Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.

OBJECTIVE: To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes. DESIGN: Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation. SETTING: 11 diabetes clinics in England and Wales. PARTICIPANTS: Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention. INTERVENTION: We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use. RESULTS: Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents. CONCLUSIONS: Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes. TRIAL REGISTRATION NUMBER: ISRCTN17551624.

Community-based interventions to prevent fatal overdose from illegal drugs: a systematic review protocol.

INTRODUCTION: Drug overdose is the most frequent cause of death among people who misuse illegal drugs. People who inject these drugs are 14-17 times more likely to die than their non-drug using peers. Various strategies to reduce drug-related deaths have failed to meet target reductions. Research into community-based interventions for preventing drug overdose deaths is promising. This review seeks to identify published studies describing community-based interventions and to evaluate their effectiveness at reducing drug overdose deaths. METHODS AND ANALYSIS: We will systematically search key electronic databases using a search strategy which groups terms into four facets: (1) Overdose event, (2) Drug classification, (3) Intervention and (4) Setting. Searches will be limited where possible to international literature published in English between 1998 and 2014. Data will be extracted by two independent reviewers using a predefined table adapted from the Cochrane Collaboration handbook. The quality of included studies will be evaluated using the Cochrane Collaboration's tool for assessing risk of bias. We will conduct a meta-analysis for variables which can be compared across studies, using statistical methods to control for heterogeneity where appropriate. Where clinical or statistical heterogeneity prevents a valid numerical synthesis, we will employ a narrative synthesis to describe community-based interventions, their delivery and use and how effectively they prevent fatal overdoses. ETHICS AND DISSEMINATION: We will publish findings from this systematic review in a peer-reviewed scientific journal and present results at national and international conferences. It will be disseminated electronically and in print. TRIAL REGISTRATION NUMBER: PROSPERO CRD42015017833.

Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients.

BACKGROUND: The incidence of incisional hernias (IHs) following midline abdominal incisions is difficult to estimate. Furthermore recent analyses have reported inconsistent findings on the superiority of absorbable versus non-absorbable sutures. OBJECTIVE: To estimate the mean IH rate following midline laparotomy from the published literature, to identify variables that predict IH rates and to analyse whether the type of suture (absorbable versus non-absorbable) affects IH rates. METHODS: We undertook a systematic review according to PRISMA guidelines. We sought randomised trials and observational studies including patients undergoing midline incisions with standard suture closure. Papers describing two or more arms suitable for inclusion had data abstracted independently for each arm. RESULTS: Fifty-six papers, describing 83 separate groups comprising 14,618 patients, met the inclusion criteria. The prevalence of IHs after midline incision was 12.8% (range: 0 to 35.6%) at a weighted mean of 23.7 months. The estimated risk of undergoing IH repair after midline laparotomy was 5.2%. Two meta-regression analyses (A and B) each identified seven characteristics associated with increased IH rate: one patient variable (higher age), two surgical variables (surgery for AAA and either surgery for obesity surgery (model A) or using an upper midline incision (model B)), two inclusion criteria (including patients with previous laparotomies and those with previous IHs), and two circumstantial variables (later year of publication and specifying an exact significance level). There was no significant difference in IH rate between absorbable and non-absorbable sutures either alone or in conjunction with either regression analysis. CONCLUSIONS: The IH rate estimated by pooling the published literature is 12.8% after about two years. Seven factors account for the large variation in IH rates across groups. However there is no evidence that suture type has an intrinsic effect on IH rates.

Cost-effectiveness of steroid (methylprednisolone) injections versus anaesthetic alone for the treatment of Morton's neuroma: economic evaluation alongside a randomised controlled trial (MortISE trial).

