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

BACKGROUND: Recruitment 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. METHODS: Studies 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. RESULTS: Seventeen 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. CONCLUSIONS: There is a need to develop recruiter training programmes that can lead to improved recruitment and informed consent in randomised trials. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0908-6) contains supplementary material, which is available to authorized users

Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial

Objectives To explore trial participants' understandings of randomisation. Design In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. Setting The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. Subjects 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. Interventions and outcome measures Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. Results Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. Conclusions The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent

'Why don't they tell me straight, why allocate it?' The struggle to make sense of participation in a randomised controlled trial

Randomised controlled trials are the acknowledged ‘gold standard’ method of evaluating the effectiveness of treatments, but little is known about how and why patients decide to participate in trials nor how much they understand about trial design. In this study, in-depth, semi-structured interviews were carried out with 33 middle aged and older men with lower urinary tract symptoms related to benign prostatic disease, 22 of whom had consented to participate and 11 refused to take part in a randomised trial. The trial was evaluating the effectiveness of a new technology (laser therapy) compared with standard surgery (transurethral resection of the prostate) and conservative management (monitoring without active intervention) (the CLasP study). Purposive sampling was used to include participants from different centres, each treatment arm, and at different stages in participation, as well as those indicated to have refused participation. Interviews explored their recall and understanding of trial information, and their reasoning about how they were allocated to a treatment. Data were analysed thematically according to the methods of constant comparison, and by examining each participant's narrative of their experiences. Most participants recalled major aspects of trial design, including the involvement of chance, but the case studies showed that most also held other co-existing (and sometimes contradictory) views about their treatment allocation. The key to understanding their experiences was their engagement in a struggle to understand the trial in the context of their own beliefs, their recall of the study information and their actual experiences of the trial. The outcome of the struggle was the placing of trust in clinicians or the development of distrust. Non-participants made sense of their experiences in similar ways, but gave different reasons for non-participation than indicated by recruiters. This study shows that most eligible patients, whatever their level of knowledge, will struggle to make sense of their participation in randomised trials. The provision of clearer written information or time to discuss the trial with particular individuals might be beneficial, although greater public understanding of trials is also needed

Patients’ experiences of life after bariatric surgery and follow-up care:A qualitative study

ObjectivesBariatric surgery is the most clinically effective treatment for people with severe and complex obesity, however, the psychosocial outcomes are less clear. Follow-up care after bariatric surgery is known to be important, but limited guidance exists on what this should entail, particularly related to psychological and social well-being. Patients’ perspectives are valuable to inform the design of follow-up care. This study investigated patients’ experiences of life after bariatric surgery including important aspects of follow-up care, in the long term.DesignA qualitative study using semistructured individual interviews. A constant comparative approach was used to code data and identify themes and overarching concepts.SettingBariatric surgery units of two publicly funded hospitals in the South of England.ParticipantsSeventeen adults (10 women) who underwent a primary operation for obesity (mean time since surgery 3.11 years, range 4 months to 9 years), including Roux-en-Y gastric bypass, adjustable gastric band and sleeve gastrectomy, agreed to participate in the interviews.ResultsExperiences of adapting to life following surgery were characterised by the concepts of ‘normality’ and ‘ambivalence’, while experiences of ‘abandonment’ and ‘isolation’ dominated participants’ experiences of follow-up care. Patients highlighted the need for more flexible, longer-term follow-up care that addresses social and psychological difficulties postsurgery and integrates peer support.ConclusionsThis research highlights unmet patient need for more accessible and holistic follow-up care that addresses the long-term multidimensional impact of bariatric surgery. Future research should investigate effective and acceptable follow-up care packages for patients undergoing bariatric surgery

Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales

BACKGROUND: The Cancer Drugs Fund (CDF) provides £200 million annually in England for ‘anti-cancer' drugs. METHODS: We used a controlled pre-/post-intervention design to compare IMS Health dispensing data for 15 cancer drugs (2007–2012) in England vs Wales, stratified by pre-CDF NICE drug approval status (rejected, mixed recommendations, recommended, not appraised). RESULTS: The CDF was associated with increased prescribing in England for three of five drugs rejected or with mixed NICE recommendations. The prescribing volume ratios (PVR) ranged from 1.29 (95% CI 1.00, 1.67) for sorafenib to 3.28 (2.59, 4.14) for bevacizumab (NICE rejected) and 0.93 (0.81, 1.06) and 1.35 (1.21, 1.49) for sunitinib and imatinib respectively (mixed recommendations). Post CDF prescribing in England increased for both drugs awaiting NICE appraisal pre-CDF (lapatinib PVR=7.44 (5.81, 9.54), panitumumab PVR=5.40 (1.20, 24.42)) and subsequently rejected. The CDF was not associated with increased prescribing in England of NICE-recommended drugs. The three most recently launched, subsequently recommended drugs were adopted faster in Wales (from pazopanib PVR=0.51 (0.28, 0.96) to abiraterone PVR=0.78 (0.61–0.99)). INTERPRETATION: These data indicate that the CDF is used to access drugs deemed not cost-effective by NICE. The CDF did not expedite access to new cost-effective cancer agents prior to NICE approval

Equity of access to treatment on the Cancer Drugs Fund:A missed opportunity for cancer research?

AbstractUsing mixed-methods, we investigated the CDF in the South West of England (3193 cancer patients treated through the CDF, April 1st 2011–March 31st 2013) for evidence of: (1) equitable access across socioeconomic groups, age groups, sex, and Cancer Network; (2) time-to-treatment by socioeconomic group; and (3) the perception of the CDF as fair, using semi-structured interviews with oncology consultants.There was no evidence of inequitable access to anti-cancer therapy for those in more deprived areas. For all cancer types, there was a lower proportion of women in the CDF cohort than in the Cancer Registry reference population (e.g., melanoma, CDF 36.8% female, reference population 48.7%; difference 11.9%, 95% CI 3.1–20.7%). There was a lower proportion of older patients in the CDF compared with the reference population (e.g., colorectal cancer, CDF 6.9% ≥80 years, reference population 30.1%; difference 23.2%, 95% CI 20.2–26.2%). Interviewed oncologists felt differences in performance status, not age, influenced referral to the CDF, with neither deprivation, nor gender contributing.Our study suggests that the CDF has differential access by age and sex, but not by deprivation. The absence of high quality CDF data represents a missed opportunity to fully evaluate equity of access and the real-world costs and outcomes of novel anti-cancer drugs

Men’s knowledge and attitudes towards dietary prevention of a prostate cancer diagnosis:a qualitative study

BACKGROUND: Prostate cancer (PC) incidence and progression may be influenced by dietary factors, but little is known about the acceptability of dietary modification to men at increased risk of PC. Qualitative interviews with men participating in the ProDiet study were undertaken to explore the feasibility of implementing dietary interventions for the prevention of prostate cancer. METHODS: An interview study nested within the ProDiet randomised feasibility trial of dietary interventions to prevent a PC diagnosis. Men (n = 133) who previously participated in community based prostate specific antigen (PSA) testing without PC but who were at increased risk of the disease were randomly allocation to both lycopene (lycopene or placebo capsules or lycopene rich diet) and green tea (green tea or placebo capsules or green tea drink) for 6 months. Semi-structured interviews were conducted with participants shortly after randomisation, to investigate attitudes towards dietary modification for PC prevention and dietary information. Interviews were audio-recorded, transcribed and analysed to identify common themes. RESULTS: Interviews were conducted with 21 participants aged 52-72 years with PSA levels between 2.5 and 2.95 ng/ml, or a negative prostate biopsy result. Most men identified the major causes of cancer in general to include diet, environment, ageing and genetic factors. This contrasted sharply with men’s uncertainty about PC aetiology, and the function of the prostate. Men were confused by conflicting messages in the media about dietary practices to promote health overall, but were positive about the potential of lycopene and green tea in relation to PC prevention, valuing their natural components. Furthermore these men wanted tailored dietary advice for PC prevention from their clinicians, whom they considered a trusted source of information. CONCLUSION: Men at elevated risk of PC reported uncertainty about PC aetiology and the role of diet in PC prevention, but enthusiasm for dietary modifications that were perceived as ‘simple’ and ‘natural’. The men looked to clinicians to provide consistent disease specific dietary advice. These factors should be taken into consideration by clinicians discussing elevated PSA results with patients and those planning to embark on future trials investigating dietary modification interventions for the prevention of a PC diagnosis

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