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1.  Fidelity in complex behaviour change interventions: a standardised approach to evaluate intervention integrity 
BMJ Open  2013;3(11):e003555.
Objectives
The aim of this study was to (1) demonstrate the development and testing of tools and procedures designed to monitor and assess the integrity of a complex intervention for chronic pain (COping with persistent Pain, Effectiveness Research into Self-management (COPERS) course); and (2) make recommendations based on our experiences.
Design
Fidelity assessment of a two-arm randomised controlled trial intervention, assessing the adherence and competence of the facilitators delivering the intervention.
Setting
The intervention was delivered in the community in two centres in the UK: one inner city and one a mix of rural and urban locations.
Participants
403 people with chronic musculoskeletal pain were enrolled in the intervention arm and 300 attended the self-management course. Thirty lay and healthcare professionals were trained and 24 delivered the courses (2 per course). We ran 31 courses for up to 16 people per course and all were audio recorded.
Interventions
The course was run over three and a half days; facilitators delivered a semistructured manualised course.
Outcomes
We designed three measures to evaluate fidelity assessing adherence to the manual, competence and overall impression.
Results
We evaluated a random sample of four components from each course (n=122). The evaluation forms were reliable and had good face validity. There were high levels of adherence in the delivery: overall adherence was two (maximum 2, IQR 1.67–2.00), facilitator competence exhibited more variability, and overall competence was 1.5 (maximum 2, IQR 1.25–2.00). Overall impression was three (maximum 4, IQR 2.00–3.00).
Conclusions
Monitoring and assessing adherence and competence at the point of intervention delivery can be realised most efficiently by embedding the principles of fidelity measurement within the design stage of complex interventions and the training and assessment of those delivering the intervention. More work is necessary to ensure that more robust systems of fidelity evaluation accompany the growth of complex interventions.
Trial Registration ISRCTN No
ISRCTN24426731.
doi:10.1136/bmjopen-2013-003555
PMCID: PMC3831105  PMID: 24240140
Complex Interventions; Fidelity; Treatment Integrity
2.  Pain management for chronic musculoskeletal conditions: the development of an evidence-based and theory-informed pain self-management course 
BMJ Open  2013;3(11):e003534.
Objective
To devise and test a self-management course for chronic pain patients based on evidence and underpinned by theory using the Medical Research Council (MRC) framework for developing complex interventions.
Design
We used a mixed method approach. We conducted a systematic review of the effectiveness of components and characteristics of pain management courses. We then interviewed chronic pain patients who had attended pain and self-management courses. Behavioural change theories were mapped onto our findings and used to design the intervention. We then conducted a feasibility study to test the intervention.
Setting
Primary care in the inner city of London, UK.
Participants
Adults (18 years or older) with chronic musculoskeletal pain.
Outcomes
Related disability, quality of life, coping, depression, anxiety, social integration and healthcare resource use.
Results
The systematic reviews indicated that group-based courses with joint lay and healthcare professional leadership and that included a psychological component of short duration (<8 weeks) showed considerable promise. The qualitative research indicated that participants liked relaxation, valued social interaction and course location, and that timing and good tutoring were important determinants of attendance. We used behavioural change theories (social learning theory and cognitive behaviour approaches (CBA)) to inform course content. The course addressed: understanding and accepting pain, mood and pain, unhelpful thoughts and behaviour, problem solving, goal setting, action planning, movement, relaxation and social integration/reactivation. Attendance was 85%; we modified the recruitment of patients, the course and the training of facilitators as a result of testing.
Conclusions
The MRC guidelines were helpful in developing this intervention. It was possible to train both lay and non-psychologists to facilitate the courses and deliver CBA. The course was feasible and well received.
doi:10.1136/bmjopen-2013-003534
PMCID: PMC3831098  PMID: 24231458
PAIN MANAGEMENT; PRIMARY CARE
3.  How might the London 2012 Olympics influence health and the determinants of health? Local newspaper analysis of pre-Games pathways and impacts 
BMJ Open  2012;2(6):e001791.
Objectives
To conduct a content analysis of pre-Games local media coverage of the potential impact on health and the determinants of health in Newham, the site of the Olympic Park.
Design
Local newspaper content analysis.
Setting
Olympic park host site of the London Borough of Newham.
Outcome measures
Media coverage of employment, physical activity and well-being.
Results
Three hundred and 51 articles meeting the inclusion criteria were included in the analysis. The overwhelming majority of the articles took a positive perspective on the Olympic Games being hosted in Newham with less than 10% (32/351) addressing potential adverse effects. The frequency of articles reporting on both employment and well-being increased significantly over time (p=0.002 and p=0.006, respectively). A non-significant increasing trend was observed for physical activity (p=0.146). New employment opportunities and the promotion of physical activity in young people were the pathways most frequently reported in the local media. However, much less attention is devoted to understanding the uncertainties about how much of these new opportunities will directly improve the determinants of health in the Newham population.
Conclusions
Pre-Games reporting on the impact on health and the determinants of health increased over time in the London Borough of Newham, and is overwhelmingly positive. However, specific uncertainties around the true nature of its impact on local employment and physical activity were articulated. Further evaluation of the tangible impacts on population health, and the determinants of health and health inequalities from the London 2012 Olympics, is required.
doi:10.1136/bmjopen-2012-001791
PMCID: PMC3533038  PMID: 23151394
Public Health; Qualitative Research; Social Medicine
4.  The Olympic Regeneration in East London (ORiEL) study: protocol for a prospective controlled quasi-experiment to evaluate the impact of urban regeneration on young people and their families 
BMJ Open  2012;2(4):e001840.
