Cost-effectiveness of rehabilitation after an acute coronary event: a randomised controlled trial

OBJECTIVE: To estimate the incremental effects on cost and quality of life of cardiac rehabilitation after an acute coronary syndrome. DESIGN: Open randomised controlled trial with 1 year's follow-up. Analysis was on an intention-to-treat basis. SETTING: Two tertiary hospitals in Sydney. INTERVENTION: 18 sessions of comprehensive exercise-based outpatient cardiac rehabilitation or conventional care as provided by the treating doctor. PARTICIPANTS: 113 patients aged 41-75 years who were self-caring and literate in English. Patients with uncompensated heart failure, uncontrolled arrhythmias, severe and symptomatic aortic stenosis or physical impairment were excluded. MAIN OUTCOME MEASURES: Costs (hospitalisations, medication use, outpatient visits, investigations, and personal expenses); and measures of quality of life. Incremental cost per quality-adjusted life year (QALY) saved at 1 year (this estimate combines within-study utility effects with reported 1-year risk of survival and treatment effects of rehabilitation on mortality). Sensitivity analyses around a base case estimate included alternative assumptions of no treatment effect on survival, 3 years of treatment effect on survival and variations in utility. RESULTS: The estimated incremental cost per QALY saved for rehabilitation relative to standard care was 42,535 US dollars when modelling included the reported treatment effect on survival. This increased to 70,580 US dollars per QALY saved if treatment effect on survival was not included. The results were sensitive to variations in utility and ranged from 19,685 US dollars per QALY saved to rehabilitation not being cost-effective. CONCLUSIONS: The effects on quality of life tend to reinforce treatment advantages on survival for patients having postdischarge rehabilitation after an acute coronary syndrome. The estimated base case incremental cost per QALY saved is consistent with those historically accepted by decision making authorities such as the Pharmaceutical Benefits Advisory Committee.     

Hospital in the home: a randomised controlled trial

OBJECTIVES: To compare treatment of acute illness at home and in hospital, assessing safety, effect on geriatric complications, and patient/carer satisfaction. DESIGN: Randomised controlled trial. SETTING: A tertiary referral hospital affiliated with the University of New South Wales. PARTICIPANTS: 100 patients (69% older than 65 years) with a variety of acute conditions, who were assessed in the emergency department as requiring admission to hospital. INTERVENTIONS: Patients were allocated at random to be treated by a hospital-in-the-home (HIH) service in their usual residence or to be admitted to hospital. MAIN OUTCOME MEASURES: Geriatric complications (confusion, falls, urinary incontinence or retention, faecal incontinence or constipation, phlebitis and pressure areas), patient/carer satisfaction, adverse events, and death. RESULTS: There was a lower incidence of confusion (0 v. 20.4% [95% CI, 9.1%-31.7%]; P = 0.0005), urinary complications (incontinence or retention) (2.0% [95% CI, -1.8%, 5.8%] v. 16.3% [95% CI, 6.0%, 26.6%]; P = 0.01), and bowel complications (incontinence or constipation) (0 v. 22.5% [95% CI, 10.7%, 34.1%]; P = 0.0003) among HIH-treated patients. No significant difference in number of adverse events and deaths (to 28 days after discharge) in the two groups was found (although numbers were small). Patient and carer satisfaction was significantly higher in the HIH group. CONCLUSIONS: Home treatment appears to provide a safe alternative to hospitalisation for selected patients, and may be preferable for some older patients. We found high levels of both patient and carer satisfaction with home treatment.     

Vegetarian diet in mild hypertension: a randomised controlled trial

In a randomised crossover trial 58 subjects aged 30-64 with mild untreated hypertension were allocated either to a control group eating a typical omnivorous diet or to one of two groups eating an ovolactovegetarian diet for one of two six week periods. A fall in systolic blood pressure of the order of 5 mm Hg occurred during the vegetarian diet periods, with a corresponding rise on resuming a meat diet. The main nutrient changes with the vegetarian diet included an increase in the ratio of polyunsaturated to saturated fats and intake of fibre, calcium, and magnesium and a decrease in the intake of protein and vitamin B12. There were no consistent changes in urinary sodium or potassium excretion or body weight. In untreated subjects with mild hypertension, changing to a vegetarian diet may bring about a worthwhile fall in systolic blood pressure.     

