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Results for “Randomised Controlled Trial”

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PubMed2000

Effects of a clinical-practice guideline and practice-based education on detection and outcome of depression in primary care: Hampshire Depression Project randomised controlled trial.

BACKGROUND: Depression is a major individual and public-health burden throughout the world and is managed mainly in primary care. The most effective strategy to reduce this burden has been believed to be education of primary-care practitioners. We tested this assumption by assessing the effectiveness of an educational programme based on a clinical-practice guideline in improving the recognition and outcome of primary-care depression. METHODS: We carried out a randomised controlled trial in a representative sample of 60 primary-care practices (26% of the total) in an English health district. Education was delivered to practice teams and quality tested by feedback from participants and expert raters. The primary endpoints were recognition of depression, defined by the hospital anxiety and depression (HAD) scale, and clinical improvement. Analysis was by intention to treat. FINDINGS: The education was well received by participants, 80% of whom thought it would change their management of patients with depression. 21409 patients were screened, of whom 4192 were classified as depressed by the HAD scale. The sensitivity of physicians to depressive symptoms was 39% in the intervention group and 36% in the control group after education (odds ratio 1.2 [95% CI 0.88-1.61]). The outcome of depressed patients as a whole at 6 weeks or 6 months after the assessment did not significantly improve. INTERPRETATION: Although well received, this in-practice programme, which was designed to convey the current consensus on best practice for the care of depression, did not deliver improvements in recognition of or recovery from depression.

Antidepressive Agents, Tricyclic↗

PubMed2002

A randomised controlled trial of the effect of educational outreach by community pharmacists on prescribing in UK general practice.

BACKGROUND: Educational outreach visits are commonly used to promote changes in prescribing in family practice. However, the effectiveness of outreach visits has not been evaluated across a range of settings. AIM: To estimate the effectiveness of educational outreach visits on United Kingdom (UK) general practice prescribing and to examine the extent to which practice characteristics influenced outcome. DESIGN OF STUDY: Randomised controlled trial. SETTING: General practices in 12 health authorities in England. METHOD: Educational outreach visits were made to practices that received two of four guidelines. Each practice provided data on treatment of patients for all four guidelines for both pre and post-intervention periods. The primary outcome is average effect across all four guidelines. Secondary analyses examined the predictive effect of practice and guideline characteristics. RESULTS: Seventy per cent of practices approached agreed to take part in the intervention. Overall, educational outreach was associated with a significant improvement in prescribing practice (odds ratio [OR] = 1.24 [95% CI = 1.07 to 1.42]), a 5.2% (95% CI = 1.7% to 8.7%) increase in the number of patients treated within the guideline recommendations. Smaller practices (two or fewer full-time equivalent practitioners) responded much more favourably to educational outreach than larger practices. Smaller practices improved their performance in line with the guidelines by 13.5% (95% CI = 6% to 20.9%) attributable to outreach, while larger practices improved by only 1.4% (95% CI = -2.4% to 5.3%, P-value for interaction <0.001). CONCLUSION: In large practices, educational outreach alone is unlikely to achieve worthwhile change. There is good evidence to support the use of educational outreach visits in small practices.

Community Pharmacy Services↗

PubMed2000

Cost effectiveness of an intensive blood glucose control policy in patients with type 2 diabetes: economic analysis alongside randomised controlled trial (UKPDS 41). United Kingdom Prospective Diabetes Study Group.

