Beyond Tradition: Investigating TruScreen's Performance Versus Pap Smear in Cervical Cancer Detection

doi:10.21203/rs.3.rs-4638793/v1

Objectives: The study aimed to determine whether the real-time optoelectronic device (TruScreen™; TS) could be used as an alternative or adjunct to Pap Smear (Liquid Based Cytology (LBC)) for cervical cancer screening.

Method: We conducted a prospective observational study that recruited women who were routinely followed at the gynaecology clinics during the data collection period. All eligible women opportunistically underwent TS and LBC examinations after study enrolment. Women with abnormal findings were referred for colposcopy and cervical biopsy within one month of the abnormal screening results.

Results:Overall, 507 women fulfilled the eligibility criteria and were included in this study, of which 30 women (5.9%) had abnormal TS findings and underwent colposcopy. Thirteen women (43.3%) had low-grade lesions, and only one (3.3%) had a high-grade lesion. Regarding biopsy findings, three women had cervical intraepithelial neoplasia (CIN) I, two women had CIN II+, and one had glandular hyperplasia. The TS yielded a sensitivity of 83.3% (95% CI: 35.9-99.6%) and a specificity of 95% (95% CI: 92.7- 96.8%) for the detection of pathologically diagnosed cervical neoplasms, compared to 66.7% (95% CI: 22.3-95.7%) and 98.2% (95%: CI 96.6%-99.2%) of the Pap smear, respectively. The difference between both screening tools was not statistically significant (p=0.91). The sensitivity (100%, 95% CI 15.6–100%) and specificity (95.6%, 95% CI 93.4-97.2%) of TS and Pap smear for CIN II+ lesions were notably high.

Conclusion: TS represents a reliable and practical screening tool for cervical neoplasms without the need for cervical samples, laboratory equipment, or trained staff. Our study showed that the tool provided real-time and accurate screening results, making it suitable for screening women at risk of cervical cancer.

Cervical cancer

Optoelectronic cervical screening

TruScreen

Real-time screening

pap smear

CIN

Globally, cervical carcinoma ranks as the fourth most frequent cancer and one of the leading causes of cancer-related mortality in women [1]. According to the Global Cancer Statistics (GLOBOCAN 2020) report, there were about 604,000 females diagnosed with cervical cancer, with an estimated mortality rate of 342,000 women in 2020 [2]. The incidence and death rates of cervical cancer were profoundly elevated (about 85%) in low to middle-income countries, while they accounted for only 3.6% in developed countries [3]. This increased incidence and mortality rates correlate significantly with the lack of screening programs for cervical cancer [4, 5].

Human papillomavirus (HPV) infection is a major risk factor for cervical cancer, as the infection can lead to cervical intraepithelial neoplasia (CIN) [6]. Nonetheless, it takes about 5-10 years for lesions to progress from CIN II+ to invasive cancer [7]. Therefore, cervical cancer is considered a preventable malignancy, and there is a great opportunity for early detection of the precancerous lesion by screening methods [8, 9].

In light of this, the World Health Organization (WHO) has aimed to eliminate cervical cancer by 2030 through a comprehensive approach that includes prevention, early diagnosis, effective screening, and treatment programs [10]. Cervical cancer prevention is critical for lowering the disease burden and achieving sustainable development goals for health [11]. Moreover, multiple vaccines are available to protect against common cancer-causing types of HPV [12].

Furthermore, early diagnosis is also critical for reducing the incidence and mortality of cervical cancer, yet many countries, including Saudi Arabia, have no established national screening programs. In women with pathologically detected lesions, cryotherapy or loop electrosurgical excision procedure (LEEP) are effective ablation techniques. To prevent cancer development or treat it at an early stage, the WHO recommends the following screening modalities: HPV, cytology, and visual inspection with acetic acid (VIA) for women whose transformation zone is visible [5].

Over the last few decades, the importance of national screening programs for detecting the early stages of cervical cancer has emerged. The Pap smear, i.e., conventional cytology, is the most commonly used test; however, it has limitations regarding sensitivity and specificity. The false negative rate has been reported to be as high as 53%, which is related to subjective errors in smear preparation and evaluation [5, 13]. Besides, the cytology results cannot be obtained promptly, increasing the risk of women being lost to follow-up. In many countries, including Saudi Arabia, two visits are required to obtain the results of cytology screening within one to two weeks.

