ORCID Profile
0000-0001-5692-0314
Current Organisation
University of Oxford
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Publisher: Public Library of Science (PLoS)
Date: 27-04-2022
DOI: 10.1371/JOURNAL.PMED.1003980
Abstract: We previously found that 25% of 1,017 randomized clinical trials (RCTs) approved between 2000 and 2003 were discontinued prematurely, and 44% remained unpublished at a median of 12 years follow-up. We aimed to assess a decade later (1) whether rates of completion and publication have increased (2) the extent to which nonpublished RCTs can be identified in trial registries and (3) the association between reporting quality of protocols and premature discontinuation or nonpublication of RCTs. We included 326 RCT protocols approved in 2012 by research ethics committees in Switzerland, the United Kingdom, Germany, and Canada in this metaresearch study. Pilot, feasibility, and phase 1 studies were excluded. We extracted trial characteristics from each study protocol and systematically searched for corresponding trial registration (if not reported in the protocol) and full text publications until February 2022. For trial registrations, we searched the (i) World Health Organization: International Clinical Trial Registry Platform (ICTRP) (ii) US National Library of Medicine ( ClinicalTrials.gov ) (iii) European Union Drug Regulating Authorities Clinical Trials Database (EUCTR) (iv) ISRCTN registry and (v) Google. For full text publications, we searched PubMed, Google Scholar, and Scopus. We recorded whether RCTs were registered, discontinued (including reason for discontinuation), and published. The reporting quality of RCT protocols was assessed with the 33-item SPIRIT checklist. We used multivariable logistic regression to examine the association between the independent variables protocol reporting quality, planned s le size, type of control (placebo versus other), reporting of any recruitment projection, single-center versus multicenter trials, and industry versus investigator sponsoring, with the 2 dependent variables: (1) publication of RCT results and (2) trial discontinuation due to poor recruitment. Of the 326 included trials, 19 (6%) were unregistered. Ninety-eight trials (30%) were discontinued prematurely, most often due to poor recruitment (37% 36/98). One in 5 trials (21% 70/326) remained unpublished at 10 years follow-up, and 21% of unpublished trials (15/70) were unregistered. Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). The median proportion of reported SPIRIT items in included RCT protocols was 69% (interquartile range 61% to 77%). We found no variables associated with trial discontinuation however, lower reporting quality of trial protocols was associated with nonpublication (odds ratio, 0.71 for each 10% increment in the proportion of SPIRIT items met 95% confidence interval, 0.55 to 0.92 p = 0.009). Study limitations include that the moderate s le size may have limited the ability of our regression models to identify significant associations. We have observed that rates of premature trial discontinuation have not changed in the past decade. Nonpublication of RCTs has declined but remains common 21% of unpublished trials could not be identified in registries. Only 16% of investigator-sponsored trials reported results in a trial registry. Higher reporting quality of RCT protocols was associated with publication of results. Further efforts from all stakeholders are needed to improve efficiency and transparency of clinical research.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 23-04-2018
Publisher: Springer Science and Business Media LLC
Date: 10-02-2022
Publisher: Springer Science and Business Media LLC
Date: 03-03-2016
DOI: 10.1007/S00586-016-4461-0
Abstract: To determine whether emotional distress reported at the initial consultation affects subsequent healthcare use either directly or indirectly via moderating the influence of symptoms. Longitudinal observational study of 2891 participants consulting primary care for low back pain. Negative binomial regression models were constructed to estimate independent effects of emotional distress on healthcare use. Potential confounders were identified using directed acyclic graphs. After the initial consultation, participants had a mean (SD) of one (1.2) visit for back pain over 3 months, and nine (14) visits for back pain over 12 months. Higher reports of anxiety during the initial consultation led to increased short-term healthcare use (IRR 1.06, 95 % CI 1.01-1.11) and higher reports of depression led to increased long-term healthcare use (IRR 1.04, 95 % CI 1.02-1.07). The effect sizes suggest that a patient with a high anxiety score (8/10) would consult 50 % more frequently over 3 months, and a person with a high depression score (8/10) would consult 30 % more frequently over 12 months, compared to a patient with equivalent pain and disability and no reported anxiety or depression. Emotional distress in the acute stage of low back pain increased subsequent consultation rates. Interventions that target emotional distress during the initial consultation are likely to reduce costly and potentially inappropriate future healthcare use for patients with non-specific low back pain.
Publisher: BMJ
Date: 27-02-2014
DOI: 10.1136/BJSPORTS-2012-091853
Abstract: YouTube is one of the largest social networking websites, allowing users to upload and view video content that provides entertainment and conveys many messages, including those related to health conditions, such as concussion. However, little is known about the content of videos relating to concussion. To identify and classify the content of concussion-related videos available on YouTube. An observational study using content analysis. YouTube's video database was systematically searched using 10 search terms selected from MeSH and Google Adwords. The 100 videos with the largest view counts were chosen from the identified videos. These videos and their accompanying text were analysed for purpose, source and description of content by a panel of assessors who classified them into data-driven thematic categories. 434 videos met the inclusion criteria and the 100 videos with the largest view counts were chosen. The most common categories of the videos were the depiction of a sporting injury (37%) and news reports (25%). News and media organisations were the predominant source (51%) of concussion-related videos on YouTube, with very few being uploaded by professional or academic organisations. The median number of views per video was 26 191. Although a wide range of concussion-related videos were identified, there is a need for healthcare and educational organisations to explore YouTube as a medium for the dissemination of quality-controlled information on sports concussion.
