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Abstract Background Childhood intermittent exotropia [X(T)] is a type of strabismus (squint) in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision). Treatment options for X(T) include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T) are limited, and there is no randomised controlled trial (RCT) evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia) pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T). Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T). Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring); 3-, 6- and 9-month (primary outcome) clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire); qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates (to inform power calculations for a definitive RCT); completion rates of outcome measures. Discussion The SamExo pilot trial will provide important pointers regarding the feasibility of a full RCT of immediate surgery versus deferred surgery/active monitoring. The results of this pilot, including differences in cure rates, will inform the design of a definitive RCT. Trial registration ISRCTN44114892

Abstract Background In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of the methods, the performance of the theories, and consider where these methods sit alongside the range of methods for studying healthcare professional behavior change. Methods These were five studies of the theory-based cognitions and clinical behaviors (taking dental radiographs, performing dental restorations, placing fissure sealants, managing upper respiratory tract infections without prescribing antibiotics, managing low back pain without ordering lumbar spine x-rays) of random samples of primary care dentists and physicians. Measures were derived for the explanatory theoretical constructs in the Theory of Planned Behavior (TPB), Social Cognitive Theory (SCT), and Illness Representations specified by the Common Sense Self Regulation Model (CSSRM). We constructed self-report measures of two constructs from Learning Theory (LT), a measure of Implementation Intentions (II), and the Precaution Adoption Process. We collected data on theory-based cognitions (explanatory measures) and two interim outcome measures (stated behavioral intention and simulated behavior) by postal questionnaire survey during the 12-month period to which objective measures of behavior (collected from routine administrative sources) were related. Planned analyses explored the predictive value of theories in explaining variance in intention, behavioral simulation and behavior. Results Response rates across the five surveys ranged from 21% to 48%; we achieved the target sample size for three of the five surveys. For the predictor variables, the mean construct scores were above the mid-point on the scale with median values across the five behaviors generally being above four out of seven and the range being from 1.53 to 6.01. Across all of the theories, the highest proportion of the variance explained was always for intention and the lowest was for behavior. The Knowledge-Attitudes-Behavior Model performed poorly across all behaviors and dependent variables; CSSRM also performed poorly. For TPB, SCT, II, and LT across the five behaviors, we predicted median R2 of 25% to 42.6% for intention, 6.2% to 16% for behavioral simulation, and 2.4% to 6.3% for behavior. Conclusions We operationalized multiple theories measuring across five behaviors. Continuing challenges that emerge from our work are: better specification of behaviors, better operationalization of theories; how best to appropriately extend the range of theories; further assessment of the value of theories in different settings and groups; exploring the implications of these methods for the management of chronic diseases; and moving to experimental designs to allow an understanding of behavior change.

Abstract Background Healthcare professional response rates to postal questionnaires are declining and this may threaten the validity and generalisability of their findings. Methods to improve response rates do incur costs (resources) and increase the cost of research projects. The aim of these randomised controlled trials (RCTs) was to assess whether 1) incentives, 2) type of reminder and/or 3) reduced response burden improve response rates; and to assess the cost implications of such additional effective interventions. Methods Two RCTs were conducted. In RCT A general dental practitioners (dentists) in Scotland were randomised to receive either an incentive; an abridged questionnaire or a full length questionnaire. In RCT B non-responders to a postal questionnaire sent to general medical practitioners (GPs) in the UK were firstly randomised to receive a second full length questionnaire as a reminder or a postcard reminder. Continued non-responders from RCT B were then randomised within their first randomisation to receive a third full length or an abridged questionnaire reminder. The cost-effectiveness of interventions that effectively increased response rates was assessed as a secondary outcome. Results There was no evidence that an incentive (52% versus 43%, Risk Difference (RD) -8.8 (95%CI −22.5, 4.8); or abridged questionnaire (46% versus 43%, RD −2.9 (95%CI −16.5, 10.7); statistically significantly improved dentist response rates compared to a full length questionnaire in RCT A. In RCT B there was no evidence that a full questionnaire reminder statistically significantly improved response rates compared to a postcard reminder (10.4% versus 7.3%, RD 3 (95%CI −0.1, 6.8). At a second reminder stage, GPs sent the abridged questionnaire responded more often (14.8% versus 7.2%, RD −7.7 (95%CI −12.8, -2.6). GPs who received a postcard reminder followed by an abridged questionnaire were most likely to respond (19.8% versus 6.3%, RD 8.1%, and 9.1% for full/postcard/full, three full or full/full/abridged questionnaire respectively). An abridged questionnaire containing fewer questions following a postcard reminder was the only cost-effective strategy for increasing the response rate (£15.99 per response). Conclusions When expecting or facing a low response rate to postal questionnaires, researchers should carefully identify the most efficient way to boost their response rate. In these studies, an abridged questionnaire containing fewer questions following a postcard reminder was the only cost-effective strategy. An increase in response rates may be explained by a combination of the number and type of contacts. Increasing the sampling frame may be more cost-effective than interventions to prompt non-responders. However, this may not strengthen the validity and generalisability of the survey findings and affect the representativeness of the sample.

