Use of the FallAkte Plus System as an IT Infrastructure for the North Rhine-Westphalian General Practice Research Network: Mixed Methods Usability Study.

BACKGROUND: Primary care research networks can generate important information in the setting where most patients are seen and treated. However, this requires a suitable IT infrastructure (ITI), which the North Rhine-Westphalian general practice research network is looking to implement. OBJECTIVE: This mixed methods research study aims to evaluate (study 1) requirements for an ITI and (study 2) the usability of an IT solution already available on the market, the FallAkte Plus (FA+) system for the North Rhine-Westphalian general practice research network, which comprises 8 primary care university institutes in Germany's largest state. METHODS: In study 1, a survey was conducted among researchers from the institutes to identify the requirements for a suitable ITI. The questionnaire consisted of standardized questions with open-ended responses. In study 2, a mixed method approach combining a think-aloud approach and a quantitative survey was used to evaluate the usability and acceptance of the FA+ system among 3 user groups: researchers, general practitioners, and practice assistants. Respondents were asked to assess the usability with the validated system usability scale and to test a short questionnaire on vaccination management through FA+. RESULTS: In study 1, five of 8 institutes participated in the requirements survey. A total of 32 user requirements related primarily to study management were identified, including data entry, data storage, and user access management. In study 2, a total of 36 participants (24 researchers and 12 general practitioners or practice assistants) were surveyed in the mixed methods study of an already existing IT solution. The tutorial video and handouts explaining how to use the FA+ system were well received. Researchers, unlike practice personnel, were concerned about data security and data protection regarding the system's emergency feature, which enables access to all patient data. The median overall system usability scale rating was 60 (IQR 33.0-85.0), whereby practice personnel (median 82, IQR 58.0-94.0) assigned higher ratings than researchers (median 44, IQR 14.0-61.5). Users appreciated the option to integrate data from practices and other health care facilities. However, they voted against the use of the FA+ system due to a lack of support for various study formats. CONCLUSIONS: Usability assessments vary markedly by professional group and role. In its current stage of development, the FA+ system does not fully meet the requirements for a suitable ITI. Improvements in the user interface, performance, interoperability, security, and advanced features are necessary to make it more effective and user-friendly. Collaborating with end users and incorporating their feedback are crucial for the successful development of any practice network research ITI.

[17 years of the critical incident reporting and learning system "jeder-fehler-zaehlt.de" for primary care: Analysis of reports]. / 17 Jahre hausärztliches Fehlerberichts- und Lernsystem "jeder-fehler-zaehlt.de" ­ Analyse des Berichtsbestandes.

BACKGROUND: The topic of patient safety has been a subject of much discussion since the end of the last millennium. Ensuring patient safety is a central challenge in health care. An important tool to raise awareness for and learn from adverse events and thus promote patient safety are error-reporting and learning systems (Critical Incident Reporting System = CIRS). METHODS: More than 17 years after its establishment, the CIRS "jeder-fehler-zaehlt.de" (JFZ) for German primary care has undergone a revision in terms of content and technology. The revised web-based system can be used for reporting as well as for classifying and analyzing incident reports. During this process, a descriptive analysis of the current report inventory was carried out, with a focus on serious medication errors. This included all 781 valid incident reports received between September 2004 and December 2021. RESULTS: In 576 of the 781 reports (73.8%), the GP practice was directly involved in the critical incident. Among error types, process errors predominated (79.8% of the classifications, 99.1% of the reports) compared with knowledge and skills errors (20.2% of the classifications, 39.7% of the reports). Communication errors (63.0%) were the most common contributing factor to critical incidents, followed by flaws in tasks and measures (39.7%). Serious and permanent patient harm was rarely reported (8.3% of the reports), whereas temporary patient harm was more common (40.3% of the reports). Incident reports about medication errors with at least serious patient harm included, in particular, substances that affected blood clotting, corticosteroids, and opiates. DISCUSSION: Our results complement the rates that are reported internationally for error types, patient harm, and contributing factors. Serious but preventable adverse events, so-called never events, are frequently associated with the medication process in both JFZ reports and the literature. CONCLUSION: Critical incident reporting systems cannot provide accurate information about the frequency of errors in health care, but they can offer important insights into, for example, serious medication errors. Therefore, they offer both employees and healthcare institutions an opportunity for individual and institutional learning.

[General practitioners' perspectives on the perceived effectiveness of the disease management programs for type 2 diabetes and coronary heart disease: Results of a focus group study]. / Die wahrgenommene Effektivität der Disease Management Programme für Diabetes mellitus Typ 2 und Koronare Herzkrankheit aus Sicht von Hausärzt*innen ­ Ergebnisse einer Fokusgruppenstudie.