BACKGROUND: Morton's neuroma is a common foot condition affecting health-related quality of life. Though its management frequently includes steroid injections, evidence of cost-effectiveness is sparse. So, we aimed to evaluate whether steroid injection is cost-effective in treating Morton's neuroma compared with anaesthetic injection alone. METHODS: We undertook incremental cost-effectiveness and cost-utility analyses from the perspective of the National Health Service, alongside a patient-blinded pragmatic randomised trial in hospital-based orthopaedic outpatient clinics in Edinburgh, UK. Of the original randomised sample of 131 participants with Morton's neuroma (including 67 controls), economic analysis focused on 109 (including 55 controls). Both groups received injections guided by ultrasound. We estimated the incremental cost per point improvement in the area under the curve of the Foot Health Thermometer (FHT-AUC) until three months after injection. We also conducted cost-utility analyses using European Quality of life-5 Dimensions-3 Levels (EQ-5D-3L), enhanced by the Foot Health Thermometer (FHT), to estimate utility and thus quality-adjusted life years (QALYs). RESULTS: The unit cost of an ultrasound-guided steroid injection was £149. Over the three months of follow-up, the mean cost of National Health Service resources was £280 for intervention participants and £202 for control participants - a difference of £79 [bootstrapped 95% confidence interval (CI): £18 to £152]. The corresponding estimated incremental cost-effectiveness ratio was £32 per point improvement in the FHT-AUC (bootstrapped 95% CI: £7 to £100). If decision makers value improvement of one point at £100 (the upper limit of this CI), there is 97.5% probability that steroid injection is cost-effective. As EQ-5D-3L seems unresponsive to changes in foot health, we based secondary cost-utility analysis on the FHT-enhanced EQ-5D. This estimated the corresponding incremental cost-effectiveness ratio as £6,400 per QALY. Over the recommended UK threshold, ranging from £20,000 to £30,000 per QALY, there is 80%-85% probability that steroid injection is cost-effective. CONCLUSIONS: Steroid injections are effective and cost-effective in relieving foot pain measured by the FHT for three months. However, cost-utility analysis was initially inconclusive because the EQ-5D-3L is less responsive than the FHT to changes in foot health. By using the FHT to enhance the EQ-5D, we inferred that injections yield good value in cost per QALY. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13668166.

Randomised controlled trial. Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: Trial design and protocol (CONSTRUCT).

INTRODUCTION: Many patients with ulcerative colitis (UC) present with acute exacerbations needing hospital admission. Treatment includes intravenous steroids but up to 40% of patients do not respond and require emergency colectomy. Mortality following emergency colectomy has fallen, but 10% of patients still die within 3 months of surgery. Infliximab and ciclosporin, both immunosuppressive drugs, offer hope for treating steroid-resistant UC as there is evidence of their short-term effectiveness. As there is little long-term evidence, this pragmatic randomised trial, known as Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT), aims to compare the clinical and cost-effectiveness of infliximab and ciclosporin for steroid-resistant UC. METHODS AND ANALYSIS: Between May 2010 and February 2013, 52 UK centres recruited 270 patients admitted with acute severe UC who failed to respond to intravenous steroids but did not need surgery. We allocated them at random in equal proportions between infliximab and ciclosporin.The primary clinical outcome measure is quality-adjusted survival, that is survival weighted by Crohn's and Colitis Questionnaire (CCQ) participants' scores, analysed by Cox regression. Secondary outcome measures include: the CCQ-an extension of the validated but community-focused UK Inflammatory Bowel Disease Questionnaire (IBDQ) to include patients with acute severe colitis and stoma; two general quality of life measures-EQ-5D and SF-12; mortality; survival weighted by EQ-5D; emergency and planned colectomies; readmissions; incidence of adverse events including malignancies, serious infections and renal disorders; disease activity; National Health Service (NHS) costs and patient-borne costs. Interviews investigate participants' views on therapies for acute severe UC and healthcare professionals' views on the two drugs and their administration. ETHICS AND DISSEMINATION: The Research Ethics Committee for Wales has given ethical approval (Ref. 08/MRE09/42); each participating Trust or Health Board has given NHS Reseach & Development approval. We plan to present trial findings at international and national conferences and publish in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER ISRCTN: 22663589; EudraCT number: 2008-001968-36.

Mindfulness-based cognitive therapy for preventing relapse in recurrent depression: a randomized dismantling trial.

