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.

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.

Challenges in Acceptance and Compliance in Digital Health Assessments During Pregnancy: Prospective Cohort Study.

BACKGROUND: Pregnant women are increasingly using mobile apps to access health information during the antenatal period. Therefore, digital health solutions can potentially be used as monitoring instruments during pregnancy. However, a main factor of success is high user engagement. OBJECTIVE: The aim of this study was to analyze engagement and factors influencing compliance in a longitudinal study targeting pregnant women using a digital health app with self-tracking. METHODS: Digitally collected data concerning demographics, medical history, technical aspects, and mental health from 585 pregnant women were analyzed. Patients filling out ≥80% of items at every study visit were considered to be highly compliant. Factors associated with high compliance were identified using logistic regression. The effect of a change in mental and physical well-being on compliance was assessed using a one-sample t test. RESULTS: Only 25% of patients could be considered compliant. Overall, 63% left at least one visit blank. Influential variables for higher engagement included higher education, higher income, private health insurance, nonsmoking, and German origin. There was no relationship between a change in the number of physical complaints or depressive symptoms and study dropout. CONCLUSIONS: Maintaining high engagement with digital monitoring devices over a long time remains challenging. As cultural and socioeconomic background factors had the strongest influence, more effort needs to be directed toward understanding the needs of patients from different demographic backgrounds to ensure high-quality care for all patients. More studies need to report on compliance to disclose potential demographic bias.

Reduction in physical activity significantly increases depression and anxiety in the perinatal period: a longitudinal study based on a self-report digital assessment tool.

PURPOSE: Physical activity can reduce pregnancy-related complications and contributes substantially to improving maternal mental health. A reduction in activity encompassing exercise and daily household tasks throughout the course of pregnancy increases the risk of depression and anxiety. The following research examines the longitudinal interaction between exercise, general physical activity, and mental health outcomes in pregnant women. METHODS: This prospective longitudinal study was conducted at the maternity departments of two major university hospitals in Germany. Self-reported data of 597 women were digitally assessed every 4 weeks from the second trimester until birth as well as 3 and 6 months postnatally. Depressive and anxiety symptoms were assessed using the EPDS, PRAQ, and STAI and physical activity levels were measured using the PPAQ questionnaire. Cross-sectional and longitudinal analyses using Pearson's correlation coefficient and multiple regression models were conducted. RESULTS: We found a significant reduction in general physical activity in the period from the 20th to 32nd gestational week. Women who reported a greater decline during pregnancy showed significantly higher depression and anxiety scores. In stratified analyses, only baseline mental health scores proved to be variables with stronger impact on postnatal depression and anxiety outcomes. CONCLUSION: General physical activity and maternal mental health significantly influence each other during and after pregnancy. Both physical activity and the prevention of perinatal mental disorders should be systematically encouraged during perinatal care to prevent adverse maternal and fetal birth outcomes.

Maternal-fetal attachment protects against postpartum anxiety: the mediating role of postpartum bonding and partnership satisfaction.

PURPOSE: Maternal mental disorders develop frequently during the perinatal period, and can have detrimental effects on the developing bond between a mother and her child. While depression has already been widely associated with bonding disorders, the link between anxiety disorders and maternal-fetal attachment has received only limited attention. This study aimed to explore the link between maternal-fetal attachment in the third trimester and postpartum anxiety, as previous research has suggested a potentially protective association. Additionally, we hypothesized a mediating influence of postpartum bonding and partnership satisfaction as additional measurements of attachment capacity. METHODS: Self-report questionnaires assessing maternal-fetal attachment, postpartum bonding, anxiety, depression, and partnership quality were completed at three time points: third trimester (T1, N = 324), first week postpartum (T2, N = 249), and 4 months postpartum (T3, N = 166). Conditional process analyses were used to test for mediation. RESULTS: A statistically significant negative correlation of maternal-fetal attachment was found with maternal anxiety postpartum. Overall, the analyses supported the mediation hypothesis. There was a significant, indirect effect of maternal-fetal attachment during pregnancy on state anxiety in the first week postpartum, mediated through postpartum bonding quality and partnership satisfaction. All three variables together accounted for 18.25% (state anxiety) or 30.35% (trait anxiety) of the variance in postpartum anxiety. CONCLUSIONS: Our results showed that a close maternal-fetal attachment buffers postpartum symptoms of anxiety, partially mediated through postpartum bonding and partnership satisfaction. Therefore, strengthening the maternal-fetal attachment and the partnership during pregnancy has the potential to reduce maternal postpartum symptoms of anxiety.

An Electronic Patient-Reported Outcome Tool for the FACT-B (Functional Assessment of Cancer Therapy-Breast) Questionnaire for Measuring the Health-Related Quality of Life in Patients With Breast Cancer: Reliability Study.

