Implementation of an Innovative Technology Called the OR Black Box: A Feasibility Study.

Introduction. The operating room (OR) Black Box is an innovative technology that captures and compiles extensive real-time data from the OR, allowing identification and analysis of factors that influence intraoperative procedures and performances - ultimately improving patient safety. Implementation of this kind of technology is still an emerging research area and prone to face challenges. Methods. Observational study running from May 2017 to May 2021 conducted at Copenhagen University Hospital - Rigshospitalet, Denmark, involving 152 OR staff and 306 patients. Feasibility of the OR Black Box was assessed in accordance with Bowen's framework with 8 focus areas. Results. The OR Black Box had a high level of acceptability among stakeholders with 100% participation from management, 93% from OR staff, and 98% from patients. The implementation process improved over time, and an average of 80% of the surgeries conducted were captured. The practical aspects such as numerous formal and informal meetings, ethical and legal approval, recruitment of patients were acceptable, albeit time-consuming. The OR Black Box was adopted without any changes in scheduled surgery program, but capturing hours were adjusted to match the surgery program and relocation of OR staff declining to provide consent was possible. Conclusions. Implementation of the OR Black Box was feasible yet challenging. Management, nearly all staff, and patients embraced the initiative; however, ongoing evaluation, information meetings, and commitment from stakeholders are required and crucial to sustain momentum, continue implementation and expansion. Ideas from this study can be useful in the implementation of similar initiatives.

The distress thermometer in survivors of gynaecological cancer: accuracy in screening and association with the need for person-centred support.

PURPOSE: Unrecognised psychological distress among cancer survivors may be identified using short screening tools. We validated the accuracy of the distress thermometer (DT) to detect psychological distress on the Hospital Anxiety and Depression Scale (HADS) among early stage gynaecological cancer survivors and whether the women's DT and HADS scores were associated with the need of an individualised supportive intervention. METHODS: One hundred sixty-five gynaecological cancer survivors answered DT and HADS before randomisation in a trial testing a nurse-led, person-centred intervention using supportive conversations. The number of conversations was decided in the woman-nurse dyad based on the woman's perceived need. Nurses were unaware of the women's DT and HADS scores. We validated DT's accuracy for screening using HADS as gold standard and receiver operating characteristic curves. Associations between DT and HADS scores and the number of conversations received were investigated. RESULTS: For screening of distress (HADS ≥ 15), a DT score ≥ 2, had a sensitivity of 93% (95% CI 82-98%), a specificity of 40% (32-49%), and positive and negative predictive values of 36% (28-45%), and 94% (84-98%), respectively; area under curve was 0.73 (0.64-0.81). Higher DT and HADS scores were associated with more interventional conversations. CONCLUSIONS: In gynaecological cancer survivors, DT may perform fairly well as a first stage screening tool for distress, but a second stage is likely needed due to a high number of false positives. DT and HADS scores may predict the number of supportive conversations needed in an individualised intervention in gynaecological cancer survivors.

Type I Versus Type II Endometrial Cancer: Differential Impact of Comorbidity.

OBJECTIVE: Two distinct types of endometrial carcinoma (EC) with different etiology, tumor characteristics, and prognosis are recognized. We investigated if the prognostic impact of comorbidity varies between these 2 types of EC. Furthermore, we studied if the recently developed ovarian cancer comorbidity index (OCCI) is useful for prediction of survival in EC. MATERIALS AND METHODS: This nationwide register-based cohort study was based on data from 6487 EC patients diagnosed in Denmark between 2005 and 2015. Patients were assigned a comorbidity index score according to the Charlson comorbidity index (CCI) and the OCCI. Kaplan-Meier survival statistics and adjusted multivariate Cox regression analyses were used to investigate the differential association between comorbidity and overall survival in types I and II EC. RESULTS: The distribution of comorbidities varied between the 2 EC types. A consistent association between increasing levels of comorbidity and poorer survival was observed for both types. Cox regression analyses revealed a significant interaction between cancer stage and comorbidity indicating that the impact of comorbidity varied with stage. In contrast, the interaction between comorbidity and EC type was not significant. Both the CCI and the OCCI were useful measurements of comorbidity, but the CCI was the strongest predictor in this patient population. CONCLUSIONS: Comorbidity is an important prognostic factor in type I as well as in type II EC although the overall prognosis differs significantly between the 2 types of EC. The prognostic impact of comorbidity varies with stage but not with type of EC.

