APPENDICES - NIHR Health Technology Assessment Programme

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212 Appendix 13 Study details Population details Treatment details Results Interpretation Authors’ conclusions Short incubation (1–3 hr) broad area ALA–PDT appears as effective in eradicating AKs as the long incubation application, with tolerable phototoxicity Brief study appraisal Little information on methods and very limited results presented for this very small study. The conclusions appear inappropriate if they were based on the study results, as short incubation appears to be defined as 1–3 hr, yet no group received long incubation treatment Morbidity Results not broken down by treatment group, but it was reported that there was no effect of ALA incubation time or urea cream on any of the measured outcomes. At 1 mth, 90% of AKs had cleared (analysis on 17 patients) QoL and return to normal activity Patient satisfaction with cosmetic results was reported as moderately high, and all patients commented on improved skin texture AEs Phototoxic reactions were well tolerated Trial treatments ALA–PDT, 1-hr incubation vs 2-hr incubation vs 3-hr incubation Intervention 1-hr incubation: Pretreatment with 40% urea cream (penetration enhancer) and xylocaine HCL 3% (pain control) followed by 20% ALA–PDT with 417-nm blue light. Further PDT parameters were not reported Comparator 2 hr incubation: See above 2nd comparator 3-hr incubation: See above Treatment intention Curative Type(s) of lesion and histology Nonhypertrophic AK Main eligibility criteria Patients with at least four nonhypertrophic AK and diffuse photodamage Patient characteristics Not stated Concomitant treatment Not stated Authors Touma et al. (2003) 39 Data source Abstract Country USA Language English Study design RCT No. of participants Total: 18 Intervention: Not stated Comparator: Not stated 2nd Comparator: Not stated No. of recruiting centres Not stated Follow-up period and frequency Day 1, then at 1 wk, and 1 and 5 mth
DOI: 10.3310/hta14370 Health Technology Assessment 2010; Vol. 14: No. 37 Study details Population details Treatment details Results Interpretation Authors’ conclusions Treating field cancerisation in organ transplant recipients with topical MAL–PDT is efficacious and generally well tolerated (further conclusions relating to prevention of AK reported) Brief study appraisal This study was primarily intended to evaluate prophylactic PDT in immunosuppressed patients and this should be borne in mind. Few details were provided about concealment of allocation, and blinding was not used. The control treatment was not predefined and intercentre differences are likely to have impacted on the results (of which few figures were provided). As a comparative study, the results should be considered with caution and may not be reliable Morbidity This trial aimed to treat existing lesions and also prevent recurrence. Only response rates and cosmetic outcomes have been reported here. Lesion CR rate at 3 mth: MAL–PDT 77% and control 74% (no p-value reported). Lesion response rate at 15 mth: MAL–PDT 88% and control 89% Recurrence rates for lesions that were present at baseline and rated as CR by 3 mth were similar in both groups (PDT 24% and 20% control) with no significant difference QoL and return to normal activity Cosmetic outcomes were rated by the investigator on a 3-point scale. Overall MAL–PDT resulted in more favourable outcomes than the control treatments for hypopigmentation (p < 0.001). At 15 mth, more hypopigmentation was reported in the control group and obvious hypopigmentation was 0% (MAL–PDT) vs 25% (control). No significant difference was found between groups for scar formation AEs Local AEs associated with MAL–PDT were reported by 75% of patients although most were transient and resolved within 1 wk (erythema, pain and crusting). 6% of patients discontinued MAL–PDT due to pain; pain was judged as severe in 17 out of 420 treatment sessions but most reported were of moderate pain. 48% of patients reported AEs in the control area including pain, erythema, crusting or blistering of mild to moderate intensity Trial treatments MAL–PDT vs investigator’s choice of treatment (within-participant comparison) Intervention MAL–PDT: 2 treatments were given, 1 wk apart (baseline and 1 wk after randomisation). Additional single treatments were given at 3, 9 and 15 mth for a total of five treatments. Any visible lesions at 21 and 27 mth were treated at the investigators’ discretion. Lesions were prepared using a small curette to debride the area. MAL 160 mg/g cream applied in 1-mm layer to 50-cm2 treatment area and covered for 3 hr with an occlusive dressing. Excess cream was removed with saline and the area illuminated with non-coherent red light from a lamp (630 nm, light dose 37 J/cm2 ). Patients’ eyes were protected during treatment. Fans and cold water spraying were used for all patients to minimise pain Comparator Control area was treated at the investigator’s discretion utilising any suitable therapy in accordance with normal clinical practice EXCEPT 5-FU cream or imiquimod cream. Treatment was carried out at baseline and 3, 9 and 15 mth later. Any visible lesions at 21 or 27 mth were treated according to the investigator’s preference. Control treatments utilised: cryotherapy (83%) curettage and cautery (4%) laser therapy (2%) surgery (1%) Treatment intention Curative. This trial aimed to treat existing lesions and also prevent recurrence. Only response rates and cosmetic outcomes have been reported here Type(s) of lesion and histology AK (some BCC and SCC in situ included but data not reported) Main eligibility criteria Organ transplant recipients who had received immunosuppressive therapy for more than 3 yr and had between two and 10 lesions in two symmetrical 50-cm2 contralateral areas on the face, scalp, neck, trunk or extremities. All patients were required to have received at least one previous treatment for the lesions. Exclusion criteria were reported Patient characteristics % Male: 68 Age range: 30–78 yr Median age: 57 yr Most patients had Fitzpatrick skin types I–III, organ transplantation occurred between 3 and 34 yr previously (median 16 yr) with the majority more than 10 yr prior to treatment. Selected treatment areas were mostly on the face, scalp or extremities. AKs were mostly grade I or II and almost all were ≤ 10 mm in diameter Concomitant treatment Not stated Authors Wennberg et al. (2008) 59 Linked publications176–178 Data source Full published paper Country Not stated, ‘Europe’ Language English Study design RCT No. of participants Total: 81 (889 lesions, 90% AK) Intervention: 476 lesions Comparator: 413 lesions No. of recruiting centres 11 Follow-up period and frequency 3, 9, 15, 21 and 27 mth after initial treatment © 2010 Queen’s Printer and Controller of HMSO. All rights reserved. 213
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Feedback The HTA programme and the
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APPENDICES - NIHR Health Technology Assessment Programme

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