Effect of educational intervention on computer-aided-design and computer-aided-manufacturing technology to preclinical dental students.

INTRODUCTION: This study evaluated the effectiveness of a video presentation instruction compared to the prevailing traditional lecture provided in the preclinical classroom when introducing computer-aided design/computer-aided manufacturing (CAD/CAM) technology. MATERIALS AND METHODS: This study was conducted as a controlled educational trial (single-blind) on 120 first-year dental students. Students were assigned to two learning groups: the control (n = 60, traditional lecture) and the intervention (n = 60, video presentation). Both groups completed a self-efficacy scale (SES) survey before instruction. Then, the intervention group actively participated in a one-session video presentation while the control group was given a traditional lecture. After the presentations, student knowledge was assessed with a hands-on simulated exercise that was scored out of 60 points. At last, students completed a post-instruction student perception and attitude (SPA) survey. Inferential hypothesis testing was conducted with two-sample t-tests, and significance was defined as p ≤ .05. RESULTS: There were no significant differences in the student pre-instruction SES scores between the control and intervention groups. After the video learning, CAD/CAM knowledge application during the hands-on simulated exercise showed significantly higher results in the intervention group as the assessment scores from the intervention group averaged 13.6 ± 2.0 points higher than the control group (p < .001). The results from the post-instruction SPA survey showed no statistically significant difference between groups. CONCLUSION: With the video presentation technique, our first-year dental students were able to greatly enhance their CAD/CAM application skills. The results from this study could be applied at other dental educational institutions with potential similar outcomes.

Nivolumab Switch Maintenance Therapy After Tyrosine Kinase Inhibitor Induction in Metastatic Renal Cell Carcinoma: A Randomized Clinical Trial by the Interdisciplinary Working Group on Renal Tumors of the German Cancer Society (NIVOSWITCH; AIO-NZK-0116ass).

BACKGROUND: The role of immune checkpoint inhibitor (ICI) maintenance therapy in metastatic renal cell carcinoma (mRCC) is undefined. OBJECTIVE: To determine whether switch maintenance therapy with nivolumab improves clinical outcomes in patients with mRCC with tyrosine kinase inhibitor (TKI) sensitivity. DESIGN, SETTING, AND PARTICIPANTS: This open-label phase 2 trial randomized patients with a partial response or stable disease after 10-12-wk TKI induction therapy to either TKI or nivolumab maintenance. Key inclusion criteria were measurable disease, clear cell histology, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2, and adequate organ function. INTERVENTION: Intravenous nivolumab 8 × 240 mg every 2 wk, followed by 480 mg every 4 wk or sunitinib 50 mg (4-2 regimen) or pazopanib 800 mg once daily orally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: The primary endpoint was overall survival (OS). Secondary endpoints were the objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), progression-free survival (PFS), safety (Common Terminology Criteria for Adverse Events v4.03), and patient-reported outcomes (Functional Assessment of Cancer Therapy Kidney Symptom Index). The Kaplan-Meier method, two-sided log-rank tests, and Cox regression models were used for statistical analysis. RESULTS AND LIMITATIONS: Maintenance therapy was nivolumab for 25 patients (51.0%) and TKI for 24 (48.9%). The median age was 65 yr (range 35-79). Nine patients (18.4%) were female, 31 (63.3%) had ECOG PS of 0, and 15 (30.6%) had favorable risk. OS data are immature (17 deaths, 34.7%). The ORR was 20.0% (n = 5) for nivolumab and 52.2% (n = 12) for TKI. PFS was worse with nivolumab (hazard ratio 2.57, 95% confidence interval 1.36-4.89; p = 0.003). Grade ≥3 adverse events occurred in 14 patients (56.0%) with nivolumab and 17 (70.8%) with TKI. A major limitation is early termination of our study. CONCLUSIONS: TKI treatment achieved superior ORR and PFS in comparison to nivolumab maintenance therapy. Our data do not indicate a role for nivolumab switch maintenance in mRCC. PATIENT SUMMARY: Patients with metastatic kidney cancer who experienced a tumor response or disease stabilization after a short period of targeted treatment with a tyrosine kinase inhibitor did not benefit from a switch to the immunotherapy drug nivolumab. Patients who continued their original treatment achieved better responses and a longer time without disease progression. This trial is registered on EudraCT as 2016-002170-13 and on ClinicalTrials.gov as NCT02959554.

