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Item Laparoscopic supracervical hysterectomy compared with second-generation endometrial ablation for heavy menstrual bleeding : the HEALTH RCT(2019-10-02) Cooper, Kevin; Breeman, Suzanne; Scott, Neil William; Scotland, Graham Stewart; Hernández, Rodolfo Andrés; Clark, T Justin; Hawe, Jed; Hawthorn, Robert; Phillips, Kevin; Wileman, Samantha Mary; McCormack, Kirsty; Norrie, John; Bhattacharya, Siladitya; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Aberdeen Centre for Evaluation; University of Aberdeen.Institute of Applied Health Sciences; University of Aberdeen.Medical Statistics; University of Aberdeen.Health Economics Research Unit; University of Aberdeen.M&D School Administration; University of Aberdeen.Aberdeen Centre for Women’s Health ResearchItem 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 The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness : a pragmatic randomised controlled trial(BMJ, 2009) Cuthbertson, Brian; Rattray, J; Campbell, Marion Kay; Gager, M; Roughton, S; Smith, A; Hull, A; Breeman, S; Norrie, John David; Jenkinson, David James; Hernández, Rodolfo Andrés; Johnston, Marie; Wilson, E; Waldman, C; PRaCTICaL Study Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjectives To test the hypothesis that nurse led follow-up programmes are effective and cost effective in improving quality of life after discharge from intensive care. Design A pragmatic, non-blinded, multicentre, randomised controlled trial. Setting Three UK hospitals (two teaching hospitals and one district general hospital). Participants 286 patients aged ≥18 years were recruited after discharge from intensive care between September 2006 and October 2007. Intervention Nurse led intensive care follow-up programmes versus standard care. Main outcome measure(s) Health related quality of life (measured with the SF-36 questionnaire) at 12 months after randomisation. A cost effectiveness analysis was also performed. Results 286 patients were recruited and 192 completed one year follow-up. At 12 months, there was no evidence of a difference in the SF-36 physical component score (mean 42.0 (SD 10.6) v 40.8 (SD 11.9), effect size 1.1 (95% CI −1.9 to 4.2), P=0.46) or the SF-36 mental component score (effect size 0.4 (−3.0 to 3.7), P=0.83). There were no statistically significant differences in secondary outcomes or subgroup analyses. Follow-up programmes were significantly more costly than standard care and are unlikely to be considered cost effective. Conclusions A nurse led intensive care follow-up programme showed no evidence of being effective or cost effective in improving patients’ quality of life in the year after discharge from intensive care. Further work should focus on the roles of early physical rehabilitation, delirium, cognitive dysfunction, and relatives in recovery from critical illness. Intensive care units should review their follow-up programmes in light of these results.Item Romiplostim for the treatment of chronic immune or idiopathic thrombocytopenic purpura : a single technology appraisal(Gray, 2009) Mowatt, Graham; Boachie, C; Crowther, M; Fraser, Cynthia Mary; Hernández, Rodolfo Andrés; Jia, X; Ternent, LauraThis paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of romiplostim for the treatment of adults with chronic immune or idiopathic thrombocytopenic purpura (ITP) based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s evidence came from two relatively high-quality randomised controlled trials (RCTs). The ERG found no evidence that any important data were missed or that data extraction was inaccurate. In both RCTs more patients in the romiplostim than in the placebo group achieved a durable platelet response [non-splenectomised patients: romiplostim 25/41 (61%), placebo 1/21 (5%), odds ratio (OR) 24.45, 95% confidence interval (CI) 3.34 to 179.18; splenectomised patients: romiplostim 16/42 (38%), placebo 0/21 (0%), OR 8.5 (95% CI 1.15 to 372)] and an overall platelet response [non splenectomised patients: romiplostim 36/41 (88%), placebo 3/21 (14%), OR 34.74, 95% CI 7.77 to 155.38; splenectomised patients: romiplostim 33/42 (79%), placebo 0/21 (0%), OR 16.6 (95% CI 2.37 to 706]. The difference in mean period with a platelet response was 13.9 weeks (95% CI 10.5 to 17.4) in favour of romiplostim in the RCT of non-splectomised patients and 12.1 weeks (95% CI 8.7 to 15.6) in favour of romiplostim in the RCT of splectomised patients. The manufacturer’s economic model evaluated the cost-effectiveness of romiplostim compared with standard care. The ERG had concerns about the way the decision problem was addressed in the economic model and about the non-adjustment of findings for confounding factors. In non-splenectomised patients, using romiplostim as a first option treatment, the base-case incremental costeffectiveness ratio (ICER) was £14,840 per quality adjusted life-year (QALY). In splenectomised patients the ICER was £14,655 per QALY. Additional sensitivity analyses performed by the ERG identified two issues of importance: whether individuals entered the model on watch and rescue or on active therapy in the comparator arm (ICER £21,674 per QALY for non-splenectomised patients, £29,771 per QALY for splenectomised patients); whether it was assumed that any unused medicine would be wasted. Combining all of the separate sensitivity analyses, and assuming that watch and rescue was not the first-line treatment, increased the ICERs further (non-splenectomised £37,290 per QALY; splenectomised £131,017 per QALY). In conclusion, the manufacturer’s submission and additional work conducted by the ERG suggest that romiplostim has short-term efficacy for the treatment of ITP, but there is no robust evidence on long-term effectiveness or cost-effectiveness of romiplostim compared with relevant comparators.Item 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 Economic evaluation of screening for open angle glaucoma(Cambridge University Press, 2008) Hernández, Rodolfo Andrés; Burr, Jennifer Margaret; Vale, Luke David; OAG Screening Project Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjectives: The aim of this study was to assess the cost-effectiveness of screening for open-angle glaucoma (OAG) in the United Kingdom, given that OAG