scholarly journals Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
William J. Cragg ◽  
Kathryn McMahon ◽  
Jamie B. Oughton ◽  
Rachel Sigsworth ◽  
Christopher Taylor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Online Survey ◽  
Strong Support ◽  
Clinical Trial Design ◽  
Research Unit ◽  
Free Text ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Protocol Development ◽  
The Uk

Abstract Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters’ experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.

scholarly journals Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey

2021 ◽  
Author(s):  
William Cragg ◽  
Kathryn McMahon ◽  
Jamie B Oughton ◽  
Rachel Sigsworth ◽  
Christopher Taylor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Online Survey ◽  
Strong Support ◽  
Clinical Trial Design ◽  
Research Unit ◽  
Free Text ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Protocol Development ◽  
Mailing Lists

Abstract BackgroundEligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants' safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters' experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed.MethodsOur survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes.ResultsA total of 823 eligible respondents participated. 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%) and suitability (14%). 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea that they might review eligibility criteria earlier in the protocol development process.ConclusionsOur survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.

scholarly journals Correction to: Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
William J. Cragg ◽  
Kathryn McMahon ◽  
Jamie B. Oughton ◽  
Rachel Sigsworth ◽  
Christopher Taylor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Online Survey ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
The Uk

scholarly journals Mental Health, Information and Being Connected: Qualitative Experiences of Social Media Use during the COVID-19 Pandemic from a Trans-National Sample

Healthcare ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 735
Author(s):  
Schoultz Mariyana ◽  
Leung Janni ◽  
Bonsaksen Tore ◽  
Ruffolo Mary ◽  
Thygesen Hilde ◽  
...  
Keyword(s):  
Mental Health ◽  
Social Media ◽  
Health Information ◽  
Online Survey ◽  
Negative Impact ◽  
National Study ◽  
Free Text ◽  
Cross Sectional ◽  
Mental Health Information ◽  
The Uk

Background: Due to the COVID-19 pandemic and the strict national policies regarding social distancing behavior in Europe, America and Australia, people became reliant on social media as a means for gathering information and as a tool for staying connected to family, friends and work. This is the first trans-national study exploring the qualitative experiences and challenges of using social media while in lockdown or shelter-in-place during the current pandemic. Methods: This study was part of a wider cross-sectional online survey conducted in Norway, the UK, USA and Australia during April/May 2020. The manuscript reports on the qualitative free-text component of the study asking about the challenges of social media users during the COVID-19 pandemic in the UK, USA and Australia. A total of 1991 responses were included in the analysis. Thematic analysis was conducted independently by two researchers. Results: Three overarching themes identified were: Emotional/Mental Health, Information and Being Connected. Participants experienced that using social media during the pandemic amplified anxiety, depression, fear, panic, anger, frustration and loneliness. They felt that there was information overload and social media was full of misleading or polarized opinions which were difficult to switch off. Nonetheless, participants also thought that there was an urge for connection and learning, which was positive and stressful at the same time. Conclusion: Using social media while in a shelter-in-place or lockdown could have a negative impact on the emotional and mental health of some of the population. To support policy and practice in strengthening mental health care in the community, social media could be used to deliver practical advice on coping and stress management. Communication with the public should be strengthened by unambiguous and clear messages and clear communication pathways. We should be looking at alternative ways of staying connected.

Knowledge of, and attitudes to, shared decision-making in orthodontics in the UK

2020 ◽  
Vol 47 (4) ◽  
pp. 294-302
Author(s):  
Sophy K Barber ◽  
Fiona Ryan ◽  
Susan J Cunningham
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Orthodontic Treatment ◽  
Online Survey ◽  
Free Text ◽  
Shared Decision ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Treatment Providers ◽  
The Uk

