Dr Rebecca Hodder

Implementation science is the study of methods to promote the systematic uptake of evidence based interventions into practice and policy to improve health. Despite the need for high quality evidence from implementation research, randomised trials of implementation strategies often have serious limitations. These limitations include high risks of bias, limited use of theory, a lack of standard terminology to describe implementation strategies, narrowly focused implementation outcomes, and poor reporting. This paper aims to improve the evidence base in implementation science by providing guidance on the development, conduct, and reporting of randomised trials of implementation strategies. Established randomised trial methods from seminal texts and recent developments in implementation science were consolidated by an international group of researchers, health policy makers, and practitioners. This article provides guidance on the key components of randomised trials of implementation strategies, including articulation of trial aims, trial recruitment and retention strategies, randomised design selection, use of implementation science theory and frameworks, measures, sample size calculations, ethical review, and trial reporting. It also focuses on topics requiring special consideration or adaptation for implementation trials. We propose this guide as a resource for researchers, healthcare and public health policy makers or practitioners, research funders, and journal editors with the goal of advancing rigorous conduct and reporting of randomised trials of implementation strategies.

Background: To determine Australian primary school principals', teachers', and parents' attitudes to changing school uniform policies to allow students to wear sports uniforms every day and to assess associations between participant characteristics and their attitudes. A secondary aim was to identify principals' and teachers' perceived barriers to uniform changes. Methods: Cross-sectional surveys of principals, teachers, and parents of children in grades 2 to 3 (age 7-10 y) from 62 Australian primary schools (Oct 2017-Mar 2018) were undertaken. Mixed logistic regression analyses assessed the associations between participant characteristics and attitudes toward uniform changes. Results: In total, 73% of the principals (38/52) who responded reported that their school only allowed children to wear a sports uniform on sports days. Overall, 38% of the principals (18/47), 63% of the teachers (334/579), and 78% of the parents (965/1231) reported they would support a policy that allowed children to wear daily sports uniforms. The most commonly reported barrier was the perception that sports uniforms were not appropriate for formal occasions. Conclusions: Although the majority of the principals were not supportive of a change to a daily sports uniform, the majority of the teachers and parents were. Strategies to improve principal support may be required if broader adoption of physical activity-supporting uniforms is to be achieved.

There is a need for effective interventions that improve the health and wellbeing of school and childcare staff. This review examined the efficacy of workplace interventions to improve the dietary, physical activity and/or sleep behaviours of school and childcare staff. A secondary aim of the review was to assess changes in staff physical/mental health, productivity, and students¿ health behaviours. Nine databases were searched for controlled trials including randomised and non-randomised controlled trials and quasi-experimental trials published in English up to October 2019. PRISMA guidelines informed screening and study selection procedures. Data were not suitable for quantitative pooling. Of 12,396 records screened, seven articles (based on six studies) were included. Most studies used multi-component interventions including educational resources, work-based wellness committees and planned group practice (e.g., walking groups). Multiple outcomes were assessed, findings were mixed and on average, there was moderate risk of bias. Between-group differences in dietary and physical activity behaviours (i.e., fruit/vegetable intake, leisure-time physical activity) favoured intervention groups, but were statistically non-significant for most outcomes. Some of the studies also showed differences favouring controls (i.e., nutrient intake, fatty food consumption). Additional robust studies testing the efficacy of workplace interventions to improve the health of educational staff are needed.

Objective: To assess the effectiveness of weight-loss interventions on pain and disability in people with knee and hip osteoarthritis (OA) and spinal pain. Design: Intervention systematic review. Literature Search: Twelve online databases and clinical trial registries. Study Selection Criteria: Randomized controlled trials of any weight-loss intervention (eg, diet, physical activity, surgical, pharmaceutical) that reported pain or disability outcomes in people with knee or hip OA or spinal pain. Data Synthesis: We calculated mean differences or standardized mean differences (SMDs) and 95% confidence intervals (CIs). We used the Cochrane risk of bias tool to assess risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation tool to judge credibility of evidence. Results: Twenty-two trials with 3602 participants were included. There was very low- to very low-credibility evidence for a moderate effect of weight-loss interventions on pain intensity (10 trials, n = 1806; SMD, -0.54; 95% CI: -0.86, -0.22; I2 = 87%, P<.001) and a small effect on disability (11 trials, n = 1821; SMD, -0.32; 95% CI: -0.49, -0.14; I2 = 58%, P <.001) compared to minimal care for people with OA. For knee OA, there was low- to moderate-credibility evidence that weight-loss interventions were not more effective than exercise only for pain intensity and disability, respectively (4 trials, n = 673; SMD, -0.13; 95% CI: -0.40, 0.14; I2 = 55%; 5 trials, n = 737; SMD, -0.20; 95% CI: -0.41, 0.00; I2 = 32%). Conclusion: Weight-loss interventions may provide small to moderate improvements in pain and disability for OA compared to minimal care. There was limited and inconclusive evidence for weight-loss interventions targeting spinal pain.

Background: Economic evaluations which estimate cost-effectiveness of potential treatments can guide decisions about real-world healthcare services. We performed an economic evaluation of a healthy lifestyle intervention targeting weight loss, physical activity and diet for patients with chronic low back pain, who are overweight or obese. Methods: Eligible patients with chronic low back pain (n¿=¿160) were randomized to an intervention or usual care control group. The intervention included brief advice, a clinical consultation and referral to a 6-month telephone-based healthy lifestyle coaching service. The primary outcome was quality-adjusted life years (QALYs). Secondary outcomes were pain intensity, disability, weight and body mass index. Costs included intervention costs, healthcare utilization costs and work absenteeism costs. An economic analysis was performed from the societal perspective. Results: Mean total costs were lower in the intervention group than the control group (-$614; 95%CI: -3133 to 255). The intervention group had significantly lower healthcare costs (-$292; 95%CI: -872 to -33), medication costs (-$30; 95%CI: -65 to -4) and absenteeism costs (-$1,000; 95%CI: -3573 to -210). For all outcomes, the intervention was on average less expensive and more effective than usual care, and the probability of the intervention being cost-effective compared to usual care was relatively high (i.e., 0.81) at a willingness-to-pay of $0/unit of effect. However, the probability of cost-effectiveness was not as favourable among sensitivity analyses. Conclusions: The healthy lifestyle intervention seems to be cost-effective from the societal perspective. However, variability in the sensitivity analyses indicates caution is needed when interpreting these findings. Significance: This is an economic evaluation of a randomized controlled trial of a healthy lifestyle intervention for chronic low back pain. The findings suggest that a healthy lifestyle intervention may be cost-effective relative to usual care.

Purpose: To assess the causal mechanisms of a healthy lifestyle intervention for patients with chronic low back pain and knee osteoarthritis, who are overweight or obese. Methods: We conducted causal mediation analyses of aggregated data from two randomized controlled trials (RCTs); which included 160 patients with chronic low back pain, and 120 patients with knee osteoarthritis. The intervention consisted of brief advice and referral to a six-month telephone-based healthy lifestyle coaching service. We used causal mediation to estimate the indirect, direct and path-specific effects of hypothesized mediators including: self-reported weight, diet, physical activity, and pain beliefs. Outcomes were pain intensity, disability, and quality of life (QoL). Results: The intervention did not reduce weight, improve diet or physical activity or change pain beliefs, and these mediators were not associated with the outcomes. Sensitivity analyses showed that our estimates were robust to the possible effects of unknown and unmeasured confounding. Conclusions: Our findings show that the intervention did not cause a meaningful change in the hypothesized mediators, and these mediators were not associated with patient-reported outcomes.

