E3 PreliminaryPreliminaryPEM unclearMethods-PaperPeer-reviewedMachine draft
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.
Loades, Maria E, Smith, Lucie, Higson-Sweeney, Nina et al. · BMC medical research methodology · 2019 · DOI
Quick Summary
This study looked at why it's hard to recruit young people with ME/CFS into research studies about mental health. Researchers interviewed doctors and nurses at a specialist ME/CFS clinic to understand what makes it difficult for them to invite patients to join studies. They found that busy schedules, emotional patient appointments, and competing studies all made recruitment harder.
Why It Matters
Understanding recruitment barriers is critical for ME/CFS research, as failed or biased recruitment compromises study validity and our ability to understand disease mechanisms and comorbidities. This study provides practical insights from clinical staff about how to design better studies that young people with ME/CFS are more likely to participate in, potentially improving future research quality.
Observed Findings
- Healthcare professionals acknowledged the value of research but identified multiple recruitment barriers
- Time pressures and emotional intensity of clinical assessments created barriers to recruitment in the clinical context
- Competing multiple studies in the same service reduced capacity for recruitment
- Study-specific factors including study name, design features, and focus on mental health affected recruitment
- Healthcare professionals recommended active involvement of gatekeepers in study design to overcome barriers
Inferred Conclusions
- Recruitment success depends significantly on how well the clinical context and study design accommodate healthcare professionals' workflows and emotional labour
- Early involvement of clinical gatekeepers in study design phase is essential to identify and mitigate recruitment barriers
- Studies on sensitive topics (mental health in chronic illness) may face additional recruitment challenges beyond logistical factors
Remaining Questions
- Do the barriers identified by gatekeepers actually correlate with measured recruitment outcomes and patient consent rates?
- Which specific study design modifications most effectively overcome identified barriers?
What This Study Does Not Prove
This study does not prove that implementing the gatekeepers' recommendations will successfully improve recruitment, nor does it establish whether perceived barriers actually prevent eligible patients from consenting. The findings from one specialist centre may not generalise to other settings or research contexts. This is a qualitative study of staff perceptions, not a measurement of actual patient recruitment outcomes.
Tags
Phenotype:Pediatric
Method Flag:Exploratory Only
Metadata
- DOI
- 10.1186/s12874-019-0730-z
- PMID
- 31029100
- Review status
- Machine draft
- Evidence level
- Early hypothesis, preprint, editorial, or weak support
- Last updated
- 8 April 2026
About the PEM badge: “PEM required” means post-exertional malaise was an explicit required diagnostic criterion for participant inclusion in this study — not that PEM was studied, observed, or discussed. Studies using criteria that do not require PEM (e.g. Fukuda, Oxford) are tagged “PEM not required”. How the atlas works →
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