Ovarian Cancer and Comorbidity: Is Poor Survival Explained by Choice of Primary Treatment or System Delay?

OBJECTIVES: Comorbidity influences survival in ovarian cancer, but the causal relations between prognosis and comorbidity are not well characterized. The aim of this study was to investigate the associations between comorbidity, system delay, the choice of primary treatment, and survival in Danish ovarian cancer patients. METHODS: This population-based study was conducted on data from 5317 ovarian cancer patients registered in the Danish Gynecological Cancer Database. Comorbidity was classified according to the Charlson Comorbidity Index and the Ovarian Cancer Comorbidity Index. Pearson χ test and multivariate logistic regression analyses were used to investigate the association between comorbidity and primary outcome measures: primary treatment ("primary debulking surgery" vs "no primary surgery") and system delay (more vs less than required by the National Cancer Patient Pathways [NCPPs]). Cox regression analyses, including hypothesized mediators stepwise, were used to investigate if the impact of comorbidity on overall survival is mediated by the choice of treatment or system delay. RESULTS: A total of 3945 patients (74.2%) underwent primary debulking surgery, whereas 1160 (21.8%) received neoadjuvant chemotherapy. When adjusting for confounders, comorbidity was not significantly associated to the choice of treatment. Surgically treated patients with moderate/severe comorbidity were more often experiencing system delay longer than required by the NCPP. No association between comorbidity and system delay was observed for patients treated with neoadjuvant chemotherapy. Survival analyses demonstrated that system delay longer than NCPP requirement positively impacts survival (hazard ratio, 0.90 [95% confidence interval, 0.82-0.98]), whereas primary treatment modality has no significant impact on survival. CONCLUSIONS: Patients with moderate/severe comorbidity experience often a longer system delay than patients with no or mild comorbidity. Age, stage, and comorbidity are factors influencing the choice of treatment, with stage being the most important factor and comorbidity of lesser importance. The impact of comorbidity on survival does not seem to be mediated by the choice of treatment or system delay.

Simulation-based camera navigation training in laparoscopy-a randomized trial.

BACKGROUND: Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. MATERIALS AND METHODS: A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group). Participants were surgical novices without prior laparoscopic experience. The primary outcome was assessment of camera navigation skills during a laparoscopic cholecystectomy. The secondary outcome was technical skills after training, using a previously developed model for testing camera navigational skills. The exploratory outcome measured participants' motivation toward the task as an operating assistant. RESULTS: Thirty-six participants were randomized. No significant difference was found in the primary outcome between the three groups (p = 0.279). The secondary outcome showed no significant difference between the interventions groups, total time 167 s (95% CI, 118-217) and 194 s (95% CI, 152-236) for the camera group and the procedure group, respectively (p = 0.369). Both interventions groups were significantly faster than the control group, 307 s (95% CI, 202-412), p = 0.018 and p = 0.045, respectively. On the exploratory outcome, the control group for two dimensions, interest/enjoyment (p = 0.030) and perceived choice (p = 0.033), had a higher score. CONCLUSIONS: Simulation-based training improves the technical skills required for camera navigation, regardless of practicing camera navigation or the procedure itself. Transfer to the clinical setting could, however, not be demonstrated. The control group demonstrated higher interest/enjoyment and perceived choice than the camera group.

