James Raftery

University of Southampton, Southampton, England, United Kingdom

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Publications (112)770.21 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Handwashing to prevent transmission of respiratory tract infections (RTIs) has been widely advocated, especially during the H1N1 pandemic. However, the role of handwashing is debated, and no good randomised evidence exists among adults in non-deprived settings. We aimed to assess whether an internet-delivered intervention to modify handwashing would reduce the number of RTIs among adults and their household members. We recruited individuals sharing a household by mailed invitation through general practices in England. After consent, participants were randomised online by an automated computer-generated random number programme to receive either no access or access to a bespoke automated web-based intervention that maximised handwashing intention, monitored handwashing behaviour, provided tailored feedback, reinforced helpful attitudes and norms, and addressed negative beliefs. We enrolled participants into an additional cohort (randomised to receive intervention or no intervention) to assess whether the baseline questionnaire on handwashing would affect handwashing behaviour. Participants were not masked to intervention allocation, but statistical analysis commands were constructed masked to group. The primary outcome was number of episodes of RTIs in index participants in a modified intention-to-treat population of randomly assigned participants who completed follow-up at 16 weeks. This trial is registered with the ISRCTN registry, number ISRCTN75058295. Across three winters between Jan 17, 2011, and March 31, 2013, we enrolled 20 066 participants and randomly assigned them to receive intervention (n=10 040) or no intervention (n=10 026). 16 908 (84%) participants were followed up with the 16 week questionnaire (8241 index participants in intervention group and 8667 in control group). After 16 weeks, 4242 individuals (51%) in the intervention group reported one or more episodes of RTI compared with 5135 (59%) in the control group (multivariate risk ratio 0·86, 95% CI 0·83-0·89; p<0·0001). The intervention reduced transmission of RTIs (reported within 1 week of another household member) both to and from the index person. We noted a slight increase in minor self-reported skin irritation (231 [4%] of 5429 in intervention group vs 79 [1%] of 6087 in control group) and no reported serious adverse events. In non-pandemic years, an effective internet intervention designed to increase handwashing could have an important effect in reduction of infection transmission. In view of the heightened concern during a pandemic and the likely role of the internet in access to advice, the intervention also has potential for effective implementation during a pandemic. Medical Research Council. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 08/2015; DOI:10.1016/S0140-6736(15)60127-1 · 45.22 Impact Factor
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    ABSTRACT: Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting. We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4-11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1-3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation. Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in earrelated quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score -0.42, 95% CI -0.63 to -0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups. Autoinflation in children aged 4-11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. ISRCTN, No. 55208702. © 8872147 Canada Inc.
    Canadian Medical Association Journal 07/2015; DOI:10.1503/cmaj.141608 · 5.81 Impact Factor
  • Health technology assessment reports 02/2015; 19(11):1-166.
  • Health technology assessment (Winchester, England) 02/2015; 19(11). · 5.12 Impact Factor
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    ABSTRACT: By 2011, the Health Technology Assessment (HTA) programme had published the results of over 100 trials with another 220 in progress. The aim of the project was to develop and pilot 'metadata' on clinical trials funded by the HTA programme. The aim of the project was to develop and pilot questions describing clinical trials funded by the HTA programme in terms of it meeting the needs of the NHS with scientifically robust studies. The objectives were to develop relevant classification systems and definitions for use in answering relevant questions and to assess their utility. Published monographs and internal HTA documents. A database was developed, 'populated' using retrospective data and used to answer questions under six prespecified themes. Questions were screened for feasibility in terms of data availability and/or ease of extraction. Answers were assessed by the authors in terms of completeness, success of the classification system used and resources required. Each question was scored to be retained, amended or dropped. One hundred and twenty-five randomised trials were included in the database from 109 monographs. Neither the International Standard Randomised Controlled Trial Number nor the term 'randomised trial' in the title proved a reliable way of identifying randomised trials. Only limited data were available on how the trials aimed to meet the needs of the NHS. Most trials were shown to follow their protocols but updates were often necessary as hardly any trials recruited as planned. Details were often lacking on planned statistical analyses, but we did not have access to the relevant statistical plans. Almost all the trials reported on cost-effectiveness, often in terms of both the primary outcome and quality-adjusted life-years. The cost of trials was shown to depend on the number of centres and the duration of the trial. Of the 78 questions explored, 61 were well answered, 33 fully with 28 requiring amendment were the analysis updated. The other 17 could not be answered with readily available data. The study was limited by being confined to 125 randomised trials by one funder. Metadata on randomised controlled trials can be expanded to include aspects of design, performance, results and costs. The HTA programme should continue and extend the work reported here. The National Institute for Health Research HTA programme.
