Implementation and evaluation of Illness Management and Recovery (IMR) in mandated forensic psychiatric care - Study protocol for a multicenter cluster randomized trial.

Introduction: Forensic mental health care is hampered by lack of evidence-based treatments. The Swedish forensic mental health population consists of patients suffering from severe illnesses such as schizophrenia and bipolar disorders, similar to populations in international studies. Illness Management and Recovery (IMR) is an intervention for patients with serious mental illness, based on psychoeducational, cognitive-behavioral and motivational components. The purpose is to strengthen participants' illness management skills and recovery. Objective: To test effectiveness of IMR within forensic mental health by comparing it to treatment as usual. Method: This is a cluster-randomized controlled trial. Patients in forensic mental health inpatient units are randomized to an active (IMR) or a control condition (treatment as usual). Clustering of patients is based on ward-units where inpatients are admitted. Patients in the active condition receive two group and one individual IMR sessions per week. The treatment phase is estimated to last nine months. Outcomes include illness related disability, illness management skills, sense of recovery, hope, mental health and security related problems. Outcomes are measured at baseline, four months into treatment, at treatment completion and at three months follow-up. Staff experiences of implementing IMR will be explored by a self-report measure and semi-structured interview based on Normalization Process Theory. Ethics and dissemination: The study is approved by the Swedish Ethical Review Authority (Registration No. 2020-02046). Participation will be voluntary based on written informed consent. Results will be disseminated through peer-reviewed articles and conferences. The study is registered in the US registry of clinical trials (NCT04695132).

Nine surface plasmon resonance assays for specific protein quantitation during cell culture and process development.

Quantitation of protein is essential during pharmaceutical development, and a variety of methods and technologies for determination of total and specific protein concentration are available. Here we describe the development of a streamlined assay platform for specific quantitation assays using surface plasmon resonance (SPR) technology. A total of nine different assays were developed using similar conditions, of which eight assays were for quantitation of different human blood plasma proteins (IgG, IgG1-4 subclasses, IgA, transferrin, and albumin) from a chromatography-based IgG plasma process. Lastly, an assay for monitoring the concentration of a recombinant monoclonal antibody during 13 days of CHO cell culturing was developed. Assay performances were compared with enzyme-linked immunosorbent assay (ELISA), nephelometry, ARCHITECT, and Cobas c501. SPR assays were shown to have higher sensitivity than analysis using nephelometry, ARCHITECT, and Cobas and to have significantly lower analysis and hands-on time compared with ELISA. Furthermore, the SPR assays were robust enough to be used for up to 12 days, allowing specific protein concentration measurement of a sample to be completed at line within 10 min. Using the same platform with only few varied parameters between different assays has saved time in the lab as well as for evaluation and presentation of results.

Sensitive methods for evaluation of antibodies for host cell protein analysis and screening of impurities in a vaccine process.

BACKGROUND: Host cell proteins (HCP) should be carefully monitored in vaccine production. To achieve a reliable HCP estimation, a mixture of polyclonal antibodies (pAbs) with broad affinity would be of preference. Sensitive evaluations of the pAbs are therefore of value. METHODS: Column purification of specific HCPs with affinity to the anti-HCP pAbs was compared with Western blotting of the anti-HCP pAbs binding to filter bound total lysate. The anti-HCP pAbs were used in an HCP quantification analysis using surface plasmon resonance (SPR). Host cell derived impurities from an influenza vaccine process were analyzed using 2-D DIGE analysis. RESULTS: The Western blotting showed a similar HCP binding pattern of anti-HCP pAbs from immunizations using two adjuvants: CFA/IFA and AbISCO(®). From the column purification of HCPs, total proteins detectable were similar for all anti-HCP pAbs; however the immune response pattern differed significantly for the anti-HCP pAbs from the AbISCO(®) immunization. In the SPR HCP quantification assay the standard curve ranged from 0.3 to 40 µg/ml. The advantage of SPR compared with ELISA was the decreased hands on time and that the sample number was not limiting. The 2-D DIGE showed that most of the HCPs were removed at the clarification and virus capture step. DISCUSSION: Column purification of HCPs with affinity to the anti-HCP pAbs increased the sensitivity of affinity analysis compared with Western blotting and opened the possibility of further analysis. The anti-HCP pAbs did not interact with proteins in the virus; simplifying analysis of process samples using SPR. 2-D DIGE analysis gave a direct study of the impurity profile with the advantage of independence from antibody performance.