Publisher: Elsevier BV
Date: 02-2022
DOI: 10.1016/J.JPAIN.2021.07.007
Abstract: Patient education is recommended as first-line care for low back pain (LBP), although its efficacy for providing clinically meaningful reductions in disability has been questioned. One way to improve treatment effects is to identify and improve targeting of treatment mechanisms. We conducted a pre-planned causal mediation analysis of a randomized, placebo-controlled trial investigating the effectiveness of patient education for patients with acute LBP. 202 patients who had fewer than six-weeks' duration of LBP and were at high-risk of developing chronic LBP completed two, one-hour treatment sessions of either intensive patient education, or placebo patient education. 189 participants provided data for the outcome self-reported disability at three-months and the mediators, pain self-efficacy, pain catastrophizing, and back beliefs at one-week post treatment. This causal mediation analysis found that pain catastrophizing (mediated effect, -0.64 95% Confidence Interval [CI], -1.31 to -0.15) and back beliefs (mediated effect, -0.51 95% CI, -1.15 to -0.02) partly explained the effect of patient education on disability but pain self-efficacy did not (mediated effect, -0.40 95% CI -1.13 to 0.28). Considering the mediator-outcome relationship, patient education would need to induce an 8 point difference on the pain self-efficacy questionnaire (0-60) an 11 point difference on the back beliefs questionnaire (9-45) and a 21 point difference on the pain catastrophizing scale (0-52) to achieve a minimally clinically important difference of 2 points on the Roland Morris Disability Questionnaire (0-24). PERSPECTIVE: Understanding the mechanisms of patient education can inform how this treatment can be adapted to provide clinically meaningful reductions in disability. Our findings suggest that adapting patient education to better target back beliefs and pain self-efficacy could result in clinically meaningful reductions in disability whereas the role of pain catastrophizing in acute LBP is less clear.
Publisher: Elsevier BV
Date: 12-2017
DOI: 10.1016/J.BERH.2017.04.001
Abstract: In recent years, there has been increasing interest in studying causal mechanisms in the development and treatment of back pain. The aim of this article is to provide an overview of our current understanding of causal mechanisms in the field. In the first section, we introduce key concepts and terminology. In the second section, we provide a brief synopsis of systematic reviews of mechanism studies relevant to the clinical course and treatment of back pain. In the third section, we reflect on the findings of our review to explain how understanding causal mechanisms can inform clinical practice and the implementation of best practice. In the final sections, we introduce contemporary methodological advances, highlight the key assumptions of these methods, and discuss future directions to advance the quality of mechanism-related studies in the back pain field.
Publisher: BMJ
Date: 19-07-2023
Publisher: Wiley
Date: 20-08-2014
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-10-2021
DOI: 10.1097/J.PAIN.0000000000002506
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/m 2 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.
Publisher: Elsevier BV
Date: 09-2016
DOI: 10.1016/J.PTSP.2016.03.001
Abstract: Recently image-sharing social media platforms have become a popular medium for sharing health-related images and associated information. However within the field of sports medicine, and more specifically sports related concussion, the content of images and meta-data shared through these popular platforms have not been investigated. The aim of this study was to analyse the content of concussion-related images and its accompanying meta-data on image-sharing social media platforms. We retrieved 300 images from Pinterest, Instagram and Flickr by using a standardised search strategy. All images were screened and duplicate images were removed. We excluded images if they were: non-static images illustrations animations or screenshots. The content and characteristics of each image was evaluated using a customised coding scheme to determine major content themes, and images were referenced to the current international concussion management guidelines. From 300 potentially relevant images, 176 images were included for analysis 70 from Pinterest, 63 from Flickr, and 43 from Instagram. Most images were of another person or a scene (64%), with the primary content depicting injured in iduals (39%). The primary purposes of the images were to share a concussion-related incident (33%) and to dispense education (19%). For those images where it could be evaluated, the majority (91%) were found to reflect the Sports Concussion Assessment Tool 3 (SCAT3) guidelines. The ability to rapidly disseminate rich information though photos, images, and infographics to a wide-reaching audience suggests that image-sharing social media platforms could be used as an effective communication tool for sports concussion. Public health strategies could direct educative content to targeted populations via the use of image-sharing platforms. Further research is required to understand how image-sharing platforms can be used to effectively relay evidence-based information to patients and sports medicine clinicians.
