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IntroductionPatients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care.Methods and analysisTwo uncontrolled before-and-after feasibility studies, where all participants will receive the intervention. We will examine the feasibility and acceptability of the SAFER-MH in inpatient mental health settings in patients aged 18 years or older who are being discharged and the feasibility and acceptability of the SAFER-YMH intervention in inpatient mental health settings in patients aged between 14 and 18 years who are being discharged. The baseline period and intervention periods are both 6 weeks. SAFER-MH will be implemented in three wards and SAFER-YMH in one or two wards, ideally across different trusts within England. We will use quantitative (eg, questionnaires, completion forms) and qualitative (eg, interviews, process evaluation) methods to assess the acceptability and feasibility of the two versions of the intervention. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients/wards should be included.Ethics and disseminationEthical approval was obtained from the National Health Service Cornwall and Plymouth Research Ethics Committee and Surrey Research Ethics Committee (reference: 22/SW/0096 and 22/LO/0404). Research findings will be disseminated with participating sites and shared in various ways to engage different audiences. We will present findings at international and national conferences, and publish in open-access, peer-reviewed journals.

Importance: Residents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents.Objective: To assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association.Data Sources: MEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology.Study Selection: Controlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria.Data Extraction and Synthesis: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest.Main Outcomes and Measures: The primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity.Results: Of 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals.Conclusions and Relevance: Emerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

ObjectiveTo describe the distribution of consultations at the practice level and examine whether increases are uniform or driven by people who consult more frequently.DesignRetrospective cohort study.SettingUK general practice data from the Clinical Practice Research Datalink (CPRD) GOLD database.Participants1 699 709 314 consultation events from 12 330 545 patients, in 845 general practices (1 April 2000 to 31 March 2019).MethodsConsultation information was aggregated by financial year into: all consultations/all staff; all consultations/general practitioners (GPs); face-to-face consultations/all staff; face-to-face consultations/GPs. Patients with a number of consultations above the 90th centile, within each year, were classified as frequent attenders. Negative binomial regressions examined the association between available practice characteristics and consultation distribution.ResultsAmong frequent attenders, all consultations by GPs increased from a median (25th and 75th centile) of 13 (10 and 16) to 21 (18 and 25) and all consultations by all staff increased from 27 (23–30) to 60 (51–69) over the study period. Approximately four out of ten consultations of any type concerned frequent attenders and the proportion of consultations attributed to them increased over time, particularly for face-to-face consultations with GPs, from a median of 38.0% (35.9%–40.3%) in 2000–2001 to 43.0% (40.6%–46.4%) in 2018–2019. Regression analyses indicated decreasing trends over time for face-to-face consultations and increasing trends for all consultation types, for both GPs and all staff. Frequent attenders consulted approximately five times more than the rest of the practice population, on average, with adjusted incidence rate ratios ranging between 4.992 (95% CI 4.917 to 5.068) for face-to-face consultations with all staff and 5.603 (95% CI 5.560 to 5.647) for all consultations with GPs.ConclusionsFrequent attenders progressively contributed to increased workload in general practices across the UK from 2000 to 2019. Important knowledge gaps remain in terms of the demographic, social and health characteristics of frequent attenders and how UK general practices can be prepared to meet the needs of these patients.