Objective: To establish UK orthodontic treatment providers’ knowledge of, and attitudes to, shared decision-making (SDM). SDM involves patients as equal partners in decisions about treatment. Design: Cross-sectional survey. Setting: Online survey across the UK. Population: Dentists and orthodontists providing orthodontic treatment in the UK. Methods: Potential participants were contacted through the British Orthodontic Society mailing lists. An online survey was developed to examine knowledge of, and attitudes to, SDM using a combination of evidence-based statements and free text boxes. Questions regarding previous training in SDM and preferences for further training were also included. Results: The survey was completed by 210 respondents, yielding an approximate response rate of 15%. Respondents were mainly consultants (34%) and specialist orthodontists (42%). SDM was well described in terms of the people involved in this process, how it is approached, the components and topics of discussion, and the overall purpose of SDM. Generally, there was consistency in attitudinal responses, with the largest variance in responses to questions about the professional–patient partnership, the interface between SDM and clinical guidelines, and accepting a decision that is discordant with the professional’s opinion. Fifty-one respondents reported having some previous teaching/training in SDM, with the majority (87%) indicating that they would like more training. Conclusion: Clinicians providing orthodontic treatment in the UK have a good understanding of the meaning of shared decision-making. Concerns raised about using SDM and knowledge gaps suggest there is value in providing SDM training for the orthodontic team and that orthodontic providers would welcome it.

Quantifying empathy levels among UK undergraduate medical students: an online survey

2020 ◽  
Vol 70 (suppl 1) ◽  
pp. bjgp20X711293
Author(s):  
Sarah Garnett ◽  
Hajira Dambha-Miller ◽  
Beth Stuart
Keyword(s):  
Medical Students ◽  
Health Outcomes ◽  
Medical School ◽  
Curriculum Design ◽  
Online Survey ◽  
Mental Wellbeing ◽  
Reactivity Index ◽  
Free Text ◽  
Undergraduate Medical Students ◽  
Cross Sectional

BackgroundEmpathy is a key health care concept and refers to care that incorporates understanding of patient perspective’s, shared decision making, and consideration of the broader context in which illness is experience. Evidence suggests experiences of doctor empathy correlate with improved health outcomes and patient satisfaction. It has also been linked to job satisfaction, and mental wellbeing for doctors. To date, there is a paucity of evidence on empathy levels among medical students. This is critical to understand given that it is a key point at which perceptions and practices of empathy in the longer term might be formed.AimTo quantify the level of empathy among UK undergraduate medical studentsMethodAn anonymised cross-sectional online survey was distributed to medical students across three universities. The previously validated Davis’s Interpersonal Reactivity Index was used to quantify empathy. The survey also collected information on age, sex, ethnicity, year of medical school training and included a free-text box for ‘any other comments’.ResultsData analysis is currently underway with high response rates. Mean empathy scores by age, sex, year of study and ethnic group are presented. A correlation analysis will examine associations between age and year of study, and mean empathy sores.ConclusionThese data will help to provide a better understanding of empathy levels to inform the provision of future empathy training and medical school curriculum design. Given previous evidence linking experiences of empathy to better health outcomes, the findings may also be significant to future patient care

scholarly journals Survey of young people in one region of the UK on accessing COVID-19 information (SOCIAL)

2021 ◽  
Vol 5 (1) ◽  
pp. e000942
Author(s):  
Oliver G P Lawton ◽  
Sarah A Lawton ◽  
Lisa Dikomitis ◽  
Joanne Protheroe ◽  
Joanne Smith ◽  
...  
Keyword(s):  
Social Media ◽  
Young People ◽  
Significant Role ◽  
Online Survey ◽  
Descriptive Statistics ◽  
Sources Of Information ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Education Gaps ◽  
The Uk

COVID-19 has significantly impacted young people’s lives yet little is known about the COVID-19 related sources of information they access. We performed a cross-sectional survey of pupils (11–16 years) in North Staffordshire, UK. 408 (23%) pupils responded to an online survey emailed to them by their school. Descriptive statistics were used to summarise the data. Social media, accessed by 68%, played a significant role in the provision of information, despite it not being considered trustworthy. 89% felt that COVID-19 had negatively affected their education. Gaps in the provision of information on COVID-19 have been identified.

scholarly journals How is the COVID-19 lockdown impacting the mental health of parents of school-age children in the UK? A cross-sectional online survey

