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Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
research-article
Author(s):
Isabelle Budin-Ljøsne
1
,
2
,
,
Harriet J. A. Teare
3 ,
Jane Kaye
3 ,
Stephan Beck
4 ,
Heidi Beate Bentzen
1
,
2
,
5 ,
Luciana Caenazzo
6 ,
Clive Collett
7 ,
Flavio D’Abramo
8 ,
Heike Felzmann
9 ,
Teresa Finlay
3 ,
Muhammad Kassim Javaid
10 ,
Erica Jones
4 ,
Višnja Katić
11 ,
Amy Simpson
12 ,
Deborah Mascalzoni
13
,
14
Publication date (Electronic):
25 January 2017
Journal:
BMC Medical Ethics
Publisher:
BioMed Central
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Abstract
Background
Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.
Methods
An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.
Results
Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.
Conclusions
Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.
Related collections
Most cited references54
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Barriers to participation in randomised controlled trials: a systematic review.
S. Ross, A. Grant, C. Counsell … (1999)
A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.
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Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
Adam Nishimura, Jantey Carey, Patricia Erwin … (2013)
Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.
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Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review
Ben Fletcher, Adrian Gheorghe, David Moore … (2012)
Introduction When evaluating the effectiveness of healthcare interventions, randomised controlled trials (RCTs) are seen as the gold standard research design. It is important that RCTs recruit their target number of participants in order to avoid being underpowered, particularly as a lack of statistical power may lead to the reporting of clinically important effects as statistically non-significant. Statistically non-significant findings can increase the risk that potentially effective interventions may be abandoned before their true value is established or that there will be a delay in demonstrating their value while more trials are carried out. For example, Collins et al 1 calculated that there were as many as 10 000 unnecessary deaths in the USA due to delays in recruitment to a RCT of streptokinase in acute myocardial infarction. Many RCTs are abandoned or do not produce unequivocal evidence due to recruitment difficulties, which also means that the resources spent for setting up and running the RCT have not been put to their best use. Studies that fail to recruit their target number of participants also raise ethical problems, particularly when clinicians have exposed participants to interventions with uncertain benefit and, at the end of the trial, are still unable to determine whether the intervention is clinically effective.2 There are also ethical implications associated with recruiting patients to a trial in which they invest their time, only to be told that the trial will not go ahead. There is the additional financial impact of trials that fail to recruit successfully or in a timely manner. It has been hypothesised that slow acquisition of trial evidence due to poor recruitment may have reduced investment in the conduct of RCTs by some funding agencies, which may prefer to invest in less reliable, but more rapid approaches.3 Delayed or extended trials may cost more, leading to fewer trials being carried out from the limited funds available. There are a number of published studies that highlight how common recruitment problems are in healthcare RCTs.4–11 It is likely that 50% of RCTs fail to recruit to target and that only 50% of those that successfully recruit do so in a timely manner as shown in table 1. The table also demonstrates the lack of any real improvement over time. Table 1 Reports of difficulties recruiting to RCTs Authors Year Findings Charleson and Horwitz4 1984 A study of 41 trials listed with the National Institutes of Health (USA) showed that a third of trials recruited 0.05) or total numbers of patients recruited (control 271, intervention 302, p>0.05). No significant differences were found between groups in quality or quantity of reported data or patient follow-up time. Monaghan et al 24 (2007) used a RCT to evaluate the effect of extra communication from central trial coordinators on recruitment to a diabetes RCT. The intervention included frequent emails, personalised mail-outs of league tables describing recruitment performance relative to other centres, certificates acknowledging achievement of recruitment milestones and promotional materials related to the trial. The study found no significant effect of extra communication on median number of patients recruited (control 37.0, intervention 37.5, p=0.68) or median time to half recruitment target (control 4.4 months, intervention 5.8 months, p=0.08). Use of qualitative research embedded in host RCT Two studies investigated the use of qualitative methods embedded in a host trial. In