OBJECTIVE: We compared mindfulness-based cognitive therapy (MBCT) with both cognitive psychological education (CPE) and treatment as usual (TAU) in preventing relapse to major depressive disorder (MDD) in people currently in remission following at least 3 previous episodes. METHOD: A randomized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU, CPE plus TAU, and TAU alone, and data were analyzed for the 255 (93%; MBCT = 99, CPE = 103, TAU = 53) retained to follow-up. MBCT was delivered in accordance with its published manual, modified to address suicidal cognitions; CPE was modeled on MBCT, but without training in meditation. Both treatments were delivered through 8 weekly classes. RESULTS: Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up, hazard ratio for MBCT vs. CPE = 0.88, 95% CI [0.58, 1.35]; for MBCT vs. TAU = 0.69, 95% CI [0.42, 1.12]. However, severity of childhood trauma affected relapse, hazard ratio for increase of 1 standard deviation = 1.26 (95% CI [1.05, 1.50]), and significantly interacted with allocated treatment. Among participants above median severity, the hazard ratio was 0.61, 95% CI [0.34, 1.09], for MBCT vs. CPE, and 0.43, 95% CI [0.22, 0.87], for MBCT vs. TAU. For those below median severity, there were no such differences between treatment groups. CONCLUSION: MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma, but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression.

Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial.

BACKGROUND: Morton neuroma is a common cause of neuralgia affecting the web spaces of the toes. Corticosteroid injections are commonly administered as a first-line therapy, but the evidence for their effectiveness is weak. Our primary research aim was to determine whether corticosteroid injection is an effective treatment for Morton neuroma compared with an anesthetic injection as a placebo control. METHODS: We performed a pragmatic, patient-blinded randomized trial set within hospital orthopaedic outpatient clinics in Edinburgh, United Kingdom. One hundred and thirty-one participants with Morton neuroma (mean age, fifty-three years; 111 [85%] female) were randomized to receive either corticosteroid and anesthetic (1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine) or anesthetic alone (2 mL 1% lignocaine). An ultrasonographic image was obtained before treatment, and injections were performed with the needle placed under ultrasonographic guidance. The primary outcome was the difference in patient global assessment of foot health between the two groups at three months after injection. This was measured with use of a 100-unit visual analog scale (VAS) anchored by "best imaginable health state" and "worst imaginable health state." RESULTS: Compared with the control group, global assessment of foot health in the corticosteroid group was significantly better at three months (mean difference, 14.1 scale points [95% confidence interval, 5.5 to 22.8 points]; p = 0.002). The difference between the groups was also significant at one month. Significant and nonsignificant improvements associated with the corticosteroid injection were observed for measures of pain, function, and patient global assessment of general health at one and three months after injection. The size of the neuroma as determined by ultrasonography did not significantly influence the treatment effect. CONCLUSIONS: Corticosteroid injections for Morton neuroma can be of symptomatic benefit for at least three months.

Enhancing ventilation in homes of children with asthma: pragmatic randomised controlled trial.

BACKGROUND: Few robust studies have tested whether enhancing housing also improves health. AIM: To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma. DESIGN AND SETTING: Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK. METHOD: A pragmatic RCT was carried out, of a tailored package of housing improvements providing adequate ventilation and temperature, following inspection by a housing officer. One hundred and ninety-two children with asthma aged 5 to 14 years, identified from general practice registers, were randomised to receive this package, either immediately or a year after recruitment. At baseline, and after 4 and 12 months, parents reported their child's asthma-specific and generic quality of life, and days off school. RESULTS: The package improved parent-reported asthma-specific quality of life significantly at both 4 and 12 months. At 12 months, this showed an adjusted mean difference between groups of 7.1 points (95% confidence interval [CI] = 2.8 to 11.4, P= 0.001): a moderate standardised effect size of 0.42. The generic quality-of-life scale showed reported physical problems were significantly reduced at 4 months, but not quite at 12 months, when the mean difference was 4.5 (95% CI = -0.2 to 9.1, P= 0.061). The improvement in psychosocial quality of life at 12 months was not significant, with a mean difference of 2.2 (95% CI = -1.9 to 6.4, P= 0.292). Parent-reported school attendance improved, but not significantly. CONCLUSION: This novel and pragmatic trial, with integrated economic evaluation, found that tailored improvement of the housing of children with moderate to severe asthma significantly increases parent-reported asthma-related quality of life and reduces physical problems. Collaborative housing initiatives have potential to improve health.

