Veterans Administration Cooperative Study of medical versus surgical treatment for stable angina--progress report. Section 6. Symptom severity and prognosis.
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Angina Pectoris↗
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Assessment of nutritional status of the National Cooperative Dialysis Study population.
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Adult↗
A clinician's guide for conducting randomized trials in individual patients.
In determining optimal treatment for a patient conventional trials of therapy are susceptible to bias. Large-scale randomized trials can provide only a partial guide and have not been or cannot be carried out for most clinical disorders. However, randomized controlled trials (RCTs) in individual patients (N of 1 RCTs) may in some circumstances provide a solution to this dilemma. In an N of 1 RCT a patient undergoes pairs of treatment periods (one period of each pair with the active drug and one with matched placebo, assigned at random); both the patient and the clinician are blind to allocation, and treatment targets are monitored. N of 1 RCTs are useful for chronic, stable conditions for which the proposed treatment, which has a rapid onset of action and ceases to act soon after it is discontinued, has shown promise in an open trial of therapy. The monitoring of treatment targets usually includes quantitative measurement of the patient's symptoms with the use of simple patient diaries or questionnaires. Pairs of treatment periods are continued until effectiveness is proved or refuted. The cooperation of a pharmacy is required for the preparation of matching placebos and conduct of the trial. Formal statistical analysis may be helpful for interpreting the results. The practical approach presented in this paper allows clinicians to conduct their own N of 1 RCTs.
Clinical Trials as Topic↗
Effect of single-drug therapy on reduction of left ventricular mass in mild to moderate hypertension: comparison of six antihypertensive agents. The Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents.
BACKGROUND: Antihypertensive drugs may differ in their ability to reduce LV mass. Covariates other than drug selection, such as pretreatment LV mass, body weight, the magnitude of blood pressure reduction, race, and age may modify the response of LV mass to therapy. METHODS AND RESULTS: Patients with mild to moderate hypertension (diastolic blood pressure, 95 to 109 mm Hg) were randomly allocated to treatment with atenolol, captopril, clonidine, diltiazem, hydrochlorothiazide, or prazosin in a double-masked trial. Patients achieving the goal diastolic blood pressure of <90 mm Hg during drug titration entered a 1-year maintenance period. Longitudinal analysis examined changes from baseline echocardiogram in LV mass at 8 weeks and at 1 year, statistically adjusted for pretreatment LV mass, systolic blood pressure, body weight, sodium excretion, physical activity, race, and age. Significant reductions at 1 year in adjusted LV mass were seen for patients in the highest tertile of pretreatment LV mass treated with hydrochlorothiazide (mean, -42.9; 95% confidence limits, -65.5, -20.2 g), captopril (mean, -38.7; 95% confidence limits, -61.0, -16.4 g), and atenolol (mean, -28.1; 95% confidence limits, -50.9, -5.3 g). These treatment effects differed from those of prazosin, diltiazem, or clonidine. CONCLUSIONS: Antihypertensive drugs have disparate effects on LV mass independent of the magnitude of blood pressure reduction. Patients with adequate blood pressure control on captopril, hydrochlorothiazide, and atenolol show a reduction of LV mass after 1 year of treatment, whereas patients on diltiazem, clonidine, or prazosin do not.
Adrenergic alpha-Antagonists↗
Streptokinase and urokinase in the treatment of pulmonary thromboemboli; from a national cooperative study.
In Phase I of this study of 160 patients with pulmonary embolism, it was demonstrated that of 12 hours of urokinase accelerated the resolution of pulmonary thromboemboli compared to heparin alone. Phase II compared 12 hours of urokinase, 24 hours of urokinase and 24 hours of streptokinase in 167 patients. All patients had a clinical history and angiographic diagnosis of pulmonary embolism. Patients were randomly allocated to treatment. All physicians making patient observations were unaware of drug assignment. Resolution of the thromboembolism 24-30 hours after therapy had been instituted was determined by pulmonary angiography, lung perfusion scans and cardiopulmonary hemodynamics. Twenty-four hours of urokinase did not demonstrate greater clot resolution than 12 hours of urokinase. Twenty-four hours of urokinase resulted in greater improvement than streptokinase in lung perfusion scans, but not in angiograms. In patients with massive embolism, this difference was statistically significant. Hemodynamic differences varied. Bleeding complications and morbidity due to allergic reactions with streptokinase and urokinase were minimal. There was no statistically significant difference in mortality in the three threatment groups. From the Phase I and Phase II data it is reasonable to conclude that all three regimens of thrombolytic therapy are more effective than heparin alone in accelerating resolution of pulmonary emboli. Thrombolytic therapy offers the clinician an alternative to pulmonary embolectomy.
