The COVID-19 pandemic impacted the operationalisation of non-COVID-19 clinical trials globally, particularly site and participant recruitment and trial success/stoppage. Trials which anticipate ...recruitment challenges may embed methods such as the QuinteT Recruitment Intervention (QRI) to help identify and understand the sources of challenges. Such interventions can help shed light on pandemic-related challenges. This paper reports our experience of the impact of the COVID-19 pandemic on conducting clinical trials with an embedded QRI, highlighting how the QRI aided in identifying challenges and potential solutions, particularly related to the site set-up and participant recruitment.
We report on 13 UK clinical trials which included a QRI. Information is from QRI data and researchers' experience and reflections. In most trials, recruitment was lower than even the lowest anticipated rates. The flexibility of the QRI facilitated rapid data collection to understand and document, and in some instances respond to, operational challenges. Challenges were mostly logistical, pandemic-related and beyond the control of the site or central trial teams. Specifically: disrupted and variable site opening timelines -often due to local research and development (R&D) delays- shortages of staff to recruit patients; fewer eligible patients or limited access to patients; and intervention-related factors. Almost all trials were affected by pandemic-related staffing issues including redeployment, prioritisation of COVID-19 care and research, and COVID-19-related staff illness and absence. Trials of elective procedures were particularly impacted by the pandemic, which caused changes to care/recruitment pathways, deprioritisation of services, reduced clinical and surgical capacity and longer waiting lists. Attempted solutions included extra engagement with staff and R&D departments, trial protocol changes (primarily moving online) and seeking additional resourcing.
We have highlighted wide-ranging, extensive and consistent pandemic-related challenges faced by UK clinical trials, which the QRI helped to identify and, in some cases, address. Many challenges were insurmountable at individual trials or trials unit level. This overview highlights the need to streamline trial regulatory processes, address staffing crises, improve recognition of NHS research staff and for clearer, more nuanced central guidance on the prioritisation of studies and how to deal with the backlog. Pre-emptively embedding qualitative work and stakeholder consultation into trials with anticipated difficulties, moving some processes online, and flexible trial protocols may improve the resilience of trials in the current challenging context.
Background
Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed ...to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019.
Methods
We evaluated changes in the trends for each procedure after its inclusion in the EBI’s first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance.
Results
Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI.
Conclusions
The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours.
ObjectivesRecruiting to randomised trials is often challenging particularly when the intervention arms are markedly different. The Mesothelioma and Radical Surgery 2 randomised controlled trial (RCT) ...compared standard chemotherapy with or without (extended) pleurectomy decortication surgery for malignant pleural mesothelioma. Anticipating recruitment difficulties, a QuinteT Recruitment Intervention was embedded in the main trial phase to unearth and address barriers. The trial achieved recruitment to target with a 4-month COVID-19 pandemic-related extension. This paper presents the key recruitment challenges, and the strategies delivered to optimise recruitment and informed consent.DesignA multifaceted, flexible, mixed-method approach to investigate recruitment obstacles drawing on data from staff/patient interviews, audio recorded study recruitment consultations and screening logs. Key findings were translated into strategies targeting identified issues. Data collection, analysis, feedback and strategy implementation continued cyclically throughout the recruitment period.SettingSecondary thoracic cancer care.ResultsRespiratory physicians, oncologists, surgeons and nursing specialists supported the trial, but recruitment challenges were evident. The study had to fit within a framework of a thoracic cancer service considered overstretched where patients encountered multiple healthcare professionals and treatment views, all of which challenged recruitment. Clinician treatment biases, shaped in part by the wider clinical and research context alongside experience, adversely impacted several aspects of the recruitment process by restricting referrals for study consideration, impacting eligibility decisions, affecting the neutrality in which the study and treatment was presented and shaping patient treatment expectations and preferences. Individual and group recruiter feedback and training raised awareness of key equipoise issues, offered support and shared good practice to safeguard informed consent and optimise recruitment.ConclusionsWith bespoke support to overcome identified issues, recruitment to a challenging RCT of surgery versus no surgery in a thoracic cancer setting with a complex recruitment pathway and multiple health professional involvement is possible.Trial registration numberISRCTN ISRCTN44351742, Clinical Trials.gov NCT02040272.
