Incorporating ex-vivo lung perfusion into the UK adult lung transplant service: an economic evaluation and decision analytic model.

BACKGROUND: An estimated 20-30% of end-stage lung disease patients awaiting lung transplant die whilst on the waiting list due to a shortage of suitable donor lungs. Ex-Vivo Lung Perfusion is a technique that reconditions donor lungs initially not deemed usable in order to make them suitable for transplantation, thereby increasing the donor pool. In this study, an economic evaluation was conducted as part of DEVELOP-UK, a multi-centre study assessing the clinical and cost-effectiveness of the Ex-Vivo Lung Perfusion technique in the United Kingdom. METHODS: We estimated the cost-effectiveness of a UK adult lung transplant service combining both standard and Ex-Vivo Lung Perfusion transplants compared to a service including only standard lung transplants. A Markov model was developed and populated with a combination of DEVELOP-UK, published and clinical routine data, and extrapolated to a lifetime horizon. Probabilistic sensitivity and scenario analyses were used to explore uncertainty in the final outcomes. RESULTS: Base-case model results estimated life years gained of 0.040, quality-adjusted life-years (QALYs) gained of 0.045 and an incremental cost per QALY of £90,000 for Ex-Vivo Lung Perfusion. Scenario analyses carried out suggest that an improved rate of converting unusable donor lungs using Ex-Vivo Lung Perfusion, similar resource use post-transplant for both standard and EVLP lung transplant and applying increased waiting list costs would reduce ICERs to approximately £30,000 or below. CONCLUSION: DEVELOP-UK base-case results suggest that incorporating Ex-Vivo Lung Perfusion into the UK adult lung transplant service is more effective, increasing the number of donor lungs available for transplant, but would not currently be considered cost-effective in the UK using the present NICE threshold. However, results were sensitive to change in some model parameters and in several plausible scenario analyses results indicate that a service incorporating Ex-vivo lung perfusion would be considered cost-effective . TRIAL REGISTRATION: ISRCTN registry number: ISRCTN44922411 . Date of registration: 06/02/2012. Retrospectively registered.

Optimization of Time- and Code-Division-Multiplexed Readout for Athena X-IFU.

Readout of a large, spacecraft-based array of superconducting transition-edge sensors (TESs) requires careful management of the layout area and power dissipation of the cryogenic-circuit components. We present three optimizations of our time- (TDM) and code-division-multiplexing (CDM) systems for the X-ray Integral Field Unit (X-IFU), a several-thousand-pixel-TES array for the planned Athena-satellite mission. The first optimization is a new readout scheme that is a hybrid of CDM and TDM. This C/TDM architecture balances CDM's noise advantage with TDM's layout compactness. The second is a redesign of a component: the shunt resistor that provides a dc-voltage bias to the TESs. A new layout and a thicker Pd-Au resistive layer combine to reduce this resistor's area by more than a factor of 5. Third, we have studied the power dissipated by the first-stage SQUIDs (superconducting quantum-interference devices) and the readout noise versus the critical current of the first-stage SqUIDs. As a result, the X-IFU TDM and C/TDM SQUIDs will have a specified junction critical current of 5 µA. Based on these design optimizations and TDM experiments described by Durkin, et al. (these proceedings), TDM meets all requirements to be X-IFU's backup-readout option. Hybrid C/TDM is another viable option that could save spacecraft resources.

Demonstration of Athena X-IFU Compatible 40-Row Time-Division-Multiplexed Readout.

Time-division multiplexing (TDM) is the backup readout technology for the X-ray Integral Field Unit (X-IFU), a 3,168-pixel X-ray transition-edge sensor (TES) array that will provide imaging spectroscopy for ESA's Athena satellite mission. X-0IFU design studies are considering readout with a multiplexing factor of up to 40. We present data showing 40-row TDM readout (32 TES rows + 8 repeats of the last row) of TESs that are of the same type as those being planned for X-IFU, using measurement and analysis parameters within the ranges specified for X-IFU. Singlecolumn TDM measurements have best-fit energy resolution of (1.91 ± 0.01) eV for the Al Kα complex (1.5 keV), (2.10 ± 0.02) eV for Ti Kα (4.5 keV), (2.23 ± 0.02) eV for Mn Kα (5.9 keV), (2.40 ± 0.02) eV for Co Kα (6.9 keV), and (3.44 ± 0.04) eV for Br Kα (11.9 keV). Three-column measurements have best-fit resolution of (2.03 ± 0.01) eV for Ti Kα and (2.40 ± 0.01) eV for Co Kα. The degradation due to the multiplexed readout ranges from 0.1 eV at the lower end of the energy range to 0.5 eV at the higher end. The demonstrated performance meets X-IFU's energy-resolution and energy-range requirements. True 40-row TDM readout, without repeated rows, of kilopixel scale arrays of X-IFU-like TESs is now under development.