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e043397
Author(s):  
Austen El-Osta ◽  
Aos Alaa ◽  
Iman Webber ◽  
Eva Riboli Sasco ◽  
Emmanouil Bagkeris ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Social Isolation ◽  
Online Survey ◽  
Female Gender ◽  
School Age Children ◽  
School Age ◽  
Cross Sectional ◽  
The Uk ◽  
The Impact

ObjectiveInvestigate the impact of the COVID-19 lockdown on feelings of loneliness and social isolation in parents of school-age children.DesignCross-sectional online survey of parents of primary and secondary school-age children.SettingCommunity setting.Participants1214 parents of school-age children in the UK.MethodsAn online survey explored the impact of lockdown on the mental health of parents with school-age children, and in particular about feelings of social isolation and loneliness. Associations between the UCLA Three-Item Loneliness Scale (UCLATILS), the Direct Measure of Loneliness (DMOL) and the characteristics of the study participants were assessed using ordinal logistic regression models.Main outcome measuresSelf-reported measures of social isolation and loneliness using UCLATILS and DMOL.ResultsHalf of respondents felt they lacked companionship, 45% had feelings of being left out, 58% felt isolated and 46% felt lonely during the first 100 days of lockdown. The factors that were associated with higher levels of loneliness on UCLATILS were female gender, parenting a child with special needs, lack of a dedicated space for distance learning, disruption of sleep patterns and low levels of physical activity during the lockdown. Factors associated with a higher DMOL were female gender, single parenting, parenting a child with special needs, unemployment, low physical activity, lack of a dedicated study space and disruption of sleep patterns during the lockdown.ConclusionsThe COVID-19 lockdown has increased feelings of social isolation and loneliness among parents of school-age children. The sustained adoption of two modifiable health-seeking lifestyle behaviours (increased levels of physical activity and the maintenance of good sleep hygiene practices) wmay help reduce feelings of social isolation and loneliness during lockdown.

scholarly journals 764 Human Factors in Operative Theatres During the Covid-19 Pandemic: A Cross-sectional Analysis of Operating Theatre Staff Experiences in a Regional Centre

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
L E Murchison ◽  
R Anbarasan ◽  
A Mathur ◽  
M Kulkarni
Keyword(s):  
Human Factors ◽  
Online Survey ◽  
Situational Awareness ◽  
Negative Impact ◽  
High Stress ◽  
Operating Theatre ◽  
Free Text ◽  
Cross Sectional ◽  
Chi Squared ◽  
Theatre Staff

Abstract Introduction In the already high-risk, high-stress environment of the operating theatre, operating during Covid-19 has brought its own unique challenges. Communication, teamwork and anxiety related new operating practices secondary to Covid-19 are hypothesised to have a negative impact on patient care. Method We conducted a single-centre online survey of operating theatre staff from 22nd June–6th July 2020. Respondents completed 18 human factors questions related to COVID-19 precautions including communication, teamwork, situational awareness, decision making, stress, fatigue, work environment and organisational culture. Questions consisted of yes/no responses, multiple choice and Likert items. Kruskall-Wallis tests, Chi-Squared, Mann Whitney U tests, Spearman’s correlation coefficient, lambda and Cramer’s V tests were used. Free-text responses were also reviewed. Results 116 theatre staff responded. Visual (90.5%), hearing/ understanding (96.6%) difficulties, feeling faint/lightheaded (66.4%) and stress (47.8%) were reported. Decreased situational awareness was reported by 71.5% and correlated with visors (r = 0.27 and p = 0.03) and FFP2/3 mask usage (r = 0.29 and p = 0.01). Reduced efficiency of theatre teams was reported by 75% of respondents and 21.5% felt patient safety was at greater risk due to Covid-19 precautions in theatre. Conclusions Organisational adjustments are required, and research focused on development of fit-for-purpose personal protective equipment (PPE).

scholarly journals The Perceived Impact of The First UK Covid-19 Lockdown on Companion Animal Welfare and Behaviour: A Mixed-Method Study of Associations with Owner Mental Health

