Individuals with musculoskeletal conditions awaiting orthopaedic surgery consultation: an untapped opportunity for patient health management?

OBJECTIVE: To describe the health characteristics, condition-specific measures, chronic disease risk factors, and healthcare and medication use over time of individuals with musculoskeletal conditions awaiting orthopaedic surgical consultation. Study importance: Musculoskeletal conditions are highly prevalent in the general population and often coexist with chronic diseases. However, little is documented about the overall health of this group. This study describes the health of these individuals, with particular emphasis on modifiable risk factors of chronic disease. STUDY TYPE: A repeated measures longitudinal cohort study of individuals referred for orthopaedic consultation across three time points (2014, 2015 and 2016). METHODS: This study was undertaken in the orthopaedic outpatient service of a public tertiary referral hospital in New South Wales, Australia. Participants were aged 18 years and older and were referred for and awaiting orthopaedic surgical consultation for a musculoskeletal condition (back, neck, hand or wrist pain, or hip or knee osteoarthritis). Measures included patient demographics, condition-specific indicators (e.g. pain, disability, quality of life [QoL]) and chronic disease risk factors (e.g., excess weight, smoking). RESULTS: The mean age of participants was 57.7 years, and 7.3% identified as Aboriginal and/or Torres Strait Islander. Back (43.1%) and knee (35.0%) pain were the most prevalent conditions. At baseline (N = 1052), participants reported moderate pain (mean numerical pain rating scale score of 6.4, standard deviation [SD] 2.4) and QoL (Physical Component Score of 32.7, SD 10.7; Mental Component Score of 46.6, SD 13.3). Chronic disease risk factors were highly prevalent, with 74.6% of participants having three or more. For most measures, there were only small changes over time. CONCLUSION: Individuals with musculoskeletal conditions who are awaiting orthopaedic surgical consultation have a complex clinical picture and numerous chronic disease risk factors. Given the modifiable nature of many of these risk factors, identifying and addressing them before or while awaiting consultation may improve the health of these individuals.

Meaningful coproduction with clinicians: establishing a practice-based research network with physiotherapists in regional Australia.

BACKGROUND: The disconnect between research and clinical practice leads to research evidence that is often not useful for clinical practice. Practice-based research networks are collaborations between researchers and clinicians aimed at coproducing more useful research. Such networks are rare in the physiotherapy field. We aimed to describe (i) clinicians' motivations behind, and enablers to, participating in a network, (ii) the process of network establishment and (iii) research priorities for a practice-based network of physiotherapists in the Hunter Region of New South Wales (NSW), Australia that supports research coproduction. METHODS: We describe the methods and outcomes of the three steps we used to establish the network. Step 1 involved consultation with local opinion leaders and a formative evaluation to understand clinicians' motivations behind, and enablers to, participating in a network. Step 2 involved establishment activities to generate a founding membership group and codesign a governance model. Step 3 involved mapping clinical problems through a workshop guided by systems thinking theory with local stakeholders and prioritizing research areas. RESULTS: Through formative evaluation focus groups, we generated five key motivating themes and three key enablers for physiotherapists' involvement in the network. Establishment activities led to a founding membership group (n = 29, 67% from private practice clinics), a network vision and mission statement, and a joint governance group (9/13 [70%] are private practice clinicians). Our problem-mapping and prioritization process led to three clinically relevant priority research areas with the potential for significant change in practice and patient outcomes. CONCLUSIONS: Clinicians are motivated to break down traditional siloed research generation and collaborate with researchers to solve a wide array of issues with the delivery of care. Practice-based research networks have promise for both researchers and clinicians in the common goal of improving patient outcomes.

Mixed messages: most spinal pain and osteoarthritis observational research is unclear or misaligned.

OBJECTIVES: We assessed authors' language and methods to determine alignment between reported aims, methods, intent, and interpretations in observational studies in spinal pain or osteoarthritis. STUDY DESIGN AND SETTING: We searched five databases for observational studies that included people with spinal pain or osteoarthritis published in the last 5 years. We randomized 100 eligible studies, and classified study intent (aims and methods) and interpretations as causal, non-causal, unclear, or misaligned. RESULTS: Overall, 38% of studies were aligned regarding their intent and interpretation (either causally (22%) or non-causally (16%)). 29% of studies' aims and 29% of study methods were unclear. Intent was misaligned in 16% of studies (where aim differed to method) and 23% of studies had misaligned interpretations (where there were multiple conflicting claims). The most common kind of aim was non-causal (38%), and the most common type of method (39%), intent (38%), and interpretations (35%) was causal. CONCLUSIONS: Misalignment and mixed messages are common in observational research of spinal pain and osteoarthritis. More than 6 in 10 observational studies may be uninterpretable, because study intent and interpretations do not align. While causal methods and intent are most common in observational research, authors commonly shroud causal intent in non-causal terminology.

