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1.  The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial 
BMJ Open  2014;4(9):e006204.
People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.
Methods and analysis
A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months.
Ethics and dissemination
The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.
Trial registration number
ISRCTN 61215213.
PMCID: PMC4158215  PMID: 25186159
Diabetes Mellitus; Type 1/therapy*; Insulin/administration & dosage*; Insulin Infusion Systems; Patient Education as Topic/methods*
2.  The Association between Contrast Dose and Renal Complications Post PCI across the Continuum of Procedural Estimated Risk 
PLoS ONE  2014;9(3):e90233.
Prior studies have proposed to restrict the contrast volume (CV) to <3x calculated creatinine clearance (CCC), to prevent contrast induced nephropathy (CIN) post percutaneous coronary interventions (PCI). The predictive value of this algorithm for CIN and therefore the benefit of this approach in high risk patients has been questioned. The aim of our study was to assess the association between contrast dose and the occurrence of CIN in patients at varying predicted risks of CIN and baseline CCC following contemporary PCI.
Consecutive patients undergoing PCI between 2010–2012 were included. Baseline risk of CIN was calculated using a previously validated risk tool. High contrast dose was defined as CV/CCC >3. Likelihood ratio tests were used to evaluate whether the effect of a high contrast dose on the risk of CIN and nephropathy requiring dialysis (NRD) varied across the spectrum of baseline predicted risk.
Of the 82,120 PCI included in our analysis, 25% were performed using a high contrast dose. Patients treated with a high compared with a low contrast dose were at increased risks of CIN and NRD, throughout the entire range of baseline predicted risk and CCC in our population. The effect size of a high contrast dose on risks of both outcomes varied significantly with baseline predicted CIN risk and CCC (CIN p = 0.004, NRD p<0.001 for adding interactions), and was largest for patients with predicted CIN risk <10% and pre-existing chronic kidney disease.
The use of a high contrast dose is associated with increased risks of CIN and NRD across the continuum of baseline predicted risk and CCC. Efforts to reduce contrast dose may therefore be effective in preventing renal complications in all patients undergoing PCI.
PMCID: PMC3953074  PMID: 24625555
3.  The effectiveness of salicylic acid plasters compared with ‘usual’ scalpel debridement of corns: a randomised controlled trial 
Corns are a common foot problem and surveys have indicated that between 14-48% of people suffer from them. Many of these will seek podiatry treatment, however there is little evidence to indicate which current treatments provide long term resolution. This study compared ‘usual’ treatment (enucleation with a scalpel) with the application of 40% salicylic acid plasters to corns to investigate which is the most effective in terms of clinical, economic and patient-centred outcomes.
A parallel-group randomised controlled trial was carried out in two centres where adults who presented with one or more corns and who met the inclusion criteria were allocated to either ‘usual’ scalpel debridement or corn plaster treatment. All participants had measurements of corn size, pain using a 100 mm visual analogue scale (VAS) and health-related quality of life (EQ-5D) measures by an independent podiatrist, blind to treatment allocation at baseline, 3, 6, 9 and 12 months.
202 participants were randomised to receive scalpel debridement or corn plaster treatment (101 in each group). At 3 months 34% (32/95) of corns had completely resolved in the corn plaster group compared with 21% (20/94) in the scalpel group (p = 0.044), and 83% (79/95) had reduced in size in the corn plaster group compared with 56% (53/94) in the scalpel group (p < 0.001). At 12 months, time to corn recurrence was longer in the corn plaster group (p < 0.001). Pain from the corns was significantly lower in the corn plaster group at 3 months (p < 0.001) and EQ-5D scores changed (improved), from baseline, by 0.09 (SD ±0.31) and 0.01 (SD ±0.25) points in the corn plaster and scalpel groups respectively (p = 0.056). By month 12, EQ-5D scores had changed by 0.12 and −0.05 in the corn plaster and scalpel groups respectively (p = 0.005). The EQ-5D, VAS scores and the four domains of the Foot Disability Scale were similar in both groups at 3 and 12 months. The economic analysis indicated that corn plasters were a cost effective intervention.
The use of corn plasters was associated with a higher proportion of resolved corns, a prolonged time to corn recurrence, less pain and reduced corn size over the first 6 months in comparison with ‘usual’ scalpel treatment and this intervention was cost effective. Used under supervision of a podiatrist on appropriate patients, corn plasters offer an effective alternative to scalpel debridement.
