Mental health conditions and COVID-19 vaccine outcomes: A scoping review.

OBJECTIVE: Research shows that people with a history of mental health conditions were at increased risk of COVID-19 infection, hospitalisation, and mortality. However, the relationship between mental health conditions and COVID-19 vaccine outcomes such as vaccine intention, uptake and vaccine breakthrough is not yet well-understood. METHODS: We conducted a systematic search on the topics of COVID-19 vaccine intentions, vaccine uptake, and vaccine breakthrough, in relation to mental health conditions (e.g., depression, schizophrenia), in four databases: PubMed, MEDLINE, SCOPUS, and PsychINFO, and the publication lists of Clinical Practice Research Datalink (CPRD), The Health Improvement Network (THIN), OpenSAFELY, and QResearch. Inclusion criteria focussed on studies reporting any of the aforementioned COVID-19 vaccine outcomes among people with mental health conditions. RESULTS: Of 251 publications initially identified, 32 met our inclusion criteria. Overall, the evidence is inconclusive regarding the levels of intention to accept COVID-19 vaccines among people with mental health conditions. People with mental health conditions were more likely to have lower uptake of COVID-19 vaccines, compared to people without. Common barriers to COVID-19 vaccine uptake included concerns about the safety, effectiveness, and side effects of the vaccines. Limited evidence also suggests that vaccine breakthrough may be a particular risk for those with substance use disorder. CONCLUSIONS: Evidence for the association between COVID-19 vaccine intentions and mental health conditions is mixed. Vaccine uptake might be lower in people with mental health conditions compared to people without, yielding interventions to encourage vaccine uptake in this population. Our understanding of COVID-19 vaccine breakthrough in this population also needs enhancing.

Fatigue during the COVID-19 pandemic - prevalence and predictors: findings from a prospective cohort study.

The COVID-19 pandemic and consequent lockdowns had a substantial impact on mental health. Distress and fatigue are highly correlated. However, little is known about the determinants of fatigue in the general population during the pandemic. This study aimed to examine the prevalence and predictors of fatigue during the COVID-19 pandemic in the UK population. Online surveys were completed by a UK community cohort in April 2020 (wave 1), July-September 2020 (wave 2) and November-December 2020 (wave 3). In total, 3097 participants completed the wave 1 survey, and 1385 and 1087 participants (85.4% women) completed wave 2 and 3 surveys respectively. Fatigue was assessed using the Chalder Fatigue Scale at waves 2 and 3. Hair samples were provided by 827 participants (90.6% women) at wave 1 and wave 2, which were analyzed to indicate HairE (stress hormone). The mean total fatigue score during wave 2 was 14.7 (SD = 4.7), significantly higher than pre-pandemic levels observed in the community (mean difference 0.50, p = .003). At wave 2, 614 (44.3%) participants met the case definition for fatigue, only 15.6% of whom indicated that fatigue lasted for more than 6 months (suggesting it had started prior to the pandemic). Predictors of fatigue at wave 3 included being in a risk group, depression and belief in having COVID-19, which explained 23.8% of the variability in fatigue scores. Depression at wave 1 was the only significant predictor of remaining a fatigue case at wave 3. Fatigue was highly prevalent in the UK community during the COVID-19 pandemic and limited people's daily function. Depression and sociodemographic variables were significant predictors of fatigue.

Fatigue levels between July-December 2020 were higher compared to pre-pandemic levels.Predictors of fatigue levels 7-8 months later included being a clinical risk group, depression and belief in having had COVID-19.HairE was not associated with fatigue.Depression was the only significant predictor of remaining a fatigue case.

Smoking, nicotine and pregnancy 2 (SNAP2) trial: protocol for a randomised controlled trial of an intervention to improve adherence to nicotine replacement therapy during pregnancy.