both studies, qualitative methods (in-depth interviews, audiotape recordings of recruitment appointments, study of trial documents) and analysis (content, thematic and conversation analysis) were used to assess aspects of the trials that were amenable to improvement; followed by the design and implementation of interventions to improve the recruitment activity of clinicians. Donovan et al (2002) reports the results of a feasibility study before the main trial (Donovan et al 2009).27 28 Donovan et al 27 (2002) reported the results of an observational time series study investigating recruitment to a prostate cancer RCT. Qualitative methods were used to elicit strategies, which had the potential to improve recruitment. Strategies identified by qualitative methods included presentations of the study design and the implementation of a training programme delivered to clinicians. The intervention improved the proportion of eligible patients consenting to randomisation (after 10 months, RR 1.36, 95% CI 1.01 to 1.85), while there was no significant change in the proportion of randomised patients accepting allocation (after 10 months, RR 0.90, 95% CI 0.70 to 1.15). Donovan et al (2009)28 reported the results of the main trial. Qualitative methods allowed a complex intervention to be developed which included regular training for all staff involved in recruitment and initiation for new staff, centre reviews for underperformers, documents providing tips and advice and personalised individual feedback to recruiters as required. The study reports the results of audits of two centres before and after the intervention (12 and 24 months post-intervention). The results of the two centres are not pooled in this review as interventions were tailored to each centre using qualitative research; therefore, the intervention that the two centres received was different. The first centre showed a significant improvement in the proportion of eligible patients recruited at 12 months (RR 1.87, 95% CI 1.15 to 3.04) and 24 months (RR 1.79, 95% CI 1.07 to 2.99) post-intervention, and no significant change in the proportion of randomised patients accepting allocation (12 months, RR 1.22, 95% CI 0.62 to 2.39; 24 months, RR 1.43, 95% CI 0.75 to 2.71). The second centre also showed a significant improvement in the proportion of eligible patients recruited at 12 months (RR 1.55, 95% CI 1.11 to 2.16) and no significant change at 24 months (RR 1.36, 95% CI 0.92 to 2.02) post-intervention. No significant change in the proportion of randomised patients accepting allocation was found at 12 months (RR 1.33, 95% CI 0.96 to 1.85) and a slight increase in those accepting allocation at 24 months (RR 1.44, 95% CI 1.05 to 1.99). Complex intervention Fletcher et al 26 used an observational time series study design to examine whether changes in the conduct of a stroke RCT were associated with changes in recruitment. Over the recruitment period, changes included procedural changes to reduce clinician workload and time to recruitment, enrolment of more sites and changes to the approach to recruitment and retention of practices. Recruitment rates per 1000 eligible population were calculated, and a moving F statistic was used to assess changes over time. There was a statistically significant increase in recruitment in the last 6 months of the trial associated with efforts to reduce clinician workload. Extra training and protected research time Kenyon et al 29 used a before and after study design to measure the effect of increased training, and paying for protected research time for midwives recruiting to a large perinatal multicentre RCT. The intervention involved the employment of lead local midwives to work for 3 hours per week on the trial. The midwives were provided with intensive training, 6 monthly updates and regular contact visits. Recruitment in all the maternity units improved by an average of 69% (range −89% to 200%) when comparing the 6 months prior to the intervention with the 6 months immediately after the intervention. Results of review of qualitative studies Findings relating to clinicians' involvement in, and recruiting to RCTs, were extracted for each of the 11 included studies. A line-by-line content analysis isolated a total of 73 findings, which were consolidated into eight abstracted themes by combining like statements and eliminating redundant statements. There is some overlap between abstracted findings. The abstracted themes are described below. Understanding of research (in general; RCTs; in light of specific trials) RCTs are understood by clinicians to be a valuable tool in healthcare (ie, description of RCT as gold standard; RCTs provide the best available evidence); however, it is suggested that some clinicians are exposed to too much research, leading to a feeling of being overwhelmed with requests for research participation. It is reported that there is a poor understanding among clinicians of RCT methods and concepts (ie, equipoise, randomisation, allocation, eligibility criteria, informed