Results of a pilot cluster randomised trial of the use of a Medication Review Tool for people taking antipsychotic medication

BACKGROUND: Government policy encourages increasing involvement of patients in their long-term care. This paper describes the development and pilot evaluation of a 'Medication Review Tool' designed to assist people to participate more effectively in discussions about antipsychotic drug treatment. METHODS: The Medication Review Tool developed consisted of a form to help patients identify pros and cons of their current antipsychotic treatment and any desired changes. It was associated with a website containing information and links about antipsychotics. For the trial, participants diagnosed with psychotic disorders were recruited from community mental health services. Cluster randomisation was used to allocate health professionals (care co-ordinators) and their associated patients to use of the Medication Review Tool or usual care. All participants had a medical consultation scheduled, and those in the intervention group completed the Medication Review Tool, with the help of their health professional prior to this, and took the completed Form into the consultation. Two follow-up interviews were conducted up to three months after the consultation. The principal outcome was the Decision Self Efficacy Scale (DSES). Qualitative feedback was collected from patients in the intervention group. RESULTS: One hundred and thirty patients were screened, sixty patients were randomised, 51 completed the first follow-up assessment and 49 completed the second. Many patients were not randomised due to the timing of their consultation, and involvement of health professionals was inconsistent. There was no difference between the groups on the DSES (-4.16 95 % CI -9.81, 1.49), symptoms, side effects, antipsychotic doses or patient satisfaction. Scores on the Medication Adherence Questionnaire indicated an increase in participants' reported inclination to adherence in the intervention group (coefficient adjusted for baseline values -0.44; 95 % CI -0.76, -0.11), and there was a small increase in positive attitudes to antipsychotic medication (Drug Attitude Inventory, adjusted coefficient 1.65; 95 % CI -0.09, 3.40). Qualitative feedback indicated patients valued the Tool for identifying both positive and negative aspects of drug treatment. CONCLUSIONS: The trial demonstrated the design was feasible, although challenges included service re-configurations and maintaining health professional involvement. Results may indicate a more intensive and sustained intervention is required to facilitate participation in decision-making for this group of patients. TRIAL REGISTRATION: Current controlled trials ISRCTN12055530 , Retrospectively registered 9/12/2013

Support Needs and Experiences of People Bereaved by Suicide: Qualitative Findings from a Cross-Sectional British Study of Bereaved Young Adults.

People bereaved by suicide are at increased risk of suicide, but evidence is lacking that available interventions reduce suicide risk. Few large-scale studies have described the views of suicide-bereaved people regarding their needs for support. Our objective was to explore the nature of young adults' experiences of support after bereavement by suicide and their views on valued and unhelpful aspects. We conducted a cross-sectional study of staff and students aged 18-40 at 37 United Kingdom (UK) higher educational institutions in 2010, eliciting qualitative responses to two questions probing experiences of support and unmet needs after the suicide of a close contact. We conducted thematic analysis of responses from 420 adults bereaved by suicide, of whom 75% had received support after the loss. We identified three broad descriptive areas corresponding to important aspects of support: value and experiences of the support received; views on specific support needs; and reasons for not seeking support. We found that needs for emotional support exist throughout the social networks of people who die by suicide but are often hidden. Our findings suggest a need for proactive offers of support from family, friends, and professionals after suicide, repeated regularly in case a bereaved person does not feel ready for support early on

The Impact of Suicide Bereavement on Educational and Occupational Functioning: A Qualitative Study of 460 Bereaved Adults.

People bereaved by suicide are at an increased risk of suicide and of dropping out of education or work. Explanations for these associations are unclear, and more research is needed to understand how improving support in educational or work settings for people bereaved by suicide might contribute to reducing suicide risk. Our objective was to explore the impact of suicide on occupational functioning. We conducted a cross-sectional online study of bereaved adults aged 18-40, recruited from staff and students of British higher educational institutions in 2010. We used thematic analysis to analyse free text responses to two questions probing the impact of suicide bereavement on work and education. Our analysis of responses from 460 adults bereaved by suicide identified three main themes: (i) specific aspects of grief that impacted on work performance, cognitive and emotional domains, and social confidence; (ii) structural challenges in work or educational settings including a lack of institutional support, the impact of taking time off, and changes to caring roles; and (iii) new perspectives on the role of work, including determination to achieve. Institutional support should be tailored to take account of the difficulties and experiences described

