238 Appendix 15 Study details Population details Treatment details Results Interpretation Authors’ conclusions ALA–PDT is comparable with cryosurgery as a treatment modality for BCCs. Retreatments are more common with PDT, but this can easily be performed due to shorter healing times, less scarring, and better cosmetic outcome, which follows ALA–PDT Brief study appraisal This study was generally quite well conducted and the results are likely to be reliable. However, more information on losses to FU and any sample size calculation used, would have been useful Mortality One patient died in each group after the 3-mth FU. Both deaths were unrelated to BCC and its treatment Morbidity More participants in the PDT group had to be re-treated (13/44, 30%) compared with the cryosurgery group (1/39, 3%). The recurrence rate at 1 yr was higher in the PDT group (11/44, 25% vs 6/39, 15%), though not statistically significant (and the PDT group had fewer clinically obvious recurrences). After 1 wk, the PDT group had a significantly shorter healing time in terms of leakage and oedema (p < 0.001), but not erythema. There was also a significant difference in leakage at 1 mth, favouring the PDT group QoL and return to normal activity The cosmetic outcome was significantly better at 1 yr in the PDT group for hypopigmentation, scar formation, tissue defects (all p < 0.001), and hyperpigmentation (p < 0.05) AEs There was no statistically significant difference in mean pain VAS scores during treatment (PDT 43 vs cryosurgery 32). One PDT patient required local anaesthetic. One cryosurgery patient developed a bacterial infection at the treatment site. During the 1st week post treatment eight PDT patients and two cryosurgery patients used analgesic medication (p < 0.05) Trial treatments ALA–PDT vs Cryotherapy Intervention Lesions were 1st prepared (removal of stratum corneum material using scalpel/96% alcohol/ isotonic saline). 20% ALA was then applied to lesion with 1-cm margin, and covered with a thin occlusive dressing. 6 hr after ALA, 635-nm light through a 600-µm optical fibre (with a clear-cut polished end) from a Nd:YAG laser was applied. The single light dose was 60 J/cm2 , and the mean fluence rate 80 mW/cm2 . Larger lesions had to be illuminated with more than one light source. Patients with pain during light exposure received water spray at 15–20°C. Additional treatment given if there was evidence of residual tumour growth at the 4, 8 or 12 wk examinations Comparator Treatment with a liquid nitrogen unit using a spray technique. Two freeze–thaw cycles were given, and the area frozen for 25–30 s each time, with a thawing period of 2–4 min in between. Additional treatment given if there was evidence of residual tumour growth at the 4-, 8- or 12-wk examinations Treatment intention Curative Type(s) of cancer and histology Non-morphoeic BCCs (superficial and nodular) Main eligibility criteria Patients aged 20–90, with histopathologically verified BCCs suitable for both PDT and cryosurgery, were eligible. Exclusion criteria (e.g. pregnancy) were also reported Patient characteristics % Male: 50 Age range: 42–88 yr There were 39 patients with superficial BCCs and 49 with nBCCs. 54% were on the trunk, 28% on head and neck, 11% on legs, and 7% on arms Concomitant treatment Local anaesthetic available during procedures. Use of analgesic drugs was permitted for pain relief during the week following procedures Authors Wang et al. (2001) 88 Data source Full published paper Country Sweden Language English Study design RCT (between-participant comparison) No. of participants Total: 88 Intervention: 47 Comparator: 41 No. of recruiting centres One Follow-up period and frequency FU at 1, 4, 8 and 12 wk, and at 1 yr
DOI: 10.3310/hta14370 <strong>Health</strong> <strong>Technology</strong> <strong>Assessment</strong> 2010; Vol. 14: No. 37 © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. Appendix 16 Barrett’s oesophagus data extraction 239