Abstract Background Regular laboratory test monitoring of patient parameters offers a route for improving the quality of chronic disease care. We evaluated the effects of brief educational messages attached to laboratory test reports on diabetes care. Methods A programme of cluster randomised controlled trials was set in primary care practices in one primary care trust in England. Participants were the primary care practices' constituent healthcare professionals and patients with diabetes. Interventions comprised brief educational messages added to paper and electronic primary care practice laboratory test reports and introduced over two phases. Phase one messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control, and foot inspection. Main outcome measures comprised practice mean HbA1c and cholesterol levels, diastolic and systolic BP, and proportions of patients having undergone foot inspections. Results Initially, 35 out of 37 eligible practices participated. Outcome data were available for a total of 8,690 patients with diabetes from 32 practices. The BP message produced a statistically significant reduction in diastolic BP (-0.62 mmHg; 95% confidence interval -0.82 to -0.42 mmHg) but not systolic BP (-0.06 mmHg, -0.42 to 0.30 mmHg) and increased the odds of achieving target BP control (odds ratio 1.05; 1.00, 1.10). The foot inspection message increased the likelihood of a recorded foot inspection (incidence rate ratio 1.26; 1.18 to 1.36). The glycaemic control message had no effect on mean HbA1c (increase 0.01%; -0.03 to 0.04) despite increasing the odds of a change in likelihood of HbA1c tests being ordered (OR 1.06; 1.01, 1.11). The cholesterol message had no effect (decrease 0.01 mmol/l, -0.04 to 0.05). Conclusions Three out of four interventions improved intermediate outcomes or process of diabetes care. The diastolic BP reduction approximates to relative reductions in mortality of 3% to 5% in stroke and 3% to 4% in ischaemic heart disease over 10 years. The lack of effect for other outcomes may, in part, be explained by difficulties in bringing about further improvements beyond certain thresholds of clinical performance. Trial Registration Current Controlled Trials, ISRCTN2186314.

Abstract Background Type 2 diabetes is an increasingly prevalent chronic illness and an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of primary care teams. This study aimed to: investigate theoretically-based organisational, team, and individual factors determining the multiple behaviours needed to manage diabetes; and identify multilevel determinants of different diabetes management behaviours and potential interventions to improve them. This paper describes the instrument development, study recruitment, characteristics of the study participating practices and their constituent healthcare professionals and administrative staff and reports descriptive analyses of the data collected. Methods The study was a predictive study over a 12-month period. Practices (N = 99) were recruited from within the UK Medical Research Council General Practice Research Framework. We identified six behaviours chosen to cover a range of clinical activities (prescribing, non-prescribing), reflect decisions that were not necessarily straightforward (controlling blood pressure that was above target despite other drug treatment), and reflect recommended best practice as described by national guidelines. Practice attributes and a wide range of individually reported measures were assessed at baseline; measures of clinical outcome were collected over the ensuing 12 months, and a number of proxy measures of behaviour were collected at baseline and at 12 months. Data were collected by telephone interview, postal questionnaire (organisational and clinical) to practice staff, postal questionnaire to patients, and by computer data extraction query. Results All 99 practices completed a telephone interview and responded to baseline questionnaires. The organisational questionnaire was completed by 931/1236 (75.3%) administrative staff, 423/529 (80.0%) primary care doctors, and 255/314 (81.2%) nurses. Clinical questionnaires were completed by 326/361 (90.3%) primary care doctors and 163/186 (87.6%) nurses. At a practice level, we achieved response rates of 100% from clinicians in 40 practices and > 80% from clinicians in 67 practices. All measures had satisfactory internal consistency (alpha coefficient range from 0.61 to 0.97; Pearson correlation coefficient (two item measures) 0.32 to 0.81); scores were generally consistent with good practice. Measures of behaviour showed relatively high rates of performance of the six behaviours, but with considerable variability within and across the behaviours and measures. Discussion We have assembled an unparalleled data set from clinicians reporting on their cognitions in relation to the performance of six clinical behaviours involved in the management of people with one chronic disease (diabetes mellitus), using a range of organisational and individual level measures as well as information on the structure of the practice teams and across a large number of UK primary care practices. We would welcome approaches from other researchers to collaborate on the analysis of this data.

Abstract Background Psychological models predict behaviour in a wide range of settings. The aim of this study was to explore the usefulness of a range of psychological models to predict the health professional behaviour 'referral for lumbar spine x-ray in patients presenting with low back pain' by UK primary care physicians. Methods Psychological measures were collected by postal questionnaire survey from a random sample of primary care physicians in Scotland and north England. The outcome measures were clinical behaviour (referral rates for lumbar spine x-rays), behavioural simulation (lumbar spine x-ray referral decisions based upon scenarios), and behavioural intention (general intention to refer for lumbar spine x-rays in patients with low back pain). Explanatory variables were the constructs within the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-Regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Weinstein's Stage Model termed the Precaution Adoption Process (PAP), and knowledge. For each of the outcome measures, a generalised linear model was used to examine the predictive value of each theory individually. Linear regression was used for the intention and simulation outcomes, and negative binomial regression was used for the behaviour outcome. Following this 'theory level' analysis, a 'cross-theoretical construct' analysis was conducted to investigate the combined predictive value of all individual constructs across theories. Results Constructs from TPB, SCT, CS-SRM, and OLT predicted behaviour; however, the theoretical models did not fit the data well. When predicting behavioural simulation, the proportion of variance explained by individual theories was TPB 11.6%, SCT 12.1%, OLT 8.1%, and II 1.5% of the variance, and in the cross-theory analysis constructs from TPB, CS-SRM and II explained 16.5% of the variance in simulated behaviours. When predicting intention, the proportion of variance explained by individual theories was TPB 25.0%, SCT 21.5%, CS-SRM 11.3%, OLT 26.3%, PAP 2.6%, and knowledge 2.3%, and in the cross-theory analysis constructs from TPB, SCT, CS-SRM, and OLT explained 33.5% variance in intention. Together these results suggest that physicians' beliefs about consequences and beliefs about capabilities are likely determinants of lumbar spine x-ray referrals. Conclusions The study provides evidence that taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour. However, a number of conceptual and methodological challenges remain.

