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Abstract
Objectives This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials.
Design This is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees’ motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses.
Setting This study was conducted within a secondary care setting in the UK.
Participants The survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews.
Results We observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies.
Conclusion Trainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.
- qualitative research
- clinical trial
- surgery
- medical education & training
Data availability statement
Data are available upon reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The mixed methods approach and triangulation of data from surveys, interviews and observations that included multi-stakeholder perspectives enabled an in-depth and comprehensive understanding of Trainee Research Collaborative (TRC) research.
A range of surgical specialties and TRCs across geographical areas increased the potential generalisability of findings.
The survey uniquely included the views of trainees not engaged in TRCs that allowed broader insight into what influences trainee engagement in trials research.
We only interviewed trainees involved in TRCs.
The study only focused on surgical TRCs.
Introduction
Trainee Research Collaboratives (TRCs) are a supportive infrastructure established by surgical trainees collaborating on multi-centre research with advice and mentoring from senior surgeons, trial methodologists and Clinical Trials Units (CTUs). The Royal College of Surgeons of England and the UK National Institute of Health Research (NIHR) also established Surgical Trials Centres and Surgical Specialty Leads to increase surgical research, led by Professor Dion Morton.1 The West Midlands Research Collaborative (WMRC) was the first TRC2 and 24 regional and national specialty surgical TRCs were formed subsequently,2 3 including GlobalSurg internationally.4 TRCs have conducted multi-centre studies ranging from clinical audits and observational studies to randomised controlled trials (RCTs) such as ROSSINI.5 6 The NIHR launched an Associate Principal Investigator (API) scheme in 2019 which built on the TRC experiences and aims to encourage trainee clinicians to engage in research with recognition given for activity and training.7 In 2020 the API scheme was used in the COVID-19 RECOVERY trial and thereafter was expanded to all NIHR portfolio studies—underlining its success. Understanding why this scheme has been so well received and beneficial will give insights into how to maintain and develop it further. This paper, therefore, aimed to identify reasons for successful trial conduct by surgical TRCs and to develop strategies to increase clinician engagement in trials.
Methods
This study included non-participant observation of TRC meetings, semi-structured interviews, and a survey to gain an in-depth understanding of trainee engagement in research and TRCs. A stakeholder workshop used these findings to devise strategies for TRCs to enhance clinician engagement in trials which were disseminated in a digital animated story. The study was underpinned by a pragmatic research paradigm which emphasises practicality and real-world application in research. The Standards for Reporting Qualitative Research were used.8
Observations and semi-structured interviews
Sample and setting
Initially, we conducted a review of TRC webpages and with coauthors (CC/KC/TP/JB/NSB/JAL) identified a range of TRCs, the types and frequency of TRC meetings and key members. A request to observe meetings was sent to the meeting organiser and TRC chair by a study researcher (CC/KC). TRC meetings were sampled opportunistically focused on TRCs, trials or training meetings between March and December 2017. Due to timing and participant confidentiality issues, no trainee-led Trial Management Group meetings were observed.
Interviewees were purposively sampled to ensure people across clinical specialties, geographical locations and roles were included. Inclusion criteria were (1) either be a trainee or consultant surgeon, research nurse or trial methodologists with experience of TRC research and (2) speak English. Thirty-two people of 70 invited were interviewed (2 declined (time restraints), 36 did not reply to a single invitation without financial incentive (reasons unknown)), 19 were interviewed in person and 13 by telephone (May 2017 to January 2018) for between 20 and 59 min (mean 37 min) until information power (adequate quality and depth of information) was reached.9
Data collection
Observational and interview data were collected in parallel by experienced qualitative researchers in health research (CC and KC). Observations were non-participant (ie, observing study researchers were not TRC members and did not participate in meetings they were observing) although researchers were known to some meeting attendees and interviewees prior to data collection. Detailed field notes were taken during TRC meetings guided by an observation topic schedule (online supplemental material 1) based on the research questions.10 Interviews were audio-recorded with permission and transcribed verbatim using a professional transcription service. Interviews were guided by a flexible topic guide (online supplemental material 2) which enabled a focus on the research questions and participants to introduce topics.