The benefits of incorporating active learning into online, asynchronous coursework in dental physiology.

The COVID-19 pandemic required a shift to online learning that posed particular challenges for the education of dental students. Basic science courses were presented in an online, asynchronous format to facilitate small group rotations through preclinical work. The success of active learning was previously examined in a Dental Physiology course, and it was desired to reassess those methods in an online environment. Students were provided with prerecorded lectures containing learning activities, and the effectiveness was compared with traditional lecture recordings. On surveys, dental students had more positive perceptions of online recordings that incorporated active learning strategies, with higher perceived effectiveness of the lecturer, ability to pay attention, motivation to study, and confidence with the material. This was similar to the previous study, in which face-2-face (F2F) active learning was more positively reviewed than traditional lectures. Compared with these past sections, the online cohort expressed similarly positive perceptions of the active learning sections, but the online traditional lectures were perceived to be less effective than F2F lectures. Despite the differences in student perceptions, unit exam scores were similar for didactic lectures in both online and F2F settings. Unit exam scores were significantly higher when active learning strategies were employed, with the highest performance levels in the F2F cohort. While active learning strategies continue to be effective, further research is needed to optimize these methods and engage students in online coursework. The results suggest the importance of active and collaborative learning opportunities in the education of students in physiology coursework.

The BACH project protocol: an international multicentre total Bile Acid Comparison and Harmonisation project and sub-study of the TURRIFIC randomised trial.

OBJECTIVES: Multicentre international trials relying on diagnoses derived from biochemical results may overlook the importance of assay standardisation from the participating laboratories. Here we describe a study protocol aimed at harmonising results from total bile acid determinations within the context of an international randomised controlled Trial of two treatments, URsodeoxycholic acid and RIFampicin, for women with severe early onset Intrahepatic Cholestasis of pregnancy (TURRIFIC), referred to as the Bile Acid Comparison and Harmonisation (BACH) study, with the aims of reducing inter-laboratory heterogeneity in total bile acid assays. METHODS: We have simulated laboratory data to determine the feasibility of total bile acid recalibration using a reference set of patient samples with a consensus value approach and subsequently used regression-based techniques to transform the data. RESULTS: From these simulations, we have demonstrated that mathematical recalibration of total bile acid results is plausible, with a high probability of successfully harmonising results across participating laboratories. CONCLUSIONS: Standardisation of bile acid results facilitates the commutability of laboratory results and collation for statistical analysis. It may provide the momentum for broader application of the described techniques in the setting of large-scale multinational clinical trials dependent on results from non-standardised assays.

Biaxial atomically resolved force microscopy based on a qPlus sensor operated simultaneously in the first flexural and length extensional modes.

Frequency-modulation atomic force microscopy (AFM) with a qPlus sensor allows one to atomically resolve surfaces in a variety of environments ranging from low-temperature in ultra-high vacuum to ambient and liquid conditions. Typically, the tip is driven to oscillate vertically, giving a measure of the vertical force component. However, for many systems, the lateral force component provides valuable information about the sample. Measuring lateral and vertical force components simultaneously by oscillating vertically and laterally has so far only been demonstrated with relatively soft silicon cantilevers and optical detection. Here, we show that the qPlus sensor can be used in a biaxial mode with electrical detection by making use of the first flexural mode and the length extensional mode. We describe the necessary electrode configuration as well as the electrical detection circuit and compare the length extensional mode to the needle sensor. Finally, we show atomic resolution in ambient conditions of a mica surface and in ultra-high vacuum of a silicon surface. In addition to this, we show how any qPlus AFM setup can be modified to work as a biaxial sensor, allowing two independent force components to be recorded.

Effects of active engagement and spaced retrieval practice on knowledge and application of a self-assessment rubric.

