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.

Interventions to prevent obesity in school-aged children 6-18 years: An update of a Cochrane systematic review and meta-analysis including studies from 2015-2021.

Background: Childhood obesity remains a global public health priority due to the enormous burden it generates. Recent surveillance data suggests there has been a sharp increase in the prevalence of childhood obesity during the COVID-19 pandemic. The Cochrane review of childhood obesity prevention interventions (0-18 years) updated to 2015 is the most rigorous and comprehensive review of randomised controlled trials (RCTs) on this topic. A burgeoning number of high quality studies have been published since that are yet to be synthesised. Methods: An update of the Cochrane systematic review was conducted to include RCT studies in school-aged children (6-18 years) published to 30 June 2021 that assessed effectiveness on child weight (PROSPERO registration: CRD42020218928). Available cost-effectiveness and adverse effect data were extracted. Intervention effects on body mass index (BMI) were synthesised in random effects meta-analyses by setting (school, after-school program, community, home), and meta-regression examined the association of study characteristics with intervention effect. Findings: Meta-analysis of 140 of 195 included studies (183,063 participants) found a very small positive effect on body mass index for school-based studies (SMD -0·03, 95%CI -0·06,-0·01; trials = 93; participants = 131,443; moderate certainty evidence) but not after-school programs, community or home-based studies. Subgroup analysis by age (6-12 years; 13-18 years) found no differential effects in any setting. Meta-regression found no associations between study characteristics (including setting, income level) and intervention effect. Ten of 53 studies assessing adverse effects reported presence of an adverse event. Insufficient data was available to draw conclusions on cost-effectiveness. Interpretation: This updated synthesis of obesity prevention interventions for children aged 6-18 years, found a small beneficial impact on child BMI for school-based obesity prevention interventions. A more comprehensive assessment of interventions is required to identify mechanisms of effective interventions to inform future obesity prevention public health policy, which may be particularly salient in for COVID-19 recovery planning. Funding: This research was funded by the National Health and Medical Research Council (NHMRC), Australia (Application No APP1153479).

Strategies for enhancing the implementation of school-based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use.

