The impact of elder abuse training on subacute health providers and older adults: study protocol for a randomized control trial.

BACKGROUND: Elder abuse often goes unreported and undetected. Older people may be ashamed, fearful, or otherwise reticent to disclose abuse, and many health providers are not confident in asking about it. In the No More Shame study, we will evaluate a co-designed, multi-component intervention that aims to improve health providers' recognition, response, and referral of elder abuse. METHODS: This is a single-blinded, pragmatic, cluster randomised controlled trial. Ten subacute hospital sites (i.e. clusters) across Australia will be allocated 1:1, stratified by state to a multi-component intervention comprising a training programme for health providers, implementation of a screening tool and use of site champions, or no additional training or support. Outcomes will be collected at baseline, 4 and 9 months. Our co-primary outcomes are change in health providers' knowledge of responding to elder abuse and older people's sense of safety and quality of life. We will include all inpatients at participating sites, aged 65 + (or aged 50 + if Aboriginal or Torres Strait Islander), who are able to provide informed consent and all unit staff who provide direct care to older people; a sample size of at least 92 health providers and 612 older people will provide sufficient power for primary analyses. DISCUSSION: This will be one of the first trials in the world to evaluate a multi-component elder abuse intervention. If successful, it will provide the most robust evidence base to date for health providers to draw on to create a safe environment for reporting, response, and referral. TRIAL REGISTRATION: ANZCTR, ACTRN12623000676617p . Registered 22 June 2023.

Assessing the fidelity of a behavioural intervention involving academic detailing in general practice: a sub-study of the 'Implementing work-related Mental health guidelines in general PRacticE' (IMPRovE) trial.

BACKGROUND: Assessing the fidelity of intervention components enables researchers to make informed judgements about the influence of those components on the observed outcome. The 'Implementing work-related Mental health guidelines in general PRacticE' (IMPRovE) trial is a hybrid III trial aiming to increase adherence to the 'Clinical Guidelines for the diagnosis and management of work-related mental health conditions in general practice'. IMPRovE is a multifaceted intervention, with one of the central components being academic detailing (AD). This study describes the fidelity to the protocol for the AD component of the IMPRovE intervention. METHOD: All AD sessions for the trial were audio-recorded and a sample of 22% were randomly selected for fidelity assessment. Fidelity was assessed using a tailored proforma based on the Modified Conceptual Framework for fidelity assessment, measuring duration, coverage, frequency and content. A descriptive analysis was used to quantify fidelity to the protocol and a content analysis was used to elucidate qualitative aspects of fidelity. RESULTS: A total of eight AD sessions were included in the fidelity assessment. The average fidelity score was 89.2%, ranging from 80 to 100% across the eight sessions. The sessions were on average 47 min long and addressed all of the ten chapters in the guideline. Of the guideline chapters, 9 were frequently discussed. The least frequently discussed chapter related to management of comorbid conditions. Most general practitioner (GP) participants used the AD sessions to discuss challenges with managing secondary mental conditions. In line with the protocol, opinion leaders who delivered the AD sessions largely offered evidence-based strategies aligning with the clinical guideline recommendations. CONCLUSIONS/IMPLICATIONS: The IMPRovE AD intervention component was delivered to high fidelity. The sessions adhered to the intended duration, coverage, frequency, and content allowing participating GPs to comprehend the implementation of the guideline in their own practice. This study also demonstrates that the Modified Conceptual Fidelity Framework with a mixed methods approach can support the assessment of implementation fidelity of a behavioural intervention in general practice. The findings enhance the trustworthiness of reported outcomes from IMPRovE and show that assessing fidelity is amenable for AD and should be incorporated in other studies using AD. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN 12620001163998, November 2020.

FEEDBACK trial - A randomised control trial to investigate the effect of personalised feedback and financial incentives on reducing the incidence of road crashes.

