Open Access

Background Up to 27% of the German population suffers from recurrent or persistent pain (lasting more than three months). Therefore, prevention of chronic pain is one major object of pain management interventions. The aim of this nationwide, multicentre, randomised controlled trial is to evaluate the efficacy of a 10-week ambulatory (outpatient) interdisciplinary multimodal pain therapy (A-IMPT) for patients with recurrent pain and at risk of developing chronic pain. This project was initiated by the German Pain Society (Deutsche Schmerzgesellschaft e.V.) and the public health insurance provider BARMER. It is currently funded by the German Innovation Fund (01NVF20023). The study PAIN2.0 focuses on reducing pain intensity and pain-related disability and investigates whether this intervention can improve physical activity, psychological well-being, and health literacy. Methods PAIN2.0 is designed as a multicentre 1:1 randomised controlled trial with two parallel groups (randomisation at the patient level, planned N = 1094, duration of study participation 12 months, implemented by 22 health care facilities nationwide). After 6 months, patients within the control group also receive the intervention. The primary outcomes are pain intensity and pain-related impairment, measured as Characteristic Pain Intensity (PI) and Disability Score (DS) (Von Korff), as well as patient-related satisfaction with the intervention. Secondary outcomes are the number of sick leave days, sickness allowance, treatment costs, psychological distress, health-related quality of life, and catastrophizing. The effects of the intervention will be analysed by a parallel-group comparison between the intervention and control groups. In addition, the long-term effects within the intervention group will be observed and a pre-post comparison of the control group before and after the intervention will be performed. Discussion Recurrent or persistent pain is common in the German population and causes high costs for patients and society. The A-IMPT aims to improve pain and pain-related impairments in pain patients at risk of chronification, thereby reducing the risk of developing chronic pain with its high socioeconomic burden. This new therapy could easily be integrated into existing therapy programs if positively evaluated. Trial registration The trial PAIN2.0 has been registered in the German Clinical Trials Register (DRKS) since 21/11/2022 with the ID DRKS00030773.

Background & Aim: In an aging society, promoting successful cognitive aging is becoming increasingly important, particularly with regard to age-related cognitive changes and dementia. Therefore, it is critical to support older people, especially those with subjective cognitive decline, through helpful tools and identify effective interventions to alleviate dementia symptoms. While pharmacological treatments have their limitations, such as limited efficacy and side effects, non-pharmacological interventions are becoming increasingly important. The aim of this dissertation was to evaluate non-pharmacological interventions, specifically coping strategies at the beginning of the cognitive spectrum and later non-pharmacological interventions in gen-eral for the treatment of dementia symptoms, in the German healthcare system. Methods: First, effective coping strategies were identified by systematically reviewing scientific evidence and then the strategies were included in a memory aid handbook for people with subjective cognitive decline. The memory aid handbook was tested and evaluated in a usability study to determine whether its use had positive effects on people with subjective cognitive decline. Moreover, the implementation of non-pharmacological interventions in German de-mentia care, as well as perceived effects and barriers were examined through focus group discussions with caregivers in general and specifically in interviews with informal caregivers. Results: Findings from the systematic review indicated that coping strategies are used across the spectrum of cognitive decline, although the nature of these strategies varied with the severity of impairment. The memory aid handbook, developed based on effective coping strate-gies, has proven to be a useful tool for supporting people with subjective cognitive decline. Participants were able to integrate new strategies and increase their confidence in their already established coping strategies. Further, findings from interviews and expert focus group discussions indicated that other non-pharmacological interventions, particularly social interactions and interventions tailored to the person with dementia, are used to alleviate dementia symptoms and improve the well-being of people with dementia and their caregivers. Despite the perceived positive effects, barriers such as bureaucracy, lack of staff and resources, lack of time, and limited services hindered implementation of non-pharmacological interventions. Conclusion: Non-pharmacological interventions are perceived as beneficial by people with subjective cognitive decline and in dementia, although the type of intervention preferred varies. By incorporating a person-centered care approach, non-pharmacological interventions might reach their full potential, although their implementation is hindered by several barriers that need to be addressed in future model projects within the community.

