Jane Morrow

The BLEED pilot study: determining the usability of a medical device before the clinical trial.

AIM 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. REVIEW 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 drapes usability. The data will be used to determine the suitability of using the drape in a clinical trial. DISCUSSION 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. CONCLUSION 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. IMPLICATIONS FOR PRACTICE 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.

Managing projected midwifery workforce deficits through collaborative partnerships

To address workforce shortages, the Australian Government funded additional nursing and midwifery places in 2009 pre-registration courses. An existing deficit in midwifery clinical placements, combined with the need to secure additional clinical placements, contributed to a serious shortfall. In response, a unique collaboration between Midwifery Academics of Victoria (MIDAC), rural and metropolitan maternity managers (RMM and MMM) groups and Department of Health (DOH) Victoria was generated, in order to overcome difficulties experienced by maternity services in meeting the increased need. This group identified the large number of different clinical assessment tools required to be being completed by midwives supervising students as problematic. It was agreed that the development of a Common Assessment Tool (CAT) for use in clinical assessment across all pre-registration midwifery courses in Victoria had the potential to reduce workload associated with student assessments and, in doing so, release additional placements within each service. The CAT was developed in 2009 and implemented in 2010. The unique collaboration involved in the development of the CAT is a blueprint for future projects. The collaboration on this project provided a range of benefits and challenges, as well as unique opportunities for further collaborations involving industry, government, regulators and the tertiary sector.