Leaders' experiences of embedding a simulation-based education programme in a teaching hospital: an interview study informed by normalisation process theory.

There is limited research on the experiences of people in working to embed, integrate and sustain simulation programmes. This interview-based study explored leaders' experiences of normalising a simulation-based education programme in a teaching hospital. Fourteen known simulation leaders across Australia and North America were interviewed. Semi-structured interviews were analysed using reflexive thematic analysis sensitised by normalisation process theory, an implementation science theory which defines 'normal' as something being embedded, integrated and sustained. We used a combined social and experiential constructivist approach. Four themes were generated from the data: (1) Leadership, (2) business startup mindset, (3) poor understanding of simulation undermines normalisation and (4) tension of competing objectives. These themes were interlinked and represented how leaders experienced the process of normalising simulation. There was a focus on the relationships that influence decision-making of simulation leaders and organisational buy-in, such that what started as a discrete programme becomes part of normal hospital operations. The discourse of 'survival' was strong, and this indicated that simulation being normal or embedded and sustained was still more a goal than a reality. The concept of being like a 'business startup' was regarded as significant as was the feature of leadership and how simulation leaders influenced organisational change. Participants spoke of trying to normalise simulation for patient safety, but there was also a strong sense that they needed to be agile and innovative and that this status is implied when simulation is not yet 'normal'. Leadership, change management and entrepreneurship in addition to implementation science may all contribute towards understanding how to embed, integrate and sustain simulation in teaching hospitals without losing responsiveness. Further research on how all stakeholders view simulation as a normal part of a teaching hospital is warranted, including simulation participants, quality and safety teams and hospital executives. This study has highlighted that a shared understanding of the purpose and breadth of simulation is a prerequisite for embedding and sustaining simulation. An approach of marketing simulation beyond simulation-based education as a patient safety and systems improvement mindset, not just a technique nor technology, may assist towards simulation being sustainably embedded within teaching hospitals.

Aligning organisational priorities and implementation science for cancer research.

BACKGROUND: The challenge of implementing evidence into routine clinical practice is well recognised and implementation science offers theories, models and frameworks to promote investigation into delivery of evidence-based care. Embedding implementation researchers into health systems is a novel approach to ensuring research is situated in day-to-day practice dilemmas. To optimise the value of embedded implementation researchers and resources, the aim of this study was to investigate stakeholders' views on opportunities for implementation science research in a cancer setting that holds potential to impact on care. The research objectives were to: 1) Establish stakeholder and theory informed organisation-level implementation science priorities and 2) Identify and prioritise a test case pilot implementation research project. METHODS: We undertook a qualitative study using semi-structured interviews. Participants held either a formal leadership role, were research active or a consumer advocate and affiliated with either a specialist cancer hospital or a cancer alliance of ten hospitals. Interview data were summarised and shared with participants prior to undertaking both thematic analysis, to identify priority areas for implementation research, and content analysis, to identify potential pilot implementation research projects. The selected pilot Implementation research project was prioritised using a synthesis of an organisational and implementation prioritisation framework - the organisational priority setting framework and APEASE framework. RESULTS: Thirty-one people participated between August 2022 and February 2023. Four themes were identified: 1) Integration of services to address organisational priorities e.g., tackling fragmented services; 2) Application of digital health interventions e.g., identifying the potential benefits of digital health interventions; 3) Identification of potential for implementation research, including deimplementation i.e., discontinuing ineffective or low value care and; 4) Focusing on direct patient engagement e.g., wider consumer awareness of the challenges in delivering cancer care. Six potential pilot implementation research projects were identified and the EMBED project, to support clinicians to refer appropriate patients with cancer for genetic testing, was selected using the synthesised prioritisation framework. CONCLUSIONS: Using a theory informed and structured approach the alignment between strategic organisational priorities and implementation research priorities can be identified. As a result, the implementation research focus can be placed on activities with the highest potential impact.

Implementation approaches to improve environmental sustainability in operating theatres: a systematic review.