Colposcopic assessment following abnormal cytological changes is a diagnostic tool that has more accuracy than traditional cytology and an estimated overall sensitivity and specificity of 80% and 92%, respectively [14, 15]. Colposcopy is considered a cost-effective diagnostic paradigm, especially in poor-resource settings. However, visual experience and well-trained healthcare professionals are required to evaluate the results accurately [16–18]. With the evolution of scientific technology, a novel real-time optoelectronic device called TruScreen (TS) has been introduced. It is considered to be an expert system approach using artificial intelligence. It has substantial advantages, being a highly objective, non-invasive, simple, and self-checking tool with real-time results and minimal resource costs [5, 19]. Several studies have proven the clinical validation of the TS device [5, 20–22], and a multicenter investigation looked at the screening utility of the TS and Pap smear combination [23]. It showed that the combination improved the sensitivity for CIN III+ diagnosis from 69% to 93% [23].

The burden of cervical cancer is still considerable in the Middle East region despite the implementation of several screening programs in the region. Despite several reports of the use of TS for cervical cancer screening over the past few years, there have been very few from the Middle East. Therefore, this study aimed to determine whether the real-time optoelectronic device (TruScreen™) could be used as an alternative or adjunct to Pap Smear (Liquid Based Cytology) for cervical cancer screening.

The report of the present study was prepared in concordance with the statement of the Standards for Reporting Diagnostic Accuracy (STARD) [24]. The study protocol was approved by the institutional review board (IRB) (Ref No. Dr. Sulaiman Al-Habib Medical Group – RC20.08.91- Aug 2020). All patients were required to sign the informed consent before enrolment

Study Design and subjects

We conducted a prospective observational multicentre study that recruited women who were routinely followed at the gynecology clinics and Takhassusi hospitals of Al-Habib Medical Group, Arrayan, Olaya, Riyadh, Saudi Arabia, from January 2021 to January 2022. The study invited five hundred and ninety-one women aged 23-65 who presented consecutively at the outpatient gynaecology clinics during data collection. All reproductive age group women who attended the outpatient gynaecology clinics during the study period were eligible for the study. The inclusion criteria included the agreement to participate in the study and signing the informed consent, with no previous history of hysterectomy, and not menstruating, pregnant, or post-partum. Conversely, women who had a confirmed diagnosis of carcinoma or had any vaginal infection were excluded from the study.

All eligible women underwent opportunistic TS and Pap smear examinations by gynecologists (who had proper training on TS) after enrolment. Women with abnormal findings were referred for colposcopy and cervical biopsy within one month. Before the examination, the following data were collected: age, ethnicity, smoking status, obstetric history, presence of any inter-menstrual bleeding, human immunodeficiency virus (HIV) status, history of HPV or warts, immunosuppressant use, method of contraception, HPV vaccination status, and previous Pap smear history.

TruScreen and Pap Smear Examinations

The TS examination was performed using TruScreen Pty Ltd (NZX/ASX: TRU) with the woman in the lithotomy position. The device provided a real-time cervical assessment following the application of the disposable photoelectric sensor to ≥15 cervical epithelial sites.

The TruScreen device is a real-time optoelectronic screening tool that detects precancerous and cancerous cervical lesions by comparing the optical and electrical physical characteristics and behaviors of the tissue of interest with those of known tissue types.

The device comprises a handheld probe connected to a wireless electromagnetic induction Qi charging cradle, with a total length of approximately 37 cm from base to tip (Figure 1-3). The length of the part of the probe that is inserted into the vagina is 120 mm, and the diameter of its tip is approximately 5 mm. The handpiece probe is also covered by a sheath that incorporates a single-use sensor, increasing the tip diameter to about 6.5mm.

The device classified all results as either normal or abnormal. All operators were blinded to the results of any previous Pap smears, and the examination was performed without colposcopic visualization. Likewise, the laboratory technicians were blinded to the results of TS. The Pap smear examination was conducted using the Liquid Based Cytology, and the results were interpreted according to the Bethesda system 2001[25]. The TS and Pap smear were performed in the same sessions.

