Characteristics of validation and impact analysis studies included
| Validation studies | ||||||
|---|---|---|---|---|---|---|
| Author year, country | Setting | CPR used | Lesions | Patient: n, sex, mean age | CPR applied by: n Experience | Reported sensitivity/specificity |
| Annessi 2007,25 Italy | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy | 198 96 melanomas, 102 non-melanoma | N=195 54% male Mean age: 43 | 2 ELM-experienced dermatologists | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 84.4 Sp: 74.5 7-point checklist for dermoscopy (cut-point ≥3) Se: 78.1 Sp: 64.7 |
| Argenziano 1998,26 Italy | Department of dermatology | 7-point checklist for dermoscopy ABCD rule of dermoscopy | 342 117 melanoma, 225 non-melanoma | NR | 5 3 experienced 2 less experienced | 7-point checklist for dermoscopy (cut-point ≥3) Expert user: Se: 95.0 Sp: 75.0 Non-expert user (mean): Se: 89.0 Sp: 61.5 ABCD rule of dermoscopy (cut-point ≥4.75) Expert user: Se: 85.0 Sp: 66.0 Non-expert user (mean): Se: 91.5 Sp: 31.0 |
| Argenziano 2003,14 9 countries | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy Menzies 1996 dermoscopy for melanoma | 108 | NR | 40 Experienced | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 82.6 Sp: 70.0 7-point checklist for dermoscopy Se: 85.7 Sp: 71.1 Menzies 1996 dermoscopy for melanoma Se: 85.7 Sp: 71.1 |
| Argenziano 2011,27 Italy | Department of dermatology | 7-point checklist for dermoscopy Revised 7-point checklist for dermoscopy | 300 100 excised melanoma, 100 excised non-melanoma, 100 non-excised non-melanoma | NR | 8 Experienced | 7-point checklist for dermoscopy (cut-point ≥3) Se: 77.9 Sp: 85.6 Revised 7-point checklist for dermoscopy (cut-point ≥1) Se: 87.8 Sp: 74.5 |
| Benelli 1999,15 Italy | Department of dermatology | 7FFM (seven features for melanoma) dermoscopy ABCDE clinical rule | 401 60 melanomas, 341 non-melanoma | NR | 2 Research team | 7FFM (seven features for melanoma) dermoscopy (cut-point of ≥2) Se: 80.0 Sp: 89.1 ABCDE clinical rule (cut-point ≥2) Se: 85.0 Sp: 44.5 |
| Benelli 2000,28 Italy | Department of dermatology | 7FFM (seven features for melanoma) dermoscopy ABCDE clinical rule | 600 76 melanomas, 524 non-melanoma | Mean age: 53 | 3 | 7FFM (seven features for melanoma) dermoscopy (cut-point of ≥2) Se: 68.8 Sp: 86.0 ABCDE clinical rule (cut-point of ≥2) Se: 47.3 Sp: 56.0 |
| Binder 1999,66 Austria | Department of dermatology | ABCD rule of dermoscopy | 250 | NR | 17 12 experienced 5 trainee | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 81.0 Sp: 77.0 ABCD rule of dermoscopy (cut-point ≥5.45) Se: 73.0 Sp: 90.0 |
| Blum 2003,71 Germany | Department of dermatology | The 3-colour dermoscopy test | 249 | NR | NR | The 3-colour dermoscopy test Se: 76.9 Sp: 90.1 |
| Blum 2004,47 Germany | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy Menzies 1996 dermoscopy for melanoma Simplified ABC-point list for dermoscopy 7FFM (seven features for melanoma) dermoscopy | 269 84 melanomas, 185 non-melanoma | NR | NR | ABCD rule of dermoscopy Se: 90.5 Sp: 72.4 7-point checklist for dermoscopy Se: 90.5 Sp: 87.0 Menzies 1996 dermoscopy for melanoma Se: 95.2 Sp: 77.8 7FFM (seven features for melanoma) dermoscopy Se: 94.0 Sp: 74.6 Simplified ABC-point list for dermoscopy Se: 90.5 Sp: 87.0 |
