Barriers to and facilitators of living guidelines use in low-income and middle-income countries: a scoping review.

INTRODUCTION: Living guidelines provide reliable, ongoing evidence surveillance and regularly updated recommendations for healthcare decision-making. As a relatively new concept, most of the initial application of living approaches has been undertaken in high-income countries. However, in this scoping review, we looked at what is currently known about how living guidelines were developed, used and applied in low-income and middle-income countries. METHODS: Searches for published literature were conducted in Medline, Global Health, Cochrane Library and Embase. Grey literature was identified using Google Scholar and the WHO website. In addition, the reference lists of included studies were checked for missing studies. Studies were included if they described or reflected on the development, application or utility of living guideline approaches for low-income and middle-income countries. RESULTS: After a full-text review, 21 studies were included in the review, reporting on the development and application of living recommendations in low-income and middle-income countries. Most studies reported living guideline activities conducted by the WHO (15, 71.4%), followed by China (4, 19%), Chile (1, 4.8%) and Lebanon (1, 4.8%). All studies based on WHO reports relate to living COVID-19 management guidelines. CONCLUSIONS: Most of the studies in this review were WHO-reported studies focusing solely on COVID-19 disease treatment living guidelines. However, there was no clear explanation of how living guidelines were used nor information on the prospects for and obstacles to the implementation of living guidelines in low-income and middle-income countries.

Making the most of audit and feedback to improve diabetes care: a qualitative study of the perspectives of Australian Diabetes Centres.

BACKGROUND: Diabetes has high burden on the health system and the individual, and many people living with diabetes struggle to optimally manage their condition. In Australia, people living with diabetes attend a mixture of primary, secondary and tertiary care centres. Many of these Diabetes Centres participate in the Australian National Diabetes Audit (ANDA), a quality improvement (QI) activity that collects clinical information (audit) and feeds back collated information to participating sites (feedback). Despite receiving this feedback, many process and care outcomes for Diabetes Centres continue to show room for improvement. The purpose of this qualitative study was to inform improvement of the ANDA feedback, identify the needs of those receiving feedback and elicit the barriers to and enablers of optimal feedback use. METHODS: Semi-structured interviews were conducted with representatives of Australian Diabetes Centres, underpinned by the Consolidated Framework for Implementation Research (CFIR). De-identified transcripts were analysed thematically, underpinned by the domains and constructs of the CFIR. RESULTS: Representatives from 14 Diabetes centres participated in this study, including a diverse range of staff typical of the Diabetes Centres who take part in ANDA. In general, participants wanted a shorter report with a more engaging, simplified data visualisation style. Identified barriers to use of feedback were time or resource constraints, as well as access to knowledge about how to use the data provided to inform the development of QI activities. Enablers included leadership engagement, peer mentoring and support, and external policy and incentives. Potential cointerventions to support use include exemplars from clinical change champions and peer leaders, and educational resources to help facilitate change. CONCLUSIONS: This qualitative study supported our contention that the format of ANDA feedback presentation can be improved. Healthcare professionals suggested actionable changes to current feedback to optimise engagement and potential implementation of QI activities. These results will inform redesign of the ANDA feedback to consider the needs and preferences of end users and to provide feedback and other supportive cointerventions to improve care, and so health outcomes for people with diabetes. A subsequent cluster randomised trial will enable us to evaluate the impact of these changes.

Improving adherence to acute low back pain guideline recommendations with chiropractors and physiotherapists: the ALIGN cluster randomised controlled trial.

BACKGROUND: Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors' and physiotherapists' adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective. METHODS: Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months). RESULTS: A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74). CONCLUSIONS: Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009.

Prevalence of sleep-disordered breathing in people with tetraplegia-a systematic review and meta-analysis.

