IMPLICACIONES DE LA INTERNACIONALIZACIÓN DE LA REVISORÍA

Prior test data: Clinical image - Participants examined the close-up clinical image of each lesion before viewing the dermoscopic image; Image contributors also asked to provide information on anatomical location, patient age and sex, and imaging modality (polarized vs nonpolarized) but unclear whether this information was provided to observers or not.

Diagnostic threshold: Observers asked to evaluate "a comprehensive list" of dermoscopic structures abstracted from various algorithms; overlapping criteria were merged into 1 criterion. Criteria were grouped into (1) global pattern, (2) pattern organization, (3) symmetry of contour, (4) symmetry of pattern, (5) architectural disorder, (6) abruptness of lesion border, (7) colours, and (8) melanocytic structures, including network and vascular structures. Algorithm performance was retrospectively assessed based on the following thresholds:7-point checklist - >=3; CASH - >=6; Menzies – NR; ABCD - >4.75; 3-point checklist – NR; Chaos and clues NR. For NR thresholds, author communications state "We assessed all of the algorithms. There isn't a threshold for these algorithms, there are just published rules of usage that determine the benign/malignant classification of the lesion"

Diagnosis based on: Consensus (>=50%) - when 50% or more of the observers identified a dermoscopic feature for a given study lesion, the attribute was considered present; n= 130 (240 participants registered via the IDS website for the study; 103 completed all available images in their data sets and 130 evaluated >=20 lesions)

Observer qualifications: GP 24; Dermatology registrar 25; Dermatologist 73; 1 medical student and 7 'other' Experience in practice: Mixed - mean 12 (SD 8.7) years of dermatology experience

Experience with dermoscopy: Mixed - 122 (93.8%) reported being comfortable using dermoscopy,and 121 (93.1%) were regular users of dermoscopy Dermoscopy training: Algorithm tutorials were created and posted by dermoscopic experts through the International Dermoscopy Society (IDS) website; review of these was encouraged but not mandatory.

Visual Inspection - in-person

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - in-person

A. Risk of Bias

B. Concerns regarding applicability

Visual inspection - image-based

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - image-based

A. Risk of Bias

Were the index test results interpreted without knowledge of the results of the reference standard? Yes

If a threshold was used, was it pre-specified? Yes

For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others? Yes

Could the conduct or interpretation of the index test have introduced bias? Low risk

B. Concerns regarding applicability

Was the test applied and interpreted in a clinically applicable manner? No

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? Yes

Was the test interpretation carried out by an experienced examiner? Unclear

Are there concerns that the index test, its conduct, or interpretation differ from the review question? High

Reference Standard

A. Risk of Bias

Target condition and reference standard(s)

Reference standard Histological diagnosis plus follow up

Histology: All melanomas (n=119) and a proportion of benign lesions (n not reported)

Clinical FU plus histology of suspicious lesions: Sequential dermoscopic imaging over time'; not further detailed; Length of FU NR; nevi required to be either histopathologically verified or to have demonstrated stability under sequential dermoscopic imaging over time.

Target condition (Final diagnoses)

Melanoma (in situ and invasive, or not reported): 119 Benign naevus: melanocytic nevus: 358

Is the reference standards likely to correctly classify the target condition? Unclear Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear

Could the reference standard, its conduct, or its interpretation have introduced bias? Unclear risk

B. Concerns regarding applicability

Expert opinion (with no histological confirmation) was not used as a reference standard Yes Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Unclear

Are there concerns that the target condition as defined by the reference standard does not match the question? Unclear

Flow and Timing

Flow and timing Excluded participants: Poor quality index test image as exclusion criterion Time interval to reference test: NR

Time interval between index test(s): in-person; sequential

Was there an appropriate interval between index test and reference standard? Unclear

Did all patients receive the same reference standard? No

Were all patients included in the analysis? No

If the reference standard includes clinical follow-up of borderline/benign appearing lesions, was there a minimum follow-up following application of index test(s) of at

least: 3 months for melanoma or cSCC or 6 months for BCC? Unclear

If more than one algorithm was evaluated for the same test, was the interval between application of the different algorithms 1 month or less? Yes

Could the patient flow have introduced bias? High risk

Comparative

A. Risk of Bias

Comparative

B. Concerns regarding applicability

Notes

Notes

Coras 2003

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series Data collection: Prospective

