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Background: UK Medical Research Council guidelines recommend end-user involvement in intervention development. There is limited evidence on the contributions of different end-users to this process. The aim of this Study Within A Trial (SWAT) was to identify and compare contributions from two groups of end-users - people with diabetes' (PWD) and healthcare professionals' (HCPs), during consensus meetings to inform an intervention to improve retinopathy screening uptake. Methods: A mixed method, explanatory sequential design comprising a survey and three semi-structured consensus meetings was used. PWD were randomly assigned to a diabetes only or combined meeting. HCPs attended a HCP only or combined meeting, based on availability. In the survey, participants rated intervention proposals on acceptability and feasibility. Survey results informed the meeting topic guide. Transcripts were analysed deductively to compare feedback on intervention proposals, suggestions for new content, and contributions to the final intervention. Results: Overall, 13 PWD and 17 HCPs completed the survey, and 16 PWD and 15 HCPs attended meetings. For 31 of the 39 intervention proposals in the survey, there were differences (≥10%) between the proportion of HCPs and PWD who rated proposals as acceptable and/or feasible. End-user groups shared and unique concerns about proposals; both were concerned about informing but not scaring people when communicating risk, while concerns about resources were mostly unique to HCPs and concerns about privacy were mostly unique to PWD. Fewer suggestions for new intervention content from the combined meeting were integrated into the final intervention as they were not feasible for implementation in general practice. Participants contributed four new behaviour change techniques not present in the original proposals: goal setting (outcome), restructuring the physical environment, material incentive (behaviour) and punishment. Conclusions: Preferences for intervention content may differ across end-user groups, with feedback varying depending on whether end-users are involved simultaneously or separately.
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BACKGROUND: Antipsychotics (APs) increase weight, metabolic syndrome, diabetes and cardiovascular disease. Guidelines recommend cardio-metabolic monitoring at initial assessment, at 3 months and then annually in people prescribed APs. AIM: To determine the rates of cardio-metabolic monitoring in AP treated early and chronic psychosis and to assess the impact of targeted improvement strategies. METHODS: Medical records were reviewed in two cohorts of first-episode psychosis (FEP) patients before and after the implementation of a physical health parameter checklist and electronic laboratory order set. In a separate group of patients with chronic psychotic disorders, adherence to annual monitoring was assessed before and 3 months after an awareness-raising educational intervention. RESULTS: In FEP, fasting glucose (39% vs 67%, p=0.05), HbA1c (0% vs 24%, p=0.005) and prolactin (18% vs 67%, p=0.001) monitoring improved. There were no significant differences in weight (67% vs 67%, p=1.0), BMI (3% vs 10%, p=0.54), waist circumference (3% vs 0%, p=1.0), fasting lipids (61% vs 76% p=0.22) or ECG monitoring (67% vs 67%, p=1.0). Blood pressure (BP) (88% vs 57%, p=0.04) and heart rate (91% vs 65%, p=0.03) monitoring dis-improved. Diet (0%) and exercise (<15%) assessment was poor. In chronic psychotic disorders, BP monitoring improved (20% vs 41.4%, p=0.05), whereas weight (17.0% vs 34.1%, p=0.12), BMI (9.7% vs 12.1%, p=1.0), fasting glucose (17% vs 24.3%, p=0.58) and fasting lipids remained unchanged (17% vs 24.3%, p=0.58). CONCLUSIONS: Targeted improvement strategies resulted in a significant improvement in a limited number of parameters in early and chronic psychotic disorders. Overall, monitoring remained suboptimal.
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Antipsicóticos , Transtornos Psicóticos , Antipsicóticos/uso terapêutico , Exercício Físico , Humanos , Lipídeos , Transtornos Psicóticos/tratamento farmacológicoRESUMO
BACKGROUND: Cognitive impairments, negative symptoms, affective symptoms, and low energy are highly prevalent features of schizophrenia. Mitochondrial dysfunction has been hypothesized as one of the numerous factors to underlie the manifestation of these symptoms. The objective of this study was to evaluate whether Coenzyme Q10 (CoQ10) has a role in the treatment of schizophrenia and schizoaffective disorder. METHODS: A double-blind, randomized, placebo-controlled trial was conducted to assess the effects of CoQ10 supplementation (300 mg/day) on the co-primary outcomes of attention and working memory performance after 3 and 6 months. Secondary outcomes included plasma CoQ10 levels, mitochondrial function, energy, depression, anxiety, negative symptoms, and quality oflife. FINDINGS: In total, 72 patients were randomized to intervention groups. Overall, there was no effect of CoQ10 supplementation on the primary outcome measures at 3 or 6 months. Further, with the exception of plasma CoQ10 levels, CoQ10 supplementation also had no effect on the secondary outcomes. At 3 months, CoQ10 concentration was significantly higher in the CoQ10 group (3.85 µg/mL) compared with placebo (1.13 µg/mL); this difference was not present at 6 months. CONCLUSIONS: The results of the study suggest that CoQ10 supplementation at 300 mg/day for 6 months is unlikely to be beneficial for cognitive, psychological and health-related outcomes in schizophrenia and schizoaffective disorder. However, a number of limitations including low adherence, modest sample size, and attrition, likely reduce estimates of effects. As such, results should be considered preliminary.
