A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion. Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorised these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list. Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool. Conclusions: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool.

Exercise therapy for treatment of acute non-specific low back pain: a Cochrane systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: To assess the effectiveness of exercise for acute non-specific low back pain (LBP) versus our main comparisons: 1) sham treatment, and 2) no treatment at short-term (main follow-up time). DATA SOURCES AND STUDY SELECTION: A comprehensive search up till November 2021 was conducted in numerous databases for randomised controlled trials (RCTs) on the effectiveness of exercise in adults with acute LBP (< 6 weeks). Studies examining LBP with a specific aetiology were excluded. The primary outcomes were back pain, back-specific functional status and recovery. DATA EXTRACTION: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to assess the certainty of the evidence. DATA SYNTHESIS: We identified 23 RCTs (2674 participants). There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants) and on functional status (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants) in the short term. There is very low-quality evidence which suggests no difference in effect on pain and functional status for exercise vs. no treatment (2 studies; n=157, not pooled due to heterogeneity) at short-term follow-up. Similar results were found for the other follow-up moments. The certainty of the evidence was downgraded because many RCTs had a high risk of bias, were small in size and/or there was substantial heterogeneity. CONCLUSION: Exercise therapy compared to sham/placebo and no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy.

Understanding how therapeutic exercise prescription changes outcomes important to patients with persistent non-specific low back pain: a realist review protocol.

INTRODUCTION: Persistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP. METHODS: We will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance. DISCUSSION: Realist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP. SYSTEMATIC REVIEW REGISTRATION: The review has been registered with PROSPERO (CRD42017072023).

Sleep as a prognostic factor in low back pain: a systematic review of prospective cohort studies and secondary analyses of randomized controlled trials.

Sleep problems are common in individuals with low back pain (LBP) and sleep restriction seems to be associated with impaired pain processing. Our objective was to investigate whether sleep is associated with future LBP outcomes (i.e. pain intensity, disability, and recovery) in adults. We conducted a systematic review of prospective cohort studies and secondary analyses of randomized controlled trials (registration-PROSPERO CRD42022370781). In December 2022, we searched the MEDLINE, Embase, CINAHL, and PsycINFO databases. Fourteen studies, totaling 19 170 participants were included. Thirteen studies were rated as having high risk of bias (QUIPS tool). We used vote-counting and meta-analysis approaches to synthesize the data. We found associations between baseline sleep with future pain intensity, recovery, and between changes in sleep with changes in pain intensity, changes in disability, and recovery. We further synthesized outcomes as "overall LBP improvement" outcomes. Baseline poor sleep was moderately associated with non-improvement in LBP in the long-very long term (OR 1.55, 95% CI: 1.39 to 1.73; three studies providing unadjusted effect sizes), and non-improvement in sleep was largely associated with non-improvement in LBP in the short-moderate term (OR 3.45, 95% CI: 2.54 to 4.69; four studies providing unadjusted effect sizes). We found no association between baseline sleep with future disability and overall LBP improvement in the short-moderate term. Therefore, sleep may be a prognostic factor for pain intensity and recovery from LBP. All findings were supported by low to very low-quality evidence. Better-conducted studies are needed to strengthen our certainty about the evidence.

Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review.

OBJECTIVE: Therapeutic exercises are a core treatment for low back pain (LBP), but it is uncertain how rehabilitative exercise facilitates change in outcomes. Realist reviews explore how the context (C) of certain settings or populations and underlying mechanisms (M) create intended or unintended outcomes (O). Our objective was to explore and understand the behavioural mechanisms by which therapeutic exercise creates change in outcomes of adherence, engagement and clinical outcomes for patients with LBP. METHODS: This was a realist review reported following the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidance. We developed initial programme theories, modified with input from a steering group (experts, n=5), stakeholder group (patients and clinicians, n=10) and a scoping search of the published literature (n=37). Subsequently, an information specialist designed and undertook an iterative search strategy, and we refined and tested CMO configurations. RESULTS: Of 522 initial papers identified, 75 papers were included to modify and test CMO configurations. We found that the patient-clinician therapeutic consultation builds a foundation of trust and was associated with improved adherence, engagement and clinical outcomes, and that individualised exercise prescription increases motivation to adhere to exercise and thus also impacts clinical outcomes. Provision of support such as timely follow-up and supervision can further facilitate motivation and confidence to improve adherence to therapeutic exercises for LBP. CONCLUSIONS: Engagement in and adherence to therapeutic exercises for LBP, as well as clinical outcomes, may be optimised using mechanisms of trust, motivation and confidence. These CMO configurations provide a deeper understanding of ways to optimise exercise prescription for patients with LBP.

