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Goal-directed fluid therapy (GDFT) has been shown to reduce the complications following a variety of major surgical procedures, possibly mediated by improved organ perfusion and function. We have shown that it is feasible to randomise patients to GDFT or standard fluid management following liver transplant in the cardiac-output optimisation following liver transplantation (COLT) trial. The current study compares end organ function in patients from the COLT trial who received GDFT in comparison to those receiving standard care (SC) following liver transplant.Adult patients with liver cirrhosis undergoing liver transplantation were randomised to GDFT or SC for the first 12 h following surgery as detailed in a published trial protocol. GDFT protocol was based on stroke volume (SV) optimisation using 250 ml crystalloid boluses. Total fluid administration and time to extubation were recorded. Hourly SV and cardiac output (CO) readings were recorded from the non-invasive cardiac output monitoring (NICOM) device in both groups. Pulmonary function was assessed by arterial blood gas (ABG) and ventilatory parameters. Lung injury was assessed using PaO60 patients were randomised to GDFT (n = 30) or SC (n = 30). All patients completed the 12 h intervention period. GDFT group received a significantly higher total volume of fluid during the 12 h trial intervention period (GDFT 5317 (2335) vs. SC 3807 (1345) ml, p = 0.003); in particular crystalloids (GDFT 3968 (2073) vs. SC 2510 (1027) ml, p = 0.002). There was no evidence of significant difference between the groups in SV or CO during the assessment periods. Time to extubation, PaO2: FIOIn this randomised trial of fluid therapy post liver transplant, GDFT was associated with an increased volume of crystalloids administered but did not alter early post-operative pulmonary or renal function when compared with standard care.

Perianal fistulae are a common complication of Crohn’s disease (CD) and pose a substantial burden on quality of life. Data capturing health-related utility associated with perianal fistulae in CD are scarce. The current study aims to value health states related to different stages of the disease to quantitatively evaluate the impact of complex perianal fistulae on CD patients’ quality of life. Eight health state descriptions associated with complex perianal fistulae in CD were developed following qualitative research with patients and validation by clinicians. Following pre-testing, a survey was administered online in two samples of UK respondents: the general population and patients with CD. A choice-based valuation technique, the time trade-off (TTO), was used for direct utility measurement. CD patients also valued their current health state using the TTO. Exclusion criteria for respondents displaying logical inconsistencies were applied. Usable responses were received from 835 respondents, reflective of the UK population in age and sex, in the general population survey and 162 CD patients in the patient survey. Non-remission states were valued much lower than the remission state by both samples, ranging from 0.20 for proctectomy with a negative outcome to 0.66 for chronic symptomatic fistulae with mild symptoms. Patients currently experiencing fistulae reported lower values for current health than those without fistulae. Low utility values were assigned to the non-remission health states for perianal fistulae in CD by the general public and patients with CD. This demonstrates the high humanistic burden of inadequately managed perianal fistula in CD.

Background The recent shift to an integrated approach to health and social care aims to provide cohesive support to those who are in need of care, but raises a challenge for resource allocation decision making, in particular for comparison of diverse benefits from different types of care across the two sectors. Objective To investigate the relationship of social care needs and well-being with a generic health status measure using multivariate regression. Methods We empirically compared responses to health and well-being measures and social care needs from a cross-sectional data set of the general population (the Health Survey for England). Multivariate regression analyses were conducted to examine whether social care needs measured by the Barthel index can be explained by health status as captured by the EuroQol five-dimensional questionnaire (EQ-5D) and two well-being measures—the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) and the General Health Questionnaire (GHQ-12). Results Our study found that poor overall scores for EuroQol visual analogue scale, EQ-5D index, GHQ-12, and WEMWBS indicated a need for social care. Investigation of the dimensions found that the EQ-5D dimensions self-care and pain/discomfort were statistically significantly associated with the need for social care. Two dimensions of the WEMWBS ("been feeling useful" and "had energy to spare") were statistically significantly associated with the Barthel index, but none of the GHQ-12 dimensions were. Conclusions The results show that the need for social care, which is dependent on the ability to perform personal day-to-day activities, is more closely related to the EQ-5D dimensions than the well-being measures WEMWBS and GHQ-12.

