Risk of progression of cervical intraepithelial neoplasia grade 2 in human papillomavirus-vaccinated and unvaccinated women: a population-based cohort study.

BACKGROUND: Many countries have implemented active surveillance (ie, leaving the lesion untreated) as an option among younger women with cervical intraepithelial neoplasia grade 2 because regression rates are high and excisional treatment increases the risk for preterm birth in subsequent pregnancies. However, early identification of women at increased risk for progression to cervical intraepithelial neoplasia grade 3 or worse is important to ensure timely treatment. Because women who have received a human papillomavirus vaccine have a lower risk for cervical cancer, they may have a lower risk for progression of untreated cervical intraepithelial neoplasia grade 2 to cervical intraepithelial neoplasia grade 3 or worse. OBJECTIVE: This study aimed to investigate if women who received a human papillomavirus vaccine and who are undergoing active surveillance for cervical intraepithelial neoplasia grade 2 are less likely to progress to cervical intraepithelial neoplasia grade 3 or worse when compared with women who did not receive the vaccine. STUDY DESIGN: We conducted a population-based cohort study in Denmark using data from national health registers. We identified all women aged 18 to 40 years who were undergoing active surveillance for cervical intraepithelial neoplasia grade 2 from January 1, 2007, to December 31, 2020. Women with a previous record of cervical intraepithelial neoplasia grade 2 or worse, hysterectomy, or a loop electrosurgical excision procedure were excluded. Exposure was defined as having received ≥1 dose of a human papillomavirus vaccine at least 1 year before the cervical intraepithelial neoplasia grade 2 diagnosis. We used cumulative incidence functions to estimate the risk for progression to cervical intraepithelial neoplasia grade 3 or worse within 28 months using hysterectomy, emigration, and death as competing events. We used modified Poisson regression to calculate crude and adjusted relative risks of progression during the 28-month surveillance period. Results were stratified by age at vaccination and adjusted for index cytology, disposable income, and educational level. RESULTS: The study population consisted of 7904 women of whom 3867 (48.9%) were vaccinated at least 1 year before a diagnosis of cervical intraepithelial neoplasia grade 2. At the time of cervical intraepithelial neoplasia grade 2 diagnosis, women who were vaccinated were younger (median age, 25 years; interquartile range, 23-27 years) than those who were not (median age, 29 years; interquartile range, 25-33 years). The 28-month cumulative risk for cervical intraepithelial neoplasia grade 3 or worse was significantly lower among women who were vaccinated before the age of 15 years (22.9%; 95% confidence interval, 19.8-26.1) and between the ages of 15 and 20 years (31.5%; 95% confidence interval, 28.8-34.3) when compared with women who were not vaccinated (37.6%; 95% confidence interval, 36.1-39.1). Thus, when compared with women who were not vaccinated, those who were vaccinated before the age of 15 years had a 35% lower risk for progression to cervical intraepithelial neoplasia grade 3 or worse (adjusted relative risk, 0.65; 95% confidence interval, 0.57-0.75), whereas women who were vaccinated between the ages of 15 and 20 years had a 14% lower risk (adjusted relative risk, 0.86; 95% confidence interval, 0.79-0.95). For women who were vaccinated after the age of 20 years, the risk was comparable with that among women who were not vaccinated (adjusted relative risk, 1.02; 95% confidence interval, 0.96-1.09). CONCLUSION: Women who were vaccinated and who were undergoing active surveillance for cervical intraepithelial neoplasia grade 2 had a lower risk for progression to cervical intraepithelial neoplasia grade 3 or worse during 28 months of follow-up when compared with women who were not vaccinated but only if the vaccine was administered by the age of 20 years. These findings may suggest that the human papillomavirus vaccination status can be used for risk stratification in clinical management of cervical intraepithelial neoplasia grade 2.

Anxiety and depression among women with newly diagnosed vulvar cancer - A nationwide longitudinal study.