Publisher: Elsevier BV
Date: 2013
DOI: 10.1016/J.JSAMS.2012.03.013
Abstract: The purpose of this systematic review was to determine the viability of the dual-task paradigm in the evaluation of a sports-related concussion. Systematic review and meta-analysis. Eight electronic databases were searched from their inception until the 11(th) of April 2011. Studies were grouped according to their reported gait performance variables and their time(s) of assessment(s). Raw mean differences (MD) and 95% confidence intervals (CI) were calculated based on raw means and standard deviations for gait performance measures in both single- and dual-task conditions. Dual-task deficits were pooled using a random effects model and heterogeneity (I(2)) between studies was assessed. Ten studies representing a total s le of 168 concussed and 167 matched (age and gender) non-concussed participants met the inclusion criteria. Meta-analysis demonstrated that dual-task performance deficits were detected (p<0.05) in the concussed group for gait velocity (GV) (MD=-0.133 95% CI -0.197, -0.069) and range of motion of the centre of mass in the coronal plane (ML-ROM) (MD=0.007 95% CI 0.002, 0.011), but not in the non-concussed group GV (MD=-0.048 95% CI -0.101, 0.006), ML-ROM (MD=0.002 95% CI -0.001, 0.005). The results of this study indicate that GV and ML-ROM are sensitive measures of dual-task related changes in concussed patients and should be considered as part of a comprehensive assessment for a sports-related concussion.
Publisher: BMJ
Date: 09-2021
DOI: 10.1136/BMJOPEN-2021-049938
Abstract: To investigate (1) self-reported societal comprehension of common and usually non-serious terms found in lumbar spine imaging reports and (2) its relationship to perceived seriousness, likely persistence of low back pain (LBP), fear of movement, back beliefs and history and intensity of LBP. Cross-sectional online survey of the general public. Five English-speaking countries: UK, USA, Canada, New Zealand and Australia. Adults (age years) with or without a history of LBP recruited in April 2019 with quotas for country, age and gender. Self-reported understanding of 14 terms (annular fissure, disc bulge, disc degeneration, disc extrusion, disc height loss, disc protrusion, disc signal loss, facet joint degeneration, high intensity zone, mild canal stenosis, Modic changes, nerve root contact, spondylolisthesis and spondylosis) commonly found in lumbar spine imaging reports. For each term, we also elicited worry about its seriousness, and whether its presence would indicate pain persistence and prompt fear of movement. From 774 responses, we included 677 (87.5%) with complete and valid responses. 577 (85%) participants had a current or past history of LBP of whom 251 (44%) had received lumbar spine imaging. Self-reported understanding of all terms was poor. At best, 235 (35%) reported understanding the term ‘disc degeneration’, while only 71 (10.5%) reported understanding the term ‘Modic changes’. For all terms, a moderate to large proportion of participants (range 59%–71%), considered they indicated a serious back problem, that pain might persist (range 52%–71%) and they would be fearful of movement (range 42%–57%). Common and usually non-serious terms in lumbar spine imaging reports are poorly understood by the general population and may contribute to the burden of LBP. ACTRN12619000545167.
Publisher: Elsevier BV
Date: 04-2018
Publisher: BMJ
Date: 16-11-2017
Publisher: JMIR Publications Inc.
Date: 02-07-2021
DOI: 10.2196/26053
Abstract: Chronic low back pain (CLBP) is a global health problem associated with an increasing burden on in iduals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence. This protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation. We will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses. Ethical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia. The RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient-reported outcomes. These results will help guide the treatment refinement and implementation. Australian and New Zealand Clinical Trials Registry ACTRN12615000610538 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619& isReview=true DERR1-10.2196/26053
Publisher: BMJ
Date: 24-01-2021
DOI: 10.1136/BMJEBM-2019-111296
Abstract: Scientific progress requires transparency and openness. The ability to critique, replicate and implement scientific findings depends on the transparency of the study design and methods, and the open availability of study materials, data and code. Journals are key stakeholders in supporting transparency and openness. This study aimed to evaluate 10 highest ranked pain journals’ authorship policies with respect to their support for transparent and open research practices. Two independent authors evaluated the journal policies (as at 27 May 2019) using three tools: the self-developed Transparency and Openness Evaluation Tool, the Centre for Open Science (COS) Transparency Factor and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosure of conflicts of interest. We found that the journal policies had an overall low level of engagement with research transparency and openness standards. The median COS Transparency Factor score was 3.5 (IQR 2.8) of 29 possible points, and only 7 of 10 journals’ stated requirements for disclosure of conflicts of interest aligned fully with the ICMJE recommendations. Improved transparency and openness of pain research has the potential to benefit all that are involved in generating and using research findings. Journal policies that endorse and facilitate transparent and open research practices will ultimately improve the evidence base that informs the care provided for people with pain.
Publisher: Springer Science and Business Media LLC
Date: 12-03-2018
Publisher: Elsevier BV
Date: 03-2021
Publisher: Elsevier BV
Date: 09-2015
DOI: 10.1016/J.JPAIN.2015.05.007
Abstract: Upper limb fracture is a common musculoskeletal injury and can lead to marked pain-related disability. Unlike other common painful musculoskeletal conditions, such as low back pain, little consideration has been given to the role that psychological variables may play in explaining the relationship between pain and disability during early fracture recovery. This cross-sectional study aimed to determine if psychological distress (symptoms of depression, anxiety, and/or stress) mediate the relationship between pain and disability in acute hand/wrist fractures. Self-reported data from a consecutive s le of 594 patients with acute hand/wrist fracture were used. Mediation analyses were conducted to determine the role of depression, anxiety, and stress in the relationship between pain and disability, controlling for relevant demographic and fracture-related variables. Depression and stress, but not anxiety, significantly mediated the relationship between pain and disability. That is, although each psychological distress variable was associated with pain (P < .001), only depression (b1 = 0.27, P = .03) and stress (b3 = .23, P = .02) were significantly associated with disability and fulfilled recommended criteria for establishing a mediating variable. Increased depression and stress, but not anxiety, explain the relationship between pain and disability and may be novel targets for interventions designed to reduce pain-related disability after upper limb fracture. Perspective: This study presents the mediating effect of psychological distress on the relationship between pain and disability in acute upper limb fracture. These factors may be novel targets for interventions designed to reduce pain-related disability after acute fracture.