Investigating Real-World Clopidogrel Pharmacogenetics in Stroke Using a Bioresource Linked to Electronic Medical Records

Clopidogrel efficacy is influenced by genetic variation of CYP2C19, however few studies have considered stroke patients. We used electronic medical records (EMR) linked to a bioresource to examine real-world implications of clopidogrel pharmacogenetics in stroke. Patients hospitalized for any arterial thrombo-occlusive event (ATO) who subsequently redeemed clopidogrel prescriptions in the community were entered into the study (n=651). During 24 months follow-up the primary endpoint of recurrent ATO or death occurred in 299 (46%) patients. CYP2C19*2 loss-of-function allele carriers had an increased risk, hazard ratio (HR) 1.29 (95% confidence interval 1.04-1.59, P=0.019). In the ischemic stroke subgroup (n=94) the estimate of risk was greater (HR 2.23, 95% confidence interval 1.17-4.24, P=0.015) further supported by a meta-analysis of available studies. In conclusion, we have demonstrated the clinical impact of CYP2C19*2 on clopidogrel efficacy using a purely EMR approach. This suggests that the risk in the ischemic stroke population may be particularly high.</p

Development of a peer-supported, self-management intervention for people following mental health crisis

BACKGROUND: A documented gap in support exists for service users following discharge from acute mental health services, and structured interventions to reduce relapse are rarely provided. Peer-facilitated self-management interventions have potential to meet this need, but evidence for their effectiveness is limited. This paper describes the development of a peer-provided self-management intervention for mental health service users following discharge from crisis resolution teams (CRTs). METHODS: A five-stage iterative mixed-methods approach of sequential data collection and intervention development was adopted, following the development and piloting stages of the MRC framework for developing and evaluating complex interventions. Evidence review (stage 1) included systematic reviews of both peer support and self-management literature. Interviews with CRT service users (n = 41) regarding needs and priorities for support following CRT discharge were conducted (stage 2). Focus group consultations (n = 12) were held with CRT service-users, staff and carers to assess the acceptability and feasibility of a proposed intervention, and to refine intervention organisation and content (stage 3). Qualitative evaluation of a refined, peer-provided, self-management intervention involved qualitative interviews with CRT service user participants (n = 9; n = 18) in feasibility testing (stage 4) and a pilot trial (stage 5), and a focus group at each stage with the peer worker providers (n = 4). RESULTS: Existing evidence suggests self-management interventions can reduce relapse and improve recovery. Initial interviews and focus groups indicated support for the overall purpose and planned content of a recovery-focused self-management intervention for people leaving CRT care adapted from an existing resource: The personal recovery plan (developed by Repper and Perkins), and for peer support workers (PSWs) as providers. Participant feedback after feasibility testing was positive regarding facilitation of the intervention by PSWs; however, the structured self-management booklet was underutilised. Modifications to the self-management intervention manual and PSWs' training were made before piloting, which confirmed the acceptability and feasibility of the intervention for testing in a future, definitive trial. CONCLUSIONS: A manualised intervention and operating procedures, focusing on the needs and priorities of the target client group, have been developed through iterative stages of intervention development and feedback for testing in a trial context. Trial Registration ISRCTN01027104 date of registration: 11/10/2012

5-Fluorouracil as protracted continuous intravenous infusion can be added to full-dose docetaxel (Taxotere®)-cisplatin in advanced gastric carcinoma: a phase I-II trial