Background Patient and public involvement (PPI) in research is increasingly common (1), but the experience of research participants is rarely evaluated, missing opportunities to gain insights for improving future studies. (2) Observational studies are often used to study natural progression and treatment response in chronic diseases like rheumatoid arthritis (RA). Objectives We aimed to pilot a participant experience questionnaire in an observational study of RA patients, to gain feedback on the study and evaluate the questionnaire as a feedback tool. Methods The Rheumatoid Arthritis Medication Study (RAMS) is a large UK prospective observational study of patients with RA or undifferentiated polyarthritis starting methotrexate (MTX) for the first time. Participants were recruited prior to initiation of MTX and followed-up at 3, 6 and 12 months. At visits, disease activity is measured and participants complete a study questionnaire including patient reported outcomes. Participants also complete a weekly diary about their MTX use. (3) A subset of RAMS participants were given a feedback questionnaire at their final visit. The questionnaire was designed by researchers and study coordinators with feedback from patients. Questions addressed the value of participation, study conduct and priorities for future research. Multiple-choice question responses were summarised and key themes were identified in the free-text responses. Results 201 of 357 (56%) patients eligible to receive the questionnaire completed it. Multiple-choice questions had 100% completion and responses are presented in Table 1. 189 (94%) participants agreed that participating in RAMS was worthwhile and 180 (90%) would recommend participation to eligible friends and family. The most frequent theme in recommending the study was the desire to “help people” (47%) and most respondents (57%) did not know what future research they would like carried out or did not answer. Conclusion The majority of RAMS participants were happy to share their experience of participation and had positive views. Many had altruistic reasons for taking part. Multiple-choice questions had high completion rates and free-text fields were less completed. More details on participant research priorities may be gained by offering options to select from. Future investigation of participant experience should also consider those lost to follow-up, participants who choose to withdraw, and potential participants who did not enrol. References [1] INVOLVE. Approaches to Public Involvement: NIHR; [http://www.invo.org.uk/posttyperesource/approaches-to-public-involvement/] [2] Planner C, Bower P. Trials need participants but not their feedback? A scoping review of measures of participant experience of taking part in trials. School for Primary Care Research - 2017 Showcase Blavatnik School of Government; Oxford: NIHR; 2017 [3] Sergeant JC, Hyrich KL, Anderson J, et al. OP0013 Prediction of Non-Response To Methotrexate Therapy in The Rheumatoid Arthritis Medication Study (RAMS). Annals of the Rheumatic Diseases2016. p. 57-8 Disclosure of Interests None declared

Introduction The increasing prevalence of type 2 diabetes mellitus (T2DM) presents a significant burden on affected individuals and healthcare systems internationally. There is, however, no agreed validated measure to infer diabetes severity from electronic health records (EHRs). We aim to quantify T2DM severity and validate it using clinical adverse outcomes. Methods and analysis Primary care data from the Clinical Practice Research Datalink, linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in England will be used to develop a clinical algorithm to grade T2DM severity. The EHR-based algorithm will incorporate main risk factors (severity domains) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores. Provisionally, T2DM severity domains, identified through a systematic review and expert opinion, are: Diabetes duration, glycated haemoglobin, microvascular complications, comorbidities and coprescribed treatments. Severity scores will be developed by two approaches: (1) calculating a count score of severity domains; (2) through hierarchical stratification of complications. Regression models estimates will be used to calculate domains weights. Survival analyses for the association between weighted severity scores and future outcomes-cardiovascular events, hospitalisation (diabetes-related, cardiovascular) and mortality (diabetes-related, cardiovascular, all-cause mortality)-will be performed as statistical validation. The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions. We anticipate that the developed algorithm will be a practical tool for practitioners, aid clinical management decision-making, inform stratified medicine, support future clinical trials and contribute to more effective service planning and policy-making. Ethics and dissemination The study protocol was approved by the Independent Scientific Advisory Committee. Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase, September 2017, Oxford, UK and the Diabetes UK Professional Conference March 2018, London, UK. The study findings will be disseminated in relevant academic conferences and peer-reviewed journals.

