How to Make Outpatient Healthcare Data in Germany Available for Research in the Dynamic Course of Digital Transformation.

INTRODUCTION: There is increasing interest on re-use of outpatient healthcare data for research, as most medical diagnosis and treatment is provided in the ambulatory sector. One of the early projects to bring primary data from German ambulatory care into clinical research technically, organizationally and in compliance with legal demands has been the RADAR project, that is based on a broad consent and has used the then available practice information system's interfaces to extract and transfer data to a research repository. In course of the digital transformation of the German healthcare system, former standards are abandoned and new interoperability standards, interfaces and regulations on secondary use of patient data are defined, however with slow adoption by Health-IT systems. Therefore, it is of importance for all initiatives that aim at using ambulatory healthcare data for research, how to access this data in an efficient and effective way. METHODS: Currently defined healthcare standards are compared regarding coverage of data relevant for research as defined by the RADAR project. We compare four architectural options to access ambulatory health data through different components of healthcare and health research data infrastructures along the technical, organizational and regulatory conditions, the timetable of dissemination and the researcher's perspective. RESULTS: A high-level comparison showed a high degree of semantic overlap in the information models used. Electronic patient records and practice information systems are alternative data sources for ambulatory health data - but differ strongly in data richness and accessibility. CONCLUSION: Considering the compared dimensions of architectural routes to access health data for secondary research use we conclude that data extraction from practice information systems is currently the most promising way due to data availability on a mid-term perspective. Integration of routine data into the national research data infrastructures might be enforced by convergence of to date different information models.

Different definitions of multimorbidity and their effect on prevalence rates: a retrospective study in German general practices.

BACKGROUND: Multimorbidity is common among general practice patients and increases a general practitioner's (GP's) workload. But the extent of multimorbidity may depend on its definition and whether a time delimiter is included in the definition or not. AIMS: The aims of the study were (1) to compare practice prevalence rates yielded by different models of multimorbidity, (2) to determine how a time delimiter influences the prevalence rates and (3) to assess the effects of multimorbidity on the number of direct and indirect patient contacts as an indicator of doctors' workload. METHODS: This retrospective observational study used electronic medical records from 142 German general practices, covering 13 years from 1994 to 2007. The four models of multimorbidity ranged from a simple definition, requiring only two diseases, to an advanced definition requiring at least three chronic conditions. We also included a time delimiter for the definition of multimorbidity. Descriptive statistics, such as means and correlation coefficients, were applied. FINDINGS: The annual percentage of multimorbid primary care patients ranged between 84% (simple model) and 16% (advanced model) and between 74% and 13% if a time delimiter was included. Multimorbid patients had about twice as many contacts annually than the remainder. The number of contacts were different for each model, but the ratio remained similar. The number of contacts correlated moderately with patient age (r = 0.35). The correlation between age and multimorbidity increased from model to model up to 0.28 while the correlations between contacts and multimorbidity varied around 0.2 in all four models. CONCLUSION: Multimorbidity seems to be less prevalent in primary care practices than usually estimated if advanced definitions of multimorbidity and a temporal delimiter are applied. Although multimorbidity increases in any model a doctor's workload, it is especially the older person with multiple chronic diseases who is a challenge for the GP.

[Secondary Use of Electronic Medical Record Data from Primary Health Care is Feasible: Report from RADAR Project]. / Sekundäre Nutzung von hausärztlichen Routinedaten ist machbar ­ Bericht vom RADAR Projekt.

