ObjectiveTo evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall.DesignCluster trial randomised by paramedic; modelling.Setting13 ambulance stations in two UK emergency ambulance services.Participants42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.InterventionsIntervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Main Outcome MeasuresEffectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.SafetyFurther emergency contacts or death within one month.Cost-EffectivenessCosts and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.Results17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS −0.74, 95% CI −2.83 to +1.28; PCS −0.13, 95% CI −1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.ConclusionsIntervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.Trial Registration ISRCTN Register ISRCTN10538608

BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.

International audienceRenewed excavations at FLK Zinj and its surrounding landscape have yielded valuable information regarding its paleoecological situation and the prehistoric behavioral function of the site. The density of materials at the main cluster of the site excavated by Leakey contrasts with the bone and lithic scatters surrounding the site. The location of FLK Zinj, situated a few hundred meters away from a freshwater spring, would have enabled hominins access to water, plants and game. The appeal of the spot for hominins (also explained by the presence of a wooded habitat) is confirmed by inferences of its redundant use prior and during the formation of the FLK Zinj paleosol, as witnessed by materials accumulated both under and on the waxy clay deposit that constitutes the FLK Zinj stratum. The single-cluster nature of the site indicates central-place behavior and evidence is provided that hominins occupied the site at a time of very low predation hazards in the area