A realist process evaluation within the Facilitating Implementation of Research Evidence (FIRE) cluster randomised controlled international trial: an exemplar.

BACKGROUND: Facilitation is a promising implementation intervention, which requires theory-informed evaluation. This paper presents an exemplar of a multi-country realist process evaluation that was embedded in the first international randomised controlled trial evaluating two types of facilitation for implementing urinary continence care recommendations. We aimed to uncover what worked (and did not work), for whom, how, why and in what circumstances during the process of implementing the facilitation interventions in practice. METHODS: This realist process evaluation included theory formulation, theory testing and refining. Data were collected in 24 care home sites across four European countries. Data were collected over four time points using multiple qualitative methods: observation (372 h), interviews with staff (n = 357), residents (n = 152), next of kin (n = 109) and other stakeholders (n = 128), supplemented by facilitator activity logs. A combined inductive and deductive data analysis process focused on realist theory refinement and testing. RESULTS: The content and approach of the two facilitation programmes prompted variable opportunities to align and realign support with the needs and expectations of facilitators and homes. This influenced their level of confidence in fulfilling the facilitator role and ability to deliver the intervention as planned. The success of intervention implementation was largely dependent on whether sites prioritised their involvement in both the study and the facilitation programme. In contexts where the study was prioritised (including release of resources) and where managers and staff support was sustained, this prompted collective engagement (as an attitude and action). Internal facilitators' (IF) personal characteristics and abilities, including personal and formal authority, in combination with a supportive environment prompted by managers triggered the potential for learning over time. Learning over time resulted in a sense of confidence and personal growth, and enactment of the facilitation role, which resulted in practice changes. CONCLUSION: The scale and multi-country nature of this study provided a novel context to conduct one of the few trial embedded realist-informed process evaluations. In addition to providing an explanatory account of implementation processes, a conceptual platform for future facilitation research is presented. Finally, a realist-informed process evaluation framework is outlined, which could inform future research of this nature. TRIAL REGISTRATION: Current controlled trials ISRCTN11598502 .

Facilitating Implementation of Research Evidence (FIRE): an international cluster randomised controlled trial to evaluate two models of facilitation informed by the Promoting Action on Research Implementation in Health Services (PARIHS) framework.

BACKGROUND: Health care practice needs to be underpinned by high quality research evidence, so that the best possible care can be delivered. However, evidence from research is not always utilised in practice. This study used the Promoting Action on Research Implementation in Health Services (PARIHS) framework as its theoretical underpinning to test whether two different approaches to facilitating implementation could affect the use of research evidence in practice. METHODS: A pragmatic clustered randomised controlled trial with embedded process and economic evaluation was used. The study took place in four European countries across 24 long-term nursing care sites, for people aged 60 years or more with documented urinary incontinence. In each country, sites were randomly allocated to standard dissemination, or one of two different types of facilitation. The primary outcome was the documented percentage compliance with the continence recommendations, assessed at baseline, then at 6, 12, 18, and 24 months after the intervention. Data were analysed using STATA15, multi-level mixed-effects linear regression models were fitted to scores for compliance with the continence recommendations, adjusting for clustering. RESULTS: Quantitative data were obtained from reviews of 2313 records. There were no significant differences in the primary outcome (documented compliance with continence recommendations) between study arms and all study arms improved over time. CONCLUSIONS: This was the first cross European randomised controlled trial with embedded process evaluation that sought to test different methods of facilitation. There were no statistically significant differences in compliance with continence recommendations between the groups. It was not possible to identify whether different types and "doses" of facilitation were influential within very diverse contextual conditions. The process evaluation (Rycroft-Malone et al., Implementation Science. doi: 10.1186/s13012-018-0811-0) revealed the models of facilitation used were limited in their ability to overcome the influence of contextual factors. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11598502 . Date 4/2/10. The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 223646.

The health literacy dyad: the contribution of future GPs in England.

BACKGROUND: Health literacy studies have primarily focused on the cognitive and social skills of individuals needed to gain access to, understand, and use health information. This area of study is undergoing a paradigm shift with increased attention being paid to the skills of practitioners and an examination of their contribution to the link between literacy and health outcomes. The aim of this study was to describe the health literacy related competencies of General Practice (GP) trainees who will soon be responsible for the clinical encounter. METHODS: A cross-sectional survey of a convenience sample of 206 GP trainees was conducted online. Univariate and bivariate analysis methods were used to describe GP trainees' health literacy-related competencies. RESULTS: GP trainees overestimated the numeracy and literacy levels of the English population and did not regard the improvement of patient health literacy as a GP responsibility. GP trainees rated their general communication skills highly but the skills that are important for patients in health decision-making such as coaching skills, explaining risk and using visual aids to clarify were rated low. CONCLUSION: This study demonstrates that health literacy is insufficiently addressed in the undergraduate and postgraduate medical education of GPs to enable them to fulfil the core competence which is part of building an effective partnership with patients.

A prospective observational study of machine translation software to overcome the challenge of including ethnic diversity in healthcare research.

