Implementation and Evaluation of a Breast Cancer Disease Model Using Real-World Claims Data in Germany from 2010 to 2020.

Breast cancer is the leading cause of cancer-related mortality among women in Germany and worldwide. This retrospective claims data analysis utilizing data from AOK Baden-Wuerttemberg, a major statutory German health insurance provider, aimed to construct and assess a real-world data breast cancer disease model. The study included 27,869 female breast cancer patients and 55,738 age-matched controls, analyzing data from 2010 to 2020. Three distinct breast cancer stages were analyzed: Stage A (early breast cancer without lymph node involvement), Stage B (early breast cancer with lymph node involvement), and Stage C (primary distant metastatic breast cancer). Tumor subtypes were estimated based on the prescription of antihormonal or HER2-targeted therapy. The study established that 77.9% of patients had HR+ breast cancer and 9.8% HER2+; HR+/HER2- was the most common subtype (70.9%). Overall survival (OS) analysis demonstrated significantly lower survival rates for stages B and C than for controls, with 5-year OS rates ranging from 79.3% for stage B to 35.4% for stage C. OS rates were further stratified by tumor subtype and stage, revealing varying prognoses. Distant recurrence-free survival (DRFS) analysis showed higher recurrence rates in stage B than in stage A, with HR-/HER2- displaying the worst DRFS. This study, the first to model breast cancer subtypes, stages, and outcomes using German claims data, provides valuable insights into real-world breast cancer epidemiology and demonstrates that this breast cancer disease model has the potential to be representative of treatment outcomes.

The role of perinatal maternal symptoms of depression, anxiety and pregnancy-specific anxiety for infant's self-regulation: A prospective longitudinal study.

BACKGROUND: Maternal symptoms of anxiety and depression are highly prevalent during pregnancy and postpartum and have the potential to impact fetal development and offspring behavior. However, research on the effects of fetal exposure to maternal subclinical affective symptoms on infant self-regulation is still lacking. Self-regulation provides a fundamental precondition for healthy development and overall life success whereas dysfunctional self-regulation can lead to behavioral problems, poor academic achievement, social rejection, and physical/mental disorders. During pregnancy and infancy, children largely depend upon their mothers in order to successfully regulate their internal states. Given the high prevalence of mothers suffering from anxiety and depressive symptoms during pregnancy and after childbirth, the aim of the present study is to explore how maternal affective symptoms change during the pre- and postnatal period, and how measures obtained in pregnancy and beyond impact self-regulation in infants, as indicated by crying-, sleeping-, and/or feeding problems. METHODS: This prospective longitudinal study investigates the effects of maternal symptoms of depression, anxiety, and pregnancy-specific anxiety on infant's self-regulation in N = 225 mother-infant dyads. Maternal affective symptoms were examined at five prenatal and three postnatal time-points using the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory (STAI) and the Pregnancy Related Anxiety Questionnaire Revised (PRAQ-R2). Infant's self-regulation was assessed twice - at the age of three and six months - using the Crying Feeding Sleeping Scale (SFS). RESULTS: Maternal pregnancy-specific anxiety was the most significant predictor for infant self-regulatory problems. It predicted crying-, sleeping, and feeding problems and explained up to 18 % of the variance. Even when controlling for maternal postpartum affective symptoms, pregnancy-specific anxiety remained a significant predictor for infant self-regulation problems. LIMITATIONS: Rather homogenous sample (high socioeconomic status). Data based on maternal reports of infant behavior. CONCLUSIONS: Our results suggest that fetal exposure to maternal affective symptoms - specifically pregnancy-related anxiety - plays a substantial role in the development of infant self-regulation problems, potentially mediated by epigenetic modifications. Importantly, even though maternal symptoms of depression and anxiety only reached subclinical levels, they were predictive for infant crying-, sleeping-, and feeding problems. Our findings underline the importance of early prevention and clearly tailored interventions during pregnancy and postpartum to prevent adverse outcome for mother, child and family.

