Browsing by Author "Grant, Adrian Maxwell"

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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.
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 Group
Purpose 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.
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.
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
Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.
(Trials, 2006-12-21) Snowdon, Claire; Elbourne, Diana R.; Garcia, Jo; Campbell, Marion Kay; Entwistle, Vikki; Francis, David; Grant, Adrian Maxwell; Knight, Rosemary C.; McDonald, Alison Mary; Roberts, Ian; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
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 Sciences
Background: 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.
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.
Marketing and clinical trials : a case study
(BioMed Central, 2007-11-20) Francis, David; Roberts, Ian; Elbourne, Diana R.; Shakur, Haleema; Knight, Rosemary C.; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki; McDonald, Alison Mary; Grant, Adrian Maxwell; Campbell, Marion Kay; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Background: Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods: Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results: The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion: The performance of future clinical trials could be enhanced if trialists routinely considered these factors.
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 Sciences
ABSTRACT 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 ISRCTN15517081
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.
New postnatal urinary incontinence: obstetric and other risk factors in primparae.
(Blackwell Publishing, 2006-02) Glazener, Cathryn Margaret Anne; Herbison, G.P; MacArthur, C; Lancashire, R; McGee, M; Grant, Adrian Maxwell
Objective To identify obstetric and other risk factors for urinary incontinence which occurs during pregnancy or after childbirth. Design Questionnaire survey of women. Setting Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand). Population 3405 primiparous women with singleton births delivered during one year. Methods Questionnaire responses and obstetric casenote data were analysed using multivariate analysis to identify associations with urinary incontinence. Main outcome measures Urinary incontinence at three months after delivery first starting in pregnancy or after birth. Results The prevalence of urinary incontinence was 29%. New incontinence first beginning after delivery was associated with higher maternal age (oldest versus youngest group, odds ratio, OR 2.02, 95% CI 1.35 to 3.02); and method of delivery (caesarean section versus spontaneous vaginal delivery, OR 0.28, 95% CI 0.19 to 0.41). There were no significant associations with forceps delivery (OR 1.18, 95% CI 0.92 to 1.51) or vacuum delivery (OR 1.16, 95% CI 0.83 to 1.63). Incontinence first occurring during pregnancy and still present at three months was associated with higher maternal body mass index (BMI > 25, OR 1.68, 95% CI 1.16 to 2.43), and heavier babies (birthweight in top quartile, OR 1.56, 95% CI 1.12 to 2.19). In these women, caesarean section was associated with less incontinence (OR 0.39, 95% CI 0.27 to 0.58) but incontinence was not associated with age. Conclusions Women have less urinary incontinence after a first delivery by caesarean section whether or not that first starts during pregnancy. Older maternal age was associated with new postnatal incontinence, and higher body mass index and heavier babies with incontinence first starting during pregnancy. The effect of further deliveries may modify these findings.
Persistent urinary incontinence and delivery mode history: a six-year longitudinal study.
(Blackwell Publishing, 2006-02) MacArthur, C; Glazener, Cathryn Margaret Anne; Wilson, P.D; Lancashire, R; Herbison, G.P; Grant, Adrian Maxwell
Objective: To investigate the prevalence of persistent and long term postpartum urinary incontinence and associations with mode of first and subsequent delivery. Setting: Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand). Design: Longitudinal study Population: 4214 women who returned postal questionnaires 3 months and 6 years after the index birth. Methods: Symptom data were obtained from both questionnaires and obstetric data from case-notes for the index birth and the second questionnaire for subsequent births. Logistic regression investigated the independent effects of mode of first delivery and delivery mode history. Main outcome measures: Urinary incontinence – persistent (at 3 months and 6 years after index birth) and long-term (at 6 years after index birth). Results: The prevalence of persistent urinary incontinence was 24%. Delivering exclusively by Caesarean section was associated with both less persistent (OR= 0.46, 95% CI 0.32 to 0.68) and long term urinary incontinence (OR=0.50, 95% CI 0.40 to 0.63). Caesarean section birth in addition to vaginal delivery however was not associated with significantly less persistent incontinence (OR 0.93, 95%CI 0.67 to 1.29). There were no significant associations between persistent or long-term urinary incontinence and forceps or vacuum extraction delivery. Other significantly associated factors were increasing number of births and older maternal age. Conclusions: The risk of persistent and long term urinary incontinence is significantly lower following Caesarean section deliveries but not if there is another vaginal birth. Even when delivering exclusively by Caesarean section, the prevalence of persistent symptoms (14%) is still high.
