The effectiveness of sexual health interventions for people with severe mental illness: a systematic review

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 12/74/01. The contractual start date was in January 2013. The draft report began editorial review in March 2013 and was accepted for publication in June 2013. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Copyright statement

© Queen’s Printer and Controller of HMSO 2014. This work was produced by Kaltenthaler et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Description of the health problem

Severe mental illness (SMI) describes a wide range of major psychiatric disorders (including schizophrenia and bipolar disorder)1 which persist over time and cause extensive disability leading to impairments in social and occupational functioning. 2 There are occasional inconsistencies in the use of the term and some studies may include severe anxiety and depressive symptoms and borderline personality. Schizophrenia is estimated to affect approximately 180,4713 to 220,0004 people in the UK and bipolar disorder approximately 136,4403 to 297,000. 5 The incidence of schizophrenia is higher in men than in women6 whereas bipolar disorder is equally distributed. 5 Incidence rates among black and ethnic minority groups are higher than in a comparable white population. 5,6 About 45% of people who receive a diagnosis of schizophrenia experience recovery after one or more episodes, but about 20% show continuous symptoms and increasing disability and the remaining 35% show a mixed pattern with varying periods of remission and relapse. 7 For most patients, bipolar disorder is chronic and recurrent. Recovery may or may not be complete between episodes. Considerable variability exists in the pattern of remissions and relapses; however, remissions tend to get shorter as time goes on and depressions become more frequent and longer lasting. 5

People with SMI have higher morbidity and mortality due to physical illness than the general population. 8,9 De Hert et al. 10 reported prevalence rates of several physical illnesses in people with SMI. They found nutritional and metabolic, cardiovascular, viral, respiratory tract and musculoskeletal diseases as well as sexual dysfunction, pregnancy complications, stomatognathic diseases and possibly obesity-related cancers to be more prevalent among people with SMI. Levels of obesity are extremely high among people with SMI – nearly twice those of the overall population. 11 This can have a perceived effect on sexual attractiveness and consequent functioning. Daumit et al. 11 conducted a randomised controlled trial (RCT) to address this serious problem. The study of overweight or obese adults with SMI used a behavioural weight loss intervention programme and resulted in significantly reduced weight over a period of 18 months in the group of patients receiving the intervention.

Reasons for physical health problems in people with SMI were explored by Robson and Gray,9 who found that limitations in health services, the effects of having a SMI, health behaviours and the effects of psychotropic medication may contribute to disparities in health. A systematic review by Tosh et al. 12 found no evidence from RCTs that physical health-care monitoring for people with SMI is useful in preventing deterioration in physical health and maintaining quality of life, although the authors add that this does not mean that physical health monitoring does not affect the physical health of people with SMI.

People with SMI are often on medications, which may have an impact on sexual function. The European Schizophrenia Outpatient Health Outcome (SOHO) study,13 a large prospective, observational study of the health outcomes associated with antipsychotic treatment in approximately 11,000 outpatients with schizophrenia in 10 European countries, found that sexually related adverse events were frequent at baseline before commencing medication and included erectile dysfunction in 40% of men and loss of libido in 50% of both male and female patients. The study also found that some second-generation atypical antipsychotics such as olanzapine (ZypAdhera^®, Eli Lilly and Company), clozapine (Zaponex^®, TEVA UK) and quetiapine (Seroquel^®, AstraZeneca) were significantly less likely to result in drug-induced sexual dysfunction after six months of treatment than other atypical antipsychotics [risperidone (Risperdal Consta^®, Janssen-Cilag Ltd) and amisulpride (Solian^®, Sanofi-aventis)]. Montejo et al. 14 report in a study of 243 patients with a psychotic disorder that 46% of patients exhibited drug-related sexual dysfunction, which included 50% of the males and 37% of females in the study. A review by Baggaley15 that looked at the relative impact of antipsychotics on sexual dysfunction found that risperidone was associated with the greatest level of sexual dysfunction and aripiprazole (Abilify^®, Bristol-Myers Squibb) with the least. Sexual dysfunction included reduced libido, erectile dysfunction, ejaculatory difficulties and impaired orgasm in men and menstrual irregularity/amenorrhoea, reduced libido, impaired orgasm and decreased vaginal lubrication in women. Various strategies have been suggested for the management of sexual dysfunction due to antipsychotic drug therapy, including dose reduction, drug holidays, adjunctive medication and switching to another drug. These options were reviewed by Schmidt et al.,16 who found little evidence to support these strategies, although sildenafil (Viagra^®, Pfizer; Revatio^®, Pfizer), a drug typically prescribed to men to treat erectile dysfunction, was considered to be a useful treatment option in men with schizophrenia. Although antipsychotic medication is an important cause of sexual dysfunction in SMI, Aizenberg et al. 17 found that even patients with a diagnosis of schizophrenia who were not receiving medication exhibited decreased sexual desire. Few studies have examined diagnostic differences and sexual activity and results have been inconclusive. 18

