Verteporfin photodynamic therapy for neovascular age-related ...
Verteporfin photodynamic therapy for neovascular age-related ... Verteporfin photodynamic therapy for neovascular age-related ...
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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- 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
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- 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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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 <strong>for</strong>m supplied by the Data Man<strong>age</strong>ment Centre. The<strong>for</strong>m should be retained and be placed in the patient’s notes. The protocol <strong>for</strong> CSassessment is described in Appendix 6. Note that it is essential to record thedate of assessment and the patient’s hospital number on the <strong>for</strong>m. 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 <strong>for</strong> one eye thedatabase automatically fills in same details <strong>for</strong> other eye.) The protocol <strong>for</strong>undertaking 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 in<strong>for</strong>mation isrequested, depending on the eye status selected, e.g. reasons <strong>for</strong> 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 <strong>for</strong> an algorithm <strong>for</strong> classifying CNVlesions).• After an eye has been treated, on subsequent visits the eye status options <strong>for</strong>that eye are restricted to (a) treated or (b) not treated. Note that eye status shouldbe chosen independently <strong>for</strong> right and left eyes so that, <strong>for</strong> 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 <strong>for</strong> Health.