Evaluation and patient experience of wireless noninvasive fetal heart rate monitoring devices.

INTRODUCTION: In clinical practice, fetal heart rate monitoring is performed intermittently using Doppler ultrasound, typically for 30 minutes. In case of a non-reassuring heart rate pattern, monitoring is usually prolonged. Noninvasive fetal electrocardiography may be more suitable for prolonged monitoring due to improved patient comfort and signal quality. This study evaluates the performance and patient experience of four noninvasive electrocardiography devices to assess candidate devices for prolonged noninvasive fetal heart rate monitoring. MATERIAL AND METHODS: Non-critically sick women with a singleton pregnancy from 24 weeks of gestation were eligible for inclusion. Fetal heart rate monitoring was performed during standard care with a Doppler ultrasound device (Philips Avalon-FM30) alone or with this Doppler ultrasound device simultaneously with one of four noninvasive electrocardiography devices (Nemo Fetal Monitoring System, Philips Avalon-Beltless, Demcon Dipha-16 and Dräger Infinity-M300). Performance was evaluated by: success rate, positive percent agreement, bias, 95% limits of agreement, regression line, root mean square error and visual agreement using FIGO guidelines. Patient experience was captured using a self-made questionnaire. RESULTS: A total of 10 women were included per device. For fetal heart rate, Nemo performed best (success rate: 99.4%, positive percent agreement: 94.2%, root mean square error 5.1 BPM, bias: 0.5 BPM, 95% limits of agreement: -9.7 - 10.7 BPM, regression line: y = -0.1x + 11.1) and the cardiotocography tracings obtained simultaneously by Nemo and Avalon-FM30 received the same FIGO classification. Comparable results were found with the Avalon-Beltless from 36 weeks of gestation, whereas the Dipha-16 and Infinity-M300 performed significantly worse. The Avalon-Beltless, Nemo and Infinity-M300 closely matched the performance of the Avalon-FM30 for maternal heart rate, whereas the performance of the Dipha-16 deviated more. Patient experience scores were higher for the noninvasive electrocardiography devices. CONCLUSIONS: Both Nemo and Avalon-Beltless are suitable devices for (prolonged) noninvasive fetal heart rate monitoring, taking their intended use into account. But outside its intended use limit of 36 weeks' gestation, the Avalon-Beltless performs less well, comparable to the Dipha-16 and Infinity-M300, making them currently unsuitable for (prolonged) noninvasive fetal heart rate monitoring. Noninvasive electrocardiography devices appear to be preferred due to greater comfort and mobility.

Implementation of integrated maternity care in the southwestern region of the Netherlands: evaluation of its effect on preterm birth, low birthweight infants and number of secondary care consultations.

OBJECTIVES: To determine whether integrated maternity care is associated with reduced preterm births (PTB) and fewer small-for-gestational-age infants (SGA), and whether its implementation leads to a reduction of secondary care consultations. DESIGN: Retrospective study. SETTING: Integrated maternity care organisation in the southwestern region of the Netherlands. PARTICIPANTS: All singleton pregnancies (≥24 weeks) within integrated maternity care organisation Annature between 2015 and 2020. INTERVENTION: Implementation of a shared maternity record in primary and secondary care. METHODS: Data of 20 818 women were derived from patient records and from the Netherlands Perinatal Registry. Intervention was the introduction of integrated maternity care in January 2018. Through multivariate logistic regression and segmented regression analysis we assessed the combined prevalence of SGA and PTB (SGA-PTB) before (2015-2017), and after the intervention (2018-2020). Regional rates were contrasted with nationwide rates (n=782 176). MAIN OUTCOME MEASURES: SGA-PTB prevalence and mean number of secondary care consultations per pregnancy. RESULTS: SGA-PTB prevalence declined from 618/3443 (17.9%) in 2015 to 560/3501 (16.0%) in 2017 to 507/3459 (14.7%) in 2020 (p<0.005). Mean number of secondary care consultations declined from six per pregnancy in 2015 to three in 2020. Logistic regression demonstrated a significant decline in odds of SGA-PTB (OR 0.83 (95% CI 0.77 to 0.89)) between 2015-2017 and 2018-2020 adjusted for changes in sociodemographic characteristics over time. A statistically significant average monthly 7.3% (p=0.05) reduction in SGA-PTB prevalence and 12.4% (p<0.005) mean monthly reduction in secondary care consultations were demonstrated for 2015-2017. Immediately after the intervention, mean monthly prevalence of SGA-PTB dropped non-significantly to 14.7%. Between 2018 and 2020 a significant 15.2% (p<0.005) reduction in secondary care consultations was shown. CONCLUSION: Our results suggest that implementation of integrated maternity care was associated with reduced PTBs and/or low birth weight, and fewer secondary care consultations. These encouraging findings were observed in a less favourable sociodemographic profile and should be confirmed in other regions with sufficiently large populations, and the possibility to test individual components of integrated maternity care.