Are Exercise Interventions in Clinical Trials for Chronic Low Back Pain Dosed Appropriately to Meet the World Health Organization's Physical Activity Guidelines?

OBJECTIVE: This study aimed to estimate the proportion of exercise interventions tested in clinical trials of people with chronic low back pain (CLBP) that meet the World Health Organization's (WHO) physical activity guidelines. METHODS: A secondary analysis of the 2021 Cochrane review of exercise therapy for CLBP was performed. Data from each study were extracted by 1 reviewer and were checked by a second reviewer. Data extracted related to the frequency, duration and intensity of each exercise intervention, and the proportion of exercise interventions that met the WHO's physical activity guidelines (aerobic, muscle strengthening, or both) were determined. RESULTS: The 249 included trials comprised 426 exercise interventions. Few interventions reported an exercise type and dose consistent with the WHO guidelines (aerobic: 1.6%, muscle strengthening: 5.6%, both: 1.6%). Poor reporting of exercise intensity limited our ability to determine whether interventions met the guidelines. CONCLUSION: Few interventions tested in clinical trials for people with CLBP prescribe an exercise type and dose consistent with the WHO guidelines. Therefore, they do not appear sufficiently dosed to achieve broader health outcomes. Future trials should investigate the effect of WHO guideline-recommended exercise interventions on patient-reported outcomes (pain and disability) as well as health-related outcomes in people with CLBP. IMPACT: This exploratory analysis showed the lack of exercise interventions in the CLBP literature that meet the WHO's physical activity guidelines. With people in chronic pain groups, such as people with CLBP, being at higher risk for noncommunicable disease, it appears this is a key consideration for exercise practitioners when designing interventions for people with CLBP.

Systematic Review Procedures for the World Health Organization (WHO) Evidence Syntheses on Benefits and Harms of Structured and Standardized Education/Advice, Structured Exercise Programs, Transcutaneous Electrical Nerve Stimulation (TENS), and Needling Therapies for the Management of Chronic Low Back Pain in Adults.

As commissioned by the WHO, we updated and expanded the scope of four systematic reviews to inform its (in development) clinical practice guideline for the management of CPLBP in adults, including older adults. Methodological details and results of each review are described in the respective articles in this series. In the last article of this series, we discuss methodological considerations, clinical implications and recommendations for future research.

Systematic Review to Inform a World Health Organization (WHO) Clinical Practice Guideline: Benefits and Harms of Structured Exercise Programs for Chronic Primary Low Back Pain in Adults.

PURPOSE: Evaluate benefits and harms of structured exercise programs for chronic primary low back pain (CPLBP) in adults to inform a World Health Organization (WHO) standard clinical guideline. METHODS: We searched for randomized controlled trials (RCTs) in electronic databases (inception to 17 May 2022). Eligible RCTs targeted structured exercise programs compared to placebo/sham, usual care, or no intervention (including comparison interventions where the attributable effect of exercise could be isolated). We extracted outcomes, appraised risk of bias, conducted meta-analyses where appropriate, and assessed certainty of evidence using GRADE. RESULTS: We screened 2503 records (after initial screening through Cochrane RCT Classifier and Cochrane Crowd) and 398 full text RCTs. Thirteen RCTs rated with overall low or unclear risk of bias were synthesized. Assessing individual exercise types (predominantly very low certainty evidence), pain reduction was associated with aerobic exercise and Pilates vs. no intervention, and motor control exercise vs. sham. Improved function was associated with mixed exercise vs. usual care, and Pilates vs. no intervention. Temporary increased minor pain was associated with mixed exercise vs. no intervention, and yoga vs. usual care. Little to no difference was found for other comparisons and outcomes. When pooling exercise types, exercise vs. no intervention probably reduces pain in adults (8 RCTs, SMD = - 0.33, 95% CI - 0.58 to - 0.08) and functional limitations in adults and older adults (8 RCTs, SMD = - 0.31, 95% CI - 0.57 to - 0.05) (moderate certainty evidence). CONCLUSIONS: With moderate certainty, structured exercise programs probably reduce pain and functional limitations in adults and older people with CPLBP.

Improving Rehabilitation Research to Optimize Care and Outcomes for People with Chronic Primary Low Back Pain: Methodological and Reporting Recommendations from a WHO Systematic Review Series.

Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. Methods and analysis: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

Bias in the measurement of the outcome is associated with effect sizes in randomized clinical trials on exercise therapy for chronic low back pain: a meta-epidemiological study.

OBJECTIVES: To explore the relationships between the risk of bias and treatment effect estimates for exercise therapy interventions on pain intensity and physical functioning outcomes in randomized controlled trials (RCTs) involving patients with chronic low back pain. STUDY DESIGN AND SETTING: A cross-sectional meta-epidemiological study of the 230 RCTs (31,674 participants) in the 2021 'Exercise therapy for chronic low back pain' Cochrane Review were included. Study design characteristics, sample size, prospective trial registration, flowchart information, interventions, and comparisons were extracted. Independent pairs of reviewers assessed the risk of bias using the Cochrane Risk of Bias 2 tool. RESULTS: The metaregression included 220 (pain intensity) and 203 (physical functioning) effect sizes. Unadjusted and adjusted metaregression models showed no significant associations between the bias domains and pain intensity effect sizes. Only domain 'bias in the measurement of the outcome' was significantly associated with physical functioning (standardized mean difference: -0.40, 95% confidence interval: -0.77 to -0.02) when adjusted for flowchart reported (yes/no), prospective trial registration, sample size, and comparator type. CONCLUSION: The risk of bias in the measurement of the outcome could lead to slight overestimates of the effect size for physical functioning. Clinicians should consider this when they read and assess RCT results in this field. We encourage metaresearchers to replicate our findings using a consistent approach for evaluating the risk of bias (i.e., the RoB 2 tool) in other musculoskeletal conditions and interventions to investigate their generalizability.

The Maritime SPOR SUPPORT Unit (MSSU) Bridge Process: An Integrated Knowledge Translation Approach to Address Priority Health Issues and Increase Collaborative Research in Nova Scotia, Canada.

BACKGROUND: There is evidence of the benefits of integrated knowledge translation (IKT), yet there is limited research outlining the purpose of a knowledge broker (KB) within this approach. The Maritime SPOR SUPPORT Unit (MSSU) acts as a KB to support patient-oriented research across the Maritime provinces in Canada. The "Bridge Process" was developed by the Nova Scotia (NS) site as a strategy that involves work leading up to and following the Bridge Event. The process supports research addressing priority health topics discussed at the event by stakeholder groups. The objectives of this paper were to (1) describe the outputs/outcomes of this IKT approach; and (2) examine the role of the KB. METHODS: Quantitative data were collected from registration and evaluation surveys. Outputs are described with descriptive statistics. Qualitative data were collected through evaluation surveys and internal documents. Data related to KB tasks were categorized into three domains: (1) Knowledge Manager, (2) Linkage and Exchange Agent, and (3) Capacity Developer. RESULTS: The Bridge Process was implemented four times. A total of 314 participants including government, health, patient/citizen, community, and research personnel attended the events. We identified 24 priority topics, with 7 led by teams receiving support to complete related projects. Participants reported improved understanding of the research gaps and policy needs and engaged with individuals they would not have otherwise. Although patients/citizens attended each Bridge Event, only 61% of participants who completed an evaluation survey indicated that they were 'actively engaged in group discussion.' The KB's role was identified in all three domains including Knowledge Manager (eg, defining questions), Linkage and Exchange Agent (eg, engaging stakeholders), and Capacity Builder (eg, research interpretation). CONCLUSION: The MSSU facilitated an IKT approach by acting as a KB throughout the Bridge Process. This deliberative and sequential process served as an effective strategy to increase collaborative health research in the province.

Exercise therapy for treatment of acute non-specific low back pain.