People with SMI are more likely to engage in high-risk sexual behaviour (e.g. unprotected intercourse, having multiple partners, involvement in the sex trade and illicit drug use), putting them at risk of poorer sexual health outcomes, including sexually transmitted infections (STIs), e.g. with human immunodeficiency virus (HIV). 2,19,20 HIV infection rates among people with SMI have been estimated to be approximately 6.9%, much higher than rates for the general US population for the same time period, estimated to be 0.4%. 18 The HIV infection range among those with SMI is reported to be 3–23%, with the highest rates found among those with SMI and substance abuse disorders. 21 Homeless people with SMI were also reported to have higher rates. Among people with SMI, the age and ethnic distributions of those infected with HIV appear to be similar to those in the general population, although women with SMI are as likely as males to be infected with HIV, in contrast to the general US population, in which the ratio of men to women is 5 : 1. 18 A number of risk behaviours are thought to contribute to the higher rates of HIV among people with SMI, and these include comorbid alcohol and drug use disorders; more frequent same-sex intercourse than the non-psychiatric population; multiple sex partners; lack of condom use; trading sex for drugs or money; and transient living circumstances, among others. 18 A review of the risk behaviour associated with people with SMI explored this more fully. 2 The authors found 52 studies which showed that the majority of adults with SMI were sexually active and engaged in risk behaviours associated with HIV transmission. Correlates of HIV risk were organised into the domains of psychiatric illness, substance use, childhood abuse, cognitive behavioural factors, social relationships and demographics. Most studies identified in this review found that people with a schizophrenia spectrum disorder were significantly less likely to be sexually active compared with those with other major psychiatric disorders. Although many correlates of HIV risk factors were identified in this review, the authors suggest caution in view of the cross-sectional design of many studies and the heavy reliance on univariate analyses. Most studies also recruited participants from centres where they were receiving treatment; thus, the results may not be generalisable to people with SMI who do not seek or receive mental health care. Meade et al. 22 reviewed the evidence regarding the relationship between substance abuse and HIV sexual risk behaviour among people with SMI. The authors concluded that little is known about how substance misuse contributes to sexual health risk. Gray et al. 19 reported that, although people with schizophrenia are more likely than the general population to engage in high-risk behaviours (e.g. men having sex with men, illicit drug use and having multiple sexual partners), many health policy reports do not address the risk of HIV in people with schizophrenia and recommend that research, policy and clinical practice need to be developed to address this issue.

Many individuals with SMI will also have co-existing drug and alcohol problems23 and difficulties in establishing stable and sexual relationships. 9 O’Cleirigh and Safren24 suggest that those with SMI and substance use disorders present complexities that may be better suited to adapted or modified models of cognitive behavioural therapy to support HIV prevention. The authors suggest that these models need to incorporate design elements of efficacy (such as random assignment) and design elements that support external validity (such as usual treatment comparison). Individuals with SMI report high rates of childhood sexual abuse, which is associated with sexual risk behaviour in individuals with SMI as well as in the general population. 25

Sexual health promotion interventions (such as educational and behavioural interventions, motivational exercises, counselling and service delivery), developed and implemented for people with SMI, may improve participants’ knowledge, attitudes, beliefs or behavioural practices (including assertiveness skills) and could lead to a reduction in risky sexual behaviour. 20 McCann26 states that although there have been many initiatives in the UK to make health and social care more responsive and inclusive, the sexual needs of individuals with psychosis appear to remain marginalised and neglected. In this study of 30 people with schizophrenia living in community, 90% of clients felt some need in relation to sexual expression and only 10% of staff recognised sexual expression as a need in their clients.

