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 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 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

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 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 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.

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.

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data

2021 ◽  
Vol 12 (04) ◽  
pp. 816-825
Author(s):  
Yingcheng Sun ◽  
Alex Butler ◽  
Ibrahim Diallo ◽  
Jae Hyun Kim ◽  
Casey Ta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Electronic Health Records ◽  
The United States ◽  
Design Stage ◽  
Common Data Model ◽  
Free Text ◽  
Eligibility Criteria ◽  
Health Records ◽  
Electronic Health

Abstract Background Clinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population. Objectives This research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage. Methods We present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial. Results We calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness. Conclusion This research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.

Family medicine physicians’ report strong support, barriers and preferences for Registered Dietitian Nutritionist care in the primary care setting

2020 ◽  
Author(s):  
Lauren R Sastre ◽  
Leslie T Van Horn
Keyword(s):  
Family Medicine ◽  
Online Survey ◽  
Interprofessional Collaboration ◽  
Health Care Systems ◽  
Descriptive Analysis ◽  
Strong Support ◽  
Full Time ◽  
Registered Dietitian ◽  
Cross Sectional ◽  
Care Systems

Abstract Background Previous studies have examined barriers (e.g. time) for Family Medicine Providers (FMPs) to provide nutrition and lifestyle counseling, however, to date no studies have examined access or interest to Registered Dietitian Nutritionist (RDN) care for patients. Objective The objective of this study was to explore FMP access, referral practices, barriers and preferences for RDN care. Methods A cross-sectional online survey, with content and face validation was conducted with Family Medicine Departments within large academic health care systems in the Southeastern United States. The main variables of interest included: FMP access, interest, current referrals and referral preferences for RDN care, barriers to referrals and overall perceptions regarding RDN care. Descriptive analysis of close-ended responses was performed with SPSS 26.0. Open-ended responses were analysed using inductive content analysis. Results Over half of the respondents (n = 151) did not have an RDN on-site (64%) yet were highly interested in integrating an RDN (94.9%), with reported preferences for full-time on-site, part-time on-site or off-site RDN care (49.1%, 39.5% and 11.4% respectively). The greatest reported barriers to RDN referrals were perceived cost for the patient (64.47%) and uncertainty how to find a local RDN (48.6%). The most consistent theme reported in the open-ended responses were concerns regarding reimbursement, e.g. ‘Insurance does not cover all of the ways I would like to use an RDN’. Conclusions FMPs report interest and value in RDN services despite multiple perceived barriers accessing RDNs care. Opportunities exist for interprofessional collaboration between dietetic and FMP professional groups to address barriers.

scholarly journals 2166

2017 ◽  
Vol 1 (S1) ◽  
pp. 12-12
Author(s):  
Jianyin Shao ◽  
Ram Gouripeddi ◽  
Julio C. Facelli
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Power Distribution ◽  
Large Scale ◽  
Search Space ◽  
Free Text ◽  
Eligibility Criteria ◽  
Clinical Notes ◽  
Semantic Concepts ◽  
Mimic Iii

OBJECTIVES/SPECIFIC AIMS: This poster presents a detailed characterization of the distribution of semantic concepts used in the text describing eligibility criteria of clinical trials reported to ClincalTrials.gov and patient notes from MIMIC-III. The final goal of this study is to find a minimal set of semantic concepts that can describe clinical trials and patients for efficient computational matching of clinical trial descriptions to potential participants at large scale. METHODS/STUDY POPULATION: We downloaded the free text describing the eligibility criteria of all clinical trials reported to ClinicalTrials.gov as of July 28, 2015, ~195,000 trials and ~2,000,000 clinical notes from MIMIC-III. Using MetaMap 2014 we extracted UMLS concepts (CUIs) from the collected text. We calculated the frequency of presence of the semantic concepts in the texts describing the clinical trials eligibility criteria and patient notes. RESULTS/ANTICIPATED RESULTS: The results show a classical power distribution, Y=210X(−2.043), R2=0.9599, for clinical trial eligibility criteria and Y=513X(−2.684), R2=0.9477 for MIMIC patient notes, where Y represents the number of documents in which a concept appears and X is the cardinal order the concept ordered from more to less frequent. From this distribution, it is possible to realize that from the over, 100,000 concepts in UMLS, there are only ~60,000 and 50,000 concepts that appear in less than 10 clinical trial eligibility descriptions and MIMIC-III patient clinical notes, respectively. This indicates that it would be possible to describe clinical trials and patient notes with a relatively small number of concepts, making the search space for matching patients to clinical trials a relatively small sub-space of the overall UMLS search space. DISCUSSION/SIGNIFICANCE OF IMPACT: Our results showing that the concepts used to describe clinical trial eligibility criteria and patient clinical notes follow a power distribution can lead to tractable computational approaches to automatically match patients to clinical trials at large scale by considerably reducing the search space. While automatic patient matching is not the panacea for improving clinical trial recruitment, better low cost computational preselection processes can allow the limited human resources assigned to patient recruitment to be redirected to the most promising targets for recruitment.

Stoma support garments: a survey on patient information needs, product selection and equity of provision

2020 ◽  
Vol 18 (3) ◽  
pp. 18-26
Author(s):  
Claire Taylor ◽  
Julie Munro ◽  
William Goodman ◽  
Rebecca Beeken ◽  
Nicola Dames ◽  
...  
Keyword(s):  
Support Groups ◽  
Information Needs ◽  
Online Survey ◽  
Information Provision ◽  
Abdominal Muscles ◽  
Free Text ◽  
Cross Sectional ◽  
Product Selection ◽  
Patient Information Needs ◽  
Stoma Care

Many people with a stoma wear support garments, often a belt or underwear, to support the abdominal muscles, secure the stoma and conceal the appliance. There is some evidence that they reduce the risk of a parastomal hernia developing or getting worse. To investigate the experiences of UK adults living with a stoma regarding the use of support garments, a cross-sectional online survey was designed and distributed on social media and via a mailing list. The questionnaire was completed by 1528 people, 598 of whom answered a free-text question. These responses underwent thematic analysis. This article discusses the responses related to information provision, product selection and equity of provision, while separate articles discuss those related to the rationale for wearing stoma support garments. A third of respondents had not received any expert information on support garments and had to rely on their own research to make their selection. Of the 1004 who had received information, the main sources were stoma care nurses (73.4%), commercial suppliers (49.7%), peers (20.9%) and support groups (19.2%). Free-text comments indicated that respondents did not always feel they had been adequately counselled about support garments or shown the range available. Many respondents described restrictions being imposed on the number or range of products they could order. This study highlights the important role stoma care nursing specialists can play in assessment and review of support garments to ensure ostomates select the right product for their prescription.

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