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2.
BMC Pregnancy Childbirth ; 24(1): 134, 2024 Feb 13.
Article in English | MEDLINE | ID: mdl-38350865

ABSTRACT

BACKGROUND: Pump-dependent mothers of very low birth weight (VLBW, < 1500g) infants experience specific challenges achieving sufficient milk supply in the neonatal intensive care unit (NICU) and are therefore less frequently able to achieve (exclusive) breast milk feeding. Stress due to the limitations on participating in the infant's care may contribute to this problem. Some explorative studies suggest that pressure to provide milk may be an additional stressor in mothers. However, the type of pressure to provide milk perceived by mothers of VLBW infants has rarely been examined. METHODS: A retrospective and anonymous questionnaire was conducted with mothers of VLBW infants aged 6 to 24 months at the time of data collection. Quantitative data and written comments were used to examine the mothers' perceptions. Descriptive and bivariate tests (Spearman´s rho, Pearson's chi2) were performed to show correlations between pressure to provide breast milk, parental stress (PSS:NICU: role alteration subscale), milk volume, and maternal factors. Pressure to provide milk was measured through two self-developed single items to differentiate between internal and external pressures. RESULTS: Data of n = 533 mothers of VLBW infants was analysed. More than 70% of the mothers agreed that they pressured themselves to provide milk for their infant. In contrast, 34% of the mothers agreed that they felt pressure from outside to provide milk. Higher milk volume 14 days post-partum was significantly correlated with higher internal (Spearman´s rho = 0.2017, p = 0.000) and higher external pressure to provide milk (Spearman´s rho = 0.2991; p = 0.000). Higher PSS:NICU parental role alteration scores were significantly correlated with more internal (Spearman´s rho = -0.2865, p = 0.000) and more external pressure to provide milk (Spearman´s rho = -0.1478; p = 0.002). Milk volume 14 days post-partum and the PSS:NICU were not significantly correlated (Spearman´s rho = -0.0190; p = 0.701). Qualitative analyses highlighted these results and enhanced the bidirectional relationships between maternal pressure to provide milk and milk volume. CONCLUSIONS: Especially internal pressure to provide milk is perceived by many mothers, being mutually dependent on milk supply and parental stress. Pressure to provide milk may be an important factor to decrease maternal stress in the NICU and, therefore, lead to more positive pumping and breastfeeding experiences. More research and validated instruments are needed to adequately measure pressure to provide milk with its different psychological, social, and environmental dimensions.


Subject(s)
Infant, Very Low Birth Weight , Mothers , Infant, Newborn , Female , Infant , Humans , Retrospective Studies , Mothers/psychology , Breast Feeding/psychology , Milk, Human , Intensive Care Units, Neonatal
4.
Front Public Health ; 11: 1167499, 2023.
Article in English | MEDLINE | ID: mdl-37711241

ABSTRACT

Background: Pulmonary embolism (PE) is a common cardiovascular disease and health literacy is necessary to deal with its consequences after the acute event. The aim of this study was to develop and validate a new questionnaire to measure PE-specific health literacy. Methods: A mixed-methods design with qualitative and quantitative elements was used in the development process. A literature review about health literacy concepts and instruments and interviews with patients with PE and clinicians were conducted. Quantitative analyses included factor analyses, item response theory with a graded partial credit model, and reliability analyses in different test and validation samples. Furthermore, convergent and known-groups validity and responsiveness were assessed. Results: The qualitative results supported a concept of PE-related health literacy with four main topics: dealing with PE-related health information, disease management, health-related selfcare, and social support. An initial item pool of 91 items was developed. Further interviews and an online survey with patients with PE (n = 1,013) were used to reduce the number of items and to confirm structural validity. Confirmatory factor analyses in the final evaluation study with patients with PE (n = 238) indicated a good model fit of the four-factor structure. The Health Literacy in Pulmonary Embolism (HeLP)-Questionnaire showed good reliability (Cronbach's alpha: 0.82 to 0.90). All four subscales were responsive toward receiving a brochure with PE-related health information. Conclusion: The newly developed German HeLP Questionnaire comprises 23 items in four domains and showed good psychometric properties. Further evaluation of the questionnaire in different samples of patients with PE is needed.


