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Verteporfin photodynamic therapy for neovascular age-related ...

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DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 65Chapter 2Aims and objectivesThe overarching aim of the VPDT cohort study was to broaden the understanding of thepathogenesis of CNV and its treatment with VPDT through a longitudinal analysis ofoutcomes in patients undergoing VPDT <strong>for</strong> CNV.The a priori objectives of the study were set out in the manual of operations (see Appendix 1).These were:1. to estimate the prevalence and incidence of patients with CNV being referred <strong>photodynamic</strong><strong>therapy</strong> (PDT) who meet the eligibility criteria <strong>for</strong> treatment2. to describe the clinical man<strong>age</strong>ment of patients with CNV being referred <strong>for</strong> VPDT whomeet the eligibility criteria <strong>for</strong> treatment3. to characterise changes over time in clinical outcomes, self-reported visual functioning(SRVF), generic quality of life and the societal costs of illness in patients receiving VPDTwho meet the eligibility criteria <strong>for</strong> treatment4. to describe the relationship between clinical outcomes, SRVF and HRQoL5. to estimate incremental cost-effectiveness, cost–utility and cost impact on the NHS (usingdata estimated <strong>for</strong> objectives 1–4 of implementing VPDT in the NHS <strong>for</strong> patients who meetthe eligibility criteria <strong>for</strong> treatment.During the first year of the project and following review of progress by the Health TechnologyAssessment programme, but be<strong>for</strong>e any analyses of data collected in the study, theseobjectives were updated to characterise better the uncertainties experienced by the NICEappraisal committee:(a) Is VPDT in the NHS provided as in randomised trials?(b) Is ‘outcome’ the same in the NHS as in randomised trials?(c) Is ‘outcome’ the same <strong>for</strong> patients who would have been ineligible <strong>for</strong> randomised trials?(d) Is VPDT safe when provided in the NHS?(e) How effective and cost-effective is VPDT?These objectives will be referred to in sequence in the rest of the report.© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State <strong>for</strong> Health.

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