INTRODUCTION: Smoking during pregnancy is harmful to unborn babies, infants and women. Nicotine replacement therapy (NRT) is offered as the usual stop-smoking support in the UK. However, this is often used in insufficient doses, intermittently or for too short a time to be effective. This randomised controlled trial (RCT) explores whether a bespoke intervention, delivered in pregnancy, improves adherence to NRT and is effective and cost-effective for promoting smoking cessation. METHODS AND ANALYSIS: A two-arm parallel-group RCT was conducted for pregnant women aged ≥16 years and who smoke ≥1 daily cigarette (pre-pregnancy smoked ≥5) and who agree to use NRT in an attempt to quit. Recruitment is from antenatal care settings and via social media adverts. Participants are randomised using blocked randomisation with varying block sizes, stratified by gestational age (<14 or ≥14 weeks) to receive: (1) usual care (UC) for stop smoking support or (2) UC plus an intervention to increase adherence to NRT, called 'Baby, Me and NRT' (BMN), comprising adherence counselling, automated tailored text messages, a leaflet and website. The primary outcome is biochemically validated smoking abstinence at or around childbirth, measured from 36 weeks gestation. Secondary outcomes include NRT adherence, other smoking measures and birth outcomes. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 16% in the control and intervention groups, respectively (risk ratio=1.6). By recruiting 1320 participants, the trial should have 90% power (alpha=5%) to detect this intervention effect. An economic analysis will use the Economics of Smoking in Pregnancy model to determine cost-effectiveness. ETHICS AND DISSEMINATION: Ethics approval was granted by Bloomsbury National Health Service's Research Ethics Committee (21/LO/0123). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice/policy representatives, researchers and participants. TRIAL REGISTRATION NUMBER: ISRCTN16830506. PROTOCOL VERSION: 5.0, 10 Oct 2023.

Patient and health professional views on risk-stratified monitoring of immune-suppressing treatment in adults with inflammatory diseases.

OBJECTIVE: To explore the acceptability of an individualised risk-stratified approach to monitoring for target-organ toxicity in adult patients with immune-mediated inflammatory diseases established on immune-suppressing treatment(s). METHODS: Adults (≥18 years) taking immune-suppressing treatment(s) for at-least six months, and healthcare professionals (HCPs) with experience of either prescribing and/or monitoring immune-suppressing drugs were invited to participate in a single, remote, one-to-one, semi-structured interview. Interviews were conducted by a trained qualitative researcher and explored their views and experiences of current monitoring and acceptability of a proposed risk-stratified monitoring plan. Interviews were transcribed verbatim and inductively analysed using thematic analysis in NVivo. RESULTS: Eighteen patients and 13 HCPs were interviewed. While participants found monitoring of immune-suppressing drugs with frequent blood-tests reassuring, the current frequency of these was considered burdensome by patients and HCPs alike, and to be a superfluous use of healthcare resources. Given abnormalities rarely arose during long-term treatment, most felt that monitoring blood-tests were not needed as often. Patients and HCPs found it acceptable to increase the interval between monitoring blood-tests from three-monthly to six-monthly or annually depending on the patients' risk profiles. Conditions of accepting such a change included: allowing for clinician and patient autonomy in determining an individuals' frequency of monitoring blood-tests, the flexibility to change monitoring frequency if someone's risk profile changed, and endorsement from specialist societies and healthcare providers such as the National Health Service. CONCLUSION: A risk-stratified approach to monitoring was acceptable to patients and HCPs. Guideline groups should consider these findings when recommending blood-test monitoring intervals.

Changes in hair cortisol in a New Zealand community sample during the Covid-19 pandemic.

Background: Evidence suggests that countries with higher Covid-19 infection rates experienced poorer mental health. This study examined whether hair cortisol reduced over time in New Zealand, a country that managed to eliminate the virus in the first year of the pandemic due to an initial strict lockdown. Methods: A longitudinal cohort study assessed self-reported stress, anxiety and depression and collected hair samples that were analyzed for cortisol, across two waves in 2020. The sample consisted of 44 adults who each returned two 3 cm hair samples and completed self-reports. Hair cortisol was assessed per centimetre. Results: Hair cortisol reduced over time (F (5, 99.126) = 10.15, p < .001, partial eta squared = 0.19), as did anxiety and depression. Higher hair cortisol was significantly associated with more negative life events reported at wave two (r = 0.30 segment 1, r = 0.34 segment 2, p < .05), but not anxiety or depression. Conclusions: Strict virus control measures may not only reduce infection rates, but also reduce psychological distress, and hair cortisol over time.

