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Results for “Randomised Controlled Trial”

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PubMed1998

Effectiveness of screening older people for impaired vision in community setting: systematic review of evidence from randomised controlled trials.

OBJECTIVE: To assess whether population screening for impaired vision among older people in the community leads to improvements in vision. DESIGN: Systematic review of randomised controlled trials of population screening in the community that included any assessment of vision or visual function with at least 6 months' follow up. SUBJECTS: Adults aged 65 or over. MAIN OUTCOME MEASURE: Proportions with visual impairment in intervention and control groups with any method of assessing visual impairment. RESULTS: There were no trials that primarily assessed visual screening. Outcome data on vision were available for 3494 people in five trials of multiphasic assessment. All the trials used self reported measures for vision impairment, both as screening tools and as outcome measures. The inclusion of a visual screening component in the assessment did not result in improvements in self reported visual problems (pooled odds ratio 1.04:95% confidence interval 0.89 to 1.22). A small reduction (11%) in the number of older people with self reported visual problems cannot be excluded. CONCLUSIONS: Screening of asymptomatic older people in the community is not justified on present evidence. Visual impairment in this age group can usually be reduced with treatment. It is unclear why no benefit was seen. Further work is needed to clarify what interventions are appropriate for older people with unreported impairment of vision.

Aged↗

PubMed1998

Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials.

OBJECTIVE: To determine whether antibiotic prophylaxis reduces respiratory tract infections and overall mortality in unselected critically ill adult patients. DESIGN: Meta-analysis of randomised controlled trials from 1984 and 1996 that compared different forms of antibiotic prophylaxis used to reduce respiratory tract infections and mortality with aggregate data and, in a subset of trials, data from individual patients. SUBJECTS: Unselected critically ill adult patients; 5727 patients for aggregate data meta-analysis, 4343 for confirmatory meta-analysis with data from individual patients. MAIN OUTCOME MEASURES: Respiratory tract infections and total mortality. RESULTS: Two categories of eligible trials were defined: topical plus systemic antibiotics versus no treatment and topical preparation with or without a systemic antibiotic versus a systemic agent or placebo. Estimates from aggregate data meta-analysis of 16 trials (3361 patients) that tested combined treatment indicated a strong significant reduction in infection (odds ratio 0.35; 95% confidence interval 0.29 to 0.41) and total mortality (0.80; 0.69 to 0.93). With this treatment five and 23 patients would need to be treated to prevent one infection and one death, respectively. Similar analysis of 17 trials (2366 patients) that tested only topical antibiotics indicated a clear reduction in infection (0.56; 0.46 to 0.68) without a significant effect on total mortality (1.01; 0.84 to 1.22). Analysis of data from individual patients yielded similar results. No significant differences in treatment effect by major subgroups of patients emerged from the analyses. CONCLUSIONS: This meta-analysis of 15 years of clinical research suggests that antibiotic prophylaxis with a combination of topical and systemic drugs can reduce respiratory tract infections and overall mortality in critically ill patients. This effect is significant and worth while, and it should be considered when practice guidelines are defined.

Administration, Topical↗

PubMed1989

Randomised controlled trial of interferon alfa 2A (rbe) (Roferon-A) for the treatment of chronic hepatitis B virus (HBV) infection: factors that influence response.

In a randomised controlled trial recombinant interferon alpha 2A (Roferon-A, rIFN alfa A) given at a dosage of 10 million units (MU)/m2 thrice weekly for six months was significantly better (p less than 0.02) than no treatment in producing a sustained loss of hepatitis Be antigen (HBeAg) in hepatitis B virus (HBV) chronic carriers. Although lower doses (5 MU/m2 and 2.5 MU/m2) also produced some responses, the seroconversion rate was not significantly greater than that observed in the control group. Sixteen of the 45 patients receiving interferon were human immunodeficiency virus (HIV) antibody positive: none of these responded. Forty one per cent of the anti-HIV negative patients receiving interferon (12/29, p less than 0.005) lost HBeAg and 17% (5/29) lost hepatitis B surface antigen (HBsAg). The response rate among these anti-HIV negative patients receiving at least three months therapy was 46% and 19% respectively. Low pretreatment HBV-DNA and absence of anti-HIV were the only significant independent variables predicting response to therapy (p less than 0.03 and p less than 0.05 respectively). In six patients, neutralising antibodies to alpha interferon were detected during therapy, the majority being non-responders.