BACKGROUND: Road crashes continue to pose a significant threat to global health. Young drivers aged between 18 and 25 are over-represented in road injury and fatality statistics, especially the first six months after obtaining their license. This study is the first multi-centre two-arm parallel-group individually randomised controlled trial (the FEEDBACK Trial) that will examine whether the delivery of personalised driver feedback plus financial incentives is superior to no feedback and no financial incentives in reducing motor vehicle crashes among young drivers (18 to 20 years) during the first year of provisional licensing. METHODS: A total of 3,610 young drivers on their provisional licence (P1, the first-year provisional licensing) will participate in the trial over 28 weeks, including a 4-week baseline, 20-week intervention and 4-week post-intervention period. The primary outcome of the study will be police-reported crashes over the 20-week intervention period and the 4-week post-intervention period. Secondary outcomes include driving behaviours such as speeding and harsh braking that contribute to road crashes, which will be attained weekly from mobile telematics delivered to a smartphone app. DISCUSSION: Assuming a positive finding associated with personalised driver feedback and financial incentives in reducing road crashes among young drivers, the study will provide important evidence to support policymakers in introducing the intervention(s) as a key strategy to mitigate the risks associated with the burden of road injury among this vulnerable population. TRIAL REGISTRATION: Registered under the Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12623000387628p on April 17, 2023.

Improving the lives of ethnically diverse family carers and people living with dementia using digital media resources - Protocol for the Draw-Care randomised controlled trial.

Objectives: Ethnically diverse family carers of people living with dementia (hereafter carers and people with dementia) experience more psychological distress than other carers. To reduce this inequality, culturally adapted, multilingual, evidence-based practical assistance is needed. This paper details the Draw-Care study protocol including a randomised control trial (RCT) to test the effectiveness of a digital intervention comprising a multilingual website, virtual assistant, animated films, and information, on the lives of carers and people with dementia in Australia. Methods: The Draw-Care intervention will be evaluated in a 12-week active waitlist parallel design RCT with 194 carers from Arabic, Cantonese, Greek, Hindi, Italian, Mandarin, Spanish, Tamil, and Vietnamese-speaking language groups. Our intervention was based on the World Health Organization's (WHO) iSupport Lite online carer support messages and was co-designed with carers, people with dementia, service providers, and clinicians. Culturally adapted multilingual digital resources were created in nine languages and English. Results: In Phase I (2022), six co-design workshops with stakeholders and interviews with people with dementia informed the development of the intervention which will be trialled and evaluated in Phases II and III (2023 and 2024). Conclusions: Digital media content is a novel approach to providing cost-effective access to health care information. This study protocol details the three study phases including the RCT of a co-designed, culturally adapted, multilingual, digital intervention for carers and people with dementia to advance the evidence in dementia and digital healthcare research and help meet the needs of carers and people with dementia in Australia and globally.

'It's Too nice': Adapting iSupport Lite for Ethnically Diverse Family Carers of a Person with Dementia.

OBJECTIVES: Resources to support dementia carers from ethnically diverse families are limited. We explored carers' and service providers' views on adapting the World Health Organization's iSupport Lite messages to meet their needs. METHODS: Six online workshops were conducted with ethnically diverse family carers and service providers (n = 21) from nine linguistic groups across Australia. Recruitment was via convenience and snowball sampling from existing networks. Data were analyzed using thematic analysis. RESULTS: Participants reported that iSupport Lite over-emphasized support from family and friends and made help-seeking sound "too easy". They wanted messages to dispel notions of carers as "superheroes", demonstrate that caring and help-seeking is stressful and time-consuming, and that poor decision-making and relationship breakdown does occur. Feedback was incorporated to co-produce a revised suite of resources. CONCLUSIONS: Beyond language translation, cultural adaptation using co-design provided participants the opportunity to develop more culturally relevant care resources that meet their needs. These resources will be evaluated for clinical and cost-effectiveness in future research. CLINICAL IMPLICATIONS: By design, multilingual resources for carers must incorporate cultural needs to communicate support messages. If this intervention is effective, it could help to reduce dementia care disparities in ethnically diverse populations in Australia and globally.

Donor versus recipient preferences for aid allocation: A systematic review of stated-preference studies.

