Screening Setting Research Articles

Is It Useful to Determine the Temperature of Children for COVID-19 Screening in the Dental Setting?

Background: To date, the efficacy of temperature readings of children in the dental setting for COVID-19 screening has not been evaluated. The aim of this pilot study was to assess the usefulness of forehead temperature measurements in a dental clinic for COVID-19 screening in healthy children (without systemic disease) and in children with neurodevelopmental disorders. Methods: Using an infrared thermometer, we recorded the forehead temperature of 200 pediatric patients (100 healthy children and 100 children with neurodevelopmental disorders). We performed temperature measurements “before”, “during”, and “after” the dental procedure. Oropharyngeal swabs were taken of all participants to detect SARS-CoV-2. Results: Sex, age, administration of local anesthesia, and use of rotary instrumentation did not affect the temperature values. In the children with neurodevelopmental disorders with a value of 1 on the Frankl behavior scale, the temperatures were significantly higher than in those with values of 2, 3, and 4 (p = 0.032, p = 0.029, and p = 0.03, respectively). The PCR for SARS-CoV-2 was positive for two patients (one healthy and the other with a neurodevelopmental disorder), whose “before” temperatures were 36.4 °C and 36.5 °C, respectively. Conclusions: Forehead temperatures increase during dental procedures and are conditioned by the patient’s behavior. An isolated temperature reading does not identify children infected by SARS-CoV-2.

Serum RNAs can predict lung cancer up to 10 years prior to diagnosis.

Lung cancer (LC) prognosis is closely linked to the stage of disease when diagnosed. We investigated the biomarker potential of serum RNAs for the early detection of LC in smokers at different prediagnostic time intervals and histological subtypes. In total, 1061 samples from 925 individuals were analyzed. RNA sequencing with an average of 18 million reads per sample was performed. We generated machine learning models using normalized serum RNA levels and found that smokers later diagnosed with LC in 10 years can be robustly separated from healthy controls regardless of histology with an average area under the ROC curve (AUC) of 0.76 (95% CI, 0.68-0.83). Furthermore, the strongest models that took both time to diagnosis and histology into account successfully predicted non-small cell LC (NSCLC) between 6 and 8 years, with an AUC of 0.82 (95% CI, 0.76-0.88), and SCLC between 2 and 5 years, with an AUC of 0.89 (95% CI, 0.77-1.0), before diagnosis. The most important separators were microRNAs, miscellaneous RNAs, isomiRs, and tRNA-derived fragments. We have shown that LC can be detected years before diagnosis and manifestation of disease symptoms independently of histological subtype. However, the highest AUCs were achieved for specific subtypes and time intervals before diagnosis. The collection of models may therefore also predict the severity of cancer development and its histology. Our study demonstrates that serum RNAs can be promising prediagnostic biomarkers in an LC screening setting, from early detection to risk assessment.

Liquid biopsies for colorectal cancer: a narrative review of ongoing clinical trials and the current use of this technology at a comprehensive cancer center.

In this review, we summarize ongoing clinical trials involving liquid biopsies (LB) for colorectal cancer (CRC), outlining the current landscape and the future implementation of this technology. We also describe the current use of LB in CRC treatment at our institution, the Mayo Clinic Enterprise. The use of LB in CRC treatment merits close attention. Their role is being evaluated in the screening, non-intervention, intervention, and surveillance settings through many active trials. This, coupled with the technique's rapid integration into clinical practice, creates constant evolution of care. Review of ClinicalTrials.gov was performed identifying relevant and active trials involving LB for CRC. "Colorectal cancer" plus other terms including "liquid biopsies" and "ctDNA" were used as search terms, identifying 35 active trials. LB use for the CRC is actively being investigated and requires close attention. Based on current evidence, Mayo Clinic Enterprise currently uses LB in the non-interventional, interventional and surveillance setting, but not for screening. Results of these trials may further establish the use of LB in the management of CRC.

Psychiatric Distress and Suicidal Tendencies in Adult Cancer Survivors: Verifying the Validity of the Brief Symptom Inventory-18 for Identifying Suicidal Ideation in the Hospitalized Population of Mainland China.

