Evaluation of research co-design in health: a systematic overview of reviews and development of a framework.

BACKGROUND: Co-design with consumers and healthcare professionals is widely used in applied health research. While this approach appears to be ethically the right thing to do, a rigorous evaluation of its process and impact is frequently missing. Evaluation of research co-design is important to identify areas of improvement in the methods and processes, as well as to determine whether research co-design leads to better outcomes. We aimed to build on current literature to develop a framework to assist researchers with the evaluation of co-design processes and impacts. METHODS: A multifaceted, iterative approach, including three steps, was undertaken to develop a Co-design Evaluation Framework: 1) A systematic overview of reviews; 2) Stakeholder panel meetings to discuss and debate findings from the overview of reviews and 3) Consensus meeting with stakeholder panel. The systematic overview of reviews included relevant papers published between 2000 and 2022. OVID (Medline, Embase, PsycINFO), EBSCOhost (Cinahl) and the Cochrane Database of Systematic reviews were searched for papers that reported co-design evaluation or outcomes in health research. Extracted data was inductively analysed and evaluation themes were identified. Review findings were presented to a stakeholder panel, including consumers, healthcare professionals and researchers, to interpret and critique. A consensus meeting, including a nominal group technique, was applied to agree upon the Co-design Evaluation Framework. RESULTS: A total of 51 reviews were included in the systematic overview of reviews. Fifteen evaluation themes were identified and grouped into the following seven clusters: People (within co-design group), group processes, research processes, co-design context, people (outside co-design group), system and sustainment. If evaluation methods were mentioned, they mainly included qualitative data, informal consumer feedback and researchers' reflections. The Co-Design Evaluation Framework used a tree metaphor to represent the processes and people in the co-design group (below-ground), underpinning system- and people-level outcomes beyond the co-design group (above-ground). To evaluate research co-design, researchers may wish to consider any or all components in the tree. CONCLUSIONS: The Co-Design Evaluation Framework has been collaboratively developed with various stakeholders to be used prospectively (planning for evaluation), concurrently (making adjustments during the co-design process) and retrospectively (reviewing past co-design efforts to inform future activities).

Understanding factors that influence goal setting in rehabilitation for paediatric acquired brain injury: a qualitative study using the Theoretical Domains Framework.

Background While goal setting with children and their families is considered best practice during rehabilitation following acquired brain injury, its successful implementation in an interdisciplinary team is not straightforward. This paper describes the application of a theoretical framework to understand factors influencing goal setting with children and their families in a large interdisciplinary rehabilitation team. Methods A semi-structured focus group was conducted with rehabilitation clinicians and those with lived experience of paediatric acquired brain injury (ABI). The 90-min focus group was audio-recorded and transcribed verbatim. Data were thematically coded and mapped against the Theoretical Domains Framework (TDF) to understand influencing factors, which were then linked to the Capability, Opportunity, Motivation - Behaviour (COM-B) model. Results A total of 11 participants (nine paediatric rehabilitation clinicians, one parent and one young person with lived experience of paediatric ABI) participated in the focus group. Factors influencing collaborative goal setting mapped to the COM-B and six domains of the TDF: Capabilities (Skills, Knowledge, Beliefs about capabilities, and Behavioural regulation), Opportunities (Environmental context and resources), and Motivation (Social/professional role and identity). Results suggest that a multifaceted intervention is needed to enhance rehabilitation clinicians' and families' skills and knowledge of goal setting, restructure the goal communication processes, and clarify the roles clinicians play in goal setting within the interdisciplinary team. Conclusion The use of the TDF and COM-B enabled a systematic approach to understanding the factors influencing goal setting for children with acquired brain injury in a large interdisciplinary rehabilitation team, and develop a targeted, multifaceted intervention for clinical use. These represent important considerations for the improvement of collaborative goal setting in paediatric rehabilitation services to ensure that best practice approaches to goal setting are implemented effectively in clinical practice.