consent), along with the opinion that RCTs can be too complex. There is some discussion regarding the funding of research, for example, questioning whether RCTs are the best way to spend money, particularly given the current economic climate; is there enough money available for research. It is seen to be the responsibility of the whole community (researchers, clinicians and patients) to take part in research. However, some clinicians are suspicious of the motives of researchers, and others have no interest in research whatsoever—leading to resistance to research participation (obstructive/difficult to engage). Communication (clinician to patient; clinician to trial coordinator) Clinicians report a difficulty in communicating the aims and concepts of RCTs to patients. The choice of language used is perceived as very important. Communicating research to patients is described as a sales pitch. Language used to describe RCT design is a concern, particularly allocation and randomisation, which has been likened to describing a lottery, with ‘winners and losers’. Clinicians report that they are able to communicate with certain patients and patient groups about RCTs better than others. Social class of patients is discussed, with clinicians finding communication with ‘people like themselves’ easier. Poor communication of research by trial coordinators can lead to suspicion of their motives. There is often a perceived divergence between clinical and research goals. Clinicians feel that they should be seen as ‘partners in research’, with greater involvement in design leading to improved recruitment. Perceived patient barriers Barriers to recruitment are often seen by clinicians to be more related to the patients, and therefore out of their control. Perceived patient barriers include poor community awareness and understanding of RCTs, low motivation to take part in research, lack of interest, fear and mistrust of being treated as guinea pigs and fear of negative effects of taking part. Patient–clinician relationship Clinicians acting as recruiters are particularly concerned with the conflicting roles that taking part in research activities imposed. Recruiting clinicians may act as gatekeepers, only suggesting research to those patients that they deem suitable for research (ie, not approaching all patients who meet eligibility criteria for a study). This can be perceived to be paternalistic as clinicians make decisions on the patients' behalf, believing that they know what is best, without consulting the patients. Clinicians feel responsible for the patients they put forward for research, particularly as they believe they can influence patients' decision making. Also clinicians put patient needs above those of researchers; patient well-being is seen as paramount. Concern that trust may be affected by asking patients to take part in research is mentioned, as well as the concern for some clinicians that they risk feelings of ineptitude or rejection if they invite patients to take part in RCTs and they refuse. Effect on patients (harms and benefits) Clinicians often describe possible patient benefit as motivation for participation in RCTs, and equally concerns are expressed about possible harms. Some clinicians have difficulty reconciling potentially putting individual patients at risk for possible population gain. Clinicians want to avoid being seen to pressurise patients to take part in RCTs. The stage of patient illness is a concern, as it is suggested that asking terminally ill patients or patients with poor prognosis to take part in an RCT with a placebo can be emotionally detrimental for some patients. Also, side effects of treatments used in RCTs are seen as possible negatives for patients. It is important to note that these are what the clinicians perceive their patients to be thinking, and the patients themselves may not share these views. Inviting patients to take part in research can have the effect of raising patient awareness of disease, which can be interpreted in both a positive and negative light (ie, more awareness may lead to increased participation in research but also more health seeking behaviour, stretching current resources). Research can be thought to be inequitable by clinicians, with some special patient groups seen as receiving more attention than others. Effects on clinical practice A positive aspect of taking part in RCTs is the beneficial influence it can have on clinical practice. Being a research active practice enhances services offered by practices, encouraging confidence and loyalty from patients. It is also thought that the discipline needed to adhere to some trial protocols has beneficial effects on clinical practice. Advancements in clinical practice are dependent on carrying out good quality clinical trials. Taking part in RCTs can improve treatment strategies used in everyday practice, conferring benefits to patients outside the RCT in the medium and long term. Negatives include the possible disruption caused to normal practice brought about by