The Brief Symptom Inventory-18 (BSI-18) is widely used to assess psychiatric distress but has not been verified in the Chinese population. From March to April 2019, 293 hospitalized cancer patients, aged 20-87, completed the cross-sectional survey with demographics questionnaire, BSI-18, and PHQ-9. We analyzed the single suicide-related item of PHQ-9 with the full score clinical outpoint for BSI-18 and PHQ-9 using SPSS 22.0 and R 2.15, including Pearson's χ2 test and ROC curve analyses. A Pearson's χ2 test was carried out to compare the three different methods with the gold screening criteria. The p-value was correspondingly to .006, .066, .838. When the PHQ-9 ≥ 10 criteria for the BSI-18, receiver operating characteristic analysis revealed that AUC values were 0.839, optimal cut-off points for both BSI-18 ≥ 50, the sensitivity of 85.8%, and 62.5%, respectively. The BSI-18 is suitable for a screening tool for psychological distress and could also be used in clinical settings for preliminary screening of hospitalized cancer patients.

Advances in Abbreviated Breast MRI and Ultrafast Imaging

Abbreviated breast MRI is an emerging technique that is being incorporated into clinical practice for breast cancer imaging and screening. Conventional breast MRI includes barriers such as high examination cost and lengthy examination times which make its use in the screening setting challenging. Abbreviated MRI aims to address these pitfalls by reducing overall examination time and increasing accessibility to MRI while preserving diagnostic accuracy. Sequences selected for abbreviated MRI protocols allow for preserved accuracy in breast cancer detection and characterization. Novel techniques such as ultrafast imaging are being used to provide kinetic information from early post-contrast imaging.

Diagnostic Accuracy of Abbreviated Bi-Parametric MRI (a-bpMRI) for Prostate Cancer Detection and Screening: A Multi-Reader Study.

(1) Background: There is currently limited evidence on the diagnostic accuracy of abbreviated biparametric MRI (a-bpMRI) protocols for prostate cancer (PCa) detection and screening. In the present study, we aim to investigate the performance of a-bpMRI among multiple readers and its potential application to an imaging-based screening setting. (2) Methods: A total of 151 men who underwent 3T multiparametric MRI (mpMRI) of the prostate and transperineal template prostate mapping biopsies were retrospectively selected. Corresponding bpMRI (multiplanar T2WI, DWI, ADC maps) and a-bpMRI (axial T2WI and b 2000 s/mm2 DWI only) dataset were derived from mpMRI. Three experienced radiologists scored a-bpMRI, standard biparametric MRI (bpMRI) and mpMRI in separate sessions. Diagnostic accuracy and interreader agreement of a-bpMRI was tested for different positivity thresholds and compared to bpMRI and mpMRI. Predictive values of a-bpMRI were computed for lower levels of PCa prevalence to simulate a screening setting. The primary definition of clinically significant PCa (csPCa) was Gleason ≥ 4 + 3, or cancer core length ≥ 6 mm. (3) Results: The median age was 62 years, the median PSA was 6.8 ng/mL, and the csPCa prevalence was 40%. Using a cut off of MRI score ≥ 3, the sensitivity and specificity of a-bpMRI were 92% and 48%, respectively. There was no significant difference in sensitivity compared to bpMRI and mpMRI. Interreader agreement of a-bpMRI was moderate (AC1 0.58). For a low prevalence of csPCa (e.g., <10%), higher cut offs (MRI score ≥ 4) yield a more favourable balance between the predictive values and positivity rate of MRI. (4) Conclusion: Abbreviated bpMRI protocols could match the diagnostic accuracy of bpMRI and mpMRI for the detection of csPCa. If a-bpMRI is used in low-prevalence settings, higher cut-offs for MRI positivity should be prioritised.

Remote Screening for Atrial Fibrillation by a Federal Cardiac Monitoring System in Primary Care Patients in Russia: Results from the Prospective Interventional Multicenter FECAS-AFS Study.