Operating theatres consume large amounts of energy and consumables and produce large amounts of waste. There is an increasing evidence base for reducing the climate impacts of healthcare that could be enacted into routine practice; yet, healthcare-associated emissions increase annually. Implementation science aims to improve the systematic uptake of evidence-based care into practice and could, therefore, assist in addressing the environmental impacts of healthcare. The aim of this systematic search with narrative synthesis was to explore what implementation approaches have been applied to reduce the environmental impact of operating theatre activities, described by implementation phases and methodologies. A search was conducted in EMBASE, PubMed, and CINAHL, limited to English and publication since 2010. In total, 3886 articles were retrieved and 11 were included. All were in the exploratory phase (seven of 11) or initial implementation phase (four of 11), but none were in the installation or full implementation phase. Three studies utilised a recognised implementation theory, model, or framework in the design. Four studies used interprofessional education to influence individuals' behaviour to reduce waste, improve waste segregation, or reduce anaesthetic gases. Of those that utilised behaviour change interventions, all were qualitatively successful in achieving environmental improvement. There was an absence of evidence for sustained effects in the intervention studies and little follow-up from studies that explored barriers to innovation. This review demonstrates a gap between evidence for reducing environmental impacts and uptake of proposed practice changes to deliver low-carbon healthcare. Future research into 'greening' healthcare should use implementation research methods to establish a solid implementation evidence base. SYSTEMATIC REVIEW PROTOCOL: PROSPERO CRD42022342786.

Utilisation and application of implementation science in complex suicide prevention interventions: A systematic review.

OBJECTIVES: Little is known about how complex, multilevel, and multicomponent suicide prevention interventions work in real life settings. Understanding the methods used to systematically adopt, deliver, and sustain these interventions could ensure that they have the best chance of unfolding their full effect. This systematic review aimed to examine the application and extent of utilisation of implementation science in understanding and evaluating complex suicide prevention interventions. METHODS: The review adhered to updated PRISMA guidelines and was prospectively registered with PROSPERO (CRD42021247950). PubMed, CINAHL, PsycINFO, ProQuest, SCOPUS and CENTRAL were searched. All English-language records (1990-2022) with suicide and/or self-harm as the primary aims or targets of intervention were eligible. A forward citation search and a reference search further bolstered the search strategy. Interventions were considered complex if they consisted of three or more components and were implemented across two or more levels of socio-ecology or levels of prevention. RESULTS: One hundred thirty-nine records describing 19 complex interventions were identified. In 13 interventions, use of implementation science approaches, primarily process evaluations, was explicitly stated. However, extent of utilisation of implementation science approaches was found to be inconsistent and incomprehensive. LIMITATIONS: The inclusion criteria, along with a narrow definition of complex interventions may have limited our findings. CONCLUSION: Understanding the implementation of complex interventions is crucial for unlocking key questions about theory-practice knowledge translation. Inconsistent reporting and inadequate understanding of implementation processes can lead to loss of critical, experiential knowledge related to what works to prevent suicide in real world settings.

Consensus on Prioritisation of Actions for Reducing the Environmental Impact of a Large Tertiary Hospital: Application of the Nominal Group Technique.

Hospitals are the largest greenhouse gas producers within the Australian healthcare sector due to the large amounts of energy, resource utilization, equipment and pharmaceuticals required to deliver care. In order to reduce healthcare emissions, healthcare services must take multiple actions to address the broad range of emissions produced when delivering patient care. The goal of this study was to seek consensus on the priority actions needed to reduce the environmental impact of a tertiary Australian hospital. A nominal group technique was utilized within a multidisciplinary, executive-led environmental sustainability committee to find consensus on the 62 proposed actions to reduce the environmental impact of a tertiary Australian hospital. Thirteen participants joined an online workshop during which an educational presentation was delivered, 62 potential actions were privately ranked according to two domains of 'amenability to change' and 'scale of climate impact' and a moderated group discussion ensued. The group achieved verbal consensus on 16 actions that span staff education, procurement, pharmaceuticals, waste, transport and advocacy on all-electric capital works upgrades. In addition, the individual ratings of potential actions according to each domain were ranked and shared with the group. Despite a large number of actions and varied perspectives within the group, the nominal group technique can be used to focus a hospital leadership group on priority actions to improve environmental sustainability.

Healthcare professional behaviour: health impact, prevalence of evidence-based behaviours, correlates and interventions.