Summary Background People with severe mental ill health are three times more likely to smoke but typically do not access conventional smoking cessation services, contributing to widening health inequalities and reduced life expectancy. We aimed to pilot an intervention targeted at smokers with severe mental ill health and to test methods of recruitment, randomisation, and follow up before implementing a full trial. Methods The Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR) is a pilot randomised controlled trial of a smoking cessation strategy designed specifically for people with severe mental ill health, to be delivered by mental health nurses and consisting of behavioural support and drugs, compared with a conventional smoking cessation service (ie, usual care). Adults (aged 18 years or older) with bipolar disorder or schizophrenia, who were current smokers, were recruited from NHS primary care and mental health settings in the UK (York, Scarborough, Hull, and Manchester). Eligible participants were randomly allocated to either usual care (control group) or usual care plus the bespoke smoking cessation strategy (intervention group). Randomisation was done via a central telephone system, with computer-generated random numbers. We could not mask participants, family doctors, and researchers to the treatment allocation. Our primary outcome was smoking status at 12 months, verified by carbon monoxide measurements or self-report. Only participants who provided an exhaled CO measurement or self-reported their smoking status at 12 months were included in the primary analysis. The trial is registered at ISRCTN.com, number ISRCTN79497236. Findings Of 97 people recruited to the pilot study, 51 were randomly allocated to the control group and 46 were assigned to the intervention group. Participants engaged well with the bespoke smoking cessation strategy, but no individuals assigned to usual care accessed NHS smoking cessation services. At 12 months, 35 (69%) controls and 33 (72%) people assigned to the intervention group provided a CO measurement or self-reported their smoking status. Smoking cessation was highest among individuals who received the bespoke intervention (12/33 [36%] vs 8/35 [23%]; adjusted odds ratio 2·9, 95% CI 0·8–10·5). Interpretation We have shown the feasibility of recruiting and randomising people with severe mental ill health in a trial of this nature. The level of engagement with a bespoke smoking cessation strategy was higher than with a conventional approach. The effectiveness and safety of a smoking cessation programme designed particularly for people with severe mental ill health should be tested in a fully powered randomised controlled trial. Funding National Institute of Health Research Health Technology Assessment Programme.

Background Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. Objective To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. Design A modified Delphi process including a two round online survey and a stakeholder consensus meeting. Participants In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty‐seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Results Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. Conclusions The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

BackgroundSmoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial.MethodsQualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method.ResultsGeneric services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users’ illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems.ConclusionThe bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness.Trial registrationCurrent Controlled Trials ISRCTN79497236. Registered 3rd July 2009.

Objectives Little is known about the prevalence of comorbidity rates in people with severe mental illness (SMI) in UK primary care. We calculated the prevalence of SMI by UK country, English region and deprivation quintile, antipsychotic and antidepressant medication prescription rates for people with SMI, and prevalence rates of common comorbidities in people with SMI compared with people without SMI.\ud \ud Design Retrospective cohort study from 2000 to 2012.\ud \ud Setting 627 general practices contributing to the Clinical Practice Research Datalink, a UK primary care database.\ud \ud Participants Each identified case (346 551) was matched for age, sex and general practice with 5 randomly selected control cases (1 732 755) with no diagnosis of SMI in each yearly time point.\ud \ud Outcome measures Prevalence rates were calculated for 16 conditions.\ud \ud Results SMI rates were highest in Scotland and in more deprived areas. Rates increased in England, Wales and Northern Ireland over time, with the largest increase in Northern Ireland (0.48% in 2000/2001 to 0.69% in 2011/2012). Annual prevalence rates of all conditions were higher in people with SMI compared with those without SMI. The discrepancy between the prevalence of those with and without SMI increased over time for most conditions. A greater increase in the mean number of additional conditions was observed in the SMI population over the study period (0.6 in 2000/2001 to 1.0 in 2011/2012) compared with those without SMI (0.5 in 2000/2001 to 0.6 in 2011/2012). For both groups, most conditions were more prevalent in more deprived areas, whereas for the SMI group conditions such as hypothyroidism, chronic kidney disease and cancer were more prevalent in more affluent areas.\ud \ud Conclusions Our findings highlight the health inequalities faced by people with SMI. The provision of appropriate timely health prevention, promotion and monitoring activities to reduce these health inequalities are needed, especially in deprived areas.

Objectives Little is known about service utilisation by patients with severe mental illness (SMI) in UK primary care. We examined their consultation rate patterns and whether they were impacted by the introduction of the Quality and Outcomes Framework (QOF), in 2004. Design Retrospective cohort study using individual patient data collected from 2000 to 2012. Setting 627 general practices contributing to the Clinical Practice Research Datalink, a large UK primary care database. Participants SMI cases (346 551) matched to 5 individuals without SMI (1 732 755) on age, gender and general practice. Outcome measures Consultation rates were calculated for both groups, across 3 types: face-to-face (primary outcome), telephone and other (not only consultations but including administrative tasks). Poisson regression analyses were used to identify predictors of consultation rates and calculate adjusted consultation rates. Interrupted time-series analysis was used to quantify the effect of the QOF. Results Over the study period, face-to-face consultations in primary care remained relatively stable in the matched control group (between 4.5 and 4.9 per annum) but increased for people with SMI (8.8–10.9). Women and older patients consulted more frequently in the SMI and the matched control groups, across all 3 consultation types. Following the introduction of the QOF, there was an increase in the annual trend of face-to-face consultation for people with SMI (average increase of 0.19 consultations per patient per year, 95% CI 0.02 to 0.36), which was not observed for the control group (estimates across groups statistically different, p=0.022). Conclusions The introduction of the QOF was associated with increases in the frequency of monitoring and in the average number of reported comorbidities for patients with SMI. This suggests that the QOF scheme successfully incentivised practices to improve their monitoring of the mental and physical health of this group of patients.

