Health care utilization of patients with acute abdominal pain before and after emergency department visits.

BACKGROUND: Acute abdominal pain (AAP) is a major driver for capacity-use in emergency departments (EDs) worldwide. Yet, the health care utilization of patients with AAP before and after the ED remains unclear. The primary objective of this study was to describe adult patients presenting to the ED with AAP and their outpatient care (OC) use before and after the ED. Secondary objectives included description of hospitalization rates, in-hospital mortality, ED re-visits, and exploration of potential risk factors for hospitalization and ED re-visits. METHODS: For the analysis, we combined routine hospital data from patients who visited 15 EDs in Germany in 2016 with their statutory health insurance OC claims data from 2014 to 2017. Adult patients were included based on a chief complaint or an ED diagnosis indicating unspecific AAP or the Manchester Triage System indicator "Abdominal pain in adults". Baseline characteristics, ED diagnosis, frequency and reason of hospitalization, frequency and type of prior-OC (prOC) use up to 3 days before and of post-OC use up to 30 days after the ED visit. MAIN RESULTS: We identified 28,085 adults aged ≥ 20 years with AAP. 39.8% were hospitalized, 33.9% sought prOC before the ED visit (48.6% of them were hospitalized) and 62.7% sought post-OC up to 30 days after the ED visit. Hospitalization was significantly more likely for elderly patients (aged 65 and above vs. younger; adjusted OR 3.05 [95% CI 2.87; 3.25]), prOC users (1.71 [1.61; 1.90]) and men (1.44 [1.37; 1.52]). In-hospital mortality rate was 3.1% overall. Re-visiting the ED within 30 days was more likely for elderly patients (1.32 [1.13; 1.55) and less likely for those with prOC use (0.37 [0.31; 0.44]). CONCLUSIONS: prOC use was associated with more frequent hospitalizations but fewer ED re-visits. ED visits by prOC patients without subsequent hospitalization may indicate difficulties of OC resources to meet the complex diagnostic requirements and expectations of this patient population. Fewer ED re-visits in prOC users indicate effective care in this subgroup.

Practicing Interoceptive Sensitivity as a Couple: A Mixed-Methods Acceptance Analysis of a Dyadic vs. Single Pilot Randomized Controlled Trial.

Training interoceptive sensitivity (IS) might be a first step in effectively promoting intuitive eating (IE). A dyadic interoception-based pilot randomized controlled trial was conducted to increase IE among couples aged 50+. The training consisted of three exercises, a Body Scan (BS), a hunger exercise (HU), and a satiety (SA) exercise. This study explored how spouses accepted the (dyadic vs. single) training. In a mixed-methods convergence design, the findings of a survey (n = 68 couples) and focus groups (n = 4) were synthesized. Moderate general acceptance (e.g., regarding feasibility and low burden) and a hierarchical gradient in favor of the BS (e.g., pleasantness and improved sleep quality) emerged. Barriers concerned a perceived lack of the exercises' usefulness and a limited understanding of the training purpose. A wish for regular feedback and exchange with the study stuff and other participants was expressed. Spousal training involvement was experienced as being rather beneficial. Previously harmonized dietary practices and daily routines appeared as constructive pre-conditions for the joint training. This study highlights the potential and implications of training couples in IS. Future interventions should involve a regular exchange and closer guidance by study staff to promote a better understanding of the processes and goals of IS and IE.

YouTube and the implementation and discontinuation of the oral contraceptive pill: A mixed-method content analysis.

BACKGROUND: Women living in high-quality healthcare systems are more likely to use oral contraceptives at some point in their lives. Research findings have sparked controversial discussions about contraception in the scientific community and the media, potentially leading to higher rates of method discontinuation. Understanding the underlying motives for method discontinuation is crucial for reproductive health equity and future programming interventions. To address this question, this study aims to explore women's experiences of oral contraceptive use and discontinuation on YouTube. METHODS: A concurrent explanatory mixed-methods design was used to conduct content analysis of German YouTube videos. The information from 175 videos of 158 individuals was extracted through quantitative descriptive content analysis. Twenty-one individuals were included in the qualitative content analysis. FINDINGS: The body was a recurring theme in the pill biographies. Women described, for example, bodily sensations as reasons for taking and stopping the pill. They also described positive and negative side effects while taking the pill and after stopping. The most common side effects of taking the pill mentioned by YouTubers were mood swings (76/158), weight gain (45/158), headaches (33/158), and depressed mood (45/158). The symptoms after discontinuation reported most were facial skin impurities (108/158), decreased mood swings (47/158), hair loss (42/158), and weight loss (36/158). Overall, women overwhelmingly rated their discontinuation experience as positive (87/91). CONCLUSIONS: The study identified key symptoms of oral contraceptive initiation and discontinuation by portraying the experiences of female YouTubers, adding valuable insights to the understanding of method initiation and discontinuation. Further research is needed to explore women's personal experiences with method discontinuation beyond the YouTube platform.

Evaluation of cross-cultural competence among German health care professionals: A quasi-experimental study of training in two hospitals.

Sociocultural diversity in the German health care system is increasingly reflected in multicultural teams and the diversity of patients. To ensure successful collaboration in a multicultural environment and effective care to diverse patients the importance of cross-cultural competence training is growing. There is a lack of evidence-based training approaches for the German health care system, and it is unclear how the theoretical-conceptual promotion of cross-cultural competence can be achieved sustainably. The aim of the study is to evaluate the effectiveness of cross-cultural competence training for German health care professionals. A quasi-experimental evaluation study in two German hospitals was conducted. Cross-cultural competence was examined in an intervention and a control group (n = 196) using the self-reported instrument Cross-Cultural Competence of Healthcare Professionals (CCCHP) and analyzed with SPSS Statistics 25. Cross-cultural training had a cognitive level impact on knowledge, awareness, and attitudes and showed a highly significant reduction in social desirability. On an affective level, cross-cultural motivation and curiosity initially increased at t1 and decreased at t2. Cross-cultural emotion and empathy increased slightly. On a behavioral level, cross-cultural skills decreased after the training. For sustainable effects, cross-cultural training should focus more on practical skills in addition to theoretical content. Training interventions should be long-term. The results show that more needs to be done in the German health care sector to meet the increasing diversity and demands.

To Eat or Not to Eat-A Qualitative Exploration and Typology of Restrictive Dietary Practices among Middle-Aged and Older Adults.

Favorable diets often include restrictive practices that have proven health benefits, even if initiated later in life. The aim of this qualitative study is to gain a comprehensive understanding of Restrictive Dietary Practices (RDPs) among a sample of middle-aged and older German adults (aged 59-78 years). We conducted 24 narrative in-depth interviews and analyzed the data using qualitative content analysis (Kuckartz). Following an inductive thematic approach, a typology was reconstructed comprising four typical RDP characteristics: I. The Holistically Restraining Type, II. The Dissonant-savoring Restraining Type, III. The Reactively Restraining Type, and IV. The Unintentionally Restraining Type. These types differed regarding the practical implementation of, e.g., restrictive food choice into everyday routines, barriers to do so, as well as with respect to attitudes and motives underlying RDPs. The major motives for adopting a RDP involved health, well-being, ethical, and ecological concerns. The most prominent barriers to a 'successful' adoption of RDPs were the enjoyment of food and the desire for spontaneity and freedom of (food) choice. Our study offers an in-depth understanding of the aspects that shape the widespread practice of dietary restriction among middle-aged and older adults. Lifeworld-related changes in RDPs and possible 'type shiftings' are discussed as well as the meaning and chances of RDPs for public health promotion.

Malnutrition is associated with six-month mortality in older patients admitted to the emergency department with hip fracture.