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVES: To determine the prevalence of sleep-disordered breathing (SDB) in people with tetraplegia and to identify the characteristics associated with SDB. METHODS: A systematic literature search using Medline, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and grey literature sources was conducted using a combination of spinal cord injury (SCI) and SDB related terms. Articles were restricted to publication dates between 1/1/2000 and 4/9/2020 and with objectively measured SDB with an overnight sleep study. The frequency of SDB stratified by the apnoea hypopnea index (AHI) was extracted and weighted averages, using a random effects model, were calculated with 95% confidence intervals. Sub-group analyses were performed where possible. RESULTS: Twelve articles were included in the review; of these nine were included in meta-analysis (combined sample = 630). Sample sizes and case detection methods varied. Reported SDB prevalence rates ranged from 46 to 97%. The prevalence of at least mild (AHI ≥ 5), moderate (AHI ≥ 15) and severe (AHI ≥ 30) SDB were 83% (95% CI = 73-91), 59% (46-71) and 36% (26-46), respectively. Sub-group analyses found that prevalence increased with age (p < 0.001). There were no statistically significant differences in SDB prevalence by sex (p = 0.06), complete/incomplete SCI (p = 0.06), body mass index (p = 0.07), acute/chronic SCI (p = 0.73) or high/low level of cervical SCI (p = 0.90). CONCLUSION: Our results confirm that SDB is highly prevalent in people with tetraplegia, and prevalence increases with age. The high prevalence suggests that routine screening and subsequent treatment should be considered in both acute and community care.

Barriers and enablers to the implementation of multidisciplinary team meetings: a qualitative study using the theoretical domains framework.

BACKGROUND: Evidence-based clinical practice guidelines recommend discussion by a multidisciplinary team (MDT) to review and plan the management of patients for a variety of cancers. However, not all patients diagnosed with cancer are presented at an MDT. OBJECTIVES: (1) To identify the factors (barriers and enablers) influencing presentation of all patients to, and the perceived value of, MDT meetings in the management of patients with pancreatic cancer and; (2) to identify potential interventions that could overcome modifiable barriers and enhance enablers using the theoretical domains framework (TDF). METHODS: Semistructured interviews were conducted with radiologists, surgeons, medical and radiation oncologists, gastroenterologists, palliative care specialists and nurse specialists based in New South Wales and Victoria, Australia. Interviews were conducted either in person or via videoconferencing. All interviews were recorded, transcribed verbatim, deidentified and data were thematically coded according to the 12 domains explored within the TDF. Common belief statements were generated to compare the variation between participant responses. RESULTS: In total, 29 specialists were interviewed over a 4-month period. Twenty-two themes and 40 belief statements relevant to all the TDF domains were generated. Key enablers influencing MDT practices included a strong organisational focus (social/professional role and identity), beliefs about the benefits of an MDT discussion (beliefs about consequences), the use of technology, for example, videoconferencing (environmental context and resources), the motivation to provide good quality care (motivation and goals) and collegiality (social influences). Barriers included: absence of palliative care representation (skills), the number of MDT meetings (environmental context and resources), the cumulative cost of staff time (beliefs about consequences), the lack of capacity to discuss all patients within the allotted time (beliefs about capabilities) and reduced confidence to participate in discussions (social influences). CONCLUSIONS: The internal and external organisational structures surrounding MDT meetings ideally need to be strengthened with the development of agreed evidence-based protocols and referral pathways, a focus on resource allocation and capabilities, and a culture that fosters widespread collaboration for all stages of pancreatic cancer.

Barriers and enablers to the implementation of protocol-based imaging in pancreatic cancer: A qualitative study using the theoretical domains framework.

BACKGROUND: Accurate pre-operative imaging plays a vital role in patient selection for surgery and in allocating stage-appropriate therapies to patients diagnosed with pancreatic cancer (PC). This study aims to: (1) understand the current diagnosis and staging practices for PC; and (2) explore the factors (barriers and enablers) that influence the use of a pancreatic protocol computed tomography (PPCT) or magnetic resonance imaging (MRI) to confirm diagnosis and/or accurately stage PC. METHODS: Semi-structured interviews were conducted with radiologists, surgeons, gastroenterologists, medical and radiation oncologists from the states of New South Wales (NSW) and Victoria, Australia. Interviews were conducted either in person or via video conferencing. All interviews were recorded, transcribed verbatim, de-identified and data were thematically coded according to the 12 domains explored within the Theoretical Domains Framework (TDF). Common belief statements were generated to compare the variation between participant responses. FINDINGS: In total, 21 clinicians (5 radiologists, 10 surgeons, 2 gastroenterologists, 4 medical and radiation oncologists) were interviewed over a four-month-period. Belief statements relevant to the TDF domains were generated. Across the 11 relevant domains, 20 themes and 30 specific beliefs were identified. All TDF domains, with the exception of social influences were identified by participants as relevant to protocol-based imaging using either a PPCT or MRI, with the domains of knowledge, skills and environmental context and resources being offered by most participants as being relevant in influencing their decisions. CONCLUSIONS: To maximise outcomes and personalise therapy it is imperative that diagnosis and staging investigations using the most appropriate imaging modalities are conducted in a timely, efficient and effective manner. The results provide an understanding of specialists' opinion and behaviour in relation to a PPCT or MRI and should be used to inform the design of future interventions to improve compliance with this practice.

