Obstacles to recruitment in paediatric studies focusing on mental health in a physical health context: the experiences of clinical gatekeepers in an observational cohort study

In clinical studies, healthcare professionals often act as gatekeepers who facilitate access to potential participants by introducing the study to them and gaining their consent to share their contact details with researchers [1]. Gatekeepers also appear to influence willingness to participate; patients approached about research by their usual doctor are more likely to participate than those who were approached by someone unfamiliar to them or who saw advertisements about the research [2]. Universally, recruitment problems in the context of clinical studies are commonly experienced across settings and patient groups [3‐5], including in paediatric settings [4, 6] and in psychiatric research [7‐9]. Recruitment issues pose 2 problems for researchers, firstly that a study may fail to recruit sufficient participants to have the power required to detect an effect, and secondly, that the sample recruited may not be representative of the wider population to which inferences are made, affecting the validity of the conclusions drawn due to selection bias [7, 10].

A number of factors are known to influence a gatekeeper’s decision to inform a potential participant about a study. The gatekeeper needs to assess the potential participant as being eligible for the study, and then to decide to inform them about it. The health status of the patient, the gatekeeper’s engagement with the patient, and their own attitude towards research are likely to affect this decision [8]. The gatekeeper is likely to inform the patient of the study only if they perceive the potential benefits of doing so to outweigh the potential risks.

Although recruitment to studies often depends on healthcare professionals acting as gatekeepers, the views of these professionals, including barriers to recruitment and potential solutions, are poorly understood. Therefore, in the context of an observational study of mental health problems in adolescents with paediatric Chronic Fatigue Syndrome (CFS/ME) presenting to a specialist paediatric CFS team, we undertook a qualitative study to explore healthcare professionals’ views. We did this because we noticed that rates of healthcare professionals failing to undertake eligibility assessments to this study were considerably higher than for other studies in the clinic; approximately 15% of patients were not assessed for eligibility for this study as compared to < 4% in the SMILE trial [11], conducted in the same service. The aim of the current study was to further understand the barriers to recruitment to mental health studies in paediatric health populations, and to generate recommendations for how these can be addressed.

Three specific themes were identified: the value of research, barriers to recruitment at gatekeeping stage, and what can be done to help to overcome these barriers. Each theme (and concomitant subthemes) is summarised below, with illustrative quotes in Table 1. Individual participants are referred to by number (e.g. P1, P2, etc.).

Multidisciplinary healthcare professionals who were actively acting as gatekeepers for the initial stage of recruitment to an observational study of mental health in adolescents with CFS/ME all valued research, but perceived there to be a number of contextual and study specific factors which acted as barriers to recruitment. The clinical context of the recruitment activity, including a lack of time, and the emotionally demanding nature of the initial clinical assessment, as well as the wider research context of competing studies were apparent barriers. The name of the specific study, which was experienced as off-putting and misleading to patients, the sensitive nature of the questions asked in the study, participants’ own lack of training and resources to manage emergent mental health problems, and the lack of a direct beneficial outcome for the patients, were also cited as barriers. Recruitment activities could be supported by study familiarisation, regular reminders, greater flexibility about the point of recruitment, promoting the value of the case specific information gained from participating in the study and thinking carefully about the name of the study.

The clinical context, in this study, was perceived to be a barrier to recruitment; participants talked about the pressures of time within the initial clinical assessment as the recruitment point. Contextual barriers have been reported in previous studies [13] which have recommended making it as easy as possible for clinical gatekeepers to assess for eligibility and seek consent to contact from the research team [14, 15]. Providing easily accessible study information such as printed study recruitment packs is critically important. In interventional studies, recruiting and potentially randomising participants prior to their having received any interventions is an important part of study design; therefore, the initial clinical assessment is a key recruitment point. In an observational study, determining a consistent point of recruitment is important, but it may be worth having some flexibility (for example, to recruit at the first follow-up) or recruiting at a subsequent point in a patient’s journey through a specialist service where this is possible within the requirements of the study design. However, the gatekeeping activities within this study did not differ from that of previous studies within the same clinical context, although the rates of assessment for eligibility did. Therefore, it may be that factors specific to this study hampered gatekeeping activities beyond that which would be accounted for by the clinical context.