Incidence of pelvic organ prolapse repair subsequent to hysterectomy: a comparison between radical hysterectomy and total abdominal hysterectomy.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the incidence of subsequent pelvic organ prolapse (POP) repair in women following radical hysterectomy versus total abdominal hysterectomy. METHODS: From the Danish National Patient Registry, we collected data on all radical hysterectomies, all total abdominal hysterectomies, and all POP operations performed in Denmark from 1 January 1977 to 31 December 2009. We excluded patients with prior POP repair, POP diagnosis, or concomitant POP repair at hysterectomy. We analyzed the incidence of POP surgery using Kaplan-Meier curves and hazard ratio (HR). RESULTS: In all, 5279 women underwent radical hysterectomy, and 63 of these underwent subsequent POP surgery. In the same period, 149,920 women underwent total abdominal hysterectomy, and 6107 of these had POP surgery subsequent to the hysterectomy. The cumulative incidence of POP surgery was significantly lower for radical hysterectomy than for abdominal hysterectomy-3.4 % and 9.5 %, respectively, at the end of the study period, yielding a crude HR of 0.36 and an adjusted HR of 0.40 in favor of the radical hysterectomy. The distribution of POP operations in the defined compartments was the same for the two types of hysterectomy. CONCLUSIONS: This study found a significantly lower incidence of subsequent POP operations among women who undergo radical hysterectomy than total abdominal hysterectomy.

Vaginal vault suspension during hysterectomy for benign indications: a prospective register study of agreement on terminology and surgical procedure.

INTRODUCTION AND HYPOTHESIS: Several suspension methods are used to try to prevent pelvic organ prolapse (POP) after hysterectomy. We aimed to evaluate agreement on terminology and surgical procedure of these methods. METHODS: We randomly chose 532 medical records of women with a history of hysterectomy from the Danish Hysterectomy and Hysteroscopy Database (DHHD). Additionally, we video-recorded 36 randomly chosen hysterectomies. The hysterectomies were registered in the DHHD. The material was categorized according to predefined suspension methods. Agreement compared suspension codes in DHHD (gynecologists' registrations) with medical records (gynecologists' descriptions) and with videos (reviewers' categorizations) respectively. Whether the vaginal vault was suspended (pooled suspension) or not (no suspension method + not described) was analyzed, in addition to each suspension method. RESULTS: Regarding medical records, agreement on terminology was good among patients undergoing pooled suspension in cases of hysterectomy via the abdominal and vaginal route (agreement 78.7, 92.3%). Regarding videos, agreement on surgical procedure was good among pooled suspension patients in cases of hysterectomy via the abdominal, laparoscopic, and vaginal routes (agreement 88.9, 97.8, 100%). Agreement on individual suspension methods differed regarding both medical records (agreement 0-90.1%) and videos (agreement 0-100%). CONCLUSIONS: Agreement on terminology and surgical procedure regarding suspension method was good in respect of pooled suspension. However, disagreement was observed when individual suspension methods and operative details were scrutinized. Better consensus of terminology and surgical procedure is warranted to enable further research aimed at preventing POP among women undergoing hysterectomy.

Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation.

BACKGROUND: Simulation-based medical education (SBME) has traditionally been conducted as off-site simulation in simulation centres. Some hospital departments also provide off-site simulation using in-house training room(s) set up for simulation away from the clinical setting, and these activities are called in-house training. In-house training facilities can be part of hospital departments and resemble to some extent simulation centres but often have less technical equipment. In situ simulation, introduced over the past decade, mainly comprises of team-based activities and occurs in patient care units with healthcare professionals in their own working environment. Thus, this intentional blend of simulation and real working environments means that in situ simulation brings simulation to the real working environment and provides training where people work. In situ simulation can be either announced or unannounced, the latter also known as a drill. This article presents and discusses the design of SBME and the advantage and disadvantage of the different simulation settings, such as training in simulation-centres, in-house simulations in hospital departments, announced or unannounced in situ simulations. DISCUSSION: Non-randomised studies argue that in situ simulation is more effective for educational purposes than other types of simulation settings. Conversely, the few comparison studies that exist, either randomised or retrospective, show that choice of setting does not seem to influence individual or team learning. However, hospital department-based simulations, such as in-house simulation and in situ simulation, lead to a gain in organisational learning. To our knowledge no studies have compared announced and unannounced in situ simulation. The literature suggests some improved organisational learning from unannounced in situ simulation; however, unannounced in situ simulation was also found to be challenging to plan and conduct, and more stressful among participants. The importance of setting, context and fidelity are discussed. Based on the current limited research we suggest that choice of setting for simulations does not seem to influence individual and team learning. Department-based local simulation, such as simulation in-house and especially in situ simulation, leads to gains in organisational learning. The overall objectives of simulation-based education and factors such as feasibility can help determine choice of simulation setting.

