APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
APPENDICES - NIHR Health Technology Assessment Programme
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218<br />
Appendix 14<br />
Study details Population details Treatment details Results Interpretation<br />
Authors’ conclusions ALA–PDT<br />
may offer the best treatment option<br />
for Bowen’s disease. This study shows<br />
the potential of light fractionation for<br />
enhancing the response of the disease to<br />
ALA–PDT and illustrates the need for a<br />
larger, suitably powered trial to determine<br />
if the effect is statistically significant<br />
Brief study appraisal This was a<br />
small trial with unclear methods of<br />
randomisation and blinding. Treatment<br />
methods were reported but not all<br />
outcomes were detailed. This study shows<br />
the potential of PDT and its enhancement<br />
through light fractionation but would need<br />
confirmation, as the authors state, in an<br />
adequately powered trial<br />
Morbidity In the single illumination<br />
group, CR was seen in 22 patches (80%)<br />
at 12 mth. In the twofold-illumination<br />
group CR was seen in 22 patches (88%)<br />
(NS). Patients reported a 3-wk maximum<br />
healing time, which was not different<br />
between treatments<br />
QoL and return to normal activity<br />
Not assessed<br />
AEs All patients in both groups<br />
experienced some discomfort during<br />
treatment but all finished therapy. No<br />
SAEs were seen in either group. In the<br />
single-illumination group none of the<br />
patients complained of pain during<br />
treatment. In the twofold-illumination<br />
group five patients complained about pain<br />
in the treatment of six patches. Lidocaine<br />
without adrenaline was used in four<br />
patches<br />
Trial treatments ALA–PDT using a<br />
single illumination vs ALA–PDT with a<br />
twofold illumination<br />
Intervention Single Illumination: Surface<br />
scale or crusts were removed. 20% ALA,<br />
locally produced, was applied topically and<br />
left in place for 4 hr with a margin of 1 cm.<br />
A diode laser and light emitting diode<br />
provided illumination at a wavelength of<br />
630 nm, 4 hr after ALA application at a<br />
dose of 75 J/cm2 Further PDT parameters were not<br />
reported<br />
Comparator Twofold illumination: As<br />
for single illumination except patches<br />
were light treated 4 and 6 hr after ALA<br />
application at doses of 20 and 80 J/cm2 ,<br />
respectively, separated by a 2-hr dark<br />
interval. Each illumination was delivered at<br />
50 mW/cm2 Type(s) of lesion<br />
and histology<br />
Bowen’s disease<br />
Main eligibility<br />
criteria Not stated<br />
Patient<br />
characteristics<br />
% Male: 43<br />
Age range: 49–91 yr<br />
Mean age: 74 yr<br />
Mean lesion diameter:<br />
14.5 mm (range<br />
5–40 mm)<br />
Locations: Trunk 12,<br />
lower leg 11, hand<br />
8, ear 7, upper leg 4,<br />
cheek and/or nose 3,<br />
eyelid 2, arm 1, frontal<br />
and/or temporal area<br />
1, scalp 1<br />
The sample included<br />
seven organ recipients<br />
Concomitant<br />
treatment Lidocaine,<br />
2% without adrenaline<br />
was used if patients<br />
required it<br />
Authors de Haas et<br />
al. (2007) 69<br />
Data source Full<br />
published paper<br />
Country The<br />
Netherlands<br />
Language English<br />
Study design RCT<br />
No. of participants<br />
Total: 40 (50 Bowen’s<br />
disease patches)<br />
Intervention: 25<br />
lesions (participant no.<br />
not stated)<br />
Comparator: 25<br />
lesions (participant no.<br />
not stated)<br />
No. of recruiting<br />
centres One<br />
Follow-up period<br />
and frequency 4 wk,<br />
then at 3 mth intervals<br />
up to 28 mth