Motivation communication training programme for healthcare professionals to support adherence in patients with diabetic foot ulcers: Proof of concept study.

Patients with diabetic foot ulcers have poor adherence to treatment recommendations. However, the most effective way to support adherence in this population is unknown. This study aimed to assess the preliminary effectiveness of a motivation communication training programme for healthcare professionals working with these patients, using theory and evidence-based strategies.A proof-of-concept study using a non-randomised, controlled before-and-after design. Six podiatrists took part in the motivation communication training programme. Pre-training, observation was undertaken to examine the communication style currently used by podiatrists in routine consultations. Patients' (n = 25) perceptions of podiatrist autonomy support, self-determination for limiting weight-bearing activity and average daily step count were also assessed. Post training, observations and patient measures were repeated with a different group of patients (n = 24). Observations indicated that podiatrists exhibited a more need-supportive communication style (e.g., taking time to understand patients' perspectives) after undergoing the training programme. Patients in the post-training group reported higher levels of autonomy support, while self-determination to limit weight-bearing activity remained unchanged. Although the post-training group had a lower average daily step count, the difference was not statistically significant. This is the first study to investigate implementation of motivation communication strategies in routine consultations with patients with diabetic foot ulcers. Results suggest that training can enhance healthcare professionals' motivation communication skills with potential for addressing adherence issues, however, a larger cluster randomised controlled trial is necessary to confirm this.

Optimizing mood prior to influenza vaccination in older adults: A three-arm randomized controlled trial.

OBJECTIVE: This trial explored the psychological and immunological effects of two brief interventions, targeting improving positive mood, administered to older adults immediately prior to influenza vaccination. The primary aim was to examine whether the interventions resulted in greater positive mood compared to usual care, and if so, which was superior. Secondary outcomes included antibody responses to vaccination and feasibility of collecting clinical outcome data (e.g., respiratory infections). METHOD: Six hundred and fifty-four older adults (65-85 years) participated in a three-arm, parallel, randomized controlled trial between September 2019 and May 2020. Immediately prior to receiving an adjuvanted trivalent influenza vaccine (Fluad, Seqirus UK Ltd), participants viewed one of two brief (15-min) video-based positive mood interventions (one fixed content, one allowing participant choice) or received usual care. State affect was measured immediately prior to, and following, intervention exposure or usual care. Antibody responses were measured prevaccination and 4 weeks postvaccination. Clinical outcomes were extracted from primary care records for 6 months following vaccination. RESULTS: Both interventions were equally effective at improving mood prior to vaccination compared to usual care. Antibody responses were highly robust with postvaccination seroprotection rates of > 88% observed for all vaccine strains. Antibody responses did not significantly differ between groups. Clinical outcome data were feasible to collect. CONCLUSIONS: Brief psychological interventions can improve mood prior to vaccination. However, altering antibody responses to highly immunogenic adjuvanted vaccines may require more targeted or prolonged interventions. The provision of choice did not notably enhance the interventions impact on mood or antibody outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Development of a Motivation Communication Training to Aid Diabetes-Specialist Podiatrists With Adherence Discussions.