    Health technology assessment (Winchester, England) 02/2015; 19(11):1-138. DOI:10.3310/hta19110 · 5.12 Impact Factor
  • James Raftery
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    ABSTRACT: Mit der Neuverfassung des National Health Service 2010 wurden Rechte und Zuständigkeiten konkretisiert; die Kosten-Nutzen-Bewertung wurde beim National Institute for Clinical and Social Excellence (NICE) und beim Joint Committee on Vaccinations and Immunisations (JCVI) angesiedelt. Das National Screening Committe und die Health Protection Agency können die Regierung auch auf Grundlage von Kosten-Nutzen-Bewertungen beraten. Die Behörden und Einrichtungen richten sich dabei nach den Methoden des NICE. Die gesundheitsökonomischen Methoden des NICE werden allgemein unter dem Begriff des Extrawelfarismus subsumiert, um sie von der neoklassischen Wohlfahrstheorie abzugrenzen. Im Kern schlägt sich dies in unterschiedlichen Erhebungs- und Bewertungsmethoden des Nutzens (QALYs) und der Kosten (Perspektive des NHS) nieder. Zu erwähnen ist außerdem, dass sich die Diskontierung über die Zeit und zwischen den verschiedenen Einrichtungen unterschiedlich entwickelt. Im Zusammenhang mit der Einführung des Value Based Pricing wurde und wird in einer Ende Juni endenden öffentlichen Debatte darüber gestritten, ob sich die Methoden des NICE nicht näher an die des britischen Finanzministeriums (UK Treasury) anlehnen sollten. Da man einige Entscheidungen des NICE zu Arzneimitteln als politisch inakzeptabel ansah, wurden besondere Budgets für Interventionen eingeführt, deren Erstattung von NICE abgelehnt wurden. Dazu gehören das Multiple Sclerosis Risk Sharing Scheme (2002) und der Cancer Drugs Fund (2010) sowie besondere Prämien für Interventionen am Ende des Lebens und für Innovationen. Seit 2009 werden über Patient Access Schemes Preissenkungen gefordert, sodass die Schwellenwerte des NICE erreicht werden. Insgesamt muss man sagen, dass der NHS in England auf der Basis von Kosteneffektivität die Erstattung von sehr wenigen Interventionen abgelehnt hat.
    Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen 12/2014; 108(7). DOI:10.1016/j.zefq.2014.08.019
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    BMJ Clinical Research 11/2014; 349(nov28 2):g7276. DOI:10.1136/bmj.g7276 · 14.09 Impact Factor
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    ABSTRACT: AimsWe wish to assess the clinical and cost-effectiveness of remote monitoring of heart failure patients with cardiac implanted electronic devices.MethodsREM-HF is a multicentre, randomized, non-blinded, parallel trial designed to compare weekly remote monitoring-driven management with usual care for patients with cardiac implanted electronic devices (ICD, CRT-D, or CRT-P). The trial is event driven, and the final analysis will be performed when 546 events have been observed or the study is terminated at the interim analysis. We have randomized 1650 patients to be followed up for a minimum of 2 years. Patients will remain in the trial up to study termination. The first patient was randomized in September 2011 and the study is expected to complete in early 2016. The primary combined endpoint is time to first event of all-cause death or unplanned hospitalization for cardiovascular reasons. An economic evaluation will be performed, estimating the cost per quality-adjusted lifeyear, with direct costs estimated from the National Health Service perspective and quality of life assessed by the EQ-5D, Short-Form12, and Kansas City Cardiomyopathy Questionnaires. The study design has been informed by a feasibility study.ConclusionREM-HF is a multicentre randomized study that will provide important data on the effect of remote monitoring-driven management of implanted cardiac devices on morbidity and mortality, as well as the cost-effectiveness of this approach.Trial registration: UKCRN 10383.