BACKGROUND: Low back pain (LBP) is the leading cause of disability globally. It generates considerable direct costs (healthcare) and indirect costs (lost productivity). The many available treatments for LBP include exercise therapy, which is practised extensively worldwide. OBJECTIVES: To evaluate the benefits and harms of exercise therapy for acute non-specific low back pain in adults compared to sham/placebo treatment or no treatment at short-term, intermediate-term, and long-term follow-up. SEARCH METHODS: This is an update of a Cochrane Review first published in 2005. We conducted an updated search for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We screened the reference lists of all included studies and relevant systematic reviews published since 2004. SELECTION CRITERIA: We included RCTs that examined the effects of exercise therapy on non-specific LBP lasting six weeks or less in adults. Major outcomes for this review were pain, functional status, and perceived recovery. Minor outcomes were return to work, health-related quality of life, and adverse events. Our main comparisons were exercise therapy versus sham/placebo treatment and exercise therapy versus no treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. We evaluated outcomes at short-term follow-up (time point within three months and closest to six weeks after randomisation; main follow-up), intermediate-term follow-up (between nine months and closest to six months), and long-term follow-up (after nine months and closest to 12 months); and we used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 23 studies (13 from the previous review, 10 new studies) that involved 2674 participants and provided data for 2637 participants. Three small studies are awaiting classification, and four eligible studies are ongoing. Included studies were conducted in Europe (N = 9), the Asia-Pacific region (N = 9), and North America (N = 5); and most took place in a primary care setting (N = 12), secondary care setting (N = 6), or both (N = 1). In most studies, the population was middle-aged and included men and women. We judged 10 studies (43%) at low risk of bias with regard to sequence generation and allocation concealment. Blinding is not feasible in exercise therapy, introducing performance and detection bias. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on pain scores in the short term (mean difference (MD) -0.80, 95% confidence interval (CI) -5.79 to 4.19; 1 study, 299 participants). The absolute difference was 1% less pain (95% CI 4% more to 6% less), and the relative difference was 4% less pain (95% CI 20% more to 28% less). The mean pain score was 20.1 (standard deviation (SD) 21) for the intervention group and 20.9 (SD 23) for the control group. There is very low-certainty evidence that exercise therapy compared with sham/placebo treatment has no clinically relevant effect on functional status scores in the short term (MD 2.00, 95% CI -2.20 to 6.20; 1 study, 299 participants). The absolute difference was 2% worse functional status (95% CI 2% better to 6% worse), and the relative difference was 15% worse (95% CI 17% better to 47% worse). The mean functional status score was 15.3 (SD 19) for the intervention group and 13.3 (SD 18) for the control group. We downgraded the certainty of the evidence for pain and functional status by one level for risk of bias and by two levels for imprecision (only one study with fewer than 400 participants). There is very low-certainty evidence that exercise therapy compared with no treatment has no clinically relevant effect on pain or functional status in the short term (2 studies, 157 participants). We downgraded the certainty of the evidence by two levels for imprecision and by one level for inconsistency. One study associated exercise with small benefits and the other found no differences. The first study was conducted in an occupational healthcare centre, where participants received one exercise therapy session. The other study was conducted in secondary and tertiary care settings, where participants received treatment three times per week for six weeks. We did not pool data from these studies owing to considerable clinical heterogeneity. In two studies, there were no reported adverse events. One study reported adverse events unrelated to exercise therapy. The remaining studies did not report whether any adverse events had occurred. Owing to insufficient reporting of adverse events, we were unable to reach any conclusions on the safety or harms related to exercise therapy. AUTHORS' CONCLUSIONS: Exercise therapy compared to sham/placebo treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. Exercise therapy compared to no treatment may have no clinically relevant effect on pain or functional status in the short term in people with acute non-specific LBP, but the evidence is very uncertain. We downgraded the certainty of the evidence to very low for inconsistency, risk of bias concerns, and imprecision (few participants).

Continuous Ultrafiltration Enhances Recovery After Adult Cardiac Surgery With Cardiopulmonary Bypass: A Systematic Review and Meta-analysis.

