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1.  PAin SoluTions In the Emergency Setting (PASTIES); a protocol for two open-label randomised trials of patient-controlled analgesia (PCA) versus routine care in the emergency department 
BMJ Open  2013;3(2):e002577.
Introduction
Pain is the commonest reason that patients present to an emergency department (ED), but it is often not treated effectively. Patient controlled analgesia (PCA) is used in other hospital settings but there is little evidence to support its use in emergency patients. We describe two randomised trials aiming to compare PCA to nurse titrated analgesia (routine care) in adult patients who present to the ED requiring intravenous opioid analgesia for the treatment of moderate to severe pain and are subsequently admitted to hospital.
Methods and analysis
Two prospective multi-centre open-label randomised trials of PCA versus routine care in emergency department patients who require intravenous opioid analgesia followed by admission to hospital; one trial involving patients with traumatic musculoskeletal injuries and the second involving patients with non-traumatic abdominal pain. In each trial, 200 participants will be randomised to receive either routine care or PCA, and followed for the first 12 h of their hospital stay. The primary outcome measure is hourly pain score recorded by the participant using a visual analogue scale (VAS) over the 12 h study period, with the primary statistical analyses based on the area under the curve of these pain scores. Secondary outcomes include total opioid use, side effects, time spent asleep, patient satisfaction, length of hospital stay and incremental cost effectiveness ratio.
Ethics and dissemination
The study is approved by the South Central—Southampton A Research Ethics Committee (REC reference 11/SC/0151). Data collection will be completed by August 2013, with statistical analyses starting after all final data queries are resolved. Dissemination plans include presentations at local, national and international scientific meetings held by relevant Colleges and societies. Publications should be ready for submission during 2014. A lay summary of the results will be available to study participants on request, and disseminated via a publically accessible website.
Registration details
The study is registered with the European Clinical Trials Database (EudraCT Number: 2011-000194-31) and is on the ISCRTN register (ISRCTN25343280).
doi:10.1136/bmjopen-2013-002577
PMCID: PMC3586149  PMID: 23418302
Accident & Emergency Medicine; Health Economics; Pain Management; Trauma Management
2.  Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme 
BMJ Open  2012;2(3):e000390.
Objectives
To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme.
Design
Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme.
Setting
Four city primary schools (two control and two intervention) in the South West of England.
Participants
202 children aged 9–10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class.
Intervention
Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6.
Primary and secondary outcomes
Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months.
Results
At 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less ‘negative food markers’, more ‘positive food markers’, lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures.
Conclusions
Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.
Article summary
Article focus
To present behavioural and weight status outcomes from an exploratory cluster randomised controlled trial of a novel school-based obesity prevention programme with English primary school children.
To present sample size estimates required for a definitive trial of the programme based on outcome results, attrition rates and estimates of the intraclass correlations of the outcome measures.
Key messages
The Healthy Lifestyles Programme (HeLP) has been developed using behaviour change theory and extensive stakeholder involvement to engage and support children and their families in healthy lifestyles.
Behavioural and weight status outcomes at 18 and 24 months from this exploratory trial (Phase 3 pilot) show consistency in the direction of effects, all in favour of the intervention, demonstrating ‘proof of concept’.
Results from the exploratory trial have provided sufficient evidence to support the evaluation of HeLP in a full-scale trial.
Strengths and limitations of this study
The HeLP intervention has undergone a systematic development process using research evidence, behavioural theory, stakeholder consultation and piloting. This has enabled the researchers to gain a deeper understanding of the context in which the intervention was to be delivered in order to maximise engagement at all levels. The exploratory trial presented in this paper (Phase 3 pilot) has demonstrated not only that the design of the trial is feasible, with outcome data obtained from 92% of the original cohort at 24 months after transition to secondary school, but also that behavioural and weight status outcome measures at 18 and 24 months show consistency in the direction of effects (although the differences are relatively small), all in favour of the intervention, demonstrating ‘proof of concept’. This shows that a definitive trial of HeLP is both feasible and justified.
