Nicola Crichton

Clinical Validation of the Paediatric Pain Profile

The Paediatric Pain Profile (PPP) is a 20–item behaviour rating scale designed to assess pain in children with severe neurological disability. We assessed the validity and reliability of the scale in 140 children (76 females, mean age 9 years 11 months, SD 4 years 7 months; range 1 to 18 years), unable to communicate through speech or augmentative communication. Parents used the PPP to rate retrospectively their childs behaviour when‘at their best’and when in pain. To assess interrater reliability, two raters concurrently observed and individually rated each childs behaviour. To assess construct validity and responsiveness of the scale, behaviour of 41 children was rated before and for four hours after administration of an‘as required’analgesic. Behaviour of 30 children was rated before surgery and for five days after. Children had significantly higher scores when reported to have pain than‘at their best’and scores increased in line with global evaluations of pain. Internal consistency ranged from 0.75 to 0.89 (Cronbachs alpha) and interrater reliability from 0.74 to 0.89 (intraclass correlation). Sensitivity (1.00) and specificity (0.91) were optimized at a cut‐off of 14/60. PPP score was significantly greater before administration of the analgesic than after (paired‐sample t‐tests, p < 0.001). Though there was no significant difference in mean pre‐ and postoperative scores, highest PPP score occurred in the first 24 hours after surgery in 14 (47%) children. Results suggest that the PPP is reliable and valid and has potential for use both clinically and in intervention research.

The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework

BackgroundThe case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework.MethodsThe PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets.ResultsA robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes.ConclusionsThis study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.Trial registrationISRCTN18046709 - Peri-operative Implementation Study Evaluation (PoISE).

School sex education: an experimental programme with educational and medical benefit

Abstract Objective:To develop and teach a school sex education programme that will lead to a decrease in sexual activity. Design:A matched internal and external control experiment, comparing control populations which received their own sex education programmes with populations which received a novel sex education intervention that included medical and peer led teaching. Setting:Comprehensive secondary schools; control and intervention populations within Devon, and distant controls from rural, semiurban, and urban areas of England excluding major conurbations. Subjects:Schoolchildren were taught from age 12 to 16; three successive cohorts of students were evaluated in school year 11 (mean age 16.0) Main outcome measures:Questionnaire conducted under “examinationconditions” and invigilated by the research team and other trained medical staff. Results:In the intervention population, progressive increase in knowledge related to contraception, sexually transmitted diseases, and prevalence of sexual activity (χ2 (trend) P<0.001 for all three series); relative increase between intervention and control populations in knowledge, relative decrease in attitudes suggesting that sexual intercourse is of itself beneficial to teenagers and their relationships, relative decrease in sexual activity, and relative increase in approval of their “sex education” (relative risk >1.00 with 95% confidence limits not including 1.00 for all series and for comparisons with both control populations); odds ratio (control v programme) for sexual activity of 1.45, controlling for sociodemographic variables. Conclusion:School sex education that includes specific targeted methods with the direct use of medical staff and peers can produce behavioural changes that lead to health benefit.

Complex interventions to improve the health of people with limited literacy: A systematic review

OBJECTIVE To evaluate the published literature on the effects of complex (multi-faceted) interventions intended to improve the health-related outcomes of individuals with limited literacy or numeracy. METHODS We undertook a systematic review of randomized and quasi-randomized controlled trials with a narrative synthesis. The search strategy included searching eight databases from start date to 2007, reference checking and contacting expert informants. After the initial screen, two reviewers independently assessed eligibility, extracted data and evaluated study quality. RESULTS The searches yielded 2734 non-duplicate items, which were reduced to 15 trials. Two interventions were directed at health professionals, one intervention was literacy education, and 12 were health education/management interventions. The quality of the trials was mixed, 13/15 trials were conducted in North America, and all focused on literacy rather than numeracy. 13/15 trials reported at least one significant difference in primary outcome, all favoring the intervention group. Only 8/15 trials measured direct clinical outcomes. Knowledge and self-efficacy were the class of outcome most likely to improve. CONCLUSION A wide variety of complex interventions for adults with limited literacy are able to improve some health-related outcomes. PRACTICE IMPLICATIONS This review supports the wider introduction of interventions for people with limited literacy, particularly within an evaluation context.

FIRE (Facilitating Implementation of Research Evidence): a study protocol.

BackgroundResearch evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS) framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated) affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids.ObjectivesThis study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community.Setting and sampleFour European countries, each with six long-term nursing care sites (total 24 sites) for people aged 60 years and over with documented urinary incontinenceMethods and designPragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation), with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline, then at 6, 12, 18, and 24 months after the start of the facilitation interventions. Detailed contextual and process data are collected throughout, using interviews with staff, residents and next of kin, observations, assessment of context using the Alberta Context Tool, and documentary evidence. A realistic evaluation framework is used to develop explanatory theory about what works for whom in what circumstances.Trial registrationCurrent Controlled Trials ISRCTN11598502.