Subject(s)
Health Literacy , Pulmonary Embolism , Humans , Reproducibility of Results , Patients , Factor Analysis, Statistical
5.
PLoS One ; 17(8): e0273115, 2022.
Article in English | MEDLINE | ID: mdl-36001620

ABSTRACT

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.


Subject(s)
Critical Pathways , Emergency Service, Hospital , Abdominal Pain/diagnosis , Abdominal Pain/therapy , Adolescent , Adult , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Research Design , Surveys and Questionnaires
6.
BMC Pediatr ; 22(1): 406, 2022 07 11.
Article in English | MEDLINE | ID: mdl-35820872

ABSTRACT

BACKGROUND: Some neonatal intensive care units offer parents webcam systems for times when they cannot be in the ward. Leaving an infant in the ward can be challenging for parents, and trust in the neonatal healthcare professionals mitigates parents' worries of not knowing how their infant is doing while they are away. If parents lack trust in the neonatal healthcare professionals, they may attempt to compensate by using webcams. In this work, we examine whether an association exists between the parental preference to use a webcam and low trust in physicians and nursing staff. METHODS: In a nationwide, retrospective cross-sectional study, parents of infants with a birth weight below 1500 g were surveyed six to 18 months after their infant's birth. Parents who were not offered a webcam system in the ward were asked whether they would have opted for it. Trust was measured by the Trust in Physician and Trust in Nursing Staff scales. RESULTS: Of the parents who were not offered a webcam, 69% would have chosen to use a webcam if they had been granted the opportunity. The decision for or against a webcam was not significantly associated with either trust in physicians (OR = 0.654, 95% CI = 0.456, 0.937, p = .124) or trust in nursing staff (OR = 1.064, 95% CI = 0.783, 1.446, p = .932). CONCLUSIONS: While the majority of parents surveyed would opt for webcam usage, this preference should not be interpreted as an indicator of lacking trust in neonatal healthcare professionals.


Subject(s)
Intensive Care Units, Neonatal , Trust , Cross-Sectional Studies , Humans , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Parents , Retrospective Studies
8.
BMC Cardiovasc Disord ; 22(1): 72, 2022 02 26.
Article in English | MEDLINE | ID: mdl-35219312

ABSTRACT

BACKGROUND: Coronary angiographies (CAs) are among the most common diagnostic procedures carried out in German hospitals, and substantial regional differences in their frequency of use have been documented. Given the heterogeneity with regard to the expected benefits and the varying scope for discretion depending on the indication for the procedure, we hypothesized that the observed variation and the association of need and supply factors differs by indication for CA. METHODS: We investigated the correlation between supply factors and the regional rates of CAs in Germany while controlling for need using spatial-autoregressive error models (SARE) and spatial cross-regressive models with autoregressive errors (SCRARE). The overall rates of CAs and the rates in specific patient subgroups, namely, patients with and without myocardial infarction (MI), were calculated based on a comprehensive set of nationwide routine data from three statutory health insurances at the district level. RESULTS: Although little variation was found in cases with MI, considerable variation was seen in the overall cases and cases without MI. The SARE models revealed a positive association between the number of hospitals with a cardiac catheterization laboratory per 10,000 population and the rates of overall cases and cases without MI, whereas no such relationship existed in cases with MI. Additionally, an association between regional deprivation and the rates of CAs was found in cases with MI, but no such association was seen in cases without MI. CONCLUSIONS: The results supported the hypothesis that the relative association of need and supply factors differed by the indication for CA. Although the regional differences in the frequency of use of CAs can only be explained in part by the factors examined in our study, it offers insight into patient access to and the provision of CA services and can provide a platform for further local research.