The study was conducted in the South West of England, where the population is predominantly white, and although there are areas of deprivation, none of the four schools had ≥25% of children eligible for free school meals (the national average of proportion of children eligible for free school meals). However, the intervention has been developed to allow the flexibility and adaptation to ensure that it is recognising and responding to the local needs of children and families from different socioeconomic and ethnic groups while still maintaining fidelity. Food intake and television (TV) viewing/screen time were self-reported, and although children were asked to sit in their literacy tables so that appropriate support could be provided to each child during completion, the information children are able to provide is limited. We did, however, go to great lengths to ensure that the questionnaires were simple and presented in such a way so as to trigger recall.
doi:10.1136/bmjopen-2011-000390
PMCID: PMC3358612  PMID: 22586282
3.  The development, feasibility and acceptability of a school-based obesity prevention programme: results from three phases of piloting 
BMJ Open  2011;1(1):e000026.
Objectives
To develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster randomised trial.
Design
This was a three stage pilot involving six schools (398 children) in South West England, including an exploratory randomised controlled trial and qualitative interviews and focus groups with teachers, parents and children.
Intervention
The Healthy Lifestyle Programme uses a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage schools, children and their families.
Results
Of the 398 eligible children in the three pilot phases, only four opted out and a further three withdrew from the exploratory trial. In the exploratory trial, baseline measurements (anthropometric and behavioural) were obtained for 202/204 eligible children in four schools and both 18- and 24-month outcome measurements for 193/204 and 187/204 participants, respectively. Qualitative data show that delivery of the intervention is feasible within schools and acceptable to teachers, children and families. In the exploratory trial, 18/80 children (24%) in the intervention schools and 31/122 (26%) in the control schools were overweight or obese at baseline, increasing, at 18-month follow-up, to 38/119 (32%) in the control schools compared with 18/74 (24%) in the intervention schools. At 24 months the proportion of overweight and obese children in the control schools remained at 32% (36/114), whereas the proportion in the intervention schools decreased slightly to 22% (16/73).
Conclusion
The Healthy Lifestyle Programme is feasible to deliver and acceptable to schools, children and their families. We recruited, retained and obtained outcome measurements from 92% of eligible children in the exploratory trial, including measurements taken after transition to secondary school, suggesting that a definitive trial is likely to be deliverable.
Article Summary
Article focus
To show the development and evaluation of a novel school-based obesity prevention programme through three detailed stages of piloting.
To demonstrate the acceptability of the Healthy Lifestyle Programme (HeLP) to schools, children and their families.
To present evidence showing the feasibility of the trial design and outcome measurements through an exploratory trial involving four schools and 202 children.
Key messages
HeLP has been systematically developed and uses drama-based activities to engage the school, children and their families in healthy lifestyle messages and activities.
The programme has been piloted in six schools involving 398 children and results suggest that it is acceptable and feasible for schools, children and their families.
Results from the pilot phases have provided sufficient evidence to support the evaluation of the HeLP intervention in a full scale trial.
Strengths and limitations of this study
Strengths
The HeLP intervention has undergone a systematic development process using research evidence, behavioural theory, stakeholder consultation and piloting. This has enabled the researchers to gain a deeper understanding of the context in which the intervention is to be delivered in order to maximise engagement at all levels. Preliminary results suggest the programme may affect behaviours associated with overweight and obesity.
Limitations
Interviews and focus groups were conducted by the lead researcher who had built up a relationship with the schools, children and their families. This may have affected responses as the participants might not have wanted to express negative opinions. However, the ongoing support and retention of the schools and children would suggest that if there was such an effect, it was very slight. Piloting has taken place in schools in varying socioeconomic areas, and although there is a limited ethnic mix of children in South West England, the drama framework has been specifically developed to allow flexibility and adaptation to ensure it is recognising and responding to the needs of the children receiving it.
doi:10.1136/bmjopen-2010-000026
PMCID: PMC3191390  PMID: 22021732

Results 1-3 (3)