Verteporfin photodynamic therapy for neovascular age-related ...

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116 Appendix 1level of benefit from treatment. The proposed study will measure both SRVF(NEIVFQ [4]) and generic QoL (SF-36 [5]). Defining the relationships betweenchanges in clinical measures of vision and SRVF/QoL is a specified secondaryobjective of the study, allowing the average reduction in QoL experienced by AMDpatients per unit of MDVA or CS lost to be estimated. Questionnaires will beadministered 6 monthly.9.5 Resource useAs described above, a questionnaire will be administered to patients every 6 months(as part of the extended dataset) to ask patients about the costs and consequencesto them of having the treatment and about their use of resources in other agencies(e.g. GP, district nurse) relating to the intervention. Treatment resources used will beidentified from the number of treatments given (documented in the database) andfrom observation of the resources used in providing treatment in a number of DPs.When measuring the total costs of the intervention, the resources used in providingthe intervention will be recorded separately from the unit costs. The review performedfor the NICE appraisal found that cost-utility estimates for PDT could be influencedby the number of treatments and that the same benefits as found in the existing trialsof PDT might be achieved at lower costs. In particular, the frequency of re-treatmentin routine practice, which may be a key component of costs, may differ from a clinicaltrials setting. The review also suggested additional resources might be needed toimplement the intervention at each DP which have been ignored in previous costutility analyses. The resources used in setting up the service will be recorded by sitevisitsto several of the DPs, chosen to reflect differences in clinical practice. Inaddition to the costs of providing the intervention to the health service, the resourcesused by patients and their carers in accessing the service will be recorded andcompared indirectly with the resource use for untreated patients (see 10.4).9.6 Morphological changes in lesionsThese secondary outcomes will be estimated from angiographic evidence of changein total lesion size, total CNV leakage, classic leakage and fibrosis. Note, theseparameters will be used for analysis and should not be confused with the lesionfeatures that determine eligibility and re-treatment (see section 4).
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 611710. Statistical issues10.1 Sample size considerationsThe study population size is the number of patients recruited during the study period.Uncertainties, e.g. about the proportion of ineligible patients identified, theproportions of eligible patients categorised as having different CNV sub-types, andthe precise ways in which control data will be modelled, make it difficult to provide aclear sample size calculation. However, for illustrative purposes, we have considereda simple comparison of a continuously scaled outcome, i.e. MDVA, between twosubgroups of patients with different types of CNV lesions [6]. The followingassumptions have been made for this illustration: (a) equal sample sizes for the twogroups, (b) analysis adjusted for baseline MDVA, (c) SD of changes in MDVA = 0.1logMAR, (d) 2-tailed significance level of 0.01, (e) power = 0.95. Such a comparisonwould require only about 50 subjects in each group to detect a difference of 0.1logMAR in the mean change between groups. Other outcomes may have a largerSD, and groups may not have equal sample sizes. A comparison for a continuouslyscaled outcome with SD=0.3, and two groups with sample sizes as unequal as 4:1,would require a total of about 1200 (960:240). These simple illustrations do not takeinto account the added strength from the longitudinal nature of the data, but also donot consider dependencies between patients treated by the same retinal teams.10.2 Descriptive statistical analysesMonthly reports will be generated for the Steering Committee for monitoringpurposes. Similar information, tabulated by DP providing PDT, will be produced forcommissioners and DPs. Each DP will receive patient specific information for its ownservice.Details of the information that will be provided in reports has not been finalised, andadditional information may be added as the study progresses. However, the followingitems are illustrative of the information that will be distributed:• number of subjects for whom data have been submitted and recruitment ratesover time;• number of subjects considered for PDT and treated, by CNV category;• demographic and baseline data;• details of treatments provided;© 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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38 Results (1) - study cohortTABLE
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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 126 and 127: 112 Appendix 1• Additional clinic
Page 128 and 129: 114 Appendix 18. Recording adverse
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
Page 140 and 141: 126 Appendix 114. References[1] Ref
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
Page 160 and 161: 146 Appendix 1Appendix 5:Protocol f
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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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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