the extra work involved in assessing patients for eligibility and approaching those who are eligible for participation (ie, describing RCT, obtaining informed consent, etc). The extra time associated with recruiting to RCTs in addition to normal duties is often stated as a major barrier to involvement. In the climate of trying to achieve service targets within tight budgets, carrying out extra work to recruit patients to trials may not be seen as a priority. It is felt by some clinicians that although they are crucial to the successful running of trials by recruiting subjects, they often do not receive the acknowledgment/rewards they feel they deserve. Being asked to recruit for RCTs is seen to be intrusive by some clinicians. Individual benefits for clinicians Motivation for involvement in research can be seen to move beyond altruism. Taking part and recruiting patients to RCTs is seen by many to have personal benefits for clinicians. Involvement with colleagues from different fields is seen to be important personally, as well as professionally. Participation in RCTs is seen by some as crucial for career development and professional recognition. Methods associated with successful recruitment Community awareness of RCTs and research in general is linked to good recruitment. Promotion efforts should be tried to improve awareness, which should have the effect of increasing the number of patients willing to take part in RCTs. Endorsements of research by the patients' own general practitioner or practice can improve recruitment. The research question addressed by an RCT is of vital importance to clinicians. The question should be both interesting and relevant to practice. Initial contact with clinicians about involvement in a trial should be brief but informative. Trial methods should be easy to understand and then to communicate to patients. Inviting recruiters to take part in the design of RCTs could improve recruitment. The funding of protected research time is an intervention that could improve recruitment performance. This would allow clinicians more time to discuss the trial with patients. More time would also allow clinicians to tailor their approach to each individual, an approach that is desirable for some clinicians. If protected research time is not a possibility, then minimisation of workload related to recruitment is the key. Financial incentives are important for many, with criticism when reimbursement for time is not offered. Clinicians should be reimbursed for time spent on recruitment rather than placing a bounty on patients' heads. Conversely some argue that financial incentives are unethical, and others that being paid would not significantly affect recruitment efforts. It was also noted that all staff should be rewarded for participation in research, not just clinicians. Organisationally, being part of a research active practice is linked with good recruitment to RCTs. Having a research mentor or a trial coordinator or being involved in a research network are also factors in successful recruitment. Competition with other recruiters is a constructive way to maximise recruitment. Appropriate training about research methods and recruitment methods is regarded as the key to success by many. Training should focus on addressing many common misconceptions about RCTs, particularly equipoise and informed consent. Qualitative frequency effect size (metasummary) By dividing the number of studies containing each theme/abstracted finding by the total number of studies, a frequency effect size was calculated. Table 4 shows the findings with frequency effect sizes >20%, as proposed by Sandelowski and Barroso.22 A full list of findings and frequency effect sizes is given in online appendix 4. Table 4 Summary of qualitative findings with frequency effect size >20% Abstracted finding Subtheme Studies in which subtheme is present Frequency effect size (%) Understanding of research RCTs provide the best evidence. 31 35 36 27 Poor understanding of research 32 33 36 39–41 55 Communication Difficulty communicating trial methods 31 32 35 37 39–41 64 Patient–clinician relationship Conflicting roles of being a recruiting physician 31 35 39 40 36 Clinicians acting as gatekeepers 38–40 27 Paternalism 35 38 39 27 Clinician influence on patient decision making 32 35 37 39 36 Patient well-being a priority 31 32 35 37 39 45 Effect on patients Possible benefits of taking part in RCTs 31 32 34 38 36 Possible harms of taking part in RCTs 31 36 39 27 Effect on clinical practice Positive effect of being involved in RCTs 31 32 34 35 38 45 Individual benefit for clinician Career development 32 38 41 27 Methods associated with successful recruitment Importance of research question 31 32 35–37 45 Trial methods easy to understand, communicate and carry out 32 34 37 38 41 45 Financial incentives 31 33 34 27 Appropriate training 32–34 38 36 RCT, randomised controlled trials. Difficulty communicating trial methods (randomisation, equipoise, etc) was the most common subtheme (64%) and was linked to