As Official Development Assistance (ODA) tops 180 billion USD per year, there is a need to understand the mechanisms underlying aid effectiveness. Over the past decade we have seen some low- and middle-income countries become developed nations with record economic growth. Others remain in development purgatory, unable to provide their citizens with access to essential services. In an effort to improve aid effectiveness, the prescriptive nature of aid, where (typically) Western countries allocate funds based on perceived need or the strategic priorities of donors is being reconsidered in favour of locally-led development, whereby recipient governments and sometimes citizens are involved in the allocation and delivery of development aid. Meeting the preferences of donors (both governments and citizens) has been a longstanding priority for international development organisations and democratically governed societies. Understanding how these donor preferences relate to recipient preferences is a more recent consideration. This systematic review analysed 58 stated preference studies to summarise the evidence around donor and recipient preferences for aid and, to the extent possible, draw conclusions on where donor and recipient preferences diverge. While the different approaches, methods, and attributes specified by included studies led to difficulties drawing comparisons, we found that donors had a stronger preference than recipients for aid to the health sector, and that aid effectiveness could be more important to donors than recipients when deciding how to allocate aid. Importantly, our review identifies a paucity of literature assessing recipient perspectives for aid using stated preference methods. The dearth of studies conducted from the recipient perspective is perplexing after more than 30 years of 'alignment with recipient preferences', 'local ownership of aid', 'locally-led development' and 'decolonisation of aid'. Our work points to a need for further research describing preferences for aid across a consistent set of attributes in both donor and recipient populations.

The Cost-Effectiveness of Adjunctive Lifestyle Interventions for the Management of Cancer: A Systematic Review.

OBJECTIVE: There is a paucity of papers synthesizing the cost-effectiveness (CE) of lifestyle interventions to support cancer patients, and the synthesis papers available have used analytic methods that do not permit easy comparison between studies. We therefore evaluated the CE of adjunctive lifestyle interventions compared with usual care. METHODS: A systematic literature search of Scopus, MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library databases was conducted from database inception until June 2021. Eligible studies were economic evaluations from randomised controlled trials or modelled economic evaluations that recruited subjects with a confirmed diagnosis of cancer and were allocated to a lifestyle intervention as an adjunct or supportive treatment, or usual care. Studies were excluded if there was no cost-effectiveness analysis or if costs were identified but not related back to measures of effectiveness. CE of the included interventions was recalculated, adjusting for key differences (with respect to absolute resource costs and timing) between the broad range of study settings and a common 'target' setting. All CE data were converted into incremental net monetary benefit using a common cost-effectiveness threshold to facilitate comparison. The quality of the studies was evaluated for risk of bias using the ECOBIAS check list. RESULTS: Nine studies were included in our review. Seven studies investigated the benefits of physical exercise in combination with cancer treatment and two studies investigated the combination of exercise and psychosocial counselling alongside cancer treatment. Six studies with an exercise intervention reported larger quality-adjusted life year (QALY) gains compared with usual care and when cost per QALY gained was considered, three of the interventions were cost effective. One of the two interventions combining exercise with psychosocial counselling was cost effective. All studies were considered of good quality but all had some limitations. CONCLUSIONS: The evidence to support the cost effectiveness of lifestyle interventions in patients with cancer is mixed with four of the nine interventions found to be cost effective and two remaining cost effective when uncertainty was taken into account. Sensitivity analysis showed the influence of the CE threshold on the results, highlighting the importance of selecting a CE threshold that is appropriate to the setting. SYSTEMATIC REVIEW REGISTRATION: PROSPERO Registration Number: CRD42020185376.

The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and design of a randomized, controlled trial of cognitive behavioral and bright light therapy for insomnia and fatigue in women with breast cancer receiving chemotherapy.

BACKGROUND: Insomnia and fatigue symptoms are common in breast cancer. Active cancer treatment, such as chemotherapy, appears to be particularly disruptive to sleep. Yet, sleep complaints often go unrecognised and under treated within routine cancer care. The abbreviated delivery of cognitive behavioral therapy for Insomnia (CBTI) and bright light therapy (BLT) may offer accessible and cost-effective sleep treatments in women receiving chemotherapy for breast cancer. METHODS: The Sleep, Cancer and Rest (SleepCaRe) Trial is a 6-month multicentre, randomized, controlled, 2 × 2 factorial, superiority, parallel group trial. Women receiving cytotoxic chemotherapy for breast cancer at tertiary Australian hospitals will be randomly assigned 1:1:1:1 to one of four, non-pharmacological sleep interventions: (a) Sleep Hygiene and Education (SHE); (b) CBTI; (c) BLT; (d) CBT-I + BLT combined and simultaneously delivered. Each sleep intervention is delivered over 6 weeks, and will comprise an introductory session, a mid-point phone call, and regular emails. The primary (insomnia, fatigue) and secondary (health-related quality of life, rest activity rhythms, sleep-related impairment) outcomes will be assessed via online questionnaires at five time-points: baseline (t0, prior to intervention), mid-point intervention (t2, Week 4), post-intervention (t3, Week 7), 3-months (t4, Week 18), and 6-months follow-up (t5, Week 30). CONCLUSIONS: This study will report novel data concerning the comparative and combined efficacy of CBT-I and BLT during chemotherapy. Findings will contribute to the development of evidence-based early sleep and fatigue intervention during chemotherapy for breast cancer. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.

