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.     

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.     

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.     

Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community-based,multicentre, double-blind randomised controlled trial

OBJECTIVES: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone-iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children. DESIGN AND PARTICIPANTS: Aboriginal community-controlled, community-based, multicentre, double-blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM. MAIN OUTCOME MEASURES: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10-21 days after starting treatment. RESULTS: 111 children aged 1-14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%-33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%). CONCLUSIONS: Twice-daily ear cleaning and topical ciprofloxacin is effective at community-level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first-line treatment.     

Stress debriefing after childbirth: a randomised controlled trial

OBJECTIVE: To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. DESIGN: Randomised single-blind controlled trial stratified for parity and delivery mode. SETTING: Two large maternity hospitals in Perth. PARTICIPANTS: 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). INTERVENTION: An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. MAIN OUTCOME MEASURES: Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. RESULTS: Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). CONCLUSIONS: There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.     

Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial

OBJECTIVES: To investigate the effectiveness of telephone counselling as an adjunct to nicotine replacement therapy (NRT) by transdermal patch in smoking cessation. DESIGN: Randomised controlled trial. PARTICIPANTS AND SETTING: 854 smokers from New South Wales, aged 18 years and older, who had smoked at least 10 cigarettes per day for the past year and responded to newspaper advertisements between October 2001 and January 2002; the trial was conducted between October 2001 and August 2002. INTERVENTIONS: Random allocation to either NRT alone or NRT plus telephone counselling (5 sessions spaced according to a relapse-sensitive call schedule). MAIN OUTCOME MEASURES: Self-reported abstinence assessed by telephone questionnaires at 1, 2, 3 and 6 months: 28-day continuous abstinence at 3 and 6 months, and 90-day continuous abstinence at 6 months. RESULTS: 28-day continuous abstinence rates among participants receiving telephone counselling were significantly greater than among those not receiving telephone counselling at both 3 and 6 months (31.6% v 25.1%; P = 0.04 at 3 months; and 30.1% v 22.4%; P = 0.01 at 6 months). Similarly, 90-day continuous abstinence rates at 6 months were significantly greater for participants receiving counselling (26.7% v 18.6%; P = 0.004). CONCLUSION: Telephone counselling as an adjunct to NRT increases abstinence rates beyond the use of NRT alone.     

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.     

Anxiety and depression in an older research population and their impact on clinical outcomes in a randomised controlled trial

Introduction: Anxiety and depression are common in older people living in the community. The aim of the study was to investigate their impact on clinical outcomes during a randomised controlled trial investigating the cost benefits of influenza vaccination in fit and healthy, independent living 65–74 year olds. Subjects and methods: A total of 729 people were recruited. Participants completed the hospital anxiety and depression scale (HADS) and EuroQol EQ-5D quality of life questionnaire immediately before receiving vaccination and every two months for the next six months after this. Side effects three days after vaccination and Barthel score at baseline were also recorded. Results: At baseline the prevalence of "definite" anxiety in this sample (HADS score ≥11) was 4% and 1.2% of individuals had definite depression (HADS score ≥11). Individuals with anxiety or depression (HADS score ≥8) were more likely to complain of systemic side effects after vaccination and have a lower Barthel index score (p<0.001). Quality of life as measured by the EQ-5D visual analogue scale was reduced (p<0.001) at all time periods in those individuals with both anxiety and depression (HADS score ≥8 on both scales). Conclusion: Although the prevalence of anxiety and depression in this sample was low, people with anxiety or depression were more likely to suffer from perceived side effects after influenza vaccine and have a lower Barthel and EQ-5D visual analogue score. In future studies the effect of anxiety and depression on older participants should be remembered and care taken to ensure that they do not affect results more than the intervention under study.     

Preventing pressure ulcers with the Australian Medical Sheepskin: an open-label randomised controlled trial

OBJECTIVE: To estimate the effectiveness of a new high-performance Australian medical sheepskin (meeting Australian Standard 4480.1-1998) in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers. DESIGN:Open-label randomised controlled clinical trial. SETTING:A large metropolitan teaching hospital in Melbourne, Victoria, in 2000. PARTICIPANTS: 441 patients aged over 18 years admitted between 12 June and 30 November 2000, with expected length of stay over 2 days and assessed as at low to moderate risk of developing pressure ulcers. INTERVENTION: Patients were randomly allocated to receive a sheepskin mattress overlay for the duration of their hospital stay (218 patients) or usual treatment, as determined by ward staff (referent group, 223 patients). MAIN OUTCOME MEASURES:Incidence rate and cumulative incidence of pressure ulcers, assessed daily throughout hospital stay. RESULTS: 58 patients developed pressure ulcers (sheepskin group, 21; referent group, 37). Cumulative incidence risk was 9.6% in the sheepskin group (95% CI, 6.1%-14.3%) versus 16.6% in the referent group (95% CI, 12.0%-22.1%). Patients in the sheepskin group developed new pressure ulcers at a rate less than half that of referent patients (rate ratio, 0.42; 95% CI, 0.26-0.67). CONCLUSIONS: The Australian Medical Sheepskin is effective in reducing the incidence of pressure ulcers in general hospital inpatients at low to moderate risk of these ulcers.