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

Use of external evidence for design and Bayesian analysis of clinical trials:a qualitative study of trialists’ views

Abstract Background Evidence from previous studies is often used relatively informally in the design of clinical trials: for example, a systematic review to indicate whether a gap in the current evidence base justifies a new trial. External evidence can be used more formally in both trial design and analysis, by explicitly incorporating a synthesis of it in a Bayesian framework. However, it is unclear how common this is in practice or the extent to which it is considered controversial. In this qualitative study, we explored attitudes towards, and experiences of, trialists in incorporating synthesised external evidence through the Bayesian design or analysis of a trial. Methods Semi-structured interviews were conducted with 16 trialists: 13 statisticians and three clinicians. Participants were recruited across several universities and trials units in the United Kingdom using snowball and purposeful sampling. Data were analysed using thematic analysis and techniques of constant comparison. Results Trialists used existing evidence in many ways in trial design, for example, to justify a gap in the evidence base and inform parameters in sample size calculations. However, no one in our sample reported using such evidence in a Bayesian framework. Participants tended to equate Bayesian analysis with the incorporation of prior information on the intervention effect and were less aware of the potential to incorporate data on other parameters. When introduced to the concepts, many trialists felt they could be making more use of existing data to inform the design and analysis of a trial in particular scenarios. For example, some felt existing data could be used more formally to inform background adverse event rates, rather than relying on clinical opinion as to whether there are potential safety concerns. However, several barriers to implementing these methods in practice were identified, including concerns about the relevance of external data, acceptability of Bayesian methods, lack of confidence in Bayesian methods and software, and practical issues, such as difficulties accessing relevant data. Conclusions Despite trialists recognising that more formal use of external evidence could be advantageous over current approaches in some areas and useful as sensitivity analyses, there are still barriers to such use in practice

Genetic analysis of members of the species Oropouche virus and identification of a novel M segment sequence

Oropouche virus (OROV) is a public health threat in South America, and in particular Northern Brazil, causing frequent outbreaks of febrile illness. Using a combination of deep sequencing and Sanger sequencing approaches we have determined complete genome sequences of eight clinical isolates that were obtained from patient sera during an Oropouche fever outbreak in Amapa state, northern Brazil in 2009. We also report complete genome sequences of two OROV reassortants isolated from two marmosets in Minas Gerais state, southeast Brazil in 2012 that contain a novel M genome segment. Interestingly, all ten isolates posses a 947 nucleotide long S segment that lacks 11 residues in the S segment 3' UTR compared to the recently redetermined Brazilian prototype OROV strain BeAn19991. OROV maybe circulating more widely in Brazil and in the non-human primate population than previously appreciated and the identification of yet another reassortant highlights the importance of bunyavirus surveillance in South America

Understanding stage of innovation of invasive procedures and devices:Protocol for a systematic review and thematic analysis

INTRODUCTION: Surgical innovation has generally occurred in an unstandardised manner. This has led to unnecessary exposure of patients to harm, research waste and inadequate evidence. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration provided a set of recommendations for evaluating surgical innovations based on their stage of innovation. Despite further refinements and guidance, adoption of the IDEAL recommendations has been slow; an important reason may be that determining the stage of innovation is often difficult. To facilitate evaluation of surgical innovations, there is a need for a detailed insight into what stage of innovation means, and how it can be determined. The aim of this study is to understand the concept of stage of innovation as reported in the literature. METHODS AND ANALYSIS: A systematic review is being conducted. Ovid MEDLINE and Embase databases were searched from their inception until July 2021 using an iteratively developed strategy based on the concepts of stage of innovation, invasive procedures or devices and guidance. Articles were included if they described an approach to evaluating surgical innovations in stages, described a method for determining stage of innovation, described indicators of stage of innovation, defined stages or described potential sources of stage-related information. Conference abstracts and non-English language articles were excluded. Other articles were detected from citations within included articles and suggestions from experts in surgical innovation. Data will be extracted regarding approaches to evaluating surgical innovations, methods for determining stage of innovation, indicators of stage of innovation, definitions of stages and potential sources of stage-related information. A thematic analysis will be conducted, and findings summarised in a narrative report. ETHICS AND DISSEMINATION: Ethical approval will not be required. This systematic review will be published in a peer-reviewed journal and presented at appropriate conferences. PROSPERO REGISTRATION NUMBER: CRD42021270812

Dressing use issues in primary abdominal wounds : a qualitative study of health staff and patient views

Primary surgical abdominal wounds are usually covered with a dressing. However, little is known about the practical issues and costs around these dressings. This study aimed to provide an in-depth description of patients' and health professionals' perspectives on the clinical and practical issues associated with standard and novel dressing (glue-as-a-dressing) use on primary surgical wounds, and to establish whether and how their experience compares with these perspectives. During semi-structured interviews, patients and health professionals discussed their positive experience of glue-as-a-dressing and no dressing around six themes: wound contamination and infection, wound healing, wound care, physical protection afforded by simple dressings, the potential psychological impact of an exposed wound, and ability to carry out everyday tasks. Current views on the practice of dressings for primary abdominal wounds are influenced by ingrained clinical practice. These views can be challenged when exposed to novel dressing strategies or as new evidence of the clinical effect of dressing strategies emerges

‘The worst day of my life’: Foster carers’ experiences of allegations

Appropriate allegation investigations within social care are paramount to protect children. However, many allegations are unsubstantiated (Biehal et al., 2014) and result in stress and anxiety for fostering families (Adams, Hassett and Lumsden, 2018), financial uncertainty (Boffey, Stanton and Thomas, 2019), unplanned endings and foster carers leaving their role (Adams, Hassett and Lumsden, 2018). There is little research into the prevalence, nature and outcomes of allegations against foster carers. This UK-based study uses The Fostering Network’s State of the Nation’s Foster Care (SOTN) 2021 survey and analyses responses from 3,352 UK foster carers and 99 fostering service staff. Qualitative findings reflect six themes: (1) emotional impacts, (2) financial implications, (3) independent support, (4) social services involvement, (5) understanding allegations, and (6) children being removed or foster carers leaving their role. Quantitative findings show only 25% of those experiencing an allegation believed they were sufficiently communicated with, only 20% believed specified timescales were adhered to, 57% did not receive independent support, and 36% said no support was offered to children in their home. Poor information-sharing and lack of support were found to have exacerbated the stress experienced

Patient information leaflets for placebo-controlled surgical trials : a review of current practice and recommendations for developers

Contributions Sian Cousin: methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Marc Huttman: data collection, review and editing. Natalie Blencowe: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Carmen Tsang: data collection, review and editing. Daisy Elliott: formal analysis, review and editing. Jane Blazeby: review and editing. David Beard: conceptualisation, review and editing. Marion Campbell: conceptualisation, review and editing. Katie Gillies: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation.Peer reviewe