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

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.

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

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.

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

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,

Postoperative complications in glaucoma surgery: literature review-based recommendations to improve reporting consistency

AimsTo recommend a list of complications of glaucoma surgery to be used in future glaucoma surgery research and reporting by exploring the spectrum of complications’ names, the variety of definitions and time frames used for reporting them in glaucoma surgical trials.MethodsComplications’ names, definitions and time frames identified from a previously conducted systematic review of glaucoma surgery trials (registration number: CRD42019121226) were reviewed. Only postoperative complications were considered. Surgical techniques described in the papers from the previous systematic review were retrieved and grouped according their mechanism of action.Reviewers independently recommended each complication’s inclusion or exclusion in a list to be proposed as a potential standard for reporting in glaucoma interventions. A literature-based definition of a ‘surgical complication’ was used to inform these decisions. Recorded complication’s details were used to inform the development of clinically relevant definitions, a consensus-driven exercise between reviewers resolved disagreements.ResultsWe identified 48/111 (43.2%) of the reported complications as suitable for inclusion, of which 17 were merged into other included complications having a broader meaning making up a final table of 32 postoperative complications. For 25 of them, the authors kept ‘names’ that were previously used in the systematic review, but provided a definition that was not mentioned in these papers. Five included complications were given both ‘names’ and definitions not previously mentioned. The authors maintained the name and definition for one complication. There were 16 complications that were in common to all the procedures retrieved from the previous review.ConclusionsWe propose a table of revised names and comprehensive definitions of postoperative complications, to simplify the process of reporting complications after glaucoma surgery and to improve consistency among surgical trials.