PURPOSE/OBJECTIVES: This study examined effects of active engagement (ENG) and spaced retrieval practice (SRP) on D1 dental students' self-assessment knowledge acquisition. METHODS: D1 dental students (N = 120) were randomly assigned to one of four conditions in a 2 (ENG or no ENG) X 2 (SRP or no SRP) design. Students were tested on their knowledge of a self-assessment grading rubric (on a 30-item multiple-choice exam) and their ability to apply the rubric (on a simulated dentoform assessment). RESULTS: There were significant main effects of both ENG and SRP on both outcome measures. Both ENG and SRP increased students' knowledge of, and ability to apply, the self-assessment rubric. Effects of ENG were larger than those of SRP. There was also a significant ENG X SRP interaction on the knowledge measure. The effect of SRP was larger in the no-ENG conditions than the ENG conditions, which may reflect a ceiling effect in the ENG conditions. CONCLUSIONS: ENG and SRP have the potential to substantially enhance D1 dental students' learning outcomes. These results should motivate dental educators to reject outdated instructional techniques and thereby unleash students' full learning potential. Additional research is needed with a wider range of dental students and learner topics.

Patient, nurse, and physician preferences: final results of the CONVENIENCE study evaluating pegfilgrastim prophylaxis via pre-filled syringe or on-body injector in cancer patients.

PURPOSE: The on-body injector (OBI) automatically delivers pegfilgrastim the day after chemotherapy (CTx), thus eliminating the need of return visits to the medical office for guideline-compliant pegfilgrastim administration. The CONVENIENCE study aimed to evaluate patient, nurse, and physician preferences as well as health economics for pegfilgrastim administration either with OBI or manually using a pre-filled syringe (PS). METHODS: Patients with early breast cancer, receiving two or three weekly anthracycline/cyclophosphamide or three weekly taxane-based CTx, and patients with Non-Hodgkin lymphoma (NHL) receiving first-line R-CHOP-14 or -21 were randomized 1:1 to receive both pegfilgrastim application forms for four consecutive CTx cycles in an alternating sequence starting either with OBI or PS. Primary endpoint was patient preference, assessed by questionnaires. RESULTS: A total of 308 patients were evaluable in the per-protocol analysis. Patients slightly preferred OBI over PS (OBI, n = 133, 43.2%; vs. PS, n = 111, 36.0%; p-value = 0.159), while study nurses slightly preferred PS (n = 19, 46.3%) over OBI (n = 18, 43.9%) and physicians clearly preferred PS (n = 24, 58.8%) over OBI (n = 15, 36.6%). Among patients with preference for OBI, saving of time was their major reason for preference (53.4%). Pegfilgrastim was administered 24-72 h after each CTx cycle in 97.6% of OBI and 63.1% of PS applications. CONCLUSION: The OBI was slightly preferred by patients and saving time was the major reason for their preference. PS was physicians' most preferable choice and slightly preferred by nurses. Using OBI, pegfilgrastim was almost always administered within the time period recommended by current guidelines, while it was often not applied as specified using PS. TRIAL REGISTRATION: No: ClinicalTrials.gov No. NCT03619993. Registered on June 25, 2018.

The stress of success: An online module to help first-year dental students cope with the Impostor Phenomenon.

CONTEXT: Professors often spend a great deal of time counseling poorly performing students, which limits the time dedicated to high achievers. This may be problematic, as psychiatrists have determined that gifted students may be susceptible to feelings of inadequacy despite positive external evidence. Dr. Pauline Clance coined the term "Impostor Phenomenon" (IP) to describe these traits. OBJECTIVE: Dental students, while academically successful, may be prone to IP and lack appropriate coping strategies. The goal of this project was to create and publish an online module to educate dental students about IP and provide 6 coping mechanisms. DESIGN: After viewing the video at the beginning of the semester, students completed the Clance IP Scale to determine the prevalence of IP thoughts. This was repeated at the end of the semester to determine the impact of the online training module. RESULTS: There was a decrease in postsemester scores from 63.44 (±14.92) to 59.12 (±14.56), n = 103, 86% response rate, dependent samples within subjects t-test, P < 0.001). The percentage of students reporting intense impostor experiences decreased from 13.6% to 4.9%. Females exhibited significantly higher scores than males, but there was no statistically significant impact of age or race on results. The most common reported coping strategies were a reduction in time spent on nonessential tasks and the use of scheduling to prevent procrastination. CONCLUSION: These results suggest that an online training module can improve awareness of the Impostor Phenomenon and help high-achieving students to cope with their stress and feelings of inadequacy.