a poor understanding of research methods by clinicians, and research in general by the public (55%). Ease of understanding and carrying out RCT methods was also commonly described as associated with successfully recruiting trials (45%). Clinicians found it difficult reconciling the roles of clinician and recruiter (36%). Clinicians were often described to only put forward patients who they deemed appropriate (gatekeeping) (27%), which links to paternalism (27%) and prioritising patient well-being (45%). The positive and negative aspects of taking part in RCTs were frequently mentioned, with a balance between possible negative (36%) and positive effects on patients (27%) and the effect on clinical practice (45%). The most frequently found abstracted finding was methods associated with successful recruitment to RCTs, with four subthemes with a frequency effect >20%. It was thought that the research question should be interesting and relevant to practice (45%). Financial incentives were seen by most as important for participation (27%). Training relevant to running trials should improve recruitment by targeting poor understanding of RCT methodology, as well as teaching recruitment methods (45%). Discussion The aim of this review was to identify, and synthesise, evidence of the effectiveness of interventions aimed at improving the recruitment activity of clinicians in RCTs, and evidence of their attitudes towards recruitment to RCTs. Methodological challenges As the volume of evidence was perceived to be small, an aim of the review was to include as much evidence as possible, regardless of method, several methodological issues had to be dealt with. Many systematic reviews of interventions exclude studies that do not use RCTs. While good quality RCTs of interventions would provide the best evidence, the nature of this research question lends itself to retrospective descriptive studies. This may be due to the logistical, ethical and scientific obstacles of performing randomised trials of recruitment nested within host RCTs.42 Challenges for host trials include increasing complexity and management burden, compatibility between host and nested study and the impact of the nested study on host trial design. Challenges for nested studies include investigators' concerns that host study investigators might have strong preferences, limiting the nested study investigators control over their research; and concerns about sample size which might limit statistical power. ‘Evidential nihilism’, where narrow inclusion criteria are set regarding trial design would have led to an emptier review, which would not help further our understanding of the problem as much.43 Qualitative studies were included in this review as it is important not just to understand what works but also to have an understanding of why. It is hoped that a better understanding of clinicians' attitudes towards recruitment to RCTs may inform the development of interventions aimed to improve the support and training given to those involved in RCTs. The search was broad and included no methodological filters, but still returned a large number of results. There is often a trade-off between sensitivity and specificity when performing a search for a systematic review, and in this case, it was decided to err on the side of over inclusion, so a sensitive search was designed. The review of quantitative studies found limited high-quality evidence of interventions aimed at improving clinician activity and shows the importance of building the evidence base to allow those running RCTs to have access to a range of proven strategies to maximise recruitment. Quality of the included qualitative studies was found to be good; however, there was a tendency for the included studies to focus on the barriers to recruitment from the perspective of poorly recruiting trials. Little evidence was found of studies that aimed to assess how and why those clinicians who recruited well did so. It could be argued that facilitators are more illuminating, as barriers can often be seen as excuses, that is, if the barrier was removed would the clinicians recruit more successfully? What interventions work? Evidence-based interventions are necessary for RCTs to recruit successfully; however, there is currently limited evidence, and interventions are being used that have no evidential grounding. For example, a study of seven primary care-based RCTs found that only 37% of interventions to promote recruitment were judged to be evidence based.7 Further to this, Graffy et al 42 stated that currently, where nested studies of recruitment methods are conducted on the initiative of individual investigators, there is no systematic method of choosing the intervention. The authors go on to suggest the creation of a portfolio of interventions that could be made available to investigators for inclusion within an individual trial or multiple trials. This lack of evidence-based interventions is particularly salient given that ‘common sense’, interventions that could be assumed