Intranasal Lidocaine Administration via Mucosal Atomization Device: A Simple and Successful Treatment for Postdural Puncture Headache in Obstetric Patients.

(1) Background: Postdural puncture headache (PDPH) remains a serious complication in obstetric patients. While the epidural blood patch represents the current gold standard in therapy, a growing number of alternative measures are thought to be beneficial for clinical management. The purpose of this study was to retrospectively analyze the efficacy of intranasal lidocaine administration to treat PDPH in obstetrics at our university hospital; (2) Methods: A retrospective analysis of the medical records of patients with PDPH has been performed focusing on the techniques of administration, dosing, treatment duration, impact on pain intensity as well as side effects of intranasal lidocaine; (3) Results: During the study period, 5610 obstetric patients received neuraxial anesthesia, of whom 43 (0.77%) developed PDPH. About one third of the patients with PDPH after spinal anesthesia (n = 8), epidural anesthesia (n = 5) or both (n = 2) were treated with intranasal lidocaine. Lidocaine was administered either via gauze compresses (GC, n = 4), a mucosal atomization device (MAD, n = 8) or with a second-line mucosal atomization device due to low gauze compress efficacy (n = 3). All patients treated with lidocaine refused the epidural blood patch. Nebulization of lidocaine resulted in a significant reduction in pain intensity after the first dose (p = 0.008). No relevant side effects developed except sporadic temporal pharyngeal numbness. The utilization of the mucosal atomization device averted the necessity for an epidural blood patch, whether employed as the primary or secondary approach; (4) Conclusions: Our data imply that the mucosal atomization device enhances the efficacy of intranasal lidocaine administration in obstetric patients suffering from PDPH.

Using an Electronic Mindfulness-based Intervention (eMBI) to improve maternal mental health during pregnancy: Results from a randomized controlled trial.

Prevalence rates of peripartum depression and anxiety are high and correlate with adverse maternal and neonatal outcomes. Mindfulness-based interventions (MBI) have been shown to reduce mental distress during pregnancy. A multicenter, randomized controlled study was conducted after screening for depressive symptoms. The intervention group (IG) was given access to an 8-week supervised eMBI between weeks 29 and 36 of pregnancy and followed up to 5 months postpartum. Psychometric data were collected using the Edinburgh Postnatal Depression Scale (EPDS), the State-Trait Anxiety Inventory (STAI), the Pregnancy-Related Anxiety Questionnaire (PRAQ-R), the Freiburg Mindfulness Inventory (FMI-14) as well as the Patient Health Questionnaire (PHQ). Out of 5299 pregnant women, 1153 scored >9 on the EPDS and N = 460 were included in the RCT. No significant interaction effects for depressive symptoms and anxiety were found. Pregnancy- and birth-related anxiety decreased significantly in the IG and 6 weeks after birth, the rate of women at risk for adverse mental outcome was significantly lower compared to the CG. Mindfulness scores improved significantly in the IG. The eMBI program did not show effective regarding general depressive or anxiety symptoms, however, positive results were demonstrated regarding pregnancy and birth-related anxiety and the prevention of postpartum depression.

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 2 with Recommendations for Surgical Termination of Pregnancy and Follow-up Care After Termination of Pregnancy.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, counselling of affected persons, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for an S2k-guideline, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations The guideline provides recommendations on the surgical termination of pregnancy and follow-up care after termination of pregnancy.

Abortion in the First Trimester. Guideline of the DGGG (S2k-Level, AWMF Registry No. 015-094, December 2022) - Part 1 with Recommendations on Care Structures, Information and Advice on Decision-Making, Measures Before Abortion and Medical Abortion.