Supplemental material
Supplementary video
Qualitative analysis
Interview transcripts and field notes were analysed using thematic analysis.11 Analysis began shortly after data collection started with early insights used in subsequent data collection. The main study researcher (CC) analysed all transcripts and field notes and the second researcher (KC) analysed nine transcripts. A hybrid approach using both deductive coding based on study aims and inductive coding to allow for theme development was used to create an initial coding framework based on the nine double-coded transcripts12 (online supplemental material 3). The framework was agreed by the study team (CC, KC and JAL) and applied to remaining data. Triangulation addressed differences and similarities within themes across interviews and meeting observations for disconfirming and confirming instances. Data management and coding were facilitated using NVIVO V.10 software.13
Survey and analysis
An email invitation for the online survey was sent to trainees from all surgical specialties via administrators at the 18 Local Education Training Boards (LETB) in England and Deaneries in Scotland, Wales and Northern Ireland and advertised on social media in 2017. The anonymous survey asked about attitudes to, and involvement in, surgical research and collected basic demographic information (online supplemental material 4). Survey data were collected using Bristol Online Surveys (https://onlinesurveys.ac.uk/). Participants could enter a prize draw for a £50 voucher. Responses were analysed using descriptive statistics in STATA statistical software. Responses to open-ended survey questions were transferred into Microsoft Excel and two researchers (KC and NH) independently coded each response thematically then agreed the final themes to be integrated with the observation and interview data.
Stakeholder workshop and digital story
Thirty-seven expert stakeholders were invited to a workshop in 2018, of whom 13 attended: two consultant surgeons, four trainee surgeons, four trial methodologists, two research nurses, one chief operating officer for an NIHR Clinical Research Network, plus the study chief investigator (JAL) and researchers (CC and KC). Findings from the interviews, observations and survey were developed into key statements (CC/KC/JAL/NSB/NH) (online supplemental material 5) and these experts ranked the most useful strategies for TRCs and trainee development. Subsequently, a digital story outlining key strategies for enhancing trainee engagement in trials was produced using an Integrated Participant Digital Storytelling technique (IPDS). IPDS uses digital storytelling techniques and participant data to combine stories from personal experiences with multi-media tools to communicate evidence in an approachable and engaging manner.
Patient and public involvement
As the primary focus of engagement in trials was on trainees as the key stakeholders who would be affected by the research, we did not include a patient and public representative.
Reflexivity
Throughout our research, we recognised the impact of our multidisciplinary team’s roles on data interpretation and recommendations. While analysing data and shaping strategies, we embraced multiple perspectives, resulting in comprehensive data representation and more relevant findings. The team comprised social researchers, methodologists, clinicians and TRC members. Regular study management group meetings were held to review findings and key decisions.
Results
TRC meeting observation and interview participants
We observed five TRC meetings at different geographical locations, four were approximately 2 hours in the evening, and a 1 day national TRC meeting with plenary sessions and breakout workshops. Interviews included trainees from 9 of the 14 LETBs and 5 clinical specialties (characteristics in online supplemental material 6) and half of the consultant and trainee surgeons had been involved in RCTs (n=16, 50%).
Trainee survey participants
Seventy-three participants completed the survey from 11 LETBs and 10 clinical specialties (online supplemental materials 6 for respondent characteristics). Of these trainees, 36 (49%) were currently involved in TRC research, 7 had previously been involved (10%) and 30 had never been involved (41%). In total, 37 trainees (51%) were undergoing or had completed formal research training and 12 reported being a current or former academic trainee (16%).
Thematic findings
Three main themes were developed which are mapped in figure 1: (1) motivations for engagement in trainee collaborative research, (2) challenges to that engagement and (3) facilitating and optimising trainee collaborative research.
Thematic map of main themes for facilitating engagement with trainee collaborative research. CTU, Clinical Trials Unit; TRC, Trainee Research Collaborative.
Motivations for engagement in trainee collaborative research
Trainees, consultants and researchers recognised that TRCs provided momentum to trial conduct, contributed to higher quality study designs which produced greater impact on clinical practice than individualised research and so motivated their involvement. Interviewees spoke of the ‘power’ (P02, trainee, interview) of TRCs to deliver large studies relatively quickly by mobilising a cohort of trainees who facilitated access to, and recruited, patients and collected and reported data. Trainee engagement in TRCs and trials was viewed as mutually beneficial. It was also thought that trainees who engaged with TRCs would develop into research-active consultants (table 1).
