ORCID Profile
0000-0001-5386-4097
Current Organisation
University of Aberdeen
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Publisher: Springer Science and Business Media LLC
Date: 20-11-2018
Publisher: Springer Science and Business Media LLC
Date: 23-10-2014
Publisher: Oxford University Press (OUP)
Date: 11-05-2021
Abstract: Antibiotics are over-prescribed for upper respiratory tract infection (URTI). It is unclear how factors known to influence prescribing decisions operate ‘in the moment’: dual process theories, which propose two systems of thought (‘automatic’ and ‘analytical’), may inform this. Investigate cognitive processes underlying antibiotic prescribing for URTI and the factors associated with inappropriate prescribing. We conducted a mixed methods study. Primary care physicians in Scotland (n = 158) made prescribing decisions for patient scenarios describing sore throat or otitis media delivered online. Decision difficulty and decision time were recorded. Decisions were categorized as appropriate or inappropriate based on clinical guidelines. Regression analyses explored relationships between scenario and physician characteristics and decision difficulty, time and appropriateness. A subgroup (n = 5) verbalized their thoughts (think aloud) whilst making decisions for a subset of scenarios. Interviews were analysed inductively. Illness duration of 4+ days was associated with greater difficulty. Inappropriate prescribing was associated with clinical factors suggesting viral cause and with patient preference against antibiotics. In interviews, physicians made appropriate decisions quickly for easier cases, with little deliberation, reflecting automatic-type processes. For more difficult cases, physicians deliberated over information in some instances, but not in others, with inappropriate prescribing occurring in both instances. Some interpretations of illness duration and unilateral ear examination findings (for otitis media) were associated with inappropriate prescribing. Both automatic and analytical processes may lead to inappropriate prescribing. Interventions to support appropriate prescribing may benefit from targeting interpretation of illness duration and otitis media ear exam findings and facilitating appropriate use of both modes of thinking.
Publisher: Public Library of Science (PLoS)
Date: 30-03-2023
DOI: 10.1371/JOURNAL.PONE.0283000
Abstract: The introduction of robot-assisted surgery is costly and requires whole system transformation, which makes the assessment of benefits (or drawbacks) complex. To date, there has been little agreement on which outcomes should be used in this regard. The aim of the RoboCOS study was to develop a core outcome set for the evaluation of robot-assisted surgery that would account for its impact on the whole system. Identification of a long-list of potentially relevant outcomes through systematic review of trials and health technology assessments interviews with in iduals from a range of stakeholder groups (surgeons, service managers, policy makers and evaluators) and a focus group with patients and public prioritisation of outcomes via a 2-round online international Delphi survey consensus meeting. 721 outcomes were extracted from the systematic reviews, interviews and focus group which were conceptualised into 83 different outcome domains across four distinct levels (patient, surgeon, organisation and population) for inclusion in the international Delphi prioritisation survey (128 completed both rounds). The consensus meeting led to the agreement of a 10-item core outcome set including outcomes at: patient level (treatment effectiveness overall quality of life disease-specific quality of life complications (including mortality) surgeon level (precision/accuracy visualisation) organisation (equipment failure standardisation of operative quality cost-effectiveness) and population (equity of access). The RoboCOS core outcome set, which includes the outcomes of importance to all stakeholders, is recommended for use in all future evaluations of robot-assisted surgery to ensure relevant and comparable reporting of outcomes.
Publisher: BMJ
Date: 18-04-2013
DOI: 10.1136/BMJ.F1908
Publisher: Massachusetts Medical Society
Date: 25-09-2014
Publisher: Massachusetts Medical Society
Date: 05-09-2019
Publisher: Springer Science and Business Media LLC
Date: 12-2012
Publisher: Elsevier BV
Date: 02-2017
Publisher: SAGE Publications
Date: 02-10-2013
Abstract: To assess the value of conducting a glaucoma screening randomized controlled trial in the UK. Decision model based economic evaluation and value of information analysis. Model derived from a previous health technology assessment. Model updated in terms of structure and parameter estimates with data from surveys, interviews with members of the public and health care providers and routine sources. On average, across a range of ages of initiating screening (40–60 years), glaucoma prevalence (1–5%), screening uptake (30–100%), and the performance of current case finding, screening was not cost-effective at a £30,000 threshold per quality adjusted life year (QALY) from the perspective of the National Health Service (NHS). The societal value of removing all uncertainty around glaucoma screening is £107 million at a threshold of £20,000 per QALY. For informing policy decisions on glaucoma screening, reducing uncertainty surrounding the NHS and personal social care cost of sight impairment (£74 million) was of most value, followed by reducing uncertainty in test performance (£14 million) and uptake of either screening or current eye care (£8 million each). A glaucoma screening trial in the UK is unlikely to be the best use of research resources. Further research to quantify the costs of sight impairment falling on the NHS and personal social services is a priority. Further development of glaucoma tests and research into strategies to promote the uptake of screening or current eye care such as through the use of a behavioural intervention would be worthwhile.
Publisher: Wiley
Date: 18-10-2004
Publisher: BMJ
Date: 15-12-2008
DOI: 10.1136/BMJ.A2664
Publisher: Springer Science and Business Media LLC
Date: 24-07-2014
Publisher: Elsevier BV
Date: 11-2013
DOI: 10.1016/J.AUCC.2013.04.002
Abstract: This study sought to identify and describe the clinical and behavioural components (e.g. the what, how, when, where and by whom) of 'selective decontamination of the digestive tract' (SDD) as routinely implemented in the care of critically ill patients. Multi-methods study, consisting of semi-structured observations of SDD delivery, interviews with clinicians and documentary analysis, conducted in two ICUs in the UK that routinely deliver SDD. Data were analysed within-site to describe clinical and behavioural SDD components and synthesised across-sites to describe SDD in context. SDD delivery involved multiple behaviours extending beyond administration of its clinical components. Not all behaviours were specified in relevant clinical documentation. Overall, SDD implementation and delivery included: adoption (i.e. whether to implement SDD), operationalisation (i.e. implementing SDD into practice), provision (i.e. delivery of SDD) and surveillance (i.e. monitoring the ecological effects). Implementation involved organisational, team and in idual-level behaviours. Delivery was perceived as easy by in idual staff, but displayed features of complexity (including multiple interrelated behaviours, staff and contexts). This study is the first to formally outline the full spectrum of clinical and behavioural aspects of SDD. It identified points in the delivery process where complex behaviours occur and outlined how SDD can be interpreted and applied variably in practice. This comprehensive specification allows greater understanding of how this intervention could be implemented in units not currently using it, or replicated in research studies. It also identified strategies required to adopt SDD and to standardise its implementation.
Publisher: National Institute for Health and Care Research
Date: 04-2015
DOI: 10.3310/HTA19270
Abstract: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. Eleven UK specialist vascular centres. Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292 surgery, n = 294 EVLA, n = 212). Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Quality of life at 6 weeks residual varicose veins Venous Clinical Severity Score (VCSS) complication rates return to normal activity truncal vein ablation rates and costs. The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size −1.74, 95% confidence interval (CI) −2.97 to −0.50 p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06 p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 5%). With regard to secondary outcomes, health gains at 6 weeks ( p 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) ( p 0.001). Participants returned to a wide range of behaviours more quickly following foam or EVLA than following surgery ( p 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery ( p 0.001) and EVLA ( p 0.001) than for foam, and were similar for surgery and EVLA. Considerations of both the 6-month clinical outcomes and the estimated 5-year cost-effectiveness suggest that EVLA should be considered as the treatment of choice for suitable patients. Five-year trial results are currently being evaluated to compare the cost-effectiveness of foam, surgery and EVLA, and to determine the recurrence rates following each treatment. This trial has highlighted the need for long-term outcome data from RCTs on QoL, recurrence rates and costs for foam sclerotherapy and other endovenous techniques compared against each other and against surgery. Current Controlled Trials ISRCTN51995477. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 27. See the NIHR Journals Library website for further project information.
Publisher: Springer Science and Business Media LLC
Date: 21-04-2011
Abstract: Glaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be evaluated in any glaucoma screening trial would be. The purpose of this study was to develop the clinical components of an intervention for evaluation in a glaucoma (open angle) screening trial that would be feasible and acceptable in a UK eye-care service. A mixed-methods study, based on the Medical Research Council (MRC) framework for complex interventions, integrating qualitative (semi-structured interviews with 46 UK eye-care providers, policy makers and health service commissioners), and quantitative (economic modelling) methods. Interview data were synthesised and used to revise the screening interventions compared within an existing economic model. The qualitative data indicated broad based support for a glaucoma screening trial to take place in primary care, using ophthalmic trained technical assistants supported by optometry input. The precise location should be tailored to local circumstances. There was variability in opinion around the choice of screening test and target population. Integrating the interview findings with cost-effectiveness criteria reduced 189 potential components to a two test intervention including either optic nerve photography or screening mode perimetry (a measure of visual field sensitivity) with or without tonometry (a measure of intraocular pressure). It would be more cost-effective, and thus acceptable in a policy context, to target screening for open angle glaucoma to those at highest risk but for both practicality and equity arguments the optimal strategy was screening a general population cohort beginning at age forty. Interventions for screening for open angle glaucoma that would be feasible from a service delivery perspective were identified. Integration within an economic modelling framework explicitly highlighted the trade-off between cost-effectiveness, feasibility and equity. This study exemplifies the MRC recommendation to integrate qualitative and quantitative methods in developing complex interventions. The next step in the development pathway should encompass the views of service users.
Publisher: BMJ
Date: 11-2002
DOI: 10.1046/J.1525-1438.2002.01116.X
Abstract: Changes to the present age policy of cervical screening are currently under consideration. We conducted a retrospective matched case-control study and cost analysis study to identify risk factors for the development of an abnormal smear after age 50 and to determine the impact of age-restricted cervical screening on the annual cost of the screening program. All women (229) from an 11-year birth cohort who developed an abnormal smear at age 50 or over were age-matched for two controls with negative smears. Routine screening smears taken between age 48 and 52 were tested for human papillomavirus (HPV) subtypes 16 and 18. Epidemiologic data were collected by postal questionnaire. Changes in costs under a policy of HPV testing and age-restricted screening were assessed. We found that HPV 16 status was the only independently significant risk factor for abnormal cytology after age 50 with an odds ratio of 10.26 (95% CI 1.25-84.11). A policy of early withdrawal from screening at age 50 on the basis of HPV testing would produce net cost savings. These findings suggest that HPV testing could be a valuable means of identifying the small proportion of women still at risk after 50, and of releasing health care resources.
Publisher: Springer Science and Business Media LLC
Date: 2013
DOI: 10.1186/CC13096
Publisher: BMJ
Date: 11-2022
DOI: 10.1136/BMJOPEN-2022-067427
Abstract: The effective implementation of a fast-changing healthcare delivery innovation, such as robotic-assisted surgery (RAS), into a healthcare system, can be affected (both positively and negatively) by external contextual factors. As part of a wider project investigating ways to optimise the implementation of RAS, this qualitative study aimed to uncover current issues of RAS and predictions about the future of robotic surgery. We refer to ‘current issues’ as the topical and salient challenges and opportunities related to the introduction of RAS in the UK healthcare system, from the perspectives of key stakeholders involved in the delivery and implementation of RAS. Semi-structured interviews and focus groups were conducted. A thematic analysis was conducted to summarise salient issues that were articulated by the participants. The interview s le (n=35) comprised surgeons, wider theatre staff and other relevant personnel involved in the introduction and delivery of RAS services across the UK, including service managers and policymakers/commissioners. Two focus groups were also conducted with surgical trainees (n=7) and members of the public (n=8), respectively. The results revealed a largely positive attitude towards the introduction of RAS technology and an expectation of continued rapid expansion. Areas perceived to be particularly pertinent and requiring ongoing attention were also highlighted, including the need to achieve improved quality control, expertise quantification and training issues and the need to educate the public. Issues of centralisation, service organisation and equity of access were also emphasised. Our study has highlighted a range of issues perceived to be particularly pertinent to the current and future provision of RAS which should be addressed. The areas outlined can enable healthcare managers and surgeons to plan for the adoption and/or expansion of RAS services.