A statistically guided grid generation method and its application to intermolecular potential energy surfaces.

We present a method for the generation of points in space needed to create training data for fitting of nonlinear parametric models. This method uses statistical information extracted from an initial fit on a sparse grid to select optimal grid points in an iterative manner and is, therefore, called the iterative variance minimizing grid approach. We demonstrate the method in the case of six-dimensional intermolecular potential energy surfaces (PESs) fitted to ab initio computed interaction energies. The number of required grid points is reduced by roughly a factor of two in comparison to alternative systematic sampling methods. The method is not limited to fitting PESs and can be applied to any cases of fitting parametric models where data points may be chosen freely but are expensive to obtain.

Automatic Generation of Flexible-Monomer Intermolecular Potential Energy Surfaces.

A method is developed for automatic generation of nonreactive intermolecular two-body potential energy surfaces (PESs) including intramonomer degrees of freedom. This method, called flex-autoPES, is an extension of the autoPES method developed earlier, which assumes rigid monomers. In both cases, the whole PES development proceeds without any human intervention. The functional form used is a sum of products of site-site functions (both atomic and off-atomic sites can be used). The leading terms with sites involving different monomers are of physically motivated form. The long-range part of a PES is computed from monomer properties without using any dimer information. The close-range part is fitted to dimer interaction energies computed using electronic structure methods. Virtually any method can be used in such calculations, but the use of symmetry-adapted perturbation theory provides a seamless connection to the long-range part of the PES. The performance of the flex-autoPES code was tested by developing a full-dimensional PES for the water dimer and PESs including only some soft intramonomer degrees of freedom for the ethylene glycol dimer and for the ethylene glycol-water dimer. In the case of the water dimer, the root-mean-square error (RMSE) of the PES from the data points with negative total energies is 0.03 kcal/mol, and we expect this PES to be more accurate than any previously published PES of this type. For the ethylene glycol dimer and the ethylene glycol-water dimers, the analogous RMSEs are 0.25 and 0.1 kcal/mol, respectively.

Molecular dimers of methane clathrates: ab initio potential energy surfaces and variational vibrational states.

Motivated by the energetic and environmental relevance of methane clathrates, highly accurate ab initio potential energy surfaces (PESs) have been developed for the three possible dimers of the methane and water molecules: (H2O)2, CH4·H2O, and (CH4)2. While only a single monomer geometry was used for each monomer in the ab initio calculations, the PES parameterization makes it possible to produce distinct surfaces for all isotopologues within the rigid-monomer approximation. The PESs were fitted to computations at the frozen-core coupled-cluster level with single, double, and non-iterative triple excitations, employing basis sets of augmented triple- and quadruple-zeta quality plus bond functions, followed by extrapolations to the complete basis set limit. The long-range parts of the PESs are computed using the asymptotic version of symmetry-adapted perturbation theory based on a density-functional description of the monomers. All PESs are polarizable, i.e., in cluster or condensed-phase applications they approximate many-body effects by the induced dipole polarization model. The PESs were developed in a fully automated procedure applying the autoPES method, which is used for the first time to generate near-spectroscopic quality surfaces. The stationary points (SPs) on the PESs have been determined and compared with literature data. For CH4·H2O, previously unknown SPs have been identified and the first detailed study of the (CH4)2 potential energy landscape has been carried out. The PESs were used in variational quantum nuclear motion computations. For the water dimer, the resulting vibrational transitions are in excellent agreement with available high-resolution spectroscopic data. For (CH4)2, the intermonomer vibrational states are reported for the first time.

Outcome-Based Critical Result Thresholds in the Adult Patient Population.

