Appendix 1 (as submitted by the authors): Summary of Articles

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1 Appdix 1 (as submitted by the autho): Summary of Articles Author/ Elias et al., 1983 (5) Kivlahan Ingram, 1985 (6) Method Aim of Timeline Crosssectional Prospectiv e cohort Evaluate the relationship of columnar cells to the cytologic idtification of abnormality in the cervix Evaluated Papanicolaou to compare the frequcy of cervical atypia in without columnar cells in their 3 yea: yea: Wom aged participating in a cancer screing program in the region of Nijemeg, the Netherlands Wom aged who had at least two Papanicolaou performed during 4 yr period 62, , , , ,9 79 Atypical squamous cells/ atypical squamous metaplasia Slight dysplasia/ moderate dysplasia Severe dysplasia in situ/microinvas carcinoma Atypia EC+: 15.8% EC-: 10.5% (squamous metaplastic cells); 4.3% (squamous cells only) Relat risk: 2.2 (slight and moderate abnormality) 4.4 (severe abnormality) P<0.05 Group 1 (2 ) EC+: 3.3% EC-: 3.0% Group 2 (3 ) EC+: 2.7% EC-: 3.2% Group 3 (4 ) EC+: 4.4% EC-: 0% Wh cells are not prest, a repeat r should be tak unless the absce of columnar cells can be explained satisfactorily. It may remain in the best interest of the patit to continue to consider Papanicolaou without columnar cells as less than optimal. Vooijis 1985 (7) Cohort Examine data on the presce of columnar cells in cervical and its 6 yea Wom yea of age agreeing to participate in study in Nijmeg, the Netherlands 85, ,5 55 Minimal atypia Slight and moderate dysplasia Severe NS* Negat cytology: Fit screing EC+: 85.2% EC-:92.4% The chance of missing an abnormal epithelial change is increased in without columnar cells. Wh columnar cells are abst, the r should be considered to be of unreliable quality and a repeat r cells. CMAJ DOI: /cmaj

2 Method Aim of Timeline relation to the finding of epithelial abnormalities from a group of in a mass-screing program dysplasia, CIS, (micro-) invas carcinoma Second screing EC+: 77.8% EC-:82.2% Fit screing EC+: 14.4% (minimal atypia), 0.40% (slight and moderate dysplasia), 1.1% (severe dysplasia, CIN [micro-] invas carcinoma) EC-: 7.4% (minimal atypia), 0.23% (slight and moderate dysplasia) should be tak after a short interval, unless the absce of columnar cells can be satisfactorily explained. Krists 1990 (8) Evaluate occurrce of and possible reasons for negat and undercalled in developing invas cervical 4 yea: Wom living in the county of Fun with a diagnosis of invas cervical cancer Smea with original or review cytodiagnosis of less than cancer Atypia CIN Second screing EC+: 21,1% (minimal atypia), 0.89% (slight and moderate dysplasia), 0.16% (severe dysplasia, CIN [micro-] invas carcinoma) EC-: 17.0% (minimal atypia), 0.79% (slight and moderate dysplasia), 0.05% (severe dysplasia, CIN [micro-] invas carcinoma) Negat cytology: EC+: 55.5% EC-: 45.5% EC+: 84.4% (atypia); 97.8% (CIN) EC-: 15.6% (atypia); 2.2% (CIN) P< Smea without cells should be considered inadequate and should be repeated. cells. CMAJ DOI: /cmaj