OBJECTIVES: Atrial fibrillation (AF) reduces survival and quality of life (QoL). It can be treated at the time of major cardiac surgery using ablation procedures ranging from simple pulmonary vein isolation to a full maze procedure. The aim of this study is to evaluate the impact of adjunct AF surgery as currently performed on sinus rhythm (SR) restoration, survival, QoL and cost-effectiveness. METHODS: In a multicentre, Phase III, pragmatic, double-blinded, parallel-armed randomized controlled trial, 352 cardiac surgery patients with >3 months of documented AF were randomized to surgery with or without adjunct maze or similar AF ablation between 2009 and 2014. Primary outcomes were SR restoration at 1 year and quality-adjusted life years at 2 years. Secondary outcomes included SR at 2 years, overall and stroke-free survival, medication, QoL, cost-effectiveness and safety. RESULTS: More ablation patients were in SR at 1 year [odds ratio (OR) 2.06, 95% confidence interval (CI) 1.20–3.54; P = 0.009]. At 2 years, the OR increased to 3.24 (95% CI 1.76–5.96). Quality-adjusted life years were similar at 2 years (ablation − control −0.025, P = 0.6319). Significantly fewer ablation patients were anticoagulated from 6 months postoperatively. Stroke rates were 5.7% (ablation) and 9.1% (control) (P = 0.3083). There was no significant difference in stroke-free survival [hazard ratio (HR) = 0.99, 95% CI 0.64–1.53; P = 0.949] nor in serious adverse events, operative or overall survival, cardioversion, pacemaker implantation, New York Heart Association, EQ-5D-3L and SF-36. The mean additional ablation cost per patient was £3533 (95% CI £1321–£5746). Cost-effectiveness was not demonstrated at 2 years. CONCLUSIONS: Adjunct AF surgery is safe and increases SR restoration and costs but not survival or QoL up to 2 years. A continued follow-up will provide information on these outcomes in the longer term. Study registration: ISRCTN82731440 (project number 07/01/34).

BackgroundAtrial fibrillation (AF) can be treated using a maze procedure during planned cardiac surgery, but the effect on clinical patient outcomes, and the cost-effectiveness compared with surgery alone, are uncertain.ObjectivesTo determine whether or not the maze procedure is safe, improves clinical and patient outcomes and is cost-effective for the NHS in patients with AF.DesignMulticentre, Phase III, pragmatic, double-blind, parallel-arm randomised controlled trial. Patients were randomised on a 1 : 1 basis using random permuted blocks, stratified for surgeon and planned procedure.SettingEleven acute NHS specialist cardiac surgical centres.ParticipantsPatients aged ≥ 18 years, scheduled for elective or in-house urgent cardiac surgery, with a documented history (> 3 months) of AF.InterventionsRoutine cardiac surgery with or without an adjunct maze procedure administered by an AF ablation device.Main outcome measuresThe primary outcomes were return to sinus rhythm (SR) at 12 months and quality-adjusted life-years (QALYs) over 2 years after randomisation. Secondary outcomes included return to SR at 2 years, overall and stroke-free survival, drug use, quality of life (QoL), cost-effectiveness and safety.ResultsBetween 25 February 2009 and 6 March 2014, 352 patients were randomised to the control (n = 176) or experimental (n = 176) arms. The odds ratio (OR) for return to SR at 12 months was 2.06 [95% confidence interval (CI) 1.20 to 3.54;p = 0.0091]. The mean difference (95% CI) in QALYs at 2 years between the two trial arms (maze/control) was –0.025 (95% CI 0.129 to 0.078;p = 0.6319). The OR for SR at 2 years was 3.24 (95% CI 1.76 to 5.96). The number of patients requiring anticoagulant drug use was significantly lower in the maze arm from 6 months after the procedure. There were no significant differences between the two arms in operative or overall survival, stroke-free survival, need for cardioversion or permanent pacemaker implants, New York Heart Association Functional Classification (for heart failure), EuroQol-5 Dimensions, three-level version score and Short Form questionnaire-36 items score at any time point. Sixty per cent of patients in each trial arm had a serious adverse event (p = 1.000); most events were mild, but 71 patients (42.5%) in the maze arm and 84 patients (45.5%) in the control arm had moderately severe events; 31 patients (18.6%) in the maze arm and 38 patients (20.5%) in the control arm had severe events. The mean additional cost of the maze procedure was £3533 (95% CI £1321 to £5746); the mean difference in QALYs was –0.022 (95% CI –0.1231 to 0.0791). The maze procedure was not cost-effective at £30,000 per QALY over 2 years in any analysis. In a small substudy, the active left atrial ejection fraction was smaller than that of the control patients (mean difference of –8.03, 95% CI –12.43 to –3.62), but within the predefined clinically equivalent range.LimitationsLow recruitment, early release of trial summaries and intermittent resource-use collection may have introduced bias and imprecise estimates.ConclusionsAblation can be practised safely in routine NHS cardiac surgical settings and increases return to SR rates, but not survival or QoL up to 2 years after surgery. Lower anticoagulant drug use and recovery of left atrial function support anticoagulant drug withdrawal provided that good atrial function is confirmed.Further workContinued follow-up and long-term clinical effectiveness and cost-effectiveness analysis. Comparison of ablation methods.Trial registrationCurrent Controlled Trials ISRCTN82731440.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 19. See the NIHR Journals Library website for further project information.