Influence of pre-pregnancy leisure time physical activity on gestational and postpartum weight gain and birth weight - a cohort study.

In order to examine the association between pre-pregnancy leisure time physical activities and gestational weight gain, postpartum weight gain and birth weight, we analysed prospectively collected data from 1827 women with singleton term pregnancies. Women were categorised in groups of sedentary women, light exercisers, moderate exercisers and competitive athletes. The results showed that sedentary women on average gained 14.1 kg during pregnancy, whereas light exercisers gained 13.7 kg, moderate exercisers gained 14.3 kg and competitive athletes 16.1 kg. Competitive athletes had an increased risk of having a gestational weight gain above Institute of Medicine (IOM) recommendations with an odds ratio of 2.60 (1.32-5.15) compared to light exercisers. However, birth weight and one year postpartum weight was similar for all four groups. Thus, although competitive athletes gain more weight than recommended during pregnancy, this may not affect birth weight or postpartum weight. Impact statement What is already known on this subjectPrevious studies have found that increased pre-pregnancy physical activity is associated with lower gestational weight gain during the last trimester, but showed no association between the pre-pregnancy level of physical activity and mean birth weight. What the results of this study addWe found that women classified as competitive exercisers had a 2.6-fold increased risk of gaining more weight than recommended compared to light exercisers. Nearly 6 out of 10 women among the competitive exercisers gained more weight than recommended by IOM. Surprisingly, this did not appear to increase birth weight or post-partum weight gain, but other adverse effects cannot be excluded. What the implications are of these findings for clinical practice and/or further researchIn the clinical practice it may be relevant to focus on and advise pre-pregnancy competitive exercisers in order to prevent excessive gestational weight gain.

Parental rheumatoid arthritis and long-term child morbidity: a nationwide cohort study.

OBJECTIVE: To estimate the influence of parental rheumatoid arthritis (RA) on child morbidity. DESIGN: Nationwide cohort study. SETTING: Individual linkage to nationwide Danish registries. PARTICIPANTS: All singletons born in Denmark during 1977-2008 (n=1 917 723) were followed for an average of 16 years. MAIN OUTCOME MEASURES: Adjusted HRs for child morbidity; that is, 11 main diagnostic groups and specific autoimmune diseases within the International Classification of Diseases 8th and 10th versions. RESULTS: Compared with unexposed children, children exposed to maternal RA ('clinical' and 'preclinical') (n=13 566) had up to 26% higher morbidity in 8 of 11 main diagnostic groups. Similar tendencies were found in children exposed to paternal RA ('clinical' and 'preclinical') (n=6330), with statistically significantly higher morbidity in 6 of 11 diagnostic groups. HRs were highest for autoimmune diseases with up to three times increased risk of juvenile idiopathic arthritis (HR, 95% CI 3.30, 2.71 to 4.03 and 2.97, 2.20 to 4.01) and increased risk of up to 40% of diabetes mellitus type 1 (HR, 95% CI 1.37, 1.12 to 1.66 and 1.44, 1.09 to 1.90) and up to 30% increased HR of asthma (HR, 95% CI 1.28, 1.20 to 1.36 and 1.15, 1.04 to 1.26). Conclusions were roughly similar for children exposed to maternal clinical RA and for children only followed up to 16 years of age. CONCLUSION: Children of parents with RA had consistent excess morbidity. If the associations reflect biological mechanisms, genetic factors seem to play an important role. These findings call for attention given to children of parents with RA.

A new clinically applicable age-specific comorbidity index for preoperative risk assessment of ovarian cancer patients.

