Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening.

While HC2 and GP5+/6+ PCR-EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second-generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second-generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC-group I), and show consistent non-inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first-generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta-analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately.

Planning and performing simultaneous bariatric surgery and robotic hysterectomy in a super-obese patient with endometrial cancer.

Endometrial cancer (EC) is the most common gynecological malignancy in developed countries, and endometrial intraepithelial neoplasia (EIN) is the defined precancerous lesion. Obesity is considered a risk factor for both EC and EIN. On the other hand, mortality is often attributed to obesity-related conditions in patients with early-stage EC. Bariatric surgery has been shown to improve oncological outcomes and obesity-related morbidity and mortality in patients with EC. Therefore, combination surgery addressing both uterine disease and obesity is a very recent point of interest. Here, we present a video article to demonstrate the crucial surgical steps for a simultaneous robotic-assisted total laparoscopic hysterectomy and sleeve gastrectomy in a patient with super obesity and EIN. A patient in her 40s with a body mass index of 62.4 kg/m² and a diagnosis of EIN was scheduled for combo surgery. The operation started with sleeve gastrectomy in the reverse Trendelenburg position. The da Vinci Xi Surgical System™ (Intuitive Surgical Inc., Sunnyvale, CA, USA) with left-side docking was used for surgery. After the mobilization of the stomach, gastric resection was performed using a stapler. Following sleeve gastrectomy, the patient was positioned in the Trendelenburg position, and the robotic system was positioned for hysterectomy. Hysterectomy and salpingectomy were performed. The excised stomach and hysterectomy material were removed through the vagina. A frozen examination revealed EC below 2 cm with superficial invasion, and bilateral oophorectomy was performed. The whole surgery took approximately 4 hours. No postoperative complications occurred, and the patient was discharged on the 3rd day.

Evaluation of Endocervical Curettage in Colposcopy in the Turkish Cervical Cancer Screening Program.

Background/Objectives: To investigate the risk factors for CIN2+ lesions (cervical intraepithelial neoplasia 3 or worse) in endocervical curettage (ECC) and to evaluate the relationship between the addition of ECC to punch biopsy in terms of the yield of CIN2+ lesions. Methods: Between February 2018 and 2019, data on colposcopy results from 11,944 patients were gathered from the Cancer Department of the Turkish Ministry of Health across the country. A total of 6370 women whom were referred to colposcopy were included in this study. Risk factors were identified using both univariate and multivariate logistic analyses. Results: The median age was 42 years old (range, 30-65). ASC-H (atypical squamous cells-suggestive of high-grade squamous intraepithelial lesion)/HSIL (high-grade intraepithelial lesion) cytology (OR 7.648 95% CI (3.933-14.871)) and HPV (human papillomavirus)-16/18 infection (OR 2.541 95% CI (1.788-3.611)) were identified as risk factors for having CIN2+ lesions. CIN2+ diagnostic yield by ECC is only 1.2% all patients. CIN2+ diagnostic yield by punch biopsy and ECC are 9.7% and 6% of patients, respectively. A higher CIN2+ yield by ECC was observed with increasing age. Among cytology groups, ASC-H/HSIL has highest CIN2+ yield by ECC. Finally, in patients with incomplete visualization of the squamocolumnar junction (SCJ), ECC yields approximately twice as many CIN2+ lesions. Conclusions: ECC should be considered in cases of advanced patient age and in situations where the SCJ is not routinely visualized. In addition, evaluation of the endocervical canal is necessary in HPV-positive cases infected with HPV-16/18 types and in cases infected with HPV of any type but with cytological abnormalities.

Patient care and access to clinical trials in gynaecological oncology: global implications of the early phase of the COVID-19 pandemic.

