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Results for “Randomised Controlled Trial”

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PubMed1998

Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group.

BACKGROUND: The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days. METHODS: 11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion. FINDINGS: The rate of IUD removal for any reason other than partial expulsion was 3.8% (35/918) in the antibiotic group and 3.4% (31/915) in the placebo group (relative risk 1.1 [95% CI 0.7-1.8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria. INTERPRETATION: Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genital-tract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics.

Adult↗

PubMed2004

Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of adenoidectomy compared with long term chemoprophylaxis and placebo in the prevention of recurrent acute otitis media in children aged between 10 months and 2 years. DESIGN: Randomised, double blind, controlled trial. SETTING: Oulu University Hospital, a tertiary centre in Finland. PARTICIPANTS: 180 children aged 10 months to 2 years with recurrent acute otitis media. INTERVENTION: Adenoidectomy, sulfafurazole (sulphisoxazole) 50 mg/kg body weight, given once a day for six months or placebo. Follow up lasted for two years, during which time all symptoms and episodes of acute otitis media were recorded. MAIN OUTCOME MEASURES: Intervention failure (two episodes in two months or three in six months or persistent effusion) during follow up, number of episodes of acute otitis media, number of visits to a doctor because of any infection, and antibiotic prescriptions Number of prescriptions, and days with symptoms of respiratory infection. RESULTS: Compared with placebo, interventions failed during both the first six months and the rest of the follow up period of 24 months similarly in the adenoidectomy and chemoprophylaxis groups (at six months the differences in risk were 10% (95% confidence interval -9% to 29%) and 18% (-2% to 38%), respectively). No significant differences were observed between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection. CONCLUSIONS: Adenoidectomy, as the first surgical treatment of children aged 10 to 24 months with recurrent acute otitis media, is not effective in preventing further episodes. It cannot be recommended as the primary method of prophylaxis.

Adenoidectomy↗

PubMed1998

Pressure ulcers--randomised controlled trial comparing hydrocolloid and saline gauze dressings.

An open comparative randomised study comparing the performance of hydrocolloid dressings (DuoDERM CGF) to saline gauze dressings in the treatment of pressure ulcers was done to evaluate the overall dressing performance, wound healing and cost effectiveness. Thirty-four subjects were enrolled at the University Hospital, Kuala Lumpur over a 643 days period. Inclusion criteria were Stage II or III pressure ulcers, at least 18 years of age and written informed consent. Only one pressure ulcer per subject was enrolled in the study. Patients with infected pressure ulcers, diabetes mellitus, an immuno-compromised status and known sensitivity to the study dressings were excluded. Subjects who met the enrollment criteria were randomised to one of the two dressing regimes. They were expected to participate in the study for a maximum of eight weeks or until the pressure ulcer healed, which ever occurred first. Overall subject age averaged 58 years and the mean duration of pressure ulcer existence was about 1 month. Twenty-one of the thirty-four ulcers enrolled were stage II and thirteen were stage III. The majority of the ulcers (88%) were located in the sacral area and seventeen subjects (50%) were incontinent. In the evaluation of dressing performance in terms of adherence to wound bed, exudate handling ability, overall comfort and pain during dressing removal; all favoured the hydrocolloid dressing by a statistically significant margin (p < 0.001). Subjects assigned the hydrocolloid dressing experienced a mean 34% reduction from their baseline surface area measurement compared to a mean 9% increase by subjects assigned gauze dressings. This was not statistically significant (p = 0.2318). In cost evaluation of the study products, there was no statistical significance in the total cost of wound management per subject. When only labour time and cost was evaluated, there was a statistically significant advantage towards hydrocolloid dressings.

Adult↗

PubMedDate not supplied

Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series.

OBJECTIVE: To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series. DESIGN: Randomised, double blind, placebo controlled, parallel group, multicentre study. SETTING: Four general practices and a hospital ear, nose, and throat outpatient department. PARTICIPANTS: 51 patients with perennial allergic rhinitis. INTERVENTION: Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo. MAIN OUTCOME MEASURES: Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation. RESULTS: Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007). CONCLUSION: The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.

Adolescent↗

PubMed1996

The ethics of randomised controlled trials: a matter of statistical belief?

This paper outlines the approaches of two apparently competing schools of statistics. The criticisms made by supporters of Bayesian statistics about conventional Frequentist statistics are explained, and the Bayesian claim that their method enables research into new treatments without the need for clinical trials is examined in detail. Several further important issues are considered, including: the use of historical controls and data routinely collected on patients; balance in randomised trials; the possibility of giving information to patients; patient choice and patient autonomy; and how widely the results of clinical trials can be used. It is concluded that good statistical techniques in the design and analysis of medical studies are essential, but the statistical school used in developing such techniques is relatively unimportant.