Subject(s)
Myocardial Infarction , Coronary Angiography , Germany/epidemiology , Hospitals , Humans , Myocardial Infarction/epidemiology , Spatial Analysis
9.
BJU Int ; 129(4): 470-479, 2022 04.
Article in English | MEDLINE | ID: mdl-34242474

ABSTRACT

OBJECTIVES: To investigate real-world haematological toxicity, overall survival (OS) and the treatment characteristics of docetaxel and cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This retrospective claims data study followed patients with mCRPC receiving cabazitaxel or docetaxel from their first chemotherapy infusion. Haematological toxicities were measured using treatment codes and inpatient diagnoses. OS was estimated using the Kaplan-Meier method. A multivariable Cox regression analysis was used to identify OS predictors. RESULTS: Data from 539 patients administered docetaxel and 240 administered cabazitaxel were analysed. Regarding adverse events, within 8 months of treatment initiation, some kind of treatment for haematological toxicity was documented in 31% of patients given docetaxel and in 61% of patients given cabazitaxel. In the same period, hospitalization associated with haematological toxicity was documented in 11% of the patients in the docetaxel cohort and in 15% of the patients in the cabazitaxel cohort. In the docetaxel cohort, 9.9% of patients required reverse isolation and 13% were diagnosed with sepsis during hospitalization. In the cabazitaxel cohort, the cumulative incidence was 7.9% and 15%, respectively. The median OS was reached at 21.9 months in the docetaxel cohort and, because of a later line of therapy, at 11.3 months in the cabazitaxel cohort. A multivariate Cox regression revealed that indicators of locally advanced and metastatic disease, severe comorbidities, and prior hormonal/cytotoxic therapies were independent predictors of early death. CONCLUSION: Cabazitaxel patients face an increased risk of haematological toxicities during treatment. Together with their short survival time, this calls for a strict indication when using cabazitaxel in patients with mCRPC.


Subject(s)
Prostatic Neoplasms, Castration-Resistant , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Docetaxel/adverse effects , Humans , Kaplan-Meier Estimate , Male , Prostatic Neoplasms, Castration-Resistant/pathology , Retrospective Studies , Taxoids , Treatment Outcome
10.
Acta Paediatr ; 111(3): 527-535, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34779058

ABSTRACT

AIM: To examine parents' perceptions of stress and their trust in physicians and nursing staff and to investigate whether trust influences the parental perceptions of potential stressors resulting from their infant's hospitalisation in a neonatal intensive care unit. METHODS: Parents of very and extremely low birth weight infants were surveyed in a nationwide retrospective cross-sectional study 6-18 months after their child's birth. Parental stress was measured utilising the PSS:NICU_German/2-scales, and trust was measured by the scales Trust in Physicians and Trust in Nursing Staff. In addition to descriptive analyses, multiple linear regression models were conducted. RESULTS: The change in parents' anticipated roles was assessed as more stressful than their infant's appearance and behaviour. Trust in nursing staff significantly influenced the parental stress level. Although the level of trust in physicians was rated higher than trust in nursing staff, trust in physicians did not yield a significant effect on the parental stress experience. CONCLUSION: Efforts to foster parental trust in nursing staff may reduce the parental stress level and hence enable parents to better cope with the situation. The parental resources unleashed in this way can be employed to enhance parenting.


Subject(s)
Parents , Trust , Child , Cross-Sectional Studies , Humans , Infant , Infant, Newborn , Infant, Premature , Intensive Care Units, Neonatal , Retrospective Studies , Stress, Psychological
11.
BMC Health Serv Res ; 21(1): 456, 2021 May 12.
Article in English | MEDLINE | ID: mdl-33980220

ABSTRACT

BACKGROUND: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences. METHODS: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data. DISCUSSION: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them. TRIAL REGISTRATION: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.