OBJECTIVES: To derive outcome-based critical result thresholds in the adult patient population. METHODS: We extracted deidentified laboratory results and outcomes (death or discharged) of patients 18 years and older from the Medical Information Mart for Intensive Care database. The lower and upper critical result thresholds were obtained from the nearest minimum and maximum laboratory values, which corresponded to predicted probability of death at 90%. RESULTS: The critical value thresholds were sodium (<123, >153 mmol/L), potassium (<2.2, >6.6 mmol/L), bicarbonate (<15, >49 mmol/L), chloride (<82, >121 mmol/L), urea (>20 mmol/L), creatinine (>1,052 µmol/L), glucose (<1.5, >23.8 mmol/L), total calcium (<1.62, >2.95 mmol/L), magnesium (<0.37, >1.48 mmol/L), phosphate (<0.19, >2.52 mmol/L), pH (<7.22, >7.57), lactate (>5.0 mmol/L), hemoglobin (<4.6 g/dL), WBCs (>32 × 103/µL), prothrombin time (>90 seconds), and international normalized ratio (>10). CONCLUSIONS: The indirect approach described in this study is a pragmatic way to obtain threshold values that are clinically and operationally meaningful.

Relative criticalness of common laboratory tests for critical value reporting.

We determined the relative strengths of association between 23 most commonly ordered laboratory tests and the adverse outcome as indicators of relative criticalness. The lowest and highest results for 23 most commonly ordered laboratory tests, 24 hours prior to death during critical care unit (CCU) stay or discharge from CCU were extracted from a publicly available CCU database (Medical Information Mart for Intensive Care-III). Following this, the Random Forest model was applied to assess the association between the laboratory results and the outcomes (death or discharge). The mean decrease in Gini coefficient for each laboratory test was then ranked as an indication of their relative importance to the outcome of a patient. In descending order, the 10 laboratory tests with the strongest association with death were: bicarbonate, phosphate, anion gap, white cell count (total), partial thromboplastin time, platelet, total calcium, chloride, glucose and INR; moreover, the strength of association was different for critically high versus low results.

The in's and out's of science outreach: assessment of an engaging new program.

Many professors are interested in providing science outreach to local K-12 students, but may not have the time or resources needed to create an engaging presentation. The American Physiological Society supports outreach initiatives through programs such as the Physiology Understanding (PhUn) Week. Building on these activities, it was desired to create and assess an immersive and engaging Outreach Program in a disadvantaged K-12 student population. Three distinct modules were created on cardiovascular physiology, respiratory physiology, and oral health. All resources for these modules underwent peer review and publication, allowing other professors to easily execute their own outreach programming. The outreach modules were presented to 288 students in 3rd, 5th, 6th, and 7th grade classes. Implementation of the modules resulted in significant increases in student content knowledge, ranging from 32 to 57% improvement ( P < 0.001, dependent t-test), with an average increase of 46%. K-12 science teachers reported that the program was at an appropriate educational level, increased students' enthusiasm for science, and increased students' exposure to science careers. Additionally, the presenters of the Outreach Program were perceived to be enthusiastic, knowledgeable, and proficient at interacting with the students. On open-response survey items, the science teachers indicated a high level of satisfaction with the program and an enthusiasm for continued collaborations. These results indicate the importance of organized and interactive science activities for the success of a new Outreach Program.

Derivation of Outcome-Based Pediatric Critical Values.

OBJECTIVES: There is currently a lack of an outcomes-based definition of critical values for the pediatric population. This has contributed to a highly heterogeneous critical value reporting practice between laboratories. METHODS: Anonymized results were extracted from a laboratory information system for 10 biochemistry tests. The probability of high-dependency/intensive care unit admission (as a proxy for adverse outcomes) for each individual laboratory concentration was calculated and adjusted to fit using a polynomial function to model the probability trend. The laboratory value that intersected the 90% probability trend line was considered the critical value threshold. RESULTS: The critical value thresholds for the serum analytes were sodium (mmol/L: <131, >148), potassium (mmol/L: <2.4, >6.4), bicarbonate (mmol/L: <13, >37), chloride (mmol/L: <91, >115), urea (mmol/L: >12), creatinine (µmol/L: >129), glucose (mmol/L: >17.2), total calcium (mmol/L: <1.9), magnesium (mmol/L: <0.6, >1.2), and phosphate (mmol/L: <0.4, >2.6). CONCLUSIONS: This study described an approach to derive contemporary pediatric critical value thresholds.

An Online Module to Understand Body Fluid Status in Clinical Cases.