OBJECTIVE: To estimate the cost effectiveness of conventional versus intensive blood glucose control in patients with type 2 diabetes. DESIGN: Incremental cost effectiveness analysis alongside randomised controlled trial. SETTING: 23 UK hospital clinic based study centres. PARTICIPANTS: 3867 patients with newly diagnosed type 2 diabetes (mean age 53 years). INTERVENTIONS: Conventional (primarily diet) glucose control policy versus intensive control policy with a sulphonylurea or insulin. MAIN OUTCOME MEASURES: Incremental cost per event-free year gained within the trial period. RESULTS: Intensive glucose control increased trial treatment costs by pound 695 (95% confidence interval pound 555 to pound 836) per patient but reduced the cost of complications by pound 957 (pound 233 to pound 1681) compared with conventional management. If standard practice visit patterns were assumed rather than trial conditions, the incremental cost of intensive management was pound 478 (-pound 275 to pound 1232) per patient. The within trial event-free time gained in the intensive group was 0.60 (0.12 to 1.10) years and the lifetime gain 1.14 (0.69 to 1.61) years. The incremental cost per event-free year gained was pound 1166 (costs and effects discounted at 6% a year) and pound 563 (costs discounted at 6% a year and effects not discounted). CONCLUSIONS: Intensive blood glucose control in patients with type 2 diabetes significantly increased treatment costs but substantially reduced the cost of complications and increased the time free of complications.

Adult↗

PubMed2006

Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation.

BACKGROUND: Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested. AIM: To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: General practices in the Eastern Regional Health Authority area of Ireland. METHOD: Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment. RESULTS: At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06). CONCLUSION: General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice.

Adult↗

PubMed2005

Early assessment by a mobile stroke team: a randomised controlled trial.

BACKGROUND: There is overwhelming evidence of the effectiveness of specialist stroke rehabilitation, but more limited evidence of the effectiveness of organised stroke care during the acute phase of stroke. OBJECTIVE: To determine the impact on outcome of access to a mobile team during the acute phase of stroke among patients admitted to general wards. STUDY POPULATION: 308 patients admitted to one of two hospitals within 5 days of the onset of a clinically diagnosed stroke. STUDY DESIGN: Randomised controlled trial. STUDY GROUPS: Following admission, patients in the intervention arm were visited by members of a mobile stroke team who advised clinical staff on appropriate and timely investigation and management. They co-ordinated early input from therapy groups and identified those ready for transfer to the stroke rehabilitation unit. Patients in the control arm were not visited by the mobile stroke team. MAIN OUTCOME MEASURE: All-cause mortality measured at 6 weeks and 12 months. RESULTS: There was no statistically significant difference observed between study groups in mortality at 6 weeks (95% CI(adj) -7.4 to 7.4%) nor at 12 months ( 95% CI(adj) -4.1 to 15.9%). There were also no differences observed between study groups in morbidity outcomes or health-related quality of life measured at 12 months. CONCLUSION: The trial was terminated before the necessary sample size was collected but findings suggest that the mobile stroke team failed to confer significant long-term mortality benefit compared with general ward-based care alone.

Aged↗

PubMed2000

A telephone call reminder to improve outpatient attendance in patients referred from the emergency department: a randomised controlled trial.

BACKGROUND: Poor compliance with attendance at outpatient clinic appointments in patients referred from emergency departments (EDs) is a major problem in public hospitals. AIMS: To determine whether the intervention of a telephone call within three days of ED attendance would improve: 1. the proportion of patients making recommended outpatient appointments; and 2. the proportion of patients attending scheduled appointments. To characterise reasons for non-attendance at appointments made by patients referred from the ED. METHODS: A randomised controlled trial was undertaken of 400 patients recommended to make outpatient appointments during attendance at The Royal Melbourne Hospital ED in July-August 1999. INTERVENTION: a telephone call one to three days after attendance to remind the patient about the appointment (and its importance for medical follow-up) if one had been made and to offer to make an appointment if one had not been made. OUTCOME MEASURES: 1. making the recommended appointment; 2. attendance at the scheduled appointment; and 3. reasons for non-attendance at scheduled appointments. RESULTS: The telephone intervention improved attendance at scheduled appointments from 54.4% to 70.7% (p=0.002). The proportion of patients making appointments was not significantly affected. The commonest reasons given for non-attendance were: attended general practitioner (13%), attended private specialist (6.6%), inpatient in hospital at time of appointment (6.6%), too busy or inconvenient (5.3%), claimed to have attended (5.3%) and did not differ by intervention. CONCLUSIONS: A significant improvement in the proportion of patients attending outpatients appointments can be made by a simple reminder telephone call one to three days after attendance at the ED.