OBJECTIVE: To develop and validate a new feasible comorbidity index based on self-reported information suited for preoperative risk assessment of ovarian cancer patients. METHODS: The study was based on patient self-reported data from ovarian cancer patients registered in the Danish Gynecological Cancer Database between January 1, 2005 and December 31, 2012. The study population was divided into a development cohort (n=2020) and a validation cohort (n=1975). Age-stratified multivariate Cox regression analyses were conducted to identify comorbidities significantly impacting five-year overall survival in the development cohort, and regression coefficients were used to construct a new weighted comorbidity index. The index was applied to the validation cohort, and its predictive ability in regard to overall and cancer-specific five-year-survival was investigated. Finally, the performance of the new index was compared to that of the Charlson Comorbidity Index. RESULTS: Regression coefficients of age and five comorbidities (atherosclerotic cardiac disease, chronic obstructive pulmonary disease, diabetes, dementia and hypertension) were included in the new comorbidity index. The validation study found the new index to be significantly associated to both overall survival (HR 1.44, p=0.013) and cancer-specific survival (HR 1.51, p=0.017) in multivariate analyses adjusted for other prognostic factors. The index was a significantly better predictor than the Charlson Comorbidity Index. CONCLUSION: This new age-specific comorbidity index based on self-reported information is a significant predictor of overall and cancer-specific survival in ovarian cancer. It can be used to quickly identify those ovarian cancer patients requiring special attention in terms of preoperative optimization and postoperative care.

Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial.

BACKGROUND: Hysterectomy is one of the most frequently performed major gynecological surgical procedures. Even when the indication for the procedure is benign, relatively high complication rates have been reported. Perioperative bleeding seems to represent the most common cause of complications and in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an antifibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge about the drug's effect in relation to benign hysterectomy is still missing. OBJECTIVE: To investigate the antihemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy. STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at 4 gynecological departments in Denmark from April 2013 to October 2014. A total of 332 women undergoing benign abdominal, laparoscopic, or vaginal hysterectomy were included in the trial, randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-square test and Student t test statistical analyses were applied. RESULTS: The primary outcome of intraoperative total blood loss was reduced in the group treated with tranexamic acid compared to the placebo group when estimated both subjectively by the surgeon and objectively by weight (98.4 mL vs 134.8 mL, P = .006 and 100.0 mL vs 166.0 mL, P = .004). The incidence of blood loss ≥500 mL was also significantly reduced (6 vs 21, P = .003), as well as the use of open-label tranexamic acid (7 vs 18, P = .024). Furthermore, the risk of reoperations owing to postoperative hemorrhage was significantly reduced in the tranexamic acid group compared to the placebo group (2 vs 9, P = .034). This corresponds to an absolute risk reduction of 4.2% and number needed to treat of 24. No incidence of thromboembolic events or death was observed in any of the groups. CONCLUSION: The results support the hypothesis that prophylactic treatment with tranexamic acid reduces the overall total blood loss, the incidence of substantial blood loss, and the need for reoperations owing to postoperative hemorrhage in relation to benign hysterectomy. No incidences of serious adverse events occurred. Thus, tranexamic acid should be considered as a prophylactic treatment prior to elective benign hysterectomy.

Age at hysterectomy as a predictor for subsequent pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate the association between patient age at the time of hysterectomy and subsequent pelvic organ prolapse (POP) surgery. METHODS: We gathered data on all benign hysterectomies and POP surgeries performed in Denmark on Danish women from 1977 to 2009 from the Danish National Patient Registry. The cohort consisted of 154,882 hysterectomized women, who were followed up for up to 32 years. Survival analysis for each age group at hysterectomy was performed using Kaplan-Meier product limit methods. RESULTS: For all hysterectomized women, we found that low age at hysterectomy yielded a lower risk of subsequent POP surgery than did hysterectomy at an older age. This difference diminished after stratification by indication; all non-POP hysterectomies had a low cumulative incidence at 8-11 % at the end of the follow-up period. For all women hysterectomized, the predominant compartment for POP surgery was the posterior. Women hysterectomized when aged over 66 years had a higher proportion of POP surgery in the apical compartment than in the other age groups (p = 0.000). CONCLUSION: Our findings indicate that age at hysterectomy only marginally influences the risk of subsequent POP surgery for women hysterectomized for indications other than POP. If POP is the indication for hysterectomy, the risk of undergoing subsequent POP surgery increases substantially.