Colposcopy and biopsy

Women with abnormal TS or Pap smear results were referred for colposcopic examination by a qualified gynecologist. Biopsies were obtained from abnormal areas and sent for histopathology. Patients whose squamocolumnar junction could not be fully exposed had an endocervical curettage. Patient management was based on a 2-tier grading system for low-grade (CIN I) and high-grade (CIN II+ and CIN III+) abnormalities [26].

Statistical analysis

The sample size was calculated to detect a significant sensitivity, given that the prevalence of CIN II+ ranges between 5% and 20% in a referral hospital. Based on these prevalence rates and a 95% confidence interval (95% CI), a sample size of 600 patients was a conservative estimate for the study covering most gynecological abnormalities. The selected patients for the clinical performance evaluation have a higher prevalence of abnormal lesions compared to the general population, which allows for the assessment of the sensitivity and the false negative rate of the device. A loss of follow-up up to 20% was also considered.

The statistical analysis was conducted using Stata version 16.0 (Stata Corp LLC, College Station, TX 77845, USA). Data were summarized using mean and standard deviation (SD) for continuous parameters, while counts and percentages were used for categorical parameters. The screening performance of TS and Pap smear was calculated with a 95% CI using sensitivity (number of patients with pathologically diagnosed lesions who had abnormal results divided by all patients with pathologically diagnosed lesions X 100), specificity (number of patients with normal results divided by all patients with normal pathologies X 100), positive predictive value (PPV; the number of patients with true positive results divided by the number of patients with true positive and false positive results X 100), and negative predictive value (NPV; the number of patients with true negative results divided by the total number of patients with negative results X 100). The Chi-square test or Fisher's exact test was used to compare the screening performance of TS and Pap smear, as appropriate. A p-value < 5% was considered statistically significant.

Five hundred and ninety-one women were recruited in the study; 84 of them who were lost to follow-up were excluded. Five hundred and seven women fulfilled the eligibility criteria and were included, with a mean age of 38.7 ±8.5 years (range 23 – 61). Most women were Arabs (79.3%), and only (4.7%) were smokers. Overall, 22.5% and 12.6% of the women reported a history of abnormal vaginal and post-coital bleeding, respectively. Seventy-nine women (15.6%) were on one or more contraceptive methods, mainly combined oral contraceptives. Only one woman (0.2%) had HIV, while 16 women (3.2%) had a history of HPV/vaginal warts. Nearly 27% of the women reported previous Pap smear results, and 18.7% of them were abnormal.

Table 1: Demographics and Baseline Characteristics of the Included Women

Variables		Women (n =507)
Age (Year), mean ±SD		38.7 ±8.5
Ethnicity, N (%)	Arab	402 (79.3)
	Indian	16 (3.1)
	Asian	57 (11.2)
	African	2 (0.4)
	Caucasian	11 (2.2)
	Other	19 (3.7)
Smoking, N (%)		24 (4.7)
Parity, mean ±SD		2.7 ±1.9
Abnormal vaginal bleeding, N (%)		114 (22.5)
Postcoital bleeding, N (%)		73 (14.4)
Contraception, N (%)		79 (15.6)
Contraception type, N (%)	Combined contraceptives	42 (8.3)
	IUCD	30 (5.9)
	IMPLANON /DEPO/pop	6 (1.2)
Known HIV, N (%)		1 (0.2)
HPV/vaginal warts, N (%)		16 (3.2)
Immunosuppressant use, N (%)		7 (1.4)
HPV vaccination, N (%)		6 (1.2)
Previous Smear, N (%)		136 (26.8)
Smear Results*, N (%)	Normal	106 (77.9)
	Abnormal	25 (18.7)
	Unsatisfactory	1 (0.7)
Previous HPV test, N (%)		9 (1.8)

* n =136

Abbreviations: IUCD, Intrauterine contraceptive device; HIV, Human Immunodeficiency Virus; HPV, Human Papillomavirus

