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Item Developing the Intervention and Outcome Components of a Proposed Randomised Controlled trial (RCT) of a National Screening Programme for Open Angle Glaucoma (OAG) : Medical Research Council funded trial platform study (G0701759): Study protocol(2008) Burr, Jennifer; Azuara-Blanco, Augusto; Hernández, Rodolfo Andrés; Ramsay, Craig R; Vale, Luke David; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Institute of Applied Health SciencesItem Effectiveness and efficiency of methods of dialysis therapy for end-stage renal disease : a review(1998-06) Macleod, Alison; Grant, Adrian Maxwell; Donaldson, C; Khan, Izhar; Campbell, Marion Kay; Daly, C; Lawrence, P; Wallace, Sheila Ann; Vale, Luke David; Cody, Dorothy June; Fitzhugh, K; Montague, G; Ritchie, C; University of Aberdeen.Medical Education; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Medicine, Medical Sciences & NutritionItem Systematic review of the clinical effectiveness and cost-effectiveness of laparoscopic surgery for inguinal hernia repair.(2005) McCormack, Kirsty; Wake, B.; Gonzalez Perez, Juan Gregorio; Fraser, Cynthia Mary; Cook, Jonathan Alistair; McIntosh, Emma; Vale, Luke David; Grant, Adrian Maxwell; University of Aberdeen.Other Applied Health SciencesItem Economic evaluation of early administration of prednisolone and/or aciclovir for the treatment of Bell's palsy(2009) Hernandez, Rodolfo Andres; Sullivan, F.; Donnan, P.; Swann, I.; Vale, Luke David; BELLS Trial Group; University of Aberdeen.Health Economics Research Unit; University of Aberdeen.Institute of Applied Health Sciences; University of Aberdeen.Other Applied Health SciencesItem Systematic review of long-term lifestyle interventions to prevent weight gain and morbidity in adults(2009-11) Brown, Tamara Joanne; Avenell, Alison; Edmunds, E; Moore, H; Whittaker, V; Avery, L; Summerbell, C; Ryan, Mandy Elaine; Vale, Luke David; PROGRESS team; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Institute of Applied Health SciencesItem Systematic review of economic evaluations of laparoscopic surgery for colorectal cancer(Wiley-Blackwell, 2008) Hernández, Rodolfo Andrés; De Verteuil, Robyn; Fraser, Cynthia Mary; Vale, Luke David; Aberdeen Health Technology Assessment Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjective Colorectal cancer is one of the most common cancers and the standard surgical treatment for this cancer is open resection (OS), but laparoscopic surgery (LS) may be an alternative treatment. In 2000, a Health Technology Assessment (HTA) review found little evidence on costs and cost-effectiveness in comparing the two methods. The evidence base has since expanded and this study systematically reviews the economic evaluations on the subject published since 2000. Method Systematic review of studies reporting costs and outcomes of LS vs OS for colorectal cancer. National Health Service Economic Evaluation Database (NHS EED) methods for abstract writing were followed. Studies were summarized and incremental cost-effectiveness ratios (ICER) for common outcomes were calculated. Results Five studies met the inclusion criteria. LS generally had higher healthcare costs. Most studies reported longer operational time and shorter length of stay and similar long-term outcomes with LS vs OS. Only one outcome, complications, was common across all studies but results lacked consistency (e.g. in two studies, OS was less costly but more effective; in another study, LS was less costly but more effective; and in the further two studies, LS could potentially be cost effective depending on the decision-makers' willingness to pay for the health gain). Conclusion The evidence on cost-effectiveness is not consistent. LS was generally more costly than OS. However, the effectiveness data used in individual economic evaluation were imprecise and unreliable when compared with data from systematic reviews of effectiveness. Nevertheless, short-term benefits of LS (e.g. shorter recovery) may make LS appear less costly when productivity gains are considered.Item A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell’s palsy: the BELLS study(Gray Publications, 2009-10) Sullivan, F.M.; Swan, I.R.C; Donnan, P.T.; Morrison, J.M.; Smith, Blair Hamilton; McKinstry, B; Davenport, R.J.; Vale, Luke David; Clarkson, J.E.; Hernández, Rodolfo Andrés; Stewart, K; Hammersley, V; Hayavi, S; McAteer, Anne; Gray, Denise Ann; Daley, F; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjective: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell’s palsy, improves the chances of recovery at 3 and 9 months. Design: A 2 × 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. Setting: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. Participants: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. Interventions: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 × 25-mg capsules) and aciclovir (2000 mg per day, 5 × 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. Outcome measures: The primary outcome was recovery of facial function assessed by the House– Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and costeffectivenes Results: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24–48 hours and the remainder within 48–72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the acyclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of – 5.3%. There was no significant prednisolone–aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir– prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir–prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. Conclusions: This study provided robust evidence to support the early use of oral prednisolone in Bell’s palsy as an effective treatment which may be considered costeffective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome. Trial registration: Current Controlled Trials ISRCTN71548196.Item Systematic review of the clinical effectiveness and cost-effectiveness of oesophageal Doppler monitoring in critically ill and high-risk surgical patients(National Institute for Health Research, 2009-01) Mowatt, Graham; Houston, G.; Hernández, Rodolfo Andrés; De Verteuil, Robyn; Fraser, Cynthia Mary; Cuthbertson, Brian; Vale, Luke David; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjectives: To assess the effectiveness and costeffectiveness of oesophageal Doppler monitoring (ODM) compared with conventional clinical assessment and other methods of monitoring cardiovascular function. Data sources: Electronic databases and relevant websites from 1990 to May 2007 were searched. Review methods: This review was based on a systematic review conducted by the US Agency for Healthcare Research and Quality (AHRQ), supplemented by evidence from any additional studies identified. Comparator interventions for effectiveness were standard care, pulmonary artery catheters (PACs), pulse contour analysis monitoring and lithium or thermodilution cardiac monitoring. Data were extracted on mortality, length of stay overall and in critical care, complications and quality of life. The economic assessment evaluated strategies involving ODM compared with standard care, PACs, pulse contour analysis monitoring and lithium or thermodilution cardiac monitoring. Results: The AHRQ report contained eight RCTs and was judged to be of high quality overall. Four comparisons were reported: ODM plus central venous pressure (CVP) monitoring plus conventional assessment vs CVP monitoring plus conventional assessment during surgery; ODM plus conventional assessment vs CVP monitoring plus conventional assessment during surgery; ODM plus conventional assessment vs conventional assessment during surgery; and ODM plus CVP monitoring plus conventional assessment vs CVP monitoring plus conventional assessment postoperatively. Five studies compared ODM plus CVP monitoring plus conventional assessment with CVP monitoring plus conventional assessment during surgery. There were fewer deaths [Peto odds ratio (OR) 0.13, 95% CI 0.02–0.96], fewer major complications (Peto OR 0.12, 95% CI 0.04–0.31), fewer total complications (fixed-effects OR 0.43, 95% CI 0.26–0.71) and shorter length of stay (pooled estimate not presented, 95% CI –2.21 to –0.57) in the ODM group. The results of the meta analysis of mortality should be treated with caution owing to the low number of events and low overall number of patients in the combined totals. Three studies compared ODM plus conventional assessment with conventional assessment during surgery. There was no evidence of a difference in mortality (fixed-effects OR 0.81, 95% CI 0.23–2.77). Length of hospital stay was shorter in all three studies in the ODM group. Two studies compared ODM plus CVP monitoring plus conventional assessment vs CVP monitoring plus conventional assessment in critically ill patients. The patient groups were quite different (cardiac surgery and major trauma) and neither study, nor a meta-analysis, showed a statistically significant difference in mortality (fixed-effects OR 0.84, 95% CI 0.41–1.70). Fewer patients in the ODM group experienced complications (OR 0.49, 95% CI 0.30–0.81) and both studies reported a statistically significant shorter median length of hospital stay in that group. No economic evaluations that met the inclusion criteria were identified from the existing literature so a series of balance sheets was constructed. The results show that ODM strategies are likely to be cost-effective. Conclusions: More formal economic evaluation would allow better use of the available data. All identified studies were conducted in unconscious patients. However, further research is needed to evaluate new ODM probes that may be tolerated by awake patients. Given the paucity of the existing economic evidence base, any further primary research should include an economic evaluation or should provide data suitable for use in an economic model.Item The value of myocardial perfusion scintigraphy in the diagnosis and management of angina and myocardial infarction : a probabilistic analysis(Sage, 2007-11-07) Hernández, Rodolfo Andrés; Vale, Luke David; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground and Aim. Coronary heart disease (CHD) is the most common cause of death in the United Kingdom, accounting for more than 120,000 deaths in 2001, among the highest rates in the world. This study reports an economic evaluation of single photon emission computed tomography myocardial perfusion scintigraphy (SPECT) for the diagnosis and management of coronary artery disease (CAD). Methods. Strategies involving SPECT with and without stress electrocardiography (ECG) and coronary angiography (CA) were compared to diagnostic strategies not involving SPECT. The diagnosis decision was modelled with a decision tree model and long-term costs and consequences using a Markov model. Data to populate the models were obtained from a series of systematic reviews. Unlike earlier evaluations, a probabilistic analysis was included to assess the statistical imprecision of the results. The results are presented in terms of incremental cost per quality-adjusted life year (QALY). Results. At prevalence levels of CAD of 10.5%, SPECT-based strategies are costeffective; ECG-CA is highly unlikely to be optimal. At a ceiling ratio of _20,000 per QALY, SPECT-CA has a 90% likelihood of being optimal. Beyond this threshold, this strategy becomes less likely to be cost-effective. At more than _75,000 per QALY, coronary angiography is most likely to be optimal. For higher levels of prevalence (around 50%) and more than a _10,000 per QALY threshold, coronary angiography is the optimal decision. Conclusions. SPECTbased strategies are likely to be cost-effective when risk of CAD is modest (10.5%). Sensitivity analyses show these strategies dominated non-SPECT-based strategies for risk of CAD up to 4%. At higher levels of prevalence, invasive strategies may become worthwhile. Finally, sensitivity analyses show stress echocardiography as a potentially costeffective option, and further research to assess the relative cost-effectiveness of echocardiography should also be performed.Item Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial : FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study)(BMC, 2008-11-03) Lois, Noemi; Burr, Jennifer Margaret; Norrie, John David; Vale, Luke David; Cook, Jonathan Alistair; McDonald, Alison Mary; FILMS Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground: A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM) peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Fullthickness macular hole and Internal Limiting Membrane peeling Study) is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. Methods/Design: Patients with stage 2–3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant) and with a visual acuity ≤ 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months), health related quality of life (HRQOL) at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY) and adverse events. Discussion: FILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery. Trial registration: This trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.
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