Bayes Theorem↗

PubMed2003

A cluster randomised, controlled trial of the value of dental health educators in general dental practice.

AIM: To test the effectiveness of dental health educators in general dental practice. OBJECTIVE: To evaluate the effectiveness and cost of primary care trusts seconding dental health educators free of charge to suitable general dental practices to provide dental health counselling to mothers of regularly attending pre-school children at risk to caries. METHOD: Two-cell, parallel group, cluster randomised, controlled clinical trial of two years' duration. CLINICAL SETTING: 30 general dental practices in North-West England. PARTICIPANTS: 269 mothers of 334 pre-school children. INTERVENTIONS: Those in the test group were given visits to a dental health educator over a 2-year period to counsel mothers of at-risk, pre-school children. The rest were held as a control. MAIN OUTCOME MEASURES: Caries prevalence of the children and dental health knowledge, attitudes and toothbrushing skills of the parents. The full costs of the exercise were kept throughout. The statistical analysis controlled for the clustering of children within practices. RESULTS: After 2 years, 271 (81%) children and 248 (92%) mothers remained in the study. There was an 18% difference in mean dmft between the groups in favour of the test group children but this was not statistically significant. At the end of the study there was an 18% difference in mean dmft between the groups in favour of the test group children but this was not statistically significant. No difference in plaque levels was found. The mothers in the test group were more knowledgeable, had better attitudes towards the dental health of their offspring and better toothbrushing skills than those in the control. Each 2-hour session to counsel ten parents cost pound 40. CONCLUSION: Primary care trusts should carefully consider the cost value of seconding dental health educators to counsel parents of regularly attending, at-risk, pre-school children when considering such an option.

Attitude to Health↗

PubMed1998

Randomised controlled trial of sucrose by mouth for the relief of infant crying after immunisation.

OBJECTIVES: To evaluate the effect of sucrose solution given by mouth on infant crying times and measures of distress in the immunisation clinic. DESIGN: Randomised, double blind, placebo controlled trial of sucrose solution 75% wt/vol v sterile water as a control. SETTING: The immunisation clinic of the Women's and Children's Hospital, Adelaide. PATIENTS: A total of 107 healthy infants attending for 2, 4, or 6 month immunisations with polio by mouth (Sabin), intramuscular diphtheria, tetanus, and pertussis (DTP), and intramuscular Haemophilus influenzae type b were randomised to receive 2 ml 75% sucrose solution or sterile water by mouth before the two injections. METHODS: The duration of infant crying was recorded during and immediately after two intramuscular immunisations and infant distress was assessed by a visual analogue scale (Oucher scores) independently by a nurse and a parent. RESULTS: The administration of 2 ml 75% sucrose solution by mouth reduced the infant crying time and Oucher distress scores after immunisation with DTP/H influenzae type b. CONCLUSIONS: Infant immunisation by intramuscular injection is a distressing procedure for infants and parents. Sucrose solution at a high concentration reduces infant distress and is safe and clinically useful in this setting.

Administration, Oral↗

PubMed2005

Effects of atorvastatin and vitamin E on lipoproteins and oxidative stress in dialysis patients: a randomised-controlled trial.

OBJECTIVES: The objective of this study was to examine the effects of treatment with atorvastatin, alpha-tocopherol and the combination of both, on lipoproteins and oxidative stress in dialysis patients. DESIGN AND SETTING: This double-blind randomised placebo-controlled trial was performed at the dialysis department of a non-university hospital. SUBJECTS, INTERVENTION AND MEASUREMENTS: A total of 44 clinically stable, non-diabetic patients on dialysis therapy (23 on haemo- and 21 on peritoneal-dialysis) without manifest cardiovascular disease were included in this study. They were randomised for treatment during a period of 12 weeks with 40 mg atorvastatin + placebo alpha-tocopherol (group 1) once daily, 800 IU alpha-tocopherol + placebo atorvastatin once daily (group 2), 40 mg atorvastatin + 800 IU alpha-tocopherol once daily (group 3), or placebo atorvastatin + placebo alpha-tocopherol once daily (group 4). Assessment of lipid profile and oxidative stress was performed at the start of the study and after 12 weeks of treatment. RESULTS: Treatment with atorvastatin reduced total cholesterol, triglycerides (TG), low-density lipoprotein (LDL) cholesterol, apolipoprotein B (apoB) and levels of oxidised LDL (oxLDL) with 30-43%. It had no influence on LDL oxidisability. Additional supplementation with alpha-tocopherol had no effect on lipid profile and oxLDL levels but decreased in vitro LDL oxidisability. No side-effects were observed. CONCLUSIONS: Treatment with atorvastatin is effective in lowering plasma total cholesterol, TG, LDL, apoB and oxLDL in a population of stable dialysis patients and might therefore be an effective tool in improving the poor cardiovascular outcome in these patients. Supplementation of alpha-tocopherol to atorvastatin had beneficial effects on in vitro LDL oxidisability and might therefore be of additional value. Further research on the clinical effects of treatment with atorvastatin in combination with alpha-tocopherol is necessary.

