Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders' attitudes.

BACKGROUND: Patients with acute conditions often lack the capacity to provide informed consent, and narrow therapeutic windows mean there is no time to seek consent from surrogates prior to treatment being commenced. One method to enable the inclusion of this study population in emergency research is through recruitment without prior consent, often known as 'deferred consent'. However, empirical studies have shown a large disparity in stakeholders' opinions regarding this enrolment method. This systematic review aimed to understand different stakeholder groups' attitudes to deferred consent, particularly in relation to the context in which deferred consent might occur. METHODS: Databases including MEDLINE, EMCare, PsychINFO, Scopus, and HMIC were searched from 1996 to January 2021. Eligible studies focussed on deferred consent processes for adults only, in the English language, and reported empirical primary research. Studies of all designs were included. Relevant data were extracted and thematically coded using a narrative approach to 'tell a story' of the findings. RESULTS: Twenty-seven studies were included in the narrative synthesis. The majority examined patient views (n = 19). Data from the members of the public (n = 5) and health care professionals (n =5) were also reported. Four overarching themes were identified: level of acceptability of deferred consent, research-related factors influencing acceptability, personal characteristics influencing views on deferred consent, and data use after refusal of consent or participant death. CONCLUSIONS: This review indicates that the use of deferred consent would be most acceptable to stakeholders during low-risk emergency research with a narrow therapeutic window and where there is potential for patients to benefit from their inclusion. While the use of narrative synthesis allowed assessment of the included studies, heterogeneous outcome measures meant that variations in study results could not be reliably attributed to the different trial characteristics. Future research should aim to develop guidance for research ethics committees when reviewing trials using deferred consent in emergency research and investigate more fully the views of healthcare professionals which to date have been explored less than patients and members of the public. Trial registration PROSPERO CRD42020223623.

Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study).

BACKGROUND: People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared. OBJECTIVE: The aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes. METHODS: The study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set. RESULTS: Following the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and 'other' (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden. CONCLUSION: Using a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.

Barriers and facilitators to the use of personal information documents in health and social care settings for people living with dementia: A thematic synthesis and mapping to the COM-B framework.

INTRODUCTION: People living with dementia experience communication difficulties. Personal information documents, or healthcare passports, enable communication of information essential for the care of a person with dementia. Despite the potential for providing person-centred care, personal information documents are not ubiquitously used. The Capability Opportunity Motivation-Behaviour (COM-B) model can be used to understand factors determining individuals' behaviours. OBJECTIVES: This study aimed to identify the barriers to and facilitators of the use of healthcare passports for people living with dementia through a systematic review methodology. METHODS: A systematic search of six electronic databases was undertaken. Grey literature was searched using three databases. All study types reporting barriers to or facilitators of the use of personal information documents in the care of adults living with dementia in high-income countries were included. Study quality was assessed using the NICE Quality Appraisal Checklist. Thematic synthesis was used to develop descriptive themes, which were subsequently mapped to the COM-B framework. RESULTS: Nineteen papers were included. Themes included training, awareness, embedding the process in norms and appreciating the value of the personal information documents. A broad range of barriers and facilitators was identified within each COM-B domain. CONCLUSION: This framework provides a starting point for evidence-informed initiatives to improve the use of personal information documents in the care of people with dementia. PATIENT AND PUBLIC CONTRIBUTION: This is a review of studies and did not involve patients or the public. Review results will guide evaluation of a local personal information document, which will be designed with input from the Dementia Champions Network (includes carers and other stakeholders).

Does exercise influence burn-induced inflammation: A cross-over randomised controlled feasibility trial.