Publisher: Elsevier BV
Date: 07-2021
Publisher: BMJ
Date: 10-2020
Publisher: National Institute for Health and Care Research
Date: 02-2021
DOI: 10.3310/HTA25090
Abstract: Cognitive–behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive–behavioural therapy systematic reviews suggested that cognitive–behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials. This project was undertaken to map the quality and gaps in the cognitive–behavioural therapy systematic review of randomised controlled trial evidence base. Panoramic meta-analyses were also conducted to identify any across-condition general effects of cognitive–behavioural therapy. The overview was designed with cognitive–behavioural therapy patients, clinicians and researchers. The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Child Development & Adolescent Studies, Database of Abstracts of Reviews of Effects and OpenGrey databases were searched from 1992 to January 2019. Study inclusion criteria were as follows: (1) fulfil the Centre for Reviews and Dissemination criteria (2) intervention reported as cognitive–behavioural therapy or including one cognitive and one behavioural element (3) include a synthesis of cognitive–behavioural therapy trials (4) include either health-related quality of life, depression, anxiety or pain outcome and (5) available in English. Review quality was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR)-2. Reviews were quality assessed and data were extracted in duplicate by two independent researchers, and then mapped according to condition, population, context and quality. The effects from high-quality reviews were pooled within condition groups, using a random-effect panoramic meta-analysis. If the across-condition heterogeneity was I 2 75%, we pooled across conditions. Subgroup analyses were conducted for age, delivery format, comparator type and length of follow-up, and a sensitivity analysis was performed for quality. A total of 494 reviews were mapped, representing 68% (27/40) of the categories of the International Classification of Diseases, Eleventh Revision, Mortality and Morbidity Statistics. Most reviews (71%, 351/494) were of lower quality. Research on older adults, using cognitive–behavioural therapy preventatively, ethnic minorities and people living outside Europe, North America or Australasia was limited. Out of 494 reviews, 71 were included in the primary panoramic meta-analyses. A modest effect was found in favour of cognitive–behavioural therapy for health-related quality of life (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.05 to 0.50, I 2 = 32%), anxiety (standardised mean difference 0.30, 95% confidence interval 0.18 to 0.43, prediction interval –0.28 to 0.88, I 2 = 62%) and pain (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval –0.28 to 0.74, I 2 = 64%) outcomes. All condition, subgroup and sensitivity effect estimates remained consistent with the general effect. A statistically significant interaction effect was evident between the active and non-active comparator groups for the health-related quality-of-life outcome. A general effect for depression outcomes was not produced as a result of considerable heterogeneity across reviews and conditions. Data extraction and analysis were conducted at the review level, rather than returning to the in idual trial data. This meant that the risk of bias of the in idual trials could not be accounted for, but only the quality of the systematic reviews that synthesised them. Owing to the consistency and homogeneity of the highest-quality evidence, it is proposed that cognitive–behavioural therapy can produce a modest general, across-condition benefit in health-related quality-of-life, anxiety and pain outcomes. Future research should focus on how the modest effect sizes seen with cognitive–behavioural therapy can be increased, for ex le identifying alternative delivery formats to increase adherence and reduce dropout, and pursuing novel methods to assess intervention fidelity and quality. This study is registered as PROSPERO CRD42017078690. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 9. See the NIHR Journals Library website for further project information.
Publisher: Research Square Platform LLC
Date: 27-01-2020
Abstract: Background There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). Methods/Design AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. Discussion The development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Publisher: JMIR Publications Inc.
Date: 25-11-2020
Abstract: hronic low back pain (CLBP) is a global health problem associated with an increasing burden on in iduals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence. his protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation. e will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses. thical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia. he RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient-reported outcomes. These results will help guide the treatment refinement and implementation. ustralian and New Zealand Clinical Trials Registry ACTRN12615000610538 www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619& isReview=true ERR1-10.2196/26053
Publisher: Elsevier BV
Date: 11-2012
DOI: 10.1016/J.PTSP.2011.10.004
Abstract: To investigate physical therapy students' understanding of the concept of rest following a sport concussion and to ascertain if this understanding changes following a lecture based on current best practice concussion knowledge. Pre-post observational survey. University classroom setting. A cohort of 118 (40 male, 78 female) physical therapy students participating in volunteer sports medic training. Participants provided 320 (pre) and 350 (post) responses depicting activities which should be restricted following a concussion. The responses were classified into three rest-related categories: 'Physical rest', 'Cognitive rest' and 'Mixed' (a combination of physical and cognitive rest). Pre-lecture, approximately 74% of the student's responses were categorized as Physical rest, and 25% under Mixed. There was a shift in the response pattern post-lecture, with 96% of the responses falling in the Mixed category. The results of the study highlight a lack of understanding of the concept of cognitive rest in concussion management among trainee sport medics. The need for wider dissemination of this concept as recommended by the recent consensus statement on sports concussion is indicated.
