EP.WE.842Maintaining Recruitment to Surgical Trials during the Pandemic

Abstract Aims Recruitment to Randomised Controlled Trials (RCTs) has traditionally been the domain of Research Nurses. Due to the unprecedented pressures of the COVID pandemic, the majority of Research Nurses have been redeployed to other clinical roles, or those still working within research have had to focus on COVID-related projects. This has left existing surgical trials struggling to recruit. We report on our experience of engaging Specialist Nurses without a research background as well as Consultants and Trainees to support surgical research in these challenging circumstances. Method The Sunflower RCT was first opened to recruitment in August 2019 at our trust. The recruitment was led by single Research Nurse, but the delegation log included a range of Consultants, Trainees, and Specialist Nurses. Due to the COVID pandemic, recruitment was paused from March 2020 and restarted in July 2020. Data were collected on recruitment until January 2021. Results In the seven months before the recruitment pause, 80 patients were recruited (average 11 per month), with the highest proportion of recruits by the sole Research Nurse. Following the recruitment pause, a further 45 patients were recruited (average 7.5 per month). These patients were recruited by Consultants (20, 44%), Specialist Nurses (12, 27%), Trainees (7, 16%), Research Nurse (3, 7%) and postal consents (3, 7%). Conclusions We have demonstrated that surgical research activity can be maintained even with minimal Research Nurse recruitment by engaging all members of the surgical team, especially utilising Specialist Nurses, who may not commonly be approached for such a role.

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Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Trials ◽

10.1186/s13063-021-05348-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Alice MacLachlan ◽

Karen Crawford ◽

Shona Shinwell ◽

Catherine Nixon ◽

Marion Henderson

Keyword(s):

Pregnant Women ◽

Randomised Controlled Trials ◽

Social Care ◽

Early Years ◽

Controlled Trials ◽

Recruitment Strategies ◽

Recruitment Activities ◽

Research Nurses ◽

Randomised Controlled ◽

The Impact

Abstract Background Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we report the recruitment strategies and costs for the Trial for Healthy Relationship Initiatives in the Very Early years (THRIVE), an RCT evaluating two group-based parenting interventions for pregnant women. Methods THRIVE aimed to recruit 500 pregnant women with additional health and social care needs in Scotland between 2014 and 2018. Three recruitment strategies were employed: (1) referrals from a health or social care practitioner or voluntary/community organisation (practitioner-led referral), (2) direct engagement with potential participants by research staff (researcher-led recruitment) and (3) self-referral in response to study advertising (self-referral). The number of referrals and recruited participants from each strategy is reported along with the overall cost of recruitment. The impact of recruitment activities and the changes in maternity policy/context on recruitment throughout the study are examined. Results THRIVE received 973 referrals: 684 (70%) from practitioners (mainly specialist and general midwives), 273 (28%) from research nurses and 16 (2%) self-referrals. The time spent in antenatal clinics by research nurses each month was positively correlated with the number of referrals received (r = 0.57; p < 0.001). Changes in maternity policies and contexts were reflected in the number of referrals received each month, with both positive and negative impacts throughout the trial. Overall, 50% of referred women were recruited to the trial. Women referred via self-referral, THRIVE research nurses and specialist midwives were most likely to go on to be recruited (81%, 58% and 57%, respectively). Key contributors to recruitment included engaging key groups of referrers, establishing a large flexible workforce to enable recruitment activities to adapt to changes in context throughout the study and identifying the most appropriate setting to engage with potential participants. The overall cost of recruitment was £377 per randomised participant. Conclusions Recruitment resulted from a combination of all three strategies. Our reflections on the successes and challenges of these strategies highlight the need for recruitment strategies to be flexible to adapt to complex interventions and real-world challenges. These findings will inform future research in similar hard-to-reach populations. Trial registration International Standard Randomised Controlled Trials Number Registry ISRCTN21656568. Retrospectively registered on 28 February 2014

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Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop

Health Technology Assessment ◽

10.3310/hta25530 ◽

2021 ◽

Vol 25 (53) ◽

pp. 1-52

Author(s):

David J Beard ◽

Marion K Campbell ◽

Jane M Blazeby ◽

Andrew J Carr ◽

Charles Weijer ◽

...