Clinical Trials as Topic↗
Organising unrestricted open access gastroscopy in South Tees.
Increasing demand for upper gastrointestinal endoscopy has forced many clinicians to reconsider the policy of seeing all patients in a specialist clinic before gastroscopy. The following are considered essential in setting up an open access gastroscopy service. (1) Assessment of the need by examination of waiting times for the outpatient clinic and the proportion of patients requiring upper gastrointestinal endoscopy, and consultation with colleagues in general practice. During the first 2 years of the service the average waiting time for a medical gastrointestinal outpatient appointment has fallen from over 120 days to 37 days in this area. (2) An adequately staffed and equipped gastrointestinal unit with well motivated nurses (the workload will increase) and sufficient clinical support to allocate patients to the next available gastroscopy list is vital. A safe mechanism for relaying information back to the GP (including histology reports) is essential otherwise medicolegal problems could arise. Open access gastroscopy now accounts for 29% of the total endoscopy workload in South Tees. (3) Close cooperation between medical and surgical gastroenterologists must be achieved to ensure a uniform approach to the provision of this service and equal distribution of the endoscopy workload. This will require close examination of the potential numbers and may necessitate appointment of a clinical assistant or additional consultant. Clinical assistants perform just over 50% of the open access gastroscopies in South Tees and the waiting time has been kept short (average 17 days). (4) A comprehensive request form with guidelines for GPs and a specific box identifying whether the GP requires a report and brief advice only or follow up at the discretion of the endoscopist (often a clinical assistant) is required. (5) Management must be involved in identifying adequate resources. (6) Methods of monitoring requests and outcome measures to ensure effective audit must be established.
Endoscopy, Gastrointestinal↗
Oxaliplatin plus high-dose folinic acid and 5-fluorouracil i.v. bolus (OXAFAFU) versus irinotecan plus high-dose folinic acid and 5-fluorouracil i.v. bolus (IRIFAFU) in patients with metastatic colorectal carcinoma: a Southern Italy Cooperative Oncology Group phase III trial.
PURPOSE: The primary end point of this phase III trial was to compare the response rate (RR) of oxaliplatin (OXA) plus levo-folinic acid (l-FA) and 5-fluorouracil (5-FU) bolus with that of irinotecan (IRI) plus l-FA and 5-FU bolus in advanced colorectal carcinoma. PATIENTS AND METHODS: Patients with measurable metastatic colorectal carcinoma were randomly allocated to receive: IRI 200 mg/m(2) on day 1, l-FA 250 mg/m(2) intravenously plus 5-FU 850 mg/m(2) on day 2 (IRIFAFU); or OXA 100 mg/m(2) on day 1, l-FA 250 mg/m(2) plus 5-FU 1050 mg/m(2) on day 2 [OXAFAFU high dose (hd)]. Cycles were given every 2 weeks. After a planned interim analysis, OXA was reduced to 85 mg/m(2) and 5-FU to 850 mg/m(2) [OXAFAFU low dose (ld)]. RESULTS: Two hundred and seventy-four patients (IRIFAFU, 135; OXAFAFUhd, 71; OXAFAFUld, 68) were treated. Forty-two confirmed responses were achieved with IRIFAFU, 29 with OXAFAFUhd and 32 with OXAFAFUld. The response rate with OXAFAFU [44%; 95% confidence interval (CI) 35% to 52%] was significantly higher (P=0.029) than that of IRIFAFU (31%; 95% CI 23% to 40%). Occurrence of grade > or =3 neutropenia with OXAFAFUld was similar to that for IRIFAFU (29% versus 31%), while severe diarrhoea was significantly lower (12% versus 24%). Median failure-free survival (7 versus 5.8 months; P=0.046) and overall survival of patients (18.9 versus 15.6 months; P=0.032) were significantly prolonged with OXAFAFU. CONCLUSIONS: OXAFAFU was more active and less toxic than IRIFAFU, and it should be preferred in the first-line treatment of advanced colorectal cancer patients.
