How a National Organization Works in Partnership With People Who Have Lived Experience in Mental Health Improvement Programs: Protocol for an Exploratory Case Study.

BACKGROUND: This is a research proposal for a case study to explore how a national organization works in partnership with people with lived experience in national mental health improvement programs. Quality improvement is considered a key solution to addressing challenges within health care, and in Scotland, there are significant efforts to use quality improvement as a means of improving health and social care delivery. In 2016, Healthcare Improvement Scotland (HIS) established the improvement hub, whose purpose is to lead national improvement programs that use a range of approaches to support teams and services. Working in partnership with people with lived experience is recognized as a key component of such improvement work. There is, however, little understanding of how this is manifested in practice in national organizations. To address gaps in evidence and strengthen a consistent approach, a greater understanding is required to improve partnership working. OBJECTIVE: The aim of this study is to better understand how a national organization works in partnership with people who have lived experience with improvement programs in mental health services, exploring people's experiences of partnership working in a national organization. An exploratory case study approach will be used to address the research questions in relation to the Personality Disorder (PD) Improvement Programme: (1) How is partnership working described in the PD Improvement Programme? (2) How is partnership working manifested in practice in the PD Improvement Programme? and (3) What factors influence partnership working in the PD Improvement Programme? METHODS: An exploratory case study approach will be used in relation to the PD Improvement Programme, led by HIS. This research will explore how partnership working with people with lived experience is described and manifested in practice, outlining factors influencing partnership working. Data will be gathered from various qualitative sources, and analysis will deepen an understanding of partnership working. RESULTS: This study is part of a clinical doctorate program at the University of Stirling and is unfunded. Data collection was completed in October 2023; analysis is expected to be completed and results will be published in January 2025. CONCLUSIONS: This study will produce new knowledge on ways of working with people with lived experience and will have practical implications for all improvement-focused interventions. Although the main focus of the study is on national improvement programs, it is anticipated that this study will contribute to the understanding of how all national public service organizations work in partnership with people with lived experience of mental health care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51779.

Sleep health among people with severe mental ill health during the COVID-19 pandemic: Results from a linked UK population cohort study.

Objectives: Sleep problems are a transdiagnostic feature of nearly all psychiatric conditions, and a strong risk factor for initial and recurrent episodes. However, people with severe mental ill health (SMI) are often excluded from general population surveys, and as such the extent and associates of poor sleep in this population are less well understood. This study explores sleep health in an SMI sample during the COVID-19 pandemic, using multiple regression to identify risk factors, including daily routine, wellbeing and demographics. Methods: An existing cohort of people with an SMI diagnosis were sampled. Participants were invited to complete a self-report survey about their health and the impacts of COVID-19 and associated public health measures. Sleep duration, efficiency, and quality were measured using items from the Pittsburgh Sleep Quality Index (PSQI). Results: Two hundred forty-nine adults (aged 21-84 years) completed the survey. Mean sleep duration and efficiency were similar to general population estimates, at 7 h 19 min and 78%, respectively. However, 43% reported "bad" sleep quality that was associated with being younger in age as well as disturbed routine and declined wellbeing. Indeed, 37% reported a disturbed routine during the pandemic. Conclusions: High estimates of perceived poor sleep quality in the SMI population align with previous findings. Supporting people with SMI to maintain routine regularity may work to protect sleep quality and wellbeing. Future research should more closely examine sleep health in people with SMI, using accessible and scalable measures of objective and subjective sleep, examining longitudinal trends.

Influences on the physical and mental health of people with serious mental ill-health during the COVID-19 pandemic: a qualitative interview study.

PURPOSE: People with severe mental ill-health (SMI) experience profound health inequalities. The Optimizing Wellbeing in Self-isolation study (OWLS) explored the effects of the COVID-19 pandemic restrictions on people with SMI, including how and why their physical and mental health may have changed during the pandemic. METHODS: The OLWS study comprised two surveys and two nested qualitative studies. Of 367 people recruited to the study, 235 expressed interest in taking part in a qualitative interview. In the first qualitative study eighteen interviews were conducted with a purposive sample of participants. RESULTS: We identified six factors which influenced peoples' health, positively and negatively: Staying Physically Active; Maintaining a Balanced and Healthy Diet; Work or Not Working; Daily Routine and Good Sleep; Staying Connected to Family, Friends and the Local Community; and Habits, Addictions and Coping with Anxiety Created by the Pandemic. CONCLUSIONS: Different aspects of lifestyle are highly interconnected. For people with SMI, loss of routine and good sleep, poor diet and lack of exercise can compound each other, leading to a decline in physical and mental health. If people are supported to understand what helps them stay well, they can establish their own frameworks to draw on during difficult times.

Transformation Beyond COVID-19: Accessibility in Lived Experience Involvement in Research Post Pandemic. Experience, Reflections and Future Direction From the Closing the Gap Network and OWLS Study.