Diabetic foot ulcers (DFUs) impact a substantial proportion of patients with diabetes, with high recurrence rates, severe complications, and significant financial burden to health care systems. Adherence to treatment advice (e.g., limiting weight-bearing activity) is low with patients reporting dissatisfaction with the way in which advice is communicated. This study aimed to address this problem via the systematic development of a motivation communication training program. The program was designed to support diabetes-specialist podiatrists in empowering patients to actively engage with treatment. The development process followed an intervention mapping approach. Needs assessment involved observations of 24 patient-practitioner consultations within a diabetes-specialist foot clinic. This informed specification of a theory of change (self-determination theory) and relevant evidence-based communication strategies (drawing from motivational interviewing). The training program was developed iteratively with changes made following feedback from five diabetic foot health care professionals. The resulting training program, consisting of six one-hour face-to-face sessions over an 8-week period, was delivered to a further six diabetes specialist podiatrists, with five participating in postprogram telephone interviews to assess acceptability. Deductive thematic analysis of interview data revealed positive aspects of the training (e.g., valuable and relevant content), ideas for improvement (e.g., online resources and context-specific video examples), the acceptability of motivation strategies, and challenges putting the strategies into practice (such as time constraints and breaking old communication habits). This study contributes to our understanding of integrating motivation principles into routine consultations and holds potential for enhancing adherence to treatment recommendations in patients living with diabetic foot ulcers.

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial.

OBJECTIVE: To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. DESIGN: Randomised controlled trial. SETTING: Participants' homes and communities at five sites in the United Kingdom. PARTICIPANTS: 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. INTERVENTION: The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia. Up to 50 therapy sessions were provided over 12 months. The control group received usual care plus a falls risk assessment. Procedures were adapted during the covid-19 pandemic. MAIN OUTCOME MEASURES: The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation. Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15. RESULTS: 365 patient participants were randomised, 183 to intervention and 182 to control. The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men. Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week. Primary outcome data were available for 149 intervention and 141 control participants. Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference -1.3, 95% confidence interval -5.2 to 2.6; Cohen's d effect size -0.06, 95% confidence interval -0.26 to 0.15; P=0.51). Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures. Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3). CONCLUSION: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake. Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15320670.

The facilitators and barriers to improving functional activity and wellbeing in people with dementia: a qualitative study from the process evaluation of Promoting Activity, Independence and Stability in Early Dementia (PrAISED).

BACKGROUND: The PRomoting Activity, Independence and Stability in Early Dementia (PrAISED) study delivered an exercise and functional activity programme to participants living with dementia. A Randomised Controlled Trial showed no measurable benefits in activities of daily living, physical activity or quality of life. OBJECTIVE: To explore participants' responses to PrAISED and explain why an intervention that might be expected to have produced measurable health gains did not do so. METHODS: A process evaluation using qualitative methods, comprising interviews and researcher notes. SETTING: Data were collected in participants' homes or remotely by telephone or videoconferencing. SAMPLE: A total of 88 interviews were conducted with 44 participants living with dementia (n = 32 intervention group; n = 12 control group) and 39 caregivers. A total of 69 interviews were conducted with 26 therapists. RESULTS: Participants valued the intervention as proactively addressing health issues that were of concern to them, and as a source of social contact, interaction, information and advice. Facilitators to achieving positive outcomes included perceiving progress towards desired goals, positive expectations, therapists' skills and rapport with participants, and caregiver support. Barriers included: cognitive impairment, which prevented independent engagement and carry-over between sessions; chronic physical health problems and intercurrent acute illness and injury; 'tapering' (progressively infrequent supervision intended to help develop habits and independent activity); and the COVID-19 pandemic. CONCLUSIONS: Self-directed interventions may not be appropriate in the context of dementia, even in the mild stages of the condition. Dementia-specific factors affected outcomes including caregiver support, rapport with therapists, availability of supervision, motivational factors and the limitations of remote delivery. The effects of cognitive impairment, multimorbidity and frailty overwhelmed any positive impact of the intervention. Maintenance of functional ability is valued, but in the face of inevitable progression of disease, other less tangible outcomes become important, challenging how we frame 'health gain' and trial outcomes.

Influence of setting-dependent contacts and protective behaviours on asymptomatic SARS-CoV-2 infection amongst members of a UK university.

We survey 62 users of a university asymptomatic SARS-CoV-2 testing service on details of their activities, protective behaviours and contacts in the 7 days prior to receiving a positive or negative SARS-CoV-2 PCR test result in the period October 2020-March 2021. The resulting data set is novel in capturing very detailed social contact history linked to asymptomatic disease status during a period of significant restriction on social activities. We use this data to explore 3 questions: (i) Did participation in university activities enhance infection risk? (ii) How do contact definitions rank in their ability to explain test outcome during periods of social restrictions? (iii) Do patterns in the protective behaviours help explain discrepancies between the explanatory performance of different contact measures? We classify activities into settings and use Bayesian logistic regression to model test outcome, computing posterior model probabilities to compare the performance of models adopting different contact definitions. Associations between protective behaviours, participant characteristics and setting are explored at the level of individual activities using multiple correspondence analysis (MCA). We find that participation in air travel or non-university work activities was associated with a positive asymptomatic SARS-CoV-2 PCR test, in contrast to participation in research and teaching settings. Intriguingly, logistic regression models with binary measures of contact in a setting performed better than more traditional contact numbers or person contact hours (PCH). The MCA indicates that patterns of protective behaviours vary between setting, in a manner which may help explain the preference for any participation as a contact measure. We conclude that linked PCR testing and social contact data can in principle be used to test the utility of contact definitions, and the investigation of contact definitions in larger linked studies is warranted to ensure contact data can capture environmental and social factors influencing transmission risk.

Adherence to limiting weight-bearing activity in patients with diabetic foot ulcers: A qualitative study.

Patients with diabetic foot ulcers are advised to limit weight-bearing activity for ulcers to heal. Patients often disregard this advice although the reasons are not yet fully understood. This study explored (1) patients' experiences of receiving the advice and (2) factors influencing adherence to the advice. Semi-structured interviews were conducted with 14 patients with diabetic foot ulcers. Interviews were transcribed and analysed using inductive thematic analysis. Advice regarding limiting weight-bearing activity was described by patients as directive, generic and conflicting with other priorities. Rapport, empathy and rationale supported receptivity to the advice. Barriers and facilitators to limiting weight-bearing activity included demands of daily living, enjoyment of exercise, sick/disabled identity and burden, depression, neuropathy/pain, health benefits, fear of negative consequences, positive feedback, practical support, weather and active/passive role in recovery. It is important that healthcare professionals pay attention to how limiting weight-bearing activity advice is communicated. We propose a more person-centred approach in which advice is tailored to individuals' specific needs with discussion around patient priorities and constraints.

Assessing and investigating children with suspected bone and abdominal tumours: an e-Delphi consensus process.

BACKGROUND: The incidence of childhood cancer has risen by 15% since the 1990s. Early diagnosis is key to optimising outcomes, however diagnostic delays are widely reported. Presenting symptoms are often non-specific causing a diagnostic dilemma for clinicians. This Delphi consensus process was conducted to develop a new clinical guideline for children and young people presenting with signs/symptoms suggestive of a bone or abdominal tumour. METHODS: Invitation emails were sent to primary and secondary healthcare professionals to join the Delphi panel. 65 statements were derived from evidence review by a multidisciplinary team. Participants were asked to rank their level of agreement with each statement on a 9-point Likert scale (1=strongly disagree, 9=strongly agree), with responses ≥7 taken to indicate agreement. Statements not reaching consensus were rewritten and reissued in a subsequent round. RESULTS: All statements achieved consensus after two rounds. 96/133 (72%) participants responded to round 1 (R1) and 69/96 (72%) completed round 2 (R2). 62/65 (94%) statements achieved consensus in R1 with 29/65 (47%) gaining more than 90% consensus. Three statements did not reach consensus scoring between 61% and 69%. All reached numerical consensus at the end of R2. Strong consensus was reached on best practice of conducting the consultation, acknowledging parental instinct and obtaining telephone advice from a paediatrician to decide the timing and place of review, rather than adult cancer urgent referral pathways. Dissensus in statements was due to unachievable targets within primary care and valid concerns over a potential overinvestigation of abdominal pain. CONCLUSIONS: This consensus process has consolidated statements that will be included in a new clinical guideline for suspected bone and abdominal tumours for use in both primary and secondary care. This evidence base will be translated into awareness tools for the public as part of the Child Cancer Smart national awareness campaign.

Wound healing and healing process in patients with diabetic foot ulcers: A survival analysis study.

AIMS: This study aimed to identify demographic, clinical, and psychological contributors to DFU healing and favorable healing process. METHODS: Patients with a chronic DFU were evaluated at baseline (T0; n = 153), two months later (T1; n = 108), and six months later (T2; n = 71). Patients were evaluated on health literacy, perceived stress, anxiety, depression, and illness perceptions. Cox proportional hazard models were built to analyze the predictors of DFU healing and favorable healing process (wound area reduction), including the assessment of time to achieve those outcomes. RESULTS: More than half of patients had their DFU healed (56.1%) or showed a favorable healing process (83.6%). Median time for healing was 112 days, while for favorable process was 30 days. Illness perceptions were the only predictor of wound healing. Being female , with adequate health literacy, and a first DFU predicted a favorable healing process. CONCLUSIONS: This is the first study showing that beliefs about DFU are significant predictors of DFU healing, and that health literacy is a significant predictor of a favorable healing process. Brief, comprehensive interventions should be implemented, at the treatment initial stage, in order to change misperceptions and to promote DFU literacy and better health outcomes.

Psychology Meets Biology in COVID-19: What We Know and Why It Matters for Public Health.

Psychosocial factors are related to immune, viral, and vaccination outcomes. Yet, this knowledge has been poorly represented in public health initiatives during the COVID-19 pandemic. This review provides an overview of biopsychosocial links relevant to COVID-19 outcomes by describing seminal evidence about these associations known prepandemic as well as contemporary research conducted during the pandemic. This focuses on the negative impact of the pandemic on psychosocial health and how this in turn has likely consequences for critically relevant viral and vaccination outcomes. We end by looking forward, highlighting the potential of psychosocial interventions that could be leveraged to support all people in navigating a postpandemic world and how a biopsychosocial approach to health could be incorporated into public health responses to future pandemics.

How people with knee pain understand why their pain changes or remains the same over time: A qualitative study.

Objectives: Guidelines recommend knee osteoarthritis pain management based on biopsychosocial mechanisms. Treatment adherence and effectiveness may be affected if there is a mismatch between patient perspectives and treatment focus. We therefore examined patient perspectives on mechanisms of their knee pain, why it persisted or changed over the past year, whether their understanding had changed, and whether their understanding aligned with that of others with whom they interact. Methods: Individuals with chronic knee pain (n â€‹= â€‹50) were purposively recruited from the Knee Pain and related health In the Community (KPIC) cohort to represent worsened, improved, or unchanged pain or anxiety between baseline and one year later. Framework analysis, a comparative form of thematic analysis, was used across transcripts of semi-structured telephone interviews. Results: Data were collapsed into themes of diagnosis, joint structure, ageing, physical activity, weight management, and treatment. Participants focused on biomechanical rather than psychological pain mechanisms. Some participants attributed pain improvement to increased and others to decreased physical activity. Participants reported no change in their understanding of their pain during the preceding year, but that their attitudes to pain, for example acceptance, had changed. Participants reported that they and others around them lacked understanding of their pain and why it did or did not change. Conclusion: People report a predominantly biomechanical understanding of why their knee pain remains constant or changes over time. Clinicians should support patients to develop a biopsychosocial understanding of knee pain aligned to treatment across the range of biological, psychological, and social modalities.

Increases in stress hormone levels in a UK population during the COVID-19 pandemic: A prospective cohort study.