Subject(s)
Intensive Care Units, Neonatal , Parents , Child , Cross-Over Studies , Focus Groups , Humans , Infant , Infant, Newborn , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Surveys and Questionnaires
12.
Pharmacoecon Open ; 5(2): 299-310, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32474839

ABSTRACT

PURPOSE: Treatments for patients with metastatic castration-resistant prostate cancer (mCRPC) have expanded rapidly. They include the chemotherapies docetaxel and cabazitaxel, hormonal drugs abiraterone and enzalutamide, and best supportive care (BSC). Cabazitaxel has proven to be the last life-prolonging option, associated with a significant risk of serious adverse events. Given the lack of real-world evidence, we aimed to compare healthcare resource utilization (HRU) and costs in patients with mCRPC treated with cabazitaxel, docetaxel, abiraterone, enzalutamide, and BSC. METHODS: We used 2014-2017 claims data from a large German statutory health insurance fund, the Techniker Krankenkasse, to identify patients with mCRPC. Patient allocation to individual therapy regimens was based on clinical knowledge and included therapy cycles, duration of therapy, and continuous treatment. The study period lasted from the first claim until death, the end of data availability, a drug switch, or discontinuation of therapy, whichever came first. Multivariate regression models were used to compare monthly all-cause and mCRPC-related HRU and costs across cohorts by adjusting for baseline covariates (including age and comorbidities). RESULTS: The 3944 identified patients with mCRPC initiated treatment with cabazitaxel (n = 240), docetaxel (n = 539), abiraterone (n = 486), enzalutamide (n = 351), or BSC (n = 2328). In most domains, HRU was highest in the cabazitaxel cohort and lowest in the BSC group. Accordingly, the highest all-cause and mCRPC-related costs per month, respectively, were observed in patients receiving cabazitaxel (€7631/€6343), followed by abiraterone (€5226/€4579), enzalutamide (€5079/€4416), docetaxel (€2392/€1580), and BSC (€959/€438). Cost variations were mostly attributable to drugs, inpatient treatment, and sick leave payments. CONCLUSION: mCRPC treatment imposes a high economic burden on statutory health insurance. Cabazitaxel is associated with substantially higher expenses, resulting from higher drug costs and a greater need for inpatient treatment. As mCRPC continues to be incurable, decision makers and clinician leaders should carefully evaluate public access to innovative agents and optimal treatment strategies.

13.
Thorac Cardiovasc Surg ; 69(7): 599-606, 2021 Oct.
Article in English | MEDLINE | ID: mdl-33339068

ABSTRACT

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are available for revascularization of coronary artery disease (CAD) with the aims to reduce cardiovascular morbidity and mortality and to improve disease-related quality of life in particular. The German National Care Guideline (NVL-cKHK) on chronic CAD recommends the establishment of so-called heart teams for decision making in myocardial revascularization to improve the quality of care. Preferred recommendations for PCI or CABG are given for different patient subgroups depending on patient characteristics, concomitant diseases, and coronary morphology. The myocardial revascularization study (REVASK) is a noninterventional cohort study on care of patients undergoing PCI or CABG based on retrospective statutory health insurance (SHI) routine data, registry data from the German Cardiac Society (DGK) resp., the German Society for Thoracic and Cardiovascular Surgery (DGTHG), combined with prospective primary data collection from health care providers and patients. The primary goal is to investigate whether and to which extent heart teams, consisting of cardiologists and cardiac surgeons, increase guideline adherence in decision making for myocardial revascularization. Ultimately the study project aims to improve patient care in terms of decision making for appropriate myocardial revascularization. Through the consistent implementation of the German National Care Guideline on chronic Coronary Artery Disease (NVL-cKHK) and the European Guidelines on myocardial revascularization, the reduction of morbidity, mortality and the reduced need for subsequent revascularization procedures are also desirable from a health economics perspective.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Cohort Studies , Coronary Artery Disease/diagnosis , Coronary Artery Disease/surgery , Delivery of Health Care , Humans , Multicenter Studies as Topic , Myocardial Revascularization , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Quality of Life , Retrospective Studies , Treatment Outcome
14.
BMJ Open ; 10(12): e042886, 2020 12 13.
Article in English | MEDLINE | ID: mdl-33318120

