Routine Care Group Research Articles

Bispectral index monitoring to prevent awareness during anaesthesia: The B-aware randomised controlled trial

Summary Background Awareness is an uncommon complication of anaesthesia, affecting 0·1–0·2% of all surgical patients. Bispectral index (BIS) monitoring measures the depth of anaesthesia and facilitates anaesthetic titration. In this trial we determined whether BIS-guided anaesthesia reduced the incidence of awareness during surgery in adults. Methods We did a prospective, randomised, double-blind, multicentre trial. Adult patients at high risk of awareness were randomly allocated to BIS-guided anaesthesia or routine care. Patients were assessed by a blinded observer for awareness at 2–6 h, 24–36 h, and 30 days after surgery. An independent committee, blinded to group identity, assessed every report of awareness. The primary outcome measure was confirmed awareness under anaesthesia at any time. Findings Of 2463 eligible and consenting patients, 1225 were assigned to the BIS group and 1238 to the routine care group. There were two reports of awareness in the BIS-guided group and 11 reports in the routine care group (p=0·22). BIS-guided anaesthesia reduced the risk of awareness by 82% (95% CI 17–98%). Interpretation BIS-guided anaesthesia reduces the risk of awareness in at-risk adult surgical patients undergoing relaxant general anaesthesia. With a cost of routine BIS monitoring at US$16 per use in Australia and a number needed to treat of 138, the cost of preventing one case of awareness in high-risk patients is about $2200.

Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial

Awareness is an uncommon complication of anaesthesia, affecting 0.1-0.2% of all surgical patients. Bispectral index (BIS) monitoring measures the depth of anaesthesia and facilitates anaesthetic titration. In this trial we determined whether BIS-guided anaesthesia reduced the incidence of awareness during surgery in adults. We did a prospective, randomised, double-blind, multicentre trial. Adult patients at high risk of awareness were randomly allocated to BIS-guided anaesthesia or routine care. Patients were assessed by a blinded observer for awareness at 2-6 h, 24-36 h, and 30 days after surgery. An independent committee, blinded to group identity, assessed every report of awareness. The primary outcome measure was confirmed awareness under anaesthesia at any time. Of 2463 eligible and consenting patients, 1225 were assigned to the BIS group and 1238 to the routine care group. There were two reports of awareness in the BIS-guided group and 11 reports in the routine care group (p=0.022). BIS-guided anaesthesia reduced the risk of awareness by 82% (95% CI 17-98%). BIS-guided anaesthesia reduces the risk of awareness in at-risk adult surgical patients undergoing relaxant general anaesthesia. With a cost of routine BIS monitoring at US16 dollars per use in Australia and a number needed to treat of 138, the cost of preventing one case of awareness in high-risk patients is about 2200 dollars.

Systematic review of studies of self-management of oral anticoagulation.

This work is aimed at assessing the evidence for the possible improvement of therapeutic control of anticoagulation, reduction of major bleedings, thromboembolism and improvement of treatment-related quality of life in patients with self-managed oral anticoagulation therapy versus oral anticoagulation patients on routine care. Randomised controlled trials (RCTs) were identified using the COCHRANE LIBRARY, MEDLINE and EMBASE from 1966 to 2003. RCTs were selected involving patients with oral anticoagulation, which were designed to compare a self-management group to a routine care group. Abstracts and keywords were screened and, in the case of potential inclusion, evaluated. We identified nine potentially relevant trials. Five were excluded for the following reasons: double publication, the patients involved performed only self-testing, or the results of the trial were only published as an abstract. Ultimately, four randomised controlled studies fulfilled the criteria for inclusion. Anticoagulation control: Statistical analysis was not possible because of the great variety of international normalised ratio measurements per patient between the different studies. Comparing the four studies, there was no difference in oral anticoagulation control between self-management care and management by a specialised anticoagulation clinic. In comparison with routine care by general practitioners, self-management care was found to be better. Major bleeding, arterial and venous thromboembolism: Data were available for all studies; however, the studies were either underpowered or obviously not valid and therefore not suitable for statistical analysis. Treatment-related quality of life: Data were available for two studies, which showed that self-management could clearly improve treatment-related quality of life. Patients' self-management can improve the quality of oral anticoagulation as an indirect parameter of a reduced risk for thromboembolic and bleeding complications. Self-management oral anticoagulation treatment is safe and improves treatment-related quality of life. Patients' self-management is safe and can improve the quality of anticoagulation control, however, no valid long term study has yet actually demonstrated reduction of bleeding and thromboembolic events.

