Implementation research in emergency medicine: a systematic scoping review.

INTRODUCTION: Implementation research aims to increase the uptake of research findings into clinical practice to improve the quality of healthcare. This scoping systematic study aims to assess the volume and scope of implementation research in emergency medicine (EM) to obtain an overview and inform future implementation research. METHODS: Studies were identified by searching electronic databases and reference lists of included studies for the years 2002, 2007 and 2012. Titles/abstracts were screened, full papers checked and data extracted by one author, with a random sample checked by a second author. RESULTS: A total of 3581 citations were identified with 197 eligible papers included. The number of papers significantly increased over time from 26 in 2002 to 77 in 2007 and 94 in 2012 (p<0.05). Eighty-two (42%) focused on identifying evidence-practice gaps, 77 (39%) evaluated the effectiveness of implementation interventions and 38 (19%) explored barriers and enablers to change. Only two papers explicitly stated that theory was used. Five of the 77 effectiveness studies used a randomised design and few provided sufficient detail about the intervention undergoing evaluation. CONCLUSIONS: Although there was a significant increase in the number of implementation research papers, most studies focused on identifying evidence-practice gaps or used weak study designs to evaluate the effects of implementation interventions. Recommendations for improving implementation research in EM include identifying barriers and enablers to implementation, using theory in areas where proven important gaps exist, improving the reporting of the content of interventions and using rigorous study designs to evaluate their effectiveness.

Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis.

BACKGROUND AND PURPOSE: We systematically compared and appraised contemporary guidelines on management of asymptomatic and symptomatic carotid artery stenosis. METHODS: We systematically searched for guideline recommendations on carotid endarterectomy (CEA) or carotid angioplasty/stenting (CAS) published in any language between January 1, 2008, and January 28, 2015. Only the latest guideline per writing group was selected. Each guideline was analyzed independently by 2 to 6 authors to determine clinical scenarios covered, recommendations given, and scientific evidence used. RESULTS: Thirty-four eligible guidelines were identified from 23 different regions/countries in 6 languages. Of 28 guidelines with asymptomatic carotid artery stenosis procedural recommendations, 24 (86%) endorsed CEA (recommended it should or may be provided) for ≈50% to 99% average-surgical-risk asymptomatic carotid artery stenosis, 17 (61%) endorsed CAS, 8 (29%) opposed CAS, and 1 (4%) endorsed medical treatment alone. For asymptomatic carotid artery stenosis patients considered high-CEA-risk because of comorbidities, vascular anatomy, or undefined reasons, CAS was endorsed in 13 guidelines (46%). Thirty-one of 33 guidelines (94%) with symptomatic carotid artery stenosis procedural recommendations endorsed CEA for patients with ≈50% to 99% average-CEA-risk symptomatic carotid artery stenosis, 19 (58%) endorsed CAS and 9 (27%) opposed CAS. For high-CEA-risk symptomatic carotid artery stenosis because of comorbidities, vascular anatomy, or undefined reasons, CAS was endorsed in 27 guidelines (82%). Guideline procedural recommendations were based only on results of trials in which patients were randomized 12 to 34 years ago, rarely reflected medical treatment improvements and often understated potential CAS hazards. Qualifying terminology summarizing recommendations or evidence lacked standardization, impeding guideline interpretation, and comparison. CONCLUSIONS: This systematic review has identified many opportunities to modernize and otherwise improve carotid stenosis management guidelines.

Heart failure patients' experiences with continuity of care and its relation to medication adherence: a cross-sectional study.