Findings TruScreen, Pap Smear, Colposcopy, and Biopsy

Overall, 30 women (5.9%) had abnormal TS findings, while the distribution of Pap smear results was as follows: normal (75%), atypical squamous cells of undetermined significance (ASCUS) (0.6%), low-grade squamous intraepithelial lesion (LSIL) (0.8%), high-grade squamous intraepithelial lesions (HSIL) (0.4%), inflammatory/reactive cellular (21.1%), endometrial cells (1%), and unsatisfactory (1.2%). When we correlated the findings of TS with Pap smear results, we observed the following: 14 women with normal smear results had an abnormal TS (2.8%); two of the three women with ASCUS (66.7%) and two of the four women with LSIL (50%) had a normal TS, and none of the patients with endometrial cells had an abnormal TS (Figure 4). Thirty women underwent colposcopy, of whom 13 (43.3%) had low-grade lesions, and only one (3.3%) had a high-grade lesion. Nine women (30%) had vascular patterns, while none of the women had microinvasion (Figure 5). Regarding biopsy findings, three women had CIN I, two had CIN II+, and one had glandular hyperplasia (Supplementary Table 1).

Screening Performance of TruScreen and Pap Smear

The TS yielded a sensitivity of 83.3% (95% CI: 35.9% - 99.6%) and a specificity of 95% (95% CI: 92.7% - 96.8%) for the detection of pathologically diagnosed cervical neoplasms, compared to 66.7% (95% CI: 22.3% - 95.7%) and 98.2% (95% CI: 96.6% - 99.2%) for Pap smear, respectively. The difference between both screening tools was not statistically significant (p =0.91). For women with CIN I, the TS had a sensitivity of 66.7% (95% CI: 12.5% – 98%) and a specificity of 95.6% (95% CI: 93.4% - 97.2%), compared to 66.7% (95% CI: 12.5% – 98%) and 98.2% (95% CI: 96.6% - 99.2%) for the Pap smear, respectively. For CIN II+ lesions, the sensitivity (100%; 95% CI 15.8% – 100%) and specificity (95.6%; 95% CI 93.4% - 97.2%) of TS and the sensitivity (100%; 95% CI 15.8% – 100%) and specificity (98.6%; 95% CI 97.1 - 99.4%) of the Pap smear were both high. There was no significant difference in TS and Pap smear screening performance concerning glandular hyperplasia (Table 2).

When we combined the TS and Pap smear, the following diagnostic parameters were observed: for pathologically diagnosed cervical neoplasms, the sensitivity was 100% (95% CI: 54.1% - 100%), and the specificity was 99.8% (95% CI: 98.89% – 99.9%). For women with CIN I, the sensitivity was 100% (95% CI: 54.1% - 100%), and the specificity was 99.8% (95% CI: 98.89% – 99.99%). While for CIN II+ lesions, the sensitivity was 100% (95% CI: 54.1% - 100%), and the specificity was 99.80% (95% CI: 98.89% – 99.99%).

Table 2: Screening Performance of TruScreen and Pap Smear

*Statistic*	TruScreen			Pap smear			Combined Pap + Trusscreen			P-value*
*Statistic*	*No/total*	*Value*	*95% CI*	*No/total*	*Value*	*95% CI*	*No/total*	*Value*	*95% CI*	P-value*
Detection of abnormal cases (n =6)
Sensitivity	5/6	83.3%	35.9% to 99.6%	4/6	66.7%	22.3% to 95.7%	6/6	100%	54.1% to 100.0%	0.910^#
Specificity	476/501	95%	92.7% to 96.8%	492/501	98.2%	96.6% to 99.2%	500/501	99.80%	98.89% to 99.99%
Positive Predictive Value	5/5	100%	54.1% to 100.0%	4/4	100%	54.1% to 100%	5/5	100%	54.1% to 100.0%
Negative Predictive Value	467/467	100%	54.1% to 100.0%	492/492	100%	54.1% to 100%	500/500	100%	54.1% to 100%
Detection of CIN I (n =3)
Sensitivity	2/3	66.7%	12.5 – 98%	2/3	66.7%	12.5 – 98%	3/3	100%	54.1% to 100%	---
Specificity	476/498	95.6%	93.4% to 97.2%	492/501	98.2%	96.6% to 99.2%	500/501	99.80%	98.89% to 99.99%
Positive Predictive Value	2/2	100%	20.0 – 100%	2/2	100%	20 – 100%	3/3	100%	54.1% to 100.0%
Negative Predictive Value	467/467	100%	54.1% to 100%	492/492	100%	54.07% to 100%	500/500	100%	54.1% to 100%
CIN II+ (n =2)
Sensitivity	2/2	100%	15.81% to 100%	2/2	100%	15.8% to 100%	2/2	100%	54.1% to 100%	---
Specificity	476/499	95.3%	93.2% to 97.1%	492/499	98.6%	97.1% to 99.4%	500/501	99.80%	98.89% to 99.99%
Positive Predictive Value	1/1	100%	15.8% to 100%	1/1	100%	15.8% to 100%	2/2	100%	54.1% to 100.0%
Negative Predictive Value	467/467	100%	54.07% to 100%	492/492	100%	54.07% to 100%	500/500	100%	54.1% to 100%
Glandular hyperplasia (n =1)
Sensitivity	1/1	100%	5.5 to 100%	0/1	0%	0 to 94%	1/1	100%	54.1% to 100%	0.761
Specificity	476/500	95.2%	92.9% to 96.9%	492/500	98.4%	96.8% to 99.3%	500/501	99.80%	98.89% to 99.99%
Positive Predictive Value	1/1	100%	5.5 to 100%	0/1	0%	0 to 94%	1/1	100%	54.1% to 100.0%
Negative Predictive Value	467/467	100%	54.1% to 100.0%	492/492	100%	54.1% to 100%	500/500	100%	54.1% to 100%

