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Purpose
A setting-sensitive instrument for assessing Quality of Life (QoL) in Telemedicine (TM) was unavailable. To close this gap, a content-valid “add-on” measure was developed. In parallel, a brief index was derived featuring six items that summarise the main content of the multidimensional assessment. After pre- and pilot-testing, the psychometric performance of the final measures was investigated in an independent validation study.
Methods
The questionnaires were applied along with other standardised instruments of similar concepts as well as associated, yet disparate concepts for validation purposes. The sample consisted of patients with depression or heart failure, with or without TM (n = 200). Data analyses were aimed at calculating descriptive statistics and testing the psychometric performance on item, scale, and instrument level, including different types of validity and reliability.
Results
The proposed factor structure of the multidimensional Tele-QoL measure has been confirmed. Reliability coefficients for internal consistency, split-half, and test-retest reliability of the subscales and index reached sufficient values. The Tele-QoL subscales and the index demonstrated Rasch scalability. Validity of both instruments can be assumed. Evidence for discriminant construct validity was provided. Known-groups validity was indicated by respective score differences for various classes of disease severity.
Conclusion
Both measures show convincing psychometric properties. The final multidimensional Tele-QoL assessment consists of six outcome scales and two impact scales assessing (un-)intended effects of TM on QoL. In addition, the Tele-QoL index provides a short alternative for outcome assessment. The Tele-QoL measures can be used as complementary modules to existing QoL instruments capturing healthcare-related aspects of QoL from the patients’ perspective.
In rural areas, healthcare providers, patients and relatives have to cover long distances. For specialised ambulatory palliative care (SAPV), a supply radius of max. 30 km is recommended. The aim of this study was to analyse whether there are regional disparities in the supply of SAPV and whether it is associated with the distance between the SAPV team’s site and the patient’s location. Therefore, anonymised data of the Association of Statutory Health Insurance Physicians of the Federal State of Mecklenburg-Western Pomerania (M-V) were retrospectively analysed for the period of 2014–2017. Identification as a palliative patient was based on palliative-specific items from the ambulatory reimbursement catalogue. In total, 6940 SAPV patients were identified; thereof, 48.9% female. The mean age was 73.3 years. For 28.3% of the identified SAPV patients (n = 1961), the SAPV teams had a travel distance of >30 km. With increasing distance, the average number of treatment days per patient increased. It was found that there are regional disparities in the provision of SAPV services in M-V and that local structures have an important impact on regional supply patterns. The distance between the SAPV team’s site and the patient’s location is not the only determining factor; other causes must be considered.
Background
The national Network Genomic Medicine (nNGM) Lung Cancer provides comprehensive and high-quality multiplex molecular diagnostics and standardized personalized treatment recommendation for patients with advanced non-small cell lung cancer (aNSCLC) in Germany. The primary aim of this study was to investigate the effectiveness of the nNGM precision medicine program in terms of overall survival (OS) using real-world data (RWD).
Methods
A historical nationwide cohort analysis of patients with aNSCLC and initial diagnosis between 04/2019 and 06/2020 was conducted to compare treatment and OS of patients with and without nNGM-participation. Patients participating within the nNGM (nNGM group) were selected based on a prospective nNGM database. The electronic health records (EHR) of the prospective nNGM database were case-specifically linked to claims data (AOK, German health insurance). The control group was selected from claims data of patients receiving usual care without nNGM-participation (non-nNGM group). The minimum follow-up period was six months.
Findings
Overall, n = 509 patients in the nNGM group and n = 7213 patients in the non-nNGM group met the inclusion criteria. Patients participating in the nNGM had a significantly improved OS compared to the non-nNGM group (median OS: 10.5 months vs. 8.7 months, p = 0.008, HR = 0.84, 95% CI: 0.74–0.95). The 1-year survival rates were 46.8% (nNGM) and 41.3% (non-nNGM). The use of approved tyrosine kinase inhibitors (TKI) in the first-line setting was significantly higher in the nNGM group than in the non-nNGM group (nNGM: 8.4% (43/509) vs. non-nNGM: 5.1% (366/7213), p = 0.001). Overall, patients receiving first-line TKI treatment had significantly higher 1-year OS rates than patients treated with PD-1/PD-L1 inhibitors and/or chemotherapy (67.2% vs. 40.2%, p < 0.001).