BACKGROUND: Burn injuries trigger a greater and more persistent inflammatory response than other trauma cases. Exercise has been shown to positively influence inflammation in healthy and diseased populations, however little is known about the latent effect of exercise on chronic inflammation in burn injured patients. The aims of the pilot study were to assess the feasibility of implementing a long duration exercise training program, in burn injured individuals including learnings associated with conducting a clinical trial in COVID-19 pandemic. METHODS: Fifteen participants with a burn injury between 5-20% total body surface area acquired greater than a year ago were randomised in a within-subject designed study, into one of two conditions, exercise-control or control-exercise. The exercise condition consisted of six weeks of resistance and cardiovascular exercises, completed remotely or supervised in a hospital gym. A comprehensive outcome measurement was completed at the initial, mid and end point of each exercise and control condition. To determine the success of implementation, the feasibility indicator for the data completeness across the comprehensive outcome battery was set at 80%. RESULTS: Half (49%) of eligible participants in the timeframe, were recruited and commenced the study. Six participants withdrew prior to completion and a total of 15 participants completed the study. Eight participants were randomised to the exercise-control and seven to the control exercise group. Five participants trained remotely and seven did supervised training. Three participants completed a mix of both supervised and remote training initiated due to COVID restrictions. Outcome measures were completed on 97% of protocolised occasions and 100% of participants completed the exercise training. CONCLUSIONS: Conducting a long duration exercise training study on burn injured individuals is feasible using the described methods. The knowledge gained helps improve the methodology in larger-scale projects. Insights into the impact of COVID-19 on this clinical trial and success enhancing adaptations for the researcher, research practice and the participant, are presented.

Unpacking the 'black box of horrendousness': a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent.

BACKGROUND: Trials involving adults who lack capacity to consent encounter a range of ethical and methodological challenges, resulting in these populations frequently being excluded from research. Currently, there is little evidence regarding the nature and extent of these challenges, nor strategies to improve the design and conduct of such trials. This qualitative study explored researchers' and healthcare professionals' experiences of the barriers and facilitators to conducting trials involving adults lacking capacity to consent. METHODS: Semi-structured interviews were conducted remotely with 26 researchers and healthcare professionals with experience in a range of roles, trial populations and settings across the UK. Data were analysed using thematic analysis. RESULTS: A number of inter-related barriers and facilitators were identified and mapped against key trial processes including during trial design decisions, navigating ethical approval, assessing capacity, identifying and involving alternative decision-makers and when revisiting consent. Three themes were identified: (1) the perceived and actual complexity of trials involving adults lacking capacity, (2) importance of having access to appropriate support and resources and (3) need for building greater knowledge and expertise to support future trials. Barriers to trials included the complexity of the legal frameworks, the role of gatekeepers, a lack of access to expertise and training, and the resource-intensive nature of these trials. The ability to conduct trials was facilitated by having prior experience with these populations, effective communication between research teams, public involvement contributions, and the availability of additional data to inform the trial. Participants also identified a range of context-specific recruitment issues and highlighted the importance of 'designing in' flexibility and the use of adaptive strategies which were especially important for trials during the COVID-19 pandemic. Participants identified a need for better training and support. CONCLUSIONS: Researchers encountered a number of barriers, including both generic and context or population-specific challenges, which may be reinforced by wider factors such as resource limitations and knowledge deficits. Greater access to expertise and training, and the development of supportive interventions and tailored guidance, is urgently needed in order to build research capacity in this area and facilitate the successful delivery of trials involving this under-served population.

Perceived threat of COVID-19, attitudes towards vaccination, and vaccine hesitancy: A prospective longitudinal study in the UK.

OBJECTIVES: Using the Health Belief Model as a conceptual framework, we investigated the association between attitudes towards COVID-19, COVID-19 vaccinations, and vaccine hesitancy and change in these variables over a 9-month period in a UK cohort. METHODS: The COPE study cohort (n = 11,113) was recruited via an online survey at enrolment in March/April 2020. The study was advertised via the HealthWise Wales research registry and social media. Follow-up data were available for 6942 people at 3 months (June/July 2020) and 5037 at 12 months (March/April 2021) post-enrolment. Measures included demographics, perceived threat of COVID-19, perceived control, intention to accept or decline a COVID-19 vaccination, and attitudes towards vaccination. Logistic regression models were fitted cross-sectionally at 3 and 12 months to assess the association between motivational factors and vaccine hesitancy. Longitudinal changes in motivational variables for vaccine-hesitant and non-hesitant groups were examined using mixed-effect analysis of variance models. RESULTS: Fear of COVID-19, perceived susceptibility to COVID-19, and perceived personal control over COVID-19 infection transmission decreased between the 3- and 12-month surveys. Vaccine hesitancy at 12 months was independently associated with low fear of the disease and more negative attitudes towards COVID-19 vaccination. Specific barriers to COVID-19 vaccine uptake included concerns about safety and efficacy in light of its rapid development, mistrust of government and pharmaceutical companies, dislike of coercive policies, and perceived lack of relaxation in COVID-19-related restrictions as the vaccination programme progressed. CONCLUSIONS: Decreasing fear of COVID-19, perceived susceptibility to the disease, and perceptions of personal control over reducing infection-transmission may impact future COVID-19 vaccination uptake.