BACKGROUND: The majority of patients in disease management programs (DMPs) for type 2 diabetes (T2DM) and coronary heart disease (CHD) in Germany are enrolled by their general practitioner (GP). The aim of this study was, in the context of upcoming DMP expansions, to elicit GPs' current experiences and opinions regarding the perceived effectiveness and acceptance of the DMPs T2DM and CHD, as well as to determine beneficial and hindering aspects of the implementation of these programs from a GP's perspective. METHODS: In August and September 2020, 20 GPs of teaching practices of the University Hospital Cologne with experiences in DMPs were interviewed in semi-structured focus group discussions. Their expectations, attitudes and opinions regarding the DMPs T2DM and CHD were evaluated and analyzed according to the content-structuring qualitative content analysis by Kuckartz. RESULTS: The DMP T2DM was rated as generally positive by the respondents due to the structured treatment including regular foot and eye examinations, close patient contacts and perceptions of improved health outcomes. The DMP CHD was rated more negatively by the respondents because of a high and partly unnecessary documentation workload and limited therapeutic freedom, leading to a perceived ineffectiveness for patients' health outcomes. Thus, there was a discrepancy in the perceived effectiveness of the examined DMPs, causing a lower acceptance of the DMP CHD. Therefore, some of the respondents tended to enroll fewer patients into the DMP CHD or to drop out of the DMP CHD. DISCUSSION: In order to increase the acceptance and sustainability of DMPs some elements of the DMP CHD as well as the remuneration and the documentation need to be reconsidered. Additionally, future studies on the acceptance of DMPs should differentiate between different DMPs in order to generate valid results.

Medical error analysis in dermatology according to the reports of the North Rhine Medical Association from 2004 to 2018.

BACKGROUND: Assessment of complaints addressed to the Expert Committee for Medical Malpractice Claims of the North Rhine Medical Association helps to identify quality assurance problems in dermatology. METHODS: 333 dermatological reports (years 2004-2018) were allocated to three five-year intervals in order to show changes of total number of reports and with regard to indications, types of care, defined diagnosis categories, and therapeutic interventions. Statistical analysis was mainly descriptive (SPSS 27). Representative cases are explained in more detail. RESULTS: The number of dermatological reports fell from 119 in the first to 92 reports in the last five-year interval, along with a decline in treatment error rates (43 % and 29 %) despite an increasing number of procedures across disciplines. 104 reports dealt with (supposed) diagnostic errors, 156 with physical or pharmacological therapies, and 73 reports with surgery. The latter had a low treatment error rate (29 %). CONCLUSIONS: In comparison to the number of dermatological treatments in Germany, patient allegations are raised only rarely indicating greater patient satisfaction and/or a lower risk potential in dermatology. Incorrect dosages or device settings, diagnostic errors, and deficits in obtaining informed consent are relevant sources of error as underlined by the presented case reports.

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: 1) Meetings of peer support groups 2) Personalised telephone-based health coaching for patients with low literacy and/or low patient activation 3) Personalised patient feedback 4) A browser-based web portal METHODS: Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. DISCUSSION: If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network ( https://www.drks.de/drks_web/setLocale_EN.do ) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given ( https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

Medical error analysis in dermatology according to the reports of the North Rhine Medical Association from 2004-2013.

BACKGROUND: Patient safety is a central issue of health care provision. There are various approaches geared towards improving health care provision and patient safety. By conducting a systematic retrospective error analysis, the present article aims to identify the most common complaints brought forth within the field of dermatology over a period of ten years. METHODS: The reports of the Expert Committee for Medical Malpractice Claims of the North Rhine Medical Association (from 2004 to 2013) on dermatological procedures were analyzed (n =  247 reports in the field of dermatology). RESULTS: Expert medical assessments in the field of dermatology are most frequently commissioned for nonsurgical therapies (e.g. laser therapy, phototherapy). While suspected diagnostic errors constitute the second most common reason for complaints, presumed dermatosurgery-related errors represent the least common reason for commissioning expert medical assessments. CONCLUSIONS: The most common and easily avoidable sources of medical errors include failure to take a biopsy despite suspicious clinical findings, or incorrect clinicopathological correlations resulting in deleterious effects for the patient. Furthermore, given the potential for incorrect indications and the inadequate selection of devices to be used as well as their parameter settings, laser and phototherapies harbor an increased risk in the treatment of dermatological patients. The fourth major source of error leading to complaints relates to incorrect indications as well as incorrect dosage and administration of drugs. Analysis of expert medical assessment reports on treatment errors in dermatology as well as other medical specialties is helpful and provides an opportunity to identify common sources of error and error-prone structures.