Background Measuring and responding to patient experience in clinical services is a policy priority, but this focus has not extended to the research setting. At the same time, with only 45% of trials recruiting to target, increasing recruitment and retention is a priority. It is hypothesised that using patient experience of trials data to improve the design of trials may have an impact on these outcomes. The study explored current measurement of patient experience of trials and stakeholder views around the feasibility of collecting and using this type of data.

Children are a particularly challenging group of patients when trying to ensure the safe use of medicines. The increased need for calculations, dilutions and manipulations of paediatric medicines, together with a need to dose on an individual patient basis using age, gestational age, weight and surface area, means that they are more prone to medication errors at each stage of the medicines management process. It is already known that dose calculation errors are the most common type of medication error in neonatal and paediatric patients. Interventions to reduce the risk of dose calculation errors are therefore urgently needed. A systematic literature review was conducted to identify published articles reporting interventions; 28 studies were found to be relevant. The main interventions found were computerised physician order entry (CPOE) and computer-aided prescribing. Most CPOE and computer-aided prescribing studies showed some degree of reduction in medication errors, with some claiming no errors occurring after implementation of the intervention. However, one study showed a significant increase in mortality after the implementation of CPOE. Further research is needed to investigate outcomes such as mortality and economics. Unit dose dispensing systems and educational/risk management programmes were also shown to reduce medication errors in children. Although it is suggested that 'smart' intravenous pumps can potentially reduce infusion errors in children, there is insufficient information to draw a conclusion because of a lack of research. Most interventions identified were US based, and since medicine management processes are currently different in different countries, there is a need to interpret the information carefully when considering implementing interventions elsewhere.

BackgroundThere is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI.ObjectiveThe objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI.DesignA pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation.SettingPrimary care and secondary care mental health services in England.ParticipantsSmokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking.InterventionsA BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care.Main outcome measuresThe primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation.ResultsThe trial recruited 97 people aged 19–73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis.ConclusionsIt was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness.Trial registrationCurrent Controlled Trials ISRCTN79497236.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

Policies and guidelines from across the international community are attempting to galvanise action to address the unacceptably high morbidity and mortality rates amongst people with a serious mental illness (SMI). Primary care has a pivotal role to play in translating policy into evidence based practice in conjunction with other providers of health care services. This paper explores the current and potential of role of primary care providers in delivering health care to people with SMI. A review of research in the following key areas of primary health care provision is provided: access, screening and preventative care, routine monitoring and follow-up, diagnosis and delivery of treatments in accordance with guidelines and delivery of interventions. There is undoubtedly a need for further research to establish the effectiveness of primary care interventions and the organisation of services. Equally, understanding how primary care services can deliver high quality care and promoting effective working at the interface with other services must be priorities.