Abstract Background Psychological models are used to understand and predict behaviour in a wide range of settings, but have not been consistently applied to health professional behaviours, and the contribution of differing theories is not clear. This study explored the usefulness of a range of models to predict an evidence-based behaviour -- the placing of fissure sealants. Methods Measures were collected by postal questionnaire from a random sample of general dental practitioners (GDPs) in Scotland. Outcomes were behavioural simulation (scenario decision-making), and behavioural intention. Predictor variables were from the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Stage Model, and knowledge (a non-theoretical construct). Multiple regression analysis was used to examine the predictive value of each theoretical model individually. Significant constructs from all theories were then entered into a 'cross theory' stepwise regression analysis to investigate their combined predictive value Results Behavioural simulation - theory level variance explained was: TPB 31%; SCT 29%; II 7%; OLT 30%. Neither CS-SRM nor stage explained significant variance. In the cross theory analysis, habit (OLT), timeline acute (CS-SRM), and outcome expectancy (SCT) entered the equation, together explaining 38% of the variance. Behavioural intention - theory level variance explained was: TPB 30%; SCT 24%; OLT 58%, CS-SRM 27%. GDPs in the action stage had significantly higher intention to place fissure sealants. In the cross theory analysis, habit (OLT) and attitude (TPB) entered the equation, together explaining 68% of the variance in intention. Summary The study provides evidence that psychological models can be useful in understanding and predicting clinical behaviour. Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that may predict clinical behaviour and so provide possible targets for knowledge translation interventions. Results suggest that more evidence-based behaviour may be achieved by influencing beliefs about the positive outcomes of placing fissure sealants and building a habit of placing them as part of patient management. However a number of conceptual and methodological challenges remain.

Abstract Background Quality of care in general practice may be affected by the team climate perceived by its health and non-health professionals. Better team working is thought to lead to higher effectiveness and quality of care. However, there is limited evidence available on what affects team functioning and its relationship with quality of care in general practice. This study aimed to explore individual and practice factors that were associated with team climate, and to explore the relationship between team climate and quality of care. Methods Cross sectional survey of a convenience sample of 14 general practices and their staff in South Tyneside in the northeast of England. Team climate was measured using the short version of Team Climate Inventory (TCI) questionnaire. Practice characteristics were collected during a structured interview with practice managers. Quality was measured using the practice Quality and Outcome Framework (QOF) scores. Results General Practitioners (GP) had a higher team climate scores compared to other professionals. Individual's gender and tenure, and number of GPs in the practice were significantly predictors of a higher team climate. There was no significant correlation between mean practice team climate scores (or subscales) with QOF scores. Conclusion The absence of a relationship between a measure of team climate and quality of care in this exploratory study may be due to a number of methodological problems. Further research is required to explore how to best measure team functioning and its relationship with quality of care.

Abstract Background Within implementation research, using theory-based approaches to understanding the behaviours of healthcare professionals and the quality of care that they reflect and designing interventions to change them is being promoted. However, such approaches lead to a new range of methodological and theoretical challenges pre-eminent among which are how to appropriately relate predictors of individual's behaviour to measures of the behaviour of healthcare professionals. The aim of this study was to explore the relationship between the theory of planned behaviour proximal predictors of behaviour (intention and perceived behavioural control, or PBC) and practice level behaviour. This was done in the context of two clinical behaviours – statin prescription and foot examination – in the management of patients with diabetes mellitus in primary care. Scores for the predictor variables were aggregated over healthcare professionals using four methods: simple mean of all primary care team members' intention scores; highest intention score combined with PBC of the highest intender in the team; highest intention score combined with the highest PBC score in the team; the scores (on both constructs) of the team member identified as having primary responsibility for the clinical behaviour. Methods Scores on theory-based cognitive variables were collected by postal questionnaire survey from a sample of primary care doctors and nurses from northeast England and the Netherlands. Data on two clinical behaviours were patient reported, and collected by postal questionnaire survey. Planned analyses explored the predictive value of various aggregations of intention and PBC in explaining variance in the behavioural data. Results Across the two countries and two behaviours, responses were received from 37 to 78% of healthcare professionals in 57 to 93% practices; 51% (UK) and 69% (Netherlands) of patients surveyed responded. None of the aggregations of cognitions predicted statin prescription. The highest intention in the team (irrespective of PBC) was a significant predictor of foot examination. Conclusion These approaches to aggregating individually-administered measures may be a methodological advance of theoretical importance. Using simple means of individual-level measures to explain team-level behaviours is neither theoretically plausible nor empirically supported; the highest intention was both predictive and plausible. In studies aiming to understand the behaviours of teams of healthcare professionals in managing chronic diseases, some sort of aggregation of measures from individuals is necessary. This is not simply a methodological point, but a necessary step in advancing the theoretical and practical understanding of the processes that lead to implementation of clinical behaviours within healthcare teams.