Background: Hip fractures in older people are a common health problem often associated with malnutrition that might affect outcomes. Screening for malnutrition is not a routine examination in emergency departments (ED). This analysis of the EMAAge study, a prospective, multicenter cohort study, aimed to evaluate the nutritional status of older patients (≥ 50 years) with hip fracture, factors associated with malnutrition risk, and the association between malnutrition and the six-months mortality. Methods: Risk of malnutrition was evaluated using the Short Nutritional Assessment Questionnaire. Clinical data as well as data on depression and physical activity were determined. Mortality was captured for the first six months after the event. To assess factors associated with malnutrition risk we used a binary logistic regression. A Cox proportional hazards model was used to assess the association of malnutrition risk with six-month survival adjusted for other relevant risk factors. Results: The sample consisted of N = 318 hip fracture patients aged 50 to 98 (68% women). The prevalence of malnutrition risk was 25.3% (n = 76) at the time of injury. There were no differences in triage categories or routine parameters measured in the ED that could point to malnutrition. 89% of the patients (n = 267) survived for six months. The mean survival time was longer in those without malnutrition risk (171.9 (167.1-176.9) days vs. 153.1 (140.0-166.2) days). The Kaplan Meier curves and the unadjusted Cox regression (Hazard Ratio (HR) 3.08 (1.61-5.91)) showed differences between patients with and patients without malnutrition risk. In the adjusted Cox regression model, risk of death was associated with malnutrition risk (HR 2.61, 1.34-5.06), older age (70-76 years: HR 2.5 (0.52-11.99); 77-82 years: HR 4.25 (1.15-15.62); 83-99 years: HR 3.82 (1.05-13.88)) and a high burden of comorbidities (Charlson Comorbidity Index ≥3: HR 5.4 (1.53-19.12)). Conclusion: Risk of malnutrition was associated with higher mortality after hip fracture. ED parameters did not differentiate between patients with nutritional deficiencies and those without. Therefore, it is particularly important to pay attention to malnutrition in EDs to detect patients at risk of adverse outcomes and to initiate early interventions.

Recommendations for collecting and analysing migration-related determinants in public health research.

Background: According to the definition of the German Federal Statistical Office, about every fourth person living in Germany has a so-called migration background (MB), i.e., the person or at least one of their parents was born without German citizenship. However, MB has been defined differently in many studies. Also, the MB summarises people in different living situations, making differentiated analysis in health science more difficult. This article formulates recommendations for the collection and analysis of migration-related, as well as social and structural, determinants of health. Indicators for capturing relevant determinants of health: As part of the Improving Health Monitoring in Migrant Populations project (IMIRA), the previous approaches to operationalise and measure migration-related determinants were revised based on literature research and exchange formats, such as workshops, meetings, congress contributions, etc. Instead of MB, the country of birth of the respondents and their parents, duration of residence, citizenship(s), residence status, and German language proficiency should be recorded as minimum indicators and analysed as individual variables. Further social and structural determinants, such as socioeconomic position, working and housing conditions, or self-reported discrimination, should be included. Conclusions: In order to describe health inequalities and to specifically identify the needs of people with a history of migration, a mutual and differentiated consideration of migration-related and social determinants of health is essential.

Middle-aged and older adults' acceptance of mobile nutrition and fitness tools: A qualitative typology.

Background: The utilization of mobile health (mHealth) devices such as nutrition and fitness tools seems to be promising in facilitating healthy lifestyle behaviors in middle-aged and older adults. As user acceptance plays a decisive role in the successful implementation of mHealth tools, it is vital to examine the target groups' acceptance, particularly their usage behavior and attitudes toward these tools. This qualitative study aimed to explore how far middle-aged as well as older adults accept mobile nutrition and fitness tools and to identify facilitators and barriers shaping their acceptance. Methods: Twenty-one qualitative semi-structured interviews were conducted with German adults aged 50 years and older. Data material was analyzed using Qualitative Content Analysis (Kuckartz). Results: A comprehensive acceptance typology with three acceptance types could be reconstructed: The Rejection Type, The Selective Acceptance Type, and The Comprehensive Acceptance Type. The target group's acceptance of mobile nutrition and fitness tools appeared to differ considerably across the three acceptance types and between the two different types of mHealth tools - with mobile nutrition tools having been less accepted. Among others, high levels of usability were identified as a key facilitator, while a desire for autonomy and privacy concerns showed to be prominent barriers. Conclusion: The resulting typology indicates a pronounced heterogeneity among middle-aged and older adults regarding their acceptance of mobile nutrition and fitness tools. The findings highlight a need for more individualized mHealth tools along with respective promotion strategies that are specifically tailored to the needs and expectations of middle-aged and older adults.

