Verteporfin photodynamic therapy for neovascular age-related ...

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26 Key changes to the protocolPlan of analysisThe objectives of the study were reformulated prior to analytical comparisons as described inChapter 2.A detailed description of our approach to derivation of new variables for the analyses from thedata collected and analysis plans to address each of the objectives of the study are described inthe ensuing sections. These data management decisions and analysis plans were established byexploring the accumulating data descriptively and before the key analytic comparisons werecarried out. Methods of fitting of final models could not be completely pre-specified, but evolvedprimarily to optimise the fit of the models given the limitations of the data set.Data analysis decisions and definitions of derived analysis variablesClose of data collection for the data analysesCentres were told in advance that recruitment to the study and documentation of study visitswould stop for the data analyses on 14 September 2007. An exception to this rule was made forcentres that did not submit their final data download on or after this date. For these centres, thecut-off date for calculating whether or not a patient had a completed treatment episode was thedate of the last data submission.Because the NICE guidance stated that patients with predominantly classic CNV lesions withsome occult CNV should be treated only in a research study, the VPDT cohort study was fundedto continue to collect data up to 31 March 2008. This allowed sites to continue to address datavalidation queries and missing data for visits that took place up to 14 September 2007. Datasubmitted for visits after 14 September 2007 were excluded from the analyses in this report. Fewnew patients were recruited, and few additional visits took place during this period for patientswho were already recruited, because new treatments, primarily drugs that inhibited vascularendothelial growth factor (VEGF), were supplanting VPDT (Figure 4).Definition of eligible patients and eligible eyesA patient was eligible for inclusion in the analysis if he/she had at least one eligible eye andhad consented to VPDT and to submission of his/her data to the study. Although eligibility fortreatment was also defined with respect to visual acuity and lesion composition (see Chapter 3,Participants), these criteria were not always adhered to (judged by BCVA data submitted by thesite and by independent grading of the baseline FA).An eye was defined as eligible for inclusion in the analysis if it had been treated with VPDT atleast once and had BCVA recorded at the first treatment visit and at least one follow-up visit. If apatient had had both eyes treated with VPDT, the first treated eye was included in preference tothe second because it was more likely to have longer follow-up, or to have a completed treatmentepisode, that is to be eligible for inclusion. If the first treated eye of a patient was ineligible, thesecond treated eye was included if it met the above criteria. If both eyes were treated at same timeand both were eligible, one eye was chosen at random. Some treated eyes with missing BCVAat baseline or no BCVA measurements after treatment could not contribute to the analysis andwere excluded. Untreated patients were excluded from all analyses, except the description of theoverall cohort.Definition of year 1 and year 2In order to compare the number of treatments administered in the VPDT cohort study with thenumber of treatments administered in the TAP trials, we needed to classify visits as occurring
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 627Number of patients(a)500450400350300250200UntreatedTreatedCumulative number of patients(b)15010050012,00011,00010,0009000800070006000500040003000200010000May 2004July 2004September 2004June 2004August 2004October 2004December 2004November 2004January 2005March 2005May 2005July 2005September 2005November 2005January 2006March 2006February 2005April 2005June 2005August 2005October 2005December 2005February 2006April 2006Calendar timeCalendar timeMay 2006July 2006September 2006November 2006January 2007March 2007May 2007June 2006August 2006October 2006December 2006February 2007April 2007June 2007August 2007October 2007December 2007July 2007September 2007November 2007February 2008April 2008June 2008January 2008March 2008May 2008FIGURE 4 Recruitment to the VPDT cohort study for the UK. (a) Monthly recruitment up to the end of June 2008.(b) Cumulative monthly recruitment up to the end of June 2008.UntreatedTreatedin year 1 or year 2 of follow-up. Cut-off dates for year 1 and year 2 were defined, respectively,as ≤ 350 days and > 350 and ≤ 715 days after the date of first treatment on the assumption thatscheduled visits would tend to slip over time, and were unlikely to occur at shorter time intervalsthan scheduled.© 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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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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88 References83. Margrain TH. Minim
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90 Appendix 1THE VERTEPORFIN PHOTOD
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92 Appendix 11. Overview of Manual
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94 Appendix 1And, if also collectin
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96 Appendix 1more patients in the v
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98 Appendix 12.4 Limitations of the
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100 Appendix 1Box 2 Key advantages
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102 Appendix 14. Study population4.
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104 Appendix 15. Recruitment to the
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106 Appendix 16. Background data co
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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112 Appendix 1• Additional clinic
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114 Appendix 18. Recording adverse
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116 Appendix 1level of benefit from
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118 Appendix 1• comparison of num
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120 Appendix 110.6 Sub-group analys
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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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126 Appendix 114. References[1] Ref
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128 Appendix 1Barnes RM, Gee L, Tay
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130 Appendix 1Appendix 1: Classifyi
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132 Appendix 1Liverpool re-treatmen
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134 Appendix 1Service StructurePlea
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136 Appendix 1Has your photographer
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138 Appendix 1There are many differ
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140 Appendix 1testing on vision tes
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144 Appendix 1College of Ophthalmol
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146 Appendix 1Appendix 5:Protocol f
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148 Appendix 16.2 Subjective Refrac
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152 Appendix 1Appendix 6:Protocol f
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154 Appendix 18. It is customary to
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170 Appendix 1Dos and Don’tsDosDo
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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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