One way of defining the concept of health-related quality of life (HRQoL) is: “The extent to which one’s usual or expected physical, emotional and social well-being are affected by a medical condition or its treatment” [1]. Individual patients with the same objective health status can report dissimilar HRQoL due to unique differences in expectations and coping abilities and it must be measured from the individual’s viewpoint. There is a growing interest in HRQoL and there are several reasons for this. An increasing share of interventions is aimed at improving the quality of patients’ lives rather than preventing premature deaths (e.g., hip replacement, hypnotics). As people live longer, they become more susceptible to disorders and conditions that decrease their quality of life. With a greater amount of shared decision-making in the health care, patients are also requesting treatments that can improve their HRQoL [2]. However, although reporting of several important aspects of trial methods has improved, quality of reporting remains well below an acceptable level. Without complete and transparent reporting of how a trial was designed and conducted, it is difficult for readers to assess its conduct and validity [3].

Impaired quality of life is most likely a consequence of Restless Legs Syndrome/Willis–Ekbom Disease (RLS/WED) and there is a growing knowledge in the area. However, as in most research fields there are some methodological differences between studies. Different questionnaires measuring HRQoL among RLS/WED patients have been used and the quality of life has in some studies been addressed in clinical samples, in some others in the general population. There are also differences in how control groups are chosen, some use general population norms, others RLS/WED negatives in the studied group. Some studies suggest that RLS/WED affects the physical aspects more than the mental aspects of quality of life [4–7], but there are studies in favor of the opposite [8, 9]. In several previous studies, RLS/WED-positives have been shown to score their own health below population norms, in analogy with patients suffering from other chronic medical conditions. As is described, sleep-related movement disorders (e.g., RLS/WED and periodic limb movements, PLM) is associated with several other comorbidities. A problem when HRQoL is evaluated in RLS/WED is that the symptomatology of the disease is very multifaceted in its character with number of different distressing symptoms, such as sleep disturbance, social deprivations, depressive or anxious mood, and side effects of treatments. The main challenge is to discriminate changes in HRQoL that are due to the key symptoms of RLS (urge to move, unpleasant sensations, circadian rhythm) from those that comes from concomitant or subsequent sleep disturbances, daytime tiredness or psychopathological symptoms. If there is RLS/WED by itself or comorbidity associated with the condition that causes poorer HRQoL is only explored, as we know of, in two previous studies [6, 10] Thus, there is likely a lack of facts in this specific area.

There are several studies using HRQoL as an assessment of treatment in WED, most of them reporting a positive effect [11, 12]. Only a few studies have examined treatment effects longer than 12 weeks [13] and the benefit on HRQoL may request a longer period of time. However, during recent years there are a few long-term studies performed. During the year of 2011, two Cochrane reviews were published, dealing with the issue on treatment for RLS/WED by levodopa [14] and dopamine agonists [15], both substances recommended for the treatment of RLS/WED. The two meta-analyses compared treatment to placebo or to other active treatment in RLS/WED. The topic HRQoL is dealt with but because of the strict criteria many/most studies were not included in the analysis. However, in the analysis of Levodopa and the effect on HRQoL, two studies were used and the result was that QoL was markedly improved. Turning to dopamine agonists and effect on HRQoL, 17 studies were included with the same positive result.

Most used instruments measures HRQoL independently of underlying medical condition, assessing more general characteristics of HRQoL (generic). The advantage with these questionnaires is the possibility to compare different conditions and its influence on HRQoL. The disadvantage is, in the case of a disease with more specific symptoms, that it can be a fairly blunt tool. RLS/WED has several disease-specific symptoms influencing quality of life and therefore there are disease-specific scales to sleep disturbance in RLS/WED created. There are examples of other used questionnaires in studies of HRQoL and RLS/WED but for an overview these has been chosen.