3 Kwikkel, Quaak de With, 1986 (15) Laverty 1989 (9) Mauney, Eide Sotham, Method Aim of Timeline cancer Controlled trial cross- Evaluate the validity and performance of the Pap r, as a diagnostic test Evaluating the reliability of that were made with the Cervex Sampler compared to those tak with a convtional modified Ayre spatula Assess the effect of the presce or 18 yea: year: 1987 (Ayre spatula) 3 months: 1988 (Cervex Sampler ) ½ year: 1988 Wom with at least one abnormal Pap r registered at the Gynaecological Clinic, Vrije Uniteit, Amsterdam Excluded patits referred for clinically overt invas carcinoma without previous Pap Smea collected by 119 docto by the Ayre spatula Smea collected by 10 docto selected to sample the Cervex Sampler Wom age Smea from private physicians cells. CMAJ DOI: /cmaj Class IIIa (mild or moderate dysplasia) Class IIIb (severe dysplasia) Class IV (carcinomoa in situ) Class V (suspicious of invas cancer) - 36, , 785 Abnormal cytology/histology: Before at 6 mnths EC+: 4% EC-: 9% - at 12 mnths EC+: 4% EC-: 9% After at 6 mnths EC+: 3% EC-: 7% - at 12 mnths EC+: 3% EC-: 7% Atypia Spearman s rank correlation: EC+ and cytological atypia=0.379 Condyloma acuminatum CIN I P<0.001 EC+: 3.02% EC-: 1.32% We are inclined to agree with previous worke who concluded that the presce or absce of idtifiable cells did not appear to have a major bearing on the adequacy of the sample. Our study confirms these findings [posit correlation betwe presce of cells and the detection of squamous-cell atypia] which lack cells offer no opportunity for the detection of or columnar atypias (glandular intraepithelial neoplasia). We found a significantly higher rate of dysplasia in with cells than in those without We do not,

4 1989 (10) Woodm an 1989 (11) Mitchell Medley, 1991 (16) Method Aim of Timeline section absce of cells on the detection rate of condyloma and dysplasia Case Longitudin al Assess whether inadequate can be distinguished by the absce of columnar cells of origin and immature metaplastic cells Report the results of a longitudinal study of abnormality rates, according and large institutions with specific diagnoses of condyloma acuminatum, CIN I, CIN II, and CIN III 10 yea Wom attding the Birminghan and Midland Hospital for Wom for investigation of abnormal cytology over a 20 year period with 3 over an 18 month period with CIN The initial and final suggested presce of histological abnormality, however, the intermediate r did not 3 yea: Wom with negat cytology report during 1987 (try r) and a later r (exit r) from the cells. CMAJ DOI: /cmaj CIN I CIN II CIN III 22, , , ,2 22 CIN II CIN III P< RR=0.41 ( cells) (95% CI ) RR=0.04 (immature metaplastic cells) (95% CI ) RR=0.05 ( and immature metaplastic cells) (95% CI ) CIN Abnormal cytology at follow up : Definite/equivocal CIN EC+:4.0% EC-:1.4% χ 2 =128.9, p<0.001 however, suggest that the presce of cells alone constitutes an adequate or satisfactory r. Nor do we feel that those lacking cells should necessarily be reported as unsatisfactory. However, presce or absce of these cells should be routinely reported so that the clinician may weigh clinical facto in deciding appropriate follow-up. Endocervical cells alone were less likely to be found in inadequate than in adequate, but this association was not statistically significant. Our study demonstrates that the subsequt incidce of CIN is not substantially higher in whose are negat but lack an compont than in whose are reported as negat

5 Mitchell Medley, 1992 (17) Mitchell Medley, 1993 (18) Method Aim of Timeline to status, among who have reced negat cytology reports to investigate the assumption underlying the recommdatio n for an early repeat test for that lack an compont Case Case Replicate previous case studies indicating that there is no significant differce in cell status for prediction of CIN Detail the proportion of reported as including an compont 8 yea: yea: database of all whose are reported by the Victorian Cytology Service Wom with a chronologic cytological report of CIN, a cytologic report of no abnormality, and a histologic report of CIN Smea tered into the computerized files of the Victorian Cytology Service Smea reported as including an compont from computerized records Excluded cells. CMAJ DOI: /cmaj Definite EC+: 1.6% EC-: 0.4% χ 2 =89.6, p< CIN Negat histology: EC+:71% EC-:29% Over 0,000 Severe dysplasia Moderate/se vere dysplasia Moderate dysplasia EC+: 84% EC-:14% OR: 2.45 (95% CI, , P<0.05) Rate per 10,000 betwe of all abnormalities (lowest to highest): EC+: EC-: with an compont. Thus there appea to be no scitific basis for recommding an immediate or early repreat test for whose cytology report is negat but whose lack an compont. Should negat that lack an compont be repeated early? No. The rationale for an early repeat test would be that a higher rate of abnormality was evidt on the repeat tests, indicating that important abnormalities were being missed on the negat that lacked an compont. The declining ration of reported abnormalities in with an compont indicates a weaking of the relationship betwe status and the probability of an abnormality being reported.