Two narrative reviews of interventions to improve the sexual health of people with SMI were identified. Johnson-Masotti et al.,27 in their review of the clinical effectiveness and cost-effectiveness studies of HIV prevention interventions, report that the studies identified in their review have shown only limited success in helping people with SMI reduce their HIV risk. The cost-effectiveness literature they identified also showed mixed results. Higgins et al. 20 undertook a review on sexual health education. The authors identified six studies that were descriptive or anecdotal, three using post-evaluation or pre–post-evaluation designs and five studies with a randomised intervention design. The review found that people who attended sexual health education programmes which were facilitated in a sensitive and supportive manner developed attitudes more favourable to condom use, improved intention to avoid unsafe sexual practices, reduced the number of casual partners and were less likely to engage in unprotected vaginal intercourse. Education tended to produce a self-reported reduction in sexual risk behaviour as opposed to complete cessation. Small-group interventions combining information giving, motivational exercises and skills acquisition were found to be effective in reducing sexual risk behaviour and raising awareness of personal risk behaviour. The authors highlight the limitations of the included studies such as small sample size, lack of quality tools tested for reliability and validity and short follow-up periods. Most outcomes were self-reported and participants were self-selected. Studies did not describe method of random allocation or provide information on refusal or attrition rates and were mostly conducted in the USA.

Other studies identified in the literature explored different aspects of sexual health interventions. Melo et al. 28 conducted a cross-sectional national multicentre study throughout Brazil to measure HIV/acquired immunodeficiency syndrome (AIDS) knowledge among patients with mental illness. The study included 2475 patients from 26 mental health institutions. The authors found that psychiatric patients in Brazil lag behind the general population with regard to HIV/AIDS knowledge scores. Sikkema et al. 21 report a pilot study involving a community level HIV prevention programme for people with SMI living in supportive housing. This study of 28 residents involved a cognitive behavioural skills training HIV risk reduction programme and a 4-month follow-up period. The results were considered promising and demonstrated significant improvements in psychosocial risk factors with indications of sexual behaviour change at follow-up. DiFranceisco et al. 29 looked at differences between completers and early dropouts from two HIV intervention trials, including one with severely mentally ill participants. Non-attendees in the SMI group were younger than completers, more likely to associate condom use with positive outcomes and somewhat more confident of their ability to negotiate safe sex with their partners. Johnson-Masotti et al. 30 assessed the cost-effectiveness of a RCT by Kelly et al.,31 which had three interventions: single session, one-on-one, multisession small group and multisession small-group advocates. For men, all three were found to be cost-effective, with advocacy training the most cost-effective. Cost-effectiveness was measured using cost–utility analysis in terms of the quality-adjusted life-years saved by the intervention as a result of preventing participants from becoming infected with AIDS. For women, only the single-session intervention was cost-effective.

Blank and Hennessy32 explored the feasibility of a reasoned action approach for this population through the use of two interventions: Preventing AIDS Through Health (PATH), delivered by case managers to persons with mental illnesses who were HIV negative, and PATH PLUS, delivered by nurses to persons with mental illness who were HIV positive. The authors concluded that this approach may be useful for changing behaviour and intentions in people with SMI. As part of the same study, Tennille et al. 33 conducted focus groups and interviews with case managers and administrators to determine changes in the service and the case managers as a result of their skills training and experience. Case managers felt transformed by their training experience and that this improved their understanding of the issues around sexual health faced by their clients. In a related study by Tennille et al.,34 the researchers held focus groups with people with mental illnesses to focus on HIV risks and condom use. Participants discussed the sexual side effects of medication and how this may be associated with HIV risk behaviours, such as not using a condom. A final qualitative study by Solomon et al. 35 used rapid assessment procedures to look at HIV prevention services, and found that case managers had little formalised training on HIV prevention and felt that doctors or nurses would be better placed to deliver HIV prevention interventions.

The studies described above highlight the challenges and risk of poor sexual health outcomes (including establishing relationships) encountered by people with SMI, which may be exaggerated by co-existing drug and alcohol problems. The purpose of this review is to evaluate the effectiveness of sexual health interventions that may be suitable for people with SMI in the UK.