Trabecular bone density in middle-aged women with reproductive disorders.

Besides age, estrogen exposure plays a crucial role in changes in bone density (BD) in women. Premature ovarian insufficiency (POI) and polycystic ovary syndrome (PCOS) are conditions in reproductive-aged women in which the exposure to estrogen is substantially different. Women with a history of preeclampsia (PE) are expected to have normal estrogen exposure. Within the CREw-IMAGO study, we investigated if trabecular BD is different in these women because of differences in the duration of estrogen exposure. Trabecular BD was measured in thoracic vertebrae on coronary CT scans. Women with an reduced estrogen exposure (POI) have a lower BD compared to women with an intermediate exposure (PE) (mean difference (MD) -26.8, 95% confidence interval (CI) -37.2 - -16.3). Women with a prolonged estrogen exposure (PCOS) have the highest BD (MD 15.0, 95% CI 4.3 - 25.7). These results support the hypothesis that the duration of estrogen exposure in these women is associated with trabecular BD.

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial.

AIM: To investigate the association between continuous glucose monitoring (CGM) metrics and perinatal outcomes in insulin-treated diabetes mellitus in pregnancy. MATERIALS AND METHODS: In a post-hoc analysis of the GlucoMOMS randomized controlled trial, we investigated the association between the metrics of an offline, intermittent CGM, glycated haemoglobin (HbA1c) and perinatal outcomes per trimester in different types of diabetes (type 1, 2 or insulin-treated gestational diabetes mellitus [GDM]). Data were analysed using multivariable binary logistic regression. Outcomes of interest were neonatal hypoglycaemia, pre-eclampsia, preterm birth, large for gestational age (LGA) and Neonatal Intensive Care Unit (NICU) admission. The glucose target range was defined as 3.5-7.8 mmol/L (63-140 mg/dL). RESULTS: Of the 147 participants (N = 50 type 1 diabetes, N = 94 type 2 diabetes/insulin-treated GDM) randomized to the CGM group of the GlucoMOMS trial, 115 participants had CGM metrics available and were included in the current study. We found that, in pregnancies with type 1 diabetes, a higher second trimester mean glucose was associated with LGA (odds ratio 2.6 [95% confidence interval 1.1-6.2]). In type 2 and insulin-treated gestational diabetes, an increased area under the curve above limit was associated with LGA (odds ratio 10.0 [95% confidence interval 1.4-72.8]). None of the CGM metrics were associated with neonatal hypoglycaemia, pre-eclampsia, shoulder dystocia, preterm birth and NICU admission rates for pregnancies complicated by any type of diabetes. CONCLUSION: In this study, in type 2 diabetes or insulin-treated GDM, the glucose increased area under the curve above limit was associated with increased LGA. In type 1 diabetes, the mean glucose was the major determinant of LGA. Our study found no evidence that other CGM metrics determined adverse pregnancy outcomes.

Differing Professional Perspectives on the Interprofessional Collaboration in IPUs: A Mixed-methods Study.

Introduction: An important aspect of Value-Based Healthcare (VBHC) is providing the full cycle of care for a specific medical condition through interprofessional collaboration. This requires employees from diverse professional backgrounds to interact, but there is limited knowledge on how professionals perceive such interprofessional collaboration. We aimed to provide insight into how different professionals perceive Integrated Practice Unit (IPU) composition and what factors influence the quality of interprofessional collaboration within IPUs. Methods: A survey was administered to employees from different professional backgrounds (medical specialists, nurses, allied health professionals, administrative employees) working in IPUs to assess their perception of the composition of their IPU and the quality of the interactions. Subsequently, semi-structured interviews were conducted to gain a deeper understanding of the findings of the survey. Results: Medical specialists and nurses were most frequently considered to be part of an IPU and indicated that they have high quality interactions. Allied health professionals were less often considered part of the team by all other professional groups and all report low quality interaction with this group. The extent to which a professional group is perceived as a team member depends on their visibility, involvement in the treatment of the patient, and shared interest. Differences in the quality of interprofessional collaboration are influenced by organizational structures, knowledge of each other's expertise, and by ways of communication. Conclusions: In VBHC, there seems to be a lack of common perception of an IPU's composition and a failure to always achieve high quality interprofessional collaboration. Given the importance of interprofessional collaboration in VBHC, effort should be invested in achieving a shared understanding and improved collaboration.

Assessing the Well-Being at Work of Nurses and Doctors in Hospitals: Protocol for a Scoping Review of Monitoring Instruments.