Background:Screening for atrial fibrillation has the potential to significantly reduce cardiovascular morbidity and mortality. However, questions in regard to how to screen, on whom to screen, and the optimal setting of screening remain unanswered.Objective:To assess the applicability of a federal cardiac monitoring for atrial fibrillation (AF) screening and remote heart rhythm monitoring in patients at high cardiovascular risk in a mixed urban and rural population in Russia.Methods:This is a prospective multicenter cohort study including 3249 individuals with high cardiovascular risk (mean age 56 ± 12.8 years) from the larger Moscow region who were screened for AF using a smartphone-case based single-lead ECG monitor over a period of 18 month. The endpoints were considered as number of newly diagnosed AF; mean time to diagnosis; number of patients for the first time assigned to anticoagulation therapy; frequency of adverse events.Results:A trial fibrillation was diagnosed in 126 patients, 36 of them for the first time. The mean time to diagnosis was 3 ± 2 days. Of 36 patients, the CHA2DS2-VASc score was ≥1 in 34 cases, ≥2 in 29 cases. Anticoagulant therapy was first induced in 31 patients. One death in newly diagnosed group and two deaths in chronic group were registered. There were a total of eight hospitalizations: one in newly diagnosed and seven in chronic AF patients.Conclusion:Our results indicate that a Federal AF screening system in patients at high cardiovascular risk by using a smartphone-case based single lead ECG which is supported by centrally located ECG specialist and central data management is feasible and reliable when performed in a mixed urban and rural area. Further studies are needed to evaluate the full potential of this approach.

Clinical Utility of Germline Genetic Testing in Japanese Men Undergoing Prostate Biopsy.

BackgroundMultiple common variants and also rare variants in monogenic risk genes such as BRCA2 and HOXB13 have been reported to be associated with risk of prostate cancer (PCa); however, the clinical setting in which germline genetic testing could be used for PCa diagnosis remains obscure. Herein, we tested the clinical utility of a 16 common variant–based polygenic risk score (PRS) that has been developed previously for Japanese men and also evaluated the frequency of PCa-associated rare variants in a prospective cohort of Japanese men undergoing prostate biopsy.MethodsA total of 1336 patients undergoing first prostate biopsy were included. PRS was calculated based on the genotype of 16 common variants, and sequencing of 8 prostate cancer–associated genes was performed by multiplex polymerase chain reaction based target sequencing. PRS was combined with clinical factors in logistic regression models to assess whether addition of PRS improves the prediction of biopsy positivity.ResultsThe top PRS decile was associated with an odds ratio of 4.10 (95% confidence interval = 2.46 to 6.86) with reference to the patients at average risk, and the estimated lifetime absolute risk approached 20%. Among the patients with prostate specific antigen 2-10 ng/mL who had prebiopsy magnetic resonance imaging, high PRS had an equivalent impact on biopsy positivity as a positive magnetic resonance imaging finding. Rare variants were detected in 19 (2.37%) and 7 (1.31%) patients with positive and negative biopsies, respectively, with BRCA2 variants being the most prevalent. There was no association between PRS and high-risk rare variants.ConclusionsGermline genetic testing could be clinically useful in both pre- and post-PSA screening settings.

Performance evaluation of digital mammography, digital breast tomosynthesis and ultrasound in the detection of breast cancer using pathology as gold standard: an institutional experience