6 Sidawy, Tabarra Silverbe rg, 1992 (19) Beeby 1993 (12) Roberts on Wood d, 1993 Method Aim of Timeline which correlate with the detection rate of high-grade intraepithelial lesions and with the reporting of abnormalities of the docervix case Assess the effect of the presce or absce of the compont on the detection rate of condyloma and dysplasia Evaluate the relationship betwe various epidemiological, cytological, colposcopic, and histological facto and negat cytology Idtify the causes of failure in the screing process related 1 year: yea: yea: that were technically unsatisfactory or tak posthysterectomy Wom referred to The George Washington Unity Medical Cter whose biopsies revealed histologic evidce of condyloma/dysplas ia or carcinoma Ages yea Wom diagnosed by colposcopic biopsy referred from practitione and clinics with 2 prior to colposcopic examination Wom aged yea in Northern Ireland Diagnosed with cells. CMAJ DOI: /cmaj LSIL HSIL Negat histology: EC+: 18.4% EC-: 20% EC+: 81.6% EC-: 80.0% P= CIN Negat histology: EC+: 63% EC-: 37% EC+: 75% EC-: 25% χ 2 =6.6, df=1, P< Dysplasia Negat cytology: EC+: 36% EC-: 64% Although the presce or absce of an compont should be documted in the cytology report, its absce should not be an indication to report the cervical as unsatisfactory. There is a need either to consider alternat methods of assessing r quality or to recognize that false negats can occur despite appartly adequate sampling of the transformation zone. Smea lacking an compont are unreliable.

7 Method Aim of Timeline (13) to prest laboratory practice O Sulliva n 1998 (20) Bos et al., 2001 (21) Case Investigate if there is a type of severly dyskaryotic r that is likely to be missed in a normal screing situation Compare the incidce of invas cervical cancer and the incidce of preinvas lesions after negat with and without cells Unknow n 8.25 yea: 1990/ invas cervical cancer over previous 12 yea with initial negat diagnosis or containing with few dysplasia cells Excluded patits with microinvas disease Smea from 5 major cytopathology departmts with biopsy-prov CIN III Smea from the Dutch Network and National Database for Pathology Excluded obtained for medical indications and unknown reasons Excluded that followed a posit r within 4 yea Comparison included cells. CMAJ DOI: /cmaj EC+: 31% EC-: 69% CIN III Negat histology: EC+: 57% EC-: 43% - 1,27 2, , 983 CIN I CIN II CIN III Invas cervical cancer EC+: 56% EC-: 44% NS* Odds ratio (Invas cervical cancer): 1.01(EC+ to EC-) (95% CI ) [No] significant differce in the proportions of true posits and false negat showing or metaplastic cells. These data suggest there is no reason to advise with negat without cells to undergo an additional r.

8 Method Aim of Timeline prevt negat only Mitchell, 2001 (22) Selvaggi Guidos, 2001(23 ) Cohort Determine the incidce of histologically confirmed highgrade cervical disease after a negat Pap r report according to the status of the negat r Assess the effect of the presce or absce of an compont on the detection rate of cervical intraepithelial neoplasia (CIN) II/III 3 yea: yea: Wom with a negat Pap r report issued during the study time period and a further Pap r during the next 36 months from the Victorian Cervical Cytology Registry Asymptomatic from Loyola Unity Medical Cter Reced yearly routine gynecological exams Previous atypical or previously treated 60, , ,1 44 cells. CMAJ DOI: /cmaj ,1 44 High grade abnormality Low grade abnormality Abnormal cytology report CIN II CIN III HSIL LSIL Abnormal histology at follow up : Standardized incidce ratio (high-grade disease): EC+ (Cohort A and B respectly): 1.00, 0.89 (95% CI , P>0.05) EC- (Cohort C and D, respectly): 0.24 (95% CI , P<0.001), 0.26 (95% CI , P<0.001) Standardized incidce ration (low-grade disease): EC+ (Cohort A and B respectly): 1.00, 0.67 (95% CI , P<0.01) EC- (Cohort C and D, respectly): 0.32 (95% CI , P<0.001), 0.32 (95% CI , P<0.001) EC+: 27% EC-: 23% P>0.5 These findings suggest that the extt to which Pap without an compont are considered limited should be reviewed. The issue of the lack of an compont as a determinant of cervical specim adequacy should be revisited.