Background: A phase I-II multicenter trial was conducted to define the maximum tolerated dose (MTD) according to tolerance and toxicity (primary objective), as well as to describe the clinical activity, in terms of response and survival (secondary objectives), of a combination of 5-fluorouracil (5-FU) in protracted continuous intravenous infusion (p.i.v.) with docetaxel and cisplatin for patients with advanced gastric cancer. Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, World Health Organization performance status ≤1, normal hematological and renal functions, adequate hepatic function and not pretreated for advanced disease by chemotherapy, received up to eight cycles of a combination of docetaxel on day 1, cisplatin on day 1 and 5-FU p.i.v. on days 1-14 (TCF) every 3 weeks, which was escalated up to the MTD, defined by the occurrence of dose-limiting toxicity in two patients in one dose level. Results: Fifty-two patients were accrued and treated (43 in the phase I part of the trial and nine additional at the recommended dose level). A median of five cycles/patient was given. The recommended dose of TCF was docetaxel 85 mg/m2 on day 1, cisplatin 75 mg/m2 on day 1 and 5-FU p.i.v. 300 mg/m2/day on days 1-14. Grade ≥3 toxicities were neutropenia 79%, alopecia 46%, fatigue 23%, mucositis 10%, diarrhea 19%, nausea/vomiting 13%, neurological 4% and palmar-plantar 2%. Ten non-fatal febrile neutropenia episodes were recorded in eight patients. There were no treatment-related deaths. Among 41 patients with measurable disease (79%), we observed one complete and 20 partial responses for an overall intent-to-treat response rate of 51% (95% confidence interval 35-67%). Five patients (20%) had stable disease for ≥12 weeks (four cycles). The median overall survival was 9.3 months. Conclusions: 5-FU p.i.v. at 300 mg/m2/day for 2 weeks out of three could be safely added to the docetaxel-cisplatin (TC) combination, but the dose of docetaxel had to be reduced to 75 mg/m2 in a subsequent phase II trial. This drug regimen seems to be very active in advanced gastric cancer. Comparison with both TC and ECF in a randomized SAKK trial is ongoin

Talking to Others About Sexual Assault: A Narrative Analysis of Survivors' Journeys

Previous research suggested the benefits for sexual assault survivors to talk about their trauma and its mental health implications, but it remained unclear what steps sexual assault survivors need to take to be able to have these conversations. To address this gap in the literature, this study aims to explore the journeys of sexual assault survivors with the use of narrative interviews to retain the richness of the data. This study reports the findings of a narrative analysis of the accounts of six female sexual assault survivors aged between 20 and 38. The analysis provides an individual case profile for each participant, the core aspects and tone of each narrative, and a cross-case analysis. The cross-case analysis reveals an overarching theme of “the bumpy journey” within which the individual difficulties encountered are examined. The analysis also reveals the two main factors that motivated the participant to strive to make a difference for other sexual violence survivors and to improve their mental health through talking about their experiences. The implications for services providing continuous and long-term support to sexual assault survivors and clinical practices are discussed

Refugees Who Have Experienced Extreme Cruelty: A Qualitative Study of Mental Health and Wellbeing after Being Granted Leave to Remain in the UK

This study explores how vulnerable refugees’ experiences in the first year after being granted leave to remain in the UK impact on mental health and wellbeing. Nine semi-structured interviews were conducted with refugee survivors of extreme cruelty. Data were analyzed using thematic analysis with a narrative influence. Reported challenges included requirements to organize housing, finances and welfare benefits rapidly. Most respondents reported low mood, worry, exacerbated PTSD symptoms, physical ailments and isolation, but valued stable housing, meaningful activities, emotional support and service provider sensitivity in managing this transition. Policy and service recommendations are made, to assist integration and improve wellbeing

Shared decision-making for psychiatric medication : A mixed-methods evaluation of a UK training programme for service users and clinicians

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).Background: Shared decision making (SDM) is recognised as a promising strategy to enhance good collaboration between clinicians and service users, yet it is not practised regularly in mental health. Aims: Develop and evaluate a novel training programme to enhance SDM in psychiatric medication management for service users, psychiatrists and care co-ordinators. Methods: The training programme design was informed by existing literature and local stakeholders consultations. Parallel group-based training programmes on SDM process were delivered to community mental health service users and providers. Evaluation consisted of quantitative measures at baseline and 12-month follow-up, post-programme participant feedback and qualitative interviews. Results: Training was provided to 47 service users, 35 care-coordinators and 12 psychiatrists. Participant feedback was generally positive. Statistically significant changes in service users’ decisional conflict and perceptions of practitioners’ interactional style in promoting SDM occurred at the follow-up. Qualitative data suggested positive impacts on service users’ and care co-ordinators confidence to explore medication experience, and group-based training was valued. Conclusions: The programme was generally acceptable to service users and practitioners. This indicates the value of conducting a larger study and exploring application for non-medical decisions.Peer reviewedFinal Published versio