Implementation of a standard outcome set in perinatal care: a qualitative analysis of barriers and facilitators from all stakeholder perspectives

Background: To improve their quality, healthcare systems are increasingly focused on value delivered to patients. For perinatal care, the International Consortium for Health Outcomes Measurement (ICHOM) proposed a patient-centred outcome set with both clinical and patient-reported measures for pregnancy and childbirth (PCB set). This study aimed to identify factors that affect the implementation of the PCB set at the pre-implementation stage, using the consolidated framework for implementation research (CFIR). Methods: In this qualitative study, we conducted semi-structured interviews amongst a purposive sample of key stakeholders within an obstetric care network (OCN): 1) patients, 2) perinatal care professionals involved in the full cycle of perinatal care, and 3) policy makers, including hospital managers, administrative staff and health care insurers. While the CFIR guided data capture and structuring, thematic analysis revealed overarching themes that best reflected the barriers and facilitators from different stakeholder perspectives. Within these overarching themes, the CFIR constructs were maintained. Results: Interviews were conducted with 6 patients, 16 professionals and 5 policy makers. Thematic analysis supported by the CFIR framework identified four main themes: the instrument and its implementation process, use in individual patient care, use in quality improvement, and the context of the OCN. Important barriers included professional workload, data reliability, and interprofessional and interorganizational collaboration. Potential facilitators were the PCB set’s direct value in individual care, interprofessional feedback and education, and aligning with existing systems. Prominent variations between stakeholder groups included the expected patient burden, the level of use, transparency of outcomes and the degree of integrated care. Conclusions: This study clarified critical factors that affect successful implementation of the PCB set in perinatal care. Practice recommendations, suggested at multiple levels, can enable structural patient-centred care improvement and may unite stakeholders towards integrated birth care

Telemonitoring for COVID-19 positive pregnant women; feasibility and user experience of SAFE@home Corona: prospective pilot study

BACKGROUND: COVID-19 has catalysed digital innovations enabling remote healthcare. Pregnant women are at increased risk for severe course of COVID-19 infection. Also, the pandemic has a negative emotional impact on pregnant women as they worry about their own health and the health of their unborn child. We developed a telemonitoring platform called SAFE@home-corona consisting of a pulse oximeter and an app with symptom checklist. The aim of this study was to examine the feasibility, defined by compliance to the platform and by monitoring the course of COVID-19, patient satisfaction and user experience of a telemonitoring platform in COVID-19 positive pregnant women in the Netherlands. METHODS: We conducted a prospective pilot study among Dutch-speaking COVID-19 symptomatic pregnant women. Women were asked to monitor their oxygen-saturation with a pulse oximeter and COVID-related complaints with an in-app questionnaire daily. Oxygen-saturation and complaints were monitored by the Medical Management Centre with triage protocol. COVID-19, pregnancy, and user experience data were collected. To assess feasibility, compliance of daily self-monitoring and compliance of all intended measurements were calculated. Severity of COVID-19 was assessed via the platform and medical record. Patient satisfaction and user experience were measured through a self-developed questionnaire. RESULTS: Twenty-eight women were eligible of which 27 (93.1%) completed the study. Compliance of daily measurement and all intended measurements was high with 98.9 and 93.9%, respectively. Six women were hospitalized, of whom one to the intensive care unit. Overall, women indicated high satisfaction scores, varying from 8 to 10/10. Women were more concerned for the health of their unborn child or family then for themselves (66.7%). They stated that the platform offered reassurance. Patients would highly recommend the platform to pregnant peers during COVID infection. CONCLUSIONS: This pilot study demonstrated feasibility of the SAFE@home-corona platform for self-monitoring COVID-19 course in pregnant women. Patients were satisfied, it offered reassurance, women would recommend use to peers. Upscaling the platform is needed to draw conclusions from the early signalling abilities and to keep evaluating patient satisfaction. The platform has great potential for self-monitoring of COVID-19 and possibly other pulmonary infections in pregnant women

Additional value of advanced ultrasonography in pregnancies with two inconclusive cell-free DNA draws