    European Journal of Heart Failure 09/2014; 16(9). DOI:10.1002/ejhf.149 · 6.58 Impact Factor
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    ABSTRACT: Objective To assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab (Avastin) and ranibizumab (Lucentis) for neovascular age-related macular degeneration (nAMD) from a UK National Health Service (NHS) perspective. Design A within-trial cost-utility analysis with a 2-year time horizon, based on a multicentre factorial, non-inferiority randomised controlled trial. Setting 23 hospital ophthalmology clinics. Participants 610 patients aged ≥50 years with untreated nAMD in the study eye. Interventions 0.5 mg ranibizumab or 1.25 mg bevacizumab given continuously (monthly) or discontinuously (as-needed) for 2 years. Main outcome measures Quality-adjusted life-years (QALYs). Results Total 2-year costs ranged from £3002/patient ($4700; 95% CI £2601 to £3403) for discontinuous bevacizumab to £18 590/patient ($29 106; 95% CI £18 258 to £18 922) for continuous ranibizumab. Ranibizumab was significantly more costly than bevacizumab for both continuous (+£14 989/patient ($23 468); 95% CI £14 522 to £15 456; p<0.001) and discontinuous treatment (+£8498 ($13 305); 95% CI £7700 to £9295; p<0.001), with negligible difference in QALYs. Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay £3.5 million ($5.5 million) per additional QALY gained. Patients receiving continuous bevacizumab accrued higher total costs (+£599 ($938); 95% CI £91 to £1107; p=0.021) than those receiving discontinuous bevacizumab, but also accrued non-significantly more QALYs (+0.020; 95% CI −0.032 to 0.071; p=0.452). Continuous bevacizumab therefore cost £30 220 ($47 316) per QALY gained versus discontinuous bevacizumab. However, bootstrapping demonstrated that if the NHS is willing to pay £20 000/QALY gained, there is a 37% chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab. Conclusions Ranibizumab is not cost-effective compared with bevacizumab, being substantially more costly and producing little or no QALY gain. Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial, although there is a 37% chance that continuous bevacizumab is cost-effective. Trial registration number ISRCTN92166560.
    BMJ Open 07/2014; 4(7):e005094. DOI:10.1136/bmjopen-2014-005094 · 2.06 Impact Factor
  • J P Raftery
    PharmacoEconomics 05/2014; 32(7). DOI:10.1007/s40273-014-0158-6 · 3.34 Impact Factor
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    ABSTRACT: The New Forest Parenting Programme (NFPP) is a home-delivered, evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder (ADHD) in preschool children. It has been adapted for use with 'hard-to-reach' or 'difficult-to-treat' children. This trial will compare the adapted-NFPP with a generic parenting group-based programme, Incredible Years (IY), which has been recommended for children with preschool-type ADHD symptoms.Methods/design: This multicentre randomized controlled trial comprises three arms: adapted-NFPP, IY and treatment as usual (TAU). A sample of 329 parents of preschool-aged children with a research diagnosis of ADHD enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio 3:3:1. Participants in the adapted-NFPP and IY arms receive an induction visit followed by 12 weekly parenting sessions of 11/2 hours (adapted-NFPP) or 21/2 hours (IY) over 2.5 years. Adapted-NFPP will be delivered as a one-to-one home-based intervention; IY, as a group-based intervention. TAU participants are offered a parenting programme at the end of the study. The primary objective is to test whether the adapted-NFPP produces beneficial effects in terms of core ADHD symptoms. Secondary objectives include examination of the treatment impact on secondary outcomes, a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function. The primary outcome is change in ADHD symptoms, as measured by the parent-completed version of the SNAP-IV questionnaire, adjusted for pretreatment SNAP-IV score. Secondary outcome measures are: a validated index of behaviour during child's solo play; teacher-reported SNAP-IV (ADHD scale); teacher and parent Eyberg Child Behaviour Inventory - Oppositional Defiant Disorder scale; Revised Client Service Receipt Inventory - Health Economics Costs measure and EuroQol (EQ5D) health-related quality-of-life measure. Follow-up measures will be collected 6 months after treatment for participants allocated to adapted-NFPP and IY. This trial will provide evidence as to whether the adapted-NFPP is more effective and cost-effective than the recommended treatment and TAU. It will also provide information about mediating factors (improved parenting and neuropsychological function) and moderating factors (parent and child genetic factors) in any increased benefit.Trial registration: Current Controlled Trials, ISRCTN39288126.