PMCID: PMC3856524  PMID: 24063387
Foot; Pain; Podiatry; Callosities; Debridement
4.  Induction of mesenchymal stem cell chondrogenesis by polyacrylate substrates 
Acta Biomaterialia  2013;9(4):6041-6051.
Mesenchymal stem cells (MSCs) can generate chondrocytes in vitro, but typically need to be cultured as aggregates in the presence of transforming growth factor beta (TGF-β), which makes scale-up difficult. Here we investigated if polyacrylate substrates modelled on the functional group composition and distribution of the Arg-Gly-Asp (RGD) integrin-binding site could induce MSCs to undergo chondrogenesis in the absence of exogenous TGF-β. Within a few days of culture on the biomimetic polyacrylates, both mouse and human MSCs, and a mesenchymal-like mouse-kidney-derived stem cell line, began to form multi-layered aggregates and started to express the chondrocyte-specific markers, Sox9, collagen II and aggrecan. Moreover, collagen II tended to be expressed in the centre of the aggregates, similarly to developing limb buds in vivo. Surface analysis of the substrates indicated that those with the highest surface amine content were most effective at promoting MSC chondrogenesis. These results highlight the importance of surface group functionality and the distribution of those groups in the design of substrates to induce MSC chondrogenesis.
PMCID: PMC3594746  PMID: 23237986
Mesenchymal stem cell; Cell culture; Chondrocyte; Polyacrylate; Surface chemistry
5.  A Value-Based Analysis of Hemodynamic Support Strategies for High-Risk Heart Failure Patients Undergoing a Percutaneous Coronary Intervention 
The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care.
To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs).
Hospital bills were collected for patients enrolled in the PROTECT II trial who received hemodynamic support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP.
Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY.
For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new hemodynamic support strategies.
PMCID: PMC4031707  PMID: 24991349
6.  The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks 
Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE) programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days.
We aim to compare DAFNE delivered over five consecutive days (1 week course) with DAFNE delivered one day a week over five weeks (5 week course) in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course) include HbA1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA1c <12%, with no lower limit). Qualitative interviews were undertaken with a sub-sample of n=30 patients and their course educators (n=11) to help understand and interpret differences and similarities in outcomes between the two arms, and to identify logistical problems and unanticipated issues arising from the adaptation and delivery of a 5 week course.
This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other fields of medicine.
Trial Registration NCT01069393
PMCID: PMC3515469  PMID: 23136929
Type 1 diabetes; Education; Teaching; Training programs
7.  Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial 
BMC Neurology  2012;12:74.
Motor neurone disease (MND) is a devastating illness which leads to muscle weakness and death, usually within 2-3 years of symptom onset. Respiratory insufficiency is a common cause of morbidity, particularly in later stages of MND and respiratory complications are the leading cause of mortality in MND patients. Non Invasive Ventilation (NIV) is the current standard therapy to manage respiratory insufficiency. Some MND patients however do not tolerate NIV due to a number of issues including mask interface problems and claustrophobia. In those that do tolerate NIV, eventually respiratory muscle weakness will progress to a point at which intermittent/overnight NIV is ineffective. The NeuRx RA/4 Diaphragm Pacing System was originally developed for patients with respiratory insufficiency and diaphragm paralysis secondary to stable high spinal cord injuries. The DiPALS study will assess the effect of diaphragm pacing (DP) when used to treat patients with MND and respiratory insufficiency.
108 patients will be recruited to the study at 5 sites in the UK. Patients will be randomised to either receive NIV (current standard care) or receive DP in addition to NIV. Study participants will be required to complete outcome measures at 5 follow up time points (2, 3, 6, 9 and 12 months) plus an additional surgery and 1 week post operative visit for those in the DP group. 12 patients (and their carers) from the DP group will also be asked to complete 2 qualitative interviews.
The primary objective of this trial will be to evaluate the effect of Diaphragm Pacing (DP) on survival over the study duration in patients with MND with respiratory muscle weakness. The project is funded by the National Institute for Health Research, Health Technology Assessment (HTA) Programme (project number 09/55/33) and the Motor Neurone Disease Association and the Henry Smith Charity. Trial Registration: Current controlled trials ISRCTN53817913. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.
PMCID: PMC3462709  PMID: 22897892
8.  Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol 
BMC Family Practice  2012;13:18.
The benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.
The DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.
The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.
Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.
The DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.
Trial registration
PMCID: PMC3364887  PMID: 22416896
9.  Deriving health state utilities for the numerical pain rating scale 
The use of patient reported outcome measures within cost-effectiveness analysis has become commonplace. However, specific measures are required that produce values, referred to as 'utilities', that are capable of generating quality adjusted life years. One such measure - the EQ-5D - has come under criticism due to the inherent limitations of its three-level response scales. In evaluations of chronic pain, the numerical pain rating scale (NPRS) which has eleven levels is routinely used which has a greater measurement range, but which can not be used in cost-effetiveness analyses. This study derived utility values for a series of EQ-5D health states that replace the pain dimensions with the NPRS, thereby allowing a potentially greater range of pain intensities to be captured and included in economic analyses.
Interviews were undertaken with 100 member of the general population. Health state valuations were elicited using the time trade-off approach with a ten year time horizon. Additionally, respondents were asked where the EQ-5D response scale descriptors of moderate and extreme pain lay on the 11-point NPRS scale.
625 valuations were undertaken across the study sample with the crude mean health state utilities showing a negative non-linear relationship with respect to increasing pain intensity. Relative to a NPRS of zero (NPRS0), the successive pain levels (NPRS1-10) had mean decrements in utility of 0.034, 0.043, 0.061, 0.121, 0.144, 0.252, 0.404, 0.575, 0.771 and 0.793, respectively. When respondents were asked to mark on the NPRS scale the EQ-5D pain descriptors of moderate and extreme pain, the median responses were '4' and '8', respectively.
These results demonstrate the potential floor effect of the EQ-5D with respect to pain and provide estimates of health reduction associated with pain intensity described by the NPRS. These estimates are in excess of the decrements produced by an application of the EQ-5D scoring tariff for both the United States and the United Kingdom.
PMCID: PMC3217931  PMID: 22054241
health economics; pain measurement; cost-effectiveness; quality of life
10.  A Randomized Controlled Trial Comparing the Arctic Sun to Standard Cooling for Induction of Hypothermia After Cardiac Arrest 
Resuscitation  2009;81(1):9.
Hypothermia improves neurological outcome for comatose survivors of out-of-hospital cardiac arrest. Use of computer controlled high surface area devices for cooling may lead to faster cooling rates and potentially improve patient outcome.
To compare the effectiveness of surface cooling with the standard blankets and ice packs to the Arctic Sun, a mechanical device used for temperature management.
Design, Setting, and Patients
Multi-center randomized trial of hemodynamically stable comatose survivors of out-of-hospital cardiac arrest.
Standard post-resuscitative care inducing hypothermia using cooling blankets and ice (n=30) or the Arctic Sun (n=34).
Main Outcome Measures
The primary end point was the proportion of subjects who reached a target temperature within 4 hours of beginning cooling. The secondary end points were time interval to achieve target temperature (34°) and survival to 3 months.
The proportion of subjects cooled below the 34°C target at 4 hours was 71% for the Arctic Sun group and 50% for the standard cooling group (p=0.12). The median time to target was 54 minutes faster for cooled patients in the Arctic Sun group than the standard cooling group (p<0.01). Survival rates with good neurological outcome were similar; 46% of Arctic Sun patients and 38% of standard patients had a cerebral performance category of 1 or 2 at 30 days (P=0.6).
While the proportion of subjects reaching target temperature within 4 hours was not significantly different, the Arctic Sun cooled patients to a temperature of 34° C more rapidly than standard cooling blankets.
Trial Registration NCT00282373, registered January 24, 2006.
PMCID: PMC2815241  PMID: 19854555
11.  The relationship between staff skill mix, costs and outcomes in intermediate care services 
The purpose of this study was to assess the relationship between skill mix, patient outcomes, length of stay and service costs in older peoples' intermediate care services in England.
We undertook multivariate analysis of data collected as part of the National Evaluation of Intermediate Care Services. Data were analysed on between 337 and 403 older people admitted to 14 different intermediate care teams. Independent variables were the numbers of different types of staff within a team and the ratio of support staff to professionally qualified staff within teams. Outcome measures include the Barthel index, EQ-5D, length of service provision and costs of care.
Increased skill mix (raising the number of different types of staff by one) is associated with a 17% reduction in service costs (p = 0.011). There is weak evidence (p = 0.090) that a higher ratio of support staff to qualified staff leads to greater improvements in EQ-5D scores of patients.