Triage tools for detecting cervical spine injury in paediatric trauma patients.

BACKGROUND: Paediatric cervical spine injury (CSI) after blunt trauma is rare but can have severe consequences. Clinical decision rules (CDRs) have been developed to guide clinical decision-making, minimise unnecessary tests and associated risks, whilst detecting all significant CSIs. Several validated CDRs are used to guide imaging decision-making in adults following blunt trauma and clinical criteria have been proposed as possible paediatric-specific CDRs. Little information is known about their accuracy. OBJECTIVES: To assess and compare the diagnostic accuracy of CDRs or sets of clinical criteria, alone or in comparison with each other, for the evaluation of CSI following blunt trauma in children. SEARCH METHODS: For this update, we searched CENTRAL, MEDLINE, Embase, and six other databases from 1 January 2015 to 13 December 2022. As we expanded the index test eligibility for this review update, we searched the excluded studies from the previous version of the review for eligibility. We contacted field experts to identify ongoing studies and studies potentially missed by the search. There were no language restrictions. SELECTION CRITERIA: We included cross-sectional or cohort designs (retrospective and prospective) and randomised controlled trials that compared the diagnostic accuracy of any CDR or clinical criteria compared with a reference standard for the evaluation of paediatric CSI following blunt trauma. We included studies evaluating one CDR or comparing two or more CDRs (directly and indirectly). We considered X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) of the cervical spine, and clinical clearance/follow-up as adequate reference standards. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts for relevance, and carried out eligibility, data extraction and quality assessment. A third review author arbitrated. We extracted data on study design, participant characteristics, inclusion/exclusion criteria, index test, target condition, reference standard and data (diagnostic two-by-two tables) and calculated and plotted sensitivity and specificity on forest plots for visual examination of variation in test accuracy. We assessed methodological quality using the Quality Assessment of Diagnostic Accuracy Studies Version 2 tool. We graded the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included five studies with 21,379 enrolled participants, published between 2001 and 2021. Prevalence of CSI ranged from 0.5% to 1.85%. Seven CDRs were evaluated. Three studies reported on direct comparisons of CDRs. One study (973 participants) directly compared the accuracy of three index tests with the sensitivities of NEXUS, Canadian C-Spine Rule and the PECARN retrospective criteria being 1.00 (95% confidence interval (CI) 0.48 to 1.00), 1.00 (95% CI 0.48 to 1.00) and 1.00 (95% CI 0.48 to 1.00), respectively. The specificities were 0.56 (95% CI 0.53 to 0.59), 0.52 (95% CI 0.49 to 0.55) and 0.32 (95% CI 0.29 to 0.35), respectively (moderate-certainty evidence). One study (4091 participants) compared the accuracy of the PECARN retrospective criteria with the Leonard de novo model; the sensitivities were 0.91 (95% CI 0.81 to 0.96) and 0.92 (95% CI 0.83 to 0.97), respectively. The specificities were 0.46 (95% CI 0.44 to 0.47) and 0.50 (95% CI 0.49 to 0.52) (moderate- and low-certainty evidence, respectively). One study (270 participants) compared the accuracy of two NICE (National Institute for Health and Care Excellence) head injury guidelines; the sensitivity of the CG56 guideline was 1.00 (95% CI 0.48 to 1.00) compared to 1.00 (95% CI 0.48 to 1.00) with the CG176 guideline. The specificities were 0.46 (95% CI 0.40 to 0.52) and 0.07 (95% CI 0.04 to 0.11), respectively (very low-certainty evidence). Two additional studies were indirect comparison studies. One study (3065 participants) tested the accuracy of the NEXUS criteria; the sensitivity was 1.00 (95% CI 0.88 to 1.00) and specificity was 0.20 (95% CI 0.18 to 0.21) (low-certainty evidence). One retrospective study (12,537 participants) evaluated the PEDSPINE criteria and found a sensitivity of 0.93 (95% CI 0.78 to 0.99) and specificity of 0.70 (95% CI 0.69 to 0.72) (very low-certainty evidence). We did not pool data within the broader CDR categories or investigate heterogeneity due to the small quantity of data and the clinical heterogeneity of studies. Two studies were at high risk of bias. We identified two studies that are awaiting classification pending further information and two ongoing studies. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the diagnostic test accuracy of CDRs to detect CSIs in children following blunt trauma, particularly for children under eight years of age. Although most studies had a high sensitivity, this was often achieved at the expense of low specificity and should be interpreted with caution due to a small number of CSIs and wide CIs. Well-designed, large studies are required to evaluate the accuracy of CDRs for the cervical spine clearance in children following blunt trauma, ideally in direct comparison with each other.