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Cognição/efeitos dos fármacos , Esquizofrenia/tratamento farmacológico , Psicologia do Esquizofrênico , Ubiquinona/análogos & derivados , Adulto , Idoso , Atenção/efeitos dos fármacos , Método Duplo-Cego , Feminino , Humanos , Masculino , Memória de Curto Prazo/efeitos dos fármacos , Pessoa de Meia-Idade , Ubiquinona/sangue , Ubiquinona/uso terapêutico , Adulto JovemRESUMO
BACKGROUND: Guidelines recommend involving intervention users in the intervention development process. However, there is limited guidance on how to involve users in a meaningful and effective way. OBJECTIVE: The aim of this Study within a trial was to compare participants' experiences of taking part in one of three types of consensus meetings-people with diabetes-only, combined people with diabetes and health-care professionals (HCPs) or HCP-only meeting. DESIGN: The study used a mixed methods convergent design. Quantitative (questionnaire) and qualitative (observation notes and semi-structured telephone interviews) data were collected to explore participants' experiences. A triangulation protocol was used to compare quantitative and qualitative findings. PARTICIPANTS: People with diabetes (recruited via multiple strategies) were randomly assigned to attend the people with diabetes or combined meeting. HCPs (recruited through professional networks) attended the HCP or combined meeting based on their availability. RESULTS: Sixteen people with diabetes and 15 HCPs attended meetings, of whom 18 participated in a telephone interview. Participants' questionnaire responses suggested similar positive experiences across the three meetings. Observation and semi-structured interviews highlighted differences experienced by participants in the combined meeting relating to: perceived lack of common ground; feeling empowered versus undervalued; needing to feel safe and going off task to fill the void. CONCLUSIONS: The qualitative theme 'needing to feel safe' may explain the dissonance (disagreement) between quantitative and qualitative data. In this study, involving patients and HCPs simultaneously in a consensus process was not found to be as suitable as involving each stakeholder group separately.
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Diabetes Mellitus , Pessoal de Saúde , Diabetes Mellitus/terapia , Humanos , Pesquisa Qualitativa , Inquéritos e QuestionáriosRESUMO
BACKGROUND: A mental health needs assessment in the Irish prison population confirmed findings from other jurisdictions showing high prevalence of severe mental illness, including psychosis amongst those newly committed. We implemented a participatory action research approach in order to provide an integrated mental health prison in-reach and court liaison service for this population. RESULTS: Following extensive consultation, a two stage screening process was developed which was supplemented by an inter-agency referral management system. During the six years 2006-2011, all 20,084 new remands to the main remand prison serving 58% of the national population were screened. Following the first stage screen, 3,195 received a comprehensive psychiatric assessment. Of these 561 (2.8%) had symptoms of psychosis - corresponding to the prior research finding - and 572 were diverted from the criminal justice system to mental health services (89 to a secure forensic hospital, 164 to community mental health hospitals and 319 to other community mental health services). CONCLUSIONS: We have shown that it is possible to match research findings in clinical practice by systematic screening, to sustain this over a long period and to achieve consistent levels of diversion from the criminal justice system to appropriate mental health services. The sustained and consistent performance of the model used is likely to reflect the use of participatory action research both to find the most effective model and to achieve wide ownership and cooperation with the model of care.
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BACKGROUND: The criteria for deciding who should be admitted first from a waiting list to a forensic secure hospital are not necessarily the same as those for assessing need. Criteria were drafted qualitatively and tested in a prospective 'real life' observational study over a 6-month period. METHODS: A researcher rated all those presented at the weekly referrals meeting using the DUNDRUM-1 triage security scale and the DUNDRUM-2 triage urgency scale. The key outcome measure was whether or not the individual was admitted. RESULTS: Inter-rater reliability and internal consistency for the DUNDRUM-2 were acceptable. The DUNDRUM-1 triage security score and the DUNDRUM-2 triage urgency score correlated r = 0.663. At the time of admission, after a mean of 23.9 (SD35.9) days on the waiting list, those admitted had higher scores on the DUNDRUM-2 triage urgency scale than those not admitted, with no significant difference between locations (remand or sentenced prisoners, less secure hospitals) at the time of admission. Those admitted also had higher DUNDRUM-1 triage security scores. At baseline the receiver operating characteristic area under the curve for a combined score was the best predictor of admission while at the time of admission the DUNDRUM-2 triage urgency score had the largest AUC (0.912, 95% CI 0.838 to 0.986). CONCLUSIONS: The triage urgency items and scale add predictive power to the decision to admit. This is particularly true in maintaining equitability between those referred from different locations.
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BACKGROUND: The assessment of those presenting to prison in-reach and court diversion services and those referred for admission to mental health services is a triage decision, allocating the patient to the appropriate level of therapeutic security. This is a critical clinical decision. We set out to improve on unstructured clinical judgement. We collated qualitative information and devised an 11 item structured professional judgment instrument for this purpose then tested for validity. METHODS: All those assessed following screening over a three month period at a busy remand committals prison (n = 246) were rated in a retrospective cohort design blind to outcome. Similarly, all those admitted to a mental health service from the same prison in-reach service over an overlapping two year period were rated blind to outcome (n = 100). RESULTS: The 11 item scale had good internal consistency (Cronbach's alpha = 0.95) and inter-rater reliability. The scale score did not correlate with the HCR-20 'historical' score. For the three month sample, the receiver operating characteristic area under the curve (AUC) for those admitted to hospital was 0.893 (95% confidence interval 0.843 to 0.943). For the two year sample, AUC distinguished at each level between those admitted to open wards, low secure units or a medium/high secure service. Open wards v low secure units AUC = 0.805 (95% CI 0.680 to 0.930); low secure v medium/high secure AUC = 0.866, (95% CI 0.784 to 0.949). Item to outcome correlations were significant for all 11 items. CONCLUSIONS: The DUNDRUM-1 triage security scale and its items performed to criterion levels when tested against the real world outcome. This instrument can be used to ensure consistency in decision making when deciding who to admit to secure forensic hospitals. It can also be used to benchmark admission thresholds between services and jurisdictions. In this study we found some divergence between assessed need and actual placement. This provides fertile ground for future research as well as practical assistance in assessing unmet need, auditing case mix and planning care pathways.