Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial.

BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive form of neurostimulation with potential for development as a self-administered intervention. It has shown promise as a safe and effective treatment for obsessive compulsive disorder (OCD) in a small number of studies. The two most favourable stimulation targets appear to be the left orbitofrontal cortex (L-OFC) and the supplementary motor area (SMA). We report the first study to test these targets head-to-head within a randomised sham-controlled trial. Our aim was to inform the design of future clinical research studies, by focussing on the acceptability and safety of the intervention, feasibility of recruitment, adherence to and tolerability of tDCS, and the size of any treatment-effect. METHODS: FEATSOCS was a randomised, double-blind, sham-controlled, cross-over, multicentre study. Twenty adults with DSM-5-defined OCD were randomised to treatment, comprising three courses of clinic-based tDCS (SMA, L-OFC, Sham), randomly allocated and delivered in counterbalanced order. Each course comprised four 20-min 2 mA stimulations, delivered over two consecutive days, separated by a 'washout' period of at least four weeks. Assessments were carried out by raters who were blind to stimulation-type. Clinical outcomes were assessed before, during, and up to four weeks after stimulation. Patient representatives with lived experience of OCD were actively involved at all stages. RESULTS: Clinicians showed willingness to recruit participants and recruitment to target was achieved. Adherence to treatment and study interventions was generally good, with only two dropouts. There were no serious adverse events, and adverse effects which did occur were transient and mostly mild in intensity. Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores were numerically improved from baseline to 24 h after the final stimulation across all intervention groups but tended to worsen thereafter. The greatest effect size was seen in the L-OFC arm, (Cohen's d = -0.5 [95% CI -1.2 to 0.2] versus Sham), suggesting this stimulation site should be pursued in further studies. Additional significant sham referenced improvements in secondary outcomes occurred in the L-OFC arm, and to a lesser extent with SMA stimulation. CONCLUSIONS: tDCS was acceptable, practicable to apply, well-tolerated and appears a promising potential treatment for OCD. The L-OFC represents the most promising target based on clinical changes, though the effects on OCD symptoms were not statistically significant compared to sham. SMA stimulation showed lesser signs of promise. Further investigation of tDCS in OCD is warranted, to determine the optimal stimulation protocol (current, frequency, duration), longer-term effectiveness and brain-based mechanisms of effect. If efficacy is substantiated, consideration of home-based approaches represents a rational next step. TRIAL REGISTRATION: ISRCTN17937049. https://doi.org/10.1186/ISRCTN17937049.

The Impact of COVID-19 on Lung Cancer Incidence in England: Analysis of the National Lung Cancer Audit 2019 and 2020 Rapid Cancer Registration Datasets.

BACKGROUND: The COVID-19 pandemic has caused significant disruption to health-care services and delivery worldwide. The impact of the pandemic and associated national lockdowns on lung cancer incidence in England have yet to be assessed. RESEARCH QUESTION: What was the impact of the first year of the COVID-19 pandemic on the incidence and presentation of lung cancer in England? STUDY DESIGN AND METHODS: In this retrospective observational study, incidence rates for lung cancer were calculated from The National Lung Cancer Audit Rapid Cancer Registration Datasets for 2019 and 2020, using midyear population estimates from the Office of National Statistics as the denominators. Rates were compared using Poisson regression according to time points related to national lockdowns in 2020. RESULTS: Sixty-four thousand four hundred fifty-seven patients received a diagnosis of lung cancer across 2019 (n = 33,088) and 2020 (n = 31,369). During the first national lockdown, a 26% reduction in lung cancer incidence was observed compared with the equivalent calendar period of 2019 (adjusted incidence rate ratio [IRR], 0.74; 95% CI, 0.71-0.78). This included a 23% reduction in non-small cell lung cancer (adjusted IRR, 0.77; 95% CI, 0.74-0.81) and a 45% reduction in small cell lung cancer (adjusted IRR, 0.55; 95% CI, 0.46-0.65) incidence. Thereafter, incidence rates almost recovered to baseline, without overcompensation (adjusted IRR, 0.96; 95% CI, 0.94-0.98). INTERPRETATION: The incidence rates of lung cancer in England fell significantly by 26% during the first national lockdown in 2020 and did not compensate later in the year.