The Digital Brain Bank, an open access platform for post-mortem imaging datasets.

Post-mortem magnetic resonance imaging (MRI) provides the opportunity to acquire high-resolution datasets to investigate neuroanatomy and validate the origins of image contrast through microscopy comparisons. We introduce the Digital Brain Bank (open.win.ox.ac.uk/DigitalBrainBank), a data release platform providing open access to curated, multimodal post-mortem neuroimaging datasets. Datasets span three themes-Digital Neuroanatomist: datasets for detailed neuroanatomical investigations; Digital Brain Zoo: datasets for comparative neuroanatomy; and Digital Pathologist: datasets for neuropathology investigations. The first Digital Brain Bank data release includes 21 distinctive whole-brain diffusion MRI datasets for structural connectivity investigations, alongside microscopy and complementary MRI modalities. This includes one of the highest-resolution whole-brain human diffusion MRI datasets ever acquired, whole-brain diffusion MRI in fourteen nonhuman primate species, and one of the largest post-mortem whole-brain cohort imaging studies in neurodegeneration. The Digital Brain Bank is the culmination of our lab's investment into post-mortem MRI methodology and MRI-microscopy analysis techniques. This manuscript provides a detailed overview of our work with post-mortem imaging to date, including the development of diffusion MRI methods to image large post-mortem samples, including whole, human brains. Taken together, the Digital Brain Bank provides cross-scale, cross-species datasets facilitating the incorporation of post-mortem data into neuroimaging studies.

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.

Implementing work-related Mental health guidelines in general PRacticE (IMPRovE): a protocol for a hybrid III parallel cluster randomised controlled trial.

BACKGROUND: The Clinical Guideline for the Diagnosis and Management of Work-related Mental Health Conditions in General Practice (the Guideline) was published in 2019. The objective of this trial is to implement the Guideline in general practice. TRIAL DESIGN: Implementing work-related Mental health conditions in general PRacticE is a hybrid III, parallel cluster randomised controlled trial undertaken in Australia. Its primary aim is to assess the effectiveness of a complex intervention on the implementation of the Guideline in general practice. Secondary aims are to assess patient health and work outcomes, to evaluate the cost-effectiveness of the trial, and to develop a plan for sustainability. METHODS: A total of 86 GP clusters will be randomly allocated either to the intervention arm, where they will receive a complex intervention comprising academic detailing, enrolment in a community of practice and resources, or to the control arm, where they will not receive the intervention. GP guideline concordance will be assessed at baseline and 9 months using virtual simulated patient scenarios. Patients who meet the eligibility criteria (>18years, employed, and receiving care from a participating GP for a suspected or confirmed work-related mental health condition) will be invited to complete surveys about their health and work participation and provide access to their health service use data. Data on health service use and work participation compensation claim data will be combined with measures of guideline concordance and patient outcomes to inform an economic evaluation. A realist evaluation will be conducted to inform the development of a plan for sustainability. RESULTS: We anticipate that GPs who receive the intervention will have higher guideline concordance than GPs in the control group. We also anticipate that higher concordance will translate to better health and return-to-work outcomes for patients, as well as cost-savings to society. CONCLUSIONS: The trial builds on a body of work defining the role of GPs in compensable injury, exploring their concerns, and developing evidence-based guidelines to address them. Implementation of these guidelines has the potential to deliver improvements in GP care, patient health, and return-to-work outcomes. TRIAL REGISTRATION: ACTRN12620001163998 , November 2020.