Healthcare professional (HCP) behaviours are actions performed by individuals and teams for varying and often complex patient needs. However, gaps exist between evidence-informed care behaviours and the care provided. Implementation science seeks to develop generalizable principles and approaches to investigate and address care gaps, supporting HCP behaviour change while building a cumulative science. We highlight theory-informed approaches for defining HCP behaviour and investigating the prevalence of evidence-based care and known correlates and interventions to change professional practice. Behavioural sciences can be applied to develop implementation strategies to support HCP behaviour change and provide valid, reliable tools to evaluate these strategies. There are thousands of different behaviours performed by different HCPs across many contexts, requiring different implementation approaches. HCP behaviours can include activities related to promoting health and preventing illness, assessing and diagnosing illnesses, providing treatments, managing health conditions, managing the healthcare system and building therapeutic alliances. The key challenge is optimising behaviour change interventions that address barriers to and enablers of recommended practice. HCP behaviours may be determined by, but not limited to, Knowledge, Social influences, Intention, Emotions and Goals. Understanding HCP behaviour change is a critical to ensuring advances in health psychology are applied to maximize population health.

A randomised fractional factorial screening experiment to predict effective features of audit and feedback.

BACKGROUND: Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. Variability in effectiveness of audit and feedback is attributed to intervention design; separate randomised trials to address multiple questions about how to optimise effectiveness would be inefficient. We evaluated different feedback modifications to identify leading candidates for further "real-world" evaluation. METHODS: Using an online fractional factorial screening experiment, we randomised recipients of feedback from five UK NCAs to different combinations of six feedback modifications applied within an audit report excerpt: use effective comparators, provide multimodal feedback, recommend specific actions, provide optional detail, incorporate the patient voice, and minimise cognitive load. Outcomes, assessed immediately after exposure to the online modifications, included intention to enact audit standards (primary outcome, ranked on a scale of -3 to +3, tailored to the NCA), comprehension, user experience, and engagement. RESULTS: We randomised 1241 participants (clinicians, managers, and audit staff) between April and October 2019. Inappropriate repeated participant completion occurred; we conservatively excluded participant entries during the relevant period, leaving a primary analysis population of 638 (51.4%) participants. None of the six feedback modifications had an independent effect on intention across the five NCAs. We observed both synergistic and antagonistic effects across outcomes when modifications were combined; the specific NCA and whether recipients had a clinical role had dominant influences on outcome, and there was an antagonistic interaction between multimodal feedback and optional detail. Among clinical participants, predicted intention ranged from 1.22 (95% confidence interval 0.72, 1.72) for the least effective combination in which multimodal feedback, optional detail, and reduced cognitive load were applied within the audit report, up to 2.40 (95% CI 1.88, 2.93) for the most effective combination including multimodal feedback, specific actions, patient voice, and reduced cognitive load. CONCLUSION: Potentially important synergistic and antagonistic effects were identified across combinations of feedback modifications, audit programmes, and recipients, suggesting that feedback designers must explicitly consider how different features of feedback may interact to achieve (or undermine) the desired effects. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN41584028.

Interventions to increase attendance for diabetic retinopathy screening.

