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.

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.

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.

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.

A prospective population-based multicentre study on the impact of maternal body mass index on adverse pregnancy outcomes: Focus on normal weight.

BACKGROUND: Maternal body mass index (BMI) below or above the reference interval (18.5-24.9 kg/m2) is associated with adverse pregnancy outcomes. Whether BMI exerts an effect within the reference interval is unclear. Therefore, we assessed the association between adverse pregnancy outcomes and BMI, in particular within the reference interval, in a general unselected pregnant population. METHODS: Data was extracted from a prospective population-based multicentre cohort (Risk Estimation for PrEgnancy Complications to provide Tailored care (RESPECT) study) conducted between December 2012 to January 2014. BMI was studied in categories (I: <18.5, II: 18.5-19.9, III: 20.0-22.9, IV: 23.0-24.9, V: 25.0-27.4, VI: 27.5-29.9, VII: >30.0 kg/m2) and as a continuous variable within the reference interval. Adverse pregnancy outcomes were defined as composite endpoints for maternal, neonatal or any pregnancy complication, and for adverse pregnancy outcomes individually. Linear trends were assessed using linear-by-linear association analysis and (adjusted) relative risks by regression analysis. RESULTS: The median BMI of the 3671 included women was 23.2 kg/m2 (IQR 21.1-26.2). Adverse pregnancy outcomes were reported in 1256 (34.2%). Linear associations were observed between BMI categories and all three composite endpoints, and individually for pregnancy-induced hypertension (PIH), preeclampsia, gestational diabetes mellitus (GDM), large-for-gestational-age (LGA) neonates; but not for small-for-gestational-age neonates and preterm birth. Within the reference interval, BMI was associated with the composite maternal endpoint, PIH, GDM and LGA, with adjusted relative risks of 1.15 (95%CI 1.06-1.26), 1.12 (95%CI 1.00-1.26), 1.31 (95%CI 1.11-1.55) and 1.09 (95%CI 1.01-1.17). CONCLUSIONS: Graded increase in maternal BMI appears to be an indicator of risk for adverse pregnancy outcomes even among women with a BMI within the reference interval. The extent to which BMI directly contributes to the increased risk in this group should be evaluated in order to determine strategies most valuable for promoting safety and long-term health for mothers and their offspring.

Associations between periconceptional lifestyle behaviours and adverse pregnancy outcomes.

BACKGROUND: While the potential adverse outcomes of prenatal exposure to unhealthy lifestyle are widely evidenced, little is known about these exposures in the periconception period. We investigated the associations between lifestyle behaviours and adverse pregnancy outcomes with a unique distinction between preconceptional- and prenatal lifestyle behaviours. METHODS: A secondary analysis took place within a prospective multicentre cohort study in the Netherlands, including 3,684 pregnant women. Baseline characteristics and preconceptional and first trimester lifestyle behaviours were assessed through a self-administered questionnaire in the first trimester. Adverse pregnancy outcomes (hypertensive disorders in pregnancy (HDP), small for gestational age (SGA), gestational diabetes (GDM) and spontaneous preterm birth (sPTB)) were reported by healthcare professionals. Data were collected between 2012 and 2014 and analysed using multivariate logistic regression. RESULTS: Women who are overweight, and especially obese, have the highest odds of developing any adverse pregnancy outcome (adjusted odds ratio (aOR) 1.61 (95 % Confidence Interval (CI) 1.31-1.99) and aOR 2.85 (95 %CI 2.20-3.68), respectively), particularly HDP and GDM. Women who prenatally continued smoking attained higher odds for SGA (aOR 1.91 (95 %CI 1.05-1.15)) compared to the reference group, but these odds decreased when women prenatally quit smoking (aOR 1.14 (95 %CI 0.59-2.21)). Women who did not use folic acid supplements tended to have a higher odds of developing adverse pregnancy outcomes (aOR 1.28 (95 %CI 0.97-1.69)), while women who prenatally started folic acid supplements did not (aOR 1.01 (95 %CI 0.82-1.25)). CONCLUSIONS: Our results indicate that smoking cessation, having a normal body mass index (BMI) and initiating folic acid supplements preconceptionally may decrease the risk of adverse pregnancy outcomes. Therefore, intervening as early as the preconception period could benefit the health of future generations.