BACKGROUND: A growing number of health care providers are nowadays involved in heart failure care. This could lead to discontinuity and fragmentation of care, thus reducing trust and hence poorer medication adherence. This study aims to explore heart failure patients' experiences with continuity of care, and its relation to medication adherence. METHODS: We collected data from 327 primary care patients with chronic heart failure. Experienced continuity of care was measured using a patient questionnaire and by reviewing patients' medical records. Continuity of care was defined as a multidimensional concept including personal continuity (seeing the same doctor every time), team continuity (collaboration between care providers in general practice) and cross-boundary continuity (collaboration between general practice and hospital). Medication adherence was measured using a validated patient questionnaire. The relation between continuity of care and medication adherence was analysed by using chi-square tests. RESULTS: In total, 53% of patients stated not seeing any care provider in general practice in the last year concerning their heart failure. Of the patients who did contact a care provider in general practice, 46% contacted two or more care providers. Respectively 38% and 51% of patients experienced the highest levels of team and cross-boundary continuity. In total, 14% experienced low levels of team continuity and 11% experienced low levels of cross-boundary continuity. Higher scores on personal continuity were significantly related to better medication adherence (p < 0.01). No clear relation was found between team- or cross-boundary continuity and medication adherence. CONCLUSIONS: A small majority of patients that contacted a care provider in general practice for their heart failure, contacted only one care provider. Most heart failure patients experienced high levels of collaboration between care providers in general practice and between GP and cardiologist. However, in a considerable number of patients, continuity of care could still be improved. Efforts to improve personal continuity may lead to better medication adherence.

Organizational culture, team climate, and quality management in an important patient safety issue: nosocomial pressure ulcers.

BACKGROUND: Increasingly, policy reform in health care is discussed in terms of changing organizational culture, creating practice teams, and organizational quality management. Yet, the evidence for these suggested determinants of high-quality care is inconsistent. AIMS: To determine if the type of organizational culture (Competing Values Framework), team climate (Team Climate Inventory), and preventive pressure ulcer quality management at ward level were related to the prevalence of pressure ulcers. Also, we wanted to determine if the type of organizational culture, team climate, or the institutional quality management related to preventive quality management at the ward level. METHODS: In this cross-sectional observational study multivariate (logistic) regression analyses were performed, adjusting for potential confounders and institution-level clustering. Data from 1274 patients and 460 health care professionals in 37 general hospital wards and 67 nursing home wards in the Netherlands were analyzed. The main outcome measures were nosocomial pressure ulcers in patients at risk for pressure ulcers (Braden score ≤ 18) and preventive quality management at ward level. RESULTS: No associations were found between organizational culture, team climate, or preventive quality management at the ward level and the prevalence of nosocomial pressure ulcers. Institutional quality management was positively correlated with preventive quality management at ward level (adj. ß 0.32; p < 0.001). CONCLUSIONS AND IMPLICATIONS: Although the prevalence of nosocomial pressure ulcers varied considerably across wards, it did not relate to organizational culture, team climate, or preventive quality management at the ward level. These results would therefore not subscribe the widely suggested importance of these factors in improving health care. However, different designs and research methods (that go beyond the cross-sectional design) may be more informative in studying relations between such complex factors and outcomes in a more meaningful way.

Public reporting in health care: how do consumers use quality-of-care information? A systematic review.

BACKGROUND: One of the underlying goals of public reporting is to encourage the consumer to select health care providers or health plans that offer comparatively better quality-of-care. OBJECTIVE: To review the weight consumers give to quality-of-care information in the process of choice, to summarize the effect of presentation formats, and to examine the impact of quality information on consumers' choice behavior. The evidence is organized in a theoretical consumer choice model. DATA SOURCES: English language literature was searched in PubMed, the Cochrane Clinical Trial, and the EPOC Databases (January 1990-January 2008). STUDY SELECTION: Study selection was limited to randomized controlled trails, controlled before-after trials or interrupted time series. Included interventions focused on choice behavior of consumers in health care settings. Outcome measures referred to one of the steps in a consumer choice model. The quality of the study design was rated, and studies with low quality ratings were excluded. RESULTS: All 14 included studies examine quality information, usually CAHPS, with respect to its impact on the consumer's choice of health plans. Easy-to-read presentation formats and explanatory messages improve knowledge about and attitude towards the use of quality information; however, the weight given to quality information depends on other features, including free provider choice and costs. In real-world settings, having seen quality information is a strong determinant for choosing higher quality-rated health plans. CONCLUSIONS: This review contributes to an understanding of consumer choice behavior in health care settings. The small number of included studies limits the strength of our conclusions.

Structured chronic primary care and health-related quality of life in chronic heart failure.

BACKGROUND: Structured care is proposed as a lever for improving care for patients with chronic conditions. The purpose of this study was to explore the associations of structured care characteristics, derived from the Chronic Care Model, with health-related quality of life (HRQOL) and optimal clinical management in chronic heart failure (CHF) patients in primary care, as well as the association between optimal management and HRQOL. METHODS: Cross-sectional observational study using multi-level random-coefficient analyses of a representative sample of 357 patients diagnosed with CHF from 42 primary care practices in the Netherlands. We combined individual medical record data with patient and physician questionnaires. RESULTS: There was large variation in the levels and presence of structured care elements. A 91% of physicians indicated that next appointments for CHF patients were made immediately after visits, while 11% indicated that reminders on CHF management were periodically received in their practice. Few associations were found between the organizational characteristics and optimal treatment or HRQOL. Optimal pharmacological treatment related to better quality of life (beta = -11.5, P < .0001). Also, more lifestyle advice was given in practices with an appointment system allowing contact with more than one professional during the encounter (beta = 1.0, P = .04). CONCLUSION: HRQOL and treatment quality in CHF patients were not consistently associated with characteristics of structured care in primary care practices.

Using psychological theory to understand the clinical management of type 2 diabetes in Primary Care: a comparison across two European countries.

BACKGROUND: Long term management of patients with Type 2 diabetes is well established within Primary Care. However, despite extensive efforts to implement high quality care both service provision and patient health outcomes remain sub-optimal. Several recent studies suggest that psychological theories about individuals' behaviour can provide a valuable framework for understanding generalisable factors underlying health professionals' clinical behaviour. In the context of the team management of chronic disease such as diabetes, however, the application of such models is less well established. The aim of this study was to identify motivational factors underlying health professional teams' clinical management of diabetes using a psychological model of human behaviour. METHODS: A predictive questionnaire based on the Theory of Planned Behaviour (TPB) investigated health professionals' (HPs') cognitions (e.g., beliefs, attitudes and intentions) about the provision of two aspects of care for patients with diabetes: prescribing statins and inspecting feet.General practitioners and practice nurses in England and the Netherlands completed parallel questionnaires, cross-validated for equivalence in English and Dutch. Behavioural data were practice-level patient-reported rates of foot examination and use of statin medication. Relationships between the cognitive antecedents of behaviour proposed by the TPB and healthcare teams' clinical behaviour were explored using multiple regression. RESULTS: In both countries, attitude and subjective norm were important predictors of health professionals' intention to inspect feet (Attitude: beta = .40; Subjective Norm: beta = .28; Adjusted R2 = .34, p < 0.01), and their intention to prescribe statins (Attitude: beta = .44; Adjusted R2 = .40, p < 0.01). Individuals' self-reported intention did not predict practice-level performance of either clinical behaviour. CONCLUSION: Using the TPB, we identified modifiable factors underlying health professionals' intentions to perform two clinical behaviours, providing a rationale for the development of targeted interventions. However, we did not observe a relationship between health professionals' intentions and our proxy measure of team behaviour. Significant methodological issues were highlighted concerning the use of models of individual behaviour to explain behaviours performed by teams. In order to investigate clinical behaviours performed by teams it may be necessary to develop measures that reflect the collective cognitions of the members of the team to facilitate the application of these theoretical models to team behaviours.

Factors associated with persistent post-concussion symptoms following mild traumatic brain injury in adults.

OBJECTIVES: Debate regarding factors associated with persistent symptoms following mild traumatic brain injury continues. Nested within a trial aiming to change practice in emergency department management of mild traumatic brain injury, this study investigated the nature of persistent symptoms, work/study outcomes, anxiety and quality of life and factors associated with persistent symptoms following injury, including the impact of receiving information about mild traumatic brain injuries in the emergency department. METHODS: A total of 343 individuals with mild traumatic brain injury completed the Rivermead Post-Concussion Symptom Questionnaire, Hospital Anxiety Depression Scale - Anxiety Scale, and Quality of Life - Short Form in average 7 months post-injury. RESULTS: Overall, 18.7% of participants reported 3 or more post-concussional symptoms, most commonly fatigue (17.2%) and forgetfulness (14.6%). Clinically significant anxiety was reported by 12.8%, and was significantly associated with symptom reporting, as were mental and physical quality of life scores. Significant predictors of post-concussional symptoms at follow-up were pre-injury psychological issues, experiencing loss of consciousness, and having no recall of receiving information about brain injury in the emergency department. CONCLUSION: This study confirms that loss of consciousness and pre-injury psychological issues are associated with persistent symptom reporting. Not receiving injury information in the emergency department may also negatively influence symptom reporting.

