Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials.

BACKGROUND: Induction of labour is one of the most common obstetric interventions globally. Balloon catheters and vaginal prostaglandins are widely used to ripen the cervix in labour induction. We aimed to compare the effectiveness and safety profiles of these two induction methods. METHODS: We did an individual participant data meta-analysis comparing balloon catheters and vaginal prostaglandins for cervical ripening before labour induction. We systematically identified published and unpublished randomised controlled trials that completed data collection between March 19, 2019, and May 1, 2021, by searching the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and PubMed. Further trials done before March 19, 2019, were identified through a recent Cochrane review. Data relating to the combined use of the two methods were not included, only data from women with a viable, singleton pregnancy were analysed, and no exclusion was made based on parity or membrane status. We contacted authors of individuals trials and participant-level data were harmonised and recoded according to predefined definitions of variables. Risk of bias was assessed with the ROB2 tool. The primary outcomes were caesarean delivery, indication for caesarean delivery, a composite adverse perinatal outcome, and a composite adverse maternal outcome. We followed the intention-to-treat principle for the main analysis. The primary meta-analysis used two-stage random-effects models and the sensitivity analysis used one-stage mixed models. All models were adjusted for maternal age and parity. This meta-analysis is registered with PROSPERO (CRD42020179924). FINDINGS: Individual participant data were available from 12 studies with a total of 5460 participants. Balloon catheters, compared with vaginal prostaglandins, did not lead to a significantly different rate of caesarean delivery (12 trials, 5414 women; crude incidence 27·0%; adjusted OR [aOR] 1·09, 95% CI 0·95-1·24; I2=0%), caesarean delivery for failure to progress (11 trials, 4601 women; aOR 1·20, 95% CI 0·91-1·58; I2=39%), or caesarean delivery for fetal distress (10 trials, 4441 women; aOR 0·86, 95% CI 0·71-1·04; I2=0%). The composite adverse perinatal outcome was lower in women who were allocated to balloon catheters than in those allocated to vaginal prostaglandins (ten trials, 4452 neonates, crude incidence 13·6%; aOR 0·80, 95% CI 0·70-0·92; I2=0%). There was no significant difference in the composite adverse maternal outcome (ten trials, 4326 women, crude incidence 22·7%; aOR 1·02, 95% CI 0·89-1·18; I2=0%). INTERPRETATION: In induction of labour, balloon catheters and vaginal prostaglandins have comparable caesarean delivery rates and maternal safety profiles, but balloon catheters lead to fewer adverse perinatal events. FUNDING: Australian National Health and Medical Research Council and Monash Health Emerging Researcher Fellowship.

Testing the acceptability of stillbirth awareness messages in an SMS program for fathers.

ISSUE ADDRESSED: To raise expectant fathers' awareness of risk factors for stillbirth. METHODS: A set of brief text messages was developed addressing recognised risk factors for stillbirth: avoidance of maternal cigarette smoking, maternal going to sleep on side messaging, awareness of the importance of noticing and reporting changes in foetal movement and fathers' involvement in shared decision making for timing of birth. Eight messages were inserted into the SMS4dads pilot program being conducted by NSW Health. Feedback on the messages was requested. Participants rated the quality of the messages on a three-point Likert scale and provided comments. RESULTS: Overall, 2528 messages were sent to 626 fathers' mobile phones, 45% of fathers replied with 666 ratings and 115 comments evaluating the texts. The quantitative ratings indicated substantial overall approval of the messages. Within the coding category "Evaluation of Message Content," three themes described fathers' reactions and feelings about the smoking, movement, side sleeping and birth timing messages: "important-good information," "not appropriate/anxiety provoking" and "not relevant-obvious." Three themes reflecting the attributes of the messages within the "Service Quality" category were "need more information," "complements public health" and "child voice fit." CONCLUSIONS: Results indicate that the messages are an acceptable way to provide information and suggested actions addressing stillbirth risk factors to fathers-to-be. SO WHAT?: Fathers' awareness of the risk factors for stillbirth can assist mothers to take appropriate actions for a healthy birth. Information on risk factors can be provided to fathers via a father-focused text messaging service.

Practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.

BACKGROUND: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. METHODS: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. RESULTS: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable. CONCLUSIONS: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true.

