APPENDICES - NIHR Health Technology Assessment Programme

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200 Appendix 13 Study details Population details Treatment details Results Interpretation Authors’ conclusions PDT with fractionated and unfractionated illumination were similarly effective in reducing AKs. However, pain sensation during PDT was significantly less intense with standard fractionated than unfractionated illumination Brief study appraisal Few methodological details were provided in the abstract and the results of this small study may not be generalisable Morbidity The mean number of AK at wk 4, 12 and 24 was reduced by 65, 60 and 48% with unfractionated PDT and 56, 53, and 50% with fractionated PDT respectively (difference not significant, n = 14). Similar results seen for alternative fractionated PDT group QoL and return to normal activity Not assessed AEs PDT induced pain (VAS score) was 6.7 (SE 0.5) for unfractionated PDT and 6.0 (0.5) for fractionated PDT (n = 14, p = 0.02). There was no significant difference in pain between fractionated and alternative fractionated patients [8.0 (0.7) vs 8.2 (0.3) respectively] Trial treatments PDT with fractionated illumination vs PDT with unfractionated illumination. Within-participant comparison, but six patients had PDT with fractionated illumination vs alternative fractionated illumination, due to severe pain after 1st fractionated dose Intervention PDT with unfractionated illumination: Following application of MAL cream for 3 hr, red light illumination (peak emission 635 nm) of a single dose of 37 J/cm2 was applied Comparator PDT with fractionated illumination: As for PDT with unfractionated illumination except PDT was given in two doses of 18.5 J/cm2 divided by a dark interval of 15 min 2nd comparator PDT with alternative fractionated illumination: As for PDT with unfractionated illumination except with three doses of 12.3 J/cm2 , with two dark intervals of 5 min Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Not stated Patient characteristics % Male: 100 Age range: 59–84 yr Median age: 75 yr Patients had multiple AKs Concomitant treatment Not stated Authors Legat et al. (2006) 36 Data source Abstract Country Austria Language English Study design RCT No. of participants Total: 22 (mean number AKs 47, range 17–89) Intervention: 22 (no. of AK not reported) Comparator: 22 (no. of AK not reported) 2nd Comparator: six (no. of AK not reported) No. of recruiting centres Not stated Follow-up period and frequency FU at 4, 12 and 24 wk
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Both ALA and MAL–PDT result in significant reduction in scalp AKs. There is no significant difference in efficacy. However, ALA is more painful than MAL–PDT in the treatment of extensive scalp AKs Brief study appraisal The abstract provided few methodological details and involved a small sample, followed up for only 1 mth, so the reliability of the conclusions is unclear Morbidity AK counts reduced by 5.6 ± 3.2 (MAL) vs 6.2 ± 1.9 (ALA) (p = 0.588) (n = 15) QoL and return to normal activity Not assessed AEs All patients (n = 15) experienced pain, which was of greater intensity on the ALA treated side at all time points: 3 min, p = 0.151; 6 min, p = 0.085; 12 min, p = 0.012; 16 min, p = 0.029. There was also longer duration of discomfort post treatment with ALA (p = 0.044) Trial treatments MAL–PDT vs ALA– PDT Intervention MAL–PDT: MAL cream was applied for 3 hr. Further PDT parameters were not reported Comparator ALA–PDT: 20% ALA cream was applied for 5 hr. Further PDT parameters were not reported © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Treatment intention Curative Type(s) of lesion and histology AK Main eligibility criteria Not stated Patient characteristics % Male: 100 Age range: 59–87 yr All patients had AKs on the scalp Concomitant treatment Not stated Authors Moloney et al. (2007) 37 Data source Abstract Country Not stated Language English Study design RCT No. of participants Total: 16 Intervention: 16 Comparator: 16 No. of recruiting centres Not stated Follow-up period and frequency 1 mth 201
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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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