Effect of Vitamin D Supplementation on Outcomes in People With Early Psychosis: The DFEND Randomized Clinical Trial.

Importance: People with psychotic disorders have an increased risk of vitamin D deficiency, which is evident during first-episode psychosis (FEP) and associated with unfavorable mental and physical health outcomes. Objective: To examine whether vitamin D supplementation contributes to improved clinical outcomes in FEP. Design, Setting, and Participants: This multisite, double-blind, placebo-controlled, parallel-group randomized clinical trial from the UK examined adults 18 to 65 years of age within 3 years of a first presentation with a functional psychotic disorder who had no contraindication to vitamin D supplementation. A total of 2136 patients were assessed for eligibility, 835 were approached, 686 declined participation or were excluded, 149 were randomized, and 104 were followed up at 6 months. The study recruited participants from January 19, 2016, to June 14, 2019, with the final follow-up (after the last dose) completed on December 20, 2019. Interventions: Monthly augmentation with 120 000 IU of cholecalciferol or placebo. Main Outcomes and Measures: The primary outcome measure was total Positive and Negative Syndrome Scale (PANSS) score at 6 months. Secondary outcomes included total PANSS score at 3 months; PANSS positive, negative, and general psychopathology subscale scores at 3 and 6 months; Global Assessment of Function scores (for symptoms and disability); Calgary Depression Scale score, waist circumference, body mass index, and glycated hemoglobin, total cholesterol, C-reactive protein, and vitamin D concentrations at 6 months; and a planned sensitivity analysis in those with insufficient vitamin D levels at baseline. Results: A total of 149 participants (mean [SD] age, 28.1 (8.5) years; 89 [59.7%] male; 65 [43.6%] Black or of other minoritized racial and ethnic group; 84 [56.4%] White [British, Irish, or of other White ethnicity]) were randomized. No differences were observed in the intention-to-treat analysis in the primary outcome, total PANSS score at 6 months (mean difference, 3.57; 95% CI, -1.11 to 8.25; P = .13), or the secondary outcomes at 3 and 6 months (PANSS positive subscore: mean difference, -0.98; 95% CI, -2.23 to 0.27 at 3 months; mean difference, 0.68; 95% CI, -0.69 to 1.99 at 6 months; PANSS negative subscore: mean difference, 0.68; 95% CI, -1.39 to 2.76 at 3 months; mean difference, 1.56; 95% CI, -0.31 to 3.44 at 6 months; and general psychopathology subscore: mean difference, -2.09; 95% CI, -4.36 to 0.18 at 3 months; mean difference, 1.31; 95% CI, -1.42 to 4.05 at 6 months). There also were no significant differences in the Global Assessment of Function symptom score (mean difference, 0.02; 95% CI, -4.60 to 4.94); Global Assessment of Function disability score (mean difference, -0.01; 95% CI, -5.25 to 5.23), or Calgary Depression Scale score (mean difference, -0.39; 95% CI, -2.05 to 1.26) at 6 months. Vitamin D levels were very low in the study group, especially in Black participants and those who identified as another minoritized racial and ethnic group, 57 of 61 (93.4%) of whom had insufficient vitamin D. The treatment was safe and led to a significant increase in 25-hydroxyvitamin D concentrations. Conclusions and Relevance: In this randomized clinical trial, no association was found between vitamin D supplementation and mental health or metabolic outcomes at 6 months. Because so few patients with FEP were vitamin D replete, the results of this study suggest that this group would benefit from active consideration in future population health strategies. Trial Registration: isrctn.org Identifier: ISRCTN12424842.

Implementation, Adoption, and Perceptions of Telemental Health During the COVID-19 Pandemic: Systematic Review.