Physiotherapists' opinions, barriers, and enablers to providing evidence-based care: a mixed-methods study.

BACKGROUND: Physiotherapists deliver evidence-based guideline recommended treatments only half of the time to patients with musculoskeletal conditions. Physiotherapists' behaviour in clinical practice are influenced by many cognitive, social, and environmental factors including time and financial pressures. Many initiatives aimed at improving physiotherapists' uptake of evidence-based care have failed to appreciate the context involved in clinical decisions and clinical practice. Therefore, we aimed to describe: i) opinions toward evidence; ii) how evidence is accessed; iii) factors influencing evidence access; iv) factors influencing evidence application, for physiotherapists working in regional areas. METHODS: We used a mixed-methods study with online survey and focus groups. We included registered physiotherapists in the survey and physiotherapists practising in regional New South Wales in the focus groups. Quantitative and qualitative data were used to inform all research objectives. We used eight domains of the Transtheoretical Domains Framework to design survey questions. We analysed quantitative and qualitative data in parallel, then integrated both sources through by developing a matrix while considering the Transtheoretical Domains Framework domains to generate themes. RESULTS: Fifty-seven physiotherapists participated in the study (survey only n = 41; focus group only n = 8; both survey and focus group n = 8). Participants reported that evidence was important, but they also considered patient expectations, colleagues' treatment choices, and business demands in clinical decision making. Physiotherapists reported they access evidence on average 30 minutes or less per week. Competing demands like business administration tasks are barriers to accessing evidence. Participants reported that patient expectations were a major barrier to applying evidence in practice. Environmental and systemic factors, like funding structures or incentives for evidence-based care, and social factors, like lacking or having a culture of accountability and mentorship, were reported as both barriers and enablers to evidence application. CONCLUSIONS: This study provides context to physiotherapists' opinion, access, and application of evidence in clinical practice. Physiotherapists' provision of evidence-based care may be improved by enhancing structural support from workplaces to access and apply evidence and exploring discrepancies between physiotherapists' perceptions of patient expectations and actual patient expectations.

"Myths and Facts" Education Is Comparable to "Facts Only" for Recall of Back Pain Information but May Improve Fear-Avoidance Beliefs: An Embedded Randomized Trial.

OBJECTIVE: To assess the effectiveness of patient education with "myths and facts" versus "facts only" on recall of back pain information and fear-avoidance beliefs in patients with chronic low back pain (LBP). DESIGN: Randomized Study Within A Trial. METHODS: One hundred fifty-two participants with chronic LBP were included. Participants allocated to the "facts only" group received an information sheet with 6 LBP facts, whereas those allocated to the "myths and facts" group received the same information sheet, with each myth refuted by its respective fact. The primary outcome was a correct recall of back pain facts, and the secondary outcome was the physical activity component of the Fear-Avoidance Beliefs Questionnaire (FABQ-PA), 2 weeks after the provision of the information sheet. RESULTS: There was no evidence of a difference in the proportion of participants with a correct recall between the "myths and facts" and "facts only" groups (odds ratio = 0.98; 95% confidence interval [CI]: 0.48, 1.99) and no significant difference in FABQ-PA mean scores between groups (-1.58; 95% CI: -3.77, 0.61). Sensitivity analyses adjusted for prognostic factors showed no difference in information recall but a larger difference in FABQ-PA scores (-2.3; 95% CI: -4.56, -0.04). CONCLUSION: We found no overall difference in the recall of back pain information for patients provided with "myths and facts" compared with that for patients provided with "facts only" and a slight reduction in fear-avoidance beliefs for physical activity using "myths and facts" compared with that using "facts only," but the meaningfulness of this result is uncertain. J Orthop Sports Phys Ther 2022;52(9):586-594. Epub: 9 July 2022. doi:10.2519/jospt.2022.10989.

Compliance with telephone-based lifestyle weight loss programs improves low back pain but not knee pain outcomes: complier average causal effects analyses of 2 randomised trials.