Adult↗

PubMed1992

Antenatal care of low risk obstetric patients by midwives. A randomised controlled trial.

OBJECTIVES: To assess the practicality, acceptability to patients and salary costs of the antenatal care of low risk obstetric patients by midwives. DESIGN: A randomised controlled trial. SETTING: The antenatal clinic at Westmead Hospital, a teaching hospital of the University of Sydney in western Sydney. PATIENTS: From January 1989 until November 1990, 89 women booking for full antenatal care at Westmead Hospital and classified as low risk were randomly allocated to one of two groups. Group 1 (43 patients) had their antenatal care provided by registered midwives. Group 2 (46 patients) had their antenatal care provided by an obstetrician (either Visiting Medical Officer or Staff Specialist) in a routine hospital antenatal clinic. INTERVENTIONS: Patients in the midwives' clinic were seen by an obstetrician at their first visit to the antenatal clinic and again at 30 weeks and at 40 weeks. MAIN OUTCOME MEASURES: These were the salary costs of each clinic and the patients' levels of satisfaction. Maternal and neonatal indicators, delivery details and analgesic requirements were also considered. These indicators were planned before data collection commenced. RESULTS: The major differences found were a 28% to 68% salary cost saving and that patients cared for by midwives showed appreciation of the continuity of care and information given at the midwives' clinic. CONCLUSIONS: The care of low risk obstetric patients by midwives in a midwives' clinic showed salary cost savings and high patient acceptance.

Continuity of Patient Care↗

PubMed1997

Satisfaction and the three C's: continuity, choice and control. Women's views from a randomised controlled trial of midwife-led care.

OBJECTIVE: 1. To explore whether there are differences in women's satisfaction with care in a midwife-managed delivery unit compared with that in a consultant-led labour ward. 2. To compare factors relating to continuity, choice and control between the two randomised groups. DESIGN: A pragmatic randomised controlled trial. SETTING: Aberdeen Maternity Hospital, Grampian. SAMPLE: 2844 women, identified at booking as low risk, were randomised in a 2:1 ratio between the midwives' unit and the labour ward. MAIN OUTCOME MEASURES: Satisfaction, continuity of carer, choice, and control. RESULTS: Satisfaction with the overall experience did not differ between the groups. Satisfaction with how labour and delivery was managed by staff was slightly higher in the midwives' unit group, but this did not reach the 0.1% level of significance. Women allocated to the midwives' unit group saw significantly fewer medical staff and were less likely to report numerous individuals entering the room. They were more likely to report having had a choice regarding mobility and alternative positions for delivery and were significantly more likely to have made their own decisions regarding pain relief. CONCLUSIONS: The issues surrounding the measurement of satisfaction with childbirth need further investigation. Until this area is clarified it would be unwise to use an overall measure of satisfaction as an indicator of the quality of maternity service provision. In particular, the current measures are not sensitive enough to examine the specific factors which affect women's satisfaction. Further research is required to assess which factors are important to women if they are to have a positive experience of childbirth and how these priorities change over time.

Adult↗

PubMed1995

UKCCCR multicentre randomised controlled trial of one and two view mammography in breast cancer screening.

OBJECTIVE: To compare one view (oblique) and two view (oblique and craniocaudal) mammography in breast cancer screening. DESIGN: Randomised controlled trial. SETTING: Nine breast screening centres in England. SUBJECTS: 40,163 women aged 50-64 attending their first breast screening examination. INTERVENTIONS: Women were randomised to have one view mammography, two view mammography, or two view mammography in which one view was read by one reader and both views were read by another. MAIN OUTCOME MEASURES: Prevalence of cancer detected, recall rates, cost per cancer detected, and marginal cost per extra cancer detected. RESULTS: Two view mammography detected 24% more women with breast cancer (95% confidence interval 16% to 31%) than one view mammography. Prevalence of detected cancer was 6.84 with two view mammography and 5.52 per 1000 women with one view. The proportion of women recalled for assessment was 15% lower (95% confidence interval 6% to 23%) with two view (6.97%) than with one view (8.16%) mammography. The cost of two view screening was higher (26.46 pounds compared with 22.00 pounds per examination) but the average cost per cancer detected was similar (5330 pounds compared with 5310 pounds) and the marginal cost per extra cancer detected with two views was similar to the average cost (5400 pounds). CONCLUSION: Two view mammography is medically more effective than one view; it detects more cancers and reduces recall rates; it is also similarly cost effective financially.