AIM: This study investigates whether machine translation could help with the challenge of enabling the inclusion of ethnic diversity in healthcare research. DESIGN: A two phase, prospective observational study. METHODS: Two machine translators, Google Translate and Babylon 9, were tested. Translation of the Strengths and Difficulties Questionnaire (SDQ) from 24 languages into English and translation of an English information sheet into Spanish and Chinese were quality scored. Quality was assessed using the Translation Assessment Quality Tool. RESULTS: Only six of the 48 translations of the SDQ were rated as acceptable, all from Google Translate. The mean number of acceptably translated sentences was higher (P = 0·001) for Google Translate 17·1 (sd 7·2) than for Babylon 9 11 (sd 7·9). Translation by Google Translate was better for Spanish and Chinese, although no score was in the acceptable range. Machine translation is not currently sufficiently accurate without editing to provide translation of materials for use in healthcare research.

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.

Traditional and complementary approaches to health for children: Modelling the parental decision-making process using Andersen's Sociobehavioural Model.

OBJECTIVES: Traditional and complementary approaches to health (TCA) are common for children. Andersen's Sociobehavioural Model (SBM) is often used to explain healthcare decision-making. This study aimed to identify the prevalence and determinants of traditional and complementary approaches to health (TCA) in a multi-ethnic child population, and to explore whether the SBM explained TCA health care decision-making in this population. DESIGN: Cross-sectional questionnaire survey. NHS ethical approval was given. SETTING: GP waiting rooms, Northwest London. MAIN OUTCOME MEASURE AND ANALYSIS: All carers/parents (with children under 16), attending GP appointments on specific days, were asked to complete a questionnaire about TCA use; primary outcome 12-month child TCA use. Forward stepwise logistic regression tested appropriateness of the SBM. RESULTS: A total of 394 questionnaires were returned, representing 737 children; a quarter White British. Prevalence of 12-month TCA use was 45.4%, mainly food-based herbs/spices for minor illnesses which were used prior to GP consultation. Over half identified that TCA was part of their ethnic/cultural background. Only 29% had discussed TCA with their GP. The strongest predictor of child TCA use in the SBM was carer TCA use, itself influenced by carer gender and ethnicity, and GP advice. Need factors were not influential. CONCLUSIONS: Child TCA use was common in this multi-ethnic community, particularly the use of food-based remedies for minor illnesses, and carers' experience and background are central in deciding to use TCA for a child. TCA appears practiced as part of cultural background, with implications for GPs to be aware of their role in guiding patients to ensure safe practice.

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

BACKGROUND: The 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. METHODS: The 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. RESULTS: A 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. CONCLUSIONS: This 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.

A pragmatic cluster randomised trial evaluating three implementation interventions.

BACKGROUND: Implementation 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. METHODS: A 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. RESULTS: Nineteen 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. CONCLUSIONS: This 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 REGISTRATION: ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).

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.

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

BACKGROUND: Research 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. OBJECTIVES: This 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 SAMPLE: Four European countries, each with six long-term nursing care sites (total 24 sites) for people aged 60 years and over with documented urinary incontinence METHODS AND DESIGN: Pragmatic 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 REGISTRATION: Current Controlled Trials ISRCTN11598502.

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.

A randomised controlled trial to assess the effectiveness of a single session of nurse administered massage for short term relief of chronic non-malignant pain.

BACKGROUND: Massage is increasingly used to manage chronic pain but its benefit has not been clearly established. The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety. METHODS: A randomised controlled trial design was used, in which the patients were assigned to a massage or control group. The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain. Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study. An observer blind to the patients' treatment group carried out assessments immediately before (baseline), after treatment and 1, 2, 3 and 4 hours later. Pain was assessed using 100 mm visual analogue scale and the McGill Pain Questionnaire. Pain Relief was assessed using a five point verbal rating scale. Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory. RESULTS: 101 patients were randomised and evaluated, 50 in the massage and 51 in the control group. There were no statistically significant differences between the groups at baseline interview. Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment. 95% confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm. Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment. CONCLUSION: Massage is effective in the short term for chronic pain of moderate to severe intensity. TRIAL REGISTRATION: [ISRCTN98406653].

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.

Development of the paediatric pain profile: role of video analysis and saliva cortisol in validating a tool to assess pain in children with severe neurological disability.

The Paediatric Pain Profile (PPP) is a 20-item behavior-rating scale designed to assess pain in children with severe to profound neurological impairment. Three raters independently used the PPP to rate behavior of 29 children (mean age 9.6, SD 5.8) filmed during everyday morning activities. The validation process included assessment of interrater reliability and exploration of the relationship of PPP scores with saliva cortisol concentration. There was substantial agreement between raters. The PPP showed strong association with global pain assessments and differentiated between preselected high- and low-pain groups. PPP score showed moderate correlation with saliva cortisol concentration, but a single child explained the strength of the relationship and overall, saliva cortisol concentrations appeared low. The data provide additional evidence that the PPP is a reliable and valid instrument for pain assessment in neurologically impaired children. Cortisol levels are not a useful criterion for pain in this population and further study of cortisol response to stress/pain in children with severe neurological impairments is needed.

