scholarly journals Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial

2019 ◽  
Author(s):  
Emma Phelps ◽  
Elizabeth Tutton ◽  
Xavier Griffin ◽  
Janis Baird

Abstract Background Qualitative research has been used to explore patients’ and healthcare professionals’ experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research however, has explored patients’ and healthcare professionals’ experiences of surgical RCTs in a trauma setting. This study aimed to understand participants’ and staffs’ experiences of an orthopaedic trauma trial. Methods We carried out semi-structured interviews with 11 participants and 24 staff (10 surgeons and 14 research associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking plates for fractures of the distal femur (TrAFFix). Interviews explored patients’ experience of TrAFFix and their reason for participating and staffs’ experience of recruiting to TrAFFix and trauma trials more generally. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis. Results Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii) knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates supported and guided patients through the consent process enabling them to participate, ii) the difficulty in engaging surgeons in a trial when individual equipoise and experience of the interventions is low despite the presence of community equipoise and iii) the way in which research teams worked together and encouraged the development of a research culture within the clinical teams in order to facilitate recruitment. Conclusions Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons’ difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment.

2018 ◽  
Author(s):  
Emma Phelps ◽  
Elizabeth Tutton ◽  
Xavier Griffin ◽  
Janis Baird

Abstract Background: Qualitative research has been used to explore patients’ and healthcare professionals’ experiences of surgical randomised controlled trials (RCTs). From this research, reasons why patients accept or decline participation and barriers to engaging clinicians in trials have been identified. In a trauma setting, recruitment to surgical trials can be particularly difficult as patients may require urgent treatment and their ability to consider their options, ask questions and reach a decision may be hindered by the impact of their injury. Little research however, has explored patients’ and healthcare professionals’ experiences of surgical RCTs in a trauma setting. This study aimed to understand participants’ and staffs’ experiences of an orthopaedic trauma trial. Methods: We carried out semi-structured interviews with 11 participants and 24 staff (10 surgeons and 14 research associates) participating in a UK multi-centre feasibility trial comparing intramedullary nails versus distal locking plates for fractures of the distal femur (TrAFFix). Interviews explored patients’ experience of TrAFFix and their reason for participating and staffs’ experience of recruiting to TrAFFix and trauma trials more generally. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using thematic analysis. Results: Three themes were identified. These were i) navigating research with patients after orthopaedic trauma, ii) knowing that it is the right decision and iii) making it work. These themes reflect: i) how research associates supported and guided patients through the consent process enabling them to participate, ii) the difficulty in engaging surgeons in a trial when individual equipoise and experience of the interventions is low despite the presence of community equipoise and iii) the way in which research teams worked together and encouraged the development of a research culture within the clinical teams in order to facilitate recruitment. Conclusions: Our findings highlight the pivotal role of research associates (RAs) in facilitating trial recruitment. RAs supported patients to enable them to make a decision about participation and assisted in developing a research culture within the team by promoting studies and communicating research to clinical staff. Our findings also reinforce surgeons’ difficulty with equipoise and suggest that accepting community equipoise could facilitate recruitment. Keywords: Qualitative, Interviews, experience, recruitment, trials,


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Noémie Aubert Bonn ◽  
Wim Pinxten

Abstract Background Research misconduct and questionable research practices have been the subject of increasing attention in the past few years. But despite the rich body of research available, few empirical works also include the perspectives of non-researcher stakeholders. Methods We conducted semi-structured interviews and focus groups with policy makers, funders, institution leaders, editors or publishers, research integrity office members, research integrity community members, laboratory technicians, researchers, research students, and former-researchers who changed career to inquire on the topics of success, integrity, and responsibilities in science. We used the Flemish biomedical landscape as a baseline to be able to grasp the views of interacting and complementary actors in a system setting. Results Given the breadth of our results, we divided our findings in a two-paper series with the current paper focusing on the problems that affect the integrity and research culture. We first found that different actors have different perspectives on the problems that affect the integrity and culture of research. Problems were either linked to personalities and attitudes, or to the climates in which researchers operate. Elements that were described as essential for success (in the associate paper) were often thought to accentuate the problems of research climates by disrupting research culture and research integrity. Even though all participants agreed that current research climates need to be addressed, participants generally did not feel responsible nor capable of initiating change. Instead, respondents revealed a circle of blame and mistrust between actor groups. Conclusions Our findings resonate with recent debates, and extrapolate a few action points which might help advance the discussion. First, the research integrity debate must revisit and tackle the way in which researchers are assessed. Second, approaches to promote better science need to address the impact that research climates have on research integrity and research culture rather than to capitalize on individual researchers’ compliance. Finally, inter-actor dialogues and shared decision making must be given priority to ensure that the perspectives of the full research system are captured. Understanding the relations and interdependency between these perspectives is key to be able to address the problems of science. Study registration https://osf.io/33v3m


