Introduction of a Maternal-Fetal Medicine Tele-Ultrasound Program in Rural Alberta.

OBJECTIVES: We established a program of Maternal-Fetal Medicine (MFM) telemedicine that is safe and acceptable. Since December 2019, a multi-disciplinary team has been planning this quality improvement project. METHODS: We performed a pilot study to investigate the feasibility of using telemedicine and tele-ultrasound to enable prompt MFM consultations for patients in remote locations. We began with the training of sonographers followed by implementation in a small pilot. Interim analysis of the acceptability and feasibility of the program was done through patient surveys, images audit, and review of neonatal outcomes. RESULTS: Our background epidemiologic data showed that in Alberta, between 2017 and 2022, 460 patients travelled >6 hours, and 5038 travelled >2 hours from home to reach their site of birth. Patients were appropriately triaged to delivery/consultation at the tertiary level center based on diagnosis/suspicion of anomalies, such as abnormally invasive placenta, intrauterine growth restriction, hydrops, and partial agenesis of the corpus callosum, all of which were confirmed postdelivery. There was no neonatal mortality, and the single stillbirth was related to an unpreventable peri-viable co-twin demise. The patient survey demonstrated that for >85% of respondents the program reduced costs and stress. Ultrasound image audit found improvement and consistency in image quality after 3 months of training combined with supervision. CONCLUSION: MFM telemedicine is feasible and can be safe with adequate supervision. Additional support and resources are needed to scale and spread this quality improvement initiative.

Impact of birth tourism on health care systems in Calgary, Alberta.

BACKGROUND: Birth tourism refers to non-resident women giving birth in a country outside of their own in order to obtain citizenship and/or healthcare for their newborns. We undertook a study to determine the extent of birth tourism in Calgary, the characteristics and rationale of this population, and the financial impact on the healthcare system. METHODS: A retrospective analysis of 102 women identified through a Central Triage system as birth tourists who delivered in Calgary between July 2019 and November 2020 was performed. Primary outcome measures were mode of delivery, length of hospital stay, complications or readmissions within 6 weeks for mother or baby, and NICU stay for baby. RESULTS: Birth Tourists were most commonly from Nigeria (24.5%). 77% of Birth Tourists stated that their primary reason to deliver their baby in Canada was for newborn Canadian citizenship. The average time from arrival in Calgary to the EDD was 87 days. Nine babies required stay in the neonatal intensive care unit (NICU) and 3 required admission to a non NICU hospital ward in first 6 weeks of life, including 2 sets of twins. The overall amount owed to Alberta Health Services for hospital fees for this time period is approximately $694 000.00. CONCLUSION: Birth Tourists remain a complex and poorly studied group. The process of Central Triage did help support providers in standardizing process and documentation while ensuring that communication was consistent. These findings provide preliminary data to guide targeted public health and policy interventions for this population.

Uterosacral vault suspension (USLS) at the time of hysterectomy: laparoscopic versus vaginal approach.

INTRODUCTION AND HYPOTHESIS: To compare laparoscopic and vaginal approaches to uterosacral ligament vault suspension (USLS) by perioperative data, short-term complications, rates of successful concomitant adnexal surgery and procedural efficacy. METHODS: Retrospective cohort of USLS procedures performed at the time of hysterectomy at a tertiary care center over a 3-year period. Patient demographics, surgical data, concomitant adnexal procedures and complications were abstracted from a surgical database and compared using parametric or non-parametric tests as appropriate. Validated questionnaires (POPDI-6, UDI-6, PROMIS) were used to collect information on recurrence and long-term complications. Patients were analyzed according to both intention-to-treat analysis based on the intended approach and the completed route of surgery to deal with intraoperative conversions. RESULTS: Two hundred six patients met the criteria for inclusion; 152 underwent vaginal USLS (V-USLS) and 54 laparoscopic USLS (L-USLS). No statistically significant differences in mean case time, postoperative length of stay or perioperative infection were found. While no ureteric obstructions occurred in the L-USLS group, in the V-USLS group 14 (9%) obstructions occurred (p = 0.023). Postoperative urinary retention was higher with V-USLS (31% vs. 15%, p = 0.024). Rates of successfully completed adnexal surgery differed (56% vs. 98%, p < 0.001) in favor of L-USLS. Patient-reported symptomatic recurrence of prolapse was higher in the V-USLS group (41% vs. 24%, p = 0.046); despite this, re-treatment did not differ between the groups (0% vs. 7%, p = 0.113). CONCLUSIONS: Perioperative case time and complications did not differ between approaches. However, rates of completed adnexal surgery were significantly higher in the laparoscopic group, which could influence surgical decisions concerning approaches to prolapse surgery.

No. 383-Screening, Diagnosis, and Management of Placenta Accreta Spectrum Disorders.

BACKGROUND: Placenta accreta spectrum (PAS) disorders are a potentially life-threatening complication of pregnancy that demand coordinated interdisciplinary care to achieve safer outcomes. The rising incidence of this disease is due to a growing number of uterine surgical procedures, including the rising incidence of pregnancy following Caesarean section. OBJECTIVE: To provide current evidence-based guidelines on the optimal methods used to effectively screen, diagnose, and manage PAS disorders. METHODS: Members of the guideline committee were selected on the basis of their ongoing expertise in managing this condition across Canada and by practice setting. The committee reviewed all available evidence in the English medical literature, including published guidelines, and evaluated diagnostic tests, surgical procedures, and clinical outcomes. EVIDENCE: Published literature, including clinical practice guidelines, was retrieved through searches of Medline and The Cochrane Library to March 2018 using appropriate controlled vocabulary and key words. Results were restricted to systematic reviews, randomized controlled trials, and observational studies written in English. Searches were updated on a regular basis and incorporated in the guideline to July 2018. VALUES: The quality of evidence in this document was graded using the criteria described in the Report of the Canadian Task Force on Preventive Health Care. RESULTS: This document reviews the evidence regarding the available diagnostic and surgical techniques used for optimal management of women with suspected PAS disorders, including anaesthesia and practical considerations for interdisciplinary care. BENEFITS, HARMS, AND COSTS: Implementation of the guideline recommendations will improve awareness of this disease and increase the proportion of affected women receiving interdisciplinary care in regional centres. CONCLUSIONS: Interdisciplinary team-based care providing accurate diagnostic services, coordinated planning, and safer surgery deliver effective care with improved clinical outcomes in comparison with alternative management. SUMMARY STATEMENTS: RECOMMENDATIONS.

A new bovine tuberculosis model for England and Wales (BoTMEW) to simulate epidemiology, surveillance and control.

BACKGROUND: Bovine tuberculosis (bTB) is a zoonotic disease of cattle caused by Mycobacterium bovis, widespread in England and Wales. It has high incidence towards the South West of England and Wales, with much lower incidence to the East and North. A stochastic simulation model was developed to simulate M. bovis transmission among cattle, transfer by cattle movements and transmission from environmental reservoirs (often wildlife and especially badgers). It distinguishes five surveillance streams, including herd tests, pre-movement testing and slaughter surveillance. The model thereby simulates interventions in bTB surveillance and control, and generates outputs directly comparable to detailed disease records. An anonymized version of the executable model with its input data has been released. The model was fitted to cattle bTB records for 2008-2010 in a cross-sectional comparison, and its projection was compared with records from 2010 to 2016 for validation. RESULTS: The fitted model explained over 99% of the variation among numbers of breakdowns in four defined regions and surveillance streams in 2010. It classified 7800 (95% confidence interval c. 5500 - 14,000) holdings within high incidence regions as exposed to infectious environmental reservoirs, out of over 31,000 cattle holdings identified as potentially exposed to such sources. The model was consistent with previous estimates of low M. bovis transmission rate among cattle, but cattle to cattle transmission was clearly required to generate the number of cattle cases observed. When projected to 2016, the model as fitted to 2010 continued to match the distribution of bTB among counties, although it was notable that the actual distribution of bTB in 2010 was itself a close match for its distribution in 2016. CONCLUSIONS: The close model fit demonstrated that cattle movements could generate breakdowns as observed in low incidence regions, if persistent environmental reservoirs such as wildlife maintained infection levels in the high incidence regions. The model suggests that environmental reservoirs may be a challenge for control, because, although many holdings are exposed to infection from wildlife or the environment, they are a minority of holdings. Large impacts on disease in wildlife will be required to avoid each individual transmission event to cattle.