Continuous Positive Airway Pressure Use for Obstructive Sleep Apnea in Acute, Traumatic Tetraplegia.

OBJECTIVE: To describe continuous positive airway pressure (CPAP) use for treatment of obstructive sleep apnea (OSA) in acute tetraplegia, including adherence rates and associated factors. DESIGN: Secondary analysis of CPAP data from a multinational randomized controlled trial. SETTING: Inpatient rehabilitation units of 11 spinal cord injury centers. PARTICIPANTS: People with acute, traumatic tetraplegia and OSA (N=79). INTERVENTIONS: Autotitrating CPAP for OSA for 3 months. MAIN OUTCOME MEASURES: Adherence measured as mean daily hours of use. Adherent (yes/no) was defined as an average of at least 4 hours a night throughout the study. Regression analyses determined associations between baseline factors and adherence. CPAP device pressure and leak data were analyzed descriptively. RESULTS: A total of 79 participants from 10 spinal units (91% men; mean age ± SD, 46±16; 78±64d postinjury) completed the study in the treatment arm and 33% were adherent. Mean daily CPAP use ± SD was 2.9±2.3 hours. Better adherence was associated with more severe OSA (P=.04) and greater CPAP use in the first week (P<.01). Average 95th percentile pressure was low (9.3±1.7 cmH2O) and 95th percentile leak was high (27.1±13.4 L/min). CONCLUSION: Adherence to CPAP after acute, traumatic tetraplegia is low. Early acceptance of therapy and more severe OSA predict CPAP use over 3 months. People with acute tetraplegia require less pressure to treat their OSA than the nondisabled; however, air leak is high. These findings highlight the need for further investigation of OSA treatment in acute tetraplegia.

Understanding the clinical management of obstructive sleep apnoea in tetraplegia: a qualitative study using the theoretical domains framework.

BACKGROUND: Clinical practice guidelines recommend further testing for people with tetraplegia and signs and symptoms of obstructive sleep apnoea (OSA), followed by treatment with positive airway pressure therapy. Little is known about how clinicians manage OSA in tetraplegia. The theoretical domains framework (TDF) is commonly used to identify determinants of clinical behaviours. This study aimed to describe OSA management practices in tetraplegia, and to explore factors influencing clinical practice. METHODS: Semi-structured interviews were conducted with 20 specialist doctors managing people with tetraplegia from spinal units in Europe, UK, Canada, USA, Australia and New Zealand. Interviews were audiotaped for verbatim transcription. OSA management was divided into screening, diagnosis and treatment components for inpatient and outpatient services, allowing common practices to be categorised. Data were thematically coded to the 12 constructs of the TDF. Common beliefs were identified and comparisons were made between participants reporting different practices. RESULTS: Routine screening for OSA signs and symptoms was reported by 10 (50%) doctors in inpatient settings and eight (40%) in outpatient clinics. Doctors commonly referred to sleep specialists for OSA diagnosis (9/20 in inpatients; 16/20 in outpatients), and treatment (12/20, 17/20). Three doctors reported their three spinal units were managing non-complicated OSA internally, without referral to sleep specialists. Ten belief statements representing six domains of the TDF were generated about screening. Lack of time and support staff (Environmental context and resources) and no prompts to screen for OSA (Memory, attention and decision processes) were commonly identified barriers to routine screening. Ten belief statements representing six TDF domains were generated for diagnosis and treatment behaviours. Common barriers to independent management practices were lack of skills (Skills), low confidence (Beliefs about capabilities), and the belief that OSA management was outside their scope of practice (Social/Professional role and identity). The three units independently managing OSA were well resourced with multidisciplinary involvement (Environmental context and resources), had 'clinical champions' to lead the program (Social influences). CONCLUSION: Clinical management of OSA in tetraplegia is highly varied. Several influences on OSA management within spinal units have been identified, facilitating the development of future interventions aiming to improve clinical practice.