Adult↗

PubMed2006

Safety and efficacy of routine postoperative ibuprofen for pain and disability related to ectopic bone formation after hip replacement surgery (HIPAID): randomised controlled trial.

OBJECTIVES: To determine the benefits and risks of a non-steroidal anti-inflammatory drug (NSAID) as prophylaxis for ectopic bone formation in patients undergoing total hip replacement (or revision) surgery. DESIGN: Double blind randomised placebo controlled clinical trial, stratified by treatment site and surgery (primary or revision). SETTING: 20 orthopaedic surgery centres in Australia and New Zealand. PARTICIPANTS: 902 patients undergoing elective primary or revision total hip replacement surgery. INTERVENTION: 14 days' treatment with ibuprofen (1200 mg daily) or matching placebo started within 24 hours of surgery. MAIN OUTCOME MEASURES: Changes in self reported hip pain and physical function 6 to 12 months after surgery (Western Ontario and McMaster University Arthritis index). RESULTS: There were no significant differences between the groups for improvements in hip pain (mean difference -0.1, 95% confidence interval -0.4 to 0.2, P = 0.6) or physical function (-0.1, -0.4 to 0.2, P = 0.5), despite a decreased risk of ectopic bone formation (relative risk 0.69, 0.56 to 0.83) associated with ibuprofen. There was a significantly increased risk of major bleeding complications in the ibuprofen group during the admission period (2.09, 1.00 to 4.39). CONCLUSIONS: These data do not support the use of routine prophylaxis with NSAIDs in patients undergoing total hip replacement surgery. TRIAL REGISTRATION: NCT00145730.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed2005

Dobutamine improves thoracic aortic blood flow during off-pump coronary artery bypass surgery: results of a prospective randomised controlled trial.

OBJECTIVE: Dobutamine is commonly used to improve ventricular performance in cardiac surgery. The aim of this prospective randomised controlled study was to assess the effectiveness of using low doses of dobutamine during off-pump coronary artery bypass (OPCAB) surgery in order to reduce haemodynamic compromise due to heart displacement. METHODS: Thirty-two patients undergoing elective coronary artery bypass grafting (CABG) surgery using OPCAB technique for more than two vessels were approached and recruited. We analysed the changes in the thoracic aortic blood flow (TABF) during OPCAB using transoesophageal Doppler and by other conventional monitoring methods as cardiac output, invasive pulmonary and radial pressures and mixed venous oxygen saturation. RESULTS: The two groups were similar in preoperative characteristics. No postoperative complications were observed in the study patients. The heart rate, right atrial pressure, cardiac output measured by thermodilution and TABF changed significantly during the procedure. Also significant changes in descending thoracic aortic diameter were observed. The postoperative creatinine was significantly lower in the dobutamine group (P=0.04). Dobutamine was found responsible for the improvement in the descending TABF (P=0.006). CONCLUSIONS: This study showed that intra-operative intravenous infusion of dobutamine at 5 microg/kg per min in routine OPCAB patients safely increased cardiac output even without such changes been detected by conventional monitoring methods.

Analysis of Variance↗

PubMed1989

Randomised controlled trial comparing prednisolone alone with cyclophosphamide and low dose prednisolone in combination in cryptogenic fibrosing alveolitis.