Five years after midurethral sling surgery for stress incontinence: obesity continues to have an impact on outcomes.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate the impact of preoperative body mass index ≥30 on objective and subjective cure rates 5 years after midurethral sling surgery. METHODS: Secondary analysis of the 5-year results of a randomized clinical trial evaluating tension-free vaginal tape vs transobturator tape surgery. Women (n = 176) were classified as obese or non-obese based on preoperative height and weight. Women self-reported symptoms and quality of life, and underwent standardized physical examinations and pad-testing. Categorical data were analyzed using Chi-squared or Fisher's exact tests, continuous data by Mann-Whitney U test. Primary outcome was objective cure defined as <1 g urine lost on pad-test at 5 years post-surgery. Secondary outcomes were subjective cure of incontinence, urinary urge incontinence symptoms, and quality of life scores. RESULTS: Non-obese women had a higher rate of objective cure, 87.4 % (n = 83 out of 95) compared with 65.9 % (n = 29 out of 44) in the obese group (P = 0.003, risk difference [RD] 21.5 %, 95 % CI 5.9-37.0 %). Subjectively, non-obese women also reported higher rates of cure, 76.7 % (n = 89 out of 116) compared with 53.6 % (n = 30 out of 56) of obese women (P = 0.002, RD 23.2 %, 95 % CI 8.0-38.3 %). Overall rates of urge incontinence symptoms were similar in the two groups, but rates of bothersome symptoms were higher for obese women (58.9 % vs 42.1 %, P = 0.039, RD 16.8 % 95 % CI 1.1-32.6). CONCLUSIONS: Five years after surgery, obese women continued to experience lower rates of cure compared with non-obese women.

Early voiding dysfunction after midurethral sling surgery: comparison of two management approaches.

INTRODUCTION AND HYPOTHESIS: Early voiding dysfunction (EVD) with urinary retention (UR) is a complication of midurethral sling (MUS) surgery. Management is not standardized. Our objective was to characterize management approaches at our center, and report outcomes including resolution of UR, persistent voiding dysfunction, and recurrent stress urinary incontinence (SUI). METHODS: All women requiring catheterization for ≥7 days after MUS surgery during the period March 2014 to 2016 were eligible for inclusion in this prospective study. The management plan for each patient was decided jointly by the surgeon and the patient. Questionnaires regarding urinary symptoms were administered at enrollment, and 3 and 6 months after surgery. The timing and type of any surgical intervention were recorded. RESULTS: During the 2-year period, 31 women experienced EVD for ≥7 days after MUS surgery. At 6 months, complete data were available for 30 women (97%). Two management approaches were identified: "early mobilization" to loosen the MUS intact (in 10 patients), and continued catheterization with delayed sling lysis as needed (in 21 patients). In eight of the ten women in the early mobilization group, UR resolved after one intervention. Two required a second mobilization. For all women in this group, UR resolved after one or two procedures. In 11 of the 21 women in the continued catheterization group UR resolved without intervention. The other ten women in the continued catheterization group opted for sling lysis ≤6 months after MUS surgery. None of the women in the mobilization group reported SUI at 6 months in contrast to 9 of 20 (45%) in the planned continued catheterization group (p = 0.029). Seven of the nine women experiencing recurrent SUI had undergone sling lysis. CONCLUSIONS: Patients experiencing EVD after MUS surgery can be informed that UR will resolve in 50% with continued catheterization. Mobilization should be an option for those not comfortable with prolonged catheterization. Early intervention by mobilization may be associated with a lower risk of recurrent SUI, compared to continued catheterization and delayed sling lysis.

Autologous muscle derived cells for treatment of stress urinary incontinence in women.

