Risk-guided maternity care to enhance maternal empowerment postpartum: A cluster randomized controlled trial

Objective To investigate whether a structured inquiry during pregnancy of medical factors and social factors associated with low socioeconomic status, and subsequent patient-centred maternity care could increase maternal empowerment. Design Cluster-randomised controlled trial. Setting This study was conducted among pregnant women in selected urban areas in the Netherlands. This study was part of the nationwide Healthy Pregnancy 4 All-2 programme. Population Pregnant women listed at one of the sixteen participating maternity care organisations between July 1, 2015, and Dec 31, 2016. Methods All practices were instructed to provide a systematic risk assessment during pregnancy. Practices were randomly allocated to continue usual care (seven practices), or to provide a patient-centred, risk-guided approach to addressing any risks (nine practices) identified via the risk assessment during pregnancy. Results We recruited 1579 participants; 879 participants in the intervention arm, and 700 participants in the control arm. The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively. In our intention-to-treat analysis, the intervention resulted in a significant reduction in the odds of having a low empowerment score [i.e. the primary outcome; adjusted OR 0.69 ((95% CI 0.47; 0.99), P 0.046)]. Conclusions Implementation of addition

Geographical differences in perinatal health and child welfare in the Netherlands: Rationale for the healthy pregnancy 4 all-2 program

Background: Geographical inequalities in perinatal health and child welfare require attention. To improve the identification, and care, of mothers and young children at risk of adverse health outcomes, the HP4All-2 program was developed. The program consists of three studies, focusing on creating a continuum for risk selection and tailored care pathways from preconception and antenatal care towards 1) postpart

Exploring the applicability of the pregnancy and childbirth outcome set: A mixed methods study

Objective: The International Consortium for Health Outcomes Measurement developed the Pregnancy and Childbirth (PCB) outcome set to improve value-based perinatal care. This set contains clinician-reported outcomes and patient-reported outcomes. We validated the set for use in the Netherlands by exploring its applicability among all end-users prior to implementation. Methods: A mixed-methods design was applied. A survey was performed to assess patients (n = 142), professionals (n = 134) and administrators (n = 35) views on the PCB set. To further explore applicability, separate focus groups were held with representatives of each of these groups. Results: The majority of survey participants agreed that the PCB set contains the most important outcomes. Patient-reported experience measures were considered relevant by the majority of participants. Perceived relevance of patient-reported outcome measures varied. Main themes from the focus groups were content of the set, data collection timing, implementation (also IT and transparency), and quality-based governance. Conclusion: This study supports suitability of the PCB outcome set for implementation, evaluation of quality of care and shared decision making in perinatal care. Practice Implications: Implementation of the PCB set may change existing care pathways of perinatal care. Focus on transparency of outcomes is required in order to achieve quality-based governance with proper IT solutions

A feasibility study of implementing a patient-centered outcome set for pregnancy and childbirth.

Background and Aims: Patient-reported outcome and experience measures (PROM and PREM) can facilitate shared decision making and hold potential to improve healthcare quality. However, their adoption in perinatal care is still limited. The International Consortium for Health Outcomes Measurement (ICHOM) developed a Pregnancy and Childbirth (PCB) outcome set, including PROM and PREM questionnaires. We studied the feasibility to use these PROMs/PREMs in Dutch perinatal care, addressing both women's and professionals' perspective. Methods: Patients and professionals in primary and hospital care participated. Women under care at one of five timepoints for PROM/PREM collection of the PCB set (2 during pregnancy, 3 postpartum) were e-mailed a questionnaire and discussed their answers with their obstetric professional the next regular visit. Compliance was recorded. After discussing the PROMs/PREMs, usability and experience were assessed with separate surveys amongst women and professionals. Results: Of 26 women approached, 21 completed and discussed their PROM/PREM questionnaire. Mean questionnaire completion rate was 97%. Average reported time completing the questionnaires was 10 minutes; most women (90%) stated this was acceptable. Women preferred completing questionnaires digitally and discuss their answers with an obstetric professional rather than other care professionals, also 6 months postpartum. Over half of women agreed PROMs/PREMs supported shared decision making (58%), ability to raise issues (60%), and patient-clinician relationship (52%). Six professionals participated: two obstetricians, two clinical midwives, and two community midwives. Most professionals experienced sufficient time to discuss the responses, except at 6 months postpartum. They knew what items to discuss but did not always feel responsible to act upon them. Professionals agreed PROMs/PREMs supported symptom detection and personalized care. Conclusions: Patients and obstetric professionals consider the PCB set a feasible instrument for PROM/PREM assessment, with good compliance, acceptability and usability. Important determinants of successful implementation are a well-equipped ICT-tool, agreements regarding professionals' responsibilities and how outcomes are discussed or acted upon.status: Published onlin