Publisher: Wiley
Date: 30-01-2022
Abstract: We aimed to determine, in those who present to the ED with low back pain (LBP): (i) the prevalence of four key diagnostic categories, (ii) trends in lumbar imaging from 2015 to 2019 and (iii) the effect of a new model of care on lumbar imaging in the ED. We conducted a retrospective analysis of routinely collected medical data of four tertiary hospitals in Sydney, Australia. We analysed ED presentations for LBP between January 2012 and October 2019. Outcomes were the prevalence of four key diagnostic categories of LBP and use of lumbar imaging. We examined trends in lumbar imaging over time and used interrupted time series analysis to determine the impact of model of care implementation on imaging use. There were 31 168 presentations for LBP of which 64.5% were non‐specific LBP, 27.2% were problems beyond the spine, 5.3% were LBP with neurological signs and 2.3% were serious spinal conditions. 28.9% received lumbar imaging use did not change substantially between 2012 and 2019. Patients diagnosed with serious spinal conditions were more likely to receive imaging (59%) than those diagnosed with non‐specific LBP (29%). Implementation of a state‐wide model of care in November 2016 did not appear to influence imaging use. Most presentations to the ED for LBP are for non‐specific LBP. Around 2% will have specific spinal pathology. Use of imaging in those diagnosed with non‐specific LBP remains high and was unaffected by implementation of a state‐wide model of care.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 08-03-2018
DOI: 10.1097/J.PAIN.0000000000001198
Abstract: 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 ( months in duration) and body mass index ≥27 kg/m 2 and kg/m 2 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.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 12-2015
Publisher: Elsevier BV
Date: 10-2021
Publisher: MDPI AG
Date: 16-02-2021
Abstract: Clinicians have an increasing number of evidence-based interventions to treat pain in youth. Mediation analysis offers a way of investigating how interventions work, by examining the extent to which an intermediate variable, or mediator, explains the effect of an intervention. This systematic review examined studies that used mediation analysis to investigate mechanisms of interventions on pain-relevant outcomes for youth (3–18 years) with acute or chronic pain, and provides recommendations for future mediation research in this field. We searched five electronic databases for clinical trials or observational longitudinal studies that included a comparison group and conducted mediation analyses of interventions on youth and assessed pain outcomes. We found six studies (N = 635), which included a total of 53 mediation models examining how interventions affect pain-relevant outcomes for youth. Five studies were secondary analyses of randomized controlled trials of psychological interventions for chronic pain one was a longitudinal observational study of morphine for acute pain. The pain conditions studied were irritable bowel syndrome, functional abdominal pain, juvenile fibromyalgia, mixed chronic pain, and post-operative pain. Fourteen putative mediators were tested, of which three partially mediated treatment effect seven did not significantly mediate treatment effect and four had mixed results. Methodological and reporting limitations were common. There are substantial gaps in the field with respect to investigating, and therefore understanding, how paediatric interventions work.
Publisher: SAGE Publications
Date: 2020
Abstract: To estimate synergistic effects of hip/knee osteoarthritis (OA) and comorbidities on mobility or self-care limitations among older adults. We used baseline, cross-sectional data from the Oxford Pain, Activity and Lifestyle (OPAL) study. Participants were community-dwelling adults aged 65 years or older who completed a postal questionnaire. Participants reported demographic information, hip/knee OA, comorbidities and mobility and self-care limitations. We used modified Poisson regression models to estimate the independent and combined relative risks (RR) of mobility or self-care limitations, the relative excess risk due to interaction (RERI) between hip/knee OA and comorbidities, attributable proportion of the risk due to the interaction and the ratio of the combined effect and the sum of the in idual effects, known as the synergy index. Of the 4,972 participants included, 1,532 (30.8%) had hip/knee OA, and of them 42.9% reported mobility limitations and 8.4% reported self-care limitations. Synergistic effects impacting self-care limitations were observed between hip/knee OA and anxiety (RR: 3.09, 95% Confidence Interval (CI): 2.00 to 4.78 RERI: 0.93, 95% CI: 0.01 to 1.90), and between hip/knee OA and depressive symptoms (RR: 2.71, 95% CI: 1.75 to 4.20 RERI: 0.58, 95% CI: 0.03 to 1.48). The portion of the total RR attributable to this synergism was 30% and 22% respectively. This study demonstrates that synergism between hip/knee OA and anxiety or depressive symptoms contribute to self-care limitations. These findings highlight the importance of assessing and addressing anxiety or depressive symptoms when managing older adults with hip/knee OA to minimize self-care limitations.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2015
Publisher: Springer Science and Business Media LLC
Date: 03-02-2020
DOI: 10.1186/S12874-020-0915-5
Abstract: There are a growing number of studies using mediation analysis to understand the mechanisms of health interventions and exposures. Recent work has shown that the reporting of these studies is heterogenous and incomplete. This problem stifles clinical application, reproducibility, and evidence synthesis. This paper describes the processes and methods that will be used to develop a guideline for reporting studies of mediation analyses (AGReMA). AGReMA will be developed over five overlapping stages. Stage one will comprise a systematic review to examine relevant evidence on the quality of reporting in published studies that use mediation analysis. In the second stage we will consult a group of methodologists and applied researchers by using a Delphi process to identify items that should be considered for inclusion in AGReMA. The third stage will involve a consensus meeting to consolidate and prioritise key items to be included in AGReMA. The fourth stage will involve the production of AGReMA and an accompanying explanation and elaboration document. In the final stage we will disseminate the AGReMA statement via journals, conferences, and professional meetings across multiple disciplines. The development and implementation of AGReMA will improve the standardization, transparency, and completeness in the reporting of studies that use mediation analysis to understand the mechanisms of health interventions and exposures.