BACKGROUND: Several school-based interventions are effective in improving child diet and physical activity, and preventing excessive weight gain, and tobacco or harmful alcohol use. However, schools are frequently unsuccessful in implementing such evidence-based interventions. OBJECTIVES: 1. To evaluate the benefits and harms of strategies aiming to improve school implementation of interventions to address student diet, physical activity, tobacco or alcohol use, and obesity. 2. To evaluate the benefits and harms of strategies to improve intervention implementation on measures of student diet, physical activity, obesity, tobacco use or alcohol use; describe their cost or cost-effectiveness; and any harms of strategies on schools, school staff or students. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search was between 1 September 2016 and 30 April 2021 to identify any relevant trials published since the last published review. SELECTION CRITERIA: We defined 'Implementation' as the use of strategies to adopt and integrate evidence-based health interventions and to change practice patterns within specific settings. We included any trial (randomised controlled trial (RCT) or non-randomised controlled trial (non-RCT)) conducted at any scale, with a parallel control group that compared a strategy to implement policies or practices to address diet, physical activity, overweight or obesity, tobacco or alcohol use by students to 'no intervention', 'usual' practice or a different implementation strategy. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Given the large number of outcomes reported, we selected and included the effects of a single outcome measure for each trial for the primary (implementation) and secondary (student health behaviour and obesity) outcomes using a decision hierarchy. Where possible, we calculated standardised mean differences (SMDs) to account for variable outcome measures with 95% confidence intervals (CI). For RCTs, we conducted meta-analyses of primary and secondary outcomes using a random-effects model, or in instances where there were between two and five studies, a fixed-effect model. The synthesis of the effects for non-randomised studies followed the 'Synthesis without meta-analysis' (SWiM) guidelines. MAIN RESULTS: We included an additional 11 trials in this update bringing the total number of included studies in the review to 38. Of these, 22 were conducted in the USA. Twenty-six studies used RCT designs. Seventeen trials tested strategies to implement healthy eating, 12 physical activity and six a combination of risk factors. Just one trial sought to increase the implementation of interventions to delay initiation or reduce the consumption of alcohol. All trials used multiple implementation strategies, the most common being educational materials, educational outreach and educational meetings. The overall certainty of evidence was low and ranged from very low to moderate for secondary review outcomes. Pooled analyses of RCTs found, relative to a control, the use of implementation strategies may result in a large increase in the implementation of interventions in schools (SMD 1.04, 95% CI 0.74 to 1.34; 22 RCTs, 1917 participants; low-certainty evidence). For secondary outcomes we found, relative to control, the use of implementation strategies to support intervention implementation may result in a slight improvement on measures of student diet (SMD 0.08, 95% CI 0.02 to 0.15; 11 RCTs, 16,649 participants; low-certainty evidence) and physical activity (SMD 0.09, 95% CI -0.02 to 0.19; 9 RCTs, 16,389 participants; low-certainty evidence). The effects on obesity probably suggest little to no difference (SMD -0.02, 95% CI -0.05 to 0.02; 8 RCTs, 18,618 participants; moderate-certainty evidence). The effects on tobacco use are very uncertain (SMD -0.03, 95% CIs -0.23 to 0.18; 3 RCTs, 3635 participants; very low-certainty evidence). One RCT assessed measures of student alcohol use and found strategies to support implementation may result in a slight increase in use (odds ratio 1.10, 95% CI 0.77 to 1.56; P = 0.60; 2105 participants). Few trials reported the economic evaluations of implementation strategies, the methods of which were heterogeneous and evidence graded as very uncertain. A lack of consistent terminology describing implementation strategies was an important limitation of the review. AUTHORS' CONCLUSIONS: The use of implementation strategies may result in large increases in implementation of interventions, and slight improvements in measures of student diet, and physical activity. Further research is required to assess the impact of implementation strategies on such behavioural- and obesity-related outcomes, including on measures of alcohol use, where the findings of one trial suggest it may slightly increase student risk. Given the low certainty of the available evidence for most measures further research is required to guide efforts to facilitate the translation of evidence into practice in this setting.

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.

School-Based Nutrition Interventions in Children Aged 6 to 18 Years: An Umbrella Review of Systematic Reviews.

Schools are identified as a key setting to influence children's and adolescents' healthy eating. This umbrella review synthesised evidence from systematic reviews of school-based nutrition interventions designed to improve dietary intake outcomes in children aged 6 to 18 years. We undertook a systematic search of six electronic databases and grey literature to identify relevant reviews of randomized controlled trials. The review findings were categorised for synthesis by intervention type according to the World Health Organisation Health Promoting Schools (HPS) framework domains: nutrition education; food environment; all three HPS framework domains; or other (not aligned to HPS framework domain). Thirteen systematic reviews were included. Overall, the findings suggest that school-based nutrition interventions, including nutrition education, food environment, those based on all three domains of the HPS framework, and eHealth interventions, can have a positive effect on some dietary outcomes, including fruit, fruit and vegetables combined, and fat intake. These results should be interpreted with caution, however, as the quality of the reviews was poor. Though these results support continued public health investment in school-based nutrition interventions to improve child dietary intake, the limitations of this umbrella review also highlight the need for a comprehensive and high quality systematic review of primary studies.