| Blum 2004,48 Germany | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy Menzies 1996 dermoscopy for melanoma 7FFM (seven features for melanoma) dermoscopy | 269 84 melanomas, 185 non-melanoma | NR | NR | ABCD rule of dermoscopy Se: 90.5 Sp: 72.4 7-point checklist for dermoscopy Se: 90.5 Sp: 87.0 Menzies 1996 dermoscopy for melanoma Se: 95.2 Sp: 77.8 7FFM (seven features for melanoma) dermoscopy Se: 94.0 Sp: 74.6 |
| Buhl 2012,35 Germany | Department of dermatology | DynaMel Algorithm 7-point checklist for dermoscopy | 675 | N=688 57% male Mean age: 42 | Dermatology residents | DynaMel Algorithm Se: 77.1 Sp: 98.1 7-point checklist for dermoscopy (cut-point ≥3) Se: 47.5 Sp: 99.0 |
| Carli 2002,29 Italy | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy | 200 44 melanomas, 156 non-melanoma | NR | 5 Dermatology residents | ABCD rule of dermoscopy (cut-point ≥5.45) Se: 88.1 Sp: 45.7 7-point checklist for dermoscopy (cut-point ≥3) Se: 91.9 Sp: 35.2 |
| Dal Pozzo 1999,30 Italy | Department of dermatology | 7FFM (seven features for melanoma) dermoscopy | 713 168 melanomas, 545 non-melanoma | NR | 3 | 7FFM (seven features for melanoma) dermoscopy Se: 94.6 Sp: 85.5 |
| Dolianitis 2005,49 Australia | Primary care and dermatology department | 7-point checklist for dermoscopy ABCD rule of dermoscopy Menzies 1996 dermoscopy for melanoma | 40 20 melanomas, 20 non-melanoma | NR | 61 35 primary care physicians, 10 dermatologists, 16 trainee dermatologists | 7-point checklist for dermoscopy Se: 81.4 Sp: 73.0 ABCD rule of dermoscopy (cut-point ≥5.45) Se: 77.5 Sp: 80.4 Menzies 1996 dermoscopy for melanoma Se: 84.6 Sp: 77.7 |
| Emery 2010,36 UK | Family practice | Emery 2010 SIAscopy in primary care for melanoma | 1211 | N=858 52% male Mean age: 50 | 1 SIAscopy expert | Emery 2010 SIAscopy in primary care for melanoma Se: 50.0 Sp: 84.0 |
| Feldman 1998,67 Austria | Department of dermatology | ABCD rule of dermoscopy | 500 30 melanomas, 470 non-melanoma | NR | NR | ABCD rule of dermoscopy (cut-point ≥4.2) Se: 88.0 Sp: 64.0 |
| Gereli 2010,50 Turkey | Department of dermatology | 7-point checklist for dermoscopy 3-point checklist for dermoscopy | 96 48 melanoma, 48 non-melanoma | NR | 3 2 experienced 1 inexperienced | 7-point checklist for dermoscopy (cut-point ≥3) Se: 87.5 Sp: 16.2 3-point checklist for dermoscopy (cut-point ≥2) Se: 89.6 Sp: 31.2 |
| Guitera 2012,51 Multiple | Skin cancer clinic | Guitera 2012 confocal microscopy for melanoma | 710 216 melanomas, 494 non-melanoma | N=663 | NR | Guitera 2012 confocal microscopy for melanoma Se: 87.6 Sp: 70.8 |
| Haenssle 2010,37 Germany | Department of dermatology | 7-point checklist for dermoscopy | 1219 127 melanomas, 1092 non-melanoma | N=688 57% male Mean age: 42 | Inexperienced | 7-point checklist for dermoscopy (cut-point ≥3) Se: 62.0 Sp: 97.0 |
| Healsmith 1993,64 UK | Pigmented lesion clinic | Revised 7-point checklist (clinical) ABCDE clinical rule | 165 65 melanoma, 100 non-melanoma | NR | NR | Revised 7-point checklist (clinical) Se: 100 Sp: NR ABCDE clinical rule Se: 92.3 Sp: NR |
| Henning 2008,52 USA | Department of dermatology | CASH dermoscopy algorithm ABCD rule of dermoscopy 7-point checklist for dermoscopy Menzies 1996 dermoscopy for melanoma | 150 50 melanoma, 100 non-melanoma | NR | 2 Inexperienced | CASH dermoscopy algorithm Se: 87.0 Sp: 67.0 ABCD rule of dermoscopy Se: 86.0 Sp: 74.0 7-point checklist for dermoscopy Se: 76.0 Sp: 57.0 Menzies 1996 dermoscopy for melanoma Se: 92.0 Sp: 38 |