Enhancing ventilation in homes of children with asthma: cost-effectiveness study alongside randomised controlled trial.

BACKGROUND: There has been little rigorous economic analysis of the relationship between asthma and improved housing. AIM: To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with 'moderate' or 'severe' asthma. DESIGN AND SETTING: An incremental cost-effectiveness analysis alongside a pragmatic randomised controlled trial of a tailored package of housing modifications designed to improve ventilation and household heating in homes within Wrexham County Borough, Wales, UK. METHOD: A total of 177 children aged between 5 and 14 years, identified from general practice registers, were studied. Parents reported on the quality of life of their children over a 12-month period. General practices reported on health-service resources used by those children, and their asthma-related prescriptions, over the same period. RESULTS: The tailored package shifted 17% of children in the intervention group from 'severe' to 'moderate' asthma, compared with a 3% shift in the control group. The mean cost of these modifications was £1718 per child treated or £12300 per child shifted from 'severe' to 'moderate'. Healthcare costs over 12 months following randomisation did not differ significantly between intervention and control groups. Bootstrapping gave an incremental cost-effectiveness ratio (ICER) of £234 per point improvement on the 100-point PedsQL™ asthma-specific scale, with 95% confidence interval (CI) = £140 to £590. The ICER fell to £165 (95% CI = £84 to £424) for children with 'severe' asthma. CONCLUSION: This novel and pragmatic trial, with integrated economic evaluation, reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public resources. This is a rare example of evidence for collaboration between local government and the NHS.

Staying well after depression: trial design and protocol.

BACKGROUND: Depression is often a chronic relapsing condition, with relapse rates of 50-80% in those who have been depressed before. This is particularly problematic for those who become suicidal when depressed since habitual recurrence of suicidal thoughts increases likelihood of further acute suicidal episodes. Therefore the question how to prevent relapse is of particular urgency in this group. METHODS/DESIGN: This trial compares Mindfulness-Based Cognitive Therapy (MBCT), a novel form of treatment combining mindfulness meditation and cognitive therapy for depression, with both Cognitive Psycho-Education (CPE), an equally plausible cognitive treatment but without meditation, and treatment as usual (TAU). It will test whether MBCT reduces the risk of relapse in recurrently depressed patients and the incidence of suicidal symptoms in those with a history of suicidality who do relapse. It recruits participants, screens them by telephone for main inclusion and exclusion criteria and, if they are eligible, invites them to a pre-treatment session to assess eligibility in more detail. This trial allocates eligible participants at random between MBCT and TAU, CPE and TAU, and TAU alone in a ratio of 2:2:1, stratified by presence of suicidal ideation or behaviour and current anti-depressant use. We aim to recruit sufficient participants to allow for retention of 300 following attrition. We deliver both active treatments in groups meeting for two hours every week for eight weeks. We shall estimate effects on rates of relapse and suicidal symptoms over 12 months following treatment and assess clinical status immediately after treatment, and three, six, nine and twelve months thereafter. DISCUSSION: This will be the first trial of MBCT to investigate whether MCBT is effective in preventing relapse to depression when compared with a control psychological treatment of equal plausibility; and to explore the use of MBCT for the most severe recurrent depression--that in people who become suicidal when depressed.

Follow-up of cancer in primary care versus secondary care: systematic review.