BACKGROUND: Well-being at work can be defined as "creating an environment to promote a state of contentment which allows an employee to flourish and achieve their full potential for the benefit of themselves and their organisation." In the health care context, well-being at work of nurses and doctors is important for good patient care. Moreover, it is strongly associated with individual- and organization-level consequences. Relevant literature presents models and concepts of physical, mental, and social well-being. This study uses the 6 elements of the job demands-resources (JD-R) model to interpret well-being at work (job demands, job resources, personal resources, leadership, well-being, and outcomes) as part of a Netherlands Federation of University Medical Hospitals program to find ways to improve and monitor health care professionals' well-being in Dutch hospitals. Many instruments exist to measure well-being at work in terms of population, setting, and other aspects. An overview of available and eligible instruments assessing and monitoring the well-being of nurses and doctors is currently missing. OBJECTIVE: We will perform a scoping review aiming to provide an overview of validated instruments assessing and monitoring the well-being of nurses and doctors at work. METHODS: We will perform a search of published literature in the following databases: Medline, Embase, and CINAHL. Studies will be eligible if they (1) assess well-being at work of nurses and doctors employed in hospitals; (2) describe an evaluation of an instrument or review an instrument; (3) measure well-being at work or aspects of well-being at work according to the elements of the JD-R model, and (4) were published in English from 2011 onwards. Title/abstract screening according to the eligibility criteria will be followed by full-text screening. Data extraction of included studies will be conducted by 3 reviewers independently. Reviewers will use standardized data extraction forms that include study characteristics, sample characteristics, measurement instrument details, and psychometric properties. The analysis will be descriptive. When synthesizing the data, a distinction will be made between comprehensive instruments and common instruments. RESULTS: This scoping review identifies instruments that have been developed and validated for monitoring the well-being of nurses and doctors at work. Studies were searched between September and December 2021 and screened between December 2021 and May 2022. A total of 739 studies were included. CONCLUSIONS: Timely screening of well-being at work may be beneficial for individual health care workers, the organization, and patients. There is often a substantial gap and mismatch between employer perceptions of well-being and well-being interventions. It is important to develop and implement suitable interventions adapted to the needs of nurses and doctors and their health or other problems. Well-being screening should be timely to gain insight into these needs and problems. Moreover, to determine the effectiveness of well-being interventions, measurement is mandatory. The results will be critical for organizations to select a monitoring instrument that best fits the needs of employees and organizations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43692.

The immaturity of patient engagement in value-based healthcare-A systematic review.

Introduction: In recent years, Value-Based Healthcare (VBHC) has been gaining traction, particularly in hospitals. A core VBHC element is patient value, i.e., what matters most to the patient and at what cost can this be delivered. This interpretation of value implies patient engagement in patient-doctor communication. Although patient engagement in direct care in the VBHC setting is well described, patient engagement at the organizational level of improving care has hardly been studied. This systematic review maps current knowledge regarding the intensity and impact of patient engagement in VBHC initiatives. We focus on the organizational level of a continuous patient engagement model. Methods: We performed a systematic review following PRISMA guidelines using five electronic databases. The search strategy yielded 1,546 records, of which 21 studies were eligible for inclusion. Search terms were VBHC and patient engagement, or similar keywords, and we included only empirical studies in hospitals or transmural settings at the organizational level. Results: We found that consultation, using either questionnaires or interviews by researchers, is the most common method to involve patients in VBHC. Higher levels of patient engagement, such as advisory roles, co-design, or collaborative teams are rare. We found no examples of the highest level of patient engagement such as patients co-leading care improvement committees. Conclusion: This study included 21 articles, the majority of which were observational, resulting in a limited quality of evidence. Our review shows that patient engagement at the organizational level in VBHC initiatives still relies on low engagement tools such as questionnaires and interviews. Higher-level engagement tools such as advisory roles and collaborative teams are rarely used. Higher-level engagement offers opportunities to improve healthcare and care pathways through co-design with the people being served. We urge VBHC initiatives to embrace all levels of patient engagement to ensure that patient values find their way to the heart of these initiatives.

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.

Prevention and Screening for Cardiometabolic Disease Following Hypertensive Disorders in Pregnancy in Low-Resource Settings: A Systematic Review and Delphi Study.