Use of multi-attribute decision-making to inform prioritization of Cochrane review topics relevant to rehabilitation.

BACKGROUND: Limited resources imply the need for prioritization; this also applies to the conduct of Cochrane Reviews. Therefore, processes for identifying the most important topics for review should be determined. AIM: The aim of this study was to describe some examples of prioritization approaches used within Cochrane; to introduce the concept of multi-criteria decision analysis, provide an example of how this is being used to determine the relative importance of research questions in musculoskeletal health by the Australasian Musculoskeletal Clinical Trials (ANZMUSC) network and how a similar approach could be used to inform Cochrane Rehabilitation priorities. METHODS: A narrative overview of the Cochrane Methods Priority Setting Group and new guidance from Cochrane on priority setting; a description of the ANZMUSC prioritization project and the proposed outline of a prioritization process that could be undertaken by Review Groups related to rehabilitation. RESULTS: There are no explicit processes for prioritization for Cochrane Reviews that involve multi-criteria decision making, even though such approaches appear to be potentially useful and may overcome some disadvantages of alternative approaches. DISCUSSION: Although the ANZMUSC prioritization project is not yet complete nor shown to be successful, it may offer a useful road-map for developing a transparent method of prioritizing which research topics to pursue, in a way that could be easily implemented and updated.

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.

Worth the effort? Weighing up the benefit and burden of continuous positive airway pressure therapy for the treatment of obstructive sleep apnoea in chronic tetraplegia.

STUDY DESIGN: Mixed methods OBJECTIVES: Continuous positive airway pressure (CPAP) therapy is the recommended treatment for obstructive sleep apnoea (OSA). The aim of this study was to estimate CPAP adherence in people with tetraplegia and OSA, and to explore the barriers and facilitators to CPAP use. SETTING: Hospital outpatient department in Melbourne, Australia METHODS: People with chronic tetraplegia and OSA were commenced with auto-titrating CPAP and supported for 1 month. Semi-structured interviews were conducted with participants at one month and analysed thematically. CPAP usage was measured at 1, 6 and 12 months, with "adherent" defined as achieving more than 4 h average per night. RESULTS: Sixteen participants completed the study (80% male; mean age 56 (SD = 15)). Mean nightly CPAP use at one month was 3.1 h (SD = 2.5; 38% adherent), and at 6 months and 12 months were 2.6 h (SD = 2.8; 25% adherent) and 2.1 h (SD = 3.2; 25% adherent). The perceived benefit/burden balance strongly influenced ongoing use. Burden attributed to CPAP use was common, and included mask discomfort, and physical and emotional problems. Adherent participants were motivated by the immediate daytime benefits to mood, alertness and sleepiness. There was a tendency to not recognise symptoms of OSA until after they were treated. CONCLUSION: CPAP use is challenging for people with tetraplegia, who experience substantial burden from using the device. When tolerated, the proximate benefits are substantial. People with tetraplegia need more intensive support for longer to help them overcome the burdens of CPAP and benefit from the treatment.

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.

Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia.

BACKGROUND: Obstructive sleep apnoea (OSA) is highly prevalent in people with spinal cord injury (SCI). Polysomnography (PSG) is the gold-standard diagnostic test for OSA, however PSG is expensive and frequently inaccessible, especially in SCI. A two-stage model, incorporating a questionnaire followed by oximetry, has been found to accurately detect moderate to severe OSA (MS-OSA) in a non-disabled primary care population. This study investigated the accuracy of the two-stage model in chronic tetraplegia using both the original model and a modified version for tetraplegia. METHODS: An existing data set of 78 people with tetraplegia was used to modify the original two-stage model. Multivariable analysis identified significant risk factors for inclusion in a new tetraplegia-specific questionnaire. Receiver operating characteristic (ROC) curve analyses of the questionnaires and oximetry established thresholds for diagnosing MS-OSA. The accuracy of both models in diagnosing MS-OSA was prospectively evaluated in 100 participants with chronic tetraplegia across four international SCI units. RESULTS: Injury completeness, sleepiness, self-reported snoring and apnoeas were included in the modified questionnaire, which was highly predictive of MS-OSA (ROC area under the curve 0.87 (95% CI 0.79 to 0.95)). The 3% oxygen desaturation index was also highly predictive (0.93 (0.87-0.98)). The two-stage model with modified questionnaire had a sensitivity and specificity of 83% (66-93) and 88% (75-94) in the development group, and 77% (65-87) and 81% (68-90) in the validation group. Similar results were demonstrated with the original model. CONCLUSION: Implementation of this simple alternative to full PSG could substantially increase the detection of OSA in patients with tetraplegia and improve access to treatments. TRIAL REGISTRATION NUMBER: Results, ACTRN12615000896572 (The Australian and New Zealand Clinical Trials Registry) and pre-results, NCT02176928 (clinicaltrials.gov).