Objective: We aimed to evaluate the additional value of advanced fetal anatomical assessment by ultrasound in pregnancies with twice inconclusive noninvasive testing (NIPT) due to low fetal fraction (FF). Methods: We performed a multicenter-retrospective study between 2017 and 2020 including 311 pregnancies with twice inconclusive NIPT due to low FF ≤ 1%. Women were offered invasive testing and advanced fetal anatomical assessment at ≤18 weeks' gestation. Ultrasound findings, genetic testing, and pregnancy/postnatal outcomes were evaluated. Results: Ninety-two/311 (29.6%) women underwent invasive testing. Structural anomalies were diagnosed in 13/311 (4.2%) pregnancies (nine at the first scan and four at follow-up). In 6/13 (46.2%) cases, genetic aberrations were confirmed (one case of Trisomy 13 (detectable by NIPT), two of Triploidy, one of 16q12-deletion, HCN4-mutation and UPD(16) (nondetectable by NIPT). Genetic aberrations were found in 4/298 (1.3%) structurallynormal pregnancies (one 47XYY, two microscopic aberrations, one monogenic disorder found postpartum). Structural anomalies in genetically normal fetuses (2.0%) were not more prevalent compared to the general pregnant population (OR 1.0 [0.4–2.2]). Conclusion: In pregnancies with twice inconclusive NIPT due to low FF, fetal structural anomalies are not more prevalent than in the general obstetric population. The detailed anatomical assessment has the added value to detect phenotypical features suggestive of chromosomal/genetic aberrations and identify pregnancies where advanced genetic testing may be indicated

User Experiences With and Recommendations for Mobile Health Technology for Hypertensive Disorders of Pregnancy: Mixed Methods Study

BACKGROUND: Hypertensive disorders of pregnancy (HDP) are a primary cause of adverse maternal and neonatal outcomes worldwide. For women at risk of hypertensive complications, guidelines recommend frequent surveillance of blood pressure and signs of preeclampsia. Clinic visits range from every 2 weeks to several times a week. Given the wide ubiquity of smartphones and computers in most countries and a growing attention for self-management, digital technologies, including mobile health (mHealth), constitute a promising component of monitoring (self-measured) blood pressure during pregnancy. Currently, little is known about the experiences of women using such platforms and how mHealth can be aligned with their needs and preferences. OBJECTIVE: The objectives were twofold: (1) to explore the experiences of Dutch women who had an increased risk of HDP with a blended care approach (mHealth combined with face-to-face care) for remote self-monitoring of blood pressure and preeclampsia symptoms and (2) to formulate recommendations for the use and integration of mHealth in clinical care. METHODS: Alongside a prospective blended care study (SAFE@home study) that monitors pregnant women at increased risk of HPD with mHealth technology, a mixed methods study was conducted, including questionnaires (n=52) and interviews (n=11). Results were analyzed thematically. RESULTS: Of the 4 themes, 2 themes were related to the technologies themselves (expectations, usability), and 2 themes were related to the interaction and use of mHealth (autonomy and responsibilities of patients, responsibilities of health care professionals). First, the digital platform met the expectations of patients, which contributed to user satisfaction. Second, the platform was considered user-friendly, and patients favored different moments and frequencies for measuring their blood pressure. Third, patient autonomy was mentioned in terms of increased insight about their own condition and being able to influence clinical decision making. Fourth, clinical expertise of health care professionals was considered essential to interpret the data, which translates to subsequent responsibilities for clinical management. Data from the questionnaires and interviews corresponded. CONCLUSIONS: Blended care using an mHealth tool to monitor blood pressure in pregnancy was positively evaluated by its users. Insights from participants led to 7 recommendations for designing and implementing similar interventions and to enhance future, morally sound use of digital technologies in clinical care

SAFE@HOME: Digital health platform facilitating a new care path for women at increased risk of preeclampsia – A case-control study

Objective: In women at risk of developing preeclampsia, we evaluated the use of a digital health platform for telemonitoring blood pressure and symptoms combined with a minimal antenatal visit schedule. Study design: A case-control study for women with chronic hypertension, history of preeclampsia, or maternal cardiac or kidney disease. A care path was designed with reduced visits enhanced with a digital platform (SAFE@HOME) for daily blood pressure and symptom monitoring starting from 16 weeks of gestation. Home-measurements were monitored in-hospital by obstetric professionals, taking actions upon alarming results. This prospective SAFE@HOME group was compared to a retrospective control group managed without self-monitoring. Main outcome measures: Primary: healthcare consumption (number of antenatal visits, ultrasounds, admissions and diagnostics), user experiences of the platform. Secondary: maternal and perinatal outcomes. Results: Baseline characteristics of the SAFE@HOME (n = 103) and control group (n = 133) were comparable. In the SAFE@HOME group, antenatal visits (mean 13.7 vs 16.0, p < 0.001) and ultrasounds (6.3 vs 7.4, p = 0.005) were lower compared to the control group. Admissions for hypertension or suspected preeclampsia were significantly fewer in the SAFE@HOME group (2.9% versus 13.5%, p = 0.004). Telemonitoring participants were highly satisfied using the platform. No differences were observed for maternal and perinatal outcomes. Conclusions: Our care path including blood pressure telemonitoring for women at risk of preeclampsia allows fewer antenatal visits, ultrasounds and hypertension-related admissions. We observed no differences in perinatal outcomes. These results suggest that telemonitoring of blood pressure is feasible in a high-risk pregnant population and has the potential to profoundly change antenatal care

