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Therapeutic nursing or unblocking beds? A randomised controlled trial of a post-acute intermediate care unit.

OBJECTIVES: To compare post-acute intermediate care in an inpatient nurse-led unit with conventional post-acute care on general medical wards of an acute hospital and to examine the model of care in a nurse-led unit. DESIGN: Randomised controlled trial with six month follow up. SETTING: Urban teaching hospital and surrounding area, including nine community hospitals. PARTICIPANTS: 238 patients accepted for admission to nurse-led unit. INTERVENTIONS: Care in nurse-led unit or usual post-acute care. MAIN OUTCOME MEASURES: Patients' length of stay, functional status, subsequent move to more dependent living arrangement. RESULTS: Inpatient length of stay was significantly longer in the nurse-led unit than in general medical wards (14.3 days longer (95% confidence interval 7.8 to 20.7)), but this difference became non-significant when transfers to community hospitals were included in the measure of initial length of stay (4.5 days longer (-3.6 to 12.5)). No differences were observed in mortality, functional status, or living arrangements at any time. Patients in the nurse-led unit received significantly fewer minor medical investigations and, after controlling for length of stay, significantly fewer major reviews, tests, or drug changes. CONCLUSIONS: The nurse-led unit seemed to be a safe alternative to conventional management, but a full accounting of such units' place in the local continuum of care and the costs associated with acute hospitals managing post-acute patients is needed if nurse-led units are to become an effective part of the government's recent commitment to intermediate care.

Acute Disease↗

Tailored written invitations for second round breast cancer screening: a randomised controlled trial.

OBJECTIVES: Firstly, to determine if attendance for second round mammography screening in those sent a tailored letter (that is, making reference to their screening history) is increased compared with those sent a standard letter; secondly, to investigate the acceptability of tailored letters. SETTING: North West Glasgow Breast Screening Centre. METHODS: A randomised controlled trial. RESULTS: Overall attendance was unrelated to whether the women were sent a tailored or standard letter; 60% of those sent the standard letter attended (922/1531) compared with 62% of those sent the tailored letter (956/1552) (chi 2 = 0.61, P = 0.4) (difference 2%; 95% confidence interval -2% to 5%). There were no significant differences in percentage attendance within each of the study subgroups: women who attended previously and received an all clear result, women who attended previously and received a false positive result, women who were invited previously and failed to attend, and women who were previously too young to be invited for screening. However, there was a statistically significant difference in percentage attendance between these four groups, independent of letter type (chi 2 = 510, P < 0.00001). Although women found the letters acceptable and understandable, they did not seem to pay close attention to the content. CONCLUSIONS: Tailoring invitation letters does not have a significant effect on uptake rates for breast screening and does not justify the additional workload required.

Breast Neoplasms↗

Use of randomised controlled trials for producing cost-effectiveness evidence: potential impact of design choices on sample size and study duration.

BACKGROUND: A number of approaches to conducting economic evaluations could be adopted. However, some decision makers have a preference for wholly stochastic cost-effectiveness analyses, particularly if the sampled data are derived from randomised controlled trials (RCTs). Formal requirements for cost-effectiveness evidence have heightened concerns in the pharmaceutical industry that development costs and times might be increased if formal requirements increase the number, duration or costs of RCTs. Whether this proves to be the case or not will depend upon the timing, nature and extent of the cost-effectiveness evidence required. OBJECTIVE: To illustrate how different requirements for wholly stochastic cost-effectiveness evidence could have a significant impact on two of the major determinants of new drug development costs and times, namely RCT sample size and study duration. DESIGN: Using data collected prospectively in a clinical evaluation, sample sizes were calculated for a number of hypothetical cost-effectiveness study design scenarios. The results were compared with a baseline clinical trial design. RESULTS: The sample sizes required for the cost-effectiveness study scenarios were mostly larger than those for the baseline clinical trial design. Circumstances can be such that a wholly stochastic cost-effectiveness analysis might not be a practical proposition even though its clinical counterpart is. In such situations, alternative research methodologies would be required. For wholly stochastic cost-effectiveness analyses, the importance of prior specification of the different components of study design is emphasised. However, it is doubtful whether all the information necessary for doing this will typically be available when product registration trials are being designed. CONCLUSIONS: Formal requirements for wholly stochastic cost-effectiveness evidence based on the standard frequentist paradigm have the potential to increase the size, duration and number of RCTs significantly and hence the costs and timelines associated with new product development. Moreover, it is possible to envisage situations where such an approach would be impossible to adopt. Clearly, further research is required into the issue of how to appraise the economic consequences of alternative economic evaluation research strategies.