| Higgins 1992,38 UK | Department of dermatology | 7-point checklist (clinical) 7-point checklist (clinical) revised | 100 0 melanoma, 100 non-melanoma | N=100 30% male Mean age: 36.7 | NR | 7-point checklist (clinical) revised Se: NR Sp: 70.0 |
| Kittler 1999,39 Austria | Department of dermatology | ABCD rule of dermoscopy ABCDE rule (dermoscopy) | 356 73 melanomas, 283 non-melanoma | N=352 43% male Mean age: 52 | NR | NR |
| Keefe 1989,40 Scotland | Hospital dermatology clinic | 7-point checklist (clinical) | 222 | N=195 22% male Mean age: 43 | Dermatologists 195 patients | 7-point checklist (clinical) (cut-point ≥3) Dermatologists: Se: 85.7 Sp: 66.5 Patients: Se: 71.4 Sp: 66.2 |
| Kreusch 1992,84 Germany | Department of dermatology | Kreusch 1992 dermoscopy for melanoma | 317 96 melanomas, 221 non-melanoma | NR | 2 1 experienced 1 inexperienced | Kreusch 1992 dermoscopy for melanoma Experienced: Se: 98.9 Sp: 94.1 Inexperienced: Se: 97.0 Sp: 94.2 |
| Lorentzen 1999,68 Denmark | Department of dermatology | ABCD rule of dermoscopy | 232 | NR | 8 4 experienced 4 inexperienced | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 59.0 Sp: 92.0 ABCD rule of dermoscopy (cut-point ≥5.45) Se: 41.0 Sp: 98.0 |
| Lorentzen 2000,53 Denmark | Department of dermatology | ABCD rule of dermoscopy | 258 64 melanoma, 194 non-melanoma | NR | 3 Experienced | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 70.7 Sp: 88.0 |
| Luttrell 2012,54 Austria | Department of dermatology | AC rule for dermoscopy | 200 25 melanoma, 178 non-melanoma | NR | 17 Lay persons | AC rule for dermoscopy Se: 91.2 Sp: 94.0 |
| Mackie 2002,55 Scotland | Pigmented lesion clinic | The 3-colour dermoscopy test | 126 69 melanoma 57 non-melanoma | NR | 3 Experienced | The 3-colour dermoscopy test Se: 97.0 Sp: 55.0 |
| McGovern 1992,41 USA | Dermatology clinic | 7-point checklist (clinical) ABCD clinical rule | 237 16 malignant, 221 non-melanoma | N=179 50% male Mean age: 44 | NR | 7-point checklist (clinical) Se: 0.44 Sp: 0.94 |
| Menzies 1996,85 Australia | Melanoma unit | Menzies 1996 dermoscopy for melanoma | 385 107 melanomas | NR | NR | Menzies 1996 dermoscopy for melanoma Se: 92.0 Sp: 71.0 |
| Menzies 200856 | 7-point checklist for dermoscopy 3-point checklist of dermoscopy Menzies 1996 dermoscopy for melanoma Menzies 2008 dermoscopy for melanoma Menzies 2008 dermoscopy for skin cancer | 497 105 melanomas, 392 non-melanoma | NR | 12 Experienced | 7-point checklist for dermoscopy Se: 41.0 Sp: 83.0 3-point checklist of dermoscopy Se: 50.0 Sp: 71.0 Menzies 1996 dermoscopy for melanoma Se: 54.0 Sp: 76.0 Menzies 2008 dermoscopy for melanoma Se: 70.0 Sp: 56.0 Menzies 2008 dermoscopy for skin cancer Se: 95.0 Sp: 80.0 | |
| Menzies 201357 | ABCD rule of dermoscopy 7-point checklist for dermoscopy 3-point checklist of dermoscopy Menzies 1996 dermoscopy for melanoma CASH dermoscopy algorithm Menzies 2013 dermoscopy for nodular melanoma | 465 217 melanomas, 248 non-melanoma | NR | 12 | ABCD rule of dermoscopy Se: 81.5 Sp: NR 7-point checklist for dermoscopy Se: 94.4 Sp: NR 3-point checklist of dermoscopy Se: 83.9 Sp: NR Menzies 1996 dermoscopy for melanoma Se: 98.4 Sp: NR CASH dermoscopy algorithm Se: 41.0 Sp: 83.0 Menzies 2013 dermoscopy for nodular melanoma Se: 93.0 Sp: 70.0 | |
| Nachbar 1994,69 Germany | Department of dermatology | ABCD rule of dermoscopy | 194 69 melanomas | NR | NR | ABCD rule of dermoscopy (cut-point ≥5.45) Se: 92.8 Sp: 91.2 |
