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ABSTRACT: 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.
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."
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.
Corticosteroid injections for Morton neuroma can be of symptomatic benefit for at least three months.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
The Journal of Bone and Joint Surgery 05/2013; 95(9):790-8. · 3.27 Impact Factor
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ABSTRACT: There has been little rigorous economic analysis of the relationship between asthma and improved housing.
To evaluate the cost-effectiveness of installing ventilation systems, and central heating if necessary, in homes of children with 'moderate' or 'severe' asthma.
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.
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.
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.
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.
British Journal of General Practice 11/2011; 61(592):e733-41. · 1.83 Impact Factor
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ABSTRACT: Few robust studies have tested whether enhancing housing also improves health.
To evaluate the effectiveness of installing ventilation systems, and central heating where necessary, in the homes of children with moderate or severe asthma.
Pragmatic randomised controlled trial (RCT) in homes within Wrexham County Borough, Wales, UK.
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.
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.
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.
British Journal of General Practice 11/2011; 61(592):e724-32. · 1.83 Impact Factor
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ABSTRACT: 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.
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.
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.
BMC Psychiatry 03/2010; 10:23. · 2.55 Impact Factor
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ABSTRACT: Abstract
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.
Trial Registration
Current Controlled Trials: ISRCTN97185214.
BMC Psychiatry. 01/2010;
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Ruth A Lewis,
Richard D Neal,
Nefyn H Williams,
Barbara France,
Maggie Hendry, Daphne Russell,
Dyfrig A Hughes,
Ian Russell,
Nicholas S A Stuart,
David Weller,
Clare Wilkinson
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ABSTRACT: Cancer follow-up has traditionally been undertaken in secondary care, but there are increasing calls to deliver it in primary care.
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.
Systematic review.
Primary and secondary care settings.
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.
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.
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.
British Journal of General Practice 08/2009; 59(564):e234-47. · 1.83 Impact Factor
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Ruth A Lewis,
Richard D Neal,
Maggie Hendry,
Barbara France,
Nefyn H Williams, Daphne Russell,
Dyfrig A Hughes,
Ian Russell,
Nicholas S A Stuart,
David Weller,
Clare Wilkinson
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ABSTRACT: Cancer follow-up places a significant burden on hospital outpatient clinics. There are increasing calls to develop alternative models of provision.
To undertake a systematic review of qualitative studies examining patients' and healthcare professionals' views about cancer follow-up.
Systematic review.
Primary and secondary care.
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.
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.
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.
British Journal of General Practice 08/2009; 59(564):e248-59. · 1.83 Impact Factor
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ABSTRACT: 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.
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.
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.
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).
Findings on feasibility are encouraging and secondary analyses replicated earlier clinical benefits and showed improved mindfulness of thoughts and images, but not voices.
Behavioural and Cognitive Psychotherapy 07/2009; 37(4):403-12. · 1.69 Impact Factor
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Ruth Lewis,
Richard D Neal,
Nefyn H Williams,
Barbara France,
Clare Wilkinson,
Maggie Hendry, Daphne Russell,
Ian Russell,
Dyfrig A Hughes,
Nicholas S A Stuart,
David Weller
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ABSTRACT: This paper is a report of a systematic review of the effectiveness and cost-effectiveness of nurse-led follow-up for patients with cancer.
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.
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.
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.
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.
Journal of Advanced Nursing 05/2009; 65(4):706-23. · 1.48 Impact Factor
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ABSTRACT: 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.
Journal of Consulting and Clinical Psychology 07/2008; 76(3):524-9. · 4.85 Impact Factor
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John Wright,
John Bibby,
Joe Eastham,
Stephen Harrison,
Maureen McGeorge,
Chris Patterson,
Nick Price, Daphne Russell,
Ian Russell,
Neil Small,
Matt Walsh,
John Young
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ABSTRACT: To evaluate clinical and cost effectiveness of implementing evidence-based guidelines for the prevention of stroke.
Cluster-randomised trial
Three primary care organisations in the North of England covering a population of 400,000.
Seventy six primary care teams in four clusters: North, South & West, City I and City II.
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.
Identification and appropriate treatment of patients with atrial fibrillation or TIA, and cost effectiveness.
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.
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.
Quality and Safety in Health Care 03/2007; 16(1):51-9. · 1.68 Impact Factor
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ABSTRACT: 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.
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.
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.
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.
Cost Effectiveness and Resource Allocation 02/2007; 5:1. · 0.87 Impact Factor
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Palliative Medicine 01/2007; 20(8):845-6. · 2.38 Impact Factor
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ABSTRACT: Abstract
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.
Cost Effectiveness and Resource Allocation. 01/2007;
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ABSTRACT: 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.
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.
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.
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.
British Journal of Health Psychology 12/2006; 11(Pt 4):581-93. · 2.70 Impact Factor
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ABSTRACT: 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.