BACKGROUND: Early in 2020, mental health services had to rapidly shift from face-to-face models of care to delivering the majority of treatments remotely (by video or phone call or occasionally messaging) due to the COVID-19 pandemic. This resulted in several challenges for staff and patients, but also in benefits such as convenience or increased access for people with impaired mobility or in rural areas. There is a need to understand the extent and impacts of telemental health implementation, and barriers and facilitators to its effective and acceptable use. This is relevant both to future emergency adoption of telemental health and to debates on its future use in routine mental health care. OBJECTIVE: To investigate the adoption and impacts of telemental health approaches during the COVID-19 pandemic, and facilitators and barriers to optimal implementation. METHODS: Four databases (PubMed, PsycINFO, CINAHL, and Web of Science) were searched for primary research relating to remote working, mental health care, and the COVID-19 pandemic. Preprint servers were also searched. Results of studies were synthesized using framework synthesis. RESULTS: A total of 77 papers met our inclusion criteria. In most studies, the majority of contacts could be transferred to a remote form during the pandemic, and good acceptability to service users and clinicians tended to be reported, at least where the alternative to remote contacts was interrupting care. However, a range of impediments to dealing optimal care by this means were also identified. CONCLUSIONS: Implementation of telemental health allowed some continuing support to the majority of service users during the COVID-19 pandemic and has value in an emergency situation. However, not all service users can be reached by this means, and better evidence is now needed on long-term impacts on therapeutic relationships and quality of care, and on impacts on groups at risk of digital exclusion and how to mitigate these. TRIAL REGISTRATION: PROSPERO International prospective register of systematic reviews CRD42021211025; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021211025.

Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT.

BACKGROUND: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive-behavioural therapy for adults with dissociative seizures. DESIGN: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial. SETTING: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive-behavioural therapy services. PARTICIPANTS: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017. INTERVENTIONS: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive-behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care. MAIN OUTCOME MEASURES: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness. RESULTS: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n = 182; and cognitive-behavioural therapy plus standardised medical care, n = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1-35 dissociative seizures); cognitive-behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0-20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive-behavioural therapy at a p-value < 0.05, including the following at a p-value ≤ 0.001: the longest dissociative seizure-free period in months 7-12 inclusive post randomisation (incidence rate ratio 1.64, 95% confidence interval 1.22 to 2.20; p = 0.001); better psychosocial functioning (Work and Social Adjustment Scale, standardised treatment effect -0.39, 95% confidence interval -0.61 to -0.18; p < 0.001); greater self-rated and clinician-rated clinical improvement (self-rated: standardised treatment effect 0.39, 95% confidence interval 0.16 to 0.62; p = 0.001; clinician rated: standardised treatment effect 0.37, 95% confidence interval 0.17 to 0.57; p < 0.001); and satisfaction with treatment (standardised treatment effect 0.50, 95% confidence interval 0.27 to 0.73; p < 0.001). Rates of adverse events were similar across arms. Cognitive-behavioural therapy plus standardised medical care produced 0.0152 more quality-adjusted life-years (95% confidence interval -0.0106 to 0.0392 quality-adjusted life-years) than standardised medical care alone. The incremental cost-effectiveness ratio (cost per quality-adjusted life-year) for cognitive-behavioural therapy plus standardised medical care versus standardised medical care alone based on the EuroQol-5 Dimensions, five-level version, and imputed data was £120,658. In sensitivity analyses, incremental cost-effectiveness ratios ranged between £85,724 and £206,067. Qualitative and quantitative process evaluations highlighted useful study components, the importance of clinical experience in treating patients with dissociative seizures and potential benefits of our multidisciplinary care pathway. LIMITATIONS: Unlike outcome assessors, participants and clinicians were not blinded to the interventions. CONCLUSIONS: There was no significant additional benefit of dissociative seizure-specific cognitive-behavioural therapy in reducing dissociative seizure frequency, and cost-effectiveness over standardised medical care was low. However, this large, adequately powered, multicentre randomised controlled trial highlights benefits of adjunctive dissociative seizure-specific cognitive-behavioural therapy for several clinical outcomes, with no evidence of greater harm from dissociative seizure-specific cognitive-behavioural therapy. FUTURE WORK: Examination of moderators and mediators of outcome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN05681227 and ClinicalTrials.gov NCT02325544. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 43. See the NIHR Journals Library website for further project information.

