2 - Schools incorporating the Life Sciences and Medicine
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Item A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses : the Knee Arthroplasty Trial (KAT)(2014-03-01) Murray, David W; MacLennan, Graeme S; Breeman, Suzanne; Dakin, Helen A; Johnston, Linda; Campbell, Marion Kay; Gray, Alastair M; Fiddian, Nick; Fitzpatrick, Ray; Morris, Richard W; Grant, Adrian Maxwell; KAT group; University of Aberdeen.Other Applied Health Sciences; University of Aberdeen.Institute of Applied Health Sciences; University of Aberdeen.University of AberdeenItem 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 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 The Knee Arthroplasty Trial (KAT) : design features, baseline characteristics and two-year functional outcomes after alternative approaches to knee replacement(Wiley, 2009-01-01) Campbell, Marion Kay; Fiddian, Nick; Fitzpatrick, Ray; Grant, Adrian Maxwell; Gray, Alastair; Morris, Richard; Murray, David; Rowley, David; Johnston, Linda; MacLennan, Graeme Stewart; McCormack, Kirsty; Ramsay, Craig R; Walker, Allan; KAT Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesBackground: The aim of continued development of total knee replacement systems has been the further improvement of the quality of life and increasing the duration of prosthetic survival. Our goal was to evaluate the effects of several design features, including metal backing of the tibial component, patellar resurfacing, and a mobile bearing between the tibial and femoral components, on the function and survival of the implant. Methods: A pragmatic, multicenter, randomized, controlled trial involving 116 surgeons in thirty-four centers in the United Kingdom was performed; 2352 participants were randomly allocated to be treated with or without a metal backing of the tibial component (409), with or without patellar resurfacing (1715), and/or with or without a mobile bearing (539). Randomization to more than one comparison was allowed. The primary outcome measures were the Oxford Knee Score (OKS), Short Form-12, EuroQol-5D, and the need for additional surgery. The results up to two years postoperatively are reported. Results: Functional status and quality-of-life scores were low at baseline but improved markedly across all trial groups following knee replacement (mean overall OKS, 17.98 points at baseline and 34.82 points at two years). Most of the change was observed at three months after the surgery. Six percent of the patients had additional knee surgery within two years. There was no evidence of differences in clinical, functional, or quality-of-life measures between the randomized groups at two years. Conclusions: Patients have substantial improvement following total knee replacement. This is the first adequately powered randomized controlled trial, of which we are aware, in which the effects of metal backing, patellar resurfacing, and a mobile bearing were investigated. We found no evidence of an effect of these variants on the rate of early complications or on functional recovery up to two years after total knee replacement. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.Item Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease : UK collaborative randomised trial(BMJ, 2009-01-10) Grant, Adrian Maxwell; Wileman, Samantha M; Ramsay, Craig R; Mowat, N Ashley; Krukowski, Zygmunt H; Heading, Robert C; Thursz, Mark R; Campbell, Marion Kay; REFLUX Trial Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health SciencesABSTRACT Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Multicentre, pragmatic randomised trial (with parallel preference groups). Setting 21 hospitals in the United Kingdom. Participants 357 randomised participants (178 surgical,179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months. Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care. Main outcome measures The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications. Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001). Differences of a third to half of 1 SD in other health status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group. Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD. Trial registration ISRCTN15517081Item 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.Item Bowel dysfunction after transposition of intestinal segments into the urinary tract : 8-year prospective cohort study(Elsevier, 2007) Somani, Bhaskar K.; Kumar, Vinod; Wong, Susan; Pickard, Robert; Ramsay, Craig R; Nabi, Ghulam; Grant, Adrian Maxwell; N'Dow, James Michael Olu; ABACUS Research GroupPurpose Bowel function may be disturbed after intestinal segments are transposed into the urinary tract to reconstruct or replace the bladder. In 1997, our group were the first to report major bowel dysfunction in a cohort of such patients: up to 42% of those who were asymptomatic preoperatively describing new bowel symptoms postoperatively including explosive diarrhoea, nocturnal diarrhoea, faecal urgency, faecal incontinence and flatus leakage . We now describe bowel symptoms in this same cohort eight years later (2005). Materials and Methods 116 patients were evaluable. Of the remaining 37 from the original report: 30 had died, five no longer wished to be involved, and two could not be traced. Patients were asked to complete postal questionnaires identical to those used in the first follow-up, assessing the severity of bowel symptoms and quality of life using two validated instruments. Responses were compared with those from the original study. The Nottingham Health Profile quality of life scores were also compared to age and sex matched norms. Results 96 (83%) completed eight-year follow-up questionnaires: 43 after ileal conduit diversion (Group 1), 17 after clam enterocystoplasty for overactive bladder (Group 2), 18 after reconstructed bladder for neurogenic bladder dysfunction (Group 3), and 18 with bladder replacement for non-neurogenic causes (Group 4). High prevalence rates of bowel symptoms persisted with no statistically significant differences between the two time points. Of those with symptoms in 2005, around 50% had reported similar symptoms in 1997. Clam enterocystoplasty patients (Group 2) still reported the highest prevalence (59%) of troublesome diarrhoea with one in two on regular anti-diarrhoeal medication. They also had high rates of faecal incontinence (47%), faecal urgency (41%) and nocturnal bowel movement (18%); with high proportions reporting a moderate or severe adverse effect on work (36%), social life (50%) and sex life (43%). High rates were also reported by neurogenic bladder dysfunction patients, including 50% with troublesome diarrhoea. This symptom was reported by 19% after ileal conduit and by 17% after bladder replacement for non-neurogenic causes. The impact of bowel symptoms on every-day activities and quality of life persisted, remaining most severe after clam enterocystoplasty, with 24% regretting undergoing the procedure because of subsequent bowel symptoms. Conclusions: After more than eight years, operations involving transposition of intestinal segments continue to be associated with high rates of bowel symptoms, which impact on everyday activities. These are particularly troublesome following enterocystoplasty for overactive bladder and bladder reconstruction for neurogenic bladder dysfunction. These risks should influence patient selection and potential patients should be warned prior to surgery.