APPENDICES - NIHR Health Technology Assessment Programme

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Appendix 13 214 Study details Population details Treatment detailsResults Interpretation Authors’ conclusions Continuous activation PDT using daylight exposure was as effective as, and better tolerated than, conventional PDT Brief study appraisal This was a generally well conducted but small study and the results appear likely to be reliable. It should be noted though that six patients had previously received PDT in the treated areas (although more than 1 yr before the study), and that the LED illumination time was not clearly stated Morbidity At 3 mth the absolute decrease in the mean number of lesions compared to baseline was 8.0 (71%) in the LED areas vs 8.4 (79%) in the daylight areas (p = 0.13 for percentage, p = 0.50 for mean number) QoL and return to normal activity Eighteen patients (62%) preferred the daylight treatment, four (14%) LED treatment, and six (21%) had no preference AEs Analyses based on 24 patients: The daylight areas were significantly less painful on a 10-point VAS scale than the LED areas (mean maximal pain score, 2.0 for daylight vs 6.7 for LED, p < 0.0001). In the LED light group, 15 patients needed cold water spray to make pain tolerable, and one-half of these patients needed one or two breaks during illumination. In two patients this was not enough, so treatments were stopped after one-third of illumination time. Pain scores 6 hr after LED treatment were not significantly different (mean maximal score of 1 for daylight vs 1.3 for LED, p = 0.14). Both areas developed erythema and crusting after treatment. These AEs were most severe in the daylight area in 10 patients (42%), in the LED area in five patients (21%) and there was no difference between the areas in nine patients (38%) Trial treatments MAL–PDT with daylight vs MAL–PDT with red LED (within-participant comparison) Intervention PDT with daylight: Before treatment, lesions were counted, graded, mapped, and photographed. AK lesions of face or scalp were marked into two symmetrical treatment areas (~80 cm2 each) and scales and hyperkeratoses were removed using a curette. Around 1 g of MAL cream was applied to each area and covered with a dressing and light-impermeable lead rubber. Following 30 min indoors, the daylight area had the dressing removed and patients spent 2.5 hr outside in daylight (mean effective total dose 43 J/cm2 , mean effective red light dose 1.9 J/cm2 , patients treated in period between July and September), before returning to have MAL cream from both treatment areas removed. The area randomised to red LED light was treated with a light dose of 37 J/cm2 (effective red light dose 1.2 J/cm2 , peak irradiance at 632 nm) after covering the daylight treatment area with light-impermeable rubber Comparator PDT with red LED: See above Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Patients with AKs symmetrically distributed on the face or scalp. Pregnant or lactating women were excluded Patient characteristics % Male: 79 Age range: 63–90 yr Mean age: 78 yr Most lesions were grade I, with around a third grade II and very small number were grade III Concomitant treatment Sunscreen for exposed areas not covered by treatment Authors Wiegell et al. (2008) 53 Data source Full published paper Country Denmark Language English Study design RCT No. of participants Total: 30 (29 treated) Intervention: 30 (29 treated) Comparator: 30 (29 treated) No. of recruiting centres One Follow-up period and frequency FU at 1–3 d (AEs) and 3 mth (CR)
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT using daylight activation will make AK treatment more time and cost-effective, and more convenient for the patient Brief study appraisal The authors compared overall pain scores, and AEs in a small sample, with those seen in conventional PDT, but using a comparator treatment of conventional PDT in this study would have been much more informative. This abstract also featured minimal reporting of methods and results Morbidity At 3 mth, there was no significant difference in CR rate (77% in 16% area vs 80% in 8% area), p = 0.37 QoL and return to normal activity Not assessed AEs Erythema and crusting occurred in both treatments (and were similar to inflammation seen after conventional PDT). Pain diaries were used but not reported by intervention arm Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Patients with AK of the face and scalp Patient characteristics Not stated Concomitant treatment Not stated Authors Wiegell et al. (2008) 40 Data source Abstract Country Denmark Language English Study design RCT No. of participants Total: 29 Intervention: 29 Comparator: 29 No. of recruiting centres Not stated Follow-up period and frequency FU at 3 mth © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Trial treatments PDT with 8% MAL vs PDT with 16% MAL (within-participant comparison) Intervention PDT 8% MAL: Patients were given both treatments, randomised to two symmetric areas, one area was given 8% MAL cream and the other 16% MAL cream. Patients were sent home and instructed to spend as much time as possible outside, in daylight. Patients spent an average of 210 min outdoors (range 62–372 min). Light exposure was measured using an electronic dosimeter watch Comparator PDT 16% MAL: See above 215
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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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