BackgroundMammography is the primary imaging modality for diagnosing breast cancer in women more than 40 years of age. Digital breast tomosynthesis (DBT), when supplemented with digital mammography (DM), is useful for increasing the sensitivity and improving BIRADS characterization by removing the overlapping effect. Ultrasonography (US), when combined with the above combination, further increases the sensitivity and diagnostic confidence. Since most of the research regarding tomosynthesis has been in screening settings, we wanted to quantify its role in diagnostic mammography. The purpose of this study was to assess the performance of DM alone vs. DM combined with DBT vs. DM plus DBT and ultrasound in diagnosing malignant breast neoplasms with the gold standard being histopathology or cytology.ResultsA prospective study of 1228 breasts undergoing diagnostic or screening mammograms was undertaken at our institute. Patients underwent 2 views DM, single view DBT and US. BIRADS category was updated after each step. Final categorization was made with all three modalities combined and pathological correlation was done for those cases in which suspicious findings were detected, i.e. 256 cases. Diagnosis based on pathology was done for 256 cases out of which 193 (75.4%) were malignant and the rest 63 (24.6%) were benign. The diagnostic accuracy of DM alone was 81.1%. Sensitivity, Specificity, PPV and NPV were 87.8%, 60%, 81.3% and 61.1%, respectively. With DM + DBT the diagnostic accuracy was 84.8%. Sensitivity, Specificity, PPV and NPV were 92%, 56.5%, 89% and 65%, respectively. The diagnostic accuracy of DM + DBT + US was found to be 85.1% and Sensitivity, Specificity, PPV and NPV were 96.3%, 50.7%, 85.7% and 82%, respectively.ConclusionThe combination of DBT to DM led to higher diagnostic accuracy, sensitivity and PPV. The addition of US to DM and DBT further increased the sensitivity and diagnostic accuracy and significantly increased the NPV even in diagnostic mammograms and should be introduced in routine practice for characterizing breast neoplasms.

Management of Non-Mass Enhancement at Breast Magnetic Resonance in Screening Settings Referred for Magnetic Resonance-Guided Biopsy.

Rationale and Objectives:According to the Breast Imaging and Reporting Data System (BI-RADS), one of the main limitations of MRI is diagnosing the non-mass enhancement (NME). The NME lesion is challenging since it is unique to the MRI lexicon. This study aims to report our experience with NME lesions diagnosed by MRI referred for MRI-guided biopsies and discuss the management and follow-up of these lesions.Materials and Methods:We retrospectively evaluated all MRI-guide breast biopsies. We included all patients referred for NME breast MRI-guided biopsy in screening settings. All patients had a negative second-look mammography or ultrasonography. We correlated the distribution and internal enhancement pattern (IEP) of the NME lesions with histology. Invasive ductal carcinomas (IDC) of no special type and ductal carcinoma in situ (DCIS) were considered malignant lesions.Results:From January-2018 to July-2021, we included 96 women with a total of 96 lesions in the study. There were 90 benign and 6 malignant lesions with DCIS prevalence (5/6 cancers). The most frequent benign lesion type was fibrocystic changes. There were no NME lesions with diffuse or multiple area distribution features referred to MRI-guided biopsy. The positive-predictive values (PPV) were respectively 0.0%, 2.5%, 9.0%, and 11.0% for linear, focal, regional, and segmental distribution describers, and 0.0, 3.0%, 7.9%, and 50% for homogenous, heterogeneous, clumped, and clustered-ring enhancement patterns.Conclusion:We observe the high potential risk for malignancy in the clustered-ring enhancement followed by the clumped pattern. Segmental distribution presented the highest predictive-positive values.

Identifying Frailty in Thermal/Spa Clinical Setting: A Cross-Sectional Study.

No investigation has assessed frailty in the clinical setting of thermal/spa facilities, which often receive older patients with osteo-articular and musculoskeletal conditions. To examine the prevalence of frailty in older adults receiving thermal/spa treatment and to gather preliminary evidence about the feasibility of integrating geriatric assessments, including frailty, in the routine clinical consultations in spa facilities. Mixed design, with a quantitative cross-sectional investigation performed among 197 volunteer patients (mean age 73.2 ± 6.4 years-old; 82.2% women) of seven French thermal/spa facilities and a qualitative investigation (semi-structured interviews) with the nine physicians working in the participating facilities. Frailty was defined according to a modified Fried frailty phenotype based on six self-reported criteria (including mobility impairment, nutritional status, and fatigue): individuals meeting ≥3 criteria were considered frail; 1-2 criteria, pre-frail; no criterion, robust. Interviews with the participating physicians on the feasibility of integrating geriatric assessments in routine clinical consultations at spa facilities were recorded and their content, analyzed. Frailty was detected in 112 individuals (56.9%), 26 (13.2%) were considered prefrail, and 59 (29.9%), robust. Regarding the interviews, three physicians indicated the geriatric assessments could be integrated in the routine spa consultations; two, in the consultations of specific/targeted patients, but not in routine; two, only in the context of health education; two, in the context of research protocols. The content of interviews highlighted geriatric assessments provided a better overview of the health/clinical status of the patients. Frailty is very prevalent in older patients of spa facilities. Such facilities may constitute an interesting clinical setting for screening for frailty through the implementation of geriatric assessments.