Health-related quality of life and associated factors after hip fracture. Results from a six-month prospective cohort study.

Background: Hip fractures are a major public health problem with increasing relevance in aging societies. They are associated with high mortality rates, morbidity, and loss of independence. The aim of the EMAAge study was to determine the impact of hip fractures on patient-reported health-related quality of life (HRQOL), and to identify potential risk factors for worse outcomes. Methods: EMAAge is a multicenter, prospective cohort study of patients who suffered a hip fracture. Patients or, if necessary, proxies were interviewed after initial treatment and after six months using standardized questionnaires including the EQ-5D-5L instrument, the Oxford Hip Score, the PHQ-4, the Short Nutritional Assessment Questionnaire, and items on patients living situation. Medical data on diagnoses, comorbidities, medications, and hospital care were derived from hospital information systems. Results: A total of 326 patients were included. EQ-5D index values decreased from a mean of 0.70 at baseline to 0.63 at six months. The mean self-rated health on the EQ-VAS decreased from 69.9 to 59.4. Multivariable linear regression models revealed three relevant associated factors with the six-months EQ-5D index: symptoms of depression and anxiety, pre-fracture limitations in activities of daily living, and no referral to a rehabilitation facility had a negative impact. In addition, the six-months EQ-VAS was negatively associated with polypharmacy, living in a facility, and migration background. Conclusions: Hip fractures have a substantial negative impact on patients HRQOL. Our results suggest that there are modifying factors that need further investigation including polypharmacy and migration background. Structured and timely rehabilitation seems to be a protective factor.

Primary and secondary data in emergency medicine health services research - a comparative analysis in a regional research network on multimorbid patients.

BACKGROUND: This analysis addresses the characteristics of two emergency department (ED) patient populations defined by three model diseases (hip fractures, respiratory, and cardiac symptoms) making use of survey (primary) and routine (secondary) data from hospital information systems (HIS). Our aims were to identify potential systematic inconsistencies between both data samples and implications of their use for future ED-based health services research. METHODS: The research network EMANET prospectively collected primary data (n=1442) from 2017-2019 and routine data from 2016 (n=9329) of eight EDs in a major German city. Patient populations were characterized using socio-structural (age, gender) and health- and care-related variables (triage, transport to ED, case and discharge type, multi-morbidity). Statistical comparisons between descriptive results of primary and secondary data samples for each variable were conducted using binomial test, chi-square goodness-of-fit test, or one-sample t-test according to scale level. RESULTS: Differences in distributions of patient characteristics were found in nearly all variables in all three disease populations, especially with regard to transport to ED, discharge type and prevalence of multi-morbidity. Recruitment conditions (e.g., patient non-response), project-specific inclusion criteria (e.g., age and case type restrictions) as well as documentation routines and practices of data production (e.g., coding of diagnoses) affected the composition of primary patient samples. Time restrictions of recruitment procedures did not generate meaningful differences regarding the distribution of characteristics in primary and secondary data samples. CONCLUSIONS: Primary and secondary data types maintain their advantages and shortcomings in the context of emergency medicine health services research. However, differences in the distribution of selected variables are rather small. The identification and classification of these effects for data interpretation as well as the establishment of monitoring systems in the data collection process are pivotal. TRIAL REGISTRATION: DRKS00011930 (EMACROSS), DRKS00014273 (EMAAGE), NCT03188861 (EMASPOT).

Effort-reward imbalance and its association with sociocultural diversity factors at work: findings from a cross-sectional survey among physicians and nurses in Germany.