BACKGROUND: The most frequent malignant disease in women is breast cancer. In the metastatic setting, quality of life is the primary therapeutic goal, and systematic treatment has only a limited effect on survival rates; therefore, the concept of the health-related quality of life (HRQoL) and measurement of patient-reported outcomes (PROs) are gaining more and more importance in the therapy setting of diseases such as breast cancer. One of the frequently used questionnaires for measuring the HRQoL in patients with breast cancer is the Functional Assessment of Cancer Therapy-Breast (FACT-B). Currently, paper-based surveys still predominate, as only a few reliable and validated electronic-based questionnaires are available. ePRO tools for the FACT-B questionnaire with proven reliability are missing so far. OBJECTIVE: The aim of this study was to analyze the reliability of tablet-based measurement of FACT-B in the German language in adjuvant (curative) and metastatic breast cancer patients. METHODS: Paper- and tablet-based questionnaires were completed by a total of 106 female adjuvant and metastatic breast cancer patients. All patients were required to complete the electronically based (ePRO) and paper-based version of the FACT-B. A frequency analysis was performed to determine descriptive sociodemographic characteristics. Both dimensions of reliability (parallel forms reliability using Wilcoxon test and test of internal consistency using Spearman ρ) and agreement rates for single items, Kendall tau for each subscale, and total score were analyzed. RESULTS: High correlations were shown for both dimensions of reliability (parallel forms reliability and internal consistency) in the patients' response behavior between paper-based and electronically based questionnaires. Regarding the reliability test of parallel forms, no significant differences were found in 35 of 37 single items, while significant correlations in the test for consistency were found in all 37 single items, in all 5 sum individual item subscale scores, as well as in total FACT-B score. CONCLUSIONS: The ePRO version of the FACT-B questionnaire is reliable for patients with breast cancer in both adjuvant and metastatic settings, showing highly significant correlations with the paper-based version in almost all questions all subscales and the total score.

COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer.

PURPOSE: Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking. METHODS: Patients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18-24 weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair loss ≤ grade 2 (≤ 50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL). RESULTS: Seventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p < 0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p < 0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms. CONCLUSIONS: This trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC.

The influence of partnership quality and breastfeeding on postpartum female sexual function.

INTRODUCTION: Female sexual dysfunction is known to have a huge impact on quality of life and is highly prevalent during the peripartum period. Several influencing variables were found to be associated with impaired sexual function postpartum, among them breastfeeding and partnership quality. However, little is known about the predictive value of these variables. Therefore, this longitudinal cohort study aimed to examine prospectively the influence of the two variables on sexual function 4-month postpartum. MATERIALS AND METHODS: Questionnaires were administered to 330 women prenatally (TI, third trimester) and postpartum (TII, 1 week; TIII, 4 months). Medical data were collected from the respondents' hospital records. The Female Sexual Function Index (FSFI) was used to determine overall sexual function, desire, arousal, lubrication, orgasm, satisfaction, and pain perinatally. RESULTS: At all timepoints, mean FSFI scores were below the critical FSFI-score of 26.55. Partnership quality, breastfeeding, high maternal education, and maternal depressive symptoms correlated significantly with FSFI scores postpartum. Further analyses confirmed antenatal partnership quality and breastfeeding behavior as strong predictors of sexual function 4-month postpartum, explaining 24.3% of variance. Women who stopped breastfeeding or never breastfed at all showed the highest FSFI scores. CONCLUSION: Our findings indicate that exclusively breastfeeding women and those who report low partnership quality have an increased likelihood of sexual functioning problems 4-month postpartum. Health-care providers need to be encouraged to counsel on postpartum sexuality and influencing factors during prenatal classes to de-pathologize those changes and to foster a positive approach to peripartum sexuality.

Reliability and validity of the German version of the Maternal-Fetal Attachment Scale.

OBJECTIVES: In understanding early disturbances in the mother-child relationship, maternal-fetal attachment has become an important concept. To date no study has investigated the reliability and validity of the German version of the Maternal Fetal Attachment Scale (MFAS). The present study aimed to close this gap. METHODS: Questionnaires were completed in a sample of 324 women [third trimester (T1), first week postpartum (T2), and 4 months postpartum (T3)]. In addition to the MFAS (T1), the following measures were assessed: the questionnaire of partnership (T1), the postpartum bonding questionnaire (T2), the Edinburgh Postnatal Depression Scale (T1-T3), the State Trait Anxiety Inventory (T1-T3), and the pregnancy related anxiety questionnaire (T1-T3). Factor structure was analyzed using a principal component analysis (PCA) with varimax rotation. Internal and convergent validities were calculated. RESULTS: In contrast to the original version with five subscales, PCA yielded a three-factor solution, consisting of the three independent dimensions "anticipation", "empathy", and "caring", explaining 34.9% of the variance together. Good internal reliabilities were found for the total MFAS scale. Maternal-fetal attachment showed a significant negative correlation with postpartum bonding impairment. While no correlations were found with depression, general anxiety and pregnancy-related anxiety during pregnancy, maternal-fetal attachment was significantly related to aspects of partnership quality. In the postpartum period, maternal attachment showed a strong negative correlation with maternal anxiety. CONCLUSIONS: Our results suggest that the German version of the MFAS is a reliable and valid questionnaire to measure the emotional relationship of the mother to the unborn child during pregnancy.