Current practice of first-trimester ultrasound screening for structural fetal anomalies in developed countries

Objectives: First-trimester ultrasound screening is increasingly performed to detect fetal anomalies early in pregnancy, aiming to enhance reproductive autonomy for future parents. This study aims to display the current practice of first-trimester ultrasound screening in developed countries. Method: An online survey among 47 prenatal screening experts in developed countries. Results: First-trimester structural anomaly screening is available in 30 of the 33 countries and is mostly offered to all women with generally high uptakes. National protocols are available in 23/30 (76.7%) countries, but the extent of anatomy assessment varies. Monitoring of scan quality occurs in 43.3% of the countries. 23/43 (53.5%) of the respondents considered the quality of first-trimester ultrasound screening unequal in different regions of their country. Conclusions: First-trimester screening for structural fetal anomalies is widely offered in developed countries, but large differences are reported in availability and use of screening protocols, the extent of anatomy assessment, training and experience of sonographers and quality monitoring systems. Consequently, this results in an unequal offer to parents in developed countries, sometimes even within the same country. Furthermore, as offer and execution differ widely, this has to be taken into account when results of screening policies are scientifically published or compared.</p

Nationwide implementation of a decision aid on vaginal birth after cesarean:a before and after cohort study

Woman with a history of a previous cesarean section (CS) can choose between an elective repeat CS (ERCS) and a trial of labor (TOL), which can end in a vaginal birth after cesarean (VBAC) or an unplanned CS. Guidelines describe women's rights to make an informed decision between an ERCS or a TOL. However, the rates of TOL and vaginal birth after CS varies greatly between and within countries. The objective of this study is to asses nation-wide implementation of counselling with a decision aid (DA) including a prediction model, on intended delivery compared to care as usual. We hypothesize that this may result in a reduction in practice variation without an increase in cesarean rates or complications. In a multicenter controlled before and after cohort study we evaluate the effect of nation-wide implementation of a DA. Practice variation was defined as the standard deviation (SD) of TOL percentages. A total of 27 hospitals and 1,364 women were included. A significant decrease was found in practice variation (SD TOL rates: 0.17 control group vs. 0.10 intervention group following decision aid implementation, p=0.011). There was no significant difference in the ERCS rate or overall CS rates. A 21% reduction in the combined maternal and perinatal adverse outcomes was seen. Nationwide implementation of the DA showed a significant reduction in practice variation without an increase in the rate of cesarean section or complications, suggesting an improvement in equality of care

Fetal fraction of cell-free DNA in noninvasive prenatal testing and adverse pregnancy outcomes:a nationwide retrospective cohort study of 56,110 pregnant women