BACKGROUND: Cancer follow-up has traditionally been undertaken in secondary care, but there are increasing calls to deliver it in primary care. AIM: To compare the effectiveness and cost-effectiveness of primary versus secondary care follow-up of cancer patients, determine the effectiveness of the integration of primary care in routine hospital follow-up, and evaluate the impact of patient-initiated follow-up on primary care. DESIGN OF STUDY: Systematic review. SETTING: Primary and secondary care settings. METHOD: A search was carried out of 19 electronic databases, online trial registries, conference proceedings, and bibliographies of included studies. The review included comparative studies or economic evaluations of primary versus secondary care follow-up, hospital follow-up with formal primary care involvement versus conventional hospital follow-up, and hospital follow-up versus patient-initiated or minimal follow-up if the study reported the impact on primary care. RESULTS: There was no statistically significant difference for patient wellbeing, recurrence rate, survival, recurrence-related serious clinical events, diagnostic delay, or patient satisfaction. GP-led breast cancer follow-up was cheaper than hospital follow-up. Intensified primary health care resulted in increased home-care nurse contact, and improved discharge summary led to increased GP contact. Evaluation of patient-initiated or minimal follow-up found no statistically significant impact on the number of GP consultations or cancer-related referrals. CONCLUSION: Weak evidence suggests that breast cancer follow-up in primary care is effective. Interventions improving communication between primary and secondary care could lead to greater GP involvement. Discontinuation of formal follow-up may not increase GP workload. However, the quality of the data in general was poor, and no firm conclusions can be reached.

Patients' and healthcare professionals' views of cancer follow-up: systematic review.

BACKGROUND: Cancer follow-up places a significant burden on hospital outpatient clinics. There are increasing calls to develop alternative models of provision. AIM: To undertake a systematic review of qualitative studies examining patients' and healthcare professionals' views about cancer follow-up. DESIGN OF STUDY: Systematic review. SETTING: Primary and secondary care. METHOD: Comprehensive literature searches included: 19 electronic databases, online trial registries, conference proceedings, and bibliographies of included studies. Eligible studies included qualitative studies examining patients' and healthcare professionals' views of cancer follow-up. Studies of patients with any type of cancer, considered free of active disease, or no longer receiving active treatment were included. Findings were synthesised using thematic analysis. RESULTS: Nineteen studies were included; seven were linked to randomised controlled trials. Eight studies examined the views of healthcare professionals (four of which included GPs) and 16 examined the views of patients. Twelve descriptive themes were identified, from which 12 perceived implications for practice were derived. Most themes related to conventional follow-up in secondary care. Some views concerning other models of care were based on participants' ideas, rather than experiences. CONCLUSION: Patients' main concern is recurrent disease, and they find regular follow-up, expertise of specialists, and quick access to tests reassuring. Information regarding the effectiveness of follow-up is not given to patients who also have unmet information needs, which would help them to cope and be more involved. Continuity of care, unhurried consultations, and psychosocial support are important, but sometimes lacking in secondary care. GPs are thought to be unwilling and to have insufficient time and expertise to conduct follow-up.

Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial.

BACKGROUND: The clinical literature cautions against use of meditation by people with psychosis. There is, however, evidence for acceptance-based therapy reducing relapse, and some evidence for clinical benefits of mindfulness groups for people with distressing psychosis, though no data on whether participants became more mindful. AIMS: To assess feasibility of randomized evaluation of group mindfulness therapy for psychosis, to replicate clinical gains observed in one small uncontrolled study, and to assess for changes in mindfulness. METHOD: Twenty-two participants with current distressing psychotic experiences were allocated at random between group-based mindfulness training and a waiting list for this therapy. Mindfulness training comprised twice-weekly sessions for 5 weeks, plus home practice (meditation CDs were supplied), followed by 5 weeks of home practice. RESULTS: There were no significant differences between intervention and waiting-list participants. Secondary analyses combining both groups and comparing scores before and after mindfulness training revealed significant improvement in clinical functioning (p = .013) and mindfulness of distressing thoughts and images (p = .037). CONCLUSIONS: Findings on feasibility are encouraging and secondary analyses replicated earlier clinical benefits and showed improved mindfulness of thoughts and images, but not voices.