PURPOSE: Our prospective international survey evaluated the impact of the early phase of the COVID-19 pandemic on the management gynaecological malignancies from the multidisciplinary physicians' perspective with particular focus on clinical infrastructures and trial participation. METHODS: Our survey consisted of 53 COVID-related questions. It was sent to healthcare professionals in gynaecological oncology centres across Europe and Pan-Arabian region via the study groups and gynaecological societies from April 2020 to October 2020. All healthcare professionals treating gynaecological cancers were able to participate in our survey. RESULTS: A total of 255 answers were collected from 30 countries. The majority (73%) of participants were gynaecological oncologists from university hospitals (71%) with at least an Intensive Care Unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years (range 0-12 weeks). Most cases that were prioritised for surgical intervention across all gynaecological tumours were early-stage disease (74%), primary situation (61%) and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumour types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. Almost half of the participants stated the pandemic negatively impacted the financial structure and support for clinical trials. Approximately 20% of clinicians did not feel well-informed regarding clinical algorithm for COVID-19 patients throughout the pandemic. Thirty percent stated that they are currently having trouble in providing adequate medical care due to staff shortage. CONCLUSION: Despite well-established guidelines, pandemic clearly affected clinical research and patientcare. Our survey underlines the necessity for building robust emergency algorithms tailored to gynaecological oncology to minimise negative impact in crises and to preserve access to clinical trials.

Impact of adjuvant treatments and risk factors on survival in 2023 FIGO stage IIB endometrial cancer patients: Turkish Gynecologic Oncology Group Study.

OBJECTIVE: The aim of this study was to investigate the impact of adjuvant treatments, factors influencing recurrence, and survival data in patients with 2023 International Federation of Gynecology and Obstetrics (FIGO) stage IIB endometrial cancer. METHODS: A retrospective analysis was conducted on patients with endometrial cancer who underwent surgery between 2005 and 2022 at seven different centers in Turkey. Demographic, clinicopathological, and survival data were collected and analyzed. RESULTS: Among 7323 patients, 565 (7.7%) were classified as 2023 FIGO stage IIB based on pathological results. Of 565 patients, 214 were followed without receiving adjuvant treatment, while 335 (95.4%) received adjuvant radiotherapy, and 16 (4.6%) received radiotherapy and chemotherapy. The locoregional recurrence rate was higher in patients with a tumor size >4 cm (p=0.038) and myometrial invasion >50% (p=0.045). In patients with distant metastasis, the recurrence rate was lower in those with myometrial invasion <50% compared with myometrial invasion ≥50% (p=0.031). The impact of adjuvant treatment on endometrial cancer patients revealed no significant differences for both disease free survival (p=0.85) and overall survival (p=0.54). Subgroup analyses showed that in patients with deep myometrial invasion, adjuvant treatment was associated with a significant increase in overall survival (p=0.044), but there was no effect on disease-free survival (p=0.12). CONCLUSIONS: Patients with stage IIB endometrial cancer with myometrial invasion ≥50% were more likely to have locoregional and distant metastases. Adjuvant radiotherapy or chemoradiotherapy did not demonstrate an overall survival benefit in these patients.

Lower Limb Lymphedema Awareness among Gynecological Cancer Patients: An International Survey Supported by the European Network of Gynecological Cancer Advocacy Groups (ENGAGe) Group.

INTRODUCTION: Patient awareness of postoperative lymphedema in the field of gynecologic oncology has been poorly documented in the international literature. We wished to capture and document the awareness among gynecological cancer survivors about postoperative lymphedema, including aspects such as the adequacy of perioperative counseling, management, and quality of life. METHODS: A web-based survey comprising 25 multiple-choice questions was distributed to gynecological cancer advocacy groups within the European Network of Gynecological Cancer Advocacy Groups (ENGAGe) group. The survey was validated in a pilot group of gynecological patients prior to distribution. RESULTS: Overall, 386 women from 20 countries completed the questionnaire. Only half of the patients (n = 211) knew what lymphedema is, whereas 52% of the respondents stated that they were never informed at their pre-operative assessment about the potential risk of developing lymphedema. Fifty-three percent of those women who were informed about the risk and management of lymphedema received information through self-initiative, connecting mainly with patient groups or online. Approximately 84% of patients with lymphedema reported that they informed their doctor about their symptoms. Ninety-four patients (55.3%, which is not 55% of the 386) were treated for lymphedema. Forty-five women out of 136 reported that lymphedema significantly affected their everyday lives. DISCUSSION: We report a large lack of awareness and a significant gap of knowledge about the risks and treatment options related to postoperative lymphedema among gynecological cancer survivors. Institutional practice routines and awareness among professionals need to be urgently recalled and adapted to adequately inform and support gynecological cancer patients.

Ethanol Sclerotherapy in the Management of Ovarian Endometrioma: Technical Considerations for Catheter- and Needle-Directed Sclerotherapy.

