Verteporfin photodynamic therapy for neovascular age-related ...

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110 Appendix 1The Verteporfin Photodynamic Therapy Cohort Study For The United KingdomManual of Operations, version 1.0 20/01/12Figure 2 :Flow diagram showing patients’ pathways in the VPDT cohort study;dotted line indicates that patients re-enter the pathway at differentpoints, depending on schedule of visits (see Table 1)Patient referred fromPrimary CareOther NHSCentresNHS PDT CentresPrivate ClinicPatient Consented &Registered withVPDT StudyPrivate PDTClerk Recorddemographic and otherpatient detailsCarry out fluoresceinangiogramMeasure bestcorrected VA( logMAR )Also contrast sensitivityif extended dataset iscollectedAlso quality of lifeand resource usequestionnaires ifextended datasetis collectedOphthalmologistRecord clinical details required fordatabase formClassify status (and reasons) forboth eyesif one or both eyestreatedif observedif ineligible or NOCNVRecord treatmentdetails, enter visit dateas “baseline”Submit data to DMCBook follow - upappointmentReview at appropriatetimeDischarge from PDTclinicSubmit angiogram toCARF23
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6111• Contrast sensitivity (CS); CS need only be collected by DPs who have beennominated to collect the extended dataset. CS must be assessed using PelliRobson CS charts, with precise details of the letters seen/not seen on each linebeing recorded on the paper form supplied by the Data Management Centre. Theform should be retained and be placed in the patient’s notes. The protocol for CSassessment is described in Appendix 6. Note that it is essential to record thedate of assessment and the patient’s hospital number on the form. Details of thesupplier of Pelli-Robson CS charts can be found in Appendix 5.• Fluorescein angiography: details of the date and type of angiogram carried outmust be entered in the database. (As details are entered for one eye thedatabase automatically fills in same details for other eye.) The protocol forundertaking fluorescein angiography and colour photography is described inAppendix 7. Details of how to submit angiograms to the Angiographic ResourceFacility in Belfast are described in Appendix 8.• Eye status: at the first visit (and subsequent visits if an eye is not treated), theophthalmologist examining the patients must select one of four options: (a) noCNV, (b) ineligible, (c) observed, (d) treatment this visit. Additional information isrequested, depending on the eye status selected, e.g. reasons for ineligibility orobservation, lesion characteristics if treated. It is assumed that when the patientis undergoing the clinical examination that a fundus fluorescein angiogram,carried out in accordance with the protocol (see Appendix 7) will be available tohelp the clinician reach a decision on whether the lesion is eligible . To make thedecision about eligibility, the clinician will need to be familiar with theclassification of CNV (see Appendix 1 for an algorithm for classifying CNVlesions).• After an eye has been treated, on subsequent visits the eye status options forthat eye are restricted to (a) treated or (b) not treated. Note that eye status shouldbe chosen independently for right and left eyes so that, for example, a fellow eyecan become a treated eye at any time. Note also that the ‘clock’ describingmonths since baseline does not start ‘ticking’ until an eye is first treated. Fortreated eyes, the ophthalmologist must enter ‘months since baseline’ to indicatewhich the current visit is considered to be. For example, a follow-up visit maytake place 4 months (rather than exactly 3 months) after initial treatment; theophthalmologist should indicate that this represents the ‘3 month visit’ using themonths since baseline data field.© 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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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 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 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
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
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Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
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Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
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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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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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