Original Title: Avis: maladie de Lyme – stades localisé et disséminés, situation actuelle et accompagnement vers le changement

Authors' objectives: To address the lack of clear guidance on managing patients with Lyme disease in Québec, the Direction générale adjointe de la protection de la santé publique (DGAPSP), in collaboration with the Direction de la biovigilance et de la biologie médicale (DBBM) and the Direction des affaires pharmaceutiques et du médicament (DAPM) of the Ministère de la Santé et des Services sociaux (MSSS), asked the Institut national d’excellence en santé et en services sociaux (INESSS) to make recommendations and create knowledge transfer tools concerning post-exposure prophylaxis (PEP) for preventing Lyme disease and the identification, diagnosis and treatment of patients with this disease. This will help Québec's health professionals, especially those in primary care, to deal with this emerging disease. It was agreed with the requester that the project would be carried out in two parts. The first would address PEP and the localized and disseminated stages of the disease, while the second would concern the controversial form of Lyme disease (sometimes referred to as "chronic") and tick-borne coinfections. Publication of the second part is scheduled for 2020.

Authors' results and conclusions: RESULTS: Making the diagnosis is the main challenge in Lyme disease. Its clinical presentation varies from patient to patient, both in terms of the type of manifestations and their severity and the pace of disease progression. Since the manifestations of Lyme disease can be consistent with an array of other diseases, the clinician should, in the presence of these manifestations, examine the possibility of tick exposure, perform a complete physical examination in search of other manifestations suggestive of Lyme disease, and consider the other possible clinical conditions. The only manifestation of Lyme disease from which the diagnosis can be made in a patient whose clinical picture is consistent is the typical isolated erythema migrans. Since isolated erythema migrans does not always have a typical appearance and is not always present or notice its absence should not lead the clinician to rule out Lyme disease. Two-tier serology has low sensitivity during the onset of the infection but increases as the disease progresses, with the result that it is high in patients with Lyme arthritis. However, the level of scientific evidence for the diagnostic value of two-tier serology is low or insufficient, mainly because of the studies’ designs. Because of the limitations of the serological tests, their results are used mainly to complement the clinical picture and should not be used alone to make or rule out the diagnosis. The approach to treating localized or disseminated stage Lyme disease does not seem to pose any particular problems once a diagnosis has been made. The recommended antibiotics are generally similar from one guideline to the next, but the scientific evidence is weak. The differences reside mainly in the duration of treatment, the route of administration and the ranking of the lines of therapy. The analysis shows that it is crucial to properly assess the patient’s overall condition before deciding on the antibiotic and the manner in which it will be administered, since failure to notice manifestations of the early disseminated stage could lead to the wrong choice of antibiotic or a duration of treatment that is inappropriate for the patient’s condition. As well, if there are any doubts about the diagnosis of Lyme disease, the treatment approach decision should be made jointly with one or more medical specialists or experienced colleagues. It would be advisable for patients with the early or late disseminated stage or persistent symptoms post-treatment that cannot be explained by other clinical conditions to be managed by one or more specialists. CONCLUSION: Lyme disease can be clinically challenging when it exhibits atypical cutaneous manifestations or multisystem symptoms, and it can become more complex if diagnosed and treated late. With the exception of the high-risk regions, such as the Eastern Townships and the Montérégie, Québec clinicians’ experience with this emerging disease is, on the whole, limited. The recommendations and clinical decision support tools developed by INESSS are therefore a first step that could lead to practice changes for a better care experience.

Authors' methods: To carry out that part of the project specifically dealing with identification, diagnosis and treatment, INESSS gathered scientific data, best clinical practice recommendations published by learned societies and health technology assessment agencies, contextual information and experiential knowledge in order to document the pathophysiological, epidemiological, technological, pharmacological, clinical and professional and organizational aspects and the patient-related issues. To this end, a systematic search of the scientific literature published in French, English and German was conducted on these aspects and for clinical practice guidelines and guidance documents published in North America, Europe and Oceania. An additional search, using the Google search engine, was conducted for reports, practice standards, regulations and guidance documents. This search was extended to include the government websites of Canadian, American, French, British, New Zealand and Australian public health agencies and departments of health. The websites of Québec's regional public health departments, the Institut national de santé publique du Québec (INSPQ), the MSSS’s Direction générale de santé publique and public documents from the Association québécoise de la maladie de Lyme (AQML) were consulted as well. To gather experiential knowledge, INESSS created an advisory committee consisting of clinicians, including specialists in different disciplines, an expert in laboratory tests and acarological surveillance, and two patient partners who had been diagnosed with Lyme disease. This was supplemented by consultations with representatives from the AQML and interviews with eight patients who had contracted Lyme disease. To ensure that the recommendations and clinical decision support tools would be contextualized to Québec's needs, they were developed with the advisory committee using analysis and triangulation of the scientific, contextual and experiential data and the practice standards recommended by different learned societies and health technology assessment agencies in Canada and abroad. To ensure compliance with the statute and regulations governing reserved professional activities, as well as the feasibility, applicability and acceptability of the recommendations intended for decision-makers and different stakeholders, and to check that the potential impact of implementation was taken into consideration, a follow-up committee consisting of representatives from the INSPQ, the Collège des médecins, the Ordre des infirmières et infirmiers du Québec, the Ordre des pharmaciens du Québec, the federations of general practitioners and medical specialists as well as the MSSS’s DGAPSP, DBBM and Info-Santé was created. INESSS's Comité d'excellence clinique en usage optimal du médicament and the governance committee of the MSSS’s DAPM were invited to raise other issues from a societal and strategic perspective.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/diagnostic-et-traitement-de-la-maladie-de-lyme.html

Year Published: 2019

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/diagnostic-et-traitement-de-la-maladie-de-lyme.html

Requestor: Minister of Health

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec