‘Self-Management Intervention through Lifestyle Education for Kidney health’ (the SMILE-K study): protocol for a single-blind longitudinal randomised control trial with nested pilot study (preprint)

ABSTRACT Introduction Many people living with chronic kidney disease (CKD) are expected to self-manage their condition. Patient activation is the term given to describe the knowledge, skills, and confidence a person has in managing their own health and is closely related to the engagement in preventive health behaviors. Self-management interventions have the potential to improve remote disease management and health outcomes. We are testing an evidence- and theory-based digital self-management structured 10-week programme developed for CKD patients called ‘My Kidneys & Me’. The primary aim of the study (SMILE-K) is to assess the effect on patient activation levels. Methods and analysis A single-blind randomised control trial (RCT) with a nested pilot study will assess the feasibility of the intervention and study design before continuation to a full RCT. Individuals aged 18 years or older, with established CKD stage 3-4 (eGFR of 15-59 ml/min/1.73m 2 ) will be recruited through both primary and secondary care pathways. Participants will be randomised into two groups: intervention group and control group. The primary outcome is the Patient Activation Measure (PAM-13). The full RCT will assess the effect of the programme on online self-reported outcomes which will be assessed at baseline, after 10-weeks, and then after 20-weeks in both groups. A total sample size of n=432 participants are required based on a 2:1 randomisation. A sub-study will measure physiological changes (e.g., muscle mass, physical function) and patient experience (qualitative semi-structured interviews). Ethics and dissemination This study was fully approved by the Research Ethics Committee-Leicester South on the 19/11/2020 (reference: 17/EM/0357). All participants are required to provide informed consent obtained online. The results are expected to be published in scientific journals and presented at clinical research conferences. This is protocol version 1.0 dated 27/01/2021. Trial registration number The study was prospectively registered as ISRCTN18314195 in December 2020.

Association of working shifts, inside and outside of healthcare, with risk of severe COVID-19: An observational study (preprint)

BackgroundHealth and key workers are at an increased risk of developing severe COVID-19; it is not known, however, if this risk is exacerbated in those with irregular work patterns. We aimed to investigate the risk of severe COVID-19 in health and shift workers. MethodsWe included UK Biobank participants in employment or self-employed at baseline and with linked COVID-19 data to 31st August 2020. Participants were grouped as neither a health worker nor shift worker (reference category), health worker only, shift worker only, or both and associations with severe COVID-19 investigated in logistic regressions. FindingsOf 235,685 participants (81{middle dot}5% neither health nor shift worker, 1{middle dot}4% health worker only, 16{middle dot}9% shift worker only, and 0{middle dot}3% both), there were 580 (0{middle dot}25%) cases of severe COVID-19. The risk of severe COVID-19 was higher in health workers (adjusted odds ratio: 2.32 [95% CI: 1{middle dot}33, 4{middle dot}05]; shift workers (2{middle dot}06 [1{middle dot}72, 2{middle dot}47]); and in health workers who worked shifts (7{middle dot}56 [3{middle dot}86, 14{middle dot}79]). Being both a health worker and a shift worker had a possible greater impact on the risk severe COVID-19 in South Asian and Black and African Caribbean ethnicities compared to White individuals. InterpretationBoth health and shift work were independently associated with over twice the risk of severe COVID-19; the risk was over seven times higher in health workers who work shifts. Vaccinations, therapeutic and preventative options should take into consideration not only health and key worker status but also shift worker status. FundingNational Institute for Health Research, UK Research and Innovation. Research in contextO_ST_ABSEvidence before this studyC_ST_ABSThe risk of developing severe COVID-19 is greater in occupational groups with higher levels of viral exposure, e.g. health and key workers. We searched PubMed and medRxiv up to December 8, 2020 for papers on shift work patterns, health work and incidence of COVID-19 using the keywords "COVID-19", "SARS-CoV-2", "shift work" "health worker". Recent evidence suggests shift workers are also at increased risk of severe COVID-19 but it is not clear if the risk is exacerbated in those who work shifts in healthcare. Added value of this studyThis study uses data from UK Biobank, a prospective cohort of >500,000 adults aged 40-69 years with baseline assessments between March 2006 and July 2010. Participants occupation was categorised according to whether or not they were health workers and/or shift workers at baseline. Results showed that being a health worker, or working shifts, were similarly and independently associated with over twice the population level risk of severe COVID-19 independent of age, sex, ethnicity, deprivation and co-morbidities. The risk was seven times higher in health workers with shift working patterns. The impact of health and shift work tended to be higher in males and in minority ethnic groups, who are already at an increased risk of severe COVID-19. In people over the age of retirement, the risk of developing severe COVID-19 associated with baseline health worker status was no longer apparent, suggesting the risk is likely explained by exposure to the virus. However, the elevated risk associated with baseline shift worker status persisted, albeit attenuated. Implications of all the available evidenceShift workers are at elevated risk of developing severe COVID-19. The persistence of an elevated risk in people who are now over retirement age, but had a shift worker status at baseline, suggests the risk may not be fully explained by increased exposure to the virus. Vaccination, therapeutic and prevention programmes are being prioritised for health care workers. Our data suggests that shift workers should also be prioritised for these preventive measures.

Perceptions of Risk of Attending Hospital during the COVID-19 Pandemic: a UK patient and public survey and focus groups (preprint)

We aim to rapidly assess public attitudes to attending hospital across the UK for research purposes and clinical appointments, and attitudes to vaccine research using an online survey and online focus groups. Online surveys offer a rapid and, during a global pandemic, safe way of collecting information about public opinion. However, they are flawed in relying on self-report, and subject to abuse by means of multiple responses from one person or even merely random responses. Sampling methods associated with online surveys require opt-in so respondents are likely to be motivated, and specifically interested in research. Thus the methodology will attract a 'warm' audience when discussing questions about research as is standard in public involvement.Online focus groups with public involvement volunteers will also experience similar issues with generalisability. All online methodologies will exclude those without access to the online world.

Perceptions of Risk of Attending Hospital during the COVID-19 Pandemic: a UK public opinion survey (preprint)

In order to inform clinical and research practice in secondary care in light of the COVID-19 pandemic, an online survey was used to collect public opinions on attending hospitals. The survey link was circulated via the National Institute for Health Research (NIHR) Public Involvement (PPI) Leads network and social media. 402 people completed the survey. Participants age ranged from the 18-85+, with the majority (337 (84%)) aged between 35 to 74 years. There were a higher number of women (77%) compared to men (23%); and were mainly White European (91%) compared to BAME (6%), or other (2%). Data collection included self-identified risk status due to comorbidity or age, and 100 point Likert-type scales to measures feelings of safety, factors affecting feelings of safety, intention to participate in research, comfort with new ways of working and attitudes to research. Results for feelings of safety scales indicate two distinct groups; one of respondents who felt quite safe and one of those who did not. Implementation of COVID-19 related safety measures such as social distancing, use of PPE and cleaning were strongly supported by most respondents. There was ambivalence around less certain measures such as regular staff antigen and antibody testing. Respondents were most likely to participate in research related to their own condition, COVID-19 research and vaccine research, but less likely to participate in healthy volunteer research, especially if suffering from a pre-existing comorbidity identified with increased risk or were female. There was general agreement that participants are comfortable with new ways of working, such as remote consultation, though women and BAME respondents were less comfortable. Findings raise concerns for health inequalities already impacting some groups in the pandemic. The role of clinical necessity and personal benefit support the reopening of services in line with clinical necessity. Moderate caution in respect of vaccine research relative to patient-participant research presents a challenge for pending recruitment demands, and would benefit from qualitative research to explore themes and concerns in more depth and support development and targeting of key messaging.