Verteporfin photodynamic therapy for neovascular age-related ...

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120 Appendix 110.6 Sub-group analysesThe effectiveness and cost-effectiveness will be compared between different CNVsub-types, with sub-types defined as in Appendix 1, using data from the assessmentscarried out by the angiogram reading DPs. Variations in effectiveness will also beinvestigated for sub-types defined by the ophthalmologist at the time of treatment,and for the individual lesion components on which the definitions are based. Othersub-group analyses have not yet been formulated. The Steering Committee iscommitted to approving a detailed analysis plan, in advance of carrying out anytreatment-related analyses, to ensure that sub-group analyses can be clearlydistinguished as a priori or post-hoc.10.7 Interim analysesSerious adverse effects of PDT are not anticipated, since none have been identifiedin trials of PDT that have been carried out to-date. Given the circumstances in whichit has been commissioned, the VPDT cohort study is also very unlikely to haltrecruitment early. Therefore, no interim analyses are planned. Other aspects of dataand safety monitoring are discussed below (see 13.2).
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 612111. Documentation and use of study findings11.1 DocumentationRegular descriptive summaries of the progress of the project will provide on-goingdocumentation (see 10.2). All minutes of the Steering Committee, updates to thisprotocol, and progress reports to the NCCHTA, will be carefully archived.Details of arrangements for final reporting of the study findings have not yet beenfinalised, but will need to take into account the need for NICE to be able to review thefindings in time for its review of PDT. Whatever arrangements are agreed for finalreporting, it is envisaged that the study findings will be presented at appropriateconferences and written up for publication in peer-reviewed journals (see 11.2).11.2 Publication / dissemination policyInvestigators and lead contacts from all DPs will form the “Verteporfin PhotodynamicTherapy Cohort Study” group. Publications will be authored by a “writing committee”on behalf of this group. All group members will be listed and acknowledged on theRCOphth website and in all publications or journal websites, subject to the conditionsfor publishing in specific journals.© 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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24 Key changes to the protocolADVER
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26 Key changes to the protocolPlan
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28 Key changes to the protocolClass
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30 Key changes to the protocolFor i
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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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
Page 112 and 113: 98 Appendix 12.4 Limitations of the
Page 114 and 115: 100 Appendix 1Box 2 Key advantages
Page 116 and 117: 102 Appendix 14. Study population4.
Page 118 and 119: 104 Appendix 15. Recruitment to the
Page 120 and 121: 106 Appendix 16. Background data co
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
Page 132 and 133: 118 Appendix 1• comparison of num
Page 136 and 137: 122 Appendix 112. Data issues12.1 D
Page 138 and 139: 124 Appendix 113. Organisation13.1
Page 140 and 141: 126 Appendix 114. References[1] Ref
Page 142 and 143: 128 Appendix 1Barnes RM, Gee L, Tay
Page 144 and 145: 130 Appendix 1Appendix 1: Classifyi
Page 146 and 147: 132 Appendix 1Liverpool re-treatmen
Page 148 and 149: 134 Appendix 1Service StructurePlea
Page 150 and 151: 136 Appendix 1Has your photographer
Page 152 and 153: 138 Appendix 1There are many differ
Page 154 and 155: 140 Appendix 1testing on vision tes
Page 156 and 157: 142 Appendix 1something to do with
Page 158 and 159: 144 Appendix 1College of Ophthalmol
Page 160 and 161: 146 Appendix 1Appendix 5:Protocol f
Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
Page 164 and 165: 150 Appendix 1• The patient shoul
Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
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170 Appendix 1Dos and Don’tsDosDo
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172 Appendix 1Resource use question
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174 Appendix 1Appendix 11: Recommen
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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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