Benefits of supplementary tube feeding after fractured neck of femur: a randomised controlled trial

A total of 744 elderly women with fractured neck of femur were classified into three groups according to anthropometric measurements on admission: group 1, well nourished; group 2, thin; group 3, very thin. Group 1 ate well and had a low mortality and a short rehabilitation time. The thinner the patients the lower their voluntary food intake, the higher their mortality and the longer their rehabilitation time. A series of 122 patients from groups 2 and 3 were entered postoperatively into a randomised controlled trial of overnight supplementary nasogastric tube feeding (4.2 MJ (1000 kcal), including 28 g protein) in addition to their normal ward diet. This treatment was associated with improvements not only in anthropometric and plasma protein measurements but also in clinical outcome, especially in the very thin group 3 patients. Rehabilitation time and hospital stay were shortened. Mortality in group 3 was less in the tube fed patients (8%) than in the controls (22%) but this difference did not reach statistical significance. One in five patients could not tolerate the nasogastric tube, but in the remainder the treatment caused no side effects and did not seriously diminish voluntary oral food intake by day.     

Effect of warming adult diphtheria-tetanus vaccine on discomfort after injection: a randomised controlled trial

OBJECTIVE: To determine whether warming or rubbing adult diphtheria tetanus (ADT) vaccine immediately before administration affects its temperature and reduces the incidence of pain. DESIGN: Double-blind, randomised controlled trial and in-vitro temperature study. SETTING: Emergency department (ED) of a regional hospital between April and December 2001. PATIENTS: Convenience sample of 150 patients aged 16 years or over who presented to the ED requiring ADT booster vaccination. INTERVENTION: Patients were randomised to receive vaccine that was "cold" (no deliberate warming), "rubbed" between the palms for 1 minute, or "warmed" in a 37 degrees C incubator; vaccine was administered as recommended in Australian guidelines. MAIN OUTCOME MEASURES: Incidence of pain and pain score on McGill Present Pain Intensity Questionnaire at 5 minutes, 24 hours and 48 hours after injection; and temperature of vaccine after preparation for simulated administration. RESULTS: The "cold" vaccine had significantly lower temperature (mean, 19.1 degrees C; 95% CI, 17.5-20.7 degrees C) than the "warmed" vaccine (mean, 28.9 degrees C; 95% CI, 28.4-29.4 degrees C) and "rubbed" vaccine (mean, 26.9 degrees C; 95% CI, 24.5-29.3 degrees C). There was no significant difference in incidence of pain between the groups who received vaccine prepared in different ways at any follow-up (5 min: P = 0.62; 24 h: P = 0.58; 48 h: P = 0.61) or overall (P = 0.99). Among those who completed follow-up, incidence of pain at any time was 77/138 (56%); there was no difference in their time-averaged pain scores (P = 0.63) or peak pain scores (P = 0.60). CONCLUSIONS: Warming or rubbing ADT vaccine does not reduce the incidence of pain after administration. Regardless of how ADT vaccine is prepared, its temperature approaches ambient by the time it is injected.     

Blood pressure reduction in elderly: a randomised controlled trial of methyldopa

A total of 123 out of 549 elderly residents of local authority welfare homes in Nottinghamshire were found at screening to have a standing or lying diastolic blood pressure of 100 mm Hg or more. These 123 subjects were randomly allocated to simple observation or to treatment with methyldopa. The cumulative mortality was similar in the observed and treated groups and in the normotensive group from which the subjects had been separated. Thus moderate hypertension, whether treated or not, was not a major risk predictor in the elderly population studied.     

Melatonin premedication versus placebo in wisdom teeth extraction: a randomised controlled trial

INTRODUCTION

Pain after wisdom teeth surgery can be moderate in severity and is compounded by preoperative anxiety in young patients. We studied the effect of melatonin premedication on postoperative pain and preoperative anxiety in patients undergoing wisdom teeth extractions.