IntroductionRecruitment to randomised trials (RCTs) is often challenging. Reviews of interventions to improve recruitment have highlighted a paucity of effective interventions aimed at recruiters and ...the need for further research in this area. Understanding the perspectives and experiences of those involved in RCT recruitment can help to identify barriers and facilitators to recruitment, and subsequently inform future interventions to support recruitment. This protocol describes methods for a proposed qualitative evidence synthesis (QES) of recruiters’ perspectives and experiences relating to RCT recruitment.Methods and analysisThe proposed review will synthesise studies reporting clinical and non-clinical recruiters’ perspectives and experiences of recruiting to RCTs. The following databases will be searched: Ovid MEDLINE, CINAHL, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, ORRCA and Web of Science. A thematic synthesis approach to analysing the data will be used. An assessment of methodological limitations of each study will be performed using the Critical Appraisal Skills Programme tool. Assessing the confidence in the review findings will be evaluated using the GRADE Confidence in Evidence from Reviews of Qualitative research (GRADE-CERQual) tool.Ethics and disseminationThe proposed QES will not require ethical approval as it includes only published literature. The results of the synthesis will be published in a peer-reviewed journal and publicised using social media. The results will be considered alongside other work addressing factors affecting recruitment in order to inform future development and refinement of recruitment interventions.PROSPERO registration numberCRD42020141297.
Abstract
Background
Recruiting patients to randomised controlled trials (RCTs) is often reported to be challenging, and the evidence base for effective interventions that could be used by staff ...(recruiters) undertaking recruitment is lacking. Although the experiences and perspectives of recruiters have been widely reported, an evidence synthesis is required in order to inform the development of future interventions. This paper aims to address this by systematically searching and synthesising the evidence on recruiters’ perspectives and experiences of recruiting patients into RCTs.
Methods
A qualitative evidence synthesis (QES) following Thomas and Harden’s approach to thematic synthesis was conducted. The Ovid MEDLINE, CINAHL, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, ORRCA and Web of Science electronic databases were searched. Studies were sampled to ensure that the focus of the research was aligned with the phenomena of interest of the QES, their methodological relevance to the QES question, and to include variation across the clinical areas of the studies. The GRADE CERQual framework was used to assess confidence in the review findings.
Results
In total, 9316 studies were identified for screening, which resulted in 128 eligible papers. The application of the QES sampling strategy resulted in 30 papers being included in the final analysis. Five overlapping themes were identified which highlighted the complex manner in which recruiters experience RCT recruitment: (1) recruiting to RCTs in a clinical environment, (2) enthusiasm for the RCT, (3) making judgements about whether to approach a patient, (4) communication challenges, (5) interplay between recruiter and professional roles.
Conclusions
This QES identified factors which contribute to the complexities that recruiters can face in day-to-day clinical settings, and the influence recruiters and non-recruiting healthcare professionals have on opportunities afforded to patients for RCT participation. It has reinforced the importance of considering the clinical setting in its entirety when planning future RCTs and indicated the need to better normalise and support research if it is to become part of day-to-day practice.
Trial registration
PROSPERO CRD42020141297 (registered 11/02/2020).
Cervical traumatic spinal cord injury is a devastating condition. Current management (bony decompression) may be inadequate as after acute severe TSCI, the swollen spinal cord may become compressed ...against the surrounding tough membrane, the dura. DISCUS will test the hypothesis that, after acute, severe traumatic cervical spinal cord injury, the addition of dural decompression to bony decompression improves muscle strength in the limbs at 6 months, compared with bony decompression alone.
This is a prospective, phase III, multicenter, randomized controlled superiority trial. We aim to recruit 222 adults with acute, severe, traumatic cervical spinal cord injury with an American Spinal Injury Association Impairment Scale grade A, B, or C who will be randomized 1:1 to undergo bony decompression alone or bony decompression with duroplasty. Patients and outcome assessors are blinded to study arm. The primary outcome is change in the motor score at 6 months vs. admission; secondary outcomes assess function (grasp, walking, urinary + anal sphincters), quality of life, complications, need for further surgery, and mortality, at 6 months and 12 months from randomization. A subgroup of at least 50 patients (25/arm) also has observational monitoring from the injury site using a pressure probe (intraspinal pressure, spinal cord perfusion pressure) and/or microdialysis catheter (cord metabolism: tissue glucose, lactate, pyruvate, lactate to pyruvate ratio, glutamate, glycerol; cord inflammation: tissue chemokines/cytokines). Patients are recruited from the UK and internationally, with UK recruitment supported by an integrated QuinteT recruitment intervention to optimize recruitment and informed consent processes. Estimated study duration is 72 months (6 months set-up, 48 months recruitment, 12 months to complete follow-up, 6 months data analysis and reporting results).
We anticipate that the addition of duroplasty to standard of care will improve muscle strength; this has benefits for patients and carers, as well as substantial gains for health services and society including economic implications. If the addition of duroplasty to standard treatment is beneficial, it is anticipated that duroplasty will become standard of care.
IRAS: 292031 (England, Wales, Northern Ireland) - Registration date: 24 May 2021, 296518 (Scotland), ISRCTN: 25573423 (Registration date: 2 June 2021); ClinicalTrials.gov number : NCT04936620 (Registration date: 21 June 2021); NIHR CRN 48627 (Registration date: 24 May 2021).
Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research ...funders. We aimed to identify and describe current PPI practice in surgical trials in the United Kingdom, and to explore the views and experiences of surgical trial staff and patient or public contributors in relation to these practices. This was part of a larger study to inform development of a robust PPI intervention aimed at improving recruitment and retention in surgical trials.
Our study had two stages: 1) an online survey to identify current PPI practice in active UK-led, adult surgical trials; and 2) focus groups and interviews with key stakeholders (surgical trial investigators, administrators, and patient or public contributors) to explore their views and experiences of PPI.
Of 129 eligible surgical trial teams identified, 71 (55%) took part in the survey. In addition, 54 stakeholders subsequently took part in focus groups or interviews. Sixty-five (92%) survey respondents reported some kind of PPI, most commonly at the design and dissemination stages and in oversight or advisory roles. The single most common PPI activity was developing participant information sheets (72%). Participants reported mixed practice and views on a variety of issues including the involvement of patients versus lay members of the public, recruitment methods, use of role descriptions and payment for the time of PPI contributors. They suggested some solutions, including the use of written role descriptions and databases of potential PPI contributors to aid recruitment.
UK surgical trials involve patients and members of the public in a variety of different ways, most commonly at the beginning and end of the trial lifecycle and in oversight or advisory roles. These are not without challenges and there remain uncertainties about who best to involve, why, and how. Future research should aim to address these issues.
ObjectiveNew evidence about existing health technologies can raise questions about the benefits of continued provision. It may be possible to stop or reduce the technology use in people where benefit ...may not justify health system costs. The EBI programme was introduced in the English National Health Service (NHS) in April 2019. The programme provides guidance for local health system managers to stop or reduce certain procedures where evidence indicates limited or no benefit (for some or all patients). The aim of this study is to investigate patients’ understanding and experiences of care for symptoms where access to procedures may be constrained by the EBI programme.MethodsThis is a qualitative study based on case study design. The data collection methods planned are semi-structured interview(s) with patients who are potential candidates for three case study procedures from the EBI programme. Alongside this, audio-recordings of these patients’ clinical consultations will be collected, with a focus on how treatment options are discussed. Data will be analysed thematically, using the constant comparative approach.ResultsData collection will commence in January 2022 with preliminary findings presented. The topics that will be covered in the interviews and audio-recordings include patients’ experiences of their initial referral by primary care and their pathway leading to specialist consultation; any expectations they may have had for their care and what the implications were if these were not met; and their general views on access to NHS care.ConclusionResearch on the impact of initiatives that aim to reduce healthcare use from stakeholders’ perspectives is lacking. This study is one of the first to focus on patients’ understanding and perspectives of care in this context. Findings from this study will provide timely information on the implications of these initiatives on patients’ experiences of care.
ObjectiveThe impact of the COVID-19 pandemic on the English National Health Service (NHS) has been profound. Those who commission health services face questions and pressures around addressing ...growing waiting lists and ensuring patients receive appropriate and timely treatment. In 2019, NHS England launched the Evidence-Based Interventions (EBI) programme, a national initiative that intends to reduce provision of medical and surgical interventions found to have insufficient evidence of effectiveness - either in general, or in select patient groups. The EBI programme originally produced treatment policy recommendations for 17 interventions across several surgical specialties. Reducing provision of treatments already embedded in practice has been historically challenging for health services worldwide. Our ongoing NIHR-funded mixed methods study seeks to evaluate the impact and acceptability of the EBI programme. As part of this work, a key objective is to investigate national policy-makers’ experiences of implementing the EBI programme during the COVID-19 pandemic, and its role in the COVID recovery programme.MethodsSemi-structured interviews with informants working within English Clinical Commissioning Groups (CCGs) and at a national level. Data are being analysed thematically, using the constant comparison approach. Data collection and analysis are ongoing, with 10 interviews having been undertaken with informants from 6 geographically spread CCGs.ResultsEmerging findings indicate that although the pandemic impacted how informants were able to implement evidence-based treatment policies, these were perceived to be potentially useful in supporting healthcare providers to manage waiting lists in a clinically appropriate manner.DiscussionThis research will provide early empirical insights into informants’ experiences of priority setting during and in the wake of COVID-19. Early findings suggest that historically challenging priority setting processes may be easier to implement, from informants’ perspectives, under the auspices of waiting list management following the pandemic. More developed findings and implications will be reported at the conference.
In the era of “culture wars,” instances where client and practitioner discuss political issues in therapy may become more frequent. This paper introduces the way in which “culture wars” manifest in ...today's societies and highlights the importance of therapeutic practitioners to engage with and explore their own views in relation to these polarising political debates. In doing so, this paper reflects upon the existing research focussing on the way in which “culture wars” enter the therapeutic encounter and highlights the feelings of anxiety and conflict that arise when practitioners are tasked with “talking politics” with clients. It considers the implications for practice and policy and concludes with recommendations for future scholarship, arguing for more culturally specific studies that examine how “culture wars” issues impact therapeutic work in a variety of international settings.
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