Purpose The aim was to develop evidence-based recommendations where possible. The guideline presents the medical principles and scientific evidence for indications, the counselling of affected women, performing terminations, the choice of method, and the care and monitoring of a terminated pregnancy up until week 12 + 0 of gestation p. c. Methods In accordance with the requirements for S2k-guidelines, the contents of the guideline were drafted following a systematic search of the literature by a representative interdisciplinary group of experts. Guideline authors held several formal meetings under the auspices of the German Society for Gynaecology and Obstetrics (DGGG) during which the contents of the guideline were finalised and agreed upon. Recommendations A total of 61 recommendations are provided, covering care structures, provision of information and counselling to support decision-making, the measures to be taken before terminating the pregnancy, and medical termination of the pregnancy.

Fibrinolytic potential as a risk factor for postpartum hemorrhage.

Background: Postpartum hemorrhage (PPH) is still the leading cause of maternal morbidity and mortality worldwide. While impaired fibrin polymerization plays a crucial role in the development and progress of PPH, recent approaches using viscoelastic measurements have failed to sensitively detect early changes in fibrinolysis in PPH. This study aimed to evaluate whether women experiencing PPH show alterations in POC-VET fibrinolytic potential during childbirth and whether fibrinolytic potential offers benefits in the prediction and treatment of PPH. Methods: Blood samples were collected at three different timepoints: T0 = hospital admission (19 h ± 18 h prepartum), T1 = 30-60 min after placental separation, and T2 = first day postpartum (19 h ± 6 h postpartum). In addition to standard laboratory tests, whole-blood impedance aggregometry (Multiplate) and viscoelastic testing (VET) were performed using the ClotPro system, which included the TPA-test lysis time, to assess the POC-VET fibrinolytic potential, and selected coagulation factors were measured. The results were correlated with blood loss and clinical outcome markers. Severe PPH was defined as a hemoglobin drop > 4g/dl and/or the occurrence of shock or the need for red blood cell transfusion. Results: Blood samples of 217 parturient women were analyzed between June 2020 and December 2020 at Heidelberg University Women's Hospital, and 206 measurements were eligible for the final analysis. Women experiencing severe PPH showed increased fibrinolytic potential already at the time of hospital admission. When compared to non-PPH, the difference persisted 30-60 min after placental separation. A higher fibrinolytic potential was accompanied by a greater drop in fibrinogen and higher d-dimer values after placental separation. While 70% of women experiencing severe PPH showed fibrinolytic potential, 54% of those without PPH showed increased fibrinolytic potential as well. Conclusion: We were able to show that antepartal and peripartal fibrinolytic potential was elevated in women experiencing severe PPH. However, several women showed high fibrinolytic potential but lacked clinical signs of PPH. The findings indicate that high fibrinolytic potential is a risk factor for the development of coagulopathy, but further conditions are required to cause PPH.

Prenatal paternal depression, anxiety, and somatic symptom burden in different risk samples: an explorative study.

PURPOSE: Growing evidence implies that transition to parenthood triggers symptoms of mental burden not only in women but likewise in men, especially in high-risk pregnancies. This is the first study that examined and compared the prevalence rates of depression, anxiety, and somatic symptom burden of expectant fathers who face different risk situations during pregnancy. METHODS: Prevalence rates of paternal depression (Edinburgh postnatal depression scale), anxiety (generalized anxiety disorder seven), and somatic symptom burden (somatic symptom scale eight) were examined in two risk samples and one control group in the third trimester of their partners' pregnancy: risk sample I (n = 41) consist of expectant fathers whose partners were prenatally hospitalized due to medical complications; risk sample II (n = 52) are fathers whose partners were prenatally mentally distressed; and control group (n = 70) are those non-risk pregnancies. RESULTS: On a purely descriptive level, the data display a trend of higher symptom burden of depression, anxiety, and somatic symptoms in the two risk samples, indicating that expectant fathers, whose pregnant partners were hospitalized or suffered prenatal depression, were more prenatally distressed. Exploratory testing of group differences revealed an almost three times higher prevalence rate of anxiety in fathers whose partner was hospitalized (12.2%) compared to those non-risks (4.3%). CONCLUSION: Results underline the need for screening implementations for paternal prenatal psychological distress, as well as specific prevention and treatment programs, especially for fathers in risk situations, such as their pregnant partners' prenatal hospitalization. The study was registered with the German clinical trials register (DRKS00020131) on 2019/12/09.