Interpretation
This is the first study to demonstrate a significant survival benefit and higher utilization of targeted therapies for aNSCLC patients participating within nNGM. Our data indicate that precision medicine programs can enhance collaborative personalized lung cancer care and promote the implementation of treatment innovations and the latest scientific knowledge into clinical routine care.
Funding
The study was funded by the AOK Federal Association Germany.
Introduction
In response to the COVID-19 pandemic, a general lockdown was enacted across Germany in March 2020. As a consequence, patients with mental health conditions received limited or no treatment in day hospitals and outpatient settings. To ensure continuity of care, the necessary technological preparations were made to enable the implementation of telemedical care via telephone or video conferencing, and this option was then used as much as possible. The aim of this study was to investigate the satisfaction and acceptance with telemedical care in a heterogeneous patient group of psychiatric outpatients in Germany during the first COVID-19 lockdown.
Methods
In this observational study, patients in ongoing or newly initiated outpatient psychiatric therapy as well as those who had to be discharged from the day clinic ahead of schedule received telemedical treatment via telephone. Data collection to assess the patients’ and therapists’ satisfaction with and acceptance of the telemedical care was adjusted to the treatment setting.
Results
Of 60 recruited patients, 57 could be included in the analysis. 51.6% of the patients and 52.3% of their therapists reported that the discussion of problems and needs worked just as well over the phone as in face-to-face consultations. In the subgroup of patients who were new to therapy due to being discharged from hospital early, acceptance was higher and telemedicine was rated as equally good in 87.5% of contacts. Both patients and therapists felt that telemedicine care during lockdown was an alternative for usual therapy in the outpatient clinic and that the option of telemedicine care should continue for the duration of the coronavirus pandemic.
Discussion
The results show a clear trend towards satisfaction with and acceptance of telemedicine care in a heterogeneous group of unselected psychiatric patients. Although the number of patients is small, the results indicate that the mostly positive results of telemedicine concepts in research projects can probably be transferred to real healthcare settings.
Conclusions
Telemedicine can be employed in healthcare for psychiatric patients either an alternative treatment option to maintain continuity of care or as a potential addition to regular care.
Background
Pregnancy and the postpartum period are times when women are at increased risk for depression and mental problems. This may also negatively affect the foetus. Thus, there is a need for interventions with low-threshold access and care. Telemedicine interventions are a promising approach to address these issues. This systematic literature review examined the efficacy of telemedicine interventions for pregnant women and/or new mothers to address mental health-related outcomes. The primary objective was to analyse whether telemedicine interventions can reduce mental health problems in pregnant women and new mothers. The secondary aim was to clarify the impact of type of interventions, their frequency and their targets.
Methods
Inclusion criteria: randomized controlled trials, with participants being pregnant women and/or new mothers (with infants up to twelve months), involving telemedicine interventions of any kind (e.g. websites, apps, chats, telephone), and addressing any mental health-related outcomes like depression, postnatal depression, anxiety, stress and others. Search terms were pregnant women, new mothers, telemedicine, RCT (randomised controlled trials), mental stress as well as numerous synonyms including medical subject headings. The literature search was conducted within the databases PubMed, Cochrane Library, Web of Science and PsycINFO. Screening, inclusion of records and data extraction were performed by two researchers according to the PRISMA guidelines, using the online tool CADIMA.
Results
Forty four articles were included. A majority (62%) reported significantly improved mental health-related outcomes for participants receiving telemedicine interventions compared to control. In particular (internet-delivered) Cognitive Behavioural Therapy was successful for depression and stress, and peer support improved outcomes for postnatal depression and anxiety. Interventions with preventive approaches and interventions aimed at symptom reduction were largely successful. For the most part there was no significant improvement in the symptoms of anxiety.
