Page 11 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

Guiding Questions

Our analysis of the current literature was based on the following guiding questions. These
guiding questions are partly derived from the hierarchical model of technology assessment first
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proposed by Thornbury and Fryback in 1992. According to this hierarchical model, there are
six sequential levels to be considered in the evaluation of a technology assessment. They are:
(1) technical efficacy, (2) diagnostic accuracy efficacy, (3) diagnostic thinking efficacy,
(4) therapeutic efficacy, (5) patient outcome efficacy, and (6) societal efficacy. Each level is built
upon the previous level. The guiding questions posed to the different technologies will be
addressed to the extent that they have satisfied the sequential levels (e.g., some of the modalities
have not progressed beyond the first level of technical efficacy stage and therefore it makes little
sense to assess the second level questions like diagnostic accuracy).

Guiding Question 1. What are the different noninvasive
techniques/modalities that have been proposed to be used for the early
detection of skin cancer?

i. What are the postulated advantages and disadvantages of these noninvasive diagnostic
techniques compared with biopsy, among individuals who should be considered for these
technologies?
ii. What are the potential safety issues and harms associated with the use of noninvasive
diagnostic techniques for the evaluation of suspicious skin lesions?
iii. What is the current FDA clearance status of these modalities?
iv. What kinds of training and certifications are needed to use these techniques/modalities?
v. What are some of the newer techniques/modalities in development?
Guiding Question 2. What is the current clinical context in which these new
noninvasive modalities are used—who uses them, in what setting, for
which cancers, with which patients?

i. Are there reasons to consider that some techniques may be more or less effective for the
early detection of skin cancers in those patients who had a previous history of skin
cancer, previous history of any cancer, or no history of cancer?
ii. Are there reasons to consider that some techniques may be more or less effective for the
early detection of skin cancers among Whites, Blacks, and Hispanics?
Guiding Question 3. What published and unpublished studies have
reported on the use and safety of these noninvasive modalities? Provide a
synthesis of the following information:

i. Indication/patient inclusion criteria
ii. Study design and size
iii. Role of the test in patient management
iv. Outcomes assessed
v. Adverse events, harms, and safety issues reported
vi. Comparators used (applicable only to comparative studies)
vii. Length of follow-up (applicable only to longitudinal studies)

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