^#Chi-square with Fisher's exact; *for Truscreen versus Pap smear

Several developed countries have witnessed a significant reduction in cervical cancer incidence and cause-specific mortality over recent years due to the implementation of national screening protocols [27, 28]. Still, the incidence and mortality of cervical cancer are considerable in the Middle East region and have increased over the period from 2000 to 2017 [29]. While such an increase can be attributed to improved access to healthcare services and lifestyle changes [29], previous reports have suggested that suboptimal implementation of screening programs and the unavailability of trained staff were also major contributors [30].

While cytology is considered the main screening tool in Middle Eastern countries, including Saudi Arabia, it has several disadvantages, including the need for cervical sampling, laboratory equipment, and trained cytopathologists. These all limit accessibility to cytology in rural and low-resource settings. Besides, the cultural acceptance of a Pap smear may be limited in some parts of the world [31–33]. Therefore, there is an unmet need to adopt a more practical but accurate tool for cervical cancer screening. TS can provide a rapid and practical assessment of cervical neoplasms by detecting the voltage response to different frequencies applied to the cervical tissue [19]. While the TS cannot determine the degree of abnormalities, a growing body of evidence has demonstrated that TS has a high screening yield in detecting cervical neoplasms [34]. A comparative study between TS and the conventional Pap test at the Whittington Hospital in London found that TS was associated with significantly less pain, pressure, and scraping compared to the spatula or brushes used to collect cells from the cervix in cytology-based screening [23]. Additionally, women strongly preferred access to an immediate result [23].

The present study showed that the real-time TS had high sensitivity (83.3%) and specificity (95%) for detecting cervical neoplasia, comparable to LBC results. The screening performance of TS was consistent across the CIN I, CIN II+, and glandular hyperplasia lesions (sensitivity ranging from 66.7 to 100% and specificity of nearly 96%). Besides, the TS showed a high PPV, highlighting its role in reducing the cost associated with screening by lowering the number of women who unnecessarily undergo colposcopy and biopsy. Additionally, our results showed that the positive rate of TS increased markedly with increasing severity of lesions.

Our findings align with a previous prospective study showing that TS had a sensitivity and NPV of 86.1% and 89.5%, respectively, for detecting cervical pathologies [34]. Moreover, a more recent report showed that TS had a sensitivity and specificity of 96.3% and 46.4%, respectively, for detecting CIN II+ in HPV-positive patients [20]. In a previous meta-analysis, TS had a sensitivity and specificity of 76% and 69%, respectively [35].

Other reports have shown lower TS sensitivity than our results. For example, Campos et al. reported a sensitivity of 43% for detecting high-grade intraepithelial lesions. However, the study showed good-to-excellent agreement between TS and colposcopy [19]. This discrepancy in the published literature can be attributed to the difference in the screened population, the standard detection method, and/or methodological differences in calculating the screening performance of TS.