Hypertensive disorders in pregnancy (HDP) and cardiometabolic and kidney diseases are rising in low- and middle-income countries (LMICs). While HDP are risk factors for cardiometabolic and kidney diseases, cost-effective, scalable strategies for screening and prevention in women with a history of HDP are lacking. Existing guidelines and recommendations require adaptation to LMIC settings. This article aims to generate consensus-based recommendations for the prevention and screening of cardiometabolic and kidney diseases tailored for implementation in LMICs. We conducted a systematic review of guidelines and recommendations for prevention and screening strategies for cardiometabolic and chronic kidney diseases following HDP. We searched PubMed/Medline, Embase and Cochrane Library for relevant articles and guidelines published from 2010 to 2021 from both high-income countries (HICs) and LMICs. No other filters were applied. References of included articles were also assessed for eligibility. Findings were synthesized narratively. The summary of guiding recommendations was subjected to two rounds of Delphi consensus surveys with experts experienced in LMIC settings. Fifty-four articles and 9 guidelines were identified, of which 25 were included. Thirty-five clinical recommendations were synthesized from these and classified into six domains: identification of women with HDP (4 recommendations), timing of first counseling and provision of health education (2 recommendations), structure and care setting (12 recommendations), information and communication needs (5 recommendations), cardiometabolic biomarkers (8 recommendations) and biomarkers thresholds (4 recommendations). The Delphi panel reached consensus on 33 final recommendations. These recommendations for health workers in LMICs provide practical and scalable approaches for effective screening and prevention of cardiometabolic disease following HDP. Monitoring and evaluation of implementation of these recommendations provide opportunities for reducing the escalating burden of noncommunicable diseases in LMICs.

The multidimensional impact of maternal near-miss on the lives of women in Zanzibar, Tanzania: a prospective, 1-year follow-up study.

BACKGROUND: Severe maternal morbidity has been shown to have specific, long-term effects on health and wellbeing, such as daily functioning and mental health. OBJECTIVE: This study aimed to multidimensionally assess the long-term impact of maternal near-miss complications in Zanzibar. STUDY DESIGN: A prospective cohort study was conducted in Zanzibar's referral hospital. Women with maternal near-miss complications were matched with controls. At 3, 6, and 12 months after hospital discharge, history was taken, blood pressure and haemoglobin levels were measured, and multiple validated questionnaires (WHOQOL-BREF, WHODAS2.0, Patient Health Questionnaire-9, Harvard Trauma Questionnaire-16) were administered assessing experienced quality of life and disability, and screening for depression and posttraumatic stress disorder. RESULTS: We included 223 women after maternal near-miss complications and 213 women controls. There was a high prevalence of hypertension at 6 and 12 months in both groups and significantly higher after a near-miss. The proportion of women with low quality of life, disability, depression, or posttraumatic stress disorder was not significantly different between the 2 groups. A poor outcome for at least 1 of these 3 health domains was more prevalent after a near-miss complication. CONCLUSION: In Zanzibar, women after maternal near-miss complications report similar but slower recovery to control participants in the assessed dimensions. Adaptation of perceptions on and coping mechanisms with daily reality might partly explain this. Hypertension has a high prevalence after childbirth and should be treated adequately to prevent recurrent obstetrical and cardiovascular complications. Blood pressure follow-up for all women who delivered at Mnazi Mmoja Hospital seemed justified.

PROMs and PREMs in routine perinatal care: mixed methods evaluation of their implementation into integrated obstetric care networks.

BACKGROUND: In the transition towards value-based healthcare, patient-reported outcome and experience measures (PROM and PREM) are recommended by international collaborations and government programs to guide clinical practice and quality improvement. For many conditions, using PROM/PREM over the complete continuum of care requires implementation across care organizations and disciplines. Along PROM/PREM implementation in obstetric care networks (OCN), we aimed to evaluate implementation outcomes and the processes influencing these outcomes in the complex context of care networks across the continuum of perinatal care. METHODS: Three OCN in the Netherlands implemented PROM/PREM in routine practice, using an internationally developed outcomes set with care professionals and patient advocates. Their aim was to use PROM/PREM results individually to guide patient-specific care decisions and at group-level to improve quality of care. The implementation process was designed following the principles of action research: iteratively planning implementation, action, data generation and reflection to refine subsequent actions, involving both researchers and care professionals. During the one-year implementation period in each OCN, implementation outcomes and processes were evaluated in this mixed-methods study. Data generation (including observation, surveys and focus groups) and analysis were guided by two theoretical implementation frameworks: the Normalization Process Theory and Proctor's taxonomy for implementation outcomes. Qualitative findings were supplemented with survey data to solidify findings in a broader group of care professionals. RESULTS: Care professionals in OCN found the use of PROM/PREM acceptable and appropriate, recognized their benefits and felt facilitated in their patient-centered goals and vision. However, feasibility for daily practice was low, mainly due to IT issues and time constraints. Hence PROM/PREM implementation did not sustain, but strategies for future PROM/PREM implementation were formulated in all OCN. Processes contributing positively to implementation outcomes were internalization (understand the value) and initiation (driven by key-participants), whereas challenges in relational integration (maintain confidence) and reconfiguration (refine activities) affected implementation negatively. CONCLUSION: Although implementation did not sustain, network-broad PROM/PREM use in clinic and quality improvement matched professionals' motivation. This study provides recommendations to implement PROM/PREM meaningfully in practice in ways that support professionals in their drive towards patient-centered care. In order for PROM/PREM to fulfill their potential for value-based healthcare, our work highlights the need for sustainable IT infrastructures, as well as an iterative approach to refine their complex implementation into local contexts.