The effect of telematic based feedback and financial incentives on driving behaviour: A randomised trial.

AIM: In-vehicle telematics monitoring systems that provide driver feedback have been identified as a promising intervention to influence driver behaviours and reduce the growing burden of road injury. The current study was undertaken to assess the effect of driver feedback alone and feedback plus financial incentives on driving behaviours (speeding, hard acceleration and hard braking). METHOD: A pragmatic randomised trial was undertaken over a 28-week observational period. Drivers were recruited and randomly allocated to one of three groups namely, driver feedback, driver feedback plus incentives and a control group. The feedback group received a weekly summary of their driving performance via SMS text message and access to more detailed feedback via an online dashboard or smartphone application. The feedback plus financial incentive group received the feedback but lost financial incentives for risky driving behaviour above a threshold. RESULTS: A total of 174 drivers completed at least one driving trip during the study period; 18,082 trip days completed by these 174 drivers during the study period provided the sample for analysis. For the primary outcomes of probability of speeding, hard acceleration and hard braking on any given trip, neither feedback alone nor feedback plus incentives delivered statistically significant improvements in driving behaviour relative to the controls. Treatment effects for feedback plus incentives were, however, consistently in the expected direction and large enough to warrant further investigation. For the secondary composite measure of risky driving, namely the DriveScore™, a statistically significant improvement was observed for the feedback and incentive group compared to the control group (TE = 2.6 points on a 0-100 scale, p < 0.05). DISCUSSION: This study adds to our understanding of the potential effects of feedback and financial incentives. Findings suggest that, while feedback alone may be insufficient to motivate behaviour change, combining feedback with financial incentives can deliver potentially important and statistically significant reductions in risky driving behaviours.

Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial.

BACKGROUND: Agitation is common in the early stages of recovery from traumatic brain injury (TBI), when patients are in post-traumatic amnesia (PTA). Agitation is associated with risk of harm to patients and caregivers. Recent guidelines recommend that agitation during PTA is managed using environmental modifications. Agitation is also frequently treated pharmacologically, with the use of atypical antipsychotics such as olanzapine among the most common. This is despite a lack of well-designed studies to support the use of antipsychotics within this context. This study will be a double-blind, placebo-controlled randomised controlled trial. We will examine the efficacy, safety, cost-effectiveness and outcomes associated with the use of olanzapine for reducing agitation in patients in PTA following TBI over and above recommended environmental management. METHODS: Fifty-eight TBI rehabilitation inpatients who are in PTA and are agitated will receive olanzapine or placebo for the duration of PTA. All participants will additionally receive optimal environmental management for agitation. Measures of agitation, PTA and health will be undertaken at baseline. Treatment administration will begin at a dose of 5 mg daily and may be escalated to a maximum dose of 20 mg per day. Throughout the treatment period, agitation and PTA will be measured daily, and adverse events monitored weekly. Efficacy will be assessed by treatment group comparison of average Agitated Behaviour Scale scores during PTA. Participants will cease treatment upon emergence from PTA. Agitation levels will continue to be monitored for a further 2 weeks, post-treatment measures of health will be undertaken and cognitive and functional status will be assessed. Level of agitation and functional health will be assessed at hospital discharge. At 3 months post-discharge, functional outcomes and health service utilisation will be measured. DISCUSSION: This trial will provide crucial evidence to inform the management of agitation in patients in PTA following TBI. It will provide guidance as to whether olanzapine reduces agitation over and above recommended environmental management or conversely whether it increases or prolongs agitation and PTA, increases length of inpatient hospitalisation and impacts longer term cognitive and functional outcomes. It will also speak to the safety and cost-effectiveness of olanzapine use in this population. TRIAL REGISTRATION: ANZCTR ACTRN12619000284167 . Registered on 25 February 2019.

A systematic review and network meta-analysis of incentive- and non-incentive-based interventions for increasing blood donations.

