Verteporfin photodynamic therapy for neovascular age-related ...

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122 Appendix 112. Data issues12.1 Data protectionThe Data Management Centre has registered the study with the Data ProtectionOfficer at the London School of Hygiene and Tropical Medicine.12.2 Data confidentialityAll data will be treated as confidential. Information to identify patients is required inorder to link study participants with the National NHS Register. Making this link isrequired to identify promptly patients who have died, or who have moved. Identifyingpatients who move into residential accommodation is of particular importancebecause of the societal costs of these changes in circumstances.12.3 Data securityDPs are responsible for holding their own database securely. However, it should benoted that DPs are not holding any more information than they would hold anyway,for the purposes of managing and treating their patients efficiently.The Steering Committee are extremely aware of the sensitivity about transmittingidentifiable patient data outside the NHS. Two methods of data transmission arebeing used.First, submission of data from the Strategen database generates two passwordprotected and encrypted files. One contains clinical and treatment data and anarbitrary identifying code, generated by the database. A second file contains patients’names and addresses, genders, dates of birth, hospital numbers, arbitrary consultantand DP codes, but no clinical data. The first file is transmitted to Strategen, thecompany that administers the clinical database, so that the company cantroubleshoot any problems with the database that DPs experience. These data aresubsequently transmitted to the Data Management Centre. The second file istransmitted directly to the Data Management Centre. The Data Management Centrewill transmit sufficient identifying information about patients, but no clinical data, tothe Office of National Statistics to allow the patients to be identified on the NationalNHS Register.Second, a revised ‘LSHTM’ database is being implemented which allows submissionof data using SSL, the gold standard method for secure transmission which isapproved by the NHS Information Authority. From this database, all data are
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6123submitted directly to the Data Management Centre, avoiding the need for data to berouted via a third party.Data reports from the Data Management Centre to DPs are usually sent by email aspassword protected electronic documents. DPs can request paper copies if required.All data held by the Data Management Centre will be stored on a secure institutionalnetwork, in accordance with the policy on data security of the London School ofHygiene and Tropical Medicine.12.4 Data ownershipThe entire cohort study dataset will be under the guardianship of the SteeringCommittee. For the duration of the study, the dataset will be held and maintained atthe Data Management Centre, London School of Hygiene and Tropical Medicine.All data for a particular DP can be made available to the originating DP (formattedand cleaned) at the end of the study. Summaries of data will be fed back to DPsregularly (see 10.2) during the study, for local review. Requests for additionalstatistics in regular reports, and secondary analyses of the whole dataset, will beconsidered by the Steering Committee. Requests for all data for a DP during thestudy will also be considered by the Steering Committee, but will need to justify thespecial circumstances that make this necessary because of the potentially timeconsumingnature of satisfying such one-off requests.The dataset will be archived securely at the end of the study and any requests foraccess or further analysis will be considered by the Steering Committee, or by askeleton committee after the disbandment of the existing Steering Committee toconsist of one of the investigators, a separate representative of the Royal College ofOphthalmologists, and one other member of the original Steering Committee whohas no day-to-day involvement with the study.© 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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30 Key changes to the protocolFor i
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38 Results (1) - study cohortTABLE
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46 Results (2) - objectives A, B, C
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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70 Discussion of resultsOur analyse
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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 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 138 and 139: 124 Appendix 113. Organisation13.1
Page 140 and 141: 126 Appendix 114. References[1] Ref
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
Page 160 and 161: 146 Appendix 1Appendix 5:Protocol f
Page 162 and 163: 148 Appendix 16.2 Subjective Refrac
Page 164 and 165: 150 Appendix 1• The patient shoul
Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
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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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