This study provides limited evidence on the relationship between multidisciplinary skill mix and outcomes in intermediate care services.
PMCID: PMC2921080  PMID: 20670428
12.  Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care 
Objective To evaluate benefits for postnatal women of two psychologically informed interventions by health visitors.
Design Prospective cluster trial randomised by general practice, with 18 month follow-up.
Setting 101 general practices in Trent, England.
Participants 2749 women allocated to intervention, 1335 to control.
Intervention Health visitors (n=89 63 clusters) were trained to identify depressive symptoms at six to eight weeks postnatally using the Edinburgh postnatal depression scale (EPDS) and clinical assessment and also trained in providing psychologically informed sessions based on cognitive behavioural or person centred principles for an hour a week for eight weeks. Health visitors in the control group (n=49 38 clusters) provided usual care.
Main outcome measures Score ≥12 on the Edinburgh postnatal depression scale at six months. Secondary outcomes were mean Edinburgh postnatal depression scale, clinical outcomes in routine evaluation-outcome measure (CORE-OM), state-trait anxiety inventory (STAI), SF-12, and parenting stress index short form (PSI-SF) scores at six, 12, 18 months.
Results 4084 eligible women consented and 595 women had a six week EPDS score ≥12. Of these, 418 had EPDS scores available at six weeks and six months. At six months, 34% women (93/271) in the intervention group and 46% (67/147) in the control group had an EPDS score ≥12. The odds ratio for score ≥12 at six months was 0.62 (95% confidence interval 0.40 to 0.97, P=0.036) for women in the intervention group compared with women in the control group. After adjustment for covariates, the odds ratio was 0.60 (0.38 to 0.95, P=0.028). At six months, 12.4% (234/1880) of all women in the intervention group and 16.7% (166/995) of all women in the control group had scores ≥12 (0.67, 0.51 to 0.87, P=0.003). Benefit for women in the intervention group with a six week EPDS score ≥12 and for all women was maintained at 12 months postnatally. There was no differential benefit for either psychological approach over the other.
Conclusion Training health visitors to assess women, identify symptoms of postnatal depression, and deliver psychologically informed sessions was clinically effective at six and 12 months postnatally compared with usual care.
Trial registration ISRCTN92195776.
PMCID: PMC2628298  PMID: 19147636
13.  Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial 
BMJ : British Medical Journal  2007;335(7626):919.
Objective To evaluate the benefits of paramedic practitioners assessing and, when possible, treating older people in the community after minor injury or illness. Paramedic practitioners have been trained with extended skills to assess, treat, and discharge older patients with minor acute conditions in the community.
Design Cluster randomised controlled trial involving 56 clusters. Weeks were randomised to the paramedic practitioner service being active (intervention) or inactive (control) when the standard 999 service was available.
Setting A large urban area in England.
Participants 3018 patients aged over 60 who called the emergency services (n=1549 intervention, n=1469 control).
Main outcome measures Emergency department attendance or hospital admission between 0 and 28 days; interval from time of call to time of discharge; patients' satisfaction with the service received.
Results Overall, patients in the intervention group were less likely to attend an emergency department (relative risk 0.72, 95% confidence interval 0.68 to 0.75) or require hospital admission within 28 days (0.87, 0.81 to 0.94) and experienced a shorter total episode time (235 v 278 minutes, 95% confidence interval for difference −60 minutes to −25 minutes). Patients in the intervention group were more likely to report being highly satisfied with their healthcare episode (relative risk 1.16, 1.09 to 1.23). There was no significant difference in 28 day mortality (0.87, 0.63 to 1.21).
Conclusions Paramedics with extended skills can provide a clinically effective alternative to standard ambulance transfer and treatment in an emergency department for elderly patients with acute minor conditions.
Trial registration ISRCTN27796329.
PMCID: PMC2048868  PMID: 17916813
14.  Pre-endoscopy serological testing for coeliac disease: evaluation of a clinical decision tool 
BMJ : British Medical Journal  2007;334(7596):729.
Objective To determine an effective diagnostic method of detecting all cases of coeliac disease in patients referred for gastroscopy without performing routine duodenal biopsy.