BACKGROUND: Despite evidence supporting the effectiveness of diabetic retinopathy screening (DRS) in reducing the risk of sight loss, attendance for screening is consistently below recommended levels. OBJECTIVES: The primary objective of the review was to assess the effectiveness of quality improvement (QI) interventions that seek to increase attendance for DRS in people with type 1 and type 2 diabetes.Secondary objectives were:To use validated taxonomies of QI intervention strategies and behaviour change techniques (BCTs) to code the description of interventions in the included studies and determine whether interventions that include particular QI strategies or component BCTs are more effective in increasing screening attendance;To explore heterogeneity in effect size within and between studies to identify potential explanatory factors for variability in effect size;To explore differential effects in subgroups to provide information on how equity of screening attendance could be improved;To critically appraise and summarise current evidence on the resource use, costs and cost effectiveness. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, Web of Science, ProQuest Family Health, OpenGrey, the ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to identify randomised controlled trials (RCTs) that were designed to improve attendance for DRS or were evaluating general quality improvement (QI) strategies for diabetes care and reported the effect of the intervention on DRS attendance. We searched the resources on 13 February 2017. We did not use any date or language restrictions in the searches. SELECTION CRITERIA: We included RCTs that compared any QI intervention to usual care or a more intensive (stepped) intervention versus a less intensive intervention. DATA COLLECTION AND ANALYSIS: We coded the QI strategy using a modification of the taxonomy developed by Cochrane Effective Practice and Organisation of Care (EPOC) and BCTs using the BCT Taxonomy version 1 (BCTTv1). We used Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital (PROGRESS) elements to describe the characteristics of participants in the included studies that could have an impact on equity of access to health services.Two review authors independently extracted data. One review author entered the data into Review Manager 5 and a second review author checked them. Two review authors independently assessed risks of bias in the included studies and extracted data. We rated certainty of evidence using GRADE. MAIN RESULTS: We included 66 RCTs conducted predominantly (62%) in the USA. Overall we judged the trials to be at low or unclear risk of bias. QI strategies were multifaceted and targeted patients, healthcare professionals or healthcare systems. Fifty-six studies (329,164 participants) compared intervention versus usual care (median duration of follow-up 12 months). Overall, DRS attendance increased by 12% (risk difference (RD) 0.12, 95% confidence interval (CI) 0.10 to 0.14; low-certainty evidence) compared with usual care, with substantial heterogeneity in effect size. Both DRS-targeted (RD 0.17, 95% CI 0.11 to 0.22) and general QI interventions (RD 0.12, 95% CI 0.09 to 0.15) were effective, particularly where baseline DRS attendance was low. All BCT combinations were associated with significant improvements, particularly in those with poor attendance. We found higher effect estimates in subgroup analyses for the BCTs 'goal setting (outcome)' (RD 0.26, 95% CI 0.16 to 0.36) and 'feedback on outcomes of behaviour' (RD 0.22, 95% CI 0.15 to 0.29) in interventions targeting patients, and 'restructuring the social environment' (RD 0.19, 95% CI 0.12 to 0.26) and 'credible source' (RD 0.16, 95% CI 0.08 to 0.24) in interventions targeting healthcare professionals.Ten studies (23,715 participants) compared a more intensive (stepped) intervention versus a less intensive intervention. In these studies DRS attendance increased by 5% (RD 0.05, 95% CI 0.02 to 0.09; moderate-certainty evidence).Fourteen studies reporting any QI intervention compared to usual care included economic outcomes. However, only five of these were full economic evaluations. Overall, we found that there is insufficient evidence to draw robust conclusions about the relative cost effectiveness of the interventions compared to each other or against usual care.With the exception of gender and ethnicity, the characteristics of participants were poorly described in terms of PROGRESS elements. Seventeen studies (25.8%) were conducted in disadvantaged populations. No studies were carried out in low- or middle-income countries. AUTHORS' CONCLUSIONS: The results of this review provide evidence that QI interventions targeting patients, healthcare professionals or the healthcare system are associated with meaningful improvements in DRS attendance compared to usual care. There was no statistically significant difference between interventions specifically aimed at DRS and those which were part of a general QI strategy for improving diabetes care. This is a significant finding, due to the additional benefits of general QI interventions in terms of improving glycaemic control, vascular risk management and screening for other microvascular complications. It is likely that further (but smaller) improvements in DRS attendance can also be achieved by increasing the intensity of a particular QI component or adding further components.

Theoretical and empirical dimensions of the Aberdeen Glaucoma Questionnaire: a cross sectional survey and principal component analysis.

BACKGROUND: To develop patient-reported outcome instruments, statistical techniques (e.g., principal components analysis; PCA) are used to examine correlations among items and identify interrelated item subsets (empirical factors). However, interpretation and labelling of empirical factors is a subjective process, lacking precision or conceptual basis. We report a novel and reproducible method for mapping between theoretical and empirical factor structures. We illustrate the method using the pilot Aberdeen Glaucoma Questionnaire (AGQ), a new measure of glaucoma-related disability developed using the International Classification of Functioning and Disability (ICF) as a theoretical framework and tested in a sample representing the spectrum of glaucoma severity. METHODS: We used the ICF to code AGQ item content before mailing the AGQ to a UK sample (N = 1349) selected to represent people with a risk factor for glaucoma and people with glaucoma across a range of severity. Reflecting uncertainty in the theoretical framework (items with multiple ICF codes), an exploratory PCA was conducted. The theoretical structure informed our interpretation of the empirical structure and guided the selection of theoretically-derived factor labels. We also explored the discrimination of the AGQ across glaucoma severity groups. RESULTS: 656 (49%) completed questionnaires were returned. The data yielded a 7-factor solution with a simple structure (using cut-off point of a loading of 0.5) that together accounted for 63% of variance in the scores. The mapping process resulted in allocation of the following theoretically-derived factor labels: 1) Seeing Functions: Participation; 2) Moving Around & Communication; 3) Emotional Functions; 4) Walking Around Obstacles; 5) Light; 6) Seeing Functions: Domestic & Social Life; 7) Mobility. Using the seven factor scores as independent variables in a discriminant function analysis, the AGQ scores resulted in correct glaucoma severity grading of 32.5% of participants (p < 0.001). CONCLUSIONS: This paper addresses a methodological gap in the application of classical test theory (CTT) techniques, such as PCA, in instrument development. Labels for empirically-derived factors are often selected intuitively whereas they can inform existing bodies of knowledge if selected on the basis of theoretical construct labels, which are more explicitly defined and which relate to each other in ways that are evidence based.