Background: Noninvasive prenatal testing by cell-free DNA analysis is offered to pregnant women worldwide to screen for fetal aneuploidies. In noninvasive prenatal testing, the fetal fraction of cell-free DNA in the maternal circulation is measured as a quality control parameter. Given that fetal cell-free DNA originates from the placenta, the fetal fraction might also reflect placental health and maternal pregnancy adaptation. Objective: This study aimed to assess the association between the fetal fraction and adverse pregnancy outcomes. Study Design: We performed a retrospective cohort study of women with singleton pregnancies opting for noninvasive prenatal testing between June 2018 and June 2019 within the Dutch nationwide implementation study (Trial by Dutch Laboratories for Evaluation of Non-Invasive Prenatal Testing [TRIDENT]-2). Multivariable logistic regression analysis was used to assess associations between fetal fraction and adverse pregnancy outcomes. Fetal fraction was assessed as a continuous variable and as &lt;10th percentile, corresponding to a fetal fraction &lt;2.5%. Results: The cohort comprised 56,110 pregnancies. In the analysis of fetal fraction as a continuous variable, a decrease in fetal fraction was associated with increased risk of hypertensive disorders of pregnancy (adjusted odds ratio, 2.27 [95% confidence interval, 1.89–2.78]), small for gestational age neonates &lt;10th percentile (adjusted odds ratio, 1.37 [1.28–1.45]) and &lt;2.3rd percentile (adjusted odds ratio, 2.63 [1.96–3.57]), and spontaneous preterm birth from 24 to 37 weeks of gestation (adjusted odds ratio, 1.02 [1.01–1.03]). No association was found for fetal congenital anomalies (adjusted odds ratio, 1.02 [1.00–1.04]), stillbirth (adjusted odds ratio, 1.02 [0.96–1.08]), or neonatal death (adjusted odds ratio, 1.02 [0.96–1.08]). Similar associations were found for adverse pregnancy outcomes when fetal fraction was &lt;10th percentile. Conclusion: In early pregnancy, a low fetal fraction is associated with increased risk of adverse pregnancy outcomes. These findings can be used to expand the potential of noninvasive prenatal testing in the future, enabling the prediction of pregnancy complications and facilitating tailored pregnancy management through intensified monitoring or preventive measures.</p

Quality Improvement with Outcome Data in Integrated Obstetric Care Networks: Evaluating Collaboration and Learning Across Organizational Boundaries with an Action Research Approach

Introduction: Patient-reported outcome and experience measures (PROM and PREM) are used to guide individual care and quality improvement (QI). QI with patient-reported data is preferably organized around patients, which is challenging across organisations. We aimed to investigate network-broad learning for QI with outcome data. Methods: In three obstetric care networks using individual-level PROM/PREM, a learning strategy for cyclic QI based on aggregated outcome data was developed, implemented and evaluated. The strategy included clinical, patient-reported, and professional-reported data; together translated into cases for interprofessional discussion. This study’s data generation (including focus groups, surveys, observations) and analysis were guided by a theoretical model for network collaboration. Results: The learning sessions identified opportunities and actions to improve quality and continuity of perinatal care. Professionals valued the data (especially patient-reported) combined with in-dept interprofessional discussion. Main challenges were professionals’ time constraints, data infrastructure, and embedding improvement actions. Network-readiness for QI depended on trustful collaboration through connectivity and consensual leadership. Joint QI required information exchange and support including time and resources. Conclusions: Current fragmented healthcare organization poses barriers for network-broad QI with outcome data, but also offers opportunities for learning strategies. Furthermore, joint learning could improve collaboration to catalyse the journey towards integrated, value-based care

Prognostic models versus single risk factor approach in first trimester selective screening for gestational diabetes mellitus: a prospective population-based multicentre cohort study

Objectives: To evaluate whether (1) first-trimester prognostic models for gestational diabetes mellitus (GDM) outperform the currently used single risk factor approach, and (2) a first-trimester random venous glucose measurement improves model performance. Design: Prospective population-based multicentre cohort. Setting: Thirty-one independent midwifery practices and six hospitals in the Netherlands. Population: Women recruited before 14 weeks of gestation without pre-existing diabetes. Methods: The single risk factor approach (presence of at least one risk factor: BMI ≥30 kg/m 2, previous macrosomia, history of GDM, positive first-degree family history of diabetes, non-western ethnicity) was compared with the four best performing models in our previously published external validation study (Gabbay-Benziv 2014, Nanda 2011, Teede 2011, van Leeuwen 2010) with and without the addition of glucose. Main outcome measures: Discrimination was assessed by c-statistics, calibration by calibration plots, added value of glucose by the likelihood ratio chi-square test, net benefit by decision curve analysis and reclassification by reclassification plots. Results: Of the 3723 women included, a total of 181 (4.9%) developed GDM. The c-statistics of the prognostic models were higher, ranging from 0.74 to 0.78 without glucose and from 0.78 to 0.80 with glucose, compared with the single risk factor approach (0.72). Models showed adequate calibration, and yielded a higher net benefit than the single risk factor approach for most threshold probabilities. Teede 2011 performed best in the reclassification analysis. Conclusions: First-trimester prognostic models seem to outperform the currently used single risk factor approach in screening for GDM, particularly when glucose was added as a predictor. Tweetable abstract: Prognostic models seem to outperform the currently used single risk factor approach in screening for gestational diabetes