BACKGROUND: Research suggests that psychological factors may influence vulnerability to SARS-CoV-2 infection, although the mechanisms are unclear. PURPOSE: We examined whether the hypothalamic-pituitary-adrenal axis may be a possible mechanism, by measuring the relationship between indices of psychological distress and cortisone in hair (hairE) in a UK cohort during the COVID-19 pandemic. METHODS: Participants (N = 827) provided two 3 cm hair samples over a 6-month period between April-September 2020. Samples reflected hairE in the 3 months prior to the collection date. RESULTS: HairE in the first samples (T1: commenced April 2020) did not differ significantly from pre-pandemic population norms. However, hairE in the second samples (T2: commenced July 2020) were significantly higher than T1 and pre-pandemic population norms, with a 23% increase between T1 and T2. Linear regressions, controlling for age and gender, demonstrated that at both timepoints, hairE levels were greatest in people with a history of mental health difficulties. In addition, stress reported at T1 predicted greater hairE at T2 and a greater change in hairE between T1 and T2. CONCLUSIONS: These findings demonstrate that during the COVID-19 pandemic hairE was substantially elevated across a large community cohort, with greatest levels in those with a history of mental health difficulties and greatest changes in those reporting greatest levels of stress early in the pandemic. Further research is required with verified SARS-CoV-2 outcomes to determine whether the HPA axis is among the mechanisms by which a history of mental health difficulties and stress influence SARS-CoV-2 outcomes.

Humoral and cellular immunity in patients with rare autoimmune rheumatic diseases following SARS-CoV-2 vaccination.

OBJECTIVES: Coronavirus 2019 vaccine responses in rare autoimmune rheumatic diseases (RAIRDs) remain poorly understood; in particular there is little known about whether people develop effective T cell responses. We conducted an observational study to evaluate the short-term humoral and cell-mediated T cell response after the second severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in RAIRD patients compared with healthy controls (HCs). METHODS: Blood samples were collected after the second dose and anti-spike, anti-nucleocapsid antibody levels and SARS-CoV-2-specific T cell responses were measured and compared with those of HCs. Activation-induced marker and deep phenotyping assays were used to identify differences in T cells between high and no/low antibody groups, followed by multidimensional clustering. RESULTS: A total of 50 patients with RAIRDs were included (31 with AAV, 4 with other systemic vasculitis, 9 with SLE and 6 with myositis). The median anti-spike levels were significantly lower in RAIRD patients compared with HCs (P < 0.0001). Fifteen (33%) patients had undetectable levels and 26 (57%) had levels lower than the lowest HC. Rituximab in the last 12 months (P = 0.003) was associated with reduced immunogenicity compared with a longer pre-vaccination period. There was a significant difference in B cell percentages (P = 0.03) and spike-specific CD4+ T cells (P = 0.02) between no/low antibody vs high antibody groups. Patients in the no/low antibody group had a higher percentage of terminally differentiated (exhausted) T cells. CONCLUSIONS: Following two doses, most RAIRD patients have lower antibody levels than the lowest HC and lower anti-spike T cells. RAIRD patients with no/low antibodies have diminished numbers and poor quality of memory T cells that lack proliferative and functional capacities.

Development of a resource-use measure to capture costs of diabetic foot ulcers to the United Kingdom National Health Service, patients and society.

Background: Diabetic foot ulcers (DFUs) add a significant burden to the lives of people with diabetes in the United Kingdom. They can have a considerable impact on a patient's daily life, with treatment requiring frequent changes of dressings and clinic attendances. Nurses and other allied health professionals (AHPs) within the community provide most wound care representing the primary cost driver. Aims: To collaboratively explore key resource use related to the management of DFUs to develop, and pilot, a participant-reported measure to inform economic evaluations. Methods: A literature search and semi-structured interviews determined health and non-health resource use in management of DFUs. A consensus view of the selected items was established in a modified Delphi study and further tested for acceptability and validity in a pilot study. Results: Primary care consultations with a podiatrist or orthotist, district nurse visits, out-of-hours and emergency care, scans and investigations, and consumables provided in clinics were rated as the most important resource use items. Conclusions: This work has informed the development of a measure that captures resource use considered important by the people most affected by DFUs; patients, family members and carers, and the healthcare professionals key to DFU management.