Subtotal versus total abdominal hysterectomy: randomized clinical trial with 14-year questionnaire follow-up.

OBJECTIVE: The objective of the study was to compare long-term results of subtotal vs total abdominal hysterectomy for benign uterine diseases 14 years after hysterectomy, with urinary incontinence as the primary outcome measure. STUDY DESIGN: This was a long-term follow-up of a multicenter, randomized clinical trial without blinding. Eleven gynecological departments in Denmark contributed participants to the trial. Women referred for benign uterine diseases who did not have contraindications to subtotal abdominal hysterectomy were randomized to subtotal (n = 161) vs total (n = 158) abdominal hysterectomy. All women enrolled in the trial from 1996 to 2000 who were still alive and living in Denmark (n = 304) were invited to answer the validated questionnaire used in prior 1 and 5 year follow-ups. Hospital contacts possibly related to hysterectomy from 5 to 14 years postoperatively were registered from discharge summaries from all public hospitals in Denmark. The results were analyzed as intention to treat and per protocol. Possible bias caused by missing data was handled by multiple imputation. The primary outcome was urinary incontinence; the secondary outcomes were pelvic organ prolapse, constipation, pain, sexuality, quality of life (Short Form-36 questionnaire), hospital contacts, and vaginal bleeding. RESULTS: The questionnaire was answered by 197 of 304 women (64.8%) (subtotal hysterectomy [n = 97] [63.4%]; total hysterectomy [n = 100] [66.2%]). Mean follow-up time was 14 years and mean age at follow-up was 60.1 years. After subtotal abdominal hysterectomy, 32 of 97 women (33%) complained of urinary incontinence compared with 20 of 100 women (20%) after total abdominal hysterectomy 14 years after hysterectomy (relative risk, 1.67; 95% confidence interval, 1.02-2.70; P = .035). After a multiple imputation analysis, this difference disappeared (relative risk, 1.36; 95% confidence interval, 0.86-2.13; P = .19). No differences were seen in any of the secondary outcomes. CONCLUSION: Subtotal abdominal hysterectomy was not superior to total abdominal hysterectomy on any outcomes. More women seem to have subjective urinary incontinence 14 years after subtotal abdominal hysterectomy. This result was not confirmed by multiple imputation analysis and should be interpreted cautiously.

Incidence and lifetime risk of pelvic organ prolapse surgery in Denmark from 1977 to 2009.

INTRODUCTION AND HYPOTHESIS: The purpose of the study was to describe the incidence of pelvic organ prolapse (POP) surgeries in Denmark during the last 30 years, age distribution over time, and the lifetime risk of undergoing POP surgery. METHODS: We carried out a population-based registry study. The setting was the Danish National Patient Registry. The sample consisted of Danish women of all ages undergoing prolapse surgery during the period 1977-2009. Data were retrieved from the Danish National Patient Registry. Prolapse surgery included surgery for any type of genital prolapse including hysterectomy due to prolapse. The main outcome measures were incidence of POP, age distribution over time, and lifetime risk of undergoing POP surgery. RESULTS: Surgical interventions for POP decreased by 47 % from 1977 (288 procedures/100,000 women) to 1999 (153 procedures/100,000 women). Subsequently, they increased to 75 % of the original incidence rate; in 2008, the incidence of total POP procedures was 201 out of 100,000 women and the incidence of women undergoing POP surgery was 139 out of 100,000 women. During the study period, the age-specific incidence of POP surgeries increased for women over the age of 65-69 years and decreased for women below that age. In 2008, the lifetime risk for an 80-year-old woman of undergoing at least one POP surgery was 18.7 %. CONCLUSIONS: The incidence of POP surgery varied up to 50 % during the study period. The age distribution changed so that more elderly and less young women had surgery in 2008 compared with 1978. Finally, we found that the lifetime risk of undergoing POP surgery for an 80-year-old was 26.9 % in 1978, 20.5 % in 1988, 17.2 % in 1998, and 18.7 % in 2008.