PURPOSE: To provide technical guidance on applying catheter-directed and needle-directed ethanol sclerotherapy for endometriomas and present the results of these sclerotherapy methods. MATERIALS AND METHODS: From January 2015 to March 2021, the results of the patients with symptomatic ovarian endometriomas who underwent needle-directed or catheter-directed sclerotherapy were evaluated, retrospectively. The decision to apply which sclerotherapy technique was made during the procedure for each patient considering the following factors: cyst size, cyst location, cyst viscosity, and tissue rigidity. RESULTS: Both needle-directed (n = 34 cysts) and catheter-directed (n = 34 cysts) sclerotherapy techniques were effective, with a 100% technical success rate and a 97% clinical success rate. In two of 34 cysts (6%) treated with needle-directed sclerotherapy, recurrence was detected and successfully retreated with catheter-directed sclerotherapy. Significant reductions in cyst size, pain, and serum cancer antigen 125 levels (p < 0.05) were noted. Serum anti-Müllerian hormone levels remained unaffected, indicating preserved ovarian reserve (p > 0.05). Among those treated for infertility, the pregnancy rate was 54% (n = 6/11). The mean ± SD cyst size decline was greater in catheter-directed sclerotherapy than needle-directed sclerotherapy (5.5 ± 3.1 cm vs. 4.0 ± 2.1 cm, p < 0.05). However, the pretreatment cyst volumes were considerably higher in catheter-directed sclerotherapy group (202.0 ± 233.5 mL vs. 78.8 ± 59.7 mL, p < 0.05) and were associated with significant post-treatment volume decrease (p < 0.05). CONCLUSION: The choice between catheter-directed and needle-directed ethanol sclerotherapy should be determined during the procedure, with a preference for catheter-directed sclerotherapy when feasible. Crucial factors in making this decision include cyst size, cyst location, cyst viscosity, and tissue rigidity. Level of evidence Level 3, non-controlled retrospective cohort study.

The evaluation of the nutritional status in Parkinson's disease: geriatric nutritional risk index comparison with mini nutritional assessment questionnaire.

OBJECTIVE: The symptoms associated with Parkinson's disease may lead to reduced food consumption and in turn, malnutrition. It is therefore important to apply a reliable nutrition screening tool to evaluate the nutritional status of individuals with Parkinson's disease. This cross-sectional study aims to compare the Mini Nutritional Assessment (MNA) questionnaire and the Geriatric Nutrition Risk Index (GNRI) in the assessment of the nutritional status of individuals with Parkinson's disease, and to evaluate the usability of the GNRI in cases of Parkinson's disease. METHODS: The study was conducted with 89 individuals over the age of 60 who were diagnosed with Parkinson's disease. Study data were collected using a questionnaire form administered through face-to-face interviews, the MNA-Long Form (MNA-LF), and the GNRI was calculated. RESULTS: The mean GNRI scores were significantly lower in the participants with malnutrition (106.5 ± 19.4) than in the participants at risk of malnutrition (121.0 ± 10.3) and the participants with no malnutrition (125.3 ± 9.6) according to the MNA-LF (p < 0.001). Although there was a positive correlation between the MNA-LF and the GNRI scores, this correlation was not significant (p = 0.095). CONCLUSIONS: This is the first study to research the nutritional status of individuals with Parkinson's disease using the GNRI. The malnutrition rate detected by GNRI was found to be lower than MNA in Parkinson's patients receiving outpatient treatment. Similar studies are recommended to determine the usability of GNRI on inpatients.

Genital tract microbiota composition profiles and use of prebiotics and probiotics in gynaecological cancer prevention: review of the current evidence, the European Society of Gynaecological Oncology prevention committee statement.

Female genital tract (FGT) microbiota has been associated with the development of gynaecological cancers. Thus, the possibility of whether manipulation of the FGT microbiota can help in the prevention of disease should be investigated. Various prebiotics, probiotics, and other non-clinician prescribed agents have been reported to have therapeutic effects in cervical disease. Numerous studies have reported an association between human papillomavirus infection and subsequent cervical dysplasia and a decrease in the abundance of Lactobacillus species. A continuum of microbiota composition is observed from the vagina to the upper parts of the FGT, but no evidence suggests that manipulation of the vaginal microbiota can help to modify the composition of other FGT compartments. Although prebiotics and probiotics have been reported to be beneficial, the studies are small and of varying design, and high-quality evidence to support their use is lacking. Currently, no studies have examined these therapeutics in other gynaecological malignancies. Thus, recommendation of probiotics, prebiotics, or other over-the-counter supplements for the prevention of gynaecological cancers warrants larger, well designed studies.