Evaluation of a targeted, theory-informed implementation intervention designed to increase uptake of emergency management recommendations regarding adult patients with mild traumatic brain injury: results of the NET cluster randomised trial.

BACKGROUND: Evidence-based guidelines for management of mild traumatic brain injury (mTBI) in the emergency department (ED) are now widely available; however, clinical practice remains inconsistent with these guidelines. A targeted, theory-informed implementation intervention (Neurotrauma Evidence Translation (NET) intervention) was designed to increase the uptake of three clinical practice recommendations regarding the management of patients who present to Australian EDs with mild head injuries. The intervention involved local stakeholder meetings, identification and training of nursing and medical local opinion leaders, train-the-trainer workshops and standardised education materials and interactive workshops delivered by the opinion leaders to others within their EDs during a 3 month period. This paper reports on the effects of this intervention. METHODS: EDs (clusters) were allocated to receive either access to a clinical practice guideline (control) or the implementation intervention, using minimisation, a method that allocates clusters to groups using an algorithm to minimise differences in predefined factors between the groups. We measured clinical practice outcomes at the patient level using chart audit. The primary outcome was appropriate screening for post-traumatic amnesia (PTA) using a validated tool until a perfect score was achieved (indicating absence of acute cognitive impairment) before the patient was discharged home. Secondary outcomes included appropriate CT scanning and the provision of written patient information upon discharge. Patient health outcomes (anxiety, primary outcome: Hospital Anxiety and Depression Scale) were also assessed using follow-up telephone interviews. Outcomes were assessed by independent auditors and interviewers, blinded to group allocation. RESULTS: Fourteen EDs were allocated to the intervention and 17 to the control condition; 1943 patients were included in the chart audit. At 2 months follow-up, patients attending intervention EDs (n = 893) compared with control EDs (n = 1050) were more likely to have been appropriately assessed for PTA (adjusted odds ratio (OR) 20.1, 95%CI 6.8 to 59.3; adjusted absolute risk difference (ARD) 14%, 95%CI 8 to 19). The odds of compliance with recommendations for CT scanning and provision of written patient discharge information were small (OR 1.2, 95%CI 0.8 to 1.6; ARD 3.2, 95%CI - 3.7 to 10 and OR 1.2, 95%CI 0.8 to 1.8; ARD 3.1, 95%CI - 3.0 to 9.3 respectively). A total of 343 patients at ten interventions and 14 control sites participated in follow-up interviews at 4.3 to 10.7 months post-ED presentation. The intervention had a small effect on anxiety levels (adjusted mean difference - 0.52, 95%CI - 1.34 to 0.30; scale 0-21, with higher scores indicating greater anxiety). CONCLUSIONS: Our intervention was effective in improving the uptake of the PTA recommendation; however, it did not appreciably increase the uptake of the other two practice recommendations. Improved screening for PTA may be clinically important as it leads to appropriate periods of observation prior to safe discharge. The estimated intervention effect on anxiety was of limited clinical significance. We were not able to compare characteristics of EDs who declined trial participation with those of participating sites, which may limit the generalizability of the results. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12612001286831), date registered 12 December 2012.

Organizational culture, team climate and diabetes care in small office-based practices.

BACKGROUND: Redesigning care has been proposed as a lever for improving chronic illness care. Within primary care, diabetes care is the most widespread example of restructured integrated care. Our goal was to assess to what extent important aspects of restructured care such as multidisciplinary teamwork and different types of organizational culture are associated with high quality diabetes care in small office-based general practices. METHODS: We conducted cross-sectional analyses of data from 83 health care professionals involved in diabetes care from 30 primary care practices in the Netherlands, with a total of 752 diabetes mellitus type II patients participating in an improvement study. We used self-reported measures of team climate (Team Climate Inventory) and organizational culture (Competing Values Framework), and measures of quality of diabetes care and clinical patient characteristics from medical records and self-report. We conducted multivariate analyses of the relationship between culture, climate and HbA1c, total cholesterol, systolic blood pressure and a sum score on process indicators for the quality of diabetes care, adjusting for potential patient- and practice level confounders and practice-level clustering. RESULTS: A strong group culture was negatively associated to the quality of diabetes care provided to patients (beta = -0.04; p = 0.04), whereas a more 'balanced culture' was positively associated to diabetes care quality (beta = 5.97; p = 0.03). No associations were found between organizational culture, team climate and clinical patient outcomes. CONCLUSION: Although some significant associations were found between high quality diabetes care in general practice and different organizational cultures, relations were rather marginal. Variation in clinical patient outcomes could not be attributed to organizational culture or teamwork. This study therefore contributes to the discussion about the legitimacy of the widespread idea that aspects of redesigning care such as teamwork and culture can contribute to higher quality of care. Future research should preferably combine quantitative and qualitative methods, focus on possible mediating or moderating factors and explore the use of instruments more sensitive to measure such complex constructs in small office-based practices.