Interviewee quotes for motivations for engagement in trainee collaborative research and challenges to that engagement
In the survey, trainees engaged in collaborative research because of (1) an interest in surgical research (n=43, 59%), (2) publications (n=39, 53%) and (3) improving patient care (n=37, 51%) (table 2). Some interviewees thought that their interest in publications was ‘purely selfish’ (P19, consultant, interview) to further careers, or meet training requirements so a ‘line in your CV’ (P06, consultant, interview). In contrast (and in the survey) many interviewed trainees had a genuine interest and enjoyed research and took up research training positions while others initially engaged in research to meet training requirements but came to enjoy it (table 1). Contributing to the advancement of their field and meaningful research for patient benefit were also important to interviewed trainees. Trainees welcomed the opportunity to generate study ideas and receive training to build their skills and confidence (table 1) as was observed during TRC meeting presentations by a CTU member on trial methodology and Good Clinical Practice by a Clinical Research Network representative.
Survey reasons for trainee involvement in or declining surgical collaborative research
Challenges in engagement with trainee collaborative research
Some interviewees and survey respondents reported a perception that trainee collaborative research is of poor quality as trainees have insufficient skills or time to conduct research. This appeared to discourage some trainees and collaborators and was also discussed at observed TRC meetings. One of the main concerns were competing clinical priorities and a lack of time for research and ‘trainee fatigue’ (P09, trainee, interview). Individualised, smaller studies could be quicker to complete and publish. Trainee movement between hospitals can pose problems yet amplifies engagement opportunities but necessitates careful planning (table 1).
Trainees were also hesitant about engaging with TRCs if they did not receive appropriate recognition for their contributions. Confidence and integration into a trainee collaborative were sometimes challenging as several survey participants were unaware of how to get involved in TRCs or had limited opportunities, for example, evening meetings due to childcare provision (P31, trainee, survey) (observed TRC meetings were in the evening) (table 1). Some trainees also found it difficult if TRCs had a predominantly male membership so seen as a ‘boys club’ (P13, trainee, interview) (table 1) and we also observed that junior trainees (or those moving from a different Deanery) tended to sit at the back of TRC meetings and made fewer contributions.
Strategies for facilitating and optimising trainee collaborative research
Trainee engagement and collaborative research were optimised with support from consultants, CTUs, research nurses and by having transparency over roles and authorship. Additional facilitators were study designs that the TRCs could enact easily, training and career progression opportunities.
Role of TRCs
TRCs played an important role in providing a supportive infrastructure for collaborative research and in ‘bringing together the pieces of the puzzle’ (P19, consultant, interview) through mentorship from individuals with knowledge and experience in trials. In one observed TRC meeting trainees gravitated to discussion groups led by more senior members of the TRC. Trainees also presented study ideas or had a sandpit-type session with senior academics and surgeons and some trainees providing constructive feedback. TRCs were also seen to facilitate networking and collaboration and trainees could get involved at the level and time appropriate to their circumstances (table 3).
Interviewee quotes for facilitating and optimising trainee collaborative research
Consultant surgeon support for TRCs
Consultant surgeon involvement and support was critical to establishing and maintaining TRCs and clinical trials, providing consistency for trial oversight and regulatory bodies and encouraging trial completion. Interviewees recommended seeking consultants to collaborate with, including at TRC meetings (also seen in observed meetings) (table 3).
CTU and research nurse support for TRCs
TRCs fostered communication between trainees, CTU staff and research nurses. CTUs provided important methodological and statistical support to trainees but also benefitted from the TRC-led trials in a symbiotic relationship. Research nurses helped coordinate trial recruitment and held knowledge about studies which could benefit trainees although they described how it was difficult initially working with multiple trainees on a trial as a new working practice. Nurses also felt it was important for early engagement by trainees and to develop good communication between all those involved which was helped by technology (table 3).
Transparency in roles and authorship
The importance of being clear and realistic with trainees throughout a study in a ‘terms of engagement’ and authorship agreements agreed by all parties was highlighted by many interviewees (table 3). Collaborative authorship models used by some TRCs recognised specific inputs and activities for group authorship which was supported by 49% (n=36) of surveyed trainees. However, 47% (n=34) of trainees surveyed stated coauthors should be individually named and in the observed meetings some trainees thought that collaborate authorship prevented first author publication requirements for the UK General Medical Council Certificate of Completion of Training (CCT).
