title: Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial.
abstract: BACKGROUND
  The perspectives and experiences of trial staff are increasingly being investigated as these can be used to improve recruitment, adherence to trial protocols and support given to future staff. We interviewed staff working on a type 1 diabetes trial in order to aid interpretation of trial findings, inform recommendations for the rollout of the treatments investigated and provide recommendations for the conduct of future trials. However, our interviews uncovered aspects of trial work erstwhile unrecognised or underreported in the trials literature, and it is these which form the focus of this paper.
  
  
  METHODS
  In-depth interviews were conducted with (n = 18) staff, recruited from seven centres, who were involved in recruitment and trial delivery. Data were analysed thematically.
  
  
  RESULTS
  Alongside logistical and practical issues which made trial work challenging, staff often talked spontaneously and at length about how trial work had affected them emotionally. Staff not only described the emotional stresses arising from having to meet recruitment targets and from balancing research roles with clinical responsibilities, they also discussed having to emotionally manage patients and their colleagues. The emotional aspects of trial work particularly came to the fore when staff notified patients about their treatment allocation. On such occasions, staff described having to employ emotional strategies to pre-empt and manage potential patient disappointment and anger. Staff also described having to manage their own emotions when patients withdrew from the trial or were not randomised to the treatment arm which, in their clinical judgment, would have been in their best interests. To help address the emotional challenges they encountered, staff highlighted a need for more practical, emotional and specialist psychological support.
  
  
  CONCLUSIONS
  More attention should be paid to the emotional aspects of trial work to help ensure trial staff are adequately supported. Such support could comprise: increased training for staff to improve their own and patients' understandings of randomization, role-play to develop techniques to manage patient anger and disappointment, sharing of good practice, formalised team support with psychological input and access to specialist psychological support to troubleshoot complex emotional and ethical issues.
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK. J.Lawton@ed.ac.uk.
authors.forename: Julia
authors.initials: J
authors.lastname: Lawton
authors.forename: Jackie
authors.initials: J
authors.lastname: Kirkham
authors.forename: David
authors.initials: D
authors.lastname: White
authors.forename: David
authors.initials: D
authors.lastname: Rankin
authors.forename: Cindy
authors.initials: C
authors.lastname: Cooper
authors.forename: Simon
authors.initials: S
authors.lastname: Heller
mesh_terms: D001291:Attitude of Health Personnel; D003299:Cooperative Behavior; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000451:nursing / Q000628:therapy*; D004644:Emotions; D004739:England; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033183:Interdisciplinary Communication; D007407:Interviews as Topic; D007587:Job Description; D009720:Nurse Clinicians / Q000523:psychology*; D009723:Nurse-Patient Relations; D064686:Nutritionists / Q000523:psychology*; D018579:Patient Selection; D036301:Qualitative Research; D012108:Research Personnel / Q000523:psychology*; D012606:Scotland; D016526:Workload