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*. (DOC 120 kb)

Copyright © 2014, International Society for Pharmacoeconomics and Outcomes Research(ISPOR). Published by Elsevier Inc. This is an open access article under the CCBY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/). This article has been made available through the Brunel Open Access Publishing Fund. Objectives: To systematically review the existing literature on the value associated with convenience in health care delivery, independent of health outcomes, and to try to estimate the likely magnitude of any value found. Methods: A systematic search was conducted for previously published studies that reported preferences for convenience-related aspects of health care delivery in a manner that was consistent with either cost-utility analysis or cost-benefit analysis. Data were analyzed in terms of the methodologies used, the aspects of convenience considered, and the values reported. Results: Literature searches generated 4715 records. Following a review of abstracts or full-text articles, 27 were selected for inclusion. Twenty-six studies reported some evidence of convenience-related process utility, in the form of either a positive utility or a positive willingness to pay. The aspects of convenience valued most often were mode of administration (n = 11) and location of treatment (n = 6). The most common valuation methodology was a discrete-choice experiment containing a cost component (n = 15). Conclusions: A preference for convenience-related process utility exists, independent of health outcomes. Given the diverse methodologies used to calculate it, and the range of aspects being valued, however, it is difficult to assess how large such a preference might be, or how it may be effectively incorporated into an economic evaluation. Increased consistency in reporting these preferences is required to assess these issues more accurately. The Engineering and Physical Sciences Research Council through the Multidisciplinary Assessment of Technology in Healthcare programme (EP/F063822/1 and EP/G012393/1) and the Health Economics Research Group within Brunel University.

Objectives: Our study addresses the important issue of estimating treatment costs from historical data. It is a problem frequently faced by health technology assessment analysts. We compared four approaches used to estimate current costs when good quality contemporary data are not available using liver transplantation as an example.Methods: First, the total cost estimates extracted for patients from a cohort study, conducted in the 1990s, were inflated using a published inflation multiplier. Second, resource use estimates from the cohort study were extracted for hepatitis C patients and updated using current unit costs. Third, expert elicitation was carried out to identify changes in clinical practice over time and quantify current resource use. Fourth, routine data on resource use were obtained from National Health Service Blood and Transplant (NHSBT).Results: The first two methods did not account for changes in clinical practice. Also the first was not specific to hepatitis patients. The use of experts confirmed significant changes in clinical practice. However, the quantification of resource use using experts is challenging as clinical specialists may not have a complete overview of clinical pathway. The NHSBT data are the most accurate reflection of transplantation and posttransplantation phase; however, data were not available for the whole pathway of care. The best estimate of total cost, combining NHSBT data and expert elicitation, is £121,211.Discussion: Observational data from routine care are potentially the most reliable reflection of current resource use. Efforts should be made to make such data readily available and accessible to researchers. Expert elicitation provided reasonable estimates.

IntroductionAcute pancreatitis is an inflammatory disease of the pancreas with high risk of developing multiorgan failure and death. There are no effective pharmacological interventions used in current clinical practice. Maintaining fluid and electrolyte balance is the mainstay of supportive management. Goal-directed fluid therapy (GDFT) has been shown to decrease morbidity and mortality in surgical conditions with systemic inflammatory response. There is currently no randomised controlled trial (RCT) investigating the role of GDFT based on cardiac output parameters in patients with acute pancreatitis in the ward setting. A feasibility trial was designed to determine patient and clinician support for recruitment into an RCT of ward-based GDFT in acute pancreatitis, adherence to a GDFT protocol, safety, participant withdrawal, and to determine appropriate endpoints for a subsequent larger trial to evaluate efficacy.Methods and analysisThe GDFT in Acute Pancreatitis trial is a prospective two-centre feasibility RCT. Eligible adults admitted with new onset of acute pancreatitis will be enrolled and randomised into ward-based GDFT (n=25) or standard fluid therapy (n=25) within 6 hours from the diagnosis and continuing for the following 48 hours. Cardiac output parameters will be monitored with a non-invasive device (Cheetah NICOM; Cheetah Medical). The intervention group will consist of a protocolised GDFT approach consisting of stroke volume optimisation with crystalloid fluid boluses, while the control group will receive standard care fluid therapy as advised by the clinical team. The primary endpoint is feasibility. Secondary endpoints will include safety of the intervention, complications, mortality, admission to intensive care unit, cost and quality of life.Ethics and disseminationEthics approval was granted by the London Central Research Ethics Committee (17/LO/1235, project ID: 221872). The results of this trial will be presented to international conference with interest in general surgery and acute care and published in a peer-reviewed journal.Trial registration numberISRCTN36077283.

