Reconocimiento del yo, otro y oikos, desde una ética ambiental y un sistema

A. Risk of Bias

Patient Sampling

Study design: Case series Data collection: Retrospective

Period of data collection: Jan 2006 to Jul 2009 Country: Taiwan

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: Potentially malignant biopsied or excised skin lesions (non-tumour specimens excluded)

Setting: Secondary (general dermatology)

Prior testing: Selected for excision (no further detail) Setting for prior testing: Secondary (general

dermatology)

Exclusion criteria: prior surgery; image mis- registered or poor quality images (unfocused or containing a motion artefact) (considered under Flow and Timing)

Sample size (patients): No. eligible: 3964; No. included: 676

Sample size (lesions): No. eligible: 4192; No. included: 769

Participant characteristics: Mean age: 47.6 (SD 21.0); Male: 296; 43.8%

Lesion characteristics: None reported Are the included patients and chosen study setting appropriate? No

Did the study avoid including participants with multiple lesions? No 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

Diagnostic threshold: Not reported; clinicians’ impressions prior to biopsy were classified as ‘‘benign’’, ‘‘malignant’’, or ‘‘indeterminate’’. When the clinicians were not confident enough to make a definite benign or malignant diagnosis, the clinical impression was considered as ‘‘indeterminate’’ data extracted for malignant vs rest and malignant/indeterminate vs rest

Diagnosis based on: Single observer; board-certified staff dermatologists from institute; n= 25 Observer qualifications: Dermatologist

Experience in practice: Board certified Experience with index test: High

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? Unclear

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

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

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

B. Concerns regarding applicability

Reference Standard

A. Risk of Bias

Target condition and reference standard(s)

Reference standard Histology (not further described)

Target condition (Final diagnoses) Melanoma (invasive): 4; Melanoma (in situ): 4; BCC: 110; cSCC: 20

'Benign' diagnoses: 595 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

Were the reference standard results interpreted without knowledge of the referral diagnosis?

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: mis-registered or poor quality images (unfocused or containing a motion artefact) as a study inclusion criterion 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? 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

Notes -  

Cooper 2002

Patient Selection

A. Risk of Bias Patient Sampling

Study design: Case series Data collection: Prospective

Period of data collection May to September 2000

Country UK 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: Patients attending the open access dermatology renal transplant clinic with lesions suspicious for malignancy or premalignancy and booked for biopsy

Setting: Specialist unit; dermatology renal transplant clinic

Prior testing: Clinical suspicion Setting for prior testing: Specialist unit Exclusion criteria: None reported

Sample size (patients): No. eligible: 70; No. included: NR

Sample size (lesions): No. eligible: 125; No. included: 102

Participant characteristics: Mean age: 60y; Male: 75%

Lesion characteristics Head/Neck: 43; 34.4%; Limbs: 21 16.8%; 3 genitals; 2.4%

Are the included patients and chosen study setting appropriate? Unclear Did the study avoid including participants with multiple lesions? No 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

Diagnostic threshold: Observer provisional diagnosis Diagnosis based on: Single observer (n=2)

Observer qualifications: A consultant dermatologist and a registrar Experience in practice: Not described

Experience with index test: Not described

In document Principios desde el conocimiento cultural para el diseño de una propuesta de educación ambiental (página 108-112)