Cost-Benefit Analysis↗

Virtual outreach: a randomised controlled trial and economic evaluation of joint teleconferenced medical consultations.

OBJECTIVES: To test the hypotheses that virtual outreach would reduce offers of hospital follow-up appointments and reduce numbers of medical interventions and investigations, reduce numbers of contacts with the health care system, have a positive impact on patient satisfaction and enablement, and lead to improvements in patient health status. To perform an economic evaluation of virtual outreach. DESIGN: A randomised controlled trial comparing joint teleconsultations between GPs, specialists and patients with standard outpatient referral. It was accompanied by an economic evaluation. SETTING: The trial was centred on the Royal Free Hampstead NHS Trust, London, and the Royal Shrewsbury Hospital Trust in Shropshire. The project teams recruited and trained a total of 134 GPs from 29 practices and 20 consultant specialists. PARTICIPANTS: In total, 3170 patients were referred, of whom 2094 consented to participate in the study and were eligible for inclusion. In all, 1051 patients were randomised to the virtual outreach group and 1043 to standard outpatient appointments. The patients were followed 6 months after their index consultation. INTERVENTIONS: Patients randomised to virtual outreach underwent a joint teleconsultation, in which they attended the general practice surgery where they and their GP consulted with a hospital specialist via a videolink between the hospital and the practice. MAIN OUTCOME MEASURES: Outcome measures included offers of follow-up outpatient appointments, numbers of tests, investigations, procedures, treatments and contacts with primary and secondary care, patient satisfaction (Ware Specific Visit Questionnaire), enablement (Patient Enablement Instrument) and quality of life (Short Form-12 and Child Health Questionnaire). An economic evaluation of the costs and consequences of the intervention was undertaken. Sensitivity analysis was used to test the robustness of the results. RESULTS: Patients in the virtual outreach group were more likely to be offered a follow-up appointment. Significant differences in effects were observed between the two sites and across different specialities. Virtual outreach increased the offers of follow-up appointments more in Shrewsbury than in London, and more in ENT and orthopaedics than in the other specialities. Fewer tests and investigations were ordered in the virtual outreach group, by an average of 0.79 per patient. In the 6-month period following the index consultation, there were no significant differences overall in number of contacts with general practice, outpatient visits, accident and emergency contacts, inpatient stays, day surgery and inpatient procedures or prescriptions between the randomised groups. Tests of interaction indicated that virtual outreach decreased the number of tests and investigations, particularly in patients referred to gastroenterology, and increased the number of outpatient visits, particularly in those referred to orthopaedics. Patient satisfaction was greater after a virtual outreach consultation than after a standard outpatient consultation, with no heterogeneity between specialities or sites. However, patient enablement after the index consultation, and the physical and psychological scores of the Short Form-12 for adults and the scores on the Child Health Questionnaire for children under 16, did not differ between the randomised groups at 6 months' follow-up. NHS costs over 6 months were greater for the virtual outreach consultations than for conventional outpatients, pound 724 and pound 625 per patient, respectively. The index consultation accounted for this excess. Cost and time savings to patients were found. Estimated productivity losses were also less in the virtual outreach group. CONCLUSIONS: Virtual outreach consultations result in significantly higher levels of patient satisfaction than standard outpatient appointments and lead to substantial reductions in numbers of tests and investigations, but they are variably associated with increased rates of offer of follow-up according to speciality and site. Changes in costs and technological advances may improve the relative position of virtual consultations in future. The extent to which virtual outreach is implemented will probably be dependent on factors such as patient demand, costs, and the attitudes of staff working in general practice and hospital settings. Further research could involve long-term follow-up of patients in the virtual outreach trial to determine downstream outcomes and costs; further study into the effectiveness and costs of virtual outreach used for follow-up appointments, rather than first-time referrals; and whether the costs of virtual outreach could be substantially reduced without adversely affecting the quality of the consultation if nurses or other members of the primary care team were to undertake the hosting of the joint teleconsultations in place of the GP. Qualitative work into the attitudes of the patients, GPs and hospital specialists would also be valuable.