Muscle fatigue during dynamic contractions assessed by new spectral indices.

PURPOSE: The aim of the present study was to test the applicability and sensitivity of new electromyography (EMG) spectral indices in assessing peripheral muscle fatigue during dynamic knee-extension exercise. METHODS: Seven subjects completed 10 sets of 15 repetitions of right knee-extension exercise lifting 50% of their one-repetition maximum. Torque (T), knee-joint angle, and the interference EMG of rectus femoris muscle were recorded simultaneously. Maximal voluntary isometric contraction (MVC) was tested before and after exercise. Median spectral frequency (Fmed) and new spectral indices of muscle fatigue (FInsmk) were calculated for each repetition. RESULTS: The rate and range of FInsmk- and Fmed-relative changes against the first repetition of the corresponding set increased gradually across successive repetitions within the set, reflecting accumulation of peripheral muscle fatigue. The maximal change of FInsmk observed in the present experiment was approximately eightfold, whereas that of Fmed was only 32%. Significant between-subject variability in the range of FInsmk changes (P < 0.0001) was found, so a hierarchical cluster analysis of muscle fatigue indices was conducted. Three distinct subgroups of subjects were identified: high (N = 1, FInsmk change > 400%), medium (N = 4, 200% < FInsmk change < 400%), and low (N = 2, FInsmk change < 200%) muscle fatigability. The changes in muscle performance during (last vs first repetition peak T, P = 0.03) and after (post- vs preexercise MVC, P = 0.012) exercise were significantly different between clusters (one-way ANOVA). The rate of fatigue development was also significantly different between clusters (linear regression analysis of Fmed and FInsmk changes). CONCLUSIONS: The new spectral indices are a valid and reliable tool for assessment of muscle fatigability irrespective of EMG signal variability caused by dynamic muscle contractions, and these indices are more sensitive than those traditionally used.

The culture of a trauma team in relation to human factors.

AIM: The aim of this ethnographic study was to explore the culture of a trauma team in relation to human factors. BACKGROUND: Traumatic injury is the leading cause of death in the first four decades of life in the western world. Evidence suggests that the initial assessment and resuscitation of trauma victims is most successfully carried out by an organized trauma team. Most trauma teams use Advanced Trauma Life Support principles which focus on rapid assessment and management of the patient's injuries. Similarly, most trauma education focuses on Advanced Trauma Life Support principles, concentrating firmly on the patient's physical status. Nevertheless, contemporary literature about emergency teams suggests that human factors, such as communication and interprofessional relationships, can affect the team's performance regardless of how clinically skilled the team members are. METHOD: Focused ethnography was used to explore the culture of a trauma team in one teaching hospital. Six periods of observation were undertaken followed by 11 semi-structured interviews with purposively chosen key personnel. Data from transcripts of the observation field notes and interviews were analysed using open coding, followed by formation of categories resulting in the emergence of six central categories. RESULTS: Findings suggest that leadership, role competence, conflict, communication, the environment and the status of the patient all influence the culture of the trauma team. Interpretation of these categories suggests that trauma team education should include human factor considerations such as leadership skills, team management, interprofessional teamwork, conflict resolution and communication strategies. RELEVANCE FOR CLINICAL PRACTICE: The findings suggest that support systems for role development of junior team leaders should be formalized. The proven airline industry techniques of Crew Resource Management, focusing on teamwork and effective communication, could be implemented into continuing professional development for trauma teams to engender collaboration and interprofessional practice.

Investigation of the ways in which patients' reports of their satisfaction with healthcare are constructed.

A characteristic feature of patient satisfaction research is the consistently high level of satisfaction recorded. More reliable and relevant inquiry tools are constantly being developed, but underlying psychological and social pressures that could promote such a consistent and undiscriminating response have been little investigated. Williams et al. (1998) explored the phenomenon and concluded that, by considering issues of duty and culpability, patients could make allowances for poor care, and avoid evaluating it negatively. Their study was in community mental health. This study follows up their work within elective orthopaedic surgery, and investigates the pressures promoting such apparent transformation of opinion. Using a longitudinal design, and in-depth qualitative interviews, the patient's process of reflection was explored. Three psycho-social pressures were identified that appear to work together to make the transformation of opinion almost the default process. They are: the relative dependency of patients within the healthcare system; their need to maintain constructive working relationships with those providing their care; and their general preference for holding a positive outlook. It is suggested that, while it is the patient's prerogative to re-interpret the quality of their care positively, it is not the prerogative of the inquirer to accept this re-interpretation as representative of the patient's experience. Methods of inquiry are needed which access something of patients' development of opinion, and thereby something of their initial, often more negative, untransformed responses to their healthcare experiences.

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 child's behaviour when 'at their best' and when in pain. To assess interrater reliability, two raters concurrently observed and individually rated each child's 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 (Cronbach's 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.