ABSTRACT: We conducted a complier average causal effect (CACE) analyses for 2 pragmatic randomised controlled trials. We aimed to assess the effectiveness of telephone-based lifestyle weight loss interventions compared with usual care among compliers. Participants from 2 trials with low back pain (n = 160) and knee osteoarthritis (n = 120) with a body mass index ≥27 kg/m2 were included. We defined adherence to the telephone-based lifestyle weight loss program as completing 60% (6 from 10) of telephone health coaching calls. The primary outcomes for CACE analyses were pain intensity (0-10 Numerical Rating Scale) and disability (Roland Morris Disability Questionnaire for low back pain and Western Ontario and McMaster Universities Osteoarthritis Index for knee osteoarthritis). Secondary outcomes were weight, physical activity, and diet. We used an instrumental variable approach to estimate CACE in compliers. From the intervention groups of the trials, 29% of those with low back pain (n = 23/80) and 34% of those with knee osteoarthritis (n = 20/60) complied. Complier average causal effect estimates showed potentially clinically meaningful effects, but with low certainty because of wide confidence intervals, for pain intensity (-1.4; 95% confidence interval, -3.1, 0.4) and small but also uncertain effects for disability (-2.1; 95% confidence interval, -8.6, 4.5) among compliers in the low back pain trial intervention compared with control but not in the knee osteoarthritis trial. Our findings showed that compliers of a telephone-based weight loss intervention in the low back pain trial generally had improved outcomes; however, there were inconsistent effects in compliers from the knee osteoarthritis trial. Complier average causal effect estimates were larger than intention-to-treat results but must be considered with caution.

Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial.

BACKGROUND: This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical activity, diet and smoking, to improve disability. We describe the methods for the main analyses and economic analysis of the trial. METHODS AND DESIGN: The trial is a two-arm pragmatic randomised controlled trial comparing the effect of the HeLP intervention to usual care on low back pain disability at 26 weeks. A total of 346 adults with low back pain were recruited from the Newcastle and Hunter region between September 2017 and November 2019 and randomised to either HeLP or usual care. HeLP is a 6-month intervention with participant outcomes measured at weeks 6, 12, 26 and 52 post randomisation. This statistical analysis plan describes data integrity, handling and preparation of data for analyses and methods for analyses. The primary endpoint for the trial is disability at 26 weeks using the 24-item self-report Roland Morris Disability Questionnaire. The primary analysis will follow the intention-to-treat principle using linear mixed regression models. DISCUSSION: The statistical analysis plan for this trial was produced to reduce outcome reporting bias arising from knowledge of the study findings. Any deviations will be described and justified in the final report. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617001288314 . Registered on 6 September 2017.

Exercise interventions for low back pain are poorly reported: a systematic review.

OBJECTIVE: To assess the reporting quality of exercise interventions from clinical trials of low back pain (LBP). STUDY DESIGN AND SETTING: We conducted a systematic review to assess the reporting quality of randomised controlled trials (RCTs) that investigated the effectiveness of exercise interventions for patients with LBP. Five online databases and Clinical Trial Registries were searched (October 2018). We included RCTs that reported interventions for LBP, containing at least 50% exercise. The Template for Intervention Description and Replication (TIDieR) and the Consensus on Exercise Reporting Template (CERT) reporting checklists were then used to assess quality of reporting. RESULTS: 582 trials were eligible for inclusion. Due to the large number of eligible studies, 100 studies were randomly selected for data extraction and coding with the TIDieR and CERT checklists. The random sample was representative of the 582 eligible trials. The overall completeness of reporting (median (IQR)) of TIDieR items was 59.2% (45.5%-72.7%) and CERT was 33.3% (22.2%-52.6%). CONCLUSIONS: We found poor overall reporting with both checklists, which has not improved over time or since the introduction of the checklists. More dedicated work is required to address poor reporting of exercise interventions in clinical trials.

Effectiveness of Weight-Loss Interventions for Reducing Pain and Disability in People With Common Musculoskeletal Disorders: A Systematic Review With Meta-Analysis.

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. J Orthop Sports Phys Ther 2020;50(6):319-333. Epub 9 Apr 2020. doi:10.2519/jospt.2020.9041.

Interventions Targeting Smoking Cessation for Patients With Chronic Pain: An Evidence Synthesis.