Background Collaborative care for severe mental illness (SMI) is a community-based intervention, which typically consists of a number of components. The intervention aims to improve the physical and/or mental health care of individuals with SMI. Objectives To assess the effectiveness of collaborative care approaches in comparison with standard care for people with SMI who are living in the community. The primary outcome of interest was psychiatric admissions. Search methods We searched the Cochrane Schizophrenia Group Specialised register in April 2011. The register is compiled from systematic searches of major databases, handsearches of relevant journals and conference proceedings. We also contacted 51 experts in the field of SMI and collaborative care. Selection criteria Randomised controlled trials (RCTs) described as collaborative care by the trialists comparing any form of collaborative care with 'standard care' for adults (18+ years) living in the community with a diagnosis of SMI, defined as schizophrenia or other types of schizophrenia-like psychosis (e.g. schizophreniform and schizoaffective disorders), bipolar affective disorder or other types of psychosis. Data collection and analysis Two review authors worked independently to extract and quality assess data. For dichotomous data, we calculated the risk ratio (RR) with 95% confidence intervals (CIs) and we calculated mean differences (MD) with 95% CIs for continuous data. Risk of bias was assessed. Main results We included one RCT (306 participants; US veterans with bipolar disorder I or II) in this review. We did not find any trials meeting our inclusion criteria that included people with schizophrenia. The trial provided data for one comparison: collaborative care versus standard care. All results are 'low or very low quality evidence'. Data indicated that collaborative care reduced psychiatric admissions at year two in comparison to standard care (n = 306, 1 RCT, RR 0.75, 95% CI 0.57 to 0.99). The sensitivity analysis showed that the proportion of participants psychiatrically hospitalised was lower in the intervention group than the standard care group in year three: 28% compared to 38% (n = 330, 1 RCT, RR 0.72, 95% CI 0.53 to 0.99). In comparison to the standard care group, collaborative care significantly improved the Mental Health Component (MHC) of quality of life at the three-year follow-up, (n = 306, 1 RCT, MD 3.50, 95% CI 1.80 to 5.20). The Physical Health Component (PHC) of the quality of life measure at the three-year follow-up did not differ significantly between groups (n = 306, 1 RCT, MD 0.50, 95% CI 0.91 to 1.91). Direct intervention (all-treatment) costs of collaborative care at the three-year follow-up did not differ significantly from standard care (n = 306, 1 RCT, MD -$2981.00, 95% CI $16934.93 to $10972.93). The proportion of participants leaving the study early did not differ significantly between groups (n = 306, 1 RCT, RR 1.71, 95% CI 0.77 to 3.79). There is no trial-based information regarding the effect of collaborative care for people with schizophrenia. No statistically significant differences were found between groups for number of deaths by suicide at three years (n = 330, 1 RCT, RR 0.34, 95% CI 0.01 to 8.32), or the number of participants that died from all other causes at three years (n = 330, 1 RCT, RR 1.54, 95% CI 0.65 to 3.66). Authors' conclusions The review did not identify any studies relevant to care of people with schizophrenia and hence there is no evidence available to determine if collaborative care is effective for people suffering from schizophrenia or schizophreniform disorders. There was however one trial at high risk of bias that suggests that collaborative care for US veterans with bipolar disorder may reduce psychiatric admissions at two years and improves quality of life (mental health component) at three years, however, on its own it is not sufficient for us to make any recommendations regarding its effectiveness. More large, well designed, conducted and reported trials are required before any clinical or policy making decisions can be made.

Objective: Little is known about teaching paediatricians to prescribe and assessing their competency. This study aimed to identify educational interventions to reduce dose calculation errors. Design: Literature review, questionnaire survey of paediatric healthcare professionals, observation and interviews were performed. Results: Literature review identified one paper describing an in-service test for medical trainees. 319/559 questionnaires were returned (57%). 34 mentioned educational interventions. 15 centres provided further information on teaching/assessment methods. 13 delivered presentations usually at doctor9s induction. Many had a similar format including differences to adult prescribing; common errors and how to calculate doses. Paediatric clinical pharmacists play a significant role in delivering training/competency assessment. Conclusion: Teaching of paediatric prescribing takes place mostly in the format of lectures during doctor9s induction. Few centres assess competency. No validated tool exists. There has been little evaluation of the impact of teaching on competency to prescribe.

Objective(s) To investigate the clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for the treatment of adults with pulmonary arterial hypertension (PAH) within their licensed indications. Data sources Major electronic databases (including the Cochrane Library, MEDLINE and EMBASE) were searched up to February 2007. Further data were obtained from dossiers submitted to NICE by the manufacturers of the technologies. Review methods The systematic clinical and economic reviews were conducted according to accepted procedures. Model-based economic evaluations of the cost-effectiveness of the technologies from the perspective of the UK NHS and personal social services were carried out. Results In total, 20 randomised controlled trials (RCTs) were included in this assessment, mostly of 12–18 weeks duration and comparing one of the technologies added to supportive treatment with supportive treatment alone. Four published economic evaluations were identified. None produced results generalisable to the NHS. There was no consensus in the industry submissions on the most appropriate model structure for the technology assessment. Improvement in 6-minute walk distance (6MWD) was seen with intravenous epoprostenol in primary pulmonary hypertension (PPH) patients with mixed functional class (FC) (mainly III and IV, licensed indication) compared with supportive care (58 metres; 95% CI 6–110). For bosentan compared with supportive care, the pooled result for improvement in 6MWD for FCIII patients with mixed PAH (licensed indication) was 59 metres (95% CI 20–99). For inhaled iloprost, sitaxentan and sildenafil no stratified data for improvement in 6MWD were available. The odds ratio (OR) for FC deterioration at 12 weeks was 0.40 (95% CI 0.13–1.20) for intravenous epoprostenol compared with supportive care. The corresponding values for inhaled iloprost (FCIII PPH patients; licensed indication), bosentan, sitaxentan (FCIII patients with mixed PAH; licensed indication) and sildenafil (FCIII patients with mixed PAH; licensed indication) were 0.29 (95% CI 0.07–1.18), 0.21 (95% CI 0.03–1.76), 0.18 (95% CI 0.02–1.64) and [Commercial-in-confidence information has been removed] respectively. The incremental cost-effectiveness ratios (ICERs) for the technologies plus supportive care compared with supportive care alone, determined by independent economic evaluation, were £277,000/quality-adjusted life-year (QALY) for FCIII and £343,000/QALY for FCIV patients for epoprostenol, £101,000/QALY for iloprost, £27,000/QALY for bosentan and £25,000/QALY for sitaxentan. For the most part sildenafil plus supportive care was more effective and less costly than supportive care alone and therefore dominated supportive care. In the case of epoprostenol the ICERs were sensitive to the price of epoprostenol and for bosentan and sitaxentan the ICERs were sensitive to running the model over a shorter time horizon and with a lower cost of epoprostenol. Two RCTs directly compared the technologies against each other with no significant differences observed between the technologies. Combinations of technologies were investigated in four RCTs, with some showing conflicting results. Conclusion(s) All five technologies when added to supportive treatment and used at licensed dose(s) were more effective than supportive treatment alone in RCTs that included patients of mixed FC and types of PAH. Current evidence does not allow adequate comparisons between the technologies nor for the use of combinations of the technologies. Independent economic evaluation suggests that bosentan, sitaxentan and sildenafil may be cost-effective by standard thresholds and that iloprost and epoprostenol may not. If confirmed, the use of the most cost-effective treatment would result in a reduction in costs for the NHS. Long-term, double-blind RCTs of sufficient sample size that directly compare bosentan, sitaxentan and sildenafil, and evaluate outcomes including survival, quality of life, maintenance on treatment and impact on the use of resources for NHS and personal social services are needed.

Medicines' management or pharmaceutical care in paediatric patients is particularly demanding, mainly because the majority of available drugs have been developed for use in adults. As a result, in children, drugs are often unlicensed or used off-label, suitable formulations or appropriate strengths are lacking, and drugs have to be extemporaneously prepared, liquids and injections diluted, and tablets split. These factors increase the likelihood of medication errors and may lead to a reduction in drug effect. Age-specific changes in pharmacokinetics and pharmacodynamics further complicate drug therapy in children. All these challenges provide unique opportunities for pharmacists to improve the quality of care for paediatric patients. We conducted a systematic literature review examining whether the interventions of hospital pharmacists improve drug therapy in children. Several medical and pharmaceutical databases were searched systematically to identify articles investigating hospital pharmacists' interventions that were intended to improve drug therapy in children. Inclusion criteria were English language, primary research papers and studies in which clinical pharmacists contributed directly to patient care. Exclusion criteria were reviews, editorials, questionnaire studies, modelling studies, letters and studies only available in abstract form. This systematic search identified 18 articles documenting the role of a clinical hospital pharmacist in paediatric care. These articles were divided into the following groups based on study type: (i) studies documenting interventions made by pharmacists and their role in inpatients; (ii) articles presenting the outcomes of a satellite pharmacy; and (iii) articles examining pharmacist involvement in paediatric outpatient clinics. No randomised study comparing pharmacist interventions with standard care was found. In conclusion, although it was difficult to compare the various studies identified because of the different settings, design, duration, size, methodology and definition, all these studies highlighted the importance of hospital pharmacists to medicines' management in paediatric patients. On the basis of this review, we can conclude that pharmacist reviewing of medication charts is very important in identifying medication errors; hence, it is likely to be the most effective method of improving drug therapy in children.