A randomised pilot feasibility study of eye movement desensitisation and reprocessing recent traumatic episode protocol, to improve psychological recovery following intensive care admission for COVID-19

Background: Approximately 50% of intensive care survivors experience persistent psychological symptoms. Eye-movement desensitisation and reprocessing (EMDR) is a widely recommended trauma-focussed psychological therapy, which has not been investigated systematically in a cohort of intensive care survivors: We therefore conducted a randomised pilot feasibility study of EMDR, using the Recent Traumatic Episode Protocol (R-TEP), to prevent psychological distress in intensive care survivors. Findings will determine whether it would be possible to conduct a fully-powered clinical effectiveness trial and inform trial design. Method: We aimed to recruit 26 patients who had been admitted to intensive care for over 24 h with COVID-19 infection. Consenting participants were randomised (1:1) to receive either usual care plus remotely delivered EMDR R-TEP or usual care alone (controls). The primary outcome was feasibility. We also report factors related to safety and symptom changes in post-traumatic stress disorder, (PTSD) anxiety and depression. Results: We approached 51 eligible patients, with 26 (51%) providing consent. Intervention adherence (sessions offered/sessions completed) was 83%, and 23/26 participants completed all study procedures. There were no attributable adverse events. Between baseline and 6-month follow-up, mean change in PTSD score was −8 (SD = 10.5) in the intervention group versus +0.75 (SD = 15.2) in controls (p = 0.126). There were no significant changes to anxiety or depression. Conclusion: Remotely delivered EMDR R-TEP met pre-determined feasibility and safety objectives. Whilst we achieved group separation in PTSD symptom change, we have identified a number of protocol refinements that would improve the design of a fully powered, multi-centre randomised controlled trial, consistent with currently recommended rehabilitation clinical pathways. Trial registration: ClinicalTrials.gov: NCT04455360.

A novel procedure to investigate social anxiety using videoconferencing software: A proof-of-concept study.

Social anxiety disorder (SAD) is very common and can be significantly disabling. New treatments are needed as the remission rate for SAD is the lowest of all the anxiety disorders. Experimental medicine models, in which features resembling a clinical disorder are experimentally induced, are a cost-effective and timely approach to explore potential novel treatments for psychiatric disorders. Following the emergence of SARS-CoV-2, there is a need to develop experimental medicine models that can be carried out remotely. We developed a novel procedure to investigate SAD (the InterneT-based Stress test for Social Anxiety Disorder; ITSSAD) that can be carried out entirely online by a single investigator, potentially reducing costs and maximising internal reliability. The procedure involves an anticipatory period followed by a naturalistic social interaction task. In a sample of 20 non-treatment-seeking volunteers with symptoms of SAD, the ITSSAD induced significant subjective anxiety and reduced positive affect. Further, increased social anxiety symptoms at baseline predicted increased anxiety during the social interaction task. This protocol needs further validation with physiological measures. The ITSSAD is a new tool for researchers to investigate mechanisms underlying social anxiety disorder.

Acceptability of a standalone written leaflet for the National Health Service for England Targeted Lung Health Check Programme: A concurrent, think-aloud study.

BACKGROUND: Many countries are introducing low-dose computed tomography screening programmes for people at high risk of lung cancer. Effective communication strategies that convey risks and benefits, including unfamiliar concepts and outcome probabilities based on population risk, are critical to achieving informed choice and mitigating inequalities in uptake. METHODS: This study investigated the acceptability of an aspect of NHS England's communication strategy in the form of a leaflet that was used to invite and inform eligible adults about the Targeted Lung Health Check (TLHC) programme. Acceptability was assessed in terms of how individuals engaged with, comprehended and responded to the leaflet. Semi-structured, 'think aloud' interviews were conducted remotely with 40 UK screening-naïve current and former smokers (aged 55-73). The verbatim transcripts were analysed thematically using a coding framework based on the Dual Process Theory of cognition. RESULTS: The leaflet helped participants understand the principles and procedures of screening and fostered cautiously favourable intentions. Three themes captured the main results of the data analysis: (1) Response-participants experienced anxiety about screening results and further investigations, but the involvement of specialist healthcare professionals was reassuring; (2) Engagement-participants were rapidly drawn to information about lung cancer prevalence, and benefits of screening, but deliberated slowly about early diagnosis, risks of screening and less familiar symptoms of lung cancer; (3) Comprehension-participants understood the main principles of the TLHC programme, but some were confused by its rationale and eligibility criteria. Radiation risks, abnormal screening results and numerical probabilities of screening outcomes were hard to understand. CONCLUSION: The TLHC information leaflet appeared to be acceptable to the target population. There is scope to improve aspects of comprehension and engagement in ways that would support informed choice as a distributed process in lung cancer screening. PATIENT OR PUBLIC CONTRIBUTION: The insight and perspectives of patient representatives directly informed and improved the design and conduct of this study.