Diagnostic Performance of AI for Cancers Registered in A Mammography Screening Program: A Retrospective Analysis.

Purpose: To evaluate the performance of an artificial intelligence (AI) algorithm in a simulated screening setting and its effectiveness in detecting missed and interval cancers. Methods: Digital mammograms were collected from Bahcesehir Mammographic Screening Program which is the first organized, population-based, 10-year (2009-2019) screening program in Turkey. In total, 211 mammograms were extracted from the archive of the screening program in this retrospective study. One hundred ten of them were diagnosed as breast cancer (74 screen-detected, 27 interval, 9 missed), 101 of them were negative mammograms with a follow-up for at least 24 months. Cancer detection rates of radiologists in the screening program were compared with an AI system. Three different mammography assessment methods were used: (1) 2 radiologists’ assessment at screening center, (2) AI assessment based on the established risk score threshold, (3) a hypothetical radiologist and AI team-up in which AI was considered to be the third reader. Results: Area under curve was 0.853 (95% CI = 0.801-0.905) and the cut-off value for risk score was 34.5% with a sensitivity of 72.8% and a specificity of 88.3% for AI cancer detection in ROC analysis. Cancer detection rates were 67.3% for radiologists, 72.7% for AI, and 83.6% for radiologist and AI team-up. AI detected 72.7% of all cancers on its own, of which 77.5% were screen-detected, 15% were interval cancers, and 7.5% were missed cancers. Conclusion: AI may potentially enhance the capacity of breast cancer screening programs by increasing cancer detection rates and decreasing false-negative evaluations.

A Performance Evaluation of an Optoelectronic Cervical Screening Device in Comparison to Cytology and HPV DNA Testing

Objective: An optoelectronic screening device (OESD) is evaluated for the detection of cervical intra-epithelial neoplasia (CIN) 2+ lesions in comparison to Liquid Based Cytology (LBC) and high-risk HPV DNA (hrHPV) testing. Methods: In total 506 consecutive women referred because of abnormal cervical cytology or a positive high-risk HPV test, had an examination using OESD, LBC, and hrHPV testing. They were screened in 4 colposcopy clinics in New South Wales, Australia. In a retrospective audit, results were compared to the gold standard of colposcopy and biopsies if required. Sensitivity, specificity, area under the receiver operating characteristic (ROC)-curves, and differences using McNemar tests were calculated. All results were available for comparison on 474 patients. Results: The sensitivity to detect CIN II+ lesions by OESD, LBC and hrHPV-testing was 0.72, 0.81, and 0.88, and the specificity was 0.71, 0.95, and 0.76 respectively. The age- and previous-treatment adjusted area under the ROC curve for OESD was 0.83, for LBC 0.94, and for hrHPV testing 0.89. McNemar’s tests showed no significant difference in sensitivity between OESD and LBC (p = 0.26), and no significant difference in specificity between OESD and hrHPV-testing (p = 1.0) amongst patients without previous treatment. Conclusions: The optoelectronic screening device demonstrated comparable sensitivity to high quality cytology conducted in a hospital clinical setting. Specificity was comparable to hrHPV-testing in an approximate primary screening setting. OESD has the advantage of producing an immediate result and being easy to use without need of laboratory equipment. This device can potentially become an important tool in the prevention of cervical cancer, particularly in developing countries and resource-limited settings.