Publisher: Elsevier BV
Date: 08-2014
DOI: 10.1016/J.PLACENTA.2014.04.019
Abstract: To elucidate how obstetric conditions are associated with atypical placental weight ratios (PWR)s in infants born: (a) ≥37 weeks gestation (b) at ≥33 but <37 weeks gestation and (c) <33 weeks gestation. The study included all in-hospital singleton births in London, Ontario between June 1, 2006 and March 31, 2011. PWR was assessed as 90th percentile by gestational age-specific local population standards. Multivariable analysis was carried out using multinomial logistic regression with blockwise variable entry in order of temporality. Baseline factors and maternal obstetric conditions associated with PWR 90th percentile were: underweight, overweight and obese BMIs, smoking, preecl sia, placenta previa, and placental abruption. In particular, indicators of hypoxia and altered placental function were generally associated with elevated PWR at all gestations. An association between obstetric conditions associated with fetal hypoxia and PWR ≥90th percentile was illustrated. The multivariable findings suggest that the PWR is similarly increased regardless of the etiology of the hypoxia.
Publisher: Elsevier BV
Date: 08-2019
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 2017
DOI: 10.1302/0301-620X.99B1.BJJ-2016-0424.R1
Abstract: The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff. A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283. The mean OSS improved from 26.3 (standard deviation (sd) 8.2) at baseline, to 41.7 (sd 7.9) two years post-operatively for arthroscopic surgery and from 25.0 (sd 8.0) to 41.5 (sd 7.9) for open surgery. Intention-to-treat (ITT) analysis showed no statistical difference between the groups at two years (difference in OSS score -0.76 95% confidence interval (CI) -2.75 to 1.22 p = 0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery 95% CI -6.9 to 25.8 p = 0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol. There is no evidence of difference in effectiveness between open and arthroscopic repair of rotator cuff tears. The rate of re-tear is high in both groups, for all sizes of tear and ages and this adversely affects the outcome. Cite this article: Bone Joint J 2017 -B:107–15.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: Oxford University Press (OUP)
Date: 02-2001
DOI: 10.1093/NDT/16.2.341
Abstract: Peritonitis is the most frequent serious complication of continuous ambulatory peritoneal dialysis (CAPD). It has a major influence on the number of patients switching from CAPD to haemodialysis and has probably restricted the wider acceptance and uptake of CAPD as an alternative mode of dialysis. This systematic review sought to determine if modifications of the transfer set (Y-set or double-bag systems) used in CAPD exchanges are associated with a reduction in peritonitis and an improvement in other relevant outcomes. Based on a comprehensive search strategy, we undertook a systematic review of randomized or quasi-randomized controlled trials comparing double-bag and/or Y-set CAPD exchange systems with standard systems, or comparing double-bag with Y-set systems, in patients with end-stage renal disease (ESRD) treated with CAPD. Only published data were used. Data were abstracted by a single investigator onto a standard form and subsequently entered into Review Manager 4.0.4. Its statistical package, Metaview 3.1, calculated an odds ratio (OR) for dichotomous data and a (weighted) mean difference for continuous data with 95% confidence intervals. Twelve eligible trials with a total of 991 randomized patients were identified. In trials comparing either the Y-set or double-bag systems with the standard systems, significantly fewer patients (133/363 vs 158/263 OR 0.33, 95% CI 0.24-0.46) experienced peritonitis and the number of patient-months on CAPD per episode of peritonitis was consistently greater. When the double-bag systems were compared with the Y-set systems significantly fewer patients experienced peritonitis (44/154 vs 66/138 OR 0.44, 95% CI 0.27-0.71) and the number of patient-months on CAPD per episode of peritonitis was also greater. Double-bag systems should be the preferred exchange systems in CAPD.
Publisher: Springer Science and Business Media LLC
Date: 27-09-2018
Publisher: National Institute for Health and Care Research
Date: 09-2008
DOI: 10.3310/HTA12310
Abstract: To evaluate the clinical effectiveness, cost-effectiveness 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. Relative clinical effectiveness was assessed by a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. The economic evaluation compared the cost-effectiveness 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. 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. 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. Of the 810 eligible patients who consented to participate, 357 were recruited to the 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. 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. 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 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 pounds) but also more effective [+0.088 quality-adjusted life-years (QALYs)]. The estimated incremental cost per QALY was 19,000-23,000 pounds, with a probability between 46% (when 62% received surgery) and 19% (when all received surgery) of cost-effectiveness at a threshold of 20,000 pounds per QALY. Modelling plausible longer-term scenarios (such as lifetime benefit after surgery) indicated a greater likelihood (74%) of cost-effectiveness at a threshold of 20,000 pounds, 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. Amongst patients requiring long-term medication to control symptoms of GORD, surgical management significantly increases general and reflux-specific 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 pounds 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. Current Controlled Trials ISRCTN15517081.