Evaluation of colposcopy after the addition of human papillomavirus testing to the Turkish cervical cancer screening program.

OBJECTIVE: To evaluate colposcopy performance following the human papillomavirus (HPV) DNA screening program in Turkey. METHODS: Women aged 30-65 years are screened for cervical cancer every 5 years, with individuals positive for HPV 16 and/or 18 or other high-risk HPV types with abnormal cytology referred for colposcopy. Both HPV test and cytology are obtained at the same visit. If HPV is negative, cytology will not be assessed. However, if HPV is positive, both cytology and HPV genotyping will be performed. Colposcopy-require was defined as HPV 16/18 positivity or abnormal smear results with any hrHPV positivity, and the remaining patients (normal smear with hrHPV positivity other than HPV 16/18) were grouped as colposcopy non-required. National data on colposcopy outcomes and unnecessary performance rates in February 2018-2019 were evaluated via a questionnaire. RESULTS: A total of 9808 patients were included, divided based on colposcopy requirement: 5751 (58.6%) patients required colposcopy and 4057 (41.4%) did not. Unnecessary colposcopy was performed on 90.1% of the non-required group (3657 of 4057 patients). In the colposcopy-required group, 4455 patients (79.9%) underwent punch biopsy; 3194 (57.1%), endocervical curettage (ECC); and 421 (7.5%), "see and treat" in the non-required group, the results were 2790 (76.3%), 1957 (53.2%), and 211 (5.7%), respectively. A total of 746 cervical intraepithelial neoplasia (CIN)-3 isolates were detected, including 702 using existing screening and triage with 94.1% sensitivity (702/746). Multiple biopsies were taken in 69.8% (n = 3110) of patients from the colposcopy-required group and 63.7% (n = 1777) from the non-required group. The ECC samples included 19 cervical cancers and 212 ≥CIN-3 lesions in the colposcopy-required group, and four cancers and 41 ≥CIN-3 lesions in the non-required group. The proportion of ≥CIN-3 lesions detected by ECC only was 4.7% (35 of 746 ≥CIN-3 lesions). CONCLUSION: Our results showed high rates of unnecessary colposcopies, and a high percentage of multiple and random punch biopsies and ECC.

Foreign Accent Syndrome After COVID 19 Infection: A Case Report.

ABSTRACT: Foreign accent syndrome (FAS) is an extremely rare disorder characterized by the appearance of speech changes that are perceived by the speaker and listeners as an acquired foreign accent. It still remains a poorly understood condition. Three main types of FAS have been reported in the medical literature as neurogenic, psychogenic, and mixed type. Psychogenic FAS includes all cases of FAS in which an organic cause has not been identified and a clear psychological factor has been identified after careful clinical, neurological, and neuroradiological examination. Although the COVID-19 epidemic, which has been ongoing since February 2020, primarily manifests itself with upper respiratory tract infection findings, it is seen that it also causes a wide range of neurological and psychiatric signs and symptoms. In this study, a 42-year-old female patient who started to have speech disorder after COVID-19 infection is presented in the light of clinical history, diagnosis, and differential diagnosis literature findings.

Retinal dysfunction in Parkinson's disease-results of the extended protocol for photopic negative response (PHNR) full-field electroretinogram (ERG).

BACKGROUND: We investigated whether the photopic negative response (PhNR) in the electroretinogram (ERG) was affected in Parkinson's disease (PD) patients and whether it was associated with retinal changes on optical coherence tomography (OCT). METHODS: Thirty-two patients with PD and 31 age and sex-matched healthy controls from a single tertiary centre were included in the study. Hoehn and Yahr scale scores and the presence of REM sleep behaviour were recorded. PhNR, a-wave and b-wave responses in photopic ERG (red on blue background) and retinal layer thicknesses in OCT were obtained. RESULTS: The mean age was 61 ± 10.4 in the PD group (female/male: 18/14) and 60.9 ± 7 in the control group (female/male: 18/13). The amplitudes of the PhNR, a- and b-waves in the ERG were significantly decreased in the PD group, but the implicit times were not significantly different. BCVA was significantly correlated with Hoehn and Yahr scores (p < 0.001, r = - 0.596). There was a significant correlation between BCVA and a-wave amplitude (p = 0.047, r = - 0.251). On OCT analysis, the thickness of the nasal INL was increased, and the temporal and inferior OPL and temporal peripapillary RNFL were decreased in the PD group compared to healthy controls (p = 0.032, p = 0.002, p = 0.016 and p = 0.012, respectively). CONCLUSION: This study demonstrated reduced a-wave, b-wave and PhNR-wave amplitudes on ERG measurements in PD patients. These findings suggest that the whole ERG response, not just the PhNR, is attenuated in patient with PD, suggesting a possible involvement of the visual system in the disease.

