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This study evaluates the effect of written and oral information in a primary health care setting on 1) patients referred to specialised examination for Lyme neuroborreliosis, 2) delay from patient symptom debut to treatment for Lyme neuroborreliosis, and 3) number of Borrelia serology tests from primary health care.
Lyme neuroborreliosis is among the most common neuroinfections in northern Europe. Residual symptoms after treatment are a frequent problem in Lyme neuroborreliosis, and an association between the delay from symptom debut to antibiotic treatment has been established. In a previous study on Funen Island, Denmark, the delay from day of symptom debut to treatment for Lyme neuroborreliosis patients was 24 days. This considerable treatment delay did not change in the 20 years study period.
In the Danish health system, the general practitioners are the first medical professionals to see the majority of patients. They can refer patients to the hospital for further examination if indicated. Many general practitioners use Borrelia burgdorferi antibodies (igM/IgG) as a screening tool when they suspect Lyme disease or see patients with uncharacteristic symptoms. This is unfortunate, as the rash Erythema Migrans, the most common Borreliosis manifestation in Europe, is a clinical diagnosis. Only around 50% of patients have positive antibodies at time of Erythema Migrans diagnosis. Lyme neuroborreliosis is diagnosed based on symptoms and the results from the cerebrospinal fluid, and cannot be diagnosed based on serology, which only delays the time to diagnoses and treatment. The Danish guidelines on Lyme borreliosis therefore discourage general practitioners from using Borrelia serology.
In the before mentioned study from Funen Island, several patients described multiple contacts to their general practitioners, where the symptoms of Lyme neuroborreliosis were not recognized. The cardinal symptom of radicular pain was associated with a longer delay than many of the less common symptoms of Lyme neuroborreliosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teaching arm | Experimental | The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis. |
|
| Passive arm | No Intervention | The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral and written information on tick-bites and Lyme disease | Other | See under study arm descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis | Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis. | 0-90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of yearly referred Lyme patients | Number of yearly referred patients in the two study arms in the two years before the intervention (2017+2018) and after the intervention (2019+2020). | Up to 4 years (1460 days). |
| Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrikke C Knudtzen, MD | Contact | 004529178083 | fredrikke.christie.knudtzen@rsyd.dk | |
| Sigurdur Skarphédinsson, MD, PhD | Contact | 004565414280 | s.skarphedinsson@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Fredrikke C Knudtzen, MD | Department of Infectious Diseases, Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Center for Emerging and Vectorborne Infections | Odense | Funen | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29048514 | Result | Knudtzen FC, Andersen NS, Jensen TG, Skarphedinsson S. Characteristics and Clinical Outcome of Lyme Neuroborreliosis in a High Endemic Area, 1995-2014: A Retrospective Cohort Study in Denmark. Clin Infect Dis. 2017 Oct 16;65(9):1489-1495. doi: 10.1093/cid/cix568. | |
| 35323885 | Derived | Knudtzen FC, Jensen TG, Andersen NS, Johansen IS, Hovius JW, Skarphedinsson S. An intervention in general practice to improve the management of Lyme borreliosis in Denmark. Eur J Public Health. 2022 Jun 1;32(3):436-442. doi: 10.1093/eurpub/ckac013. |
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Due to Denmark´s strict data-sharing Laws, data will not be shared after completion of study.
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| ID | Term |
|---|---|
| D020852 | Lyme Neuroborreliosis |
| ID | Term |
|---|---|
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Open label interventional study where primary Health care Physicians in areas on Funen Island, Denmark, are included if they have their practice in an area with Lyme Neuroborreliosis incidens > 4.6/100.000
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Open label study, due to the intervention (lectures) and the criteria for receiving the intervention (Lyme neuroborreliosis incidens > 4.6/100.000), the study cannot be blinded.
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Number of Borrelia antibody tests in peripheral blood ordered by primary Health care physicians in the two study arms in the two years before (2017+2018) and after (2019 + 2020) the intervention. |
| Up to 4 years (1460 days). |
| D008193 | Lyme Disease |
| D016905 | Gram-Negative Bacterial Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D002494 | Central Nervous System Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |