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Digitalisation of the guideline registry of the Association of Scientific Medical Societies in Germany for an open, guideline-based, trustworthy evidence ecosystem (Dissolve-E): a protocol of a before-after study with different user groups

Por: Nothacker · M. · Stegbauer · C. · Burckhardt · M. · Nink-Grebe · B. · Eisele-Metzger · A. · Meerpohl · J. · Mueller · I. · Kopp · I. · on behalf of the Dissolve-E study group · Litzkendorf · Knizia · Meyer · Kliemannel · Broge · Toews · Huneke · Bucher · Dincklage · Lichtner · Sta
Introduction

Internationally, the vision of a ‘Digital Trustworthy Evidence Ecosystem’ is being pursued with clinical practice guidelines (CPGs) as one element of such a system. Consequently, CPGs and CPG repositories need to be digitalised.

Methods and analysis

The objective of this prospective, before-after study is to evaluate the impact of digitalising a quality-assured CPG registry using the international data format standard ‘Fast Healthcare Interoperability Resources’ (FHIR). This includes the architecture of the registry, the format of individual guidelines and application programming interfaces to import and export CPG content. The study is guided by a scoping review.

The primary outcome is the usability of the digitalised CPG registry and CPG content for different user groups comprising CPG developers, CPG administrators, health care professionals and patients—including at the point of care in in- and outpatient settings—and technical professionals as users of CPG content in digital applications.

For the before-after comparison, semi-quantitative (surveys) and qualitative (focus groups) methods are applied. All user groups will be involved in a baseline analysis to assess user expectations and technical requirements. According to the results, the digitalised guideline registry will be implemented. The intervention comprises the testing of the digitalised registry with guideline content by all user groups. Analysis of outcomes will include formative and summative evaluation. Final results and further research needs will be discussed in a World Café with all stakeholders.

Ethics and dissemination

The Ethics Committee of the Berlin chamber of physicians, in accordance with its code of conduct §15 section 1 (Eth-KB-24-11) confirmed that no ethical approval is needed for this study. The study is registered in the German Clinical Trials Registry (No: DRKS00034111). Results will be presented at national and international conferences, published in peer-reviewed journals and on the website of the funding institution.

Trial registration number

German Clinical Trials Registry (No: DRKS00034111).

Effects of a digital tool implementing the German S3 clinical practice guideline for multimorbidity in primary care (gp-multitool.de): study protocol for a cluster-randomised controlled trial

Por: Schäfer · I. · Menzel · A. · Lezius · S. · Krause · L. · Zapf · A. · Lühmann · D. · Scherer · M. · Paucke · V. · Nothacker · J.
Introduction

Multimorbidity is prevalent and associated with complex treatment requirements. In order to assist general practitioners (GPs) addressing these requirements, the web application gp-multitool.de has been designed, which facilitates implementation of the German clinical practice guideline for multimorbidity. We will conduct a cluster-randomised clinical trial evaluating an intervention based on this tool. This protocol summarises methods and discusses ethics and dissemination of this study.

Methods and analysis

Participating patients are recruited by cooperating GP practices. Inclusion criteria are an age of 65 years or older, enrolment in any disease management programme and multimorbidity operationalised by two additional chronic conditions. To avoid postrandomisation selection bias, practices are randomised as clusters after baseline assessment of all participating patients from the respective practice. In our intervention, patients receive access to different assessments including patient preferences by email, fill out the electronic assessment forms on any device with access to the internet, receive a medication review and discuss the assessment results with their GPs. GPs in the control group do not have access to the digital tool and provide care as usual. The primary outcome is staying at least once for at least one night in hospital during the 12-month observation period. Secondary outcomes are contacts with GPs and outpatient specialists, self-reported health, health-related quality of life, patient satisfaction and GP-reported and patient-reported quality of care. A sample size of 660 patients from 66 GP practices is needed. Data are analysed by mixed effects regression models.

Ethics and dissemination

Ethics approval was obtained by the ethics committee of the Medical Association of Hamburg (2022–1 00 786-BO-ff). Study results will be presented on scientific conferences and published in journal articles. In addition, healthcare professionals, patient representatives and the interested public will be informed about study results at a symposium.

Trial registration number

The study was registered in clinicaltrials.gov (NCT06831994).

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