Dominikus Stelzer

Objectives Structured Early detection of Asymptomatic Liver fibrosis and cirrhosis (SEAL) is a population-based screening programme using non-invasive tests for the early detection of liver fibrosis. This study evaluates the cost implications if the SEAL programme were to be implemented in routine care in Germany. Design This study models cost differences with and without the SEAL screening programme. We regress costs of care on patient characteristics (age, comorbidities, sex, liver diseases, liver cancer and liver fibrosis and cirrhosis (LCI) stage) using statutory health insurance (SHI) data from routine care patients with LCI (n=4177). Based on these results, we predict per-patient costs for the patients newly diagnosed with LCI by SEAL (n=45). Costs with and without screening are estimated using patient age and LCI stage distributions from either SEAL or routine care. Setting SEAL was conducted in two German states. Initial screening was performed by patients’ primary care physicians. Participants Individuals insured by SHI without a prior diagnosis of LCI, eligible for Check-up 35, a general health check-up programme primarily targeting adults aged 35 and older, conducted by primary care physicians. Interventions Screening via aspartate aminotransferase to platelet ratio index in primary care, for further evaluation serological diagnostics and ultrasound examinations in secondary care and specific assessment for definite diagnosis including transient elastography and liver biopsy for selected cases in tertiary care. Primary and secondary outcome measures Primary outcome measures: expected 5-year cost changes for SEAL patients diagnosed with fibrosis or cirrhosis compared to costs without a screening programme. Secondary outcome measures: case mix of leading chronic liver disease and LCI stages among patients diagnosed with advanced fibrosis or cirrhosis in SEAL versus routine care without screening. Results Screening leads to fewer decompensated cases at initial diagnosis (4.6% in SEAL vs 22.8% in routine care) and thus savings in the costs of care within the first years of diagnosis: total expected costs per case were €2175 lower (bias-corrected bootstrap CIs (BCI): €527 to 3734), and LCI-associated costs were reduced by €1218 (BCI: €296 to 2164). Comparing the savings to the additional costs of diagnosis (range: €1575–1726 per detected LCI case) reveals that average changes in costs with screening range from moderate savings to moderate extra costs. Conclusions SEAL liver screening identifies patients in less advanced stages of LCI. If only costs were considered that are directly attributable to LCI, savings within 5 years are unlikely to fully outweigh the costs of screening. However, since this approach might miss additional LCI-related costs, SEAL appears to be cost-neutral compared with routine care when considering total healthcare costs. Registration number The SEAL registration number is DRKS00013460. This study relates to its results.

Background: The advancement of Artificial Intelligence, particularly Large Language Models (LLMs), is rapidly progressing. LLMs, such as OpenAI’s GPT, are becoming vital in scientific and medical processes, including text production, knowledge synthesis, translation, patient communication and data analysis. However, the outcome quality needs to be evaluated to assess the full potential for usage in statistical applications. LLMs show potential for all research areas, including teaching. Integrating LLMs in research, education and medical care poses opportunities and challenges, depending on user competence, experience and attitudes. Objective: This project aims at exploring the use of LLMs in supporting statistical consulting by evaluating the utility, efficiency and satisfaction related to the use of LLMs in statistical consulting from both advisee and consultant perspective. Within this project, we will develop, execute and evaluate a training module for the use of LLMs in statistical consulting. In this context, we aim to identify the strengths, limitations and areas for potential improvement. Furthermore, we will explore experiences, attitudes, fears and current practices regarding the use of LLMs of the staff at the Medical Center and the University of Freiburg. Materials and methods: This multimodal study includes four study parts using qualitative and quantitative methods to gather data. Study part (I) is designed as mixed mode study to explore the use of LLMs in supporting statistical consulting and to evaluate the utility, efficiency and satisfaction related to the use of LLMs. Study part (II) uses a standardized online questionnaire to evaluate the training module. Study part (III) evaluates the consulting sessions using LLMs from advisee perspective. Study part (IV) explores experiences, attitudes, fears and current practices regarding the use of LLMs of the staff at the Medical Center and the University of Freiburg. This study is registered at the Freiburg Registry of Clinical Studies under the ID: FRKS004971.

This document reports a brief update to the previously published protocol of the MinDial study.Trial registration German Clinical Trials Register DRKS00029691. Registered on 12 Sept. 2022, https://drks.de/search/en/trial/DRKS00029691.