Perceived causes of prescribing errors by junior doctors in hospital inpatients: a study from the PROTECT programme.

INTRODUCTION: Prescribing errors are a major cause of patient safety incidents. Understanding the underlying factors is essential in developing interventions to address this problem. This study aimed to investigate the perceived causes of prescribing errors among foundation (junior) doctors in Scotland. METHODS: In eight Scottish hospitals, data on prescribing errors were collected by ward pharmacists over a 14-month period. Foundation doctors responsible for making a prescribing error were interviewed about the perceived causes. Interview transcripts were analysed using content analysis and categorised into themes previously identified under Reason's Model of Accident Causation and Human Error. RESULTS: 40 prescribers were interviewed about 100 specific errors. Multiple perceived causes for all types of error were identified and were categorised into five categories of error-producing conditions, (environment, team, individual, task and patient factors). Work environment was identified as an important aspect by all doctors, especially workload and time pressures. Team factors included multiple individuals and teams involved with a patient, poor communication, poor medicines reconciliation and documentation and following incorrect instructions from other members of the team. A further team factor was the assumption that another member of the team would identify any errors made. The most frequently noted individual factors were lack of personal knowledge and experience. The main task factor identified was poor availability of drug information at admission and the most frequently stated patient factor was complexity. CONCLUSIONS: This study has emphasised the complex nature of prescribing errors, and the wide range of error-producing conditions within hospitals including the work environment, team, task, individual and patient. Further work is now needed to develop and assess interventions that address these possible causes in order to reduce prescribing error rates.

Developing the specifications of an open angle glaucoma screening intervention in the United Kingdom: a Delphi approach.

BACKGROUND: Glaucoma is a leading cause of blindness. Early detection is advocated but there is insufficient evidence from randomized controlled trials (RCTs) to inform health policy on population screening. Primarily, there is no agreed screening intervention. For a screening programme, agreement is required on the screening tests to be used, either individually or in combination, the person to deliver the test and the location where testing should take place. This study aimed to use ophthalmologists (who were experienced glaucoma subspecialists), optometrists, ophthalmic nurses and patients to develop a reduced set of potential screening tests and testing arrangements that could then be explored in depth in a further study of their feasibility for evaluation in a glaucoma screening RCT. METHODS: A two-round Delphi survey involving 38 participants was conducted. Materials were developed from a prior evidence synthesis. For round one, after some initial priming questions in four domains, specialists were asked to nominate three screening interventions, the intervention being a combination of the four domains; target population, (age and higher risk groups), site, screening test and test operator (provider). More than 250 screening interventions were identified. For round two, responses were condensed into 72 interventions and each was rated by participants on a 0-10 scale in terms of feasibility. RESULTS: Using a cut-off of a median rating of feasibility of ≥5.5 as evidence of agreement of intervention feasibility, six interventions were identified from round 2. These were initiating screening at age 50, with a combination of two or three screening tests (varying combinations of tonometry/measures of visual function/optic nerve damage) organized in a community setting with an ophthalmic trained technical assistant delivering the tests. An alternative intervention was a 'glaucoma risk score' ascertained by questionnaire. The advisory panel recommended that further exploration of the feasibility of screening higher risk populations and detailed specification of the screening tests was required. CONCLUSIONS: With systematic use of expert opinions, a shortlist of potential screening interventions was identified. Views of users, service providers and cost-effectiveness modeling are now required to identify a feasible intervention to evaluate in a future glaucoma screening trial.

Evidence base for an intervention to maximise uptake of glaucoma testing: a theory-based cross-sectional survey.