| Nilles 1994,86 Germany | Department of dermatology | Nilles 1994 dermoscopy for melanoma | 260 72 melanomas, 188 non-melanoma | NR | NR | Nilles 1994 dermoscopy for melanoma Se: 90.0 Sp: 85.0 |
| Osborne 1999,45 UK | Department of Dermatology | Revised 7-Point Checklist (clinical) | 778 778 melanomas, 0 non-melanoma | N=733 35% male | NR | Revised 7-Point Checklist (clinical) False negative rate: 18.5 |
| Piccolo 2014,31 Italy | Department of dermatology | ABCD rule of dermoscopy | 165 33 melanomas, 129 non-melanoma | N=165 59% male Mean age: 43.5 | 4 3 dermatologists 1 FP | ABCD rule of dermoscopy Se: 91.0 Sp: 52.0 |
| Pizzichetta 2002,32 Italy | Department of oncology | ABCD rule of dermoscopy | 129 | N=123 | 2 Experienced | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 90.0 Sp: 43.0 ABCD rule of dermoscopy (cut-point ≥5.45) Se: 90.0 Sp: 53.5 |
| Rao 199765 | Department of dermatology | ABCD rule of dermoscopy ABCD clinical rule | 73 | N=63 | 4 Experienced dermatologists | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 90.0 Sp: 57.0 ABCD clinical rule Se: 84.0 Sp: 78.0 |
| Skvara 2005,42 Austria | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy | 325 63 melanomas, 262 non-melanoma | N=297 44% male Mean age: 39 | 2 Experienced dermatologists | ABCD rule of dermoscopy (cut-point ≥4.75) Se: 31.7 Sp: 87.3 7-point checklist for dermoscopy Se: 11.1 Sp: 95.2 |
| Soyer 2004,33 Italy | Department of dermatology | 3-point checklist of dermoscopy | 231 68 melanomas, 163 non-melanomas | N=225 49% male | 6 Inexperienced | 3-point checklist of dermoscopy Se: 96.3 Sp: 32.8 |
| Stolz 1994,70 Germany | Department of dermatology | ABCD rule of dermoscopy | 157 | NR | NR | ABCD rule of dermoscopy(cut-point ≥5.45) Se: 97.9 Sp: 90.3 |
| Strumia 2003,34 Italy | Department of dermatology | ABCD rule of dermoscopy ABCDE rule (dermoscopy) | 49 | NR | 2 | |
| Thomas 1998,6 France | Department of dermatology | ABCDE clinical rule | 1140 | NR | NR | ABCDE clinical rule (cut-point ≥2) Se: 89.3 Sp: 65.3 |
| Unlu 2014,43 Turkey | Department of dermatology | ABCD rule of dermoscopy 7-point checklist for dermoscopy 3-point checklist of dermoscopy CASH dermoscopy algorithm | 115 24 melanomas, 91 non-melanoma | N=115 49% male Mean age: 39 | 3 Experienced dermatoscopists | ABCD rule of dermoscopy Se: 91.6 Sp: 60.4 7-point checklist for dermoscopy Se: 79.1 Sp: 62.6 3-point checklist of dermoscopy Se: 87.5 Sp: 65.9 CASH dermoscopy algorithm Se: 91.6 Sp: 64.8 |
| Wadhawan 2011,59 USA | Images from library of skin cancer | 7-point checklist for dermoscopy | 347 | NR | NR | 7-point checklist for dermoscopy Se: 87.3 Sp: 71.3 |
| Walter 2013,44 UK | Family practice | 7-point checklist (clinical) Revised 7-point checklist (clinical) | 1436 36 melanomas, 1400 non-melanoma | N=1182 35.9% male Mean age: 44.7 | NR | 7-point checklist (clinical) Se: 80.6 Sp: 61.7 Revised 7-point checklist (clinical) Se: 91.7 Sp: 33.1 |
| Zalaudek 2006,60 29 Countries | Pigmented lesion clinic | 3-point checklist for dermoscopy | 150 44 malignant, 106 non-melanoma | NR | 150 Varying levels of experience | 3-point checklist for dermoscopy Se: 94.0 Sp: 71.9 |
| Impact Analysis Studies | ||||||
| Author year, Country | Study design | Participant selection | Lesions | Intervention | Control | Outcomes |