Risk-guided maternity care to enhance maternal empowerment postpartum: A cluster randomized controlled trial

ObjectiveTo investigate whether a structured inquiry during pregnancy of medical factors and social factors associated with low socioeconomic status, and subsequent patient-centred maternity care could increase maternal empowerment.DesignCluster-randomised controlled trial.SettingThis study was conducted among pregnant women in selected urban areas in the Netherlands. This study was part of the nationwide Healthy Pregnancy 4 All-2 programme.PopulationPregnant women listed at one of the sixteen participating maternity care organisations between July 1, 2015, and Dec 31, 2016.MethodsAll practices were instructed to provide a systematic risk assessment during pregnancy. Practices were randomly allocated to continue usual care (seven practices), or to provide a patient-centred, risk-guided approach to addressing any risks (nine practices) identified via the risk assessment during pregnancy.Main outcome measuresLow postpartum maternal empowerment score.ResultsWe recruited 1579 participants; 879 participants in the intervention arm, and 700 participants in the control arm. The prevalence of one or more risk factors during pregnancy was similar between the two arms: 40% and 39%, respectively. In our intention-to-treat analysis, the intervention resulted in a significant reduction in the odds of having a low empowerment score [i.e. the primary outcome; adjusted OR 0.69 ((95% CI 0.47; 0.99), P 0.046)].ConclusionsImplementation of additional risk assessment addressing both medical and social factors and subsequent tailored preventive strategies into maternity care reduced the incidence of low maternal empowerment during the postpartum period. Introducing this approach in routine maternity care may help reduce early adversity during the postpartum period

Periconceptional maternal social, lifestyle and medical risk factors impair embryonic growth: The Rotterdam Periconceptional Cohort

Research question: What is the association between the degree of a state of maternal vulnerability, determined by suboptimal periconceptional social, lifestyle and medical exposures and embryonic growth? Design: In total, 555 pregnancies, comprising 324 naturally conceived pregnancies and 231 pregnancies conceived after IVF and intracytoplasmic sperm injection (ICSI) were included from the Rotterdam Periconceptional Cohort (Predict Study) between November 2010 and August 2018. Data on periconceptional social, lifestyle and medical exposures, i.e. vulnerability markers, were collected through self-administered questionnaires. To estimate embryonic growth, crown–rump length (CRL) and embryonic volume measurements were taken at 7, 9 and 11 weeks of gestation using three-dimensional ultrasound scans and virtual reality techniques. Results: Exposure to two or more vulnerability markers was negatively associated with embryonic growth in naturally conceived pregnancies. The CRL and embryonic volume trajectories of embryos of women exposed to two vulnerability markers were reduced compared with those of women exposed to zero or one vulnerability marker (√CRL: β = –0.29 mm, 95% CI –0.56 to –0.02; 3√EV: β = –0.14 cm3, 95% CI –0.27 to –0.01). These associations were not found in pregnancies conceived after IVF or ICSI. Conclusions: This study showed that a higher degree of the periconceptional state of maternal vulnerability is associated with reduced embryonic growth (CRL and embryonic volume) in naturally conceived pregnancies

Patient-Reported Outcome and Experience Measures in Perinatal Care to Guide Clinical Practice: Prospective Observational Study

