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.

Healthcare professionals' perception of safety culture and the Operating Room (OR) Black Box technology before clinical implementation: a cross-sectional survey.

INTRODUCTION: Comprehensive data capture systems such as the Operating Room Black Box (OR Black Box) are becoming more widely implemented to access quality data in the complex environment of the OR. Prior to installing an OR Black Box, we assessed perceptions on safety attitudes, impostor phenomenon and privacy concerns around digital information sharing among healthcare professionals in the OR. A parallel survey was conducted in Canada, hence, this study also discusses cultural and international differences when implementing new technology in healthcare. METHODS: A cross-sectional survey using three previously validated questionnaires (Safety Attitudes Questionnaire (SAQ), Clance Impostor Phenomenon Scale, Dispositional Privacy Concern) was distributed through Research Electronic Data Capture to 145 healthcare professionals from the OR (July to December 2019). Analysis of variance and analysis of covariance were used to test for differences. RESULTS: 124 responded (86%): 100 completed the survey (69%) (38 nurses, 10 anaesthesiologists, 36 obstetricians/gynaecologists, 16 residents). Significant variability in all six SAQ domains, safety climate and teamwork being the lowest ranked and job satisfaction ranked highest for all groups. The SAQ varied in all domains in Canada. Moderate to frequent impostor phenomenon was experienced by 71% predominantly among residents (p=0.003). 72% in the Canadian study. Residents were most comfortable with digital information sharing (p<0.001), only 13% of all healthcare professionals were concerned/heavy concerned compared with 45% in Canada. CONCLUSIONS: The different healthcare professional groups had diverse perceptions about safety culture, but were mainly concerned about safety climate and teamwork in the OR. Impostor phenomenon decreased with age. All groups were unconcerned about digital information sharing. The Canadian study had similar findings in terms of impostor phenomenon, but a variety within the SAQ and were more concerned about data safety, which could be due to medical litigation per se and is not widespread in Scandinavia compared with North America.

Play interventions for paediatric patients in hospital: a scoping review.

OBJECTIVE: Play is a non-invasive, safe and inexpensive intervention that can help paediatric patients and their families manage difficult aspects of being ill or hospitalised. Although play has existed in hospitals for decades, research on hospital play interventions is scarce. This review aimed to categorise and synthesise the last 20 years of research on hospital play interventions. DESIGN: Scoping review. DATA SOURCES: PubMed, CINAHL, CENTRAL, ERIC and PsycINFO (1 January 2000- 9 September 2020). STUDY SELECTION AND DATA EXTRACTION: We systematically searched for original peer-reviewed articles, written in English, on hospital play interventions in paediatric patients (0-18 years) in non-psychiatric settings. Two reviewers independently screened titles and abstracts, reviewed full text of relevant articles and extracted data. We thematically synthesised the data from the included studies, and a descriptive analysis, based on a developed framework, is presented. RESULTS: Of the 297 included articles, 78% came from high-income countries and 56% were published within the last 5 years. Play interventions were carried out across all ages by various healthcare professionals. Play interventions served different roles within four clinical contexts: A) procedures and diagnostic tests, B) patient education, C) treatment and recovery and D) adaptation. Across these contexts, play interventions were generally facilitated and purpose-oriented and had positive reported effects on pain, stress, and anxiety. CONCLUSIONS: Play in hospitals is an emerging interdisciplinary research area with a significant potential benefit for child and family health. Future research should further describe principles for play in hospitals. High-quality studies investigating short-term and long-term effects are needed to guide when and how to best integrate play in hospitals.

Pelvic organ prolapse surgery after native tissue vault suspension at hysterectomy-A prospective cohort study.