Background: Cardiac surgery with cardiopulmonary bypass is associated with systemic inflammation. Ultrafiltration used throughout the cardiopulmonary bypass time, continuously, is hypothesized to be an immunomodulatory therapy. Methods: A systematic review and meta-analysis of randomized trials investigating continuous forms of ultrafiltration during adult cardiac surgery (CRD42020219309) was conducted and is reported following PRISMA guidelines. MEDLINE, Embase, CENTRAL, and Scopus were searched on November 3, 2021. The primary endpoint was operative mortality, and secondary outcomes included intensive care unit length of stay (ICU LOS), ventilation time, acute kidney injury or renal failure, and pneumonia. Each study was assessed for risk of bias using the Cochrane Risk-of Bias-Tool for Randomized Trials (RoB2) instrument. Outcomes were analyzed with inverse variance random-effects models and assessed for GRADE quality of evidence. Results: Twelve randomized trials consisting of 989 adult patients undergoing coronary, valvular, or concomitant cardiac procedures were included. Compared to controls, patients receiving continuous ultrafiltration had no statistical difference in operative mortality; risk ratio of 0.32 (95% confidence interval [CI]: 0.10-1.03; P = 0.06). Reductions occurred in ICU LOS, by 7.01 hours (95% CI: 1.86-12.15; P = 0.008); ventilation time, by 2.11 hours (95% CI: 0.71-3.51; P = 0.003); and incidence of pneumonia, with a risk ratio of 0.33 (95% CI: 0.15-0.75; P = 0.008). There wasno difference in renal injury. The GRADE quality of evidence for these outcomes ranged from very low to low. Conclusions: Continuous forms of ultrafiltration enhance recovery after adult cardiac surgery by reducing ICU LOS, ventilation time, and incidence of pneumonia. A multicentre randomized trial could confirm and generalize these findings.

Contexte: La chirurgie cardiaque avec pontage cardiopulmonaire est associée à une inflammation généralisée. On croit que l'ultrafiltration utilisée en continu tout au long du pontage cardiopulmonaire pourrait se révéler un traitement immunomodulateur. Méthodologie: Une revue systématique et une métanalyse d'essais avec répartition aléatoire portant sur les formes d'ultrafiltration continue utilisées pendant une chirurgie cardiaque chez l'adulte (CRD42020219309) ont été réalisées, et les résultats sont présentés selon les lignes directrices PRISMA. Les bases de données MEDLINE, Embase, CENTRAL et Scopus ont été interrogées le 3 novembre 2021. L'étude avait pour critère d'évaluation principal la mortalité pendant la chirurgie, et pour critères secondaires, la durée du séjour aux soins intensifs, la durée de ventilation, la survenue de lésions rénales aiguës ou d'insuffisance rénale et la pneumonie. Pour chaque étude, le risque de biais a été évalué à l'aide de l'instrument Risk-of Bias-Tool for Randomized Trials (RoB2) du réseau Cochrane. Les résultats ont été analysés à l'aide de modèles à effets aléatoires selon l'inverse de la variance, et la qualité des données a été évaluée selon l'échelle GRADE. Résultats: Ont été incluses les données de douze essais avec répartition aléatoire auxquels ont pris part 989 patients adultes ayant subi une intervention chirurgicale coronarienne ou valvulaire, ou une chirurgie cardiaque concomitante. Le taux de mortalité enregistré pendant la chirurgie chez les patients qui avaient reçu une ultrafiltration continue ne s'est pas avéré statistiquement différent de celui relevé chez les témoins; rapport de risque = 0,32 (intervalle de confiance [IC] à 95 % : 0,10 à 1,03; p = 0,06). La durée du séjour aux soins intensifs a diminué de 7,01 heures (IC à 95 % : 1,86 à 12,15; p = 0,008), et le temps de ventilation, de 2,11 heures (IC à 95 % : 0,71 à 3,51; p = 0,003); l'incidence de pneumonie a également baissé (rapport de risques = 0,33 [IC à 95 % : 0,15 à 0,75; p = 0,008]). Aucune différence n'a été observée sur le plan des lésions rénales. La qualité des données selon l'échelle GRADE pour ces résultats allait de faible à très faible. Conclusions: L'ultrafiltration continue améliore le rétablissement après une chirurgie cardiaque chez l'adulte en réduisant la durée du séjour aux soins intensifs, le temps de ventilation et l'incidence de pneumonie. Un essai multicentrique à répartition aléatoire pourrait confirmer et généraliser ces conclusions.

Pain catastrophising and kinesiophobia mediate pain and physical function improvements with Pilates exercise in chronic low back pain: a mediation analysis of a randomised controlled trial.