Introduction: A thorough understanding of body fluid alterations is essential for the success of both practicing dentists and physicians. However, the time constraints of professional school curricula often limit the time available in physiology courses to address this material. Methods: The primary goal of this resource was to improve student comprehension of body fluid status by using three online videos that explain volume-osmolality diagrams. An additional goal was to improve students' ability to apply their physiological knowledge by showcasing real-life clinical situations in medicine and dentistry. The videos were created using custom-designed PowerPoint animations, video recordings, and Camtasia video-editing software. Results: On assessment of exam performance, students performed similarly in sections of the course that were taught using the online modules versus face-to-face lectures. Student performance was extremely high on the body fluid assessment-questions, with an average of 95%. This high level of student performance was notable, particularly given the complexity of the questions. Discussion: These results indicate that this online volume-osmolality module enabled students to improve their comprehension of body fluid concepts in physiology. Furthermore, the data indicates the feasibility of replacing lectures with online modules, freeing valuable class time for active learning or more advanced physiological concepts.

What is adolescent polycystic ovary syndrome?

The diagnostic criteria for adolescent polycystic ovary syndrome (PCOS) has been derived from adult criteria, which makes diagnosis challenging as criteria include normal physiological events that occur during puberty such as acne, hirsutism, menstrual irregularities, high androgen levels and polycystic ovarian morphology on pelvic ultrasound. The only criteria that applies from the adult criteria is exclusion of other conditions that mimic PCOS. Clinical findings consistent with hyperandrogenaemia during adolescence include inflammatory acne, hirsutism, alopecia and/or menstrual irregularities, which are severe and present 2 years after menarche. The measurement of androgen levels during adolescence should take into account age, puberty, type of androgen measured, assay used and diurnal rhythm. Multiple measurements are useful to demonstrate hyperandrogenaemia. The combination, severity and persistence of the hyperandrogenic symptoms and hyperandrogenaemia in girls 2 years or more post-menarche support the diagnosis of adolescent PCOS. Adolescent girls with these findings should be followed up into adulthood.

Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

BACKGROUND: There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. METHODS: A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. RESULTS: Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. CONCLUSIONS: Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

A retrospective cohort review of intrahepatic cholestasis of pregnancy in a South Australian population.

OBJECTIVE: To review the management and outcomes of Intrahepatic Cholestasis of Pregnancy (ICP) in South Australia (SA) over the past decade. DESIGN: Retrospective cohort review. SETTING: Public clinics at two teaching hospitals in SA. POPULATION: All pregnancies associated with ICP (defined as pruritus with serum bile acids≥10µmol/L) managed 2001-2010. METHODS: Identification of subjects (laboratory database), detailed chart-review to ascertain demographics, maternal/perinatal outcomes and associated pregnancy comorbidities, analysis of mild/severe disease cohorts, comparison with normal population data, using Student's t-test or Mann-Whitney U test as appropriate for continuous variables, and Pearson's chi-square test or Fisher's exact test for categorical variables. Unadjusted odds ratios (OR) with 95% confidence intervals (95% CI) were calculated in comparison with the general pregnant population for clinically significant outcomes. RESULTS: 320 women (359 pregnancies) were diagnosed with ICP over the 10-years: incidence 0.6%/year. Within the cohort, the incidences of gestational diabetes (12.5%; OR 3.06, 95% CI 2.23-4.18), pre-eclampsia (10.3%; OR 75.84, 95% CI 52.91-178.70), and spontaneous preterm labour (23.1%; OR 2.05, 95% CI 1.41-2.98) were much higher than in the general SA pregnant population. Pregnancies with severe ICP (serum bile acids≥40µmol/L) had ICP diagnosed earlier (231 vs 248 days, P<0.001), and ended earlier (256 vs 260 days, P<0.001) with lower birthweights (2827g vs 3093g, P <0.001) than those with mild ICP. Neonates of severe ICP mothers were more likely to require special-care-nursery admission, but perinatal complication rates did not differ. There were no stillbirths. CONCLUSION: This large Australian retrospective cohort study confirms generally favourable outcomes associated with ICP, mild or severe, with no stillbirths, likely secondary to proactive medical management. A high proportion of pregnancies were also affected by gestational diabetes, pre-eclampsia, and/or spontaneous pre-term labour compared with the general population.