Verteporfin photodynamic therapy for neovascular age-related ...

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100 Appendix 1Box 2 Key advantages of the VPDT cohort study• The study provides a pioneering framework within which the introduction of anew technology is managed and evaluated.• The study will address the gaps in knowledge about cost-effectiveness andoptimal treatment regimens for patients with predominantly classic CNV withoccult (NICE paragraph 1.2) and patients with classic CNV without occult (NICEparagraph 1.1).• We will learn more about the effectiveness of PDT for the treatment of CNVresulting from non-AMD causes of CNV• The VPDT cohort study also provides a means to quality assure clinical practicethrough standardised training and feedback.3.2 Objectives of the VPDT cohort study1. To estimate the prevalence and incidence of patients with CNV being referred forPDT and who meet the eligibility criteria for treatment.2. To describe the clinical management of patients with CNV being referred for PDTand who meet eligibility criteria for treatment.3. To characterise changes over time in clinical outcomes, self-reported visualfunctioning (SRVF), generic quality of life (QoL) and the societal costs of illness inpatients receiving PDT and who meet eligibility criteria for treatment.4. To describe the relationship between clinical outcomes, SRVF and health-relatedQoL.5. To estimate incremental cost-effectiveness, cost-utility and cost impact on theNHS (using data estimated for objectives 1-4) of implementing PDT in the NHSfor patients who meet eligibility criteria for treatment.3.3 General Study DesignThe VPDT study is a cohort study of the outcomes of treatment with PDT. It willcollect standardised and robust clinical information on patients undergoing verteporfinphotodynamic therapy within the UK. The diagram showing the overview of the studyis shown in Figure 1. Brief and relevant medical and lifestyle history will be recorded.Tests will include measures of vision, fundus photography and angiography and
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6101patients will be asked to complete a set of questionnaires at specified clinic visits.Entering all patients treated with PDT in to the study is crucial to the success of theCohort Study.Direct comparisons of outcome will be made within the cohort, e.g. between subgroupsof patients with different lesion characteristics or aetiologies. However, it isalso important to estimate the effectiveness and cost-effectiveness of treatment withPDT, in everyday practice, compared with no treatment. The cohort study does notinclude untreated patients (other than documenting ineligible patients at baseline).Therefore, these overall effects of treatment will be estimated indirectly (see 10.4).3.4 Study durationThe study will last a minimum of 3 years and data will be collected longitudinally forall subjects recruited into the study during this period. The period of data collectionmay be extended if recommended by NICE and/or Department of Health.© 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 for Health.
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xExecutive summaryretreat on criter
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xiiExecutive summaryof data, with i
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2 Introductionon-going or new clini
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4 Introductionof VPDT in routine cl
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20 Key changes to the protocolThese
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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48 Results (2) - objectives A, B, C
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Page 80 and 81: 66 Discussion of resultsStrengths a
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Page 84 and 85: 70 Discussion of resultsOur analyse
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Page 88 and 89: 74 Discussion of resultsVPDT. It is
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Page 98 and 99: 84 References16. Stelmack J. Qualit
Page 100 and 101: 86 References49. Guymer RH, Chiu AW
Page 102 and 103: 88 References83. Margrain TH. Minim
Page 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
Page 106 and 107: 92 Appendix 11. Overview of Manual
Page 108 and 109: 94 Appendix 1And, if also collectin
Page 110 and 111: 96 Appendix 1more patients in the v
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Page 116 and 117: 102 Appendix 14. Study population4.
Page 118 and 119: 104 Appendix 15. Recruitment to the
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Page 122 and 123: 108 Appendix 1Table 1: Schedule of
Page 124 and 125: 110 Appendix 1The Verteporfin Photo
Page 126 and 127: 112 Appendix 1• Additional clinic
Page 128 and 129: 114 Appendix 18. Recording adverse
Page 130 and 131: 116 Appendix 1level of benefit from
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Page 136 and 137: 122 Appendix 112. Data issues12.1 D
Page 138 and 139: 124 Appendix 113. Organisation13.1
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Page 142 and 143: 128 Appendix 1Barnes RM, Gee L, Tay
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Page 150 and 151: 136 Appendix 1Has your photographer
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166 Appendix 1Appendix 9:Site imple
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176 Appendix 1ADVERSE REACTION AND
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178 Appendix 1acute Trust; note tha
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180 Appendix 1Ophthalmologistrespon
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192 Appendix 3manufacturer’s pers
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FeedbackThe HTA programme and the a
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