Current service provision

Health promotion interventions, whether brief interventions or longer-term programmes, are used to improve various aspects of health and health behaviours. Interventions can be delivered at different levels (individual, group and community) through an action or group of actions intended to change the knowledge, attitudes, beliefs or behavioural practices of individuals and populations to reduce their sexual health risk. 36 Individual-level interventions focus on one individual at a time in an attempt to help change behaviour and may include partner notification, individual risk counselling by professionals and detached education and outreach (for those not accessing mainstream services). Group-level interventions are delivered to small groups of individuals. Group-level interventions use peer and non-peer models involving a range of skills, information and support. Community-level interventions are delivered by or within a defined ‘community’. They seek to improve the risk conditions and influence behaviour by changing social norms, policies or characteristics of the environment. 36,37

Mental health nurses and other professionals working with people with SMI would be well placed to include sexual health as part of their contribution to health promotion. 20 A study by Apantaku-Olajide et al. 38 used a survey questionnaire to determine mental health patients’ attitude to psychotropic medication for sexual dysfunction and found that participants were willing to discuss their sexual problems with health-care professionals. However, staff may require specific training in order to deliver such interventions. In a qualitative study of 27 mental health nurses in Ireland, Higgins et al. 39 found that the main concerns reported by the nurses around sexuality were related to feelings of personal and professional vulnerability, due to a lack of competence, comfort and confidence in this area. Penna and Sheehy40 administered questionnaires to occupational therapists involved in the care of people with SMI in the UK to determine their attitudes towards sex education for people with schizophrenia. The majority of occupational therapists thought sex education was within the domain of their profession but were not providing sex education currently. The study found that the length of time in practice and knowledge of employers’ policies may influence this. In NHS Shetland all mental health staff working with people with psychiatric illnesses receive sexual health training,36 although it is not clear exactly what this training includes and whether or not this varies with different types of staff.

Overall aims and objectives of assessment

The review will aim to evaluate the following objectives:

1. evaluate the effectiveness of sexual health interventions for people with SMI compared with usual care and their applicability to the UK NHS setting

2. identify key areas for primary research.

Methods for reviewing effectiveness

Results

Quantity and quality of research available

Number of studies identified and included

The literature searches identified 2590 citations. Of these, 13 studies (representing 14 references)31,46–58 met the inclusion criteria. These studies were all defined by the authors as RCTs. A flow chart describing the process of identifying relevant literature can be found in Figure 1.

FIGURE 1.

Study flow chart (adapted PRISMA diagram).

Number and type of studies excluded

A total of 20 full-text articles were excluded as they did not meet all the pre-specified inclusion criteria. The majority of the articles were excluded primarily on the basis of inappropriate study design (not controlled clinical trials),21,28,32–35,40,59,60 incorrect population (adolescents,61 inpatients only62 or patients without SMI),63,64 outcomes not identified in the protocol,65–67 not available68,69 or unsuitable publication type (reviews, commentaries or editorials). 70,71 Of the two studies that were not available, one study appeared to be a conference abstract69 of an included study (Susser et al. 56). The other study,68 which was identified on a trials register, was a planned open-label RCT that was designed to evaluate the effectiveness of motivational interviewing plus skill-building exercises compared with behavioural skill-building exercises alone in reducing HIV risk behaviour in people with SMI. Although the authors of the study were contacted, no further details were forthcoming, including information on study completion (and if the results were unpublished) or recruitment failure. A full list of excluded studies with reasons for exclusion is presented in Appendix 4.

Main findings

This is the first comprehensive systematic review of sexual health interventions for people with SMI. Despite wide variations in the study populations, interventions (e.g. programme content and duration), comparators and outcomes, four studies49,51,52,56 showed significant improvements in all measured sexual risk behaviour outcomes (e.g. HIV knowledge and behaviour change) compared with the control groups. In contrast, four studies31,50,53,58 found significant improvements in the intervention groups for some outcomes only and three studies found significant improvements in subgroups only, based on either gender54,55 or ethnicity. 57 Finally, two studies46–48 reported no significant differences in any sexual risk behaviour outcomes between the intervention and control groups. Moreover, positive findings were not consistently sustained at follow-up in many studies. These mixed results are similar to those reported in other previous reviews of the literature. 20,27 In addition, in a systematic review of sexual health improvement interventions, conducted by Fullerton and Burtney73 for NHS Scotland, the authors concluded that there was insufficient evidence to fully support or reject the identified sexual health interventions for people with SMI. The findings from this systematic review reinforce this view.