Publisher: Elsevier BV
Date: 09-2009
Publisher: National Institute for Health and Care Research
Date: 10-2015
DOI: 10.3310/HTA19800
Abstract: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. Two parallel-group randomised controlled trial. Nineteen teaching and district general hospitals in the UK. Patients ( n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was –0.76 [95% confidence interval (CI) –2.75 to 1.22 p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score –0.46, 95% CI –5.30 to 4.39 p = 0.854). The questionnaire response rate was 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was £2567 (SD £176) for arthroscopic surgery and £2699 (SD £149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by £371 (95% CI £135 to £607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI –0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. In patients aged 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. Current Controlled Trials ISRCTN97804283. This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 80. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 04-2014
DOI: 10.3310/HTA18250
Publisher: Oxford University Press (OUP)
Date: 12-2000
Abstract: Uncertainties about best management of end-stage renal disease (ESRD) are reflected in wide variations in practice. Systematic reviews aim to reduce uncertainty by strengthening the evidence base for clinical practice, allowing estimation of the benefits and risks of particular interventions, whilst minimizing the potential for bias. This paper describes the methods and conduct of six systematic reviews of aspects of the management of ESRD, and the yield in terms of trials found. Our methodology was based on that recommended by the Cochrane Collaboration (an international initiative set up to perform and disseminate systematic reviews of health care). It involved a systematic search of electronic databases and bibliographic reference lists, together with handsearching of Kidney International for studies relevant to the management of ESRD, followed by a systematic assessment of study quality. Around 12,000 abstracts were assessed which had been identified from electronic sources. Of these, 2085 (18%) were deemed to be reports of possible randomized or quasi-randomized controlled trials relevant to the management of ESRD. Three hundred and forty were relevant to the six specific reviews, and after assessment of the full manuscripts, 39 studies were finally included in our reviews. Reports of a further nine trials, which were identified from other sources, were also included. The broad search adopted allowed the parallel development of a register of trials of all aspects of the management of ESRD. This study has demonstrated that the methodology of systematic reviews, as promoted by the Cochrane Renal Group, is feasible but has significant resource implications. The development of a register of randomized controlled trials (RCTs) related to the management of ESRD will facilitate this form of research in the future.
Publisher: SAGE Publications
Date: 27-03-2020
Abstract: There is increasing evidence that access to critical care services is not equitable. We aimed to investigate whether location of residence in Scotland impacts on the risk of admission to an Intensive Care Unit and on outcomes. This was a population-based Bayesian spatial analysis of adult patients admitted to Intensive Care Units in Scotland between January 2011 and December 2015. We used a Besag–York–Mollié model that allows us to make direct probabilistic comparisons between areas regarding risk of admission to Intensive Care Units and on outcomes. A total of 17,596 patients were included. The five-year age- and sex-standardised admission rate was 352 per 100,000 residents. There was a cluster of Council Areas in the North-East of the country which had lower adjusted admission rates than the Scottish average. Midlothian, in South East Scotland had higher spatially adjusted admission rates than the Scottish average. There was no evidence of geographical variation in mortality. Access to critical care services in Scotland varies with location of residence. Possible reasons include differential co-morbidity burden, service provision and access to critical care services. In contrast, the probability of surviving an Intensive Care Unit admission, if admitted, does not show geographical variation.