Dissociative seizures resemble epileptic seizures or faints, but can be distinguished from them by trained doctors. Dissociation is the medical word for a 'trance-like' or 'switching off' state. People with dissociative seizures commonly have other psychological or physical problems. Quality of life may be low. The condition accounts for about one in every six patients seen in hospitals because of seizures. We wanted to find out if people with dissociative seizures receiving standardised treatment would also benefit from a talking therapy, called cognitive­behavioural therapy, made specific to this disorder. We did a randomised controlled trial to find out if people with dissociative seizures given standardised treatment and cognitive­behavioural therapy (talking therapy) would do better than those given standardised treatment alone. Standardised treatment of dissociative seizures began with careful diagnosis from a neurologist and then further assessment and treatment from a psychiatrist. In total, 368 people with dissociative seizures participated, with half receiving standardised treatment alone and half having talking therapy plus standardised treatment. We measured seizures and psychological and physical health in both trial groups. We also investigated whether or not cognitive­behavioural therapy was good value for money. After 12 months, patients in both trial groups seemed to have fewer monthly seizures, but there was no advantage in the talking therapy group. Patients in the talking therapy group had more consecutive days without seizures, reporting less impact from them in everyday situations. Patients in the talking therapy group, and their doctors, considered improvements to be better, and patients in this group reported greater satisfaction with treatment. However, the talking therapy was expensive and not as cost-effective as hoped. Interviews with patients and study clinicians showed that they valued aspects of both treatments and of the care provided by the multidisciplinary teams. Overall, cognitive­behavioural therapy designed for dissociative seizures plus standardised treatment was not better at reducing the total numbers of seizures reported, but did produce several positive benefits for participants compared with standardised treatment alone.

Implementation of Telemental Health Services Before COVID-19: Rapid Umbrella Review of Systematic Reviews.

BACKGROUND: Telemental health care has been rapidly adopted for maintaining services during the COVID-19 pandemic, and a substantial interest is now being devoted in its future role. Service planning and policy making for recovery from the pandemic and beyond should draw on both COVID-19 experiences and the substantial research evidence accumulated before this pandemic. OBJECTIVE: We aim to conduct an umbrella review of systematic reviews available on the literature and evidence-based guidance on telemental health, including both qualitative and quantitative literature. METHODS: Three databases were searched between January 2010 and August 2020 for systematic reviews meeting the predefined criteria. The retrieved reviews were independently screened, and those meeting the inclusion criteria were synthesized and assessed for risk of bias. Narrative synthesis was used to report these findings. RESULTS: In total, 19 systematic reviews met the inclusion criteria. A total of 15 reviews examined clinical effectiveness, 8 reported on the aspects of telemental health implementation, 10 reported on acceptability to service users and clinicians, 2 reported on cost-effectiveness, and 1 reported on guidance. Most reviews were assessed to be of low quality. The findings suggested that video-based communication could be as effective and acceptable as face-to-face formats, at least in the short term. Evidence on the extent of digital exclusion and how it can be overcome and that on some significant contexts, such as children and young people's services and inpatient settings, was found to be lacking. CONCLUSIONS: This umbrella review suggests that telemental health has the potential to be an effective and acceptable form of service delivery. However, we found limited evidence on the impact of its large-scale implementation across catchment areas. Combining previous evidence and COVID-19 experiences may allow realistic planning for the future implementation of telemental health.

Route and duration of antibiotic therapy in acute cellulitis: A systematic review and meta-analysis of the effectiveness and harms of antibiotic treatment.