Period of data collection 16 month period. Does not say the date Country Germany

Was a consecutive or random sample of patients enrolled? Unclear

Was a case-control design avoided? Yes

Did the study avoid inappropriate exclusions? Unclear

Could the selection of patients have introduced bias? Unclear risk

B. Concerns regarding applicability

Patient characteristics and setting

Inclusion criteria: Pigmented skin lesions undergoing excision due to diagnosis of melanoma or atypical nevus, to rule out melanoma or at the patient's request. Paper states "Each of the three participating dermatologists in private practive sent their digital images via email attachment including anonymized identification to the department of dermatology. (face to face diagnosis)

Setting: Secondary (general dermatology) (teledermatoscopy diagnosis); Private care- Face to face diagnosis Prior testing: Not reported

Setting for prior testing: Not reported Exclusion criteria: None reported Sample size (patients): Not reported

Sample size (lesions): No. eligible: 90; No. included: 45 Participant characteristics: None reported

Lesion characteristics: None reported

Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? Unclear

Are there concerns that the included patients and setting do not match the review question? High

Index Test

Index tests

In person assessment (for those comparing FtF vs histology)

Method of diagnosis: Participating dermatologists with experience in dermatoscopy established a clinical diagnisis based on pattern analysis after personal consultation with the patient in their private practice clinics.

Prior test data: Not reported Diagnostic threshold: Not reported Diagnosis based on: Single Number of examiners: 3

Observer qualifications: Dermatologist (experts with great experience in dermoscopy) Experience in practice: High

Experience with index test: High Teledermatology

Acquisition and transmission of images: Each of the participating dermatologists acquired digital images after face to face consultation, and send them via an email attachment with corresponding patient data and medical history.

Nature of images used: Clinical photographs and dermoscopic images

Any additional patient information provided: Clinical examination and/or case notes Observer qualifications (remote diagnosis): Physician experienced in dermatoscopy Diagnosis based on: Single observer

Method of diagnosis: A physician evaluated the images and made a diagnosis based on the images and history of the patient Other detail: The participating dermatologists used the same technical equipment for the acquisition of digital images.

Visual Inspection - in-person

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - in-person

A. Risk of Bias

Were the index test results interpreted without knowledge of the results of the reference standard? Yes

For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?

Could the conduct or interpretation of the index test have introduced bias? Low risk

B. Concerns regarding applicability

Was the test applied and interpreted in a clinically applicable manner? Yes

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? Yes

Was the test interpretation carried out by an experienced examiner? Yes

Are there concerns that the index test, its conduct, or interpretation differ from the review question? Low concern

Visual inspection - image-based

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - image-based

A. Risk of Bias

B. Concerns regarding applicability

Reference Standard

A. Risk of Bias

Target condition and reference standard(s)

Reference standard: Histology

Details: The histological diagnosis of majority of cases was performed at the Department of Dermatology Regensburg - No. patients/lesions: 45 patients; Disease positive: 16; Disease negative: 29

Target condition (Final diagnoses)

- Melanoma (invasive): 16; 'Benign' diagnoses: 29

Is the reference standards likely to correctly classify the target condition? Yes

Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear

Could the reference standard, its conduct, or its interpretation have introduced bias? Low risk

B. Concerns regarding applicability

Expert opinion (with no histological confirmation) was not used as a reference standard Yes Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Unclear

Are there concerns that the target condition as defined by the reference standard does not match the question? Unclear

Flow and Timing

A. Risk of Bias

Flow and timing

1. Excluded participants: They reported that many images were of poor quality (10) and that only 45 biopsies were done 50 patients who did not have histology excluded

2. Time interval to reference test:Unclear

3. Time interval between index test(s): most likely days (email transmission of images for remote assessment).

Was there an appropriate interval between index test and reference standard? Unclear

Did all patients receive the same reference standard? Yes

Were all patients included in the analysis? No

If the reference standard includes clinical follow-up of borderline/benign appearing lesions, was there a minimum follow-up following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC?

If more than one algorithm was evaluated for the same test, was the interval between application of the different algorithms 1 month or less?

