Verteporfin photodynamic therapy for neovascular age-related ...

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112 Appendix 1• Additional clinical features: for treated patients, the database includes fields torecord additional details about the lesion.• Treatment details: the treating ophthalmologist must record the greatest lesiondiameter (GLD), any deviation from the standard protocol for treatment (asdefined in the TAP reports), and any adverse reaction during or just aftertreatment (see below).• Next scheduled visit: this should be recorded as one of the categories provided inthe drop-down list in the database (i.e. record as the category nearest to theactual time to the next visit).• ‘Signing off’ the data for a visit: the ophthalmologist responsible for the treatmentdecision on the visit must sign off the data entry, thereby taking responsibility forthe data for that visit for that patient.For additional details about background data collection, please see the databaseuser guide and the database itself, the recommended paper data collection sheetand notes on data collection (see Appendix 11). Information about how to completethe database fields required for the minimum dataset will be provided during on-sitetraining. Appendix 9 gives a description of site implementation and training.Quality of life (QoL) questionnaires (NEIVFQ, SF-36, Visual Independent LivingQuestionnaire; see also section 9.4 and 9.5):Completion of these questionnaires at the screening visit and every 6 months formspart of extended dataset. It is envisaged that patients will complete thesequestionnaires on paper during their visits, e.g. while waiting for tests or treatment.The lead clinician at a DP collecting the extended dataset must nominate anindividual or individuals who have (joint) responsibility for ensuring the questionnairesare completed, and for providing help in doing so if required. Funding to cover thetime spent helping patients to complete these questionnaires is included in thecontracts for DPs collecting the extended dataset. Details of the instructions topatients on how to complete these questionnaires are described in Appendix 10.The main clinical database includes forms for entering responses. Alternatively, DPscan copy the completed questionnaires and send them by secure means to the DataManagement Centre.Resource use questionnaire:
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6113Completion of this questionnaire at the screening visit and every 6 months also formspart of the extended dataset. The questionnaire must be administered and the leadclinician at a DP collecting the extended dataset must nominate an individual orindividuals who have responsibility for doing this. (As in the case of the QoLquestionnaires, funding to cover the cost of administration is included in the contractsof DPs collecting the extended dataset.)Details of the instructions to patients on how to complete this questionnaire aredescribed in Appendix 10. Note that questions 1 and 2 should not be completed atthe first administration. The database supplied to DPs includes data entry screens,linked to the main clinical database, for these questionnaires. Alternatively, DPs cancopy the completed questionnaires and send them by secure means to the DataManagement Centre.© 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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DOI: 10.3310/hta16060Health Technol
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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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22 Key changes to the protocolCentr
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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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32 Key changes to the protocolIn ad
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34 Key changes to the protocolsites
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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Page 80 and 81: 66 Discussion of resultsStrengths a
Page 82 and 83: 68 Discussion of resultsThe VPDT st
Page 84 and 85: 70 Discussion of resultsOur analyse
Page 86 and 87: 72 Discussion of resultsA further c
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 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 134 and 135: 120 Appendix 110.6 Sub-group analys
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 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
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Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
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166 Appendix 1Appendix 9:Site imple
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168 Appendix 1Option 2 - units inte
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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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