Changing sexual behaviours amongst MSM during the COVID-19 restrictions in Wales: a mixed methods study.

BACKGROUND: The COVID-19 pandemic and its associated restrictions stopped people freely engaging in sexual behaviour. We explored sexual behaviour amongst men who have sex with men (MSM) using mixed methods during the multiple lockdowns in Wales. METHODS: An online survey was advertised on social media platforms (focusing on Welsh LGBT groups), from June 2020 to July 2020. MSM over 16 years were invited to take part if they were resident in Wales. Qualitative interviews were undertaken as part of a study examining knowledge and awareness of sexual health. Interviews were conducted between September 2020 and February 2021 via Zoom©. Interview data was analysed thematically and integrated with survey data. RESULTS: The survey received 70 responses, 60% (n = 42) reported not having sexual activity during lockdown. Restrictions altered the number of new sexual partners per week with over 80% (n = 56) not having any new sexual partners for the 12 weeks of the first lockdown. However, as the weeks progressed following the first lockdown there was an increase in the number of new sexual partners. Interview data indicated that the COVID-19 pandemic had a large impact on reducing sexual behaviour with other MSM in Wales. 'Lockdown fatigue' was viewed to result in different levels of adherence to the lockdown rules depending on the lockdown being discussed. Of those engaging in sex outside the rules, 'shame' was commonly reported. The restrictions were believed to have a positive impact on reducing the spread of sexually transmitted infections. CONCLUSIONS: The COVID-19 pandemic and associated restrictions had a significant impact on sexual behaviours among MSM in Wales, with the majority fully adhering to the lockdown rules. Although the population were largely compliant with the lockdown restrictions, lockdown fatigue may suggest that any future lockdowns might not have the same effect.

Cohort profile: The UK COVID-19 Public Experiences (COPE) prospective longitudinal mixed-methods study of health and well-being during the SARSCoV2 coronavirus pandemic.

Public perceptions of pandemic viral threats and government policies can influence adherence to containment, delay, and mitigation policies such as physical distancing, hygienic practices, use of physical barriers, uptake of testing, contact tracing, and vaccination programs. The UK COVID-19 Public Experiences (COPE) study aims to identify determinants of health behaviour using the Capability, Opportunity, Motivation (COM-B) model using a longitudinal mixed-methods approach. Here, we provide a detailed description of the demographic and self-reported health characteristics of the COPE cohort at baseline assessment, an overview of data collected, and plans for follow-up of the cohort. The COPE baseline survey was completed by 11,113 UK adult residents (18+ years of age). Baseline data collection started on the 13th of March 2020 (10-days before the introduction of the first national COVID-19 lockdown in the UK) and finished on the 13th of April 2020. Participants were recruited via the HealthWise Wales (HWW) research registry and through social media snowballing and advertising (Facebook®, Twitter®, Instagram®). Participants were predominantly female (69%), over 50 years of age (68%), identified as white (98%), and were living with their partner (68%). A large proportion (67%) had a college/university level education, and half reported a pre-existing health condition (50%). Initial follow-up plans for the cohort included in-depth surveys at 3-months and 12-months after the first UK national lockdown to assess short and medium-term effects of the pandemic on health behaviour and subjective health and well-being. Additional consent will be sought from participants at follow-up for data linkage and surveys at 18 and 24-months after the initial UK national lockdown. A large non-random sample was recruited to the COPE cohort during the early stages of the COVID-19 pandemic, which will enable longitudinal analysis of the determinants of health behaviour and changes in subjective health and well-being over the course of the pandemic.