Economic evaluation of the NET intervention versus guideline dissemination for management of mild head injury in hospital emergency departments.

BACKGROUND: Evidence-based guidelines for the management of mild traumatic brain injury (mTBI) in the emergency department (ED) are now widely available, and yet, clinical practice remains inconsistent with the guidelines. The Neurotrauma Evidence Translation (NET) intervention was developed to increase the uptake of guideline recommendations and improve the management of minor head injury in Australian emergency departments (EDs). However, the adoption of this type of intervention typically entails an upfront investment that may or may not be fully offset by improvements in clinical practice, health outcomes and/or reductions in health service utilisation. The present study estimates the cost and cost-effectiveness of the NET intervention, as compared to the passive dissemination of the guideline, to evaluate whether any improvements in clinical practice or health outcomes due to the NET intervention can be obtained at an acceptable cost. METHODS AND FINDINGS: Study setting: The NET cluster randomised controlled trial [ACTRN12612001286831]. STUDY SAMPLE: Seventeen EDs were randomised to the control condition and 14 to the intervention. One thousand nine hundred forty-three patients were included in the analysis of clinical practice outcomes (NET sample). A total of 343 patients from 14 control and 10 intervention EDs participated in follow-up interviews and were included in the analysis of patient-reported health outcomes (NET-Plus sample). OUTCOME MEASURES: Appropriate post-traumatic amnesia (PTA) screening in the ED (primary outcome). Secondary clinical practice outcomes: provision of written information on discharge (INFO) and safe discharge (defined as CT scan appropriately provided plus PTA plus INFO). Secondary patient-reported, post-discharge health outcomes: anxiety (Hospital Anxiety and Depression Scale), post-concussive symptoms (Rivermead), and preference-based health-related quality of life (SF6D). METHODS: Trial-based economic evaluations from a health sector perspective, with time horizons set to coincide with the final follow-up for the NET sample (2 months post-intervention) and to 1-month post-discharge for the NET-Plus sample. RESULTS: Intervention and control groups were not significantly different in health service utilisation received in the ED/inpatient ward following the initial mTBI presentation (adjusted mean difference $23.86 per patient; 95%CI - $106, $153; p = 0.719) or over the longer follow-up in the NET-plus sample (adjusted mean difference $341.78 per patient; 95%CI - $58, $742; p = 0.094). Savings from lower health service utilisation are therefore unlikely to offset the significantly higher upfront cost of the intervention (mean difference $138.20 per patient; 95%CI $135, $141; p < 0.000). Estimates of the net effect of the intervention on total cost (intervention cost net of health service utilisation) suggest that the intervention entails significantly higher costs than the control condition (adjusted mean difference $169.89 per patient; 95%CI $43, $297, p = 0.009). This effect is larger in absolute magnitude over the longer follow-up in the NET-plus sample (adjusted mean difference $505.06; 95%CI $96, $915; p = 0.016), mostly due to additional health service utilisation. For the primary outcome, the NET intervention is more costly and more effective than passive dissemination; entailing an additional cost of $1246 per additional patient appropriately screened for PTA ($169.89/0.1363; Fieller's 95%CI $525, $2055). For NET to be considered cost-effective with 95% confidence, decision-makers would need to be willing to trade one quality-adjusted life year (QALY) for 25 additional patients appropriately screened for PTA. While these results reflect our best estimate of cost-effectiveness given the data, it is possible that a NET intervention that has been scaled and streamlined ready for wider roll-out may be more or less cost-effective than the NET intervention as delivered in the trial. CONCLUSIONS: While the NET intervention does improve the management of mTBI in the ED, it also entails a significant increase in cost and-as delivered in the trial-is unlikely to be cost-effective at currently accepted funding thresholds. There may be a scope for a scaled-up and streamlined NET intervention to achieve a better balance between costs and outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001286831 , date registered 12 December 2012.