INTRODUCTION: Our objective was to investigate the trajectories of anxiety, depression, emotional and social functioning in women with newly diagnosed vulvar cancer from the time of diagnosis to 12 months after treatment. A further aim was to identify risk factors for high levels of anxiety. MATERIAL AND METHODS: PROVE (PROspective Vulvar Cancer Evaluation) is a nationwide longitudinal cohort study investigating quality of life in women with newly diagnosed vulvar cancer by the following validated patient-reported outcome measures at diagnosis, and 3 and 12 months after treatment: The Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Vulvar module VU34. Mean scores, changes over time and associations were analyzed by generalized estimated equations and log-linear regression models, adjusted for possible confounders. RESULTS: Between 2019 and 2021, 105 (69%) women completed the questionnaires at all three time points. At diagnosis, 42% of the women reported elevated anxiety levels, decreasing significantly to 30% during the first 12 months. Insomnia, persisting vulvar symptoms and high information needs were significantly associated with a high level of anxiety (relative risk [RR] 2.1, 95% CI 1.2-3.7 for insomnia; RR 2.8, 95% CI 1.7-4.6 for vulvar symptoms, RR 2.7, 95% CI 1.5-4.9 for information needs). We found a trend towards a higher level of anxiety in younger women (<65 years: RR 1.5, 95% CI 1.0-2.5). Participants reported a low and stable prevalence of depression (14%) and high social functioning throughout the study period. CONCLUSIONS: Women with newly diagnosed vulvar cancer report a high level of anxiety at diagnosis. Despite a significant improvement, anxiety remains widely prevalent during the first year of follow-up. Targeting insomnia, vulvar symptoms and unmet needs may decrease anxiety during surveillance.

Identification of endometrial cancer recurrence - a validated algorithm based on nationwide Danish registries.

INTRODUCTION: Recurrence of endometrial cancer is not routinely registered in the Danish national health registers. The aim of this study was to develop and validate a register-based algorithm to identify women diagnosed with endometrial cancer recurrence in Denmark to facilitate register-based research in this field. MATERIAL AND METHODS: We conducted a cohort study based on data from Danish health registers. The algorithm was designed to identify women with recurrence and estimate the accompanying diagnosis date, which was based on information from the Danish National Patient Registry and the Danish National Pathology Registry. Indicators of recurrence were pathology registrations and procedure or diagnosis codes suggesting recurrence and related treatment. The gold standard for endometrial cancer recurrence originated from a Danish nationwide study of 2612 women diagnosed with endometrial cancer, FIGO stage I-II during 2005-2009. Recurrence was suspected in 308 women based on pathology reports, and recurrence suspicion was confirmed or rejected in the 308 women based on reviews of the medical records. The algorithm was validated by comparing the recurrence status identified by the algorithm and the recurrence status in the gold standard. RESULTS: After relevant exclusions, the final study population consisted of 268 women, hereof 160 (60%) with recurrence according to the gold standard. The algorithm displayed a sensitivity of 91.3% (95% confidence interval (CI): 85.8-95.1), a specificity of 91.7% (95% CI: 84.8-96.1) and a positive predictive value of 94.2% (95% CI: 89.3-97.3). The algorithm estimated the recurrence date within 30 days of the gold standard in 86% and within 60 days of the gold standard in 94% of the identified patients. DISCUSSION: The algorithm demonstrated good performance; it could be a valuable tool for future research in endometrial cancer recurrence and may facilitate studies with potential impact on clinical practice.

Post robotic investment: Cost consequences and impact on length of stay for obese women with endometrial cancer.

INTRODUCTION: The aim of the study was to investigate whether robotic-assisted surgery is associated with lower incremental resource use among obese patients relative to non-obese patients after a Danish nationwide adoption of robotic-assisted surgery in women with early-stage endometrial cancer. This is a population-based cohort study based on registers and clinical data. MATERIAL AND METHODS: All women who underwent surgery (robotic, laparoscopic and laparotomy) from 2008 to 2015 were included and divided according to body mass index (<30 and ≥30). Robotic-assisted surgery was gradually introduced in Denmark (2008-2013). We compared resource use post-surgery in obese vs non-obese women who underwent surgery before and after a nationwide adoption of robotic-assisted surgery. The key exposure variable was exposure to robotic-assisted surgery. Clinical and sociodemographic data were linked with national register data to determine costs and bed days 12 months before and after surgery applying difference-in-difference analyses. RESULTS: In total, 3934 women were included. The adoption of robotic-assisted surgery did not demonstrate statistically significant implications for total costs among obese women (€3,417; 95% confidence interval [CI] -€854 to €7,688, p = 0.117). Further, for obese women, a statistically significant reduction in bed days related to the index hospitalization was demonstrated (-1.9 bed days; 95% CI -3.6 to -0.2, p = 0.025). However, for non-obese women, the adoption of robotic-assisted surgery was associated with statistically significant total costs increments of €9,333 (95% CI €3,729-€1,4936, p = 0.001) and no reduction in bed days related to the index hospitalization was observed (+0.9 bed days; 95% CI -0.6 to 2.3, p = 0.242). CONCLUSIONS: The national investment in robotic-assisted surgery for endometrial cancer seems to have more modest cost implications post-surgery for obese women. This may be partly driven by a significant reduction in bed days related to the index hospitalization among obese women, as well as reductions in subsequent hospitalizations.