    Trials 04/2014; 15(1):142. DOI:10.1186/1745-6215-15-142 · 2.12 Impact Factor
  • Osteoarthritis and Cartilage 04/2014; 22:S210-S211. DOI:10.1016/j.joca.2014.02.404 · 4.66 Impact Factor
  • Osteoarthritis and Cartilage 04/2014; 22:S214. DOI:10.1016/j.joca.2014.02.410 · 4.66 Impact Factor
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    ABSTRACT: Antibiotics are still prescribed to most patients attending primary care with acute sore throat, despite evidence that there is modest benefit overall from antibiotics. Targeting antibiotics using either clinical scoring methods or rapid antigen detection tests (RADTs) could help. However, there is debate about which groups of streptococci are important (particularly Lancefield groups C and G), and uncertainty about the variables that most clearly predict the presence of streptococci. This study aimed to compare clinical scores or RADTs with delayed antibiotic prescribing. The study comprised a RADT in vitro study; two diagnostic cohorts to develop streptococcal scores (score 1; score 2); and, finally, an open pragmatic randomised controlled trial with nested qualitative and cost-effectiveness studies. The setting was UK primary care general practices. Participants were patients aged ≥ 3 years with acute sore throat. An internet program randomised patients to targeted antibiotic use according to (1) delayed antibiotics (control group), (2) clinical score or (3) RADT used according to clinical score. The main outcome measures were self-reported antibiotic use and symptom duration and severity on seven-point Likert scales (primary outcome: mean sore throat/difficulty swallowing score in the first 2-4 days). The IMI TestPack Plus Strep A (Inverness Medical, Bedford, UK) was sensitive, specific and easy to use. Lancefield group A/C/G streptococci were found in 40% of cohort 2 and 34% of cohort 1. A five-point score predicting the presence of A/C/G streptococci [FeverPAIN: Fever; Purulence; Attend rapidly (≤ 3 days); severe Inflammation; and No cough or coryza] had moderate predictive value (bootstrapped estimates of area under receiver operating characteristic curve: 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection. In total, 38% of cohort 1 and 36% of cohort 2 scored ≤ 1 for FeverPAIN, associated with streptococcal percentages of 13% and 18%, respectively. In an adaptive trial design, the preliminary score (score 1; n = 1129) was replaced by FeverPAIN (n = 631). For score 1, there were no significant differences between groups. For FeverPAIN, symptom severity was documented in 80% of patients, and was lower in the clinical score group than in the delayed prescribing group (-0.33; 95% confidence interval -0.64 to -0.02; p = 0.039; equivalent to one in three rating sore throat a slight rather than moderately bad problem), and a similar reduction was observed for the RADT group (-0.30; -0.61 to 0.00; p = 0.053). Moderately bad or worse symptoms resolved significantly faster (30%) in the clinical score group (hazard ratio 1.30; 1.03 to 1.63) but not the RADT group (1.11; 0.88 to 1.40). In the delayed group, 75/164 (46%) used antibiotics, and 29% fewer used antibiotics in the clinical score group (risk ratio 0.71; 0.50 to 0.95; p = 0.018) and 27% fewer in the RADT group (0.73; 0.52 to 0.98; p = 0.033). No significant differences in complications or reconsultations were found. The clinical score group dominated both other groups for both the cost/quality-adjusted life-years and cost/change in symptom severity analyses, being both less costly and more effective, and cost-effectiveness acceptability curves indicated the clinical score to be the most likely to be cost-effective from an NHS perspective. Patients were positive about RADTs. Health professionals' concerns about test validity, the time the test took and medicalising self-limiting illness lessened after using the tests. For both RADTs and clinical scores, there were tensions with established clinical experience. Targeting antibiotics using a clinical score (FeverPAIN) efficiently improves symptoms and reduces antibiotic use. RADTs used in combination with FeverPAIN provide no clear advantages over FeverPAIN alone, and RADTs are unlikely to be incorporated into practice until health professionals' concerns are met and they have experience of using them. Clinical scores also face barriers related to clinicians' perceptions of their utility in the face of experience. This study has demonstrated the limitation of using one data set to develop a clinical score. FeverPAIN, derived from two data sets, appears to be valid and its use improves outcomes, but diagnostic studies to confirm the validity of FeverPAIN in other data sets and settings are needed. Experienced clinicians need to identify barriers to the use of clinical scoring methods. Implementation studies that address perceived barriers in the use of FeverPAIN are needed. Current Controlled Trials ISRCTN32027234. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 6. See the NIHR Journals Library website for further project information.