Publisher: Oxford University Press (OUP)
Date: 02-10-2014
DOI: 10.1002/BJS.9595
Abstract: The treatment of patients with varicose veins constitutes a considerable workload and financial burden to the National Health Service. This study aimed to assess the cost-effectiveness of ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) compared with conventional surgery as treatment for primary varicose veins. Participant cost and utility data were collected alongside the UK CLASS multicentre randomized clinical trial, which compared EVLA, surgery and UGFS. Regression methods were used to estimate the effects of the alternative treatments on costs to the health service and quality-adjusted life-years (QALYs) at 6 months. A Markov model, incorporating available evidence on clinical recurrence rates, was developed to extrapolate the trial data over a 5-year time horizon. Compared with surgery at 6 months, UGFS and EVLA reduced mean costs to the health service by £655 and £160 respectively. When additional overhead costs associated with theatre use were included, these cost savings increased to £902 and £392 respectively. UGFS produced 0·005 fewer QALYs, whereas EVLA produced 0·011 additional QALYs. Extrapolating to 5 years, EVLA was associated with increased costs and QALYs compared with UGFS (costing £3640 per QALY gained), and generated a cost saving (£206–439) and QALY gain (0·078) compared with surgery. Applying a ceiling willingness-to-pay ratio of £20 000 per QALY gained, EVLA had the highest probability (78·7 per cent) of being cost-effective. The results suggest, for patients considered eligible for all three treatment options, that EVLA has the highest probability of being cost-effective at accepted thresholds of willingness to pay per QALY.
Publisher: National Institute for Health and Care Research
Date: 06-2013
DOI: 10.3310/HTA17220
Publisher: BMJ
Date: 14-07-2009
DOI: 10.1136/BMJ.B2576
Publisher: Springer Science and Business Media LLC
Date: 12-2010
Publisher: Springer Science and Business Media LLC
Date: 29-05-2008
Publisher: Elsevier BV
Date: 03-2020
Publisher: National Institute for Health and Care Research
Date: 09-2021
DOI: 10.3310/HTA25530
Abstract: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.
Publisher: BMJ
Date: 09-11-2018
DOI: 10.1136/BMJ.K1614
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2019
Publisher: Wiley
Date: 23-09-2013
DOI: 10.1111/BJHP.12066
Abstract: Behaviour change interventions often target 'important' beliefs. The literature proposes four methods for assessing importance of attitudinal beliefs: elicitation frequency, importance ratings, and strength of prediction (bivariate and multivariate). We tested congruence between these methods in a Delphi study about selective decontamination of the digestive tract (SDD). SDD improves infection rates among critically ill patients, yet uptake in intensive care units is low internationally. A Delphi study involved three iterations ('rounds'). Participants were 105 intensive care clinicians in the United Kingdom, Canada, and Australia/New Zealand. In Round 1, semi-structured interviews were conducted to elicit beliefs about delivering SDD. In Rounds 2 and 3, participants completed questionnaires, rating agreement and importance for each belief-statement (9-point Likert scales). Belief importance was assessed using elicitation frequency, mean importance ratings, and prediction of global attitude (Pearson's correlations beta-weights). Correlations between indices were computed. Participants generated 14 attitudinal beliefs. Indices had adequate variation (frequencies: 4-94, mean importance ratings: 4.93-8.00, Pearson's correlations: ± 0.09 to ± 0.54, beta-weights: ± 0.01 to ± 0.30). SDD increases antibiotic resistance was the most important belief according to three methods and was ranked second by beta-weights (behind Overall, SDD benefits patients to whom it is delivered). Spearman's correlations were significant for importance ratings with frequencies and correlations. However, other indices were unrelated. The top four beliefs differed according to the measure used. Results provided evidence of congruence across three methods for assessing belief importance. Beta-weights were unrelated to other indices, suggesting that they may not be appropriate as the sole method. What is already known on this subject? Attitudinal beliefs (specific beliefs about the consequences of performing an action) are key to designing interventions to change intentions and behaviour. The literature reports four methods for assessing the importance of attitudinal beliefs: frequency of elicitation in interviews, importance ratings in questionnaires, and strength of prediction (bivariate and multivariate) of global attitude scores. The congruence between these measures of importance is not known. What does this study add? Four indices of importance were examined in a multi-professional, international study about the use of selective digestive decontamination to prevent infection in intensive care settings. Three indices were correlated with one another. Each method used to assess importance produced a different subset of the most important beliefs. Selection of the most important beliefs should use multiple assessment methods. This evidence suggests that multiple regression approaches may not be appropriate as the sole method for assessing belief importance.