Development and validation of SEER (Seeking, Engaging with and Evaluating Research): a measure of policymakers' capacity to engage with and use research.

BACKGROUND: Capacity building strategies are widely used to increase the use of research in policy development. However, a lack of well-validated measures for policy contexts has hampered efforts to identify priorities for capacity building and to evaluate the impact of strategies. We aimed to address this gap by developing SEER (Seeking, Engaging with and Evaluating Research), a self-report measure of individual policymakers' capacity to engage with and use research. METHODS: We used the SPIRIT Action Framework to identify pertinent domains and guide development of items for measuring each domain. Scales covered (1) individual capacity to use research (confidence in using research, value placed on research, individual perceptions of the value their organisation places on research, supporting tools and systems), (2) actions taken to engage with research and researchers, and (3) use of research to inform policy (extent and type of research use). A sample of policymakers engaged in health policy development provided data to examine scale reliability (internal consistency, test-retest) and validity (relation to measures of similar concepts, relation to a measure of intention to use research, internal structure of the individual capacity scales). RESULTS: Response rates were 55% (150/272 people, 12 agencies) for the validity and internal consistency analyses, and 54% (57/105 people, 9 agencies) for test-retest reliability. The individual capacity scales demonstrated adequate internal consistency reliability (alpha coefficients > 0.7, all four scales) and test-retest reliability (intra-class correlation coefficients > 0.7 for three scales and 0.59 for fourth scale). Scores on individual capacity scales converged as predicted with measures of similar concepts (moderate correlations of > 0.4), and confirmatory factor analysis provided evidence that the scales measured related but distinct concepts. Items in each of these four scales related as predicted to concepts in the measurement model derived from the SPIRIT Action Framework. Evidence about the reliability and validity of the research engagement actions and research use scales was equivocal. CONCLUSIONS: Initial testing of SEER suggests that the four individual capacity scales may be used in policy settings to examine current capacity and identify areas for capacity building. The relation between capacity, research engagement actions and research use requires further investigation.

Investigation of bias in meta-analyses due to selective inclusion of trial effect estimates: empirical study.

OBJECTIVE: To explore whether systematic reviewers selectively include trial effect estimates in meta-analyses when multiple are available, and what impact this may have on meta-analytic effects. DESIGN: Cross-sectional study. DATA SOURCES: We randomly selected systematic reviews of interventions from 2 clinical specialties published between January 2010 and 2012. The first presented meta-analysis of a continuous outcome in each review was selected (index meta-analysis), and all trial effect estimates that were eligible for inclusion in the meta-analysis (eg, from multiple scales or time points) were extracted from trial reports. ANALYSIS: We calculated a statistic (the Potential Bias Index (PBI)) to quantify and test for evidence of selective inclusion. The PBI ranges from 0 to 1; values above or below 0.5 are suggestive of selective inclusion of effect estimates more or less favourable to the intervention, respectively. The impact of any potential selective inclusion was investigated by comparing the index meta-analytic standardised mean difference (SMD) to the median of a randomly constructed distribution of meta-analytic SMDs (representing the meta-analytic SMD expected when there is no selective inclusion). RESULTS: 31 reviews (250 trials) were included. The estimated PBI was 0.57 (95% CI 0.50 to 0.63), suggesting that trial effect estimates that were more favourable to the intervention were included in meta-analyses slightly more often than expected under a process consistent with random selection; however, the 95% CI included the null hypothesis of no selective inclusion. Any potential selective inclusion did not have an important impact on the meta-analytic effects. CONCLUSION: There was no clear evidence that selective inclusion of trial effect estimates occurred in this sample of meta-analyses. Further research on selective inclusion in other clinical specialties is needed. To enable readers to assess the risk of selective inclusion bias, we recommend that systematic reviewers report the methods used to select effect estimates to include in meta-analyses.