METHODS

This randomised controlled trial recruited 76 patients at Khoo Teck Puat Hospital who were American Society of Anesthesiologists physical status I and II, aged 21 to 65 and scheduled to undergo elective extraction of all four wisdom teeth under general anaesthesia. Patients with a history of long-term use or allergy to melatonin were excluded. The patients received either 6 mg melatonin or a placebo 90 minutes before surgery. Visual analogue scale (VAS) scores at multiple time intervals for postoperative pain and preoperative anxiety, patient satisfaction and first-night sleep quality scores were obtained. Mixed-effects regression models were used for longitudinal analysis of VAS pain, anxiety and satisfaction scores.

RESULTS

Maximum VAS scores for pain and anxiety were 18.6 ± 19.1 mm at 60 minutes postoperatively and 26.2 ± 23.4 mm at 90 minutes preoperatively, respectively. After adjusting for gender, female patients who received melatonin had a faster rate of reduction of VAS pain (p = 0.020) and anxiety scores (p = 0.003) over time compared to the placebo group. No such effect was demonstrated in male patients. There was no significant difference in sleep quality or satisfaction scores.

CONCLUSION

Melatonin use did not consistently contribute to pain and anxiety amelioration in all patients. Our study demonstrated a positive effect in female patients, suggestive of sexual dimorphism.     

Pneumatic retinopexy versus scleral buckling: A randomised controlled trial

Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.     

Improvement in bronchial hyper-responsiveness in patients with moderate asthma after treatment with a hypnotic technique: a randomised controlled trial

A prospective, randomised, single blind, and controlled trial of a hypnotic technique was undertaken in 39 adults with mild to moderate asthma graded for low and high susceptibility to hypnosis. After a six week course of hypnotherapy 12 patients with a high susceptibility score showed a 74.9% improvement (p less than 0.01) in the degree of bronchial hyper-responsiveness to a standardised methacholine challenge test. Daily home recordings of symptoms improved by 41% (p less than 0.01), peak expiratory flow rates improved by 5.5% (p less than 0.01), and use of bronchodilators decreased by 26.2% (p less than 0.05). The improvement in bronchial hyper-reactivity occurred without a change in subjective appreciation of the degree of bronchoconstriction. A control group 17 patients and 10 patients undergoing treatment with low susceptibility to hypnosis had no change in either bronchial hyper-responsiveness or any of the symptoms recorded at home. This study shows the efficacy of a hypnotic technique in adult asthmatics who are moderately to highly susceptible to hypnosis.     

Home management of mild to moderately severe community-acquired pneumonia: a randomised controlled trial

OBJECTIVE: To determine whether community management of mild to moderate community-acquired pneumonia (CAP) is as effective and acceptable as standard hospital management of CAP. DESIGN: Randomised controlled trial. SETTING: Christchurch, New Zealand, primary and secondary care. PARTICIPANTS: 55 patients presenting or referred to the emergency department at Christchurch Hospital with mild to moderately severe pneumonia, assessed using a validated pneumonia severity assessment score, from July 2002 to October 2003. INTERVENTIONS: Hospital treatment as usual or comprehensive care in the home delivered by primary care teams. MAIN OUTCOME MEASURES: Primary: days to discharge, days on intravenous (IV) antibiotics, patient-rated symptom scores. Secondary: health status measured using level of functioning at 2 and 6 weeks, patient satisfaction. RESULTS: The median number of days to discharge was higher in the home care group (4 days; range, 1-14) than in the hospital groups (2 days; range, 0-10; P = 0.004). There was no difference in the number of days on IV antibiotics or on subsequent oral antibiotics. Patient-rated symptom scores at 2 and 6 weeks, median change in symptom severity from baseline to 6 weeks, and general functioning at 2 and 6 weeks did not differ between the groups. Patients in both groups were satisfied with their treatment, with a clear preference for community treatment (P < 0.001). CONCLUSIONS: Mild to moderately severe CAP can be managed effectively in the community by primary care teams. This model of comprehensive care at home can be implemented by primary care teams with suitable funding structures.