FLEX November 2023

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TABLE 2

Quality assessment of case series studies checklist from National Institute for Health and Clinical Excellence

Inclusion/ exclusion criteria Outcome Prospective Consecutive

Main findings Stratified

Study, year

Multicenter Aim

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Agrawal et al. 44

No

Yes

No

Yes

Yes

No

Yes

Yes

Altinyollar et al. 45

No

Yes

Yes

Yes

Yes

No

Yes

Yes

Civantos et al. 46

Demir et al. 47

No

Yes

Yes

Yes

Yes

No

Yes

Yes

Durham et al. 48

No

Yes

Yes

Yes

No

No

Yes

Yes

Foy et al. 49

No

Yes

No

Yes

No

No

Yes

Yes

Ilmonen et al. 50 Jankovi c et al. 51

No

No Yes

Yes

No

No

Yes

No

No

Yes

Yes

Yes

Yes

No

Yes

Yes

Jansen et al. 52 Klode et al. 53 Krediet et al. 54 Michl et al. 55

No

Yes

Yes

Yes

Yes

No

Yes

Yes

No

Yes

Yes

Yes

No

No

Yes

Yes

No

Yes

Yes

Yes

No

No

Yes

Yes

No

Yes

No

Yes

No

No

Yes

Yes

Mooney et al. 56 Rastrelli et al. 57

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

No

Yes

Yes

Yes

No

Yes

Yes

Yes

No

Yes

No

Yes

No

No

Yes

No

Samsanavic ˇ ius et al. 58

No

Yes

Yes

Yes

No

No

Yes

Yes

Takahashi et al. 59

No

Yes

Yes

Yes

No

No

Yes

Yes

Tremblay-Abel et al. 60

No

Yes

Yes

Yes

Yes

No

Yes

Yes

Vuthaluru et al. 61

Wagner et al. 62

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Wu et al. 63

No

Yes

Yes

Yes

No

No

Yes

Yes

Note : (1) Was the case series collected in more than one center (i.e., multicenter study? (2) Is the hypothesis/aim/objective of the study clearly described? (3) Are the inclusion and exclusion criteria (case definition) clearly reported? (4) Is there a clear definition of the outcomes reported? (5) Were data collected prospectively? (6) Is there an explicit statement that patients were recruited consecutively? (7) Are the main findings of the study clearly described? (8) Are outcomes stratified (e.g., by abnormal results, disease stage, patient characteristics)?

included studies, with a median score of 5.0. The main limit is that only two studies ( n = 16, 3.6%) specifically reported a consecutive patient enrollment. Moreover, only nine studies ( n = 321, 45.5%) showed a prospective design, enhancing the risk of selection bias. Finally, only 109 (15.5%) patients were included in multicenter studies. The funnel plot generated for the meta-analysis of the SLNB positive rate is shown in Figure 2. Peters' linear regression test showed a symmetric distribution of the points in the funnel plot (Intercept = 0.31, p = 0.06), suggesting no obvious publication bias.

the chin ( n = 1, 0.1%). The specific primary tumor location was not reported for 179 (25.4%) tumors. The median tumor size was 23.3 mm ( n = 344, 95%CI: 15 – 27mm).

3.3 | Methodological quality of included studies

Table 2 summarizes the risk of bias of included studies using the NICE quality assessment tool. The risk of bias assessment showed a generally moderate quality of