Impact of a home communication intervention for coronary artery bypass graft patients with ischemic heart failure on self-efficacy, coronary disease risk factor modification, and functioning

Objective The purpose of this study is to determine the impact of a home communication intervention (HCI) for ischemic heart failure Coronary Artery Bypass Graft (CABG) patients ≥ 65 years of age on self-efficacy, coronary artery disease risk factor modification and functioning posthospitalization. Design A randomized clinical trial with repeated measures was used. Sample A subsample of ischemic heart failure CABG surgery patients ( n = 35) was drawn from the parent study of 180 CABG patients. Results HCI participants ( n = 18) had significantly higher adjusted mean self-efficacy scores [F(1, 29) = 6.40, P < .05] and adjusted mean levels of functioning (physical, general health, mental, and vitality functioning) compared with the routine care group ( n = 17), using repeated measures analysis of covariance with baseline scores as covariates. There were also significant effects of time on bodily pain and role emotional functioning. Significantly higher exercise adherence (t = 3.09, P < .01) and lower reported stress (t = 3.77, P < .01) at 3 months after surgery was reported by HCI subjects. Conclusions Data from this pilot study can be used to strengthen the HCI intervention with more tailored strategies for vulnerable subgroups of CABG patients.

Novel thermoregulation system for enhancing cardiac function and hemodynamics during coronary artery bypass graft surgery

Background. Myocardial ischemia, arrhythmias, and coagulopathies are associated with postoperative hypothermia. This study assessed the efficacy of a novel thermoregulation system in alleviating these events during coronary artery bypass graft (CABG) surgery. Methods. Elective CABG surgery patients were randomized into either Allon thermoregulation (AT, n = 40) or routine thermal care (RTC, n = 20) groups in whom the maintenance of normothermia during the nonbypass phases of the operation was compared. The AT used patients’ rectal temperature as reference data to monitor the maintenance of the water temperature circulating at 37°C in a garment. Rectal temperature, patient hemodynamics, and cardiac-specific troponin I (cTnI) levels were assessed at the induction of anesthesia, 30 minutes into surgery, at discontinuation of bypass, end of surgery, and 2 hours postoperatively. Results. Body temperature was higher in the AT group compared to the RTC group at all five time points. Cardiac index (CI) (L/min) was higher in the AT group, 2.5 ± 0.5, 2.6 ± 0.5∗, 3.2 ± 0.6∗, 3.3 ± 0.5∗, 3.1 ± 0.7 at the respective time points, compared to the RTC group, 2.3 ± 0.6, 2.1 ± 0.2, 2.6 ± 0.7, 2.7 ± 0.7, 2.7 ± 0.7 (∗ p < 0.05). Systemic vascular resistance (SVR) (dyne · s)/cm 5) was consistently lower in the AT patients. Enzyme levels were elevated in both groups but were less so in the AT patients. Conclusions. The AT system can efficiently maintain normothermia. The beneficial effects are expressed by reduced SVR, elevated CI, and lower levels of cTnI, which may show a possible attenuation of myocardial injury.

The cost-effectiveness of a cardiovascular risk reduction program in general practice

An economic evaluation was conducted alongside a randomised controlled trial of two lifestyle interventions and a routine care (control) group to assess the cost-effectiveness of a general practice-based lifestyle change program for patients with risk factors for cardiovascular disease. Routine care was the base case comparator because it represents ‘current therapy’ for cardiovascular disease (CVD). A ‘no care’ control group was not considered a clinically acceptable alternative to lifestyle interventions. The interventions consisted of an education guide and video for GPs to assess individual patient risk factors and plan a program for risk factor behaviour change. Each patient received a risk factor assessment, education materials, a series of videos to watch on lifestyle behaviours and some patients received a self-help booklet. Eighty-two general practitioners were randomised from 75 general practices in Sydney's Western Metropolitan Region to (i) routine care ( n = 25), (ii) video group ( n = 29) or (iii) video + self help group ( n = 28). GPs enrolled patients into the trial who met selection criteria for being at risk of CVD. There were 255 patients in the routine care (control) group, 270 in the video (intervention) group and 232 in the video + self help (intervention) group enrolled in the trial. Outcome measures included patient risk factor status: blood pressure, body mass index, cholesterol and smoking status at entry to trial and after 1 year. Changes in risk factors were used to estimate quality adjusted life years (QALYs) gained. One hundred and thirty patients in the routine care group, 199 in the video group and 155 in the video + self help group remained in the trial at the 12-month review and had complete data. The cost per QALY for males ranged from $AUD152000 to 204000. Further analysis suggests that a program targeted at ‘high risk’ males would cost approximately $30000 per QALY. The lifestyle interventions had no significant effect on cardiovascular risk factors when compared to routine patient care. There remains insufficient evidence that lifestyle programs conducted in general practices are effective. Resources for general practice-based lifestyle programs may be better spent on high risk patients who are contemplating changes in risk factor behaviours.

