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BACKGROUND: RE-KINECT (NCT03062033), a real-world study of possible tardive dyskinesia (TD) in antipsychotic-treated patients, included a questionnaire to assess the effects of patients abnormal involuntary movements on caregivers. AIMS: To capture the experiences of caregivers who assisted individuals with abnormal involuntary movements that were confirmed by clinicians as being consistent with TD. METHODS: Qualified (nonpaid) caregivers were invited to complete a questionnaire that included the following: caregivers sociodemographic characteristics, their perceptions about the impact of abnormal involuntary movements on patients, and the impact of these movements on themselves (caregivers). RESULTS: Of the 41 participating caregivers, 25 (61.0%) were women, 20 (48.8%) were employed full time or part time, and 35 (85.4%) were family members or friends. Based on responses from caregivers who noticed patients abnormal involuntary movements and were caring for individuals who also noticed those movements, 48.0% of patients had a lot of severity in ≥1 body region and 76.0% had abnormal involuntary movements in ≥2 regions. Caregiver ratings were significantly correlated with patient ratings (but not with clinician ratings) for maximum severity of abnormal involuntary movements and the number of affected regions (both p

BackgroundTardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with antipsychotic use. Data from RE-KINECT, a real-world study of antipsychotic-treated outpatients, were analyzed to assess the effects of possible TD on patient health and social functioning.MethodsAnalyses were conducted in Cohort 1 (patients with no abnormal involuntary movements) and Cohort 2 (patients with possible TD per clinician judgment). Assessments included: EuroQoL's EQ-5D-5L utility (health); Sheehan Disability Scale (SDS) total score (social functioning); patient- and clinician-rated severity of possible TD ("none", "some", "a lot"); and patient-rated impact of possible TD ("none", "some", "a lot"). Regression models were used to analyze the following: associations between higher (worse) severity/impact scores and lower (worse) EQ-5D-5L utility (indicated by negative regression coefficients); and associations between higher (worse) severity/impact scores and higher (worse) SDS total score (indicated by positive regression coefficients).ResultsIn Cohort 2 patients who were aware of their abnormal movements, patient-rated TD impact was highly and significantly associated with EQ-5D-5L utility (regression coefficient: - 0.023, P

Purpose/backgroundRE-KINECT (NCT03062033) was designed to assess the presence and impact of possible tardive dyskinesia (TD) in antipsychotic-treated outpatients.Methods/proceduresThe study included adults with 3 or more months of lifetime antipsychotic exposure and 1 or more psychiatric disorder. Based on clinician observation and assessment, patients were assigned to cohort 1 (without involuntary movements or with non-TD involuntary movements) or cohort 2 (with involuntary movements confirmed by clinician as possible TD). Baseline assessments included the following: patient characteristics; location/severity of involuntary movements; and impact of possible TD on health-related quality of life, including the EuroQoL 5-Dimensions 5-Level questionnaire.Findings/resultsOf 739 eligible patients, 204 (27.6%) had clinician-confirmed possible TD (cohort 2). Compared with cohort 1, patients in cohort 2 were significantly older (P < 0.0001), more likely to have schizophrenia or schizoaffective disorder (P < 0.0001) and longer lifetime exposure to antipsychotics (P < 0.0001), and less likely to be working or studying, based on clinician perception (P = 0.0010). Clinician- and patient-rated severity of possible TD movements was significantly correlated in each of 4 body regions (head/face, neck/trunk, upper extremities, lower extremities), for maximum severity in any region, and for total number of affected regions (P < 0.001 for all correlations). For the patient-rated EuroQoL 5-Dimensions 5-Level, the health state visual analog scale score was significantly lower (worse) in cohort 2 versus cohort 1 (66.8 vs 69.7; P = 0.0002), as was the utility index score (0.71 vs 0.76; P < 0.0175).Implications/conclusionsResults from this real-world population indicate that TD occurs frequently and can significantly reduce quality of life in patients with a psychiatric disorder.

Background: Second-generation antipsychotics (SGAs) used to treat patients with schizophrenia generally have lower risk of motor side effects (SEs) than first-generation antipsychotics, but they are associated with other well-known SEs. The goal of this study was to understand how specific SEs of SGAs impact daily functioning, emotional well-being, and overall quality of life of patients with schizophrenia from their own perspective. Methods: This study was a cross-sectional, participant-reported web survey, conducted globally during 2017–2018. The survey captured participants’ socio-demographic information, and assessments using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) instrument, and the Glasgow Antipsychotic Side-Effect Scale (GASS). Additionally, specific questions about functional and emotional impacts were developed for SEs recognized as being bothersome to patients,2 such as activating SEs (‘Feeling restless/unable to sit still’, ‘Shaky hands or arms’, and ‘Difficulty sleeping’) sedating SEs (‘Feeling sleepy during the day’, ‘Feeling drugged/like a zombie’) and metabolic or endocrine SEs (‘Weight gain’, ‘Problems enjoying sex’). Participants noted on a visual analog scale (VAS) the degree of impact on functioning, 0 indicating ‘no impact at all’ and 100 indicating the ‘largest degree of impact’. Participants with schizophrenia (≥18 years old) stable for at least one month, taking an SGA for 1–12 months, and self-reporting at least one SE were included. Results: Of 6,556 respondents screened, 435 were included in the study – United States, n=180; Canada, n=99; Australia, n=28; and Europe, n=128 (Italy, n=90; Spain, n=22; Denmark, n=8; Norway, n=8). The majority of the participants were diagnosed within the last 5 years and nearly half were living with a spouse or partner. The employment rate (full time or part time) was 39.9% globally and 43.3% in Italy. Respondents in Italy were on ‘predominantly sedating’ (54.4%), and/or ‘similarly activating and sedating’ (43.3%) SGAs (as defined in Citrome, J Clin Psychopharmacol 2017). In Italy, Q-LES-Q-SF total score was (mean [standard deviation; SD]) 46.6 [9.1], out of a possible score range of 14–70 (globally, 44.3 [9.8]). Similar to other countries, participants from Italy showed lowest satisfaction scores for Q-LES-Q-SF items of ‘Sexual drive, interest and/or performance’, ‘Economic status’, and ‘Work’. In Italy, the most prevalent SEs reported on the GASS were ‘Feeling sleepy during the day’, ‘Difficulty sleeping’, and ‘Problems enjoying sex’, while globally patients reported ‘Feeling sleepy during the day’, ‘Difficulty sleeping’, and ‘Dry mouth’ as the most common SEs. More than half of the participants stated they had experienced gaining weight as an SE (52.4% globally and 62.2% in Italy). Globally, SEs perceived as bothersome by patients were reported to impact participants’ functioning and emotions. These SEs had at least a moderate to severe impact (defined by a VAS score ≥50) on all aspects of functioning (physical, psychological, social, and vocational). The most common emotions associated with SEs reported by participants were feeling ‘Frustrated’, ‘Dissatisfied’, and ‘Ashamed/embarrassed’. Generally, the results from the survey in Italy were comparable to those of the global survey. Discussion: Findings from this survey confirm that participants taking SGAs for the treatment of schizophrenia still have many SEs, including activating and sedating SEs, sexual SEs, and weight gain. These SEs have a considerable negative impact on participant’s daily functioning and quality of life satisfaction, including on work, and sexual drive, in addition to psychosocial effects. [ABSTRACT FROM AUTHOR]