Understanding the uptake and adaption of targeted implementation interventions for reducing bronchiolitis investigations and therapies.

AIM: To understand and evaluate the uptake and local adaptations of proven targeted implementation interventions that have effectively reduced unnecessary investigations and therapies in infants with bronchiolitis within emergency departments. METHODS: A multi-centred, mixed-methods quality improvement study in four Australian hospitals that provide paediatric emergency and inpatient care from May to December 2021. All hospitals were provided with the same implementation intervention package and training. Real-time tracking logs of adaptions were completed followed by semi-structured interviews. Interviews were recorded, transcribed and subsequently coded using FRAME-IS to further describe the adaptions made. RESULTS: Tracking logs were summarised and data from 12 interviews were compared from participating sites. The intervention resulted in 116 education sessions and a total of 23 adaptations made to educational materials, both content and contextual. Shortening education presentations, addition of bronchiolitis definitions, formatting of materials and novel interventions were the most common modifications. Audit and feedback were completed across all sites with varying utilisation. Targeted teaching was noted to dictate adaptions prior to and during implementation. CONCLUSION: Quantitative and qualitative analysis of clinical 'real-world' adaptations to proven targeted implementation interventions allows invaluable insight for future de-implementation initiatives and national roll-out of implementation packages in the ED setting.

Implementing Electronic Discharge Communication Tools in Pediatric Emergency Departments: Multicountry, Cross-Sectional Readiness Survey of Nurses and Physicians.

BACKGROUND: Pediatric emergency departments (ED) in many countries are implementing electronic tools such as kiosks, mobile apps, and electronic patient portals, to improve the effectiveness of discharge communication. OBJECTIVE: This study aimed to survey nurse and physician readiness to adopt these tools. METHODS: An electronic, cross-sectional survey was distributed to a convenience sample of currently practicing ED nurses and physicians affiliated with national pediatric research organizations in Canada, Australia, and New Zealand. Survey development was informed by the nonadoption, abandonment, scale-up, spread, sustainability framework. Measures of central tendency, and parametric and nonparametric tests were used to describe and compare nurse and physician responses. RESULTS: Out of the 270 participants, the majority were physicians (61%, 164/270), female (65%, 176/270), and had 5 or more years of ED experience (76%, 205/270). There were high levels of consensus related to the value proposition of electronic discharge communication tools (EDCTs) with 82% (221/270) of them agreeing that they help parents and patients with comprehension and recall. Lower levels of consensus were observed for organizational factors with only 37% (100/270) agreeing that their staff is equipped to handle challenges with communication technologies. Nurses and physicians showed significant differences on 3 out of 21 readiness factors. Compared to physicians, nurses were significantly more likely to report that EDs have a responsibility to integrate EDCTs as part of a modern system (P<.001) and that policies are in place to guide safe and secure electronic communication (P=.02). Physicians were more likely to agree that using an EDCT would change their routine tasks (P=.04). One third (33%, 89/270) of participants indicated that they use or have used EDCT. CONCLUSIONS: Despite low levels of uptake, both nurses and physicians in multiple countries view EDCTs as a valuable support to families visiting pediatric ED. Leadership for technology change, unclear impact on workflow, and disparities in digital literacy skills require focused research effort.