Adult↗

A randomised controlled trial of a self-management plan for patients with newly diagnosed angina.

BACKGROUND: There are approximately 1.8 million patients with angina in the United Kingdom, many of whom report a poor quality of life, including raised levels of anxiety and depression. AIM: To evaluate the effect of a cognitive behavioural disease management programme, the Angina Plan, on psychological adjustment in patients newly diagnosed with angina pectoris. DESIGN OF STUDY: Randomised controlled trial. SETTING: Patients from GP practices in a Northern UK city (York) between April 1999 and May 2000. METHOD: Recruited patients were randomised to receive the Angina Plan or to a routine, practice nurse-led secondary prevention educational session. RESULTS: Twenty of the 25 practices invited to join the study supplied patients' names; 142 patients attended an assessment clinic and were randomised There were no significant differences in any baseline measures. At the six month post-treatment follow-up, 130 (91%) patients were reassessed. When compared with the educational session patients (using analysis of covariance adjusted for baseline scores in an intention-to-treat analysis) Angina Plan patients showed a greater reduction in anxiety (P = 0.05) and depression (P = 0.01), the frequency of angina (reduced by three episodes per week, versus a reduction of 0.4 per week, P = 0.016) the use of glyceryl trinitrate (reduced by 4.19 fewer doses per week versus a reduction of 0.59 per week, P = 0.018), and physical limitations (P<0.001: Seattle Angina Questionnaire). They were also more likely to report having changed their diet (41 versus 21, P<0.001) and increased their daily walking (30 versus 2, P<0.001). There was no significant difference between the groups on the other sub-scales of the Seattle Angina Questionnaire or in any of the medical variables measured. CONCLUSION: The Angina Plan appears to improve the psychological, symptomatic, and functional status of patients newly diagnosed with angina.

Adaptation, Psychological↗

A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo.

OBJECTIVE: To investigate the incidence of post-operative infection after first trimester abortion in women treated with a long-acting cephalosporin (ceftriaxone) compared with low risk patients receiving no treatment and with high risk patients receiving our standard treatment of ampicillin/pivampicillin and metronidazole. DESIGN: A prospective, randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Rigshospitalet, University of Copenhagen, Denmark. SUBJECTS: Nine hundred and ninety-six women, admitted on an outpatient basis for legal termination of pregnancy at 12 weeks or less of gestation, were included in the study after giving informed consent. The women were divided into high risk and low risk categories and allocated either to treatment with ceftriaxone or to standard treatment. For high risk patients the standard treatment was initiated by a peroperative injection of ampicillin and metronidazole, followed by oral doses of metronidazole and pivampicillin three times daily for four days. No prophylactic antibiotics were given to the women randomised to standard treatment in the low risk group. INTERVENTIONS: All women were kept under observation, and, between six and 14 days postoperatively, underwent pelvic examination. Clinical endpoints were noted. MAIN OUTCOME MEASURES: Post-operative pelvic inflammatory disease in women applying for legal first trimester abortion. RESULTS: Seven hundred and eighty-six women fulfilled the criteria for evaluation. A tendency toward a prophylactic effect of ceftriaxone was observed in most clinical findings. A significant prophylactic effect of ceftriaxone was found in the low risk group. CONCLUSIONS: This study demonstrated a significant reduction in post-operative pelvic inflammatory disease in low risk patients, who were applying for legal first trimester abortion, treated peroperatively with ceftriaxone. No significant difference was demonstrated between high risk patients treated with ceftriaxone or ampicillin/pivampicillin and metronidazole.