Adult↗
Optimal intensity of warfarin therapy for secondary prevention of stroke in patients with nonvalvular atrial fibrillation : a multicenter, prospective, randomized trial. Japanese Nonvalvular Atrial Fibrillation-Embolism Secondary Prevention Cooperative Study Group.
BACKGROUND AND PURPOSE: The optimal intensity of warfarin therapy for secondary prevention of stroke in nonvalvular atrial fibrillation (NVAF) remains unclear. We studied the efficacy and safety of conventional- and low-intensity warfarin therapy in a prospective, randomized, multicenter trial. METHODS: The study population consisted of patients with NVAF (<80 years old) who had a stroke or transient ischemic attack. The patients were randomly allocated into a conventional-intensity group (international normalized ratio [INR] 2.2 to 3.5) and a low-intensity group (INR 1.5 to 2.1). They were carefully monitored, and the annual rate of recurrent ischemic stroke and major hemorrhagic complications were compared between the groups. RESULTS: We enrolled 115 patients (mean age 66.7+/-6.5 years) into the study. Fifty-five and 60 patients were allocated into the conventional- and low-intensity groups, respectively. The trial was stopped after a follow-up of 658+/-423 days, when major hemorrhagic complications occurred in 6 patients of the conventional-intensity group and the frequency (6.6% per year) was significantly higher than that in the low-intensity group (0% per year, P=0.01, Fisher's exact test). All of the 6 patients with major bleeding were elderly (mean age 74 years), and their mean INR before the major hemorrhage was 2.8. The annual rate of ischemic stroke was low in both groups (1.1% per year in the conventional-intensity group and 1.7% per year in the low-intensity groups) and did not differ significantly. CONCLUSIONS: For secondary prevention of stroke in persons with NVAF, especially in old patients, the low-intensity warfarin (INR 1.5 to 2. 1) treatment seems to be safer than the conventional-intensity (INR 2.2 to 3.5) treatment.
Aged↗
Incidence and prevention of supraventricular tachyarrhythmias after coronary bypass surgery.
Supraventricular tachyarrhythmias are a frequent complication encountered after coronary artery bypass grafting. A retrospective survey of 102 consecutive patients undergoing exclusive bypass grafting at St. Mary's Hospital supplemented by a review of 16 published reports over a period of 10 years revealed a mean incidence of post-operative tachyarrhythmia of 33.4% in 1344 patients (range 11.4-100%). One hundred and thirty two patients undergoing exclusive bypass surgery, were randomised prospectively in double blind fashion to receive either oral timolol or matched placebo approximately 24 hours after surgery. In the 66 patients receiving timolol, there was a significant reduction of post-operative arrhythmias compared to the 66 patients receiving placebo: from 19.7 to 7.5% (P less than 0.05). Of all arrhythmias, two thirds appeared under 48 hours after surgery. In the timolol group, 4 patients developed systemic hypotension. This was readily reversed by withdrawing the drug. No other side effects were noted. The use of oral timolol after coronary artery surgery significantly lowers the incidence of post-operative supraventricular arrhythmias.
Adult↗
Strategy planning in dogs (Canis familiaris) in a progressive elimination task.
Domestic dogs (Canis familiaris) were administered a progressive elimination task in which they had to visit and deplete three baited sites. Dogs were brought back to the starting point after each visit to any site whether they had made a correct or an incorrect choice. In Experiment 1 (n=10) the results revealed that the dogs randomly selected among the sites when they were equidistant from the starting point whereas they relied on the least distance rule when one of sites was closer to the starting point than were the other sites. In Experiment 2 (n=12), the dogs first chose the left target when angular deviation between adjacent targets varied whether the least angular deviation was on the right of the left. Results are interpreted in terms of Gibson's hypothesis about cooperative hunters. The discussion also emphasizes comparisons with cats (i.e., solitary hunters).