Adolescent↗

PubMed1998

The health and welfare effects of day-care: a systematic review of randomised controlled trials.

Day-care has long been a controversial aspect of social policy in countries such as the U.K. What evidence is there about the effects of out-of-home day-care on educational, health and welfare outcomes for children and their families? This paper applies to day-care studies, the methodology of the systematic review as pioneered in the health care field, in order to establish the evidence-base for day-care provision. Randomised controlled trials of day-care for pre-school children were identified using electronic databases, hand searches of relevant literature and contacts with authors. A total of 8 trials were identified after examining 920 abstracts and 19 books. All the trials were carried out in the U.S.A. European research on this topic is extensive but we did not identify any studies using trial design. Instead observational, case controlled and cohort studies were prominent. The trials were assessed for methodological quality. Results showed that day-care promotes children's intelligence, development and school achievement. Long-term follow up demonstrates increased employment, lower teenage pregnancy rates, higher socio-economic status and decreased criminal behaviour. There are positive effects on mothers' education, employment and interaction with children. Effects on fathers have not been examined. Few studies look at a range of outcomes spanning the health, education and welfare domains. Most of the trials combined non-parental day-care with some element of parent training or education (mostly targeted at mothers); they did not disentangle the possible effects of these two interventions. The trials had other significant methodological weaknesses, pointing to the importance of improving on study design in this field. There is a need for well designed research on day-care to provide an evidence-base for British social policy.

Child Behavior↗

PubMed2005

Treatment of ocular hypertension and open angle glaucoma: meta-analysis of randomised controlled trials.

OBJECTIVE: Open angle glaucoma is one of the most common causes of blindness in industrialised nations. Treatments to lower ocular pressure are widely used in glaucoma prevention and treatment, despite conflicting evidence. DESIGN: We performed meta-analyses to reassess the effectiveness of pressure lowering treatment to delay the development of glaucoma in ocular hypertension, as well as progression of manifest open angle glaucoma. DATA SOURCES: Medline, Embase, and the Cochrane Library. SELECTION OF STUDIES: Eligible studies were randomised controlled trials with a concurrent untreated control group and information on time to glaucomatous changes to visual field and optic disc. Trial reports were reviewed independently by two investigators in an unblinded standardised manner. RESULTS: Meta-analysis of trials in ocular hypertension showed a significant preventive effect of reducing intraocular pressure on progression to glaucoma (hazard ratio 0.56, 95% confidence interval 0.39 to 0.81, P = 0.01; number needed to treat 12). Pooled data of studies in manifest glaucoma showed a significant delay of visual field deterioration (0.65, 0.49 to 0.87, P = 0.003; NNT = 7), with subgroup analysis showing a larger effect in patients with raised pressure and a reduced effect in normal tension glaucoma (subgroup comparison: not significant). CONCLUSIONS: Lowering intraocular pressure in patients with ocular hypertension or manifest glaucoma is beneficial in reducing the risk of visual field loss in the long term.

Glaucoma, Open-Angle↗

PubMed2004

Cognitive therapy for command hallucinations: randomised controlled trial.

BACKGROUND: Command hallucinations are a distressing and high-risk group of symptoms that have long been recognised but little understood, with few effective treatments. In line with our recent research, we propose that the development of an effective cognitive therapy for command hallucinations (CTCH) would be enhanced by applying insights from social rank theory. AIMS: We tested the efficacy of CTCH in reducing beliefs about the power of voices and thereby compliance, in a single-blind, randomised controlled trial. METHOD: A total of 38 patients with command hallucinations, with which they had recently complied with serious consequences, were allocated randomly to CTCH or treatment as usual and followed up at 6 months and 12 months. RESULTS: Large and significant reductions in compliance behaviour were obtained favouring the cognitive therapy group (effect size 1.1). Improvements were also observed in the CTCH but not the control group in degree of conviction in the power and superiority of the voices and the need to comply, and in levels of distress and depression. No change in voice topography (frequency, loudness, content) was observed. The differences were maintained at 12 months' follow-up. CONCLUSIONS: The results support the efficacy of cognitive therapy for CTCH.