Nurse-led vs. conventional physician-led follow-up for patients with cancer: systematic review.

AIM: This paper is a report of a systematic review of the effectiveness and cost-effectiveness of nurse-led follow-up for patients with cancer. BACKGROUND: As cancer survivorship increases, conventional follow-up puts a major burden on outpatient services. Nurse-led follow-up is a promising alternative. Data sources. Searches were conducted covering a period from inception to February 2007 of 19 electronic databases, seven online trial registries, five conference proceedings reference lists of previous reviews and included studies. REVIEW METHODS: Standard systematic review methodology was used. Comparative studies and economic evaluations of nurse-led vs. physician-led follow-up were eligible. Studies comparing different types of nurse-led follow-up were excluded. Any cancer was considered; any outcome measure included. RESULTS: Four randomised controlled trials were identified, two including cost analyses. There were no statistically significant differences in survival, recurrence or psychological morbidity. One study showed better HRQL measures for nurse-led follow-up, but one showed no difference, two showed a statistically significant difference for patient satisfaction, but two did not. Patients with lung cancer were more satisfied with nurse-led telephone follow-up and more were able to die at home. Patients with breast cancer thought patient-initiated follow-up convenient, but found conventional follow-up more reassuring. One study showed the cost of nurse-led follow-up to be less than that of physician-led follow-up, but no statistical comparison was made. CONCLUSION: Patients appeared satisfied with nurse-led follow-up. Patient-initiated or telephone follow-up could be practical alternatives to conventional care. However, well-conducted research is needed before equivalence to physician-led follow-up can be assured in terms of survival, recurrence, patient well-being and cost-effectiveness.

Mindfulness-based cognitive therapy: further issues in current evidence and future research.

The authors respond to the article by H. F. Coelho, P. H. Canter, and E. Ernst (2007), which reviewed the current status of mindfulness-based cognitive therapy (MBCT). First, they clarify the randomization procedures in the 2 main MBCT trials. Second, they report posttreatment and follow-up data to show that trial participants allocated to "treatment as usual" did not become worse. Third, they discuss which experimental designs are better for identification of the active component of treatment. Finally, they report reanalyses of the 2 main MBCT trials with multilevel modeling that corrected for intragroup correlations. These analyses reinforce the original findings: For patients with 3 or more previous episodes, MBCT significantly reduced the risk of a further episode of depression and significantly decreased mean scores on the Beck Depression Inventory (A. T. Beck, C. H. Ward, M. Mendelson, J. Mock, & J. Erbaugh, 1961) after treatment.

Multifaceted implementation of stroke prevention guidelines in primary care: cluster-randomised evaluation of clinical and cost effectiveness.

OBJECTIVE: To evaluate clinical and cost effectiveness of implementing evidence-based guidelines for the prevention of stroke. DESIGN: Cluster-randomised trial SETTING: Three primary care organisations in the North of England covering a population of 400,000. PARTICIPANTS: Seventy six primary care teams in four clusters: North, South & West, City I and City II. INTERVENTION: Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack (TIA) were developed and implemented using a multifaceted approach including evidence-based recommendations, audit and feedback, interactive educational sessions, patient prompts and outreach visits. OUTCOMES: Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness. RESULTS: Implementation led to 36% increase (95% CI 4% to 78%) in diagnosis of atrial fibrillation, and improved treatment of TIA (odds ratio of complying with guidelines 1.8; 95% CI 1.1 to 2.8). Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater (OR 1.46 95% CI 1.10 to 1.94) in the condition for which practices had received the implementation programme. The development and implementation of guidelines cost less than 1500 pounds per practice. The estimated costs per quality-adjusted life year gained by patients with atrial fibrillation or TIA were both less than 2000 pounds, very much less than the usual criterion for cost effectiveness. CONCLUSIONS: Implementation of evidence-based guidelines improved the quality of primary care for atrial fibrillation and TIA. The intervention was feasible and very cost effective. Key components of the model include contextual analysis, strong professional support, clear recommendations based on robust evidence, simplicity of adoption, good communication and use of established networks and opinion leaders.