is an important cause of blindness worldwide. Methods: A Markov model was developed to estimate lifetime costs and benefits of a cohort of patients facing, alternatively, screening or current opportunistic case finding strategies. Strategies, varying in how screening would be organized (e.g., invitation for assessment by a glaucoma-trained optometrist [GO] or for simple test assessment by a technician) were developed, and allowed for the progression of OAG and treatment effects. Data inputs were obtained from systematic reviews. Deterministic and probabilistic sensitivity analyses were performed. Results: Screening was more likely to be cost-effective as prevalence increased, for 40 year olds compared with 60 or 75 year olds, when the re-screening interval was greater (10 years), and for the technician strategy compared with the GO strategy. For each age cohort and at prevalence levels of ≤1 percent, the likelihood that either screening strategy would be more cost-effective than current practice was small. For those 40 years of age, “technician screening” compared with current practice has an incremental cost-effectiveness ratio (ICER) that society might be willing to pay when prevalence is 6 percent to 10 percent and at over 10 percent for 60 year olds. In the United Kingdom, the age specific prevalence of OAG is much lower. Screening by GO, at any age or prevalence level, was not associated with an ICER < £30,000. Conclusions: Population screening for OAG is unlikely to be cost-effective but could be for specific subgroups at higher risk.Item The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma : a systematic review and economic evaluation(Gray Publishing, 2007-10) Burr, Jennifer Margaret; Mowatt, Graham; Hernández, Rodolfo Andrés; Siddiqui, Muhammad Ardul Rehman; Cook, Jonathan Alistair; Lourenco, Tania; Ramsay, Craig R; Vale, Luke David; Fraser, Cynthia Mary; Azuara-Blanco, Augusto; Deeks, J.; Cairns, J.; Wormald, R.; McPherson, S.; Rabindranath, K.; Grant, Adrian Maxwell; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjectives: To assess whether open angle glaucoma (OAG) screening meets the UK National Screening Committee criteria, to compare screening strategies with case finding, to estimate test parameters, to model estimates of cost and cost-effectiveness, and to identify areas for future research. Data sources: Major electronic databases were searched up to December 2005. Review methods: Screening strategies were developed by wide consultation. Markov submodels were developed to represent screening strategies. Parameter estimates were determined by systematic reviews of epidemiology, economic evaluations of screening, and effectiveness (test accuracy, screening and treatment). Tailored highly sensitive electronic searches were undertaken. Results: Most potential screening tests reviewed had an estimated specificity of 85% or higher. No test was clearly most accurate, with only a few, heterogeneous studies for each test. No randomised controlled trials (RCTs) of screening were identified. Based on two treatment RCTs, early treatment reduces the risk of progression. Extrapolating from this, and assuming accelerated progression with advancing disease severity, without treatment the mean time to blindness in at least one eye was approximately 23 years, compared to 35 years with treatment. Prevalence would have to be about 3–4% in 40 year olds with a screening interval of 10 years to approach costeffectiveness. It is predicted that screening might be cost-effective in a 50-year-old cohort at a prevalence of 4% with a 10-year screening interval. General population screening at any age, thus, appears not to be cost-effective. Selective screening of groups with higher prevalence (family history, black ethnicity) might be worthwhile, although this would only cover 6% of the population. Extension to include other at-risk cohorts (e.g. myopia and diabetes) would include 37% of the general population, but the prevalence is then too low for screening to be considered cost-effective. Screening using a test with initial automated classification followed by assessment by a specialised optometrist, for test positives, was more cost-effective than initial specialised optometric assessment. The cost-effectiveness of the screening programme was highly sensitive to the perspective on costs (NHS or societal). In the base-case model, the NHS costs of visual impairment were estimated as £669. If annual societal costs were £8800, then screening might be considered cost-effective for a 40-year-old cohort with 1% OAG prevalence assuming a willingness to pay of £30,000 per quality-adjusted life-year. Of lesser importance were changes to estimates of attendance for sight tests, incidence of OAG, rate of progression and utility values for each stage of OAG severity. Cost-effectiveness was not particularly sensitive to the accuracy of screening tests within the ranges observed. However, a highly specific test is required to reduce large numbers of false-positive referrals. The findings that population screening is unlikely to be cost-effective are based on an economic model whose parameter estimates have considerable uncertainty. In particular, if rate of progression and/or costs of visual impairment are higher than estimated then screening could be cost-effective. Conclusions: While population screening is not costeffective, the targeted screening of high-risk groups may be. Procedures for identifying those at risk, for quality assuring the programme, as well as adequate service provision for those screened positive would all be needed. Glaucoma detection can be improved by increasing attendance for eye examination, and improving the performance of current testing by either refining practice or adding in a technology-based first assessment, the latter being the more cost-effective option. This has implications for any future organisational changes in community eye-care services. Further research should aim to develop and provide quality data to populate the economic model, by conducting a feasibility study of interventions to improve detection, by obtaining further data on costs of blindness, risk of progression and health outcomes, and by conducting an RCT of interventions to improve the uptake of glaucoma testing.