OBJECTIVE: The effect of prophylactic vaginal vault suspension during hysterectomy in prevention of subsequent development of pelvic organ prolapse (POP) is unknown. We aimed to investigate incidences and risk of POP surgery in women who had undergone hysterectomy on benign indication with and without prophylactic suspension. STUDY DESIGN: We linked the national clinical Danish Hysterectomy and Hysteroscopy Database (DHHD) to administrative registries to assess data on all total hysterectomies (1 May 2012 to 31 December 2014), suspension methods, age, POP surgery, births, obstetric complications, prescriptions, socioeconomic- and vital status. Women undergoing total hysterectomy on non-prolapse and benign indication with no prior POP surgery were included and followed from hysterectomy to POP surgery, death/emigration or end of study period (maximum 2 years). Descriptive statistics, cumulative incidence curves and multivariable Cox proportional hazard models were fitted to assess the associated risk of POP in relation to prophylactic suspension. RESULTS: We included 7625 patients undergoing total hysterectomy; of these, 6538 (85.7%) were registered with prophylactic suspension during hysterectomy and 1087 (14.3%) women were specifically registered with no suspension in the DHHD. At baseline, women undergoing hysterectomy with suspension were on average 47.1 years of age (standard error SE 0.1) compared to 48.4 years (SE 0.3) in women with no suspension (p-value <0.0001). Moreover, women with suspension differed from their counterparts with no suspension with respect to geographical site of hysterectomy, hysterectomy method, parity and income. The cumulative risk of POP surgery after two years follow-up was 0.9% and 0.5% in the suspension group and the no suspension group, respectively. In the adjusted analysis, we found no association of prophylactic suspension and risk of POP surgery, hazard ratio (HR) = 2.1 (95% confidence interval (CI) 0.8-5.3, p-value 0.13). CONCLUSION: Of all women undergoing hysterectomy for benign indication, 0.84% (N = 64) were surgically treated for POP. At two-year follow-up, there was no association between prophylactic vaginal vault suspension at time of hysterectomy and subsequent POP surgery.

No evidence of association between native tissue vault suspension and risk of pelvic pain or sexual dysfunction.

OBJECTIVE: Hysterectomy is suspected of increasing risk of subsequent pelvic organ prolapse (POP). In attempt to prevent this, several suspension methods during hysterectomy on benign indication are used as a prophylactic procedure. However, possible complications to the use of prophylactic vaginal vault suspension to prevent POP are not fully investigated. We aimed to elucidate prophylactic vaginal vault suspension as a possible cause for pelvic pain and sexual dysfunction. STUDY DESIGN: We included all women registered with a total hysterectomy on benign indication and registered with a suspension method or specifically no suspension in the nationwide Danish Hysterectomy and Hysteroscopy Database (DHHD) between 10 May 2012 and 4 September 2013 (N = 3999). A postal questionnaire on pelvic pain and sexual dysfunction was sent to women 25.8 (range 23.8-28.4) months after hysterectomy. Questions were selected from a previous study as well as from the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). We used independent samples t-tests and χ2-tests for univariate analyses. In multivariable analyses, we used log-binomial - and linear regression models adjusted for risk factors of pelvic pain and sexual dysfunction, respectively. RESULTS: The response rate was 60.3% (N = 2412). Of the respondents, 88.8% (N = 2143) were registered with a suspension method and 11.2% (N = 269) were registered with specifically no suspension. Overall, pelvic pain of any kind was reported in 24.3% (N = 576) of the respondents. In adjusted log-binomial regression, suspension did not increase risk of pelvic pain compared to no suspension (RR 0.92; 95% CI 0.75 to 1.14; p-value 0.45). In adjusted linear regression, suspension was significantly associated with less degree of sexual dysfunction (regression coefficient -0.92; 95% CI -1.70 to -0.14; p-value 0.02). CONCLUSIONS: In women undergoing prophylactic vaginal vault suspension during hysterectomy, we found less sexual dysfunction and no evidence of increased risk of pelvic pain compared to women with no vaginal vault suspension.

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.

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.

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.

Development and evaluation of an endoscopic surgery course for medical students.

INTRODUCTION: Surgical training has changed with the introduction of endoscopic surgery. However, a gap in undergraduate medical training has become evident regarding theoretical principles of and basic skills training in endoscopic surgery. The objective of this study was to develop and evaluate a course in endoscopic surgery for medical students. METHODS: Kern's six-step approach in curriculum development was used. A course including interactive, faculty-led didactic sessions (14 hours, distributed over three days) and simulation-based basic skills training in endoscopic surgery (nine hours, distributed over four sessions) was developed. Knowledge was tested using a 35-item test before and after the course, and finally the course was evaluated electronically. The project group in cooperation with the faculty -developed the goals and objectives, the test and the evaluation questionnaire. RESULTS: The test-scores significantly improved after the course, p < 0.0001, with a mean difference of 12.95 (95% confidence interval: 11.47-14.44). A total of 74% (14/19) responded that the course increased their interest in a career in a surgical specialty and 58% (11/19) were considering specialising in a surgical specialty. CONCLUSIONS: A course in endoscopic surgery was developed based on Kern's six-step approach. The course was positively perceived by the students in terms of contents as well as structure and relevance. FUNDING: University of Copenhagen, Aase og Ejner Danielsen Fonden, The Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet. TRIAL REGISTRATION: not relevant.

