Allameh 2015.

Study characteristics
Patient Sampling	Country: Iran Study design: cross‐sectional pilot study for patients undergoing staging surgery for stage I and II endometrial or cervical cancer (15 endometrial, 8 cervical) between November 2012 and February 2014 Inclusion criteria: patients with stage I and II endometrial or cervical cancer who were candidate for systematic lymph node dissection Exclusion criteria: patients with prior radiotherapy
Patient characteristics and setting	Number of patients: 23 (15 endometrial, 8 cervical) Mean age: 63.47 +/‐ 1.09 years Mean body mass index: 29.13 +/‐ 0.5 kg/m2 Histopathological cell type: endometrioid carcinoma = 13 (86.7%), clear cell carcinoma = 1 (6.7%), papillary serous carcinoma = 1 (6.7%) FIGO stage (pre 2009): IA = 7 (46.7%), IB = 3 (20%), IC= 1 (6.7%), IIA = 1 (6.7%), IIB = 2 (13.3%), IIIA = 1 (6.7%). Estimated FIGO stage (post 2009) = IA=10; IB+=5. Grade on hysterectomy specimen: not reported. Lymphovascular space involvement: not reported. Setting: two centres in Isfahan, Iran, namely Shahid Beheshti and Sadoughi Hospitals.
Index tests	Type of endometrial sampling: not reported. Experience of operator: mention of limitations for access to trained surgeons, though no explicit report of experience of operators. Tracer used and amount: 4 mL of 1% methylene blue Method and timing of application: injection into the fundus of the uterus after clamping the fallopian tubes using a 25‐gauge needle. To prevent spillage of dye, fundal gentle pressure on the sites of injection was used. Method of detection: sections from nodal tissue, including SLN were first stained with haematoxylin and eosin (H&E) and studied for metastatic involvement. SLNs showing metastatic involvement on H&E stained sections were considered as positive for metastatic disease. One extra section from the deeper levels of SLN was then prepared and stained with immunohistochemistry (IHC) technique using anti‐cytokeratin (AE1/AE3) antibody if results from the initial study of SLN for metastatic disease were negative. If the SLN section stained with IHC technique was positive for keratin immunoreactivity, SLN was considered to have metastatic disease.
Target condition and reference standard(s)	Type: patients with stage I or II endometrial cancer all underwent systematic lymph node dissection. All patients were treated by laparotomy The level of lymph node dissection is not reported. Lymph node number and site: a total of 15 SLNs were identified. The most common anatomical sites were: obturator = 8 (53.3%), internal iliac = 6 (40%), para‐aortic = 1 (6.7%).
Flow and timing	All patients received the index and reference standard within 1 month. It is unclear whether all patients received the same reference standard, as the level of the lymph node dissection is not reported. All patients were included in the analysis.
Comparative
Notes	Study results: the median SLN count was 3 (range, 1‐4). Sentinel LN detection rate was 80%. Sensitivity was 100%, specificity was 25%; PPV was 25%; NPV was 100%. There were no FP nodes. Adverse reaction from index or reference test: uneventful light blue urine was made in most patients that resolved by 24 hours postoperatively. TP = 3; FP = O; FN = 0 ; TN = 9; failed = 3. Type 1 tumours. FIGO Stage IA = 10; FIGO stage IB+ = 5. Subserosal uterine injections; bilateral detection rate = not reported. Operating time: not reported. Other intraoperative complications: no perioperative complication was observed. Other postoperative complications: no perioperative complication was observed.
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
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
Are there concerns that the included patients and setting do not match the review question?			Low concern
DOMAIN 2: Index Test (All tests)
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
Could the conduct or interpretation of the index test have introduced bias?		Unclear risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
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
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Unclear
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Unclear risk