Achievable study designs
Interviewees recommended that new TRCs commence with audits or feasibility/pilot studies to build skills and confidence as RCTs were regarded as daunting due to their duration, complexity, skills required and funding requirements. It was also helpful to identify specific aspects for trainees to contribute to obtain outputs (table 3).
Training and career progression
Interviewees felt that greater recognition of research activity was needed in their career pathway and greater emphasis on research training in the surgical curriculum. Survey respondents also thought TRCs should be part of surgical training (94.5%, n=69) but research should not be compulsory. Trainees valued informal, experiential in addition to formal training. Having trainees colead studies with more senior colleagues also allowed trainees to build confidence and skills and addressed funder requirements for a ‘consistent’, consultant on grant applications. Trainees could benefit from dedicated research time away from their busy clinical routines or for formal research training (eg, undertaking a PhD/MD) (table 3).
TRC engagement strategies and dissemination
The expert workshop prioritised five strategies for enhancing TRCs (table 4). These strategies were converted into a 6 min animated digital story on YouTube in 2019 (https://www.youtube.com/watch?v=vbITEHMjQfU) with 378 views (online supplemental video 1). A presentation at the national TRC meeting in 2019 received positive feedback including 232 Twitter impressions and was subsequently uploaded to four national and international TRC websites illustrating its perceived usefulness.
Top five strategies for enhancing Trainee Research Collaborative engagement
Discussion
Interviewees thought that surgical TRCs were generally successful in engaging trainees in research. However, we identified barriers and issues for trainees engaging in TRCs including time pressures due to clinical and other competing priorities (eg, childcare), concerns about research quality and wanting recognition for their inputs, most notably authorship. Trainees wished to increase surgical evidence and improve patient care; advance their careers and receive training and we used these motivations in developing strategies for enhancing engagement in TRCs. TRC strategies included gaining consultant and CTU support, creating opportunities for mentoring of trainees and to design studies, promoting the TRC with a rapid simple study and transparency about involvement and recognition, including authorship. These principles are valuable insights for TRCs as they are now being expanded into all clinical areas by the NIHR through their API scheme. The strategies can be accessed most easily by TRCs through the digital animation which was produced to promote their dissemination and wider uptake.
The establishment of TRCs, their structure and conduct of trainee-led studies have been described for several clinical specialties,14 ,15 ,16 including some of the strategies developed in this research, for example, a consultant champion.5 Consultant support was also highlighted in a recent study of a trainee-led clinical trial involved with the NIHR API scheme.17 Some TRC-led publications also advocated starting with a simple study design to give rapid recruitment and outcomes15 since trainee and consultant support can be variable until they are convinced of the merits of TRCs.15 16 Providing opportunities for trainees to generate study ideas and take on leadership roles, for example, as co-PI in TRC-led studies had not been highlighted previously to engage trainees. The interests of trainees in progressing their careers were also highlighted clearly in this study and although regarded by some as ‘selfish’ this benefitted the TRCs and potentially research more broadly. Identifying committed trainees was a WMRC principle5 but we showed that time and competing priorities are significant barriers, possibly reflecting increased trainee workloads since the formation of the WMRC. If TRCs can offer different options and levels of activity this could potentially increase trainee engagement.
The expectation of trainees for transparency around their involvement in a TRC and recognition of their inputs has been raised by several TRCs5 15 and in an analysis of TRC-led publications.18 Some TRCs have collaborative authorship policies to acknowledge trainee inputs.5 14 Although our study found some support for this model, others preferred ‘headline’ named authors, in part through concerns about publication requirements for the CCT. A consensus group has subsequently defined which TRC roles qualify for ‘significant authorship’ for journal and CCT requirements19 although acknowledging that named authorship for a TRC writing group could be appropriate. The National Research Collaborative (a TRC umbrella organisation) is also campaigning for recognition of collaborative research in training pathways.20
Advice and support from methodologists and CTUs in designing and conducting TRC studies was a key strategy in this study which was also highlighted by the WMRC.5 Professional specialty associations have provided infrastructure, academic and logistical support to TRCs2 20 although this was not a main strategy found in our study. Several TRCs have called for more tangible support to maintain their success,18 for example, data collection systems or funding20 having relied on technologically expert trainees for project infrastructure and database skills.16
Challenges in clinician involvement with TRCs, like competing priorities and time constraints, also impact engagement at the trial level.21 Limited awareness of research chances and training also hinders clinician engagement with trials.22 We propose addressing these through TRC involvement and provide organisational/network level strategies to surmount trial-level clinician engagement challenges.