A longitudinal, observational study of the features of transitional healthcare associated with better outcomes for young people with long-term conditions.

BACKGROUND: Most evidence about what works in transitional care comes from small studies in single clinical specialties. We tested the hypothesis that exposures to nine recommended features of transitional healthcare were associated with better outcomes for young people with long-term conditions during transition from child-centred to adult-oriented health services. METHODS: This is a longitudinal, observational cohort study in UK secondary care including 374 young people, aged 14-18.9 years at recruitment, with type 1 diabetes (n = 150), cerebral palsy (n = 106) or autism spectrum disorder with an associated mental health problem (n = 118). All were pre-transfer and without significant learning disability. We approached all young people attending five paediatric diabetes centres, all young people with autism spectrum disorder attending four mental health centres, and randomly selected young people from two population-based cerebral palsy registers. Participants received four home research visits, 1 year apart and 274 participants (73%) completed follow-up. Outcome measures were Warwick Edinburgh Mental Wellbeing Scale, Mind the Gap Scale (satisfaction with services), Rotterdam Transition Profile (Participation) and Autonomy in Appointments. RESULTS: Exposure to recommended features was 61% for 'coordinated team', 53% for 'age-banded clinic', 48% for 'holistic life-skills training', 42% for 'promotion of health self-efficacy', 40% for 'meeting the adult team before transfer', 34% for 'appropriate parent involvement' and less than 30% for 'written transition plan', 'key worker' and 'transition manager for clinical team'. Three features were strongly associated with improved outcomes. (1) 'Appropriate parent involvement', example association with Wellbeing (b = 4.5, 95% CI 2.0-7.0, p = 0.001); (2) 'Promotion of health self-efficacy', example association with Satisfaction with Services (b = - 0.5, 95% CI - 0.9 to - 0.2, p = 0.006); (3) 'Meeting the adult team before transfer', example associations with Participation (arranging services and aids) (odds ratio 5.2, 95% CI 2.1-12.8, p < 0.001) and with Autonomy in Appointments (average 1.7 points higher, 95% CI 0.8-2.6, p < 0.001). There was slightly less recruitment of participants from areas with greater socioeconomic deprivation, though not with respect to family composition. CONCLUSIONS: Three features of transitional care were associated with improved outcomes. Results are likely to be generalisable because participants had three very different conditions, attending services at many UK sites. Results are relevant for clinicians as well as for commissioners and managers of health services. The challenge of introducing these three features across child and adult healthcare services, and the effects of doing so, should be assessed.

Barriers to and enablers of diabetic retinopathy screening attendance: a systematic review of published and grey literature.

AIMS: To identify and synthesize studies reporting modifiable barriers/enablers associated with retinopathy screening attendance in people with Type 1 or Type 2 diabetes, and to identify those most likely to influence attendance. METHODS: We searched MEDLINE, EMBASE, PsycINFO, Cochrane Library and the 'grey literature' for quantitative and qualitative studies to February 2017. Data (i.e. participant quotations, interpretive summaries, survey results) reporting barriers/enablers were extracted and deductively coded into domains from the Theoretical Domains Framework; with domains representing categories of theoretical barriers/enablers proposed to mediate behaviour change. Inductive thematic analysis was conducted within domains to describe the role each domain plays in facilitating or hindering screening attendance. Domains that were more frequently coded and for which more themes were generated were judged more likely to influence attendance. RESULTS: Sixty-nine primary studies were included. We identified six theoretical domains ['environmental context and resources' (75% of included studies), 'social influences' (51%), 'knowledge' (51%), 'memory, attention, decision processes' (50%), 'beliefs about consequences' (38%) and 'emotions' (33%)] as the key mediators of diabetic retinopathy screening attendance. Examples of barriers populating these domains included inaccurate diabetic registers and confusion between routine eye care and retinopathy screening. Recommendations by healthcare professionals and community-level media coverage acted as enablers. CONCLUSIONS: Across a variety of contexts, we found common barriers to and enablers of retinopathy screening that could be targeted in interventions aiming to increase screening attendance.