Aims This presentation describes and analyses patient characteristics and service usage over one year of a cohort of people with a diagnosis of severe mental illness across England, including contacts with primary and secondary care and continuity- of-care. Methods Data were collected from primary care patient notes (n=1150) by trained nurses from 64 practices in England, covering all service contacts from 1st April 2008 to 31st March 2009. Results The estimated national rate of patients seen only in primary care was 31.1% and rates of schizophrenia and bipolar disorder were 56.8% and 37.9%. Patients had 7,961 consultations within primary care and 1,993 contacts with mental health services (20% of the total). Of those seen in secondary care, 61% had at most two secondary care contacts recorded in primary care notes. Median consultation rates with GPs were lower than have been reported for previous years and were only slightly above the general population. Relational continuity in primary care was poor for 21% of patients (Modified Modified Continuity Index = Conclusions Primary care is centrally involved in the care of people with serious mental illness, but primary care and cross- boundary continuity is poor for a substantial proportion. Research is needed to determine the impact of poor continuity on patient outcomes, and above all, the impact of new collaborative ways of working at the primary/secondary care interface

Introduction Collaborative care is a community based intervention which typically consists of a number of components. The intervention aims to improve the physical and/or mental health and health care of people with a severe mental illness (SMI). Objectives To explore how collaborative care is implemented. To assess the effectiveness of collaborative care approaches in comparison to standard care for people with SMI who are living in the community. Methods A Cochrane Review: The Cochrane Schizophrenia Group Specialised register was searched in April 2011. Fifty one experts in the field of SMI and collaborative care were also contacted. Results We included one RCT (306 participants; US veterans with bipolar disorder I or II) in this review. The trial provides data for one comparison: collaborative care versus standard care The reanalysis of data from the one included study indicated that collaborative care significantly reduced psychiatric admissions at year 2 in comparison to standard care (N= 306, 1 RCT, RR 0.75, 95% CI 0.57 to 0.99). Direct intervention (all-treatment) costs of collaborative care at the three year follow up did not differ significantly from standard care,mean difference -$2981.00 (N= 306, 1 RCT95% CI $16934.93 to $10972.93). Conclusions One trial at moderate risk of bias suggests that collaborative care may significantly reduce psychiatric admissions. More large, well designed, conducted and reported trials may be required to determine the effects of collaborative care and help inform healthcare professionals and policy makers about the value of collaborative care for people with SMI

Background Severe mental illness is a serious and potentially life changing set of conditions. This paper describes and analyses patient characteristics and service usage over one year of a representative cohort of people with a diagnosis of severe mental illness across England, including contacts with primary and secondary care and continuity of care. Methods and Findings Data were collected from primary care patient notes (n = 1150) by trained nurses from 64 practices in England, covering all service contacts from 1st April 2008 to 31st March 2009. The estimated national rate of patients seen only in primary care in the period was 31.1% (95% C.I. 27.2% to 35.3%) and the rates of schizophrenia and bipolar disorder were 56.8% (95% C.I. 52.3% to 61.2%) and 37.9% (95% C.I. 33.7% to 42.2%). In total, patients had 7,961 consultations within primary care and 1,993 contacts with mental health services (20% of the total). Unemployed individuals diagnosed more recently were more likely to have contact with secondary care. Of those seen in secondary care, 61% had at most two secondary care contacts in the period. Median annual consultation rates with GPs were lower than have been reported for previous years and were only slightly above the general population. Relational continuity in primary care was poor for 21% of patients (Modified Modified Continuity Index =