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Research has reported the benefits of companion animals for people with severe mental illness (SMI). However, this evidence base is fragmented and unclear. The COVID-19 pandemic presents an opportunity to explore the role of companion animals in the context of social distancing and isolation measures for people with SMI. Therefore, we aimed to investigate the links between mental and physical health and animal ownership in people with SMI and to explore animal owners’ perceptions related to human–animal interactions during the pandemic restrictions. A survey was conducted with a previously assembled cohort of individuals with SMI in the UK. The survey included previously validated and new bespoke items measuring demographics, and outcomes related to mental and physical health, and human–animal interactions. The survey also included a question inviting free-text responses, allowing participants to describe any experiences of their human–animal relationships during the pandemic. Of 315 participants who consented to participate, 249 (79%) completed the survey. Of these, 115 (46.2%) had at least one companion animal. Regression analyses indicated that animal ownership was not significantly associated with well-being and loneliness. However, animal ownership was associated with a self-reported decline in mental health (b = 0.640, 95% CI [0.102–1.231], p = 0.025), but no self-reported change in physical health. Thematic analysis identified two main themes relating to the positive and negative impact of animal ownership during pandemic restrictions. Animal ownership appeared to be linked to self-reported mental health decline in people with SMI during the second wave of the pandemic in the UK. However, the thematic analysis also highlighted the perceived benefit of animal ownership during this time. Further targeted investigation of the role of human–animal relationships and the perceived human–animal bond for human health is warranted.

PurposePopulation surveys underrepresent people with severe mental ill health. This paper aims to explore perceived social support and loneliness and factor associations during the Covid-19 pandemic in a sample of individuals with severe mental ill health.Design/methodology/approachWe sampled an already existing cohort of people with severe mental ill health. Researchers contacted participants by phone or by post to invite them to take part in a survey about how the pandemic restrictions had impacted health, Covid-19 experiences, perceived social support, employment and loneliness. Loneliness was measured by the three item UCLA loneliness scale.FindingsIn the pandemic sub-cohort, 367 adults with a severe mental ill health diagnosis completed a remote survey. 29-34% of participants reported being lonely. Loneliness was associated with being younger in age (adjusted OR = -.98, p = .02), living alone (adjusted OR = 2.04, p = .01), high levels of social and economic deprivation (adjusted OR = 2.49, p = .04), and lower perceived social support (B = -5.86, p < .001). Living alone was associated with lower perceived social support. Being lonely was associated with a self-reported deterioration in mental health during the pandemic (adjusted OR = 3.46, 95%CI 2.03-5.91).Practical implicationsIntervention strategies to tackle loneliness in the severe mental ill health population are needed. Further research is needed to follow-up the severe mental ill health population after pandemic restrictions are lifted to understand perceived social support and loneliness trends.OriginalityLoneliness was a substantial problem for the severe mental ill health population before the Covid-19 pandemic but there is limited evidence to understand perceived social support and loneliness trends during the pandemic.

BackgroundRestrictions due to the COVID-19 pandemic have led to everyday reliance on digitalisation of life, including access to health care services. People with severe mental ill health (SMI – e.g., bipolar or psychosis spectrum disorders) are at greater risk for digital exclusion and it is unknown to what extent they are able to adapt to online service delivery. This cross-sectional survey study explored use of the Internet and digital devices during the pandemic restrictions and its association with physical and mental health changes.Methods367 adults with an SMI diagnosis completed a survey (online or offline) and provided information on access to Internet connection and devices, internet skills, online activities, and barriers to using the Internet. They also self-reported changes in mental and physical health.ResultsDuring the pandemic restrictions 61.6% were limited or non-users of the Internet. The majority had access to the Internet and digital devices but around half reported knowledge deficits. Most common activities were accessing information and entertainment (88.9%), staying in touch with friends and families (84.8%), and purchasing goods (other than food) (84.3%). Most common barriers were finding the Internet ‘not interesting’ (28.3%) or ‘too difficult’ (27.9%), as well as ‘security concerns’ (22.1% to 24.3%). Using the Internet ‘a lot’ (vs ‘just a bit or not at all’) during the pandemic was associated with younger age (Adj ORs = 4.76 – 6.39, Ps < .001), having a diagnosis of bipolar disorder (compared to psychosis; Adj OR = 3.88, P < .001), or reporting a decline in mental health (compared to no decline; Adj OR = 1.92, P = .01).ConclusionMost people with SMI were limited or non-users of the Internet during the pandemic, which seems to be mainly attributable to lack of interest and skills, rather than lack of devices or connectivity. Older adults with psychosis should be the focus of interventions to support digital engagement in people with SMI.