Introduction
Recent systematic reviews suggest that there is a dearth of evidence on the effectiveness of large-scale urban regeneration programmes in improving health and well-being and alleviating health inequalities. The development of the Olympic Park in Stratford for the London 2012 Olympic and Paralympic Games provides the opportunity to take advantage of a natural experiment to examine the impact of large-scale urban regeneration on the health and well-being of young people and their families.
Design and methods
A prospective school-based survey of adolescents (11–12 years) with parent data collected through face-to-face interviews at home. Adolescents will be recruited from six randomly selected schools in an area receiving large-scale urban regeneration (London Borough of Newham) and compared with adolescents in 18 schools in three comparison areas with no equivalent regeneration (London Boroughs of Tower Hamlets, Hackney and Barking & Dagenham). Baseline data will be completed prior to the start of the London Olympics (July 2012) with follow-up at 6 and 18 months postintervention. Primary outcomes are: pre–post change in adolescent and parent mental health and well-being, physical activity and parental employment status. Secondary outcomes include: pre–post change in social cohesion, smoking, alcohol use, diet and body mass index. The study will account for individual and environmental contextual effects in evaluating changes to identified outcomes. A nested longitudinal qualitative study will explore families’ experiences of regeneration in order to unpack the process by which regeneration impacts on health and well-being.
Ethics and dissemination
The study has approval from Queen Mary University of London Ethics Committee (QMREC2011/40), the Association of Directors of Children's Services (RGE110927) and the London Boroughs Research Governance Framework (CERGF113). Fieldworkers have had advanced Criminal Records Bureau clearance. Findings will be disseminated through peer-reviewed publications, national and international conferences, through participating schools and the study website (http://www.orielproject.co.uk).
doi:10.1136/bmjopen-2012-001840
PMCID: PMC3432843  PMID: 22936822
5.  Effectiveness of innovations in nurse led chronic disease management for patients with chronic obstructive pulmonary disease: systematic review of evidence 
BMJ : British Medical Journal  2005;331(7515):485.
Objective To determine the effectiveness of innovations in management of chronic disease involving nurses for patients with chronic obstructive pulmonary disease (COPD).
Design Systematic review of randomised controlled trials.
Data sources 24 electronic databases searched for English or Dutch language studies published between January 1980 and January 2005.
Review methods Included studies described inpatient, outpatient, and community based interventions for chronic disease management that were led, coordinated, or delivered by nurses. Hospital at home and early discharge schemes for acute exacerbations of COPD were excluded.
Results We identified nine relevant randomised controlled trials, most of which had some potential methodological flaws. All the interventions seemed to be variations on a case management model. The interventions described could be divided into brief (one month) and longer term (around a year) or more intensive interventions. Only two studies examined the effect of brief interventions, these found little evidence of any benefit. Meta-analysis of the long term interventions failed to detect any influence on mortality at 9-12 months' follow-up (Peto odds ratio 0.85, 95% confidence interval 0.58 to 1.26). There was evidence that the long term interventions had not improved patients' health related quality of life, psychological wellbeing, disability, or pulmonary function. The evidence on whether long term interventions reduced readmissions to hospital was equivocal, but the only study exclusively directed at patients on long term oxygen therapy reported a reduction in readmission. We identified several outcomes where little or no evidence was available; these included patients' satisfaction, self management skills, adherence with treatment recommendations, the likelihood of smoking cessation, and the effect of the interventions on carers.
Conclusion There is little evidence to date to support the widespread implementation of nurse led management interventions for COPD, but the data are too sparse to exclude any clinically relevant benefit or harm arising from such interventions.
doi:10.1136/bmj.38512.664167.8F
PMCID: PMC1199024  PMID: 16093253
8.  Collaborative working within UK NHS secondary care and across sectors for COPD and the impact of peer review: qualitative findings from the UK National COPD Resources and Outcomes Project 
Introduction
We investigated the effects on collaborative work within the UK National Health Service (NHS) of an intervention for service quality improvement: informal, structured, reciprocated, multidisciplinary peer review with feedback and action plans. The setting was care for chronic obstructive pulmonary disease (COPD).
Theory and methods
We analysed semi-structured interviews with 43 hospital respiratory consultants, nurses and general managers at 24 intervention and 11 control sites, as part of a UK randomised controlled study, the National COPD Resources and Outcomes Project (NCROP), using Scott's conceptual framework for action (inter-organisational, intra-organisational, inter-professional and inter-individual). Three areas of care targeted by NCROP involved collaboration across primary and secondary care.
Results
Hospital respiratory department collaborations with commissioners and hospital managers varied. Analysis suggested that this is related to team responses to barriers. Clinicians in unsuccessful collaborations told ‘atrocity stories’ of organisational, structural and professional barriers to service improvement. The others removed barriers by working with government and commissioner agendas to ensure continued involvement in patients' care. Multidisciplinary peer review facilitated collaboration between participants, enabling them to meet, reconcile differences and exchange ideas across boundaries.
Conclusions
The data come from the first randomised controlled trial of organisational peer review, adding to research into UK health service collaborative work, which has had a more restricted focus on inter-professional relations. NCROP peer review may only modestly improve collaboration but these data suggest it might be more effective than top-down exhortations to change when collaboration both across and within organisations is required.
PMCID: PMC2948684  PMID: 20922063
collaboration; inter-organizational; inter-professional; quality improvement; respiratory disease

Results 1-8 (8)