9 Siebe 2003 (24) Pajtler and Audy- Jurkovic, 2002 (25) Tack Method Aim of Timeline Prospectiv e case Prospectiv e cross Determine the prevalce rate ratio of squamous lesions in with rect without compont veus having a r with compont To analyze the association betwe the presce of cells and 1) prevalce of abnormal cells, 2) prevalce of histological diagnosed lesions, and 3) ssitivity and negat predict value of Pap r Investigate efficacy of the 3 yea: for gital malignancies Initial diagnosed in east Netherlands and follow-up from the National Pathology Database Excluded with epithelial atrophy 2 yea Non-pregnant betwe the age of 20 and 50 from whom a vaginal, cervical, r was tak during a clinical exam 4 yea: Wom eligible for population-based - 195, , ASCUS+ LSIL+ HSIL+ Cervical lesions CIN II CIN III Negat cytology: EC+: 5.0% EC-: 1.4% EC+:95.0% EC-: 98.6% EC+: 20% EC-: 11% P< Abnormalities Abnormal cytology at 6 month follow-up: These findings lt support to the decision to abolish the repeat of compont negat in the Dutch population screing program. negat without cells which, in accordance with the applied classification, are less than optimal, do not need to be repeated earlier than those with cells. Our study demonstrates that the effect [6 month follow up for with EC- pap cells. CMAJ DOI: /cmaj

10 2005 (26) Ribeiro 2006 (14) Rossi et al., 2010 (27) Method Aim of Timeline sectional six month 2001 cervical screing recommded with a 6-month follow-up after follow up mass screing recommdation of Pap from the National because of the Information absce of Network of Geral Practices columnar cells in the Netherlands Comparati ve crosssectional Prospectiv e (noncurre nt) Correlate the number of cells and the number of atypical cells in cervical with cytological abnormalities Measure the risk of CIN2+in the 4.5 yea following a negat Pap r with adequate cells or abst/scarce cells Unknow n 11 yea: Convtional cervical including LSILs and HSILs year old with a fit negat pap r from the archs of 11 Italian populationbased screing programs Wom from the sample with a follow-up r within 4.5 yea of fit negat r LSIL HSIL - 490, , 290 EC-: 15.9% Negat cytology at 6 month follow-up: EC-: 84.1% Odds ratio: 2.87 ( cells to squamous atypical cells) (95% CI ) CIN II+ Incidce: EC+: 2.06 per 0 (95% CI ) EC-: 1.09 per 0 (95% CI ) Relat risk (unadjusted): 0.55 (95% CI ) ] for the is negligible, because in most of the EC- cases no abnormalities were found in the subsequt Pap r tak after 36 weeks. A higher number of cells were significantly associated with the detection of a higher number of squamous atypical cells it would be possible to consider that 10 or metaplastic cells as defined by Bethesda System may be insufficit to adequate transformation zone compont. A lower risk of CIN II+ in the 4.5 yea following the fit negat Pap r is associated with EC- compared to EC+ status. According to these findings, with a negat Pap test lacking EC should be referred for retesting at normal screing intervals indepdt of age. *NS: Not significant CIS : Carcinoma in situ CIN: Cervical intraepithelial neoplasia cells. CMAJ DOI: /cmaj

11 P: Significance χ 2 : Chi square df : Degrees of freedom CI: Confidce interval CIN I: Cervical intraepithelial neoplasia mild dysplasia CIN II: Cervical intraepithelial neoplasia moderate dysplasia CIN II+: Cervical intraepithelial neoplasia moderate dysplasia or higher (grade 2 or higher) CIN III: Cervical intraepithelial neoplasia severe dysplasia, carcinoma in situ LSIL: low grade sqaumous intraepithelial lesion LSIL+: low grade sqaumous intraepithelial lesion HSIL: high grade sqaumous intraepithelial lesion HSIL+: high grade sqaumous intraepithelial lesion ASCUS+: Abnormal cervical cells cells. CMAJ DOI: /cmaj