Validation of two brief instruments (the SURE and CollaboRATE) to measure shared decision‐making in patients with restless legs syndrome

Abstract

SummaryRestless legs syndrome (RLS) is a common neurological disorder characterised by an urge to move arms and legs, usually associated with discomfort, pain, motor restlessness, and sleep disturbance. An individually adapted treatment is needed but difficult to optimise, which makes shared decision‐making (SDM) important. However, brief validated instruments on how patients with RLS perceive their involvement in treatment decisions are lacking. Therefore, the aim was to validate two instruments, SURE (Sure of myself, Understand information, Risk–benefit ratio, Encouragement, i.e., to assess decisional conflict) and CollaboRATE (brief patient survey focused on SDM, i.e., to assess SDM), in patients with RLS. A cross‐sectional design, including 788 participants with RLS (65% females, mean [SD] age 70.8 [11.4] years) from a national patient organisation for RLS, was used. A postal survey was sent out to collect data regarding weight, height, comorbidities, demographics, and RLS‐related treatment data. The following instruments were included: the SURE, CollaboRATE, Restless Legs Syndrome‐6 Scale, and eHealth Literacy Scale. Confirmatory factor analysis and Rasch models were used to assess the validity and reliability of the SURE and CollaboRATE. Measurement invariance, unidimensionality, and differential item functioning (DIF) across age, gender, and medication groups were assessed. The SURE and CollaboRATE were both identified as unidimensional instruments with satisfactory internal consistency. No DIF across age and gender was identified, while significant DIF was observed for both the SURE and CollaboRATE regarding medication use categories. However, both the SURE and CollaboRATE are potential instruments to be used in research, but also as reflection tools by healthcare professionals, patients, and students to explore and assess SDM, and support its development in clinical care.

Experiences of facilitators and barriers for fulfilment of human needs when living with restless legs syndrome: a qualitative study

“…Short instruments are preferred in clinical situations to measure SDM (e.g., CollaboRATE, three items, Elwyn et al, 2016 ) or decisional conflict (e.g., SURE, four items, Légaré & Thompson-Leduc, 2014 ). Both these instruments have recently been validated in RLS-patients with good results (Björk et al, 2023 ) and could be used in clinical situations to evaluate SDM.…”

The ethos brief index—validation of a brief questionnaire to evaluate wellness based on a holistic perspective in patients with restless legs syndrome

“…Consequently, the EBI could, supported by other tools measuring symptoms related to RLS itself (e.g., [12]), or sleep-related consequences (e.g., [24,25]), be used as a patient-centered tool before and after initiation of RLS treatment. A shared decision-making approach [22], including the use of EBI as a holistic patient-centered assessment tool, might facilitate patient involvement in clinical care situations [23] both when a RLS diagnosis is set and when treatment is initiated and evaluated.…”

“…One problem is that the EtWeQ is extensive, but the last part of the EtWeQ, the Ethos Brief Index (EBI), has proven valid in patients with obstructive sleep apnea (OSA) [21]. The EBI could, if found valid and reliable also in an RLS population, be a comprehensive tool for clinicians and researchers to evaluate Ethos before and after treatment initiation and could work as a holistic tool to strengthen the patient's perspective during shared decisionmaking [22,23]. The aim of this study was therefore to validate the EBI in patients with RLS.…”