Adult↗

PubMed2003

A randomised controlled trial of joint consultations with general practitioners and cardiologists in primary care.

BACKGROUND: Joint consultation sessions of a small group of general practitioners (GPs) and a specialist in orthopaedics proved to be an effective way of decreasing the referral rate of orthopaedic patients. Cardiac complaints comprise an important category of health problems with high referral rates. AIMS: To study the effects of joint consultation on the quality of care and referrals for patients with cardiac complaints. DESIGN OF STUDY: Randomised controlled trial. SETTING: Forty-nine GPs participated in 16 consultation groups, each with one of 13 cardiologists, in monthly joint consultations over a period of about 18 months. METHOD: The GPs selected patients about whom they were uncertain, and those needing urgent referral were excluded. Patients were randomly assigned to joint consultation or to usual care. After a follow-up period all patients had a joint consultation for outcome assessment. Referral data were provided by two regional health insurance companies and questionnaires were given to the patients, GPs, and cardiologists to gauge their opinion of the trial. RESULTS: One hundred and forty-eight patients in the intervention group and 158 patients in the control group fulfilled the whole protocol. The quality of care was similar in both groups. In the intervention group, 34% of the patients were referred, compared with 55% in the control group (P = 0.001), and fewer patients underwent further diagnostic procedures (7% compared with 16%, P = 0.013). Referrals to cardiology as a proportion of all referrals decreased in the practices of the participating GPs, compared with their reference districts (P = 0.024). CONCLUSION: Joint consultation is an effective method that provides a quality of care that at least equals usual care and that contributes to a better selection of patients who need specialist care.

Adult↗

PubMed2002

Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials.

OBJECTIVE: To compare glycaemic control and insulin dosage in people with type 1 diabetes treated by continuous subcutaneous insulin infusion (insulin infusion pump therapy) or optimised insulin injections. DESIGN: Meta-analysis of 12 randomised controlled trials. PARTICIPANTS: 301 people with type 1 diabetes allocated to insulin infusion and 299 allocated to insulin injections for between 2.5 and 24 months. MAIN OUTCOME MEASURES: Glycaemic control measured by mean blood glucose concentration and percentage of glycated haemoglobin. Total daily insulin dose. RESULTS: Mean blood glucose concentration was lower in people receiving continuous subcutaneous insulin infusion compared with those receiving insulin injections (standardised mean difference 0.56, 95% confidence interval 0.35 to 0.77), equivalent to a difference of 1.0 mmol/l. The percentage of glycated haemoglobin was also lower in people receiving insulin infusion (0.44, 0.20 to 0.69), equivalent to a difference of 0.51%. Blood glucose concentrations were less variable during insulin infusion. This improved control during insulin infusion was achieved with an average reduction of 14% in insulin dose (difference in total daily insulin dose 0.58, 0.34 to 0.83), equivalent to 7.58 units/day. CONCLUSIONS: Glycaemic control is better during continuous subcutaneous insulin infusion compared with optimised injection therapy, and less insulin is needed to achieve this level of strict control. The difference in control between the two methods is small but should reduce the risk of microvascular complications.

Blood Glucose↗

PubMed2000

Endometrial protection from tamoxifen-stimulated changes by a levonorgestrel-releasing intrauterine system: a randomised controlled trial.