Satisfaction with care and adherence to treatment when using patient reported outcomes to individualize follow-up care for women with early breast cancer - a pilot randomized controlled trial.

Background: The population of breast cancer survivors is increasing as a positive consequence of early detection and enhanced treatment. The disease and treatment associated side-effects or late-effects often impact on quality of life and daily life functions during survivorship. This calls for optimization of follow-up care. We aimed to evaluate the patients' satisfaction with the care provided, when using electronic patient reported outcomes (ePROs) to individualize follow-up care in women with early breast cancer receiving adjuvant endocrine therapy.Material and methods: Postmenopausal women treated for hormone receptor positive early breast cancer were included in a pilot randomized controlled trial and randomized to receive standard follow-up care with prescheduled consultations every six months or individualized follow-up care with the active use of ePROs to screen for the need of consultations. ePROs were distributed every third month over a two-year period. Primary outcomes were satisfaction with the assigned follow-up care and unmet needs. Secondary outcomes were use of consultations, adherence to treatment and quality of life.Results: Of the 207 consecutive patients who were potentially eligible for the study, 134 women were enrolled (65%). In total 64 women in standard care and 60 women in individualized care were analyzed. No statistically significant differences were reported in relation to satisfaction, unmet needs, adherence to treatment or quality of life. Women in standard care attended twice as many consultations during the two year follow-up period as women in individualized care; 4.3 (95% CI 3.9-4.7) versus 2.1 (95% CI: 1.6-2.6), p < .001.Conclusion: A significant reduction in consultations was observed for the group attending individualized care without compromising the patients' satisfaction, quality of life or adherence to treatment. For the majority of postmenopausal women treated for early breast cancer, implementation of ePROs to individualize follow-up care was feasible.

Clinical impact of pre-treatment FDG-PET/CT staging of primary ovarian, fallopian tube, and peritoneal cancers in women.

INTRODUCTION: To assess the clinical impact of preoperative fludeoxyglucose (FDG) with positron emission tomography (PET) and computed tomography (CT) in women with ovarian, fallopian tube, or peritoneal cancer with focus on consequences of added findings (AFs). MATERIAL AND METHODS: FDG-PET/CT was implemented as a standard imaging modality for women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer at our institution in 2008. After full implementation, all preoperative scans were reviewed and AFs were evaluated from January 2011 to December 2012. Decisions regarding further examination made at the first multidisciplinary team conference were recorded. Subsequent procedures were tracked via medical records, and the impact of AFs on additional examinations, delay, and change in treatment plans was evaluated. RESULTS: Forty-four (21.1%) of 209 women presented with AFs. Further examination was performed in 35/44 (79.5%). Malignancy was identified in 15/35 (42.9%), revealing metastases from ovarian, fallopian tube, or peritoneal cancer in 11, a synchronous primary cancer in 3, and recurrence of a previous cancer in 1 woman. The ovarian, fallopian tube, or peritoneal cancer metastases were localized in the lungs, uterus, colon, vagina, and breasts. The remaining 20 AFs revealed 2 benign lesions and 1 pre-malignant lesion, whereas no abnormality was found in 17. Further examination of AFs resulted in a significant time delay until treatment start of median 4 days (range 1-83 days, P < 0.004). CONCLUSIONS: Further examinations of AFs by FDG-PET/CT delayed time to start of treatment by median 4 days in women with newly diagnosed ovarian, fallopian tube, or peritoneal cancer in a contemporary institution with fast-track access to additional diagnostics. The clinical implications of this must be balanced against the gain of detecting unrecognized malignancy in 15 of 209 women (7.2%).

Long term resource consequences of a nationwide introduction of robotic surgery for women with early stage endometrial cancer.