Design An initial retrospective cohort of patients attending for gastroscopy was analysed to derive a clinical decision tool that could increase the detection of coeliac disease without performing routine duodenal biopsy. The tool incorporated serology (measuring antibodies to tissue transglutaminase) and stratifying patients according to their referral symptoms (patients were classified as having a “high risk” or “low risk” of coeliac disease). The decision tool was then tested on a second cohort of patients attending for gastroscopy. In the second cohort all patients had a routine duodenal biopsy and serology performed.
Setting Teaching hospital in Sheffield.
Participants 2000 consecutive adult patients referred for gastroscopy recruited prospectively.
Main outcome measure Evaluation of a clinical decision tool using patients' referral symptoms, tissue transglutaminase antibody results, and duodenal biopsy results.
Results No cases of coeliac disease were missed by the pre-endoscopy testing algorithm. The prevalence of coeliac disease in patients attending for endoscopy was 3.9% (77/2000, 95% confidence interval 3.1% to 4.8%). The prevalence in the high risk and low risk groups was 9.6% (71/739, 7.7% to 12.0%) and 0.5% (6/1261, 0.2% to 1.0%). The prevalence of coeliac disease in patients who were negative for tissue transglutaminase antibody was 0.4% (7/2000). The sensitivity, specificity, positive predictive value, and negative predictive value for a positive antibody result to diagnose coeliac disease was 90.9%, 90.9%, 28.6%, and 99.6%, respectively. Evaluation of the clinical decision tool gave a sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 60.8%, 9.3%, and 100%, respectively.
Conclusions Pre-endoscopy serological testing in combination with biopsy of high risk cases detected all cases of coeliac disease. The use of this decision tool may enable the endoscopist to target patients who need a duodenal biopsy.
PMCID: PMC1847864  PMID: 17383983
15.  Evaluation of Advanced Access in the National Primary Care Collaborative 
Background: An aim of the National Primary Care Collaborative is to improve quality and access for patients in primary care using principles of Advanced Access.
Aims: To determine whether Advanced Access led to improved availability of appointments with general practitioners (GPs) and to examine GPs' views of the process.
Design: Observational study.
Setting: Four hundred and sixty-two general practices in England participating in four waves of the collaborative during 2000 and 2001.
Method: Regression analysis of the collaborative's monthly data on the availability of GP appointments for the 352 practices in waves 1–3, and a postal survey of lead GPs in all four waves. The main outcome measures were the change in mean time to the third available appointment with GPs, and the proportion of GPs thinking it worthwhile participating in the collaborative.
Results: The time to the third available appointment improved from a mean of 3.6 to 1.9 days, difference = 1.7 days, 95% confidence interval (CI) = 1.4 to 2.0 days. It improved in two-thirds of practices (66% [219/331]), remained the same in 16% (53/331), and worsened in 18% (59/331). The majority of GPs in all four waves, 83% (308/371, 95% CI = 79 to 87), felt that it was worthwhile participating in the collaborative, although one in 12 practices would not recommend it. One-fifth of GPs cited a lack of resources as a constraint, and some expressed concerns about the trade-off between immediate access and continuity of care.
Conclusion: Advanced Access helped practices to improve availability of GP appointments, and was well received by the majority of practices.
PMCID: PMC1266165  PMID: 15113514
access to health care; general practitioner perceptions; primary care
16.  Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial. 
OBJECTIVE: To evaluate the clinical and cost impact of providing cognitive behaviour therapy (CBT) for insomnia (comprising sleep hygiene, stimulus control, relaxation and cognitive therapy components) to long-term hypnotic drug users in general practice. DESIGN: A pragmatic randomised controlled trial with two treatment arms (a CBT treated 'sleep clinic' group, and a 'no additional treatment' control group), with post-treatment assessments commencing at 3 and 6 months. SETTING: Twenty-three general practices in Sheffield, UK. PARTICIPANTS: Two hundred and nine serially referred patients aged 31-92 years with chronic sleep problems who had been using hypnotic drugs for at least 1 month (mean duration = 13.4 years). RESULTS: At 3- and 6-month follow-ups patients treated with CBT reported significant reductions in sleep latency, significant improvements in sleep efficiency, and significant reductions in the frequency of hypnotic drug use (all P<0.01). Among CBT treated patients SF-36 scores showed significant improvements in vitality at 3 months (P<0.01). Older age presented no barrier to successful treatment outcomes. The total cost of service provision was 154.40 per patient, with a mean incremental cost per quality-adjusted life-year of 3416 (at 6 months). However, there was evidence of longer term cost offsets owing to reductions in sleeping tablet use and reduced utilisation of primary care services. CONCLUSIONS: In routine general practice settings, psychological treatments for insomnia can improve sleep quality and reduce hypnotic consumption at a favourable cost among long-term hypnotic users with chronic sleep difficulties.