The indication for hysterectomy as a risk factor for subsequent pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to investigate whether the indication for hysterectomy was itself a risk factor for subsequent pelvic organ prolapse (POP) in Danish women who underwent hysterectomy from 1977 to 2009. METHODS: Data from 154,882 women who underwent hysterectomy for benign conditions during the period 1977 - 2009 were extracted from the Danish National Patient Register. Patients were followed up from hysterectomy to POP surgery, death/emigration, or end of study period. Hazard ratios (HR) for the first POP surgery in each woman were calculated using the Cox proportional hazards model. Survival analysis for each indication for hysterectomy was performed using the Kaplan-Meier product limit method. RESULTS: Fibroids/polyps as the indication was used as the reference when calculating HRs. After adjustment for calendar period, patient age, and hysterectomy route, the HR for POP was 6.57 (95% confidence interval 5.91 - 7.30). The HR for abnormal uterine bleeding (AUB), pain, endometriosis, and "other indications" was significantly higher than the reference. POP surgery was performed predominantly in the posterior compartment for all indications except benign ovarian tumors. CONCLUSIONS: POP as the indication for hysterectomy was associated with the highest cumulative incidence of subsequent POP surgery 32 years after hysterectomy. But the indications AUB, pain, endometriosis, and "other indications" were associated with a higher risk of subsequent POP surgery after hysterectomy than the indication fibroids/polyps. The predominant compartment for POP surgery was the posterior compartment for almost all indications. The indication for hysterectomy and the compartment in which POP surgery was performed subsequent to hysterectomy were associated.

Pelvic organ prolapse (POP) surgery among Danish women hysterectomized for benign conditions: age at hysterectomy, age at subsequent POP operation, and risk of POP after hysterectomy.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to describe the incidence of pelvic organ prolapse (POP) surgery after hysterectomy from 1977 to 2009, the time interval from hysterectomy to POP surgery, and age characteristics of women undergoing POP surgery after hysterectomy and to estimate the risk of undergoing POP surgery after hysterectomy. METHODS: The study was a population-based registry study. Patient data from 154,882 women hysterectomized for benign conditions in the period from 1977 to 2009 were extracted from the Danish National Patient Registry. Patients were followed up from hysterectomy to POP surgery, death/emigration, or end of study period. An estimate of the hazard of undergoing POP surgery following hysterectomy was calculated. Survival analysis was performed using the Kaplan-Meier product limit method. RESULTS: The frequency of POP surgery on hysterectomized women was high the first 2 years of the follow-up period with almost 800 women operated yearly. More than one third (n = 2,872) of all women operated for POP were operated less than 5 years after the hysterectomy with a median of 8.6 years. The cumulated incidence of POP surgery after hysterectomy with follow-up of up to 32 years was 12 %; 50 % (n = 5,451) of all POP surgeries were in the posterior compartment. The mean age of women undergoing a first POP surgery after hysterectomy was 60 years. CONCLUSIONS: POP after hysterectomy occurs as a long-term complication of hysterectomy; 12 % of hysterectomized women were operated for POP. They were operated at younger age than non-hysterectomized women and half the POP operations were performed in the posterior compartment.

The effect of dyad versus individual simulation-based ultrasound training on skills transfer.

CONTEXT: Dyad practice may be as effective as individual practice during clinical skills training, improve students' confidence, and reduce costs of training. However, there is little evidence that dyad training is non-inferior to single-student practice in terms of skills transfer. OBJECTIVES: This study was conducted to compare the effectiveness of simulation-based ultrasound training in pairs (dyad practice) with that of training alone (single-student practice) on skills transfer. METHODS: In a non-inferiority trial, 30 ultrasound novices were randomised to dyad (n = 16) or single-student (n = 14) practice. All participants completed a 2-hour training programme on a transvaginal ultrasound simulator. Participants in the dyad group practised together and took turns as the active practitioner, whereas participants in the single group practised alone. Performance improvements were evaluated through pre-, post- and transfer tests. The transfer test involved the assessment of a transvaginal ultrasound scan by one of two clinicians using the Objective Structured Assessment of Ultrasound Skills (OSAUS). RESULTS: Thirty participants completed the simulation-based training and 24 of these completed the transfer test. Dyad training was found to be non-inferior to single-student training: transfer test OSAUS scores were significantly higher than the pre-specified non-inferiority margin (delta score 7.8%, 95% confidence interval -3.8-19.6%; p = 0.04). More dyad (71.4%) than single (30.0%) trainees achieved OSAUS scores above a pre-established pass/fail level in the transfer test (p = 0.05). There were significant differences in performance scores before and after training in both groups (pre- versus post-test, p < 0.01) with large effect sizes (Cohen's d = 3.85) and no significant interactions between training type and performance (p = 0.59). The dyad group demonstrated higher training efficiency in terms of simulator score per number of attempts compared with the single-student group (p = 0.03). CONCLUSION: Dyad practice improves the efficiency of simulation-based training and is non-inferior to individual practice in terms of skills transfer.