Reconciling competing priorities in commissioning: the future of bone densitometry service for North Wales.

BACKGROUND: Osteoporosis creates brittle bones susceptible to fracture, with resulting high levels of morbidity and mortality. Poor access to bone densitometry services for the residents of North Wales led to the Welsh Assembly Government offering capital to purchase a dual-energy X-ray absorptiometry (DXA) scanner, used to diagnose osteoporosis, for the region. The commissioning question for the six Local Health Boards across North Wales was where to site the new scanner. This decision needed to reflect current inequalities in access to services and concerns over inappropriate prescribing relative to Welsh norms. METHODS: Epidemiological, corporate and comparative healthcare needs assessments were performed. In addition, two cross-sectional surveys were conducted to determine the views of general practices and users of bone densitometry services resident in North Wales. An option appraisal and sensitivity analysis of 13 costed options for DXA scanning was conducted. RESULTS: We estimated that only 31% of the people in North Wales who met national guidelines were receiving DXA scans. There was definite inequity of access to the current service provided by area of residence. There was also evidence of inequity of access by age and sex. The most suitable option identified in the option appraisal was a bone densitometry service based in the central location of Llandudno. CONCLUSION: The assessment identified significant unmet need for DXA scanning. A recommendation was made to improve access through the introduction of a new bone densitometry service based at Llandudno. This would double scanning provision provided and reduce travel costs and time for many North Wales residents. This recommendation was adopted by a joint commissioning group established by the six Local Health Boards in North Wales at the end of 2004 - evidence based commissioning in practice.

Sample size for regression analyses of theory of planned behaviour studies: case of prescribing in general practice.

OBJECTIVES: Interest has been growing in the use of the theory of planned behaviour (TBP) in health services research. The sample sizes range from less than 50 to more than 750 in published TPB studies without sample size calculations. We estimate the sample size for a multi-stage random survey of prescribing intention and actual prescribing for asthma in British general practice. To our knowledge, this is the first systematic attempt to determine sample size for a TPB survey. METHODS: We use two different approaches: reported values of regression models' goodness-of-fit (the lambda method) and zero-order correlations (the variance inflation factor or VIF method). Intra-cluster correlation coefficient (ICC) is estimated and a socioeconomic variable is used for stratification. We perform sensitivity analysis to estimate the effects of our decisions on final sample size. RESULTS: The VIF method is more sensitive to the requirements of a TPB study. Given a correlation of .25 between intention and behaviour, and of .4 between intention and perceived behavioural control, the proposed sample size is 148. We estimate the ICC for asthma prescribing to be around 0.07. If 10 general practitioners were sampled per cluster, the sample size would be 242. CONCLUSIONS: It is feasible to perform sophisticated sample size calculations for a TPB study. The VIF is the appropriate method. Our approach can be used with adjustments in other settings and for other regression models.

Assessing adherence to the evidence base in the management of poststroke dysphagia.

OBJECTIVE: To evaluate the reliability and responsiveness to change of an audit tool to assess adherence to evidence of effectiveness in the speech and language therapy (SLT) management of poststroke dysphagia. DESIGN: The tool was used to review SLT practice as part of a randomized study of different education strategies. Medical records were audited before and after delivery of the trial intervention. SETTING: Seventeen SLT departments in the north-west of England participated in the study. SUBJECTS: The assessment tool was used to assess the medical records of 753 patients before and 717 patients after delivery of the trial intervention across the 17 departments. A target of 10 records per department per month was sought, using systematic sampling with a random start. ANALYSIS: Inter- and intra-rater reliability were explored, together with the tool's internal consistency and responsiveness to change. RESULTS: The assessment tool had high face validity, although internal consistency was low (ra = 0.37). Composite scores on the tool were however responsive to differences between SLT departments. Both inter- and intra-rater reliability ranged from 'substantial' to 'near perfect' across all items. CONCLUSIONS: The audit tool has high face validity and measurement reliability. The use of a composite adherence score should, however, proceed with caution as internal consistency is low.