Long-term effects of preeclampsia on maternal cardiovascular health and postpartum utilization of primary care: an observational claims data study.

PURPOSE: Preeclampsia occurs in up to 15% of pregnancies and constitutes a major risk factor for cardiovascular disease. This observational cohort study aimed to examine the association between preeclamptic pregnancies and cardiovascular outcomes as well as primary and specialized care utilization after delivery. METHODS: Using statutory claims data we identified women with singleton live births between 2010 and 2017. Main outcomes included the occurrence of either hypertension or cardiovascular disease after one or more preeclamptic pregnancies, number of contacts to a general practitioner or cardiologist after delivery and prescribed antihypertensive medication. Data were analyzed using Cox proportional hazard regression models adjusted for maternal age, diabetes, dyslipidemia, and obesity. RESULTS: The study cohort consisted of 181,574 women with 240,698 births. Women who experienced preeclampsia once had an increased risk for cardiovascular (hazard ratio, HR = 1.29) or hypertensive (HR = 4.13) events. In women affected by recurrent preeclampsia, risks were even higher to develop cardiovascular disease (HR = 1.53) or hypertension (HR = 6.01). In the following years after delivery, general practitioners were seen frequently, whereas cardiologists were consulted rarely (0.3 and 2.4%). CONCLUSION: Women affected by preeclampsia experience an increased risk of developing chronic hypertension and cardiovascular disease, especially those with recurrent preeclampsia. Future medical guidelines should take this potential risk into account.

Comorbidity, life-style factors and healthcare utilization in incident chronic kidney disease: sex-specific analyses of claims data.

BACKGROUND: Chronic kidney disease (CKD) is common in aging men and women. In contrast to other European countries, Germany lacks CKD registries. The aim of this study was to determine the incidence of CKD stages 2-5 in men and women in Germany. Furthermore, differences between the sexes in terms of comorbidities, potentially inappropriate medications (PIM), and healthcare utilization were examined. METHODS: In this retrospective observational study, claims data from members of a statutory health insurance fund aged 18 years or older with incident CKD between 2011 and 2018 were analyzed. Incident CKD was defined as having two confirmed diagnoses of CKD stages 2-5 from outpatient care or one primary or secondary diagnosis from inpatient care. RESULTS: The age- and sex-standardized incidence of all CKD stages was 945/100 000 persons between 2011 and 2018. Incident CKD, especially stages 3 and 4, occurred more frequently in women, while the incidence of stages 2 and 5 was higher in men. While women visited their GP more frequently and were prescribed PIMs more often, men were more likely to visit a nephrologist and were more often hospitalized after the incident CKD diagnosis. CONCLUSION: More awareness needs to be raised towards the early detection of CKD and the use of PIMs, especially in women. Improved care coordination is needed to avoid an overprovision of patients with uncomplicated incident stages and ensure that patients with advanced CKD stages get timely access to specialist care.

Observational database study on preeclampsia and postpartum medical care up to 7.5 years after birth.

