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BACKGROUND: The British Society for Disability and Oral Health guidelines made recommendations for oral health care for people with mental health problems, including providing oral health advice, support, promotion and education. The effectiveness of interventions based on these guidelines on oral health-related outcomes in mental health service users is untested. OBJECTIVE: To acquire basic data on the oral health of people with or at risk of serious mental illness. To determine the effects of an oral health checklist in routine clinical practice. DESIGN: Clinician and service user-designed cluster randomised trial. SETTINGS AND PARTICIPANTS: The trial compared a simple form for monitoring oral health care with standard care (no form) for outcomes relevant to service use and dental health behaviour for people with suspected psychosis in Mid and North England. Thirty-five teams were divided into two groups and recruited across 2012-3 with one year follow up. RESULTS: 18 intervention teams returned 882 baseline intervention forms and 274 outcome sheets one year later (31%). Control teams (n=17) returned 366 baseline forms. For the proportion for which data were available at one year we found no significant differences for any outcomes between those allocated to the initial monitoring checklist and people in the control group (Registered with dentist (p=0.44), routine check-up within last year (p=0.18), owning a toothbrush (p=0.99), cleaning teeth twice a day (p=0.68), requiring urgent dental treatment (p=0.11). CONCLUSION: This trial provides no clear evidence that Care Co-ordinators (largely nursing staff) using an oral health checklist improves oral health behaviour or oral health state in those thought to be at risk of psychosis or with early psychosis.

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BACKGROUND: People with serious mental illness have rates of Human Immuno-deficiency Virus (HIV) infection higher than expected in the general population for the same demographic area. Despite this elevated prevalence, UK national strategies around sexual health and HIV prevention do not state that people with serious mental illness are a high risk group. However, a significant proportion in this group are sexually active and engage in HIV-risk behaviours including having multiple sexual partners, infrequent use of condoms and trading sex for money or drugs. Therefore we propose the provision of HIV prevention advice could enhance the physical and social well being of this population. OBJECTIVES: To assess the effects of HIV prevention advice in reducing morbidity, mortality and preserving the quality of life in people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (24 January 2012; 4 July 2016). SELECTION CRITERIA: We planned to include all randomised controlled trials focusing on HIV prevention advice versus standard care or comparing HIV prevention advice with other more focused methods of delivering care or information for people with serious mental illness. DATA COLLECTION AND ANALYSIS: Review authors (NW, AC, AA, GT) independently screened search results and did not identify any studies that fulfilled the review's criteria. MAIN RESULTS: We did not identify any randomised studies that evaluated advice regarding HIV for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to both people with serious mental illness and HIV risk are possible. AUTHORS' CONCLUSIONS: Policy makers, clinicians, researchers and service users need to collaborate to produce guidance on how best to provide advice for people with serious mental illness in preventing the spread of HIV infection. It is entirely feasible that this could be within the context of a well-designed simple large randomised study.

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BACKGROUND: People with serious mental illness not only experience an erosion of functioning in day-to-day life over a protracted period of time, but evidence also suggests that they have a greater risk of experiencing oral disease and greater oral treatment needs than the general population. Poor oral hygiene has been linked to coronary heart disease, diabetes, and respiratory disease and impacts on quality of life, affecting everyday functioning such as eating, comfort, appearance, social acceptance, and self esteem. Oral health, however, is often not seen as a priority in people suffering with serious mental illness. OBJECTIVES: To review the effects of oral health education (advice and training) with or without monitoring for people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (5 November 2015), which is based on regular searches of MEDLINE, EMBASE, CINAHL, BIOSIS, AMED, PubMed, PsycINFO, and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: All randomised clinical trials focusing on oral health education (advice and training) with or without monitoring for people with serious mental illness. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. MAIN RESULTS: We included three randomised controlled trials (RCTs) involving 1358 participants. None of the studies provided useable data for the key outcomes of not having seen a dentist in the past year, not brushing teeth twice a day, chronic pain, clinically important adverse events, and service use. Data for leaving the study early and change in plaque index scores were provided. Oral health education compared with standard careWhen 'oral health education' was compared with 'standard care', there was no clear difference between the groups for numbers leaving the study early (1 RCT, n = 50, RR 1.67, 95% CI 0.45 to 6.24, moderate-quality evidence), while for dental state: no clinically important change in plaque index, an effect was found. Although this was statistically significant and favoured the intervention group, it is unclear if it was clinically important (1 RCT, n = 40, MD - 0.50 95% CI - 0.62 to - 0.38, very low quality evidence).These limited data may have implications regarding improvement in oral hygiene. Motivational interview + oral health education compared with oral health educationSimilarly, when 'motivational interview + oral health education' was compared with 'oral health education', there was no clear difference for the outcome of leaving the study early (1 RCT, n = 60 RR 3.00, 95% CI 0.33 to 27.23, moderate-quality evidence), while for dental state: no clinically important change in plaque index, an effect favouring the intervention group was found (1 RCT, n = 56, MD - 0.60 95% CI - 1.02 to - 0.18 very low-quality evidence). These limited, clinically opaque data may or may not have implications regarding improvement in oral hygiene. Monitoring compared with no monitoringFor this comparison, only data for leaving the study early were available. We found a difference in numbers leaving early, favouring the 'no monitoring' group (1 RCT, n = 1682, RR 1.07, 95% CI 1.00 to 1.14, moderate-quality evidence). However, these data are problematic. The control denominator is implied and not clear, and follow-up did not depend only on individual participants, but also on professional caregivers and organisations - the latter changing frequently resulting in poor follow-up, but not a good reflection of the acceptability of the monitoring to patients. For this comparison, no data were available for 'no clinically important change in plaque index'. AUTHORS' CONCLUSIONS: We found no evidence from trials that oral health advice helps people with serious mental illness in terms of clinically meaningful outcomes. It makes sense to follow guidelines and recommendations such as those put forward by the British Society for Disability and Oral Health working group until better evidence is generated. Pioneering trialists have shown that evaluative studies relevant to oral health advice for people with serious mental illness are possible.

