Verteporfin photodynamic therapy for neovascular age-related ...

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92 Appendix 11. Overview of Manual of Operations for the VPDT CohortStudy1.1 Content of the Manual of OperationsThis manual of operations has been written as a handbook for designated providers(DPs) registered with the VPDT Cohort Study. It should be read in conjunction withthe user guide for the data transfer software and, if appropriate, the data entry forms.It includes protocols / instructions for:• standardised methods for undertaking visual assessments,• undertaking fundus photography and angiography,• angiographic definitions,• angiogram submission,• eligibility criteria for treatment based on NICE guidance,• guidelines for assessments at follow-up and re-treatment decision-making,• treatment delivery.We expect that it will be necessary to clarify some aspects of this manual as thestudy proceeds, because of the difficulty of anticipating all eventualities at the outset.Modifications of the manual will be circulated to all contacts at registered DPs. Themost up-to-date version of the manual will also be available through the website forthe study:http://www.lshtm.ac.uk/hsru/vpdt1.2 Changes made in this revision1. The Overview section has been revised to include this sub-section, itemising therevisions changes since the last version, and a quick reference sub-section.2. The term “treating centre” has been changed to “designated provider” (DP)throughout, to highlight that centres providing PDT have been designated byLocal Specialist Commissioners.3. Section 4.1: revised to clarify (a) that patients should be consented immediatelywhen they attend the PDT clinic, i.e. irrespective of whether subsequently foundto be eligible or not, (b) that data for patients ineligible for PDT should be entered
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 693into the database and submitted to the Data Management Centre (DMC) and (c)the distinction between partial and full consent.4. Section 5.5: revised to provide more explicit guidance on data collection.5. Section 6: revised to clarify that, in DPs collecting the extended dataset, patientsshould complete/have administered quality of life and resource usequestionnaires at the first visit (except for questions 1 and 2 of the resource usequestionnaire).6. Section 7: revised to include a reminder that the DMC provides duplicate forms forcollecting raw monocular distance visual acuity data and that, for every patientevery 3 months, one copy of this form should be returned to the DMC.7. Section 12: revised to include a description of data transmission for DPs who usethe revised LSHTM clinical database.8. Appendix 3: revised registration form (contact details)9. Appendix 4: revised patient information sheet10. Appendix 5: inclusion of details about measuring binocular VA; details of suppliersof ETDRS and Pelli-Robson charts have been added.11. Appendix 8: revised contact details for the Central Angiographic Resource Facility12. Appendix 10: revised instructions for the resource use questionnaire.13. Appendix 11: recommended paper datasheet and notes on data collection.1.3 Quick reference guideThis section aims to summarise what designated providers are required to do.At first ‘screening’ visit:Collect the following data on all screened patients that give full or partial consent,irrespective of whether they are treated or not:(a) Informed consent (p. 19)(b) Clinical history (p.21)(c) Binocular presenting distance visual acuity (BDVA, p.21)(d) Refraction (p. 21)(e) Monocular distance visual acuity (MDVA, p.21)(f) Ophthalmic examination (p.20)(g) Stereo colour photography and angiography (p.22)© 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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30 Key changes to the protocolFor i
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38 Results (1) - study cohortTABLE
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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 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
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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
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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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144 Appendix 1College of Ophthalmol
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146 Appendix 1Appendix 5:Protocol f
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166 Appendix 1Appendix 9:Site imple
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192 Appendix 3manufacturer’s pers
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FeedbackThe HTA programme and the a
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