PLEASE5+ - Long-term outcomes and quality of life of patients with symptoms attributed to Lyme borreliosis

This study is a longitudinal follow-up study utilizing questionnaires, blood and urine sampling and – in selected subgroups – interviews and focus groups, among subjects who have participated 5-8 years ago in the randomized PLEASE trial (NL2362). The primary objective is to assess the long-term (5-8 years) quality of life in patients who previously participated in the placebo-controlled randomized controlled trial on the effect of prolonged antibiotic treatment on persistent symptoms attributed to Lyme borreliosis (PLEASE). The main secondary objectives are to investigate the long-term impact of persistent symptoms attributed to Lyme borreliosis on societal status and ability to work, to collect data on the additional medical or complementary care that patients have undergone after participation in PLEASE, and to correlate these data with their course of symptoms, quality of life and ability to work.

Patients with persistent symptoms attributed to Lyme borreliosis report a substantial disease burden and a poor quality of life. Little is known about the long-term outcomes of patients with persistent symptoms attributed to Lyme borreliosis. The impact of these persistent symptoms on workability has not been investigated to date.
After completion of the study visits, many patients in the PLEASE cohort have followed other after long-term antibiotic treatment or complementary therapies.
We hypothesize that patients included in the PLEASE study may have ongoing symptoms during long-term follow-up, affecting their quality of life, workability and social costs. Furthermore, we hypothesize that specific interventions or supportive strategies that patients have undergone have an impact on long-term outcomes.

One time point, and in a subset of patients one or more additional time points for interviews and focus groups (upon additional consent).

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