MODELS FOR DIAGNOSING CHEST PAIN: IS CART HELPFUL?

The use of classification and regression tree (CART) methodology is explored for the diagnosis of patients complaining of anterior chest pain. The results are compared with those previously obtained using correspondence analysis and independent Bayes classification. The technique is shown to be of potential value for identifying important indicators and cutpoints for continuous variables, although the overall classification performance was rather disappointing. Suggestions are made for extensions to the methodology to make it more suitable for clinical practice.

A pragmatic cluster randomised trial evaluating three implementation interventions

BackgroundImplementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.MethodsA pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.ResultsNineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.ConclusionsThis was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions’ impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.Trial registrationISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).

Effectiveness of relaxation for postoperative pain and anxiety: randomized controlled trial

AIM This paper is a report of a study to determine the effectiveness of jaw and total body relaxation for postoperative pain, anxiety and level of relaxation, and to determine any patient expectancy effects. BACKGROUND Relaxation is increasingly suggested as a pain control technique that can be used by nurses in daily practice. A systematic review of the effectiveness of relaxation for postoperative pain relief revealed many poorly designed studies and only some weak evidence supporting the use of relaxation for postoperative pain. METHOD A randomized controlled trial (n = 118) was conducted between 2002 and 2003 to compare total body relaxation, jaw relaxation, attention control and usual care. Consenting patients admitted for elective orthopaedic surgery aged 18 or over, able to speak English and able to tense and relax more than two muscle groups were included. Pain at rest and on movement, anxiety and relaxation were assessed at pre-admission clinic, pre-intervention, immediately post-intervention and 1, 2, 3 and 4 hours later. However, the trial was under-powered. FINDINGS There were statistically significant reductions in pain at rest from pre- to post-intervention for both the relaxation groups and the attention control group. The usual care group had a small increase in pain, whilst the other three groups had similar small decreases in pain. There was no statistically significant difference in anxiety or relaxation scores pre- to post-intervention between groups. CONCLUSION Jaw relaxation could give these orthopaedic patients a small, very short-lasting additional amount of pain relief, and it may be that staff and patients feel this small benefit to be worthwhile.

Using population segmentation to inform local obesity strategy in England

Little is known about the views of obese people and how best to meet their needs. Amongst London boroughs Barking and Dagenham has the highest prevalence of adult obesity at 28.7%; the lowest level of healthy eating and of physical activity; and is the 22nd most deprived area of England. The study aimed to gain insight into the attitudes, motivations and priorities of people who are obese or overweight to inform the social marketing of an obesity strategy. Two hundred and ten obese or overweight adults were recruited through visual identification in public thoroughfares to attempt to recruit those seldom seen in primary care. One hundred and eighty-one street-intercept and 52 in-depth interviews were conducted. Thematic analysis was followed by psychographic segmentation. Eleven population segments were identified based on their readiness to change, the value accorded to tackling obesity, identified enabling factors and barriers to weight management and perceived self-efficacy. This population showed considerable variation in its readiness to change and perceived control over obesity but considerable similarity in the exchange value they attributed to tackling their obesity. Even within a relatively homogenous socio-demographic community, there needs to be a range of interventions and messages tailored for different population segments that vary in their readiness to change and confidence about tackling obesity. The dominant emphasis of policy and practice on the health consequences of obesity does not reflect the priorities of this obese population for whom the exchange value of addressing obesity was daily functioning especially in relation to family life.

Methods for assessing cardiovascular disease risk in a UK black population

Objective To assess differences between cardiovascular disease (CVD) risk estimation methods when applied to a black UK population. Design Cross-sectional study. Setting 51 GP practices in Lambeth, south-east London. Patients 26 370 black and 52 288 white registered patients aged 40–74 years. Main outcome measures 10-year CVD risk score estimates derived using Framingham, QRISK2, ASSIGN and ETHRISK algorithms. κ measures of agreement between risk scores and age-adjusted black/white mean risk ratios (RR) derived for each score. Results There was a moderate agreement between the various risk scores for the black population (pooled κ 0.59 (95% CI 0.57 to 0.61) for men and 0.42 (95% CI 0.39 to 0.46) for women). For the white population, agreement was significantly improved (pooled κ 0.74 (95% CI 0.73 to 0.76) for men and 0.51 (95% CI 0.49 to 0.54) for women). Except for QRISK2, each method consistently overpredicted the CVD risk for the black population in comparison with national (Health Survey for England) prevalence figures. QRISK2 estimates were the least divergent from national data, giving a black/white mean RR of 0.73 (95% CI 0.71 to 0.74) for men and 0.85 (95% CI 0.83 to 0.87) for women. Conclusions The choice of risk estimation method does make a difference to estimates of CVD risk for black patients. The QRISK2 method, which incorporates ethnicity as a risk factor, appears to have the best fit with national data for this population.