To our knowledge, this is the first multi-stakeholder investigation of trainee motivations to engage in surgical TRCs and research using quantitative and qualitative methods. The digital animation was also a novel dissemination strategy and potentially enhanced uptake by trainees and TRCs. The positive evaluation of using digital videos in science communication has highlighted their potential to expand dissemination, enhance understanding and shift perspectives.23–26 The range of surgical specialties and TRCs across geographical areas increased the potential generalisability of findings. Triangulation of survey, interview and observation data gave an in-depth understanding of trainee collaborative research and correlations between data sources reinforced the main themes. The survey, we believe, uniquely included trainees not involved in TRCs so giving a broader perspective to inform these strategies. There are some limitations to the study as we only interviewed trainees involved in TRCs and those who were not involved may have held different views, possibly more negative or less informed about TRCs and enhanced understanding of engagement. The survey response rate was unknown (as there was no access to LEFT/Deanery registers) but was likely to be low and the uptake of the invitation to the stakeholder workshop was around 40% as some individuals did not reply to the invitation or were unavailable. The causes of interview non-response are unknown. Therefore, those who took part in interviews and the survey might have had greater interest and stronger beliefs about TRCs than non-respondents, possibly affecting these findings. This study predates the NIHR API scheme,7 so we were unable to assess its impact on trainee research and engagement with TRCs which would be an interesting extension to this study. Involving patients and public in the research process may also have added value. This study focused on surgical TRCs so these results may not be applicable to other TRCs although similar benefits and challenges were identified for physician TRCs in a recent study.27 Limited time during the COVID-19 pandemic led to a publication delay from 2019 to 2023, during which time practice may have changed. However, reports of continuing challenges to clinician engagement in trials21 22 suggest these strategies are still relevant.
Conclusions
Trainee surgeons are generally motivated to engage with research and through TRCs can conduct RCTs. Trainee engagement in collaborative research can be facilitated by enhancing relationships between key stakeholders, maximising multi-disciplinary working and providing trainees with training and career development opportunities. This study focused on surgical trainees and TRCs, but these findings and recommendations may be applicable to other clinical specialties and health professional groups which is important since the NIHR API scheme has been expanded recently across the NIHR portfolio.
Data availability statement
Data are available upon reasonable request. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
Ethical approval was obtained from the research ethics committee of the Faculty of Health Sciences at the University of Bristol (47721). All interview participants gave informed consent and agreed to publication of anonymised quotations. Survey completion was taken as implied consent and all responses were anonymised.
Acknowledgments
We thank all those who took part in the research and the expert workshop panel.
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @clareclement1, @NatalieBlencowe, @ProfJACook, @drjamesglasbey, @dnepo
Contributors JAL and NSB conceived the study idea. CC, KC, NH, TP, JB, NSB, RB, AA-P and JAL were involved in the design of the study. CC and KC conducted qualitative data collection and analysis with input from JAL. NSB, NH and KC conducted the survey data collection and analysis with assistance from other trainee surgeons. CS, ZH, LM, GM, JG, DN and VH were involved in the stakeholder workshop. CC drafted the initial manuscript. All authors commented on drafts and have seen and approved the final manuscript. JAL is responsible for the overall content as guarantor.
Funding This work was supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/2/N86), including an impact award for the digital animation, and was undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation in Difficult and Complex randomised controlled Trials) (MR/K025643/1). This study was designed and delivered in collaboration with the Bristol Trials Centre (BTC), a UKCRC registered clinical trials unit which was in receipt of National Institute for Health Research CTU support funding. KC, is currently funded by Health Education England (HEE)/National Institute for Health Research (NIHR) (ICA-CL-2018-04-ST2-008) and The Bristol Centre for Surgical Research and The NIHR Bristol and Weston Biomedical Research Centre (various grants) at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the authors and not necessarily those of the NIHR, NHS, the UK Department of Health and Social Care, RCS Eng or MRC.
Competing interests NH, TP, JB, NSB, JG, DN have been involved with a TRC; CC, KC, JAC, RB, AA-P, CS, LM, GM, JAL are methodologists who work with a CTU or in trials methodology and ZH and VH are research nurses who work with clinical research networks.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.