Patient-reported outcome and experience measures for quality improvement in pregnancy and childbirth care: a retrospective cohort study.

BACKGROUND: Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) can highlight issues that remain unnoticed when using standard clinical quality indicators. However, estimations of the potential power of measuring PROMs and PREMs to identify unrecognised areas suitable for quality improvement are often limited by a lack of reliable real-world data. Here, we report on how the indicator set for PROMs and PREMs that was recently developed by the International Consortium for Health Outcome Measures can change perspectives on quality assessment in women receiving care for pregnancy and childbirth. METHODS: PROMs and PREMs were captured 6 months after childbirth via an online survey in a single academic maternity unit in the Netherlands between 2018 and 2019. Indicators of abnormality were scored using predefined cut-off values established by a national consensus group. We used regression analysis to identify associations between PROMs, PREMs and healthcare use, and further stratified data to explore the distribution of indicators among relevant patient subgroups. RESULTS: Of 2775 questionnaires, 645 were completed and linked to medical health records. Despite only 5% of women reporting overall dissatisfaction with care, suboptimal scores were often found; in birth experience for 32% of the population, and 42% who experienced painful sexual intercourse. Subgroup analysis further revealed associations with relevant indicators of quality of care; inadequate pain relief among women with preterm birth (OR 8.8), pain with sexual intercourse among women undergoing vaginal assisted delivery (OR 2.2) and women living in a deprived area had problematic birth experiences (coefficient -3.2). CONCLUSION: Use of PROMs and PREMs in pregnancy and childbirth care provides new insights on quality of care, resulting in potentially actionable targets for improvement not normally identified with standard clinical quality indicators. Implementation strategies and follow-up are needed to act on these findings.

Provision and experience of care among women with hypertension in pregnancy: a multi-center qualitative study in Ghana.

BACKGROUND: Hypertensive disorders of pregnancy (HDP) remain a leading global health problem with complex clinical presentations and potentially grim birth outcomes for both mother and fetus. Improvement in the quality of maternal care provision and positive women's experiences are indispensable measures to reduce maternal and perinatal adverse outcomes. OBJECTIVE: To explore the perspectives and lived experiences of healthcare provision among women with HDP and the associated challenges. METHODS: A multi-center qualitative study using in-depth interviews (IDIs) and focus group discussions (FGDs) was conducted in five major referral hospitals in the Greater Accra Region of Ghana between June 2018 and March 2019. Women between 26 and 34 weeks' gestation with confirmed HDP who received maternity care services were eligible to participate. Thematic content analysis was performed using the inductive analytic framework approach. RESULTS: Fifty IDIs and three FGDs (with 22 participants) were conducted. Most women were between 20 and 30 years, Akans (ethnicity), married/cohabiting, self-employed and secondary school graduates. Women reported mixed (positive and negative) experiences of maternal care. Positive experiences reported include receiving optimal quality of care, satisfaction with care and good counselling and reassurance from the health professionals. Negative experiences of care comprised ineffective provider-client communication, inappropriate attitudes by the health professionals and disrespectful treatment including verbal and physical abuse. Major health system factors influencing women's experiences of care included lack of logistics, substandard professionalism, inefficient national health insurance system and unexplained delays at health facilities. Patient-related factors that influenced provision of care enumerated were financial limitations, chronic psychosocial stress and inadequate awareness about HDP. CONCLUSION: Women with HDP reported both positive and negative experiences of care stemming from the healthcare system, health providers and individual factors. Given the importance of positive women's experiences and respectful maternal care, dedicated multidisciplinary women-centered care is recommended to optimize the care for pregnant women with HDP.

High blood pressure (hypertension) in pregnancy can have severe complications for both mother and fetus including loss of life. The outcome of pregnancy for women who develop hypertension during pregnancy can be improved by ensuring optimal quality of care. In this study, we explored the opinions and experiences of women whose pregnancies were affected by hypertension concerning the care they received during their recent admission at different hospitals in Ghana and the challenges they faced. In four major referral hospitals in the Greater Accra Region of Ghana, we interviewed the women and had focus group discussions. Women who were pregnant for 26 weeks up to 34 weeks and had hypertension in pregnancy were invited for inclusion in the study.We conducted in-depth interviews with fifty women and three focus group discussions with 22 women. Most women who participated in the study were between 20 and 30 years old, Akans (ethnicity), married/cohabiting, self-employed and secondary school graduates. The women reported both positive and negative experiences of care during their admission at the hospitals. Examples of positive experiences were receiving good quality of care, satisfaction with care, and adequate counselling from the health workers. Examples of negative experiences were poor communication between the providers and affected women, inappropriate attitudes by the healthcare providers, and disrespectful treatment such as verbal and physical abuse. The major factors in the health system that influenced women's experiences of care were lack of logistics, substandard professionalism, inefficient national health insurance system and long delays at health facilities prior to receiving treatment. The individual women's factors that affected the quality of care included financial constraints, psychosocial stress and inadequate knowledge about hypertension during pregnancy.In conclusion, we determined that women with hypertension in pregnancy experience both positive and negative aspects of care and these may be due to challenges associated with the healthcare system, health providers and women themselves. There is the need to ensure optimal quality and respectful maternity care considering the nature of hypertension in pregnancy. These women require dedicated hospital staff with significant  experience to improve the quality of care provided to women with hypertension in pregnancy.

