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Study Title and Description

The effect of 595 nm pulsed dye laser on superficial and nodular basal cell carcinomas.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title The effect of 595 nm pulsed dye laser on superficial and nodular basal cell carcinomas.
Author Shah SM., Konnikov N., Duncan LM., Tannous ZS.
Country Department of Internal Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts 02215, USA.
Year 2009
Numbers Pubmed ID: 19588534

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Pulse dye laser
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2 no treatment
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design Prospective nRCS
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Multicenter etc. Single center
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Country/Region U.S.
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Funding No industry support
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Inclusion criteria male patients with biopsy-proven BCCs on the trunk and extremities
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Exclusion criteria Morpheaform, infiltrative, and recurrent BCCs
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N Enrolled/Randomized/Analyzed 32
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32
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Notes/Comments matched historic controls design
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... biopsy-proven BCCs
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question Pulse dye laser no treatment Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines No data entered.
Gender/Racial descent No data entered.
Lesion location 2 matched, but not specified
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10 matched, but not specified
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19
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90
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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 12 20
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21 20
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1
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excluded becaus it could not be matched
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20
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Lesion extent number of people 9 matched, but not specified
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10 matched, but not specified
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2 matched, but not specified
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Odds Ratio (OR) P-Value
Outcome: Lack of histological clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure Pulse dye laser no treatment Comparison Measure Pulse dye laser vs. no treatment


>= 2 week after last tx weeks

N Analyzed 20 20 16.7
Counts 7 18 0.0004


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
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RCT:....Adequate allocation concealment reported
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RCT:....Adequate blinding of PATIENTS reported
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RCT:....Adequate blinding of PROVIDERS reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No
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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).
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RCT.....Is the treatment effect by Intention to treat?
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ALL....Group similarity at baseline. Unsure stated, but baselines not given for controls
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No AEs not reported
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Overall, by outcome (judgement - put directly into notes field) high
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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.