| Westerhoff 2000,62 Australia Primary care | Controlled before and after | 74 FPs | n=100 (50 melanoma, 50 non-melanoma) Selected randomly from the Sydney Melanoma Unit image database | Educational intervention. FPs given educational material on Menzies 1996 rule, followed by a 1-hour Presentation on surface microscopy | Usual care | Correct diagnosis of melanoma, percent (SD): Intervention 75.9 (12) Control 54.8 (22) Correct diagnosis of non-melanoma, percent (SD): Intervention 57.8 (14) Control 55.8(15) |
| Walter 2012,63 England Primary care | RCT | 15 FP practices | 1580 from 1297 patients | Patients assessed using the MoleMate system (SIAscopy with primary care scoring algorithm) | Best practice (clinical history, naked eye examination, 7-checklist clinical) | Primary, appropriateness of referral (defined as the proportion of referred lesions that secondary care experts decided to biopsy or monitor): no statistically significant difference between intervention and control; 56.8% vs 64.5%; difference −8.1% (95% CI −18.0% to 1.8%). Secondary: Appropriate management of benign lesions in primary care: no statistically significant difference between intervention and control (99.6% vs 99.2%, p=0.46). Agreement with an expert decision to biopsy or monitor: no statistically significant difference between intervention and control (98.5% vs control 95.7%, p=0.26). Patient satisfaction: more intervention patients ranked their consultation very good/excellent for thoroughness than control (83.1% vs 71.2%, p<0.001). Patient anxiety: no statistically significant difference between intervention and control in anxiety scores (32.56 vs 34.72, p=0.013) |
| Argenziano 2006,72 Spain, Italy Primary Care | RCT | 73 FPs | 2548 lesions from 2522 patients presenting to primary care with a pigmented skin lesion. 1203 lesions in dermoscopy group (six melanoma) 1345 lesions in control group (six melanoma) | Use of dermoscopy in addition to ‘naked-eye’ lesion screening. Both groups received a 4 hours educational intervention incorporating clinical examination and use of the 3-point checklist (dermoscopy algorithm) | Naked-eye screening alone. | Primary outcome: Referral accuracy of PCPs (defined as the ability of the PCP to correctly determine a lesion may be malignant or benign, when the gold standard is diagnosis by a second expert clinician) reported as sensitivity, specificity, PPV, NPV. Significant difference in sensitivity (dermoscopy 79.2%, naked eye 54.1%, p=0.002) and negative predictive value (dermoscopy 9801%, naked eye 95.8%, p=0.004) Secondary outcome: Number of malignant tumours missed by PCPs using naked-eye examination (n=23) and using dermoscopy (n=6) (p=0.002) |
ABC, Asymmetry, irregular Borders, more than one or uneven distribution of Color; ABCD, Asymmetry, irregular Borders, more than one or uneven distribution of Colour, or a large (greater than 6 mm) Diameter; ABCDE, Asymmetry, irregular Borders, more than one or uneven distribution of Colour, or a large (greater than 6mm) Diameter, Evolution of moles; AC, asymmetry, colour variation; CASH, colour, architecture, symmetry, and homogeneity; CPR, clinical prediction rules, ELM, epiluminescence microscopy; FP, family physicians; PCP, primary care physicians; PPV, positive predictive value; NPV, negative predictive value; NR, Not reported; RCT, randomised controlled trials; Se, sensitivity; Sp, specificity.