Abstract Background Type 2 diabetes is an increasingly prevalent chronic illness and is an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of the primary care team. Studies of the quality of care for patients with diabetes suggest less than optimum care in a number of areas. Aim The aim of this study is to improve the quality of care for patients with diabetes cared for in primary care in the UK by identifying individual, team, and organisational factors that predict the implementation of best practice. Design Participants will be clinical and non-clinical staff within 100 general practices sampled from practices who are members of the MRC General Practice Research Framework. Self-completion questionnaires will be developed to measure the attributes of individual health care professionals, primary care teams (including both clinical and non-clinical staff), and their organisation in primary care. Questionnaires will be administered using postal survey methods. A range of validated theories will be used as a framework for the questionnaire instruments. Data relating to a range of dimensions of the organisational structure of primary care will be collected via a telephone interview at each practice using a structured interview schedule. We will also collect data relating to the processes of care, markers of biochemical control, and relevant indicator scores from the quality and outcomes framework (QOF). Process data (as a proxy indicator of clinical behaviours) will be collected from practice databases and via a postal questionnaire survey of a random selection of patients from each practice. Levels of biochemical control will be extracted from practice databases. A series of analyses will be conducted to relate the individual, team, and organisational data to the process, control, and QOF data to identify configurations associated with high quality care. Study registration UKCRN ref:DRN120 (ICPD)

Abstract Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between intervention and control groups. Treatment success is defined as improvement of 3 points for those with a baseline ARAT of 0–3 and 6 points for those with ARAT of 4–56. Trial registration ISRCTN78533119 EudraCT 2004-002427-40 CTA 17136/0230/001 Funding National Institute for Health Research, Health Technology Assessment Programme. Ipsen Ltd provide botulinum toxin type A (Dysport®).

Abstract Background Psychological theories of behaviour may provide a framework to guide the design of interventions to change professional behaviour. Behaviour change interventions, designed using psychological theory and targeting important motivational beliefs, were experimentally evaluated for effects on the behavioural intention and simulated behaviour of GPs in the management of uncomplicated upper respiratory tract infection (URTI). Methods The design was a 2 × 2 factorial randomised controlled trial. A postal questionnaire was developed based on three theories of human behaviour: Theory of Planned Behaviour; Social Cognitive Theory and Operant Learning Theory. The beliefs and attitudes of GPs regarding the management of URTI without antibiotics and rates of prescribing on eight patient scenarios were measured at baseline and post-intervention. Two theory-based interventions, a "graded task" with "action planning" and a "persuasive communication", were incorporated into the post-intervention questionnaire. Trial groups were compared using co-variate analyses. Results Post-intervention questionnaires were returned for 340/397 (86%) GPs who responded to the baseline survey. Each intervention had a significant effect on its targeted behavioural belief: compared to those not receiving the intervention GPs completing Intervention 1 reported stronger self-efficacy scores (Beta = 1.41, 95% CI: 0.64 to 2.25) and GPs completing Intervention 2 had more positive anticipated consequences scores (Beta = 0.98, 95% CI = 0.46 to 1.98). Intervention 2 had a significant effect on intention (Beta = 0.90, 95% CI = 0.41 to 1.38) and simulated behaviour (Beta = 0.47, 95% CI = 0.19 to 0.74). Conclusion GPs' intended management of URTI was significantly influenced by their confidence in their ability to manage URTI without antibiotics and the consequences they anticipated as a result of doing so. Two targeted behaviour change interventions differentially affected these beliefs. One intervention also significantly enhanced GPs' intentions not to prescribe antibiotics for URTI and resulted in lower rates of prescribing on patient scenarios compared to a control group. The theoretical frameworks utilised provide a scientific rationale for understanding how and why the interventions had these effects, improving the reproducibility and generalisability of these findings and offering a sound basis for an intervention in a "real world" trial. Trial registration Clinicaltrials.gov NCT00376142

Abstract Background Evidence shows that antibiotics have limited effectiveness in the management of upper respiratory tract infection (URTI) yet GPs continue to prescribe antibiotics. Implementation research does not currently provide a strong evidence base to guide the choice of interventions to promote the uptake of such evidence-based practice by health professionals. While systematic reviews demonstrate that interventions to change clinical practice can be effective, heterogeneity between studies hinders generalisation to routine practice. Psychological models of behaviour change that have been used successfully to predict variation in behaviour in the general population can also predict the clinical behaviour of healthcare professionals. The purpose of this study was to design two theoretically-based interventions to promote the management of upper respiratory tract infection (URTI) without prescribing antibiotics. Method Interventions were developed using a systematic, empirically informed approach in which we: selected theoretical frameworks; identified modifiable behavioural antecedents that predicted GPs intended and actual management of URTI; mapped these target antecedents on to evidence-based behaviour change techniques; and operationalised intervention components in a format suitable for delivery by postal questionnaire. Results We identified two psychological constructs that predicted GP management of URTI: "Self-efficacy," representing belief in one's capabilities, and "Anticipated consequences," representing beliefs about the consequences of one's actions. Behavioural techniques known to be effective in changing these beliefs were used in the design of two paper-based, interactive interventions. Intervention 1 targeted self-efficacy and required GPs to consider progressively more difficult situations in a "graded task" and to develop an "action plan" of what to do when next presented with one of these situations. Intervention 2 targeted anticipated consequences and required GPs to respond to a "persuasive communication" containing a series of pictures representing the consequences of managing URTI with and without antibiotics. Conclusion It is feasible to systematically develop theoretically-based interventions to change professional practice. Two interventions were designed that differentially target generalisable constructs predictive of GP management of URTI. Our detailed and scientific rationale for the choice and design of our interventions will provide a basis for understanding any effects identified in their evaluation. Trial registration Clinicaltrials.gov NCT00376142

