Julia Langham

Variation in Outcome After Subarachnoid Hemorrhage A Study of Neurosurgical Units in UK and Ireland

Backgrounds and Purpose— The purpose of the study was to describe the characteristics, management, and outcomes of patients with confirmed aneurysmal subarachnoid hemorrhage and to compare outcomes across neurosurgical units (NSUs) in the UK and Ireland. Methods— A cohort of patients admitted to NSUs with subarachnoid hemorrhage between September 14, 2001 and September 13, 2002 was studied longitudinally. Information was collected to characterize clinical condition on admission and treatment. Death or severe disability, defined by the Glasgow Outcome Score–Extended, was ascertained at 6 months. Results— Data for 2397 patients with a confirmed aneurysm and no coexisting neurological pathology were collected by all 34 NSUs in the UK and Ireland. Aneurysm repair was attempted in 2198 (91.7%) patients (surgical clipping, 57.7%; endovascular coiling, 41.2%; other repair, 1.0%). Most patients (65.0%) were admitted to the NSU on the same day or the day after their hemorrhage; 32.0% of treated patients had the aneurysm repaired on the day of admission to the NSU (day 0), day 1 or day 2 and a further 39.3% by day 7. Glasgow Outcome Score–Extended at 6 months was obtained for 90.6% of patients (2172), of whom 38.5% had an unfavorable outcome. The median risk of an unfavorable outcome for all patients was 31% (5th and 95th percentiles, 12% and 83%), depending on prerepair prognostic factors. After adjustment for case-mix, the percentage of patients with an unfavorable outcome in each NSU did not differ significantly from the overall mean. Conclusions— In this study that collected representative data from the UK and Ireland, there was no evidence that the performance of any NSU differed from the average.

Orlistat and the risk of acute liver injury: self controlled case series study in UK Clinical Practice Research Datalink

Objective To measure the association between orlistat and acute liver injury. Design Self controlled case series study. Setting Population based primary care setting, United Kingdom. Participants 94 695 patients receiving orlistat and registered in the UK Clinical Practice Research Datalink and linked with Hospital Episode Statistics data between 1999 and 2011. Main outcome measure Relative incidence of acute liver injury comparing periods when patients were receiving orlistat with periods of non-usage. Results Among 94 695 patients who received orlistat, 988 cases of acute liver injury were identified, with 335 confirmed as definite cases and 653 as probable cases. For all cases an increased incidence of liver injury was detected during the 90 day period before orlistat was first started, with an incidence rate ratio of 1.50 (95% confidence interval 1.10 to 2.06). The incidence remained raised during the first 30 days of treatment (2.21, 1.43 to 3.42), before returning to baseline levels with prolonged treatment. When the risk during the first 90 days of treatment was compared with the 90 days preceding first treatment, the incidence of liver injury was not increased (1.02, 0.67 to 1.56). An analysis restricted to definite cases showed no evidence of an increased risk of liver injury during treatment. Conclusion The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment. This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug.

Large-scale, prospective, observational studies in patients with psoriasis and psoriatic arthritis: A systematic and critical review

BackgroundObservational studies, if conducted appropriately, play an important role in the decision-making process providing invaluable information on effectiveness, patient-reported outcomes and costs in a real-world environment. We conducted a systematic review of large-scale, prospective, cohort studies with the aim of (a) summarising design characteristics, the interventions or aspects of the disease studied and the outcomes measured and (b) investigating methodological quality.MethodsWe included prospective, cohort studies which included at least 100 adults with psoriasis or psoriatic arthritis. Studies were identified through searches in electronic databases (Pubmed, Medline, Cochrane library, Centre for Reviews and Dissemination). Information on study characteristics were extracted and tabulated and quality assessment, using a checklist of 18 questions, was conducted.ResultsThirty five papers covering 16 cohorts met the inclusion criteria. There were ten treatment-related studies, only two of which provided a comparison between treatments, and six non-treatment studies which examined a number of characteristics of the disease including mortality, morbidity, cost of illness and health-related quality of life. All studies included a clinical outcome measure and 11 included patient-reported outcomes, however only two studies reported information on patient utilities and two on costs. The quality of the assessed studies varied widely. Studies did well on a number of quality assessment questions including having clear objectives, documenting selection criteria, providing a representative sample, defining interventions/characteristics under study, defining and using appropriate outcomes, describing results clearly and using appropriate statistical tests. The quality assessment criteria least adhered to involved questions regarding sample size calculations, describing potential selection bias, defining and adjusting for confounders and losses to follow-up, and defining and describing a comparison group.ConclusionThe review highlights the need for well designed prospective observational studies on the effectiveness, patient-reported outcomes and economic impact of treatment regimes for patients with psoriasis and psoriatic arthritis in a real-world environment.

