Impact of a diagnostic decision support system in the diagnosis of rheumatic diseases
Organizational Data
- DRKS-ID:
- DRKS00024433
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-02-05
- Last update in DRKS:
- 2021-02-05
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Digitization is slowly but surely changing everyday procedures in medicine. Digital diagnostic support systems represent potentially valuable help for medical professionals. Especially with rare diseases such as rheumatology, these systems could be the decisive aid in solving complex cases. Especially with students and young professionals who cannot look back on many years of experience, there is great potential for avoiding misdiagnoses and improving diagnostic and therapeutic procedures. The aim of the study is to evaluate the app "Ada - your health assistant" with regard to (1) support for medical diagnoses, (2) diagnostic accuracy and (3) user friendliness. In order to be able to measure the effect of the app, medical students with and without the app should create up to 5 differential diagnoses for 3 virtual patient cases. An assessment of the user friendliness should also take place.
Brief summary in scientific language
Clinical decision support tools have the potential to significantly reduce misplaced, incorrect and not made diagnoses. It has been shown that the diagnosis accuracy of doctors can be improved by using clinical decision support tools. Despite the large number of offers, there are no adequate evaluation studies for symptom checkers that include the groups of people using them. Ada was able to show in several studies that it is superior to other tools. So far, however, there is no data as to whether the physician diagnostic accuracy can be increased through Ada usage. It is also unclear whether the stated probability of diagnosis by Ada agrees with the actual diagnostic accuracy. It is also unclear whether the list of differential diagnosis can be expanded through Ada use. It is also unclear how the acceptance among medical students is and how long the case processing with Ada takes. These open questions are to be answered in this study.
Health condition or problem studied
- ICD10:
- M05 - Seropositive rheumatoid arthritis
- ICD10:
- M31.3 - Wegener granulomatosis
- ICD10:
- M32.1 - Systemic lupus erythematosus with organ or system involvement
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervention group: Use of the Ada app for case processing. The test persons enter the symptoms of the vignettes and are then asked to write down up to 5 differential diagnoses. (unique, not longitudinal)
- Arm 2:
- Control group: Subjects should work through the three cases without any helping tools and name up to 5 differential diagnoses. (unique, not longitudinal)
Endpoints
- Primary outcome:
- Diagnostic accuracy of the specified differential diagnoses (students, students with app, Ada app)
- Secondary outcome:
- Case processing time Recommendation rate regarding Ada App Number of differential diagnoses Correlation of demographic data with diagnostic accuracy Correlation of entered symptoms with diagnostic accuracy
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Medizinische Klinik 3 Erlangen
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2019-11-07
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-05-25
- Target Sample Size:
- 100
- Final Sample Size:
- 102
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Medical students at the University of Erlangen in the clinical section with at least one semester of internal medicine
Exclusion Criteria
Inclusion criteria not met
Addresses
Primary Sponsor
- Address:
- Medizinische Klinik 3 Uniklinikum ErlangenJohannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- 091318543217
- Fax:
- 091318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Klinik 3 Uniklinikum ErlangenJohannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- 091318543217
- Fax:
- 091318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Contact for Public Queries
- Address:
- Medizinische Klinik 3 Uniklinikum ErlangenJohannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- 091318543217
- Fax:
- 091318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Principal Investigator
- Address:
- Medizinische Klinik 3 Uniklinikum ErlangenJohannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- 091318543217
- Fax:
- 091318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Medizinische Klinik 3 Uniklinikum ErlangenUlmenweg 1891054 ErlangenGermany
- Telephone:
- 091318543217
- Fax:
- 091318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Erlangen-NürnbergKrankenhausstr. 1291054 ErlangenGermany
- Telephone:
- +40-9131-8522270
- Fax:
- +49-9131-8526021
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-10-30
- Ethics committee number:
- 423_18 B
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-11-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- available upon reasonable request from first author
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry