The use of psychoactive, potentially dependence-producing substances is highly prevalent around the world, and contributes substantially to global disease burden. There is a major gap between the need for treatment for substance use disorders. Changes proposed for the classification of substance use disorders in the Eleventh Revision of the International Classification of Diseases and Related Health Problems, based on a public health approach, have important implications for the conceptualisation, structure and availability of services. These include: (1) an updated and expanded range of substance classes; (2) greater specification of different harmful patterns of substance use, which may be continuous or episodic and recurrent; (3) a new category to denote single episodes of harmful use; (4) a category describing hazardous use of substances; and (5) simplification of diagnostic guidelines for substance dependence. This paper describes these changes and the opportunities they present for improved prevention, treatment, monitoring and health policy.

The risks associated with psychotropic drugs use should be accurately documented at the population level in view of the growing number of persons exposed to these drugs. The strengths of observational studies regarding the identification of drug-related harms mirror the limitations of randomised controlled trials and vice-versa. Observational studies can be carried out in large samples of unselected participants treated in real-life conditions and who may be followed up over long periods. Serious adverse effects undetected during pre-marketing clinical trials may be observed only in post-marketing use, such as metabolic effects of second-generation antipsychotics. Observational studies play a key role in the identification of teratogenic risks, such as those induced by prenatal exposure to anticonvulsants. These studies are the main source of information to investigate the long-term effects of drugs, such as the possible increased risk of dementia in benzodiazepine users. They may also contribute to the accurate assessment at population level of risks overestimated by studies carried out in non-representative samples, such as the risk of congenital heart diseases in babies prenatally exposed to lithium. Owing to the lack of random allocation of drugs, confounding by indication or by disease severity are the major sources of biases in observational studies exploring drug safety. An adverse outcome may be wrongly imputed to drug exposure while it is a symptom/outcome of the disease motivating the decision to prescribe. Such a bias may occur in studies investigating the link between exposure to antidepressants and suicidality. As several methods have been developed to lessen the impact of such biases, pharmaco-epidemiological studies based upon stringent methodological designs should be regarded as a valid approach for assessing psychotropic drug safety.

Efforts to support the scale-up of integrated mental health care in low- and middle-income countries (LMICs) need to focus on building human resource capacity in health system strengthening, as well as in the direct provision of mental health care. In a companion editorial, we describe a range of capacity-building activities that are being implemented by a multi-country research consortium (Emerald: Emerging mental health systems in low- and middle-income countries) for (1) service users and caregivers, (2) service planners and policy-makers and (3) researchers in six LMICs (Ethiopia, India, Nepal, Nigeria, South Africa and Uganda). In this paper, we focus on the methodology being used to evaluate the impact of capacity-building in these three target groups. We first review the evidence base for approaches to evaluation of capacity-building, highlighting the gaps in this area. We then describe the adaptation of best practice for the Emerald capacity-building evaluation. The resulting mixed method evaluation framework was tailored to each target group and to each country context. We identified a need to expand the evidence base on indicators of successful capacity-building across the different target groups. To address this, we developed an evaluation plan to measure the adequacy and usefulness of quantitative capacity-building indicators when compared with qualitative evaluation. We argue that evaluation needs to be an integral part of capacity-building activities and that expertise needs to be built in methods of evaluation. The Emerald evaluation provides a potential model for capacity-building evaluation across key stakeholder groups and promises to extend understanding of useful indicators of success.

How things are perceived from a distance may help better understand their nature. Perceptions at home are likely to shape perceptions abroad. The mutual cross-references between local and distant perspectives on the Italian Mental Health Law 180 may help understand the process which preceded and resulted in the reform. This editorial argues that Law 180 came about at a unique – enabling – time in history. It argues that the run-up to and passing of Law 180 constituted a great accomplishment by professionals, the wider public and politicians/administrators. This editorial goes on to argue that the profession managed to cope with (many) adverse effects of the reform. The attention that Law 180 has received internationally should be devoted to other national (or regional) mental health reform processes as this may help us to understand how mental health care systems evolve and what defines ‘windows of (operative) opportunity’ or ‘moments for (public) action’.

Approximately one-third of people who have obtained refugee status live in high-income countries. Over recent years, the number of refugees has been increasing, and there are questions on how many of them need mental health care and which type of interventions are beneficial. Meta-analyses showed highly variable rates of mental disorders in adult refugees. This variability is likely to reflect both real differences between groups and contexts, and methodological inconsistencies across studies. Overall prevalence rates after resettlement are similar to those in host populations. Only post-traumatic stress disorder (PTSD) is more prevalent in refugees. In long-term resettled refugees, rates of anxiety and depressive disorders are higher and linked to poor social integration. Research on mental health care for refugees in high-income countries has been extensive, but often of limited methodological quality and with very context-specific findings. The existing evidence suggests several general principles of good practice: promoting social integration, overcoming barriers to care, facilitating engagement with treatment and, when required, providing specific psychological treatments to deal with traumatic memories. With respect to the treatment of defined disorders, only for the treatment of PTSD there has been substantial refugee-specific research. For other diagnostic categories, the same treatment guidelines apply as to other groups. More systematic research is required to explore how precisely the general principles can be specified and implemented for different groups of refugees and in different societal contexts in host countries, and which specific interventions are beneficial and cost-effective. Such interventions may utilise new communication technologies. Of particular importance are long-term studies to identify when mental health interventions are appropriate and to assess outcomes over several years. Such research would benefit from sufficient funding, wide international collaboration and continuous learning over time and across different refugee groups.

There is increasing international recognition of the need to build capacity to strengthen mental health systems. This is a fundamental goal of the ‘Emerging mental health systems in low- and middle-income countries’ (Emerald) programme, which is being implemented in six low- and middle-income countries (LMICs) (Ethiopia, India, Nepal, Nigeria, South Africa, Uganda). This paper discusses Emerald's capacity-building approaches and outputs for three target groups in mental health system strengthening: (1) mental health service users and caregivers, (2) service planners and policy-makers, and (3) mental health researchers. When planning the capacity-building activities, the approach taken included a capabilities/skills matrix, needs assessments, a situational analysis, systematic reviews, qualitative interviews and stakeholder meetings, as well as the application of previous theory, evidence and experience. Each of the Emerald LMIC partners was found to have strengths in aspects of mental health system strengthening, which were complementary across the consortium. Furthermore, despite similarities across the countries, capacity-building interventions needed to be tailored to suit the specific needs of individual countries. The capacity-building outputs include three publicly and freely available short courses/workshops in mental health system strengthening for each of the target groups, 27 Masters-level modules (also open access), nine Emerald-linked PhD students, two MSc studentships, mentoring of post-doctoral/mid-level researchers, and ongoing collaboration and dialogue with the three groups. The approach taken by Emerald can provide a potential model for the development of capacity-building activities across the three target groups in LMICs.

Self-help peer-support groups in Israel emerged in the 1980s and, over time, dynamically interacted and co-developed with the statutory mental health (MH) system. In this editorial, I outline historical milestones of how the evolution of the Israeli mental health system was influenced by the consumer movement. A brief depiction of the consumer movement history. At first, consumers operated outside of the mainstream MH system. Gradually, consumer groups and institutional personnel joined efforts towards community integration and enhancement of quality of life, pushing forward a person-centered recovery orientation. In turn, some administrators and key stakeholders in rehabilitation community services grew to value the impact of knowledge-by-experience in contemporary mental health care. In this context, over the past decade, peer roles were developed in the mental health system, including consumer-providers in community services and peer specialists in inpatient psychiatric hospitals. The insertion of peer roles into the mainstream MH system is far-reaching, including the placement of a peer-project coordinator within the ministry of health. I describe the unique contribution of peers, as experts-by-experience, to mainstream professional knowledge and practice. I also highlight the potential challenges involved when peer models of care are added to traditional medical models of care. The Israeli case demonstrates how the consumer movement can play an active role in MH systems and be acknowledged and recognised as a partner for changing policy, practice and reshaping formal institutions. In addition, they play a vital role in the development of peer-support services.

Large numbers of refugee children are arriving in high-income countries. The evidence to date suggests that they have mental health needs that are higher than for the general population and that these are exacerbated by the numbers of traumatic events they have experienced and the post-migration stressors they continue to be exposed to. The importance of a thorough and thoughtful assessment is discussed. Treatments of note are described for post-traumatic stress disorder, family functioning, general mental health problems and school environments. Future opportunities to operationalise outcome measures, develop multimodal interventions and utilise implementation science methodology are considered.

On 13 May 1978, the Italian Parliament approved Law 180, universally known as ‘Basaglia Law’ after the name of the leader of the anti-institutional movement which promoted this radical community mental health care reform. Forty years later, Italian psychiatry still runs a community care system, albeit with degrees of solidity and quality very varied along the peninsula. Mental health care is still an integral part of the National Health System, with liberal regulations on coercion and a lowest number of general hospital and residential facilities beds. Recently, Italy has also closed the special forensic psychiatric institutions and brought the care of the mentally ill offenders within the responsibilities of local Mental Health Departments. Over time, psychiatric deinstitutionalisation inspired policies in other sectors of Italian society, such as those regarding physical and intellectual disabilities, education of children with special needs, drug addictions and management of deviant minors. Furthermore, debate about Law 180 has reached and maintained an international dimension, becoming a term of reference for international agencies such as the World Health Organization and the European Commission, for good and for evil. The overall balance sheet of the Reform process would seem mostly positive, though the last decade has seen many threats challenging the system. Mental health care services have been asked to do much more, in terms of care to a larger population with very diversified needs, but with much less resources, due to the financial consequences of the economic crisis. Although there is no evidence of a trend towards re-institutionalisation, intensity and quality of care may have fallen below acceptable standards in some parts of Italy.

The subtype system for categorising presentations of schizophrenia will be removed from International Classification of Diseases 11th Revision. In its place will be a system for rating six domains of psychotic disorder pathology: positive symptoms, negative symptoms, depressive symptoms, manic symptoms, psychomotor symptoms and cognitive symptoms. This paper outlines the rationale and description of the proposed symptom rating scale, including current controversies. In particular, the scale could adopt either a 4-point severity rating or a 2-point presence/absence rating. The 4-point scale has the advantage of gathering more information, but potentially at the cost of reliability. The paper concludes by describing the field testing process for evaluating the proposed scale.

ὠφελέειν, ἢ μὴ βλάπτειν (Primum non nocere) – Hιppocrates’ principle should still guide daily medical prescribing. Therefore, assessing evidence of psychopharmacologic agents’ safety and harms is essential. Randomised controlled trials (RCTs) and observational studies may provide complementary information about harms of psychopharmacologic medications from both experimental and real-world settings. It is considered that RCTs provide a better control of confounding variables, while observational studies provide evidence from larger samples, longer follow-ups, in more representative samples, which may be more reflective of real-life clinical scenarios. However, this may not always hold true. Moreover, in observational studies, safety data are poorly or inconsistently reported, precluding reliable quantitative synthesis in meta-analyses. Beyond individual studies, meta-analyses, which represent the highest level of ‘evidence’, can be misleading, redundant and of low methodological quality. Overlapping meta-analyses sometimes even reach different conclusions on the same topic. Meta-analyses should be assessed systematically. Descriptive reviews of reviews can be poorly informative. Conversely, ‘umbrella reviews’ can use a quantitative approach to grade evidence. In this editorial, we present the main factors involved in the assessment of psychopharmacologic agents’ harms from individual studies, meta-analyses and umbrella reviews. Study design features, sample size, number of the events of interest, summary effect sizes, p-values, heterogeneity, 95% prediction intervals, confounding factor adjustment and tests of bias (e.g., small-study effects and excess significance) can be combined with other assessment tools, such as AMSTAR and GRADE to create a framework for assessing the credibility of evidence.

Lately on these pages, a discussion is going on over the opportunity of the use of the definition ‘outsider’. Especially in the USA, it is judged as demeaning, discriminating and inappropriate, whilst in Europe, it is used in a much more unconcerned way. Mr Gioni curator of numerous international exhibitions including Manifesta 5 (2004), the 4th Berlin Biennale (2006), the 8th Gwangju Biennale (2010) and the 55th Venice Biennale (2013) shares his perspective on contemporary culture and self-taught art.