Breast Neoplasms↗

PubMed1997

Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis.

BACKGROUND: Controlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis. OBJECTIVE: To assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis. DESIGN: Double blind placebo controlled randomised sequence crossover trial. Fluticasone propionate (400 micrograms/day) was given as a dry powder inhaler for six weeks with a four week washout period before crossover. OUTCOME MEASURES: Sputum inflammatory markers (interleukin-8, tumour necrosis factor-alpha (TNF-alpha) and neutrophil elastase-both free and bound to alpha 1-antiprotease), sputum interleukin-10, lung function, and symptomatology. SUBJECTS: Twenty three children from a regional cystic fibrosis centre were enrolled into the study, with mean age 10.3 years (range 7 to 17 years) and mean baseline forced expiratory volume in one second (FEV1) of 64% (range 21% to 102%) predicted for sex and height. One patient was excluded for non-compliance to the study protocol. RESULTS: No significant benefit was shown for the use of fluticasone propionate in any of the outcomes. For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml (95% confidence interval (CI) 8 to 2866 pg/ml) in favour of placebo; while for maximal expiratory flow at 25% (MEF25%) remaining forced vital capacity predicted for sex and height there was a 15 percentage points (pp) (95% CI 4 to 26 pp) mean treatment difference in favour of placebo. Sputum interleukin-10 was undetected in any samples and unaffected by fluticasone propionate. Neither atopic status, baseline FEV1, nor concomitant DNase therapy had any effect on response to treatment. CONCLUSIONS: Lack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways. It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy.

Administration, Inhalation↗

PubMed1999

Serotherapy in scorpion envenomation: a randomised controlled trial.

BACKGROUND: Evidence for the benefit of scorpion antivenom, the only specific treatment for scorpion envenomation, is scarce, despite its common use. We did a prospective, randomised, controlled trial to assess the efficacy of routine administration of scorpion antivenom to scorpion-stung patients, irrespective of clinical severity. METHODS: We included 825 consecutive patients older than 10 years, who presented to the accident and emergency department of the hospital in Tozeur, Tunisia. We graded severity by absence (grade I) or presence (grade II) of systemic manifestations of scorpion envenomation. Patients were randomly assigned placebo (n=413) or 20 mL bivalent intraveneous scorpion antivenom (n=412). All patients were observed for 4 h. Patients who developed life-threatening symptoms were admitted to the intensive-care unit. At the end of 4 h observation we reassessed grade and discharged grade II patients and admitted grade II patients. We assessed the preventive and curative effects of scorpion antivenom by prevention of worsening grade or by improvement from grade II to grade I. FINDINGS: Distribution of severity grades was similar in the two groups at baseline, as were the cure rates (55% scorpion antivenom, 66% placebo, absolute difference, 11% [95% CI -4.8 to 26.8]; p=0.234). Preventive effects were seen in 94% and 96% of patients in the scorpion antivenom and placebo groups, respectively, who were initially grade I and who remained symptom-free (absolute difference, 2% [-1.27 to 5.27]; p=0.377). Time from scorpion sting to administration of scorpion antivenom did not affect curative and preventive effects. INTERPRETATION: We found no benefit in routine administration of scorpion antivenom after scorpion sting, irrespective of clinical severity. Future studies should focus on patients with the most severe symptoms and signs.

Adolescent↗

PubMed1984

Randomised controlled trial of routine hospital clinic care versus routine general practice care for type II diabetics.