Women's experiences with using patient-reported outcome and experience measures in routine perinatal care in the Netherlands: a mixed-methods study.

OBJECTIVES: To gain insight into the experiences of women with completing and discussing patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), and tailoring their care based on their outcomes. DESIGN: A mixed-methods prospective cohort study. SETTING: Seven obstetric care networks in the Netherlands that implemented a set of patient-centred outcome measures for pregnancy and childbirth (PCB set), published by the International Consortium for Health Outcomes Measurement. PARTICIPANTS: All women, receiving the PROM and PREM questionnaires as part of their routine perinatal care, received an invitation for a survey (n=460) and an interview (n=16). The results of the survey were analysed using descriptive statistics; thematic inductive content analysis was applied on the data from open text answers and the interviews. RESULTS: More than half of the survey participants (n=255) felt the need to discuss the outcomes of PROM and PREM with their care professionals. The time spent on completing questionnaires and the comprehensiveness of the questions was scored 'good' by most of the survey participants. From the interviews, four main themes were identified: content of the PROM and PREM questionnaires, application of these outcomes in perinatal care, discussing PREM and data capture tool. Important facilitators included awareness of health status, receiving personalised care based on their outcomes and the relevance of discussing PREM 6 months post partum. Barriers were found in insufficient information about the goal of PROM and PREM for individual care, technical problems in data capture tools and discrepancy between the questionnaire topics and the care pathway. CONCLUSIONS: This study showed that women found the PCB set an acceptable and useful instrument for symptom detection and personalised care up until 6 months post partum. This patient evaluation of the PCB set has several implications for practice regarding the questionnaire content, role of care professionals and congruity with care pathways.

Home telemonitoring versus hospital care in complicated pregnancies in the Netherlands: a randomised, controlled non-inferiority trial (HoTeL).

BACKGROUND: Women with complicated pregnancies often require hospital admission. Telemonitoring at home is a promising alternative that fulfils a worldwide need in obstetric health care. Moreover, the COVID-19 pandemic has accelerated the transformation to digital care. The aim of this study was to evaluate safety, clinical effectiveness, patient satisfaction, and costs of home telemonitoring against hospital care in complicated pregnancies. METHODS: We did a multicentre, randomised, controlled, non-inferiority trial in six hospitals (four general teaching hospitals and two university hospitals) in the Netherlands (located in Utrecht, Amsterdam, and Groningen). Women aged 18 years and older with singleton pregnancies (>26 weeks gestation) requiring monitoring for pre-eclampsia, fetal growth restriction, fetal anomaly, preterm rupture of membranes, reduced fetal movements, or history of fetal death were included in the study. Participants were randomly assigned to either hospital admission or telemonitoring in (1:1), stratified for the six diagnoses for inclusion and the six centres of inclusion, using block randomisation (block sizes of four and six). When assigned to telemonitoring, participants went home with devices for cardiotocography and blood pressure measurements and had daily contact with their care providers after digitally sending their home measurements. When assigned to hospital admission, participants received care as usual on the ward until the postpartum period. The primary outcome was a composite of adverse perinatal outcomes assessed after delivery, including mortality; an Apgar score below 7 after 5 min or an umbilical arterial pH at birth below 7·05; maternal morbidity; admission of the newborn to the neonatal intensive care unit; and rate of caesarean section. The primary outcome was assessed in the intention-to-treat population. The non-inferiority margin for the primary outcome was a 10% absolute increase in composite primary endpoint based on baseline 20% incidence. The study was registered at the Dutch Trial Registration (NL5888) and is now closed to new participants. FINDINGS: From Dec 1, 2016, to Nov 30, 2019, 201 pregnant women were randomly assigned to an intervention procedure. 101 women were allocated to the telemonitoring group and 100 to the hospital admission group. One participant in the telemonitoring group withdrew consent before the intervention was initiated, and 100 participants were analysed for the primary outcome. In the hospital admission group, four participants did not receive the allocated intervention because they did not accept hospital admission. 100 participants in each group were analysed for the primary outcome according to the intention-to-treat principal. No participants were lost to follow-up. The primary outcome occurred in 31 (31%) of 100 participants in the telemonitoring group and in 40 (40%) of 100 participants in the hospital admission group. Adjusted for centre of inclusion, diagnosis, and nulliparity, the risk difference in primary outcome between both groups was 10·3% (95% CI -22·4 to 2·2) lower in the telemonitoring group, below the pre-defined non-inferiority margin of 10% absolute increase. A similar distribution for each of the individual components within the composite primary outcome was seen between groups. Five serious adverse events were reported: one neonatal death in the hospital admission group, in addition to one intra-uterine fetal death, two neonatal deaths, and one case of eclampsia in the telemonitoring group, all unrelated to the study. INTERPRETATION: This non-inferiority trial shows the first evidence that telemonitoring might be as safe as hospital admission for monitoring complicated pregnancies. FUNDING: Stichting Achmea Gezondheidszorg and ICT Healthcare Technology Solutions.