Recruitment problems in paediatric studies specifically are compounded by added complexity of requiring parental consent and requiring time out of school for children and potentially out of work for parents; across 181 Principal Investigators on paediatric trials at the Boston Children’s Hospital, 46% of studies were reported to have experienced delays in recruitment [6]. Our finding that gatekeepers may assume that patients and families may find it too overwhelming to be invited to participate in research at the end of an emotional session might be the result of paternalism, which has also been found in previous research [8, 13] and it may be that further education of healthcare professionals about the potential benefits to patients of participating in research is indicated. However, further work with patients and their families would be important to ensure that research is introduced in the most sensitive manner possible, and at the most appropriate time, and it is possible that there may be risks associated with participation in psychiatric studies, such as a potential worsening of mental state as a result of the research procedures which may potentially elicit distress or discomfort [9].

Furthermore, the wider research context can create barriers to recruitment. Previous studies also found that have numerous competing studies recruiting in parallel within one clinical location can serve as a barrier to recruitment. Fenlon et al. [1] found that clinical staff are reluctant to recruit to more than 1 study at a time; in the current study, the patient eligibility criteria for the studies open to recruitment meant that each patient could only be recruited to 1 study, although they were potentially eligible for more than 1 study. Studies have also found that clinicians feel bombarded with too much research [13]. Therefore, carefully considering the timeframes of recruitment for all the research activities within a clinical setting, and having a clinical team member who leads on overseeing research could enable better management of research demands arising from multiple studies recruiting in parallel. Having a clinical team member who champions research has also been recommended elsewhere [1, 14], with the added benefit that these individuals can be involved from design stage [13]. Prompts for the gatekeepers to remind them about the research, both generic and patient-specific, can be helpful.

Study design also seems to be very important as the nature of the research may also affect the views of gatekeepers. The current study was an observational study, and participants commented that they did not perceive there to be a direct benefit to patients of participating in the study, which discouraged them from undertaking study related gatekeeping activities. It may be that the research team could have further highlighted potential benefits of participating to the clinical gatekeepers, particularly at study initiation stage. Prior studies have found that drug studies are more likely to be given priority over epidemiological studies [1], although clinicians recruiting to research studies have also reported that clinical trials are harder to recruit to as they demand greater commitment from participants, both with regard to time and risk [2].

Another barrier in the current study was the gatekeepers’ perceptions of a lack of training and resources to deal with any mental health issues that emerged as an outcome from the research assessments. This may have led to selection bias, with gatekeepers being less likely to introduce the study to patients who were more distressed.

Importantly, the current study found that the name of the study is important to consider, particularly in the context of stigmatised conditions such as mental health, where patients may be reluctant to participate by association [8]. Whilst the study name needs to be appealing, it should not be misleading. Involving key stakeholders, including patients and clinical gatekeepers, at design stage to generate a meaningful and appropriate study name could prevent the name from subsequently posing a barrier to recruitment.

Arguably, due to these barriers, in this study, patients were denied access to taking part in research. All potential participants should be given the option of participating in studies. The NHS constitution commits to informing all patients of research studies that they are eligible to participate in [16], consistent with the ethos of ‘No decision about me without me’ [17]. Participating in research may be therapeutic and empowering, giving patients an additional opportunity to talk about their experiences [9, 18].

Gatekeeping professionals generally valued research, but highlighted a number of barriers to recruiting, related to both the wider research and clinical contexts, and to the design of a study specifically. The current study highlights the need to carefully consider, at design stage, how to overcome potential barriers to recruitment where it is possible to do so (see Table 2). Gatekeepers should be actively involved at this stage to ensure that the study is set up in such a way to best enable recruitment activities within the clinical setting. It is also worth spending time educating busy clinical gatekeepers about the study to ensure that they understand its relevance and importance.