Verteporfin photodynamic therapy for neovascular age-related ...

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56 Results (3) – objective ETABLE 13 Numbers of patients with data for BCVA in the best-seeing eye and HRQoL instrument for different HRQoLinstruments and durations since first treatmentHRQoL instrumentDuration of follow-up in months0 3 6 9 12 > 12SF-36 – PCS 1196 116 680 158 459 383 2992SF-36 – MCS 1196 116 680 158 459 383 2992SF-6D 1156 117 683 152 469 385 2962NEIVFQ – composite 1270 130 739 174 504 435 3252NEIVFQ – distance activities 1267 129 736 174 504 434 3244NEIVFQ – near activities 1268 130 739 174 504 435 3250TotalTABLE 14 Numbers of patients with data for CS in the best-seeing eye and HRQoL instrument for different HRQoLinstruments and durations since first treatmentHRQoL instrumentDuration of follow-up (months)0 3 6 9 12 > 12SF-36 – PCS 1122 82 599 108 392 320 2623SF-36 – MCS 1122 82 599 108 392 320 2623SF-6D 1084 81 605 104 401 325 2600NEIVFQ – composite 1187 89 649 119 428 356 2828NEIVFQ – distance activities 1184 88 647 119 428 355 2821NEIVFQ – near activities 1185 89 649 119 428 356 2826Total10.8SF-6D utility score0.60.40.2–20 0 20 40 60 80 100Best BCVA in either eyeFIGURE 13 Scatterplot showing SF-6D preference-based measure of health (equivalent to utility score) comparedwith better-seeing eye BCVA. The fitted regression line (see Table 15) is superimposed on a scatterplot of the raw data.Values of BCVA < 0 (–10 and –20) represent ‘counting fingers’ and ‘hand movements’ levels of vision respectively.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 657TABLE 15 Relationships between visual function and SF-6D/SF-36HRQoLscoreHRQoLscaleLinear regression coefficient(95% CI)Quadratic regressioncoefficient (95% CI)HRQoL change per 100HRQoL change per fiveline) a range) aletters (≡ one chart letters (i.e. whole chartBCVASF-6D 0–1 0.0012 (0.0009 to 0.0014) – 0.0058 0.116SF-36 PCS b Mean = 50 0.049 (0.025 to 0.073) – 0.245 4.906SF-36 MCS b Mean = 50 0.109 (0.078 to 0.140) – 0.546 10.920HRQoL change perthree letters (i.e. onecontrast sensitivitytriad) a,c HRQoL change per 48letters (i.e. whole chartrange) aCSSF-6D 0–1 –0.0016 (–0.0041 to 0.0009) 0.0001 (0.00003 to 0.014 ~0.140.00015)SF-36 PCS Mean = 50 –0.269 (–0.476 to –0.062) 0.008 (0.003 to 0.013) 0.792 ~7.7SF-36 MCS Mean = 50 –0.120 (–0.382 to 0.143) 0.008 (0.002 to 0.016) 1.155 ~12.1a Estimated HRQoL change assumes the change in BCVA CS occurs in the better-seeing eye.b PCS and MCS: scored on a scale with a mean of 50 and an SD of 10. PCS and MCS are also normalised, i.e. 50 represents the mean for thereference (i.e. ‘normal’) population.c Change in HRQoL estimated for a three-letter contrast sensitivity triad from 35 to 32 letters for relationships.Contrast sensitivity in the better-seeing eye predicted SF-6D, PCS and MCS (p < 0.01 for all threeHRQoL measures) but less strongly. The relationship between CS and the SF-6D utility scoreis shown in Figure 14, with the fitted regression superimposed. For all HRQoL measures, thebest-fitting models were positive and quadratic, with the fitted values tending to an asymptotewhen < 15 letters could be read (see Figure 14). As with BCVA, no evidence was found to supportthe prior hypothesis of a sigmoid relationship. Predicted changes in SF-6D, PCS and MCS forthree-letter (one ‘triad’) and 48-letter reductions in BCVA are shown in Table 15. The latterpredicted changes are described as approximate because the quadratic models sometimes causedfitted values to increase slightly when very few letters were read. The predicted changes reportedare the fitted value for 48 letters minus the minimum fitted value.For predominantly classic nAMD lesions, VPDT was observed to confer a net benefit of 11ETDRS and 5 CS letters after 1 year. 4,30 Based on the best-fitting model for SF-6D, these visualfunction benefits ‘translate’ into utility differences of 0.013 and 0.022 respectively (on a scale of0–1). In the VPDT cohort study, the net BCVA benefit compared with the TAP sham VPDTgroup was slightly smaller, at about nine letters (see Figure 7); this BCVA benefit ‘translates’ into autility difference of about 0.011.For minimally classic nAMD lesions, VPDT was observed to confer a net benefit of four ETDRSletters after 1 year. 4,30 Based on the best-fitting model for SF-6D, these visual function benefits‘translate’ into a utility difference of 0.005. The net BCVA benefit observed in the study, of aboutfive letters (see Figure 8), ‘translates’ into a utility difference of about 0.006.Vision-specific health-related quality of lifeIn the better-seeing eye, BCVA also strongly predicted the composite total NEIVFQ score, andthe distance and near activity subscales (p < 0.0001 for all three NEIVFQ scores). The relationshipbetween BCVA in the better-seeing eye and NEIVFQ composite total score is shown in Figure 15;© 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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Page 80 and 81: 66 Discussion of resultsStrengths a
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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 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
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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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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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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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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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