Verteporfin photodynamic therapy for neovascular age-related ...

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24 Key changes to the protocolADVERSE REACTION AND EVENT FORMCentre Code______ Surname_________________ Date of Birth__/__/__/Part 1: Adverse reaction during or just after treatment(Tick and add details if necessary)Date of Treatment__/__/__/□ Back pain during infusion □ mild □ moderate □ severetime of onset _________________ (minutes since infusion start)further details_____________________________________________□ Pain at the injection site further details_____________________________________________□ Extravasations at injection site further details_____________________________________________□ Other events detailsfurther details_____________________________________________Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___IReaction attributable toVisudyne treatment?□ definitely; □ probably; □ possibly; □ no (tick one only)Part 2: Adverse event since last visit(Tick and add details if necessary)Date of last treatment□ Transient visual loss□ Loss of ≥ 20 letters□ RPE tear□ Haemorrhage□ Photosensitivity□ OtherEvent attributable to Visudynetreatment?__/__/__/Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___IOnset within 7 days of treatment / last visit? Y / NWas deterioration?Sudden / Gradualfurther details____________________________________________further details____________________________________________further details____________________________________________Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___Ifurther details____________________________________________Date of onset I___I___I / I___I___I / I___I___IDate of resolution I___I___I / I___I___I / I___I___I□ definitely; □ probably; □ possibly; □ no (tick one only)Ophthalmologist _________________________ Signature __________________________FIGURE 3 Paper data collection forms recommended by the data management centre. (continued)
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 625overcome inadequacies in local computer networks or the refusal to install the database at somesites. In two cases the database could be installed only on a stand-alone personal computerwith no network/internet connection. Other obstacles which made networking the databasedifficult included a virtual private network at one clinic, a complex arrangement of virtualservers at another, specialist optometry software which altered the configuration of dates andan unwillingness to install the software which the database required to operate. These caseshighlighted that the hardware infrastructure at clinics was far from standard.Centres generated a data report by executing a standard query on their local database andsubmitted the data periodically to the co-ordinating centre by the secure internet link, exceptfor the two sites without an internet connection which submitted data by computer disk sent byregistered post. The co-ordinating centre implemented data validation checks and sent back dataqueries to sites centres, as originally planned (see Chapter 3, Data collection and management).Collection of health-related quality-of-life dataThe protocol specified that participants should complete HRQoL questionnaires in large-printversions at baseline and every 6 months thereafter. An assisted self-administration approach wasspecified, described in detail in the manual of operations. Some centres were unable to follow thisapproach because of a lack of resources. Therefore, it was agreed that selected patients who hadsufficiently good vision to read the questions and who, for example, had already completed a setof questionnaires using the assisted self-administration method could be given the questionnairesto complete at home and return by post.BiasAttrition was very much worse than expected in that many patients were not followed up asdescribed in the protocol. Consequently, we were required to rethink the approach to the analysisplan (see Chapter 3, Plan of analysis). The revised analysis plan allowed us to include data for allof the observation time/documented visits in the analysis plan, irrespective of compliance withthe schedule, but did not address the risk of attrition bias/informative censoring.Sample size considerationsThe sample size considerations remained the same as described in Chapter 3, Sample sizeconsiderations. However, we originally expected the study to document VPDT in about 20,000–25,000 patients over 3 years. Although the rate of recruitment increased substantially over thecourse of the study, it was quickly apparent that the difficulties in ensuring that DHs participatedwould mean that the actual sample recruited would be considerably smaller.Detailed consideration of possible biases also led us to decide to exclude from the main analysesof BCVA patients who were within 1 year of their first treatment, unless their treatment episodeswere completed (see Plan of analysis). We used this strategy because the TAP trials reported1-year outcome and suggested that outcomes continue to improve with repeated treatment upto 1 year.Despite these limitations, the study still had considerable precision (greater than in the TAPtrials) when estimating treatment outcomes after 1 year by virtue of the continuously scaledoutcomes of BCVA and HRQoL and their repeated measurement over time in the study.These attributes of the outcomes contrast with primary outcome in the TAP trials, namely thepercentage of patients losing > 15 ETDRS letters at a particular time point.© 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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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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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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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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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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152 Appendix 1Appendix 6:Protocol f
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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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FeedbackThe HTA programme and the a
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