Verteporfin photodynamic therapy for neovascular age-related ...

More documents

Recommendations

Info

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.
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 31: DOI: 10.3310/hta16060Health Technol
Page 34 and 35: 20 Key changes to the protocolThese
Page 36 and 37: 22 Key changes to the protocolCentr
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 60 and 61: 46 Results (2) - objectives A, B, C
Page 77: DOI: 10.3310/hta16060Health Technol
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:
DOI: 10.3310/hta16060Health Technol
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 176 and 177:
162 Appendix 1---------------------
Page 178 and 179:
164 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 188 and 189:
174 Appendix 1Appendix 11: Recommen
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:
Page 199 and 200:
Page 201 and 202:
Page 203:
Page 206 and 207:
192 Appendix 3manufacturer’s pers
Page 209 and 210:
Page 211 and 212:
Page 213 and 214:
Page 216:
FeedbackThe HTA programme and the a
show all

Verteporfin photodynamic therapy for neovascular age-related ...

Create successful ePaper yourself

Delete template?

Save as template?