OBJECTIVE: The majority of cost-studies related to robotic surgery has a short follow-up and primarily report the costs from the index surgery. The aim of this study was to evaluate the long-term resource consequences of introducing robotic surgery for early stage endometrial cancer in Denmark. METHODS: The study included all women with early stage endometrial cancer who underwent robotic, laparoscopic and open access surgery from January 2008 to June 2015. Data was linked from national databases to determine resource consumption and costs from hospital treatments, outpatient contacts, primary health care sector visits, labor market affiliation and prescription of medication. Each patient was observed in a period of 12 months before- and after surgery. The key exposure variable was women who were exposed to robotic surgery compared to those who were not. RESULTS: A total of 4133 women underwent surgery for early stage endometrial cancer. The study found additional costs of $7309 (95% confidence interval [CI] 2100-11,620, P = 0.001) per patient in the group exposed to robotic surgery including long-term costs post-surgery compared to the non-exposed group (non-robotic group). When controlling for time trends, the introduction of robotic surgery did not reduce the number of bed days (mean diff -0.42, 95% CI -3.03-2.19, P = 0.752). CONCLUSIONS: The introduction of robotic surgery for early stage endometrial cancer did not generate any long-term cost savings. The additional costs of robotic surgery were primarily driven by the index surgery. Any reduction in bed days could be explained by time trends.

How Do We Follow Up Patients With Endometrial Cancer?

PURPOSE OF REVIEW: In this review, we present the existing evidence regarding follow-up care after endometrial cancer, including content of follow-up and type of provider. We furthermore discuss the future perspectives for follow-up care and research in the field. RECENT FINDINGS: Recently published randomized controlled trials show that nurse-led telephone follow-up and patient-initiated follow-up are feasible alternatives to routine hospital-based follow-up. No randomized or prospective study has evaluated the effect of routine follow-up on survival. Hence, current knowledge is derived from retrospective studies with the inherent risk of bias. The most important method for recurrence detection is a review of symptoms. There is no evidence to support a survival benefit from the use of routine physical examinations, additional tests, or imaging. One in three of the women attending hospital-based follow-up experience unmet needs, and alternative models for follow-up focused on survivorship care and empowerment should be tested.

Goal setting in cancer rehabilitation and relation to quality of life among women with gynaecological cancer.

BACKGROUND: Rehabilitation should be integrated in the routine cancer care of women treated for gynaecological cancers. Goal setting is expected to facilitate the process through patient involvement and motivation. Our knowledge about goal setting in cancer rehabilitation is, however, sparse. OBJECTIVES: This study aimed to: 1) analyse rehabilitation goals defined during hospital-based rehabilitation in patients with gynaecological cancer, with regard to number, category, changes over time, and differences between cancer diagnosis, and 2) analyse the association between health-related quality of life and goals defined for rehabilitation. MATERIAL AND METHODS: Consecutively, all patients treated surgically for endometrial, ovarian, and cervical cancer were invited for hospital-based rehabilitation at Odense University Hospital, Denmark, including two sessions at the hospital one and three months following surgery and two phone calls for follow-up. Questionnaires from the EORTC were used to prepare patients and facilitate individual goal setting with definitions of up to three goals. All goals were grouped into six categories. RESULTS: A total of 151 (63%) patients accepted the invitation including 50 endometrial, 65 ovarian, and 36 cervical cancers patients. All patients defined goals at the first session, 76.4% defined three goals, 21.9% two, and 1.6% had one goal. Physical goals decreased over time but were the most frequent at both sessions (98% and 89%). At both sessions, the social and emotional categories were the second and third most frequent among patients with endometrial and ovarian cancer. Sexual issues were dominant among the cervical cancer patients. Regression analysis showed significant association between quality of life scores and goal setting within the social and emotional domains. CONCLUSION: Goal setting seemed feasible in all problem areas. The EORTC questionnaires were helpful during the process although expectations of the sub-scores being predictive of which areas to address were not convincing.

A federated approach to identify women with early-stage cervical cancer at low risk of lymph node metastases.