Factors influencing health professionals' use of high-flow nasal cannula therapy for infants with bronchiolitis - A qualitative study.

Aim: To explore the factors influencing the use of high-flow nasal cannula (HFNC) therapy for infants with bronchiolitis. Design: Qualitative approach using semi-structured interviews. Methods: The semi-structured interviews (face-to-face or virtual) were conducted between September 2020 and February 2021. Deductive content analysis was used to map key influencing factors for use of HFNC therapy to the Theoretical Domains Framework (TDF). Results: Nineteen interviews were undertaken before reaching thematic saturation (7 nurses, 12 doctors) in emergency departments and paediatric wards from four purposively selected hospitals in Australia and New Zealand. Influencing factors were mapped to eight domains in the TDF with 21 themes identified. Main findings included: (1) Health professionals' expectations of HFNC therapy on patient deterioration, work of breathing and oxygenation; (2) Staff emotions relating to concern and anxiety about deterioration and "need to do something"; (3) Social influences from other health professionals and parents and (4) Environmental factors relating to logistics of care and patient transfer considerations. These factors, combined with the ready availability of HFNC equipment and health professionals having the required skills to administer the therapy, contributed to its initiation. Conclusion: Individual/personal and contextual/environmental factors contribute to the use of HFNC therapy for infants with bronchiolitis. It is evident these influences contribute substantially to increased use, despite evidence-based guidelines recommending a more nuanced approach to this therapy. These findings will inform a targeted implementation intervention to promote evidence-based use of HFNC therapy in infants with bronchiolitis.

Evaluation of targeted implementation interventions for reducing investigations and therapies in infants with bronchiolitis.

AIM: To evaluate the impact of locally adapted targeted implementation interventions on bronchiolitis management through reduction in ineffective investigation and therapies within emergency departments. METHODS: A multi-centred, quality improvement study in four different grades of hospitals in Western Australia that provide paediatric emergency and inpatient care. All hospitals incorporated an adapted implementation intervention package for infants under 1 year with bronchiolitis. The proportion whose care complied with guideline recommendations to not receive investigations and therapies of minimal benefit were compared to pre-intervention care in a previous bronchiolitis season. RESULTS: A total of 457 infants in 2019 (pre-intervention) and 443 in 2021 (post-intervention) were included, with mean age of 5.6 months (SD 3.2, 2019; SD 3.0, 2021). In 2019, compliance was 78.1% versus 85.6% in 2021, RD 7.4 (95% CI -0.6; 15.5). The strongest evidence was reduced salbutamol use (compliance improvement: 88.6% to 95.7%, RD 7.1 95% CI (1.7; 12.4)). Hospitals initially at <80% compliance demonstrated greatest improvements (Hospital 2: 95 (78.5%) to 108 (90.8%) RD 12.2 95% CI (3.3; 21.2); Hospital 3: 67 (62.6%) to 63 (76.8%) RD 14.2 95% CI (1.3; 27.2)). CONCLUSION: Targeted site-adapted implementation interventions resulted in improvement in compliance with guideline recommendations, particularly for those hospitals with initial low compliance. Maximising benefits through guidance on how to adapt and effectively use interventions will enhance sustainable practice change.

Qualitative study of emergency clinicians to inform a national guideline on the management of children with mild-to-moderate head injuries.