OBJECTIVE: Due to staff shortages and reports of high work stress, work conditions of hospital physicians and nurses receive wide attention. Additionally, sociocultural diversity of the workforce and patient population is increasing. Our study aim is to analyze how individual and organizational diversity-related factors are associated with the experience of staff's work stress. METHODS: A cross-sectional online survey was conducted with healthcare staff from 22 acute hospitals operated by two healthcare organizations in Germany in 2018. Sociodemographic, occupational and organizational factors were surveyed. Participants further reported work conditions related to the sociocultural diversity of colleagues and patients. Effort-reward imbalance (ERI) was measured with the German short version. Multivariable regression models were calculated with ER ratio as an outcome. RESULTS: N = 800 healthcare staff were included. Variables associated with higher ERI were longer work experience (ß = 0.092, p < 0.05), not holding a leading position (0.122, < 0.01), being a witness (0.149, < 0.001) or victim (0.099, < 0.05) of discrimination at one's own ward, reporting frequent burden due to language barriers with patients (0.102, < 0.01) and colleagues (0.127, < 0.001), and having restricted access to translators at work (0.175, < 0.001). Factors associated with lower ERI were having a first generation migration background (- 0.095, < 0.05) and being a physician (- 0.112, < 0.05). CONCLUSIONS: Catering to the needs of healthcare personnel in dealing with the additional effort related to language barriers at work, e.g., readily available translator services, and creating non-discriminatory work environments might be one cornerstone for the prevention of work-related ill health and retention of qualified hospital staff.

Associations among navigational support and health care utilization and costs in patients with advanced cancer: An analysis based on administrative health insurance data.

BACKGROUND: Fragmented and complex healthcare systems make it difficult to provide continuity of care for patients with advanced cancer near the end of life. Nurse-based cross-sectoral navigation support has the potential to increase patients' quality of life. The objective of this paper was to evaluate associations between navigation support and health care utilization, and the associated costs of care. METHODS: The evaluation is based on claims data from 37 statutory health insurance funds. Non-randomized recruitment of the intervention group (IG) took place between 2018 and 2019 in four German hospitals. The comparison group (CG) was defined ex post. It comprises nonparticipating clients of the involved health insurance funds matched on age, gender, and diagnosis in a 1:4 ratio to the IG. Healthcare resource utilization was compared using incident rate ratios (IRRs) based on negative binomial regression models. Linear mixed models were performed to compare differences in lengths of hospital stays and costs between groups. RESULTS: A total of 717 patients were included (IG: 149, CG: 568). IG patients showed shorter average lengths of hospital stays (IG: 11 days [95% CI: 10, 13] vs. CG: 15 days [95% CI: 14, 16], p < 0.001). In the IG, 21% fewer medications were prescribed and there were on average 15% fewer outpatient doctor contacts per month. Average billed costs in the IG were 23% lower than in the CG (IG: 6754 EUR [95% CI: 5702, 8000] vs. CG: 8816 EUR [95% CI: 8153, 9533], p < 0.001). CONCLUSIONS: The intervention was associated with decreased costs mainly as a result of a non-intended navigation effect. The social care nurses had navigated patients within the hospital early, needs-oriented and effectively but interpreted their function less cross-sectorally. Linkage of hospital-based navigators with the outpatient care sector needs further exploration.

An experimental approach to training interoceptive sensitivity: study protocol for a pilot randomized controlled trial.

BACKGROUND: Eating in absence of hunger is quite common and often associated with an increased energy intake co-existent with a poorer food choice. Intuitive eating (IE), i.e., eating in accordance with internal hunger and satiety cues, may protect from overeating. IE, however, requires accurate perception and processing of one's own bodily signals, also referred to as interoceptive sensitivity. Training interoceptive sensitivity might therefore be an effective method to promote IE and prevent overeating. As most studies on eating behavior are conducted in younger adults and close social relationships influence health-related behavior, this study focuses on middle-aged and older couples. METHODS: The present pilot randomized intervention study aims at investigating the feasibility and effectiveness of a 21-day mindfulness-based training program designed to increase interoceptive sensitivity. A total of N = 60 couples participating in the NutriAct Family Study, aged 50-80 years, will be recruited. This randomized-controlled intervention study comprises three measurement points (pre-intervention, post-intervention, 4-week follow-up) and a 21-day training that consists of daily mindfulness-based guided audio exercises (e.g., body scan). A three-arm intervention study design is applied to compare two intervention groups (training together as a couple vs. training alone) with a control group (no training). Each measurement point includes the assessment of self-reported and objective indicators of interoceptive sensitivity (primary outcome), self-reported indicators of intuitive and maladaptive eating (secondary outcomes), and additional variables. A training evaluation applying focus group discussions will be conducted to assess participants' overall acceptance of the training and its feasibility. DISCUSSION: By investigating the feasibility and effectiveness of a mindfulness-based training program to increase interoceptive sensitivity, the present study will contribute to a deeper understanding of how to promote healthy eating in older age. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), no. DRKS00024903. Retrospectively registered on April 21, 2021.