AimsTo explore: how satisfied people with severe mental illness (SMI) are with the support received during the pandemic; understand any difficulties encountered when accessing both mental health and primary care services; consider ways to mitigate these difficulties; and assess the perceived need for future support from mental health services.Materials and MethodsA representative sample was drawn from a large transdiagnostic clinical cohort of people with SMI, which was recruited between April 2016 and March 2020. The sample was re-surveyed a few months after the beginning of the restrictions. Descriptive frequency statistics were used to analyse the quantitative data. The free text responses were analysed thematically.Results367 participants responded to the survey. Two thirds were receiving support from mental health services with the rest supported in primary care or self-managing. A quarter thought they would need more mental health support in the coming year. Half had needed to used community mental health services during the pandemic and the majority had been able to get support. A minority reported that their mental health had deteriorated but they had either not got the supported they wanted or had not sought help. The biggest service change was the reduction in face-to-face appointments and increasing use of phone and video call support. Nearly half of those using mental health services found this change acceptable or even preferred it; acceptability was influenced by several factors. Participants were more likely to be satisfied with support received when seen in person.DiscussionAlthough most participants were satisfied with the mental health support they had received, a minority were not. This, couple with findings on future need for mental health support has implications for post pandemic demand on services. Remote care has brought benefits but also risks that it could increase inequalities in access to services.

Background: Citizenship has been promoted within mental health for several decades however, its application in the field of mental health policy and practice is relatively novel. The voices of people who experience mental health problems (MHPs) are often absent in ongoing discourses about citizenship. Aims: To explore how adults with experience of MHPs and other life disruptions identify potential barriers to citizenship.Method: A community based participatory research approach was adopted with peer researchers. Six focus groups (N = 40) using semi-structured interviews were conducted, consisting of participants who had experience of MHPS and other life disruption(s) within the last 5 years. The focus groups were audio recorded, transcribed verbatim and analysed in NVIVO using a thematic approach. Results: Three major themes associated with participants lived experiences of barriers to citizenship were identified: ‘stigmatisation (internal & external) creates further divide’; ‘being socially excluded leads to isolation’; and ‘a sense of difference (as perceived by the self and others)’. Conclusions: Those who have experienced major life disruption(s) face multi-level barriers to citizenship. An awareness of such barriers has important implications for mental health research, policy and practice. Citizenship-oriented implementation strategies that aim to address multi-level barriers merit further investigation.

BackgroundPeople with severe mental ill health (SMI) experience a mortality gap of 15-20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities.MethodsWe sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic.Outcomes367 people provided health risk data. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health and younger age were significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22-2.07; adjusted OR for Age 0.99, 95%CI 0.98-1.00).InterpretationCOVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic.FundingMedical Research council, Yorkshire and Humber Applied Research Collaboration, Wellcome and UKRI.

Background People with severe mental ill health (SMI) experience a mortality gap of 15–20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities. Methods We sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic. Outcomes 367 people provided health risk data. The mean age of the participants was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health was significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22–2.07; adjusted OR for Age 0.99, 95%CI 0.98–1.00). Interpretation COVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic.

Background: People with severe mental illness die 15-20 years earlier than the general population. This excess mortality is explained largely by preventable physical health conditions. Evaluating the effectiveness of interventions that target risk behaviours in people with SMI is a global health priority. Interventions focussing on single behaviours may be ineffective in changing health outcomes. No systematic review has compared the effectiveness of targeting multiple or single risk behaviours in this population. Methods: We searched Cochrane Central Register of Controlled Trials (CENTRAL), Embase, MEDLINE, PsycINFO and Science Citation Index in March 2020 and Applied Social Science Index and Abstracts (ASSIA) in September 2020. We included randomised controlled trials of single or multiple health risk behaviour interventions in people with SMI. The study is registered on PROSPERO (CRD42018104724). We conducted network meta-analyses to compare effectiveness of interventions targeting multiple and single risk behaviours. Findings: We included 67 RCTs. Just over half of studies had high overall risk of bias. Trials focusing on smoking alone led to greater smoking abstinence than targeting smoking and other behaviours. However, heterogeneity means we cannot rule out other interpretations explanations. For weight loss (e.g. any risk behaviour intervention: -2.10 kg, 95% CrI -3.14, -1.06) and BMI (e.g. any risk behaviour intervention: -0.49, 95% CrI -0.97, -0.01) all risk behaviour interventions had positive but modest benefits compared with treatment as usual. There were potential synergies for targeting multiple health behaviours for reduction in systolic blood pressure. We found no evidence of a deterioration in mental health for people with SMI engaging in these interventions. Interpretation: Multiple and single risk behaviour interventions were associated with positive but modest benefits. Targeting smoking alone appeared to be more effective, but few studies assessed behavioural outcomes. Interventions were not associated with deterioration in mental health. Funding: National Institute for Health Research Declaration of Interest: We declare no competing interests.

