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"McAuley, James H."
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The prognosis of acute and persistent low-back pain: a meta-analysis
by
da C. Menezes Costa, Luciola
,
Maher, Christopher G.
,
Herbert, Robert D.
in
Acute Pain
,
Back pain
,
Chronic Pain
2012
Although low-back pain is a highly prevalent condition, its clinical course remains uncertain. Our main objective was to systematically review the literature on the clinical course of pain and disability in patients with acute and persistent low-back pain. Our secondary objective was to investigate whether pain and disability have similar courses.
We performed a meta-analysis of inception cohort studies. We identified eligible studies by searching MEDLINE, Embase and CINAHL. We included prospective studies that enrolled an episode-inception cohort of patients with acute or persistent low-back pain and that measured pain, disability or recovery. Two independent reviewers extracted data and assessed methodologic quality. We used mixed models to determine pooled estimates of pain and disability over time.
Data from 33 discrete cohorts (11 166 participants) were included in the review. The variance-weighted mean pain score (out of a maximum score of 100) was 52 (95% CI 48–57) at baseline, 23 (95% CI 21–25) at 6 weeks, 12 (95% CI 9–15) at 26 weeks and 6 (95% CI 3–10) at 52 weeks after the onset of pain for cohorts with acute pain. Among cohorts with persistent pain, the variance-weighted mean pain score (out of 100) was 51 (95% CI 44–59) at baseline, 33 (95% CI 29–38) at 6 weeks, 26 (95% CI 20–33) at 26 weeks and 23 (95% CI 16–30) at 52 weeks after the onset of pain. The course of disability outcomes was similar to the time course of pain outcomes in the acute pain cohorts, but the pain outcomes were slightly worse than disability outcomes in the persistent pain cohorts.
Patients who presented with acute or persistent low-back pain improved markedly in the first six weeks. After that time improvement slowed. Low to moderate levels of pain and disability were still present at one year, especially in the cohorts with persistent pain.
Journal Article
If exercise is medicine, why don’t we know the dose? An overview of systematic reviews assessing reporting quality of exercise interventions in health and disease
2022
ObjectiveTo determine how well exercise interventions are reported in trials in health and disease.DesignOverview of systematic reviews.Data sourcesPubMed, EMBASE, CINAHL, SPORTDiscus and PsycINFO from inception until June 2021.Eligibility criteriaReviews of any health condition were included if they primarily assessed quality of exercise intervention reporting using the Consensus on Exercise Reporting Template (CERT) or the Template for Intervention Description and Replication (TIDieR). We assessed review quality using a modified version of A MeaSurement Tool to Assess systematic Reviews.ResultsWe identified 7804 studies and included 28 systematic reviews. The median (IQR) percentage of CERT and TIDieR items appropriately reported was 24% (19%) and 49% (33%), respectively. TIDieR items 1, Brief name (median=100%, IQR 4) and 2, Why (median=98%, IQR 6), as well as CERT item 4, Supervision and delivery (median=68%, IQR 89), were the best reported. For replication of exercise interventions, TIDieR item 8, When and how much, was moderately well reported (median=62%, IQR 68) although CERT item 8, Description of each exercise to enable replication (median=23%, IQR 44) and item 13, Detailed description of the exercise intervention (median=24%, IQR 66) were poorly reported. Quality of systematic reviews ranged from moderate to critically low quality.ConclusionExercise interventions are poorly reported across a range of health conditions. If exercise is medicine, then how it is prescribed and delivered is unclear, potentially limiting its translation from research to practice.PROSPERO registration numberCRD42021261285; Open Science Framework: osf.io/my3ec/.
Journal Article
Musculoskeletal conditions may increase the risk of chronic disease: a systematic review and meta-analysis of cohort studies
2018
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; I
2
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.
Journal Article
Improving reporting of observational studies of interventions: The TARGET guideline
by
Hansford, Harrison J.
,
McAuley, James H.
,
Cashin, Aidan G.
in
Clinical trials
,
Guidelines as Topic
,
Humans
2025
Emulating a target trial when conducting an observational study of interventions can reduce the likelihood of design-related biases. The TARGET guideline aims to improve the reporting transparency of observational studies emulating a target trial and help readers appraise and apply the results.
Journal Article
Rescaling pain intensity measures for meta-analyses of analgesic medicines for low back pain appears justified: an empirical examination from randomised trials
by
McAuley, James H.
,
Wewege, Michael A.
,
Williams, Sam A.
in
Adult
,
Analgesics
,
Analgesics - therapeutic use
2022
Objective
Meta-analyses of analgesic medicines for low back pain often rescale measures of pain intensity to use mean difference (MD) instead of standardised mean difference for pooled estimates. Although this improves clinical interpretability, it is not clear whether this method is justified. Our study evaluated the justification for this method.
Methods
We identified randomised clinical trials of analgesic medicines for adults with low back pain that used two scales with different ranges to measure the same construct of pain intensity. We transformed all data to a 0–100 scale, then compared between-group estimates across pairs of scales with different ranges.