Preeclampsia is associated with a substantially increased long-term risk for cardiovascular, cerebrovascular and renal disease. It remains unclear whether and to which extent specialized medical postpartum care is sought. We aimed to assess current utilization of postpartum primary and specialized care and medication prescription behavior in women who experienced preeclampsia. This retrospective observational study based on statutory claims data included 193,205 women with 258,344 singleton live births between 2010 and 2017 in Southern Germany. Postpartum care was evaluated by analyzing and comparing the frequency of medical consultations in primary and specialized care and prescriptions for antihypertensive medication among women with and without preeclampsia up to 7.5 years after delivery. Gynecologists and general practitioners were the main health care providers for all women. Although specialized postpartum care was sought by more women after preeclampsia, the effect size indices revealed no considerable association between a history of preeclampsia and the utilization of specialized outpatient aftercare (e.g. 2% vs. 0.6% of patients with and without preeclampsia who consulted a nephrologist during the first year postpartum, r = 0.042). Preeclampsia was associated with an increased risk to take any antihypertensive medication after delivery (HR 2.7 [2.6; 2.8]). Postpartum referral to specialized outpatient care and quarterly prescriptions of antihypertensives following preeclampsia failed to match the early and rapidly increased incidence and risk of hypertension. These data highlight the missed opportunity to implement a reasonable follow-up strategy and prevention management in order to achieve long-term clinical benefits.

Implementing a Perinatal Depression Screening in Clinical Routine: Exploring the Patient's Perspective.

Introduction Perinatal depression (PND) is a frequently observed mental disorder, showing a prevalence of up to 20% and resulting in unfavorable maternal and neonatal outcomes. Targeted screening for PND offers the potential to identify and treat undiagnosed cases and help prevent its deleterious consequences. The aim of the present study was to evaluate participants' personal attitudes and acceptance of a routine screening program for PND in pregnancy care, identify any potential underlying factors, and appraise the general perspective on perinatal mental health problems. Methods In total, 732 women in their second trimester of pregnancy took part in a PND screening program that was incorporated in routine prenatal care using the Edinburgh Postnatal Depression Scale (EPDS) and completed a web-based survey on screening acceptance. Results Participants viewed PND screening as useful (78.7%, n = 555/705), especially in terms of devoting attention to perinatal mental health problems (90.1%, n = 630/699), easy to complete (85.4%, n = 606/710), and without feelings of discomfort (88.3%, n = 628/711). Furthermore, women with previous or current mental health issues rated the usefulness of screening significantly higher, as did women with obstetric risks (p < 0.01 - p = 0.04). The final regression model explained 48.4% of the variance for screening acceptance. Conclusion Patient acceptance for PND screening was high in our study cohort, supporting the implementation of screening programs in routine pregnancy care with the potential to identify, sensitize, and treat undiagnosed patients to reduce stigmatization and offer access to tailored dedicated PND care programs.

Acceptance, experiences, and needs of hospitalized pregnant women toward an electronic mindfulness-based intervention: A pilot mixed-methods study.

Background: Anxiety disorders and depression during pregnancy are highly prevalent. Hospitalized pregnant women with high maternal or fetal risk represent a particularly vulnerable population often excluded from research samples. Screening for mental health disorders is not routinely offered for this particular patient group. Electronic mindfulness-based interventions constitute an accessible, convenient, and cost-effective mental health resource but have not yet been evaluated for acceptance in inpatient settings. To date, little is known about the needs and perceptions of this group of women. Objective: The aim of this study was to examine whether a brief electronic mindfulness-based intervention (eMBI) is accepted among hospitalized high-risk pregnant women. We assessed personal motivation and barriers, experiences, usability requirements, and overall acceptance of the eMBI, as well the specific needs and demands of patients with high-risk pregnancies regarding mental health services. Methods: An exploratory pilot study with a mixed-methods study design was carried out among 30 women hospitalized with a high obstetric risk. The study participants were given access to an eMBI with a 1-week mindfulness program on how to deal with stress, anxiety, and depressive symptoms. Semi-structured interviews were conducted with the 30 participants and analyzed using systematic content analysis. In addition, acceptance and usability were assessed via questionnaires. Results: Study findings showed a high level of acceptance of the eMBI. Most of the respondents were satisfied with the usability and considered the eMBI program to be helpful. The greatest barriers to using the eMBI were a general negative attitude toward using apps, preference for personal contact, or no current need for psychotherapy. Participants criticized the lack of awareness of mental health issues during pregnancy and expressed a need for low-threshold treatment offers, especially during hospitalization. Conclusions: There is a strong need for mental health services in pregnancy care, especially for pregnant women with risk profiles. An eMBI offers an acceptable means of providing mental health support for hospitalized women with a severe obstetric risk.