OBJECTIVE: Lymph node metastases (pN+) in presumed early-stage cervical cancer negatively impact prognosis. Using federated learning, we aimed to develop a tool to identify a group of women at low risk of pN+, to guide the shared decision-making process concerning the extent of lymph node dissection. METHODS: Women with cervical cancer between 2005 and 2020 were identified retrospectively from population-based registries: the Danish Gynaecological Cancer Database, Swedish Quality Registry for Gynaecologic Cancer and Netherlands Cancer Registry. Inclusion criteria were: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma; The International Federation of Gynecology and Obstetrics 2009 IA2, IB1 and IIA1; treatment with radical hysterectomy and pelvic lymph node assessment. We applied privacy-preserving federated logistic regression to identify risk factors of pN+. Significant factors were used to stratify the risk of pN+. RESULTS: We included 3606 women (pN+ 11%). The most important risk factors of pN+ were lymphovascular space invasion (LVSI) (odds ratio [OR] 5.16, 95% confidence interval [CI], 4.59-5.79), tumour size 21-40 mm (OR 2.14, 95% CI, 1.89-2.43) and depth of invasion>10 mm (OR 1.81, 95% CI, 1.59-2.08). A group of 1469 women (41%)-with tumours without LVSI, tumour size ≤20 mm, and depth of invasion ≤10 mm-had a very low risk of pN+ (2.4%, 95% CI, 1.7-3.3%). CONCLUSION: Early-stage cervical cancer without LVSI, a tumour size ≤20 mm and depth of invasion ≤10 mm, confers a low risk of pN+. Based on an international privacy-preserving analysis, we developed a useful tool to guide the shared decision-making process regarding lymph node dissection.

Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Survival after a nationwide adoption of robotic minimally invasive surgery for early-stage cervical cancer - A population-based study.

AIM: Lately, the safety of minimally invasive surgery (MIS) in the treatment of cervical cancer (CC) has been questioned. This study aimed to evaluate the risk of recurrence and survival after a nationwide adoption of robotic MIS for the treatment of early-stage CC in Denmark. METHODS: Population-based data on all Danish women with early-stage CC, who underwent radical hysterectomy January 1st 2005-June 30th 2017 were retrieved from the Danish Gynecologic Cancer Database and enriched with follow-up data on recurrence, death and cause of death. The cohort was divided into two groups according to the year of robotic MIS introduction at each cancer centre. Chi-squared or Fischer test, the Kaplan Meier method and multivariate Cox regression were used for comparison between groups. RESULTS: One thousand one hundred twenty-five patients with CC were included; 530 underwent surgery before (group 1) and 595 underwent surgery after (group 2) the introduction of robotic MIS. The 5-year rate of recurrence was low: 8.2% and 6.3% (p = 0.55) in group 1 and 2, respectively. In adjusted analyses, this corresponded to a five-year disease-free survival, hazard ratio (HR) 1.23 [95% confidence interval (CI) 0.79-1.93]. No difference in site of recurrence (P = 0.19) was observed. The cumulative cancer-specific survival was 94.1% and 95.9% (P = 0.10) in group 1 and 2, respectively, corresponding to a HR 0.60 [95% CI 0.32-1.11] in adjusted analyses. CONCLUSION: In this population-based cohort study, the Danish nationwide adoption of robotic MIS for early-stage CC was not associated with increased risk of recurrence or reduction in survival outcomes.

Self-assessment of Goal Achievements Within a Gynecological Cancer Rehabilitation Counseling.

BACKGROUND: There is an increasing focus on patient involvement in cancer rehabilitation. Goal assessment may improve the patient's self-management of life after cancer. OBJECTIVE: The aim of this study was to evaluate whether (1) nurse-led supported goal setting and assessment of goal achievement were feasible in a clinical setting and (2) there was a positive association between women's goal achievement and their self-assessed global health status (GHS). METHODS: Women surgically treated for gynecological cancer were offered rehabilitation counseling consisting of 2 face-to-face sessions and 2 phone calls carried out by a nurse. The Goal Attainment Scale evaluated goal achievement, whereas GHS was assessed with a quality-of-life questionnaire (European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30). RESULTS: One hundred fifty-one women consented to participate; 70% of the women at the first phone call and 72% at the second phone call achieved their goals as "expected" or "more or much more than expected." Endometrial cancer patients more often achieved their goals than ovarian or cervical cancer patients. Approximately 32% of ovarian and 40% of cervical cancer patients scored their goal achievement "below expected." The patients' GHS was not associated with goal attainment measured at each phone call. CONCLUSION: Goal measurement is feasible in cancer rehabilitation, in both goal setting and goal achievement. Goal achievement less than expected levels in women recovering from ovarian or cervical cancer suggests a need for additional support. IMPLICATIONS FOR PRACTICE: This study supports goal setting and goal achievement as a feasible approach to improve cancer rehabilitation and that nursing professionals can facilitate individualized rehabilitation efforts.