Verteporfin Photodynamic Therapy Cohort Study: Report 2: Clinical Measures of Vision and Health-Related Quality of Life

PURPOSE To quantify decreases in health-related quality of life (HRQoL) for given deterioration in clinical measures of vision; to describe the shape of these relationships; and to test whether the gradients of these relationships change with duration of visual loss. DESIGN A prospective, longitudinal study of patients treated with verteporfin photodynamic therapy in the United Kingdom National Health Service. PARTICIPANTS Patients with neovascular age-related macular degeneration (AMD) treated in 18 ophthalmology departments in the United Kingdom with expertise in management of neovascular AMD. METHODS Responses to HRQoL questionnaires (Short Form 36 [SF-36] and National Eye Institute Visual Functioning Questionnaire [NEIVFQ]) and clinical measures of vision were recorded at baseline and at follow-up visits. Mixed regression models were used to characterize the relationships of interest. MAIN OUTCOME MEASURES Measures of vision were best-corrected visual acuity (BCVA) and contrast sensitivity (CS). The SF-36 physical and mental component scores (PCS and MCS), SF-6D utility, and distance, near, and composite NEIVFQ scores were derived to characterize HRQoL. RESULTS The SF-6D, PCS, and MCS were linearly associated with BCVA; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 0.0058, 0.245, and 0.546, respectively (all P<0.0001). Gradients were not influenced by duration of follow-up. Models predicting distance, near, and composite NEIVFQ scores from BCVA were quadratic; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 5.08, 5.48, and 3.90, respectively (all P<0.0001). The BCVA predicted HRQoL scores more strongly than CS. CONCLUSIONS Clinically significant deterioration in clinical measures of vision is associated with small decreases in generic and vision-specific HRQoL. Our findings are important for further research modeling the cost effectiveness of current and future interventions for neovascular AMD.

Findings of the International Subarachnoid Aneurysm Trial and the National Study of Subarachnoid Haemorrhage in context

Concern has been expressed about the applicability of the findings of the International Subarachnoid Aneurysm Trial (ISAT) with respect to the relative effects on outcome of coiling and clipping. It has been suggested that the findings of the National Study of Subarachnoid Haemorrhage may have greater relevance for neurosurgical practice. The objective of this paper was to interpret the findings of these two studies in the context of differences in their study populations, design, execution and analysis. Because of differences in design and analysis, the findings of the two studies are not directly comparable. The ISAT analysed all randomized patients by intention-to-treat, including some who did not undergo a repair, and obtained the primary outcome for 99% of participants. The National Study only analysed participants who underwent clipping or coiling, according to the method of repair, and obtained the primary outcome for 91% of participants. Time to repair was also considered differently in the two studies. The comparison between coiling and clipping was susceptible to confounding in the National Study, but not in the ISAT. The two study populations differed to some extent, but inspection of these differences does not support the view that coiling was applied inappropriately in the National Study. Therefore, there are many reasons why the two studies estimated different sizes of effect. The possibility that there were real, systematic differences in practice between the ISAT and the National Study cannot be ruled out, but such explanations must be seen in the context of other explanations relating to chance, differences in design or analysis, or confounding.

Verteporfin Photodynamic Therapy Cohort Study: Report 3: Cost Effectiveness and Lessons for Future Evaluations

PURPOSE To report (1) the costs of verteporfin photodynamic therapy (VPDT) in routine treatment of neovascular age-related macular degeneration (nAMD), (2) the relationship between health and social service costs and best-corrected visual acuity (BCVA), (3) the cost-effectiveness of VPDT versus a best supportive care (BSC) group who were assumed to have no active treatment, and (4) lessons for future cost-effectiveness analyses (CEAs). DESIGN The CEA of VPDT versus BSC that uses health-related quality of life (HrQoL), resource use, and visual acuity data from the United Kingdom (UK) VPDT Cohort Study. PARTICIPANTS Data on VPDT use were collected from patients attending 45 ophthalmology provider units in the UK National Health Service, 15 units collected data on self-reported use of services. METHODS Incremental costs of VPDT versus BSC were calculated from treatment costs, change in cost associated with declining BCVA, and difference in BCVA previously attributed to VPDT. Similarly, incremental quality-adjusted life years (QALYs) were calculated from change in HRQoL associated with declining BCVA, giving an incremental cost per QALY of VPDT versus BSC over 2 years. MAIN OUTCOME MEASURES Incremental costs (UK pounds [ pound]; United States dollars [

Verteporfin Photodynamic Therapy Cohort Study: Report 1: Effectiveness and Factors Influencing Outcomes

]); incremental QALYs; costs per QALY. RESULTS The treatment costs of VDPT were pound 3026 (

Navigational cue effects in Alzheimer's disease and posterior cortical atrophy

4544) in year 1 and pound 845 (

OP93 Orlistat and the Risk of Acute Liver Injury: A Self-Controlled Case-Series Study in United Kingdom General Practice Research Database

1269) in year 2. For patients who used services, a 5-letter decrease in BCVA was associated with an increase in annual costs of approximately pound 110 (

A Self-Controlled Case-Series Study To Assess the Effect of Orlistat on the Risk of Idiopathic Acute Liver Injury, Using Data from the United Kingdom General Practice Research Database

165; 95% confidence intervals, approximately pound 48 [