title: The BLEED pilot study: determining the usability of a medical device before the clinical trial.
abstract: OBJECTIVE
  To discuss the methods of a study which will aim to determine the usability of a medical device not yet approved for use in a clinical trial.
  
  
  BACKGROUND
  The Blood Loss Estimation and Evaluation of Drape (BLEED) pilot aims to determine the usability of a drape which measures blood loss during third stage labour. Third stage blood loss is usually estimated visually. This method has been found to be inaccurate. The drape has been tested in developing countries overseas and has been found to more accurately measure third stage blood loss when compared with visual methods. The usability of the drape has not yet been evaluated.
  
  
  METHODS
  Before starting the BLEED pilot study, the risks to the participants were evaluated and the drape was determined to pose minimal risk of harm for participants. The pilot study will involve recruitment of women and health professionals who will use the drape to measure third stage blood loss and then complete a survey about their opinion of the drape's usability. The data will be used to determine the suitability of using the drape in a clinical trial.
  
  
  CONCLUSIONS
  The benefits of pursing this programme of research outweigh the challenges. The drape has been validated as more accurate than visual estimation for evaluating blood loss during third stage labour, yet the usability has not been established and a clinical trial is needed. This programme of research will determine if routine use of this drape in research and practice is justified.
  
  
  CONCLUSIONS
  This work will assist health professionals who are considering ways to improve clinical outcomes and will particularly inform researchers who are interested in piloting new devices in maternity care. While adherence to monitoring requirements and governance of clinical trials is essential, the system has become complicated for investigator-initiated research using devices. Despite these challenges, the authors of this paper believe that this research programme is justified.
  
  
  CONCLUSIONS
  The complexity of navigating documentation and governance required for clinical trials may deter some healthcare professionals who plan to initiate research that involves the use of a medical device. While adherence to monitoring requirements and governance of clinical research is essential, research involving the evaluation of emerging medical technologies can be complicated, particularly for an investigator-initiated (clinician) researcher who does not have the support of a biotech company. These issues may deter clinician researchers from initiating trials and impede their ability to implement clinical research. Despite the challenges, the effectiveness and safety of technologies must be evaluated for their effectiveness in improving clinical outcomes for patients.
authors.affiliation: University of Melbourne, Carlton, Victoria, Australia.
authors.forename: Sharon
authors.initials: S
authors.lastname: Licqurish
authors.affiliation: Australian Catholic University, Melbourne, Australia.
authors.forename: Laura
authors.initials: L
authors.lastname: Biggs
authors.affiliation: Australian Catholic University.
authors.forename: Jane
authors.initials: J
authors.lastname: Morrow
mesh_terms: D000328:Adult; D035843:Biomedical Research / Q000458:organization & administration*; D002986:Clinical Trials as Topic; D019719:Diagnostic Equipment; D004867:Equipment Design; D005260:Female; D006470:Hemorrhage / Q000175:diagnosis*; D006801:Humans; D007749:Labor Stage, Third / Q000502:physiology*; D008875:Middle Aged; D009774:Obstetrics / Q000295:instrumentation*; D010865:Pilot Projects; D011247:Pregnancy; D055815:Young Adult
keywords: Clinical trials; governance; labour; medical devices; monitoring; pilot study; third stage