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.

Providing services for acute low-back pain: A survey of Australian physiotherapists.

OBJECTIVE: To determine whether physiotherapists avoid lumbar X-rays for acute non-specific low back pain and advise people to stay active. METHODS: We conducted a cross sectional survey of Australian physiotherapists. 880 physiotherapists were randomly sampled from Victoria (495), South Australia (158), and Western Australia (227). Physiotherapists were asked which investigations they would order and interventions they would provide for five acute low back pain (LBP) presentations described in vignettes. Four of the five vignettes represented people who would not require a plain lumbar X-ray and would benefit from advice to stay active; one described a patient with a suspected vertebral fracture and would require a plain X-ray. Participants selected from a list of response options or provided free text responses. RESULTS: Questionnaires were completed by 203 of 567 potentially eligible physiotherapists (response rate 36%). Across the four vignettes where an X-ray was not indicated, 75% (95%CI 71-78%) of physiotherapists reported they would practice concordant with the guidelines and not order an X-ray, and 62% (95%CI 57-66%) provided advice to stay active. CONCLUSIONS: Most physiotherapists report intended compliance with recommendations in Australian clinical practice guidelines (CPGs) regarding avoiding the use of X-rays and providing advice to stay active for people with simple acute low back pain, given a vignette based scenario. The majority of respondents reported that they would not advise bed rest. Possible opportunities to further enhance compliance need to be developed and tested to reinforce the role of CPGs in informing physiotherapy practice.

Evaluation of the fidelity of an interactive face-to-face educational intervention to improve general practitioner management of back pain.

OBJECTIVES: Implementation intervention effects can only be fully realised and understood if they are faithfully delivered. However the evaluation of implementation intervention fidelity is not commonly undertaken. The IMPLEMENT intervention was designed to improve the management of low back pain by general medical practitioners. It consisted of a two-session interactive workshop, including didactic presentations and small group discussions by trained facilitators. This study aimed to evaluate the fidelity of the IMPLEMENT intervention by assessing: (1) observed facilitator adherence to planned behaviour change techniques (BCTs); (2) comparison of observed and self-reported adherence to planned BCTs and (3) variation across different facilitators and different BCTs. DESIGN: The study compared planned and actual, and observed versus self-assessed delivery of BCTs during the IMPLEMENT workshops. METHOD: Workshop sessions were audiorecorded and transcribed verbatim. Observed adherence of facilitators to the planned intervention was assessed by analysing the workshop transcripts in terms of BCTs delivered. Self-reported adherence was measured using a checklist completed at the end of each workshop session and was compared with the 'gold standard' of observed adherence using sensitivity and specificity analyses. RESULTS: The overall observed adherence to planned BCTs was 79%, representing moderate-to-high intervention fidelity. There was no significant difference in adherence to BCTs between the facilitators. Sensitivity of self-reported adherence was 95% (95% CI 88 to 98) and specificity was 30% (95% CI 11 to 60). CONCLUSIONS: The findings suggest that the IMPLEMENT intervention was delivered with high levels of adherence to the planned intervention protocol. TRIAL REGISTRATION NUMBER: The IMPLEMENT trial was registered in the Australian New Zealand Clinical Trials Registry, ACTRN012606000098538 (http://www.anzctr.org.au/trial_view.aspx?ID=1162).

Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.

OBJECTIVES: To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain). STUDY DESIGN AND SETTING: We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported. RESULTS: We included 171 trials. Most trials measured pain (87%), function (72%), and range of movement (67%), whereas adverse events, global assessment of treatment success, strength, and health-related quality of life were measured in 18-27% of trials, and work disability and referral for surgery were measured in less than 5% of trials. Thirty-five different measurement instruments for pain and 29 for function were noted. Measurement of function increased markedly from 1973 to 2014. In rotator cuff disease trials, there was a more frequent measurement of pain and strength and a less frequent measurement of range of movement compared with adhesive capsulitis trials. CONCLUSIONS: There was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core domain and outcome measurement set for use in future shoulder pain trials.

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.