INTRODUCTION: Smoking is a risk factor for chronic pain conditions. Epidemiological evidence suggests that smoking cessation may be an important treatment target in people with chronic pain. The aim of this study was to examine the effectiveness of smoking cessation interventions in people with chronic pain. METHODS: We systematically searched for clinical trials investigating the effectiveness of smoking cessation interventions for people with chronic pain, compared with any control comparator. Primary outcomes were pain and physical function. Secondary outcomes were smoking status, quality of life, psychological and cognitive function, and adverse events. We assessed risk of bias using the Cochrane Risk of Bias criteria and the quality of evidence with GRADE. RESULTS: Searches retrieved 3845 records and identified two trials for inclusion (total n = 99 participants). There was low-quality evidence of no effect of smoking cessation programs on pain and very low-quality evidence of no effect on function at short-term follow-up. There was conflicting evidence on the effect of smoking cessation interventions for changing the smoking status and number of cigarettes consumed per day. There was no effect on depression and anxiety. CONCLUSION: Current evidence does not indicate clinically important effects of smoking cessation interventions in people with chronic pain. There is a need for high-quality trials in this area. IMPLICATIONS: Our review highlights an important evidence gap. We found only two studies investigating smoking cessation programs for chronic pain conditions providing very low- to low-quality evidence.

Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial.

INTRODUCTION: Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS: The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION: This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617001288314.

Causal mechanisms of a healthy lifestyle intervention for patients with musculoskeletal pain who are overweight or obese.

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.

Economic evaluation of a healthy lifestyle intervention for chronic low back pain: A randomized controlled trial.

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.

Economic evaluation of telephone-based weight loss support for patients with knee osteoarthritis: a randomised controlled trial.

BACKGROUND: The prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese. METHODS: An economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6 weeks and 26 weeks. The primary cost-effectiveness analysis was performed from the societal perspective. RESULTS: Mean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values. CONCLUSIONS: From a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis. TRIAL REGISTRATION NUMBER: ACTRN12615000490572 , registered 18th May 2015.

Musculoskeletal conditions may increase the risk of chronic disease: a systematic review and meta-analysis of cohort studies.

BACKGROUND: Chronic diseases and musculoskeletal conditions have a significant global burden and frequently co-occur. Musculoskeletal conditions may contribute to the development of chronic disease; however, this has not been systematically synthesised. We aimed to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease. METHODS: We searched CINAHL, Embase, Medline, Medline in Process, PsycINFO, Scopus and Web of Science to February 8, 2018, for cohort studies reporting adjusted estimates of the association between baseline musculoskeletal conditions (neck or back pain or osteoarthritis of the knee or hip) and subsequent diagnosis of a chronic disease (cardiovascular disease, cancer, diabetes, chronic respiratory disease or obesity). Two independent reviewers performed data extraction and assessed study quality. Adjusted hazard ratios were pooled using the generic inverse variance method in random effect models, regardless of the type of musculoskeletal condition or chronic disease. PROSPERO: CRD42016039519. RESULTS: There were 13 cohort studies following 3,086,612 people. In the primary meta-analysis of adjusted estimates, osteoarthritis (n = 8 studies) and back pain (n = 2) were the exposures and cardiovascular disease (n = 8), cancer (n = 1) and diabetes (n = 1) were the outcomes. Pooled adjusted estimates from these 10 studies showed that people with a musculoskeletal condition have a 17% increase in the rate of developing a chronic disease compared to people without (hazard ratio 1.17, 95% confidence interval 1.13-1.22; I2 52%, total n = 2,686,113 people). CONCLUSIONS: This meta-analysis found that musculoskeletal conditions may increase the risk of chronic disease. In particular, osteoarthritis appears to increase the risk of developing cardiovascular disease. Prevention and early treatment of musculoskeletal conditions and targeting associated chronic disease risk factors in people with long standing musculoskeletal conditions may play a role in preventing other chronic diseases. However, a greater understanding about why musculoskeletal conditions may increase the risk of chronic disease is needed.

Interventions for increasing fruit and vegetable consumption in children aged five years and under.

