Nicola Mills

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

BackgroundWell-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study.MethodsSemistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved.ResultsSurgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held.ConclusionThere is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

Does population screening for Chlamydia trachomatis raise anxiety among those tested? Findings from a population based chlamydia screening study

BackgroundThe advent of urine testing for Chlamydia trachomatis has raised the possibility of large-scale screening for this sexually transmitted infection, which is now the most common in the United Kingdom. The purpose of this study was to investigate the effect of an invitation to be screened for chlamydia and of receiving a negative result on levels of anxiety, depression and self-esteem.Methods19,773 men and women aged 16 to 39 years, selected at random from 27 general practices in two large city areas (Bristol and Birmingham) were invited by post to send home-collected urine samples or vulvo-vaginal swabs for chlamydia testing. Questionnaires enquiring about anxiety, depression and self-esteem were sent to random samples of those offered screening: one month before the dispatch of invitations; when participants returned samples; and after receiving a negative result.ResultsHome screening was associated with an overall reduction in anxiety scores. An invitation to participate did not increase anxiety levels. Anxiety scores in men were lower after receiving the invitation than at baseline. Amongst women anxiety was reduced after receipt of negative test results. Neither depression nor self-esteem scores were affected by screening.ConclusionPostal screening for chlamydia does not appear to have a negative impact on overall psychological well-being and can lead to a decrease in anxiety levels among respondents. There is, however, a clear difference between men and women in when this reduction occurs.

Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences

BackgroundPatients’ treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients’ treatment preferences and identified key strategies to improve informed decision-making and trial recruitment.MethodsAudio-recordings of 103 RCT recruitment appointments with 96 participants in three UK multicenter pragmatic RCTs were analyzed using content and thematic analysis. Recruiters’ responses to expressed treatment preferences were assessed in one RCT (ProtecT - Prostate testing for cancer and Treatment) in which training on exploring preferences had been given, and compared with two other RCTs where this specific training had not been given.ResultsRecruiters elicited treatment preferences similarly in all RCTs but responses to expressed preferences differed substantially. In the ProtecT RCT, patients’ preferences were not accepted at face value but were explored and discussed at length in three key ways: eliciting and acknowledging the preference rationale, balancing treatment views, and emphasizing the need to keep an open mind and consider all treatments. By exploring preferences, recruiters enabled participants to become clearer about whether their views were robust enough to be sustained or were sufficiently weak that participation in the RCT became possible. Conversely, in the other RCTs, treatment preferences were often readily accepted without further discussion or understanding the reasoning behind them, suggesting that patients were not given the opportunity to fully consider all treatments and trial participation.ConclusionsRecruiters can be trained to elicit and address patients’ treatment preferences, enabling those who may not have considered trial participation to do so. Without specific guidance, some RCT recruiters are likely to accept initial preferences at face value, missing opportunities to promote more informed decision-making. Training interventions for recruiters that incorporate key strategies to manage treatment preferences, as in the ProtecT study, are required to facilitate recruitment and informed consent.Trial registrationProtecT RCT: Current Controlled Trials ISRCTN20141297. The other two trials are registered but have asked to be anonymized.

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

Exploring inequalities in access to care and the provision of choice to women seeking breast reconstruction surgery: a qualitative study.

Background:Breast reconstruction (BR) may improve psychosocial and cosmetic outcomes after mastectomy for breast cancer but currently, few women opt for surgery. Reasons for this are unclear. The aim of this qualitative study was to explore access to care and the provision of procedure choice to women seeking reconstructive surgery.Methods:Semi-structured interviews with a purposive sample of patients who had undergone BR and professionals providing specialist care explored participants’ experiences of information provision before BR. Interviews were transcribed verbatim and analysed using the constant comparative technique of grounded theory. Sampling, data collection and analysis were performed concurrently and iteratively until data saturation was achieved.Results:Both patients and professionals expressed concerns about the provision of adequate procedure choice and access to care. Lack of information and/or time, involvement in decision making and issues relating to the evolution and organisation of reconstructive services, emerged as potential explanations for the inequalities seen. Interventions to improve cross-speciality collaboration were proposed to address these issues.Conclusion:Inequalities in the provision of choice in BR exist, which may be explained by a lack of integration between surgical specialities. Pathway restructuring, service reorganisation and standardisation of training may enhance cross-speciality collaboration and improve the patient experience.