BACKGROUND AND OBJECTIVES: Blood services are tasked with efficiently maintaining a reliable blood supply, and there has been much debate over the use of incentives to motivate prosocial activities. Thus, it is important to understand the relative effectiveness of interventions for increasing donations. MATERIALS AND METHODS: This systematic review used a broad search strategy to identify randomized controlled trials comparing interventions for increasing blood donations. After full-text review, 28 trials from 25 published articles were included. Sufficient data for meta-analysis were available from 27 trials. Monetary incentives were assumed to be equivalent regardless of value, and non-monetary incentives were assumed to be equivalent regardless of type. Non-incentive-based interventions identified included existing practice, letters, telephone calls, questionnaires, and the combination of a letter & telephone call. A network meta-analysis was used to pool the results from identified trials. A subgroup analysis was performed in populations of donors and non-donors as sensitivity analyses. RESULTS: The best performing interventions were letter & telephone call and telephone call-only with odds ratios of 3·08 (95% CI: 1·99, 4·75) and 1·99 (95% CI: 1·47, 2·69) compared to existing practice, respectively. With considerable uncertainty around the pooled effect, we found no evidence that monetary incentives were effective at increasing donations compared to existing practice. Non-monetary incentives were only effective in the donor subgroup. CONCLUSION: When pooling across modes of interventions, letter & telephone call and telephone call-only are effective at increasing blood donations. The effectiveness of incentives remains unclear with limited, disparate evidence identified.

Mapping the Functional Independence Measure to a multi-attribute utility instrument for economic evaluations in rehabilitation: a secondary analysis of randomized controlled trial data.

Purpose: To test whether the Functional Independence Measure (FIM) could be mapped to the EQ-5D-3L to give researchers a viable but "second-best" option for calculating quality-adjusted life-years (QALYs) and conducting a cost-utility analysis when only clinical outcomes have been collected.Materials and methods: Secondary analysis of repeated measures data collected during a randomized controlled trial (n = 3506 observations) at two inpatient rehabilitation centres. Participants had a mean age of 74 (SD 13) years, 63% were women and 58% were admitted with an orthopaedic diagnosis. Ordinary least-squares regression and adjusted limited dependent variable mixture models were used to estimate regression-based mappings. Performance was evaluated based on mean absolute error and the proportion of errors in excess of the minimally important difference.Results: In orthopaedic and neurological patients, high mean absolute errors (0.2 on the quality-adjusted life years scale) and a high proportion of errors (60%) in excess of the minimally important difference suggest that predicted EQ-5D-3L values provided a poor substitute for observed EQ-5D-3L values.Conclusions: Regression-based mappings from the FIM to the EQ-5D-3L are error-prone and unsuitable for calculating QALYs in rehabilitation patients. Researchers and rehabilitation professionals should therefore include a multi-attribute utility instrument such as the EQ-5D as well as the FIM to evaluate the effect of rehabilitation interventions and in rehabilitation registries. This will provide additional information on health-related quality of life and support cost-utility analyses.Implications for rehabilitationThe Functional Independence Measure (FIM) cannot be used to calculate quality-adjusted life-years (QALYs) for cost-utility analyses.Predicting QALYs from FIM data is a poor substitute for direct measurement of QALYs in orthopaedic or neurological rehabilitation populations.Multi-attribute utility instruments (MAUIs) allow direct measurement of QALYs, as well as providing a patient-reported measure of clinical quality and outcomes in rehabilitation.A MAUI should be included routinely in clinical practice by rehabilitation professionals as well as in rehabilitation trials and registries to track patient outcomes and improve clinical practice.

Co-creation of services to maintain independence and optimise well-being: Learnings from Australia's Older Women Living Alone (OWLA) project.

For many populations at risk of social isolation, including Older Women Living Alone (OWLA), existing services to maintain independence and optimise well-being are difficult to access, unsuitable or unavailable. Co-creation is a strategy to develop 'person-centred' services that meet the needs of individuals. We adapted an existing framework for co-creation and used participatory action research methods, supported by an evidence base comprising a systematic review, analysis of routinely collected data and interviews, to develop person-centred services for OWLA. This approach achieved co-creation through an iterative process of consultation and review, involving a series of facilitated discussions with women living alone and stakeholders. A total of 13 women living alone, aged ≥55 years, and 11 stakeholders representing service providers and advocacy groups, were recruited to participate in these discussions. Sessions with between three and five OWLA, were held across Melbourne. The information was compiled and presented to service stakeholders in a single facilitated forum, held in central Melbourne. Smaller facilitated sessions with OWLA followed, to review and discuss the collated service stakeholder input. The information from these OWLA sessions were again compiled and directed back to the service stakeholders for consideration and further discussion. The two groups came together for a final forum to prioritise the co-created ten services that they believed would be feasible and would address unmet need to support OWLA maintain independence. The process of co-creation was time-consuming and required considerable preparation to facilitate input from the target population. Small groups, gathering at convenient local locations, with transport support were essential in removing barriers to participation. However, co-creation was a viable method of eliciting the women's preferences and developing services more likely to meet their needs.