Background: The International Consortium for Health Outcomes Measurement has published a set of patient-centered outcome measures for pregnancy and childbirth (PCB set), including patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). To establish value-based pregnancy and childbirth care, the PCB set was implemented in the Netherlands, using the outcomes on the patient level for shared decision-making and on an aggregated level for quality improvement. Objective: This study aims to report first outcomes, experiences, and practice insights of implementing the PCB set in clinical practice. Methods: In total, 7 obstetric care networks across the Netherlands, each consisting of 1 or 2 hospitals and multiple community midwifery practices (ranging in number from 2 to 18), implemented the PROM and PREM domains of the PCB set as part of clinical routine. This observational study included all women participating in the clinical project. PROMs and PREMs were assessed with questionnaires at 5 time points: 2 during pregnancy and 3 post partum. Clinical threshold values (alerts) supported care professionals interpreting the answers, indicating possibly alarming outcomes per domain. Data collection took place from February 2020 to September 2021. Data analysis included missing (pattern) analysis, sum scores, alert rates, and sensitivity analysis. Results: In total, 1923 questionnaires were collected across the 5 time points: 816 (42.43%) at T1 (first trimester), 793 (41.23%) at T2 (early third trimester), 125 (6.5%) at T3 (maternity week), 170 (8.84%) at T4 (6 weeks post partum), and 19 (1%) at T5 (6 months post partum). Of these, 84% (1615/1923) were filled out completely. Missing items per domain ranged from 0% to 13%, with the highest missing rates for depression, pain with intercourse, and experience with pain relief at birth. No notable missing patterns were found. For the PROM domains, relatively high alert rates were found both in pregnancy and post partum for incontinence (469/1798, 26.08%), pain with intercourse (229/1005, 22.79%), breastfeeding self-efficacy (175/765, 22.88%), and mother-child bonding (122/288, 42.36%). Regarding the PREM domains, the highest alert rates were found for birth experience (37/170, 21.76%), shared decision-making (101/982, 10.29%), and discussing pain relief ante partum (310/793, 39.09%). Some domains showed very little clinical variation; for example, role of the mother and satisfaction with care. Conclusions: The PCB set is a useful tool to assess patient-reported outcomes and experiences that need to be addressed over the whole course of pregnancy and childbirth. Our results provide opportunities to improve and personalize perinatal care. Furthermore, we could propose several recommendations regarding methods and timeline of measurements based on our findings. This study supports the implementation of the PCB set in clinical practice, thereby advancing the transformation toward patient-centered, value-based health care for pregnancy and childbirth

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

Evolution of ibrutinib resistance in chronic lymphocytic leukemia (CLL)

The Bruton tyrosine kinase inhibitor (BTKi) ibrutinib is a new targeted therapy for patients with chronic lymphocytic leukemia (CLL). Ibrutinib is given orally on a continuous schedule and induces durable remissions in the majority of CLL patients. However, a small proportion of patients initially responds to the BTKi and then develops resistance. Estimating the frequency, timing, and individual risk of developing resistance to ibrutinib, therefore, would be valuable for long-term management of patients. Computational evolutionary models, based on measured kinetic parameters of patients, allow us to approach these questions and to develop a roadmap for personalized prognosis and treatment management. Our kinetic models predict that BTKi-resistant mutants exist before initiation of ibrutinib therapy, although they only comprise a minority of the overall tumor burden. Furthermore, we can estimate the time required for resistant cells to grow to detectable levels. We predict that this can be highly variable, depending mostly on growth and death rates of the individual CLL cell clone. For a specific patient, this time can be predicted with a high degree of certainty. Our model can thus be used to predict for how long ibrutinib can suppress the disease in individual patients. Furthermore, the model can suggest whether prior debulking of the tumor with chemo-immunotherapy can prolong progression-free survival under ibrutinib. Finally, by applying the models to data that document progression during ibrutinib therapy, we estimated that resistant mutants might have a small ( > 2%) mean fitness advantage in the absence of treatment, compared with sensitive cells

Geographical differences in perinatal health and child welfare in the Netherlands: rationale for the healthy pregnancy 4 all-2 program

Background: Geographical inequalities in perinatal health and child welfare require attention. To improve the identification, and care, of mothers and young children at risk of adverse health outcomes, the HP4All-2 program was developed. The program consists of three studies, focusing on creating a continuum for risk selection and tailored care pathways from preconception and antenatal care towards 1) postpartum care, 2) early childhood care, as well as 3) interconception care. The program has been implemented in ten municipalities in the Netherlands, aiming to target communities with a relatively disadvantageous position with regard to perinatal and child health outcomes. To delineate the position of the ten participating municipalities, we present municipal and regional differences in the prevalence of perinatal mortality, perinatal morbidity, children living in deprived neighbourhoods, and children living in families on welfare.Methods: Data on all singleton births in the Netherlands between 2009 and 2014 were analysed for the prevalence of perinatal mortality and morbidity. In addition, national data on children living in deprived neighbourhoods and children living in families on welfare between 2009 and 2012 were analysed. The prevalence of these outcomes were calculated and ranked for 62 geographical areas, the 50 largest municipalities and the 12 provinces, to determine the position of the municipalities that participate in HP4All-2.Results: Considerable geographical differences were present for all four outcomes. The municipalities that participate in HP4All-2 are among the 25 municipalities with the highest prevalence of perinatal mortality, perinatal morbidity, children living in deprived neighbourhoods, or children in families on welfare.Conclusion: This study illustrates geographical differences in perinatal health and/or child welfare outcomes and demonstrates that the HP4All-2 program targets municipalities with a relative unfavourable position. By targeting these municipalities, the program is expected to contribute most to improving the care for young children and their mothers at risk, and hence to reducing their risks and health inequalities