Background: Early identification of patients with chronic kidney disease (CKD) and advancing kidney insufficiency, followed by specialist care, can decelerate the progression of the disease. However, awareness of the importance and possible consequences of kidney insufficiency is low among doctors and patients. Since kidney insufficiency can be asymptomatic even in higher stages, it is often not even known to those belonging to risk groups. This study aims to clarify whether, for hospitalised patients with advanced chronic kidney disease, a risk-based appointment with a nephrology specialist reduces disease progression. Methods: The target population of the study is hospitalised CKD patients with an increased risk of end-stage renal disease (ESRD), more specifically with an ESRD risk of at least 9% in the next 5 years. This risk is estimated by the internationally validated Kidney Failure Risk Equation (KFRE). The intervention consists of a specific appointment with a nephrology specialist after the hospital stay, while control patients are discharged from the hospital as usual. Eight medical centres include participants according to a stepped-wedge design, with randomised sequential centre-wise crossover from recruiting patients into the control group to recruitment to the intervention. The estimated glomerular filtration rate (eGFR) is measured for each patient during the hospital stay and after 12 months within the regular care by the general practitioner. The difference in the change of the eGFR over this period is compared between the intervention and control groups and considered the primary endpoint. Discussion: This study is designed to evaluate the effect of risk-based appointments with nephrology specialists for hospitalised CKD patients with an increased risk of end-stage renal disease. If the intervention is proven to be beneficial, it may be implemented in routine care. Limitations will be examined and discussed. The evaluation will include further endpoints such as non-guideline-compliant medication, economic considerations and interviews with contributing physicians to assess the acceptance and feasibility of the intervention. Trial registration: German Clinical Trials Register DRKS00029691. Registered on 12 September 2022.

Objective: This study aimed to explore psychosocial consequences of (false) positive liver screening results and to identify influencing factors for perceived strain within a multistage screening programme for liver cirrhosis and fibrosis in Germany.Methods: Between June 2018 and May 2019, all positively screened patients were asked to participate in the study (n = 158). N = 11 telephone interviews and n = 4 follow‐up interviews were conducted. Semi‐structured telephone interviews were carried out. The analysis followed a structuring content analysis approach. Thereby, categories were first defined deductively. Second, the categories were revised inductively based on the data.Results: The main themes found regarding the consequences of the screening were categorised in emotional reactions and behavioural reactions. Few respondents described negative emotional consequences related to screening. Those seem to be mostly driven by suboptimal patient–provider communication and might be worsened when transparent information transfer fails to happen. As a result, patients sought information and support in their social environment. All patients reported positive attitudes towards liver screening.Conclusion: To reduce the potential occurrence of psychosocial consequences during the screening process, medical screening should be performed in the context of transparent information. Regular health communication on the side of health professionals and increasing patients' health literacy might contribute to avoiding negative emotions in line with screening.Patient or Public Contribution: This study recognises the wide‐ranging patients' perspectives regarding the consequences of liver screening which should be taken into consideration when implementing a new screening programme to ensure a patient‐centred approach.

Background: The regional integrated health care model “Healthy Kinzigtal” started in 2006 with the goal of optimizing health care and economic efficiency. The INTEGRAL project aimed at evaluating the effect of this model on the quality of care over the first 10 years. Methods: This methodological protocol supplements the study protocol and the main publication of the project. Comparing quality indicators based on claims data between the intervention region and 13 structurally similar control regions constitutes the basic scientific approach. Methodological key issues in performing such a comparison are identified and solutions are presented. Results: A key step in the analysis is the assessment of a potential trend in prevalence for a single quality indicator over time in the intervention region compared to the corresponding trends in the control regions. This step has to take into account that there may be a common - not necessarily linear - trend in the indicator over time and that trends can also appear by chance. Conceptual and statistical approaches were developed to handle this key step and to assess in addition the overall evidence for an intervention effect across all indicators. The methodology can be extended in several directions of interest. Conclusions: We believe that our approach can handle the major statistical challenges: population differences are addressed by standardization; we offer transparency with respect to the derivation of the key figures; global time trends and structural changes do not invalidate the analyses; the regional variation in time trends is taken into account. Overall, the project demanded substantial efforts to ensure adequateness, validity and transparency.