Middle-aged and older adults' acceptance of mobile nutrition and fitness apps: A systematic mixed studies review.

BACKGROUND: To promote healthy aging, the support of digital mobile health tools such as mobile applications (apps) addressing a healthy diet or physical activity appears promising, particularly when initiated before entering old age. For such tools to be effective, middle-aged and older adults' acceptance need to be studied in depth. OBJECTIVE: The aim of this systematic review was to provide an integrative synthesis of the current state of research regarding the question in how far middle-aged and older adults (people aged 50 years and above) accept mobile nutrition and fitness apps to gain a deeper understanding of the influencing factors shaping this target group's usage behaviour and needs. METHODS: The review process followed the PRISMA guidelines. The databases Medline, Embase, Web of Science as well as reference lists were systematically searched. Study quality was assessed using the MMAT and AXIS appraisal tools. Data of the included studies were extracted and thereupon narratively synthesized, involving thematic analysis. RESULTS: Of N = 8823 articles screened, n = 7 studies could be identified-five quantitative, cross-sectional ones and two qualitative studies. Overall, the synthesized findings showed a lower acceptance among middle-aged and older adults compared to younger populations, which was particularly reflected in lower usage rates and more negative attitudes towards such apps (e.g., Perceived usefulness, Ease of use). The target group's acceptance of fitness apps was greater compared to nutrition apps. Findings on contextual factors and social determinants were inconsistent (e.g., regarding gender differences). CONCLUSION: While cross-study comparability was limited, the synthesized evidence underscores the importance to target mobile nutrition and fitness apps to the distinctive and heterogeneous needs of middle-aged and, particularly, of older adults. The scarcity of the existing body of knowledge highlights the need of further (longitudinal) research. PROSPERO PROTOCOL REGISTER NUMBER: CRD42020159409.

Observed and personally experienced discrimination: findings of a cross-sectional survey of physicians and nursing staff.

BACKGROUND: Discrimination against hospital staff based on ascribed features is prevalent in healthcare systems worldwide. Detrimental effects on health and quality of patient care have been shown. Our study aims to describe and analyse the discrimination experiences of both physicians and nurses, specifically for the German hospital context. METHODS: A cross-sectional online survey on observed and personally experienced discrimination at work addressed staff from 22 hospitals of two organizations in Germany. Sociodemographic and occupational as well as institutional characteristics served as independent variables. In multivariable analyses, block- and stepwise logistic regressions were calculated for the two dependent variables (witness and victim of discrimination). Sensitivity analyses with imputed data for missings were performed. RESULTS: N = 800 healthcare professionals (n = 243 physicians, n = 557 nurses; response rate: 5.9%) participated in the survey. 305 respondents (38.1%) were witnesses of discrimination, while 108 respondents (13.5%) were victims of discrimination in their wards. Reasons for observed discriminatory acts were predominantly attributed to the ethnicity of the person concerned, their appearance and language, whereas personally affected staff most frequently cited gender as a reason, followed by ethnicity, and physical appearance. In multivariable models, cultural competence significantly increased the likelihood of witnessing discrimination (ß = .575; p = .037). In terms of the likelihood of being a victim of discrimination, in addition to cultural competence (ß = 2.838; p = < .001), the interaction of the effects of gender and professional group was statistically significant (ß = .280; p = .010). CONCLUSIONS: Given the extent of experienced and observed discrimination, appropriate institutional responses are needed. Further research on discriminatory structures in the German-speaking health care system should focus on discrimination at the intersection of ethnicity, gender and occupation.

Work-life balance in physicians working in two emergency departments of a university hospital: Results of a qualitative focus group study.