Objectives It is difficult to obtain longitudinal 'real world' data from ambulatory medical care in Germany in a systematic way. Our vision is a large German research data repository featuring representative, anonymized patient and outpatient health care data, longitudinal, continuously updated and across different providers, offering a perspective of linking secondary care data or additional data obtained from research cohorts, for example patient reported data or biodata, and will be accessible for other researchers. Here we report specific methods and results from the RADAR project.Methods Survey of legislation, design of technical processes and organisational solutions, with a feasibility study to evaluate technical and content functionality, acceptability and performance fitness for health services research questions.Results In 2016, a multi-disciplinary scientific team initiated the development of a privacy protection and IT security concept for data exported from the electronic medical records (EMR) of physicians' practices in line with the European General Data Protection Regulation. Technical and organisational requirements for lawful research infrastructure were developed and executed for use in a specific case, namely ̒oral anticoagulation'. In 7 Lower Saxonian general practices, 100 patients were selected by their physician and their data - reduced to 40 essential data fields - extracted from EMR via a mandatory software interface after informed consent. Still in the practice, the data were split into identifying or medical data. These were encrypted and transferred either to a trusted third party (TTP) or to a data repository, respectively. 75 patients who met our inclusion criteria (minimum of one year of oral anticoagulation treatment) received a quality-of-life questionnaire via the TTP. Of the 66 returns, 63 responses were then linked to the EMR data in the repository.Conclusion Results from RADAR project proved the technical and organisational feasibility of lawful, pseudonymised data acquisition and the linkage of questionnaires to EMR data. The protecting concepts privacy by design and data minimization (Art. 25 GDPR with Recital 78) were implemented. Without informed consent, secondary use of routine data from ambulatory care which are sufficiently anonymized but still meaningful is all but impossible under current German law.

Designing and piloting a generic research architecture and workflows to unlock German primary care data for secondary use.

BACKGROUND: Medical data from family doctors are of great importance to health care researchers but seem to be locked in German practices and, thus, are underused in research. The RADAR project (Routine Anonymized Data for Advanced Health Services Research) aims at designing, implementing and piloting a generic research architecture, technical software solutions as well as procedures and workflows to unlock data from family doctor's practices. A long-term medical data repository for research taking legal requirements into account is established. Thereby, RADAR helps closing the gap between the European countries and to contribute data from primary care in Germany. METHODS: The RADAR project comprises three phases: (1) analysis phase, (2) design phase, and (3) pilot. First, interdisciplinary workshops were held to list prerequisites and requirements. Second, an architecture diagram with building blocks and functions, and an ordered list of process steps (workflow) for data capture and storage were designed. Third, technical components and workflows were piloted. The pilot was extended by a data integration workflow using patient-reported outcomes (paper-based questionnaires). RESULTS: The analysis phase resulted in listing 17 essential prerequisites and guiding requirements for data management compliant with the General Data Protection Regulation (GDPR). Based on this list existing approaches to fulfil the RADAR tasks were evaluated-for example, re-using BDT interface for data exchange and Trusted Third Party-approach for consent management and record linkage. Consented data sets of 100 patients were successfully exported, separated into person-identifying and medical data, pseudonymised and saved. Record linkage and data integration workflows for patient-reported outcomes in the RADAR research database were successfully piloted for 63 responders. CONCLUSION: The RADAR project successfully developed a generic architecture together with a technical framework of tools, interfaces, and workflows for a complete infrastructure for practicable and secure processing of patient data from family doctors. All technical components and workflows can be reused for further research projects. Additionally, a Trusted Third Party-approach can be used as core element to implement data privacy protection in such heterogeneous family doctor's settings. Optimisations identified comprise a fully-electronic consent recording using tablet computers, which is part of the project's extension phase.

[The risk of re-identification when analyzing electronic health records: a critical appraisal and possible solutions]. / Das Risiko von Re-Identifizierung bei der Auswertung medizinischer Routinedaten ­ Kritische Bewertung und Lösungsansätze.

