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Item Randomised controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids : Long-term results(2010-06) Shanmugam, V.; Muthukumarasamy, G.; Cook, Jonathan Alistair; Vale, Luke David; Watson, Angus; Loudon, M. A.; University of Aberdeen.Other 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 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 Quality of life in the five years after intensive care : a cohort study(2010-01-20) Cuthbertson, Brian; Roughton, Sian; Jenkinson, David James; MacLennan, Graeme Stewart; Vale, Luke David; 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 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 The effectiveness and cost-effectiveness of minimal access surgery amongst people with gastro-oesophageal reflux disease – a UK collaborative study(National Institute for Health Research, 2008-09) Grant, Adrian Maxwell; Wileman, Samantha Mary; Ramsay, Craig R; Bojke, Laura; Sculpher, Mark J.; Kilonzo, Mary Mueni; Vale, Luke David; Francis, Jillian Joy; Mowat, Ashley G.; Krukowski, Zygmunt H.; Campbell, Marion Kay; Epstein, David; Macran, Sue; Heading, Robert; Thursz, Mark; Russell, Ian; REFLUX Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences*Corresponding author randomised arm of the trial (178 allocated to surgical management,179 allocated to continued, but optimised,medical management) and 453 recruited to the parallel non-randomised preference arm (261 chose surgical management, 192 chose to continue with best medical management). The type of fundoplication was left to the discretion of the surgeon. Main outcome measures: Participants completed a baseline reflux questionnaire, developed specifically for this study, containing a disease-specific outcome measure, the Short Form with 36 Items (SF-36), the EuroQol-5 Dimensions (EQ-5D) and the Beliefs about Medicines and Surgery questionnaires (BMQ/BSQ).Postal questionnaires were completed at participant specific time intervals after joining the trial (equivalent to approximately 3 and 12 months after surgery).Intraoperative data were recorded by the surgeons and all other in-hospital data were collected by the research nurse. At the end of the study period, participants completed a discrete choice experiment questionnaire. Results: The randomised groups were well balanced at entry. Participants had been taking GORD medication for a median of 32 months; the mean age of participants was 46 years and 66% were men. Of 178 randomised to surgery, 111 (62%) actually had fundoplication.There was a mixture of clinical and personal reasons why some patients did not have surgery, sometimes Objectives: To evaluate the clinical effectiveness, costeffectiveness and safety of a policy of relatively early laparoscopic surgery compared with continued medical management amongst people with gastro-oesophageal reflux disease (GORD) judged suitable for both policies. Design: Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgerybased policy with a continued medical management policy. The economic evaluation compared the costeffectiveness of the two management policies in order to identify the most efficient provision of future care and describe the resource impact that various policies for fundoplication would have on the NHS.Setting: A total of 21 hospitals throughout the UK with a local partnership between surgeon(s) and gastroenterologist(s) who shared the secondary care of patients with GORD.Participants: The 810 participants, who were identified retrospectively or prospectively via their participating clinicians, had both documented evidence of GORD (endoscopy and/or manometry/24-hour pH monitoring) and symptoms for longer than 12 months. In addition,the recruiting clinician(s) was clinically uncertain about which management policy was best.Intervention: Of the 810 eligible patients who consented to participate, 357 were recruited to the related to long waiting times. A total or partial wrap procedure was performed depending on surgeon preference. Complications were uncommon and there were no deaths associated with surgery. By the equivalent of 12 months after surgery, 38% in the randomised surgical group (14% amongst those who had surgery) were taking reflux medication compared with 90% in the randomised medical group. There were substantial differences (one-third to one-half standard deviation) favouring the randomised surgical group across the health status measures, the size depending on assumptions about the proportion that actually had fundoplication. These differences were the same or somewhat smaller than differences observed at 3 months. The lower the reflux score, the worse the symptoms at trial entry and the larger the benefit observed after surgery. The preference surgical group had the lowest reflux scores at baseline. These scores improved substantially after surgery, and by 12 months they were better than those in the preference medical group. The BMQ/BSQ and discrete choice experiment did distinguish the preference groups from each other and from the randomised groups. The latter indicated that the risk of serious complications was the most important single attribute of a treatment option. A within trial cost-effectiveness analysis suggested that the surgery policy was more costly (mean £2049) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was £19,000–£23,000, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of £20,000 per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of costeffectiveness at a threshold of £20,000, but applying a range of alternative