Background: Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services.\ud Objectives: To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use.\ud Design: Cluster randomised controlled trial.\ud Participants: Participating paramedics at three ambulance services in England and Wales were based at stations randomised to intervention or control arms. Participants were aged 65 years and over, attended by a study paramedic for a fall-related emergency service call, and resident in the trial catchment areas.\ud Interventions: Intervention paramedics received a clinical protocol with referral pathway, training and support to change practice. Control paramedics continued practice as normal.\ud Outcomes: The primary outcome comprised subsequent emergency health-care contacts (emergency admissions, emergency department attendances, emergency service calls) or death at 1 month and 6 months. Secondary outcomes included pathway of care, ambulance service operational indicators, self-reported outcomes and costs of care. Those assessing outcomes remained blinded to group allocation.\ud Results: Across sites, 3073 eligible patients attended by 105 paramedics from 14 ambulance stations were randomly allocated to the intervention group, and 2841 eligible patients attended by 110 paramedics from 11 stations were randomly allocated to the control group. After excluding dissenting and unmatched patients, 2391 intervention group patients and 2264 control group patients were included in primary outcome analyses. We did not find an effect on our overall primary outcome at 1 month or 6 months. However, further emergency service calls were reduced at both 1 month and 6 months; a smaller proportion of patients had made further emergency service calls at 1 month (18.5% vs. 21.8%) and the rate per patient-day at risk at 6 months was lower in the intervention group (0.013 vs. 0.017). Rate of conveyance to emergency department at index incident was similar between groups. Eight per cent of trial eligible patients in the intervention arm were referred to falls services by attending paramedics, compared with 1% in the control arm. The proportion of patients left at scene without further care was lower in the intervention group than in the control group (22.6% vs. 30.3%). We found no differences in duration of episode of care or job cycle. No adverse events were reported. Mean cost of the intervention was £17.30 per patient. There were no significant differences in mean resource utilisation, utilities at 1 month or 6 months or quality-adjusted life-years. In total, 58 patients, 25 paramedics and 31 stakeholders participated in focus groups or interviews. Patients were very satisfied ...

A clinical protocol for paramedics reduced emergency ambulance calls for patients attended for a fall safely and at modest cost.

ObjectiveTo evaluate the effectiveness and cost utility of a universally provided early years parenting programme.DesignMulticentre randomised controlled trial with cost-effectiveness analysis.SettingEarly years centres in four deprived areas of South Wales.ParticipantsFamilies with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control.InterventionThe Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions.Main outcome measuresNegative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures.ResultsThere were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With ‘+’ indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI −1.90 to 3.69); in supportive parenting, +0.17 (95%CI −0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485–46 578) over 5 years and £18 954 (range 11 664–25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up.ConclusionsOur trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains.Trial registrationThe trial is registered with Current Controlled Trials ISRCTN13919732.

Should randomised controlled trials be the 'gold standard' for research on preventive interventions for children. Abstract (152 words)Randomised Controlled Trials (RCTs) have been offered a privileged position in terms of the evidence base for preventive interventions for children, but there are practical and theoretical issues that challenge this research methodology. Well recognised issues include the impossibility of blinding participants, the problem of identifying a pre-eminent outcome measure for complex interventions, and problems with limiting access to equivalent interventions in real world settings. A further theoretical problem is the exclusion from RCTs of families who are most ready to change, resulting in an apparently reduced level of intervention effectiveness. Qualitative evidence from a recent RCT suggests that this problem could be operating in some prevention trials. Increasing sample sizes can overcome some of these problems, but the cost of the necessarily huge trials becomes disproportionate to the low cost of preventive interview. Given the limitations on RCTs in preventive settings, their privileged position in terms of research evidence maybe undeserved. Summary of policy and practice implications (135)Policy makers and commissioners value certainty and RCTs are considered most likely to provide that certainty. In times of scare resources, interventions without an RCT evidence base are an easy target for cuts and/or decisions not to invest. In the context of preventive services for children this view is debatable. Because social, educational and public health interventions are complex and are offered in the context of a complex world, it is simplistic to believe that one research approach can provide all the necessary information on what works. A more sophisticated understanding of RCTs and complex interventions suggest that we should rebalance the hierarchy of evidence and give more credence to good studies of other designs. This might make policy makers and commissioners lives more complex and less certain, but it might improve outcomes for children. Category 2 Methodological Issues and DevelopmentsWord Count 3684

IntroductionEmergency calls to ambulance services are frequent for older people who have fallen, but ambulance crews often leave patients at the scene without ongoing care. Evidence shows that when left at home with no further support older people often experience subsequent falls which result in injury and emergency-department attendances. SAFER 2 is an evaluation of a new clinical protocol which allows paramedics to assess and refer older people who have fallen, and do not need hospital care, to community-based falls services. In this protocol paper, we report methods and progress during trial implementation. SAFER 2 is recruiting patients through three ambulance services. A successful trial will provide robust evidence about the value of this new model of care, and enable ambulance services to use resources efficiently.DesignPragmatic cluster randomised trial.Methods and analysisWe randomly allocated 25 participating ambulance stations (clusters) in three services to intervention or control group. Intervention paramedics received training and clinical protocols for assessing and referring older people who have fallen to community-based falls services when appropriate, while control paramedics deliver care as usual. Patients are eligible for the trial if they are aged 65 or over; resident in a participating falls service catchment area; and attended by a trial paramedic following an emergency call coded as a fall without priority symptoms. The principal outcome is the rate of further emergency contacts (or death), for any cause and for falls. Secondary outcomes include further falls, health-related quality of life, ‘fear of falling’, patient satisfaction reported by participants through postal questionnaires at 1 and 6 months, and quality and pathways of care at the index incident. We shall compare National Health Service (NHS) and patient/carer costs between intervention and control groups and estimate quality-adjusted life years (QALYs) gained from the intervention and thus incremental cost per QALY. We shall estimate wider system effects on key-performance indicators. We shall interview 60 intervention patients, and conduct focus groups with contributing NHS staff to explore their experiences of the assessment and referral service. We shall analyse quantitative trial data by ‘treatment allocated’; and qualitative data using content analysis.Ethics and disseminationThe Research Ethics Committee for Wales gave ethical approval and each participating centre gave NHS Research and Development approval. We shall disseminate study findings through peer-reviewed publications and conference presentations.Trial Registration: ISRCTN 60481756