In a randomised, controlled study alternate day prednisolone with an initial high dose phase ("prednisolone only series") has been compared with cyclophosphamide plus alternate day low dose prednisolone ("cyclophosphamide-prednisolone series") in 43 patients with previously untreated fibrosing alveolitis (five patients had received prednisolone in minimal dosage). In the prednisolone only series prednisolone 60 mg daily was given for one month and then reduced by 5 mg a week to 20 mg on alternate days or the minimum dose to maintain early improvement. Patients in the cyclophosphamide-prednisolone series received 100, 110, or 120 mg cyclophosphamide daily (depending on body weight) plus 20 mg prednisolone on alternate days. Treatment was continued indefinitely, or changed to the alternative regimen if the patient deteriorated, failed to improve, or developed drug toxicity. For response to treatment (as judged by change in breathlessness score, radiographic appearance, and lung function) patients were classified as improved, stable, or deteriorating. Deaths from cryptogenic fibrosing alveolitis were also analysed. Improvement had occurred at one or more assessments in seven of the 22 patients in the prednisolone only series and in five of the 21 patients in the cyclophosphamide-prednisolone series. At three years, however, only two of the 22 patients in the prednisolone only series were still improved and three stable, compared with one and seven of the 21 patients in the cyclophosphamide-prednisolone series (three of the seven had stopped treatment because of toxicity). Life table analysis suggested better survival in patients in the cyclophosphamide-prednisolone series but this was not significant. At three years 10 of 22 patients in the prednisolone only series had died compared with three of 21 patients in the cyclophosphamide-prednisolone series. With death or failure of first treatment regimen as outcome there was a significant advantage to the patients having cyclophosphamide-prednisolone. This advantage was explained in part by the better lung volumes in this group on admission. After allowance had been made for total lung capacity (TLC), no other factor was predictive of outcome. Analyses of subgroups according to TLC on admission showed that patients with a TLC below 60% predicted did badly and those with a TLC of 80% or more predicted did well with both regimens. Patients with an initial TLC of 60-79% predicted did better with the cyclophosphamide-prednisolone regimen. Side effects were uncommon in both series and those due to cyclophosphamide resolved when treatment was stopped. The combination of cyclophosphamide with prednisolone may be an alternative to prednisolone alone with an initial high dose phase. Many patients, however, failed to respond to either treatment.

Adult↗

PubMed2004

Randomised controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee.

OBJECTIVE: To determine the effectiveness of commercially available magnetic bracelets for pain control in osteoarthritis of the hip and knee. DESIGN: Randomised, placebo controlled trial with three parallel groups. SETTING: Five rural general practices. PARTICIPANTS: 194 men and women aged 45-80 years with osteoarthritis of the hip or knee. INTERVENTION: Wearing a standard strength static bipolar magnetic bracelet, a weak magnetic bracelet, or a non-magnetic (dummy) bracelet for 12 weeks. MAIN OUTCOME MEASURES: Change in the Western Ontario and McMaster Universities osteoarthritis lower limb pain scale (WOMAC A) after 12 weeks, with the primary comparison between the standard and dummy groups. Secondary outcomes included changes in WOMAC B and C scales and a visual analogue scale for pain. RESULTS: Mean pain scores were reduced more in the standard magnet group than in the dummy group (mean difference 1.3 points, 95% confidence interval 0.05 to 2.55). Self reported blinding status did not affect the results. The scores for secondary outcome measures were consistent with the WOMAC A scores. CONCLUSION: Pain from osteoarthritis of the hip and knee decreases when wearing magnetic bracelets. It is uncertain whether this response is due to specific or non-specific (placebo) effects.

Aged↗

PubMed1997

Effects on birth weight and perinatal mortality of maternal dietary supplements in rural Gambia: 5 year randomised controlled trial .

OBJECTIVE: To test the efficacy in terms of birth weight and infant survival of a diet supplement programme in pregnant African women through a primary healthcare system. DESIGN: 5 year controlled trial of all pregnant women in 28 villages randomised to daily supplementation with high energy groundnut biscuits (4.3 MJ/day) for about 20 weeks before delivery (intervention) or after delivery (control). SETTING: Rural Gambia. SUBJECTS: Chronically undernourished women (twin bearers excluded), yielding 2047 singleton live births and 35 stillbirths. MAIN OUTCOME MEASURES: Birth weight; prevalence of low birth weight (< 2500 g); head circumference; birth length; gestational age; prevalence of stillbirths; neonatal and postneonatal mortality. RESULTS: Supplementation increased weight gain in pregnancy and significantly increased birth weight, particularly during the nutritionally debilitating hungry season (June to October). Weight gain increased by 201 g (P < 0.001) in the hungry season, by 94 g (P < 0.01) in the harvest season (November to May), and by 136 g (P < 0.001) over the whole year. The odds ratio for low birthweight babies in supplemented women was 0.61 (95% confidence interval 0.47 to 0.79, P < 0.001). Head circumference was significantly increased (P < 0.01), but by only 3.1 mm. Birth length and duration of gestation were not affected. Supplementation significantly reduced perinatal mortality: the odds ratio was 0.47 (0.23 to 0.99, P < 0.05) for stillbirths and 0.54 (0.35 to 0.85, P < 0.01) for all deaths in first week of life. Mortality after 7 days was unaffected. CONCLUSION: Prenatal dietary supplementation reduced retardation in intrauterine growth when effectively targeted at genuinely at-risk mothers. This was associated with a substantial reduction in the prevalence of stillbirths and in early neonatal mortality. The intervention can be successfully delivered through a primary healthcare system.