Abortion, Induced↗

Are investigations anxiolytic or anxiogenic? A randomised controlled trial of neuroimaging to provide reassurance in chronic daily headache.

OBJECTIVES: Aims were to investigate (a) whether neuroimaging in patients with chronic daily headache reassures patients or fails to reassure them and/or worsens outcome, impacting on service use, costs, health anxieties, and symptoms, and (b) whether this reassurance process occurs differentially in patients with different levels of psychological morbidity. METHODS DESIGN: randomised controlled trial; setting: headache clinic in secondary care, South London; participants: 150 patients fulfilling criteria for chronic daily headache, stratified using the Hospital Anxiety and Depression Scale (HADS); intervention: treatment as usual or the offer of an MRI brain scan; main outcome measures: use of services, costs, and health anxiety. RESULTS: Seventy six patients were randomised to the offer of a brain scan and 74 patients to treatment as usual. One hundred and thirty seven (91%) primary care case notes were examined at 1 year, 103 (69%) patients completed questionnaires at 3 months and 96 (64%) at 1 year. Sixty six (44%) patients were HADS positive (scored >11 on either subscale). Patients offered a scan were less worried about a serious cause of the headaches at 3 months (p = 0.004), but this was not maintained at 1 year; other health anxiety measures did not differ by scan status. However, at 1 year HADS positive patients offered a scan cost significantly less, by 465 pounds Sterling (95% confidence interval (CI): -1028 pounds Sterling to -104 pounds Sterling), than such patients not offered a scan, due to lower utilisation of medical resources. CONCLUSIONS: Neuroimaging significantly reduces costs for patients with high levels of psychiatric morbidity, possibly by changing subsequent referral patterns of the general practitioner.

Adult↗

A cross-sectional study of hypertension in an elderly population (75 years and over) with atrial fibrillation: secondary analysis of data from the Birmingham Atrial Fibrillation in the Aged (BAFTA) randomised controlled trial.

BACKGROUND: Atrial fibrillation and hypertension are two common conditions in the elderly, associated with significant morbidity and mortality. Little information is available regarding the epidemiology of hypertension in elderly patients with atrial fibrillation. SUBJECTS AND METHODS: A secondary analysis of data from the Birmingham Atrial Fibrillation Treatment of the Aged study, a randomised controlled trial of thrombo-prophylaxis in atrial fibrillation in a primary care population. The study population comprised patients aged 75 and over with electrocardiogram (ECG) confirmed atrial fibrillation. Blood pressure was recorded in the general practice surgery on two occasions using standardised methods. History of hypertension was sought from the medical records and from asking the patient. RESULTS: 3059 subjects had ECG confirmed atrial fibrillation. The prevalence of a history of hypertension in this group was 57.5%. The mean systolic blood pressure was 141 mmHg (standard deviation: 21 mmHg) in men and 144 mmHg (22 mmHg) in women. The mean diastolic blood pressure was 79 mmHg (12 mmHg) in men and 80 mmHg in women (12 mmHg). The mean systolic blood pressure was slightly lower than that of the general population aged 75 and over, but the mean diastolic blood pressure was significantly higher in patients in atrial fibrillation (by 8 mmHg). Among the patients with a diagnosis of hypertension, 86.5% were on blood pressure lowering medications. CONCLUSIONS: Hypertension is more commonly diagnosed in older patients with atrial fibrillation than in the general population. The mean systolic blood pressure is slightly lower, but the mean diastolic blood pressure substantially higher in older patients in atrial fibrillation, compared to the general population.