BACKGROUND: Insufficient consumption of fruits and vegetables in childhood increases the risk of future non-communicable diseases, including cardiovascular disease. Interventions to increase consumption of fruit and vegetables, such as those focused on specific child-feeding strategies and parent nutrition education interventions in early childhood may therefore be an effective strategy in reducing this disease burden. OBJECTIVES: To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and two clinical trials registries to identify eligible trials on 25 January 2018. We searched Proquest Dissertations and Theses in November 2017. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included studies to identify further potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risks of bias of included studies; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures. MAIN RESULTS: We included 63 trials with 178 trial arms and 11,698 participants. Thirty-nine trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Fourteen trials examined the impact of parent nutrition education in increasing child fruit and vegetable intake. Nine studies examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. One study examined the effect of a nutrition education intervention delivered to children in increasing child fruit and vegetable intake.We judged 14 of the 63 included trials as free from high risks of bias across all domains; performance, detection and attrition bias were the most common domains judged at high risk of bias for the remaining studies.There is very low quality evidence that child-feeding practices versus no intervention may have a small positive effect on child vegetable consumption equivalent to an increase of 3.50 g as-desired consumption of vegetables (SMD 0.33, 95% CI 0.13 to 0.54; participants = 1741; studies = 13). Multicomponent interventions versus no intervention may have a very small effect on child consumption of fruit and vegetables (SMD 0.35, 95% CI 0.04 to 0.66; participants = 2009; studies = 5; low-quality evidence), equivalent to an increase of 0.37 cups of fruit and vegetables per day. It is uncertain whether there are any short-term differences in child consumption of fruit and vegetables in meta-analyses of trials examining parent nutrition education versus no intervention (SMD 0.12, 95% CI -0.03 to 0.28; participants = 3078; studies = 11; very low-quality evidence).Insufficient data were available to assess long-term effectiveness, cost effectiveness and unintended adverse consequences of interventions. Studies reported receiving governmental or charitable funds, except for four studies reporting industry funding. AUTHORS' CONCLUSIONS: Despite identifying 63 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains limited. There was very low- and low-quality evidence respectively that child-feeding practice and multicomponent interventions may lead to very small increases in fruit and vegetable consumption in children aged five years and younger. It is uncertain whether parent nutrition education interventions are effective in increasing fruit and vegetable consumption in children aged five years and younger. Given that the quality of the evidence is very low or low, future research will likely change estimates and conclusions. Long-term follow-up is required and future research should adopt more rigorous methods to advance the field.This is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

Impaired Fast Network Oscillations and Mitochondrial Dysfunction in a Mouse Model of Alpha-synucleinopathy (A30P).

Intracellular accumulation of alpha-synuclein (α-syn) is a key pathological process evident in Lewy body dementias (LBDs), including Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB). LBD results in marked cognitive impairments and changes in cortical networks. To assess the impact of abnormal α-syn expression on cortical network oscillations relevant to cognitive function, we studied changes in fast beta/gamma network oscillations in the hippocampus in a mouse line that over-expresses human mutant α-syn (A30P). We found an age-dependent reduction in the power of the gamma (20-80 Hz) frequency oscillations in slices taken from mice aged 9-16 months (9+A30P), that was not present in either young 2-6 months old (2+A30P) mice, or in control mice at either age. The mitochondrial blockers potassium cyanide and rotenone both reduced network oscillations in a concentration-dependent manner in aged A30P mice and aged control mice but slices from A30P mice showed a greater reduction in the oscillations. Histochemical analysis showed an age-dependent reduction in cytochrome c oxidase (COX) activity, suggesting a mitochondrial dysfunction in the 9+A30P group. A deficit in COX IV expression was confirmed by immunohistochemistry. Overall, our data demonstrate an age-dependent impairment in mitochondrial function and gamma frequency activity associated with the abnormal expression of α-syn. These findings provide mechanistic insights into the consequences of over-expression of α-syn which might contribute to cognitive decline.

Interventions for increasing fruit and vegetable consumption in children aged five years and under.

BACKGROUND: Insufficient consumption of fruits and vegetables in childhood increases the risk of future chronic diseases, including cardiovascular disease. OBJECTIVES: To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE and Embase to identify eligible trials on 25 September 2017. We searched Proquest Dissertations and Theses and two clinical trial registers in November 2017. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included studies to identify further potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risks of bias of included studies; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures. We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures. MAIN RESULTS: We included 55 trials with 154 trial arms and 11,108 participants. Thirty-three trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Thirteen trials examined the impact of parent nutrition education in increasing child fruit and vegetable intake. Eight studies examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. One study examined the effect of a nutrition intervention delivered to children in increasing child fruit and vegetable intake.We judged 14 of the 55 included trials as free from high risks of bias across all domains; performance, detection and attrition bias were the most common domains judged at high risk of bias for the remaining studies.Meta-analysis of trials examining child-feeding practices versus no intervention revealed a positive effect on child vegetable consumption (SMD 0.38, 95% confidence interval (CI) 0.15 to 0.61; n = 1509; 11 studies; very low-quality evidence), equivalent to a mean difference of 4.03 g of vegetables. There were no short-term differences in child consumption of fruit and vegetables in meta-analyses of trials examining parent nutrition education versus no intervention (SMD 0.11, 95% CI -0.05 to 0.28; n = 3023; 10 studies; very low-quality evidence) or multicomponent interventions versus no intervention (SMD 0.28, 95% CI -0.06 to 0.63; n = 1861; 4 studies; very low-quality evidence).Insufficient data were available to assess long-term effectiveness, cost effectiveness and unintended adverse consequences of interventions. Studies reported receiving governmental or charitable funds, except for three studies reporting industry funding. AUTHORS' CONCLUSIONS: Despite identifying 55 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains sparse. There was very low-quality evidence that child-feeding practice interventions are effective in increasing vegetable consumption in children aged five years and younger, however the effect size was very small and long-term follow-up is required. There was very low-quality evidence that parent nutrition education and multicomponent interventions are not effective in increasing fruit and vegetable consumption in children aged five years and younger. All findings should be considered with caution, given most included trials could not be combined in meta-analyses. Given the very low-quality evidence, future research will very likely change estimates and conclusions. Such research should adopt more rigorous methods to advance the field.This is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.