OBJECTIVES: Compared with guideline recommendations, antibiotic overuse is common in treating cellulitis. We conducted a systematic review and meta-analyses on antibiotic route and duration of treatment for cellulitis in adults and children. METHODS: We searched MEDLINE, EMBASE and trial registries from inception to Dec 11, 2019 for interventional and observational studies of antibiotic treatment for cellulitis. Exclusions included case series/reports, pre-septal/orbital cellulitis and non-English language articles. Random-effects meta-analyses were used to produce summary relative risk (RR) estimates for our primary outcome of clinical response. PROSPERO: CRD42018100602. RESULTS: We included 47/8423 articles, incorporating data from eleven trials (1855 patients) in two meta-analyses. The overall risk of bias was moderate. Only two trials compared the same antibiotic agent in each group. We found no evidence of difference in clinical response rates for antibiotic route or duration (RR(oral:IV)=1.12, 95%CI 0.98-1.27, I2=32% and RR(shorter:longer)=0.99, 95%CI 0•96-1.03, I2 = 0%, respectively). Findings were consistent in observational studies. Follow-up data beyond 30 days were sparse. CONCLUSIONS: The evidence base for antibiotic treatment decisions in cellulitis is flawed by biased comparisons, short follow-up and lack of data around harms of antibiotic overuse. Future research should focus on developing patient-tailored antibiotic prescribing for cellulitis to reduce unnecessary antibiotic use.

The experience of trial participation, treatment approaches and perceptions of change among participants with dissociative seizures within the CODES randomized controlled trial: A qualitative study.

BACKGROUND: Nested within a large, multicenter randomized controlled trial (RCT) for people with dissociative seizures (DS), the study used purposive sampling to explore participants' experience of participating in an RCT, their experience of DS-specific cognitive behavioral therapy (CBT) and another component of the RCT, Standardized Medical Care (SMC) and their perceptions of and reflections on seizure management and change. METHODS: A qualitative study using semistructured interviews was conducted with 30 participants in an RCT (the COgnitive behavioral therapy vs standardized medical care for adults with Dissociative non-Epileptic Seizures (CODES) Trial) investigating the effectiveness of two treatments for DS. Key themes and subthemes were identified using thematic framework analysis (TFA). RESULTS: Analysis yielded three overarching themes: taking part in a treatment trial - "the only thing out there", the experience of treatment techniques that were perceived to help with seizure management, and reflections on an "unpredictable recovery". CONCLUSIONS: People with DS are amenable to participating in a psychotherapy RCT and described a largely positive experience. They also described the applicability of aspects of DS-specific CBT and SMC in the management of their DS, received within the confines of the CODES trial. Factors that appeared to account for the variability in response to treatment delivery included individual preferences for the nature of sessions, the nature of therapeutic relationships, readiness to discuss trauma, other aspects of emotional avoidance, and whether therapy provided something new.

Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial.

BACKGROUND: People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. METHODS/DESIGN: The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. DISCUSSION: The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis. TRIAL REGISTRATION: ISRCTN, ISRCTN12424842. Registered on 25 February 2015.

Heart Rate Monitoring in Newborn Babies: A Systematic Review.

BACKGROUND: Around 10% of newborn infants require assistance during transition after birth. Heart rate (HR) is the most important clinical indicator to evaluate the clinical status of a newborn. AIM: Our study aimed to review all established and novel methods to detect HR in babies giving special consideration to non-invasive techniques. METHODS: We performed a systematic literature search on the following databases: MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL. The inclusion criteria were studies on methods to detect HR in both term and preterm infants in comparison to one of the current gold standards: pulse oximetry (PO) or electrocardiography (ECG) published in the last 15 years. Two independent reviewers screened titles and abstracts for eligibility. Data extracted in an Excel table were analysed to produce a narrative review structured around the type of monitoring, identified obstacles in use, as well as methods to overcome these limitations. RESULTS: The search revealed 649 studies after duplicates were removed. Full article analysis was performed on 26 studies of which 25 met the inclusion criteria. Well established methods such as auscultation and palpation, although rapid and easily available, have been shown to be inaccurate. ECG and PO were both more precise but the delay in obtaining a reliable HR signal from birth often exceeded 1-2 min. Novel sensors offered the advantages of minimally obtrusive technologies but have limitations mainly due to movement artefact, bad sensor coupling, intermittent measurement, and poor-quality recordings. CONCLUSIONS: The limitations of existing methods have a potential impact on short- and long-term morbidity and mortality outcomes. The development of a technological solution to determine HR accurately and quickly in babies at birth has immense implications for further research and can guide interventions, such as placental transfusion and resuscitation.

