Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Helen Snooks, Gaze S A, Russell I T, Other A N and Watkins A J
ScientificTracks Abstracts-Workshop: J Clin Trials
Background: The SAFER programme conducts research into treating falls in older people; SAFER1 was a pragmatic cluster
randomised controlled trial that examined a Computerised Clinical Decision Support system for paramedics, using a hierarchy of
outcomes comprising death, unscheduled hospital admission, unscheduled ED attendance, and 999 calls. SAFER2 used a similar
study framework to assess new protocols which allow emergency ambulance paramedics to assess and refer patients to appropriate
community based care.
Objectives: In SAFER2, all participants consent to follow up through routine medical records, and some by postal questionnaire.
We consider (a) the characteristics of those providing data through two routes, (b) the consistency between data on hierarchy
outcomes available through the two routes, and (c) any resulting effect on reported study outcomes.
Methods: Routine medical records are available anonymously through the SAIL Databank in Wales and HSCIC in England;
following successful linkage with study participants, data on each component in the hierarchy of outcomes is assessed at one
month (for safety)and six months (for effectiveness). Data on QoL is also available at both time points.
Results: Data from the two routes are broadly consistent; linkage problems are diminishing as experience develops. Respondents
to postal questionnaires comprised approximately one quarter of study participants, and were generally younger & healthier than
non-respondents. HTA of the SAFER2 intervention reaches similar conclusions with data from different routes.
Conclusions: Routinely recorded data provides accurate information on the full range of study participants over multiple time
points in follow-up, are based on increased sample sizes, and are more generalizable.
Helen Snooks is the Professor of Health Services Research in the Swansea University Medical School, UK. She is the Interim Director of the Swansea Trials Unit (STU)
and leads the Patient and Population Health and Informatics (PPHI) research stream at Swansea University. Helen’s main research interests and expertise lie in the
fields of Emergency Pre-hospital and Unscheduled Care, Clinical Audit and Effectiveness, and research support. The focus of her work is to plan, design and carry out
evaluations of health technologies and new models of service delivery. Helen has a Bsc (Hons) Economics, Sociology, Statistics from University of Surrey with a PhD
in Health Services Research ‘Post Traumatic Stress Disorder in seriously injured accident victims’ at the University of Sheffield in 2000.