By applying an explorative approach, we aimed to identify a wide set of challenges and opportunities for the compatibility of the work and life domains in emergency department (ED) physicians as well as their suggestions for practical approaches to improve work-life balance. Four focus groups with 14 physicians of differing hierarchical position and family status were carried out at two EDs of one major university hospital. Data analysis was based on qualitative content analysis. Discussed themes within main categories included ED work conditions, aspects of residency training, physician's mentality and behaviors as well as context factors of university medicine. Working in an ED is associated with a comparatively high work-life-interference, mostly due to the unpredictable nature of ED work. Based on our context-specific findings, further research might address factors influencing work-life balance in ED physicians with a mixed-methods approach for identification of relevant associations and intervention approaches in this field.

The Abdominal Pain Unit (APU). Study protocol of a standardized and structured care pathway for patients with atraumatic abdominal pain in the emergency department: A stepped wedged cluster randomized controlled trial.

This study aims to improve emergency department (ED) care for patients suffering from atraumatic abdominal pain. An application-supported pathway for the ED will be implemented, which supports quick, evidence-based, and standardized diagnosis and treatment steps for patients with atraumatic abdominal pain at the ED. A mixed-methods multicentre cluster randomized controlled stepped wedge trial design will be applied. A total of 10 hospitals with EDs (expected n = 2.000 atraumatic abdominal pain patients) will consecutively (every 4 months) be randomized to apply the intervention. Inclusion criteria for patients are a minimum age of 18 years, suffering from atraumatic abdominal pain and being insured with a German statutory health insurance. Primary outcomes: acute pain score at time of discharge from ED, duration of treatment at the ED, patient-reported satisfaction. Secondary endpoints include patient safety and quality of care parameters, process evaluation parameters, and costs and cost-effectiveness parameters. Quantitative data will be gathered from patient-surveys, clinical records, and routine data from hospital information systems as well as from a participating German statutory health insurance. Descriptive and analytic statistical analysis will be performed to provide summaries and associations for primary patient-reported outcomes, process measures, quality measures, and costs. Qualitative data collection consists of participatory patient observations and semi-structured expert interviews, which will be inductively analysed. Findings will be disseminated in publications in peer-reviewed journals, on conferences, as well as via a project website. To ensure data protection, appropriate technical and organisational measures will be taken. Trial registration: DRKS00021052.

What happens when you stop using the combined contraceptive pill? A qualitative study protocol on consequences and supply needs for women who discontinued the combined contraceptive pill in Germany.

INTRODUCTION: For more than 60 years, contraceptive pills have been prescribed to mostly healthy biological women. An emerging body of research concerning the possible physiological and psychological side effects of hormonal contraception has been published over the past two decades. Consequently, discontinuing combined oral contraceptives (COCs) as a conscious decision for reasons other than desired pregnancy has become increasingly common for menstruating individuals. The question remains as to what physical and psychological consequences can be observed after discontinuing COCs. In addition, the consequent healthcare needs and situations of affected individuals in Germany have not been explored. This study aims to gain greater insight into the relationship between discontinuation of COCs and (1) possible health consequences, and (2) to explore the supply situation for affected women within the German healthcare system. METHODS AND ANALYSIS: Qualitative episodic interviews with women who discontinue COC therapy will explore possible health consequences, and their current healthcare needs and situations in Germany. The interviews will be transcribed verbatim, coded, and in-depth thematic interpretation will be conducted. Subsequently, expert interviews with health professionals who work with women who discontinue COCs will also be conducted. The expert interviews will be analysed according to the documentary method. Overarching themes will represent the perspectives of women and health professionals on the discontinuation of COCs. ETHICS AND DISSEMINATION: Ethical approval for this study has been granted by the Ethics Review Committee of Martin Luther University, Halle-Wittenberg (Germany), reference number 2021-34. The findings will be disseminated via peer-reviewed publications, posting via social media and presentations at conferences. This study is registered on the OSF platform under the following number: https://doi.org/10.17605/OSF.IO/JYWXM.

Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer.

PURPOSE: Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer. METHODS: Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups. RESULTS: The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044). CONCLUSION: Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.