Animals↗
Presidential address: bioethics and social responsibility.
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Bioethical Issues↗
Enalapril in moderate to severe hypertension: a comparison with atenolol.
Patients with moderate to severe essential hypertension (mean untreated supine blood pressure 190/112 mm Hg) received once daily enalapril 20-40 mg or atenolol 50-100 mg, supplemented if required by hydrochlorothiazide 25-100 mg, in a randomized observer-blind trial. Both regimens produced a highly significant reduction in supine and standing blood pressure. There was no significant difference in the antihypertensive effects of enalapril and atenolol when they were used as monotherapy. After hydrochlorothiazide was added to patients not achieving 'target' blood pressure, the fall in systolic pressure was significantly greater in the enalapril group than in the atenolol group, despite similar dosage of hydrochlorothiazide in the two groups. At the end of 6 months' treatment, a supine diastolic blood pressure of 90 mm Hg or below was achieved in 74% of patients on enalapril plus hydrochlorothiazide and 56% of patients on atenolol plus hydrochlorothiazide. This difference was not statistically significant. A small rise in plasma urea and creatinine was observed in the enalapril group and a small rise of urea only in the atenolol group. These changes were statistically significant but of uncertain clinical importance. This study confirms that once daily enalapril and atenolol, both alone and in combination with hydrochlorothiazide, are effective drugs in the management of moderate to severe hypertension.
Adolescent↗
Bupivacaine versus bupivacaine plus fentanyl for epidural analgesia: effect on maternal satisfaction.
OBJECTIVE: To compare a combination of epidural fentanyl and bupivacaine with bupivacaine alone for epidural analgesia in labour and to evaluate factors in addition to analgesia that may influence maternal satisfaction. DESIGN: A prospective randomised pilot study. SETTING: Birmingham Maternity Hospital. SUBJECTS: 85 primiparous women who requested epidural analgesia in labour and their babies. INTERVENTIONS: Group 1 mothers were treated with bupivacaine conventionally, group 2 mothers with bupivacaine and fentanyl in a more complex way designed to provide satisfactory analgesia but with less troublesome side effects. MAIN OUTCOME MEASURES: Overall maternal satisfaction, maternal perception of epidural analgesia and its side effects, and aspects of mothers' psychological states during labour, quantified using 100 mm visual linear analogue scales; the frequency of normal and operative deliveries; and measurements of neonatal wellbeing. RESULTS: Satisfaction was higher in group 2 mothers (median group difference +3 mm, 95% confidence interval +1 to +5, p = 0.012): this was associated with more normal deliveries (difference between proportions 0.23, 95% confidence interval +0.03 to +0.42); greater self control (median group difference -7 mm, -17 to -2, p = 0.003); and reduced unpleasantness of motor blockade (-10 mm, -19 to -5, p less than 0.001), sensory blockade (-5 mm, -11 to -2, p = 0.002) and shivering (-5 mm, -18 to 0, p = 0.046) at the expense of mild itching (0 mm, 0 to 0, p less than 0.001). Group 1 mothers found restricted movements more unpleasant (-1 mm, -11 to 0, p = 0.006) and were more sleepy (-4 mm, -20 to 0, p = 0.032). The addition of fentanyl to bupivacaine reduced the requirement for local anaesthetic (-33 mg, -55 to -15, p less than 0.001) without compromising analgesia. No adverse effects in neonates were attributed to the use of fentanyl. CONCLUSIONS: The already high maternal satisfaction from conventional epidural analgesia can be improved; epidural fentanyl may be combined with bupivacaine to reduce operative deliveries and confer other advantages that may increase maternal satisfaction. Further investigations should be performed to determine the exact mechanisms of these findings and, in particular, to develop a safe method of delivering such analgesia to women.
Analgesia, Epidural↗
Constitutional rights to health care: the consequences of placing limits on the right to health care in several Western and Eastern European countries.
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Advisory Committees↗
Effect of energy and lysine intake in gestation on sow performance.