What do patients want and get from a primary care epilepsy specialist nurse service

PURPOSE To assess what patients want and get from a primary care epilepsy specialist nurse service, and whether this matches their expectations and self-defined needs. METHODS A qualitative study nested within a controlled trial to evaluate the effectiveness of a primary care epilepsy specialist nurse service in Bristol, UK. Twelve patients who had had at least one seizure in the previous year were purposely selected from the trial population for an in-depth interview. Interviews were audiotape recorded and transcribed verbatim. Transcribed text was methodically coded and themes were identified using the method of constant comparison. RESULTS Not all informants wanted to see the epilepsy nurse as they felt their epilepsy was well controlled and thus they did not see the need for care or attention. Those that chose to use the nurse service did so as they wanted information on epilepsy or better control of their seizures. The epilepsy nurse was able to provide them with the information they wanted but was not able to improve their seizure control. Informants felt able to communicate effectively with the nurse and they valued the information and advice received. They were unable to get this kind of communication and empathy from other clinicians. Informants generally praised the nurse service but were aware that it was unlikely to improve the control of their seizures. Most accepted this. CONCLUSIONS Effective communication with clinicians is as much, if not more of a priority for patients with epilepsy, than is controlling the clinical manifestations of their condition.

The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction

BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR.Methods/designThe iBRA study is a trainee-led research collaborative project with four phases:Phase 1 – a national practice questionnaire (NPQ) to survey current practicePhase 2 – a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3– an IBBR-RCT acceptability survey and qualitative work to explore patients’ and surgeons’ views of proposed trial designs and candidate outcomes.Phase 4 – phases 1 to 3 will inform the design and conduct of the future RCTAll centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons).Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data.DiscussionThe preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery.Trial registrationISRCTN37664281

A systematic review of training programmes for recruiters to randomised controlled trials

BackgroundRecruitment to randomised controlled trials (RCTs) is often difficult. Clinician related factors have been implicated as important reasons for low rates of recruitment. Clinicians (doctors and other health professionals) can experience discomfort with some underlying principles of RCTs and experience difficulties in conveying them positively to potential trial participants. Recruiter training has been suggested to address identified problems but a synthesis of this research is lacking. The aim of our study was to systematically review the available evidence on training interventions for recruiters to randomised trials.MethodsStudies that evaluated training programmes for trial recruiters were included. Those that provided only general communication training not linked to RCT recruitment were excluded. Data extraction and quality assessment were completed by two reviewers independently, with a third author where necessary.ResultsSeventeen studies of 9615 potentially eligible titles and abstracts were included in the review: three randomised controlled studies, two non-randomised controlled studies, nine uncontrolled pre-test/post-test studies, two qualitative studies, and a post-training questionnaire survey. Most studies were of moderate or weak quality. Training programmes were mostly set within cancer trials, and usually consisted of workshops with a mix of health professionals over one or two consecutive days covering generic and trial specific issues. Recruiter training programmes were well received and some increased recruiters’ self-confidence in communicating key RCT concepts to patients. There was, however, little evidence that this training increased actual recruitment rates or patient understanding, satisfaction, or levels of informed consent.ConclusionsThere is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials.

Adolescents and mothers value referral to a specialist service for chronic fatigue syndrome or myalgic encephalopathy (CFS/ME)

BACKGROUND Paediatric chronic fatigue syndrome or myalgic encephalopathy (CFS/ME) is relatively common and disabling. Current guidance recommends referral to specialist services, although some general practitioners believe the label of CFS/ME is harmful and many are not confident about diagnosing CFS/ME. Aim Explore whether or not adolescents and their mothers value referral to a specialist service for young people with CFS/ME. METHODS A qualitative study nested within a feasibility study of interventions for CFS/ME [Specialist Medical Intervention and Lightning Evaluation (SMILE)]. In-depth interviews were undertaken with 13 mothers and 12 adolescents participating in the SMILE study. Transcripts were systematically assigned codes using the qualitative data organisation package NVivo and analysed thematically using techniques of constant comparison. RESULTS Gaining access to the specialist service was difficult and took a long time. Mothers felt that they needed to be proactive and persistent, partly because of a lack of knowledge in primary and secondary care. Having gained access, mothers felt the CFS/ME service was useful because it recognised and acknowledged their childs condition and opened channels of dialogue between health-care professionals and education providers. Adolescents reported that specialist medical care resulted in better symptom management, although some adolescents did not like the fact that the treatment approach limited activity. CONCLUSIONS Adolescents and their mothers value receiving a diagnosis from a specialist service and making progress in managing CFS/ME. General practitioners should support adolescents with CFS/ME in accessing CFS/ME specialist services, consistent with current guidance.

Providing adequate and practical descriptions in surgical trials

Cook and colleagues highlight that descriptions of non-pharmacological interventions in randomised controlled trials are inadequate.1 Although reporting standards need to be improved, the level of information they suggest may not always be necessary. Surgical interventions are complex, comprising many components that are delivered with multiple concomitant interventions (such as anaesthesia and postoperative care), so it may be impractical to control them all. Individual surgeons …