Bronchiolitis obliterans syndrome in heart-lung transplantation: surveillance biopsies.

Transbronchial biopsies (TBBs) are useful to diagnose acute rejection and infection in patients with lung transplants. The value of routine surveillance biopsies (S-TBBs) is not known, and such biopsies with a clinical indication are not without risk and are expensive. One hundred twenty-six 6-mo survivors of heart-lung transplantation (HLT) were studied to determine the effect of stopping S-TBBs on the development of bronchiolitis obliterans syndrome (BOS) and subsequent survival. Fifty-one received transplants while S-TBB was part of routine care (group A), and 75 received transplants after this practice was stopped (group B). There was no difference in patient characteristics. Group A had shorter graft ischemia (p < 0.01) and longer postoperative ventilation (p < 0.01). Maintenance immunosuppression was similar, but group A had more steroid pulses in the second 6 mo after HLT (p < 0.01). The number of patients free from any functional deterioration at 49 to 60 mo after HLT declined to 39% in group A and 64% in group B. The risk of developing BOS grade 1 in group A relative to group B was 1.63 (95% confidence intervals: 0.96-2.79, p = 0.07). Patient survival was similar in the two groups. A total of 86 TBBs were taken in the absence of any signs or symptoms and had low diagnostic yield. In summary, there was no increased incidence of BOS after stopping S-TBBs.

An emergency department-based protocol for rapidly ruling out myocardial ischemia reduces hospital time and expense: Results of a randomized study (ROMIO)

Objectives. We tested the hypothesis that an emergency department-based protocol for rapidly ruling out myocardial ischemia would reduce hospital time and expense but maintain diagnostic accuracy.Background. Patients with a missed diagnosis of myocardial infarction have a high mortality rate; however, providing routine hospital care to low risk patients may not be time- or cost-effective.Methods. One hundred low risk patients were entered into the study and randomized either to an emergency department-based rapid rule-out protocol (n = 50) or to routine hospital care (n = 50). Patients receiving routine care were managed by their attending physicians. The rapid protocol included serum enzyme testing at 0, 3, 6 and 9 h, serial electrocardiograms with continuous ST segment monitoring and, if results were negative, a predischarge graded exercise test. Study patients were also compared with 160 historical control subjects.Results. Myocardial infarction or unstable angina occurred in 6% of patients within 30 days; no diagnoses were missed. By intention to treat analysis (n = 50 in each group), the hospital stay was shorter and charges were lower with the rapid protocol than with routine care (p = 0.0001). Among patients in whom ischemia was ruled out, those assigned to the rapid protocol had a shorter hospital stay (median 11.9 vs. 22.8 h, p = 0.0001) and lower initial ($893 vs. $1,349, p = 0.0001) and 30-day ($898 vs. $1,522, p = 0.0001) hospital charges than did patients given routine care. In historical control subjects, the hospital stay was longer (median 34.5 h, p = 0.0001 vs. either group) and charges greater (median $2,063, p = 0.0001, vs. rapid protocol, p = 0.02, vs. routine care group).Conclusions. In low risk patients who present to the emergency department with chest pain, the rapid protocol ruled out myocardial infarction and unstable angina more quickly and cost-effectively than did routine hospital care.

Psychological treatment of chronic stable angina pectoris

Abstract Angina pectoris patients frequently report exacerbation of their symptoms during mental stress. However, while stress management training has been applied to a number of cardiovascular disorders it has not, as yet, received controlled evaluation in angina. The present study represented an attempt to remedy matters. Following cardiological evaluation twenty nine subjects with chronic stable angina were randomly assigned either to a cognitive-behavioural stress management training group or to a routine care group. Exercise tolerance, self-reported angina symptoms, medication use, and anxiety levels were monitored before and after intervention and at eight weeks follow-up. Stress management training was associated with improvements in symptomatology, reliance on medication, and exercise tolerance relative to routine care. Both groups reported reductions in anxiety over the study period.