Strengths and limitations of the assessment

Although an extensive literature search was conducted, it is possible that some relevant studies may have been missed. However, such omissions are likely to have been minimal, as the search included all identifiable publications in the grey literature (including contact with clinical experts in the field). Another limitation is that the initial screening was undertaken by only one reviewer and relevant studies may have potentially been missed.

Many of the studies included in the systematic review included participants with major depression, which was not included in the definition of SMI used for this review, which only included bipolar disorder and schizophrenia. Many studies also included participants with schizoaffective disorder, which again was not part of our initial definition of SMI. It was not possible to differentiate results for patients with different diagnoses reported in the studies. Patients with major depression may respond differently to interventions than those with bipolar disorder or schizophrenia, or indeed there may be differences between these two diagnoses. Another issue related to diagnosis is the lack of uniformity in determining how the diagnoses were made.

Little detail was provided in the studies regarding the content of interventions, how they were delivered and by whom, making replication or generalisability difficult. The control groups used in the studies often included components of the intervention such as education or were not appropriate controls; for example, the control group may have received one session where the intervention group received six or more. This makes it difficult to assess the true effectiveness of the intervention. It was not always clear in the studies what the primary outcomes were and whether or not data from all recorded outcomes were reported. This could potentially result in outcome reporting bias. 74 In addition, the follow-up periods reported in the studies varied and were often quite short, ranging from 2 weeks to 18 months, and positive results were often diminished at follow-up assessments. The main threats to validity in this group of patients relate to study outcomes and participants. Most outcomes were measured by self-reporting and participants self-selecting, thus raising the possibility of bias and recall problems. 20

Although none of the studies reported that it had been designed to have adequate power to assess differences in subgroups, some reported differences in results between male and female participants. This issue needs to be explored further as there may be differences between male and female responses to sexual health interventions. There was also a lack of data and analysis reported in the studies regarding the relationship between education levels and outcomes, as well as that between the age of the participants and outcomes, both of which are important variables in the context of sexual health.

In general, the studies identified were mostly considered to be of moderate quality although there were issues in the methods of randomisation, which were often not fully described. Other limitations were: limited blinded assessment of outcomes; little information provided regarding loss of participants to follow-up; no power calculations reported; and small sample sizes in most studies. Only some studies used validated instruments to collect data on outcomes and most relied on self-report of these outcomes. Little information was provided in any of the studies regarding acceptability to participants or those delivering the interventions. There was also little information provided regarding the feasibility of the interventions and how much they would cost to implement. None of the studies provided any information on unintended pregnancies, use of contraception, uptake of screening or treatment services, or facilitators and barriers to providing interventions.

Assessment of factors relevant to the NHS and other parties

There are considerable uncertainties around the generalisability of these findings to the UK setting as the evidence is based on studies from the USA. In addition, the ethnic groups represented in the included studies are not directly comparable to those in the UK. Nevertheless, several factors discussed above are relevant to implementing sexual health interventions for people with SMI in the NHS. These include consideration of who will deliver the interventions and where they will be delivered. There needs to be an assessment of whether or not sexual health interventions could be integrated into the current care provision provided for people with SMI on the NHS. White et al. 75 described an ongoing study to assess ways that physical comorbidity in SMI could be addressed by mental health nurses working in NHS community mental health teams. Lessons may be learned from this research that could be incorporated into sexual health intervention programmes.

The choices made regarding location of sexual health services for people with SMI will have resource implications. Likewise, whether or not interventions are delivered to groups of participants or individually will have resource implications and the potential to impact on the effectiveness of the intervention. The follow up of patients also needs to be taken into account as many of the included studies in the review showed a diminished impact at follow-up. Higgins et al. 20 suggested the need for an ongoing process rather than a single intervention.

