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1.  “Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial 
Trials  2013;14:326.
Background
The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents.
Methods/Design
One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via triaxial, accelerometry (Actigraph GT3X+), anthropometry (height, body mass, BMI, waist and upper arm circumference), health related quality of life for child (PedsQL) and parent (EQ5D), parent wellbeing (ComQol-A5), injuries and health service use. A health economic evaluation will also be undertaken.
Discussion
It is anticipated that results of this pilot trial will be published in spring 2015.
Trial registration
Current controlled trials: ISRCTN54165860
doi:10.1186/1745-6215-14-326
PMCID: PMC3852746  PMID: 24107473
Pre-school; Physical activity; Intervention; Feasibility; Early years
2.  Development of a theory-based instrument to identify barriers and levers to best hand hygiene practice among healthcare practitioners 
Background
A theoretical approach to assessing the barriers and levers to evidence-based practice (EBP) with subsequent tailoring of theoretically informed strategies to address these may go some way to positively influencing the delay in implementing research findings into practice. Hand hygiene is one such example of EBP, chosen for this study due to its importance in preventing death through healthcare associated infections (HCAI). The development of an instrument to assess barriers and levers to hand hygiene and to allow the subsequent tailoring of theoretically informed implementation strategies is reported here.
Methods
A comprehensive list of barriers and levers to hand hygiene were categorised to the Theoretical Domains Framework (TDF) in a Delphi survey. These items formed the basis of an instrument that was tested to establish validity and reliability. The relationship between self-reported compliance with hand hygiene and barriers and levers to hand hygiene was also examined along with compliance according to where the barriers and levers fit within the domains of the TDF framework.
Results
A 33-item instrument that tested well for internal consistency (α = 0.84) and construct validity (χ2/df = 1.9 [p < 0.01], RMSEA = 0.05 and CFA = 0.84) was developed. The relationship between self-reported compliance with hand hygiene moderately correlated with barriers identified by participants (total barrier score) (r = 0.41, n = 276, p <0.001). The greater the number of barriers reported, the lower the level of compliance. A one-way between groups multivariate analysis of variance was performed to investigate differences between those adopting high or low compliance with hand hygiene. Compliance was highest for this sample of participants among practitioners with high levels of motivation, strong beliefs about capabilities, when there were positive social influences, when hand hygiene was central to participants’ sense of professional identity and was easier to remember to do.
Conclusions
This study has produced encouraging findings suggesting the potential for improved hand hygiene and resulting effects on the human and financial costs of healthcare associated infection. This study identifies a further potential use for the TDF.
doi:10.1186/1748-5908-8-111
PMCID: PMC3850814  PMID: 24059289
Evidence-based practice; Implementation; Hand hygiene; Instrument; Barriers and levers; Psychological theory; Compliance
3.  Communicating with parents about vaccination: a framework for health professionals 
BMC Pediatrics  2012;12:154.
Background
A critical factor shaping parental attitudes to vaccination is the parent’s interactions with health professionals. An effective interaction can address the concerns of vaccine supportive parents and motivate a hesitant parent towards vaccine acceptance. Poor communication can contribute to rejection of vaccinations or dissatisfaction with care. We sought to provide a framework for health professionals when communicating with parents about vaccination.
Methods
Literature review to identify a spectrum of parent attitudes or ‘positions’ on childhood vaccination with estimates of the proportion of each group based on population studies. Development of a framework related to each parental position with determination of key indicators, goals and strategies based on communication science, motivational interviewing and valid consent principles.
Results
Five distinct parental groups were identified: the ‘unquestioning acceptor’ (30–40%), the ‘cautious acceptor’ (25–35%); the ‘hesitant’ (20–30%); the ‘late or selective vaccinator’ (2–27%); and the ‘refuser’ of all vaccines (<2%). The goals of the encounter with each group will vary, depending on the parents’ readiness to vaccinate. In all encounters, health professionals should build rapport, accept questions and concerns, and facilitate valid consent. For the hesitant, late or selective vaccinators, or refusers, strategies should include use of a guiding style and eliciting the parent’s own motivations to vaccinate while, avoiding excessive persuasion and adversarial debates. It may be necessary to book another appointment or offer attendance at a specialised adverse events clinic. Good information resources should also be used.
Conclusions
Health professionals have a central role in maintaining public trust in vaccination, including addressing parents’ concerns. These recommendations are tailored to specific parental positions on vaccination and provide a structured approach to assist professionals. They advocate respectful interactions that aim to guide parents towards quality decisions.
doi:10.1186/1471-2431-12-154
PMCID: PMC3480952  PMID: 22998654
4.  Randomised cluster trial to support informed parental decision-making for the MMR vaccine 
BMC Public Health  2011;11:475.