A growing body of literature has shown that combining TS with other modalities can yield higher accuracy and reduce the need for colposcopy. Wei et al. reported that TS had higher sensitivity and specificity than the Pap smear. Still, when the two were combined, the sensitivity and specificity increased [22], which is consistent with our results. The approach that exhibited the highest sensitivity (96.3%) and specificity (83.6%) for CIN II+ was the combination of HPV16/18 and TS (both positive) [20].

In a recent study, a thin-layer liquid-based cytology test (TCT) combined with HPV had a considerably lower specificity (39.9%) than HPV combined with TS (50%) for CIN II+ in women with high-risk HPV positivity, while the sensitivity for the two combinations was comparable (93.94% vs. 87.88%). Similar patterns were also observed in patients with CIN III+ [22]. Hence, a TS and HPV combination has the excellent potential to provide effective cervical cancer screening. Studies from China, Poland, and Turkey showed similar findings [24]. However, additional data are needed to analyze and verify the validity of this finding.

To our knowledge, our study represents the first evidence from the Middle East region regarding the feasibility and screening performance of TS for detecting cervical neoplasms. The present study has the strength of collecting the data prospectively, hence avoiding misclassification or ascertainment bias. Limitations include that the sample size, particularly of women referred for colposcopy, was relatively small (some of them were reluctant to proceed, while some have lost follow-up), which may increase the probability of a type II error. Although the three hospitals included were located in Riyadh, the patients came from all over the Kingdom, since they are referral hospitals. It would be recommended that future studies be conducted on more numerous sample samples around the country to validate the findings of this study on a larger scale from different regions and populations with different socioeconomic backgrounds.

TS represents a reliable, practical screening tool for cervical neoplasms without the need for cervical samples, laboratory equipment, or trained staff. Although the doctors did the examination in our study, nurses can also be trained and get involved in screening programs to perform TS examinations independently. Our study showed that the tool provided real-time and accurate screening results, making it suitable for quick screening of at-risk women or in low-resource settings. Additionally, it could potentially prompt the see-and-treat protocol as more evidence emerges in favor of such an approach.

Our results can provide an evidence-based approach for policymakers when selecting the optimal cervical cancer screening strategy in countries without an established national screening program. However, additional research is still needed to confirm the clinical efficacy of TS in the Middle East population.

Funding statement:

The authors received no financial support for the research, authorship, and/or publication of this article.

A conflict of interest statement:

All authors declare that they have no conflicts of interest.

Acknowledgements:

The authors extend their gratitude to the following colleagues for their dedicated efforts and time throughout the study period:

Dr. Shehnaz Iqbal, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Shakera Parveen, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Suhad AlKaf, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Ranya AbdelJabbar, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Shaza Yassin, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Thana Goda, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Nabeela Abu Tahoun, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Aida Saeed, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Gina Aboutaleb, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Khawar Shafiq, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Majdolin Yahya, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Salwa Ibrahim, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Huwaida Elattia, Consultant OBGYN, Dr Sulaiman Alhabib Medical Group

Dr. Nafia Chaudhry, Specialist OBGYN, Dr Sulaiman Alhabib Medical Group

Author's contribution:

Dr. Majed Alhudhud conceived and designed the analysis, and Dr. Maab El Hussien collected the data. The rest of the authors provided data and analysis tools and contributed to patients’ recruitment. Additionally, Dr. Maab Elhussien performed the analysis, and Dr. Majed Alhudhud wrote the manuscript

Data sharing statement:

Will individual participant data be available (including data dictionaries)?	Yes
What data in particular will be shared?	Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
What other documents will be available?	Study Protocol
When will data be available (start and end dates)?	Beginning 9 months and ending 36 months following article publication.
With whom?	Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses?	For individual participant data meta-analysis.
By what mechanism will data be made available?	Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our Hospital Research Centre's data warehouse without investigator support other than deposited metadata.

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Supplementary Table 1 is not available with this version.

No competing interests reported.

Beyond Tradition: Investigating TruScreen's Performance Versus Pap Smear in Cervical Cancer Detection

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Version 1

Abstract

Figures

Introduction

Patients and Methods

Results

Discussion

Conclusion

Declarations

References

Supplementary Table

Additional Declarations

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