Verteporfin photodynamic therapy for neovascular age-related ...

More documents

Recommendations

Info

174 Appendix 1Appendix 11: Recommended paper data collection forms andnotes about data collectionThese forms are available from the Data Management Centre as a pdf file.Centre code _____ VPDT DATASHEET version 2.11. Patient detailsa. Named. Hospital numberf. PCTh. Addressb. DOB ___ / ___ / ___ c. Gender M / Fe. NHS numberg. Phone numberPostcode2. Referral Details – NEW PATIENT ONLY (all ‘screened’ patients, irrespective ofwhether subsequently treated or not)a. Primary care (optometrist/GP) referral date ___ / ___ / ____ (dd/mm/yy) o tick if approximateb. Ophthalmologist referral date ___ / ___ / ____ (dd/mm/yy) o tick if approximatec. Referring hosp: First PDT centre:d. Diagnosis at referral (tick one box only) e. Smoking historyo Suspected CNVo Nevero Predominantly classic CNV o Current: Number of years smoked yrso Classic CNV o Ex-smoker: Number of years smoked yrso Other Yrs/mths since last smoked yrs mthsf . Other health-related informationg. ImagingY / N Cardiovascular disease o None o OCT onlyY / N Use of statins o ICG only o BothY / N Family historyh. Consultant name: i. Consent: o Full o Partial o Noj. Duration of symptomsk. VA at referral (Snellen)l. Number of previoustreatments for CNV(enter 0 if none)m. Cataract surgery (inc date)R weeks LR ____ / ________ / ____ LR laser photocoagulation LR PDT LR Intravenous drug injection LR PHA /ECC /NONE ___ /___/ ___ ___/ ___/ ___ PHA / ECC / NONE L3. Visit details (every visit)a. Date ___ / ___ / ___ b. Type of visit: o Interim o Scheduledc. Number of missed appoints since last visit Reason4. Assessment (every visit)a. Binocular logMAR VAb. Mths since first treatedc. LogMAR VA RL o refracted this visitd. Contrast sensitivityR (1.5, 3, 4.5, 6, 9, 12, 15, 18, etc.) LRe. Date of VA test: o this visit o = 1 week ago o > 1 week ago, ___/ ___/ ___f. Angiogram type: o film o digital o SLOg. Date of angiogram: o this visit o = 1 week ago o > 1 week ago, ___/ ___/ ___Page 1L
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 61755. Eye statusTick ONE status only (and related options) foreach eye on each visitRIGHT EYELEFT EYEa.b.c.o No CNV oIf no CNV and VA0.4 logMAR),please indicate reason for reduced VA:o AMD oo Amblyopia oo Other oo Ineligible oPlease indicate main reason(s) for beingineligible, and related options:i. o Vision below minimum standard oDelay (weeks)Reasons for delayii.iii.o Ineligible because of lesion ocharacteristicso Minimally classic with occult oo Occult / no classic oo Lesion too large oo Lesion >50% blood oo Lesion inactive oo No SRF oo No blood oo No exudates oo Lesion fibrosed oo Stable vision oiv. o Other (specify below) oo Observed oReason for observation:o No recent drop in VA oo Borderline lesion charact’cs oo 50% haemorrhage oo Bilateral CNV, treat next visit oo Other od. o Treated at this visit oe. o Previously treated but onot at this visit8. Adverse effects of treatmentAdverse event since last visit:o Y o NAdverse reaction during this treatment: o Y o NIf yes to either, FILL IN an adverse events form6. Lesion characteristicsOnly required for treated eye at the time of theFIRST treatmentRIGHT EYELEFT EYEa. Aetiology (tick one item only)o AMD oo AMD recurrence after laser oo Pathological myopia oo Juxtapapillary oo Angioid streak oo Idiopathic oo PIC/POHS oo Uveitis oo RAP oo IPCV oo Other (specify) ob. AMD characteristics (tick one only)o Classic / no occult oo Predominantly classic oo Minimally classic with no occult oo Occult / no classic oLocation of lesion (tick one only):o Subfoveal oo Juxtafoveal o7. Features of treated eyea. Required for ALL VISITSb.& c. Only required if treated at this visita. Additional features (tick all that apply)o Symptomatic drop in VA oo Angiographic leakage oo Subretinal fluid (any) oo Subretinal fluid (at centre) oo Cystoid macular oedema oo Blood oFibrosis1-24%, 25-49%, 50-74%, >75%o RPE tear oo Chorioretinal anastomosis ob. |__|__|__|__| GLDµm |__|__|__|__|c.Treatment protocol deviationo Drug dosage oo Infusion rate oo Infusion interruption oo Delay in light application oo Light exposure/laser failure oo Other oNext scheduled visit: ______ weeks/monthsOphthalmologist responsiblefor tx decisionsSignature:Page 2© 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.
Page 5 and 6:
DOI: 10.3310/hta16060Health Technol
Page 12 and 13:
xExecutive summaryretreat on criter
Page 14 and 15:
xiiExecutive summaryof data, with i
Page 16 and 17:
2 Introductionon-going or new clini
Page 18 and 19:
4 Introductionof VPDT in routine cl
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
Page 34 and 35:
20 Key changes to the protocolThese
Page 36 and 37:
22 Key changes to the protocolCentr
Page 38 and 39:
24 Key changes to the protocolADVER
Page 40 and 41:
26 Key changes to the protocolPlan
Page 42 and 43:
28 Key changes to the protocolClass
Page 44 and 45:
30 Key changes to the protocolFor i
Page 46 and 47:
32 Key changes to the protocolIn ad
Page 48 and 49:
34 Key changes to the protocolsites
Page 52 and 53:
38 Results (1) - study cohortTABLE
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
46 Results (2) - objectives A, B, C
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77:
Page 80 and 81:
66 Discussion of resultsStrengths a
Page 82 and 83:
68 Discussion of resultsThe VPDT st
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
Page 91 and 92:
Page 93 and 94:
Page 95:
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 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
Page 164 and 165: 150 Appendix 1• The patient shoul
Page 166 and 167: 152 Appendix 1Appendix 6:Protocol f
Page 168 and 169: 154 Appendix 18. It is customary to
Page 170 and 171: 156 Appendix 1Early or Transit Phas
Page 172 and 173: 158 Appendix 1
Page 174 and 175: 160 Appendix 1---------------------
Page 180 and 181: 166 Appendix 1Appendix 9:Site imple
Page 182 and 183: 168 Appendix 1Option 2 - units inte
Page 184 and 185: 170 Appendix 1Dos and Don’tsDosDo
Page 186 and 187: 172 Appendix 1Resource use question
Page 190 and 191: 176 Appendix 1ADVERSE REACTION AND
Page 192 and 193: 178 Appendix 1acute Trust; note tha
Page 194 and 195: 180 Appendix 1Ophthalmologistrespon
Page 197 and 198: DOI: 10.3310/hta16060Health Technol
Page 203: DOI: 10.3310/hta16060Health Technol
Page 206 and 207: 192 Appendix 3manufacturer’s pers
Page 216: FeedbackThe HTA programme and the a
show all

Verteporfin photodynamic therapy for neovascular age-related ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?