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.
Seventeen SLT departments in the north-west of England participated in the study.
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.
Inter- and intra-rater reliability were explored, together with the tool's internal consistency and responsiveness to change.
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.
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.
Clinical Rehabilitation 02/2006; 20(1):46-51. · 2.12 Impact Factor
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ABSTRACT: To evaluate the clinical and cost effectiveness of two training strategies to promote the use of research evidence in speech and language therapy (SLT) management of poststroke dysphagia.
Pragmatic, cluster randomized trial.
Seventeen SLT departments in north-west England.
Two SLTs from each department received training and cascaded information across their department. Process of care was measured from the notes of 708 patients with acute poststroke dysphagia across eight departments allocated to training strategy A, and 762 patients across nine departments in strategy B.
Strategy A: training on the critical appraisal of published research papers and practice guidelines. Strategy B: strategy A plus training on management of change in clinical practice.
Pre- and post-training adherence to practice guidelines in poststroke dysphagia management, based on a review of case notes. Incremental cost of increased adherence to clinical guidelines.
Departments' practice differed in adherence to guidelines. Departments changed following training (F=2.22, df 16, 1436, p=0.004). The effect of training strategy on clinical practice was not significant. Strategy B departments engaged in more activities relating to research use following training than strategy A. Total costs of training averaged ł2001, 2892 Euros, $3886 (SD ł502, 726 Euros, $975) for strategy A and ł3366, 4866 Euros, $6537 (SD ł2121, 3066 Euros, $4119) for strategy B.
Training in research implementation in addition to critical appraisal and guideline introduction is associated with increased dissemination activities and awareness of research information, but not with changes in clinical practice within six months of training. The department in which SLTs work influences their use of research. The process of poststroke dysphagia management can be measured using a tool developed from practice guidelines.
Clinical Rehabilitation 07/2005; 19(4):387-97. · 2.12 Impact Factor
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ABSTRACT: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended.
Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain.
A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping.
Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios.
A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.
Family Practice 01/2005; 21(6):643-50. · 1.50 Impact Factor
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George Priestley,
Wendy Watson,
Arash Rashidian,
Caroline Mozley, Daphne Russell,
Jonathan Wilson,
Judith Cope,
Dianne Hart,
Diana Kay,
Karen Cowley,
Jayne Pateraki
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ABSTRACT: The purpose of the study was to investigate the effects of introducing a critical care outreach service on in-hospital mortality and length of stay in a general acute hospital.
A pragmatic ward-randomised trial design was used, with intervention introduced to all wards in sequence. No blinding was possible.
Sixteen adult wards in an 800-bed general hospital in the north of England.
All admissions to the 16 surgical, medical and elderly care wards during 32-week study period were included (7450 patients in total, of whom 2903 were eligible for the primary comparison).
Essential elements of the Critical Care Outreach service introduced during the study were a nurse-led team of nurses and doctors experienced in critical care, a 24-h service, emphasis on education, support and practical help for ward staff.
The main outcome measures were in-hospital mortality and length of stay. Outreach intervention reduced in-hospital mortality compared with control (two-level odds ratio: 0.52 (95% CI 0.32-0.85). A possible increased length of stay associated with outreach was not fully supported by confirmatory and sensitivity analyses.
The study suggests outreach reduces mortality in general hospital wards. It may also increase length of stay, but our findings on this are equivocal.
Intensive Care Medicine 08/2004; 30(7):1398-404. · 5.40 Impact Factor
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ABSTRACT: BACKGROUND: Although guidelines for the care of the dying patient exist the evidence base to support the guidelines is poor. Some of the factors contributing to this include failure to recruit to trials, protective healthcare professionals and subsequent attrition from trials due to the death of the patients. Recent studies report favourably on the use of cluster randomisation as an appropriate methodology for use in this patient group. METHODS/DESIGN: A feasibility study, exploring two types of randomisation as appropriate methodology for trials involving dying patients. Cluster randomisation and randomised consent will be utilised following a crossover design at two sites, one oncology ward and one Macmillan unit within the Northwest Wales NHS Trust. All patients commencing on the Integrated Care Pathway (ICP) for the Last Days of Life will be eligible for inclusion in the study. Using the hypothesis that it is not necessary to prescribe an anti-emetic medication when setting up a syringe driver for the dying patient, the study will evaluate different models of research methodology. DISCUSSION: The identification of the most appropriate methodology for use in studies concerning this patient group will inform the development of future clinical studies. Furthermore, the outcomes of this feasibility study will inform the development, of a proposal seeking funding for Wales-wide trials in palliative care. The identification of an appropriate methodology will provide a starting point for the establishment of a robust evidence base for the care of the dying patient.
BMC Palliative Care 05/2004; 3(1):1. · 1.12 Impact Factor