Publisher: John Wiley & Sons, Ltd
Date: 23-04-2001
Publisher: Public Library of Science (PLoS)
Date: 29-08-2022
DOI: 10.1371/JOURNAL.PONE.0273696
Abstract: Implementation of Robotic Assisted Surgery (RAS) is complex as it requires adjustments to associated physical infrastructure, but also changes to processes and behaviours. With the global objective of optimising and improving RAS implementation, this study aimed to: 1) Explore the barriers and enablers to RAS service adoption, incorporating an assessment of behavioural influences 2) Provide an optimised plan for effective RAS implementation, with the incorporation of theory-informed implementation strategies that have been adapted to address the barriers/enablers that affect RAS service adoption. Semi-structured interviews were conducted with RAS personnel and stakeholders, including: surgeons, theatre staff, managers, industry representatives, and policy-makers/commissioners. The Theoretical Domains Framework (TDF) and the Consolidated Framework for Implementation Research (CFIR) was used to identify barriers and enablers that represent in idual behaviours, capabilities, attitudes, beliefs, and external organisational factors that influence the implementation of RAS. Findings suggest that implementation planning has three separate phases–pre-, early, and late implementation. For pre-implementation, barriers and enablers identified included the cost of RAS equipment and issues of economic viability, weak outcome evidence for RAS, a preponderance of an eminence driven model, the clinician/manager relationship, and views around the uptake and expansion of RAS in the future. Early implementation findings revealed role changes for theatre personnel and an enhanced team approach, reliance on industry for training provision, and changes in skill sets and attentional processes. Late implementation factors included equipment maintenance costs, technological limitations, changes to cognition during RAS routine use, and benefits to institutions/healthcare professionals (such as ergonomic improvement). Together, findings suggest the factors that affect RAS implementation are multi-faceted and change across the life-cycle of intervention adoption. Theory-informed strategies are suggested which can optimise implementation of RAS. Optimisation strategies need planning from the outset.
Publisher: National Institute for Health and Care Research
Date: 04-2020
DOI: 10.3310/HTA24200
Abstract: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection. To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers. This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target s le size was 500 patients. A web-based randomisation system was used to allocate treatments. Twenty-seven NHS hospitals (68 surgeons). Patients with medial compartment knee osteoarthritis. The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated. The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite ‘failure’ – defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed. A total of 528 patients were randomised (partial knee replacement, n = 264 total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval –0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) ( n = 233), mean 35.1 (standard deviation 9.1) ( n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 ‘failures’ of partial knee replacement and 38 ‘failures’ of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use. It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure. Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years. Further (10-year) follow-up is in progress to assess the longer-term stability of these findings. Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 20. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 08-2014
DOI: 10.1016/J.JCRC.2014.03.013
Abstract: Selective decontamination of the digestive tract (SDD) as a prophylactic intervention improves hospital-acquired infection and survival rates. Uptake of SDD is low and remains controversial. This study applied the theoretical domains framework to assess intensive care unit clinicians' views about SDD in regions with limited or no adoption of SDD. Participants were health professionals with "decisional authority" for the adoption of SDD. Semistructured interviews were conducted as the first round of a Delphi study. Views about SDD adoption, delivery, and further SDD research were explored. Directed content analysis of interview data identified subthemes, which informed item development for subsequent Delphi rounds. Linguistic features of interview data were also explored. One hundred forty-one participants provided interview data. Fifty-six subthemes were identified 46 were common across regions. Beliefs about consequences were the most widely elaborated theme. Linguistic features of how participants discussed SDD included caution expressed when discussing the risks and benefits and words such as "worry," "anxiety," and "fear" when discussing potential antibiotic resistance associated with SDD. We identified salient beliefs, barriers, and facilitators to SDD adoption and delivery. What participants said about SDD and the way in which they said it demonstrated the degree of clinical caution, uncertainty, and concern that SDD evokes.
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 05-2014
DOI: 10.1302/2046-3758.35.2000270
Abstract: This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery. Cite this article: Bone Joint Res 2014 :155–60.
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2018
End Date: 2021
Funder: Medical Research Council
View Funded ActivityStart Date: 2017
End Date: 2020
Funder: Canadian Institutes of Health Research
View Funded Activity