time for the two-step or three-step protocols in both feet. The differences between the one-step and three-step protocols were statistically significant for the left foot only. The mean peak pressure did not show statistically-significant differences among the three protocols. The one-step and three-step protocols were not used for stage two of the study. Using the two-step protocol, three measurements were found to be sufficient for obtaining a consistent average. CONCLUSIONS: The results of our study indicated that the one-step, two-step, and three-step protocols of collecting plantar pressure measurements in patients with foot complaints secondary to chronic arthritis were all similar. However, the use of the two-step protocol is recommended over the one-step and three-step protocols; the one-step protocol produced a longer stance phase that did not resemble normal walking and when comparing the two-step and three-step protocols, the two-step protocol was less time consuming and less strenuous for patients with painful feet.
OBJECTIVE: The purpose of this study was to compare the sensitivity of two electron beam tomography protocols for detection and quantification of coronary artery calcium. SUBJECTS AND METHODS: We selected 101 patients (57% men, mean age 53 +/- 10 years) to undergo two consecutive electron beam tomography and acquired imaging with both a 6-mm and a 3-mm slicing protocol. Three pixels (area, 1.03 mm(2)) and a minimal density of 130 H were used for definition of calcified plaque. RESULTS: We found coronary artery calcifications in 46 patients when we used a 6-mm protocol and in 61 patients when we used a 3-mm protocol (p < 0.001). The average total calcium score was 77 (+/-140) with a 6-mm protocol and 251 (+/-395) with a 3-mm protocol (p < 0.005). The average number of calcified lesions per patient was 1.7 for a 6-mm protocol and 3.7 for a 3-mm protocol (p < 0.01). Of 179 individual lesions seen using a 3-mm protocol, 103 (58%) were missed using a 6-mm protocol, and only 27% of the lesions with a calcium score less than or equal to 40 seen with a 3-mm protocol were detected with 6-mm slicing (p < 0.001). The mean lesion attenuation with a 6-mm protocol was 160 (+/-42) H, compared with 218 (+/-44) H with a 3-mm protocol (p < 0.001), indicating a significantly greater partial volume averaging with the former protocol. CONCLUSION: A 6-mm slicing protocol is significantly less sensitive than a 3-mm protocol for the detection and quantification of coronary artery calcium. Since one third of coronary events occur in patients with low calcium scores, a 6-mm protocol might be unreliable for risk assessment because of substantial loss of information in this calcium score range.
OBJECTIVE: To evaluate, in an elderly Portuguese population, the diagnostic capacities of the most popular treadmill stress test protocols. DESIGN: Retrospective study of an elderly Portuguese population submitted to a stress test. PATIENTS AND METHODS: A population of 45 patients (35 male), aged 65 or more years, consecutively submitted to a stress test. The average age of the group was 67.8 +/- 2.9 years. The three protocols (Bruce, Bruce Modified and Naughton) were comparatively studied in terms of the patients capacity to execute the protocol, capacity to obtain a maximum and a diagnostic stress test, and the complications of the stress test protocol. MAIN RESULTS: The Bruce protocol was used in 19 patients, the Bruce Modified in 13 patients and the Naughton protocol in 13 patients. The three protocols did not lead to any complication. The Bruce protocol led to a larger increment in heart rate (p < 0.001) and to larger maximum rate pressure product (p < 0.05) than the Naughton one. The Bruce protocol obtained a larger number of diagnostic tests (p < 0.01) and a significantly lower number of inconclusive stress tests. The Naughton protocol led to a larger duration of the exercise tests and was not suitable for some of the elderly patients owing to the exhaustion of the protocol. The results obtained with the Bruce Modified protocol were among those of other two protocols. CONCLUSIONS: In the elderly, the stress tests are safe and useful in the diagnosis of exercise induced ischemia and in the stratification of cardiovascular risk. From the protocols studied, the Bruce protocol was the most adequate, globally speaking, for this group of patients. The Bruce protocol presented a better diagnostic capacity with no complications related to the protocol.