Intervention developers concerned with improving recruitment rates could usefully focus on more than just the individual patient level factors that might be having an impact on this process. By nature, some clinical interventions will be potentially more or less attractive to prospective participants, but there is often a real scientific need to evaluate them in trials with specific comparators.
Previous research has highlighted the benefits of training for recruiting staff who struggle with the concept of equipoise and who perhaps hold particular treatment preferences, which make communicating trial rationale to patients difficult. This notion of trial work and the burden, and associated consequences, that it can place on study sites has been somewhat buried in much of the previous trial literature.
The authors would like to thank all interviewees who agreed to take part in this study. Contributors: KG conceived the study idea. All the authors contributed critically to discussions about interpretation of data and revisions of manuscript drafts. All the authors approved the final version. Competing interests: None declared. Patient consent: This study did not involve patients.
We interviewed a range of NHS staff and obtained written consent prior in interview. Provenance and peer review: Not commissioned; externally peer reviewed. Data sharing statement: To access the remainder of the data, please submit a request to the authors and the Chief Investigator of TISU. The request should include full justification for why secondary analysis of this data is being sought.
National Center for Biotechnology Information , U. BMJ Open. Published online Aug Author information Article notes Copyright and License information Disclaimer. Correspondence to Katie Gillies; ku. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This article has been cited by other articles in PMC.
Associated Data Supplementary Materials Reviewer comments. Abstract Objectives To explore trial site staff's perceptions regarding barriers and facilitators to local recruitment. Design Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Results Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial.
Conclusions Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Keywords: qualitative research, therapeutics, health services administration and management. Strengths and limitations of this study. Introduction Recruiting the desired number of participants is crucial for all clinical research and remains a major challenge for those concerned with designing and supporting the operationalisation of clinical trials.
Methods Recruitment, sampling and consent We adopted a pragmatic approach to address recruitment issues in the TISU trial by including four of eight participating UK trial sites in this qualitative study. Data generation One-to-one interviews were conducted by telephone between January and April Data analysis Interviews were audio-recorded and transcribed verbatim. Table 1 Sample characteristics. Open in a separate window. Trial work to access potentially eligible patients: issues of engagement and planning for pragmatism Engagement Site staff identified the requirement to work with clinical colleagues as part of routine patient care , who were not directly related to the trial but who were nevertheless important facilitators to recruitment as having a potentially negative impact on the identification of eligible patients.
Site 1 RNa Having a strong buy in from the site PI, particularly in terms of raising the profile of the study and generating support from other clinical colleagues was also discussed as having an important role in maintaining trial visibility and keeping external colleagues engaged: It's pretty much a top down process, I think, from the consultants and the registrars.
Mr X obviously has an invested interest in the trial doing well and tries to make sure that the medical teams are aware of the trial and refers patients if at all possible… Site 1 RNb He's PI since gone on sabbatical and what I've noticed is that actually our recruitment has taken a bit of a turn it's his trial, it's not anyone else's trial… I think that not having the PI around to kind of push things forward has made our recruitment take a little bit of a turn recently. Planning for pragmatism In addition to discussing the importance of engaging with and motivating clinical colleagues to ensure that all potentially eligible patients are identified, trial staff discussed various other challenges relating to their attempts to maximise the initial recruitment potential at their particular site.
The work involved in this process was discussed including attempts to maximise existing resources in terms of ensuring good cross cover of staff as well as developing innovative and proactive recruitment strategies: we have a lot of databases which we kind of meticulously keep … we kind of really plan everything out …then I'll put notifications in Research Nurse calendar and it's just having that organisation down so we don't miss any.
Site 3 RA there's trials that we consider generally generic between us. Site 4 PI …for TISU I am quite reliant on doctors referring patients to me… for me is the biggest barrier to recruitment is not having the control over the patients who, or the way we can identify patients… I've had some lengthy discussions with Mr X about this and how we recruit patients. Trial work to maximise recruitment after patient identification: managing organisational complexity and management of treatment preferences Managing organisational complexity In addition to identifying a range of factors which could impact either positively or negatively on attempts to access potentially eligible patients at their particular site, trial staff reflected on both site and trial-specific opportunities and challenges which they believed could affect the success or otherwise of successfully recruiting identified patients.
Management of treatment preferences In addition to various site-specific organisational opportunities or challenges which could clearly impact on trial recruitment and generate more or less work for trial recruiters, it was also apparent that various non-site specific trial factors could have an influence and these seemed to require ongoing work and negotiation on the part of recruiting staff.
Site 3 RA The condition this trial was addressing is a particularly painful, and often recurrent one and so the speed with which the pain could be alleviated was considered to have a major impact on both clinician opinions and patient decision-making. Furthermore, the patients approached for participation had often had prior experience of the condition and of the treatment options and so sometimes had formed quite rationale and personal preferences that were not simply based on misunderstandings: I know there's pros and cons to both treatments on this study so … if I feel the registrar has jumped in and decided the management plan without considering TISU… It is a terribly painful condition, ureteric colic with stones and I think the speed in with which you resolve it must have a major impact in both the medical staff impression on what to do for a patient as well as the patient's decision-making.
Site 1 RNa …one of the obstacles to recruitment is, that patients do express a preference for one treatment or the other based on their own circumstances… in a way I think that that's free choice…I think sometimes there's personal reasons that some people would prefer not to have a general anaesthetic, would prefer not to have to stay in overnight… Site 2 RN.
Discussion Principal findings This study explored views and experiences of staff involved in recruiting to a trial investigating two methods for treating ureteric stones. Strengths and limitations The approach of nesting qualitative research within the context of clinical trials is considered particularly useful for improving the evidence base for how we conduct trials.
Practice implications Recruiting to trials is a complex and ongoing process and is one, for trial site staff, that starts well before the process of attempting to consent a prospective participant eg, during a one-to-one recruitment consultation.
Supplementary Material Reviewer comments: Click here to view. Author's manuscript: Click here to view. Acknowledgments The authors would like to thank all interviewees who agreed to take part in this study. Footnotes Contributors: KG conceived the study idea. References 1. What influences recruitment to randomised controlled trials?
A review of trials funded by two UK funding agencies. Trials ; 7 :9 Clinical trial metadata: defining and extracting metadata on the design, conduct, results and costs of randomised clinical trials.
Health Technol Assess ; 19 :1— Predictors of refusal during a multi-step recruitment process for a randomized controlled trial of arthritis education. Patient Educ Couns ; 73 —5. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med ; — Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns ; 35 — Locock L, Smith L.
Personal benefit, or benefiting others? Deciding whether to take part in clinical trials. So, it fit perfectly. I sort of had my veil be my statement piece, and let the dress be very simple. A post shared by Elizabeth Gillies lizgillz. Obviously, we have to talk about Dynasty!
What was it like being back on-set after filming paused for season 3 last year? It was great. I mean, listen—it was great to be acting again, it was great to be back at work. Of course, it was a whole new world with all the protocols we had to follow and still have to follow. This year was definitely more about the work than the play, as it was for all of us, but I think we pulled out a really tremendous season and the restrictions we had on our filming and on our script.
I feel like the scripts went inward instead of outward. It was really challenging, so I feel very lucky that I was able to do that. I have so many! But I have a couple that really stand out to me. I wore this sparkly green strapless dress from season 1, it was made of sequins, it was so fitted and so beautiful. I always come back to that one, but there have been many outfits that feel very iconic to me.
The pilot dress was pretty iconic too, that black and white dress. We were sort of paying tribute to the original Dynasty pilot there too. What have you learned about fashion from Fallon over the last several years? I was somebody who always, without fail, wore all black everywhere I went. I wanted to wear the darkest clothes possible, and I wanted to layer them on as much as possible.
Fallon not only introduced me to color, but she introduced me to taking fashion risks. And working with our costume designers, particularly Meredith Markworth-Pollack , who is the one who kind of originated the show, she made me think outside of the box.
I know Fallon wears extravagantly expensive and high-end clothing, but we would mix them with bags we found at thrift stores, and we would mix them with lower pieces. How do you express yourself through your wardrobe, and who are your style inspirations? My style inspirations have definitely changed over the years. I just wanted to wear tank tops and leather pants, and jean jackets or leather jackets.
I know what fits me, I know what looks good on me, I know what I feel comfortable in. A pilot study. Page 3 of 5 Results 21 to 30 of Email z.
About z. School of Medicine, Medical Sciences and Nutrition. Current Research Baby boxes and parental capabilities: developing a measure of social outcomes.
Specific aims: To improve understanding of how issues relating to the introduction of baby boxes have been reported in a sample of media coverage. Using Care Opinion for patient-centred quality improvement NHS Scotland formally supports the use of Care Opinion as a way for patients and families to give feedback to the NHS and for hospitals to identify improvements which could be made to respond to patient comments.
Skea, Z. European Journal of Oncology Nursing , vol. Gillies, K. Clinical Trials , vol. Contributions to Journals: Conference Articles. Kazimierczak, K. Chaudhry, S. McRae, A. Journal of Medical Ethics , vol. Cochrane Database of Systematic Reviews , no. Trials , vol. Suppl 1, pp.
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