Keyword(s):

Randomised Controlled Trials ◽

Medical Research Council ◽

Placebo Control ◽

Controlled Trials ◽

Surgical Trials ◽

Surgical Interventions ◽

Placebo Controls ◽

Randomised Controlled ◽

The Uk ◽

Future Work

Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.

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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

10.21203/rs.3.rs-442878/v1 ◽

2021 ◽

Author(s):

Arabella Scantlebury ◽

Catriona McDaid ◽

Stephen Brealey ◽

Elizabeth Cook ◽

Arun Ranganathan ◽

...

Keyword(s):

Systematic Review ◽

United Kingdom ◽

Mixed Methods ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Surgical Trials ◽

Patient Pathways ◽

Study Results ◽

Randomised Controlled ◽

The Impact

Abstract Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries, or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design: Two qualitative process evaluations of a United Kingdom-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting: NHS secondary care organisations throughout the United Kingdom. Interviews were undertaken via telephone. Participants: 37 trial recruiters (surgeons, physiotherapists, research nurses) and 22 patients were interviewed. Patients included those who agreed to participate in the ACTIVE and PRESTO studies and patients that declined participation in the ACTIVE study. Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registries: ACTIVE: (ISRCTN98152560) PRESTO: (ISRCTN12094890)

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Opportunities for randomised surgical trials

Bulletin of The Royal College of Surgeons of England ◽

10.1308/147363509x449555 ◽

2009 ◽

Vol 91 (6) ◽

pp. 202-203 ◽

Cited By ~ 1

Author(s):

Jane M Blazeby

Keyword(s):

Clinical Trials ◽

Research Funding ◽

Randomised Controlled Trials ◽

Individual Decision ◽

National Guidelines ◽

Individual Decision Making ◽

Surgical Trials ◽

Randomised Controlled ◽

The Uk ◽

Quality Evidence

Well-designed and conducted randomised controlled trials (RCTs) generate quality evidence that leads to improvement in surgical practice. The evidence can inform individual decision-making about the benefits and harms of a procedure, underpin national guidelines and influence policy decisions regarding investment. Although the number of surgical RCTs is substantially higher in the UK than in many other European countries, the need for more and better surgical trials is well recognised. In the UK there have recently been several major changes in research funding and infrastructure for clinical trials and these represent an important opportunity for surgeons to collaborate with clinical trials units and methodologists to design and conduct randomised surgical trials.

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Registration and publication of emergency and elective randomised controlled trials in surgery: a cohort study from trial registries

BMJ Open ◽

10.1136/bmjopen-2018-021700 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021700 ◽

Cited By ~ 4

Author(s):

Rachael L Morley ◽

Matthew J Edmondson ◽

Ceri Rowlands ◽

Jane M Blazeby ◽

Robert J Hinchliffe

Keyword(s):

Outcome Measures ◽

Emergency Surgery ◽

Randomised Controlled Trials ◽

Primary Outcome ◽

Elective Surgery ◽

Secondary Outcome ◽

Controlled Trials ◽

Surgical Trials ◽

Surgical Interventions ◽

Randomised Controlled

ObjectivesEmergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials.DesignThe clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword ‘surgery’. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE.ParticipantsResults with no surgical interventions were excluded. The remaining results were manually categorised into ‘emergency’ or ‘elective’ and ‘surgical’ or ‘adjunct’ by two reviewers.Primary outcome measuresNumber of RCTs registered in emergency versus elective surgery.Secondary outcome measuresNumber of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery.Results2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) −0.06, 95% CI −0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD −0.18, 95% CI −0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD −0.04, 95% CI −0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD −0.18, 95% CI −0.43 to 0.07).ConclusionFewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.

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Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Trials ◽

10.1186/s13063-021-05420-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Arabella Scantlebury ◽

Catriona McDaid ◽

Stephen Brealey ◽

Elizabeth Cook ◽

Hemant Sharma ◽

...

Keyword(s):

Systematic Review ◽

Mixed Methods ◽

Health Professionals ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Surgical Trials ◽

Link Type ◽

Patient Pathways ◽

Randomised Controlled ◽

The Impact

Abstract Background Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. Design Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. Setting NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. Participants Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. Results We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient’s circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients’ treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. Conclusions A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. Trial registration ACTIVE: (ISRCTN98152560). Registered on 06/03/2018. PRESTO: (ISRCTN12094890). Registered on 22/02/2018,

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