Author(s):  
Jane Wilcock ◽  
Jill Manthorpe ◽  
Jo Moriarty ◽  
Steve Iliffe

Little is known of the experiences of directly employed care workers communicating with healthcare providers about the situations of their employers. We report findings from 30 in-depth semi-structured interviews with directly employed care workers in England undertaken in 2018–19. Findings relate to role content, communication with healthcare professionals and their own well-being. Directly employed care workers need to be flexible about the tasks they perform and the changing needs of those whom they support. Having to take on health liaison roles can be problematic, and the impact of care work on directly employed workers’ own health and well-being needs further investigation.


2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e023791 ◽  
Author(s):  
Cassandra Kenning ◽  
Amy Blakemore ◽  
Peter Bower ◽  
Melina Safari ◽  
Pim Cuijpers ◽  
...  

IntroductionDepression is now the most common illness worldwide affecting more than 300 million people. Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments. There is a need to develop better preventative interventions. The overall aim of this programme of work is to develop interventions to reduce depression symptom scores and prevent development of depression in people with subthreshold depression. The objectives are to adapt a low intensity community-based depression prevention intervention, establish the acceptability and uptake of this model and conduct a parallel randomised controlled feasibility trial to inform a full-scale trial.Methods and analysisFocus groups will be run with members of the public, voluntary sector providers and researchers to inform the adaptation of an existing depression prevention course. Sixty-four people with subthreshold depression, as represented by a score of between 5 and 9 on the Patient Health Questionnaire-9 depression measure, will be recruited to take part in the feasibility trial. Participants will be randomised equally to the intervention or usual care control groups. Participants in the intervention group will receive the new revised manual and attend a 1-day workshop delivered by voluntary sector service providers. Outcome measures will be completed 3 months after baseline. Quantitative data on recruitment, randomisation, attendance, retention, questionnaire completion rates will be collected. Primary analyses will be descriptive and a process evaluation will be conducted to assess the processes involved in implementing the intervention. Interviews will be conducted to explore acceptability and framework analysis will be used to analyse the data.Ethics and disseminationThe study has been reviewed and approved by NHS Research and Ethics Committee: NW-Greater Manchester East. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and community engagement activities.Trial registration numberISRCTN23278208;Pre-results.


Author(s):  
Gertrud Tauber

Purpose – This research aims to examine three housing projects implemented by local non-governmental organizations (NGOs) and planned by local architects after the Indian Ocean tsunami of 2004 in rural South India. The key to the acceptance of post-disaster houses lies in meeting the peoples’ wishes and needs, and in integrating local know-how into the course of the project process (a premise intensively discussed in theory). After the tsunami of 2004, many (NGOs) appointed architects, assuming that these professionals would be qualified to facilitate the implementation of people-oriented houses (and villages). However, the architects’ roles vary significantly, which had, as will be shown here, a considerable impact on the degree of success of the project. Design/methodology/approach – Primary data for this study were gathered through household questionnaires (110); informal interaction; participant-observation (work assignment: 2.5 years; field survey: 4 months); semi-structured interviews (NGO representatives, architects and engineers). Secondary literature was studied on post-disaster housing, building cultures and cultures of knowledge. Findings – This study reveals that, in the course of rural post-disaster reconstruction, there is a crying need to appoint the “right” personnel having, first of all, the capacity to comply with the social dynamics at project level, and, second, being able to address those aspects critical for the realization of people-oriented housing. Architects can be a valuable resource for both the NGO and the villagers. However, this paper shows that key to this is, among other considerations, a thorough understanding of the rural (building) culture, its abilities and requirements, the strategic interplay of various roles and abilities during the course of an intricate building process and the design of appropriate roles for adequately-skilled architects. Originality/value – To this date, the debate on the role of architects in the context of post-disaster housing has neglected to examine empirically the implications of appointing these professionals in rural post-disaster contexts. This paper addresses this imbalance and complements the existing corpus of work by examining the impact of different roles of architects on the degree of success of the project at village level.