Idiopathic inflammatory myopathy and axonal peripheral polyneuropathy in a poorly controlled coeliac disease patient

Background/Aims The current mainstay treatment of idiopathic inflammatory myopathies (IIM) includes steroid therapy with treatment escalation to steroids -sparing immunosuppressants to maintain remission. Nevertheless, some patients may not fully recover to their normal muscle strength, while exposing to potential side effects of these drugs. We report the first case of IIM and axonal peripheral polyneuropathy in a poorly controlled coeliac patient, who made complete recovery with adherence to gluten-free diet.Methods A 76-year-old white Caucasian lady, who was previously independent, presented with 6-weeks history of pain and weakness in both legs. She required the use of a wheelchair to get around as she was unable to weight bear as the result of the pain. She denied any change to regular medications, history of trauma, new rash, joint swelling, or B-symptoms. There was no history of smoking, alcohol, statins, or steroid use. She was previously diagnosed with coeliac disease 10 years ago but had opted not to adhere to a gluten-free diet due to personal preference.Results On examination, there was significant muscle tenderness on palpation of bilateral lower limbs. The rest of systemic examination was unremarkable. Duodenal biopsy revealed severe villous atrophy and chronic lymphocytic and plasma cell inflammation, which reinforced the diagnosis of coeliac disease. All immunology screen including ANA, ENA, ds-DNA, myositis and vasculitis screen were negative except anti-RO-52. This patient did not have any clinical feature of Sjogren’s or systemic lupus erythematosus. EMG revealed fibrillation potentials, positive sharp waves, and myotonic discharges in the paraspinal, upper and lower limbs muscles. It also demonstrated underlying axonal peripheral polyneuropathy. Muscle biopsy showed features consistent with the diagnosis of idiopathic inflammatory myopathy. This patient was started on a gluten-free diet during admission. Interestingly, we discovered that her creatinine kinase level had improved spontaneously along with the clinical improvement of her presenting symptoms. As her symptoms have completely resolved, she was discharged home. She was never started on steroid or immunosuppressant due to her significant clinical improvement. At three-month follow up, her creatinine kinase level had normalised, and she remained in remission while adhering to a gluten-free diet.Conclusion To the best of our knowledge, there is no reported case of complete clinical resolution of IIM with gluten withdrawal in coeliac disease patients, without the need of steroid or immunosuppressants. In addition, the concomitant of myopathy and polyneuropathy, as some described as neuromyositis, is extremely rare. The pathophysiology remains unclear;however, it is proposed that neuropathy could be an extra-muscular manifestation of IIM.The clinical remission of IIM in our patient with adherence to a gluten-free diet provide an alternative treatment option to the current recommended regimes of steroid and immunosuppressants. Such non-pharmacological approach is favourable, especially in the current SARS-CoV-2 pandemic.Disclosure Y. Tan: None. A. Mohamedalhadi: None. F. Wood: None.

Early impact of COVID-19 social distancing measures on reported sexual behaviour of HIV pre-exposure prophylaxis users in Wales.

OBJECTIVES: To describe the early impact of COVID-19 and associated control measures on the sexual behaviour of pre-exposure prophylaxis (PrEP) users in Wales. METHODS: Data were obtained from an ecological momentary assessment study of PrEP use and sexual behaviour. Participants were individuals accessing PrEP through the National Health Service (NHS) sexual health clinics across four health boards in Wales. Weekly data documenting condomless sex in the preceding week were analysed between 03/02/2020 and 10/05/2020. The introduction of social distancing measures and changes to sexual health clinics in Wales occurred on the week starting 16/03/2020. Two-level logistic regression models were fitted to condomless sex (yes/no) over time, included an indicator for the week starting 16/03/2020, and were extended to explore differential associations by relationship status and sexual health clinic. RESULTS: Data were available from 56 participants and included 697 person-weeks (89% of the maximum number that could have been obtained). On average, 42% of participants reported condomless sex in the period prior to the introduction of social distancing measures and 20% reported condomless sex after (OR=0.16, 95% CI 0.07 to 0.37, p<0.001). There was some evidence to suggest that this association was moderated by relationship status (OR for single participants=0.09, 95% CI 0.06 to 0.23; OR for not single participants=0.46, 95% CI 0.16 to 1.25). CONCLUSIONS: The introduction of social distancing measures and changes to PrEP services across Wales was associated with a marked reduction in reported instances of condomless sexual intercourse among respondents, with a larger reduction in those who were single compared with those who were not. The long-term impact of COVID-19 and associated control measures on this population's physical and mental health and well-being requires close examination.