Objective Aortic valve replacement (AVR) can be performed either through full median sternotomy (FS) or upper mini-sternotomy (MS). The Mini-Stern trial aimed to establish whether MS leads to quicker postoperative recovery and shorter hospital stay after first-time isolated AVR. Methods This pragmatic, open-label, parallel randomized controlled trial (RCT) compared MS with FS for first-time isolated AVR in 2 United Kingdom National Health Service hospitals. Primary endpoints were duration of postoperative hospital stay and the time to fitness for discharge from hospital after AVR, analyzed in the intent-to-treat population. Results In this RCT, 222 patients were recruited and randomized (n = 118 in the MS group; n = 104 in the FS group). Compared with the FS group, the MS group had a longer hospital length of stay (mean, 9.5 days vs 8.6 days) and took longer to achieve fitness for discharge home (mean, 8.5 days vs 7.5 days). Adjusting for valve type, sex, and surgeon, hazard ratios (HRs) from Cox models did not show a statistically significant effect of MS (relative to FS) on either hospital stay (HR, 0.874; 95% confidence interval [CI], 0.668-1.143; P = .3246) or time to fitness for discharge (HR, 0.907; 95% CI, 0.688-1.197; P value = .4914). During a mean follow-up of 760 days (745 days for the MS group and 777 days for the FS group), 12 patients (10%) in the MS group and 7 patients (7%) in the FS group died (HR, 1.871; 95% CI, 0.723-4.844; P = .1966). Average extra cost for MS was £1714 during the first 12 months after AVR. Conclusions Compared with FS for AVR, MS did not result in shorter hospital stay, faster recovery, or improved survival and was not cost-effective. The MS approach is not superior to FS for performing AVR.

© 2016 Taylor & Francis.This article reports the construction of a new survey—specifically, the Brunel Ethnic Behavior Inventory (BEBI)—designed to measure ethnic speech and ethnic action as separate, yet related, aspects of individuals’ ethnic behavior. Using Tajfel’s social identity theory as a conceptual frame of reference, this study sought an answer to the research question of how many factors actually are measured by the BEBI, and tested the hypothesis that a two-factor model (i.e., Ethnic Speech and Ethnic Action as two correlated factors) would provide significantly better goodness of fit to the correlational data than would a one-factor model (i.e., Ethnic Behavior as one undifferentiated factor). Across one pilot sample (n = 101) and two main samples (n = 120 for Sample 1, n = 148 for Sample 2), the study found that not only did the BEBI measure two factors at most (i.e., Ethnic Speech and Ethnic Action) but, consistent with the hypothesis, the two-factor model yielded better goodness of fit than did the one-factor model. Implications for the conceptualization and measurement of Verkuyten’s “ways of ethnicity” are discussed.

This study sought to validate the Brunel Ethnic Behavior Inventory (BEBI) as a measure of two aspects of “doing” (i.e., ethnic speech and ethnic action) among the “ways of ethnicity” identified by Verkuyten. It also evaluates the construct validity of the BEBI alongside the Multigroup Ethnic Identity Measure-Revised (MEIM-R) and evaluates the BEBI and the MEIM-R (the latter of which measures exploration as “thinking” and commitment as “feeling” among ways of ethnicity) regarding criterion-related validity. Across two samples (n = 120 for Sample 1 and n = 148 for Sample 2), the BEBI and the MEIM-R performed suitably with regard to construct validity. However, the BEBI arguably performed better with regard to criterion-related validity (i.e., in predicting scores on life satisfaction, flourishing, positive and negative moods, and positive and negative emotions). Implications for validation studies on ways of ethnicity are discussed.

This article is available open access through the publisher’s website at the link below. Copyright © 2012, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Objective - Health services often spend more on safety interventions than seems cost-effective. This study investigates whether the public value safety-related health care improvements more highly than the same improvements in contexts where the health care system is not responsible. Method - An online survey was conducted to elicit the relative importance placed on preventing harms caused by 1) health care (hospital-acquired infections, drug administration errors, injuries to health care staff), 2) individuals (personal lifestyle choices, sports-related injuries), and 3) nature (genetic disorders). Direct valuations were obtained from members of the public by using a person trade-off or “matching” method. Participants were asked to choose between two preventative interventions of equal cost and equal health benefit per person for the same number of people, but differing in causation. If participants indicated a preference, their strength of preference was measured by using person trade-off. Results - Responses were obtained from 1030 people, reflecting the sociodemographic mix of the UK population. Participants valued interventions preventing hospital-acquired infections (1.31) more highly than genetic disorders (1.0), although drug errors were valued similarly to genetic disorders (1.07), and interventions to prevent injury to health care staff were given less weight than genetic disorders (0.71). Less weight was also given to interventions related to lifestyle (0.65) and sports injuries (0.41). Conclusion - Our results suggest that people do not attach a simple fixed premium to “safety-related” interventions but that preferences depend more subtly on context. The use of the results of such public preference surveys to directly inform policy would therefore be premature. Brunel University.