BACKGROUND: Head injury is a common reason children present to EDs. Guideline development to improve care for paediatric head injuries should target the information needs of ED clinicians and factors influencing its uptake. METHODS: We conducted semi-structured qualitative interviews (November 2017-November 2018) with a stratified purposive sample of ED clinicians from across Australia and New Zealand. We identified clinician information needs, used the Theoretical Domains Framework (TDF) to explore factors influencing the use of head CT and clinical decision rules/guidelines in CT decision-making, and explored ways to improve guideline uptake. Two researchers coded the interview transcripts using thematic content analysis. RESULTS: A total of 43 clinicians (28 doctors, 15 nurses), from 19 hospitals (5 tertiary, 8 suburban, 6 regional/rural) were interviewed. Clinicians sought guidance for scenarios including ED management of infants, children with underlying medical issues, delayed or representations and potential non-accidental injuries. Improvements to the quality and content of discharge communication and parental discussion materials were suggested. Known risks of radiation from head CTs has led to a culture of observation over use of CT in Australasia (TDF domain: beliefs about consequences). Formal and informal policies have resulted in senior clinicians making most head CT decisions in children (TDF domain: behavioural regulation). Senior clinicians consider their gestalt to be more accurate and outperform existing guidance (TDF domain: beliefs about capabilities), although they perceive guidelines as useful for training and supporting junior staff. Summaries, flow charts, publication in ED-specific journals and scripted training materials were suggestions to improve uptake. CONCLUSION: Information needs of ED clinicians, factors influencing use of head CT in children with head injuries and the role of guidelines were identified. These findings informed the scope and implementation strategies for an Australasian guideline for mild-to-moderate head injuries in children.

Sustainability of evidence-based practices in the management of infants with bronchiolitis in hospital settings - a PREDICT study protocol.

BACKGROUND: Understanding how and why de-implementation of low-value practices is sustained remains unclear. The Paediatric Research in Emergency Departments International CollaboraTive (PREDICT) Bronchiolitis Knowledge Translation (KT) Study was a cluster randomised controlled trial conducted in 26 Australian and New Zealand hospitals (May-November 2017). Results showed targeted, theory-informed interventions (clinical leads, stakeholder meetings, train-the-trainer workshop, targeted educational package, audit/feedback) were effective at reducing use of five low-value practices for bronchiolitis (salbutamol, glucocorticoids, antibiotics, adrenaline and chest x-ray) by 14.1% in acute care settings. The primary aim of this study is to determine the sustainability (continued receipt of benefits) of these outcomes at intervention hospitals two-years after the removal of study supports. Secondary aims are to determine sustainability at one-year after removal of study support at intervention hospitals; improvements one-and-two years at control hospitals; and explore factors that influence sustainability at intervention hospitals and contribute to improvements at control hospitals. METHODS: A mixed-methods study design. The quantitative component is a retrospective medical record audit of bronchiolitis management within 24 hours of emergency department (ED) presentations at 26 Australian (n = 20) and New Zealand (n = 6) hospitals, which participated in the PREDICT Bronchiolitis KT Study. Data for a total of 1800 infants from intervention and control sites (up to 150 per site) will be collected to determine if improvements (i.e., no use of all five low-value practices) were sustained two- years (2019) post-trial (primary outcome; composite score); and a further 1800 infants from intervention and control sites will be collected to determine sustained improvements one- year (2018) post-trial (secondary outcome). An a priori definition of sustainability will be used. The qualitative component will consist of semi-structured interviews with three to five key emergency department and paediatric inpatient medical and nursing staff per site (total n = 78-130). Factors that may have contributed to sustaining outcomes and/or interventions will be explored and mapped to an established sustainability framework. DISCUSSION: This study will improve our understanding of the sustainability of evidence-based bronchiolitis management in infants. Results will also advance implementation science research by informing future de-implementation strategies to reduce low-value practices and sustain practice change in paediatric acute care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry No: ACTRN12621001287820.

Review article: A primer for clinical researchers in the emergency department: Part XII. Sustainability of improvements in care: An introduction.

Despite an increased focus on ways to improve implementation of evidence and de-implementation of practices with no known benefit, there is limited guidance on how to sustain these improvements. This review provides an introduction to sustainability of improvements in care and sustainability research, discussing how to support sustainability in practice and detailing a sustainability research agenda for the emergency medicine setting.

Predictors of participation and quality of life following major traumatic injuries in childhood: a systematic review.