Attitudes towards the integration of smoking cessation into lung cancer screening in the United Kingdom: A qualitative study of individuals eligible to attend.

INTRODUCTION: There is limited research exploring how smoking cessation treatment should be implemented into lung cancer screening in the United Kingdom. This study aimed to understand attitudes and preferences regarding the integration of smoking cessation support within lung cancer screening from the perspective of those eligible. METHODS: Thirty-one lung cancer screening eligible individuals aged 55-80 years with current or former smoking histories were recruited using community outreach and social media. Two focus groups (three participants each) and 25 individual telephone interviews were conducted. Data were analysed using the framework approach to thematic analysis. RESULTS: Three themes were generated: (1) bringing lung cancer closer to home, where screening was viewed as providing an opportunity to motivate smoking cessation, depending on perceived personal risk and screening result; (2) a sensitive approach to cessation with the uptake of cessation support considered to be largely dependent on screening practitioners' communication style and expectations of stigma and (3) creating an equitable service that focuses on ease of access as a key determinant of uptake, where integrating cessation within the screening appointment may sustain increased quit motivation and prevent loss to follow-up. CONCLUSIONS: The integration of smoking cessation into lung cancer screening was viewed positively by those eligible to attend. Screening appointments providing personalized lung health information may increase cessation motivation. Services should proactively support participants with possible fatalistic views regarding risk and decreased cessation motivation upon receiving a good screening result. To increase engagement in cessation, services need to be person-centred. PATIENT OR PUBLIC CONTRIBUTION: This study has included patient and public involvement throughout, including input regarding study design, research materials, recruitment strategies and research summaries.

Ninety-day mortality following lung cancer surgery: outcomes from the English national clinical outcomes audit.

Accurately explaining perioperative mortality and risk to patients is an essential part of shared decision making. In the case of lung cancer surgery, the currently available multivariable mortality prediction tools perform poorly, and could mislead patients. Using data from 2004 to 2012, this group has previously produced data tables for 90-day postoperative mortality, to be used as a communication aid in the consenting process. Using National Lung Cancer Clinical Outcomes audit data from 2017 to 2018, we have produced updated early mortality tables, to reflect current thoracic surgery practice.

What medical students think about measurement of their well-being: cross-sectional survey and qualitative interviews.

OBJECTIVES: To find out how medical students think well-being should be measured. DESIGN: A mixed-methods study comprising a cross-sectional online survey (November 2020-March 2021) and semi-structured online interviews. Views on the frequency of availability for measurement, the format, type and purpose of measurement, and with whom well-being should be discussed were measured. When an outcome was scored 7-9 on a 9-point Likert scale of agreement by ≥75% of participants it was considered critical. Inductive thematic analysis was undertaken on the interview transcripts. SETTING: All medicine programmes at University of Southampton. PARTICIPANTS: Medical students from all years took part in the survey (n=118) and interviews (n=16). RESULTS: Most participants (94%) felt able to give 5 min to measure their well-being at least once per month. Research, governance and individual feedback were all considered critically important. Only subjective assessments undertaken by the individual in real-time were rated critically important (78.1%) measurement tools. Students selected that they would discuss their well-being with other medical students (n=87) nearly as often as they selected a member of the faculty (n=104). Five interview themes further explained these findings: (1) well-being is mental well-being; (2) exercise and support from friends and family are most important; (3) isolation and the design of the medicine programme are detrimental to well-being; (4) there are advantages to surveys, and conversations; (5) personal academic tutors and medical students in later years are the best to discuss well-being with. CONCLUSIONS: Medical students thought that measurement of their well-being was critically important for governance showing their support for quality assurance of well-being and peer support. They wanted to be able to choose surveys, or conversations, to measure their well-being, as well as the person they discussed well-being with. Four recommendations are discussed in light of these findings.