Birth Weight↗

PubMedDate not supplied

Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial.

BACKGROUND: Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions. METHODS: We randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity. FINDINGS: In the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic. INTERPRETATION: The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.

Adolescent↗

PubMed2005

The effect of staff training on the use of restraint in dementia: a single-blind randomised controlled trial.

BACKGROUND: Use of restraint amongst institutionalised elderly with dementia and problem behaviour not only remains widespread, but also appears to be accepted as inevitable. OBJECTIVE: The aim of this study was to reduce problem behaviour and the use of restraint in demented patients using a staff training program as intervention. METHODS: The study was a randomised single-blind controlled trial and took place in Stavanger, Norway. Four nursing homes were randomised to a control or an intervention group after stratification for size. The intervention consisted of a full day seminar, followed by a one-hour session of guidance per month over six months. The content of the educational program focused on the decision making process in the use of restraint and alternatives to restraint consistent with professional practice and quality care. The primary outcome measures were number of restraints per patient in the nursing homes in one week and agitation as measured with the Brief Agitation Rating Scale (BARS). These were rated before and immediately after the intervention was completed. The assessments were performed blind to design and randomisation group. RESULTS: Clinical and demographic variables did not differ between the intervention and control groups at baseline. After the intervention period, the number of restraints had declined by 54% in the treatment group, and increased by 18% in the control group. The difference between the two groups was statistically significant ( p = 0.013). There was a trend towards higher BARS score in the intervention compared to the control group at follow up ( p = 0.052). CONCLUSION: Although the level of agitated behaviour remained unchanged or increased slightly, the educational program led to a significant reduction of the use of restraint in institutionalised elderly with dementia. These results suggest that educational programs can improve the quality of care of people with dementia.

Aged↗

PubMed2005

The British Rheumatoid Outcome Study Group (BROSG) randomised controlled trial to compare the effectiveness and cost-effectiveness of aggressive versus symptomatic therapy in established rheumatoid arthritis.

OBJECTIVES: To examine the effectiveness and cost-effectiveness of symptomatic versus aggressive treatment in patients with established, stable rheumatoid arthritis (RA). DESIGN: A randomised observer-blinded controlled trial and economic evaluation with an initial assessment at randomisation and follow-ups at 12, 24 and 36 months. SETTING: Five rheumatology centres in England. The 'symptomatic care' patients were managed predominantly in primary care with regular visits by a rheumatology specialist nurse. The 'aggressive care' patients were managed predominantly in the hospital setting. PARTICIPANTS: Patients with RA for more than 5 years were screened in rheumatology clinics. INTERVENTIONS: The symptomatic care patients were seen at home every 4 months by a rheumatology specialist nurse and annually by the rheumatologist. The aim of treatment was symptom control. The aggressive care patients were seen at least every 4 months in hospital. Their treatment was altered (following predefined algorithms) with the aim of suppressing both clinical and laboratory evidence of joint inflammation. MAIN OUTCOME MEASURES: The main outcome measure was the Health Assessment Questionnaire (HAQ). Others included the patient and physician global assessment, pain, tender and swollen joint counts, the erythrocyte sedimentation rate and the OSRA (Overall Status in Rheumatoid Arthritis) score. X-rays of the hands and feet were performed at the beginning and end of the study. The EQ-5D was used in the health economic evaluation. Comprehensive costs were also estimated and were combined with measures of outcome to examine between-group differences. RESULTS: A total of 466 patients were recruited; 399 patients completed the 3 years of follow-up. There was a significant deterioration in physical function (HAQ) in both arms. There was no significant difference between the groups for any of the clinical outcome measures except the physician global assessment [adjusted mean difference 3.76 (95% CI 0.03 to 7.52)] and the OSRA disease activity component [adjusted mean difference 0.41 (95% CI 0.01 to 0.71)], both in favour of the aggressive arm. During the trial, second-line drug treatment was changed in 77.1% of the aggressive arm and 59.0% of the symptomatic arm. There were instances when the rheumatologist should have changed treatment but did not do so, usually because of mild disease activity. The symptomatic arm was associated with higher costs and higher quality-adjusted life-years (QALYs). There was a net cost of 1517 Pounds Sterling per QALY gained for the symptomatic arm. Overall, the primary economic analysis and sensitivity analyses of the cost and QALY data indicate that symptomatic treatment is likely to be more cost-effective than aggressive treatment in 58-90% of cases. CONCLUSIONS: This trial showed no benefit of aggressive treatment in patients with stable established RA. However, it was difficult to persuade the rheumatologist and/or the patient to change treatment if the evidence of disease activity was minimal. Patients in the symptomatic arm were able to initiate changes of therapy when their symptoms deteriorated, without frequent hospital assessment. Approximately one-third of current clinic attenders with stable RA could be managed in a shared care setting with annual review by a rheumatologist and regular contact with a rheumatologist nurse. Further research is needed into disease progression and the use of biological agents, minimum disease activity level below which disease progression does not occur, cost-effectiveness through shared care modelling, the development of a robust and fail-safe system of primary-care based disease-modifying anti-rheumatic drug (DMARD) monitoring, and predicting response to DMARDs.