Implementation of interventions in community organisations such as schools, childcare centres, and sporting clubs are recommended to target a range of modifiable risks of non-communicable diseases. Poor implementation, however, is common and has contributed to the failure of non-communicable disease interventions globally. This study aimed to characterise experimental research regarding strategies to improve implementation of chronic disease prevention programs in community settings. The review used data collected in three comprehensive systematic reviews undertaken between August 2015 and July 2017. Randomised controlled trials, including cluster design, and non-randomised trials with a parallel control group were included. The data were extracted to describe trial characteristics, implementation strategies employed, implementation outcomes and study quality. Of the 40 implementation trials included in the study, unhealthy diet was the most common risk factor targeted (n = 20). The most commonly reported implementation strategies were educational meetings (n = 38, 95%), educational materials (n = 36, 90%) and educational outreach visits (n = 29, 73%). Few trials were conducted ¿at-scale¿ (n = 8, 20%) or reported adverse effects (n = 5, 13%). The reporting of implementation related outcomes; intervention adoption (n = 13, 33%); appropriateness (n = 11, 28%); acceptability (n = 8, 20%); feasibility (n = 8, 20%); cost (n = 3, 8%); and sustainability (n = 2, 5%); was limited. For the majority of trials, risk of bias was high for blinding of study personnel/participants and outcome assessors. Testing of strategies to improve implementation of non-communicable disease prevention strategies in community settings, delivered ¿at-scale¿, utilising implementation frameworks, including a comprehensive range of implementation outcomes should be priority areas for future research in implementation science.

BACKGROUND: During adolescence, prevalence of pain and health risk factors such as smoking, alcohol use and poor mental health all rise sharply. The aim of this study was to describe the relationship between back pain and health risk factors in adolescents. METHODS: Cross-sectional data from the Healthy Schools Healthy Futures study, and the Australian Child Wellbeing Project was used, mean age: 14-15 years. Children were stratified according to back pain frequency. Within each strata, the proportion of children that reported drinking alcohol or smoking or that experienced feelings of anxiety or depression was reported. Test-for-trend analyses assessed whether increasing frequency of pain was associated with health risk factors. RESULTS: Data was collected from ~2500 and 3900 children. Larger proportions of children smoked or drank alcohol within each strata of increasing pain frequency. The trend with anxiety and depression was less clear, although there was a marked difference between the children that reported no pain, and pain more frequently. CONCLUSION: Two large, independent samples show adolescents that experience back pain more frequently are also more likely to smoke, drink alcohol and report feelings of anxiety and depression. Pain appears to be part of the picture of general health risk in adolescents.

Objective: Individual and environmental resilience protective factors are suggested to be associated with adolescent condom use; however, previous studies have not comprehensively examined such associations. This study aimed to determine the associations between condom use, and numerous individual and environmental resilience protective factors in sexually active Australian adolescents. Methods: Participants were Grade 10 students attending 28 Australian government high schools (n=1,688). An online survey (2011) collected data regarding: sexual intercourse (past year), condom use and 14 individual and environmental resilience protective factors. Multivariable backward stepwise logistic regression models examined associations between student condom use and protective factors (total, subscale). Results: Only total environmental protective factors remained in the final total score model; students with higher total environmental protective factors scores were 2.59 times more likely to always use a condom(95%CI:1.80-3.74). Only three of 14 protective factor subscales were associated with a higher likelihood of always using a condom in the final subscale model (individual: goals/aspirations; environmental: community participation, pro-social peers). Conclusions: Total environmental and three protective factor subscales demonstrated prominent associations with consistent use of condoms in sexually active adolescents. Implications for public health: Consideration of particular resilience protective factors in adolescent sexual risk behaviour prevention, such as condom use, is warranted.