scenarios indicated wide uncertainty.The expected value of perfect information was greatest for longer-term quality of life and proportions of surgical patients requiring medication.Conclusions: Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and refluxspecific health-related quality of life measures, at least up to 12 months after surgery. Complications of surgery were rare. A surgical policy is, however, more costly than continued medical management. At a threshold of £20,000 per QALY it may well be cost-effective, especially when putative longer-term benefits are taken into account, but this is uncertain.The more troublesome the symptoms, the greater the potential benefit from surgery. Uncertainty about cost-effectiveness would be greatly reduced by more reliable information about relative longer-term costs and benefits of surgical and medical policies. This could be through extended follow-up of the reflux trial cohorts or of other cohorts of fundoplication patients.Item Minimally invasive therapies for the treatment of benign prostatic enlargement : systematic review of randomised controlled trials(BMJ, 2008-10-09) Lourenco, Tania; Pickard, Robert; Vale, Luke David; Grant, Adrian Maxwell; Fraser, Cynthia Mary; MacLennan, Graeme Stewart; N'Dow, James Michael Olu; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjective: To compare the effectiveness and risk profile of minimally invasive interventions against the current standard of transurethral resection of the prostate. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Electronic and paper records up to March 2006. Review methods: We searched for all relevant randomised controlled trials. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were performed with fixed and random effects models and reported using relative risks or weighted mean difference. Results 3794 abstracts were identified; 22 randomised controlled trials met the inclusion criteria. These provided data on 2434 participants. The studies evaluated were of moderate to poor quality with small sample sizes. Minimally invasive interventions were less effective than transurethral resection of the prostate in terms of improvement in symptom scores and increase in urine flow rate, with most comparisons showing significance despite wide confidence intervals. Rates of second operation were significantly higher for minimally invasive treatments. The risk profile of minimally invasive interventions was better than that of transurethral resection, with fewer adverse events. The results, however, showed significant heterogeneity. Conclusion: Which minimally invasive intervention is the most promising remains unclear. Their place in the management of benign prostate enlargement will continue to remain controversial until well designed and well reported randomised controlled trials following CONSORT guidelines prove they are superior and more cost effective than drug treatment or that strategies of sequential surgical treatments are preferred by patients and are more cost effective than the more invasive but more effective tissue ablative interventions such as transurethral resection.Item Alternative approaches to endoscopic ablation for benign enlargement of the prostate : a systematic review of randomised controlled trials(BMJ, 2008) Lourenco, Tania; Pickard, Robert; Vale, Luke David; Grant, Adrian Maxwell; Fraser, Cynthia Mary; MacLennan, Graeme Stewart; N'Dow, James Michael Olu; Benign Prostatic Enlargement Team; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesObjective To compare the effectiveness and risk profile of newer methods for endoscopic ablation of the prostate against the current standard of transurethral resection. Design Systematic review and meta-analysis. Data sources Electronic and paper records in subject area up to March 2006. Review methods We searched for randomised controlled trials of endoscopic ablative interventions that included transurethral resection of prostate as one of the treatment arms. Two reviewers independently extracted data and assessed quality. Meta-analyses of prespecified outcomes were done using fixed and random effects models and reported using relative risk or weighted mean difference. Results We identified 45 randomised controlled trials meeting the inclusion criteria and reporting on 3970 participants. The reports were of moderate to poor quality, with small sample sizes. None of the newer technologies resulted in significantly greater improvement in symptoms than transurethral resection at 12 months, although a trend suggested a better outcome with holmium laser enucleation (random effects weighted mean difference -0.82, 95% confidence interval 1.76 to 0.12) and worse outcome with laser vaporisation (1.49, -0.40 to 3.39). Improvements in secondary measures, such as peak urine flow rate, were consistent with change in symptoms. Blood transfusion rates were higher for transurethral resection than for the newer methods (4.8% v 0.7%) and men undergoing laser vaporisation or diathermy vaporisation were more likely to experience urinary retention (6.7% v 2.3% and 3.6% v 1.1%). Hospital stay was up to one day shorter for the newer technologies. Conclusions Although men undergoing more modern methods of removing benign prostatic enlargement have similar outcomes to standard transurethral resection of prostate along with fewer requirements for blood transfusion and shorter hospital stay, the quality of current evidence is poor. The lack of any clearly more effective procedure suggests that transurethral resection should remain the standard approach.