Using co-creation and multi-criteria decision analysis to close service gaps for underserved populations.

BACKGROUND: Navigating treatment pathways remains a challenge for populations with complex needs due to bottlenecks, service gaps and access barriers. The application of novel methods may be required to identify and remedy such problems. OBJECTIVE: To demonstrate a novel approach to identifying persistent service gaps, generating potential solutions and prioritizing action. DESIGN: Co-creation and multi-criteria decision analysis in the context of a larger, mixed methods study. SETTING AND PARTICIPANTS: Community-dwelling sample of older women living alone (OWLA), residing in Melbourne, Australia (n = 13-37). Convenience sample of (n = 11) representatives from providers and patient organizations. INTERVENTIONS: Novel interventions co-created to support health, well-being and independence for OWLA and bridge missing links in pathways to care. MAIN OUTCOME MEASURES: Performance criteria, criterion weights , performance ratings, summary scores and ranks reflecting the relative value of interventions to OWLA. RESULTS: The co-creation process generated a list of ten interventions. Both OWLA and stakeholders considered a broad range of criteria when evaluating the relative merits of these ten interventions and a "Do Nothing" alternative. Combining criterion weights with performance ratings yielded a consistent set of high priority interventions, with "Handy Help," "Volunteer Drivers" and "Exercise Buddies" most highly ranked by both OWLA and stakeholder samples. DISCUSSION AND CONCLUSIONS: The present study described and demonstrated the use of multi-criteria decision analysis to prioritize a set of novel interventions generated via a co-creation process. Application of this approach can add community voice to the policy debate and begin to bridge the gap in service provision for underserved populations.

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.

Economic Evaluation of Activities of Daily Living Retraining During Posttraumatic Amnesia for Inpatient Rehabilitation Following Severe Traumatic Brain Injury.

OBJECTIVE: To evaluate the cost-effectiveness of structured activities of daily living (ADL) retraining during posttraumatic amnesia (PTA) plus treatment as usual (TAU) vs TAU alone for inpatient rehabilitation following severe traumatic brain injury (TBI). DESIGN: Trial-based economic evaluation from a health-system perspective. SETTING: Inpatient rehabilitation center. PARTICIPANTS: Participants (N=104) admitted to rehabilitation and in PTA for >7 days following severe TBI. INTERVENTIONS: Structured ADL retraining during PTA plus TAU vs TAU alone. Structured ADL retraining was manualized to minimize the risk of agitation and maximize functional improvement, following principles of errorless and procedural learning and targeting individualized therapy goals. TAU included physiotherapy and/or speech therapy during PTA plus ADL retraining after PTA emergence. MAIN OUTCOME MEASURES: FIM total scores at baseline, PTA emergence, hospital discharge, or final follow-up (2mo postdischarge) where FIM total scores were calculated as the sum of 5 FIM motor self-care items and a FIM meal-preparation item. RESULTS: Structured ADL retraining during PTA significantly increased functional independence at PTA emergence (mean difference: 4.90, SE: 1.4, 95% confidence interval [CI]: 1.5, 8.3) and hospital discharge (mean difference: 5.22, SE: 1.4, 95% CI: 1.8, 8.7). Even in our most pessimistic scenario, structured ADL retraining was cost-saving as compared to TAU (mean: -$7762; 95% CI: -$8105, -$7419). Together, these results imply that structured ADL retraining dominates (less costly but no less effective) TAU when effectiveness is evaluated at PTA emergence and hospital discharge. CONCLUSIONS: Structured ADL retraining during PTA yields net cost-savings to the health system and offers a cost-effective means of increasing functional independence at PTA emergence and hospital discharge.

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

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