Adult↗

PubMed2002

Parental education and guided self-management of asthma and wheezing in the pre-school child: a randomised controlled trial.

BACKGROUND: The effects on morbidity were examined of providing an educational intervention and a written guided self-management plan to the parents of pre-school children following a recent attendance at hospital for asthma or wheeze. METHODS: A prospective, randomised, partially blinded, controlled trial was designed at two secondary care centres. Over a 13 month period 200 children aged 18 months to 5 years at the time of admission to a children's ward or attendance at an accident and emergency department or children's (emergency) assessment unit (A&E/CAU) with a primary diagnosis of acute severe asthma or wheezing were recruited. 101 children were randomised into the control group and received usual care and 99 were assigned to the intervention group and received: (1) a pre-school asthma booklet; (2) a written guided self-management plan; and (3) two 20 minute structured educational sessions between a specialist respiratory nurse and the parent(s) and child. Subjects were assessed at 3, 6, and 12 months. The main outcomes were GP consultation rates, hospital re-admissions, and attendances at A&E/CAU. Secondary outcomes included disability score, caregivers' quality of life, and parental knowledge of asthma. RESULTS: There were no statistically significant differences between the two groups during the 12 month follow up period for any of the main or secondary outcome measures. CONCLUSIONS: These results do not support the hypothesis that the introduction of an educational package and a written guided self-management plan to the parents of pre-school children with asthma who had recently attended hospital for troublesome asthma or wheeze reduces morbidity over the subsequent 12 months.

Asthma↗

PubMed1996

Randomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial.

BACKGROUND: The efficacy of prophylactic antibiotics in fracture surgery remains controversial for lack of well-documented prospective studies. We report here the findings of the Dutch Trauma Trial, a prospective, randomised, double-blind, placebo-controlled study of antibiotic prophylaxis in the primary operative treatment of limb fractures. Ceftriaxone was chosen because of its pharmacokinetic profile, including high serum levels, high tissue penetration, and long elimination half-life, makes it suitable for single-dose prophylaxis. METHODS: Patients aged 18 years or more, attending one of fourteen Dutch centres for acute treatment of closed fractures, were randomly allocated to a single preoperative dose of ceftriaxone 2 g or placebo, and evaluated for development of wound infection and nosocomial infection at 10 days, 30 days, and 120 days. To assess the effects of drop-outs and withdrawals, best-case and worst-case analyses were performed. FINDINGS: A total of 2195 patients were included. The incidence of superficial and deep wound infections after placebo was 8.3%, compared with 3.6% in the ceftriaxone group (p < 0.001, Pearson chi 2-test). The rate of nosocomial infection in the first month was 10.2% with placebo and 2.3% with ceftriaxone (p < 0.001, Pearson chi 2-test). Gram-positive bacteria were found in 74.5% of wound infections and 13.4% of nosocomial infections. INTERPRETATION: Adequate single-dose prophylaxis with a long-acting broad-spectrum antibiotic substantially reduces the incidence of wound infection and early nosocomial infection after surgery for closed fractures.

Adult↗