to have a positive effect on recruitment often had little or no effect. The most successful intervention identified by this review was in the two trials that used embedded qualitative research to design interventions to improve recruitment. The qualitative research investigated recruitment appointments, study documents and interviewed clinicians to understand what aspects were amenable to change in order to improve recruitment. In both studies, the intervention increased recruitment, that is, the proportion of eligible subjects who consented to be randomised in the study. Rather than discuss the strategies used to improve recruitment, the most important factor in studies employing embedded qualitative research is the way that the intervention is developed. The use of qualitative methods allowed tailored interventions to be made that attempted to address problems with recruitment that were experienced by the clinicians and trial subjects (ie, use of interviews, monitoring of recruitment interviews), as well as problems identified by the trial coordinators. This method is adaptive and allows for continuous monitoring and improvement. Although the interventions themselves may not be generalisable, the qualitative methods used to create the interventions could be transferred to other settings, potentially having a positive effect on recruitment. Another positive feature of this approach was that improvements were maintained over time. Following intervention at two centres, recruitment was shown to remain significantly higher for at least 24 months. One possible barrier to the use of this approach may be the extra time, money and personnel needed to carry out the qualitative research. However, the use of qualitative methods in pilot or feasibility trials prior to a full study would provide a cost-effective means of defining suitable interventions that could be fully incorporated into subsequent trials. If these interventions then proved successful in aiding recruitment, the extra efforts and costs involved in the preparatory phases would be offset by the greater potential for a successful full trial that would result, providing greater returns to funders and increasing the scientific validity of the trial overall. Clinicians' attitudes to recruitment to RCTs Setting aside the debate regarding the utility of metasummary frequency effect sizes, in this review, there are three key areas highlighted by the calculation of qualitative effect sizes that may be the best target for improvement in future trials: understanding of RCTs and health research in general (both by the general public and by clinicians), communication of trial methods (both trial coordinators to clinicians and clinicians to patients) and reduction of the workload associated with recruitment. It should not be assumed by trial coordinators that recruiters have a full understanding of RCT and recruitment methods. Clinicians' understanding of research in general and RCTs in particular could be improved using training specific to the RCT they are involved in as well as education relating to common misconceptions about RCTs. Some of the themes identified could be used to emphasise the individual benefits to both trial subjects and clinicians, and the positive effect taking part in research can have on clinical practice.44 For example, a study of centres involved in a multicentre breast cancer treatment trial found that both patients and clinicians benefited from participation in the RCT, due to optimised decision making with regard to therapy and patient care.45 An overall positive effect on the quality of medical care was seen across the centres. As clinicians prioritise patient well-being, emphasising the potential patient benefits to them could help remove a barrier to recruitment. It is clear that reported barriers may often be excuses for why clinicians have not recruited well. Patterson et al,40 for example, found that concerns about taking part in RCTs related to ethics and research approvals, but even when these issues were addressed clinicians remained less than enthusiastic and instead shifted the blame to administrative and clinical duties. Removal of the perceived barrier will not necessarily lead to an improvement in recruitment. This again highlights that more investigation is required to illuminate what facilitates trials that easily meet their recruitment targets. Reducing clinicians' workload associated with recruiting to RCTs was often mentioned. This could be achieved by providing extra staff support, simplification of recruitment protocols or providing protected research time. However, it remains to be seen whether clinicians saying they do not have enough time is more commonly a barrier or an excuse. Clinicians place an emphasis on patient well-being, and some may feel the need to protect their patients from the risk of taking part in a RCT. A commonly held belief among clinicians is that patients who take part in RCTs face risks that they would not otherwise face if they received their