Conization and healthcare use: a population-based register study.

The aim of this study was to assess whether negative psychological consequences of conization reported in questionnaire studies translated into increased use of the healthcare services that could relieve such symptoms. This was a population-based register study comparing women undergoing conization with a control group of women with normal cytology results. Data were derived from Danish registers. Using the difference-in-differences method, we measured contacts with general practitioners (GPs), hospitals, psychiatrist/psychologists, and use of anxiolytic and antidepressant prescription drugs over 5 years 'before' and 'after' the conization in the study group, and in comparable periods in the control group. During the 'before' period, women who later had a conization had greater contact with GPs and hospitals, and slightly more contact with psychiatrist/psychologists, than control women. In both groups, healthcare use increased significantly from the 'before' to the 'after' period. For contacts with GPs and hospitals, the increase was significantly larger for the conization group than for the control group, but this could be attributed to the standard postconization follow-up process. In the 'before' period, women who later had a conization used fewer drugs than women of the control-group, but their drug use increased similarly over time. The conization event did not result in an increased use of the healthcare services that could relieve potential negative side effects. However, women who underwent a conization seemed to constitute a select group as they already used GPs and hospitals more frequently, and anxiolytic and antidepressant drugs less frequently, than other women in the years 'before' the conization event.

Survival after a nationwide introduction of robotic surgery in women with early-stage endometrial cancer: a population-based prospective cohort study.

PURPOSE: The purpose of the study was to evaluate the association between a nationwide introduction of robotic minimally invasive surgery (RMIS) and survival in women with early-stage endometrial cancer. MATERIALS AND METHODS: Prospective data on consecutive women with early-stage endometrial cancer who underwent surgery during January 2005 to June 2015 in Denmark were identified in the nationwide Danish Gynaecological Cancer Database. Data were linked with national registries regarding comorbidity, education, income and death. The cohort was divided according to the time they underwent surgery: Group 1 before RMIS introduction in their respective region and Group 2 after RMIS introduction. Five-year overall survival was compared by multivariate Cox proportional hazards models stratified by histopathological risk between Groups 1 and 2 and between surgical modalities within Group 2: total abdominal hysterectomy (TAH), laparoscopic minimally invasive surgery (LMIS) and RMIS. RESULTS: Women in Group 1 (N = 3091) had significantly lower overall survival compared with those in Group 2 (N = 2563; hazard ratio [HR], 1.22; 95% confidence interval [CI], 1.05-1.42). Age, smoking, socioeconomic status, American Society of Anaesthesiologists (ASA) score, comorbidity and histopathological risk influenced the overall survival. Following RMIS adoption, TAH was associated with higher mortality compared with LMIS and RMIS (HR, 1.42; 95% CI 1.02-1.97 and HR, 1.70; 95% CI 1.31-2.19 for LMIS and RMIS, respectively). There was no significant survival difference between RMIS and LMIS (HR, 1.19; 95% CI 0.85-1.68). CONCLUSION: The national introduction of robotic surgery for early-stage endometrial cancer was associated with improved survival irrespective of age, body mass index, ASA score, comorbidity, smoking, socioeconomic status and histopathological risk.

A systematic review about costing methodology in robotic surgery: evidence for low quality in most of the studies.

OBJECTIVES: The main objective of this review was to evaluate the methodological design in studies reporting resource use and costs related to robotic surgery in gynecology. METHODS: Systematic searches were performed in the databases PubMed, Embase, Scopus, and The Centre for Reviews and Dissemination database for relevant studies before May 2016. The quality of the methodological design was assessed with items regarding methodology from the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). The systematic review was reported according to the PRISMA guidelines. RESULTS: Thirty-two relevant studies were included. None of the reviewed studied fully complied with the CHEERS methodological checklist. Background and objectives, Target population and subgroups and Setting and location were covered in sufficient details in all studies whereas the Study perspective, Justification of the time horizon, Discount rate, and Estimating resources and costs were covered in less than 50%. Most of the studies (29/32) used the health care sector perspective whereas the societal perspective was applied in three studies. The time horizon was stated in 18/32 of the studies. CONCLUSIONS: The methodological quality of studies evaluating costs of robotic surgery was low. The longest follow-up was 4 months and in general, the use of detailed cost data were lacking in most of the investigations. Key determinants, such as purchasing, maintenance costs of the robotic platform, and the use of surgical equipment, were rarely reported. If health care cost analyses lack transparency regarding cost drivers included it may not provide a true foundation for decision-making.