The Impact on Infant Birth Weight and Gestational Age of Cotinine-Validated Smoking Reduction During Pregnancy

Maternal smoking and low-birth weight are associated in a dose-dependent fashion. Smoking cessation trials have documented increases in mean birth weight of up to 264 gm due to smoking cessation. To date, no study has documented an association between increased infant birth weight and cotinine-validated smoking reduction in pregnancy. This was a prospective, randomized clinical trial conducted from 1986 through 1991 in the maternity clinics of a major southern city. The experimental group received a multi-faceted smoking cessation program, including a counseling session, a self-directed workbook, reinforcement by clinic staff, and the establishment of social support systems. The control group received written information and verbal advice to quit. In the experimental group 14.3 per cent women were able to stop smoking compared to 8.4 per cent of women in the routine care group. A mother's self-report of smoking cessation was validated by a salivary cotinine test at the beginning, midportion, and end of pregnancy. Based on the salivary cotinine levels, women were assigned to one of three groups: quitters who stopped smoking completely, reducers who continued to smoke but at lower levels, and no-changers who did not change smoking behavior. Reducers had either a 60-ng/ml reduction from baseline, if they were heavy smokers (baseline cotinine greater than 100 ng/ml), or a 20-ng/ml reduction, if they were light smokers (baseline cotinine level less than 100 ng/ml). A 20-ng/ml reduction in cotinine level is approximately equal to a reduction of three cigarettes smoked per day. Quitters had the highest mean birth weight (3371 ± 581 gm), followed by reducers (3121 ± 651 gm), and no-changers (3043 ± 587 gm) (Table 1). The mean birth weight of infants born to quitters, adjusted by mother's age, race, height, weight at baseline, and gestational age at delivery, was 241 gm heavier than that among the no-changers. White reducers had greater increases in birth weight than did black reducers. Smoking cessation increased infant gestational age at delivery by 1 week, whereas smoking reduction showed no changes in gestational age at delivery. Although smoking cessation remains the primary objective for pregnant smokers, this article shows that smoking reduction is associated with favorable outcomes for women who cannot or will not quit. The increase in birth weight due to smoking cessation and smoking reduction documented in this study has significant clinical and public health implications.

Predictors of general activity 8 weeks after cardiac surgery

In this secondary analysis, the influence of mood states and self-efficacy beliefs on recovery of general activities 8 weeks after cardiac surgery were investigated. Study data were taken from a randomized clinical trial with 156 subjects who were either in an efficacy enhancement nursing care group (n = 75) or in a routine care group (n = 81). It was found that self-efficacy beliefs at time of hospitalization regarding ability to resume general activities after discharge, measured tension/anxiety at 4 weeks after surgery, and experimental group status explained 21% of the variation in self-reported recovery at 8 weeks.

The Effects of Exercise in a Coronary Rehabilitation Programme

Twenty-two male and female patients who had recently suffered a myocardial infarction were randomly assigned to a treatment group who participated in a 10-week exercise-based cardiac rehabilitation programme or a routine care group who did not participate in the rehabilitation programme. Physiological and psychological function were assessed before the programme started and after it finished. Results indicated that the treatment group did not improve physiological functioning more than the control group but they did evidence statistically significant improved psychological functioning. This investigation appears to be the first attempt to assess the potential benefits of an exercise-based cardiac rehabilitation programme in Glasgow and supports the suggestion that exercise-based cardiac rehabilitation has psychological benefits.

The Clinical Management of the Double Uterus

Seventy-six women with a double uterus were studied as an extension and enlargement of an over-all series which dates back to 1936. The present study compares the reproductive performance of patients with a double uterus who received routine care (group A) with that of patients having been treated for reproductive failure (group B). Thirty-one patients (group A) with a double uterus, receiving routine care, had 102 pregnancies of which 60 (59%) resulted in a term pregnancy; 7 patients (group B 1 ) with an extrauterine factor had 16 pregnancies of which 5 (31%) resulted in a living child; 21 patients (group B 2 ) without an extrauterine factor and with only anomalous uterine development had no term pregnancies. The post-therapy pregnancy success rates in each patient treatment group were 71% and 81%, respectively. In the 1964–1975 series, excision of the uterine septum, utilizing the wedge technique in properly selected patients, resulted in an 81% chance of conception and delivery of a living child. No correlation was found between the pregnancy success rate and the uterine contour revealed by post-metroplasty hysterography. Since 1936, 39 patients with demonstrated inability to carry a pregnancy to term have undergone surgical reconstruction by wedge metroplasty, and 77% have had a successful pregnancy. The uterine anomaly most often associated with those patients requiring therapy was of the septate variety.