Objective: To determine the effectiveness of telephone-based weight loss support in reducing the intensity of knee pain in patients with knee osteoarthritis, who are overweight or obese, compared to usual care. Design: We conducted a parallel randomised controlled trial (RCT), embedded within a cohort multiple RCT of patients on a waiting list for outpatient orthopaedic consultation at a tertiary referral hospital in NSW, Australia. Patients with knee osteoarthritis, classified as overweight or obese [body mass index (BMI) between =27 kg/m2 and <40 kg/m2] were randomly allocated to receive referral to an existing non-disease specific government funded 6-month telephone-based weight management and healthy lifestyle service or usual care. The primary outcome was knee pain intensity measured using an 11-point numerical rating scale (NRS) over 6-month follow-up. A number of secondary outcomes, including self-reported weight were measured. Data analysis was by intention-to-treat according to a pre-published analysis plan. Results: Between May 19 and June 30 2015, 120 patients were randomly assigned to the intervention (59 analysed, one post-randomisation exclusion) or usual care (60 analysed). We found no statistically significant between group differences in pain intensity [area under the curve (AUC), mean difference 5.4, 95%CI: -13.7 to 24.5, P = 0.58] or weight change at 6 months (self-reported; mean difference -0.4, 95%CI: -2.6 to 1.8, P = 0.74). Conclusions: Among patients with knee osteoarthritis who are overweight, telephone-based weight loss support, provided using an existing 6-month weight management and healthy lifestyle service did not reduce knee pain intensity or weight, compared with usual care. Trial registration number: ACTRN12615000490572

Worldwide, 10¿20% of adolescents experience mental health problems. Strategies aimed at strengthening resilience protective factors provide a potential approach for reducing mental health problems in adolescents. This study evaluated the effectiveness of a universal, school-based intervention targeting resilience protective factors in reducing mental health problems in adolescents. A cluster randomised controlled trial was conducted in 20 intervention and 12 control secondary schools located in socio-economically disadvantaged areas of NSW, Australia. Data were collected from 3115 students at baseline (Grade 7, 2011), of whom 2149 provided data at follow up (Grade 10, 2014; enrolments in Grades 7 to 10 typically aged 12¿16 years; 50% male; 69.0% retention). There were no significant differences between groups at follow-up for three mental health outcomes: total SDQ, internalising problems, and prosocial behaviour. A small statistically significant difference in favour of the control group was found for externalising problems. Findings highlight the continued difficulties in developing effective, school-based prevention programs for mental health problems in adolescents. Trial registration ANZCTR (Ref no: ACTRN12611000606987).

New approaches to evidence synthesis, which use human effort and machine automation in mutually reinforcing ways, can enhance the feasibility and sustainability of living systematic reviews. Human effort is a scarce and valuable resource, required when automation is impossible or undesirable, and includes contributions from online communities (¿crowds¿) as well as more conventional contributions from review authors and information specialists. Automation can assist with some systematic review tasks, including searching, eligibility assessment, identification and retrieval of full-text reports, extraction of data, and risk of bias assessment. Workflows can be developed in which human effort and machine automation can each enable the other to operate in more effective and efficient ways, offering substantial enhancement to the productivity of systematic reviews. This paper describes and discusses the potential¿and limitations¿of new ways of undertaking specific tasks in living systematic reviews, identifying areas where these human/machine ¿technologies¿ are already in use, and where further research and development is needed. While the context is living systematic reviews, many of these enabling technologies apply equally to standard approaches to systematic reviewing.

While it is important for the evidence supporting practice guidelines to be current, that is often not the case. The advent of living systematic reviews has made the concept of ¿living guidelines¿ realistic, with the promise to provide timely, up-to-date and high-quality guidance to target users. We define living guidelines as an optimization of the guideline development process to allow updating individual recommendations as soon as new relevant evidence becomes available. A major implication of that definition is that the unit of update is the individual recommendation and not the whole guideline. We then discuss when living guidelines are appropriate, the workflows required to support them, the collaboration between living systematic reviews and living guideline teams, the thresholds for changing recommendations, and potential approaches to publication and dissemination. The success and sustainability of the concept of living guideline will depend on those of its major pillar, the living systematic review. We conclude that guideline developers should both experiment with and research the process of living guidelines.