Publisher: Elsevier BV
Date: 05-0008
DOI: 10.1016/J.JSAMS.2014.04.003
Abstract: To explore whether an exercise protocol, alone and in combination with two selected cognitive tasks related to working memory, provokes postconcussion-like symptoms in healthy in iduals. Prospective single cohort semi-randomised crossover repeated measures (time×condition) design. 36 healthy in iduals completed three submaximal exercise protocol conditions, namely: exercise alone, exercise with the paced auditory serial addition task, and exercise with Tetris. Self-reported symptoms were measured before exercise and 1-min and 15-min after the cessation of each exercise protocol using the Sports Concussion Assessment Tool 2-Postconcussion symptoms scale. Analysis of variance indicated a significant increase in symptom scores over time (p<0.001), but no effect between conditions (p=0.371) or a significant time×condition interaction (p=0.444). The combination of working memory tasks and a symptom provoking submaximal exercise protocol did not have an additional effect on the provocation of self-reported symptoms in healthy in iduals. Furthermore, the two distinct methods of cognitive load delivery, controlled (paced auditory serial addition task) and pragmatic (Tetris), did not lead to a differential symptom response. These findings provide an initial insight into the scientific foundations for the symptom provocation model that is integral to the currently accepted clinical postconcussion return-to-play protocol.
Publisher: F1000 Research Ltd
Date: 18-01-2021
DOI: 10.12688/HRBOPENRES.13119.2
Abstract: Background: There is a growing global movement towards open science and ensuring that health research is more transparent. It is vital that the researchers are adequately prepared for this research environment from early in their careers. However, limited research has been conducted on the barriers and enablers to practicing open science for early career researchers. This study aimed to explore the views, experiences and factors influencing open science practices amongst ECRs working in health research. Methods: Semi-structured in idual interviews were conducted with a convenience s le of ECRs working in health research. Participants also completed surveys regarding the factors influencing open science practices. Thematic analysis was used to analyse the qualitative data and descriptive statistical analyses were used to analyse survey data. Results: 14 ECRs participated. Two main themes were identified from interview data Valuing Open Science and Creating a Culture for Open Science. Within ‘Valuing Open Science’, participants spoke about the conceptualisation of open science to be open across the entire research cycle, and important for producing better and more impactful research for patients and the public. Within ‘Creating a Culture of Open Science’ participants spoke about a number of factors influencing their practice of open science. These included cultural and academic pressures, the positives and negatives of increased accountability and transparency, and the need for more training and supporting resources to facilitate open science practices. Conclusion: ECRs see the importance of open science for beneficially impacting patient and public health but many feel that they are not fully supported to practice open science. Resources and supports including education and training are needed, as are better incentives for open science activities. Crucially, tangible engagement from institutions, funders and researchers is needed to facilitate the development of an open science culture.
Publisher: BMJ
Date: 13-01-2020
Publisher: F1000 Research Ltd
Date: 21-08-2020
DOI: 10.12688/HRBOPENRES.13119.1
Abstract: Background: There is a growing global movement towards open science and ensuring that health research is more transparent. It is vital that the researchers are adequately prepared for this research environment from early in their careers. However, the barriers and enablers to practicing open science for early career researchers (ECRs) have been explored to a limited extent. This study aimed to explore the views, experiences and factors influencing open science practices amongst ECRs working in health research. Methods: Semi-structured in idual interviews were conducted with a convenience s le of ECRs working in health research. Participants also completed surveys regarding the factors influencing open science practices. Thematic analysis was used to analyse the qualitative data and descriptive statistical analyses were used to analyse survey data. Results: 14 ECRs participated. Two main themes were identified from interview data Valuing Open Science and Creating a Culture for Open Science. Within ‘Valuing Open Science’, participants spoke about the conceptualisation of open science to be open across the entire research cycle, and important for producing better and more impactful research for patients and the public. Within ‘Creating a Culture of Open Science’ participants spoke about a number of factors influencing their practice of open science. These included cultural and academic pressures, the positives and negatives of increased accountability and transparency, and the need for more training and supporting resources to facilitate open science practices. Conclusion: ECRs see the importance of open science for beneficially impacting patient and public health but many feel that they are not fully supported to practice open science. Resources and supports including education and training are needed, as are better incentives for open science activities. Crucially, tangible engagement from institutions, funders and researchers is needed to facilitate the development of an open science culture.
