Browsing by Author "Vale, Luke David"

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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 Sciences
Objective 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.
Assessing methods to specify the target difference for a randomised controlled trial : DELTA (Difference ELicitation in TriAls) review
(2014-05-01) Cook, Jonathan Alistair; Hislop, Jennifer Margaret; Adewuyi, Temitope E; Harrild, Kirsten Ann; Altman, Douglas G; Ramsay, Craig R; Fraser, Cynthia; Buckley, Brian; Fayers, Peter; Harvey, Ian; Briggs, Andrew H; Norrie, John D; Fergusson, Dean; Ford, Ian; Vale, Luke David; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Institute of Applied Health Sciences
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 Sciences
Background: 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.
Clinical effectiveness and cost-effectiveness of laparoscopic surgery for colorectal cancer: systematic reviews and economic evaluation.
(2006-11) Murray, Alison Catherine; Lourenco, Tania; De Verteuil, Robyn; Hernández, Rodolfo Andrés; Fraser, Mary Fraser; McKinley, Aileen Joyce; Krukowski, Zygmunt H.; Vale, Luke David; Grant, Adrian Maxwell; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
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 Sciences
Objectives: 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.
A cost-utility analysis of multivitamin and multimineral supplements in men and women aged 65 years and over
(Elsevier, 2007) Kilonzo, Mary Mueni; Vale, Luke David; Cook, Jonathan Alistair; Milne, Anne Catherine; Stephen, Audrey Isabella; Avenell, Alison; MAVIS Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Background and Aims As people age there is a progressive dysregulation of the immune system that may lead to an increased risk of infections, which may precipitate hospital admission in people with chronic heart or respiratory diseases. Mineral and vitamin supplementation in older people could therefore influence infections in older people. However, the evidence from the available randomised controlled trials is mixed. The aim of the study was to assess the relative efficiency of multivitamin and multimineral supplementation compared with no supplementation. Methods Cost-utility analysis alongside a randomised controlled trial. Participants aged 65 years or over from six general practices in Grampian, Scotland were studied. They were randomised to one tablet daily of either a multivitamin and multimineral supplement or matching placebo. Exclusion criteria were: use of mineral, vitamin or fish oil supplements in the previous three months (one month for water soluble vitamins), vitamin B12 injection in the last three months. Results Nine hundred and ten participants were recruited (454 placebo and 456 supplementation). Use of health service resources and costs were similar between the two groups. The supplementation arm was more costly although this was not statistically significant (£15 per person, 95% CI -3.75 to 34.95). After adjusting for minimisation and baseline EQ-5D scores supplementation was associated with fewer QALYs per person (–0.018, 95% CI -0.04 to 0.002). It was highly unlikely that supplementation would be considered cost-effective. Conclusions The evidence from this study suggests that it is highly unlikely that supplementation could be considered cost-effective.
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 Sciences
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 Sciences
Economic evaluation of laparoscopic surgery for colorectal cancer
(Cambridge University Press, 2007) De Verteuil, Robyn; Hernández, Rodolfo Andrés; Vale, Luke David; Aberdeen Health Technology Assessment Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Objectives: To assess the cost-effectiveness of laparoscopic surgery compared with open surgery for the treatment of colorectal cancer. Methods: A Markov model was developed to model cost-effectiveness over 25 years. Data on the clinical effectiveness of laparoscopic and open surgery for colorectal cancer were obtained from a systematic review of the literature. Data on costs came from a systematic review of economic evaluations and from published sources. The outcomes of the model were presented as the incremental cost per life year gained and using cost-effectiveness acceptability curves (CEACs) to illustrate the likelihood that a treatment was cost-effective at various threshold values for society’s willingness to pay for an additional life year. Results: Laparoscopic surgery was on average £300 more costly and slightly less effective than open surgery and had a 30% chance of being cost-effective if society is willing to pay £30,000 for a life year. One interpretation of the available data suggests equal survival and disease-free survival. Making this assumption, laparoscopic surgery had a greater chance of being considered cost-effective. Presenting the results as incremental cost per quality adjusted life year (QALY) made no difference to the results, as utility data were poor. Evidence suggests short-term benefits following laparoscopic repair. This benefit would have to be at least 0.01 of a QALY for laparoscopic surgery to be considered cost-effective. Conclusions: Laparoscopic surgery is likely to be associated with short-term quality of life benefits, similar long-term outcomes and an additional £300 per patient. A judgement is required as to whether the short-term benefits are worth this extra cost.
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 Sciences
Objectives: 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.