Professionalism and clinical short answer question marking with machine learning.

Machine learning may assist in medical student evaluation. This study involved scoring short answer questions administered at three centres. Bidirectional encoder representations from transformers were particularly effective for professionalism question scoring (accuracy ranging from 41.6% to 92.5%). In the scoring of 3-mark professionalism questions, as compared with clinical questions, machine learning had a lower classification accuracy (P < 0.05). The role of machine learning in medical professionalism evaluation warrants further investigation.

Medical student knowledge and critical appraisal of machine learning: a multicentre international cross-sectional study.

To utilise effectively tools that employ machine learning (ML) in clinical practice medical students and doctors will require a degree of understanding of ML models. To evaluate current levels of understanding, a formative examination and survey was conducted across three centres in Australia, New Zealand and the United States. Of the 245 individuals who participated in the study (response rate = 45.4%), the majority had difficulty with identifying weaknesses in model performance analysis. Further studies examining educational interventions addressing such ML topics are warranted.

Barriers to the implementation of clinical guidelines for maternal alcohol consumption in antenatal services: A survey using the theoretical domains framework.

ISSUE ADDRESSED: The aim of this study was to assess potential barriers to the implementation of clinical guideline recommendations regarding maternal alcohol consumption by antenatal clinicians and managers. METHODS: Cross-sectional surveys of antenatal clinicians and managers employed in a New South Wales Local Health District were undertaken. Survey items were developed based on 11 domains of the Theoretical Domains Framework. Consistent with previous studies, a cut point of less than 4 was applied to mean values of survey items (range: 1-5) to identify domains representing barriers to the implementation. RESULTS: Thirty-three antenatal clinicians and eight managers completed the surveys. For clinicians, the domains with the lowest mean values included "environmental context and resources" (ie, complexity of appointments and availability of supporting systems) (mean: 3.13, SD: 0.93); "social influences" (ie, expectations of others that alcohol will be addressed) (mean: 3.33, SD: 0.68); "beliefs about capabilities" (ie, confidence in providing guideline recommendations) (mean: 3.51, SD: 0.67); and "behavioural regulation" (ie, planning and responding to feedback) (mean: 3.53, SD: 0.64). For managers, "emotion regulation" (ie, stress in managing change) (mean: 2.13, SD: 0.64) and "environmental context and resources" (ie, complexities of managing change) (mean: 3.13, SD: 0.83) were the lowest scoring domains. CONCLUSIONS: The antenatal service environment and availability of resources appear to be primary barriers to both clinicians and managers implementing guidelines for maternal alcohol consumption. SO WHAT?: In the development of interventions to support the delivery of clinical guideline recommendations addressing alcohol consumption during pregnancy, a broad range of potential barriers at both the clinician and manager levels need to be considered and targeted by effective implementation strategies.

Disadvantage and the 'capacity to aspire' to medical school.

OBJECTIVES: This study was designed to elucidate why students from backgrounds of lower socio-economic status (SES) and who may be first in their family (FIF) to enter university continue to be under-represented in medical schools. METHODS: Academically able high school students (n = 33) from a range of socio-economic backgrounds participated in focus groups. School careers advisors (n = 5) were interviewed. Students discussed their career and education plans and ideas about a medical career. Careers advisors discussed enablers and barriers to a medical career for their students. RESULTS: Students of lower SES and of FIF status attending schools situated in poorer geographic locations had limited access to suitable work experience and, despite their participation in gifted and talented classes, were considered to be at greater risk of not achieving the high level of academic achievement required for admission to medical school. CONCLUSIONS: There is utility in exploring intersecting differences and Appardurai's theory of the 'capacity to aspire' for the purpose of understanding the causes of the under-representation of disadvantaged students in medical schools. A focused materialist approach to building the aspirations of disadvantaged students, particularly those attending schools located in poorer areas, is required if effective pre-entry equity programmes are to be developed and evaluated. Alternatively, medical schools might rethink their reliance on very high academic attainment in the admission process.

A common curriculum in obstetrics and gynecology for medical students globally.