PURPOSE: We assess the 12-month safety and potential efficacy of autologous muscle derived cells for urinary sphincter repair (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) in women with stress urinary incontinence. MATERIALS AND METHODS: Pooled data from 2 phase I/II studies with identical patient selection criteria and outcome measures were analyzed. Enrolled patients had stress urinary incontinence refractory to prior treatment and no symptom improvement during the last 6 months. Patients received intrasphincter injection of 10 (16), 50 (16), 100 (24) or 200×10(6) (24) autologous muscle derived cells for urinary sphincter repair, derived from biopsies of each patient's quadriceps femoris. The primary outcome measure was safety, determined by incidence and severity of adverse events. Potential efficacy was measured by changes in 3-day voiding diaries, 24-hour pad tests, and UDI-6 and IIQ-7 scores. RESULTS: A total of 80 patients underwent injection of autologous muscle derived cells for urinary sphincter repair, and 72 completed diaries and pad tests at 12-month followup. No adverse events attributed to autologous muscle derived cells for urinary sphincter repair were reported. Higher dose groups tended to have greater percentages of patients with at least a 50% reduction in stress leaks and pad weight at 12-month followup. All dose groups had statistically significant improvement in UDI-6 and IIQ-7 scores at 12-month followup compared to baseline. CONCLUSIONS: Autologous muscle derived cells for urinary sphincter repair at doses of 10, 50, 100 and 200×10(6) cells appears safe. Efficacy data suggest a potential dose response with a greater percentage of patients responsive to higher doses.

Difference in differences analysis evaluates the effects of the badger control policy on bovine tuberculosis in England.

Persistent tuberculosis (TB) in cattle populations in England has been associated with an exchange of infection with badgers (Meles meles). A badger control policy (BCP) commenced in 2013. Its aim was to decrease TB incidence in cattle by reducing the badger population available to provide a wildlife reservoir for bovine TB. Monitoring data from 52 BCP intervention areas 200-1600 km2 in size, starting over several years, were used to estimate the change in TB incidence rate in cattle herds, which was associated with time since the start of the BCP in each area. A difference in differences analysis addressed the non-random selection and starting sequence of the areas. The herd incidence rate of TB reduced by 56% (95% Confidence Interval 41-69%) up to the fourth year of BCP interventions, with the largest drops in the second and third years. There was insufficient evidence to judge whether the incidence rate reduced further beyond 4 years. These estimates are the most precise for the timing of declines in cattle TB associated with interventions primarily targeting badgers. They are within the range of previous estimates from England and Ireland. This analysis indicates the importance of reducing transmission from badgers to reduce the incidence of TB in cattle, noting that vaccination of badgers, fertility control and on farm biosecurity may also achieve this effect.

Autologous muscle derived cell therapy for stress urinary incontinence: a prospective, dose ranging study.

PURPOSE: In this feasibility study we assessed the 12-month safety and potential efficacy of autologous muscle derived cells (Cook MyoSite Incorporated, Pittsburgh, Pennsylvania) as therapy for stress urinary incontinence. MATERIALS AND METHODS: A total of 38 women in whom stress urinary incontinence had not improved with conservative therapy for 12 or more months underwent intrasphincter injection of low doses (1, 2, 4, 8 or 16 × 10(6)) or high doses (32, 64 or 128 × 10(6)) of autologous muscle derived cells, which were derived from biopsies of their quadriceps femoris. All patients could elect a second treatment of the same dose after 3-month followup. Assessments were made at 1, 3, 6 and 12 months after the last treatment. The primary end point was the incidence and severity of adverse events. In addition, changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys. RESULTS: Of the 38 patients 33 completed the study. Treatment related complications were limited to minor events such as pain/bruising at the biopsy and injection sites. Of patients who received 2 treatments of autologous muscle derived cells who were eligible for analysis, a higher percentage of those in the high dose vs the low dose group experienced a 50% or greater reduction in pad weight (88.9%, 8 of 9 vs 61.5%, 8 of 13), had a 50% or greater reduction in diary reported stress leaks (77.8%, 7 of 9 vs 53.3%, 8 of 15) and had 0 to 1 leaks during 3 days (88.9%, 8 of 9 vs 33.3%, 5 of 15) at final followup. CONCLUSIONS: Injection of autologous muscle derived cells in a wide range of doses appears safe with no major treatment related adverse events reported. In addition, treatment with autologous muscle derived cells shows promise for relieving stress urinary incontinence symptoms and improving quality of life.

Estimating the hidden burden of bovine tuberculosis in Great Britain.