OBJECTIVE: Review the literature on predictors of participation and quality of life in children and young people who sustained a traumatic brain injury (TBI), spinal cord injury (SCI), and/or multi-trauma in a motor vehicle or other accident or trauma. DESIGN: This systematic review was conducted and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The protocol was registered on PROSPERO (registration number CRD42020131698). Electronic databases were searched for studies published between January 2000 and August 2020. Prospective and retrospective cohort studies were considered and risk of bias was assessed using the Quality In Prognosis Studies (QUIPS) tool. RESULTS: The search yielded 5771 articles of which 30 studies met the inclusion criteria. Nineteen studies included patients with TBI and 11 with SCI. No studies of patients with multi-trauma met criteria. Evidence was found for associations with various factors (e.g., injury severity, level of education, mental health problems), although these findings are limited due to the quality of the studies (5 studies moderate and 25 high risk of bias). CONCLUSION: Research on predictors of participation and quality of life following major traumatic injuries in childhood is lacking. More methodologically sound prospective, longitudinal studies are needed across different injury groups to further elucidate predictors of outcome.IMPLICATIONS FOR REHABILITATIONWhile long-term participation and quality of life is influenced by injury characteristics (i.e., injury severity), a number of potential modifiable factors can be targeted to improve outcomes following traumatic injuries in childhood.Young people should be provided with support to stay in school and pursue further education.Early intervention and prevention of mental health problems may improve long-term outcomes.Better management of ongoing medical problems and greater support for functional independence may improve participation.

Can targeted interventions change the factors influencing variation in management of infants with bronchiolitis? A survey of Australian and New Zealand clinicians: A paediatric research in emergency departments international collaborative (PREDICT) study.

AIM: This study aimed to determine whether targeted interventions, proven to be effective at improving evidence-based bronchiolitis management, changed factors previously found to influence variation in bronchiolitis management. METHODS: This survey assessed change in factors influencing clinicians' (nurses and doctors) bronchiolitis management at baseline and post-intervention in a cluster randomised controlled trial of targeted, theory-informed interventions aiming to de-implement non-evidence-based bronchiolitis management (no use of chest X-ray, salbutamol, antibiotics, glucocorticoids and adrenaline). Survey questions addressed previously identified factors influencing bronchiolitis management from six Theoretical Domains Framework domains (knowledge; skills; beliefs about consequences; social/professional role and identity; environmental context and resources; social influences). Data analysis was descriptive. RESULTS: A total of 1958 surveys (baseline = 996; post-intervention = 962) were completed by clinicians from the emergency department and paediatric inpatient units from 26 hospitals (intervention = 13; control = 13). Targeted bronchiolitis interventions significantly increased knowledge of the Australasian Bronchiolitis Guideline (intervention clinicians = 74%, control = 39%, difference = 34.7%, 95% confidence interval (CI) = 25.6-43.8%), improved skills in diagnosing (intervention doctors = 89%, control = 76%, difference = 12.6%, 95% CI = 6.2-19%) and managing bronchiolitis (intervention doctors = 87%, control = 76%, difference = 9.9%, 95% CI = 3.7-16.1%), positively influenced both beliefs about consequences regarding salbutamol use (intervention clinicians = 49%, control = 29%, difference = 20.3%, 95% CI = 13.2-27.4%) and nurses questioning non-evidence-based bronchiolitis management (chest X-ray: intervention = 71%, control = 51%, difference = 20.8%, 95% CI = 11.4-30.2%; glucocorticoids: intervention = 64%, control = 40%, difference = 21.9%, 95% CI = 10.4-33.5%) (social/professional role and identity). A 14% improvement in evidence-based bronchiolitis management favouring intervention hospitals was demonstrated in the cluster randomised controlled trial. CONCLUSION: Targeted interventions positively changed factors influencing bronchiolitis management resulting in improved evidence-based bronchiolitis care. This study has important implications for improving bronchiolitis management and future development of interventions to de-implement low-value care.