BACKGROUND AND OBJECTIVES: The use of primary care data gathered from electronic health records in local practices could be an important building block for the future of health services research. However, the risks and reservations associated with using this data for research purposes should not be underestimated. We show the data protection and privacy problems that may arise through secondary analysis of routine primary care data and describe the technical solutions that are available to address these concerns - as a trust-building measure. METHODS: We screened 40 variables that are deemed important for documentation in the electronic health records of primary care physicians and rated the risk of patient re-identification when using these records from routine medical data for research purposes. The criteria used to rate the risk of re-identification were "expert perception" (inferences of a professional observer of phenotypical characteristics which are documented in the 40 variables), "researchable additional knowledge" (knowledge of characteristics of a person through publicly available information and social media networks), and "statistic frequency" according to diagnosis and medication statistics. RESULTS: Diagnoses and reasons for contacting a general practitioner can contain particularly identifiable characteristics such as "obesity" (ICD-10 E66) and "nicotine dependence" (F17). About half of all ICD codes documented in primary care fall below a critical threshold value in their absolute frequency; this is all the more problematic if diagnoses allow for re-identification due to phenotypical characteristics. Medication information holds little potential risk of re-identification of a person. However, the application of medications could be a source of re-identification, e. g., self-injections of insulin or use of inhalators. Information about times and dates are especially sensitive for the re-identification of a person. Sex and age of a patient generally pose no problems, except in the case of very young or very old individuals when these age groups are seldom represented in the practice. DISCUSSION: Routine health data are, in principle, sensitive data. Knowledge about the variables in primary care data gathered from electronic health records in local practices and the evaluation of this data allow us to more accurately estimate the risk of re-identification for the persons concerned. In particular, chronic diagnoses and/or diagnoses in long text, calendar dates for patient contacts and therapies bear a high risk of re-identification. Technical measures such as removing data, masking values and coding should make re-identification considerably more difficult. There will always be a remaining risk of re-identification which should be openly discussed to counteract concerns about a lack of data protection or a sweeping critique of digitization in healthcare.

[Obstacles in Secondary Analysis of Routine Data From Primary Care]. / Hindernisse bei der sekundären Nutzung hausärztlicher Routinedaten.

BACKGROUND: Routinely recorded data from everyday ambulatory medical care are urgently needed for health services and systems research, but this faces major limitations in Germany. In 2018, European General Data Protection Regulation (GDPR) and new German Federal Data Protection Act (FDPA) become effective. Via simulated real-life scenarios it may be possible to find out if access to and utilization of routine data for research becomes easier or faces additional obstacles. METHODS: General practitioners, information scientists, data trustees and privacy protection experts create concepts, processes and standards for lawful handling of routinely recorded data for secondary research and study their feasibility in 2 scenarios (anonymous and pseudonymous data utilization). From the point of view of technical assessment and privacy protection, technical and organizational obstacles are presented as well as the legal framework. RESULTS: Outdated software interface, insufficient maintenance by software vendors, burdens associated with organization and cost as well as poor IT standards place obstacles to systematic and longitudinal use of healthcare routine data. Future pan-European law for privacy protection will allow research utilization of ambulatory data in principle. However, there are persisting conflicts between individual (fundamental right of privacy protection) and public interests (research for quality and efficiency of public spending; European market's free exchange of goods and services). This becomes evident especially when using routine data via pseudonymization. DISCUSSION: Neither insurmountable hurdles by privacy protecting law nor a threat from Big Data are currently the major obstacles to secondary utilization of routine data but real-life problems at the technology and operational level. GDPR and FDPA that have become into effect in May 2018 have improved European legal unity and transparency of patients' interests. Tension between privacy protection of data on an identified or identifiable person and scientific utilization and exchange of such data in public interest necessitates additional legal clarification. One possible solution, an advanced and ready-to-use software interface, awaits implementation.

The linguistic validation of the gut feelings questionnaire in three European languages.