ABSTRACT

OBJECTIVES: To determine the prescription of guideline recommended drug therapy in patients with stable coronary heart disease (sCHD) prior to percutaneous coronary intervention (PCI) in Germany and to examine the role of patient characteristics and features of regional healthcare supply in a multilevel model. DESIGN: Secondary data analysis of factors associated with the prescription of guideline recommended drug therapy using a multilevel model to analyse regional-level effects, over and above the effects of patient-level demographic and health status. SETTING: Office-based prescriptions in the year prior to the invasive procedure. PARTICIPANTS: A linked nationwide dataset from Germany's three largest statutory health insurance funds of all patients receiving PCI in the year 2016. MAIN OUTCOME MEASURES: Patients' odds of receiving optimal medical therapy and symptom-oriented therapy within 1 year prior to PCI. RESULTS: 68.6% of patients received at least one lipid-lowering drug and one symptom-oriented therapy prior to PCI. 43.6% received at least two agents to control their symptoms. Patients who received treatment in accordance with the recommendations had a greater number of diagnosed risk factors, a more severe history of cardiac disease and used a higher volume of ambulatory office-based physician services. The prescriptions prevalence for the symptom-oriented therapies differed significantly between eastern and western Germany, with a higher prevalence in the eastern districts. CONCLUSIONS: Guidelines can only provide decision-making corridors, and the applicability of recommendations must always be assessed on a case by case basis. Nevertheless, our analysis indicates that the prevalence of prescriptions in routine practice is subject to substantial variation and that conservative therapy options are not fully exhausted prior to PCI. This suggests that there might be room for improvement in the care of patients with sCHD.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Coronary Artery Disease/drug therapy , Coronary Artery Disease/epidemiology , Germany/epidemiology , Guideline Adherence , Humans , Multilevel Analysis , Treatment Outcome
15.
Article in English | MEDLINE | ID: mdl-33120886

ABSTRACT

The data linkage of different data sources for research purposes is being increasingly used in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to provide methodological guidelines and recommendations for research projects that have been consented to across different German research societies. Another aim is to endow readers with a checklist for the critical appraisal of research proposals and articles. This Good Practice Data Linkage (GPD) was already published in German in 2019, but the aspects mentioned can easily be transferred to an international context, especially for other European Union (EU) member states. Therefore, it is now also published in English. Since 2016, an expert panel of members of different German scientific societies have worked together and developed seven guidelines with a total of 27 practical recommendations. These recommendations include (1) the research objectives, research questions, data sources, and resources; (2) the data infrastructure and data flow; (3) data protection; (4) ethics; (5) the key variables and linkage methods; (6) data validation/quality assurance; and (7) the long-term use of data for questions still to be determined. The authors provide a rationale for each recommendation. Future revisions will include new developments in science and updates of data privacy regulations.


Subject(s)
Information Storage and Retrieval/standards , Research Design , Translations , Language
16.
Endoscopy ; 52(12): 1103-1110, 2020 12.
Article in English | MEDLINE | ID: mdl-32869229

ABSTRACT

BACKGROUND : The efficacy and safety of over-the-scope (OTS) clips in the colon is limited. This study aimed to evaluate OTS clip use in the colon in routine colonoscopy. METHODS: Using administrative data from a large health insurance company, patients with OTS clip placement during colonoscopy were identified and analyzed by specific administrative codes. Indication for OTS clipping was analyzed, and follow-up was evaluated for surgical and repeat endoscopic interventions. RESULTS: In 505 patients, indications for OTS clips were iatrogenic perforations (n = 80; Group A), polypectomy (n = 315; Group B), colonic bleeding (n = 51; Group C), and various underlying diseases (n = 59; Group D). In 11 Group A patients (13.8 %), surgical interventions occurred, mostly within 24 hours after clipping (n = 9), predominantly overstitching (n = 8). OTS clipping during polypectomy (Group B) was for complications (e. g. bleeding in 27 %) or was applied prophylactically. Only five patients required early surgery, three of whom had colorectal cancer. In four Group C patients (7.8 %), surgical resections were performed (persistent bleeding n = 1, colorectal cancer n = 2), while six patients underwent early repeat colonoscopy for recurrent bleeding. During further follow-up (days 11-30), 17 patients underwent resection for colonic neoplasms (n = 12) or persistent bleeding (n = 4), but only one case could be directly traced back to local OTS clip complication. CONCLUSION: Colonic OTS clipping appears safe and effective in selected indications and complications in clinical routine but must be anatomically and technically feasible, avoiding overuse.