Publisher: Springer Science and Business Media LLC
Date: 23-08-2019
Publisher: BMJ
Date: 26-08-2020
DOI: 10.1136/BMJEBM-2020-111406
Abstract: Mediation analysis is a widely used quantitative method for investigating how interventions and exposures in randomised controlled trials and observational studies have an effect on healthcare outcomes. This study aimed to assess the importance of items that should be considered in a consensus meeting aimed at developing a guideline for reporting mediation analyses. International online Delphi study. International experts in the development and application of mediation analysis. The Delphi panel were asked to rate the importance of a list of items for inclusion in a guideline for reporting mediation analyses. Thresholds for disagreement and consensus on importance for inclusion were specified a priori. We used the Research ANd Development/University of California Los Angeles appropriateness method to quantitatively assess the importance for inclusion and panel agreement. Nineteen expert panellists (10 female) from seven countries agreed to participate. All panellists contributed to all three rounds conducted between 10 June 2019 and 6 November 2019. The panel reached consensus on 34 unique reporting items for study design, analytic procedures and effect estimates, with three items rated ‘optional’. Panellists added one extra item and provided 60 qualitative comments for item refinement and prioritisation. This Delphi study used a rigorous consensus process to reach consensus on 34 reporting items for studies that use mediation analysis. These results will inform a consensus meeting that will consolidate a core set of recommended items for reporting mediation analyses.
Publisher: No publisher found
Date: 2017
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2016
Publisher: BMJ
Date: 15-03-2012
Abstract: Twitter is a rapidly growing social networking site (SNS) with approximately 124 million users worldwide. Twitter allows users to post brief messages ('tweets') online, on a range of everyday topics including those dealing with health and wellbeing. Currently, little is known about how tweets are used to convey information relating to specific injuries, such as concussion, that commonly occur in youth sports. The purpose of this study was to analyse the online content of concussion-related tweets on the SNS Twitter, to determine the concept and context of mild traumatic brain injury as it relates to an online population. A prospective observational study using content analysis. Twitter traffic was investigated over a 7-day period in July 2010, using eight concussion-related search terms. From the 3488 tweets identified, 1000 were randomly selected and independently analysed using a customised coding scheme to determine major content themes. The most frequent theme was 'news' (33%) followed by 'sharing personal information/situation' (27%) and 'inferred management' (13%). Demographic data were available for 60% of the s le, with the majority of tweets (82%) originating from the USA, followed by Asia (5%) and the UK (4.5%). This study highlights the capacity of Twitter to serve as a powerful broadcast medium for sports concussion information and education.
Publisher: Wiley
Date: 21-12-2018
DOI: 10.1111/DAR.12623
Abstract: Changes in risk and protective factors of adolescent alcohol use may be contributing to the recent decline in Australian adolescents alcohol use. The study aimed to determine the: (i) prevalence of alcohol use, risk and protective factors in 2011 and 2014 and (ii) association between alcohol use and risk and protective factors in 2011 and 2014. A repeat cross-sectional study was conducted. Grade 9-10 (aged 15-17 years) students from 32 Australian secondary schools were s led in 2011 and 2014. A self-report survey collected data regarding alcohol use (ever, recent, 'binge drinking'), risk factors (e.g. alcohol use ermissive attitude to alcohol by friends/siblings arents) and protective factors (e.g. self-efficacy school/home/community support peer caring relationships). Descriptive statistics were used to determine differences in alcohol use, risk and protective factors between 2011 and 2014. Adjusted multivariable logistic regression analyses examined associations between alcohol use, risk and protective factors separately in 2011 and 2014 (six models). Fewer adolescents reported alcohol use in 2014 compared with 2011 (ever: 56.6% vs. 67.9%, recent: 17.3% vs. 21.2%, 'binge drinking': 20.0% vs. 23.5% 2011: n = 4366 2014: n = 5199). Significant differences between 2014 and 2011 were found for some risk (five lower one higher) and protective factors (four lower). Risk factors that were significantly lower in 2014 compared to 2011 were amongst variables with the strongest associations with alcohol use. The strength of associations with alcohol use, and decrease in the prevalence of certain risk factors in 2014 compared to 2011, suggests such factors may be contributing to the decline in adolescent alcohol use.
Publisher: Center for Open Science
Date: 13-10-2017
Abstract: Studies investigating causal mechanisms are becoming increasingly common.Despite growing numbers of publications and trialist embedding mechanismevaluations into randomised controlled trials and observational studies, the reporting accuracy and consistency of mechanism studies is suboptimal. The heterogeneity in the reporting of mechanism evaluations stifles systematic reviews, complicates meta-analyses, and limits transparency and replication. The aim of this initiative is to develop a reporting guideline for mechanism evaluations (mediation analyses). We also plan to develop an accompanying explanation and elaboration (E& E) paper. This project is the first initiative to address the issue of poor reporting quality of mechanism evaluations and has been registered on the “Enhancing the QUAlity and Transparency of health Research” (EQUATOR) network.This initiative is being conducted in accordance with the Guidance for Developers ofHealth Research Reporting Guidelines. This draft report provides an update on theprogress of the project summarising achievements to date and future work.Currently, multiple phases of the overall program are running in parallel, with eachphase informing the subsequent.