Interventions for increasing fruit and vegetable consumption in children aged five years and under.

BACKGROUND: Insufficient consumption of fruits and vegetables in childhood increases the risk of future chronic diseases, including cardiovascular disease. OBJECTIVES: To assess the effectiveness, cost effectiveness and associated adverse events of interventions designed to increase the consumption of fruit, vegetables or both amongst children aged five years and under. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase Classic and Embase to identify eligible trials on 30 September 2016. We searched CINAHL and PsycINFO in July 2016, Proquest Dissertations and Theses in November 2016 and three clinical trial registers in November 2016 and June 2017. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included studies to identify further potentially relevant trials. SELECTION CRITERIA: We included randomised controlled trials, including cluster-randomised controlled trials and cross-over trials, of any intervention primarily targeting consumption of fruit, vegetables or both among children aged five years and under, and incorporating a dietary or biochemical assessment of fruit or vegetable consumption. Two review authors independently screened titles and abstracts of identified papers; a third review author resolved disagreements. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risks of bias of included studies; a third review author resolved disagreements. Due to unexplained heterogeneity, we used random-effects models in meta-analyses for the primary review outcomes where we identified sufficient trials. We calculated standardised mean differences (SMDs) to account for the heterogeneity of fruit and vegetable consumption measures.We conducted assessments of risks of bias and evaluated the quality of evidence (GRADE approach) using Cochrane procedures. MAIN RESULTS: We included 50 trials with 137 trial arms and 10,267 participants. Thirty trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Eleven trials examined the impact of parent nutrition education in increasing child fruit and vegetable intake. Eight studies examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. One study examined the effect of a nutrition intervention delivered to children in increasing child fruit and vegetable intake.Thirteen of the 50 included trials were judged as free from high risks of bias across all domains; performance, detection and attrition bias were the most common domains judged at high risk of bias of remaining studies.Meta-analysis of trials examining child-feeding practices versus no intervention revealed a positive effect on child vegetable consumption (SMD 0.38, 95% CI 0.15 to 0.61; n = 1509; 11 studies; very low-quality evidence), equivalent to a mean difference of 4.03 grams of vegetables. There were no short-term differences in child consumption of fruit and vegetables in meta-analyses of trials examining parent nutrition education versus no intervention (SMD 0.11, 95% CI -0.05 to 0.28; n = 3023; 10 studies; very low-quality evidence) or multicomponent interventions versus no intervention (SMD 0.28, 95% CI -0.06 to 0.63; n = 1861; 4 studies; very low-quality evidence).Insufficient data were available to assess long-term effectiveness, cost effectiveness and unintended adverse consequences of interventions.Studies reported receiving governmental or charitable funds, except for two studies reporting industry funding. AUTHORS' CONCLUSIONS: Despite identifying 50 eligible trials of various intervention approaches, the evidence for how to increase fruit and vegetable consumption of children remains sparse. There was very low-quality evidence child-feeding practice interventions are effective in increasing vegetable consumption of children aged five years and younger, however the effect size was very small and long-term follow-up is required. There was very low-quality evidence that parent nutrition education and multicomponent interventions are not effective in increasing fruit and vegetable consumption of children aged five years and younger. All findings should be considered with caution, given most included trials could not be combined in meta-analyses. Given the very low-quality evidence, future research will very likely change estimates and conclusions. Such research should adopt more rigorous methods to advance the field.This is a living systematic review. Living systematic reviews offer a new approach to review updating, in which the review is continually updated, incorporating relevant new evidence as it becomes available. Please refer to the Cochrane Database of Systematic Reviews for the current status of this review.