Research literature published during the COVID-19 pandemic highlights the loss of involvement opportunities for people with lived experience during the pandemic as well as the vital role lived experience advisors play at all times, including highlighting unseen aspects of the impacts of crises such as the COVID-19 pandemic. During the pandemic, researchers from the Closing the Gap Network (CtG) at the University of York worked to expand and diversify patient and public involvement (PPI) whist working on a study exploring the impact of the pandemic and associated restrictions on those with the most severe forms of mental ill health. CtG had a strong record of patient and public involvement pre-pandemic and researchers wanted to ensure that this continued during the pandemic. This paper describes the experience of lived experience involvement during the pandemic from multiple perspectives and makes recommendations for future involvement models, accessibility and recommendations for future research.

Loneliness among people with severe mental illness during the COVID-19 pandemic: Results from a linked UK population cohort study.

AIM/GOAL/PURPOSE: Population surveys underrepresent people with severe mental ill health. This paper aims to use multiple regression analyses to explore perceived social support, loneliness and factor associations from self-report survey data collected during the Covid-19 pandemic in a sample of individuals with severe mental ill health. DESIGN/METHODOLOGY/APPROACH: We 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. FINDINGS: In 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 IMPLICATIONS: Intervention 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. ORIGINALITY: Loneliness 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.

The Role of Animal Ownership for People with Severe Mental Illness during the COVID-19 Pandemic: A Mixed-Method Study Investigating Links with Health and Loneliness.

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.

Use of the Internet and Digital Devices Among People With Severe Mental Ill Health During the COVID-19 Pandemic Restrictions.

Background: Restrictions 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 adapted to online service delivery. This study explored use of the Internet and digital devices during the pandemic restrictions and its association with physical and mental health changes. Methods: Three hundred sixty seven adults with an SMI diagnosis completed a survey (online or offline) and provided information on access to Internet connexion and devices, internet knowledge, online activities, and barriers to using the Internet. They also self-reported changes in mental and physical health since the beginning of the pandemic restrictions. Results: During 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" (22.1-24.3%). Using the Internet "a lot" (vs. "just a bit or not at all") during the pandemic was associated with younger age (18-30: Adj ORs 4.76; 31-45: 6.39; Ps < 0.001; vs. 66+), having a diagnosis of bipolar disorder (compared to psychosis; Adj OR = 3.88, P < 0.001), or reporting a decline in mental health (compared to no decline; Adj OR = 1.92, P = 0.01). Conclusion: Most 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.

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: Analysis of linked cohort data.

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.

Mental health among healthcare workers and other vulnerable groups during the COVID-19 pandemic and other coronavirus outbreaks: A rapid systematic review.

INTRODUCTION: Although most countries and healthcare systems worldwide have been affected by the COVID-19 pandemic, some groups of the population may be more vulnerable to detrimental effects of the pandemic on mental health than others. The aim of this systematic review was to synthesise evidence currently available from systematic reviews on the impact of COVID-19 and other coronavirus outbreaks on mental health for groups of the population thought to be at increased risk of detrimental mental health impacts. MATERIALS AND METHODS: We conducted a systematic review of reviews on adults and children residing in a country affected by a coronavirus outbreak and belonging to a group considered to be at risk of experiencing mental health inequalities. Data were collected on symptoms or diagnoses of any mental health condition, quality of life, suicide or attempted suicide. The protocol for this systematic review was registered in the online PROSPERO database prior to commencing the review (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=194264). RESULTS: We included 25 systematic reviews. Most reviews included primary studies of hospital workers from multiple countries. Reviews reported variable estimates for the burden of symptoms of mental health problems among acute healthcare workers, COVID-19 patients with physical comorbidities, and children and adolescents. No evaluations of interventions were identified. Risk- and protective factors, mostly for healthcare workers, showed the importance of personal factors, the work environment, and social networks for mental health. CONCLUSIONS: This review of reviews based on primary studies conducted in the early months of the COVID-19 pandemic shows a lack of evidence on mental health interventions and mental health impacts on vulnerable groups in the population.

Investigating smoking and nicotine dependence among people with severe mental illness during the COVID-19 pandemic: analysis of linked data from a UK Closing the Gap cohort.

Smoking rates are higher for people who use mental health services, which contributes substantially to health inequalities. Smoking can lead to worse COVID-19 outcomes, yet it remains unclear whether smoking has changed for people who use mental health services. We examined smoking patterns in a large clinical cohort of people with severe mental illness, before and during the pandemic. We found high levels of nicotine dependence and heavier patterns of smoking. Although some people had reported quitting, it is likely that smoking inequalities have become further entrenched. Mental health services should seek to mitigate this modifiable risk and source of poor health.

Exploring Access to Mental Health and Primary Care Services for People With Severe Mental Illness During the COVID-19 Restrictions.

AIMS: To 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 METHODS: A 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 analyze the quantitative data. The free text responses were analyzed thematically. RESULTS: 367 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. However, acceptability was influenced by several factors, and participants were more likely to report that they had received all the support they needed, when seen in person. DISCUSSION: Although 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.

A Year Into the Pandemic: The Diversity of Experience Amongst People With Severe Mental Ill Health.