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
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 Aberdeen
Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study
(Gray Publishing, 2007-11) Campbell, Marion Kay; Snowdon, Claire; Francis, David; Elbourne, Diana R.; McDonald, Alison Mary; Knight, Rosemary C.; Entwistle, Vikki; Garcia, Jo; Roberts, Ian; Grant, Adrian Maxwell; STEPS Group; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences
Objectives: To identify factors associated with good and poor recruitment to multicentre trials. Data sources: Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology Assessment Programmes. Part B: interviews with people playing a wide range of roles within four trials that their funders identified as ‘exemplars’. Part C: a large multicentre trial (the CRASH trial) of treatment for head injury. Review methods: The study used a number of different perspectives (‘multiple lenses’), and three components. Part A: an epidemiological review of a cohort of trials. Part B: case studies of trials that appeared to have particularly interesting lessons for recruitment. Part C: a single, in-depth case study to examine the feasibility of applying a businessorientated analytical framework as a reference model in future trials. Results: In the 114 trials found in Part A, less than one-third recruited their original target within the time originally specified, and around one-third had extensions. Factors observed more often in trials that recruited successfully were: having a dedicated trial manager, being a cancer or drug trial, and having interventions only available inside the trial. The most commonly reported strategies to improve recruitment were newsletters and mailshots, but it was not possible to assess whether they were causally linked to changes in recruitment. The analyses in Part B suggested that successful trials were those addressing clinically important questions at a timely point. The investigators were held in high esteem by the interviewees, and the trials were firmly grounded in existing clinical practices, so that the trial processes were not alien to clinical collaborators, and the results could be easily applicable to future practice. The interviewees considered that the needs of patients were well served by participation in the trials. Clinical collaborators particularly appreciated clear delineation of roles, which released them from much of the workload associated with trial participation. There was a strong feeling from interviewees that they were proud to be part of a successful team. This pride fed into further success. Good groundwork and excellent communications across many levels of complex trial structures were considered to be extremely important, including training components for learning about trial interventions and processes, and team building. All four trials had faced recruitment problems, and extra insights into the working of trials were afforded by strategies invoked to address them. The process of the case study in Part C was able to draw attention to a body of research and practice in a different discipline (academic business studies). It generated a reference model derived from a combination of business theory and work within CRASH. This enabled identification of weaker managerial components within CRASH, and initiatives to strengthen them. Although it is not clear, even within CRASH, whether the initiatives that follow from developing and applying the model will be effective in increasing recruitment or other aspects of the success of the trial, the reference model could provide a template, with potential for those managing other trials to use or adapt it, especially at foundation stages. The model derived from this project could also be used as a diagnostic tool if trials have difficulties and hence as a basis for deciding what type of remedial action to take. It may also be useful for auditing the progress of trials, such as during external review. Conclusions: While not producing sufficiently definitive results to make strong recommendations, the work here suggests that future trials should consider the different needs at different phases in the life of trials, and place greater emphasis on ‘conduct’ (the process of actually doing trials). This implies learning lessons from successful trialists and trial managers, with better training for issues relating to trial conduct. The complexity of large trials means that unanticipated difficulties are highly likely at some time in every trial. Part B suggested that successful trials were those flexible and robust enough to adapt to unexpected issues. Arguably, the trialists should also expect agility from funders within a proactive approach to monitoring ongoing trials. Further research into different recruitment patterns (including ‘failures’) may help to clarify whether the patterns seen in the ‘exemplar’ trials differ or are similar. The reference model from Part C needs to be further considered in other similar and different trials to assess its robustness. These and other strategies aimed at increasing recruitment and making trials more successful need to be formally evaluated for their effectiveness in a range of trials.