Long-term quality of life after obstetric intensive care unit admission: A cross-sectional cohort study.

OBJECTIVE: To assess the long-term quality of life (QoL) after obstetric Intensive Care Unit (ICU) admission. DESIGN: Cross-sectional survey study. SETTING: Tertiary care centre. POPULATION: Women admitted to the level 3 ICU during pregnancy or ≤6 weeks postpartum, between 2000 and 2015. METHODS: Quality of life measures were compared with the population reference values. Associations with baseline ICU parameters were assessed with multivariable linear regression. Patient-reported outcome and experience measures (PROMs/PREMs) were described. MAIN OUTCOME MEASURES: Quality of life according to the Linear Analogous Scale (LAS), the Satisfaction with Life Scale (SWLS) and the SF-36 questionnaire; PROMs/PREMs using the Pregnancy and Childbirth outcome set of the International Consortium for Health Outcomes Measurement. RESULTS: Of all 265 obstetric ICU admissions, 230 were eligible and 94 (41%) were included (median follow-up time 14 years). The LAS (75.7 versus 78.7, p = 0.077) and SWLS (25.2 versus 26, p = 0.176) sum scores were not different from the population reference values. The SF-36 subdomains bodily pain (55.3 versus 73.9), general health (58.2 versus 73.9) and vitality (56.9 versus 69.1) were lower than the reference values (all p < 0.001). PROMs/PREMs were low in 46.2% for pain, 15.1% for depression, 11.8% for satisfaction with care and 52.7% for healthcare responsiveness. An indirect obstetric ICU admission diagnosis was independently associated with a reduced physical health score (B -1.7, 95% confidence interval [CI] -3.4 to -0.1) and severe neonatal morbidity with a reduced mental health score (B -6.6, 95% CI -11.3 to -1.8). CONCLUSION: Obstetric ICU admission is associated with reductions in long-term physical health QoL and in some patients with mental health QoL. We suggest multidisciplinary rehabilitation and long-term psychosocial support.

Explaining the negative effects of patient participation in patient safety: an exploratory qualitative study in an academic tertiary healthcare centre in the Netherlands.

OBJECTIVE: Although previous studies largely emphasize the positive effects of patient participation in patient safety, negative effects have also been observed. This study focuses on bringing together the separate negative effects that have been previously reported in the literature. This study set out to uncover how these negative effects manifest themselves in practice within an obstetrics department. DESIGN: An exploratory qualitative interview study with 16 in-depth semistructured interviews. The information contained in the interviews was deductively analysed. SETTING: The study was conducted in one tertiary academic healthcare centre in the Netherlands. PARTICIPANTS: Patients (N=8) and professionals (N=8) from an obstetrics department. RESULTS: The results of this study indicate that patient participation in patient safety comes in five different forms. Linked to these different forms, four negative effects of patient participation in patient safety were identified. These can be summarised as follows: patients' confidence decreases, the patient-professional relationship can be negatively affected, more responsibility can be demanded of the patient than they wish to accept and the professional has to spend additional time on a patient. CONCLUSION: This study identifies and brings together four negative effects of patient participation in patient safety that have previously been individually identified elsewhere. In our interviews, there was a consensus among patients and professionals on five different forms of participation that would allow patients to positively participate in patient safety. Further studies should investigate ways to prevent and to mitigate the potential negative effects of patient participation.

Termination of pregnancy after a prenatal diagnosis of congenital diaphragmatic hernia: Factors influencing the parental decision process.