healthcare in the usual manner. However, a systematic review found that the outcomes of patients taking part in RCTs do not differ from those of patients receiving similar treatments who do not participate.45 Engaging clinicians in RCTs is a crucial step in the recruitment process. It is apparent that clinicians are aware of the impact they have on their patients' decision making regarding involvement in trials, and it has been shown that personal endorsement of trials by clinicians can have a positive effect on recruitment. If clinicians are fully engaged and understand the benefits, to both themselves and patients, of participating in RCTs, recruitment could improve significantly. Conclusions Few high-quality trials were identified that tested interventions to improve clinicians' recruitment activity in RCTs. The most promising intervention was the use of qualitative methods to identify and overcome barriers to clinician recruitment activity. It is clear that the barriers to nested trials of recruitment interventions in host RCTs must be overcome in future in order to add to the evidence base. The metasummary of qualitative findings identified understanding and communicating RCT methods (clinician to patient and trial coordinator to clinician) as a key target for future interventions to improve recruitment. Reinforcement of the potential benefits, both for clinicians and for their patients, could also be a successful factor in improving recruitment. A bias was found towards investigating barriers to recruitment, so future work should also encompass a focus on successfully recruiting trials. Few reviews attempt to synthesise qualitative evidence using the methods demonstrated here, and it is hoped that this review demonstrates the utility of methods for synthesising diverse evidence. Hopefully by bringing together a review of qualitative and quantitative studies, we have created a report that is more informative than carrying out two reviews in isolation. It is hoped that this work will inform the development of future studies investigating clinicians' attitudes to recruitment, as well as the design of possible future recruitment interventions to be tested using a robust trial design. Supplementary Material Supporting Statement Supporting Statement Author's manuscript Reviewer comments
Author and article information
Contributors
Isabelle Budin-Ljøsne: +47 22 85 06 24
,
i.b.ljosne@medisin.uio.no
Journal
Journal ID (nlm-ta): BMC Med Ethics
Journal ID (iso-abbrev): BMC Med Ethics
Title:
BMC Medical Ethics
Publisher:
BioMed Central
(London
)
ISSN
(Electronic):
1472-6939
Publication date
(Electronic):
25
January
2017
Publication date PMC-release: 25
January
2017
Publication date Collection: 2017
Volume: 18
Electronic Location Identifier: 4
Affiliations
[1
]Centre for Medical Ethics, Institute of Health and Society, University of Oslo, Blindern,
P.O. Box 1130, NO-0318 Oslo, Norway
[3
]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Centre for Health, Law and Emerging Technologies (HeLEX), Nuffield Department of Population
Health, , University of Oxford, ; Oxford, United Kingdom
[4
]ISNI 0000000121901201, GRID grid.83440.3b, UCL Cancer Institute, , University College London, ; London, United Kingdom
[5
]ISNI 0000 0004 1936 8921, GRID grid.5510.1, Norwegian Research Center for Computers and Law, Faculty of Law, , University of Oslo, ; Oslo, Norway
[8
]ISNI 0000 0000 9116 4836, GRID grid.14095.39, Focus Area DynAge, , Freie Universität, ; Berlin, Germany
[9
]ISNI 0000 0004 0488 0789, GRID grid.6142.1, Centre of Bioethical Research & Analysis, , NUI Galway, ; Galway, Ireland
[10
]ISNI 0000 0004 1936 8948, GRID grid.4991.5, NIHR Musculoskeletal Biomedical Research Unit, Nuffield Department of Orthopaedics,
Rheumatology and Musculoskeletal Sciences, , University of Oxford, ; Oxford, United Kingdom
[11
]ISNI 0000 0001 2236 1630, GRID grid.22939.33, School of Medicine, , University of Rijeka, ; Rijeka, Croatia
Article
Publisher ID: 162DOI: 10.1186/s12910-016-0162-9
PMC ID: 5264333
PubMed ID: 28122615
SO-VID: 06860818-2cd7-4d0a-adab-1472aa1e7a2d
Copyright © © The Author(s). 2017
License:
Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
History
Date
received
: 9
June
2016
Date
accepted
: 26
December
2016
Funding
Funded by: COST Action IS1303 CHIP ME
Funded by: Norwegian Research Council
Award ID: BIOTEK2021/ES495029
Award ID: BIOTEK2021/238999/O30
Award Recipient
:
Isabelle Budin-Ljøsne
Heidi Beate Bentzen
Funded by: Oxford NIHR Musculoskeletal BRU
Funded by: FundRef http://dx.doi.org/10.13039/100004440, Wellcome Trust;
Award ID: 096599/2/11/Z
Award Recipient
:
Jane Kaye
Funded by: Innovative Medicines Initiative BT-Cure
Award ID: 115142-1
Award Recipient
:
Deborah Mascalzoni
Funded by: BBMRI
Funded by: RD Connect FP7
Award ID: 305444
Award Recipient
:
Deborah Mascalzoni
Categories
Subject:
Research Article
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ScienceOpen disciplines: Medicine
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ScienceOpen disciplines: Medicine