    01/2014; 18(6):1-102. DOI:10.3310/hta18060
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    ABSTRACT: Aims The aim of this study was to assess resource use and health-related quality of life (HRQoL) associated with clinical scores and RADTs and to show whether these can represent an efficient use of NHS resources. Methods A cost-effectiveness study (cost/change in symptom severity) and a cost-utility study [cost/quality-adjusted life-year (QALY)] were carried out as part of the randomised controlled trial. Resource use data were obtained from GP case notes and from study clinicians. QALYs were estimated by means of EQ5D scores obtained from the 14-day diary. Results The cost-effectiveness results presented are for FeverPAIN compared with control and RADT. In total, 498 individuals had both symptom severity and cost data from case notes review. Costs for the initial visit and for the 1-month follow-up were similar at 51 pound, 44 pound and 49 pound for the delayed prescribing, FeverPAIN and RADT groups, respectively. FeverPAIN dominated both other groups for the cost/change in symptom severity analyses, being both less costly and more effective. Cost-effectiveness acceptability curves (CEACs) indicated the clinical score group to be the most likely to be cost-effective. The cost-utility analysis showed considerable uncertainty around change in QALYs, but FeverPAIN appeared to be the most likely to be cost-effective, particularly for lower values of QALY. Conclusion FeverPAIN is a more efficient use of health-care resources than the other approaches.
    Health technology assessment (Winchester, England) 01/2014; 18(6):51-63. · 5.12 Impact Factor
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    Amanda Young · James Raftery · Louise Stanton · Andrew Cook
    Trials 11/2013; 14(1):P92. DOI:10.1186/1745-6215-14-S1-P92 · 2.12 Impact Factor
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    ABSTRACT: Objective To assess the association between features of acute sore throat and the growth of streptococci from culturing a throat swab. Design Diagnostic cohort. Setting UK general practices. Participants Patients aged 5 or over presenting with an acute sore throat. Patients were recruited for a second cohort (cohort 2, n=517) consecutively after the first (cohort 1, n=606) from similar practices. Main outcome Predictors of the presence of Lancefield A/C/G streptococci. Results The clinical score developed from cohort 1 had poor discrimination in cohort 2 (bootstrapped estimate of area under the receiver operator characteristic (ROC) curve (0.65), due to the poor validity of the individual items in the second data set. Variables significant in multivariate analysis in both cohorts were rapid attendance (prior duration 3 days or less; multivariate adjusted OR 1.92 cohort, 1.67 cohort 2); fever in the last 24 h (1.69, 2.40); and doctor assessment of severity (severely inflamed pharynx/tonsils (2.28, 2.29)). The absence of coryza or cough and purulent tonsils were significant in univariate analysis in both cohorts and in multivariate analysis in one cohort. A five-item score based on Fever, Purulence, Attend rapidly (3 days or less), severely Inflamed tonsils and No cough or coryza (FeverPAIN) had moderate predictive value (bootstrapped area under the ROC curve 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection (38% in cohort 1, 36% in cohort 2 scored ≤1, associated with a streptococcal percentage of 13% and 18%, respectively). A Centor score of ≤1 identified 23% and 26% of participants with streptococcal percentages of 10% and 28%, respectively. Conclusions Items widely used to help identify streptococcal sore throat may not be the most consistent. A modified clinical scoring system (FeverPAIN) which requires further validation may be clinically helpful in identifying individuals who are unlikely to have major pathogenic streptococci.
    BMJ Open 10/2013; 3(10):e003943-e003943. DOI:10.1136/bmjopen-2013-003943 · 2.06 Impact Factor
  • James Raftery
    Value in Health 07/2013; 16(5):699-700. DOI:10.1016/j.jval.2013.03.001 · 2.89 Impact Factor
  • Primary care respiratory journal: journal of the General Practice Airways Group 06/2013; 22(2):PS1-7. DOI:10.4104/pcrj.2013.00047

Publication Stats

3k Citations
770.21 Total Impact Points

Institutions

  • 2006–2015
    • University of Southampton
      • • Faculty of Medicine
      • • Academic Unit of Primary Care and Population Science
      • • Wessex Institute for Health Research and Development
      Southampton, England, United Kingdom
  • 2013
    • National Institute for Health Research
      • Evaluation, Trials and Studies Coordinating Centre (NETSCC)
      Londinium, England, United Kingdom
  • 1998–2005
    • University of Birmingham
      • • Department of Public Health, Epidemiology and Biostatistics
      • • Health Services Management Centre (HSMC)
      • • Department of Primary Care Clinical Sciences
      • • Department of Health Economics
      Birmingham, England, United Kingdom
  • 1999
    • The University of York
      • Centre for Health Economics
      York, ENG, United Kingdom
  • 1998–1999
    • CUNY Graduate Center
      New York City, New York, United States