OBJECTIVE: To identify factors associated with intention to attend a hypothetical eye health test and provide an evidence base for developing an intervention to maximise attendance, for use in studies evaluating glaucoma screening programmes. DESIGN: Theory-based cross-sectional survey, based on an extended Theory of Planned Behaviour (TPB) and the Common Sense Self-Regulation Model, conducted in June 2010. PARTICIPANTS: General population including oversampling from low socioeconomic areas. SETTING: Aberdeenshire and the London Boroughs of Lewisham and Southwark, UK. RESULTS: From 867 questionnaires posted, 327 completed questionnaires were returned (38%). In hierarchical regression analysis, the three theoretical predictors in the TPB (Attitude, Subjective norm and Perceived Behavioural Control) accounted for two-thirds of the variance in intention scores (adjusted R(2)=0.65). All three predictors contributed significantly to prediction. Adding 'Anticipated regret' as a factor in the TPB model resulted in a significant increase in prediction (adjusted R(2)=0.74). In the Common Sense Self-Regulation Model, only illness representations about the personal consequences of glaucoma (How much do you think glaucoma would affect your life?) and illness concern (How concerned are you about getting glaucoma?) significantly predicted. The final model explained 75% of the variance in intention scores, with ethnicity significantly contributing to prediction. CONCLUSIONS: In this population-based sample (including over-representation of lower socioeconomic groupings), the main predictors of intention to attend a hypothetical eye health test were Attitude, Perceived control over attendance, Anticipated regret if did not attend and black ethnicity. This evidence informs the design of a behavioural intervention with intervention components targeting low intentions and predicted to influence health-related behaviours.

Which experiences of health care delivery matter to service users and why? A critical interpretive synthesis and conceptual map.

OBJECTIVE: Patients' experiences are often treated as health care quality indicators. Our aim was to identify the range of experiences of health care delivery that matter to patients and to produce a conceptual map to facilitate consideration of why they matter. METHODS: Broad-based review and critical interpretive synthesis of research literature on patients' perspectives of health care delivery. We recorded experiences reported by a diverse range of patients on 'concept cards', considered why they were important, and explored various ways of organizing them, including internationally recognized health care quality frameworks. We developed a conceptual map that we refined with feedback from stakeholders. RESULTS: Patients identify many health care experiences as important. Existing health care quality frameworks do not cover them all. Our conceptual map presents a rich array of experiences, including health care relationships (beyond communication) and their implications for people's valued capabilities (e.g. to feel respected, contribute to their care, experience reciprocity). It is organized to reflect our synthesis argument, which links health care delivery to what people are enabled (or not) to feel, be and do. The map highlights the broad implications of the social dynamics of health care delivery. Experiences are labelled from a patient's perspective, rendering the importance of responsiveness to individuals axiomatic. CONCLUSIONS: Our conceptual map identifies and helps explain the importance of diverse experiences of health care delivery. It challenges and helps policy-makers, service providers and researchers to attend to the range of experiences that matter, and to take seriously the need for responsiveness to individuals.

Participation in physical play and leisure: developing a theory- and evidence-based intervention for children with motor impairments.

BACKGROUND: Children with motor impairments (e.g. difficulties with motor control, muscle tone or balance) experience significant difficulties in participating in physical play and leisure. Current interventions are often poorly defined, lack explicit hypotheses about why or how they might work, and have insufficient evidence about effectiveness. This project will identify (i) the 'key ingredients' of an effective intervention to increase participation in physical play and leisure in children with motor impairments; and (ii) how these ingredients can be combined in a feasible and acceptable intervention. METHODS/DESIGN: The project draws on the WHO International Classification of Functioning, Disability and Health and the UK Medical Research Council guidance for developing 'complex interventions'. There will be five steps: 1) identifying biomedical, personal and environmental factors proposed to predict children's participation in physical play and leisure; 2) developing an explicit model of the key predictors; 3) selecting intervention strategies to target the predictors, and specifying the pathways to change; 4) operationalising the strategies in a feasible and acceptable intervention; and 5) modelling the intervention processes and outcomes within single cases. DISCUSSION: The primary output from this project will be a detailed protocol for an intervention. The intervention, if subsequently found to be effective, will support children with motor difficulties to attain life-long well-being and participation in society. The project will also be an exemplar of methodology for a systematic development of non-drug interventions for children.

Pre-validation methods for developing a patient reported outcome instrument.