Background Paediatric inflammatory bowel disease (PIBD) patients require chronic care over the lifespan. Care for these patients is complex, as it is adapted for childrens’ life stages and changing disease activity. Guideline based care for this patient group recommends a multidisciplinary approach, which includes in addition to paediatric gastroenterologists, nutritional and psychological care services. For PIBD patients, a discrepancy between available guideline-based multidisciplinary care and actual care has been found from the provider side, but to what extent patients experience this is unclear. Objectives To identify which healthcare services were used and whether socio-demographic, geographic or disease related factors have an influence on health service utilisation. Methods A standardised questionnaire (CEDNA) was distributed amongst parents of children aged 0–17 diagnosed with PIBD and adolescents (aged 12–17) with a PIBD. Items related to health service use were analysed, these included specialist care, additional care services, reachability of services and satisfaction with care. Logistic regression models on additional service use were calculated. Service availability and reachability maps were made. Results Data was analysed for 583 parent and 359 adolescent questionnaires. Over half of the respondents had Crohn’s Disease (CD, patients n = 186 parents n = 297). Most patients and parents reported their paediatric gastroenterologist as their main care contact (patients 90.5%; parents 93%). Frequently reported additional services were nutritional counselling (patients 48.6%; parents 42.2%) and psychological support (patients 28.1%; parents 25.1%). Nutritional counselling was more frequently reported by CD patients in both the patient (OR 2.86; 95%CI 1.73–4.70) and parent (OR 3.1; 95%CI 1.42–6.71) sample. Of the patients, 32% reported not using any additional services, which was more likely for patients with an illness duration of less than one year (OR 3.42; 95%CI 1.26–9.24). This was also observed for the parent population (OR 2.23; 95%CI 1.13–4.4). The population-based density of specialised paediatric gastroenterologists was not proportionate to the spatial distribution of patients in Germany, which may have an influence on access. Conclusions Parents and children reported highly specialised medical care. Multidisciplinary care offers do not reach the entire patient population. Access to multidisciplinary services needs to be ensured for all affected children.

Mortality is predicted by the sum of behavior-related health risk factors (BRFs: tobacco smoking, alcohol drinking, body overweight, and physical inactivity). We analyzed degrees and combinations of BRFs in their relation to mortality and adjusted for mental disorders. In a random sample of the general population in northern Germany aged 18–64, BRFs and mental disorders had been assessed in 1996–1997 by the Munich Composite International Diagnostic Interview. A sum score including eight ranks of the behavior-related health risk factors was built. Death and its causes were ascertained 2017–2018 using residents’ registration files and death certificates. Relations of the sum score and combinations of the BRFs at baseline with all-cause, cancer, and cardiovascular mortality 20 years later were analyzed. The sum score and combinations predicted all-cause, cardiovascular and cancer mortality. The odds ratio of the sum score was 1.38 (95% confidence interval 1.31–1.46) after adjustment for age, gender, and mental disorder. In addition to the BRFs, mood, anxiety or somatoform disorders were not related to mortality. We concluded that the sum score and combinations of behavior-related health risk factors predicted mortality, even after adjustment for mental disorders.

Background Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging aspects of clinical trials. Information technology (IT) support systems—for instance, patient recruitment systems—may help overcome existing challenges and improve recruitment rates, when customized to the user needs and environment. Objective The goal of our study is to describe the status quo of patient recruitment processes and to identify user requirements for the development of a patient recruitment system. Methods We conducted a web-based survey with 56 participants as well as semistructured interviews with 33 participants from 10 German university hospitals. Results We here report the recruitment procedures and challenges of 10 university hospitals. The recruitment process was influenced by diverse factors such as the ward, use of software, and the study inclusion criteria. Overall, clinical staff seemed more involved in patient identification, while the research staff focused on screening tasks. Ad hoc and planned screenings were common. Identifying eligible patients was still associated with significant manual efforts. The recruitment staff used Microsoft Office suite because tailored software were not available. To implement such software, data from disparate sources will need to be made available. We discussed concrete technical challenges concerning patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration, and we contributed to the support of developing a successful system. Conclusions Identifying eligible patients is still associated with significant manual efforts. To fully make use of the high potential of IT in patient recruitment, many technical and process challenges have to be solved first. We contribute and discuss concrete technical challenges for patient recruitment systems, including requirements for features, data, infrastructure, and workflow integration.