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BACKGROUND: People with a serious mental illness are more likely to smoke more and to be more dependent smokers than the general population. This may be due to a wide range of factors that could include a common aetiology to both smoking and the illness, self medication, smoking to alleviate adverse effects of medications, boredom in the existing environment, or a combination of these factors. It is important to undertake this review to facilitate improvements in both the health and safety of people with serious mental illness who smoke, and to reduce the overall burden of costs (both financial and health) to the smoker and, eventually, to the taxpayer. OBJECTIVES: To review the effects of smoking cessation advice for people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Specialized Trials Register up to 2 April 2015, which is based on regular searches of CENTRAL, BIOSIS, PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and trial registries. We also undertook unsystematic searches of a sample of the component databases (BNI, CINHAL, EMBASE, MEDLINE, and PsycINFO), up to 2 April 2015, and searched references of all identified studies SELECTION CRITERIA: We planned to include all randomised controlled trials (RCTs) that focussed on smoking cessation advice versus standard care or comparing smoking cessation advice with other more focussed methods of delivering care or information. DATA COLLECTION AND ANALYSIS: The review authors (PK, AC, and DB) independently screened search results but did not identify any trials that fulfilled the inclusion criteria of this review. MAIN RESULTS: We did not identify any RCTs that evaluated advice regarding smoking cessation for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to smokers with serious mental illness is possible. AUTHORS' CONCLUSIONS: People with serious mental illness are more likely to smoke than the general population. Yet we could not find any high quality evidence to guide the smoking cessation advice healthcare professionals pass onto service users. This is an area where trials are possible and needed.

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BACKGROUND: People with serious mental illness have rates of Human Immuno-deficiency Virus (HIV) infection higher than expected in the general population for the same demographic area. Despite this elevated prevalence, UK national strategies around sexual health and HIV prevention do not state that people with serious mental illness are a high risk group. However, a significant proportion in this group are sexually active and engage in HIV-risk behaviours including having multiple sexual partners, infrequent use of condoms and trading sex for money or drugs. Therefore we propose the provision of HIV prevention advice could enhance the physical and social well being of this population. OBJECTIVES: To assess the effects of HIV prevention advice in reducing morbidity, mortality and preserving the quality of life in people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (24 January, 2012), which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. There is no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: We planned to include all randomised controlled trials focusing on HIV prevention advice versus standard care or comparing HIV prevention advice with other more focused methods of delivering care or information for people with serious mental illness. DATA COLLECTION AND ANALYSIS: Review authors (NW, AC, AA, GT) independently screened search results and did not identify any studies that fulfilled the review's criteria. MAIN RESULTS: We did not identify any randomised studies that evaluated advice regarding HIV for people with serious mental illness. The excluded studies illustrate that randomisation of packages of care relevant to both people with serious mental illness and HIV risk are possible. AUTHORS' CONCLUSIONS: Policy makers, clinicians, researchers and service users need to collaborate to produce guidance on how best to provide advice for people with serious mental illness in preventing the spread of HIV infection. It is entirely feasible that this could be within the context of a well-designed simple large randomised study.

