Verteporfin photodynamic therapy for neovascular age-related ...
Verteporfin photodynamic therapy for neovascular age-related ... Verteporfin photodynamic therapy for neovascular age-related ...
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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- 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
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- Page 116 and 117: 102 Appendix 14. Study population4.
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- Page 124 and 125: 110 Appendix 1The Verteporfin Photo
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- Page 138 and 139: 124 Appendix 113. Organisation13.1
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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 <strong>for</strong> sub-types defined by the ophthalmologist at the time of treatment,and <strong>for</strong> the individual lesion components on which the definitions are based. Othersub-group analyses have not yet been <strong>for</strong>mulated. The Steering Committee iscommitted to approving a detailed analysis plan, in advance of carrying out anytreatment-<strong>related</strong> 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. There<strong>for</strong>e, no interim analyses are planned. Other aspects of dataand safety monitoring are discussed below (see 13.2).
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