Fecal microRNAs, Fecal microRNA Panels, or Combinations of Fecal microRNAs with Fecal Hemoglobin for Early Detection of Colorectal Cancer and Its Precursors: A Systematic Review.

Simple SummaryScreening for colorectal cancer is effective for the reduction of both CRC incidence and mortality in the population at average risk. The use of innovative and robust biomarkers to enhance the potential of noninvasive CRC screening remains desirable. We aimed to conduct a systematic literature review on the diagnostic performance of fecal miRNA markers for CRC and its precursors. Several studies have reported quite promising results, in particular by combining fecal miRNA measurements with fecal hemoglobin. However, current evidence is limited by substantial heterogeneity in the methodology from study design to biosample analysis. Our review is intended to provide a valuable reference for future biomarker studies in early colorectal cancer detection. Looking at fecal miRNAs, we draw attention to the various biases to be avoided or at least minimized, by applying a harmonized methodology including true screening settings and comparable sample pre-analytics, as well as the validation of biomarkers.Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality globally. Fecal miRNAs have been suggested to be promising biomarkers for CRC early detection. We aimed to conduct a systematic literature review on the diagnostic performance of fecal miRNA markers for CRC and its precursors. PubMed and Web of Science were searched to retrieve relevant articles published up to 7 December 2021. Information on study design, characteristics of study population, pre-analytics (sample collection, processing, and storage), fecal miRNA extraction and quantification technologies, and diagnostic performance (including sensitivity, specificity, and area under the curve (AUC)) were summarized. Twenty studies reporting on 31 individual miRNAs and 16 miRNA panels (with 2–9 markers) for CRC diagnosis were identified. Substantial heterogeneity existed regarding stool sample collection, processing, storage, and miRNA extraction and normalization. For two individual miRNAs and one miRNA panel, values ≥ 80% were reported for both sensitivity and specificity; however, none of these results were either internally or externally validated. In a study among fecal immunochemical test-positive cases recruited from a true screening setting, better diagnostic performance was identified and internally validated for a combination panel including two miRNAs, fecal hemoglobin level, and patient age and sex, compared with fecal hemoglobin concentration alone. Fecal miRNAs or miRNA panels, possibly in combination with fecal hemoglobin test, may be promising candidates for noninvasive CRC early detection. However, large prospective and well-designed studies in CRC screening cohorts are required to validate promising miRNAs or miRNA panels.

Trajectories and individual determinants of regular cancer screening use over a long period based on data from the French E3N cohort

Despite several incentive policies for cancer screenings over the last two decades, the overall and regular use of cancer screenings remains insufficient in France. While the individual determinants of cancer screening uptake have been fairly well studied, the literature has rarely focused on the regularity of screening uptake, which is key to early cancer detection. We aimed to address this issue by studying cancer screening behaviors over 15 years, emphasizing the regularity and diversity of use. Using data from 40,021 women in the French E3N cohort, we studied the individual trajectories of screenings for breast, colorectal and cervical cancer between 2000 and 2014. We employed optimal matching methods to identify typical behaviors of use for each cancer screening. Then, we determined the associations between the identified behavior screening patterns for the different cancer screenings and, finally, assessed the associated individual determinants with logistical and multinomial models. We found that screening behaviors were fairly stable over time, with few typical screening patterns for each cancer. Overall, once a woman starts screening, she continues, and once she stops, she no longer returns. Cancer screening behaviors appear consistent; in particular, insufficient use of mammography appears to be associated with long-term nonuse of other cancer screenings. Factors associated with low or nonuse of screening are overall common between cancer screenings and are similar to those identified in the literature of screening use at a single point in time. Ultimately, these barriers prevent some women from entering a screening process in the long run, ultimately reinforcing social inequalities in health. Targeting women with insufficient mammography uptake may reach women outside of cancer screening settings more generally and, thus, both increase the overall uptake of cancer screening and reduce social inequalities in cancer screening.

How much can screening reduce colorectal cancer mortality in Japan? Scenario-based estimation by microsimulation.