Dear Judith:This morning in the alley below my studio window, seven men are spreading and smoothing concrete—laying a foundation for loft apartments. Through a missing pane, I can hear the hum of t...

Johnston and Robertson examine the changes that have taken place in the funding, management and governance of the World Service since 1989. The wider context is provided by the digital revolution, anxieties about security and falling levels of trust in news media. Writing in early 2019, Johnston and Robertson return to their argument that the role of overseas broadcasting has always involved deliberations about the future of the UK, and argue that these debates are now shaped by the Government’s commitment to leave the European Union and the centrifugal currents in British politics. For the BBC, the question is not only what it means to be a global broadcaster, but what it means to be a national broadcaster in a divided kingdom.

Johnston and Robertson discuss the pioneering work of the BBC Empire Service in the 1930s and how it sought to connect expatriates living and working in the colonies and dominions to the ‘Mother Country’. Drawing on audience surveys, listeners’ letters and programme content, Johnston and Robertson chart the development of radio as a global medium and unpack how Britishness was imagined and experienced at ‘home’ and across the empire in the 1930s and early 1940s. While the BBC attempted to distance themselves from purely ‘sentimental’ motivations for overseas broadcasts, audience responses reveal the intense emotional power of interwar radio as it intertwined with diasporic nostalgia.

In this first full-length history of the BBC World Service, Johnston and Robertson argue that from the launch of the Empire Service in 1932 to the World Service of today, debates about the role of the BBC overseas broadcasting services have always involved deliberations about the future of the UK and its place in the world. To understand the history and trajectory of the BBC overseas broadcasting services, Johnston and Robertson discuss five interrelated themes: the relationship between overseas broadcasting and foreign policy; the constitutional position of the BBC and its status as a public service broadcaster; the composition of the BBC’s worldwide audiences; the impact of technological change; and the recognition that the BBC has agency in its own history.

Johnston and Robertson chart the expansion of the BBC overseas services under the auspices of the Political Warfare Executive and the Ministry of Information, in the context of the wider debate about the BBC’s wartime role. The BBC’s reputation as a wartime broadcaster was based on the comparative reliability and accuracy of its news, the military fortunes of the allied forces and the readiness of the BBC to encourage debate about post-war priorities. The degree of autonomy that the BBC overseas services should enjoy, if any, remained controversial. At the end of the war, the BBC anticipated that the overseas services would be dramatically reduced. Yet as Johnston and Robertson demonstrate, the dawn of the Cold War provided the BBC with a new global purpose.

Community based participatory research (CBPR) principles were used to develop a conceptual framework of citizenship for people experiencing mental health problems and/or other life disrupting events in Scotland. This case study illustrates the use of a participatory methodology replicating an approach adopted as part of an international collaboration in understanding citizenship across diverse social and cultural contexts. Reflecting on the approach taken, we argue that it encourages the development of a model of citizenship that is entirely grounded in the perspectives and lived experiences of the participants. We consider the importance of ‘meaningfully’ engaging peer researchers throughout the research process, exploring the methodological issues, challenges and opportunities when working in partnership. The importance of adopting a reflexive approach throughout the research approach is emphasised. We consider how the need for adequate resources, preparatory work, training and research management is key to the success of a CBPR approach with peer researchers. Finally, we suggest making appropriate adaptations to any research methodology when working with diverse populations, particularly the ‘seldom heard’ groups within society, in order to inform health and social policy and practice.

Johnston and Robertson follow the debate on foreign-language broadcasting in the 1930s and the launch of the BBC’s first foreign-language services including the Arabic, French and German services in 1938. Johnston and Robertson explore why foreign-language broadcasting was supported by the Foreign Office but opposed by critics, who equated it with propaganda that would undermine the reputation and credibility of the BBC for ‘straight news’. The Foreign Office complained that the BBC was incapable in its foreign-language broadcasts of taking guidance or following a lead. On the eve of the Second World War, Johnston and Robertson argue that challenges to the BBC’s editorial independence had become a hallmark of the BBC’s relationship with its official interlocutors, including the Foreign Office.