Evaluating the physical fit of receiver-in-the-ear hearing aids in infants.

BACKGROUND: In spite of early identification and intervention efforts achieved by Early Hearing Detection and Intervention (EHDI) programs, many infants with hearing loss experience delays in early vocabulary development in comparison to peers with normal hearing (Mayne, Yoshinaga-Itano, Sedey, 2000a; Mayne, Yoshinaga-Itano, Sedey, Carey, 2000b; Moeller et al, 2007a, 2007b). One of the several factors that may contribute to individual differences in outcomes is inconsistent hearing aid use in this age group. This may be associated with the physical fit when using traditional behind-the-ear (BTE) hearing aids, since they are relatively large in comparison with the small and soft ear of an infant. Receiver-in-the-ear (RITE) hearing aids may be advantageous for use in pediatric fittings, since they are very tiny and lightweight and therefore sit comfortably on a small soft ear. PURPOSE: To evaluate the use of a RITE hearing aid with an instant ear-tip especially developed for infants in terms of physical fit, stability, safety, and security of the device, as well as the use of retention tools (remedies for keeping the hearing aid securely on the ear) with this age group. RESEARCH DESIGN: A longitudinal study with hearing impaired infants fitted with RITE hearing aids was performed. STUDY SAMPLE: Eighteen infants with mild to moderate/severe hearing loss participated in the study. The age range was 2-36 mo. Sixteen infants had worn hearing aids prior to their participation in the study. INTERVENTION: Each hearing impaired infant was fitted with the RITE hearing aid and an instant ear-tip, the size of which was chosen by the audiologist. The infants used the device for a period of 2-5 mo. DATA COLLECTION AND ANALYSIS: Audiologists and parents completed questionnaires at every visit (5-7 visits in total). Responses were obtained using a category rating scale (Stevens, 1975) from 0 to 10. The data were analyzed using descriptive statistics and nonparametric statistics. RESULTS: Sixteen of the 18 children completed the study. At the end of the study, 11 of the 16 children were using the instant ear-tip, whereas five children were fitted with the receiver mounted in a custom earmold. The audiologists rated the RITE solution to provide a safe, stable, and secure fit. The general trend was that ratings improved over time. At the final follow-up session, all median ratings were between 8 and 10. CONCLUSIONS: Based on the positive results obtained in the study, the use of an appropriately designed RITE hearing aid is recommended for infants.

Treatment patterns among offenders with mental health problems and substance use problems.

Research on treatment utilization among offenders with mental health problems and substance use problems, i.e. the 'triply troubled', is scarce. The aim was to contribute to the general knowledge about treatment patterns among the triply troubled. This register-based study explored treatment patterns during a 3-year follow-up among 157 Swedish offenders with substance use problems who had undergone forensic psychiatric assessment. There were three subgroups of treatment users: low treatment, planned substance abuse treatment and substance abuse emergency room visits, and planned psychiatric treatment. About 40% of the participants displayed a stable treatment pattern. Outcomes were less successful for those participants displaying a non-stable treatment pattern. Allocation of treatment resources should take into account the associations between treatment patterns and recidivism into criminality. Also, it should be valuable for clinicians to gather information on treatment history in order to meet various treatment needs.

Early risk factors for criminal offending in schizophrenia: a 35-year longitudinal cohort study.