Two hundred patients with type II diabetes were entered into a randomised controlled trial lasting five years to compare routine care of this condition by a hospital diabetic clinic with routine care in general practice. Fewer patients in the group being cared for by their general practitioner (general practice group) were regularly reviewed or had regular estimations of blood glucose concentration. More patients in the general practice group than in the hospital group were admitted to hospital for medical reasons during the study (25 (24%) compared with 17 (18%] and more patients in the general practice group died (18) than did in the hospital group (6). At the end of the study mean concentrations of haemoglobin A1 were higher in the general practice group (10.4%) than in the hospital group (9.5%). Routine care in general practice for patients with type II diabetes was less satisfactory than care by the hospital diabetic clinic.

Adult↗

PubMed1999

Advising parents of asthmatic children on passive smoking: randomised controlled trial.

OBJECTIVE: To investigate whether parents of asthmatic children would stop smoking or alter their smoking habits to protect their children from environmental tobacco smoke. DESIGN: Randomised controlled trial. SETTING: Tayside and Fife, Scotland. PARTICIPANTS: 501 families with an asthmatic child aged 2-12 years living with a parent who smoked. INTERVENTION: Parents were told about the impact of passive smoking on asthma and were advised to stop smoking or change their smoking habits to protect their child's health. MAIN OUTCOME MEASURES: Salivary cotinine concentrations in children, and changes in reported smoking habits of the parents 1 year after the intervention. RESULTS: At the second visit, about 1 year after the baseline visit, a small decrease in salivary cotinine concentrations was found in both groups of children: the mean decrease in the intervention group (0.70 ng/ml) was slightly smaller than that of the control group (0.88 ng/ml), but the net difference of 0.19 ng/ml had a wide 95% confidence interval (-0.86 to 0.48). Overall, 98% of parents in both groups still smoked at follow up. However, there was a non-significant tendency for parents in the intervention group to report smoking more at follow up and to having a reduced desire to stop smoking. CONCLUSIONS: A brief intervention to advise parents of asthmatic children about the risks from passive smoking was ineffective in reducing their children's exposure to environmental tobacco smoke. The intervention may have made some parents less inclined to stop smoking. If a clinician believes that a child's health is being affected by parental smoking, the parent's smoking needs to be addressed as a separate issue from the child's health.

Adult↗

PubMed1997

Textured or smooth implants for breast augmentation? Three year follow-up of a prospective randomised controlled trial.

Silicone breast implant surface texturing has been shown to reduce the short-term incidence of adverse (Baker III/IV) capsular contracture in augmentation mammaplasty in double-blind randomised controlled trials. It is, however, undetermined whether the textured surface merely delays the onset of severe contracture or its effect on capsular contraction is persistent. The current study reviewed, after three years, 49 of the 53 patients who had undergone subglandular breast augmentation mammaplasty in a randomised double-blind study with textured or smooth silicone gel-filled implants in 1989. The incidence of adverse capsular contracture was 59% for smooth implants and 11% for textured ones (P = 0.001; chi 2 = 10.60). Eight patients (31%) with smooth prostheses underwent breast implant exchange for severe capsular contracture between the one and three year assessments, compared with a revisional surgery rate of only 7.4% (2/27 patients) for the textured group (P < 0.04). These adverse capsular contracture and revisional breast implant surgery rates clearly demonstrate that the effect of textured implants in reducing capsular contracture in augmentation mammaplasty found at one year is maintained at three years, and suggest that it may be long lasting.

Breast Implants↗

PubMed1994

No effect of birth centre care on either duration or experience of breast feeding, but more complications: findings from a randomised controlled trial.

OBJECTIVE: to study the effect of birth centre care on the duration of breast feeding, breast feeding complications, and women's experiences of breast feeding. DESIGN: randomised controlled trial. SETTING: in-hospital birth centre at South Hospital, Stockholm, and standard obstetric care in the Greater Stockholm area. SUBJECTS: 1230 women with expected date of birth between October 1989 and February 1992, interested in participating in a birth centre trial, and meeting medical low-risk criteria. 617 women were allocated to the experimental group offered birth centre care (EG), and 613 to the control group offered standard obstetric care (CG). MAIN OUTCOME MEASURES: duration of breast feeding, breast feeding complications such as sore nipples, engorgement, milk stasis, and mastitis, and women's experiences of breast feeding. FINDINGS: no difference was found between EG and CG in the duration of breast feeding. Ninety-three per cent in both groups were breast feeding exclusively two months post partum. The average number of months of breast feeding, exclusively or partly, when investigated one year after the birth was 8.6 in EG and 8.5 in CG. No difference was observed in women's experiences of breast feeding, but rather more women in EG than in CG reported sore nipples, 36% and 30% respectively (p = 0.03), and milk stasis, 26% and 19% respectively (p = 0.002). CONCLUSIONS: birth centre care had no effect on the duration of breast feeding, or on women's experiences of breast feeding. Prenatal attitudes were probably more significant predictors of these outcomes than differences in the two modes of maternity care in this population of highly breast feeding-motivated women. The larger proportion of sore nipples and milk stasis in the EG might have been due to earlier discharge, or to midwives less skilled in assisting with breast feeding at the birth centre than in the postpartum wards.

Adult↗

PubMed1998

Cost effectiveness of community leg ulcer clinics: randomised controlled trial.

OBJECTIVES: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses. DESIGN: Randomised controlled trial with 1 year of follow up. SETTING: Eight community based research clinics in four trusts in Trent. SUBJECTS: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group. INTERVENTIONS: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group). MAIN OUTCOME MEASURES: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored. RESULTS: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2. 03). No significant differences were found between the groups in health status. Mean total NHS costs were 878.06 pounds per year for the clinic group and 859.34 pounds for the control (P=0.89). CONCLUSIONS: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.

Aged↗

PubMed1999

Economic evaluation of hospital at home versus hospital care: cost minimisation analysis of data from randomised controlled trial.

OBJECTIVES: To compare the costs of admission to a hospital at home scheme with those of acute hospital admission. DESIGN: Cost minimisation analysis within a pragmatic randomised controlled trial. SETTING: Hospital at home scheme in Leicester and the city's three acute hospitals. PARTICIPANTS: 199 consecutive patients assessed as being suitable for admission to hospital at home for acute care during the 18 month trial period (median age 84 years). INTERVENTION: Hospital at home or hospital inpatient care. MAIN OUTCOME MEASURES: Costs to NHS, social services, patients, and families during the initial episode of treatment and the three months after admission. RESULTS: Mean (median) costs per episode (including any transfer from hospital at home to hospital) were similar when analysed by intention to treat-hospital at home 2569 pounds sterling (1655 pounds sterling), hospital ward 2881 pounds sterling (2031 pounds sterling), bootstrap mean difference -305 (95% confidence interval -1112 to 448). When analysis was restricted to those who accepted their allocated place of care, hospital at home was significantly cheaper-hospital at home 2557 pounds sterling(1710 pounds sterling), hospital ward 3660 pounds sterling (2903 pounds sterling), bootstrap mean difference -1071 (-1843 to -246). At three months the cost differences were sustained. Costs with all cases included were hospital at home 3671 pounds sterling (2491 pounds sterling), hospital ward 3877 pounds sterling (3405 pounds sterling), bootstrap mean difference -210 (-1025 to 635). When only those accepting allocated care were included the costs were hospital at home 3698 pounds sterling (2493 pounds sterling), hospital ward 4761 pounds sterling (3940 pounds sterling), bootstrap mean difference -1063 (-2044 to -163); P=0.009. About 25% of the costs for episodes of hospital at home were incurred through transfer to hospital. Costs per day of care were higher in the hospital at home arm (mean 207 pounds sterling v 134 pounds sterling in the hospital arm, excluding refusers, P<0.001). CONCLUSIONS: Hospital at home can deliver care at similar or lower cost than an equivalent admission to an acute hospital.

Aged↗

PubMed1997

Identification and analysis of randomised controlled trials in nursing: a preliminary study.