INTRODUCTION: Tamoxifen is currently the most commonly used adjuvant treatment for breast cancer, however, it frequently causes episodes of unscheduled uterine bleeding, which could be associated with proliferative changes of the endometrium, or even endometrial cancer. We aimed to assess whether a levonorgestrel intrauterine system could modulate the uterine responses to tamoxifen. We also aimed to assess women's tolerance of the screening procedures, the insertion, removal, and potential side-effects of the device. METHODS: We did a randomised controlled trial, in which postmenopausal women who had had at least 1 year of adjuvant tamoxifen treatment and who were undergoing regular follow-up for breast cancer were randomly assigned to either endometrial surveillance alone, or endometrial surveillance before and after insertion of the levonorgestrel intrauterine system for 12 months. We assessed tolerance of the surveillance procedures and the device with visual analogue scales. FINDINGS: Baseline assessment showed only benign uterine changes in all women (n=122). Hysteroscopic assessment indicated a uniform decidual response (confirmed histologically in 40 of 41 cases) in all women fitted with the intrauterine system; there were no new polyps in these women and 13% had fewer fibroids than in controls. Both screening procedures and device were well tolerated. There was an excess of bleeding in the women fitted with intrauterine systems but this resolved to a baseline similar to those receiving surveillance only. INTERPRETATION: The levonorgestrel-releasing intrauterine system had a protective action against the uterine effects of tamoxifen. The effectiveness of this device in preventing uterine changes in the endometrium needs to be assessed in the context of decreasing the need for repeated investigations of postmenopausal bleeding in women taking tamoxifen.

Aged↗

PubMed2001

Randomised controlled trial assessing the impact of increasing information to health visitors about children's injuries.

AIMS: To assess the effect on health visitor action of providing community health visitors with information on all injury attendances in children under 5 attending an accident and emergency (A&E) department and of providing additional information about each injury. METHODS: Children under 5 years attending the A&E department at Queen's Medical Centre, Nottingham between October 1998 and April 1999 were studied, using a randomised controlled trial with a 2x2 factorial design. All attendances or selected attendances (all children under 1, burns and scalds, poisonings, head injuries, and repeat attendances in preceding six months) were notified. Provision of standard (diagnosis, circumstances surrounding injury, and disposal) or additional information (standard information plus place of injury, number of A&E attendances for injury in previous year, and any information recorded about safety equipment) was noted. RESULTS: Many notifications (56%) do not result in any action. Health visitors were nearly twice as likely to take action of some kind and three times as likely to undertake a home visit on receipt of notifications for selected attendances than on those for all attendances. A greater number of actions per notification were taken on receipt of information about selected attendances. Providing additional information had little effect on the action taken. CONCLUSIONS: A selective policy for notifying community health visitors of child injury attendances at A&E results in a greater proportion of attendances in which the health visitor takes action and in a greater number of actions per attendance being taken. The utility of notifying all injury attendances is questionable, as many do not result in any action.

Accident Prevention↗

PubMed2002

Self-help for bulimic disorders: a randomised controlled trial comparing minimal guidance with face-to-face or telephone guidance.

BACKGROUND: There is great potential demand for treatment of bulimia nervosa and binge eating disorder. Skilled therapists are in short supply. Self-help and guided self-help based upon books have shown some promise as an economical alternative to full therapy in some cases. AIMS: To investigate the efficacy and effectiveness of self-help with and without guidance in a specialist secondary service. METHOD: A randomised controlled trial comparing three forms of self-help over 4 months with a waiting-list comparison group and measurement of service consumption over the subsequent 8 months. RESULTS: Self-help delivered with four sessions of face-to-face guidance led to improved outcome over 4 months. There is also some evidence to support the use of telephone guidance. A minority of participants achieved lasting remission of their disorder in relation to self-help, but there was no significant difference in final outcome between the groups after they had progressed through the stepped care programme. Patients initially offered guided self-help had a lower long-term drop-out rate. CONCLUSIONS: Guided self-help is a worthwhile initial response to bulimia nervosa and binge eating disorder. It is a treatment that could be delivered in primary care and in other non-specialist settings.

Adult↗

PubMedDate not supplied

Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial.