Exploring psychiatrists' perspectives of working with patients with dissociative seizures in the UK healthcare system as part of the CODES trial: a qualitative study.

OBJECTIVE: There is currently limited research exploring healthcare professionals' (HCPs) experiences of working with patients with dissociative seizures (DS). Existing studies do not focus on the role of psychiatrists in treating this complex condition. The objective of this study was to gain an understanding of UK-based psychiatrists' experiences of the DS patient group. Against the backdrop of a UK-wide randomised controlled trial (RCT), the focus was broadened to encompass issues arising in everyday practice with the DS patient group. DESIGN, PARTICIPANTS AND METHODS: A qualitative study using semistructured interviews was undertaken with 10 psychiatrists currently working with DS patients within the context of a large RCT investigating treatments for DS. Thematic analysis was used to identify key themes and subthemes. SETTING: The psychiatrists were working in Liaison or Neuropsychiatry services in England. RESULTS: The key themes identified were other HCPs' attitudes to DS and the challenges of the DS patient group. There is a clear knowledge gap regarding DS for many HCPs and other clinical services can be reluctant to take referrals for this patient group. Important challenges posed by this patient group included avoidance (of difficult emotions and help), alexithymia and interpersonal difficulties. Difficulties with alexithymia meant DS patients could struggle to identify triggers for their seizures and to express their emotions. Interpersonal difficulties raised included difficulties in attachment with both HCPs and family members. CONCLUSIONS: A knowledge gap for HCPs regarding DS has been identified and needs to be addressed to improve patient care. Given the complexity of the patient group and that clinicians from multiple disciplines will come into contact with DS patients, it is essential for any educational strategy to be implemented across the whole range of specialties, and to account for those already in practice as well as future trainees. TRIAL REGISTRATION NUMBER: ISRCTN05681227; NCT02325544; Pre-results.

Strategies for implementing placental transfusion at birth: A systematic review.

BACKGROUND: Enhanced placental transfusion reduces adverse neonatal outcomes, including death. Despite being endorsed by the World Health Organization in 2012, the method has not been adopted widely in practice. METHODS: We performed a systematic literature search and included quality improvement projects on placental transfusion at birth and studies on barriers to implementation. We extracted information on population, methods of implementation, obstacles to implementation, and strategies to overcome them. RESULTS: We screened 99 studies out of which 18 were included in the review. The preferred methods of implementation were protocol development (86% of studies) reinforced by targeted education (64% of studies) and multidisciplinary team involvement (43% of studies). Barriers to implementation were mentioned in 12 studies and divided into four categories: general factors such as lack of staff awareness (5 studies) and professional resistance to change (5 studies); obstetrician-specific concerns, including the impact during cesarean (3 studies) and the risk of postpartum hemorrhage (3 studies); pediatrician-specific concerns, including the need for resuscitation (5 studies), risk of jaundice (3 studies), and polycythemia (2 studies); and logistical difficulties. The main strategies to facilitate placental transfusion at birth included effective multidisciplinary team collaboration, protocol development, targeted education, and constructive feedback sessions. CONCLUSIONS: Placental transfusion implementation requires a multidisciplinary approach, with obstetricians, midwives, nurses, and pediatricians central to adoption of the practice. Understanding the obstacles to implementation informs strategies to increase placental transfusion adoption of practice worldwide. We suggest a stepwise approach to implementation and enhancement of placental transfusion into practice.

