Verteporfin photodynamic therapy for neovascular age-related ...

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180 Appendix 1Ophthalmologistresponsible fortreatment decisionsSignatureanother visit at the expected time. It also allows us tocheck for people who may have died or have been lost tofollow-up.The name of the ophthalmologist responsible for thetreatment decisions on the visit being recorded must bedocumented for all visits, not just visits on which patientsare treated.The ophthalmologist responsible must sign thecompleted form.NOTES FOR ADVERSE REACTION / EVENT FORMCentre codePatient’s surnameDate of birthPart 1 Adverse reactionBack pain during infusionPain at site of injectionExtravasation at injectionsiteOther eventsAdverse reaction attributableto Visudyne treatment?Please ensure this information is recorded – so thatreactions/events can be reliably linked to otherclinical information for the same patientPlease ensure this information is recorded – so thatreactions/events can be reliably linked to otherclinical information for the same patientPlease ensure this information is recorded – so thatreactions/events can be reliably linked to otherclinical information for the same patientComplete if a patient experiences an adversereaction before leaving hospitalTick the left hand box if patient reports back pain.Based on patient report, classify as mild, moderateor severe. Record how long (in minutes) after thestart of the infusion the back pain was reported.Write down any further relevant detailsTick the left hand box if patient reports pain at thesite of injection. Write down any further relevantdetailsTick the left hand box if extravasation occurs at thesite of injection. Write down any further relevantdetailsTick the left hand box if patient reports any otheradverse reaction, or if the doctor attending thepatient notices any adverse signs. Write down anyfurther relevant detailsFor all adverse reactions, the doctor attending thepatient must indicate whether the adverse reactionwas definitely, probably, possibly, or not attributableto the visudyne treatment. Use the text field,details of other of adverse reaction, to attribute anadverse reaction to some other part of the process ofhaving PDT, e.g. reaction to fluorescein, etc.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6181Part 2 Adverse event since lastvisitTransient visual lossLoss of VA ≥20 letters in thetreated eyeRPE tearHaemorrhagePhotosensitivityOtherAdverse event attributable toVisudyne treatment?Complete if a patient experienced an adverseevent between leaving hospital after the previousvisit and returning for the current visit. Notecarefully whether loss of VA ≥20 letters hasoccurred. Ask the patient about possible adverseevents (i.e. transient visual loss, details of VA loss≥20 letters, photosensitivity, other events).Ask the patient if he/she noticed a transient loss ofvision following the previous visit. If yes, tick the lefthand box, and record dates of onset and resolution (towithin 1-2 days).Check carefully whether the VA has deteriorated by≥20 letters in the treated eye. If yes, tick the left handbox, and ask the patient whether the deteriorationoccurred within one week (yes or no), and whetherthe deterioration was sudden or gradual (one of theseoptions must be ticked). Write down any furtherrelevant details.Check whether a RPE tear developed followingtreatment. If yes, tick the left hand box, and recorddates of onset and resolution (to within 1-2 days).Check whether a RPE tear developed followingtreatment. If yes, tick the left hand box, and writedown any further relevant details.Ask the patient whether he/she noticedphotosensitivity following treatment. If yes, tick theleft hand box, and record dates of onset andresolution (to within 1-2 days).Ask the patient if he/she has noticed any other visionproblem since the previous visit. Tick left hand box ifpatient reports some other adverse event, or if thedoctor attending the patient notices any adversesigns. Write down any further relevant detailsFor all adverse events, the doctor attending thepatient must indicate whether the adverse reactionwas definitely, probably, possibly, or not attributable tothe visudyne treatment. Use the text field, details ofother adverse event, to attribute an adverse event tosome other part of the process of having PDT.© 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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DOI: 10.3310/hta16060Health Technol
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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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28 Key changes to the protocolClass
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30 Key changes to the protocolFor i
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32 Key changes to the protocolIn ad
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34 Key changes to the protocolsites
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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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72 Discussion of resultsA further c
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74 Discussion of resultsVPDT. It is
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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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