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. Testing the effects of interventions to increase consumption of fruit and vegetables, including those focused on specific child-feeding strategies or broader multicomponent interventions targeting the home or childcare environment is required to assess the potential to reduce 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 2020. We searched Proquest Dissertations and Theses in November 2019. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included trials 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 trials; 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 80 trials with 218 trial arms and 12,965 participants. Fifty trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Fifteen trials examined the impact of parent nutrition education only in increasing child fruit and vegetable intake. Fourteen trials examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. Two trials examined the effect of a nutrition education intervention delivered to children in increasing child fruit and vegetable intake. One trial examined the impact of a child-focused mindfulness intervention in increasing vegetable intake. We judged 23 of the 80 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 trials. There is 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 5.30 grams as-desired consumption of vegetables (SMD 0.50, 95% CI 0.29 to 0.71; 19 trials, 2140 participants; mean post-intervention follow-up = 8.3 weeks). Multicomponent interventions versus no intervention has a small effect on child consumption of fruit and vegetables (SMD 0.32, 95% CI 0.09 to 0.55; 9 trials, 2961 participants; moderate-quality evidence; mean post-intervention follow-up = 5.4 weeks), equivalent to an increase of 0.34 cups of fruit and vegetables a 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 0.13, 95% CI -0.02 to 0.28; 11 trials, 3050 participants; very low-quality evidence; mean post-intervention follow-up = 13.2 weeks). We were unable to pool child nutrition education interventions in meta-analysis; both trials reported a positive intervention effect on child consumption of fruit and vegetables (low-quality evidence). Very few trials reported long-term effectiveness (6 trials), cost effectiveness (1 trial) or unintended adverse consequences of interventions (2 trials), limiting our ability to assess these outcomes. Trials reported receiving governmental or charitable funds, except for four trials reporting industry funding. AUTHORS' CONCLUSIONS: Despite identifying 80 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains limited in terms of quality of evidence and magnitude of effect. Of the types of interventions identified, there was moderate-quality evidence that multicomponent interventions probably lead to, and low-quality evidence that child-feeding practice may lead to, only small increases in fruit and vegetable consumption in children aged five years and under. It is uncertain whether parent nutrition education or child nutrition education interventions alone are effective in increasing fruit and vegetable consumption in children aged five years and under. Our confidence in effect estimates for all intervention approaches, with the exception of multicomponent interventions, is limited on the basis of the very low to low-quality evidence. Long-term follow-up of at least 12 months 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 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 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 August 2019. We searched Proquest Dissertations and Theses in May 2019. We reviewed reference lists of included trials and handsearched three international nutrition journals. We contacted authors of included trials 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 trials; 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 78 trials with 214 trial arms and 13,746 participants. Forty-eight trials examined the impact of child-feeding practices (e.g. repeated food exposure) in increasing child vegetable intake. Fifteen trials examined the impact of parent nutrition education in increasing child fruit and vegetable intake. Fourteen trials examined the impact of multicomponent interventions (e.g. parent nutrition education and preschool policy changes) in increasing child fruit and vegetable intake. Two trials examined the effect of a nutrition education intervention delivered to children in increasing child fruit and vegetable intake. One trial examined the impact of a child-focused mindfulness intervention in increasing vegetable intake. We judged 20 of the 78 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 trials. 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 4.45 g as-desired consumption of vegetables (SMD 0.42, 95% CI 0.23 to 0.60; 18 trials, 2004 participants; mean post-intervention follow-up = 8.2 weeks). Multicomponent interventions versus no intervention has a small effect on child consumption of fruit and vegetables (SMD 0.34, 95% CI 0.10 to 0.57; 9 trials, 3022 participants; moderate-quality evidence; mean post-intervention follow-up = 5.4 weeks), equivalent to an increase of 0.36 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; 11 trials, 3078 participants; very low-quality evidence; mean post-intervention follow-up = 13.2 weeks). We were unable to pool child nutrition education interventions in meta-analysis; both trials reported a positive intervention effect on child consumption of fruit and vegetables (low-quality evidence). Very few trials reported long-term effectiveness (6 trials), cost effectiveness (1 trial) and unintended adverse consequences of interventions (2 trials), limiting their assessment. Trials reported receiving governmental or charitable funds, except for four trials reporting industry funding. AUTHORS' CONCLUSIONS: Despite identifying 78 eligible trials of various intervention approaches, the evidence for how to increase children's fruit and vegetable consumption remains limited. There was very low-quality evidence that child-feeding practice may lead to, and moderate-quality evidence that multicomponent interventions probably lead to 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 of at least 12 months 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.