Tailoring quality improvement interventions to identified barriers: a multiple case analysis.

RATIONALE, AIMS AND OBJECTIVES: The prevailing view on implementation interventions to improve the organization and management of health care is that the interventions should be tailored to potential barriers. Ideally, possible barriers are analysed before the quality improvement interventions are developed to influence both type and content of the implementation intervention. While tailoring educational improvement interventions generally requires the assessment of professional knowledge and skills, less is known about methods to tailor organizational interventions. In the present study, the results of previous studies on the development of educational and organizational interventions to improve the quality of health care are examined. METHOD: Qualitative analyses were conducted on a purposeful sample of 20 quality improvement studies reporting barrier analyses and covering both educational and organizational interventions. RESULTS: Several methods were used to identify barriers, including focus group discussions, face-to-face interviews and telephone interviews. Attention to barriers prior to the development of the intervention did not always mean that the choice of a specific type of intervention was based on such, although identified barriers were often used to adjust the specific content of the intervention. A few methods to link improvement interventions to identified barriers were described, including theory-based reasoning and iterative design processes. Results suggest there is often a mismatch between the level of identified barriers and the type of interventions selected for use. No differences in the tailoring of educational or organizational interventions could be identified. CONCLUSIONS: The design of quality improvement interventions appears to still be in its infancy. The translation of identified barriers into tailor-made implementation interventions is still a black box for both educational and organizational interventions.

The Many Organisational Factors Relevant to Planning Change in Emergency Care Departments: A Qualitative Study to Inform a Cluster Randomised Controlled Trial Aiming to Improve the Management of Patients with Mild Traumatic Brain Injuries.

BACKGROUND: The Neurotrauma Evidence Translation (NET) Trial aims to design and evaluate the effectiveness of a targeted theory-and evidence-informed intervention to increase the uptake of evidence-based recommended practices for the management of patients who present to an emergency department (ED) with mild head injuries. When designing interventions to bring about change in organisational settings such as the ED, it is important to understand the impact of the context to ensure successful implementation of practice change. Few studies explicitly use organisational theory to study which factors are likely to be most important to address when planning change processes in the ED. Yet, this setting may have a unique set of organisational pressures that need to be taken into account when implementing new clinical practices. This paper aims to provide an in depth analysis of the organisational context in which ED management of mild head injuries and implementation of new practices occurs, drawing upon organisational level theory. METHODS: Semi-structured interviews were conducted with ED staff in Australia. The interviews explored the organisational context in relation to change and organisational factors influencing the management of patients presenting with mild head injuries. Two researchers coded the interview transcripts using thematic content analysis. The "model of diffusion in service organisations" was used to guide analyses and organisation of the results. RESULTS: Nine directors, 20 doctors and 13 nurses of 13 hospitals were interviewed. With regard to characteristics of the innovation (i.e. the recommended practices) the most important factor was whether they were perceived as being in line with values and needs. Tension for change (the degree to which stakeholders perceive the current situation as intolerable or needing change) was relatively low for managing acute mild head injury symptoms, and mixed for managing longer-term symptoms (higher change commitment, but relatively low change efficacy). Regarding implementation processes, the importance of (visible) senior leadership for all professions involved was identified as a critical factor. An unpredictable and hectic environment brings challenges in creating an environment in which team-based and organisational learning can thrive (system antecedents for innovation). In addition, the position of the ED as the entry-point of the hospital points to the relevance of securing buy-in from other units. CONCLUSIONS: We identified several organisational factors relevant to realising change in ED management of patients who present with mild head injuries. These factors will inform the intervention design and process evaluation in a trial evaluating the effectiveness of our implementation intervention.

Developing a targeted, theory-informed implementation intervention using two theoretical frameworks to address health professional and organisational factors: a case study to improve the management of mild traumatic brain injury in the emergency department.