2021 ◽  
Vol 18 (11) ◽  
pp. 6171
Author(s):  
Emily Shoesmith ◽  
Luciana Santos de Assis ◽  
Lion Shahab ◽  
Elena Ratschen ◽  
Paul Toner ◽  
...  
Keyword(s):  
Mental Health ◽  
Animal Welfare ◽  
Online Survey ◽  
Negative Impact ◽  
Companion Animals ◽  
Principal Component ◽  
Companion Animal ◽  
Free Text ◽  
Cross Sectional ◽  
Human Animal

Background: Companion animals may be a positive presence for their owners during the Covid-19 pandemic. However, the welfare of a companion animal is strongly influenced by the behaviour of their owners, as well as their physical and social environment. We aimed to investigate the reported changes in companion animal welfare and behaviour and to examine the association between these changes and companion animal owners’ mental health. Methods: A cross-sectional online survey of UK residents over 18 years of age was conducted between April and June 2020 (n = 5926). The questionnaire included validated, bespoke items measuring outcomes related to mental health, human-animal bonds and reported changes in animal welfare and behaviour. The final item of the survey invited open-ended free-text responses, allowing participants to describe experiences associated with human-animal relationships during the first UK lockdown phase. Results: Animal owners made up 89.8% of the sample (n = 5323), of whom 67.3% reported changes in their animal’s welfare and behaviour during the first lockdown phase (n = 3583). These reported changes were reduced to a positive (0–7) and negative (0–5) welfare scale, following principal component analysis (PCA) of 17 items. Participants reported more positive changes for cats, whereas more negative changes were reported for dogs. Thematic analysis identified three main themes relating to the positive and negative impact on companion animals of the Covid-19 pandemic. Generalised linear models indicated that companion animal owners with poorer mental health scores pre-lockdown reported fewer negative changes in animal welfare and behaviour. However, companion animal owners with poorer mental health scores since lockdown reported more changes, both positive and negative, in animal welfare and behaviour. Conclusion: Our findings extend previous insights into perceived welfare and behaviour changes on a very limited range of species to a wider a range of companion animals. Owner mental health status has a clear, albeit small, effect on companion animal welfare and behaviour.

scholarly journals Understanding public preferences and trade-offs for government responses during a pandemic: a protocol for a discrete choice experiment in the UK

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e043477
Author(s):  
Mesfin G Genie ◽  
Luis Enrique Loría-Rebolledo ◽  
Shantini Paranjothy ◽  
Daniel Powell ◽  
Mandy Ryan ◽  
...  
Keyword(s):  
Discrete Choice Experiment ◽  
Discrete Choice ◽  
Choice Experiment ◽  
Online Survey ◽  
Research Unit ◽  
Media Analysis ◽  
Moral Foundation ◽  
Trade Offs ◽  
Ethics Research ◽  
The Uk

IntroductionSocial distancing and lockdown measures are among the main government responses to the COVID-19 pandemic. These measures aim to limit the COVID-19 infection rate and reduce the mortality rate of COVID-19. Given we are likely to see local lockdowns until a treatment or vaccine for COVID-19 is available, and their effectiveness depends on public acceptability, it is important to understand public preference for government responses.Methods and analysisUsing a discrete choice experiment (DCE), this study will investigate the public’s preferences for pandemic responses in the UK. Attributes (and levels) are based on: (1) lockdown measures described in policy documents; (2) literature on preferences for lockdown measures and (3) a social media analysis. Attributes include: lockdown type; lockdown length; postponement of usual non-urgent medical care; number of excess deaths; number of infections; impact on household spending and job losses. We will prepilot the DCE using virtual think aloud interviews with respondents recruited via Facebook. We will collect preference data using an online survey of 4000 individuals from across the four UK countries (1000 per country). We will estimate the relative importance of the attributes, and the trade-offs individuals are willing to make between attributes. We will test if respondents’ preferences differ based on moral attitudes (using the Moral Foundation Questionnaire), socioeconomic circumstances (age, education, economic insecurity, health status), country of residence and experience of COVID-19.Ethics and disseminationThe University of Aberdeen’s College Ethics Research Board (CERB) has approved the study (reference: CERB/2020/6/1974). We will seek CERB approval for major changes from the developmental and pilot work. Peer-reviewed papers will be submitted, and results will be presented at public health and health economic conferences nationally and internationally. A lay summary will be published on the Health Economics Research Unit blog.

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