A living systematic review (LSR) should keep the review current as new research evidence emerges. Any meta-analyses included in the review will also need updating as new material is identified. If the aim of the review is solely to present the best current evidence standard meta-analysis may be sufficient, provided reviewers are aware that results may change at later updates. If the review is used in a decision-making context, more caution may be needed. When using standard meta-analysis methods, the chance of incorrectly concluding that any updated meta-analysis is statistically significant when there is no effect (the type I error) increases rapidly as more updates are performed. Inaccurate estimation of any heterogeneity across studies may also lead to inappropriate conclusions. This paper considers four methods to avoid some of these statistical problems when updating meta-analyses: two methods, that is, law of the iterated logarithm and the Shuster method control primarily for inflation of type I error and two other methods, that is, trial sequential analysis and sequential meta-analysis control for type I and II errors (failing to detect a genuine effect) and take account of heterogeneity. This paper compares the methods and considers how they could be applied to LSRs.

Systematic reviews are difficult to keep up to date, but failure to do so leads to a decay in review currency, accuracy, and utility. We are developing a novel approach to systematic review updating termed ¿Living systematic review¿ (LSR): systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. LSRs may be particularly important in fields where research evidence is emerging rapidly, current evidence is uncertain, and new research may change policy or practice decisions. We hypothesize that a continual approach to updating will achieve greater currency and validity, and increase the benefits to end users, with feasible resource requirements over time.

Universal school-based interventions that address adolescent ¿resilience¿ may represent a means of reducing adolescent substance use, however previous systematic reviews have not examined the effectiveness of such an intervention approach. A systematic review was undertaken to 1) assess whether universal school-based ¿resilience¿ interventions are effective in reducing the prevalence of tobacco, alcohol or illicit substance use by adolescents, and 2) describe such effectiveness per intervention characteristic subgroups. Eligible studies were peer-reviewed reports (1994¿2015) of randomised controlled trials including participants aged 5¿18¿years that reported adolescent tobacco, alcohol or illicit substance use, and implemented a universal school-based ¿resilience¿ intervention (i.e. those addressing both individual (e.g. self-esteem) and environmental (e.g. school connectedness) protective factors of resilience). Trial effects for binary outcomes were synthesised via meta-analyses and effect sizes reported as odds ratios. Subgroup (by intervention type, prevention approach, setting, intervention duration, follow-up length) and sensitivity analyses (excluding studies at high risk of bias) were conducted. Nineteen eligible studies were identified from 16,619 records (tobacco: n¿=¿15, alcohol: n¿=¿17, illicit: n¿=¿11). An overall intervention effect was found for binary measures of illicit substance use (n¿=¿10; OR: 0.78, 95%CI: 0.6¿0.93, p¿=¿0.007,Tau2¿=¿0.0, I2¿=¿0%), but not tobacco or alcohol use. A similar result was found when studies assessed as high risk of bias were excluded. Overall intervention effects were evident for illicit substance use within multiple intervention characteristic subgroups, but not tobacco and alcohol. Such results support the implementation of universal school-based interventions that address ¿resilience¿ protective factors to reduce adolescent illicit substance use, however suggest alternate approaches are required for tobacco and alcohol use. PROSPERO registration: CRD42014004906.

