Purpose Symptoms of psychotic disorders can complicate efforts to accurately evaluate patients’ medication ingestion. The digital medicine system (DMS), composed of antipsychotic medication co-encapsulated with an ingestible sensor, wearable sensor patches, and a smartphone application, was developed to objectively measure medication ingestion. We assessed performance and acceptance of the DMS in subjects with psychotic disorders. Methods This was an 8-week open-label, single-arm, multicenter, Phase 4 pragmatic study (NCT 03568500; EudraCT #2017-004602-17). Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. The primary endpoint was good patch coverage, defined as the proportion of days over the assessment period where ≥80.0% of patch data was available, or an ingestion was detected. Exploratory endpoints included a survey on user satisfaction, used to assess acceptance of the DMS. Safety analyses included the incidence of treatment-emergent adverse events (TEAEs). Results From May 25, 2018 to March 22, 2019, 55 subjects were screened and 44 were enrolled. Good patch coverage was achieved on 63.4% of days assessed and the DMS generated an adherence metric of ≥80.0%, reflecting the percentage of ingestion events expected when good patch coverage was reported. Most subjects (53.5%) were satisfied with the DMS. Medical device skin irritations were the only TEAEs reported. Conclusion The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated.
IntroductionIn patients with schizophrenia, medication adherence is important for relapse prevention, and effective adherence monitoring is essential for treatment planning. A digital medicine system (DMS) has been developed to objectively monitor patient adherence and support clinical decision making regarding treatment choices. This study assesses the acceptance and performance of the DMS in adults with schizophrenia, schizoaffective disorder or first-episode psychosis and in healthcare professionals (HCPs).Methods/AnalysisThis is a multicentre, 8-week, single-arm, open-label pragmatic trial designed using coproduction methodology. The study will be conducted at five National Health Service Foundation Trusts in the UK. Patients 18–65 years old with a diagnosis of schizophrenia, schizoaffective disorder or first-episode psychosis will be eligible. HCPs (psychiatrists, care coordinators, nurses, pharmacists), researchers, information governance personnel, clinical commissioning groups and patients participated in the study design and coproduction. Intervention employed will be the DMS, an integrated system comprising an oral sensor tablet coencapsulated with an antipsychotic, non-medicated wearable patch, mobile application (app) and web-based dashboard. The coencapsulation product contains aripiprazole, olanzapine, quetiapine or risperidone, as prescribed by the HCP, with a miniature ingestible event marker (IEM) in tablet. On ingestion, the IEM transmits a signal to the patch, which collects ingestion and physical activity data for processing on the patient’s smartphone or tablet before transmission to a cloud-based server for viewing by patients, caregivers and HCPs on secure web portals or mobile apps.Ethics and disseminationApproval was granted by London - City and East Research Ethics Committee (REC ref no 18/LO/0128), and clinical trial authorisation was provided by the Medicines and Healthcare products Regulatory Agency. Written informed consent will be obtained from every participant. The trial will be compliant with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines and the Declaration of Helsinki.Trial registration numberNCT03568500; EudraCT2017-004602-17; Pre-results.
Psychologic assessment and treatment of the family of the chronic pain patient has been thought to be of benefit in the outcome of pain therapy. The present study was designed to determine the presence of psychologic symptoms in the spouses of pain patients and the relationship of distress levels between the marital pair. Forty-four couples were studied. Demographic data was collected and each individual completed the SCL-90, a widely used and validated measure of psychologic symptom severity. There was a significant correlation (P = less than 0.001) on psychiatric distress scores between pain patients and their spouses particularly when pain patient distress scores were high. Distress levels tended to decrease with age and were highest among the unemployed and lowest in the retired. In addition spouses were significantly higher than nonpatient norms on most symptom subscales. These data underline the importance of conjoint assessment of the chronic pain patient and the spouse, and have implications for treatment.
The new standard for successful burn care encompasses both patient survival and the burn patient's long-term quality of life. To provide optimal long-term recovery from catastrophic injuries, including catastrophic burns, an outcome-based model using a new technology called systematic care management (SCM) has been developed. SCM provides a highly organized system of management throughout the spectrum of care that provides access to outcome data, consistent oversight, broader access to expert providers, appropriate allocation of resources, and greater understanding of total costs. Data from a population of 209 workers' compensation catastrophic burn cases with a mean TBSA of 27.9% who were managed under the SCM model of care were analyzed. The data include treatment type, cost, return to work, and outcomes achieved. Mean duration of management to achieve all guaranteed outcomes was 20 months. Of the 209 injured workers, 152 (72.7%) achieved sufficient recovery to be released to return to work, of which 97 (46.8%) were both released and competitively employed. Assessment of 10 domains of functional independence indicated that 47.2% of injured workers required total assistance at initiation of SCM. However, at termination of SCM, 84% of those injured workers were fully independent in the 10 functional activities. When compared with other burn research outcome data, the results support the value of the SCM model of care.
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