Recovery and decision-making involvement in people with severe mental illness from six countries: a prospective observational study.

BACKGROUND: Clinical decision-making is the vehicle of health care provision, and level of involvement predicts implementation and satisfaction. The aim of this study was to investigate the impact of decision-making experience on recovery. METHODS: Data derived from an observational cohort study "Clinical decision making and outcome in routine care for people with severe mental illness" (CEDAR). Adults (aged 18-60) meeting standardised criteria for severe mental illness were recruited from caseloads of outpatient and community mental health services in six European countries. After consenting, they were assessed using standardised measures of decision-making, clinical outcome and stage of recovery at baseline and 1 year later. Latent class analysis was used to identify course of recovery, and proportional odds models to investigate predictors of recovery stage and change. RESULTS: Participants (n = 581) clustered into three stages of recovery at baseline: Moratorium (N = 115; 19.8%), Awareness/Preparation (N = 145; 25.0%) and Rebuilding/Growth (N = 321; 55.2%). Higher stage was cross-sectionally associated with being male, married, living alone or with parents, and having better patient-rated therapeutic alliance and fewer symptoms. The model accounted for 40% of the variance in stage of recovery. An increased chance of worse outcome (change over 1 year to lower stage of recovery) was found for patients with active involvement compared with either shared (OR = 1.84, 95% CI 1.15-2.94) or passive (OR = 1.71, 95% CI = 1.00-2.95) involvement. Overall, both process (therapeutic relationship) and outcome (symptomatology) are cross-sectionally associated with stage of recovery. CONCLUSIONS: Patient-rated decision-making involvement and change in stage of recovery are associated. Joint consideration of decision practise within the recovery process between patient and clinician is supposed to be a useful strategy to improve clinical practice (ISRCTN registry: ISRCTN75841675. Retrospectively registered 15 September 2010).

Content and implementation of clinical decisions in the routine care of people with severe mental illness.

BACKGROUND: Clinical decision making (CDM) in the treatment of people with severe mental illness relates to a wide range of life domains. AIMS: To examine content of CDM in mental health care from the perspectives of service users and staff and to investigate variation in implementation of decisions for differing content. METHOD: As part of the European multicenter study clinical decision making and outcome in routine care for people with severe mental illness (ISRCTN75841675), 588 service users and their clinicians were asked to identify the decisions made during their last meeting. Decisions were then coded into content categories. Two months later, both parties reported if these decisions had been implemented. RESULTS: Agreement between patients and staff regarding decision making was moderate (k = 0.21­0.49; p < 0.001). Decisions relating to medication and social issues were most frequently identified. Overall reported level of implementation was 73.5% for patients and 74.7% for staff, and implementation varied by decision content. CONCLUSIONS: A variety of relevant decision topics were shown for mental health care.Implementation rates varied in relation to topic and may need different consideration within the therapeutic dyad.

Courses of helping alliance in the treatment of people with severe mental illness in Europe: a latent class analytic approach.

PURPOSE: The helping alliance (HA) between patient and therapist has been studied in detail in psychotherapy research, but less is known about the HA in long-term community mental health care. The aim of this study was to identify typical courses of the HA and their predictors in a sample of people with severe mental illness across Europe over a measurement period of one year. METHODS: Self-ratings of the HA by 588 people with severe mental illness who participated in a multicentre European study (CEDAR; ISRCTN75841675) were examined using latent class analysis. RESULTS: Four main patterns of alliance were identified: (1) high and stable (HS, 45.6 %), (2) high and increasing (HI, 36.9 %), (3) high and decreasing (HD, 11.3 %) and (4) low and increasing (LI, 6.1 %). Predictors of class membership were duration of illness, ethnicity, and education, receipt of state benefits, recovery, and quality of life. CONCLUSIONS: Results support findings from psychotherapy research about a predominantly stable course of the helping alliance in patients with severe mental illness over time. Implications for research and practice indicate to turn the attention to subgroups with noticeable courses.