PMCID: PMC1314744  PMID: 14960215
17.  Randomised controlled trial and economic evaluation of a chest pain observation unit compared with routine care 
BMJ : British Medical Journal  2004;328(7434):254.
Objectives To measure the effectiveness and cost effectiveness of providing care in a chest pain observation unit compared with routine care for patients with acute, undifferentiated chest pain.
Design Cluster randomised controlled trial, with 442 days randomised to the chest pain observation unit or routine care, and cost effectiveness analysis from a health service costing perspective.
Setting The emergency department at the Northern General Hospital, Sheffield, United Kingdom.
Participants 972 patients with acute, undifferentiated chest pain (479 attending on days when care was delivered in the chest pain observation unit, 493 on days of routine care) followed up until six months after initial attendance.
Main outcome measures The proportion of participants admitted to hospital, the proportion with acute coronary syndrome sent home inappropriately, major adverse cardiac events over six months, health utility, hospital reattendance and readmission, and costs per patient to the health service.
Results Use of a chest pain observation unit reduced the proportion of patients admitted from 54% to 37% (difference 17%, odds ratio 0.50, 95% confidence interval 0.39 to 0.65, P < 0.001) and the proportion discharged with acute coronary syndrome from 14% to 6% (8%, -7% to 23%, P = 0.264). Rates of cardiac event were unchanged. Care in the chest pain observation unit was associated with improved health utility during follow up (0.0137 quality adjusted life years gained, 95% confidence interval 0.0030 to 0.0254, P = 0.022) and a saving of £78 per patient (-£56 to £210, P = 0.252).
Conclusions Care in a chest pain observation unit can improve outcomes and may reduce costs to the health service. It seems to be more effective and more cost effective than routine care.
PMCID: PMC324451  PMID: 14724129
20.  Measuring outcomes in economic evaluations  
BMJ : British Medical Journal  1999;319(7211):705.
PMCID: PMC1116552  PMID: 10480836
21.  Cost effectiveness of community leg ulcer clinics: randomised controlled trial 
BMJ : British Medical Journal  1998;316(7143):1487-1491.
Objectives: To establish the relative cost effectiveness of community leg ulcer clinics that use four layer compression bandaging versus usual care provided by district nurses.
Design: Randomised controlled trial with 1 year of follow up.
Setting: Eight community based research clinics in four trusts in Trent.
Subjects: 233 patients with venous leg ulcers allocated at random to intervention (120) or control (113) group.
Interventions: Weekly treatment with four layer bandaging in a leg ulcer clinic (clinic group) or usual care at home by the district nursing service (control group).
Main outcome measures: Time to complete ulcer healing, patient health status, and recurrence of ulcers. Satisfaction with care, use of services, and personal costs were also monitored.
Results: The ulcers of patients in the clinic group tended to heal sooner than those in the control group over the whole 12 month follow up (log rank P=0.03). At 12 weeks, 34% of patients in the clinic group were healed compared with 24% in the control. The crude initial healing rate of ulcers in intervention compared with control patients was 1.45 (95% confidence interval 1.04 to 2.03). No significant differences were found between the groups in health status. Mean total NHS costs were £878.06 per year for the clinic group and £859.34 for the control (P=0.89).
Conclusions: Community based leg ulcer clinics with trained nurses using four layer bandaging is more effective than traditional home based treatment. This benefit is achieved at a small additional cost and could be delivered at reduced cost if certain service configurations were used.
Key messages Leg ulcer clinics based in the community using four layer compression bandaging can be more clinically effective than usual care provided by the district nursing service Community based leg ulcer clinics could be provided more cost effectively than usual home based care for venous leg ulcers Recurrence of venous leg ulcers is an important variable that should be measured in future trials of venous leg ulcer care It is difficult to measure improvements in health related quality of life among people with venous leg ulcers
PMCID: PMC28546  PMID: 9582132
22.  The Current Use of Impella 2.5 in Acute Myocardial Infarction Complicated by Cardiogenic Shock: Results from the USpella Registry 
To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI).
Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized.
Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients’ hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality.
Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups.
The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI.
PMCID: PMC4238821  PMID: 24329756

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