BackgroundPragmatic randomised controlled trials (RCTs) are considered essential to determine effective interventions for routine clinical practice, but many fail to recruit participants efficiently, and some really important RCTs are not undertaken because recruitment is thought to be too difficult. The ‘QuinteT Recruitment Intervention’ (QRI) aims to facilitate informed decision making by patients about RCT participation and to increase recruitment. This paper presents the development and implementation of the QRI.MethodsThe QRI developed iteratively as a complex intervention. It emerged from the National Institute for Health Research (NIHR) ProtecT trial and has been developed further in 13 RCTs. The final version of the QRI uses a combination of standard and innovative qualitative research methods with some simple quantification to understand recruitment and identify sources of difficulties.ResultsThe QRI has two major phases: understanding recruitment as it happens and then developing a plan of action to address identified difficulties and optimise informed consent in collaboration with the RCT chief investigator (CI) and the Clinical Trials Unit (CTU). The plan of action usually includes RCT-specific, as well as generic, aspects. The QRI can be used in two ways: it can be integrated into the feasibility/pilot or main phase of an RCT to prevent difficulties developing and optimise recruitment from the start, or it can be applied to an ongoing RCT experiencing recruitment shortfalls, with a view to rapidly improving recruitment and informed consent or gathering evidence to justify RCT closure.ConclusionsThe QRI provides a flexible way of understanding recruitment difficulties and producing a plan to address them while ensuring engaged and well-informed decision making by patients. It can facilitate recruitment to the most controversial and important RCTs. QRIs are likely to be of interest to the CIs and CTUs developing proposals for ‘difficult’ RCTs or for RCTs with lower than expected recruitment and to the funding bodies wishing to promote efficient recruitment in pragmatic RCTs.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1391-4) contains supplementary material, which is available to authorized users.

BackgroundRandomised controlled trials (RCTs) are essential for evidence-based medicine and increasingly rely on front-line clinicians to recruit eligible patients. Clinicians’ difficulties with negotiating equipoise is assumed to undermine recruitment, although these issues have not yet been empirically investigated in the context of observable events. We aimed to investigate how clinicians conveyed equipoise during RCT recruitment appointments across six RCTs, with a view to (i) identifying practices that supported or hindered equipoise communication and (ii) exploring how clinicians’ reported intentions compared with their actual practices.Methods and FindingsSix pragmatic UK-based RCTs were purposefully selected to include several clinical specialties (e.g., oncology, surgery) and types of treatment comparison. The RCTs were all based in secondary-care hospitals (n = 16) around the UK. Clinicians recruiting to the RCTs were interviewed (n = 23) to understand their individual sense of equipoise about the RCT treatments and their intentions for communicating equipoise to patients. Appointments in which these clinicians presented the RCT to trial-eligible patients were audio-recorded (n = 105). The appointments were analysed using thematic and content analysis approaches to identify practices that supported or challenged equipoise communication. A sample of appointments was independently coded by three researchers to optimise reliability in reported findings. Clinicians and patients provided full written consent to be interviewed and have appointments audio-recorded.Interviews revealed that clinicians’ sense of equipoise varied: although all were uncertain about which trial treatment was optimal, they expressed different levels of uncertainty, ranging from complete ambivalence to clear beliefs that one treatment was superior. Irrespective of their personal views, all clinicians intended to set their personal biases aside to convey trial treatments neutrally to patients (in accordance with existing evidence). However, equipoise was omitted or compromised in 48/105 (46%) of the recorded appointments. Three commonly recurring practices compromised equipoise communication across the RCTs, irrespective of clinical context. First, equipoise was overridden by clinicians offering treatment recommendations when patients appeared unsure how to proceed or when they asked for the clinician’s expert advice. Second, clinicians contradicted equipoise by presenting imbalanced descriptions of trial treatments that conflicted with scientific information stated in the RCT protocols. Third, equipoise was undermined by clinicians disclosing their personal opinions or predictions about trial outcomes, based on their intuition and experience. These broad practices were particularly demonstrated by clinicians who had indicated in interviews that they held less balanced views about trial treatments. A limitation of the study was that clinicians volunteering to take part in the research might have had a particular interest in improving t...

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BackgroundNHS expenditure has stagnated since the economic crisis of 2007, resulting in financial pressures. One response is for policy-makers to regulate use of existing health-care technologies and disinvest from inefficiently used health technologies. A key challenge to disinvestment is to identify existing health technologies with uncertain cost-effectiveness.ObjectivesWe aimed to explore if geographical variation in procedure rates is a marker of clinical uncertainty and might be used by local commissioners to identify procedures that are potential candidates for disinvestment. We also explore obstacles and solutions to local commissioners achieving disinvestment, and patient and clinician perspectives on regulating access to procedures.MethodsWe used Hospital Episode Statistics to measure geographical variation in procedure rates from 2007/8 to 2011/12. Expected procedure numbers for each primary care trust (PCT) were calculated adjusting for proxies of need. Random effects Poisson regression quantified the residual inter-PCT procedure rate variability. We benchmarked local procedure rates in two PCTs against national rates. We conducted rapid systematic reviews of two high-use procedures selected by the PCTs [carpal tunnel release (CTR) and laser capsulotomy], searching bibliographical databases to identify systematic reviews and randomised controlled trials (RCTs). We conducted non-participant overt observations of commissioning meetings and semistructured interviews with stakeholders about disinvestment in general and with clinicians and patients about one disinvestment case study. Transcripts were analysed thematically using constant comparison methods derived from grounded theory.ResultsThere was large inter-PCT variability in procedure rates for many common NHS procedures. Variation in procedure rates was highest where the diffusion or discontinuance was rapidly evolving and where substitute procedures were available, suggesting that variation is a proxy for clinical uncertainty about appropriate use. In both PCTs we identified procedures where high local use might represent an opportunity for disinvestment. However, there were barriers to achieving disinvestment in both procedure case studies. RCTs comparing CTR with conservative care indicated that surgery was clinically effective and cost-effective on average but provided limited evidence on patient subgroups to inform commissioning criteria and achieve savings. We found no RCTs of laser capsulotomy. The apparently high rate of capsulotomy was probably due to the coding inaccuracy; some savings might be achieved by greater use of outpatient procedures. Commissioning meetings were dominated by new funding requests. Benchmarking did not appear to be routinely carried out because of capacity issues and concerns about data reliability. Perceived barriers to disinvestment included lack of collaboration, central support and tools for disinvestment. Clinicians felt threshold criteria had little impact on their practice and that prior approval systems would not be cost-effective. Most patients were unaware of rationing.ConclusionsPolicy-makers could use geographical variation as a starting point to identify procedures where health technology reassessment or RCTs might be needed to inform policy. Commissioners can use benchmarking to identify procedures with high local use, possibly indicating overtreatment. However, coding inconsistency and limited evidence are major barriers to achieving disinvestment through benchmarking. Increased central support for commissioners to tackle disinvestment is needed, including tools, accurate data and relevant evidence. Early engagement with patients and clinicians is essential for successful local disinvestment.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

ObjectiveTo evaluate the impact of the QuinteT Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties and then implements “QRI actions” to address these as recruitment proceeds.Study Design and SettingA mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) qualitative case studies, including documentary analysis and interviews with RCT investigators.ResultsFive UK-based publicly funded RCTs were included in the evaluation. All recruited to target. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI actions in RCTs 1, 3, 4, and 5. Randomization rates significantly improved after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action.ConclusionThere is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.