Abstract Background For people with dementia, patient-centred care should involve timely explanation of the diagnosis and its implications. However, this is not routine. Theoretical models of behaviour change offer a generalisable framework for understanding professional practice and identifying modifiable factors to target with an intervention. Theoretical models and empirical work indicate that behavioural intention represents a modifiable predictor of actual professional behaviour. We identified factors that predict the intentions of members of older people's mental health teams (MHTs) to perform key behaviours involved in the disclosure of dementia. Design Postal questionnaire survey. Participants Professionals from MHTs in the English National Health Service. Methods We selected three behaviours: Determining what patients already know or suspect about their diagnosis; using explicit terminology when talking to patients; and exploring what the diagnosis means to patients. The questionnaire was based upon the Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), and exploratory team variables. Main outcomes Behavioural intentions. Results Out of 1,269 professionals working in 85 MHTs, 399 (31.4%) returned completed questionnaires. Overall, the TPB best explained behavioural intention. For determining what patients already know, the TPB variables of subjective norm, perceived behavioural control and attitude explained 29.4% of the variance in intention. For the use of explicit terminology, the same variables explained 53.7% of intention. For exploring what the diagnosis means to patients, subjective norm and perceived behavioural control explained 48.6% of intention. Conclusion These psychological models can explain up to half of the variation in intention to perform key disclosure behaviours. This provides an empirically-supported, theoretical basis for the design of interventions to improve disclosure practice by targeting relevant predictive factors. Trial Registration ISRCTN15871014.

Abstract Background Biomedical research constantly produces new findings, but these are not routinely incorporated into health care practice. Currently, a range of interventions to promote the uptake of emerging evidence are available. While their effectiveness has been tested in pragmatic trials, these do not form a basis from which to generalise to routine care settings. Implementation research is the scientific study of methods to promote the uptake of research findings, and hence to reduce inappropriate care. As clinical practice is a form of human behaviour, theories of human behaviour that have proved to be useful in other settings offer a basis for developing a scientific rationale for the choice of interventions. Aims The aims of this protocol are 1) to develop interventions to change beliefs that have already been identified as antecedents to antibiotic prescribing for sore throats, and 2) to experimentally evaluate these interventions to identify those that have the largest impact on behavioural intention and behavioural simulation. Design The clinical focus for this work will be the management of uncomplicated sore throat in general practice. Symptoms of upper respiratory tract infections are common presenting features in primary care. They are frequently treated with antibiotics, and research evidence is clear that antibiotic treatment offers little or no benefit to otherwise healthy adult patients. Reducing antibiotic prescribing in the community by the "prudent" use of antibiotics is seen as one way to slow the rise in antibiotic resistance, and appears safe, at least in children. However, our understanding of how to do this is limited. Participants will be general medical practitioners. Two theory-based interventions will be designed to address the discriminant beliefs in the prescribing of antibiotics for sore throat, using empirically derived resources. The interventions will be evaluated in a 2 × 2 factorial randomised controlled trial delivered in a postal questionnaire survey. Two outcome measures will be assessed: behavioural intention and behavioural simulation.