Cervical proprioception in Parkinson's disease and its correlation with manual dexterity function.

OBJECTIVE: Cervical proprioception plays a crucial role in posture and movement control. This study aimed to determine the relationships of cervical proprioception, cervical muscle strength and endurance with manual dexterity and hand strength in individuals with idiopathic Parkinson's disease (PD). METHODS: Twenty individuals with PD (mean age: 63.9 years) and 20 healthy individuals as a control group (mean age: 61.9 years) were recruited. Cervical joint position error (JPE), static endurance of neck muscles, activation of deep cervical flexor muscles (Craniocervical Flexion Test, CCFT), manual dexterity (Purdue Pegboard Test, PPT), cognitive and motor tasks of the PPT, finger tapping test (FTT), pinch strength, and grip strength were assessed. RESULTS: Cervical JPE was significantly higher in individuals with PD than in controls (p < 0.05). The strength and endurance of the cervical muscles were significantly decreased in individuals with PD (p < 0.05). Cervical JPE measurements were negatively correlated with PPT, cognitive and motor tasks of the PPT in individuals with PD (all p < 0.05). The endurance of cervical flexor muscles was negatively correlated with PPT and cognitive PPT scores in the PD group (p < 0.05). In addition, a significant positive correlation was found between cervical flexor endurance and hand strength in the PD group (p < 0.05). CONCLUSION: Cervical proprioception and the strength and endurance of cervical muscles decrease in individuals with PD compared to healthy individuals. Impairment of cervical proprioception appears to be associated with poorer upper extremity performance. Detailed evaluation of the cervical region in PD may help determine the factors affecting upper extremity function.

The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) Consensus Statement on the Management of Vaginal Intraepithelial Neoplasia.

ABSTRACT: The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) developed consensus statements on pre-invasive vulvar lesions in order to improve the quality of care for patients with vaginal intraepithelial neoplasia (VaIN). The management of VaIN varies according to the grade of the lesion: VaIN 1 (low grade vaginal squamous intraepithelial lesions (SIL)) can be subjected to follow-up, while VaIN 2-3 (high-grade vaginal SIL) should be treated. Treatment needs individualization according to the patient's characteristics, disease extension and previous therapeutic procedures. Surgical excision is the mainstay of treatment and should be performed if invasion cannot be excluded. Total vaginectomy is used only in highly selected cases of extensive and persistent disease. Carbon dioxide (CO2) laser may be used as both an ablation method and an excisional one. Reported cure rates after laser excision and laser ablation are similar. Topical agents are useful for persistent, multifocal lesions or for patients who cannot undergo surgical treatment. Imiquimod was associated with the lowest recurrence rate, highest human papillomavirus (HPV) clearance, and can be considered the best topical approach. Trichloroacetic acid and 5-fluorouracil are historical options and should be discouraged. For VaIN after hysterectomy for cervical intraepithelial neoplasia (CIN) 3, laser vaporization and topical agents are not the best options, since they cannot reach epithelium buried in the vaginal scar. In these cases surgical options are preferable. Brachytherapy has a high overall success rate but due to late side effects should be reserved for poor surgical candidates, having multifocal disease, and with failed prior treatments. VaIN tends to recur and ensuring patient adherence to close follow-up visits is of the utmost importance. The first evaluation should be performed at 6 months with cytology and an HPV test during 2 years and annually thereafter. The implementation of vaccination against HPV infection is expected to contribute to the prevention of VaIN and thus cancer of the vagina. The effects of treatment can have an impact on quality of life and result in psychological and psychosexual issues which should be addressed. Patients with VaIN need clear and up-to-date information on a range of treatment options including risks and benefits, as well as the need for follow-up and the risk of recurrence.