Subject(s)
Colonic Diseases , Surgical Instruments , Colonic Diseases/surgery , Colonoscopy , Humans , Retrospective Studies , Treatment Outcome
17.
BMJ Open ; 10(9): e038776, 2020 09 17.
Article in English | MEDLINE | ID: mdl-32948571

ABSTRACT

INTRODUCTION: Quality of emergency department (ED) care affects patient outcomes substantially. Quality indicators (QIs) for ED care are a major challenge due to the heterogeneity of patient populations, health care structures and processes in Germany. Although a number of quality measures are already in use, there is a paucity of data on the importance of these QIs on medium-term and long-term outcomes. The evaluation of outcome relevance of quality indicators in the emergency department study (ENQuIRE) aims to identify and investigate the relevance of QIs in the ED on patient outcomes in a 12-month follow-up. METHODS AND ANALYSIS: The study is a prospective non-interventional multicentre cohort study conducted in 15 EDs throughout Germany. Included are all patients in 2019, who were ≥18 years of age, insured at the Techniker Krankenkasse (statutory health insurance (SHI)) and gave their written informed consent to the study.The primary objective of the study is to assess the effect of selected quality measures on patient outcome. The data collected for this purpose comprise medical records from the ED treatment, discharge (claims) data from hospitalised patients, a patient questionnaire to be answered 6-8 weeks after emergency admission, and outcome measures in a 12-month follow-up obtained as claims data from the SHI.Descriptive and analytical statistics will be applied to provide summaries about the characteristics of QIs and associations between quality measures and patient outcomes. ETHICS AND DISSEMINATION: Approval of the leading ethics committee at the Medical Faculty of the University of Magdeburg (reference number 163/18 from 19 November 2018) has been obtained and adapted by responsible local ethics committees.The findings of this work will be disseminated by publication of peer-reviewed manuscripts and presentations as conference contributions (abstracts, poster or oral presentations).Moreover, results will be discussed with clinical experts and medical associations before being proposed for implementation into the quality management of EDs. TRIAL REGISTRATION NUMBER: German Clinical Trials Registry (DRKS00015203); Pre-results.


Subject(s)
Emergency Service, Hospital , Quality Indicators, Health Care , Cohort Studies , Germany , Humans , Multicenter Studies as Topic , Prospective Studies
18.
Clin Transl Gastroenterol ; 12(1): e00279, 2020 12 22.
Article in English | MEDLINE | ID: mdl-33464730

ABSTRACT

INTRODUCTION: Given the sparsity of longitudinal studies on colonoscopy use, we quantified utilization of repeat colonoscopy within 10 years and the proportion of persons with polypectomies at first repeat colonoscopy using a large German claims database. METHODS: Based on the German Pharmacoepidemiological Research Database, we identified persons who underwent colonoscopy between 2006 and 2015 (index colonoscopy) and assessed colonoscopies and polypectomies during follow-up. We defined 3 subcohorts based on available procedure/diagnosis codes at index colonoscopy: persons with snare polypectomy, which is reimbursable for lesions ≥5 mm in size (cohort 1), with a forceps polypectomy (cohort 2), and without such procedures/diagnoses (cohort 3). We stratified all analyses by diagnostic vs screening index colonoscopy. RESULTS: Overall, we included 3,076,657 persons (cohort 1-3: 15%, 13%, 72%). Among persons with screening index colonoscopy (30%), the proportions with a repeat colonoscopy within 10 years in cohorts 1, 2, and 3 were 78%, 66%, and 43%, respectively, and a snare polypectomy at first repeat colonoscopy was performed in 27%, 17%, and 12%, respectively. In cohort 1, 32% of persons with a (first) repeat colonoscopy after 9 years had a snare polypectomy (after 3 years: 25%). Among persons with diagnostic index colonoscopies, 80%, 78%, and 65% had a repeat colonoscopy, and 27%, 17%, and 10% had a snare polypectomy at first repeat colonoscopy, respectively. DISCUSSION: Our study suggests substantial underuse of repeat colonoscopy among persons with previous snare polypectomy and overuse among lower risk groups. One-quarter of persons with a snare polypectomy at baseline had another snare polypectomy at first repeat colonoscopy.