OBJECTIVE: To evaluate the incidence of termination of pregnancies (TOP) and factors associated with the decision for TOP in prenatally detected congenital diaphragmatic hernia (CDH). STUDY DESIGN: Single-centre retrospective cohort includes all prenatally detected CDH cases born between January 2009 and December 2021. Parental factors, such as parity, and fetal characteristics, such as disease severity, were collected. Descriptive statistics were used to present the data. Differences between terminated and continued pregnancies were analysed. RESULTS: The study population consisted of 278 prenatally detected CDH cases of which 80% detected <24 weeks of gestation. The TOP rate was 28% in cases that were detected <24 weeks of gestation. Twenty continued pregnancies resulted in either intrauterine fetal demise (n = 6), preterm birth <24 weeks (n = 2), or comfort care after birth (n = 12). The survival rate was 70% in the remaining 195 live born cases. Factors associated with the decision for TOP were additional fetal genetic or anatomical abnormalities (p < 0.0001) and expected severity of pulmonary hypoplasia in left-sided CDH (p = 0.0456). CONCLUSION: The decision to terminate a pregnancy complicated by fetal CDH depends on the severity of pulmonary hypoplasia and the presence of additional abnormalities. This emphasises the importance of early referral to expertise centres for detailed evaluation and multidisciplinary counselling.

Perinatal mortality and neonatal and maternal outcome per gestational week in term pregnancies: A registry-based study.

INTRODUCTION: Human pregnancy is considered term from 37+0/7 to 41+6/7 weeks. Within this range, both maternal, fetal and neonatal risks may vary considerably. This study investigates how gestational age per week is related to the components of perinatal mortality and parameters of adverse neonatal and maternal outcome at term. MATERIAL AND METHODS: A registry-based study was made of all singleton term pregnancies in the Netherlands from January 2014 to December 2017. Stillbirth and early neonatal mortality, as components of perinatal mortality, were defined as primary outcomes; adverse neonatal and maternal events as secondary outcomes. Neonatal adverse outcomes included birth trauma, 5-minute Apgar score ≤3, asphyxia, respiratory insufficiency, neonatal intensive care unit admission and composite neonatal outcome. Maternal adverse outcomes included instrumental vaginal birth, emergency cesarean section, obstetric anal sphincter injury, postpartum hemorrhage, hypertensive disorders of pregnancy and composite maternal outcome. The primary outcomes were evaluated by comparing weekly prospective risks of stillbirth and neonatal death using a fetuses-at-risk approach. Secondly, odds ratios (OR) for perinatal mortality, adverse neonatal and maternal outcome using a births-based approach were compared for each gestational week with all births occurring after that week. RESULTS: Data of 581 443 births were analyzed. At 37, 38, 39, 40, 41 and 42 weeks, the respective weekly prospective risks of stillbirth were 0.015%, 0.022%, 0.031%, 0.036%, 0.069% and 0.081%; the respective weekly prospective risks of early neonatal death were 0.051%, 0.047%, 0.032%, 0.031%, 0.039% and 0.035%. The OR for adverse neonatal outcomes were the lowest at 39 and 40 weeks. The OR for adverse maternal outcomes, including operative birth, continuously increased with each gestational week. CONCLUSIONS: The prospective risk of early neonatal death for babies born at 39 weeks is lower than the risk of stillbirth in pregnancies continuing beyond 39+6/7 weeks. Birth at 39 weeks was associated with the best combined neonatal and maternal outcome, fewer operative births and fewer maternal and neonatal adverse outcomes compared with pregnancies continuing beyond 39 weeks. This information with appropriate perspectives should be included when counseling term pregnant women.

A web-based decision aid for shared decision making in pelvic organ prolapse: the SHADE-POP trial.

INTRODUCTION AND HYPOTHESIS: Among women worldwide, pelvic organ prolapse (POP) is a common problem. There are three different treatment options for POP: pelvic floor muscle therapy, pessary treatment and prolapse surgery. As none of the three treatment options is clearly superior, shared decision making (SDM) is very important. A decision aid (DA) is known to facilitate patient participation and SDM. We hypothesise that the use of a web-based DA for POP increases patients' satisfaction with information and care and reduces decisional conflict. METHODS: This two-arm, multicentre, cluster randomised controlled trial was performed in women with POP in five different Dutch hospitals. The control group received usual care (UC) and the intervention group received the DA in addition to UC. Primary outcome measures were satisfaction with treatment decision making and satisfaction with information. Analyses were performed using independent sample t tests, Chi-squared tests, and multilevel linear regression analyses. RESULTS: Between the DA group (n=40) and the UC group (n=56) no differences were found concerning patients' satisfaction with information, with scores of 45.63 and 46.14 out of 50 respectively (p=0.67). Also, no differences were found concerning the perceived role in decision making, as patients scored 46.83 in the DA group and 46.41 in the UC group, out of a maximum of 54 (n=0.81). CONCLUSIONS: No differences were found concerning patients' satisfaction with information and treatment decision making between the DA and UC. However, both groups scored high on the questionnaires, which suggests that the decision process is already of high quality.