OBJECTIVE: Global variations in women's health outcomes, increased international migration, and an increase in the number of medical schools underpin the need for global standardization in obstetrics and gynecology curricula for medical students. However, there are currently no recommendations regarding the content of a common curriculum. The aim of this project was to agree the objectives for a common curriculum in obstetrics and gynecology for medical students globally. METHODS: The curriculum was developed and agreed by an international taskforce of obstetricians and gynecologists. Published curricula for medical students in a variety of regions globally were reviewed and discussed, and the objectives for a common curriculum in obstetrics and gynecology for medical students were agreed by consensus. RESULTS: The content of the proposed curriculum is classified into three domains: clinical skills, professional behaviors, and knowledge. The recommended curriculum covers health conditions that affect women globally in different social and cultural contexts, and addresses important global health issues of relevance to obstetrics and gynecology. CONCLUSION: The methods and outcomes of a project by an international taskforce of obstetricians and gynecologists to develop a common curriculum in obstetrics and gynecology for medical students globally are presented. More work is required to identify ways in which the curriculum may be adapted to a minimum essential required curriculum in times of man-made or natural disasters. Achieving these will facilitate the intended long-term aims of this curriculum, to improve women's health outcomes globally.

Differential effectiveness of a practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: Exploratory subgroup analyses within a randomised stepped-wedge controlled trial.

OBJECTIVE: A practice change intervention demonstrated improvements in the provision of antenatal care addressing alcohol consumption. The aim of this study was to explore whether the effectiveness of the intervention differed between subgroups of pregnant women and types and location of maternity services. DESIGN AND SETTING: Post-hoc exploratory subgroup analyses of the outcomes from a randomised stepped-wedge controlled trial conducted with all public maternity services within three sectors of a local health district in Australia. MEASUREMENTS: Two outcomes (receipt of alcohol assessment and complete care) measured at two visit types (initial and subsequent) were included in analyses. Logistic regression models explored interactions between pre-post differences and subgroups of women (age, Aboriginal origin, education level, disadvantage, gravidity and alcohol consumption in pregnancy) and services (geographic remoteness, service and provider type/s) that have been reported to be associated with variation in guideline implementation. FINDINGS: Surveys from 5694 women were included in the analyses. For the initial visit, no significant differential intervention effects between subgroups of women or type/location of services were found for either outcome. For subsequent visits, the intervention effect differed significantly only between Aboriginal origin subgroups (Aboriginal OR: 1.95; 95% CI: 0.99-3.85; non-Aboriginal OR: 5.34; 95% CI: 4.17-6.83; p<0.01) and women's alcohol consumption in pregnancy subgroups (consumed alcohol OR: 1.28; 95% CI: 0.59-2.78; not consumed alcohol OR: 5.22; 95% CI: 4.11-6.65; p<0.001) for assessment of alcohol consumption. KEY CONCLUSIONS: These exploratory results suggest that the intervention may have had similar effects between different subgroups of women and types and location of services, with the exception of women who were non-Aboriginal and women who had not consumed alcohol, for whom the intervention was potentially more effective. IMPLICATIONS FOR PRACTICE: The practice change intervention could be implemented with different maternity service and provider types to effectively support improvements in antenatal care addressing alcohol consumption. These exploratory results provide further data for hypothesis generation regarding targeted areas for the testing of additional strategies that enable Aboriginal women to benefit equally from the intervention, and to ensure those women most in need of care, those consuming alcohol during pregnancy, have their care needs met.

A systematic approach to workplace-based assessment for international medical graduates.

OBJECTIVES: To test whether a summative workplace-based assessment (WBA) is feasible and acceptable for international medical graduates (IMGs). DESIGN, SETTING AND PARTICIPANTS: A 6-month trial with 27 IMGs from teaching hospitals in Newcastle, Australia. IMGs were assessed by 65 trained assessors from different disciplines, using blueprinted, preset criteria. MAIN OUTCOME MEASURES: Mini-clinical evaluation exercises, case-based discussions, in-training assessments and multisource feedback. At the end of the trial, assessors and candidates gave feedback. RESULTS: All IMGs were successful at the end of the assessment. The format was well received and acceptable to the candidates and assessors. CONCLUSIONS: WBA is feasible and acceptable to assessors and candidates for assessment of IMGs, but it is intensive in use of resources and time.