BACKGROUND: Despite the availability of evidence-based guidelines for the management of mild traumatic brain injury in the emergency department (ED), variations in practice exist. Interventions designed to implement recommended behaviours can reduce this variation. Using theory to inform intervention development is advocated; however, there is no consensus on how to select or apply theory. Integrative theoretical frameworks, based on syntheses of theories and theoretical constructs relevant to implementation, have the potential to assist in the intervention development process. This paper describes the process of applying two theoretical frameworks to investigate the factors influencing recommended behaviours and the choice of behaviour change techniques and modes of delivery for an implementation intervention. METHODS: A stepped approach was followed: (i) identification of locally applicable and actionable evidence-based recommendations as targets for change, (ii) selection and use of two theoretical frameworks for identifying barriers to and enablers of change (Theoretical Domains Framework and Model of Diffusion of Innovations in Service Organisations) and (iii) identification and operationalisation of intervention components (behaviour change techniques and modes of delivery) to address the barriers and enhance the enablers, informed by theory, evidence and feasibility/acceptability considerations. We illustrate this process in relation to one recommendation, prospective assessment of post-traumatic amnesia (PTA) by ED staff using a validated tool. RESULTS: Four recommendations for managing mild traumatic brain injury were targeted with the intervention. The intervention targeting the PTA recommendation consisted of 14 behaviour change techniques and addressed 6 theoretical domains and 5 organisational domains. The mode of delivery was informed by six Cochrane reviews. It was delivered via five intervention components : (i) local stakeholder meetings, (ii) identification of local opinion leader teams, (iii) a train-the-trainer workshop for appointed local opinion leaders, (iv) local training workshops for delivery by trained local opinion leaders and (v) provision of tools and materials to prompt recommended behaviours. CONCLUSIONS: Two theoretical frameworks were used in a complementary manner to inform intervention development in managing mild traumatic brain injury in the ED. The effectiveness and cost-effectiveness of the developed intervention is being evaluated in a cluster randomised trial, part of the Neurotrauma Evidence Translation (NET) program.

Stability studies of binding and functional anti-vaccine antibodies.

BACKGROUND: As most vaccines exert their protective capacity by eliciting pathogen-specific antibodies, antibody assays assessing immunogenicity of vaccines in development should be well characterized. Part of the validation of immunogenicity assays for vaccines is the study of stability of antibodies in serum. Materials & methods: Stability of antibodies in human serum was assessed by circumsporozoite-binding IgG ELISA designed for assessing the immunogenicity of a malaria vaccine under development, adenovirus neutralization assay, designed to assess neutralizing antibodies against adenovirus and commercially available test kits for hepatitis A and B. RESULTS: Stability studies indicated stability of serum-binding IgG antibodies and serum-neutralizing antibodies in: long-term storage below -65°C and -20°C; short-term storage; multiple freeze/thaw rounds; during shipment; and during heat inactivation. CONCLUSION: RESULTS have shown the stability of both binding and functional polyclonal antibodies in human serum under stable storage and common usage circumstances.

Understanding practice: the factors that influence management of mild traumatic brain injury in the emergency department--a qualitative study using the Theoretical Domains Framework.

BACKGROUND: Mild traumatic brain injury is a frequent cause of presentation to emergency departments. Despite the availability of clinical practice guidelines in this area, there is variation in practice. One of the aims of the Neurotrauma Evidence Translation program is to develop and evaluate a targeted, theory- and evidence-informed intervention to improve the management of mild traumatic brain injury in Australian emergency departments. This study is the first step in the intervention development process and uses the Theoretical Domains Framework to explore the factors perceived to influence the uptake of four key evidence-based recommended practices for managing mild traumatic brain injury. METHODS: Semi-structured interviews were conducted with emergency staff in the Australian state of Victoria. The interview guide was developed using the Theoretical Domains Framework to explore current practice and to identify the factors perceived to influence practice. Two researchers coded the interview transcripts using thematic content analysis. RESULTS: A total of 42 participants (9 Directors, 20 doctors and 13 nurses) were interviewed over a seven-month period. The results suggested that (i) the prospective assessment of post-traumatic amnesia was influenced by: knowledge; beliefs about consequences; environmental context and resources; skills; social/professional role and identity; and beliefs about capabilities; (ii) the use of guideline-developed criteria or decision rules to inform the appropriate use of a CT scan was influenced by: knowledge; beliefs about consequences; environmental context and resources; memory, attention and decision processes; beliefs about capabilities; social influences; skills and behavioral regulation; (iii) providing verbal and written patient information on discharge was influenced by: beliefs about consequences; environmental context and resources; memory, attention and decision processes; social/professional role and identity; and knowledge; (iv) the practice of providing brief, routine follow-up on discharge was influenced by: environmental context and resources; social/professional role and identity; knowledge; beliefs about consequences; and motivation and goals. CONCLUSIONS: Using the Theoretical Domains Framework, factors thought to influence the management of mild traumatic brain injury in the emergency department were identified. These factors present theoretically based targets for a future intervention.

Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial.

BACKGROUND: Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. METHODS/DESIGN: The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).

Measuring team factors thought to influence the success of quality improvement in primary care: a systematic review of instruments.

BACKGROUND: Measuring team factors in evaluations of Continuous Quality Improvement (CQI) may provide important information for enhancing CQI processes and outcomes; however, the large number of potentially relevant factors and associated measurement instruments makes inclusion of such measures challenging. This review aims to provide guidance on the selection of instruments for measuring team-level factors by systematically collating, categorizing, and reviewing quantitative self-report instruments. DATA SOURCES: We searched MEDLINE, PsycINFO, and Health and Psychosocial Instruments; reference lists of systematic reviews; and citations and references of the main report of instruments. STUDY SELECTION: To determine the scope of the review, we developed and used a conceptual framework designed to capture factors relevant to evaluating CQI in primary care (the InQuIRe framework). We included papers reporting development or use of an instrument measuring factors relevant to teamwork. Data extracted included instrument purpose; theoretical basis, constructs measured and definitions; development methods and assessment of measurement properties. Analysis and synthesis: We used qualitative analysis of instrument content and our initial framework to develop a taxonomy for summarizing and comparing instruments. Instrument content was categorized using the taxonomy, illustrating coverage of the InQuIRe framework. Methods of development and evidence of measurement properties were reviewed for instruments with potential for use in primary care. RESULTS: We identified 192 potentially relevant instruments, 170 of which were analyzed to develop the taxonomy. Eighty-one instruments measured constructs relevant to CQI teams in primary care, with content covering teamwork context (45 instruments measured enabling conditions or attitudes to teamwork), team process (57 instruments measured teamwork behaviors), and team outcomes (59 instruments measured perceptions of the team or its effectiveness). Forty instruments were included for full review, many with a strong theoretical basis. Evidence supporting measurement properties was limited. CONCLUSIONS: Existing instruments cover many of the factors hypothesized to contribute to QI success. With further testing, use of these instruments measuring team factors in evaluations could aid our understanding of the influence of teamwork on CQI outcomes. Greater consistency in the factors measured and choice of measurement instruments is required to enable synthesis of findings for informing policy and practice.

How to define 'best practice' for use in Knowledge Translation research: a practical, stepped and interactive process.

OBJECTIVES: Defining 'best practice' is one of the first and crucial steps in any Knowledge Translation (KT) research project. Without a sound understanding of what exactly should happen in practice, it is impossible to measure the extent of existing gaps between 'desired' and 'actual' care, set implementation goals, and monitor performance. The aim of this paper is to present a practical, stepped and interactive process to develop best practice recommendations that are actionable, locally applicable and in line with the best available research-based evidence, with a view to adapt these into process measures (quality indicators) for KT research purposes. METHODS: Our process encompasses the following steps: (1) identify current, high-quality clinical practice guidelines (CPGs) and extract recommendations; (2) select strong recommendations in key clinical management areas; (3) update evidence and create evidence overviews; (4) discuss evidence and produce agreed 'evidence statements'; (5) discuss the relevance of the evidence with local stakeholders; and (6) develop locally applicable actionable best practice recommendations, suitable for use as the basis of quality indicators. CONCLUSIONS: Actionable definitions of local best practice are a prerequisite for doing KT research. As substantial resources go into rigorously synthesizing evidence and developing CPGs, it is important to make best use of such available resources. We developed a process for efficiently developing locally applicable actionable best practice recommendations from existing high-quality CPGs that are in line with current research evidence.