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Study Title and Description

Randomized comparison of photodynamic therapy with topical 5-fluorouracil in Bowen's disease.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Randomized comparison of photodynamic therapy with topical 5-fluorouracil in Bowen's disease.
Author Salim A., Leman JA., McColl JH., Chapman R., Morton CA.
Country Department of Dermatology, Falkirk Royal Infirmary, Falkirk FK1 5QE, UK.
Year 2003
Numbers Pubmed ID: 12653747

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 PDT ALA PDT
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2 5-FU 5-FU (Efudix)
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Multicenter
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Country/Region UK
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Funding NR
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Inclusion criteria Bowen's disease
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Exclusion criteria Not reported
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N Enrolled/Randomized/Analyzed 49
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40
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40
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question PDT 5-FU Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 76
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65, 88
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Gender/Racial descent 32
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40
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100
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"Caucasian"
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Lesion location 33 4
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29
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 20 20
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0 0
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20 20
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33 33
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Lesion extent number of people No data entered.
Lesion extent number of people 20 20
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Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure PDT 5-FU


1 Treatment cycle

N Analyzed 33 33
Counts 11 21


2 Treatment cycle

N Analyzed 33 33
Counts 4 11
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure PDT 5-FU


1 years

N Analyzed 33 33
Counts 6 17
Outcome: Adverse events: other      Population: All Participants
Time Point Measure PDT 5-FU


N/A N/A

N Analyzed 20 20
Counts 0 3
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure PDT 5-FU


N/A N/A

N Analyzed 20 20
Counts 0 4
Outcome: Adverse events: other      Population: All Participants
Time Point Measure PDT 5-FU


N/A N/A

N Analyzed 33 33
Counts 0 5
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure PDT 5-FU


N/A N/A

N Analyzed 19 15
Counts 14 10


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Not reported
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RCT:....Adequate allocation concealment reported No Not reported
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RCT:....Adequate blinding of PATIENTS reported No Not reported
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RCT:....Adequate blinding of PROVIDERS reported No Not reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Not reported
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
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ALL.....Selective Reporting (judgement - put directly into notes field). Did not report AE assessments from each visit
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. No Lesion location not similar. Other characteristics not provided
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Outcomes not well-defined. AEs not well-defined. Inclusion/exclusion criteria not well-defined
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No
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Overall, by outcome (judgement - put directly into notes field) High risk of bias due to between-group differences (location) and selective reporting of AEs
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes Dropouts occurred only in the 5-FU group
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Quality Rating
No quality rating data was found.