Investigating Transcranial Direct Current Stimulation (TDCS) in obsessive compulsive disorder (OCD): a double-blind, sham-controlled, cross-over randomised trial

Aims Obsessive Compulsive Disorder is a disabling and difficult-to-treat condition, new treatment options are needed to improve health outcomes. Transcranial Direct Current Stimulation, a non-invasive form of neurostimulation, has shown positive results in a small number of studies as a safe and potentially efficacious treatment for OCD. There nevertheless remains uncertainty about the optimal stimulation protocol, magnitude and duration of effect, acceptability, tolerability and practicality of applying tDCS clinical settings. As existing data are inadequate to support a full-scale trial, we will deliver a feasibility study to address key research questions and knowledge gaps to enable the design and the development of the most efficient, cost effective, definitive trial. Method We designed Feasibility And Acceptability Of Transcranial Stimulation In Obsessive Compulsive Symptoms (FEATSOCS), a double-blind, sham-controlled, cross-over randomised multicentre study in 25 adults with OCD. We will stimulate the two most promising cortical sites, the orbitofrontal cortex (OFC) and the supplementary motor area (SMA). Each participant will receive three courses of tDCS (SMA, OFC and sham), randomly allocated, given in counterbalanced order. Each course comprises four 20 minutes-stimulations, delivered over two consecutive days, separated by at least four weeks’ washout period. Blinded raters will regularly assess clinical outcomes before, during and up to four weeks after stimulation using validated scales. We will include relevant neurocognitive tasks, testing cognitive flexibility, motor disinhibition, cooperation and habit learning. Result FEATSOCS trial is currently underway and recruiting. Owing to the impact of COVID-19, a recruitment extension has been granted. At the study end, we will analyse the feasibility outcomes, magnitude of the effect of the interventions on OCD symptoms alongside the standard deviation of the outcome measure to estimate effect size, and determine the optimal stimulation target. We will also measure the duration of the effect of stimulation, to provide information on spacing treatments efficiently. We will evaluate the usefulness and limitations of specific neurocognitive tests to determine a definitive test battery. Qualitative data will be collected from participants to better understand their experience of taking part in a tDCS intervention, the impact on their overall quality of life and their views on the potential of tDCS as home based-intervention. Conclusion Further evidence is needed to establish whether tDCS could join the treatment armamentarium of OCD. The clinical outcomes in FEATSOCS will enable to further refine the methodology to ensure optimal efficiency in terms of both delivering and assessing the tDCS in OCD in a full scale trial. The funder for this study is the National Institute for Health Research Programme, Research for Patient Benefit (RfPB) [Ref. no PB-PG-1216-20005]. Extra funding to allow study extension was provided by Orchard OCD. This study has received full ethics committee approval and protocol amendments approval form the Cambridge and Hertfordshire NHS Research Ethics Committee, IRAS Project ID 254507, REC ref: 19/EE/0046.

Obsessive-compulsive symptoms and the Covid-19 pandemic: A rapid scoping review.

BACKGROUND: There has been much speculation about untoward effects of the Covid-19 pandemic on psychological symptoms. OCD may be expected to be especially impacted. Our aim was to distil the current evidence base on relationships between the pandemic and obsessive-compulsive symptoms, in patients, and general population samples. METHODS: We conducted a rapid scoping review, in the form of a systematic literature search, coupled with narrative review. 32 relevant papers were identified. RESULTS AND INTERPRETATION: (1) A sizable proportion of people with OCD (but not all) experienced/reported symptom worsening during the pandemic, especially during initial restrictions (approximately 20-65 % of cases in longitudinal studies); (2) contamination/washing symptoms appeared particularly susceptible; and (3) OCD symptoms in general population samples were associated with trait compulsivity and pandemic-related-stress. The literature was heterogeneous with various methodological issues being commonplace. FUTURE DIRECTIONS: The review identified important unaddressed issues: how should exposure based therapy be adapted during pandemics? How can we minimise harm from exacerbation of OCD in vulnerable individuals arising from public health messaging? Why do some but not all OCD patients experience worsening? And does Covid-19 infection affect (or lead to) OCD symptoms?