Results
Twelve trials were included. Overall, differences in means between pain intensity measures that were rescaled to a common 0–100 scale appeared to be small and randomly distributed. For one study that measured pain intensity on a 0–100 scale and a 0–10 scale; when rescaled to 0–100, the difference in MD between the scales was 0.8 points out of 100. For three studies that measured pain intensity on a 0–10 scale and 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.2 points out of 100 (range 5.5 points lower to 2.7 points higher). For two studies that measured pain intensity on a 0–100 scale and a 0–3 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points out of 100 (range 6.2 points lower to 12.1 points higher). Finally, for six studies that measured pain intensity on a 0–100 scale and a 0–4 scale; when rescaled to 0–100, the average difference in MD between the scales was 0.7 points (range 5.4 points lower to 8.3 points higher).
Conclusion
Rescaling pain intensity measures may be justified in meta-analyses of analgesic medicines for low back pain. Systematic reviewers may consider this method to improve clinical interpretability and enable more data to be included.
Study registration/data availability
Open Science Framework (osf.io/8rq7f).
Journal Article
Estimating the Risk of Chronic Pain: Development and Validation of a Prognostic Model (PICKUP) for Patients with Acute Low Back Pain
by
Maher, Christopher G.
,
Moseley, G. Lorimer
,
McAuley, James H.
in
Adult
,
Australia - epidemiology
,
Back pain
2016
Low back pain (LBP) is a major health problem. Globally it is responsible for the most years lived with disability. The most problematic type of LBP is chronic LBP (pain lasting longer than 3 mo); it has a poor prognosis and is costly, and interventions are only moderately effective. Targeting interventions according to risk profile is a promising approach to prevent the onset of chronic LBP. Developing accurate prognostic models is the first step. No validated prognostic models are available to accurately predict the onset of chronic LBP. The primary aim of this study was to develop and validate a prognostic model to estimate the risk of chronic LBP.
We used the PROGRESS framework to specify a priori methods, which we published in a study protocol. Data from 2,758 patients with acute LBP attending primary care in Australia between 5 November 2003 and 15 July 2005 (development sample, n = 1,230) and between 10 November 2009 and 5 February 2013 (external validation sample, n = 1,528) were used to develop and externally validate the model. The primary outcome was chronic LBP (ongoing pain at 3 mo). In all, 30% of the development sample and 19% of the external validation sample developed chronic LBP. In the external validation sample, the primary model (PICKUP) discriminated between those who did and did not develop chronic LBP with acceptable performance (area under the receiver operating characteristic curve 0.66 [95% CI 0.63 to 0.69]). Although model calibration was also acceptable in the external validation sample (intercept = -0.55, slope = 0.89), some miscalibration was observed for high-risk groups. The decision curve analysis estimated that, if decisions to recommend further intervention were based on risk scores, screening could lead to a net reduction of 40 unnecessary interventions for every 100 patients presenting to primary care compared to a \"treat all\" approach. Limitations of the method include the model being restricted to using prognostic factors measured in existing studies and using stepwise methods to specify the model. Limitations of the model include modest discrimination performance. The model also requires recalibration for local settings.
Based on its performance in these cohorts, this five-item prognostic model for patients with acute LBP may be a useful tool for estimating risk of chronic LBP. Further validation is required to determine whether screening with this model leads to a net reduction in unnecessary interventions provided to low-risk patients.
Journal Article
A meta-epidemiological study on the reported treatment effect of pregabalin in neuropathic pain trials over time
by
McAuley, James H.
,
Harris, Ian A.
,
Lin, Noelle
in
Adult
,
Analgesics
,
Analgesics - therapeutic use
2023
Pregabalin is a drug used to treat neuropathic pain, and its use has increased substantially since 2007. Early trials found a strong treatment effect on pain for post-herpetic neuralgia and diabetic neuropathy. However more recent studies have failed to replicate these results.
This meta-epidemiological study aimed to assess change in the reported effectiveness of pregabalin in neuropathic pain trials over time, and if a change is present, determine any associated factors.
We performed electronic searches for published trials in Medline, Embase and Cochrane Central Register of Controlled Trials databases; and unpublished trials on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australia New Zealand Clinical Trials Registry with no restrictions.
We included randomized, placebo-controlled trials of pregabalin for treatment of neuropathic pain in adults.
Two authors independently extracted study data: sample size and mean baseline, end-point and change in pain scores with measures of variance, trial end year, publication year, clinical indication, funding source, country of study, treatment duration, treatment dose, mean age and percentage male.
We defined treatment effect as the mean difference in pain scores between pregabalin and placebo groups at trial end-point and assessed for change over time using a random-effects meta-regression, adjusted for sample size, indication, treatment duration (weeks) and treatment dose.
We included 38 randomized published trials (9038 participants) and found that between 2003 and 2020, the reported treatment effect of pregabalin decreased by 0.4 points (95% CI: 0.3 to 0.6; p<0.001) on an 11-point pain scale per 5-year interval, from 1.3 points (95% CI: 1.0 to 1.5) in trials conducted in 2001-2005, to 0.3 (95% CI: -0.1 to 0.7) in trials conducted in 2016-2020. The reported treatment effect was lower than the minimal clinically important difference (MCID) of 1.7 points across all time periods, doses and most indications and was not found to be associated with study characteristics.