Could the patient flow have introduced bias? High risk

Comparative

A. Risk of Bias

Comparative

B. Concerns regarding applicability

Notes

Notes

Cristofolini 1994

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series Data collection: Prospective

Period of data collection: October 1990-June 1991 Country: Italy

Was a consecutive or random sample of patients enrolled? Unclear

Was a case-control design avoided? Yes

Did the study avoid inappropriate exclusions? No

Could the selection of patients have introduced bias? High risk

B. Concerns regarding applicability

Patient characteristics and setting

Inclusion criteria: Patients with pigmented lesions presenting during a campaign for the early diagnosis of cutaneous melanoma at the Dermatology Department in Trento

Setting: Secondary (general dermatology) Prior testing: Not reported

Setting for prior testing: Not reported

Exclusion criteria: Lesions that were not taken into consideration included benign lesions, naevi of Unna and Miescher types and naevi that showed no inclusion criteria at the ABCDE clinical examination

Sample size (patients): No. eligible: 700 people; No. included: not reported Sample size (lesions): No. eligible: 220; No. included: 220

Participant characteristics: None reported Lesion characteristics: None reported

Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? Unclear

Are there concerns that the included patients and setting do not match the review question? High

Index Test

Index tests

Visual inspection (VI) ABCDE Method of diagnosis: In person diagnosis Prior test data: N/A in-person diagnosis

Diagnostic threshold: lesions showing at least two of the ABCDE criteria all of which were shown the same diagnostic importance, were considered positive.

Diagnosis based on: Unclear; n=4 Observer qualifications: Dermatologist

Experience in practice: High experience or ‘Expert’; all trained in the recognition of pigmented lesions during a training course about the clinical diagnosis of naevi and melanomas; all working in a department where the early diagnosis of melanoma had been dealt with for over 10 years.

Experience with dermoscopy: High experience /‘Expert’ users

Other detail: ABCDE criteria are (asymmetry in shape, border irregular and notched, colour mottled-haphazard display, dimension >6mm, evolution changes in pigmentation)

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Dermoscopy Pattern analysis

Method of diagnosis: In person diagnosis

Prior test data: Clinical evaluation directly followed by dermoscopy

Diagnostic threshold: lesion positive for at least one criterion: irregular and multicomponent pigmentary network pattern, peripheral dark network patches, sharp network margins, pseudopods(if network present), radial streaming (if network present), black dots at periphery (if network present), blue-grey areas (if network present) and whitish veil (milky way, if network present).

Observers as described above.

Visual Inspection - in-person

A. Risk of Bias

Were the index test results interpreted without knowledge of the results of the reference standard? Yes

If a threshold was used, was it pre-specified? Yes

For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?

Could the conduct or interpretation of the index test have introduced bias? Low risk

B. Concerns regarding applicability

Was the test applied and interpreted in a clinically applicable manner? Unclear

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? Yes

Was the test interpretation carried out by an experienced examiner? Yes

Are there concerns that the index test, its conduct, or interpretation differ from the review question? Unclear

Dermoscopy - in-person

A. Risk of Bias

Were the index test results interpreted without knowledge of the results of the reference standard? Yes

If a threshold was used, was it pre-specified? Yes

For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?

Could the conduct or interpretation of the index test have introduced bias? Low risk

B. Concerns regarding applicability

Was the test applied and interpreted in a clinically applicable manner? Unclear

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? Yes

Was the test interpretation carried out by an experienced examiner? Unclear

Are there concerns that the index test, its conduct, or interpretation differ from the review question? Unclear

Visual inspection - image-based

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - image-based

A. Risk of Bias

B. Concerns regarding applicability

Reference Standard

A. Risk of Bias

Target condition and reference standard(s)

Reference standard Histological diagnosis alone

Target condition (Final diagnoses) TARGET CONDITION (Final diagnoses) Melanoma (in situ and invasive, or not reported): 33

Mild//moderate dysplasia: 23 dysplastic naevi; Sebhorrheic keratosis: 4; Benign naevus: 158 common naevus Other: 2 thrombosed angiomas

Is the reference standards likely to correctly classify the target condition? Yes

Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear

Could the reference standard, its conduct, or its interpretation have introduced bias? Low risk

B. Concerns regarding applicability

Expert opinion (with no histological confirmation) was not used as a reference standard Yes Was histology interpretation carried out by an experienced histopathologist or by a dermatopathologist? Unclear

Are there concerns that the target condition as defined by the reference standard does not match the question? Unclear

Flow and Timing

A. Risk of Bias

Flow and timing Excluded participants: No exclusions reported Time interval to reference test: Not described

Was there an appropriate interval between index test and reference standard? Unclear

Did all patients receive the same reference standard? Yes

Were all patients included in the analysis? Yes

If the reference standard includes clinical follow-up of borderline/benign appearing lesions, was there a minimum follow-up following application of index test(s) of at least: 3 months for melanoma or cSCC or 6 months for BCC?