The number of cattle herds placed under movement restrictions in Great Britain (GB) due to the suspected presence of bovine tuberculosis (bTB) has progressively increased over the past 25 years despite an intensive and costly test-and-slaughter control program. Around 38% of herds that clear movement restrictions experience a recurrent incident (breakdown) within 24 months, suggesting that infection may be persisting within herds. Reactivity to tuberculin, the basis of diagnostic testing, is dependent on the time from infection. Thus, testing efficiency varies between outbreaks, depending on weight of transmission and cannot be directly estimated. In this paper, we use Approximate Bayesian Computation (ABC) to parameterize two within-herd transmission models within a rigorous inferential framework. Previous within-herd models of bTB have relied on ad-hoc methods of parameterization and used a single model structure (SORI) where animals are assumed to become detectable by testing before they become infectious. We study such a conventional within-herd model of bTB and an alternative model, motivated by recent animal challenge studies, where there is no period of epidemiological latency before animals become infectious (SOR). Under both models we estimate that cattle-to-cattle transmission rates are non-linearly density dependent. The basic reproductive ratio for our conventional within-herd model, estimated for scenarios with no statutory controls, increases from 1.5 (0.26-4.9; 95% CI) in a herd of 30 cattle up to 4.9 (0.99-14.0) in a herd of 400. Under this model we estimate that 50% (33-67) of recurrent breakdowns in Britain can be attributed to infection missed by tuberculin testing. However this figure falls to 24% (11-42) of recurrent breakdowns under our alternative model. Under both models the estimated extrinsic force of infection increases with the burden of missed infection. Hence, improved herd-level testing is unlikely to reduce recurrence unless this extrinsic infectious pressure is simultaneously addressed.

Modelling temperature, photoperiod and vernalization responses of Brunonia australis (Goodeniaceae) and Calandrinia sp. (Portulacaceae) to predict flowering time.

BACKGROUND AND AIMS: Crop models for herbaceous ornamental species typically include functions for temperature and photoperiod responses, but very few incorporate vernalization, which is a requirement of many traditional crops. This study investigated the development of floriculture crop models, which describe temperature responses, plus photoperiod or vernalization requirements, using Australian native ephemerals Brunonia australis and Calandrinia sp. METHODS: A novel approach involved the use of a field crop modelling tool, DEVEL2. This optimization program estimates the parameters of selected functions within the development rate models using an iterative process that minimizes sum of squares residual between estimated and observed days for the phenological event. Parameter profiling and jack-knifing are included in DEVEL2 to remove bias from parameter estimates and introduce rigour into the parameter selection process. KEY RESULTS: Development rate of B. australis from planting to first visible floral bud (VFB) was predicted using a multiplicative approach with a curvilinear function to describe temperature responses and a broken linear function to explain photoperiod responses. A similar model was used to describe the development rate of Calandrinia sp., except the photoperiod function was replaced with an exponential vernalization function, which explained a facultative cold requirement and included a coefficient for determining the vernalization ceiling temperature. Temperature was the main environmental factor influencing development rate for VFB to anthesis of both species and was predicted using a linear model. CONCLUSIONS: The phenology models for B. australis and Calandrinia sp. described development rate from planting to VFB and from VFB to anthesis in response to temperature and photoperiod or vernalization and may assist modelling efforts of other herbaceous ornamental plants. In addition to crop management, the vernalization function could be used to identify plant communities most at risk from predicted increases in temperature due to global warming.

Bayesian shared spatial-component models to combine and borrow strength across sparse disease surveillance sources.

When analyzing the geographical variations of disease risk, one common problem is data sparseness. In such a setting, we investigate the possibility of using Bayesian shared spatial component models to strengthen inference and correct for any spatially structured sources of bias, when distinct data sources on one or more related diseases are available. Specifically, we apply our models to analyze the spatial variation of risk of two forms of scrapie infection affecting sheep in Wales (UK) using three surveillance sources on each disease. We first model each disease separately from the combined data sources and then extend our approach to jointly analyze diseases and data sources. We assess the predictive performances of several nested joint models through pseudo cross-validatory predictive model checks.

Simulating partial vaccine protection: BCG in badgers.