Maternal self-confidence during the first four months postpartum and its association with anxiety and early infant regulatory problems.

Maternal self-confidence has become an essential concept in understanding early disturbances in the mother-child relationship. Recent research suggests that maternal self-confidence may be associated with maternal mental health and infant development. The current study investigated the dynamics of maternal self-confidence during the first four months postpartum and the predictive ability of maternal symptoms of depression, anxiety, and early regulatory problems in infants. Questionnaires assessing symptoms of depression (Edinburgh Postnatal Depression Scale), anxiety (State-Trait Anxiety Inventory), and early regulatory problems (Questionnaire for crying, sleeping and feeding) were completed in a sample of 130 women at three different time points (third trimester (T1), first week postpartum (T2), and 4 months postpartum (T3). Maternal self-confidence increased significantly over time. High maternal trait anxiety and early infant regulatory problems negatively contributed to the prediction of maternal self-confidence, explaining 31.8% of the variance (R=.583, F3,96=15.950, p<.001). Our results emphasize the transactional association between maternal self-confidence, regulatory problems in infants, and maternal mental distress. There is an urgent need for appropriate programs to reduce maternal anxiety and to promote maternal self-confidence in order to prevent early regulatory problems in infants.

Perceptions of Patient Engagement Applications During Pregnancy: A Qualitative Assessment of the Patient's Perspective.

BACKGROUND: With growing demand for medical information and health applications in pregnancy, the potential of electronic health (eHealth) and mobile health (mHealth) solutions in clinical care is increasingly unfolding. However, we still do not know how pregnant women engage with mobile apps, how such apps impact routine medical care, and whether benefit expectations are met. Whereas recent research has raised the subject of user distribution and analyzed the content of pregnancy applications, there is still a significant knowledge gap regarding what pregnant women like and dislike about pregnancy tools, along with how such interventions could be improved. OBJECTIVE: The aim of the study was to examine the perceptions and expectations of mobile and Web-based patient-engagement pregnancy applications. We assessed usability requirements, general acceptance of eHealth, and the impact of eHealth and mHealth pregnancy applications on the doctor-patient interaction and daily clinical routine. METHODS: A qualitative study was conducted at the maternity department of a major German university hospital. The sample included 30 women with low- to medium-risk pregnancies. Half of the patients were seen during outpatient care and half were hospitalized for several days. The extent and frequency of Web- and mobile phone app usage were assessed. Semistructured interviews were conducted and analyzed using systematic thematic analysis. RESULTS: Patients had a high demand for Web-based pregnancy applications. Study findings suggested a strong request for personalization, monitoring, and accessibility for frequent use as main themes derived from the interviews. Fostering patient empowerment in the doctor-patient relationship was also highly valued for a pregnancy app. Participants favored further integration of medical apps in their daily routine and pregnancy care. However, concerns were raised about content quality, trustworthiness of Web sources, and individual data security. CONCLUSIONS: eHealth and mHealth applications are a highly frequented source of information. Expectations and usability requirements for those applications are also high, thus posing a challenge to interdisciplinary service providers. Patients' attitude toward integrating apps in routine care settings was positive with a favorable influence on patient empowerment. Health care professionals should guide pregnant women toward a successful integration of these educational tools in pregnancy care.

Sexual activity and sexual dysfunction of women in the perinatal period: a longitudinal study.

PURPOSE: Reduced sexual activity and dysfunctional problems are highly prevalent in the perinatal period, and there is a lack of data regarding the degree of normality during pregnancy. Several risk factors have been independently associated with a greater extent of Female Sexual Dysfunction (FSD). Therefore, this study aimed to assess the prevalence of sexual inactivity and sexual dysfunctions in German women during the perinatal period and the verification of potential risk factors. METHODS: Questionnaires were administered to 315 women prenatally (TI 3rd trimester) and postpartum (TII 1 week, TIII 4 months), including the Female Sexual Function Index (FSFI), the Edinburgh Postnatal Depression Scale (EPDS), and the Questionnaire of Partnership (PFB). RESULTS: The frequency of sexual inactivity was 24% (TI), 40.5% (TII), and 19.9% (TIII). Overall, 26.5-34.8% of women were at risk of sexual dysfunction (FSFI score <26.55) at all measurement points. Sexual desire disorder was the most prevalent form of Female sexual dysfunction. Furthermore, especially breastfeeding and low partnership quality were revealed as significant risk factors for sexual dysfunctional problems postpartum. Depressive symptoms having a cesarean section and high maternal education were correlated with dysfunctional problems in several subdomains. CONCLUSIONS: Findings indicated that women at risk of FSD differed significantly in aspects of partnership quality, breastfeeding, mode of delivery, maternal education, and depressive symptoms. Aspects of perinatal sexuality should be routinely implemented in the counseling of couples in prenatal classes.