OBJECTIVES: To describe preliminary work undertaken for development of a nursing contribution to the Cochrane Collaboration. To ascertain whether there are randomised controlled trials (RCTs) on nursing care which need to be identified for inclusion in systematic reviews of the effects of health care. DESIGN: Searches by Medline (1966-94) and by hand of 11 nursing research journals from inception to the end of 1994 to identify RCTs and systematic reviews; and a comparison of searches by hand and by Medline for three nursing research journals. MAIN MEASURES: Total number of RCTs identified and number of RCTs published in nursing journals; the sensitivity of Medline searches; and aspects of nursing care evaluated by RCT. RESULTS: The work is ongoing and 522 reports of RCTs and 20 systematic reviews of effectiveness have been identified so far. The sensitivity of Medline searches for RCTs in nursing journals is as low as 36% for one journal and the lack of reference to research design in the title or abstract was the main reason for the lack of sensitivity. CONCLUSIONS: There are RCTs that evaluate aspects of nursing care, and are published in nursing and non-nursing journals, and are largely undertaken by nurses. These must be reviewed in ongoing systematic reviews of the effects of health care (including those undertaken as part of the Cochrane Collaboration). Nursing journals must be hand searched to identify these studies as the lack of reference to study design in the titles and abstracts of nursing trials leads to poor indexing in electronic databases such as Medline.

MEDLINE↗

PubMedDate not supplied

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.

Cryosurgery↗

PubMed1996

Variation in the placebo effect in randomised controlled trials of analgesics: all is as blind as it seems.

The objective was to investigate the relationship between pain relief scores produced by placebo and by active interventions in randomised controlled trials (RCTs). Individual patient categorical pain relief scores from 5 placebo-controlled single-dose parallel-group RCTs in acute postoperative pain were used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) for the different treatments. One hundred and thirty of the 525 patients in the 5 trials had a placebo. Individual patients' scores with placebo varied from 0 to 100% of the maximum possible pain relief. The proportion who obtained more than 50% of the maximum possible pain relief with placebo varied from 7% to 37% across the trials; with the active drugs the variation was from 5 to 63%. Mean placebo scores were related to the mean score for the active treatments in each study; the higher the mean active score, the higher the mean placebo score. This relationship disappeared when median values were used. Medical folklore has it that the amount of relief obtained with placebo is one-third of the maximum possible (and does not vary), and that one-third of patients respond to placebo. The results show that the amount of relief obtained with placebo varies considerably between patients, that 38% of patients obtained more than 10% of the maximum possible relief, and 16% obtained greater than 50%. In double-blind, randomised parallel-group studies of high quality placebo scores should not vary. Despite these conditions being met the placebo scores did vary. The previous explanation, of a relationship between the mean placebo scores and the mean scores for the active treatments was not supported.

Analgesics↗

PubMed1999

Randomised controlled trial of effectiveness of Leicester hospital at home scheme compared with hospital care.

OBJECTIVE: To compare effectiveness of patient care in hospital at home scheme with hospital care. DESIGN: Pragmatic randomised controlled trial. SETTING: Leicester hospital at home scheme and the city's three acute hospitals. PARTICIPANTS: 199 consecutive patients referred to hospital at home by their general practitioner and assessed as being suitable for admission. Six of 102 patients randomised to hospital at home refused admission, as did 23 of 97 allocated to hospital. INTERVENTION: Hospital at home or hospital inpatient care. MAIN OUTCOME MEASURES: Mortality and change in health status (Barthel index, sickness impact profile 68, EuroQol, Philadelphia geriatric morale scale) assessed at 2 weeks and 3 months after randomisation. The main process measures were service inputs, discharge destination, readmission rates, length of initial stay, and total days of care. RESULTS: Hospital at home group and hospital group showed no significant differences in health status (median scores on sickness impact profile 68 were 29 and 30 respectively at 2 weeks, and 24 and 26 at 3 months) or in dependency (Barthel scores 15 and 14 at 2 weeks and 16 for both groups at 3 months). At 3 months' follow up, 26 (25%) of hospital at home group had died compared with 30 (31%) of hospital group (relative risk 0. 82 (95% confidence interval 0.52 to 1.28)). Hospital at home group required fewer days of treatment than hospital group, both in terms of initial stay (median 8 days v 14.5 days, P=0.026) and total days of care at 3 months (median 9 days v 16 days, P=0.031). CONCLUSIONS: Hospital at home scheme delivered care as effectively as hospital, with no clinically important differences in health status. Hospital at home resulted in significantly shorter lengths of stay, which did not lead to a higher rate of subsequent admission.

Adult↗