Screening instruments for eating disorders in pregnancy: Current evidence, challenges, and future directions.

Pregnancy is a vulnerable period for eating disorder (ED) occurrence and maternal EDs are associated with heightened risk of adverse pregnancy and infant outcomes. This highlights the need to identify pregnant women with past or current EDs in order to offer appropriate support. However, there is a knowledge and practice gap on screening pregnant women for EDs. Clinical guidance is lacking in international treatment guidelines, which is unsurprising given that no validated ED screening tool specifically designed for use in antenatal populations exists. Moreover, data on the effectiveness of general population screening tools for identifying EDs in pregnant women are scarce. This article provides a synthesis of current evidence, treatment guidelines, and data on the diagnostic accuracy for screening for EDs in antenatal samples from three studies with different screening approaches. We outline recommendations for future steps to tackle the knowledge and practice gap on screening for EDs in pregnant women, including next steps for the development of a pregnancy-specific ED screener and the use of general mental health screeners to detect EDs during pregnancy. Up-to-date, the jury is still out as how to best identify current or past EDs in pregnancy. More research is needed to assess the efficacy of using general mental health screeners versus ED-specific screening instruments to detect ED in pregnancy. Additionally, clinicians have to be trained on how to assess and manage EDs during pregnancy. PUBLIC SIGNIFICANCE: Identifying pregnant women with eating disorders (EDs) is a public health concern which can be addressed using multiple approaches, including implementation of general and specific assessments within routine antenatal care, and training of healthcare professionals.

Case Report: Prolonged Neutropenia in Premature Monoamniotic Twins With SARS-CoV-2 Infection Acquired by Vertical Transmission.

Background: Vertical transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a highly debated topic in the current pandemic situation. Early neonatal SARS-CoV-2 infection is rare and generally mild. Long-term data describing symptoms after COVID-19 in premature neonates is scarce. Case Presentation: Two premature, monoamniotic neonates were born by cesarean section to a mother 5 days after onset of symptomatic COVID-19. On day three of life both neonates developed hyperthermia, respiratory distress, and hematological changes, of which neutropenia persisted for over 40 days. Nasopharyngeal swabs for SARS-CoV-2 turned positive four days after delivery although the neonates were strictly isolated. Both neonates showed nearly identical time courses of ct values. Conclusion: Our case report revealed prolonged low absolute neutrophil counts in two preterm neonates with symptomatic SARS-CoV-2 infection that is reasonably assumed to have been transmitted vertically in utero. After preterm delivery to a SARS-CoV-2 positive mother, testing for SARS-CoV-2 infection in neonates is crucial. Both neutropenia and lymphopenia should alert physicians to test for SARS-CoV-2 infection and also to follow the case.

Implementation of an Electronic Patient-Reported Outcome App for Health-Related Quality of Life in Breast Cancer Patients: Evaluation and Acceptability Analysis in a Two-Center Prospective Trial.