Conclusion
Telemedicine interventions evaluated within RCTs were mostly successful. However, they need to be designed to specifically target a certain mental health issue because there is no one-size-fits-all approach. Further research should focus on which specific interventions are appropriate for which mental health outcomes in terms of intervention delivery modes, content, target approaches, etc. Further investigation is needed, in particular with regard to anxiety.
Background
Early diagnosis is mandatory for the medical care of children and adolescents with pediatric-onset inflammatory bowel disease (PIBD). International guidelines (‘Porto criteria’) of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition recommend medical diagnostic procedures in PIBD. Since 2004, German and Austrian pediatric gastroenterologists document diagnostic and treatment data in the patient registry CEDATA-GPGE on a voluntary basis. The aim of this retrospective study was to analyze whether the registry CEDATA-GPGE reflects the Porto criteria and to what extent diagnostic measures of PIBD according to the Porto criteria are documented.
Methods
Data of CEDATA-GPGE were analyzed for the period January 2014 to December 2018. Variables representing the Porto criteria for initial diagnostic were identified and categorized. The average of the number of measures documented in each category was calculated for the diagnoses CD, UC, and IBD-U. Differences between the diagnoses were tested by Chi-square test. Data on possible differences between data documented in the registry and diagnostic procedures that were actually performed were obtained via a sample survey.
Results
There were 547 patients included in the analysis. The median age of patients with incident CD (n = 289) was 13.6 years (IQR: 11.2–15.2), of patients with UC (n = 212) 13.1 years (IQR: 10.4–14.8) and of patients with IBD-U (n = 46) 12.2 years (IQR: 8.6–14.7).
The variables identified in the registry fully reflect the recommendations by the Porto criteria. Only the disease activity indices PUCAI and PCDAI were not directly provided by participants but calculated from obtained data. The category ‘Case history’ were documented for the largest part (78.0%), the category ‘Imaging of the small bowel’ were documented least frequently (39.1%). In patients with CD, the categories ‘Imaging of the small bowel’ (χ2 = 20.7, Cramer-V = 0.2, p < 0.001) and ‘Puberty stage’ (χ2 = 9.8, Cramer-V = 0.1, p < 0.05) were documented more often than in patients with UC and IBD-U.
Conclusion
The registry fully reproduces the guideline’s recommendations for the initial diagnosis of PIBD. The proportion of documented diagnostic examinations varied within the diagnostic categories and between the diagnoses. Despite technological innovations, time and personnel capacities at participating centers and study center are necessary to ensure reliable data entry and to enable researchers to derive important insights into guideline-based care.
Background
Long periods of uninterrupted sitting, i.e., sedentary bouts, and their relationship with adverse health outcomes have moved into focus of public health recommendations. However, evidence on associations between sedentary bouts and adiposity markers is limited. Our aim was to investigate associations of the daily number of sedentary bouts with waist circumference (WC) and body mass index (BMI) in a sample of middle-aged to older adults.
Methods
In this cross-sectional study, data were collected from three different studies that took place in the area of Greifswald, Northern Germany, between 2012 and 2018. In total, 460 adults from the general population aged 40 to 75 years and without known cardiovascular disease wore tri-axial accelerometers (ActiGraph Model GT3X+, Pensacola, FL) on the hip for seven consecutive days. A wear time of ≥ 10 h on ≥ 4 days was required for analyses. WC (cm) and BMI (kg m− 2) were measured in a standardized way. Separate multilevel mixed-effects linear regression analyses were used to investigate associations of sedentary bouts (1 to 10 min, >10 to 30 min, and >30 min) with WC and BMI. Models were adjusted for potential confounders including sex, age, school education, employment, current smoking, season of data collection, and composition of accelerometer-based time use.