BACKGROUND: The COVID-19 pandemic has amplified pre-existing health inequalities and people with severe mental ill health (SMI) are one of the groups at greatest risk. In this study, we explored the effects of the pandemic and pandemic restrictions on people with SMI during the first year of the pandemic. METHODS: We conducted a longitudinal study in a sample of people with SMI. The inception survey was carried out between July and December 2020. Participants were then re-surveyed between January and March 2021. People were contacted by telephone and invited to take part in the study over the phone, online or by postal questionnaire. Across both waves we asked participants about their physical and mental health, health risk behaviors, well-being, loneliness, and employment status. RESULTS: Three hundred and sixty-seven people with SMI completed the inception survey and 249 people completed the follow up. Whilst some people reported no change in their physical (77, 31%) or mental health (60, 24%) over the course of the pandemic 53 (21%) reported a continuing decline in physical health and 52 (21%) reported a continuing decline in mental health. Participants who maintained a daily routine or reported no decline in physical health were found to be associated with no deterioration in mental health (Daily routine OR 2.27, 95% CI 1.11-4.64; no reported physical health decline OR 0.54, 95% CI 0.17-0.70). Participants were less likely to be occupationally active in the first phase of the pandemic compared to before the pandemic and in the second phase of the pandemic. However, there was no one single experience of people with SMI and similar to studies in the general populations a range of different scenarios was experienced. CONCLUSIONS: We observed a series of factors that might amplify pre-existing health inequalities. Health systems should be mindful of this, and should redouble efforts to set in place changes to practice and policy, which can mitigate these inequalities. Examples might include; raising awareness of the importance of ensuring that people with SMI receive an annual physical health check and supporting people to maintain a daily routine.

"The biggest barrier is to inclusion itself": the experience of citizenship for adults with mental health problems.

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.

Improving the user experience of patient versions of clinical guidelines: user testing of a Scottish Intercollegiate Guideline Network (SIGN) patient version.

BACKGROUND: Guideline producers are increasingly producing versions of guidelines for the public, and knowledge of what the public want from them is also increasing. The aim of this study was to user test a patient version of a SIGN clinical guideline that was designed based on preliminary work for the DECIDE project. SIGN is the leading national guideline producer in Scotland. METHODS: People with a diagnosis of glaucoma and non-professional carers were recruited from across Scotland. User testing was conducted using a think-aloud protocol method. Each session was conducted by one interviewer and one observer. All sessions were recorded and transcribed. The data was analysed, problems with the guideline were identified and resolved and key findings were themed using a user experience model. RESULTS: Thirteen user testing sessions with people with glaucoma and one with a carer were conducted. Key facilitators of desirability and usability identified include clear branding as a patient version and a clearly described purpose, audience and contents page. Other facilitators include a "friendly" tone which is achieved by the use of colour, quotes, icons, simple language and charts, and brief chunked text. The value and usefulness of the patient guideline was influenced by its ability to: inform the public, link information to actions, and empower people in their interaction with healthcare professionals. Participants were disappointed by the lack of information on treatment in the patient version, which was outside its scope. Information on the evidence based guideline production process and the involvement of appropriately skilled professionals was key to the credibility of the guideline. Lack of awareness of guidelines and guideline producing bodies, is a potentially serious threat to findability/accessibility. CONCLUSIONS: It is important for guideline producers to maximise the user experience of the public when they access patient versions of guidelines, particularly given the current low level of access and awareness. One size does not fit all and guideline producers need to strike a balance between keeping the patient version simple and providing sufficient information to facilitate shared decision making and empower the public. Guideline producers may find the results of this study useful in designing their own patient versions.

Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.

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.

Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.

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.

A flow-through sampler for semivolatile organic compounds in air.

A widely acknowledged limitation of current passive air sampling designs for semivolatile organic chemicals is their relatively low sampling rate, severely constraining the temporal resolution that can be achieved. Addressing the need for an improved sampling design which achieves significantly faster uptake while maintaining the capability of providing quantitative information, a new sampler has been developed that provides greatly increased sampling rates by forcing the wind to blow through the sampling medium. The sampler consists of a horizontally oriented, aerodynamically shaped, stainless steel flow tube mounted on a post with ball bearings, which turns into the wind with the help of vanes. A series of polyurethane foam (PUF) discs with relatively large porosity mounted inside the flow tube serve as the sampling medium. The sampled air volume is calculated from wind speed, which is measured outside the sampler and after passage through the sampling medium using precalibrated vortex rotor and turbine anemometers mounted on top of the sampler and at the exit of the flow tube, respectively. Small battery-operated data loggers are used for data storage. Under typical wind speed conditions, the sampler can collect 100 m(3)/ day, which is approaching the sampling rates of conventional high volume samplers. Controlled experiments in the laboratory and frontal chromatography theory yield the theoretical plate number and breakthrough volumes for polychlorinated biphenyls and polycyclic aromatic hydrocarbons in the PUF plugs and allow for the estimation of breakthrough levels for relatively volatile organic chemicals. After correction for breakthrough, the air concentration obtained with the new flow-through sampler are independent of sampling length and volume and compare favorably with those obtained from conventional pumped high volume samples.