Effect of multivitamin and multimineral supplementation on cognitive function in men and women aged 65 years and over : a randomised controlled trial
(BMC, 2007-05-02) McNeil, Geraldine; Avenell, Alison; Campbell, Marion Kay; Cook, Jonathan Alistair; Hannaford, Philip Christopher; Kilonzo, Mary Mueni; Milne, Anne Catherine; Ramsay, Craig R; Seymour, David Gwyn; Stephen, Audrey Isabella; Vale, Luke David; MAVIS Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Background: Observational studies have frequently reported an association between cognitive function and nutrition in later life but randomised trials of B vitamins and antioxidant supplements have mostly found no beneficial effect. We examined the effect of daily supplementation with 11 vitamins and 5 minerals on cognitive function in older adults to assess the possibility that this could help to prevent cognitive decline. Methods: The study was carried out as part of a randomised double blind placebo controlled trial of micronutrient supplementation based in six primary care health centres in North East Scotland. 910 men and women aged 65 years and over living in the community were recruited and randomised: 456 to active treatment and 454 to placebo. The active treatment consisted of a single tablet containing eleven vitamins and five minerals in amounts ranging from 50–210 % of the UK Reference Nutrient Intake or matching placebo tablet taken daily for 12 months. Digit span forward and verbal fluency tests, which assess immediate memory and executive functioning respectively, were conducted at the start and end of the intervention period. Risk of micronutrient deficiency at baseline was assessed by a simple risk questionnaire. Results: For digit span forward there was no evidence of an effect of supplements in all participants or in sub-groups defined by age or risk of deficiency. For verbal fluency there was no evidence of a beneficial effect in the whole study population but there was weak evidence for a beneficial effect of supplementation in the two pre-specified subgroups: in those aged 75 years and over (n 290; mean difference between supplemented and placebo groups 2.8 (95% CI -0.6, 6.2) units) and in those at increased risk of micronutrient deficiency assessed by the risk questionnaire (n 260; mean difference between supplemented and placebo groups 2.5 (95% CI -1.0, 6.1) units). Conclusion: The results provide no evidence for a beneficial effect of daily multivitamin and multimineral supplements on these domains of cognitive function in community-living people over 65 years. However, the possibility of beneficial effects in older people and those at greater risk of nutritional deficiency deserves further attention.
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.
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 & Nutrition
Laparoscopic surgery for colorectal cancer : safe and effective? - a systematic review
(Springer, 2008) Lourenco, Tania; Murray, Alison Catherine; Grant, Adrian Maxwell; McKinley, Aileen Joyce; Krukowski, Zygmunt H.; Vale, Luke David; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Objective To determine the clinical effectiveness of laparoscopic and laparoscopically assisted surgery in comparison with open surgery for the treatment of colorectal cancer. Background Open resection is the standard method for surgical removal of primary colorectal tumours. However, there is significant morbidity associated with this procedure. Laparoscopic resection (LR) is technically more difficult but may overcome problems associated with open resections (OR). Methods Systematic review and meta-analysis of short- and long-term data from randomised controlled trials (RCTs) comparing LS with OR. Results Highly sensitive searches of nine databases identified 19 primary RCTs describing data from over 4,500 participants. Length of hospital stay is shorter, blood loss and pain are less, and return to usual activities is likely to be faster after LR than after OR, but duration of operation is longer. Lymph node retrieval, completeness of resection and quality of life do not appear to differ. No statistically significant differences were observed in rates of anastomotic leakage, abdominal wound breakdown, incisional hernia, wound and urinary tract infections, operative and 30-day mortality, and recurrences, nor in overall and disease-free survival up to three years. Conclusions LR is associated with a quicker recovery in terms of return to usual activities and length of hospital stay with no evidence of a difference in complications or long-term outcomes in comparison to OR, up to three years postoperatively.
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 Sciences
Objective: 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.
A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery : trial protocol
(2010-04-16) Cuthbertson, Brian; Campbell, Marion Kay; Stott, S.a.; Vale, Luke David; Norrie, John David; Kinsella, John; Cook, Jonathan Alistair; Brittenden, Julie; Grant, Adrian Maxwell; Foccus Study Group; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Applied Medicine; University of Aberdeen.Institute of Applied Health Sciences
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 Sciences
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 Sciences
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 Sciences
Objective: 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.
Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients
(BioMed Central, 2007-09-20) Andrews, Peter J.D.; Avenell, Alison; Noble, David W.; Campbell, Marion Kay; Battison, Claire G.; Croal, Bernard L.; Simpson, William G.; Norrie, John David; Vale, Luke David; Cook, Jonathan Alistair; De Verteuil, Robyn; Milne, Anne Catherine; Trials Management Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Background: Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients. Methods/design: 2 × 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrolment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route. Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and cost-effectiveness. Discussion: To date more than 285 patients have been recruited to the trial from 10 sites in Scotland. Recruitment is due to finish in August 2008 with a further six months follow up. We expect to report the results of the trial in summer 2009. Trial registration: This trial is registered with the International Standard Randomised Controlled Trial Number system. ISRCTN87144826