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BACKGROUND: There is currently much focus on provision of general physical health advice to people with serious mental illness and there has been increasing pressure for services to take responsibility for providing this. OBJECTIVES: To review the effects of general physical healthcare advice for people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group's Trials Register (last update search October 2012) which is based on regular searches of CINAHL, BIOSIS, AMED, EMBASE, PubMed, MEDLINE, PsycINFO and registries of Clinical Trials. There is no language, date, document type, or publication status limitations for inclusion of records in the register. SELECTION CRITERIA: All randomised clinical trials focusing on general physical health advice for people with serious mental illness.. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE. MAIN RESULTS: Seven studies are now included in this review. For the comparison of physical healthcare advice versus standard care we identified six studies (total n = 964) of limited quality. For measures of quality of life one trial found no difference (n = 54, 1 RCT, MD Lehman scale 0.20, CI -0.47 to 0.87, very low quality of evidence) but another two did for the Quality of Life Medical Outcomes Scale - mental component (n = 487, 2 RCTs, MD 3.70, CI 1.76 to 5.64). There was no difference between groups for the outcome of death (n = 487, 2 RCTs, RR 0.98, CI 0.27 to 3.56, low quality of evidence). For service use two studies presented favourable results for health advice, uptake of ill-health prevention services was significantly greater in the advice group (n = 363, 1 RCT, MD 36.90, CI 33.07 to 40.73) and service use: one or more primary care visit was significantly higher in the advice group (n = 80, 1 RCT, RR 1.77, CI 1.09 to 2.85). Economic data were equivocal. Attrition was large (> 30%) but similar for both groups (n = 964, 6 RCTs, RR 1.11, CI 0.92 to 1.35). Comparisons of one type of physical healthcare advice with another were grossly underpowered and equivocal. AUTHORS' CONCLUSIONS: General physical health could lead to people with serious mental illness accessing more health services which, in turn, could mean they see longer-term benefits such as reduced mortality or morbidity. On the other hand, it is possible clinicians are expending much effort, time and financial resources on giving ineffective advice. The main results in this review are based on low or very low quality data. There is some limited and poor quality evidence that the provision of general physical healthcare advice can improve health-related quality of life in the mental component but not the physical component, but this evidence is based on data from one study only. This is an important area for good research reporting outcome of interest to carers and people with serious illnesses as well as researchers and fundholders.

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BACKGROUND: Current guidance suggests that we should monitor the physical health of people with serious mental illness, and there has been a significant financial investment over recent years to provide this. OBJECTIVES: To assess the effectiveness of physical health monitoring, compared with standard care for people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Trials Register (October 2009, update in October 2012), which is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO. SELECTION CRITERIA: All randomised clinical trials focusing on physical health monitoring versus standard care, or comparing i) self monitoring versus monitoring by a healthcare professional; ii) simple versus complex monitoring; iii) specific versus non-specific checks; iv) once only versus regular checks; or v) different guidance materials. DATA COLLECTION AND ANALYSIS: Initially, review authors (GT, AC, SM) independently screened the search results and identified three studies as possibly fulfilling the review's criteria. On examination, however, all three were subsequently excluded. Forty-two additional citations were identified in October 2012 and screened by two review authors (JX and MW), 11 of which underwent full screening. MAIN RESULTS: No relevant randomised trials which assess the effectiveness of physical health monitoring in people with serious mental illness have been completed. We identified one ongoing study. AUTHORS' CONCLUSIONS: There is still no evidence from randomised trials to support or refute current guidance and practice. Guidance and practice are based on expert consensus, clinical experience and good intentions rather than high quality evidence.

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BACKGROUND: Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. METHODS/DESIGN: This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63382258.

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BACKGROUND: People with serious mental illness experience an erosion of functioning in day-to-day life over a protracted period of time. There is also evidence to suggest that people with serious mental illness have a greater risk of experiencing oral disease and have greater oral treatment needs than the general population. However, oral health has never been seen as a priority in people suffering with serious mental illness. Poor oral health has a serious impact on quality of life, everyday functioning, social inclusion and self-esteem. We feel that oral healthcare advice could have a positive impact on this disadvantaged population. OBJECTIVES: To assess the effectiveness of oral health advice in reducing morbidity, mortality and preserving the quality of life in people with serious mental illness. SEARCH METHODS: We searched the Cochrane Schizophrenia Group Trials Register (October 2009) which is based on regular searches of CENTRAL, MEDLINE, EMBASE, CINAHL and PsycINFO. SELECTION CRITERIA: We planned to include all randomised clinical trials focusing on oral health advice versus standard care or comparing oral health advice with other more focused methods of delivering care or information. DATA COLLECTION AND ANALYSIS: The review authors (GT, AC, WK) independently screened search results and did not identify any studies that fulfilled the review's criteria. MAIN RESULTS: We did not identify any studies that met our inclusion criteria. AUTHORS' CONCLUSIONS: Healthcare professionals should be more proactive in liaising with oral health professionals in developing novel ways to cater for the needs of people with serious mental illness.