Does neoadjuvant chemotherapy impair long-term survival for ovarian cancer patients? A nationwide Danish study.

OBJECTIVE: In Denmark, the proportion of women with ovarian cancer treated with neoadjuvant chemotherapy (NACT) has increased, and the use of NACT varies among center hospitals. We aimed to evaluate the impact of first-line treatment on surgical outcome and median overall survival (MOS). METHODS: All patients treated in Danish referral centers with stage IIIC or IV epithelial ovarian cancer from January 2005 to October 2011 were included. Data were obtained from the Danish Gynecological Cancer Database, the Danish National Patient Register and medical records. RESULTS: Of the 1677 eligible patients, 990 (59%) were treated with primary debulking surgery (PDS), 515 (31%) with NACT, and 172 (10%) received palliative treatment. Of the patients referred to NACT, 335 (65%) received interval debulking surgery (IDS). Patients treated with NACT-IDS had shorter operation times, less blood loss, less extensive surgery, fewer intraoperative complications and a lower frequency of residual tumor (p < 0.05 for all). No difference in MOS was found between patients treated with PDS (31.9 months) and patients treated with NACT-IDS (29.4 months), p = 0.099. Patients without residual tumor after surgery had better MOS when treated with PDS compared with NACT-IDS (55.5 and 36.7 months, respectively, p = 0.002). In a multivariate analysis, NACT-IDS was associated with increased risk of death after two years of follow-up (HR: 1.81; CI: 1.39-2.35). CONCLUSIONS: No difference in MOS was observed between PDS and NACT-IDS. However, patients without residual tumor had superior MOS when treated with PDS, and NACT-IDS could be associated with increased risk of death after two years of follow-up.

Differences in regional diagnostic strategies and in intended versus actual first-line treatment of patients with advanced ovarian cancer in Denmark.

BACKGROUND: Triage of patients with ovarian cancer to primary debulking surgery (PDS) or neoadjuvant chemotherapy (NACT) is challenging. In Denmark, the use of NACT has increased, but substantial differences in the use of NACT or PDS exist among centers. We aimed to characterize the differences between intended and actual first-line treatments in addition to the differences in the triage process among the centers and to evaluate the different diagnostic modalities and the clinical aspects' influence in the triage process. MATERIALS AND METHODS: From 4 centers, forms containing data about the diagnostic process and intended treatment were prospectively collected and merged with data from the Danish Gynecological Cancer Database and medical records. RESULTS: Of the 671 completed forms, 540 patients had stage IIIC or IV epithelial ovarian cancer. Of the 238 (44%) referred to PDS, 91% received PDS and 4% never had debulking surgery. Of the 288 patients (53%) referred to NACT, 44% were never debulked. Fourteen patients (3%) were referred to palliative treatment. The use of different imaging modalities, diagnostic laparoscopy, and laparotomy varied significantly among the centers. Diagnostic surgical procedures were considered to be most influential in the triage process. Regardless of the intended first-line treatment or center, the tumor size and dissemination was the most influential clinical aspect. CONCLUSIONS: In Denmark, substantial differences exist between intended and actual first-line treatments as well as in the diagnostic process and use of NACT, calling for further discussion on diagnostic strategy and therapeutically approach for patients with advanced ovarian cancer.