The reported treatment effect or analgesic efficacy of pregabalin from clinical trials has diminished over time. Clinical recommendations may need to be re-evaluated to account for recent evidence and to consider whether pregabalin therapy is indicated.
Journal Article
Motor Control Exercise for Persistent, Nonspecific Low Back Pain: A Systematic Review
by
Christopher G Maher
,
James H McAuley
,
Luciana G Macedo
in
Back pain
,
Care and treatment
,
Clinical trials
2009
Previous systematic reviews have concluded that the effectiveness of motor control exercise for persistent low back pain has not been clearly established.
The objective of this study was to systematically review randomized controlled trials evaluating the effectiveness of motor control exercises for persistent low back pain.
Electronic databases were searched to June 2008. Pain, disability, and quality-of-life outcomes were extracted and converted to a common 0 to 100 scale. Where possible, trials were pooled using Revman 4.2.
Fourteen trials were included. Seven trials compared motor control exercise with minimal intervention or evaluated it as a supplement to another treatment. Four trials compared motor control exercise with manual therapy. Five trials compared motor control exercise with another form of exercise. One trial compared motor control exercise with lumbar fusion surgery. The pooling revealed that motor control exercise was better than minimal intervention in reducing pain at short-term follow-up (weighted mean difference=-14.3 points, 95% confidence interval [CI]=-20.4 to -8.1), at intermediate follow-up (weighted mean difference=-13.6 points, 95% CI=-22.4 to -4.1), and at long-term follow-up (weighted mean difference=-14.4 points, 95% CI=-23.1 to -5.7) and in reducing disability at long-term follow-up (weighted mean difference=-10.8 points, 95% CI=-18.7 to -2.8). Motor control exercise was better than manual therapy for pain (weighted mean difference=-5.7 points, 95% CI=-10.7 to -0.8), disability (weighted mean difference=-4.0 points, 95% CI=-7.6 to -0.4), and quality-of-life outcomes (weighted mean difference=-6.0 points, 95% CI=-11.2 to -0.8) at intermediate follow-up and better than other forms of exercise in reducing disability at short-term follow-up (weighted mean difference=-5.1 points, 95% CI=-8.7 to -1.4).
Motor control exercise is superior to minimal intervention and confers benefit when added to another therapy for pain at all time points and for disability at long-term follow-up. Motor control exercise is not more effective than manual therapy or other forms of exercise.
Journal Article
Effect of Motor Control Exercises Versus Graded Activity in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
2012
Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other.
The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain.
This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group.
The study was conducted in primary care settings.
The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain.
Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy.
Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention.
A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (-0.7 to 0.8).
Clinicians could not be blinded to the interventions.
results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.
Journal Article
Comparative efficacy and acceptability of non-pharmacological interventions in fibromyalgia: Protocol for a network meta-analysis
by
de Zoete, Rutger M. J.
,
Mascarenhas, Rodrigo O.
,
McAuley, James H.
in
Acceptability
,
Acupuncture
,
Behavior modification
2022
Although several non-pharmacological interventions have been tested in the management of Fibromyalgia (FM), there is little consensus regarding the best options for the treatment of this health condition. The purpose of this network meta-analysis (NMA) is to investigate the comparative efficacy and acceptability of non-pharmacological interventions for FM, in order to assist clinical decision making through a ranking of interventions in relation to the most important clinical outcomes in these patients.
We will perform a systematic search to identify randomised controlled trials of non-pharmacological interventions endorsed in guidelines and systematic reviews. Information sources searched will include major bibliographic databases without language or date restrictions (MEDLINE, Cochrane Library, EMBASE, AMED, PsycINFO and PEDro). Our primary outcomes will be pain intensity, patient-reported quality of life (QoL), and acceptability of treatment will be our secondary outcome. Risk of bias of the included trials will be assessed using the Cochrane risk of bias tool (RoB2). For each pairwise comparison between the different interventions, we will present mean differences (MDs) for pain intensity and QoL outcomes and Relative Risks (RRs) for acceptability, both with respective 95% confidence intervals (CIs). Initially, standard pairwise meta-analyses will be performed using a DerSimonian-Laird random effects model for all comparisons with at least two trials and then we will perform a frequentist NMA using the methodology of multivariate meta-analysis assuming a common heterogeneity parameter, using the mvmeta command and network suite in STATA. In the NMA, two different types of control group, such as placebo/sham and no intervention/waiting list will be combined as one node called \"Control\". The competing interventions will be ranked using the P-score, which is the frequentist analogue of surface under the cumulative ranking curve (SUCRA) for the outcomes of interest at immediate- (intervention duration of up to 2 weeks), short- (over 2 weeks up to 12 weeks) and long-terms (over 12 weeks). The confidence in the results from NMA will be assessed using the Confidence in Network Meta-analysis (CINeMA) framework.
This work synthesises evidence from previously published studies and does not require ethics review or approval. A manuscript describing the findings will be submitted for publication in a peer-reviewed scientific journal.
OSF (DOI: 10.17605/OSF.IO/7MS25) and registered in the PROSPERO database (CRD42020216374).
Journal Article