Against the backdrop of imperial retreat, Johnston and Robertson focus on the work of the General Overseas Service and how the BBC responded to nationalist and independence movements in the British Empire. Particular attention is given to the BBC’s changing relationship with British exiles and its (post)colonial listeners. Johnston and Robertson argue that in this febrile environment, the independence and autonomy of the BBC were challenged by former colonies and British governments alike. The complexity of the subsequent negotiations is explored by focusing on the BBC’s relations with four African states: Rhodesia, Uganda, South Africa and Ghana. Johnston and Robertson conclude with the important observation that many former British territories – Nigeria, India, Bangladesh and Pakistan – now have some of the highest percentages of regular BBC listeners.

Johnston and Robertson examine the origins of the BBC’s Cold War and the character of its Cold War audiences and broadcasts. Drawing extensively on BBC scripts, audience surveys, letters from listeners and reports from refugees, Johnston and Robertson argue that the BBC was most influential in countries with a developed civil society. They also suggest that the level of scrutiny to which the BBC overseas services were subject in the post-war years was symptomatic of the wider uncertainty about Britain’s place in the world in the aftermath of Suez. Though ‘victory’ in the Cold War was central to the history of post-war broadcasting, it was the dismantling of the British Empire that provided the measure of the UK’s status in the world.

John Murray pioneered the modern travel guidebook. This article draws on quantitative and qualitative sources from the Murray archive and Victorian print media to examine the commercial and critical fortunes of the world's first guidebook series. In addition to highlighting the role of competition, attitudes towards wealth making, the working culture of a family firm and the relationship between commercial and critical performance, this study makes a significant contribution to our understanding of the changing routines of travel, consumption and commerciality in the nineteenth century.

The globalization of drug manufacturing, supply and testing, and a growing workload that has far outpaced FDA’s resources has created new challenges. The US generic industry recognized the importance of working in partnership with FDA to increase critical agency capacity to address the need for globalization of the inspection process, and to speed the timely review of generic product applications and proposed a holistic user fee program to help the FDA obtain the additional resources needed to ensure all participants in the U.S. generic drug system, whether US-based or foreign, comply with FDA’s high-quality standards and to make certain Americans get timely access to more affordable, high-quality generic drugs. The Generic Drug User Fee Act proposal (GDUFA) agreed to by industry and FDA is focused on three key aims: safety, access, and transparency. GDUFA also will help accelerate the market entry of additional manufacturers of drugs currently in short supply and improve quality, consistency, and availability within the supply chain, further helping to mitigate drug shortages caused by interrupted access to raw materials such as active pharmaceutical ingredients. Based on the proposal that will be submitted to Congress GDUFA would officially begin on October 1, 2012 and generate a total generic drug user fee package of $299 million per year for 5 years. In exchange for these fees, the FDA is to strive to meet key metrics which the agency must report to Congress each year, in addition to a host of other goals, metrics and efficiencies.

In 1946 Churchill's ‘iron curtain’ speech delivered to an American audience in Fulton, Missouri, provided an early marker for the onset of the Cold War; ‘peace that is no peace’ in Orwell's prescie...

The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

Fuelled by the opening up of archives in the former Soviet Union, eastern Europe, Asia, Africa and Latin America, two of the more recent developments in scholarship on the Cold War are a greater un...

On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5–7, 2015.

This paper provides an overview of key regulatory and technical issues related to the approval of biotechnology products in the USA by an abbreviated pathway. Technological advances now permit accurate analytical comparisons of innovative and generic biotechnology products. These sophisticated analytical techniques, along with pharmacodynamic, pharmacokinetic and limited clinical testing, provide an array of comparative tools to demonstrate the equivalence of innovative and generic products. Using a case by case evaluation, there are currently biotechnology products that could be approved based on abbreviated data packages.

English Social capital is increasingly regarded by politicians, policy makers and theoreticians as an antidote to a range of social ills and its absence as a cause of those same ills. Originating in Bourdieu and popularised by Putnam, much is claimed for social capital. However, there is little agreement on what social capital is, where it comes from, how it can be measured and, if it is a ‘good thing’, how we can get more of it. This article reviews the main schools of thought relating to social capital, summarises what is being claimed for it and then sketches out a research agenda to address the unresolved issues surrounding this attractive but elusive concept.