The development and evaluation of a five-language multi-perspective standardised measure: clinical decision-making involvement and satisfaction (CDIS).

BACKGROUND: The aim of this study was to develop and evaluate a brief quantitative five-language measure of involvement and satisfaction in clinical decision-making (CDIS) - with versions for patients (CDIS-P) and staff (CDIS-S) - for use in mental health services. METHODS: An English CDIS was developed by reviewing existing measures, focus groups, semistructured interviews and piloting. Translations into Danish, German, Hungarian and Italian followed the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force principles of good practice for translation and cultural adaptation. Psychometricevaluation involved testing the measure in secondary mental health services in Aalborg, Debrecen, London, Naples, Ulm and Zurich. RESULTS: After appraising 14 measures, the Control Preference Scale and Satisfaction With Decision-making English-language scales were modified and evaluated in interviews (n = 9), focus groups (n = 22) and piloting (n = 16). Translations were validated through focus groups (n = 38) and piloting (n = 61). A total of 443 service users and 403 paired staff completed CDIS. The Satisfaction sub-scale had internal consistency of 0.89 (0.86-0.89 after item-level deletion) for staff and 0.90 (0.87-0.90) for service users, both continuous and categorical (utility) versions were associated with symptomatology and both staff-rated and service userrated therapeutic alliance (showing convergent validity), and not with social disability (showing divergent validity), and satisfaction predicted staff-rated (OR 2.43, 95%CI 1.54- 3.83 continuous, OR 5.77, 95%CI 1.90-17.53 utility) and service user-rated (OR 2.21, 95%CI 1.51-3.23 continuous, OR 3.13, 95%CI 1.10-8.94 utility) decision implementation two months later. The Involvement sub-scale had appropriate distribution and no floor or ceiling effects, was associated with stage of recovery, functioning and quality of life (staff only) (showing convergent validity), and not with symptomatology or social disability (showing divergent validity), and staff-rated passive involvement by the service user predicted implementation (OR 3.55, 95%CI 1.53-8.24). Relationships remained after adjusting for clustering by staff. CONCLUSIONS: CDIS demonstrates adequate internal consistency, no evidence of item redundancy, appropriate distribution, and face, content, convergent, divergent and predictive validity. It can be recommended for research and clinical use. CDIS-P and CDIS-S in all 3 five languages can be downloaded at http://www.cedar-net.eu/instruments. TRIAL REGISTRATION: ISRCTN75841675.

Development and psychometric properties of a five-language multiperspective instrument to assess clinical decision making style in the treatment of people with severe mental illness (CDMS).

BACKGROUND: The aim of this study was to develop and evaluate psychometric properties of the Clinical Decision Making Style (CDMS) scale which measures general preferences for decision making as well as preferences regarding the provision of information to the patient from the perspectives of people with severe mental illness and staff. METHODS: A participatory approach was chosen for instrument development which followed 10 sequential steps proposed in a current guideline of good practice for the translation and cultural adaptation of measures. Following item analysis, reliability, validity, and long-term stability of the CDMS were examined using Spearman correlations in a sample of 588 people with severe mental illness and 213 mental health professionals in 6 European countries (Germany, UK, Italy, Denmark, Hungary, and Switzerland). RESULTS: In both patient and staff versions, the two CDMS subscales "Participation in Decision Making" and "Information" reliably measure distinct characteristics of decision making. Validity could be demonstrated to some extent, but needs further investigation. CONCLUSIONS: Together with two other five-language patient- and staff-rated measures developed in the CEDAR study (ISRCTN75841675) - "Clinical Decision Making in Routine Care" and "Clinical Decision Making Involvement and Satisfaction" - the CDMS allows empirical investigation of the complex relation between clinical decision making and outcome in the treatment of people with severe mental illness across Europe.