BACKGROUND: One in eight women is diagnosed with breast cancer in the course of their life. As systematic palliative treatment has only a limited effect on survival rates, the concept of health-related quality of life (HRQoL) was developed for measurement of patient-centered outcomes. Various studies have already demonstrated the reliability of paper-based patient-reported outcome (pPRO) and electronic patient-reported outcome (ePRO) surveys and that the 2 means of assessment are equally valid. OBJECTIVE: The aim of this study was to analyze the acceptance and evaluation of a tablet-based ePRO app for breast cancer patients and to examine its suitability, effort, and difficulty in the context of HRQoL and sociodemographic factors. METHODS: Overall, 106 women with adjuvant or advanced breast cancer were included in a 2-center study at 2 major university hospitals in Germany. Patients were asked to answer HRQoL and PRO questionnaires both on a tablet on-site using a specific eHealth assessment website and on paper. The suitability, effort, and difficulty of the app and self-reported technical skills were also assessed. Only the results of the electronically acquired data are presented here. The results of the reliability of the pPRO data have already been published elsewhere. RESULTS: Patients regarded the ePRO assessment as more suitable (80/106, 75.5%), less stressful (73/106, 68.9%), and less difficult (69/106, 65.1%) than pPRO. The majority of patients stated that ePRO assessment improves health care in hospitals (87/106, 82.1%). However, evaluation of ePROs depended on the level of education (P=.003) in the dimensions of effort and difficulty (regression analysis). The app was rated highly in all categories. HRQoL data and therapy setting did not show significant correlations with the app's evaluation parameters. CONCLUSIONS: The results indicate that ePRO surveys are feasible for measuring HRQoL in breast cancer patients and that those patients prefer ePRO assessment to pPRO assessment. It can also be seen that patients consider ePRO assessment to improve hospital health care. However, studies with larger numbers of patients are needed to develop apps that address the needs of patients with lower levels of education and technical skills.

The burden of incontinence in a real-world data environment-insights from a digital patient companion.

INTRODUCTION AND HYPOTHESIS: Urinary incontinence (UI) has a potentially devastating effect on women's quality of life (QoL). Conservative treatment by means of pelvic floor muscle training is the first-choice treatment modality. Nowadays, this can be supported by digital apps like pelvina©-a digital health companion pelvic floor course. METHODS: Using pelvina©, UI symptoms and QoL are regularly examined through the questionnaires QUID and SF-6D. Subsequently, we analyzed the incidence and degree of UI and its impact on QoL in 293 users in a real-world environment. RESULTS: The 293 patients included in this study had a median age of 36 years and a median of two children. Patients were slightly to moderately affected by UI with a QUID of 6 (2-11, maximum 24). Age and number of children were independently associated with the incidence of UI with an adjusted odds ratio (aOR) of 1.06 (95% CI 1.01-1.12) and aOR of 1.86 (95% CI 1.12-3.08). The severity of UI strongly correlated with impairment of QoL (ρ = 0.866, P < 0.001). CONCLUSIONS: The use of real-world data generated by digital health solutions offers the opportunity to gain insight into the reality of patients' lives. In this article, we corroborate the known associations between number of children and UI as well as the great influence UI has on QoL. This study shows that, in the future, the use of digital apps can make an important contribution to scientific data acquisition and, for example, therapy monitoring.

Evaluation of Repeated Web-Based Screening for Predicting Postpartum Depression: Prospective Cohort Study.

BACKGROUND: Postpartum depression (PPD) is a severe mental disorder that often results in poor maternal-infant attachment and negatively impacts infant development. Universal screening has recently been recommended to identify women at risk, but the optimal screening time during pregnancy has not been defined so far. Thus, web-based technologies with widespread use among women of childbearing age create new opportunities to detect pregnancies with a high risk for adverse mental health outcomes at an early stage. OBJECTIVE: The aim of this study was to stratify the risk for PPD and to determine the optimal screening time during pregnancy by using a web-based screening tool collecting electronic patient-reported outcomes (ePROs) as the basis for a screening algorithm. METHODS: In total, 214 women were repeatedly tested for depressive symptoms 5 times during and 3 times after pregnancy by using the Edinburgh Postnatal Depression Scale (EPDS), accessible on a web-based pregnancy platform, developed by the authors of this study. For each prenatal assessment, the area under the curve (AUC), sensitivity, specificity, and predictive values for PPD were calculated. Multivariate logistic regression analyses were applied to identify further potential predictors, such as age, education, parity, relationship quality, and anxiety, to increase predictive accuracy. RESULTS: Digitally collected data from 214 pregnant women were analyzed. The predictive accuracy of depressive symptoms 3 and 6 months postpartum was reasonable to good regarding the screening in the second (AUC=0.85) and third (AUC=0.75) trimester. The multivariate logistic regression analyses resulted in an excellent AUC of 0.93 at 3 months and a good AUC of 0.87 at 6 months postpartum. CONCLUSIONS: The best predictive accuracy for PPD has been shown for screening between the 24th and the 28th gestational week (GW) and seems to be beneficial for identifying women at risk. In combination with the aforementioned predictive factors, the discriminatory power improved, particularly at 3 months postpartum. Screening for depression during pregnancy, combined with the women's personal risk profile, can be used as a starting point for developing a digital screening algorithm. Thereby, web-based assessment tools constitute feasible, efficient, and cost-effective approaches. Thus, they seem to be beneficial in detecting high-risk pregnancies in order to improve maternal and infant birth outcomes in the long term.