BACKGROUND: Present treatment strategies for rheumatoid arthritis include use of disease-modifying antirheumatic drugs, but a minority of patients achieve a good response. We aimed to test the hypothesis that an improved outcome can be achieved by employing a strategy of intensive outpatient management of patients with rheumatoid arthritis--for sustained, tight control of disease activity--compared with routine outpatient care. METHODS: We designed a single-blind, randomised controlled trial in two teaching hospitals. We screened 183 patients for inclusion. 111 were randomly allocated either intensive management or routine care. Primary outcome measures were mean fall in disease activity score and proportion of patients with a good response (defined as a disease activity score <2.4 and a fall in this score from baseline by >1.2). Analysis was by intention-to-treat. FINDINGS: One patient withdrew after randomisation and seven dropped out during the study. Mean fall in disease activity score was greater in the intensive group than in the routine group (-3.5 vs -1.9, difference 1.6 [95% CI 1.1-2.1], p<0.0001). Compared with routine care, patients treated intensively were more likely to have a good response (definition, 45/55 [82%] vs 24/55 [44%], odds ratio 5.8 [95% CI 2.4-13.9], p<0.0001) or be in remission (disease activity score <1.6; 36/55 [65%] vs 9/55 [16%], 9.7 [3.9-23.9], p<0.0001). Three patients assigned routine care and one allocated intensive management died during the study; none was judged attributable to treatment. INTERPRETATION: A strategy of intensive outpatient management of rheumatoid arthritis substantially improves disease activity, radiographic disease progression, physical function, and quality of life at no additional cost.

Administration, Oral↗

PubMed2006

Effects of high volume saline enemas vs no enema during labour--The N-Ma Randomised Controlled Trial [ISRCTN43153145].

BACKGROUND: Enemas are used during labour in obstetric settings with the belief that they reduce puerperal and neonatal infections, shorten labour duration, and make delivery cleaner for attending personnel. However, a systematic review of the literature found insufficient evidence to support the use of enemas. The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates. METHODS DESIGN: RCT (randomised controlled trial; randomized clinical trial). OUTCOMES: Clinical diagnosis of maternal or neonatal infections, labour duration, delivery types, episiotomy rates, and prescription of antibiotics. SETTING: Tertiary care referral hospital at the Javeriana University (Bogotá, Colombia) that attended 3170 births during study period with a caesarean section rate of 26%. PARTICIPANTS: 443 women admitted for delivery to the obstetrics service (February 1997 to February 1998) and followed for a month after delivery. Inclusion criteria were women with: low risk pregnancy and expected to remain in Bogotá during follow up; gestational age > or = 36 weeks; no pelvic or systemic bacterial infection; intact membranes; cervix dilatation < or = 7 cm. INTERVENTION: 1 litre saline enema, versus no enema, allocated following a block random allocation sequence and using sealed opaque envelopes. RESULTS: Allocation provided balanced groups and 86% of the participants were followed up for one month. The overall infection rate for newborns was 21%, and 18% for women. We found no significant differences in puerperal or neonatal infection rates (Puerperal infection: 41/190 [22%] with enema v 26/182 [14%] without enema; RR 0.66 CI 95%: 0.43 to 1.03; neonatal infection 38/191 [20%] with enema v 40/179 [22%] without enema; RR 1.12, 95% CI 95% 0.76 to 1.66), and median labour time was similar between groups (515 min. with enema v 585 min. without enema; P = 0.24). Enemas didn't significantly change episiorraphy dehiscence rates (21/182 [12%] with enema v 32/190 [17%] without enema; P = 0.30). CONCLUSION: This RCT found no evidence to support routine use of enemas during labour. Although these results cannot rule out a small clinical effect, it seems unlikely that enemas will improve maternal and neonatal outcomes and provide an overall benefit.

Journal Article↗

PubMed2004

Long acting beta2 agonists for stable chronic obstructive pulmonary disease with poor reversibility: a systematic review of randomised controlled trials.