Objective To examine the effect of universal, school-based, resilience-focused interventions on mental health problems in children and adolescents. Method Eligible studies were randomized controlled trials (RCTs) of universal, school-based interventions that included strategies to strengthen a minimum of 3 internal resilience protective factors, and included an outcome measure of mental health problems in children and adolescents aged 5 to 18 years. Six databases were searched from 1995 to 2015. Results were pooled in meta-analyses by mental health outcome (anxiety symptoms, depressive symptoms, hyperactivity, conduct problems, internalizing problems, externalizing problems, and general psychological distress), for all trials (5-18 years). Subgroup analyses were conducted by age (child: 5-10 years; adolescent: 11-18 years), length of follow-up (short: post-=12 months; long: >12 months), and gender (narrative). Results A total of 57 included trials were identified from 5,984 records, with 49 contributing to meta-analyses. For all trials, resilience-focused interventions were effective relative to a control in reducing 4 of 7 outcomes: depressive symptoms, internalizing problems, externalizing problems, and general psychological distress. For child trials (meta-analyses for 6 outcomes), interventions were effective for anxiety symptoms and general psychological distress. For adolescent trials (meta-analyses for 5 outcomes), interventions were effective for internalizing problems. For short-term follow-up, interventions were effective for 2 of 7 outcomes: depressive symptoms and anxiety symptoms. For long-term follow-up (meta-analyses for 5 outcomes), interventions were effective for internalizing problems. Conclusion The findings may suggest most promise for using universal resilience-focused interventions at least for short-term reductions in depressive and anxiety symptoms for children and adolescents, particularly if a cognitive-behavioral therapy-based approach is used. The limited number of trials providing data amenable for meta-analysis for some outcomes and subgroups, the variability of interventions, study quality, and bias mean that it is not possible to draw more specific conclusions. Identifying what intervention qualities (such as number and type of protective factor) achieve the greatest positive effect per mental health problem outcome remains an important area for future research. Systematic review protocol and registration Systematic Review of Universal Resilience Interventions Targeting Child and Adolescent Mental Health in the School Setting; http://dx.doi.org/10.1186/s13643-015-0172-6; PROSPERO CRD42015025908.

This is the protocol for a review and there is no abstract. The objectives are as follows: The primary aims of the review are to examine the effectiveness of strategies aiming to improve the implementation of school-based policies, programs or practices that aim to promote healthy or reduce unhealthy behaviours relating to child diet, physical activity, obesity, or tobacco or alcohol use. Secondary objectives of the review are to: examine the effectiveness of implementation strategies on health behavioural (e.g. fruit and vegetable consumption) and anthropometric outcomes (e.g. BMI, weight); describe the impact of such strategies on the knowledge, skills or attitudes of stakeholders involved in implementing health promoting policies, programs or practices; describe the cost or cost effectiveness of such strategies; describe any unintended adverse effects of strategies on schools, school staff or children.

© 2015 Dray et al. Background: The mental health of children and adolescents is a key area of health concern internationally. Previous empirical studies suggest that resilience may act as a protective mechanism towards the development of mental health problems. Resilience refers to the ability to employ a collection of protective factors to return to or maintain positive mental health following disadvantage or adversity. Schools represent a potential setting within which protective factors of all children and adolescents may be fostered through resilience-focussed interventions. Despite this potential, limited research has investigated the effectiveness of universal school-based resilience-focussed interventions on mental health outcomes in children and adolescents. The objective of the present review is to assess the effects of universal school-based resilience-focussed interventions, relative to a comparison group, on mental health outcomes in children and adolescents. Methods/design: Eligible studies will be randomised (including cluster-randomised) controlled trials of universal interventions explicitly described as resilience-focussed or comprising strategies to strengthen a minimum of three internal protective factors, targeting children aged 5 to 18 years, implemented within schools, and reporting a mental health outcome. Screening for studies will be conducted across six electronic databases: MEDLINE, PsycINFO, Educational Resources Information Center (ERIC), Excerpta Medica database (EMBASE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Central Register of Controlled Trials (CENTRAL). Two reviewers will retrieve eligible articles, assess risk of bias, and extract data. Where studies are sufficiently homogenous and reported outcomes are amenable for pooled synthesis, meta-analysis will be performed. Narrative description will be used to synthesise trial outcome data where data cannot be combined or heterogeneity exists. Discussion: This review will aid in building an evidence base for the effectiveness of universal school-based resilience-focussed interventions and in doing so provide an opportunity to better inform the development of interventions to potentially prevent mental health problems in child and adolescent populations. Systematic review registration: PROSPERO CRD42015025908