BACKGROUND: Physicians' clinical decision-making may be influenced by non-analytical thinking, especially when perceiving uncertainty. Incidental gut feelings in general practice have been described, namely, as "a sense of alarm" and "a sense of reassurance". A Dutch Gut Feelings Questionnaire (GFQ) was developed, validated and afterwards translated into English following a linguistic validation procedure. The aims were to translate the GFQ from English into French, German and Polish; to describe uniform elements as well as differences and difficulties in the linguistic validation processes; to propose a procedural scheme for future GFQ translations into other languages. METHODS: We followed a structured, similar and equivalent procedure. Forward and backward-translations, repeated consensus procedures and cultural validations performed in six steps. Exchanges between the several research teams, the authors of the Dutch GFQ, and the translators involved continued throughout the procedure. RESULTS: 12 translators, 52 GPs and 8 researchers in the field participated to the study in France, Germany, Switzerland and Poland. The collaborating research teams created three versions of the 10-item GFQ. Each research team found and agreed on compromises between comparability and similarity on one hand, and linguistic and cultural specificities on the other. CONCLUSIONS: The gut feeling questionnaire is now available in five European languages: Dutch, English, French, German and Polish. The uniform procedural validation scheme presented, and agreed upon by the teams, can be used for the translation of the GFQ into other languages. Comparing results of research into the predictive value of gut feelings and into the significance of the main determinants in five European countries is now possible.

COGITA network has constructed a glossary of diagnostic reasoning terms.

The role of gut feelings in diagnostic reasoning is recognized by most GPs throughout Europe, and probably throughout the world. Studies on this topic have emerged from different countries but there is the risk that authors will use different terms for similar concepts. The European Expert Group on Cognitive and Interactive Processes in Diagnosis and Management in General Practice, COGITA for short, was founded in 2008 to conduct cross-border research in the area of non-analytical diagnostic reasoning. Academic GPs, PhD students, psychologists, linguists and students meet once a year to share their experiences, exchange results and initiate new studies on the topic. A milestone in their research is this publication of a short glossary of diagnostic reasoning terms relating to the gut feelings research topic. It was constructed by the COGITA group members following a literature review, which aimed to define salient terms used in their publications. They described the terms, cross-reviewed the wording and reached consensus within the group. Two sections were created: (1) a diagnostic reasoning section that describes concepts such as analytical and non-analytical reasoning, clinical mind lines, and intuition, and (2) a research methods section describing concepts such as linguistic validity and saturation. The glossary, including relevant literature, has been published on the website http://www.gutfeelingsingeneralpractice.eu . In the future, the glossary will be modified if necessary and completed by members of the COGITA group. [Box: see text].

Does an increase in visits to general practice indicate a malignancy?

BACKGROUND: An increase in a patient's visits to doctors usually raises concerns and may be a 'red flag' for a patient's deterioration of health. The aim of this study was to analyze whether an increase of patient-physician contacts is a first sign of a malignancy in a patient's near future. METHODS: This is a retrospective case-control study. From 153 German general practices' electronic patient records (EPR), cases with at least one new malignancy diagnosis and no-malignancy controls were matched for gender and age. We calculated (1) the number of contacts in the first quarter up to the sixth quarter before a malignancy diagnosis was made and (2) the inter-contact interval (ICI), i.e. the time lag between two consecutive patient-physician contacts measured in days. Differences between cases and controls were investigated in several analyses of variance, with group and time as main factors. RESULTS: A total of 3,310 cases and 3,310 controls could be included. The number of contacts for cases in the six quarters before a malignancy diagnosis increased from 4.8 contacts (SD 4.3) to 5.5 contacts (SD 4.8). The number of contacts for controls increased only marginally from 4.3 contacts (SD 3.6) to 4.5 (SD 4.2). The factor 'group' (cases vs. controls) was highly significant in the analyses of variance, also 'time' and the interaction 'group * time'. The effect size, however, was very small (R(2) being less than 0.02), which is the equivalent for about one additional contact per quarter in cases directly before a newly made malignancy diagnosis. CONCLUSION: An increase in contact frequency is a call for GPs to become more attentive towards these patients. It may raise the suspicion of an impending serious disease but the increase is not so dramatic and unique that it can be interpreted a reliable sign of a malignant diagnosis.