Process evaluation of a cluster randomised controlled trial to improve bronchiolitis management - a PREDICT mixed-methods study.

BACKGROUND: Bronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data. METHODS: A pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis. RESULTS: The cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use. CONCLUSION: Our targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .

Development of targeted, theory-informed interventions to improve bronchiolitis management.

BACKGROUND: Despite international guidelines providing evidence-based recommendations on appropriate management of infants with bronchiolitis, wide variation in practice occurs. This results in infants receiving care of no benefit, with associated cost and is potentially harmful. Theoretical frameworks are increasingly used to develop interventions, utilising behaviour change techniques specifically chosen to target factors contributing to practice variation, with de-implementation often viewed as harder than implementing. This paper describes the stepped process using the Theoretical Domains Framework (TDF) to develop targeted, theory-informed interventions which subsequently successfully improved management of infants with bronchiolitis by de-implementing ineffective therapies. Explicit description of the process and rationale used in developing de-implementation interventions is critical to dissemination of these practices into real world clinical practice. METHODS: A stepped approach was used: (1) Identify evidence-based recommendations and practice variation as targets for change, (2) Identify factors influencing practice change (barriers and enablers) to be addressed, and (3) Identification and development of interventions (behaviour change techniques and methods of delivery) addressing influencing factors, considering evidence of effectiveness, feasibility, local relevance and acceptability. The mode of delivery for the intervention components was informed by evidence from implementation science systematic reviews, and setting specific feasibility and practicality. RESULTS: Five robust evidence-based management recommendations, targeting the main variation in bronchiolitis management were identified: namely, no use of chest x-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline. Interventions developed to target recommendations addressed seven TDF domains (identified following qualitative clinician interviews (n = 20)) with 23 behaviour change techniques chosen to address these domains. Final interventions included: (1) Local stakeholder meetings, (2) Identification of medical and nursing clinical leads, (3) Train-the-trainer workshop for all clinical leads, (4) Local educational materials for delivery by clinical leads, (5) Provision of tools and materials targeting influencing factors, and prompting recommended behaviours, and (6) Audit and feedback. CONCLUSION: A stepped approach based on theory, evidence and issues of feasibility, local relevance and acceptability, was successfully used to develop interventions to improve management of infants with bronchiolitis. The rationale and content of interventions has been explicitly described allowing others to de-implement unnecessary bronchiolitis management, thereby improving care.

Effectiveness of Targeted Interventions on Treatment of Infants With Bronchiolitis: A Randomized Clinical Trial.

Importance: In developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care. Objective: To determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis. Design, Setting, and Participants: This international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020. Interventions: Interventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback. Main Outcomes and Measures: The primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions. Results: A total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Maori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001). Conclusions and Relevance: Targeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415.

Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children.

OBJECTIVE: Children frequently present with head injuries to acute care settings. Although international paediatric clinical practice guidelines for head injuries exist, they do not address all considerations related to triage, imaging, observation versus admission, transfer, discharge and follow-up of mild to moderate head injuries relevant to the Australian and New Zealand context. The Paediatric Research in Emergency Departments International Collaborative (PREDICT) set out to develop an evidence-based, locally applicable, practical clinical guideline for the care of children with mild to moderate head injuries presenting to acute care settings. METHODS: A multidisciplinary Guideline Working Group (GWG) developed 33 questions in three key areas - triage, imaging and discharge of children with mild to moderate head injuries presenting to acute care settings. We identified existing high-quality guidelines and from these guidelines recommendations were mapped to clinical questions. Updated literature searches were undertaken, and key new evidence identified. Recommendations were created through either adoption, adaptation or development of de novo recommendations. The guideline was revised after a period of public consultation. RESULTS: The GWG developed 71 recommendations (evidence-informed = 35, consensus-based = 17, practice points = 19), relevant to the Australian and New Zealand setting. The guideline is presented as three documents: (i) a detailed Full Guideline summarising the evidence underlying each recommendation; (ii) a Guideline Summary; and (iii) a clinical Algorithm: Imaging and Observation Decision-making for Children with Head Injuries. CONCLUSIONS: The PREDICT Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children provides high-level evidence and practical guidance for front line clinicians.