Pregnancy-induced gene expression changes in vivo among women with rheumatoid arthritis: a pilot study.

BACKGROUND: Little is known about gene expression changes induced by pregnancy in women with rheumatoid arthritis (RA) and healthy women because the few studies previously conducted did not have pre-pregnancy samples available as baseline. We have established a cohort of women with RA and healthy women followed prospectively from a pre-pregnancy baseline. In this study, we tested the hypothesis that pregnancy-induced changes in gene expression among women with RA who improve during pregnancy (pregDASimproved) overlap substantially with changes observed among healthy women and differ from changes observed among women with RA who worsen during pregnancy (pregDASworse). METHODS: Global gene expression profiles were generated by RNA sequencing (RNA-seq) from 11 women with RA and 5 healthy women before pregnancy (T0) and at the third trimester (T3). Among the women with RA, eight showed an improvement in disease activity by T3, whereas three worsened. Differential expression analysis was used to identify genes demonstrating significant changes in expression within each of the RA and healthy groups (T3 vs T0), as well as between the groups at each time point. Gene set enrichment was assessed in terms of Gene Ontology processes and protein networks. RESULTS: A total of 1296 genes were differentially expressed between T3 and T0 among the 8 pregDASimproved women, with 161 genes showing at least two-fold change (FC) in expression by T3. The majority (108 of 161 genes) were also differentially expressed among healthy women (q<0.05, FC≥2). Additionally, a small cluster of genes demonstrated contrasting changes in expression between the pregDASimproved and pregDASworse groups, all of which were inducible by type I interferon (IFN). These IFN-inducible genes were over-expressed at T3 compared to the T0 baseline among the pregDASimproved women. CONCLUSIONS: In our pilot RNA-seq dataset, increased pregnancy-induced expression of type I IFN-inducible genes was observed among women with RA who improved during pregnancy, but not among women who worsened. These findings warrant further investigation into expression of these genes in RA pregnancy and their potential role in modulation of disease activity. These results are nevertheless preliminary and should be interpreted with caution until replicated in a larger sample.

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.

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.

A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery.

BACKGROUND: The value of tranexamic acid (TA) treatment as bleeding prophylaxis in major uterine surgery is unclear. OBJECTIVES: To evaluate the antihemorrhagic effect of prophylactic TA treatment in major benign uterine surgery. SEARCH STRATEGY: PubMed, Embase, Cochrane Library, and Web of Science were searched from 1980 to 2015 without language restriction using search terms related to major uterine surgery combined with TA. SELECTION CRITERIA: Randomized controlled trials comparing prophylactic TA with placebo or no intervention in women undergoing elective major benign uterine surgery. DATA COLLECTION AND ANALYSIS: Basic information and outcomes were collected and meta-analyses performed. MAIN RESULTS: Sixteen trials were included, with five trials considered to have an overall low risk of bias. In cesarean delivery, TA significantly reduced intraoperative bleeding (mean -136 mL, 95% confidence interval [CI] -189 to -83), blood loss of more than 1000 mL (relative risk 0.38, 95% CI 0.18-0.81), and blood transfusion (relative risk 0.32, 95% CI 0.17-0.59). In abdominal myomectomy, TA also significantly reduced intraoperative bleeding (mean -251 mL, 95% CI -391 to -110). CONCLUSIONS: Prophylactic TA treatment significantly reduced operative bleeding in women undergoing elective cesarean delivery or abdominal myomectomy. Additional randomized trials with low risk of bias are needed.

Parental Rheumatoid Arthritis, Child Mortality, and Case Fatality: A Nationwide Cohort Study.