Abstract Background Psychological models can be used to understand and predict behaviour in a wide range of settings. However, they have not been consistently applied to health professional behaviours, and the contribution of differing theories is not clear. The aim of this study was to explore the usefulness of a range of psychological theories to predict health professional behaviour relating to management of upper respiratory tract infections (URTIs) without antibiotics. Methods Psychological measures were collected by postal questionnaire survey from a random sample of general practitioners (GPs) in Scotland. The outcome measures were clinical behaviour (using antibiotic prescription rates as a proxy indicator), behavioural simulation (scenario-based decisions to managing URTI with or without antibiotics) and behavioural intention (general intention to managing URTI without antibiotics). Explanatory variables were the constructs within the following theories: Theory of Planned Behaviour (TPB), Social Cognitive Theory (SCT), Common Sense Self-Regulation Model (CS-SRM), Operant Learning Theory (OLT), Implementation Intention (II), Stage Model (SM), and knowledge (a non-theoretical construct). For each outcome measure, multiple regression analysis was used to examine the predictive value of each theoretical model individually. Following this 'theory level' analysis, a 'cross theory' analysis was conducted to investigate the combined predictive value of all significant individual constructs across theories. Results All theories were tested, but only significant results are presented. When predicting behaviour, at the theory level, OLT explained 6% of the variance and, in a cross theory analysis, OLT 'evidence of habitual behaviour' also explained 6%. When predicting behavioural simulation, at the theory level, the proportion of variance explained was: TPB, 31%; SCT, 26%; II, 6%; OLT, 24%. GPs who reported having already decided to change their management to try to avoid the use of antibiotics made significantly fewer scenario-based decisions to prescribe. In the cross theory analysis, perceived behavioural control (TPB), evidence of habitual behaviour (OLT), CS-SRM cause (chance/bad luck), and intention entered the equation, together explaining 36% of the variance. When predicting intention, at the theory level, the proportion of variance explained was: TPB, 30%; SCT, 29%; CS-SRM 27%; OLT, 43%. GPs who reported that they had already decided to change their management to try to avoid the use of antibiotics had a significantly higher intention to manage URTIs without prescribing antibiotics. In the cross theory analysis, OLT evidence of habitual behaviour, TPB attitudes, risk perception, CS-SRM control by doctor, TPB perceived behavioural control and CS-SRM control by treatment entered the equation, together explaining 49% of the variance in intention. Conclusion The study provides evidence that psychological models can be useful in understanding and predicting clinical behaviour. Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour. However, a number of conceptual and methodological challenges remain.

Abstract Background Laboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself. Aim To develop and evaluate the effectiveness of a quality improvement initiative to improve the care of patients with diabetes using test report reminders. Design A programme of four cluster randomised controlled trials within one population of general practices. Participants General practices in Newcastle-upon-Tyne, UK. Intervention Brief educational messages added to paper and electronic general practice laboratory test reports introduced over two phases. Phase One messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase Two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control and foot inspection. Outcomes General practice mean levels of HbA1c and cholesterol (Phase One) and diastolic and systolic BP and proportions of patients having undergone foot inspections (Phase Two); number of tests requested. Trial registration Current Controlled Trial ISRCTN2186314.

Abstract Background For people with dementia, care should include an explanation of the diagnosis to individuals and their carers, and information about the likely prognosis and possible packages of care. However, this is neither routine nor inevitable, and there is wide variation in the practice of disclosure. The aim of this study is to develop a tailored theory-based intervention to promote appropriate disclosure of diagnosis of dementia. Methods There are three objectives. Objective 1 is to define and develop an appropriate model of disclosure; this will be addressed using a multidisciplinary consensus development process. Objective 2 is to identify factors that influence disclosure of diagnosis; a questionnaire based upon theoretical constructs from a range of behavioural theories will be developed and members of old age mental health teams will be surveyed. The analysis will identify those factors that best predict intention to disclose a diagnosis to a person with dementia. Objective 3 is to develop and pilot test a theory-based intervention to promote disclosure of diagnosis that targets attitudes, beliefs and actions most amenable to change. Objective 3 will use the results of Objectives 1&2 to design and pilot test an intervention to improve the process of and increase the proportion of individuals receiving a diagnosis of dementia, for members of old age mental health teams. This work will lead to a proposal for a randomised controlled trial of the intervention.

Abstract Background Biomedical research constantly produces new findings but these are not routinely translated into health care practice. One way to address this problem is to develop effective interventions to translate research findings into practice. Currently a range of empirical interventions are available and systematic reviews of these have demonstrated that there is no single best intervention. This evidence base is difficult to use in routine settings because it cannot identify which intervention is most likely to be effective (or cost effective) in a particular situation. We need to establish a scientific rationale for interventions. As clinical practice is a form of human behaviour, theories of human behaviour that have proved useful in other similar settings may provide a basis for developing a scientific rationale for the choice of interventions to translate research findings into clinical practice. The objectives of the study are: to amplify and populate scientifically validated theories of behaviour with evidence from the experience of health professionals; to use this as a basis for developing predictive questionnaires using replicable methods; to identify which elements of the questionnaire (i.e., which theoretical constructs) predict clinical practice and distinguish between evidence compliant and non-compliant practice; and on the basis of these results, to identify variables (based on theoretical constructs) that might be prime targets for behaviour change interventions. Methods We will develop postal questionnaires measuring two motivational, three action and one stage theory to explore five behaviours with 800 general medical and 600 general dental practitioners. We will collect data on performance for each of the behaviours. The relationships between predictor variables (theoretical constructs) and outcome measures (data on performance) in each survey will be assessed using multiple regression analysis and structural equation modelling. In the final phase of the project, the findings from all surveys will be analysed simultaneously adopting a random effects approach to investigate whether the relationships between predictor variables and outcome measures are modified by behaviour, professional group or geographical location.

Abstract Background Whilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines. Methods The study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.