Nutrient intake during gestation has an impact on gestation parameters and subsequent lactation performance. The objectives of this experiment were to determine the impact of feeding two levels of amino acids in gestation on sow BW changes in gestation and lactation, and litter size, and to evaluate a factorial method for determining daily energy requirements. At mating, 419 sows (Camborough 15; Pig Improvement Canada, Acme, AB) were assigned randomly within Parities 1, 2 or 3+ to a gestation diet containing either 0.44% (low lysine) or 0.55% (high lysine) total lysine and 3,100 kcal DE/kg; other indispensable amino acids were adjusted to lysine based on ideal protein ratios. Feed allowance in gestation was determined factorially using estimated DE requirements for maintenance, maternal gain, and conceptus growth. Sows were allowed free access to the lactation diet. Gestation BW gain from d 0 to 110 was affected by parity (61.2, 60.0, and 42.3 kg for Parity 1, 2, and 3+, respectively; P < 0.05) but not (P > 0.10) by gestation lysine level. Sow BW changes from d 0 of lactation to weaning were affected by parity (0.5, 6.8, and 5.8 kg for Parity 1, 2, and 3+, respectively; P < 0.01) and gestation BW gain (P < 0.01), but not by gestation lysine level (5.0 vs 3.8 kg for low and high lysine, respectively; P > 0.10). Total piglets born was affected by parity (11.5, 12.1, and 12.5, for Parity 1, 2, and 3+, respectively; P < 0.01) and increased with increasing sow BW gain (P < 0.05). Total piglets born alive (mean = 11.2) was increased with increasing sow BW gain (P < 0.05). Total litter weight born alive was affected by parity (15.9, 18.6, and 19.4 kg for Parities 1, 2, and 3+, respectively; P < 0.01) and gestation BW gain (P < 0.05). The model used to determine daily energy intake requirements resulted in an average BW gain of 10.6 kg above the targets set by the model. Total lysine intakes greater than 10.6 g/d in gestation did not improve sow productivity. Setting target weight gains in gestation and feeding to meet these targets may not always provide predictable results due to a number of factors that affect the energy requirement in the sow.
Animals↗
Non-pharmacological management of the behaviour of pediatric dental patients.
Behaviour modelling is frequently used to modify children's behaviour. The psychological techniques of encouragement-reprobation are an integral part of the behaviour shaping. Three hundred clinically healthy children were recruited in this study. They were aged 54-96 months and allocated to three groups according to the specific technique used: group 1 in which we applied the "live patients model" technique, in group 2 the "encouragement-reprobation" techniques was applied and group 3 was a control group. The patient's behaviour was assessed using L. Venham's Cooperative Behavioral Scale. A behavioral improvement was noticed in the experimental groups after applying the techniques for behaviour modification. The comparison shows a statistically significant difference between the two experimental groups and the control one and absence of a significant difference between the influenced groups. The study shows that there is a stable for behaviour improvement.
Behavior↗
Ethics, law, and medical genetics: after the human genome is mapped.
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Abortion, Eugenic↗
The private-public divide: impact of conflicting perceptions between the private and public health care sectors in India.
SETTING: India's private health care sector manages half the nation's tuberculosis (TB) patients, accounting for an estimated sixth of global TB cases. While several studies have demonstrated private physicians' dubious diagnosis and treatment styles and lack of cooperation with public physicians, very little is still known about the private sector. OBJECTIVES: Using a detailed questionnaire to randomly survey private and public practitioners in Ahmedebad, Gujarat, India, we quantified perceptions held by each sector. STUDY DESIGN: Cross-sectional survey of private and public physicians. RESULTS: Significant conflicts in perception were found regarding interpretation of general facts, attitudes towards each sector, and effectiveness and social implications of DOTS. We also found that such differences in perception were likely to result in mistrust, differing views on reform propositions, conflicting mindsets about social agendas, and unwillingness to cooperate. CONCLUSION: Our data suggest that reconciliation is attainable by obtaining and distributing unbiased, evidence-based information and exposing physicians to both private and public health care sectors in a professional setting.
Attitude of Health Personnel↗