OBJECTIVE: We have previously reported increased long-term morbidity in children of parents with rheumatoid arthritis (RA). Here we assess child mortality and case fatality in the same cohort. METHODS: All singletons born in Denmark from 1977 to 2008 were identified through linkage of Danish national registries. Cox proportional hazards models were used to calculate hazard ratios (HRs) of death from all causes among children exposed to parental RA, compared to unexposed children. Risk of death after infection or respiratory diseases was also assessed for children below the age of 5 years. RESULTS: This study followed 1,917,723 newborns for an average of 16 years. Of these, 13,556 were exposed to maternal RA and 6,330 to paternal RA. Overall mortality rates in children exposed to maternal or paternal RA did not differ from those in unexposed children (HR 0.98 [95% confidence interval (95% CI) 0.84-1.15] and 1.08 [95% CI 0.86-1.36], respectively), nor did the risk of death below the ages of 5 years, 3 years, or 1 year. In the group of children below the age of 5 years, 6,106 children of parents with RA were diagnosed with respiratory diseases and 3,320 with infectious diseases. The case fatality rate in children with these diseases was not significantly higher than in unexposed children (HR 1.11 [95% CI 0.74-1.66] and 0.84 [95% CI 0.52-1.35], respectively). CONCLUSION: Children of parents with RA had similar mortality rates as other children, as well as after diagnoses of respiratory or infectious diseases.

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.

Evaluation of Procedural Simulation as a Training and Assessment Tool in General Surgery-Simulating a Laparoscopic Appendectomy.

BACKGROUND: Laparoscopic appendectomy is a commonly performed surgical procedure, but few training models have been described for it. We examined a virtual reality module for practising a laparoscopic appendectomy. METHODS: A prospective cohort study with the following 3 groups of surgeons (n = 45): novices (0 procedures), intermediates (10-50 procedures), and experienced (>100 procedures). After being introduced to the simulator and 1 familiarization attempt on the procedural module, the participants practiced the module 20 times. Movements, task time, and procedure-specific parameters were compared over time. RESULTS: The time and movement parameters were significantly different during the first attempt, and more experienced surgeons used fewer movements and less time than novices (p < 0.01), although only 2 parameters were significantly different between novices and intermediates. All 3 groups improved significantly over 20 attempts (p < 0.0001). The intraclass correlation coefficient varied between 0.55 and 0.68 and did not differ significantly between the 3 groups (p > 0.05). When comparing novices with experienced surgeons, novices had a higher risk of burn damage to cecum (odds ratio [OR] = 3.0 [95% CI: 1.3; 7.0] p = 0.03), pressure damage to appendix (OR = 3.1 [95% CI: 2.0; 4.9] p < 0.0001), and grasping of the appendix (OR = 2.9 [95% CI: 1.8; 4.7] p < 0.0001). The risk of causing a perforation was not significantly different among the different experience levels (OR = 1.9 [95% CI: 0.9; 3.8] p = 0.14). Only 3 out of 5 error parameters differed significantly when comparing novices and experienced surgeons. Similarly, when comparing intermediates and novices, it was only 2 of the parameters that differed. DISCUSSION: The simulator module for practising laparoscopic appendectomy may be useful as a training tool, but further development is required before it can be used for assessment purposes. Procedural simulation may demonstrate more variation for movement parameters, and future research should focus on developing better procedure-specific parameters.

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.

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.

Parental rheumatoid arthritis and childhood epilepsy: A nationwide cohort study.

OBJECTIVE: To assess the influence of parental rheumatoid arthritis (RA) on risk of epilepsy. METHODS: We performed a nationwide cohort study including all singletons born in Denmark from 1977 to 2008 (n = 1,917,723) through individual linkage to nationwide Danish registries. The children were followed for an average of 16 years. Main outcome measures were adjusted hazard ratios (HRs) for epilepsy with onset in early childhood (29 days-4 years), late childhood (5-15 years), adolescence/adulthood (≥15 years), and at any age until the end of follow-up (December 31, 2010). RESULTS: Compared to unexposed children, children exposed to maternal RA had an increased risk of early and late childhood epilepsy (adjusted HRs 1.34 [95% confidence interval (CI) 1.13-1.60] and 1.26 [95% CI 1.13-1.41]), while children exposed to maternal RA had no increased risk of epilepsy in adolescence/adulthood (HR 1.15 [95% CI 0.92-1.45]). Paternal RA was not associated with an overall risk of epilepsy in the offspring (HR 0.96 [95% CI 0.81-1.15]) or at any age. Children exposed to maternal RA in utero had a more pronounced increased risk of early childhood epilepsy than children exposed to mothers who were diagnosed with RA after childbirth (HR 1.90 [95% CI 1.26-2.86] vs HR 1.26 [95% CI 1.03-1.52], respectively [p = 0.16]). CONCLUSIONS: Exposure to maternal RA was associated with an increased risk of childhood epilepsy, while exposure to paternal RA was not, which indicates that changes in the intrauterine environment may play a role.

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.