Results
Participants (66% females) were on average 57.1 (standard deviation, SD 8.5) years old and 36% had a school education >10 years. The mean number of sedentary bouts per day was 95.1 (SD 25.0) for 1-to-10-minute bouts, 13.3 (SD 3.4) for >10-to-30-minute bouts and 3.5 (SD 1.9) for >30-minute bouts. Mean WC was 91.1 cm (SD 12.3) and mean BMI was 26.9 kg m− 2 (SD 3.8). The daily number of 1-to-10-minute bouts was inversely associated with BMI (b = -0.027; p = 0.047) and the daily number of >30-minute bouts was positively associated with WC (b = 0.330; p = 0.001). All other associations were not statistically significant.
Conclusion
The findings provide some evidence on favourable associations of short sedentary bouts as well as unfavourable associations of long sedentary bouts with adiposity markers. Our results may contribute to a growing body of literature that can help to define public health recommendations for interrupting prolonged sedentary periods.
Trial registration
Study 1: German Clinical Trials Register (DRKS00010996); study 2: ClinicalTrials.gov (NCT02990039); study 3: ClinicalTrials.gov (NCT03539237).
Multivariate analysis of independent determinants of ADL/IADL and quality of life in the elderly
(2022)
Background
This study evaluated the determinants of disability and quality of life in elderly people who participated at the multi-centred RubiN project (Regional ununterbrochen betreut im Netz) in Germany.
Methods
Baseline data of the subjects aged 70 years and older of the RubiN project were used and only subjects with complete data sets were considered for the ensuing analysis (complete case analysis (CCA)).
Disability was examined using the concepts of ADL (activities of daily living) and IADL (instrumental activities of daily living). Subjects exhibiting one or more deficiencies in ADL respectively IADL were considered as ADL respectively IADL disabled. Quality of life was assessed using the WHOQOL-BREF and the WHOQOL-OLD. Applying multivariate analysis, sociodemographic factors, psychosocial characteristics as well as the functional, nutritional and cognitive status were explored as potential determinants of disability and quality of life in the elderly.
Results
One thousand three hundred seventy-five subjects from the RubiN project exhibited data completeness regarding baseline data. ADL and IADL disability were both associated with the respective other construct of disability, sex, a reduced cognitive and functional status as well as domains of the WHOQOL-BREF. Furthermore, ADL disability was related to social participation, while IADL disability was linked to age, education and social support. Sex, ADL and IADL disability, income, social support and social participation as well as the functional status were predictors of the domain ‘Physical Health’ (WHOQOL-BREF). The facet ‘Social Participation’ (WHOQOL-OLD) was affected by both ADL and IADL disability, income, social participation, the nutritional and also the functional status.
Conclusions
Several potential determinants of disability and quality of life were identified and confirmed in this study. Attention should be drawn to prevention schemes as many of these determinants appear to be at least partly modifiable.
Legal advice and care-effective use of care and case management: limits, risks and need for change
(2022)
Introduction
An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients.
Methods
The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements.
Results
Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks.
Discussion
With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided.
The incidence and prevalence of pediatric-onset inflammatory bowel disease (PIBD) are on the rise worldwide. Initial symptoms are often recognized with a delay, which reduces the quality of life and may lead to an increased rate of complications. The aim of this study was to determine the diagnostic delay in PIBD and to identify potential influencing factors. Therefore, data from the German-Austrian patient registry CEDATA-GPGE for children and adolescents with PIBD were analyzed for the period January 2014 to December 2018. There were 456 children identified in the data, thereof 258 children (57%) with Crohn’s disease (CD) and 198 children (43%) with Ulcerative colitis (UC). The median age was 13.3 years (interquartile range (IQR) = 10.9−15.0), and 44% were females. The median diagnostic delay was 4.1 months (IQR = 2.1–7.0) in CD and 2.4 months (IQR = 1.2–5.1) in UC (p = 0.01). UC was associated with earlier diagnosis than CD (p < 0.001). Only a few factors influencing the diagnostic delay have been verified, e.g., abdominal pain at night and if video capsule endoscopy was performed. Diagnostic delay improved over the years in participating centers, but the level of awareness needs to be high even in common symptoms like abdominal pain.