Aged↗

The views of nurses to the conduct of a randomised controlled trial of problem drinkers in an accident and emergency department.

The Trent Regional Health Authority funded a study in 1995 to train nurses in an accident and emergency (A&E) department to screen all adult attendees for alcohol problems with a view to identifying a sample of problem drinkers to participate in a randomised controlled trial (RCT). In the RCT identified drinkers were to be assigned either to health education plus brief counselling intervention or, as controls, to health education alone. Despite 16654 attendance's at A&E during the recruitment phase of the study only 20% of attendees were screened of whom a further 19% were identified as problem drinkers by the CAGE screening questionnaire. Less than half of the problem drinkers were, however, provided with feedback by the nurses, leaving a small group of 264 eligible for entry to the RCT. The great majority of this subgroup refused an initial appointment at the specialist clinic and so the trial was abandoned. A number of in-depth interviews were undertaken with the nurses in an attempt to understand ways in which the overall conduct of the study might have been improved. This paper outlines in some detail some of the reasons for the lack of success with the study which include; general environmental factors that undoubtedly led to stress and poor morale amongst the nursing team, the differences in perception between managers and clinical nurses concerning the value of research and the inadequacy of the initial training programme. The paper concludes that there are problems in the NHS which do not provide a helpful backcloth to the successful conduct of health services research.

Adult↗

Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group.

BACKGROUND: Use of some antiviral drugs for influenza infection is limited by potential rapid emergence of resistance. We studied the efficacy and safety of oseltamivir, the oral prodrug of the neuraminidase inhibitor GS4071, in adults with naturally acquired laboratory-confirmed influenza. METHODS: We did a randomised controlled trial of 726 previously healthy non-immunised adults with febrile influenza-like illness of up to 36 h duration. Patients were assigned oral oseltamivir 75 mg (n=243), oseltamivir 150 mg (n=245), or placebo (n=238) twice daily for 5 days. We assessed recovery by questionnaire and temperature recordings. The primary endpoint was time to resolution of illness in influenza-infected patients. FINDINGS: 475 (66%) patients had confirmed infection. Duration of illness was significantly shorter by 29 h (25% reduction, median duration 87.4 h [95% CI 73.3-104.7], p=0.02) with oseltamivir 75 mg and by 35 h (30%, 81.8 h [68.2-100.0], p=0.01) with oseltamivir 150 mg than with placebo (116.5 h [101.5-137.8]). The effect of oseltamivir was apparent within 24 h of the start of treatment. In patients treated within 24 h of symptom onset, symptoms were alleviated 43 h (37% reduction) and 47 h (40%) earlier with oseltamivir 75 mg and 150 mg, respectively, compared with placebo (75 mg 74.5 h [68.2-98.0], p=0.02; 150 mg 70.7 h [54.0-89.4], p=0.01; placebo 117.5 h [103.0-143.8]). Oseltamivir was associated with lower [corrected] symptom scores, less viral shedding, and improved health, activity, and sleep quality, and was well tolerated. INTERPRETATION: Oseltamivir was effective and well tolerated in the treatment of natural influenza infection in adults. The efficacy, tolerability, and ease of administration warrant further investigation in children, elderly patients, and at-risk patients.

Acetamides↗

Do community football players wear allocated protective equipment? Descriptive results from a randomised controlled trial.

Before protective equipment can be adopted as an effective sports safety intervention, its protective effects in reducing the incidence and severity of injury need to be demonstrated, Importantly, it also needs to be well accepted by the players. The Australian Football Injury Prevention Project (AFIPP) was a large scale community-based randomised controlled trial to assess the effectiveness of headgear and mouthguards in preventing head/neck/dental injuries in Australian Football. A subcomponent of this study was to assess the extent to which community football players complied with the requirement to wear protective headgear and/or mouthguards, as this equipment is not compulsory in this sport. Three hundred and one community football players from 23 teams were randomly allocated to one of three protective equipment intervention arms or one control arm. Protective equipment usage was measured by a primary data collector at each training and game session during the 2001 playing season. Mouthguard use was higher than headgear use, with the highest usage for both being measured during games rather than training. Although many players use mouthguards, particularly in games, most do not wear headgear. Given the low adoption of headgear, other strategies to prevent head injuries need further investigation.