BACKGROUND: The long acting beta2-agonists, salmeterol and formoterol, have been recommended, by some, as first line treatment of stable chronic obstructive pulmonary disease (COPD). We reviewed evidence of efficacy and safety when compared with placebo or anticholinergic agents in patients with poorly reversible COPD. METHODS: After searching MEDLINE, EMBASE, HealthSTAR, BIOSIS Previews, PASCAL, ToxFile, SciSearch, the Cochrane Library, and PubMed, as well as Web sites, selected journals, reference lists, and contacting drug manufacturers, two reviewers independently screened reports of randomised controlled trials of parallel or crossover design lasting four weeks or longer and including patients with a forced expiratory volume in one second (FEV1) < or = 75% of predicted, a ratio of FEV1 to forced vital capacity (FVC) < or = 88% of predicted, and < 15% improvement from baseline FEV1 after a dose of a beta2 agonist. We included trials comparing salmeterol or formoterol with placebo or with ipratropium bromide and reporting one of these outcomes: lung function; exercise capacity; quality of life scores; dyspnea; exacerbations; rescue inhaler use; incidence of tachycardia, hypokalemia, or dry mouth. Two reviewers assessed the quality of included reports using the Jadad scale and allocation concealment, and abstracted data. RESULTS: Twelve trials satisfied our inclusion criteria; eight were high quality (Jadad score >2) and four were low quality (< or = 2). The adequacy of allocation concealment was unclear in all of them. We did not perform a meta-analysis due to differences in trial design and how outcomes were reported.Two trials comparing salmeterol with ipratropium did not detect differences; one trial comparing formoterol and ipratropium described greater improvement with formoterol in morning PEFR (15.3 versus 7.1 l/min, p = 0.040). Of twelve trials comparing long acting beta2 agonists with placebo, six reported no improvement in exercise capacity, eleven reported improvements in FEV1 lung function (one reported no improvement), six reported less rescue inhaler usage (one reported no difference) and five reported improved dyspnea scores (two reported no improvement). Differences in quality of life were detected in one salmeterol trial; however, two salmeterol, and one formoterol trial reported no differences. Adverse effects of interest were not reported. CONCLUSION: In terms of clinical outcomes and safety, we could not find convincing evidence that salmeterol and formoterol have demonstrated advantages to ipratropium, a less expensive drug, for patients with stable COPD and poor reversibility. Compared to placebo, we found evidence of reduced rescue inhaler usage and improved spirometric outcomes without a significant impact on quality of life or exercise capacity.

Journal Article↗

PubMed2003

A cluster randomised controlled trial of patient-held medical records for people with schizophrenia receiving shared care.

BACKGROUND: Patient-held records can improve communication across the primary-secondary interface. There has been no previous rigorous assessment of the utility of patient-held records for people with schizophrenia from a primary care perspective and their value for this population is unclear. AIM: To evaluate the effectiveness of a patient-held record for patients with schizophrenia receiving shared care. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Seventy-four general practices and six community mental health localities in Birmingham, England between June 1998 and June 1999. METHOD: A sample of 201 patients with schizophrenia (ICD-10 classification F20) was recruited; of these, 100 were intervention and 101 were control. Patient-held records were given to the intervention patients. At 12-month follow-up, all patients were accounted for and 191 (95%) were revisited. Primary outcomes were the Verona Service Satisfaction Scale-54 (VSSS-54) and the Krawiecka and Goldberg (K & G) rating scale of psychopathology at 12-month follow-up. Secondary outcomes were use of primary and secondary care services. RESULTS: A total of 63/92 (68.5%) patients still had the patient-held record, 64/92 (69.6%) had used it, and 39 (60.9%) of the 64 who had used it said the patient-held record was regularly used by their keyworker. However the patient-held record had no significant effect on primary outcomes (VSSS-54: F1,116 = 0.06, P = 0.801, K & G: F1,116 = 0.6, P = 0.439) or on use of services. A higher symptom score was associated with not using the patient-held record. CONCLUSIONS: The trial provides no good evidence to suggest that patient-held records should be introduced as part of routine shared care for all patients with schizophrenia. However, the patient-held record was acceptable to patients with schizophrenia and acted as a communication tool, particularly between patients and keyworkers.

Adolescent↗