BACKGROUND: Measures that reflect patients' assessment of their health are of increasing importance as outcome measures in randomised controlled trials. The methodological approach used in the pre-validation development of new instruments (item generation, item reduction and question formatting) should be robust and transparent. The totality of the content of existing PRO instruments for a specific condition provides a valuable resource (pool of items) that can be utilised to develop new instruments. Such 'top down' approaches are common, but the explicit pre-validation methods are often poorly reported. This paper presents a systematic and generalisable 5-step pre-validation PRO instrument methodology. METHODS: The method is illustrated using the example of the Aberdeen Glaucoma Questionnaire (AGQ). The five steps are: 1) Generation of a pool of items; 2) Item de-duplication (three phases); 3) Item reduction (two phases); 4) Assessment of the remaining items' content coverage against a pre-existing theoretical framework appropriate to the objectives of the instrument and the target population (e.g. ICF); and 5) qualitative exploration of the target populations' views of the new instrument and the items it contains. RESULTS: The AGQ 'item pool' contained 725 items. Three de-duplication phases resulted in reduction of 91, 225 and 48 items respectively. The item reduction phases discarded 70 items and 208 items respectively. The draft AGQ contained 83 items with good content coverage. The qualitative exploration ('think aloud' study) resulted in removal of a further 15 items and refinement to the wording of others. The resultant draft AGQ contained 68 items. CONCLUSIONS: This study presents a novel methodology for developing a PRO instrument, based on three sources: literature reporting what is important to patient; theoretically coherent framework; and patients' experience of completing the instrument. By systematically accounting for all items dropped after the item generation phase, our method ensures that the AGQ is developed in a transparent, replicable manner and is fit for validation. We recommend this method to enhance the likelihood that new PRO instruments will be appropriate to the research context in which they are used, acceptable to research participants and likely to generate valid data.

Developing the clinical components of a complex intervention for a glaucoma screening trial: a mixed methods study.

BACKGROUND: Glaucoma is a leading cause of avoidable blindness worldwide. Open angle glaucoma is the most common type of glaucoma. No randomised controlled trials have been conducted evaluating the effectiveness of glaucoma screening for reducing sight loss. It is unclear what the most appropriate intervention to be evaluated in any glaucoma screening trial would be. The purpose of this study was to develop the clinical components of an intervention for evaluation in a glaucoma (open angle) screening trial that would be feasible and acceptable in a UK eye-care service. METHODS: A mixed-methods study, based on the Medical Research Council (MRC) framework for complex interventions, integrating qualitative (semi-structured interviews with 46 UK eye-care providers, policy makers and health service commissioners), and quantitative (economic modelling) methods. Interview data were synthesised and used to revise the screening interventions compared within an existing economic model. RESULTS: The qualitative data indicated broad based support for a glaucoma screening trial to take place in primary care, using ophthalmic trained technical assistants supported by optometry input. The precise location should be tailored to local circumstances. There was variability in opinion around the choice of screening test and target population. Integrating the interview findings with cost-effectiveness criteria reduced 189 potential components to a two test intervention including either optic nerve photography or screening mode perimetry (a measure of visual field sensitivity) with or without tonometry (a measure of intraocular pressure). It would be more cost-effective, and thus acceptable in a policy context, to target screening for open angle glaucoma to those at highest risk but for both practicality and equity arguments the optimal strategy was screening a general population cohort beginning at age forty. CONCLUSIONS: Interventions for screening for open angle glaucoma that would be feasible from a service delivery perspective were identified. Integration within an economic modelling framework explicitly highlighted the trade-off between cost-effectiveness, feasibility and equity. This study exemplifies the MRC recommendation to integrate qualitative and quantitative methods in developing complex interventions. The next step in the development pathway should encompass the views of service users.

Developing and evaluating interventions to reduce inappropriate prescribing by general practitioners of antibiotics for upper respiratory tract infections: a randomised controlled trial to compare paper-based and web-based modelling experiments.

BACKGROUND: Much implementation research is focused on full-scale trials with little evidence of preceding modelling work. The Medical Research Council Framework for developing and evaluating complex interventions has argued for more and better theoretical and exploratory work prior to a trial as a means of improving intervention development. Intervention modelling experiments (IMEs) are a way of exploring and refining an intervention before moving to a full-scale trial. They do this by delivering key elements of the intervention in a simulation that approximates clinical practice by, for example, presenting general practitioners (GPs) with a clinical scenario about making a treatment decision. METHODS: The current proposal will run a full, web-based IME involving 250 GPs that will advance the methodology of IMEs by directly comparing results with an earlier paper-based IME. Moreover, the web-based IME will evaluate an intervention that can be put into a full-scale trial that aims to reduce antibiotic prescribing for upper respiratory tract infections in primary care. The study will also include a trial of email versus postal invitations to participate. DISCUSSION: More effective behaviour change interventions are needed and this study will develop one such intervention and a system to model and test future interventions. This system will be applicable to any situation in the National Health Service where behaviour needs to be modified, including interventions aimed directly at the public. TRIAL REGISTRATION: ClinicalTrials (NCT): NCT01206738.