Background: The speech intelligibility of children with dysarthria and cerebral palsy has been observed to increase following therapy focusing on respiration and phonation. Aims: To determine if speech intelligibility change following intervention is associated with change in acoustic measures of voice. Methods & Procedures: We recorded 16 young people with cerebral palsy and dysarthria (nine girls; mean age 14 years, SD = 2; nine spastic type, two dyskinetic, four mixed; one Worster-Drought) producing speech in two conditions (single words, connected speech) twice before and twice after therapy focusing on respiration, phonation and rate. In both single-word and connected speech we measured vocal intensity (root mean square--RMS), period-to-period variability (Shimmer APQ, Jitter RAP and PPQ) and harmonics-to-noise ratio (HNR). In connected speech we also measured mean fundamental frequency, utterance duration in seconds and speech and articulation rate (syllables/s with and without pauses respectively). All acoustic measures were made using Praat. Intelligibility was calculated in previous research. Outcomes & Results: In single words statistically significant but very small reductions were observed in period-to-period variability following therapy: Shimmer APQ -0.15 (95% CI = -0.21 to -0.09); Jitter RAP -0.08 (95% CI = -0.14 to -0.01); Jitter PPQ -0.08 (95% CI = -0.15 to -0.01). No changes in period-to-period perturbation across phrases in connected speech were detected. However, changes in connected speech were observed in phrase length, rate and intensity. Following therapy, mean utterance duration increased by 1.11 s (95% CI = 0.37-1.86) when measured with pauses and by 1.13 s (95% CI = 0.40-1.85) when measured without pauses. Articulation rate increased by 0.07 syllables/s (95% CI = 0.02-0.13); speech rate increased by 0.06 syllables/s (95% CI = < 0.01-0.12); and intensity increased by 0.03 Pascals (95% CI = 0.02-0.04). There was a gradual reduction in mean fundamental frequency across all time points (-11.85 Hz, 95% CI = -19.84 to -3.86). Only increases in the intensity of single words (0.37 Pascals, 95% CI = 0.10-0.65) and reductions in fundamental frequency (-0.11 Hz, 95% CI = -0.21 to -0.02) in connected speech were associated with gains in intelligibility. Conclusions & Implications: Mean reductions in impairment in vocal function following therapy observed were small and most are unlikely to be clinically significant. Changes in vocal control did not explain improved intelligibility.

Aim: To investigate the acceptability and feasibility of adapted group therapy for anxiety in children with autism spectrum disorder in a pilot randomised controlled trial. Method: A total of 32 children aged 9-13 years were randomised to immediate or delayed therapy using the "Exploring Feelings" manual (Attwood, 2004). Child and parent groups were run in parallel, for seven weekly sessions, under the supervision of experienced psychologists. The primary blinded outcome measures addressed change in overall functioning and in severity of the primary anxiety diagnosis after 3 months. esults: Children met diagnostic criteria for 1-6 anxiety disorders (median 3). At end point, both parents and children in the immediate therapy group were more likely to report a reduction in anxiety symptoms. Fidelity of delivery of the group therapy was high, and attendance was 91%. Conclusions: This pilot trial established that children and families were willing to be recruited and randomised, the outcome measures were acceptable, the format and content of the groups were feasible within UK child and adolescent mental health services, the intervention was appreciated by families and attrition was very small.

Aim: To investigate whether speech therapy using a speech systems approach to controlling breath support, phonation, and speech rate can increase the speech intelligibility of children with dysarthria and cerebral palsy (CP). Method: Sixteen children with dysarthria and CP participated in a modified time series design. Group characteristics were as follows: seven males, nine females; age range 12 to 18 years (mean 14y, SD 2); CP type: nine spastic, two dyskinetic, four mixed, one Worster-Drought; Gross Motor Function Classification System levels range I to V (median IV). Children received three 30- to 45-minute sessions of individual therapy per week for 6 weeks. Intelligibility in single words and connected speech was compared across four points: 1 week and 6 weeks before therapy, and 1 week and 6 weeks after its completion. Three familiar listeners and three unfamiliar listeners scored each recording. Mean percentage intelligibility was compared using general linear modelling techniques. Results: After treatment, familiar listeners understood 14.7% more single words and 12.1% more words in connected speech. Unfamiliar listeners understood 15% more single words and 15.9% more words in connected speech after therapy. Interpretation: Therapy was associated with increases in speech intelligibility. Effects of the therapy should be investigated further, in an exploratory trial with younger children and in a randomized controlled trial.

Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took part in the pilot RCT. A range of primary and secondary outcome measures were collected on four occasions (baseline, 10, 18 and 24 weeks) to capture both independent ratings and parent-reported changes in RRB. This pilot established that parents were willing to be recruited and randomised, and the format and content of the intervention was feasible. Fidelity of delivery was high, and attendance was 90 %. A fully powered trial is now planned., Author(s): Victoria Grahame [sup.1] , Denise Brett [sup.2] , Linda Dixon [sup.1] , Helen McConachie [sup.2] , Jessica Lowry [sup.2] , Jacqui Rodgers [sup.3] , Nick Steen [sup.2] , Ann [...]

Behavioral theory is often tested on one behavior in isolation from other behaviors and theories. We aimed to test the predictive validity of constructs from motivation and action theories of behavior across six diabetes-related clinician behaviors, within the same sample of primary care clinicians. Physicians and nurses (n = 427 from 99 practices in the United Kingdom) completed questionnaires at baseline and 12 months. Primary outcomes: six self-reported clinician behaviors related to advising, prescribing and examining measured at 12 months; secondary outcomes: baseline intention and patient-scenario-based simulated behavior. Across six behaviors, each theory accounted for a medium amount of variance for 12-month behavior (median [R.sup.2.sub.adj] = 0.15), large and medium amount of variance for two intention measures (median [R.sup.2.sub.adj] = 0.66; 0.34), and small amount of variance for simulated behavior (median [R.sup.2.sub.adj] = 0.05). Intention/proximal goals, self-efficacy, and habit predicted all behaviors. Constructs from social cognitive theory (self-efficacy), learning theory (habit) and action and coping planning consistently predicted multiple clinician behaviors and should be targeted by quality improvement interventions. Keywords Clinician behavior * Intention * Habit * Multiple behaviors * Planning * Self-efficacy, Introduction There is enduring clinical and policy interest in promoting evidence-based health care. However, the production and dissemination of evidence of clinical best practice does not automatically lead to implementation. [...]