Differential effects of the combination of tyrosol with chlorhexidine gluconate on oral biofilms.

OBJECTIVE: This study assessed the effect of tyrosol and chlorhexidine gluconate in combination against Candida albicans, Candida glabrata, and Streptococcus mutans in the planktonic state or forming biofilms in vitro. MATERIALS AND METHODS: Checkerboard assays were performed for determination of minimum inhibitory concentration. Biofilms were cultivated during 24 h on specimens of acrylic resin and hydroxyapatite and treated with the drugs alone or in combination twice a day for 1 min, during 3 days. The antibiofilm effect was determined by quantification of the metabolic activity and cultivable cells. The drug combination was also applied on C. albicans to investigate its action on the number of hyphae. Data were statistically examined by two-way ANOVA and Holm-Sidak test (P < 0.05). RESULTS: The effect of drug combination on planktonic cells was classified as antagonistic for C. albicans and indifferent for the other strains. Also, the drugs were ineffective against the tested biofilms. However, the drug combination showed a synergistic effect in reducing the number of hyphae by C. albicans. CONCLUSION: The combination of tyrosol with chlorhexidine gluconate was only effective in reducing the number of hyphae by C. albicans, a relevant virulence factor of this species.

'Thinking that somebody's going to delay [a tonsillectomy] for one to two years is quite horrifying really': a qualitative feasibility study for the NAtional Trial of Tonsillectomy IN Adults (NATTINA Part 2).

OBJECTIVES: Level one evidence on the value of adult tonsillectomy versus non-surgical management remains scarce. Before embarking on a costly national randomised controlled trial, it is essential to establish its feasibility. DESIGN: Feasibility study with in-depth qualitative and cognitive interviews. SETTING: ENT staff and patients were recruited from nine hospital centres across England and Scotland. PARTICIPANTS: Patients who were referred for tonsillectomy (n = 15), a convenience sample of general practitioners (n = 11) and ear, nose and throat staff (n = 22). MAIN OUTCOME MEASURES: To ascertain whether ear, nose and throat staff would be willing to randomise patients to the treatment arms. To assess general practitioners' willingness to refer patients to the NAtional Trial of Tonsillectomy IN Adults (NATTINA) centres. To assess patients' willingness to be randomised and the acceptability of the deferred surgery treatment arm. To ascertain whether the study could progress to the pilot trial stage. RESULTS: Ear, nose and throat staff and general practitioners were willing to randomise patients to the proposed NATTINA. Not all ENT staff were in equipoise concerning the treatment pathways. Patients were reluctant to be randomised into the deferred surgery group if they had already waited a substantial time before being referred. CONCLUSIONS: Findings suggest that the NATTINA may not be feasible. Proposed methods could not be realistically assessed without a pilot trial. Due to the importance of the question, as evidenced by NATTINA clinicians, and strong support from ENT staff, the pilot trial proceeded, with modifications.

High-resolution X-ray emission spectroscopy with transition-edge sensors: present performance and future potential.

X-ray emission spectroscopy (XES) is a powerful element-selective tool to analyze the oxidation states of atoms in complex compounds, determine their electronic configuration, and identify unknown compounds in challenging environments. Until now the low efficiency of wavelength-dispersive X-ray spectrometer technology has limited the use of XES, especially in combination with weaker laboratory X-ray sources. More efficient energy-dispersive detectors have either insufficient energy resolution because of the statistical limits described by Fano or too low counting rates to be of practical use. This paper updates an approach to high-resolution X-ray emission spectroscopy that uses a microcalorimeter detector array of superconducting transition-edge sensors (TESs). TES arrays are discussed and compared with conventional methods, and shown under which circumstances they are superior. It is also shown that a TES array can be integrated into a table-top time-resolved X-ray source and a soft X-ray synchrotron beamline to perform emission spectroscopy with good chemical sensitivity over a very wide range of energies.