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.

Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis.

BACKGROUND: Osteoarthritis and spinal pain are common and burdensome conditions; however, the majority of patients with these conditions do not receive care that is consistent with clinical practice guidelines. Telehealth models of care have the potential to improve care for osteoarthritis and spinal pain patients. The aim of this review was to assess the effectiveness of verbal real-time telehealth interventions, including telephone-based and videoconferencing interventions to reduce pain intensity and disability in patients with osteoarthritis of the knee or hip and spinal pain (back or neck pain). METHODS: We searched seven electronic databases from inception to May 2018. Randomised controlled trials (RCTs), cluster-RCTs, and non-randomised controlled trials were included. Two review authors independently extracted data for each included study. Primary outcomes were pain intensity and disability. We conducted primary meta-analyses combining all conditions with similar interventions and comparators. Standardised mean difference (SMD) and 95% confidence intervals (CIs) were calculated using random effects models. We used the Cochrane Risk of Bias tool to assess risk of bias, and GRADE to evaluate the quality of evidence. RESULTS: We included 23 studies with 56 trial arms and 4,994 participants. All studies utilised telephone-based interventions. Only two studies used a telephone only approach and the remainder included educational materials and/or face-to-face components. We found no studies utilising videoconferencing. Meta-analysis showed telephone-based interventions (with educational materials) for osteoarthritis and spinal pain improved pain intensity (n = 5 trials, n = 1,357 participants, SMD -0.27, 95% CI [-0.53, -0.01], Tau2 = 0.06, I 2 = 74%; moderate-quality evidence) and disability (n = 7 trials, n = 1,537 participants, SMD -0.21, 95% CI [-0.40, -0.02], Tau2 = 0.03, I 2 = 56%; moderate-quality evidence) compared to usual care. Meta-analyses found telephone with face-to-face interventions does not improve pain and disability compared to usual care or face-to-face care alone. DISCUSSION: We are moderately confident that telephone-based interventions reduce pain intensity and disability in patients with osteoarthritis and spinal pain compared to usual care, but telephone plus face-to-face interventions are no more effective than usual care or face-to-face interventions alone.

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.

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.

Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis.

INTRODUCTION: Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. METHODS AND ANALYSIS: Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. ETHICS AND DISSEMINATION: The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000490572 and ACTRN12615000478516; Pre-results.

Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials.

BACKGROUND: These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. METHOD: These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. CONCLUSIONS: A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

High throughput genomic sequencing of bioaerosols in broiler chicken production facilities.

Chronic inhalation exposure to agricultural dust promotes the development of chronic respiratory diseases among poultry workers. Poultry dust is composed of dander, chicken feed, litter bedding and microbes. However, the microbial composition and abundance has not been fully elucidated. Genomic DNA was extracted from settled dust and personal inhalable dust collected while performing litter sampling or mortality collection tasks. DNA libraries were sequenced using a paired-end sequencing-by-synthesis approach on an Illumina HiSeq 2500. Sequencing data showed that poultry dust is predominantly composed of bacteria (64-67%) with a small quantity of avian, human and feed DNA (< 2% of total reads). Staphylococcus sp. AL1, Salinicoccus carnicancri and Lactobacillus crispatus were the most abundant bacterial species in personal exposure samples of inhalable dust. Settled dust had a moderate relative abundance of these species as well as Staphylococcus lentus and Lactobacillus salivarius. There was a statistical difference between the microbial composition of aerosolized and settled dust. Unlike settled dust composition, aerosolized dust composition had little variance between samples. These data provide an extensive analysis of the microbial composition and relative abundance in personal inhalable poultry dust and settled poultry dust.