An observational claims data analysis on the risk of maternal chronic kidney disease after preterm delivery and preeclampsia.

Women with complications of pregnancy such as preeclampsia and preterm birth are at risk for adverse long-term outcomes, including an increased future risk of chronic kidney disease (CKD) and end-stage kidney disease (ESKD). This observational cohort study aimed to examine the risk of CKD after preterm delivery and preeclampsia in a large obstetric cohort in Germany, taking into account preexisting comorbidities, potential confounders, and the severity of CKD. Statutory claims data of the AOK Baden-Wuerttemberg were used to identify women with singleton live births between 2010 and 2017. Women with preexisting conditions including CKD, ESKD, and kidney replacement therapy (KRT) were excluded. Preterm delivery (< 37 gestational weeks) was the main exposure of interest; preeclampsia was investigated as secondary exposure. The main outcome was a newly recorded diagnosis of CKD in the claims database. Data were analyzed using Cox proportional hazard regression models. The time-dependent occurrence of CKD was analyzed for four strata, i.e., births with (i) neither an exposure of preterm delivery nor an exposure of preeclampsia, (ii) no exposure of preterm delivery but exposure of at least one preeclampsia, (iii) an exposure of at least one preterm delivery but no exposure of preeclampsia, or (iv) joint exposure of preterm delivery and preeclampsia. Risk stratification also included different CKD stages. Adjustments were made for confounding factors, such as maternal age, diabetes, obesity, and dyslipidemia. The cohort consisted of 193,152 women with 257,481 singleton live births. Mean observation time was 5.44 years. In total, there were 16,948 preterm deliveries (6.58%) and 14,448 births with at least one prior diagnosis of preeclampsia (5.61%). With a mean age of 30.51 years, 1,821 women developed any form of CKD. Compared to women with no risk exposure, women with a history of at least one preterm delivery (HR = 1.789) and women with a history of at least one preeclampsia (HR = 1.784) had an increased risk for any subsequent CKD. The highest risk for CKD was found for women with a joint exposure of preterm delivery and preeclampsia (HR = 5.227). These effects were the same in magnitude only for the outcome of mild to moderate CKD, but strongly increased for the outcome of severe CKD (HR = 11.90). Preterm delivery and preeclampsia were identified as independent risk factors for all CKD stages. A joint exposure or preterm birth and preeclampsia was associated with an excessive maternal risk burden for CKD in the first decade after pregnancy. Since consequent follow-up policies have not been defined yet, these results will help guide long-term surveillance for early detection and prevention of kidney disease, especially for women affected by both conditions.

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial.

BACKGROUND: Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet's increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI). OBJECTIVE: The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women's hospitals of Heidelberg and Tübingen, Germany. METHODS: Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness. DISCUSSION: This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome. TRIAL REGISTRATION: Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210 . Registered on 13 January 2020. Retrospectively registered.