Screening is one of the effective interventions for the reduction of colorectal cancer mortality. Though the Japanese government recommends faecal occult blood test and colonoscopy as a follow-up examination following a diagnosis, both participation rates have not been so high and the national mortality rate has not shown a clear decreasing trend. Microsimulation models simulate the life histories of a large population of individuals under various scenarios. In this study, we applied a microsimulation model to estimate the reduction of colorectal cancer mortality based on screening scenarios. The effect of reducing the age-standardized mortality rate for colorectal cancer was estimated at 9.4% for men and 6.0% for women under the scenario which calls for 50% participation in faecal occult blood test and 90% participation of follow-up examination. This scenario corresponds to the goal setting for screening in the third-term of the Basic Plan to Promote Cancer Control Programs in Japan. Our microsimulation model was found to be useful in estimating the mortality reduction effect of cancer control policy. Such modelling techniques can be utilized to develop effective and optimal cancer control programs.

Self-sampling as the principal modality for population based cervical screening: Five-year follow-up of the PaVDaG study.

Self‐sampling provides a powerful means to engage women in cervical screening. In the original Papillomavirus Dumfries and Galloway study (PaVDaG), we demonstrated cross‐sectional similarity of high‐risk human papillomavirus (Hr‐HPV) testing on self‐taken vaginal vs clinician‐taken samples for the detection of cervical intraepithelial neoplasia 2 or worse (CIN2+). Few data exist on the longitudinal performance of self‐sampling; we present longitudinal outcomes of PaVDaG. Routinely screened women provided a self‐taken and a clinician‐collected sample. Ninety‐one percent of 5136 women from the original cohort completed a further screening round. Sensitivity, specificity, positive predictive value and complement of the negative predictive value of the Hr‐HPV test on self‐samples for detection of CIN2+ and CIN3+ up‐to 5 years after testing were determined. Additionally, clinical accuracy of Hr‐HPV testing on vaginal and clinician‐collected samples was assessed. A total of 183 CIN2+ and 102 CIN3+ lesions were diagnosed during follow‐up. Risk of CIN2+ and CIN3+ following an Hr‐HPV negative self‐sample was 0.6% and 0.2%, respectively, for up to 5 years after testing. The relative sensitivity for CIN3+ and specificity for ≤CIN1 of Hr‐HPV testing on self‐taken specimens was slightly lower vs clinician‐collected samples: 0.95 (95% CI: 0.90‐0.99; P McN = .0625) and 0.98 (95% CI: 0.95‐1.00; P McN = <.0000), respectively. The low risk of CIN2+ in women with Hr‐HPV—self‐sample(s) suggests, that the 3 to 5‐year recall interval implemented in several cervical screening settings, based on clinician‐taken samples, may be safe for self‐samples. Future assessment will show if “universal” 5‐year screening is appropriate for programs based on self‐sampling.

PP148 Liquid Biopsy For The Detection Of Ovarian Or Endometrial Cancer In Samples Taken From The Pap Smear: PapSEEK

IntroductionThe PapSEEK test is an emerging minimally invasive technique in which samples are collected from the endocervical or intrauterine cavity with the Papanicolaou (Pap) brush or the Tao brush to detect somatic mutations or aneuploidies indicating the presence of endometrial or ovarian cancer.MethodsWe systematically searched for articles published up to October 2020 in the following electronic databases: Medline, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination. We included experimental studies, observational primary studies, and cost-effectiveness studies evaluating the safety, effectiveness, and cost effectiveness of the PapSEEK test for the early detection of ovarian or endometrial cancer. Relevant outcomes included sensitivity, specificity, the coefficient of variation, re-test rates, the incremental cost-effectiveness ratio, the incremental cost-utility ratio, and the cost of each alternative.ResultsA single relevant retrospective study was identified. In this study, samples from women with endometrial cancer (n = 656) and ovarian cancer (n = 254) were collected with the Pap brush and Tao brush and compared with samples from healthy women (n = 1,002). The diagnostic validity for somatic mutation or aneuploidies obtained with a Pap brush had a sensitivity of 81% for endometrial cancer and 33% for ovarian cancer, and a specificity of 99% for both conditions. When samples were collected from the intrauterine cavity with a Tao brush, the sensitivity increased to 93% for endometrial cancer and to 45% for ovarian cancer. The sensitivity of the PapSEEK test increased only for ovarian cancer when plasma samples to detect circulating tumor DNA were collected in addition to Pap smear samples. This strategy provided a diagnostic validity of 43%, which was higher in late-stage ovarian cancer (56% versus 35%), and a specificity of 100%.ConclusionsProspectively designed studies are required to assess the safety and effectiveness of the PapSEEK test in screening settings, as well as studies comparing the technology with conventional screening methods. No cost-effectiveness studies have been conducted for the PapSEEK test.