Systematic review of the clinical effectiveness and cost-effectiveness and economic modelling of minimal incision total hip replacement approaches in the management of arthritic disease of the hip
(Gray Publishing, 2008-06) De Verteuil, Robyn; Imamura, Mari; Zhu, S.; Glazener, Cathryn Margaret Anne; Fraser, Cynthia Mary; Munro, N.; Hutchison, James Douglas; Grant, Adrian Maxwell; Coyle, D.; Coyle, K.; Vale, Luke David; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Medicine
Objectives: To assess the clinical effectiveness and cost-effectiveness of minimal incision approaches to total hip replacement (THR) for arthritis of the hip. Data sources: Major electronic databases were searched from 1966 to 2007. Relevant websites were also examined and experts in the field were consulted. Review methods: Studies of minimal (one or two) incision THR compared with standard THR were assessed for inclusion in the review of clinical effectiveness. A systematic review of economic evaluations comparing a minimal incision approach to standard THR was also performed and the estimates from the systematic review of clinical effectiveness were incorporated into an economic model. Utilities data were sourced to estimate quality-adjusted life-years (QALYs). Due to lack of data, no economic analysis was conducted for the two mini-incision surgical method. Results: Nine randomised controlled trials (RCTs), 17 non-randomised comparative studies, six case series and one registry were found to be useful for the comparison of single mini-incision THR with standard THR. One RCT compared two mini-incision THR with standard THR, and two RCTs, five non-randomised comparative studies and two case series compared two mini-incision with single mini-incision THR. The RCTs were of moderate quality. Most had fewer than 200 patients and had a follow-up period of less than 1 year. The single mini-incision THR may have some perioperative advantages, e.g. blood loss [weighted mean difference (WMD) –57.71 ml, p < 0.01] and shorter operative time, of uncertain practical significance. It may also offer a shorter recovery period and greater patient satisfaction. Evidence on long-term outcomes (especially revision) is too limited to be useful. Lack of data prevented subgroup analysis. With respect to the two-incision approach, data were suggestive of shorter recovery compared with single-incision THR, but conclusions must be treated with caution. The costs to the health service, per patient, of single mini-incision THR depend upon assumptions made, but are similar at 1 year (£7060 vs £7350 for standard THR). For a 40-year time horizon the costs were £11,618 for mini-incision and £11,899 for standard THR. Two existing economic evaluations were identified, but they added little, if any, value to the current evidence base owing to their limited quality. In the economic model, mini-incision THR was less costly and provided slightly more QALYs in both the 1- and 40-year analyses. The mean QALYs at 1 year were 0.677 for standard THR and 0.695 for mini-incision THR. At 40 years, the mean QALYs were 8.463 for standard THR and 8.480 for mini-incision. At 1 year the probabilistic sensitivity analyses indicate that mini-incision THR has a 95% probability of being cost-effective if society’s willingness to pay for a QALY were up to £50,000. This is reduced to approximately 55% for the 40-year analysis. The results were driven by the assumption of a 1-month earlier return to usual activities and a decreased hospital length of stay and operation duration following mini-incision THR. If mini-incision THR actually required more intensive use of resources it would become approximately £200 more expensive and would only be cost-effective (cost per QALY > £30,000) if recovery was 1.5 weeks faster. A threshold analysis around risk of revision showed, using the same cost per QALY threshold, mini-incision THR would have to have no more than a 7.5% increase in revisions compared with standard THR for it to be no longer considered cost-effective (one more revision for every 200 procedures performed). Further sensitivity analysis involved relaxing assumptions of equal long-term outcomes where possible. and broadly similar results to the base-case analysis were found in this and further sensitivity analyses. Conclusions: Compared with standard THR, minimal incision THR has small perioperative advantages in terms of blood loss and operation time. It may offer a shorter hospital stay and quicker recovery. It appears to have a similar procedure cost to standard THR, but evidence on its longer term performance is very limited. Further long-term follow-up data on costs and outcomes including analysis of subgroups of interest to the NHS would strengthen the current economic evaluation.
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 Sciences
What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.
(Trials, 2006-04-07) McDonald, Alison Mary; Knight, Rosemary C.; Campbell, Marion Kay; Entwistle, Vikki; Grant, Adrian Maxwell; Cook, Jonathan Alistair; Elbourne, Diana R.; Francis, David; Garcia, Jo; Roberts, Ian; Snowdon, Claire; University of Aberdeen, School of Medicine & Dentistry, Division of Applied Health Sciences