DEEP Study: does EQ-5D-5L measure the impacts of persistent oro-facial pain?

The EQ-5D-5L is a generic quality of life (QOL) measure widely used throughout the world, which has the advantage that it allows health-state preferences to be elicited. The aim of this study was to examine whether: a) variation in the standardised reference period for EQ-5D-5L from 'today' to 'the last month' had a minimal clinically meaningful difference; (b) EQ-5D-5L had convergent validity with a multidimensional pain measure in quantifying the impacts of pain. As part of a larger study into the effectiveness and efficiency of care pathways for persistent orofacial pain (POFP) (http://research.ncl.ac.uk/deepstudy), participants with POFP (n = 100) completed two versions of the EQ-5D-5L at the same time with different reference periods ('today' vs. 'last month'). Participants also completed the first section of the West Haven-Yale Multidimensional Pain Inventory (v3) to assess convergent validity. Two-tailed nonparametric inferential statistics, intra-class correlation coefficients (ICC), and within-subject change scores were used to compare the two EQ-5D-5L versions. Convergent validity was assessed using Spearman's rho correlation coefficients. Health-state valuations were significantly different (P < 0.01), and there was good similarity between the two versions' ICC 0.86 (95% CI 0.79-0.91). The within-subject mean change was 0.03 (95% CI 0.01-0.06). For convergent validity, all relationships were significant (P < 0.05) and in the expected directions. EQ-5D-5L demonstrates sufficient convergent validity to be used with POFP, and a change in the standard reference period may be unnecessary if a multidimensional pain measure is also used.

Surgeon experience in second-look transurethral resection of bladder cancer - a prospective study.

INTRODUCTION AND OBJECTIVES: Transurethral resection of bladder tumor (TURBT) is crucial in the treatment of bladder tumors and when incorrectly performed can cause staging mistakes. To avoid these errors, a second resection is recommended in selected cases. The aim of this study is to evaluate the surgeon's ability to predict histologically complete primary resection of newly diagnosed bladder tumors avoiding the need for a second TURBT. METHODS: This is a prospective, observational study involving 47 consecutive patients with newly diagnosed bladder tumors who had previously undergone primary TURBT, and met EAU criteria for second-look TURBT. Second-look TURBT specimens were analyzed for routine histological assessment and compared with the surgeon's impression of the tumor at initial resection. RESULTS: Of 91 patients submitted to primary TURBT, 47 met the criteria for second-look TURBT. Second-look specimens revealed residual disease in 20.9% of patients and 3 (6.4%) of patients showed upstaging disease. The sensitivity of a senior to detect disease on second-look TURBT in relation to muscle invasion was 75%, and the specificity was 85%. CONCLUSIONS: Second-look TURBT is crucial in the treatment of bladder cancer and cannot be replaced by a surgeon's opinion, so international recommendations should be followed. Supervision of less experienced surgeons is a cornerstone.

Table-top ultrafast x-ray microcalorimeter spectrometry for molecular structure.

This work presents an x-ray absorption measurement by use of ionizing radiation generated by a femtosecond pulsed laser source. The spectrometer was a microcalorimetric array whose pixels are capable of accurately measuring energies of individual radiation quanta. An isotropic continuum x-ray spectrum in the few-keV range was generated from a laser plasma source with a water-jet target. X rays were transmitted through a ferrocene powder sample to the detector, whose pixels have average photon energy resolution ΔE=3.14 eV full-width-at-half-maximum at 5.9 keV. The bond distance of ferrocene was retrieved from this first hard-x-ray absorption fine-structure spectrum collected with an energy-dispersive detector. This technique will be broadly enabling for time-resolved observations of structural dynamics in photoactive systems.

Quantum state tomography of an itinerant squeezed microwave field.

We perform state tomography of an itinerant squeezed state of the microwave field prepared by a Josephson parametric amplifier (JPA). We use a second JPA as a preamplifier to improve the quantum efficiency of the field quadrature measurement from 2% to 36%±4%. Without correcting for the detection inefficiency we observe a minimum quadrature variance which is 68(-7)(+9)% of the variance of the vacuum. We reconstruct the state's density matrix by a maximum likelihood method and infer that the squeezed state has a minimum variance less than 40% of the vacuum, with uncertainty mostly caused by calibration systematics.

