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Study Title and Description

Comparison of photodynamic therapy with cryotherapy in the treatment of Bowen's disease.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Comparison of photodynamic therapy with cryotherapy in the treatment of Bowen's disease.
Author Morton CA., Whitehurst C., Moseley H., McColl JH., Moore JV., Mackie RM.
Country University Department of Dermatology, Western Infirmary, Glasgow, U.K.
Year 1996
Numbers Pubmed ID: 8977678

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 cryotherapy
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2 photodynamic
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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. Unclear
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Country/Region Scotland
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Funding NR
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Inclusion criteria lesions of <=21 mm in diameter,
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Exclusion criteria
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N Enrolled/Randomized/Analyzed 19
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19
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19
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... 4-mm punch biopsy
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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 cryotherapy photodynamic Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 82 mm2 150 mm2 76
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30 mm2, 360 mm2 25 mm2, 441 mm2 62, 88
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Gender/Racial descent 16
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84
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Lesion location 1 1
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5 5
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3 2
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15 10
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16 17
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80 85
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legs legs
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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 19
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40
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19
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40
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19
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40
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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 cryotherapy photodynamic


1 treatment days

N Analyzed 20 20
Counts 10 5


2 treatments years

N Analyzed 20 20
Counts 4 0


3 treatments years

N Analyzed 20 20
Counts 0 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure cryotherapy photodynamic


during treatment days

N Analyzed 20 20
Counts 19 11


10 days

N Analyzed 20 20
Counts 10 5
Outcome: Adverse events: other      Population: All Participants
Time Point Measure cryotherapy photodynamic


10 days

N Analyzed 20 20
Counts 7 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure cryotherapy photodynamic


10 days

N Analyzed 20 20
Counts 5 0
Outcome: Adverse events: scarring      Population: All Participants
Time Point Measure cryotherapy photodynamic


12 months

N Analyzed 20 20
Counts 4 0
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure cryotherapy photodynamic


12 months

N Analyzed 20 20
Counts 2 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data Not reported
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RCT:....Adequate allocation concealment reported No Data Not reported
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RCT:....Adequate blinding of PATIENTS reported No unblinded
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RCT:....Adequate blinding of PROVIDERS reported No unblinded
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No unblinded
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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). Does not appear to be any
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RCT.....Is the treatment effect by Intention to treat? Yes no dropouts
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ALL....Group similarity at baseline. Unsure Lesions size was different; this was accounted for in a regression.
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Lack of baseline data by arm
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) Older study with poor reporting. Lack of blinding may affect AE reporting, but unlikely to affect clearance or recurrence Overall high RoB due to poor reporting
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.