Publisher: BMJ
Date: 25-03-2015
DOI: 10.1136/BJSPORTS-2013-092930
Abstract: Mobile technologies are steadily replacing traditional assessment approaches for the recognition and assessment of a sports concussion. Their ease of access, while facilitating the early identification of a concussion, also raises issues regarding the content of the applications (apps) and their suitability for different user groups. To locate and review apps that assist in the recognition and assessment of a sports concussion and to assess their content with respect to that of internationally accepted best-practice instruments. A search of international app stores and of the web using key terms such as 'concussion', 'sports concussion' and variants was conducted. For those apps meeting the inclusion criteria, data were extracted on the platform, intended users and price. The content of each app was benchmarked to the Sport Concussion Assessment Tool 2 (SCAT2) and Pocket SCAT2 using a custom scoring scheme to generate a percentage compliance statistic. 18 of the 155 apps identified met the inclusion criteria. Almost all (16/18) were available on an iOS platform and only five required a payment to purchase. The apps were marketed for a wide range of intended users from medical professionals to the general public. The content of the apps varied from 0% to 100% compliance with the selected standard, and 'symptom evaluation' components demonstrated the highest level of compliance. The surge in availability of apps in an unregulated market raises concerns as to the appropriateness of their content for different groups of end users. The consolidation of best-practice concussion instruments now provides a framework to inform the development of future apps.
Publisher: BMJ
Date: 06-2017
Publisher: Elsevier BV
Date: 2020
DOI: 10.1016/J.JCLINEPI.2019.09.027
Abstract: The objective of this study was to evaluate the methodological conduct, reporting, and risk of bias of nonrandomized studies of interventions (NRSIs) funded by UK National Institute for Health Research Biomedical Research Centres (NIHR-BRCs). We conducted a systematic review, searching the Medline and Web of Science databases between 2012 and 2018, for NRSIs funded by NIHR-BRCs. Eligible studies were published between April 2012 and December 2017. We selected a contemporary subset of NRSIs published in 2017. We extracted study design, methods for overcoming confounding bias from nonrandomization, analysis methods, and items for assessing risk of bias. Risk of bias was the primary outcome, assessed using Risk Of Bias In Non-randomised Studies-of Interventions (ROBINS-I). Fifty-two NSRI publications were included, of which over half were cohort studies and 29% before-and-after studies. Seventy-seven percent analyzed nonpurposefully collected data. All had serious or critical risk of bias. Regression adjustment was most commonly used to address confounding bias (50%). Few (12%) studies accounted for missing data and 42% reported different numbers of outcomes in their methods and results. Most reviewed NRSIs had serious or critical risk of bias. Although NRSIs can evaluate treatment effects when appropriately conducted, this review shows that their design, analysis, and reporting require more consideration.
Publisher: Cold Spring Harbor Laboratory
Date: 28-01-2022
DOI: 10.1101/2022.01.26.22269868
Abstract: Cross-disciplinary openness and transparency of research plays an important role in scientific progress. We evaluated open-science related policies of 19 high ranking health and medical journals before (February 2020) and during (May 2021) the COVID-19 pandemic. The Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) were used to audit journal policies. TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2-12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4-12) in May 2021. Most journals fulfilled all ICMJE provisions for reporting COIs before (84% n=16) and during (95% n=18) the COVID-19 pandemic. The COVID-19 pandemic has highlighted the importance of practising open science, however adherence to open science standards in audited policies was low overall, which may reduce progress in health and medical research.
Publisher: Elsevier BV
Date: 03-2022
DOI: 10.1016/J.JCLINEPI.2021.12.013
Abstract: To describe the bias assessment practice in recently published systematic reviews of mediation studies and to evaluate the quality of different bias assessment tools for mediation analysis proposed in the literature. We conducted an overview of systematic reviews by searching MEDLINE (OvidSP), PsycINFO (OvidSP), Cochrane Database of Systematic Reviews (OvidSP), and PubMed databases for systematic reviews of mediation studies published from 2007 to 2020. Two reviewers independently screened the title, abstracts, and full texts of the identified reports and extracted the data. The publications of all mediation-specific quality assessment tools used in these reviews were also identified for the evaluation of the tools' development and validation. Among 103 eligible reviews, 24 (23%) reviews did not assess the risk of bias of eligible studies, and 48 (47%) assessed risk of bias using a tool that was not specifically designed to evaluate mediation analysis. 31 (30.1%) reviews assessed the risk of mediation-specific biases, either narratively or by using specific tools for mediation studies. However, none of these tools were consensus-based, rigorously developed or validated. The quality assessment practice in recently published systematic reviews of mediation studies is suboptimal. To improve the quality and consistency of risk of bias assessments for mediation studies, a consensus-based bias assessment tool is needed.
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2017
End Date: End date not available
Funder: National Health and Medical Research Council
View Funded ActivityStart Date: 2012
End Date: 2012
Funder: Division of Health Sciences, University of Otago
View Funded ActivityStart Date: 2013
End Date: 2016
Funder: National Health and Medical Research Council
View Funded Activity