Title: A novel diagnostic screening procedure for antipsychotic-induced movement disorders
Funder: Department of Health (England)

Abstract: Antipsychotic-induced movement disorders (AIMDs) are relatively common side effects of antipsychotic medications, with a cumulative incidence ranging between 10% and 32% of patients treated with antipsychotics. AIMDs can stigmatise patients, exert negative impact on medication adherence, and confound clinical assessment of their baseline psychiatric condition. In a health-related utility elicitation study, both laypersons and patients viewed AIMDs as one of the two least desirable health states, together with psychotic relapse. New therapeutic interventions for drug-induced movement disorders are currently under investigation. In spite of this, AIMDs continue to be underrated. A very recent national audit of mental health UK Trusts demonstrated that only a small minority of patients on depot antipsychotic preparations are formally evaluated for these side effects, and that this proportion does not increase substantially after educational interventions. An important aspect of this problem is the currently available instruments to screen these side effects. Although several rating scales are available, these carry several problems that strongly limit their widespread use in routine clinical practice, including complexity of use, lack of comprehensiveness, and lack of validation for diagnostic purposes. Therefore, a diagnostic screening procedure that allows a reliable, accurate and cost-effective assessment of AIMDs is likely to yield a relevant potential benefit for the quality of health care of patients with psychosis. The main aim of this research is to develop and validate new diagnostic confidence indices for the three main categories of AIMDs (tardive dyskinesia, parkinsonism, and akathisia), and a novel, accurate and cost-effective diagnostic screening procedure to apply them in routine clinical practice. It was felt that validating a new diagnostic screening procedure applicable to patients by mental health Specialist Nurses would provide additional cost-effectiveness to this approach, and facilitate its routine clinical application. In the first Workpackage, diagnostic confidence indices will be developed by a multi-step procedure involving a Panel of neurologists and psychiatrists experienced in AIMDs. These steps will comprise: 1) identification of the clinical features to include in the diagnostic predictive models; 2) manualisation of the diagnostic reference standard procedure against which the predictive models will be tested; 3) development of the test diagnostic screening procedure to use for data collection from clinical samples; 4) training of the Clinical Research Fellow and Specialist Nurses into the diagnostic screening procedures; 5) feasibility and reliability assessment of the test screening procedure; this will be pursued by measuring inter- and intra-rater reliability, as well as general time of administration of the diagnostic screening procedure performed on 40 cases, involving Specialist Nurses from Mental Health Services as raters. In the second Workpackage, diagnostic confidence indices will undergo a process of validation that will consist of 2 steps: 1) data collection from the population sample (N=600-750 patients with psychosis, recruited from community mental health services providing care co-ordination to patients with psychosis from the North London Trusts that are part of the NoCLoR consortium); this will consist in the administration of the test diagnostic screening procedure by Specialist Nurses and of the reference standard screening procedure by a Clinical Research Fellow; 2) internal model validation will be performed using a bootstrapping approach, and diagnostic thresholds for the three diagnostic confidence indices will be tested against the references diagnostic procedure. Finally, we will conduct a preliminary evaluation of the impact of the test screening procedure upon management and quality of life: the first 100 patients recruited will be followed up 9 months after baseline assessment, evaluating any change in management occurred after baseline assessment; quality of life will also be assessed at baseline and at follow-up. Baseline and follow-up assessments will be performed by the Clinical Research Fellow.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.4 POPULATION SCREENING
Health categories: MENTAL HEALTH