DEEP Study: Modeling Outcomes and Costs of Persistent Orofacial Pain.

KNOWLEDGE OF TRANSFER STATEMENT: Despite a substantial number of consultations, individuals experiencing the care pathways in this study continued to have far from perfect health over their life course. The modeling suggests they would only experience 18 y in "perfect health." There is considerable scope to improve current care/outcomes and patient experience.

Economic evaluation of the treatment of grade II haemorrhoids: a comparison of stapled haemorrhoidopexy and rubber band ligation.

OBJECTIVES: Haemorrhoidal disease is a common condition causing considerable distress to individuals and significant cost to healthcare services. This paper explored the cost-effectiveness of stapled haemorrhoidopexy (SH) compared with the non-surgical intervention, rubber band ligation (RBL), for grade II symptomatic circumferential haemorrhoids. METHOD: An economic evaluation alongside a randomized controlled trial conducted between October 2002 and February 2005. Adults were recruited and randomized to either SH or RBL. The same surgeon performed all procedures and investigators were blinded until analyses were completed. Primary outcomes measured at 52 weeks were cumulative costs to the NHS, clinical diagnosis of recurrence and quality adjusted life years (QALYs). RESULTS: Sixty symptomatic men and women with confirmed clinical diagnosis of grade II symptomatic haemorrhoids were randomized. Loss to follow-up was up to 10% at 52 weeks. The mean cost for SH was greater than RBL (mean difference: 1483 pounds, 95% CI: 1339-1676); disease recurrence was lower (OR = 0.18, 95% CI: 0.03-0.86); and there was no evidence of a statistically significant difference in QALYs (-0.014, 95% CI: -0.076 to 0.051). SH was associated with a modest incremental cost per recurrence avoided at 12 months follow-up (4945 pounds). Based on current data, it was considered highly unlikely to be cost-effective in terms of incremental cost per QALY. CONCLUSIONS: There is insufficient evidence about the cost-effectiveness of SH for grade II haemorrhoids to recommend its routine use in place of RBL. Further information is needed from larger trials with a longer-term follow-up to inform subsequent economic evaluation.

Randomized controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids: long-term results.

OBJECTIVE: An improved understanding of the pathophysiology of haemorrhoids has resulted in the introduction of new surgical techniques including stapled haemorrhoidopexy (SH). This randomized controlled trial compared the long-term effectiveness of SH with rubber band ligation (RBL) in the treatment of grade II circumferential symptomatic haemorrhoids. METHOD: A consecutive cohort of patients was randomly allocated to either SH or RBL. Data on haemorrhoidal symptoms, Cleveland continence scores, sphincter assessment, SF-36, EQ-5D, HAD score and prior treatment history were assessed at enrollment and reassessed by long-term postal questionnaire. The details were analysed using spss 12.0 from Microsoft Access. RESULTS: Sixty patients were allocated by computer block randomization. Both groups were balanced for age, sex and symptoms. Recurrence favoured SH [3 vs 11; OR 0.18, 95% CI (0.03 to 0.86), P = 0.028] at 1 year and, at a mean of 40.67 (31-47) months [4 vs 12; OR 0.23, 95% CI (0.05, 0.95); P = 0.039]. SH patients experienced prolonged pain [Median (IQR) = 7 (5,7) vs 3 (1,7), P = 0.008] and took a longer time to return to work [6 (3,7) vs 3 (1,6) days, P = 0.018]. This was no significant difference in quality of life. CONCLUSION: Stapled haemorrhoidopexy achieved better disease control at 1 year without any major complication. This was sustained in the long-term. Further studies with greater patient numbers are needed to confirm this study.

FAB: First UK feasibility trial of a future randomised controlled trial of Family focused treatment for Adolescents with Bipolar disorder.

BACKGROUND: This first mixed-methods UK trial examined the feasibility and acceptability of a future definitive randomised controlled trial (RCT) to evaluate whether Family Focussed Treatment for Adolescents with Bipolar Disorder (FFT-A) UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD). METHOD: The trial used a randomised, parallel group, non-blinded design where participants received FFT-A UK (16 sessions over 6 months) immediately or after 12 months (delayed arm). Measures of family functioning, well-being and quality of life of the young person and the main carer (most commonly a parent) were completed at baseline, 6 and 12-months in both arms. Primary outcome measures included rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery. Qualitative interviews allowed assessment of participants' views about FFT-A and the trial processes. RESULTS: Twenty-seven of 36 young persons with PBD and their families consented; of these, 14 families were randomised to the immediate and 13 to the delayed arm. Two families from the immediate arm withdrew consent and discontinued participation. Quantitative measures were completed by 22 families (88%) at 6-months and 21 families (84%) at 12-months. Qualitative interviews were conducted with 30 participants (9 young people, 15 parents and 6 other family members). Nine families attended 3 post-trial focus groups. CONCLUSION: It was feasible to recruit and retain to this trial. The results highlighted that trial design and measures were acceptable to participants. A benefit in family relationships was reported by participants which they attributed to the intervention in qualitative interviews. Families recommended that future modifications include definitive trial(s) recruiting participants in the age range 15-25 years as it felt this was the age range with maximum need. Trial registration ISRCTN, ISRCTN59769322. Registered 20 January 2014, http://www.isrctn.com/ISRCTN59769322.

Child Caries Management: A Randomized Controlled Trial in Dental Practice.

This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).

Measuring outcomes of importance to women with stress urinary incontinence.

OBJECTIVE: To provide evidence on outcomes of importance to women who have stress urinary incontinence (SUI). The secondary aim was to identify additional outcomes that ought to be collected in future primary studies or in systematic reviews of the literature. DESIGN: Questionnaire survey of a cohort of women with SUI. SETTING: UK. SAMPLE: A total of 188 women with SUI. METHODS: Areas of importance to women who suffer from SUI were assessed using a patient generated index (PGI). In addition to the PGI, the questionnaire included the King's Health Questionnaire (KHQ) and the EuroQol-5D (EQ-5D). MAIN OUTCOME MEASURES: PGI, EQ-5D and the KHQ. RESULTS: In total, 38 different areas were reported by respondents on the PGI. PGI and EQ-5D scores were positively correlated and significant. Correlations between the seven domains of the KHQ and PGI were all negative, but only two were statistically significant: personal relationships and severity measures. CONCLUSIONS: The PGI succeeded in capturing a diverse range of outcomes of importance to women suffering with SUI. Given the limited correlation between the KHQ domains and the PGI and, in addition, that the areas mentioned in the PGI were not found to map well to the EQ-5D, the PGI in this instance may be capturing concerns of women who suffer from SUI, which are not captured by quality-of-life measures such as the EQ-5D.

Economic evaluation of early administration of prednisolone and/or aciclovir for the treatment of Bell's palsy.

OBJECTIVES: Bell's palsy (BP), which causes facial paralysis, affects 11-40 people per 100 000 per annum in the UK. Its cause is unknown but as many as 30% of patients have continuing facial disfigurement, psychological difficulties and occasionally facial pain. We present an randomised controlled trial (RCT)-based economic evaluation of the early administration of steroids (prednisolone) and/or antivirals (acyclovir) compared to placebo, for treatment of BP. METHODS: The RCT was not powered to detect differences in the cost-effectiveness; therefore, we adopted a decision analytic model approach as a way of gaining precision in our cost-effectiveness comparisons [e.g. prednisolone only (PO) versus acyclovir only versus prednisolone and acyclovir versus placebo, prednisolone versus no prednisolone (NP) and acyclovir versus no acyclovir]. We assumed that trial interventions affect the probability of being cured/not cured but their consequences are independent of the initial therapy. We used the percentage of individuals with a complete recovery (based on House-Brackmann grade = 1) at 9 months and Quality Adjusted Life Years (e.g. derived on responses to the Health Utilities Index III) as measures of effectiveness. Other parameter estimates were obtained from trial data. RESULTS: PO dominated-i.e. was less costly and more effective-all other therapy strategies in the four arms model [77% probability of cost-effective (CE)]. Moreover, Prednisolone dominated NP (77% probability of being CE at 30 000 UK pounds threshold) while no acyclovir dominated aciclovir (85% chance of CE), in the two arms models, respectively. CONCLUSIONS: Treatment of BP with prednisolone is likely to be considered CE while treatment with acyclovir is highly unlikely to be considered CE. Further data on costs and utilities would be useful to confirm findings.