Review article: Developing the Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children: An adoption/adaption approach.

The Paediatric Research in Emergency Departments International Collaborative (PREDICT) released the Australian and New Zealand Guideline for Mild to Moderate Head Injuries in Children in 2021. We describe innovative and practical methods used to develop this guideline. Informed by GRADE-ADOLOPMENT and ADAPTE frameworks, we adopted or adapted recommendations from multiple high-quality guidelines or developed de novo recommendations. A Guideline Steering Committee and a multidisciplinary Guideline Working Group of 25 key stakeholder representatives formulated the guideline scope and developed 33 clinical questions. We identified four relevant high-quality source guidelines; their recommendations were mapped to clinical questions. The choice of guideline recommendation, if more than one guideline addressed a question, was based on its appropriateness, currency of the literature, access to evidence, and relevance. Updated literature searches identified 440 new studies and key new evidence identified. The decision to develop adopted, adapted or de novo recommendations was based on the supporting evidence-base and its transferability to the local setting. The guideline underwent a 12-week consultation period. The final guideline consisted of 35 evidence-informed and 17 consensus-based recommendations and 19 practice points. An algorithm to inform imaging and observation decision-making was also developed. The resulting process was an efficient and rigorous way to develop a guideline based on existing high-quality guidelines from different settings.

Factors predictive for computed tomography use and abnormality in paediatric head injuries in Australia and New Zealand.

OBJECTIVES: To investigate patient-level factors predictive for computed tomography of the brain (CTB) use and abnormality in head injured children in Australia and New Zealand. METHODS: Retrospective data from tertiary, urban/suburban and regional/rural EDs including factors predictive for CTB use and abnormality. RESULTS: Of 3072 children at 31 EDs, 212 (6.9%) had a CTB scan, of which 66 (31%) were abnormal. Increasing age, serious mechanisms of injury and decreasing Glasgow Coma Score were predictive for ordering CTB. Decreasing age was predictive for CTB abnormalities. Other factors were not. CONCLUSION: Patient-level drivers of CTB use in children in Australia and New Zealand are consistent with international data.

Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review.

Guidelines aim to improve the quality of medical care and reduce treatment variation. The extent to which guidelines are adhered to in the field of traumatic brain injury (TBI) is unknown. The objectives of this systematic review were to (1) quantify adherence to guidelines in adult patients with TBI, (2) examine factors influencing adherence, and (3) study associations of adherence to clinical guidelines and outcome. We searched EMBASE, MEDLINE, Cochrane Central, PubMed, Web of Science, PsycINFO, SCOPUS, CINAHL, and grey literature in October 2014. We included studies of evidence-based (inter)national guidelines that examined the acute treatment of adult patients with TBI. Methodological quality was assessed using the Research Triangle Institute item bank and Quality in Prognostic Studies Risk of Bias Assessment Instrument. Twenty-two retrospective and prospective observational cohort studies, reported in 25 publications, were included, describing adherence to 13 guideline recommendations. Guideline adherence varied considerably between studies (range 18-100%) and was higher in guideline recommendations based on strong evidence compared with those based on lower evidence, and lower in recommendations of relatively more invasive procedures such as craniotomy. A number of patient-related factors, including age, Glasgow Coma Scale, and intracranial pathology, were associated with greater guideline adherence. Guideline adherence to Brain Trauma Foundation guidelines seemed to be associated with lower mortality. Guideline adherence in TBI is suboptimal, and wide variation exists between studies. Guideline adherence may be improved through the development of strong evidence for guidelines. Further research specifying hospital and management characteristics that explain variation in guideline adherence is warranted.