QUESTION: How much are the reductions in pain intensity and improvements in physical function from Pilates exercise mediated by changes in pain catastrophising and kinesiophobia? DESIGN: This was a secondary causal mediation analysis of a four-arm randomised controlled trial testing Pilates exercise dosage (once, twice or thrice per week) against a booklet control. PARTICIPANTS: Two hundred and fifty-five people with chronic low back pain. DATA ANALYSIS: All analyses were conducted in R software (version 4.1.2) following a preregistered analysis plan. A directed acyclic graph was constructed to identify potential pre-treatment mediator-outcome confounders. For each mediator model, we estimated the intervention-mediator effect, the mediator-outcome effect, the total natural indirect effect (TNIE), the pure natural direct effect (PNDE), and the total effect (TE). RESULTS: Pain catastrophising mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.21, 95% CI -0.47 to -0.03) and physical function (TNIE MD -0.64, 95% CI -1.20 to -0.18). Kinesiophobia mediated the effect of Pilates exercise compared with control on the outcomes pain intensity (TNIE MD -0.31, 95% CI -0.68 to -0.02) and physical function (TNIE MD -1.06, 95% CI -1.70 to -0.49). The proportion mediated by each mediator was moderate (21 to 55%). CONCLUSION: Reductions in pain catastrophising and kinesiophobia partially mediated the pathway to improved pain intensity and physical function when using Pilates exercise for chronic low back pain. These psychological components may be important treatment targets for clinicians and researchers to consider when prescribing exercise for chronic low back pain.

Commentary: collaborative systematic review may produce and share high-quality, comparative evidence more efficiently.

Systematic reviews are necessary to synthesize available evidence and inform clinical practice and health policy decisions. There has been an explosion of evidence available in many fields; this makes it challenging to keep evidence syntheses up to date and useful. Comparative effectiveness systematic reviews are informative; however, producing these often-large reviews bring intense time and resource demands. This commentary describes the implementation of a systematic review using a collaborative model of evidence synthesis. We are implementing the collaborative review model to update a large Cochrane review investigating the efficacy and comparative effectiveness of the design, delivery, and type of exercise treatment for people with chronic low-back pain. Three key benefits of the collaborative review model for evidence synthesis are (1) team coordination and collaboration, (2) quality control measures, and (3) advanced comparative and other analyses. This new collaborative review model is developed and implemented to produce and share high-quality, comparative evidence more efficiently while building capacity and community within a research field.

Does motor control training improve pain and function in adults with symptomatic lumbar disc herniation? A systematic review and meta-analysis of 861 subjects in 16 trials.

OBJECTIVE: To evaluate the effectiveness of motor control training (MCT) compared with other physical therapist-led interventions, minimal/no intervention or surgery in patients with symptomatic lumbar disc herniation (LDH). DESIGN: Systematic review and meta-analysis. DATA SOURCES: Eight databases and the ClinicalTrials.gov were searched from inception to April 2021. ELIGIBILITY CRITERIA: We included clinical trial studies with concurrent comparison groups which examined the effectiveness of MCT in patients with symptomatic LDH. Primary outcomes were pain intensity and functional status which were expressed as mean difference (MD) and standardised mean difference (SMD), respectively. RESULTS: We screened 6695 articles, of which 16 clinical trials (861 participants) were eligible. Fourteen studies were judged to have high risk of bias and two studies had some risk of bias. In patients who did not undergo surgery, MCT resulted in clinically meaningful pain reduction compared with other physical therapist-led interventions (ie, transcutaneous electrical nerve stimulation (TENS)) at short-term (MD -28.85, -40.04 to -17.66, n=69, studies=2). However, the robustness of the finding was poor. For functional status, a large and statistically significant treatment effect was found in favour of MCT compared with traditional/classic general exercises at long-term (SMD -0.83 to -1.35 to -0.31, n=63, studies=1) and other physical therapist-led interventions (ie, TENS) at short-term (SMD -1.43 to -2.41 to -0.46, n=69, studies=2). No studies compared MCT with surgery. In patients who had undergone surgery, large SMDs were seen. In favour of MCT compared with traditional/classic general exercises (SMD -0.95 to -1.32 to -0.58, n=124, studies=3), other physical therapist-led interventions (ie, conventional treatments; SMD -2.30 to -2.96 to -1.64, n=60, studies=1), and minimal intervention (SMD -1.34 to -1.87 to -0.81, n=68, studies=2) for functional improvement at short-term. The overall certainty of evidence was very low to low. CONCLUSION: At short-term, MCT improved pain and function compared with TENS in patients with symptomatic LDH who did not have surgery. MCT improved function compared with traditional/classic general exercises at long-term in patients who had undergone surgery. However, the results should be interpreted with caution because of the high risk of bias in the majority of studies. PROSPERO REGISTRATION NUMBER: CRD42016038166.