An RCT protocol of varying financial incentive amounts for smoking cessation among pregnant women.

BACKGROUND: Smoking during pregnancy is harmful to the unborn child. Few smoking cessation interventions have been successfully incorporated into standard antenatal care. The main aim of this study is to determine the feasibility of a personal financial incentive scheme for encouraging smoking cessation among pregnant women. DESIGN: A pilot randomised control trial will be conducted to assess the feasibility and potential effectiveness of two varying financial incentives that increase incrementally in magnitude ($20 vs. $40AUD), compared to no incentive in reducing smoking in pregnant women attending an Australian public hospital antenatal clinic. METHOD: Ninety (90) pregnant women who self-report smoking in the last 7 days and whose smoking status is biochemically verified, will be block randomised into one of three groups: a. No incentive control group (n=30), b. $20 incremental incentive group (n=30), and c. $40 incremental incentive group (n=30). Smoking status will be assessed via a self-report computer based survey in nine study sessions with saliva cotinine analysis used as biochemical validation. Women in the two incentive groups will be eligible to receive a cash reward at each of eight measurement points during pregnancy if 7-day smoking cessation is achieved. Cash rewards will increase incrementally for each period of smoking abstinence. DISCUSSION: Identifying strategies that are effective in reducing the number of women smoking during pregnancy and are easily adopted into standard antenatal practice is of utmost importance. A personal financial incentive scheme is a potential antenatal smoking cessation strategy that warrants further investigation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12612000399897.

A comparative study of efficacy and outcomes of large loop excision of the transformation zone procedure performed under general anaesthesia versus local anaesthesia.

BACKGROUND: Although Australian National Health and Medical Research Council (NHMRC) guidelines do not specify targets for mode of anaesthesia for large loop excision of the transformation zone (LLETZ) procedures, UK NHS Cervical Screening Programme (NHSCSP) guidelines recommend that >80% of LLETZ procedures be performed under local anaesthesia. There is a paucity of clinical data regarding both the proportion of women receiving general anaesthesia for treatment, factors underpinning this choice and the impact of mode of anaesthesia on treatment outcomes. AIMS: To identify the proportion of women who have a LLETZ under general anaesthesia and to establish the impact of mode of anaesthesia on outcomes including treatment efficacy, overtreatment (negative histology), short-term morbidity and attendance for follow-up. METHODS: Single-centre retrospective analysis of all women treated with LLETZ for suspected cervical dysplasia between 1, May 2005 and 1, May 2009. RESULTS: Thirty-three percent of a total 465 LLETZ procedures were carried out under general anaesthesia, although the reason for anaesthesia choice was not recorded in 52% of cases. There were no significant differences in the primary outcomes of unclear LLETZ margins or negative LLETZ histology, or in the secondary outcomes of depth and surface area of LLETZ specimen, short-term morbidity or rates of incomplete follow-up. CONCLUSIONS: Although reasons underpinning selection of anaesthesia mode remain elusive, at this centre, outcomes following LLETZ procedure for the management of suspected cervical dysplasia are not affected by the mode of anaesthesia used.

Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial.

INTRODUCTION: Antenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time. METHODS AND ANALYSIS: A stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

Predictors of alcohol use during pregnancy in Australian women.

INTRODUCTION: This paper aimed to document alcohol use during pregnancy and determine predictors of ongoing use, including knowledge and agreement with national alcohol guideline recommendations. METHODS: Pregnant women (n = 1179) attending public antenatal services in a Local Health District in NSW, Australia, were surveyed about their alcohol use before pregnancy and after pregnancy recognition, and awareness of, and agreement with, national alcohol guidelines and health-related statements. Respondent characteristics, drinking behaviour and predictors of ongoing drinking during pregnancy were assessed. RESULTS: Most women consumed alcohol before pregnancy (79.3%) but the majority (82.0%) stopped following pregnancy recognition. Half the ongoing drinkers only drank on special occasions. Most (63.6%) women were aware of the national guidelines: 78.1% knew the recommendation that consuming no alcohol in pregnancy is safest, 4.6% thought some alcohol was safe and 17.3% were unsure. Predictors [OR (95%CI)] of ongoing drinking were older age [1.11 (1.07, 1.15)]; medium [2.42 (1.46, 4.00)] or high-risk drinking pre-pregnancy [3.93 (2.35, 6.56)]; and agreement that: avoiding alcohol in pregnancy is safest [0.05 (0.006, 0.47)]; avoiding alcohol is important for baby's health [0.14 (0.06, 0.31)] and pregnancy is a good time to change alcohol use for mother's health [0.29 (0.13, 0.63)]. DISCUSSION AND CONCLUSIONS: Results emphasise the importance of asking about special occasion drinking, the link between pre-pregnancy drinking and ongoing drinking during pregnancy, and the need to understand why women disagree with the national guideline. To ensure guidelines have their intended benefit, interventions to promote behaviour change relating to alcohol consumption during pregnancy are warranted.