Author(s):  
Jasmine Zea Raziah Radha Rashid-Radha ◽  
Andrew Lockwood ◽  
Eimear-Marie Nolan-Davis

This research focuses on how the design of backpacker hostels influences social interaction among guests and how this could enhance or spoil their service experience. There are opposing views on how different aspects of hostel design and services contribute towards guests’ evaluation of their hostel stay. On one hand, it is suggested that a hostel environment which encourages social interaction adds value to the service experience while on the other hand, an environment that offers extra privacy, such as en-suite bedrooms, is more valued. The present research therefore argues that some aspects of the hostel’s current design and core services may now be redundant for certain market segments of the hostel guest. Empirical evidence is needed to illustrate the extent to which hostels are providing the right design and services to meet the current requirements of their target market. At this stage of the research, a pilot study has been carried out using semi-structured interviews with individuals who have stayed in backpacker hostels. Using the Critical Incident Technique (CIT), respondents were asked to recall a specific incident where they had interacted with other hostel guests. Details about the environment in which the interaction took place, as well as how the respondents felt about the interaction, were asked during the interview. It is expected that the findings of this research will shed light on which aspects of a hostel’s design and guests’ interaction would contribute towards enhancing the service experience.  


Author(s):  
Mohamed Galaleldin ◽  
Justine Boudreau ◽  
Hanan Anis

Engineering design courses often include a team-based project. Project-based learning offers a great opportunity for engineering students to learn about teamwork and collaboration. It also gives students a chance to learn about themselves and improve their conflict management skills. Choosing the right team members for a specific project is not trivial, as the choice of the team often affects the project outcome and the students’ experience in the course. Moreover, there is a debate among engineering educators as to whether it is better to force team composition or not. In this paper, we investigate the impact of team composition and formation on project outcomes and student satisfaction in a second-year engineering design course at the University of Ottawa. The course is open to all engineering students and has an accessibility theme. Students work in teams with a client that has a specific accessibility need. Students meet the client three times during the semester and deliver a physical prototype by the end of the semester. For this study, students in the design course were divided into two groups. Students in the first group were allowed to pick their teams, while the instructor created the teams in the second group based on multidisciplinary composition and year of study. Both groups had the same instructor and the same course material, labs, project choices, etc. Semi-structured interviews were conducted with a few teams in each group.


2018 ◽  
Vol 5 (4) ◽  
pp. 177 ◽  
Author(s):  
Emese Csipke ◽  
Lauren Yates ◽  
Esme Moniz Cook ◽  
Phuong Leung ◽  
Georgina Charlesworth ◽  
...  

<p class="abstract"><strong>Background:</strong> Dementia can lead to social exclusion, loss of identity and independence, due to deterioration in cognition and activities of daily living. The aim of the study is to investigate the feasibility of the Promoting Independence in Dementia (PRIDE) intervention, designed to facilitate independence in people with mild dementia.</p><p class="abstract"><strong>Methods:</strong> This is a mixed-methods feasibility trial of the PRIDE, in preparation for a future randomised controlled trial. Up to 50 people with dementia will be recruited. Demetia advisors will deliver the three session intervention. Quantitative outcomes will be taken at baseline and up to three months post baseline. Fidelity checklists will assess fidelity to the intervention. Qualitative implementation data will be gathered in a series of post-intervention semi-structured interviews with staff and participants. This will include data to examine participant experiences of and engagement with the intervention, and other aspects of delivery such as recruitment of DAWs, fidelity and experiences of receiving and delivering the intervention. This study aims to establish and field test the PRIDE intervention; determine the recruitment rate of sites, providers and participants; assess fidelity in delivery of the intervention and engagement with people with dementia; assess the feasibility and acceptability of outcome measure data and assess the acceptability of the intervention by stakeholders.</p><p class="abstract"><strong>Conclusions: </strong>There has been increased need for non-pharmacological interventions for mild dementia. The results of this feasibility study will allow us to plan for a definitive RCT of a three session dementia advisor led intervention for mild dementia.</p>


2021 ◽  
Author(s):  
Sarah Marshall ◽  
Anne C Moore ◽  
Aoife Fleming ◽  
Laura Sahm

Aims: The aim of this study was to design, develop and evaluate a theory and evidence-based intervention to improve human papillomavirus (HPV) and HPV vaccine knowledge, and intention to vaccinate, among parent-daughter dyads. Methods: A theory and evidence-based online behavioural intervention, "Is the HPV vaccine for me?" was developed to improve HPV and HPV vaccine knowledge, and intention to vaccinate. The impact and feasibility of the intervention was evaluated in a prospective randomised controlled feasibility trial. Results: A total of 49 parent-daughter dyads completed baseline knowledge assessment (n=24 control, n=25 intervention), and 35 dyads completed knowledge assessment at week 2 (n=17 control, n=18 intervention). The intervention was associated with a statistically significant increase in HPV, and HPV vaccine knowledge and intention to vaccinate. All intervention participants found the video interesting, while 96% found it useful. Conclusions: This intervention was found to be affordable, practicable, effective (cost-effective), acceptable, safe, and equitable, in this feasibility study.


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