This study applies psychological theory to the implementation of evidence-based clinical practice. The first objective was to see if variables from psychological frameworks (developed to understand, predict and influence behaviour) could predict an evidence-based clinical behaviour. The second objective was to develop a scientific rationale to design or choose an implementation intervention. Variables from the Theory of Planned Behaviour, Social Cognitive Theory, Self-Regulation Model, Operant Conditioning, Implementation Intentions and the Precaution Adoption Process were measured, with data collection by postal survey. The primary outcome was the number of intra-oral radiographs taken per course of treatment collected from a central fee claims database. Participants were 214 Scottish General Dental Practitioners. At the theory level, the Theory of Planned Behaviour explained 13% variance in the number of radiographs taken, Social Cognitive Theory explained 7%, Operant Conditioning explained 8%, Implementation Intentions explained 11%. Self-Regulation and Stage Theory did not predict significant variance in radiographs taken. Perceived behavioural control, action planning and risk perception explained 16% of the variance in number of radiographs taken. Knowledge did not predict the number of radiographs taken. The results suggest an intervention targeting predictive psychological variables could increase the implementation of this evidence-based practice, while influencing knowledge is unlikely to do so. Measures which predicted number of radiographs taken also predicted intention to take radiographs, and intention accounted for significant variance in behaviour (adjusted [R.sup.2] = 5%: F(1, 166) = 10.28, p Keywords: Evidence-based practice; Social cognitive theory; Intra-oral radiographs; Psychological frameworks; Theory of planned behaviour; Self-Regulation model; Dentists; Scotland

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.socscimed.2004.08.072 Byline: Debbie Bonetti (a), Martin Eccles (b), Marie Johnston (c), Nick Steen (b), Jeremy Grimshaw (d), Rachel Baker (b), Anne Walker (e), Nigel Pitts (a) Keywords: Implementation modelling experiments; Randomised controlled trials; The theory of planned behaviour; Social cognitive theory; Evidence-based practice Abstract: A consistent finding in health services research is the report of uneven uptake of research findings. Implementation trials have a variable record of success in effectively influencing clinicians' behaviour. A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials, examining intervention effects on 'interim endpoints' representing clinical behaviour, derived from empirically supported psychological theories. The objectives were to: (1) Design Intervention Modelling Experiments by backward engineering a 'real-world' randomised controlled trial (NEXUS); (2) examine the applicability of psychological theories to clinical decision-making; (3) explore whether psychological theories can illuminate how interventions achieve their effects. A 2x2 factorial randomised controlled trial was designed with pre- and post-intervention data collection by postal questionnaire surveys. The first survey was used to generate feedback data and the interventions were delivered in the second survey. General medical practitioners (GPs) in England and Scotland participated. First survey respondents were randomised twice to receive or not audit and feedback and educational reminder messages. The main outcome measures included behavioural intention (general plan to refer for lumbar X-rays) and simulated behaviour (specific, scenario-based, decisions to refer for lumbar X-ray). Predictors were attitude, subjective norm, perceived behavioural control (theory of planned behaviour), self-efficacy (social cognitive theory) and decision difficulty. Both interventions significantly influenced simulated behaviour, but neither influenced behavioural intention. There were no interaction effects. All theoretically derived cognitions significantly predicted simulated behaviour. Only subjective norm was not predictive of behavioural intention. The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control. The results of this study suggest that Intervention Modelling Experiments, using psychological models to help isolate mediators of clinical decision-making, may be a means of developing more potent interventions, and selecting implementation interventions with a greater likelihood of success in a service-level randomised controlled trial. Author Affiliation: (a) Dental Health Services Research Unit, University of Dundee, UK (b) School of Population and Health Sciences, Centre for Health Services Research, University of Newcastle upon Tyne, UK (c) School of Psychology, University of Aberdeen, UK (d) Clinical Epidemiology Programme, Ottawa Health Research Institute, Canada (e) Health Services Research Unit, University of Aberdeen, UK

A total of 2969 hospital employees from 162 wards participated in a 2-year follow-up study that examined the relationship between job decision latitude, organizational justice and employee health in Finland. We used medically certified sickness absence records as indicators of health problems. Multilevel covariance structure analysis was applied to take into account the hierarchical nature of the data. Responses from individuals within work units seem not always to be independent, and any models that ignore this lack of independence may incorrectly estimate the between individual relationships. Our results suggest that both job decision latitude and organizational justice varied considerably between work units in addition to individual level variation. Furthermore job decision latitude was associated with organizational justice both at individual and work unit level. Justice evaluations predicted sickness absence only at the individual level. Keywords: Psychosocial factors; Multilevel analysis; Health care: Organizational justice: Finland