Football↗

Droperidol and 5-HT3-receptor antagonists, alone or in combination, for prophylaxis of postoperative nausea and vomiting. A meta-analysis of randomised controlled trials.

BACKGROUND: Droperidol and 5-HT3-receptor antagonists are among the most potent antiemetics to prevent postoperative nausea and vomiting (PONV). Combinations of these drugs have been used to increase the efficacy of antiemetic treatment. However, so far the quantitative effect of this combination has not been evaluated systematically. METHODS: Results from randomised controlled trials investigating the efficacy of 5-HT3-receptor antagonists or droperidol alone versus the combination of both drugs to prevent PONV were included in a meta-analysis. Studies were systematically searched using Medline, EMBASE, the Cochrane-Library, and by manually screening the reference lists of matching review articles and current issues of locally available peer-reviewed anaesthesia journals. Seven papers with data on granisetron published by Fujii and co-workers were not considered. The main end point in each study was defined as occurrence of nausea, retching, or vomiting within 6 h ("early PONV") and within 48 h ("late PONV") after surgery. The relative risks (RR) and the numbers needed to treat (NNT) of the pooled data with their corresponding 95% confidence intervals (given in parentheses) were calculated using a random effects model. RESULTS: Eight studies with 881 patients (adults: n=801; children (mean age: 8 yr): n=80) were included in the analysis. Droperidol was applied to 340 patients, 5-HT3-receptor antagonists to 198, and 343 were treated with a combination of both drugs. Seven out of these eight studies reported increased antiemetic efficacy of the combination group compared with the single drugs (droperidol and 5-HT3-receptor antagonists respectively). However, in none of the trials did this difference reach statistical significance. When a meta-analytic analysis based on these results was performed the combination of droperidol with a 5-HT3-receptor antagonist was not associated with a significantly increased antiemetic efficacy. In 12 to 13 patients a 5-HT3-receptor antagonist has to be added to droperidol prophylaxis to prevent one additional patient from PONV who would have had suffered from PONV when treated with droperidol alone (RR "early PONV": 1.52 (0.95-2.44); RR "late PONV": 1.24 (0.89-1.74)). Similar results were obtained when the antiemetic effect of adding droperidol to a prophylaxis with 5-HT3-receptor antagonists was analysed. In this case 10 to 12 patients have to be treated with the 5-HT3-droperidol combination instead of with a 5-HT3-receptor antagonist alone to prevent one additional patient from PONV (RR "early PONV": 1.55 (0.68-3.52); RR "late PONV": 1.29 (0.77-2.17)). There were no reports of an increased incidence of adverse effects. CONCLUSION: The data on the combination of droperidol with 5-HT3-receptor antagonists suggest that there is a trend towards increased efficacy of the combination therapy compared to the single drugs. However, so far there are insufficient data to recommend this combination treatment for prophylaxis.

Antiemetics↗

Advance directives for patients compulsorily admitted to hospital with serious mental illness. Randomised controlled trial.

BACKGROUND: An advance directive is a statement of a person's preferences for treatment, should he or she lose capacity to make treatment decisions in the future. AIMS: To evaluate whether use of advance directives by patients with mental illness leads to lower rates of compulsory readmission to hospital. METHOD: In a randomised controlled trial in two psychiatric services in inner London, 156 in-patients about to be discharged from compulsory treatment under the Mental Health Act were recruited. The trial compared usual psychiatric care with usual care plus the completion of an advance directive. The primary outcome was the rate of compulsory readmission. RESULTS: Fifteen patients (19%) in the intervention group and 16 (21%) in the control group were readmitted compulsorily within 1 year of discharge. There was no difference in the numbers of compulsory readmissions, numbers of patients readmitted voluntarily, days spent in hospital or satisfaction with psychiatric services. CONCLUSIONS: Users' advance instruction directives had little observable impact on the outcome of care at 12 months.