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.

External validation of prognostic models for preeclampsia in a Dutch multicenter prospective cohort.

OBJECTIVE: To perform an external validation of all published prognostic models for first-trimester prediction of the risk of developing preeclampsia (PE). METHODS: Women <14 weeks of pregnancy were recruited in the Netherlands. All systematically identified prognostic models for PE that contained predictors commonly available were eligible for external validation. RESULTS: 3,736 women were included; 87 (2.3%) developed PE. Calibration was poor due to overestimation. Discrimination of 9 models for LO-PE ranged from 0.58 to 0.71 and of 9 models for all PE from 0.55 to 0.75. CONCLUSION: Only a few easily applicable prognostic models for all PE showed discrimination above 0.70, which is considered an acceptable performance.

Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal.

BACKGROUND: Value-based health care aims to optimize the balance of patient outcomes and health care costs. To improve value in perinatal care using this strategy, standard outcomes must first be defined. The objective of this work was to define a minimum, internationally appropriate set of outcome measures for evaluating and improving perinatal care with a focus on outcomes that matter to women and their families. METHODS: An interdisciplinary and international Working Group was assembled. Existing literature and current measurement initiatives were reviewed. Serial guided discussions and validation surveys provided consumer input. A series of nine teleconferences, incorporating a modified Delphi process, were held to reach consensus on the proposed Standard Set. RESULTS: The Working Group selected 24 outcome measures to evaluate care during pregnancy and up to 6 months postpartum. These include clinical outcomes such as maternal and neonatal mortality and morbidity, stillbirth, preterm birth, birth injury and patient-reported outcome measures (PROMs) that assess health-related quality of life (HRQoL), mental health, mother-infant bonding, confidence and success with breastfeeding, incontinence, and satisfaction with care and birth experience. To support analysis of these outcome measures, pertinent baseline characteristics and risk factor metrics were also defined. CONCLUSIONS: We propose a set of outcome measures for evaluating the care that women and infants receive during pregnancy and the postpartum period. While validation and refinement via pilot implementation projects are needed, we view this as an important initial step towards value-based improvements in care.

Neonatal Hypoglycemia Following Diet-Controlled and Insulin-Treated Gestational Diabetes Mellitus.

OBJECTIVE: To assess the risk of neonatal hypoglycemia following diet-controlled and insulin-treated gestational diabetes mellitus (GDM) and how it relates to birth weight. RESEARCH DESIGN AND METHODS: Prospective cohort study included term neonates born after GDM from January 2013 through December 2015 at the University Medical Center Utrecht (Utrecht, the Netherlands). Routine screening of neonatal blood glucose levels was performed at 1, 3, 6, 12, and 24 h after birth. Main outcome measures were neonatal hypoglycemia defined as blood glucose ≤36 mg/dL (severe) and ≤47 mg/dL (mild). RESULTS: A total of 506 neonates were included, born after pregnancies complicated by GDM treated either with insulin (22.5%) or without insulin (77.5%). The incidence of mild and severe hypoglycemia was similar in the insulin-treated and diet-controlled groups (33 vs. 35%, P = 0.66; and 20 vs. 21%, P = 0.79). A birth weight >90th centile was seen in 17.2% of all infants. Although children with a birth weight >90th centile had the highest risk for hypoglycemia, the vast majority of hypoglycemia (78.6%) was detected in those with a birth weight <90th centile. Over 95% of all hypoglycemia occurred within 12 h after birth. CONCLUSIONS: Routine screening for neonatal hypoglycemia following pregnancies complicated by GDM reveals high incidence of both mild and severe hypoglycemia for both diet-controlled and insulin-treated GDM and across the full range of birth weight centiles. We propose routine blood glucose screening for neonatal hypoglycemia within the first 12 h of life in all neonates after GDM, irrespective of maternal insulin use or birth weight.