Systematic review of same-day discharge after minimally invasive hysterectomy.

BACKGROUND: Same-day discharge has been suggested to safe and acceptable following minimally invasive hysterectomy. OBJECTIVES: To evaluate the feasibility of same-day discharge following minimally invasive hysterectomy and to identify associated factors. SEARCH STRATEGY: Medline, Embase and the Cochrane Central Register of Controlled Trials were systematically searched using the terms "same day discharge", "minimally invasive surgery", and "hysterectomy" between October 1 and October 31, 2015. No language or publication date restrictions were included. SELECTION CRITERIA: Randomized controlled trials and observational studies evaluating same-day discharge before midnight on the day of minimally invasive hysterectomy were included. DATA COLLECTION AND ANALYSIS: Study characteristics, pre-operative selection criteria, and predictive factors for same-day discharge were analyzed. MAIN RESULTS: There were 15 observational studies with 11 992 patients included. Significant heterogeneity was observed in the studies, and publication and selection bias could have potentially affected the results. All the studies concluded that same-day discharge was feasible. However, some factors were associated with a decreased possibility of same-day discharge; these were older age, beginning surgery later than 1:00 pm and completing surgery later than 6:00 pm, longer duration of operation, and high estimated blood loss. CONCLUSIONS: Same-day discharge appears feasible for a majority of patients who undergo minimally invasive hysterectomies if adequate emphasis is placed on pre-surgical planning and careful patient selection.

Longitudinal study of sexual function and vaginal changes after radiotherapy for cervical cancer.

PURPOSE: To investigate the longitudinal course of self-reported sexual function and vaginal changes in patients disease free after radiotherapy (RT) for locally advanced, recurrent, or persistent cervical cancer. MATERIALS AND METHODS: A total of 118 patients referred for RT were included. The patients were assessed, using a validated self-assessment questionnaire, at the termination of RT and 1, 3, 6, 12, 18, and 24 months later. The results were compared with an age-matched control group from the general population. RESULTS: Persistent sexual dysfunction and adverse vaginal changes were reported throughout the 2 years after RT, with small changes over time: approximately 85% had low or no sexual interest, 35% had moderate to severe lack of lubrication, 55% had mild to severe dyspareunia, and 30% were dissatisfied with their sexual life. A reduced vaginal dimension was reported by 50% of the patients, and 45% were never, or only occasionally, able to complete sexual intercourse. Despite sexual dysfunction and vaginal adverse effects, 63% of those sexually active before having cancer remained sexually active after treatment, although with a considerably decreased frequency. CONCLUSIONS: Patients who are disease free after RT for locally advanced, recurrent, or persistent cervical cancer are at high risk of experiencing persistent sexual and vaginal problems compromising their sexual activity and satisfaction.

Quality of life characteristics inpatients with cervical cancer.

AIM: Annually about 500,000 women worldwide are diagnosed with cervical cancer. For many patients, young age at the time of diagnosis and a good prognosis regarding the disease imply a long life with the side-effects and sequels of various treatment options. The present study investigated the extent to which different quality of life (QoL) domains in patients during and after treatment for cervical cancer are affected according to menopausal status, treatment status and treatment modality. METHODS: QoL data from 346 cervical cancer patients from 14 countries who were included in a cervical cancer module validation study of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Group were analysed according to menopausal status, treatment status and treatment modality. QOL was assessed using the EORTC Quality of life Questionnaire (QLQ)-C30 and the QLQ-CX24 module. Statistical analyses were performed using descriptive statistics and analysis of covariance. RESULTS: Active treatment had the strongest negative impact on 13 different QoL domains: physical, role, emotional, cognitive, social functioning, global health/QoL, fatigue, nausea and emesis, pain, appetite loss, constipation, symptom experience and sexual enjoyment. Irradiation alone ± other therapy was associated with most symptoms of diarrhoea. Age had the most negative impact on sexual activity and the strongest positive effect on sexual worry. CONCLUSION: Our results revealed that patients with cervical carcinoma had different side-effects with different impacts on QOL depending on the menopausal status and therapy modalities. Patients should be informed about the possibility that therapy may have a negative impact on QoL.