Adult↗

Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis.

OBJECTIVES: To determine the effects of a policy of using acupuncture, compared with a policy of avoiding acupuncture, on headache in primary care patients with chronic headache disorders. The effects of acupuncture on medication use, quality of life, resource use and days off sick in this population and the cost-effectiveness of acupuncture were also examined. DESIGN: Randomised, controlled trial. SETTING: General practices in England and Wales. PARTICIPANTS: The study included 401 patients with chronic headache disorder, predominantly migraine. INTERVENTIONS: Patients were randomly allocated to receive up to 12 acupuncture treatments over 3 months or to a control intervention offering usual care. MAIN OUTCOME MEASURES: Outcome measures included headache score; assessment of Short Form 36 (SF-36) health status and use of medication at baseline, 3 months and 12 months; assessment of use of resources every 3 months; and assessment of incremental cost per quality-adjusted life-year (QALY) gained. RESULTS: Headache score at 12 months, the primary end-point, was lower in the acupuncture group than in controls. The adjusted difference between means was 4.6. This result was robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year. SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication, made 25% fewer visits to GPs and took 15% fewer days off sick. Total costs during the 1-year period of the study were on average higher for the acupuncture group than for controls because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the year of the trial was 0.021 QALYs, leading to a base-case estimate of GBP9180 per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial. CONCLUSIONS: The study suggests that acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. It is relatively cost-effective compared with a number of other interventions provided by the NHS. Further studies could examine the duration of acupuncture effects beyond 1 year and the relative benefit to patients with migraine with compared to tension-type headache. Trials are also warranted examining the effectiveness and cost-effectiveness of acupuncture in patients with headache receiving more aggressive pharmacological management.

Acupuncture↗

Cost effectiveness of interventions for lateral epicondylitis: results from a randomised controlled trial in primary care.

OBJECTIVE: Lateral epicondylitis is a common complaint, with an annual incidence between 1% and 3% in the general population. The Dutch College of General Practitioners in The Netherlands has issued guidelines that recommend a wait-and-see policy. However, these guidelines are not evidence based. DESIGN AND SETTING: This paper presents the results of an economic evaluation in conjunction with a randomised controlled trial to evaluate the effects of three interventions in primary care for patients with lateral epicondylitis. PATIENTS AND INTERVENTIONS: Patients with pain at the lateral side of the elbow were randomised to one of three interventions: a wait-and-see policy, corticosteroid injections or physiotherapy. MAIN OUTCOME MEASURES AND RESULTS: Clinical outcomes included general improvement, pain during the day, elbow disability and QOL. The economic evaluation was conducted from a societal perspective. Direct and indirect costs (in 1999 values) were measured by means of cost diaries over a period of 12 months. Differences in mean costs between groups were evaluated by applying non-parametric bootstrap techniques. The mean total costs per patient for corticosteroid injections were euro430, compared with euro631 for the wait-and-see policy and euro921 for physiotherapy. After 12 months, the success rate in the physiotherapy group (91%) was significantly higher than in the injection group (69%), but only slightly higher than in the wait-and-see group (83%). The differences in costs and effects showed no dominance for any of the three groups. The incremental cost-utility ratios were (approximately): euro7000 per utility gain for the wait-and-see policy versus corticosteroid injections; euro12000 per utility gain for physiotherapy versus corticosteroid injections, and euro34500 for physiotherapy versus the wait-and-see policy. CONCLUSIONS: The results of this economic evaluation provided no reason to update or amend the Dutch guidelines for GPs, which recommend a wait-and-see policy for patients with lateral epicondylitis.