Increased rates of complications in singleton pregnancies of women previously diagnosed with polycystic ovary syndrome predominantly in the hyperandrogenic phenotype.

OBJECTIVE: To study the presence of several maternal and neonatal complications in a cohort of women with hyperandrogenic as well as normoandrogenic polycystic ovary syndrome (PCOS) and women with PCOS who received different fertility treatments. DESIGN: Prospective multicenter cohort study. SETTING: Hospitals and midwifery practices. PATIENT(S): One hundred and eighty-eight women with PCOS and singleton pregnancies (study group) and 2,889 women with a naturally conceived singleton pregnancy (reference group). INTERVENTION(S): Observational study. MAIN OUTCOME MEASURE(S): Maternal and neonatal pregnancy complications. RESULT(S): Women with PCOS had a statistically significantly increased risk of developing gestational diabetes (adjusted odds ratio [AOR] 4.15; 95% confidence interval [CI], 2.07-8.33) compared with the reference group, and their infants were more often born small for gestational age (AOR 3.76; 95% CI, 1.69-8.35). In a subgroup analysis, maternal complications were statistically significantly more often present in women with hyperandrogenic (defined as a free androgen index >4.5) PCOS (n = 76; 40% of all PCOS women) compared with those with normoandrogenic PCOS (n = 97; 52% of all PCOS women) (45% vs. 24%; P=.003); no statistically significant differences were observed between these groups regarding neonatal complications. CONCLUSION(S): Women with PCOS have an increased risk of maternal and neonatal pregnancy complications, especially women with the hyperandrogenic phenotype. CLINICAL TRIAL REGISTRATION NUMBER: NCT00821379.

Perspectives, preferences and needs regarding early prediction of preeclampsia in Dutch pregnant women: a qualitative study.

BACKGROUND: To improve early risk-identification in pregnancy, research on prediction models for common pregnancy complications is ongoing. Therefore, it was the aim of this study to explore pregnant women's perceptions, preferences and needs regarding prediction models for first trimester screening for common pregnancy complications, such as preeclampsia, to support future implementation. METHOD: Ten focus groups (of which five with primiparous and five with multiparous women) were conducted (n = 45). Six focus groups were conducted in urban regions and four in rural regions. All focus group discussions were audio taped and NVIVO was used in order to facilitate the thematic analysis conducted by the researchers. RESULTS: Women in this study had a positive attitude towards first trimester screening for preeclampsia using prediction models. Reassurance when determined as low-risk was a major need for using the test. Self-monitoring, early recognition and intensive monitoring were considered benefits of using prediction models in case of a high-risk. Women acknowledged that high-risk determination could cause (unnecessary) anxiety, but it was expected that personal and professional interventions would level out this anxiety. CONCLUSION: Women in this study had positive attitudes towards preeclampsia screening. Self-monitoring, together with increased alertness of healthcare professionals, would enable them to take active actions to improve pregnancy outcomes. This attitude enhances the opportunities for prevention, early recognition and treatment of preeclampsia and probably other adverse pregnancy outcomes.

Prediction models for the risk of gestational diabetes: a systematic review.