BACKGROUND: Recent evidence suggests that factors predicting offending among individuals with no mental disorder may also predict offending among individuals with schizophrenia. AIMS: The aims of the study were (1) to explore the prevalence of risk factors for criminal offending reported at age 18 among males later diagnosed with schizophrenia, (2) to explore the associations between risk factors reported at age 18 and lifetime criminal offending, (3) to predict lifetime serious violent offending based on risk factors reported at age 18, and (4) to compare the findings with those in males with no later diagnosis of schizophrenia. METHODS: The study was a prospective, longitudinal study of a birth cohort followed up through registers after 35 years. The cohort consisted of 49,398 males conscripted into the Swedish Army in 1969-1970, of whom 377 were later diagnosed with schizophrenia. RESULTS: Among the subjects later diagnosed with schizophrenia, strong associations were found between four of the items reported at age 18 and lifetime criminal offending: (1) low marks for conduct in school, (2) contact with the police or child care authorities, (3) crowded living conditions, and (4) arrest for public drinking. Three of these four risk factors were found to double the risk of offending among males with no later diagnosis of schizophrenia. CONCLUSIONS: Criminality in individuals with schizophrenia may at least partly be understood as a phenomenon similar to criminality in individuals in the general population.

Effects of modern forest management on winter grazing resources for reindeer in Sweden.

Boreal forests in Sweden are exploited in a number of ways, including forestry and reindeer husbandry. In the winter, reindeer feed mainly on lichens, and lichen-rich forests are a key resource in the herding system. Commercial forestry has mainly negative effects on reindeer husbandry, and conflicts between these two industries have escalated over the last century. This article reviews the effects of modern forest management practices on the winter resources available for reindeer husbandry. Forestry affects reindeer husbandry at both the stand level and the landscape level and over various time scales. Clear-cutting, site preparation, fertilization, short rotation times, and forest fragmentation have largely resulted in a reduced amount of ground growing and arboreal lichens and restricted access to resource. This article also discusses alternative forestry practices and approaches that could reduce the impacts of forestry on reindeer husbandry, both in the short and long-term.

Typologies of alcohol use disorders among men with schizophrenic disorders.

Alcohol use disorders are common among persons with schizophrenia and are associated with a vast array of negative consequences: criminality, poor compliance with treatment, and reoccurrence of acute episodes of psychosis. In samples of non-mentally disordered individuals, typologies of alcohol use disorders have been shown to be useful in furthering understanding of etiology and of effective treatments. Such typologies, however, have not previously been examined in individuals with schizophrenia. The main objective of the study was to validate four uni-dimensional typologies and the multi-dimensional Type I/II-Type A/B typology in a sample of men with schizophrenic disorders and alcohol use disorders. All uni-dimensional typologies showed at least some degree of concurrent validity. The Type I/II-Type A/B typology was successfully replicated with fair concurrent validity across the domains of pre-morbid risk factors and drug use, but not for the domains of criminality, illness, or personality. The predictive validity was poor for all typologies. The results provide evidence for the heterogeneity of alcohol use disorders among men with schizophrenia.

Kinetics of tyrosine transport and cognitive functioning in schizophrenia.

BACKGROUND: Tyrosine supplementation in humans has been shown to improve cognitive functioning. Several studies have demonstrated a decreased maximal transport capacity of tyrosine (Vmax) across the cell membrane and an increased affinity (Km) of tyrosine to membrane binding sites in schizophrenic patients. A lack of tyrosine for dopamine synthesis with impairment of dopaminergic transmission could impair cognitive functioning. Aberrant tyrosine kinetics in patients with schizophrenia might therefore be associated with cognitive dysfunction--a core feature of schizophrenia. METHODS: Tyrosine kinetics was determined in cultured fibroblasts from 36 schizophrenic patients. The kinetic parameters Vmax and Km were calculated and then the patients were divided into two groups according to the median of the kinetic parameters. A comprehensive neuropsychological test battery was used to evaluate cognitive functioning. RESULTS: Patients with low Km (below the median) had poorer cognitive performance than patients with high Km (above the median). Vmax did not discriminate schizophrenic patients with cognitive dysfunction to the same extent. CONCLUSIONS: Changes in tyrosine transport probably influence cognitive functioning via the dopamine system. However, our findings of a relation between low Km and cognitive dysfunction may have a more complex background. It is suggested that the connection is related to genetically determined membrane factors that disturb communication/transmission among neurons.