Table 3 Barriers and enablers to recruitment
Factor | Barriers | Enablers |
|---|---|---|
Study-related | • Anxious patients excluded by eligibility criteria • Acceptability of intervention to patients • Delay in trial opening unhelpful • Difficulty re-engaging sites after delay • Lack of engagement with sites by CI • Information not provided in multiple languages • Lack of thinking time for parents/guardians and patients • Amount of information parents/guardians required to read • Amount of paperwork parents/guardians required to complete • Difficult to improve recruitment | • No issues with design • Straightforward trial • Clear information for parents/guardians and patients • Use of established medications • Well organised study • Funding provided for research nurses • Supportive, available study team • Study team keeping site updated |
Participant- and population-related | • Fewer anxious patients than expected • Parents unwilling to attend appointments due to timing (school year) • Parents and patients declining to take part in trial • Patients preferring not to have a pre-medication • Concerns about child’s anxiety • Parents and patients unwilling to read necessary information • Limited proficiency with English • Anxious dental patients generally difficult to recruit • High levels of anxiety requiring higher levels of pre-medication • Limited anxiety in ENT and opthamology patients | • Generally positive response to MAGIC • Trial seen as helpful for patient anxiety • Parents wanting to help (NHS, other children) • Parents comfortable with either treatment option |
Practitioner-related | • Lack of clinician availability • Lack of research nurse availability • Not recruiting from all specialities • Lack of experience in setting • Discomfort with investigator role • Inertia around first recruit • Lack of engagement in trial • Lack of motivation following poor recruitment • Unintentionally unhelpful actions of other stakeholders | • Trial valued by clinicians and research nurses • Personal investment of PI in MAGIC • Practitioners comfortable explaining trial • Effective communication between practitioners • Organisation and preparation • Ensuring clinician availability • Ensuring research nurse availability • Ongoing engagement with the trial • Acting to improve recruitment |
Ethics-related | • Excluding patients based on clinical experience • Concern about making things more difficult for families • Concern about worsening anxiety • Concern about children who can’t give assent | • Important that assent is included • Children appreciating opportunity to give assent • Option of verbal assent is helpful |
Collaboration-related | • Anaesthetists gatekeeping • Anaesthetists wanting predictable approach • Different approaches to pre-medication among anaesthetists • Lack of personal relationships with key personnel • Issues with communication at site • Difficult to engage people outside the trial • Theatre nurses gatekeeping | • Buy-in from other clinicians, health professionals • Nurses identifying anxious patients • Effective working relationships with key personnel • Engagement work to improve relationships • PI publicising trial |
Setting- and context-related | • Difficult to recruit on the day • Pressure on resources • Challenge of recruiting in time-pressured environment • Limited time to decide about approaching patients • Lack of pre-assessment • Pre-assessment not working to enable recruitment • Delays getting prescriptions from pharmacy • Challenges following protocol in particular settings | • Advance notification of anxious patients • Actively identifying potential participants • Working well with existing system • Ability to be flexible with surgical lists • Effective organisation of paperwork • Effective process with pharmacy |
Health system-related | • Demands of NHS workload • Limitations of research nurse system • Lack of remuneration for unseen work • Pressure on NHS resources | • Good for departments to be involved in research • Research nurses available for various studies |