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In the pragmatic-explanatory continuum, a randomized controlled trial (RCT) can at one extreme investigate whether a treatment could work in ideal circumstances (explanatory), or at the other extreme, whether it would work in everyday practice (pragmatic). How explanatory or pragmatic a study is can have implications for clinicians, policy makers, patients, researchers, funding bodies, and the public. There is an increasing need for studies to be open and pragmatic; however, explanatory trials are also needed. The previously developed Pragmatic-explanatory continuum indicator summary (PRECIS) was adapted into the Pragmascope tool to assist mental health researchers in designing RCTs, taking the pragmatic-explanatory continuum into account. Ten mental health trial protocols were randomly chosen and scored using the tool by three independent raters. Their results were compared for consistency and the tool was found to be reliable and practical. This preliminary work suggests that evaluating different domains of an RCT at the protocol level is useful, and suggests that using the Pragmascope tool presented here might be a practical way of doing this.

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BACKGROUND: There is currently much focus on provision of general physical health advice to people with serious mental illness and there has been increasing pressure for services to take responsibility for providing this. OBJECTIVES: To assess the effects of general physical health advice as a means of reducing morbidity, mortality and improving or maintaining quality of life in people with serious mental illness. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group Trials Register (November 2009) which is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO. SELECTION CRITERIA: All randomised clinical trials focusing on general physical health advice. DATA COLLECTION AND ANALYSIS: We extracted data independently. For binary outcomes we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data we estimated mean difference (MD) between groups and its 95% CI. We employed a random-effects model for analyses. MAIN RESULTS: For the comparison of physical healthcare advice versus standard care we identified five studies (total n = 884) of limited quality. For measures of quality of life one trial found no difference (n = 54, 1 RCT, MD Lehman scale 0.00 CI -0.67 to 0.67) but another did (n = 407, 1 RCT, MD Quality of Life Medical Outcomes Scale - mental component 3.7 CI 1.7 to 5.6). There was no difference between groups for the outcome of death (n = 407, 1 RCT, RR 1.3 CI 0.3 to 6.0), for the outcome of uptake of ill-health prevention services, one study found percentages significantly greater in the advice group (n = 363, 1 RCT, MD 36.9 CI 33.1 to 40.7). Economic data were equivocal. Attrition was large (> 30%) but similar for both groups (n = 884, 5 RCTs, RR 1.18 CI 0.97 to 1.43). Comparisons of one type of physical healthcare advice with another were grossly underpowered and equivocal. AUTHORS' CONCLUSIONS: General physical health could lead to people with serious mental illness accessing more health services which, in turn, could mean they see longer term benefits such as reduced mortality or morbidity. On the other hand it is possible clinicians are expending much effort, time and financial expenditure on giving ineffective advice. This is an important area for good research reporting outcome of interest to carers and people with serious illnesses as well as researchers and fundholders.

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BACKGROUND: Current guidance suggests that we should monitor the physical health of people with serious mental illness and there has been a significant financial investment over recent years to provide this. OBJECTIVES: To assess the effectiveness of physical health monitoring as a means of reducing morbidity, mortality and reduction in quality of life in people with serious mental illness. SEARCH STRATEGY: We searched the Cochrane Schizophrenia Group Trials Register (October 2009) which is based on regular searches of CINAHL, EMBASE, MEDLINE and PsycINFO. SELECTION CRITERIA: All randomised or quasi-randomised clinical trials focusing on physical health monitoring versus standard care or comparing i) self monitoring vs monitoring by health care professional; ii) simple vs complex monitoring; iii) specific vs non-specific checks iv) once only vs regular checks or v) comparison of different guidance. DATA COLLECTION AND ANALYSIS: The authors (GT, AC, SM) independently screened search results and identified three studies as possibly fulfilling the review's criteria. On examination, however, all three were subsequently excluded. MAIN RESULTS: We did not identify any randomised trials which assessed the effectiveness of physical health monitoring in people with serious mental illness. AUTHORS' CONCLUSIONS: There is no evidence from randomised trials to support current guidance and practice. Guidance and practice are based on expert consensus, clinical experience and good intentions rather than high quality evidence.

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