If more than one algorithm was evaluated for the same test, was the interval between application of the different algorithms 1 month or less?

Could the patient flow have introduced bias? Unclear risk

Comparative

A. Risk of Bias

Comparative Clinical evaluation directly followed by dermoscopy

Was each index test result interpreted without knowledge of the results of other index tests or testing strategies? No

Was the interval between application of the index tests less than one month? Yes

Are there any concerns that the test comparison could have introduced bias? Low risk

B. Concerns regarding applicability

Were all tests applied and interpreted in a clinically applicable manner? Unclear

Are there concerns that the test comparison differs from the review question? Unclear

Notes

Notes

Dal Pozzo 1999

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series

Data collection: Prospective; dermoscopic images assessed remotely from the patient Period of data collection Jan 1992 to Jun 1997

Country Italy

Test set derived: "Training set" 218 pigmented lesions classified as: 45 melanomas (19 of which in situ), 38 epithelioid and/or spindle cell nevi; 45 melanocytc nevi; 45 mainly dermal melanocytic nevi."Test set"; 713 pigmented skin lesions-melanocytic in nature consecutively observed

Was a consecutive or random sample of patients enrolled? Yes

Was a case-control design avoided? Yes

Did the study avoid inappropriate exclusions? Unclear

Could the selection of patients have introduced bias? Unclear risk

B. Concerns regarding applicability

Patient characteristics and setting

Inclusion criteria: Pigmented skin lesions observed clinically and dermoscopically at the Institute of Dermatology Sciences University of Milan; all excised. Setting: Secondary (general dermatology)

Prior testing: Not reported

Setting for prior testing: Not reported Exclusion criteria: None reported Sample size (patients): NR

Sample size (lesions): No. eligible: test set - 713 PSLs; No. included: 713 Participant characteristics: Not reported

Lesion characteristics: Not reported

Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? Unclear

Are there concerns that the included patients and setting do not match the review question? High

Index Test

Index tests

Dermoscopy 7FFM (own new algorithm) Method of diagnosis: Dermoscopic images Prior test data: No further information used

Diagnostic threshold: The lesions where the sum of the features gave a score >=2 were diagnosed as being malignant. Diagnosis based on: Consensus (3 observers); n= 3

Observer qualifications: Not reported; appears to be the three co-authors; likely expert dermatologists Experience in practice: Not described

Experience with dermoscopy: Not described

Any other detail: Training set of 218 pigmented lesions used to develop new algorithm. All dermoscopic features recorded. Statistical significance of each feature assessed using Chi square test and Fischer's exact test. Final features chosen according to reproducibility by different observers and relationships with histopathological criteria predictive of malignancy. Final algorithm:To diagnose melanoma the presence of one major feature or the concurrent presence of two minor features is regarded as sufficient. "We attributed a score of 2 to the major features and a score 1 to the minor features: major features are regression erythema, radial streaming, gray-blue veil, irregularly distributed pseudopods; minor features are unhomogeneity, irregular pigment network, sharp margin."

Visual Inspection - in-person

A. Risk of Bias

B. Concerns regarding applicability

Dermoscopy - in-person

A. Risk of Bias

B. Concerns regarding applicability

Visual inspection - image-based

A. Risk of Bias

Dermoscopy - image-based

A. Risk of Bias

Were the index test results interpreted without knowledge of the results of the reference standard? Yes

If a threshold was used, was it pre-specified? Yes

For studies reporting the accuracy of multiple diagnostic thresholds, was each threshold or algorithm interpreted without knowledge of the results of the others?

Could the conduct or interpretation of the index test have introduced bias? Low risk

B. Concerns regarding applicability

Was the test applied and interpreted in a clinically applicable manner? No

In document Principales implicaciones sobre la figura de la Revisoría fiscal a partir del proceso de convergencia a Normas Internacionales de Información Financiera (NIIF) en Colombia [Recurso electrónico] (página 117-121)