Subject(s)
Colonic Polyps/surgery , Colonoscopy/statistics & numerical data , Colorectal Neoplasms/prevention & control , Mass Screening/statistics & numerical data , Patient Acceptance of Health Care/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Colon/diagnostic imaging , Colon/surgery , Colonic Polyps/diagnosis , Colorectal Neoplasms/diagnosis , Female , Follow-Up Studies , Germany , Health Services Misuse/statistics & numerical data , Humans , Intestinal Mucosa/diagnostic imaging , Intestinal Mucosa/surgery , Longitudinal Studies , Male , Middle Aged , Young Adult
19.
Gesundheitswesen ; 81(8-09): 636-650, 2019 Aug.
Article in German | MEDLINE | ID: mdl-31394579

ABSTRACT

Individual data linkage of different data sources for research purposes is being increasingly used in Germany in recent years. However, generally accepted methodological guidance is missing. The aim of this article is to define such methodological standards for research projects. Another aim is to provide readers with a checklist for critical appraisal of research proposals and articles. Since 2016, an expert panel of members of different German scientific societies have worked together and developed 7 guidelines with a total of 27 practical recommendations. These recommendations include (1) research aims, questions, data sources and resources, (2) infrastructure and data flow, (3) data privacy, (4) ethics, (5) key variables and type of linkage, (6) data validation/quality assurance and (7) long-term use for future research questions. The authors provide a rationale for each recommendation. Future revisions will include any new developments in science and data privacy.


Subject(s)
Information Storage and Retrieval , Research Design , Germany , Humans
20.
Appl Health Econ Health Policy ; 16(5): 735-744, 2018 10.
Article in English | MEDLINE | ID: mdl-30039347

ABSTRACT

BACKGROUND: Innovative technologies challenge healthcare systems, as evidence on costs and benefits frequently usually are slow to reflect new technology. We investigated these dynamics for Germany, using the emergence of transcatheter aortic valve implementation (TAVI) as an alternative to conventional aortic valve replacements (CAVR). OBJECTIVE: We focused on the role of patient co-morbidity-which would be a medical explanation for adopting TAVI-and hospital ownership status, hypothesizing that for-profit facilities are more likely to capitalize on the favorable reimbursement conditions of TAVI. METHODS: The analysis uses claims data from the Techniker Krankenkasse, the largest health insurance fund in Germany, for the years 2009-2015, covering 2892 patients with TAVI and 9523 with CAVR. The decision on TAVI versus CAVR was estimated for patient-level data, that is, socioeconomic data as well as co-morbidity. At the hospital level, we included the ownership type. We also controlled for effects of the respective owner (rather than the type of ownership), including a random intercept. RESULTS: While the co-morbidity score of TAVI patients was much higher in the early years, over time, the score almost converged with that of CAVR patients. This is in agreement with emerging evidence that suggests the use of TAVI also leads to better patient outcomes. Our results indicate that the type of ownership does not drive the switch to TAVI. We found little, if any, effect from the respective owner, regardless of ownership type. CONCLUSION: Overall, the effects of co-morbidity suggest that providers acted responsibly when adopting TAVI while evidence was still emerging.


Subject(s)
Aortic Valve Stenosis/surgery , Hospitals, Proprietary/statistics & numerical data , Hospitals, Voluntary/supply & distribution , Transcatheter Aortic Valve Replacement , Adult , Aged , Aged, 80 and over , Aortic Valve Stenosis/epidemiology , Comorbidity , Female , Germany , Heart Valve Prosthesis Implantation/economics , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/statistics & numerical data , Humans , Male , Middle Aged , Reimbursement Mechanisms/economics , Reimbursement Mechanisms/statistics & numerical data , Transcatheter Aortic Valve Replacement/economics , Transcatheter Aortic Valve Replacement/statistics & numerical data , Treatment Outcome
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