Adolescent↗

Randomised controlled trials of physical activity promotion in free living populations: a review.

OBJECTIVES: To review evidence on the effectiveness of trials of physical activity promotion in healthy, free living adults. To identify the more effective intervention programmes. METHODS: Computerised databases and references were searched. Experts were contacted and asked for information about existing work. INCLUSION CRITERIA: Randomised controlled trials of healthy, free living adult subjects, where exercise behaviour was the dependent variable were included. CONCLUSIONS: Ten trials were identified. The small number of trials limits the strength of any conclusions and highlights the need for more research. No UK based studies were found. Previously sedentary adults can increase activity levels and sustain them. Promotion of these changes requires personal instruction, continued support, and exercise of moderate intensity which does not depend on attendance at a facility. The exercise should be easily included into an existing lifestyle and should be enjoyable. Walking is the exercise most likely to fulfil these criteria.

Adult↗

Exploratory cluster randomised controlled trial of shared care development for long-term mental illness.

BACKGROUND: Primary care clinicians have a considerable amount of contact with patients suffering from long-term mental illness. The United Kingdom's National Health Service now requires general practices to contribute more systematically to care for this group of patients. AIMS: To determine the effects of Mental Health Link, a facilitation-based quality improvement programme designed to improve communication between the teams and systems of care within general practice. DESIGN OF STUDY: Exploratory cluster randomised controlled trial. SETTING: Twenty-three urban general practices and associated community mental health teams. METHOD: Practices were randomised to service development as usual or to the Mental Health Link programme. Questionnaires and an audit of notes assessed 335 patients' satisfaction, unmet need, mental health status, processes of mental and physical care, and general practitioners' satisfaction with services and beliefs about service development. Service use and intervention costs were also measured. RESULTS: There were no significant differences in patients' perception of their unmet need, satisfaction or general health. Intervention patients had fewer psychiatric relapses than control patients (mean = 0.39 versus 0.71, respectively, P = 0.02) but there were no differences in documented processes of care. Intervention practitioners were more satisfied and services improved significantly for intervention practices. There was an additional mean direct cost of pound 63 per patient with long-term mental illness for the intervention compared with the control. CONCLUSION: Significant differences were seen in relapse rates and practitioner satisfaction. Improvements in service development did not translate into documented improvements in care. This could be explained by the intervention working via the improvements in informal shared care developed through better link working. This type of facilitated intervention tailored to context has the potential to improve care and interface working.

Adult↗

Constraint-induced movement therapy following stroke: a systematic review of randomised controlled trials.

This systematic review investigated the effects on function, quality of life, health care costs, and patient/carer satisfaction of constraint-induced movement therapy (CIMT) for upper limb hemiparesis following stroke. A comprehensive search of the complete holdings of MEDLINE, CINAHL, EMBASE, Cochrane Library, PEDro and OTseeker to March 2005 was conducted. Fourteen eligible randomised controlled trials were identified and relevant data extracted by two independent reviewers. Effect sizes were calculated and results were pooled where possible. Method quality of the trials, assessed using the PEDro scale, had a mean score of five (range three to seven). Thirteen trials compared CIMT to an alternative treatment and/or a control group. One trial compared two CIMT protocols. Acute, subacute, and chronic conditions were studied. Effect sizes could be estimated for nine trials. Results were significant and in favour of CIMT in eight of these for at least one measure of upper limb function. The pooled standardised mean difference could be calculated for five outcome measures producing moderate to large effect sizes, only one of which attained statistical significance. Results indicate that CIMT may improve upper limb function following stroke for some patients when compared to alternative or no treatment. Rigorous evaluation of constraint-induced movement therapy using well-designed and adequately powered trials is required to evaluate the efficacy of different protocols on different stroke populations and to assess impact on quality of life, cost and patient/carer satisfaction.

Activities of Daily Living↗