Expectations for Return to Work Predict Return to Work in Workers with Low Back Pain: An Individual Participant Data (IPD) Meta-Analysis.

Purpose Low back pain is associated with disability and lost productivity due to inability of workers to return to work. Personal recovery expectation beliefs may be associated with return to work outcomes in those with low back pain at high risk for chronic disability. We aimed to (1) assess whether workers' expectations for return to work, following a low back pain episode, are associated with subsequent return to work; and (2) explore the relationships between return to work expectations and other prognostic factors in their association with work outcomes.Methods We conducted an Individual Participant Data (IPD) meta-analysis using data from five prospective cohort studies identified by a Cochrane prognostic factor review. A one-stage IPD meta-analysis approach was applied. Multi-level mixed effects models were used to determine the unadjusted and adjusted associations between expectations and return to work (logistic regression) and time to return to work (parametric survival models with Weibull distribution).Results The final dataset included 2302 participants. Positive expectations for return to work were associated with return to work at follow-up in both unadjusted (Odds Ratio (OR) 2.95; 95% Confidence Interval (CI) 2.21, 3.95) (n = 2071) and comprehensively adjusted (OR 2.01; 95% CI 1.46, 2.77) (n = 1109) models. Similar findings were identified for shorter length of time to return to work in both unadjusted (HR 2.40; 95% CI 2.09, 2.75) (n = 1156) and minimally adjusted (HR 2.43; 95% CI 2.12, 2.79) (n = 1154) models.Conclusions Results suggest workers with low expectations for return to work are at increased risk for long-term work disability.

Low Back Pain in a Nova Scotian Emergency Department: Prevalence and Patient Characteristics in the Older Adult Patient Population.

Low back pain is a major cause of disability in older adults, and results in many emergency department visits each year. Characteristics of the older back pain population are largely unknown. We conducted a retrospective study to examine the prevalence and patient characteristics for older (≥ 65 years of age) and younger (16-64 years of age) adults presenting with back pain. Study objectives were to describe the characteristics of older adults with back pain presenting to an emergency department and to identify age-group-based differences in management. Older adults were most commonly diagnosed with non-specific low back pain (49%). For older adults with this diagnosis, the length of stay was 2.1 times longer (p < 0.001), and odds of being admitted to the hospital were 5.1 times higher (p < 0.001) than for younger adults. Patterns of management are different for younger and older adults with low back pain; this information can be used to direct future resource planning.

Some types of exercise are more effective than others in people with chronic low back pain: a network meta-analysis.

QUESTION: What are the effects of specific types of exercise treatments on pain intensity and functional limitation outcomes for adults with chronic low back pain? DESIGN: Systematic review with network meta-analysis of randomised controlled trials. PARTICIPANTS: Adults with non-specific low back pain for ≥ 12 weeks. INTERVENTION: Exercise treatments prescribed or planned by a health professional that involved conducting specific activities, postures and/or movements with a goal to improve low back pain outcomes. OUTCOME MEASURES: Pain intensity (eg, visual analogue scale or numerical rating scale) and back-related functional limitations (eg, Roland Morris Disability Questionnaire or Oswestry Disability Index), each standardised to range from 0 to 100. RESULTS: This review included 217 randomised controlled trials with 20,969 participants and 507 treatment groups. Most exercise types were more effective than minimal treatment for pain and functional limitation outcomes. Network meta-analysis results were compatible with moderate to clinically important treatment effects for Pilates, McKenzie therapy, and functional restoration (pain only) and flexibility exercises (function only) compared with minimal treatment, other effective treatments and other exercise types. The estimated mean differences for these exercise types compared with minimal treatment ranged from -15 to -19 for pain and from -10 to -12 for functional limitation. CONCLUSION: This review found evidence that Pilates, McKenzie therapy and functional restoration were more effective than other types of exercise treatment for reducing pain intensity and functional limitations. Nevertheless, people with chronic low back pain should be encouraged to perform the exercise that they enjoy to promote adherence. REGISTRATION: DOI:10.1002/14651858.CD009790.