BACKGROUND: Numerous prediction models for gestational diabetes mellitus (GDM) have been developed, but their methodological quality is unknown. The objective is to systematically review all studies describing first-trimester prediction models for GDM and to assess their methodological quality. METHODS: MEDLINE and EMBASE were searched until December 2014. Key words for GDM, first trimester of pregnancy, and prediction modeling studies were combined. Prediction models for GDM performed up to 14 weeks of gestation that only include routinely measured predictors were eligible.Data was extracted by the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS). Data on risk predictors and performance measures were also extracted. Each study was scored for risk of bias. RESULTS: Our search yielded 7761 articles, of which 17 were eligible for review (14 development studies and 3 external validation studies). The definition and prevalence of GDM varied widely across studies. Maternal age and body mass index were the most common predictors. Discrimination was acceptable for all studies. Calibration was reported for four studies. Risk of bias for participant selection, predictor assessment, and outcome assessment was low in general. Moderate to high risk of bias was seen for the number of events, attrition, and analysis. CONCLUSIONS: Most studies showed moderate to low methodological quality, and few prediction models for GDM have been externally validated. External validation is recommended to enhance generalizability and assess their true value in clinical practice.

Absolute first trimester cell-free DNA levels and their associations with adverse pregnancy outcomes.

OBJECTIVE: To study associations of first trimester cell-free fetal DNA levels (in this paper referred to as cell-free placental DNA (cfpDNA) levels) and preeclampsia (PE), pregnancy-induced hypertension (PIH), gestational diabetes (GDM) and spontaneous preterm birth (sPB). METHOD: A nested case-control study was conducted in first trimester samples (gestational age 8+0 -13+6 weeks). A total of 226 cases and 301 controls were included. CfpDNA levels were quantified in male-bearing pregnancies using real-time DYS14-PCRs on DNA isolated from maternal serum. CfpDNA multiples of the median (MoMs) were calculated based on associations with patient characteristics (body mass index, parity, ethnicity and smoking). Associations between MoMs and adverse outcomes were studied. RESULTS: Cell-free placental DNA levels were negatively associated with body mass index (ß = -0.297, p < 0.001) and smoking (ß = -0.163, p = 0.006). MoMs were lower in women who later developed PIH (n = 84, p = 0.009) or GDM (n = 56, p = 0.037). There was no association between cfpDNA MoMs and PE (n = 37, p = 0.15) or sPB (n = 49, p = 0.19). CfpDNA was positively correlated with pregnancy-associated plasma protein A (r = 0.426, p < 0.001) but not with placental growth factor (r = 0.059, p = 0.179). CONCLUSION: Adjusted first trimester cfpDNA levels are associated with PIH and GDM but probably not with PE or sPB. © 2016 John Wiley & Sons, Ltd.

External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort: prospective multicentre cohort study.

OBJECTIVE:  To perform an external validation and direct comparison of published prognostic models for early prediction of the risk of gestational diabetes mellitus, including predictors applicable in the first trimester of pregnancy. DESIGN:  External validation of all published prognostic models in large scale, prospective, multicentre cohort study. SETTING:  31 independent midwifery practices and six hospitals in the Netherlands. PARTICIPANTS:  Women recruited in their first trimester (<14 weeks) of pregnancy between December 2012 and January 2014, at their initial prenatal visit. Women with pre-existing diabetes mellitus of any type were excluded. MAIN OUTCOME MEASURES:  Discrimination of the prognostic models was assessed by the C statistic, and calibration assessed by calibration plots. RESULTS:  3723 women were included for analysis, of whom 181 (4.9%) developed gestational diabetes mellitus in pregnancy. 12 prognostic models for the disorder could be validated in the cohort. C statistics ranged from 0.67 to 0.78. Calibration plots showed that eight of the 12 models were well calibrated. The four models with the highest C statistics included almost all of the following predictors: maternal age, maternal body mass index, history of gestational diabetes mellitus, ethnicity, and family history of diabetes. Prognostic models had a similar performance in a subgroup of nulliparous women only. Decision curve analysis showed that the use of these four models always had a positive net benefit. CONCLUSIONS:  In this external validation study, most of the published prognostic models for gestational diabetes mellitus show acceptable discrimination and calibration. The four models with the highest discriminative abilities in this study cohort, which also perform well in a subgroup of nulliparous women, are easy models to apply in clinical practice and therefore deserve further evaluation regarding their clinical impact.