A critical review of the definition of 'wellbeing' for doctors and their patients in a post Covid-19 era.

BACKGROUND: There is no international consensus definition of 'wellbeing'. This has led to wellbeing being captured in many different ways. AIMS: To construct an inclusive, global operational definition of wellbeing. METHODS: The differences between wellbeing components and determinants and the terms used interchangeably with wellbeing, such as health, are considered from the perspective of a doctor. The philosophies underpinning wellbeing and modern wellbeing research theories are discussed in terms of their appropriateness in an inclusive definition. RESULTS: An operational definition is proposed that is not limited to doctors, but universal, and inclusive: 'Wellbeing is a state of positive feelings and meeting full potential in the world. It can be measured subjectively and objectively, using a salutogenic approach'. CONCLUSIONS: This operational definition allows the differentiation of wellbeing from terms such as quality of life and emphasises that in the face of global challenges people should still consider wellbeing as more than the absence of pathology.

Changes in daily mental health service use and mortality at the commencement and lifting of COVID-19 'lockdown' policy in 10 UK sites: a regression discontinuity in time design.

OBJECTIVES: To investigate changes in daily mental health (MH) service use and mortality in response to the introduction and the lifting of the COVID-19 'lockdown' policy in Spring 2020. DESIGN: A regression discontinuity in time (RDiT) analysis of daily service-level activity. SETTING AND PARTICIPANTS: Mental healthcare data were extracted from 10 UK providers. OUTCOME MEASURES: Daily (weekly for one site) deaths from all causes, referrals and discharges, inpatient care (admissions, discharges, caseloads) and community services (face-to-face (f2f)/non-f2f contacts, caseloads): Adult, older adult and child/adolescent mental health; early intervention in psychosis; home treatment teams and liaison/Accident and Emergency (A&E). Data were extracted from 1 Jan 2019 to 31 May 2020 for all sites, supplemented to 31 July 2020 for four sites. Changes around the commencement and lifting of COVID-19 'lockdown' policy (23 March and 10 May, respectively) were estimated using a RDiT design with a difference-in-difference approach generating incidence rate ratios (IRRs), meta-analysed across sites. RESULTS: Pooled estimates for the lockdown transition showed increased daily deaths (IRR 2.31, 95% CI 1.86 to 2.87), reduced referrals (IRR 0.62, 95% CI 0.55 to 0.70) and reduced inpatient admissions (IRR 0.75, 95% CI 0.67 to 0.83) and caseloads (IRR 0.85, 95% CI 0.79 to 0.91) compared with the pre lockdown period. All community services saw shifts from f2f to non-f2f contacts, but varied in caseload changes. Lift of lockdown was associated with reduced deaths (IRR 0.42, 95% CI 0.27 to 0.66), increased referrals (IRR 1.36, 95% CI 1.15 to 1.60) and increased inpatient admissions (IRR 1.21, 95% CI 1.04 to 1.42) and caseloads (IRR 1.06, 95% CI 1.00 to 1.12) compared with the lockdown period. Site-wide activity, inpatient care and community services did not return to pre lockdown levels after lift of lockdown, while number of deaths did. Between-site heterogeneity most often indicated variation in size rather than direction of effect. CONCLUSIONS: MH service delivery underwent sizeable changes during the first national lockdown, with as-yet unknown and unevaluated consequences.

The roles of a psychiatrist in the COVID-19 pandemic

The COVID-19 pandemic and its restrictions have strained personal psychological resilience, tested family relationships, fragmented local communities, disrupted schools and other educational institutions, exhausted health and social services, and drained national economies. Initial concerns necessarily focused on the ability of primary care services and general hospitals to cope with a potentially overwhelming wave of physically unwell patients. Attention is now being drawn to adverse effects of the pandemic on individual and societal mental health. Mental health services have important roles in mitigating adverse effects of the pandemic and measures such as enforced isolation and regional lockdown on individual mental health, in supporting the recovery of psychologically affected individuals and an exhausted health workforce, and in fostering community resilience and cohesiveness.