Background
In the UK public concern about the safety of the combined measles, mumps and rubella [MMR] vaccine continues to impact on MMR coverage. Whilst the sharp decline in uptake has begun to level out, first and second dose uptake rates remain short of that required for population immunity. Furthermore, international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children. Together, this work suggests that effective interventions are required to support parents to make informed decisions about MMR.
This trial assessed the impact of a parent-centred, multi-component intervention (balanced information, group discussion, coaching exercise) on informed parental decision-making for MMR.
Methods
This was a two arm, cluster randomised trial. One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations. The intervention arm received an MMR information leaflet and participated in the intervention (parent meeting). The control arm received the leaflet only. The primary outcome was decisional conflict. Secondary outcomes were actual and intended MMR choice, knowledge, attitude, concern and necessity beliefs about MMR and anxiety.
Results
Decisional conflict decreased for both arms to a level where an 'effective' MMR decision could be made one-week (effect estimate = -0.54, p < 0.001) and three-months (effect estimate = -0.60, p < 0.001) post-intervention. There was no significant difference between arms (effect estimate = 0.07, p = 0.215). Heightened decisional conflict was evident for parents making the MMR decision for their first child (effect estimate = -0.25, p = 0.003), who were concerned (effect estimate = 0.07, p < 0.001), had less positive attitudes (effect estimate = -0.20, p < 0.001) yet stronger intentions (effect estimate = 0.09, p = 0.006). Significantly more parents in the intervention arm reported vaccinating their child (93% versus 73%, p = 0.04).
Conclusions
Whilst both the leaflet and the parent meeting reduced parents' decisional conflict, the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake.
doi:10.1186/1471-2458-11-475
PMCID: PMC3144460  PMID: 21679432
5.  Testing a workplace physical activity intervention: a cluster randomized controlled trial 
Background
Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels.
Methods
A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed.
Results and discussion
Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted.
Conclusions
The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings.
Trial registration
Current controlled trials ISRCTN08807396
doi:10.1186/1479-5868-8-29
PMCID: PMC3094266  PMID: 21481265
6.  Effective continuing professional development for translating shared decision making in primary care: A study protocol 
Background
Shared decision making (SDM) is a process by which a healthcare choice is made jointly by the healthcare professional and the patient. SDM is the essential element of patient-centered care, a core concept of primary care. However, SDM is seldom translated into primary practice. Continuing professional development (CPD) is the principal means by which healthcare professionals continue to gain, improve, and broaden the knowledge and skills required for patient-centered care. Our international collaboration seeks to improve the knowledge base of CPD that targets translating SDM into the clinical practice of primary care in diverse healthcare systems.
Methods
Funded by the Canadian Institutes of Health Research (CIHR), our project is to form an international, interdisciplinary research team composed of health services researchers, physicians, nurses, psychologists, dietitians, CPD decision makers and others who will study how CPD causes SDM to be practiced in primary care. We will perform an environmental scan to create an inventory of CPD programs and related activities for translating SDM into clinical practice. These programs will be critically assessed and compared according to their strengths and limitations. We will use the empirical data that results from the environmental scan and the critical appraisal to identify knowledge gaps and generate a research agenda during a two-day workshop to be held in Quebec City. We will ask CPD stakeholders to validate these knowledge gaps and the research agenda.
Discussion
This project will analyse existing CPD programs and related activities for translating SDM into the practice of primary care. Because this international collaboration will develop and identify various factors influencing SDM, the project could shed new light on how SDM is implemented in primary care.
doi:10.1186/1748-5908-5-83
PMCID: PMC2988066  PMID: 20977774
7.  Evidence, Theory and Context: Using intervention mapping to develop a worksite physical activity intervention 
BMC Public Health  2008;8:326.
Background
The workplace is an ideal setting for health promotion. Helping employees to be more physically active can not only improve their physical and mental health, but can also have economic benefits such as reduced sickness absence. The current paper describes the development of a three month theory-based intervention that aims to increase levels of moderate intensity physical activity amongst employees in sedentary occupations.
Methods
The intervention was developed using an intervention mapping protocol. The intervention was also informed by previous literature, qualitative focus groups, an expert steering group, and feedback from key contacts within a range of organisations.
Results
The intervention was designed to target awareness (e.g. provision of information), motivation (e.g. goal setting, social support) and environment (e.g. management support) and to address behavioural (e.g. increasing moderate physical activity in work) and interpersonal outcomes (e.g. encourage colleagues to be more physically active). The intervention can be implemented by local facilitators without the requirement for a large investment of resources. A facilitator manual was developed which listed step by step instructions on how to implement each component along with a suggested timetable.
Conclusion
Although time consuming, intervention mapping was found to be a useful tool for developing a theory based intervention. The length of this process has implications for the way in which funding bodies allow for the development of interventions as part of their funding policy. The intervention will be evaluated in a cluster randomised trial involving 1350 employees from 5 different organisations, results available September 2009.
doi:10.1186/1471-2458-8-326
PMCID: PMC2567979  PMID: 18808709

Results 1-7 (7)