The inter-contact interval: a new measure to define frequent attenders in primary care.

BACKGROUND: Frequent attenders receive much attention in primary care research. Defining frequent attendance is crucial for an adequate view on this group of demanding patients. We aimed to develop a purely contact-based definition of "frequent attendance" and to apply it to real patients. METHODS: From electronic records of 123 general practices in Germany, patients' inter-contact intervals (ICI) between two consecutive doctor-patient-contacts were calculated in this retrospective observational study. ICI less than 7 days were labelled "frequent attendance", patients with 60% or more of such intervals "frequent attenders (new view)". In contrast, patients having at least 24 contacts per calendar year were considered "frequent attenders (traditional view)". Both groups were analysed in their diseases and demands, using multiple logistic regression. RESULTS: A total of 177,057 patients with at least 3 ICI in 1996 until 2006 yielded 4,408,033 ICI. One third were "short" ICI (less than 7 days), resulting in 19,759 (11.2%) frequent attenders (new). In contrast, 22,921 (12.9%) patients were frequent attenders (traditional). Compared to non-frequent attenders, frequent attenders (new) were more likely to have pneumonia (OR 1.66), stroke (OR 1.49), dementia (OR 1.46), or severe substance abuse (OR 1.44), also to need home visits or emergency attention. Frequent attenders (traditional) were more likely to have dementia (OR 2.76) or stroke (OR 2.06), and by far to need home visits (OR 5.43; all p < 0.001). CONCLUSIONS: A new measure, the interval in days of two consecutive face-to-face contacts (ICI), widens our perspective on frequent attenders in general practice. In many cases, their consultation behaviour and need for medical services seem to follow "disease logic".

Health service use among patients with chronic or multiple illnesses, and frequent attenders: secondary analysis of routine primary care data from 1996 to 2006.

BACKGROUND: Little or no longitudinal data have been available to date on the utilization of primary care physicians' services, particularly by chronically ill and multimorbid patients and by those who see their primary care physician often ("frequent attenders"). METHODS: We collected anonymous data on 305 896 patients from 155 primary care practices over the period 1996-2006 and analyzed them with descriptive statistics, correlations, and multiple logistic regression. RESULTS: Over the period of the study, patients visited their primary care physicians about 7 times per year on average. Frequent attendance, defined as 24 or more contacts per year, was not strongly associated with chronic illness or multimorbidity (r=0.19 and r=0.24, respectively) but was found to be linked to time-consuming medical services, such as detailed counseling (adjusted odds ratio [OR], 5.8) and house calls (OR, 3.5). Chronically ill patients utilized their primary care physicians' services less than we had expected. Chronic illness and multimorbidity were more common with increasing age; also correlated with age were the utilization of medical services, the number of visits to the primary care physician, and the number of visits to the primary care physician among frequent attenders. DISCUSSION: Although in Germany visits to physicians of all types (both primary care physicians and specialists) in private practice became more frequent in total over the period of this study, visits to primary care physicians alone did not. Frequent attenders do not necessarily have chronic illness or multimorbidity but seem to constitute a particularly problematic group. Chronic illness is not a predictor for greater utilization of primary care physicians' services.

[What else is Evidence-based Medicine?]. / Was ist Evidenzbasierte Medizin auch noch?

The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence. Strange enough, scientific discussion focuses on external evidence from systematic research, but neglects its counterpart, i.e., individual clinical expertise. Apart from a lack of appropriate intellectual tools for approaching the latter, this might be due to the mutual concealment of thought and action, of sensor and motor activity (Viktor von Weizsaecker's principle of the revolving door). Behind this, and incommensurably different from each other, lie the world of physics and the world of biology with an ego animal, that is, the dilemma of the self-conscious subject in a world of objects. When practicing medicine, this dilemma of self-reference is being resolved but only through a holistic approach combining rational and external evidence with biographical, spiritual, emotional and pre-rational elements represented in the physician's individual clinical expertise.