Clinicians' caseload management behaviours as explanatory factors in patients' length of time on caseloads: a predictive multilevel study in paediatric community occupational therapy.

BACKGROUND: Long waiting times and large caseloads are a challenge to children's therapy services internationally. Research in hospital-based healthcare indicates that waiting times are a function of throughput, and that length of care episode is related to clinicians' caseload management behaviour (i.e. actions at assessment, treatment, post-treatment, and discharge). There have been few attempts to study this in community health services. The present study investigated whether community occupational therapists' behaviour predicts children's length of time (LoT) on caseloads. METHODS: Retrospective survey of case notes of children recently discharged from occupational therapy services. Using cluster random sampling, case notes were drawn from therapy records in six NHSScotland Health Boards. Data about therapists' behaviours of assessing, treating, reviewing and discharging, together with child characteristics, were used to construct regression models of factors related to LoT. RESULTS: Twenty-six therapists [median(IQR) time in paediatrics 8(6-13) years] and 154 of their cases [mean(SD) age 7(3) years; median(IQR) LoT 10(3-21)] were included. A multi-level model, adjusting for clustering, for therapists' actions of communicating assessment outcomes to parents, providing treatment, and placing the child on review, and for a diagnosis of cerebral palsy, explained 44% of variation in LoT. CONCLUSIONS: Occupational therapists' caseload management behaviours are associated with children's LoT on caseloads. Further research is required to investigate the direction of relationships between therapists' behaviours and LoT; and the relationships between contextual factors, therapists' caseload management behaviours and LoT. Further exploration of therapists' beliefs about caseload management could also be useful in identifying possible factors contributing to variation between therapists.

Multiple goals and time constraints: perceived impact on physicians' performance of evidence-based behaviours.

BACKGROUND: Behavioural approaches to knowledge translation inform interventions to improve healthcare. However, such approaches often focus on a single behaviour without considering that health professionals perform multiple behaviours in pursuit of multiple goals in a given clinical context. In resource-limited consultations, performing these other goal-directed behaviours may influence optimal performance of a particular evidence-based behaviour. This study aimed to investigate whether a multiple goal-directed behaviour perspective might inform implementation research beyond single-behaviour approaches. METHODS: We conducted theory-based semi-structured interviews with 12 general medical practitioners (GPs) in Scotland on their views regarding two focal clinical behaviours--providing physical activity (PA) advice and prescribing to reduce blood pressure (BP) to <140/80 mmHg--in consultations with patients with diabetes and persistent hypertension. Theory-based constructs investigated were: intention and control beliefs from the theory of planned behaviour, and perceived interfering and facilitating influence of other goal-directed behaviours performed in a diabetes consultation. We coded interview content into pre-specified theory-based constructs and organised codes into themes within each construct using thematic analysis. RESULTS: Most GPs reported strong intention to prescribe to reduce BP but expressed reasons why they would not. Intention to provide PA advice was variable. Most GPs reported that time constraints and patient preference detrimentally affected their control over providing PA advice and prescribing to reduce BP, respectively. Most GPs perceived many of their other goal-directed behaviours as interfering with providing PA advice, while fewer GPs reported goal-directed behaviours that interfere with prescribing to reduce BP. Providing PA advice and prescribing to reduce BP were perceived to be facilitated by similar diabetes-related behaviours (e.g., discussing cholesterol). While providing PA advice was perceived to be mainly facilitated by providing other lifestyle-related clinical advice (e.g., talking about weight), BP prescribing was reported as facilitated by pursuing ongoing standard consultation-related goals (e.g., clearly structuring the consultation). CONCLUSION: GPs readily relate their other goal-directed behaviours with having a facilitating and interfering influence on their performance of particular evidence-based behaviours. This may have implications for advancing the theoretical development of behavioural approaches to implementation research beyond single-behaviour models.