Implications for service provision

Despite the methodological limitations and variations in the populations, sexual health interventions, use of control groups and outcomes measured in the included studies, the overall findings were mixed, with only 4 of the 13 studies showing significant benefits in sexual risk behaviour interventions (e.g. HIV knowledge and behaviour change) compared with control groups in people with SMI living in the community. In view of study heterogeneity, issues with generalisability and the methodological quality of the included studies, the findings need to be interpreted with caution. Recommendations for further research are listed below.

Suggested research priorities

Contributions of authors

Eva Kaltenthaler and Abdullah Pandor carried out the systematic review and quality assessment of the studies and wrote the report. Ruth Wong carried out the searches.

About ScHARR

The School of Health and Related Research (ScHARR) is one of the nine departments that comprise the Faculty of Medicine, Dentistry and Health at the University of Sheffield. ScHARR specialises in health services and public health research, and the application of health economics and decision science to the development of health services and the improvement of public health.

The ScHARR Technology Assessment Group (ScHARR-TAG) synthesises research on the clinical effectiveness and cost-effectiveness of health-care interventions for the NIHR Health Technology Assessment Programme on behalf of a range of policy-makers, including the National Institute for Health and Care Excellence (NICE). ScHARR-TAG is part of a wider collaboration of a number of units from other regions including Southampton Health Technology Assessment Centre (SHTAC), University of Southampton; Aberdeen Health Technology Assessment Group (Aberdeen HTA Group), University of Aberdeen; Liverpool Reviews & Implementation Group (LRiG), University of Liverpool; Peninsular Technology Assessment Group (PenTAG), University of Exeter; the NHS Centre for Reviews and Dissemination, University of York; Warwick Evidence, University of Warwick; the BMJ Group and Kleijnen Systematic Reviews.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health.

HTA REFERENCE NO. 12/74 SEXUAL HEALTH OF PEOPLE WITH SEVERE MENTAL ILLNESS

29 January 2013.

1. Title of the project:

What is the effectiveness of sexual health interventions for people with severe mental illness?

2. Name of TAR team and project ‘lead’

School of Health and Related Research (ScHARR), The University of Sheffield.

Project lead:

Dr Eva Kaltenthaler, Reader in Health Technology Assessment, Health Economics and Decision Science, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA

3. Plain English Summary

Severe mental illness describes a wide range of major psychiatric disorders (including schizophrenia and bipolar disorder)1 which persist over time and cause extensive disability leading to impairments in social and occupational functioning. 2 People with severe mental illness have higher morbidity and mortality due to chronic disease than the general population,3 and are more likely to engage in high-risk sexual behaviour (e.g. unprotected intercourse, multiple partners, sex trade and injection drug use), putting them at risk of worse sexual health outcomes including sexually transmitted infections, including HIV. 2,4 Many of these individuals will also have coexisting drug and alcohol problems5 and have difficulties in establishing stable and sexual relationships. 6 Sexual health promotion interventions (such as educational and behavioural interventions, motivational exercises, counselling and service delivery), developed and implemented for people with severe mental illness, may improve participants’ knowledge, attitudes, beliefs or behavioural practices (including assertiveness skills) and could lead to a reduction in risky sexual behaviour. 4 The aim of this review is to evaluate the effectiveness of sexual health interventions for people with severe mental illness, its applicability to the UK NHS setting, and identify key areas for primary research.

4. Decision problem

5. Report methods for synthesis of evidence of clinical effectiveness

A review of the evidence for clinical effectiveness will be undertaken systematically following the general principles recommended in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement (http://www.prisma-statement.org/). The review will assess the effectiveness of sexual health interventions for people with severe mental illness compared with usual care.

6. Expertise in this TAR team

7. Competing interests of authors

The following authors do not have any competing interest: Eva Kaltenthaler, Abdullah Pandor, Ruth Wong, Professor Wylie and Dr Smith.

Professor Gray has received speaker fees and honoraria from companies (Wyeth, BMS, Otsuka, Janssen-Cilag, Eli Lilly and AstraZeneca) that manufacture products that can potentially impact on sexual functioning. He is also funded by the National Institute of Health Research to undertake a trial to promote physical (including sexual) health in patients with mental illness.

8. Timetable/milestones

9. Appendices