Effectiveness of a practice change intervention in reducing alcohol consumption in pregnant women attending public maternity services.

BACKGROUND: The aim of this study was to examine the effect of a practice change intervention to support the implementation of guideline-recommended care for addressing alcohol use in pregnancy on self-reported alcohol use during pregnancy. METHODS: A randomized, stepped-wedge controlled trial in three clusters (sectors) within the Hunter New England Local Health District (NSW, Australia). We evaluated a practice change intervention that supported the introduction of a new model of care for reducing alcohol use in pregnancy, consistent with local and international guidelines, and implemented in random order across the sectors. Each week throughout the study period, pregnant women who attended any public antenatal services within the previous week, for a 27-28 or 35-36 week gestation visit, were randomly sampled and invited to participate in the survey. The intended intervention for all women was Brief advice (to abstain from alcohol and information about potential risks). Women identified as medium-risk alcohol consumers using the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) were to be offered referral to a phone coaching service, and women identified as high-risk were to be offered referral to a Drug and Alcohol Service. Rates of self-reported alcohol use (AUDIT-C risk level and special occasion drinking) were summarized and compared in groups of women pre-intervention and post-intervention using multivariable logistic regression. RESULTS: Surveys were completed by 1309 women at pre-intervention and 2540 at post-intervention. The majority of women did not drink during pregnancy (pre-intervention: 89.68%; post-intervention: 90.74%). There was no change in the proportion of women classified as No risk from drinking (AUDIT-C score = 0) or Some risk from drinking (AUDIT-C score ≥ 1) pre- or post-intervention (p = 0.08). However, a significant reduction in special occasion drinking was observed (pre-intervention: 11.59%; post-intervention: 8.43%; p < 0.001). CONCLUSIONS: Special occasion drinking was reduced following implementation of guideline-recommended care. Failure to change other patterns of alcohol use in pregnancy may reflect barriers to implementing the model of care in antenatal care settings and the need to address other social determinants of alcohol use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (registration number: ACTRN12617000882325; date: 16 June 2017).

Modulation of the Chlamydia trachomatis in vitro transcriptome response by the sex hormones estradiol and progesterone.

BACKGROUND: Chlamydia trachomatis is a major cause of sexually transmitted disease in humans. Previous studies in both humans and animal models of chlamydial genital tract infection have suggested that the hormonal status of the genital tract epithelium at the time of exposure can influence the outcome of the chlamydial infection. We performed a whole genome transcriptional profiling study of C. trachomatis infection in ECC-1 cells under progesterone or estradiol treatment. RESULTS: Both hormone treatments caused a significant shift in the sub-set of genes expressed (25% of the transcriptome altered by more than 2-fold). Overall, estradiol treatment resulted in the down-regulation of 151 genes, including those associated with lipid and nucleotide metabolism. Of particular interest was the up-regulation in estradiol-supplemented cultures of six genes (omcB, trpB, cydA, cydB, pyk and yggV), which suggest a stress response similar to that reported previously in other models of chlamydial persistence. We also observed morphological changes consistent with a persistence response. By comparison, progesterone supplementation resulted in a general up-regulation of an energy utilising response. CONCLUSION: Our data shows for the first time, that the treatment of chlamydial host cells with key reproductive hormones such as progesterone and estradiol, results in significantly altered chlamydial gene expression profiles. It is likely that these chlamydial expression patterns are survival responses, evolved by the pathogen to enable it to overcome the host's innate immune response. The induction of chlamydial persistence is probably a key component of this survival response.