La predicción y la profecía histórica

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? Yes

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? No

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? High

Visual inspection - 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) Melanoma (invasive): 55; Melanoma (in situ): 11; BCC: 6

'Benign' diagnoses: 241;151 compound naevus, 24 junctional naevus, 12 dermal naevus, 12 lentigo simplex, 10 dysplastic naevus, 8 spindle-cell naevus, 8 sebhorrheic keratosis, 5 blue naevus, 3 spitz naevus, 8 other.

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: NR_{Interval between index and reference: NR} 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

Notes

Notes -  

Bono 2002b

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series Data collection: Prospective

Period of data collection Dec 2000 and Aug 2001

Country Italy

Was a consecutive or random sample of patients enrolled? Yes

Was a case-control design avoided? Yes

Did the study avoid inappropriate exclusions? Yes

Could the selection of patients have introduced bias? Low risk

B. Concerns regarding applicability

Patient characteristics and setting

Inclusion criteria: Consecutive cutaneous pigmented lesions that were <=6mm in diameter and required surgical biopsy for diagnosis based on clinical or dermoscopic suspicion of CMM

Setting: Specialist unit (skin cancer/pigmented lesions clinic)

Prior testing: Clinical and/or dermatoscopic suspicion Setting for prior testing: Not reported

Exclusion criteria: lesion size >6mm; non-pigmented Sample size (patients): No. eligible: 349/ No. included: 157

Sample size (lesions): No. eligible: 375/ No. included: 161

Participant characteristics: Mean age 38y (14-82); Male: 61 (39%)

Lesion characteristics: Site: head/Neck: 14 (9%); trunk: 88 (55%); limbs: 59 (36%)

Lesion size: median: 5mm (1mm to 6mm)

Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? Yes

Are there concerns that the included patients and setting do not

match the review question? High

Index tests

Visual inspection (VI). No algorithm (ABCD (asymmetry, border, colour, dimension) criteria have been the basis of training at the unit, but is not implemented in diagnosis; preferred emphasis on colour rather than dimensional character)

Method of diagnosis: In person diagnosis Prior test data: N/A in-person diagnosis

Other test data: Dermoscopy evaluated in same study by same observer(s)

Diagnostic threshold: A diagnosis of suspect CM is made when the level of suspicion is roughly 50% or more; lesions at a lower index of suspicion were considered benign for the purposes of this study. Diagnosis based on: Single observer diagnostic criteria based on the subjective experience of the single clinician examining the pigmented lesion (n=2)

Observer qualifications: Surgical oncologists

Experience in practice: High experience or ‘Expert’; observers described as “expert in the recognition of pigmented lesions"

Other detail: Diagnostic criteria were based on the subjective experience of the single clinician

examining the pigmented lesion, although the ABCD criteria have been the basis of training at the unit, they did not consider the ABCD mnemonic an essential formula for diagnosis of CM. They did not take into consideration the dimensional character and attributed great importance to the colour of a given lesion.

Dermoscopy: performed by the same two clinicians who firstly made and registered the clinical diagnosis

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? Yes

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? No

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? High

Visual inspection - 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 Disease positive: 13 CM; Disease negative: 148 Target condition (Final diagnoses)

Melanoma (invasive): 10; Melanoma (in situ): 3; BCC: 2 (1.2%)

Mild/moderate dysplasia: 26 (16.1%);

Sebhorrheic keratosis: 4 (2.5%); Benign naevus: compound nevus 57 (35.4%), junctional nevus 38 (23.6%), spindle-cell nevus 6 (3.7%), spitz nevus 5 (3.1%), blue nevus 2 (1.2%), other 6 (3.7%), Lentigo simplex 2 (1.2%)

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

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: none reported_{Time interval to reference test: not reported} 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

Notes

Notes -  

Bono 2006

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series Data collection: Retrospective

Period of data collection: Jan 2003 - Dec 2004 Country: Italy

Was a consecutive or random sample of patients enrolled? Yes

Was a case-control design avoided? Yes

Did the study avoid inappropriate exclusions? Yes

B. Concerns regarding applicability

Patient characteristics and setting

Inclusion criteria: Consecutive patients with pigmented skin lesions with a maximum diameter of <=3mm undergoing excision. The decision for diagnostic excision was based on clinical and/or dermoscopic features suggesting a more or less important suspicion for CM

Setting: Specialist unit (skin cancer/pigmented lesions clinic) Istituto NazionaleTumori of Milan

Prior testing: Clinical and/or dermatoscopic suspicion Setting for prior testing: Specialist unit (skin

cancer/pigmented lesions clinic) Exclusion criteria: - lesion size >3mm

Sample size (patients): No. eligible: 204/ No. included: 204

Sample size (lesions): No. eligible: 206/ No. included: 206

Participant characteristics: Median age: 40 (6-74); Male: 71 (35%)

Lesion characteristics Head/Neck: 8 (4%); Trunk: 84 (41%); Limbs: 114 (55%). Median size: 2mm (1 to 3mm)

Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? Yes

Are there concerns that the included patients and setting do not

match the review question? High

Index Test

Index tests

Visual inspection (VI) No algorithm Method of diagnosis: In person diagnosis Prior test data: N/A in-person diagnosis

Other test data: Dermoscopy evaluated in same study by same observer(s)

Diagnostic threshold: A diagnosis of suspicious CM is made when the level of suspicion is roughly 50% or more; lesions at a lower index of suspicion were considered not CM

Diagnosis based on: Single observer; n= 1

Observer qualifications: Not reported (assumed Oncologist as per Bono 2002 and Bono 2002b); "single clinician examining the pigmented lesion"

Experience in practice: Not described Experience with dermoscopy: Not described

Dermoscopy: evaluated in same study; Menzies criteria

Any other detail: ABCD (asymmetry, border, colour, dimension) criteria have been the basis of training at the unit, but is not implemented in diagnosis; preferred emphasis on colour rather than dimensional character

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? Yes

Were thresholds or criteria for diagnosis reported in sufficient detail to allow replication? No

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

Visual inspection - image-based

In document El problema de la explicación científica en la disciplina histórica [recurso electrónico] (página 66-70)