Kang 2011.
| Study characteristics | |||
| Patient sampling | Design: non‐comparative; retrospective (medical record review) Country: S Korea Data collection: Mar 2005 to Sep 2009 Inclusion criteria: newly diagnosed cutaneous MM undergoing staging work‐up with PET‐CT (any stage, including clinically node positive) | ||
| Patient characteristics and setting | Presentation: primary (any) Number patients: 37 Number primary lesions: 37 Number LNBs/metastases: NR Stage of disease: stage 0: 7 (18.9%); stage I: 6 (16.2%); stage II: 17 (45.9%); stage III: 6 (16.2%); stage IV: 1 (2.7%) Mean age: 61.7y ± 13.6 years; Median age: NR; Range: 48.1 to 75.3 years Male: 17 (45.9%) Primary lesion site: hand/foot 23 (62.1%), trunk 6 (16.2), head/neck 4 (10.8%), extremity 4 (10.8%) Breslow/Clark: BT < 1.0 mm 8, 22%; ≥ 1 mm 15, 41%; NR 14, 38% Ulceration: present 7, 19%; absent 30, 81% Other: mean SUVmax 2.8 ± 2.3 | ||
| Index tests |
PET‐CT: CT (U, 6 slice or 16 slice)
Machine: Reveal RT‐HiRez CTIMI (Knoxville, TN, USA), a 6‐slice CT; or Discovery ST (GE Health Systems, Milwaukee, Wl, USA), a 16‐slice CT
Scan coverage: vertex of skull to knees; plus lower limbs if with lower leg MM
Contrast: U
CT parameters: Reveal RT‐HiRez 130 kV, 95 mA; Discovery ST 140 kV, 160 mA; Reveal RT‐HiRez 2.5 mm; Discovery ST 3.75 mm
FDG: 350 to 400 MBq
Breath hold: NR; 'standard protocol'
CT used for: unclear; combined PET‐CT unit; mentions identification of anatomical location on fused PET‐CT image
Reconstruction: ordered subset expectation‐maximisation Threshold: SUVmax ≥ 2.2 (set using ROC analysis) # Number observers: 2 Qualification (experience): nuclear physicians (experienced) Diagnosis (single, consensus, etc.): consensus of 2 Info provided during test interpretation: clinical ‐ NR; other tests ‐ N/A |
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| Target condition and reference standard(s) |
Histology/Imaging FU
Histological detail (n, %): reported for only 6 of disease positive group (6 (16.2%)). Histopathologist: experienced dermatopathologist and pathologist
FNAC (n, %): N/A (0)
Follow‐up (n, %): clinical, CT, PET‐CT (37 (100%))
FU schedule: physical examination every 3 months for 1 to 2 years, then every 6 months; imaging every 6 to 12 months and/or when clinically indicated FU duration: median followup 24.3 ± l l.7 months (range 8 to 55 months) Reference blinding: NR # Target condition Data: per pt Definition: any mets (incl brain, local/skin); Prevalence: 9/37 = 24% |
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| Flow and timing | Index to histology interval: NR Index to FU interval: 3 months Exclusions: n = 0 | ||
| Comparative | |||
| Notes | Other result: sites of recurrence were LN (3); distant (5; lung or liver); 'local' (2); skin (1); 3 patients died related to CMM | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| Does the study report results for participants at the same point in the clinical pathway and who would be eligible for imaging in normal practice? | Yes | ||
| Did the study report data on a per patient rather than per lesion basis? | Yes | ||
| Unclear | Low | ||
| DOMAIN 2: Index Test PET‐CT | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
| If a threshold was used, was it pre‐specified? | No | ||
| Was the imaging 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 interpreted by an experienced examiner? | Yes | ||
| High | High | ||
| DOMAIN 3: Reference Standard | |||
| 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 based on patient follow‐up interpreted without knowledge of the original imaging test result? | Unclear | ||
| Does the study use the same definition of disease positive as the primary review question (i.e. any mets) OR is it possible to disaggregate or regroup data such that data matching the review question can be extracted? | Yes | ||
| Was histology or cytology interpretation carried out by an experienced histopathologist or by a dermatopathologist? | Yes | ||
| Low | Low | ||
| DOMAIN 4: Flow and Timing | |||
| 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? | Yes | ||
| High | |||