Missed HIV diagnoses when screening only emergency department patients who have blood samples obtained for other clinical purposes.

Emergency departments (EDs) are highly valued settings for HIV screening. Most large-volume ED HIV screening programs have attenuated operational barriers by screening only ED patients who already have a blood sample available for other clinical reasons. Our objective was to estimate the proportion of HIV positive patients who are missed when an ED excludes patients for whom HIV screening would be the only indication to obtain a blood sample. This cross-sectional analysis used existing electronic records of patients seen between 2017 and 2019 by an urban, academic ED and its HIV screening program, which includes patients regardless of whether they receive other ED blood testing. The primary outcome was the proportion of patients tested by the screening program who were newly diagnosed with HIV (Sample 1) for whom HIV screening would be the only indication for venipuncture. We secondarily 1) estimate the proportion of ED patients who received venipuncture using a representative sample of consecutively approached participants which prospectively recorded whether patients had blood obtained or intravenous catheter placement during usual ED care (Sample 2) and 2) report patient characteristics including HIV risk factors for those with and without ED venipuncture for both groups. Of 41 persons newly diagnosed with HIV by the ED screening program (Sample 1), 13 (31.7%, 95%CI 18.6-48.2) did not undergo venipuncture for any reason other than their HIV test. The proportion of ED visits without a venipuncture (Sample 2) was 44.2% (95% CI 41.9-46.6). Patient characteristics were similar for both groups. Screening only those patients with a blood sample already available or easily obtainable due to usual ED care, misses many opportunities for earlier HIV diagnosis. Innovation in research, policy, and practice is needed to overcome still unaddressed barriers to ED HIV screening when HIV screening is the only indication for collection of a biological sample.

A risk prediction model for selecting high-risk population for computed tomography lung cancer screening in China

ObjectiveTwo large randomized controlled trials (RCTs) have demonstrated that low dose computed tomography (LDCT) screening reduces lung cancer mortality. Risk-prediction models have been proved to select individuals for lung cancer screening effectively. With the focus on established risk factors for lung cancer routinely available in general cancer screening settings, we aimed to develop and internally validated a risk prediction model for lung cancer. Materials and methodsUsing data from the Cancer Screening Program in Urban China (CanSPUC) in Henan province, China between 2013 and 2019, we conducted a prospective cohort study consisting of 282,254 participants including 126,445 males and 155,809 females. Detailed questionnaire, physical assessment and follow-up were completed for all participants. Using Cox proportional risk regression analysis, we developed the Henan Lung Cancer Risk Models based on simplified questionnaire. Model discrimination was evaluated by concordance statistics (C-statistics), and model calibration was evaluated by the bootstrap sampling, respectively. ResultsBy 2020, a total of 589 lung cancer cases occurred in the follow-up yielding an incident density of 64.91/100,000 person-years (pyrs). Age, gender, smoking, history of tuberculosis and history of emphysema were included into the model. The C-index of the model for 1-year lung cancer risk was 0.766 and 0.741 in the training set and validation set, respectively. In stratified analysis, the model showed better predictive power in males, younger participants, and former or current smoking participants. The model calibrated well across the deciles of predicted risk in both the overall population and all subgroups. ConclusionsWe developed and internally validated a simple risk prediction model for lung cancer, which may be useful to identify high-risk individuals for more intensive screening for cancer prevention.