In wildlife disease management there are few diseases for which vaccination is a viable option. The human vaccine BCG has been used for the control of bovine tuberculosis in badgers since 2010 and is expected to increase. Understanding the long-term effects of repeated vaccination campaigns on disease prevalence is vital, but modelling thus far has generally assumed that a vaccine provides perfect protection to a proportion of the population, and that animals exposed to a repeated vaccination have a second independent chance of becoming protected. We held a workshop with experts in the field to obtain consensus over the main pathways for partial protection in the badger, and then simulated these using an established model. The available data supported the possibility that some individuals receive no benefit from the BCG vaccine, others may result in a delayed disease progression and in the remaining animals, vaccine protected the individual from any onward transmission. Simulating these pathways using different levels of overall efficacy demonstrated that partial protection leads to a reduced effect of vaccination, but in all of the identified scenarios it was still possible to eradicate disease in an isolated population with no disease introduction. We also identify those potential vaccination failures that require further investigation to determine which of our proposed pathways is the more likely.

Juvenility and flowering of Brunonia australis (Goodeniaceae) and Calandrinia sp. (Portulacaceae) in relation to vernalization and daylength.

BACKGROUND AND AIMS: The time at which plants are transferred to floral inductive conditions affects the onset of flowering and plant morphology, due to juvenility. Plants of Brunonia australis and Calandrinia sp. were used to investigate whether Australian native ephemeral species show a distinct juvenile phase that can be extended to increase vegetative growth and flowering. METHODS: The juvenile phase was quantified by transferring seedlings from less inductive (short day and 30/20°C) to inductive (vernalization or long day) conditions at six different plant ages ranging from 4 to 35 d after seed germination. An increase in days to first visible floral bud and leaf number were used to signify the end of juvenility. KEY RESULTS: Brunonia australis was receptive to floral inductive long day conditions about 18-22 d after seed germination, whereas plants aged 4-35 d appeared vernalization sensitive. Overall, transferring plants of B. australis from short to long day conditions reduced the time to anthesis compared with vernalization or constant short day conditions. Calandrinia sp. showed a facultative requirement for vernalization and an insensitive phase was not detected. Floral bud and branch production increased favourably as plant age at time of transfer to inductive conditions increased. Younger plants showed the shortest crop production time. CONCLUSIONS: Both species can perceive the vernalization floral stimulus from a very young age, whereas the photoperiodic stimulus is perceived by B. australis after a period of vegetative growth. However, extending the juvenile phase can promote foliage development and enhance flower production of both species.

A combined measure of tuberculous lesions for assessing the efficacy of vaccination against tuberculosis (Mycobacterium bovis) in European badgers (Meles meles) supports the 3Rs principle of reduction.

BACKGROUND: An oral vaccine is a potential tool to tackle the reservoir of Mycobacterium bovis in European badgers (Meles meles), which contributes to tuberculosis of cattle in the British Isles. Inferences about vaccine protection against experimental challenge with M. bovis depend on the measurement of tuberculosis. Assessment of tuberculosis in larger species, such as badgers, is typically based on the tuberculous lesions visible at post-mortem examination and histopathology. We have developed a robust scoring system for tuberculous lesions by combining several parallel measures, which we call the "disease burden score" (DBS). METHODS: Alternative scoring systems were compared within a regression analysis applied to observations from a total of 168 badgers from eight studies, including 107 badgers subjected to vaccination treatment and 61 non-vaccinated controls. The analysis included incidental observations that were recorded from each badger as potential covariate factors explaining some of the variation among animals sourced from the wild. RESULTS: DBS was found to be the most accurate and reliable of the scoring systems compared. By taking account of significant covariates affecting disease, application of the DBS reduced residual variance by 22.9%. A previously used measure, based on assessment of visible lesions, was suboptimal due to non-uniform variance that increased with expected value, although square root transformation addressed this issue. The covariate model fitted to DBS included sex (males had higher DBS), weight (negatively associated with DBS) and immunological evidence of prior exposure to Mycobacterium avium (positively associated with DBS). CONCLUSIONS: We identified improved measures of tuberculous disease derived from data already collected. We also demonstrated that the proper scaling of measurements of disease in such models is necessary and can be determined empirically. The covariates which were most strongly associated with the severity of disease are important in experimental studies involving outbred animals with variable background.