A qualitative analysis of the model-building process

Decision-analytic models have an important role in healthcare funding decisions in the UK and internationally. However, errors have been reported in published models, which may indicate poor modelling practices, potentially leading to sub-optimal recommendations on cost-effectiveness. Little in-depth research has been undertaken to investigate the processes used by modellers in model development. The objective of this research was to explore the modelling methods used by modellers, with particular focus on problems encountered. This work involved two qualitative phases of research. In the first phase, twenty-four in-depth interviews with modellers were undertaken. Constant comparative analysis was used to compare informant practices, and identify common issues in model development. The second phase involved two separate model-building case studies with teams of modellers and clinicians. Methods of non-participant observation, qualitative interviews, and think-aloud were used to investigate model development. The findings of the case studies were compared using framework analysis. Important themes emerging from both phases of the research concerned the diversity of practices in structural development, problems with clinician involvement in modelling, and a lack of time and resources to carry out good practice methods. This work offers important recommendations for modelling practice, and suggestions for future research to improve modelling method

Understanding and Improving Recruitment to Randomised Controlled Trials:Qualitative Research Approaches

Context The importance of evidence from randomised trials is now widely recognised, although recruitment is often difficult. Qualitative research has shown promise in identifying the key barriers to recruitment, and interventions have been developed to reduce organisational difficulties and support clinicians undertaking recruitment. Objective This article provides an introduction to qualitative research techniques and explains how this approach can be used to understand — and subsequently improve — recruitment and informed consent within a range of clinical trials. Evudence acquisition A literature search was performed using Medline, Embase, and CINAHL. All studies with qualitative research methods that focused on the recruitment activity of clinicians were included in the review. Evidence synthesis The majority of studies reported that organisational difficulties and lack of time for clinical staff were key barriers to recruitment. However, a synthesis of qualitative studies highlighted the intellectual and emotional challenges that arise when combining research with clinical roles, particularly in relation to equipoise and patient eligibility. To support recruiters to become more comfortable with the design and principles of randomised controlled trials, interventions have been developed, including the QuinteT Recruitment Intervention, which comprises in-depth investigation of recruitment obstacles in real time, followed by implementation of tailored strategies to address these challenges as the trial proceeds. Conclusions Qualitative research can provide important insights into the complexities of recruitment to trials and inform the development of interventions, and provide support and training initiatives as required. Investigators should consider implementing such methods in trials expected to be challenging or recruiting below target. Patient summary Qualitative research is a term used to describe a range of methods that can be implemented to understand participants’ perspectives and behaviours. Data are gathered from interviews, focus groups, or observations. In this review, we demonstrate how this approach can be used to understand—and improve—recruitment to clinical trials. Taken together, our review suggests that healthcare professionals can find recruiting to trials challenging and require support with this process.</p

Estimating loss in capability wellbeing in the first year of the COVID-19 pandemic:a cross-sectional study of the general adult population in the UK, Australia and the Netherlands

Objectives To estimate capability wellbeing lost from the general adult populations in the UK, Australia and the Netherlands in the first year of the COVID-19 pandemic and the associated social restrictions, including lockdowns. Design Cross-sectional with recalled timepoints. Setting Online panels in the UK, Australia and the Netherlands conducted in February 2021 (data collected 26 January-2 March 2021). Participants Representative general adult (>= 18 years old) population samples in the UK (n = 1,017), Australia (n = 1,011) and the Netherlands (n = 1,017) Main outcome measure Participants completed the ICECAP-A capability wellbeing measure in February 2021, and for two recalled timepoints during the initial lockdowns in April 2020 and in February 2020 (prior to COVID-19 restrictions in all three countries). ICECAP-A scores on a 0-1 no capability-full capability scale were calculated for each timepoint. Societal willingness to pay estimates for a year of full capability (YFC) was used to place a monetary value associated with change in capability per person and per country. Paired t tests were used to compare changes in ICECAP-A and YFC from pre- to post-COVID-19-related restrictions in each country. Results Mean (standard deviation) loss of capability wellbeing during the initial lockdown was 0.100 (0.17) in the UK, 0.074 (0.17) in Australia and 0.049 (0.12) in the Netherlands. In February 2021, losses compared to pre-lockdown were 0.043 (0.14) in the UK, 0.022 (0.13) in Australia and 0.006 (0.11) in the Netherlands. In monetary terms, these losses were equivalent to 14.8 pound billion, AUD$8.6 billion and euro2.1 billion lost per month in April 2020 and 6.4 pound billion, A$2.6 billion and euro260 million per month in February 2021 for the UK, Australia and the Netherlands, respectively. Conclusions There were substantial losses in capability wellbeing in the first year of the COVID-19 pandemic. Future research is required to understand the specific impact of particular COVID-19 restrictions on people's capabilities

Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care

Abstract Background Recruitment to randomised controlled trials (RCTs) is challenging. Pre-trial qualitative research provides insights into the feasibility and acceptability of proposed trial designs and delivery; however, this is rarely conducted. This paper reports on work undertaken in advance of the Prepare for Kidney Care trial (formerly PrepareME), which compares preparing for dialysis with preparing for conservative care for patients with chronic kidney disease. The paper describes how the findings refined plans for the forthcoming trial. Methods Semi-structured interviews were undertaken with health-care professionals involved in delivering or recruiting to the trial. Interview findings were considered in relation to observations of a patient advisory group workshop and introductory site visits, which were set up to present the trial to professionals involved in the internal pilot phase of the RCT. The use of findings and input from multiple sources was intended to support suggested refinements to the forthcoming trial. The findings were fed back to the trial management group and other expert stakeholders. Results Sixteen health-care professionals were interviewed, and one patient advisory group workshop and six introductory visits to sites involved in the internal pilot were observed. The professionals interviewed included renal consultants, nurses and renal social workers. Key themes identified from the interviews, supported by the observations, were concerns around the eligibility criteria, the feasibility of the trial intervention, imbalances in the presentation of the trial arms, and anticipated recruitment issues arising from patients’ and clinicians’ preferences for one arm or the other. Changes to the design were made in response, including to the content of the intervention, the presentation of the trial arms and the name of the RCT. Conclusions This study highlights the value of carrying out pre-trial work with health-care professionals to identify issues with delivering the proposed trial. This work can be particularly valuable in trials of new interventions, for which the barriers to their integration into routine care are unknown. This work has important implications for facilitating the identification of further obstacles in the main RCT. We suggest that pre-trial qualitative work is undertaken to address design issues early on, in addition to ongoing qualitative research to monitor the emergence of obstacles affecting recruitment

Optimising recruitment to the HAND-1 RCT feasibility study:integration 1 of the QuinteT Recruitment Intervention (QRI)

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention—the QuinteT Recruitment Intervention (QRI)—to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren’s contracture (the HAND-1 study). Methods: The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges. Results: Two key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target. Conclusions: Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a “head start” in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in “real-time” as recruitment proceeds